I.Intended Use
II.Warnings And Precautions
III.Principle Of Operation Of Ear Thermometer
IV.Product Description
V. How To Use The Ear Thermometer
VI.Setting Of The Ear Thermometer
VII.Technical Specications
VIII.Batteries
IX.Included In Delive
X.Cleaning and Disinfection
XI.Troubleshooting
XII.Signs And Symbols
XIII.EMC Declaration
XIV.Warranty/seice
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07
07
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16
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Contents
IV. Product Description VI. Setting Of The Ear ThermometerIII. Principle Of Operation Of
Ear Thermometer
I. Intended Use
II. Warnings And Precautions
02 03 0504 06 07 08 09 10
Instruction Manual
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ET101 ET102 ET103
PREHE AT
EAR
THERMOMETER
NOTE:
You must read this instruction manual completely before use and
follow all instructions. Keep the instructions for later use. You must
check the device functions according to this instruction manual
prior to each use and only use this device if it is in proper working
condition.
VII. Technical Specications
VIII. Batteries
IX. Included In Delive
X. Maintainance Of The Product
The Manufacturer Resees The Rightto Alter The Specica-
tions Of Theproduct Without Prior Notication.
Ear thermometer is intended to measure ear temperature of
people of all ages. It can be used by consumers in household
environment and doctor in clinic as reference.
All objects, solid, liquid or gas, emit energy by radiation. The
intensity of this energy depends on the temperature of the
object. The ear thermometer is therefore able to measure the
temperature of a person by the energy the person emits from
ear canal. The infrared sensor located at the front end of the
device collects the infrared radiation emitted from the ear
canal. The sensor conves the received infrared into electrical
signals and transmits them to the device chip. The device chip
calculates the human body temperature based on the
intensity and frequency of the infrared signal received by the
infrared sensor.
The goal of thermomet is to measure core body tempera-
ture which is the temperatures of the vital organs. Clinical
studies showed that the ear is an excellent site of temperature
measurement because the temperatures taked in ear can
sooner and accurately reect core body temperature’s
changes .
1) Hold down the batte cover with your ngers, gently push
down to open the batte compament, and open the batte
cover.
2) Follow the polarity label in the batte compament, place
the new batte into the compament and clamp it tightly.
During installation, pay attention to the polarity and do not
install it upside down.
3) Finally, replace the batte cover in its original state.
V. How To Use The Ear Thermometer
1.Install/replace batteries
Batte installation/replacing method is as follows:
memo number. Note:The rst set of data displayed is the
most recent temperature measurement data, while the other
31 sets of data are displayed in order of temperature
measurement from near to far. In memo mode, if no any
operation within 5 seconds, the device will return to standby
mode automatically.
Over temperature warning function
If the measured body temperature is higher than the set
value, the ear thermometer will have dierent beeps and
backlight prompts.
1. Batteries using attention
1). The product uses two AA batteries.
2). When the batte symbol “ ” appears on the screen and
ashes, it indicates that the batte is low and needs to be
replaced. theoretically it can be used continuously for about
300 times (test conditions: temperature: 25°C, relative
humidity of 65%RH, staing from power on, self-check,
measurement, and automatic shutdown). When the low
batte icon on the screen ashes “ ”, it indicates that the
batte is low and needs to be replaced.
3). If the ambient temperature is low, it will shoen the batte
life.
4). When using batteries other than alkaline batteries, the
usage frequency may be ve sho, so it is recommended to
use alkaline batteries.
5). The voltage of the rechargeable batte is unstable and
can aect measurement. It is recommended not to use it.
6). When not in use for a long time, it is recommended to
remove the batte to avoid batte leakage and damage to
the product.
2. Disposing of batteries
To protect environment, dispose of empty batteries at
appropriate collection sites according to national or local
regulations.
Ear Thermometer 1pc
Instruction Manual 1pc
Quick Reference Guide 1pc
Probe Cover 20pcs(1 box)
The ear thermometer is a multi-patient reusable device, and
the cleaning and disinfection instructions were validated,
please follow the instructions to cleaning/disinfect your
thermometer prior to use.
Cleaning:
1) Use a cotton swab moistened with hot water or neutral
detergent to throughout cleaning the casing of thermometer
and measuring probe to removal of stain or oil.
2) Visual inspection the thermometer after cleaning process,
ensure there is no soil or stain is seen. if the device is
determined not to be visually clean at the end of the cleaning
step, you should either repeat the relevant previous cleaning
steps or safely dispose of the device, so that a visibly soiled
device is not used again.
Disinfection:
1) Use an 75% ethyl alcohol swab or cotton swab moistened
with 75% ethyl alcohol to disinfect the thermometer casing
and the measuring probe about 30 seconds.
2) Repeat the above steps at least 3 times, then wipe suace
and probe d with a clean cloth, and wait about 1 minute for
ding after disinfection process.
Note:
XIII. EMC Declaration XIV. Warranty/seice
The ME EQUIPMENT or ME SYSTEM is suitable for home
healthcare and clinic environments.
Statement: The ear thermometer model ET101,ET102,ET103
was tested according to the recommendations of Technical
Repo IEC TR 60601-4-2: Medical electrical equipment – Pa
4-2: Guidance and interpretation – Electromagnetic
immunity; peormance of medical electrical equipment and
medical electrical systems.
Warning：Don’t near active HF surgical equipment and the
RF shielded room of an ME system for magnetic resonance
imaging, where the intensity of EM disturbances is high.
Warning： Use of this equipment adjacent to or stacked with
other equipment should be avoided because it could result in
improper operation. If such use is necessa, this equipment
and the other equipment should be obseed to verify that
they are operating normally.
Warning: Use of accessories, transducers and cables other
than those specied or provided by the manufacturer of this
equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.”
Warning：Poable RF communications equipment (including
peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any pa
of the equipment ET101,ET102,ET103, including cables
specied by the manufacturer. Otherwise, degradation of the
peormance of this equipment could result.
1，All necessa instructions for maintaining BASIC SAFETY
and ESSENTIAL PERFORMANCE with regard to electromag-
netic disturbances for the excepted seice life.
Poable and mobile RF communication equipment may
aect the peormance of the ET101,ET102,ET103, avoiding
strong electromagnetic inteerence when used, such as near
mobile phones, microwave ovens, etc.
2，Guidance and manufacturer’s declaration -electromag-
netic emissions and Immunity
Guidance and manufacturer’s declaration - electromag-
netic emissions and Immunity
XI. Troubleshooting
XII. Signs And Symbols
If you have problems while using your thermometer, please
refer to this guide to help resolve the problem. If the problem
persists, please contact our customer seice.
Notes on handling batteries
•If your skin or eyes come into contact with batte uid,
rinse the aected area with water and seek medical
assistance.
When the buzzer beeps, it indicates that the temperature
measurement is completed and the temperature value is
displayed on the display screen.
The screens and sound prompts for different temperature
values are as follows:
Attention: The temperature value from the last temperature
measurement is displayed in the lower right corner of the
display screen, making it easier to compare changes in body
temperature.
Reference:Herzog L.Phillips S.Addressing Concerns About
Fever Clinical Pediatrics 2011 50(5) 383‒390
Below the temperature measurement range (T<34.0 ℃):
Display LO, red backlight, 1 beep:
Above the temperature measurement range (T>43.0 ℃):
Display Hi, red backlight, 1 beep.
⑤After inserting the probe into the ear canal and aligning it
with the eardrum, short press the "switch/measure" button
to measure the temperature. During the temperature
measurement process, the screen scrolls to display "- ° C",
" - ° C" and " -° C".
⑥If you need to take the next
temperature measurement, please
remove the used probe cover and
replace the new one and repeat
step ⑤.
⑦If there is no operation for about 60 seconds after the
temperature measurement is completed, the ear thermome-
ter will automatically shut down. You can also press and hold
the "Switch/Measure" button for about 5 seconds to turn off
the device. When the device is turned off, the display screen
will flash OFF for a short time and then turn off.
In accordance with our policy of continual product
improvement, we reserve the right to make technical and
optical changes without notice.
Warranty and repair terms
Warranty: 18 months.
Please contact your dealer or the service center in case of a
claim under the warranty. If you have to return the unit,
please enclose a copy of your receipt and state what the
defect is.
The following warranty terms apply:
1. The warranty period for BERRCOM products is 18 months
from date of purchase. In case of a warranty claim, the date
of purchase has to be proven by means of the sales receipt or
invoice.
2. Defects in material or workmanship will be removed free
of charge within the warranty period.
3. Repairs under warranty do not extend the warranty period
either for the unit or for the replacement parts.
4. The following is excluded under the warranty:
a. All damage which has arisen due to improper treatment,
e.g. nonobservance of the user instructions.
b. All damage which is due to repairs or tampering by the
customer or unauthorised third parties.
c. Damage which has arisen during transport from the
manufacturer to the consumer or during transport to the
service centre.
d. Accessories which are subject to normal wear and tear.
5. Liability for direct or indirect consequential losses caused
by the unit are excluded even if the damage to the unit is
accepted as a warranty claim.
Disposal
It is required that you should not dispose of WEEE as
unsoed municipal waste and collect such WEEE separately.
In accordance with Directive 2012/19/EU and national
disposal regulations regarding old electrical and electronic
devices, please be advised that such items must be disposed
of in a special way within the European Union (EU) .
These regulations require the environmentally friendly
recycling/disposal of old electrical and electronic devices.
Such items must not be disposed of as domestic refuse. This
has been expressed using the icon of the “crossed out trash
can”.
The ear thermometer (Model: ET101,ET102,ET103) contains
batteries and recyclable electronic waste. To protect the
environment, do not dispose of it in household waste as
unsoed municipal waste, but collect separately and take it to
an appropriate local collection center.
The ear thermometer (Model:ET101,ET102,ET103) is
classied as small equipment (5th catego) according to
ANNEX IV of Directive 2012/19/EU.
Before disposing of your ear thermometer (Model:
ET101,ET102,ET103), please take away the batteries from ear
thermometer (Model: ET101,ET102,ET103) and dispose of the
batteries and ear thermometer (Model: ET101,ET102,ET103)
separately.
You can take away the batteries as follows:
＞＞Batte remove diagram
① Open the lid on the back of the device
② Remove the batteries.
Batteries represent a hazard to health and the environment!
Never open, damage, or swallow batteries or allow them to
pollute the environment. They may contain toxic, ecologically
hazardous heavy metals. The removed batteries shall be
disposed of at the point of sale or in the corresponding
containers provided at collection points by local public waste
authorities and treated according to 2006/66/EC.
The batteries and recyclable electronic waste shall be
disposed of in a separate waste container.
Packaging materials must be disposed of according to local
regulations. Consult the authorized collection points for more
information.
In Germany
For the recyclable electronic waste disposal, you can search
the authorized collection points at the following website:
https://www.ear-system.de/ear-verzeichnis/sam-
mel-und-ruecknahmestellen
For batteries, you can search the authorized collection points
at the following website:
https://www.ear-system.de/ear-verzeichnis/battghersteller#-
no-back
Search method: using your postcode or the name of the city
and state where you live to nd collection points near you.
Other countries
For count-specic information on disposal, contact your
local dealers or impoer.
ashes, it reminds you to put on the
probe cover.
To obtain accurate readings, clean
and new disposable probe cover
should be installed before each
measurement.
Inse the ear thermometer probe
into the probe cover box, then pull it
out to t the new probe cover.
Only use this ear thermometer once you have read and
understood the instruction for use.
Only use this ear thermometer for the specic purpose
described in the instruction manual. Any misuse will void the
warranty.
This ear thermometer may be used for professional
purposes or for personal home use.
Using this ear thermometer is no substitute for consulting a
doctor. Do not self-diagnose or self-medicate on the basis
of the measurements without consulting your doctor. In
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paicular, do not sta taking any new medication or
change the type and/or dosage of any existing medication
without prior approval.
This ear thermometer must be operated by adults, ensure
that children do not use this device unsupeised; some
pas are small enough to be a choking hazard or be
swallowed.
If this thermometer is stored condition that is out of its
using condition, please put it in operation place for at least
30 minutes before taking the measurement.
When the subject enters a warm room from a cold outdoor
environment and wets their ears by swimming or bathing,
the ear canal temperature will temporarily be lower than the
actual temperature. Please wait for 30 minutes before
taking the measurement.
When the subject's ears are covered by heat due to sleeping
on their side, wearing headphones or hearing aids, or long
hair covering, the ear canal temperature will temporarily be
higher than the actual temperature. Please wait for 30
minutes before taking the measurement.
The readings of the left and right ears may dier. When
obseing changes in body temperature, it is recommended
to collect the temperature of the same ear.
The measurement may result in measurement bias when the
subject takes medication that may increase or decrease
body temperature.
The subject may experience temperature uctuations after
engaging in activities such as intense exercise, cing, and
eating. It is recommended to maintain a quiet state for at
least 30 minutes before the measurement.
Dierent types and brands of temperature measurement
products do not have comparative value. It is recommended
that you use the same temperature measurement product
for multiple frequency obseations when obseing body
temperature, in order to better grasp changes in body
temperature.
People with ear diseases such as otitis externa and otitis
media should not use the ear thermometer.
It is recommended to measure about 3 times during
measurement, with a time inteal of 12s or more than 12s
between each measurement, recommend the maximum
temperature as measurement temperature.
Please check the batte level before use, as low batte
voltage may result in inaccurate measurement results.
If you nd that this product cannot achieve the claimed
peormance or if there is a change in product peormance,
please stop using it immediately and contact the manufac-
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turer for assistance in time.
To ensure an accurate measurement, this thermometer must
only be used indoors when the ambient temperature range
is between 10℃(50℉) and 40℃（104℉）.
Before measurement, please ensure that the probe is free
from small foreign objects (such as earwax, dandru,
droplets, dust, etc.). After measurement, please place it in a
storage box to protect the probe from di or damage.
When there is a lot of earwax in the ear canal of the subject
(especially young children), please clean the ear canal
before taking the measurement to avoid aecting the
accuracy.
The probe lens is the most vulnerable pa of this product,
so it must be carefully protected. Please do not touch or
blow the probe with your hands. After measuring, please
place the product in the storage box.
Before use, conrm whether the probe lens is diy. If it is
diy, clean it according to the following steps, otherwise it
may cause measurement errors:
(1) Gently wipe the probe with a cotton swab or soft cloth
dipped in 75% alcohol.
(2) D and let the device stand for 30 minutes before use.
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This ear thermometer should not be immersed in water or
directly exposed to sunlight to avoid product malfunctions.
This ear thermometer must be kept d and clean.
Please do not place this ear thermometer in an area with
electric shock to avoid product malfunction.
If any problems are found, please contact customer seice
and do not attempt to repair this product on your own. If
the original components are replaced with pas not
provided by the manufacturer, it may cause measurement
errors.
This ear thermometer is a measuring product. It is
recommended to check the accuracy of the product with a
manufacturer or a qualied third-pay organization at a
one-year inteal.
Please dispose of the waste and residue at the end of the
product's seice life in accordance with local laws and
regulations.
This ear thermometer expected seie life is 5 years.
Please use BERRCOM exclusive disposable probe cover
(model: PC001). If you use other brand’s probe cover, it may
result in inaccurate measurements. To purchase the
disposable probe cover, please contact your agent or
BERRCOM directly.
Do not use accessories, materials, etc. that are not specied
in this manual. Using accessories that are not provided or
specied by the manufacturer may result in the product not
achieving its intended use.
Before and after each use, the thermometer should be
cleaned according to the requirement of this manual to
avoid possible bacterial infections.
Do not expose this thermometer to extreme temperature
conditions of higher than 55℃(131℉) or lower than -20℃（
-4℉）.
Do not use this thermometer in relative humidity higher
than 85%RH.
Do not put this ear thermometer in the place with direct
sunlight, high temperature, high humidity, excessive dust, or
the place where it may contact with corrosive gas or liquid,
and do not use this product in the above environment.
Do not open up this thermometer. It contains small pas
which might be swallowed by children.
Remove the batteries if you do not wish to use the unit for
an extended period of time. Otherwise there is a danger
that the batteries may leak.
Keep the thermometer away from electromagnetic elds
produced by objects such as microwave ovens, arc welders
or induction heaters.
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Please keep this ear thermometer out of reach of children.
Forceful measurement by children may cause ear inju. If
the batte is accidentally swallowed, please contact a
doctor immediately.
Please store the ear thermometer according to its storage
conditions to avoid usage issues and measurement errors.
Please do not forcefully collide, fall, step on, or shake this
product to avoid product malfunction or measurement
deviation.
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Note: Do not use toilet paper or tissue to wipe.
Note: The reference body temperature for the ear thermome-
ter is oral temperature.
1、Guyton A C, Textbook of medical physiology, W.B.
Saunders, Philadelphia, 1996, p919;
eardrum
ear canal
1 2 3
4
5
6
7
8
9
① Probe cover (20 pcs/box)
② Storage box
③ Temperature sensing probe
④ Probe cover detector
⑤ Switch/Measure button
Symbols interpretation:
⑥ Batte cover
⑦ Display screen
⑧ Age selection button
⑨ Memo button
Batte
capacity
Measure
value
Probe notice
Age Groups
Unit
Memo
Last
measurement
value
Mute
AA 1.5V
2.Operate the device
The correct usage method is the key to measurement
accuracy, otherwise it may cause measurement errors. Due to
the high requirements of infrared
temperature measurement on the
surrounding environment, please
follow the prompts below for
operation.
① Take out the ear thermometer
from the storage box.
② Power on and self checking
Press the "Switch/Measure" button,
the ear thermometer will turn on
and sta self checking with a beep
sound. During self inspection, the
screen displays three full color icons.
If the following situations exist,
measurement cannot be suppoed:
1). Operating environment tempera-
ture too low or too high: Er1 is
displayed on the screen.
2). Low batte: The low batte icon
on the screen “ ” ashes to
indicate.
If the probe cover icon “ ” scrolls
Attention: If disposable probe cover is not installed, the ear
thermometer will not operate.
Attention: If the top of the disposable probe cover is found to
be damaged, they need to be replaced with new probe cover.
③ Select age groups
Press the age selection button“ ” to select the age range
of the tested object for temperature measurement. Press the
button to switch age groups.
④ Probe preheating
This product uses preheating temperature measurement
technology. Studies have shown that preheating the ear
thermometer for temperature measurement can avoid
cooling effects, improve temperature
measurement accuracy and comfort.
When the display screen shows
"00.0", it indicates that the preheat-
ing is completed and enters the test
state.
Note: This product defaults to the age range of the last
temperature measurement. If the age group of the tempera-
ture measurement object is dierent from the age group of
the last temperature measurement object, the age group
needs to be selected.
Above 36 months
0 ~ 3 months
3 ~ 36 months
Symbol
White backlight
1 beep
(Normal
temperature)
Orange
backlight
2 beeps
(Moderate fever)
Red backlight
3 beeps
(High fever)
Age
Groups
35.8°C ≤ T≤ 37.4°C
35.4°C ≤ T≤ 37.6°C 37.6°C <T≤ 38.5°C
37.7°C < T≤ 39.4°C
35.4°C ≤ T≤ 37.7°C
/ T
>
37.4°C
T
>
38.5°C
T
>
39.4°C
0 ~ 3
months
3 ~ 36
months
Above 36
months
Notice: The above steps are for use in
beep mode. If the ear thermometer
is in mute mode, the beep will turn
off, there will be mute icon “ ” on
the screen, and other prompts will
keep the same.
Attention: When measuring, the ear thermometer sensor
should be inserted into the ear canal and aligned withthe
eardrum. Otherwisr, the measured temperature will be lower
than the actual temperature.
The method of straightening the ear canal:
When measuring temperature, please fix the head of the
subject, gently pull the auricle, and horizontally insert the
probe into the ear canal and align it with the eardrum to fully
fill the ear canal. Specifically, the method of straightening
the ear canal is as follows:
36.8℃ Low measurement Low measurement
For children under 1
year old：gently pull
the auricle outward
and backward to
keep the ear canal as
straight as possible.
Children over 1 year
old and adults:
gently pullthe auricle
outward and upward
to keep it as straight
as possible.
This product can modify default settings parameters. Facto
settings have been made for dierent sales markets before
leaving the facto. It is recommended not to modify the
facto default values. If modication is necessa, please
follow the steps below.
Beep/mute mode
This product can be set to "beep mode" and "mute mode".
(Facto default is beep mode)
Setting method:
In standby mode, press and hold “Memo” button for 5
seconds, then enter beep/mute mode. And keep to hold the
“Memo” button, the screen will display two modes of with
or without mute symbol “ ” in sequence, each mode will
display about 3 seconds. Release the button when your
desired mode is displayed, then the save the mode and return
to standby mode.
Attention:
1．After each resta, the product is in beep mode；
2. When the device is turned on without wearing probe cover,
beep/mute mode conversion cannot be peormed.
Unit conversion
This product can be set to Fahrenheit (° F) and Celsius (° C).
(Facto default is Celsius)
Setting method:
In standby mode, press and hold the "Age selection" button
for 5 seconds, and the screen will display "° C" and "° F" in
sequence until the desired unit is displayed. Release the "Age
selection" button to complete the unit conversion and return
to full display standby mode.
Attention:
1. Maintain the settings before shutting down after each
resta;
2. When the device is turned on without wearing probe cover,
unit conversion cannot be peormed.
Memo que
This ear thermometer can remember the last 32 sets of body
temperature readings, making it easy to que historical
temperature data.
Setting method:
In standby mode, press the "Memo" button to enter memo
mode. In memo mode, pressing the “Memo” button, the
screen will display “M” and memo number, release the
button, the screen will display temperature data of the
Operational principle Infrared radiation detection
Audible Indicator Yes
Use of Probe Covers Ye s
Unit size Approx. 146×37×37mm (L x W x H)
Trade mark
Do not re-use
Manufacturer
Serial number
Please read the instructions carefully.
Applied pa, Type BF
Direct current
Date of manufacture
Made in China
Unique device identier
Medical device
Use-by date
Model number
Unit weight
(include batte)
Approx. 133g
( Without storage box)
Expected Seice Life 5 years
Applied pa Sensor; Type BF
IP Class IP22
Normal using
condition
Ambient temperature:10°C~40°C(50°F~104°F)
Relative humidity: ≤85%RH
Pressure altitude: 700hPa~1060hPa
Storage and
shipping condition
Essential
Peormance
Ambient temperature:-20°C~55°C(-4°F~131°F)
Relative humidity: ≤95%RH
Pressure altitude: 700hPa to 1060hPa
1.In normal using condition
10°C~40°C (50°F~104°F),
LABORATORY ACCURACY meet:
34.0°C~ 34.9°C(93.2°F~94.8°F):±0.3°C(±0.6°F)
35.0°C~ 42.0°C(95°F~107.6°F):±0.2°C(±0.4°F)
42.1°C~ 43.0°C(107.8°F~109.4°F):±0.3°C(±0.6°F)
2.OUTPUT TEMPERATURE
Display “Hi” when measuring temperature
above 43.0°C (109.4°F) and display “Lo” when
measuring temperature lower than 34.0°C
(93.2°F).
Adjusted mode
Oral
People of all ages
Ear
34.0°C~43.0°C (93.2°F~109.4°F)
≤ ±0.2°C/0.4°F
DC 3V (2pcs AA d batteries)
Approx. 3.5 seconds
LCD screen
0.1°C (0.1°F)
Approx. 60±10 seconds
34.0°C~ 34.9°C(93.2°F~94.8°F): ±0.3°C(±0.6°F)
35.0°C~ 42.0°C(95°F~107.6°F): ±0.2°C(±0.4°F)
42.1°C~ 43.0°C(107.8°F~109.4°F): ±0.3°C(±0.6°F)
OTC
Mode of operation
Patient population
RX/OTC Use
Measurement site
Measuring range
Accuracy
Clinical repeatability
Batteries
Measurement time
Display mode
Display resolution
Automatic power-o
32 sets Memo
Measurement
reference body site
Chocking hazard!
Small children may swallow and choke on batteries. Store
batteries out of the reach of small children.
•If a batte has leaked, put on protective gloves and clean
the batte compament with a d cloth.
•Protect batteries form excessive heat.
Risk of explosion! Do not throw batteries into a re.
•Use identical or equivalent batte types only.
•Always replace all batteries at the same time.
•Do not use rechargeable batteries.
•Do not disassemble, split or crush the batteries.
Ensure that no liquid enters the interior of the thermometer.
Never use abrasive cleaning agents, thinners or benzene for
cleaning and never immerse the Thermometer in water or
other cleaning liquids.
Take care not to scratch the suace of the probe lens and
the display.
If the visual inspection identies unacceptable deterioration
such as corrosion, discoloration, pitting, cracked, then the
device should be stop to use and discard.
If the thermometer is been used for between patients,
please visually inspect the thermometer to determine if
there is stain or oil on the casing or probe after each use,
and follow the instruction of cleaning and disinfection to
cleaning your thermometer.
•
•
•
•
•
GUANGZHOU BERRCOM MEDICAL DEVICE CO., LTD EXPRESSLY
DISCLAIMS ALL WARRANTIES OF MERCHANTABILITY AND
FITNESS FOR A PARTICULAR PURPOSE.
UNDER ON CIRCUMSTANCES SHALL BERRCOM HAVE ANY
OBLIGATION OR LIABILITY FOR ANY LOSS OF PROFIT OR FOR
ANY CONSEQUENTIAL, INCIDENTAL INDIRECT, SPECIAL,
PUNITIVE, OR CONTINGENT DAMAGES WHATSOEVER WITH
RESPECT TO CLAIMS MADE BY ANY CUSTOMER, CONSUMER OR
OTHER USER OF BERRCOM PRODUCTS.
IN THE EVENT THAT ANY APPLICABLE LAWS IMPOSE WARRAN-
TIES, CONDITIONS, OR OBLIGATIONS THAT CANNOT BE
EXCLUDED OR MODIFIED, THIS PARAGRAPH SHALL APPLY TO
THE GREATEST EXTENT ALLOWED BY SUCH LAWS.
•
•
•
Screen
message
Description
No display
Possible causes Solutions
Symbol Description of symbol
Symbol Symbol Description of symbol
Description of symbol
1. System error;
2. The batte is
completely power
o
Attention: If the above measures still cannot solve the problem, please
contact customer seice.
Batte
symbol
ashing, can
not measure
temperature
Batte
symbol
display, last
batte level
ashing.
Probe cover
symbol icker
in an
animated
style
Display Er1
Display“Hi”
or“Lo”
1. Not installing
probe cover,
2. The probe cover
is not properly
installed.
The current
ambient
temperature is too
low or too high,
which is not within
the operating range
specied in the
manual and cannot
be measured.
Place the product at
normal room
temperature (10 ° C to
40 ° C) or wait for a
period of time.
1. Check if the probe lens
is diy. Please clean the
probe lens and operate
again.
2. Please ask the subject
to maintain a stable
posture and measure
again according to the
correct operating method.
3. Place the product at
normal room temperature
(10 ° C to 40 ° C) and wait
for 30 minutes.
1.The measured
temperature exceeds
the measurement
range (34.0℃ to
43.0℃).
2.Unable to collect
stable temperature
values (the
environmental
temperature changes
too quickly and the
product has not yet
reached a stable state).
1. Install probe cover;
2. Remove the probe
cover and reinstall.
The current
batte level is too
low to peorm
temperature
measurement
The current
batte level is to
low, but still
operate correctly
Suggest replacing new
batteries as soon as
possible.
Replace new batteries.
1. Turn o and then
resta;
2. Remove the batte
and replace it or replace
it with a new one;
3. Please contact your
local dealer or customer
seice.
18
Guidance and manufacturer’s declaration - electromagnetic emissions
Indicates the need for the user to consult the instructions
for use for crucial cautiona information such as
warnings and precautions that can not, for a variety of
reasons, be presented on the medical device itself.
Degree of protection against harmful ingress of water
and paiculate matter
2 Protected and against solid foreign objects of 12.5mm
Φ and greater
2 Protection against veically falling water drops when
ENCLOSURE titled up to 15°
DISPOSAL: Do not dispose of this product as unsoed
municipal waste. Collection of such waste separately for
special treatment is necessa.
The CE labelling ceies that the product complies with
the essential requirements of EU regulations on medical
device.
Symbol of European Authorized Representative,
expressly indicate the name and address of European
Authorized Representative after the symbol.
CN
Impoer
(Just for Probe
Cover)
Table 1
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 2
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 3
Emissions test
Immunity Test Compliance level
IEC 60601-1-2
Test level
Harmonic emissions IEC 61000-3-2
RF emissions CISPR 11
RF emissions CISPR 11
Radiated RF
IEC61000-4-3
(Test
specications
for ENCLOSURE
PORT IMMUNITY
to RF wireless
communications
equipment)
Radiated RF
IEC61000-4-39
(Test
specications
for ENCLOSURE
PORT IMMUNITY
to proximity
magnetic elds)
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast transient
/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
±8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 kV air
Not applicable Not applicable
Radiated RF
IEC61000-4-3
10 V/m
80 MHz – 2,7 GHz
80 % AM at 2 Hz
10 V/m
80 MHz – 2,7 GHz
80 % AM at 2 Hz
Not applicable Not applicable
Conducted RF
IEC61000-4-6
Not applicable Not applicable
Not applicable
30 A/m
50Hz/60Hz
30 A/m
50Hz/60Hz
Not applicable
±8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 kV air
Group 1
Group B
Not applicable
Not applicable
Voltage uctuations/ icker emissions
IEC 61000-3-3
Compliance
Voltage dips, sho
interruptions and
voltage variations on
power supply input lines
IEC 61000-4-11
Power frequency
magnetic eld
IEC 61000-4-8
NOTE U
T is the a.c. mians voltage prior to application of the test
level.
Tes t
Frequency
(MHz)
Band
(MHz)
Seice Modulation
IEC
60601-1-2
Test Level
(V/m)
Compli-
ance
level
(V/m)
Tes t
Frequency
Modulation
IEC 60601-1-2
Test Level
(A/m)
Compliance
level
(A/m)
Pulse
modulation
18 Hz
Pulse
modulation
217 Hz
Pulse
modulation
18 Hz
FM ± 5 kHz
deviation
1 kHz sine
385 27 27
28 28
9 9
28 28
28 28
28 28
9 9
380
–390
TETRA 400
GMRS 460,
FRS 460
LTE Band 13,
17
WLAN
802.11
a/n
GSM
800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
430
–470
704
–787
800
–960
450
710
745
780
5240
30 kHz
134,2 kHz
13,56 MHz
CW
Pulse
modulation
2.1 kHz
Pulse
modulation
50 kHz
8 8
65 65
7,5 7,5
5500
5785
810
870
930
Pulse
modulation
217 Hz
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS
1700
–
1990
1720
1845
Pulse
modulation
217 Hz
Pulse
modulation
217 Hz
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
2400
–
2570
5100
–
5800
2450
1970
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 4
AA 1.5V
1
I.Intended Use
II.Warnings And Precautions
III.Principle Of Operation Of Ear Thermometer
IV.Product Description
V. How To Use The Ear Thermometer
VI.Setting Of The Ear Thermometer
VII.Technical Specications
VIII.Batteries
IX.Included In Delive
X.Cleaning and Disinfection
XI.Troubleshooting
XII.Signs And Symbols
XIII.EMC Declaration
XIV.Warranty/seice
02
02
06
07
07
05
13
15
16
16
17
18
19
22
Contents
IV. Product Description VI. Setting Of The Ear ThermometerIII. Principle Of Operation Of
Ear Thermometer
I. Intended Use
II. Warnings And Precautions
02 03 0504 06 07 08 09 10
Instruction Manual
0
m
o
n
t
h
s
+
11 12
13
14 15 16 17 19 20 21 22 23 24
ET101 ET102 ET103
PREHE AT
EAR
THERMOMETER
NOTE:
You must read this instruction manual completely before use and
follow all instructions. Keep the instructions for later use. You must
check the device functions according to this instruction manual
prior to each use and only use this device if it is in proper working
condition.
VII. Technical Specications
VIII. Batteries
IX. Included In Delive
X. Maintainance Of The Product
The Manufacturer Resees The Rightto Alter The Specica-
tions Of Theproduct Without Prior Notication.
Ear thermometer is intended to measure ear temperature of
people of all ages. It can be used by consumers in household
environment and doctor in clinic as reference.
All objects, solid, liquid or gas, emit energy by radiation. The
intensity of this energy depends on the temperature of the
object. The ear thermometer is therefore able to measure the
temperature of a person by the energy the person emits from
ear canal. The infrared sensor located at the front end of the
device collects the infrared radiation emitted from the ear
canal. The sensor conves the received infrared into electrical
signals and transmits them to the device chip. The device chip
calculates the human body temperature based on the
intensity and frequency of the infrared signal received by the
infrared sensor.
The goal of thermomet is to measure core body tempera-
ture which is the temperatures of the vital organs. Clinical
studies showed that the ear is an excellent site of temperature
measurement because the temperatures taked in ear can
sooner and accurately reect core body temperature’s
changes .
1) Hold down the batte cover with your ngers, gently push
down to open the batte compament, and open the batte
cover.
2) Follow the polarity label in the batte compament, place
the new batte into the compament and clamp it tightly.
During installation, pay attention to the polarity and do not
install it upside down.
3) Finally, replace the batte cover in its original state.
V. How To Use The Ear Thermometer
1.Install/replace batteries
Batte installation/replacing method is as follows:
memo number. Note:The rst set of data displayed is the
most recent temperature measurement data, while the other
31 sets of data are displayed in order of temperature
measurement from near to far. In memo mode, if no any
operation within 5 seconds, the device will return to standby
mode automatically.
Over temperature warning function
If the measured body temperature is higher than the set
value, the ear thermometer will have dierent beeps and
backlight prompts.
1. Batteries using attention
1). The product uses two AA batteries.
2). When the batte symbol “ ” appears on the screen and
ashes, it indicates that the batte is low and needs to be
replaced. theoretically it can be used continuously for about
300 times (test conditions: temperature: 25°C, relative
humidity of 65%RH, staing from power on, self-check,
measurement, and automatic shutdown). When the low
batte icon on the screen ashes “ ”, it indicates that the
batte is low and needs to be replaced.
3). If the ambient temperature is low, it will shoen the batte
life.
4). When using batteries other than alkaline batteries, the
usage frequency may be ve sho, so it is recommended to
use alkaline batteries.
5). The voltage of the rechargeable batte is unstable and
can aect measurement. It is recommended not to use it.
6). When not in use for a long time, it is recommended to
remove the batte to avoid batte leakage and damage to
the product.
2. Disposing of batteries
To protect environment, dispose of empty batteries at
appropriate collection sites according to national or local
regulations.
Ear Thermometer 1pc
Instruction Manual 1pc
Quick Reference Guide 1pc
Probe Cover 20pcs(1 box)
The ear thermometer is a multi-patient reusable device, and
the cleaning and disinfection instructions were validated,
please follow the instructions to cleaning/disinfect your
thermometer prior to use.
Cleaning:
1) Use a cotton swab moistened with hot water or neutral
detergent to throughout cleaning the casing of thermometer
and measuring probe to removal of stain or oil.
2) Visual inspection the thermometer after cleaning process,
ensure there is no soil or stain is seen. if the device is
determined not to be visually clean at the end of the cleaning
step, you should either repeat the relevant previous cleaning
steps or safely dispose of the device, so that a visibly soiled
device is not used again.
Disinfection:
1) Use an 75% ethyl alcohol swab or cotton swab moistened
with 75% ethyl alcohol to disinfect the thermometer casing
and the measuring probe about 30 seconds.
2) Repeat the above steps at least 3 times, then wipe suace
and probe d with a clean cloth, and wait about 1 minute for
ding after disinfection process.
Note:
XIII. EMC Declaration XIV. Warranty/seice
The ME EQUIPMENT or ME SYSTEM is suitable for home
healthcare and clinic environments.
Statement: The ear thermometer model ET101,ET102,ET103
was tested according to the recommendations of Technical
Repo IEC TR 60601-4-2: Medical electrical equipment – Pa
4-2: Guidance and interpretation – Electromagnetic
immunity; peormance of medical electrical equipment and
medical electrical systems.
Warning：Don’t near active HF surgical equipment and the
RF shielded room of an ME system for magnetic resonance
imaging, where the intensity of EM disturbances is high.
Warning： Use of this equipment adjacent to or stacked with
other equipment should be avoided because it could result in
improper operation. If such use is necessa, this equipment
and the other equipment should be obseed to verify that
they are operating normally.
Warning: Use of accessories, transducers and cables other
than those specied or provided by the manufacturer of this
equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.”
Warning：Poable RF communications equipment (including
peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any pa
of the equipment ET101,ET102,ET103, including cables
specied by the manufacturer. Otherwise, degradation of the
peormance of this equipment could result.
1，All necessa instructions for maintaining BASIC SAFETY
and ESSENTIAL PERFORMANCE with regard to electromag-
netic disturbances for the excepted seice life.
Poable and mobile RF communication equipment may
aect the peormance of the ET101,ET102,ET103, avoiding
strong electromagnetic inteerence when used, such as near
mobile phones, microwave ovens, etc.
2，Guidance and manufacturer’s declaration -electromag-
netic emissions and Immunity
Guidance and manufacturer’s declaration - electromag-
netic emissions and Immunity
XI. Troubleshooting
XII. Signs And Symbols
If you have problems while using your thermometer, please
refer to this guide to help resolve the problem. If the problem
persists, please contact our customer seice.
Notes on handling batteries
•If your skin or eyes come into contact with batte uid,
rinse the aected area with water and seek medical
assistance.
When the buzzer beeps, it indicates that the temperature
measurement is completed and the temperature value is
displayed on the display screen.
The screens and sound prompts for different temperature
values are as follows:
Attention: The temperature value from the last temperature
measurement is displayed in the lower right corner of the
display screen, making it easier to compare changes in body
temperature.
Reference:Herzog L.Phillips S.Addressing Concerns About
Fever Clinical Pediatrics 2011 50(5) 383‒390
Below the temperature measurement range (T<34.0 ℃):
Display LO, red backlight, 1 beep:
Above the temperature measurement range (T>43.0 ℃):
Display Hi, red backlight, 1 beep.
⑤After inserting the probe into the ear canal and aligning it
with the eardrum, short press the "switch/measure" button
to measure the temperature. During the temperature
measurement process, the screen scrolls to display "- ° C",
" - ° C" and " -° C".
⑥If you need to take the next
temperature measurement, please
remove the used probe cover and
replace the new one and repeat
step ⑤.
⑦If there is no operation for about 60 seconds after the
temperature measurement is completed, the ear thermome-
ter will automatically shut down. You can also press and hold
the "Switch/Measure" button for about 5 seconds to turn off
the device. When the device is turned off, the display screen
will flash OFF for a short time and then turn off.
In accordance with our policy of continual product
improvement, we reserve the right to make technical and
optical changes without notice.
Warranty and repair terms
Warranty: 18 months.
Please contact your dealer or the service center in case of a
claim under the warranty. If you have to return the unit,
please enclose a copy of your receipt and state what the
defect is.
The following warranty terms apply:
1. The warranty period for BERRCOM products is 18 months
from date of purchase. In case of a warranty claim, the date
of purchase has to be proven by means of the sales receipt or
invoice.
2. Defects in material or workmanship will be removed free
of charge within the warranty period.
3. Repairs under warranty do not extend the warranty period
either for the unit or for the replacement parts.
4. The following is excluded under the warranty:
a. All damage which has arisen due to improper treatment,
e.g. nonobservance of the user instructions.
b. All damage which is due to repairs or tampering by the
customer or unauthorised third parties.
c. Damage which has arisen during transport from the
manufacturer to the consumer or during transport to the
service centre.
d. Accessories which are subject to normal wear and tear.
5. Liability for direct or indirect consequential losses caused
by the unit are excluded even if the damage to the unit is
accepted as a warranty claim.
Disposal
It is required that you should not dispose of WEEE as
unsoed municipal waste and collect such WEEE separately.
In accordance with Directive 2012/19/EU and national
disposal regulations regarding old electrical and electronic
devices, please be advised that such items must be disposed
of in a special way within the European Union (EU) .
These regulations require the environmentally friendly
recycling/disposal of old electrical and electronic devices.
Such items must not be disposed of as domestic refuse. This
has been expressed using the icon of the “crossed out trash
can”.
The ear thermometer (Model: ET101,ET102,ET103) contains
batteries and recyclable electronic waste. To protect the
environment, do not dispose of it in household waste as
unsoed municipal waste, but collect separately and take it to
an appropriate local collection center.
The ear thermometer (Model:ET101,ET102,ET103) is
classied as small equipment (5th catego) according to
ANNEX IV of Directive 2012/19/EU.
Before disposing of your ear thermometer (Model:
ET101,ET102,ET103), please take away the batteries from ear
thermometer (Model: ET101,ET102,ET103) and dispose of the
batteries and ear thermometer (Model: ET101,ET102,ET103)
separately.
You can take away the batteries as follows:
＞＞Batte remove diagram
① Open the lid on the back of the device
② Remove the batteries.
Batteries represent a hazard to health and the environment!
Never open, damage, or swallow batteries or allow them to
pollute the environment. They may contain toxic, ecologically
hazardous heavy metals. The removed batteries shall be
disposed of at the point of sale or in the corresponding
containers provided at collection points by local public waste
authorities and treated according to 2006/66/EC.
The batteries and recyclable electronic waste shall be
disposed of in a separate waste container.
Packaging materials must be disposed of according to local
regulations. Consult the authorized collection points for more
information.
In Germany
For the recyclable electronic waste disposal, you can search
the authorized collection points at the following website:
https://www.ear-system.de/ear-verzeichnis/sam-
mel-und-ruecknahmestellen
For batteries, you can search the authorized collection points
at the following website:
https://www.ear-system.de/ear-verzeichnis/battghersteller#-
no-back
Search method: using your postcode or the name of the city
and state where you live to nd collection points near you.
Other countries
For count-specic information on disposal, contact your
local dealers or impoer.
ashes, it reminds you to put on the
probe cover.
To obtain accurate readings, clean
and new disposable probe cover
should be installed before each
measurement.
Inse the ear thermometer probe
into the probe cover box, then pull it
out to t the new probe cover.
Only use this ear thermometer once you have read and
understood the instruction for use.
Only use this ear thermometer for the specic purpose
described in the instruction manual. Any misuse will void the
warranty.
This ear thermometer may be used for professional
purposes or for personal home use.
Using this ear thermometer is no substitute for consulting a
doctor. Do not self-diagnose or self-medicate on the basis
of the measurements without consulting your doctor. In
·
·
·
·
paicular, do not sta taking any new medication or
change the type and/or dosage of any existing medication
without prior approval.
This ear thermometer must be operated by adults, ensure
that children do not use this device unsupeised; some
pas are small enough to be a choking hazard or be
swallowed.
If this thermometer is stored condition that is out of its
using condition, please put it in operation place for at least
30 minutes before taking the measurement.
When the subject enters a warm room from a cold outdoor
environment and wets their ears by swimming or bathing,
the ear canal temperature will temporarily be lower than the
actual temperature. Please wait for 30 minutes before
taking the measurement.
When the subject's ears are covered by heat due to sleeping
on their side, wearing headphones or hearing aids, or long
hair covering, the ear canal temperature will temporarily be
higher than the actual temperature. Please wait for 30
minutes before taking the measurement.
The readings of the left and right ears may dier. When
obseing changes in body temperature, it is recommended
to collect the temperature of the same ear.
The measurement may result in measurement bias when the
subject takes medication that may increase or decrease
body temperature.
The subject may experience temperature uctuations after
engaging in activities such as intense exercise, cing, and
eating. It is recommended to maintain a quiet state for at
least 30 minutes before the measurement.
Dierent types and brands of temperature measurement
products do not have comparative value. It is recommended
that you use the same temperature measurement product
for multiple frequency obseations when obseing body
temperature, in order to better grasp changes in body
temperature.
People with ear diseases such as otitis externa and otitis
media should not use the ear thermometer.
It is recommended to measure about 3 times during
measurement, with a time inteal of 12s or more than 12s
between each measurement, recommend the maximum
temperature as measurement temperature.
Please check the batte level before use, as low batte
voltage may result in inaccurate measurement results.
If you nd that this product cannot achieve the claimed
peormance or if there is a change in product peormance,
please stop using it immediately and contact the manufac-
·
·
·
·
·
·
·
·
·
·
·
·
turer for assistance in time.
To ensure an accurate measurement, this thermometer must
only be used indoors when the ambient temperature range
is between 10℃(50℉) and 40℃（104℉）.
Before measurement, please ensure that the probe is free
from small foreign objects (such as earwax, dandru,
droplets, dust, etc.). After measurement, please place it in a
storage box to protect the probe from di or damage.
When there is a lot of earwax in the ear canal of the subject
(especially young children), please clean the ear canal
before taking the measurement to avoid aecting the
accuracy.
The probe lens is the most vulnerable pa of this product,
so it must be carefully protected. Please do not touch or
blow the probe with your hands. After measuring, please
place the product in the storage box.
Before use, conrm whether the probe lens is diy. If it is
diy, clean it according to the following steps, otherwise it
may cause measurement errors:
(1) Gently wipe the probe with a cotton swab or soft cloth
dipped in 75% alcohol.
(2) D and let the device stand for 30 minutes before use.
·
·
·
·
·
This ear thermometer should not be immersed in water or
directly exposed to sunlight to avoid product malfunctions.
This ear thermometer must be kept d and clean.
Please do not place this ear thermometer in an area with
electric shock to avoid product malfunction.
If any problems are found, please contact customer seice
and do not attempt to repair this product on your own. If
the original components are replaced with pas not
provided by the manufacturer, it may cause measurement
errors.
This ear thermometer is a measuring product. It is
recommended to check the accuracy of the product with a
manufacturer or a qualied third-pay organization at a
one-year inteal.
Please dispose of the waste and residue at the end of the
product's seice life in accordance with local laws and
regulations.
This ear thermometer expected seie life is 5 years.
Please use BERRCOM exclusive disposable probe cover
(model: PC001). If you use other brand’s probe cover, it may
result in inaccurate measurements. To purchase the
disposable probe cover, please contact your agent or
BERRCOM directly.
Do not use accessories, materials, etc. that are not specied
in this manual. Using accessories that are not provided or
specied by the manufacturer may result in the product not
achieving its intended use.
Before and after each use, the thermometer should be
cleaned according to the requirement of this manual to
avoid possible bacterial infections.
Do not expose this thermometer to extreme temperature
conditions of higher than 55℃(131℉) or lower than -20℃（
-4℉）.
Do not use this thermometer in relative humidity higher
than 85%RH.
Do not put this ear thermometer in the place with direct
sunlight, high temperature, high humidity, excessive dust, or
the place where it may contact with corrosive gas or liquid,
and do not use this product in the above environment.
Do not open up this thermometer. It contains small pas
which might be swallowed by children.
Remove the batteries if you do not wish to use the unit for
an extended period of time. Otherwise there is a danger
that the batteries may leak.
Keep the thermometer away from electromagnetic elds
produced by objects such as microwave ovens, arc welders
or induction heaters.
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
Please keep this ear thermometer out of reach of children.
Forceful measurement by children may cause ear inju. If
the batte is accidentally swallowed, please contact a
doctor immediately.
Please store the ear thermometer according to its storage
conditions to avoid usage issues and measurement errors.
Please do not forcefully collide, fall, step on, or shake this
product to avoid product malfunction or measurement
deviation.
·
·
Note: Do not use toilet paper or tissue to wipe.
Note: The reference body temperature for the ear thermome-
ter is oral temperature.
1、Guyton A C, Textbook of medical physiology, W.B.
Saunders, Philadelphia, 1996, p919;
eardrum
ear canal
1 2 3
4
5
6
7
8
9
① Probe cover (20 pcs/box)
② Storage box
③ Temperature sensing probe
④ Probe cover detector
⑤ Switch/Measure button
Symbols interpretation:
⑥ Batte cover
⑦ Display screen
⑧ Age selection button
⑨ Memo button
Batte
capacity
Measure
value
Probe notice
Age Groups
Unit
Memo
Last
measurement
value
Mute
AA 1.5V
2.Operate the device
The correct usage method is the key to measurement
accuracy, otherwise it may cause measurement errors. Due to
the high requirements of infrared
temperature measurement on the
surrounding environment, please
follow the prompts below for
operation.
① Take out the ear thermometer
from the storage box.
② Power on and self checking
Press the "Switch/Measure" button,
the ear thermometer will turn on
and sta self checking with a beep
sound. During self inspection, the
screen displays three full color icons.
If the following situations exist,
measurement cannot be suppoed:
1). Operating environment tempera-
ture too low or too high: Er1 is
displayed on the screen.
2). Low batte: The low batte icon
on the screen “ ” ashes to
indicate.
If the probe cover icon “ ” scrolls
Attention: If disposable probe cover is not installed, the ear
thermometer will not operate.
Attention: If the top of the disposable probe cover is found to
be damaged, they need to be replaced with new probe cover.
③ Select age groups
Press the age selection button“ ” to select the age range
of the tested object for temperature measurement. Press the
button to switch age groups.
④ Probe preheating
This product uses preheating temperature measurement
technology. Studies have shown that preheating the ear
thermometer for temperature measurement can avoid
cooling effects, improve temperature
measurement accuracy and comfort.
When the display screen shows
"00.0", it indicates that the preheat-
ing is completed and enters the test
state.
Note: This product defaults to the age range of the last
temperature measurement. If the age group of the tempera-
ture measurement object is dierent from the age group of
the last temperature measurement object, the age group
needs to be selected.
Above 36 months
0 ~ 3 months
3 ~ 36 months
Symbol
White backlight
1 beep
(Normal
temperature)
Orange
backlight
2 beeps
(Moderate fever)
Red backlight
3 beeps
(High fever)
Age
Groups
35.8°C ≤ T≤ 37.4°C
35.4°C ≤ T≤ 37.6°C 37.6°C <T≤ 38.5°C
37.7°C < T≤ 39.4°C
35.4°C ≤ T≤ 37.7°C
/ T
>
37.4°C
T
>
38.5°C
T
>
39.4°C
0 ~ 3
months
3 ~ 36
months
Above 36
months
Notice: The above steps are for use in
beep mode. If the ear thermometer
is in mute mode, the beep will turn
off, there will be mute icon “ ” on
the screen, and other prompts will
keep the same.
Attention: When measuring, the ear thermometer sensor
should be inserted into the ear canal and aligned withthe
eardrum. Otherwisr, the measured temperature will be lower
than the actual temperature.
The method of straightening the ear canal:
When measuring temperature, please fix the head of the
subject, gently pull the auricle, and horizontally insert the
probe into the ear canal and align it with the eardrum to fully
fill the ear canal. Specifically, the method of straightening
the ear canal is as follows:
36.8℃ Low measurement Low measurement
For children under 1
year old：gently pull
the auricle outward
and backward to
keep the ear canal as
straight as possible.
Children over 1 year
old and adults:
gently pullthe auricle
outward and upward
to keep it as straight
as possible.
This product can modify default settings parameters. Facto
settings have been made for dierent sales markets before
leaving the facto. It is recommended not to modify the
facto default values. If modication is necessa, please
follow the steps below.
Beep/mute mode
This product can be set to "beep mode" and "mute mode".
(Facto default is beep mode)
Setting method:
In standby mode, press and hold “Memo” button for 5
seconds, then enter beep/mute mode. And keep to hold the
“Memo” button, the screen will display two modes of with
or without mute symbol “ ” in sequence, each mode will
display about 3 seconds. Release the button when your
desired mode is displayed, then the save the mode and return
to standby mode.
Attention:
1．After each resta, the product is in beep mode；
2. When the device is turned on without wearing probe cover,
beep/mute mode conversion cannot be peormed.
Unit conversion
This product can be set to Fahrenheit (° F) and Celsius (° C).
(Facto default is Celsius)
Setting method:
In standby mode, press and hold the "Age selection" button
for 5 seconds, and the screen will display "° C" and "° F" in
sequence until the desired unit is displayed. Release the "Age
selection" button to complete the unit conversion and return
to full display standby mode.
Attention:
1. Maintain the settings before shutting down after each
resta;
2. When the device is turned on without wearing probe cover,
unit conversion cannot be peormed.
Memo que
This ear thermometer can remember the last 32 sets of body
temperature readings, making it easy to que historical
temperature data.
Setting method:
In standby mode, press the "Memo" button to enter memo
mode. In memo mode, pressing the “Memo” button, the
screen will display “M” and memo number, release the
button, the screen will display temperature data of the
Operational principle Infrared radiation detection
Audible Indicator Yes
Use of Probe Covers Ye s
Unit size Approx. 146×37×37mm (L x W x H)
Trade mark
Do not re-use
Manufacturer
Serial number
Please read the instructions carefully.
Applied pa, Type BF
Direct current
Date of manufacture
Made in China
Unique device identier
Medical device
Use-by date
Model number
Unit weight
(include batte)
Approx. 133g
( Without storage box)
Expected Seice Life 5 years
Applied pa Sensor; Type BF
IP Class IP22
Normal using
condition
Ambient temperature:10°C~40°C(50°F~104°F)
Relative humidity: ≤85%RH
Pressure altitude: 700hPa~1060hPa
Storage and
shipping condition
Essential
Peormance
Ambient temperature:-20°C~55°C(-4°F~131°F)
Relative humidity: ≤95%RH
Pressure altitude: 700hPa to 1060hPa
1.In normal using condition
10°C~40°C (50°F~104°F),
LABORATORY ACCURACY meet:
34.0°C~ 34.9°C(93.2°F~94.8°F):±0.3°C(±0.6°F)
35.0°C~ 42.0°C(95°F~107.6°F):±0.2°C(±0.4°F)
42.1°C~ 43.0°C(107.8°F~109.4°F):±0.3°C(±0.6°F)
2.OUTPUT TEMPERATURE
Display “Hi” when measuring temperature
above 43.0°C (109.4°F) and display “Lo” when
measuring temperature lower than 34.0°C
(93.2°F).
Adjusted mode
Oral
People of all ages
Ear
34.0°C~43.0°C (93.2°F~109.4°F)
≤ ±0.2°C/0.4°F
DC 3V (2pcs AA d batteries)
Approx. 3.5 seconds
LCD screen
0.1°C (0.1°F)
Approx. 60±10 seconds
34.0°C~ 34.9°C(93.2°F~94.8°F): ±0.3°C(±0.6°F)
35.0°C~ 42.0°C(95°F~107.6°F): ±0.2°C(±0.4°F)
42.1°C~ 43.0°C(107.8°F~109.4°F): ±0.3°C(±0.6°F)
OTC
Mode of operation
Patient population
RX/OTC Use
Measurement site
Measuring range
Accuracy
Clinical repeatability
Batteries
Measurement time
Display mode
Display resolution
Automatic power-o
32 sets Memo
Measurement
reference body site
Chocking hazard!
Small children may swallow and choke on batteries. Store
batteries out of the reach of small children.
•If a batte has leaked, put on protective gloves and clean
the batte compament with a d cloth.
•Protect batteries form excessive heat.
Risk of explosion! Do not throw batteries into a re.
•Use identical or equivalent batte types only.
•Always replace all batteries at the same time.
•Do not use rechargeable batteries.
•Do not disassemble, split or crush the batteries.
Ensure that no liquid enters the interior of the thermometer.
Never use abrasive cleaning agents, thinners or benzene for
cleaning and never immerse the Thermometer in water or
other cleaning liquids.
Take care not to scratch the suace of the probe lens and
the display.
If the visual inspection identies unacceptable deterioration
such as corrosion, discoloration, pitting, cracked, then the
device should be stop to use and discard.
If the thermometer is been used for between patients,
please visually inspect the thermometer to determine if
there is stain or oil on the casing or probe after each use,
and follow the instruction of cleaning and disinfection to
cleaning your thermometer.
•
•
•
•
•
GUANGZHOU BERRCOM MEDICAL DEVICE CO., LTD EXPRESSLY
DISCLAIMS ALL WARRANTIES OF MERCHANTABILITY AND
FITNESS FOR A PARTICULAR PURPOSE.
UNDER ON CIRCUMSTANCES SHALL BERRCOM HAVE ANY
OBLIGATION OR LIABILITY FOR ANY LOSS OF PROFIT OR FOR
ANY CONSEQUENTIAL, INCIDENTAL INDIRECT, SPECIAL,
PUNITIVE, OR CONTINGENT DAMAGES WHATSOEVER WITH
RESPECT TO CLAIMS MADE BY ANY CUSTOMER, CONSUMER OR
OTHER USER OF BERRCOM PRODUCTS.
IN THE EVENT THAT ANY APPLICABLE LAWS IMPOSE WARRAN-
TIES, CONDITIONS, OR OBLIGATIONS THAT CANNOT BE
EXCLUDED OR MODIFIED, THIS PARAGRAPH SHALL APPLY TO
THE GREATEST EXTENT ALLOWED BY SUCH LAWS.
•
•
•
Screen
message
Description
No display
Possible causes Solutions
Symbol Description of symbol
Symbol Symbol Description of symbol
Description of symbol
1. System error;
2. The batte is
completely power
o
Attention: If the above measures still cannot solve the problem, please
contact customer seice.
Batte
symbol
ashing, can
not measure
temperature
Batte
symbol
display, last
batte level
ashing.
Probe cover
symbol icker
in an
animated
style
Display Er1
Display“Hi”
or“Lo”
1. Not installing
probe cover,
2. The probe cover
is not properly
installed.
The current
ambient
temperature is too
low or too high,
which is not within
the operating range
specied in the
manual and cannot
be measured.
Place the product at
normal room
temperature (10 ° C to
40 ° C) or wait for a
period of time.
1. Check if the probe lens
is diy. Please clean the
probe lens and operate
again.
2. Please ask the subject
to maintain a stable
posture and measure
again according to the
correct operating method.
3. Place the product at
normal room temperature
(10 ° C to 40 ° C) and wait
for 30 minutes.
1.The measured
temperature exceeds
the measurement
range (34.0℃ to
43.0℃).
2.Unable to collect
stable temperature
values (the
environmental
temperature changes
too quickly and the
product has not yet
reached a stable state).
1. Install probe cover;
2. Remove the probe
cover and reinstall.
The current
batte level is too
low to peorm
temperature
measurement
The current
batte level is to
low, but still
operate correctly
Suggest replacing new
batteries as soon as
possible.
Replace new batteries.
1. Turn o and then
resta;
2. Remove the batte
and replace it or replace
it with a new one;
3. Please contact your
local dealer or customer
seice.
18
Guidance and manufacturer’s declaration - electromagnetic emissions
Indicates the need for the user to consult the instructions
for use for crucial cautiona information such as
warnings and precautions that can not, for a variety of
reasons, be presented on the medical device itself.
Degree of protection against harmful ingress of water
and paiculate matter
2 Protected and against solid foreign objects of 12.5mm
Φ and greater
2 Protection against veically falling water drops when
ENCLOSURE titled up to 15°
DISPOSAL: Do not dispose of this product as unsoed
municipal waste. Collection of such waste separately for
special treatment is necessa.
The CE labelling ceies that the product complies with
the essential requirements of EU regulations on medical
device.
Symbol of European Authorized Representative,
expressly indicate the name and address of European
Authorized Representative after the symbol.
CN
Impoer
(Just for Probe
Cover)
Table 1
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 2
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 3
Emissions test
Immunity Test Compliance level
IEC 60601-1-2
Test level
Harmonic emissions IEC 61000-3-2
RF emissions CISPR 11
RF emissions CISPR 11
Radiated RF
IEC61000-4-3
(Test
specications
for ENCLOSURE
PORT IMMUNITY
to RF wireless
communications
equipment)
Radiated RF
IEC61000-4-39
(Test
specications
for ENCLOSURE
PORT IMMUNITY
to proximity
magnetic elds)
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast transient
/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
±8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 kV air
Not applicable Not applicable
Radiated RF
IEC61000-4-3
10 V/m
80 MHz – 2,7 GHz
80 % AM at 2 Hz
10 V/m
80 MHz – 2,7 GHz
80 % AM at 2 Hz
Not applicable Not applicable
Conducted RF
IEC61000-4-6
Not applicable Not applicable
Not applicable
30 A/m
50Hz/60Hz
30 A/m
50Hz/60Hz
Not applicable
±8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 kV air
Group 1
Group B
Not applicable
Not applicable
Voltage uctuations/ icker emissions
IEC 61000-3-3
Compliance
Voltage dips, sho
interruptions and
voltage variations on
power supply input lines
IEC 61000-4-11
Power frequency
magnetic eld
IEC 61000-4-8
NOTE U
T is the a.c. mians voltage prior to application of the test
level.
Tes t
Frequency
(MHz)
Band
(MHz)
Seice Modulation
IEC
60601-1-2
Test Level
(V/m)
Compli-
ance
level
(V/m)
Tes t
Frequency
Modulation
IEC 60601-1-2
Test Level
(A/m)
Compliance
level
(A/m)
Pulse
modulation
18 Hz
Pulse
modulation
217 Hz
Pulse
modulation
18 Hz
FM ± 5 kHz
deviation
1 kHz sine
385 27 27
28 28
9 9
28 28
28 28
28 28
9 9
380
–390
TETRA 400
GMRS 460,
FRS 460
LTE Band 13,
17
WLAN
802.11
a/n
GSM
800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
430
–470
704
–787
800
–960
450
710
745
780
5240
30 kHz
134,2 kHz
13,56 MHz
CW
Pulse
modulation
2.1 kHz
Pulse
modulation
50 kHz
8 8
65 65
7,5 7,5
5500
5785
810
870
930
Pulse
modulation
217 Hz
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS
1700
–
1990
1720
1845
Pulse
modulation
217 Hz
Pulse
modulation
217 Hz
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
2400
–
2570
5100
–
5800
2450
1970
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 4
AA 1.5V
1
I.Intended Use
II.Warnings And Precautions
III.Principle Of Operation Of Ear Thermometer
IV.Product Description
V. How To Use The Ear Thermometer
VI.Setting Of The Ear Thermometer
VII.Technical Specications
VIII.Batteries
IX.Included In Delive
X.Cleaning and Disinfection
XI.Troubleshooting
XII.Signs And Symbols
XIII.EMC Declaration
XIV.Warranty/seice
02
02
06
07
07
05
13
15
16
16
17
18
19
22
Contents
IV. Product Description VI. Setting Of The Ear ThermometerIII. Principle Of Operation Of
Ear Thermometer
I. Intended Use
II. Warnings And Precautions
02 03 0504 06 07 08 09 10
Instruction Manual
0
m
o
n
t
h
s
+
11 12
13
14 15 16 17 19 20 21 22 23 24
ET101 ET102 ET103
PREHE AT
EAR
THERMOMETER
NOTE:
You must read this instruction manual completely before use and
follow all instructions. Keep the instructions for later use. You must
check the device functions according to this instruction manual
prior to each use and only use this device if it is in proper working
condition.
VII. Technical Specications
VIII. Batteries
IX. Included In Delive
X. Maintainance Of The Product
The Manufacturer Resees The Rightto Alter The Specica-
tions Of Theproduct Without Prior Notication.
Ear thermometer is intended to measure ear temperature of
people of all ages. It can be used by consumers in household
environment and doctor in clinic as reference.
All objects, solid, liquid or gas, emit energy by radiation. The
intensity of this energy depends on the temperature of the
object. The ear thermometer is therefore able to measure the
temperature of a person by the energy the person emits from
ear canal. The infrared sensor located at the front end of the
device collects the infrared radiation emitted from the ear
canal. The sensor conves the received infrared into electrical
signals and transmits them to the device chip. The device chip
calculates the human body temperature based on the
intensity and frequency of the infrared signal received by the
infrared sensor.
The goal of thermomet is to measure core body tempera-
ture which is the temperatures of the vital organs. Clinical
studies showed that the ear is an excellent site of temperature
measurement because the temperatures taked in ear can
sooner and accurately reect core body temperature’s
changes .
1) Hold down the batte cover with your ngers, gently push
down to open the batte compament, and open the batte
cover.
2) Follow the polarity label in the batte compament, place
the new batte into the compament and clamp it tightly.
During installation, pay attention to the polarity and do not
install it upside down.
3) Finally, replace the batte cover in its original state.
V. How To Use The Ear Thermometer
1.Install/replace batteries
Batte installation/replacing method is as follows:
memo number. Note:The rst set of data displayed is the
most recent temperature measurement data, while the other
31 sets of data are displayed in order of temperature
measurement from near to far. In memo mode, if no any
operation within 5 seconds, the device will return to standby
mode automatically.
Over temperature warning function
If the measured body temperature is higher than the set
value, the ear thermometer will have dierent beeps and
backlight prompts.
1. Batteries using attention
1). The product uses two AA batteries.
2). When the batte symbol “ ” appears on the screen and
ashes, it indicates that the batte is low and needs to be
replaced. theoretically it can be used continuously for about
300 times (test conditions: temperature: 25°C, relative
humidity of 65%RH, staing from power on, self-check,
measurement, and automatic shutdown). When the low
batte icon on the screen ashes “ ”, it indicates that the
batte is low and needs to be replaced.
3). If the ambient temperature is low, it will shoen the batte
life.
4). When using batteries other than alkaline batteries, the
usage frequency may be ve sho, so it is recommended to
use alkaline batteries.
5). The voltage of the rechargeable batte is unstable and
can aect measurement. It is recommended not to use it.
6). When not in use for a long time, it is recommended to
remove the batte to avoid batte leakage and damage to
the product.
2. Disposing of batteries
To protect environment, dispose of empty batteries at
appropriate collection sites according to national or local
regulations.
Ear Thermometer 1pc
Instruction Manual 1pc
Quick Reference Guide 1pc
Probe Cover 20pcs(1 box)
The ear thermometer is a multi-patient reusable device, and
the cleaning and disinfection instructions were validated,
please follow the instructions to cleaning/disinfect your
thermometer prior to use.
Cleaning:
1) Use a cotton swab moistened with hot water or neutral
detergent to throughout cleaning the casing of thermometer
and measuring probe to removal of stain or oil.
2) Visual inspection the thermometer after cleaning process,
ensure there is no soil or stain is seen. if the device is
determined not to be visually clean at the end of the cleaning
step, you should either repeat the relevant previous cleaning
steps or safely dispose of the device, so that a visibly soiled
device is not used again.
Disinfection:
1) Use an 75% ethyl alcohol swab or cotton swab moistened
with 75% ethyl alcohol to disinfect the thermometer casing
and the measuring probe about 30 seconds.
2) Repeat the above steps at least 3 times, then wipe suace
and probe d with a clean cloth, and wait about 1 minute for
ding after disinfection process.
Note:
XIII. EMC Declaration XIV. Warranty/seice
The ME EQUIPMENT or ME SYSTEM is suitable for home
healthcare and clinic environments.
Statement: The ear thermometer model ET101,ET102,ET103
was tested according to the recommendations of Technical
Repo IEC TR 60601-4-2: Medical electrical equipment – Pa
4-2: Guidance and interpretation – Electromagnetic
immunity; peormance of medical electrical equipment and
medical electrical systems.
Warning：Don’t near active HF surgical equipment and the
RF shielded room of an ME system for magnetic resonance
imaging, where the intensity of EM disturbances is high.
Warning： Use of this equipment adjacent to or stacked with
other equipment should be avoided because it could result in
improper operation. If such use is necessa, this equipment
and the other equipment should be obseed to verify that
they are operating normally.
Warning: Use of accessories, transducers and cables other
than those specied or provided by the manufacturer of this
equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.”
Warning：Poable RF communications equipment (including
peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any pa
of the equipment ET101,ET102,ET103, including cables
specied by the manufacturer. Otherwise, degradation of the
peormance of this equipment could result.
1，All necessa instructions for maintaining BASIC SAFETY
and ESSENTIAL PERFORMANCE with regard to electromag-
netic disturbances for the excepted seice life.
Poable and mobile RF communication equipment may
aect the peormance of the ET101,ET102,ET103, avoiding
strong electromagnetic inteerence when used, such as near
mobile phones, microwave ovens, etc.
2，Guidance and manufacturer’s declaration -electromag-
netic emissions and Immunity
Guidance and manufacturer’s declaration - electromag-
netic emissions and Immunity
XI. Troubleshooting
XII. Signs And Symbols
If you have problems while using your thermometer, please
refer to this guide to help resolve the problem. If the problem
persists, please contact our customer seice.
Notes on handling batteries
•If your skin or eyes come into contact with batte uid,
rinse the aected area with water and seek medical
assistance.
When the buzzer beeps, it indicates that the temperature
measurement is completed and the temperature value is
displayed on the display screen.
The screens and sound prompts for different temperature
values are as follows:
Attention: The temperature value from the last temperature
measurement is displayed in the lower right corner of the
display screen, making it easier to compare changes in body
temperature.
Reference:Herzog L.Phillips S.Addressing Concerns About
Fever Clinical Pediatrics 2011 50(5) 383‒390
Below the temperature measurement range (T<34.0 ℃):
Display LO, red backlight, 1 beep:
Above the temperature measurement range (T>43.0 ℃):
Display Hi, red backlight, 1 beep.
⑤After inserting the probe into the ear canal and aligning it
with the eardrum, short press the "switch/measure" button
to measure the temperature. During the temperature
measurement process, the screen scrolls to display "- ° C",
" - ° C" and " -° C".
⑥If you need to take the next
temperature measurement, please
remove the used probe cover and
replace the new one and repeat
step ⑤.
⑦If there is no operation for about 60 seconds after the
temperature measurement is completed, the ear thermome-
ter will automatically shut down. You can also press and hold
the "Switch/Measure" button for about 5 seconds to turn off
the device. When the device is turned off, the display screen
will flash OFF for a short time and then turn off.
In accordance with our policy of continual product
improvement, we reserve the right to make technical and
optical changes without notice.
Warranty and repair terms
Warranty: 18 months.
Please contact your dealer or the service center in case of a
claim under the warranty. If you have to return the unit,
please enclose a copy of your receipt and state what the
defect is.
The following warranty terms apply:
1. The warranty period for BERRCOM products is 18 months
from date of purchase. In case of a warranty claim, the date
of purchase has to be proven by means of the sales receipt or
invoice.
2. Defects in material or workmanship will be removed free
of charge within the warranty period.
3. Repairs under warranty do not extend the warranty period
either for the unit or for the replacement parts.
4. The following is excluded under the warranty:
a. All damage which has arisen due to improper treatment,
e.g. nonobservance of the user instructions.
b. All damage which is due to repairs or tampering by the
customer or unauthorised third parties.
c. Damage which has arisen during transport from the
manufacturer to the consumer or during transport to the
service centre.
d. Accessories which are subject to normal wear and tear.
5. Liability for direct or indirect consequential losses caused
by the unit are excluded even if the damage to the unit is
accepted as a warranty claim.
Disposal
It is required that you should not dispose of WEEE as
unsoed municipal waste and collect such WEEE separately.
In accordance with Directive 2012/19/EU and national
disposal regulations regarding old electrical and electronic
devices, please be advised that such items must be disposed
of in a special way within the European Union (EU) .
These regulations require the environmentally friendly
recycling/disposal of old electrical and electronic devices.
Such items must not be disposed of as domestic refuse. This
has been expressed using the icon of the “crossed out trash
can”.
The ear thermometer (Model: ET101,ET102,ET103) contains
batteries and recyclable electronic waste. To protect the
environment, do not dispose of it in household waste as
unsoed municipal waste, but collect separately and take it to
an appropriate local collection center.
The ear thermometer (Model:ET101,ET102,ET103) is
classied as small equipment (5th catego) according to
ANNEX IV of Directive 2012/19/EU.
Before disposing of your ear thermometer (Model:
ET101,ET102,ET103), please take away the batteries from ear
thermometer (Model: ET101,ET102,ET103) and dispose of the
batteries and ear thermometer (Model: ET101,ET102,ET103)
separately.
You can take away the batteries as follows:
＞＞Batte remove diagram
① Open the lid on the back of the device
② Remove the batteries.
Batteries represent a hazard to health and the environment!
Never open, damage, or swallow batteries or allow them to
pollute the environment. They may contain toxic, ecologically
hazardous heavy metals. The removed batteries shall be
disposed of at the point of sale or in the corresponding
containers provided at collection points by local public waste
authorities and treated according to 2006/66/EC.
The batteries and recyclable electronic waste shall be
disposed of in a separate waste container.
Packaging materials must be disposed of according to local
regulations. Consult the authorized collection points for more
information.
In Germany
For the recyclable electronic waste disposal, you can search
the authorized collection points at the following website:
https://www.ear-system.de/ear-verzeichnis/sam-
mel-und-ruecknahmestellen
For batteries, you can search the authorized collection points
at the following website:
https://www.ear-system.de/ear-verzeichnis/battghersteller#-
no-back
Search method: using your postcode or the name of the city
and state where you live to nd collection points near you.
Other countries
For count-specic information on disposal, contact your
local dealers or impoer.
ashes, it reminds you to put on the
probe cover.
To obtain accurate readings, clean
and new disposable probe cover
should be installed before each
measurement.
Inse the ear thermometer probe
into the probe cover box, then pull it
out to t the new probe cover.
Only use this ear thermometer once you have read and
understood the instruction for use.
Only use this ear thermometer for the specic purpose
described in the instruction manual. Any misuse will void the
warranty.
This ear thermometer may be used for professional
purposes or for personal home use.
Using this ear thermometer is no substitute for consulting a
doctor. Do not self-diagnose or self-medicate on the basis
of the measurements without consulting your doctor. In
·
·
·
·
paicular, do not sta taking any new medication or
change the type and/or dosage of any existing medication
without prior approval.
This ear thermometer must be operated by adults, ensure
that children do not use this device unsupeised; some
pas are small enough to be a choking hazard or be
swallowed.
If this thermometer is stored condition that is out of its
using condition, please put it in operation place for at least
30 minutes before taking the measurement.
When the subject enters a warm room from a cold outdoor
environment and wets their ears by swimming or bathing,
the ear canal temperature will temporarily be lower than the
actual temperature. Please wait for 30 minutes before
taking the measurement.
When the subject's ears are covered by heat due to sleeping
on their side, wearing headphones or hearing aids, or long
hair covering, the ear canal temperature will temporarily be
higher than the actual temperature. Please wait for 30
minutes before taking the measurement.
The readings of the left and right ears may dier. When
obseing changes in body temperature, it is recommended
to collect the temperature of the same ear.
The measurement may result in measurement bias when the
subject takes medication that may increase or decrease
body temperature.
The subject may experience temperature uctuations after
engaging in activities such as intense exercise, cing, and
eating. It is recommended to maintain a quiet state for at
least 30 minutes before the measurement.
Dierent types and brands of temperature measurement
products do not have comparative value. It is recommended
that you use the same temperature measurement product
for multiple frequency obseations when obseing body
temperature, in order to better grasp changes in body
temperature.
People with ear diseases such as otitis externa and otitis
media should not use the ear thermometer.
It is recommended to measure about 3 times during
measurement, with a time inteal of 12s or more than 12s
between each measurement, recommend the maximum
temperature as measurement temperature.
Please check the batte level before use, as low batte
voltage may result in inaccurate measurement results.
If you nd that this product cannot achieve the claimed
peormance or if there is a change in product peormance,
please stop using it immediately and contact the manufac-
·
·
·
·
·
·
·
·
·
·
·
·
turer for assistance in time.
To ensure an accurate measurement, this thermometer must
only be used indoors when the ambient temperature range
is between 10℃(50℉) and 40℃（104℉）.
Before measurement, please ensure that the probe is free
from small foreign objects (such as earwax, dandru,
droplets, dust, etc.). After measurement, please place it in a
storage box to protect the probe from di or damage.
When there is a lot of earwax in the ear canal of the subject
(especially young children), please clean the ear canal
before taking the measurement to avoid aecting the
accuracy.
The probe lens is the most vulnerable pa of this product,
so it must be carefully protected. Please do not touch or
blow the probe with your hands. After measuring, please
place the product in the storage box.
Before use, conrm whether the probe lens is diy. If it is
diy, clean it according to the following steps, otherwise it
may cause measurement errors:
(1) Gently wipe the probe with a cotton swab or soft cloth
dipped in 75% alcohol.
(2) D and let the device stand for 30 minutes before use.
·
·
·
·
·
This ear thermometer should not be immersed in water or
directly exposed to sunlight to avoid product malfunctions.
This ear thermometer must be kept d and clean.
Please do not place this ear thermometer in an area with
electric shock to avoid product malfunction.
If any problems are found, please contact customer seice
and do not attempt to repair this product on your own. If
the original components are replaced with pas not
provided by the manufacturer, it may cause measurement
errors.
This ear thermometer is a measuring product. It is
recommended to check the accuracy of the product with a
manufacturer or a qualied third-pay organization at a
one-year inteal.
Please dispose of the waste and residue at the end of the
product's seice life in accordance with local laws and
regulations.
This ear thermometer expected seie life is 5 years.
Please use BERRCOM exclusive disposable probe cover
(model: PC001). If you use other brand’s probe cover, it may
result in inaccurate measurements. To purchase the
disposable probe cover, please contact your agent or
BERRCOM directly.
Do not use accessories, materials, etc. that are not specied
in this manual. Using accessories that are not provided or
specied by the manufacturer may result in the product not
achieving its intended use.
Before and after each use, the thermometer should be
cleaned according to the requirement of this manual to
avoid possible bacterial infections.
Do not expose this thermometer to extreme temperature
conditions of higher than 55℃(131℉) or lower than -20℃（
-4℉）.
Do not use this thermometer in relative humidity higher
than 85%RH.
Do not put this ear thermometer in the place with direct
sunlight, high temperature, high humidity, excessive dust, or
the place where it may contact with corrosive gas or liquid,
and do not use this product in the above environment.
Do not open up this thermometer. It contains small pas
which might be swallowed by children.
Remove the batteries if you do not wish to use the unit for
an extended period of time. Otherwise there is a danger
that the batteries may leak.
Keep the thermometer away from electromagnetic elds
produced by objects such as microwave ovens, arc welders
or induction heaters.
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
Please keep this ear thermometer out of reach of children.
Forceful measurement by children may cause ear inju. If
the batte is accidentally swallowed, please contact a
doctor immediately.
Please store the ear thermometer according to its storage
conditions to avoid usage issues and measurement errors.
Please do not forcefully collide, fall, step on, or shake this
product to avoid product malfunction or measurement
deviation.
·
·
Note: Do not use toilet paper or tissue to wipe.
Note: The reference body temperature for the ear thermome-
ter is oral temperature.
1、Guyton A C, Textbook of medical physiology, W.B.
Saunders, Philadelphia, 1996, p919;
eardrum
ear canal
1 2 3
4
5
6
7
8
9
① Probe cover (20 pcs/box)
② Storage box
③ Temperature sensing probe
④ Probe cover detector
⑤ Switch/Measure button
Symbols interpretation:
⑥ Batte cover
⑦ Display screen
⑧ Age selection button
⑨ Memo button
Batte
capacity
Measure
value
Probe notice
Age Groups
Unit
Memo
Last
measurement
value
Mute
AA 1.5V
2.Operate the device
The correct usage method is the key to measurement
accuracy, otherwise it may cause measurement errors. Due to
the high requirements of infrared
temperature measurement on the
surrounding environment, please
follow the prompts below for
operation.
① Take out the ear thermometer
from the storage box.
② Power on and self checking
Press the "Switch/Measure" button,
the ear thermometer will turn on
and sta self checking with a beep
sound. During self inspection, the
screen displays three full color icons.
If the following situations exist,
measurement cannot be suppoed:
1). Operating environment tempera-
ture too low or too high: Er1 is
displayed on the screen.
2). Low batte: The low batte icon
on the screen “ ” ashes to
indicate.
If the probe cover icon “ ” scrolls
Attention: If disposable probe cover is not installed, the ear
thermometer will not operate.
Attention: If the top of the disposable probe cover is found to
be damaged, they need to be replaced with new probe cover.
③ Select age groups
Press the age selection button“ ” to select the age range
of the tested object for temperature measurement. Press the
button to switch age groups.
④ Probe preheating
This product uses preheating temperature measurement
technology. Studies have shown that preheating the ear
thermometer for temperature measurement can avoid
cooling effects, improve temperature
measurement accuracy and comfort.
When the display screen shows
"00.0", it indicates that the preheat-
ing is completed and enters the test
state.
Note: This product defaults to the age range of the last
temperature measurement. If the age group of the tempera-
ture measurement object is dierent from the age group of
the last temperature measurement object, the age group
needs to be selected.
Above 36 months
0 ~ 3 months
3 ~ 36 months
Symbol
White backlight
1 beep
(Normal
temperature)
Orange
backlight
2 beeps
(Moderate fever)
Red backlight
3 beeps
(High fever)
Age
Groups
35.8°C ≤ T≤ 37.4°C
35.4°C ≤ T≤ 37.6°C 37.6°C <T≤ 38.5°C
37.7°C < T≤ 39.4°C
35.4°C ≤ T≤ 37.7°C
/ T
>
37.4°C
T
>
38.5°C
T
>
39.4°C
0 ~ 3
months
3 ~ 36
months
Above 36
months
Notice: The above steps are for use in
beep mode. If the ear thermometer
is in mute mode, the beep will turn
off, there will be mute icon “ ” on
the screen, and other prompts will
keep the same.
Attention: When measuring, the ear thermometer sensor
should be inserted into the ear canal and aligned withthe
eardrum. Otherwisr, the measured temperature will be lower
than the actual temperature.
The method of straightening the ear canal:
When measuring temperature, please fix the head of the
subject, gently pull the auricle, and horizontally insert the
probe into the ear canal and align it with the eardrum to fully
fill the ear canal. Specifically, the method of straightening
the ear canal is as follows:
36.8℃ Low measurement Low measurement
For children under 1
year old：gently pull
the auricle outward
and backward to
keep the ear canal as
straight as possible.
Children over 1 year
old and adults:
gently pullthe auricle
outward and upward
to keep it as straight
as possible.
This product can modify default settings parameters. Facto
settings have been made for dierent sales markets before
leaving the facto. It is recommended not to modify the
facto default values. If modication is necessa, please
follow the steps below.
Beep/mute mode
This product can be set to "beep mode" and "mute mode".
(Facto default is beep mode)
Setting method:
In standby mode, press and hold “Memo” button for 5
seconds, then enter beep/mute mode. And keep to hold the
“Memo” button, the screen will display two modes of with
or without mute symbol “ ” in sequence, each mode will
display about 3 seconds. Release the button when your
desired mode is displayed, then the save the mode and return
to standby mode.
Attention:
1．After each resta, the product is in beep mode；
2. When the device is turned on without wearing probe cover,
beep/mute mode conversion cannot be peormed.
Unit conversion
This product can be set to Fahrenheit (° F) and Celsius (° C).
(Facto default is Celsius)
Setting method:
In standby mode, press and hold the "Age selection" button
for 5 seconds, and the screen will display "° C" and "° F" in
sequence until the desired unit is displayed. Release the "Age
selection" button to complete the unit conversion and return
to full display standby mode.
Attention:
1. Maintain the settings before shutting down after each
resta;
2. When the device is turned on without wearing probe cover,
unit conversion cannot be peormed.
Memo que
This ear thermometer can remember the last 32 sets of body
temperature readings, making it easy to que historical
temperature data.
Setting method:
In standby mode, press the "Memo" button to enter memo
mode. In memo mode, pressing the “Memo” button, the
screen will display “M” and memo number, release the
button, the screen will display temperature data of the
Operational principle Infrared radiation detection
Audible Indicator Yes
Use of Probe Covers Ye s
Unit size Approx. 146×37×37mm (L x W x H)
Trade mark
Do not re-use
Manufacturer
Serial number
Please read the instructions carefully.
Applied pa, Type BF
Direct current
Date of manufacture
Made in China
Unique device identier
Medical device
Use-by date
Model number
Unit weight
(include batte)
Approx. 133g
( Without storage box)
Expected Seice Life 5 years
Applied pa Sensor; Type BF
IP Class IP22
Normal using
condition
Ambient temperature:10°C~40°C(50°F~104°F)
Relative humidity: ≤85%RH
Pressure altitude: 700hPa~1060hPa
Storage and
shipping condition
Essential
Peormance
Ambient temperature:-20°C~55°C(-4°F~131°F)
Relative humidity: ≤95%RH
Pressure altitude: 700hPa to 1060hPa
1.In normal using condition
10°C~40°C (50°F~104°F),
LABORATORY ACCURACY meet:
34.0°C~ 34.9°C(93.2°F~94.8°F):±0.3°C(±0.6°F)
35.0°C~ 42.0°C(95°F~107.6°F):±0.2°C(±0.4°F)
42.1°C~ 43.0°C(107.8°F~109.4°F):±0.3°C(±0.6°F)
2.OUTPUT TEMPERATURE
Display “Hi” when measuring temperature
above 43.0°C (109.4°F) and display “Lo” when
measuring temperature lower than 34.0°C
(93.2°F).
Adjusted mode
Oral
People of all ages
Ear
34.0°C~43.0°C (93.2°F~109.4°F)
≤ ±0.2°C/0.4°F
DC 3V (2pcs AA d batteries)
Approx. 3.5 seconds
LCD screen
0.1°C (0.1°F)
Approx. 60±10 seconds
34.0°C~ 34.9°C(93.2°F~94.8°F): ±0.3°C(±0.6°F)
35.0°C~ 42.0°C(95°F~107.6°F): ±0.2°C(±0.4°F)
42.1°C~ 43.0°C(107.8°F~109.4°F): ±0.3°C(±0.6°F)
OTC
Mode of operation
Patient population
RX/OTC Use
Measurement site
Measuring range
Accuracy
Clinical repeatability
Batteries
Measurement time
Display mode
Display resolution
Automatic power-o
32 sets Memo
Measurement
reference body site
Chocking hazard!
Small children may swallow and choke on batteries. Store
batteries out of the reach of small children.
•If a batte has leaked, put on protective gloves and clean
the batte compament with a d cloth.
•Protect batteries form excessive heat.
Risk of explosion! Do not throw batteries into a re.
•Use identical or equivalent batte types only.
•Always replace all batteries at the same time.
•Do not use rechargeable batteries.
•Do not disassemble, split or crush the batteries.
Ensure that no liquid enters the interior of the thermometer.
Never use abrasive cleaning agents, thinners or benzene for
cleaning and never immerse the Thermometer in water or
other cleaning liquids.
Take care not to scratch the suace of the probe lens and
the display.
If the visual inspection identies unacceptable deterioration
such as corrosion, discoloration, pitting, cracked, then the
device should be stop to use and discard.
If the thermometer is been used for between patients,
please visually inspect the thermometer to determine if
there is stain or oil on the casing or probe after each use,
and follow the instruction of cleaning and disinfection to
cleaning your thermometer.
•
•
•
•
•
GUANGZHOU BERRCOM MEDICAL DEVICE CO., LTD EXPRESSLY
DISCLAIMS ALL WARRANTIES OF MERCHANTABILITY AND
FITNESS FOR A PARTICULAR PURPOSE.
UNDER ON CIRCUMSTANCES SHALL BERRCOM HAVE ANY
OBLIGATION OR LIABILITY FOR ANY LOSS OF PROFIT OR FOR
ANY CONSEQUENTIAL, INCIDENTAL INDIRECT, SPECIAL,
PUNITIVE, OR CONTINGENT DAMAGES WHATSOEVER WITH
RESPECT TO CLAIMS MADE BY ANY CUSTOMER, CONSUMER OR
OTHER USER OF BERRCOM PRODUCTS.
IN THE EVENT THAT ANY APPLICABLE LAWS IMPOSE WARRAN-
TIES, CONDITIONS, OR OBLIGATIONS THAT CANNOT BE
EXCLUDED OR MODIFIED, THIS PARAGRAPH SHALL APPLY TO
THE GREATEST EXTENT ALLOWED BY SUCH LAWS.
•
•
•
Screen
message
Description
No display
Possible causes Solutions
Symbol Description of symbol
Symbol Symbol Description of symbol
Description of symbol
1. System error;
2. The batte is
completely power
o
Attention: If the above measures still cannot solve the problem, please
contact customer seice.
Batte
symbol
ashing, can
not measure
temperature
Batte
symbol
display, last
batte level
ashing.
Probe cover
symbol icker
in an
animated
style
Display Er1
Display“Hi”
or“Lo”
1. Not installing
probe cover,
2. The probe cover
is not properly
installed.
The current
ambient
temperature is too
low or too high,
which is not within
the operating range
specied in the
manual and cannot
be measured.
Place the product at
normal room
temperature (10 ° C to
40 ° C) or wait for a
period of time.
1. Check if the probe lens
is diy. Please clean the
probe lens and operate
again.
2. Please ask the subject
to maintain a stable
posture and measure
again according to the
correct operating method.
3. Place the product at
normal room temperature
(10 ° C to 40 ° C) and wait
for 30 minutes.
1.The measured
temperature exceeds
the measurement
range (34.0℃ to
43.0℃).
2.Unable to collect
stable temperature
values (the
environmental
temperature changes
too quickly and the
product has not yet
reached a stable state).
1. Install probe cover;
2. Remove the probe
cover and reinstall.
The current
batte level is too
low to peorm
temperature
measurement
The current
batte level is to
low, but still
operate correctly
Suggest replacing new
batteries as soon as
possible.
Replace new batteries.
1. Turn o and then
resta;
2. Remove the batte
and replace it or replace
it with a new one;
3. Please contact your
local dealer or customer
seice.
18
Guidance and manufacturer’s declaration - electromagnetic emissions
Indicates the need for the user to consult the instructions
for use for crucial cautiona information such as
warnings and precautions that can not, for a variety of
reasons, be presented on the medical device itself.
Degree of protection against harmful ingress of water
and paiculate matter
2 Protected and against solid foreign objects of 12.5mm
Φ and greater
2 Protection against veically falling water drops when
ENCLOSURE titled up to 15°
DISPOSAL: Do not dispose of this product as unsoed
municipal waste. Collection of such waste separately for
special treatment is necessa.
The CE labelling ceies that the product complies with
the essential requirements of EU regulations on medical
device.
Symbol of European Authorized Representative,
expressly indicate the name and address of European
Authorized Representative after the symbol.
CN
Impoer
(Just for Probe
Cover)
Table 1
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 2
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 3
Emissions test
Immunity Test Compliance level
IEC 60601-1-2
Test level
Harmonic emissions IEC 61000-3-2
RF emissions CISPR 11
RF emissions CISPR 11
Radiated RF
IEC61000-4-3
(Test
specications
for ENCLOSURE
PORT IMMUNITY
to RF wireless
communications
equipment)
Radiated RF
IEC61000-4-39
(Test
specications
for ENCLOSURE
PORT IMMUNITY
to proximity
magnetic elds)
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast transient
/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
±8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 kV air
Not applicable Not applicable
Radiated RF
IEC61000-4-3
10 V/m
80 MHz – 2,7 GHz
80 % AM at 2 Hz
10 V/m
80 MHz – 2,7 GHz
80 % AM at 2 Hz
Not applicable Not applicable
Conducted RF
IEC61000-4-6
Not applicable Not applicable
Not applicable
30 A/m
50Hz/60Hz
30 A/m
50Hz/60Hz
Not applicable
±8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 kV air
Group 1
Group B
Not applicable
Not applicable
Voltage uctuations/ icker emissions
IEC 61000-3-3
Compliance
Voltage dips, sho
interruptions and
voltage variations on
power supply input lines
IEC 61000-4-11
Power frequency
magnetic eld
IEC 61000-4-8
NOTE U
T is the a.c. mians voltage prior to application of the test
level.
Tes t
Frequency
(MHz)
Band
(MHz)
Seice Modulation
IEC
60601-1-2
Test Level
(V/m)
Compli-
ance
level
(V/m)
Tes t
Frequency
Modulation
IEC 60601-1-2
Test Level
(A/m)
Compliance
level
(A/m)
Pulse
modulation
18 Hz
Pulse
modulation
217 Hz
Pulse
modulation
18 Hz
FM ± 5 kHz
deviation
1 kHz sine
385 27 27
28 28
9 9
28 28
28 28
28 28
9 9
380
–390
TETRA 400
GMRS 460,
FRS 460
LTE Band 13,
17
WLAN
802.11
a/n
GSM
800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
430
–470
704
–787
800
–960
450
710
745
780
5240
30 kHz
134,2 kHz
13,56 MHz
CW
Pulse
modulation
2.1 kHz
Pulse
modulation
50 kHz
8 8
65 65
7,5 7,5
5500
5785
810
870
930
Pulse
modulation
217 Hz
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS
1700
–
1990
1720
1845
Pulse
modulation
217 Hz
Pulse
modulation
217 Hz
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
2400
–
2570
5100
–
5800
2450
1970
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 4
AA 1.5V
1
I.Intended Use
II.Warnings And Precautions
III.Principle Of Operation Of Ear Thermometer
IV.Product Description
V. How To Use The Ear Thermometer
VI.Setting Of The Ear Thermometer
VII.Technical Specications
VIII.Batteries
IX.Included In Delive
X.Cleaning and Disinfection
XI.Troubleshooting
XII.Signs And Symbols
XIII.EMC Declaration
XIV.Warranty/seice
02
02
06
07
07
05
13
15
16
16
17
18
19
22
Contents
IV. Product Description VI. Setting Of The Ear ThermometerIII. Principle Of Operation Of
Ear Thermometer
I. Intended Use
II. Warnings And Precautions
02 03 0504 06 07 08 09 10
Instruction Manual
0
m
o
n
t
h
s
+
11 12
13
14 15 16 17 19 20 21 22 23 24
ET101 ET102 ET103
PREHE AT
EAR
THERMOMETER
NOTE:
You must read this instruction manual completely before use and
follow all instructions. Keep the instructions for later use. You must
check the device functions according to this instruction manual
prior to each use and only use this device if it is in proper working
condition.
VII. Technical Specications
VIII. Batteries
IX. Included In Delive
X. Maintainance Of The Product
The Manufacturer Resees The Rightto Alter The Specica-
tions Of Theproduct Without Prior Notication.
Ear thermometer is intended to measure ear temperature of
people of all ages. It can be used by consumers in household
environment and doctor in clinic as reference.
All objects, solid, liquid or gas, emit energy by radiation. The
intensity of this energy depends on the temperature of the
object. The ear thermometer is therefore able to measure the
temperature of a person by the energy the person emits from
ear canal. The infrared sensor located at the front end of the
device collects the infrared radiation emitted from the ear
canal. The sensor conves the received infrared into electrical
signals and transmits them to the device chip. The device chip
calculates the human body temperature based on the
intensity and frequency of the infrared signal received by the
infrared sensor.
The goal of thermomet is to measure core body tempera-
ture which is the temperatures of the vital organs. Clinical
studies showed that the ear is an excellent site of temperature
measurement because the temperatures taked in ear can
sooner and accurately reect core body temperature’s
changes .
1) Hold down the batte cover with your ngers, gently push
down to open the batte compament, and open the batte
cover.
2) Follow the polarity label in the batte compament, place
the new batte into the compament and clamp it tightly.
During installation, pay attention to the polarity and do not
install it upside down.
3) Finally, replace the batte cover in its original state.
V. How To Use The Ear Thermometer
1.Install/replace batteries
Batte installation/replacing method is as follows:
memo number. Note:The rst set of data displayed is the
most recent temperature measurement data, while the other
31 sets of data are displayed in order of temperature
measurement from near to far. In memo mode, if no any
operation within 5 seconds, the device will return to standby
mode automatically.
Over temperature warning function
If the measured body temperature is higher than the set
value, the ear thermometer will have dierent beeps and
backlight prompts.
1. Batteries using attention
1). The product uses two AA batteries.
2). When the batte symbol “ ” appears on the screen and
ashes, it indicates that the batte is low and needs to be
replaced. theoretically it can be used continuously for about
300 times (test conditions: temperature: 25°C, relative
humidity of 65%RH, staing from power on, self-check,
measurement, and automatic shutdown). When the low
batte icon on the screen ashes “ ”, it indicates that the
batte is low and needs to be replaced.
3). If the ambient temperature is low, it will shoen the batte
life.
4). When using batteries other than alkaline batteries, the
usage frequency may be ve sho, so it is recommended to
use alkaline batteries.
5). The voltage of the rechargeable batte is unstable and
can aect measurement. It is recommended not to use it.
6). When not in use for a long time, it is recommended to
remove the batte to avoid batte leakage and damage to
the product.
2. Disposing of batteries
To protect environment, dispose of empty batteries at
appropriate collection sites according to national or local
regulations.
Ear Thermometer 1pc
Instruction Manual 1pc
Quick Reference Guide 1pc
Probe Cover 20pcs(1 box)
The ear thermometer is a multi-patient reusable device, and
the cleaning and disinfection instructions were validated,
please follow the instructions to cleaning/disinfect your
thermometer prior to use.
Cleaning:
1) Use a cotton swab moistened with hot water or neutral
detergent to throughout cleaning the casing of thermometer
and measuring probe to removal of stain or oil.
2) Visual inspection the thermometer after cleaning process,
ensure there is no soil or stain is seen. if the device is
determined not to be visually clean at the end of the cleaning
step, you should either repeat the relevant previous cleaning
steps or safely dispose of the device, so that a visibly soiled
device is not used again.
Disinfection:
1) Use an 75% ethyl alcohol swab or cotton swab moistened
with 75% ethyl alcohol to disinfect the thermometer casing
and the measuring probe about 30 seconds.
2) Repeat the above steps at least 3 times, then wipe suace
and probe d with a clean cloth, and wait about 1 minute for
ding after disinfection process.
Note:
XIII. EMC Declaration XIV. Warranty/seice
The ME EQUIPMENT or ME SYSTEM is suitable for home
healthcare and clinic environments.
Statement: The ear thermometer model ET101,ET102,ET103
was tested according to the recommendations of Technical
Repo IEC TR 60601-4-2: Medical electrical equipment – Pa
4-2: Guidance and interpretation – Electromagnetic
immunity; peormance of medical electrical equipment and
medical electrical systems.
Warning：Don’t near active HF surgical equipment and the
RF shielded room of an ME system for magnetic resonance
imaging, where the intensity of EM disturbances is high.
Warning： Use of this equipment adjacent to or stacked with
other equipment should be avoided because it could result in
improper operation. If such use is necessa, this equipment
and the other equipment should be obseed to verify that
they are operating normally.
Warning: Use of accessories, transducers and cables other
than those specied or provided by the manufacturer of this
equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.”
Warning：Poable RF communications equipment (including
peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any pa
of the equipment ET101,ET102,ET103, including cables
specied by the manufacturer. Otherwise, degradation of the
peormance of this equipment could result.
1，All necessa instructions for maintaining BASIC SAFETY
and ESSENTIAL PERFORMANCE with regard to electromag-
netic disturbances for the excepted seice life.
Poable and mobile RF communication equipment may
aect the peormance of the ET101,ET102,ET103, avoiding
strong electromagnetic inteerence when used, such as near
mobile phones, microwave ovens, etc.
2，Guidance and manufacturer’s declaration -electromag-
netic emissions and Immunity
Guidance and manufacturer’s declaration - electromag-
netic emissions and Immunity
XI. Troubleshooting
XII. Signs And Symbols
If you have problems while using your thermometer, please
refer to this guide to help resolve the problem. If the problem
persists, please contact our customer seice.
Notes on handling batteries
•If your skin or eyes come into contact with batte uid,
rinse the aected area with water and seek medical
assistance.
When the buzzer beeps, it indicates that the temperature
measurement is completed and the temperature value is
displayed on the display screen.
The screens and sound prompts for different temperature
values are as follows:
Attention: The temperature value from the last temperature
measurement is displayed in the lower right corner of the
display screen, making it easier to compare changes in body
temperature.
Reference:Herzog L.Phillips S.Addressing Concerns About
Fever Clinical Pediatrics 2011 50(5) 383‒390
Below the temperature measurement range (T<34.0 ℃):
Display LO, red backlight, 1 beep:
Above the temperature measurement range (T>43.0 ℃):
Display Hi, red backlight, 1 beep.
⑤After inserting the probe into the ear canal and aligning it
with the eardrum, short press the "switch/measure" button
to measure the temperature. During the temperature
measurement process, the screen scrolls to display "- ° C",
" - ° C" and " -° C".
⑥If you need to take the next
temperature measurement, please
remove the used probe cover and
replace the new one and repeat
step ⑤.
⑦If there is no operation for about 60 seconds after the
temperature measurement is completed, the ear thermome-
ter will automatically shut down. You can also press and hold
the "Switch/Measure" button for about 5 seconds to turn off
the device. When the device is turned off, the display screen
will flash OFF for a short time and then turn off.
In accordance with our policy of continual product
improvement, we reserve the right to make technical and
optical changes without notice.
Warranty and repair terms
Warranty: 18 months.
Please contact your dealer or the service center in case of a
claim under the warranty. If you have to return the unit,
please enclose a copy of your receipt and state what the
defect is.
The following warranty terms apply:
1. The warranty period for BERRCOM products is 18 months
from date of purchase. In case of a warranty claim, the date
of purchase has to be proven by means of the sales receipt or
invoice.
2. Defects in material or workmanship will be removed free
of charge within the warranty period.
3. Repairs under warranty do not extend the warranty period
either for the unit or for the replacement parts.
4. The following is excluded under the warranty:
a. All damage which has arisen due to improper treatment,
e.g. nonobservance of the user instructions.
b. All damage which is due to repairs or tampering by the
customer or unauthorised third parties.
c. Damage which has arisen during transport from the
manufacturer to the consumer or during transport to the
service centre.
d. Accessories which are subject to normal wear and tear.
5. Liability for direct or indirect consequential losses caused
by the unit are excluded even if the damage to the unit is
accepted as a warranty claim.
Disposal
It is required that you should not dispose of WEEE as
unsoed municipal waste and collect such WEEE separately.
In accordance with Directive 2012/19/EU and national
disposal regulations regarding old electrical and electronic
devices, please be advised that such items must be disposed
of in a special way within the European Union (EU) .
These regulations require the environmentally friendly
recycling/disposal of old electrical and electronic devices.
Such items must not be disposed of as domestic refuse. This
has been expressed using the icon of the “crossed out trash
can”.
The ear thermometer (Model: ET101,ET102,ET103) contains
batteries and recyclable electronic waste. To protect the
environment, do not dispose of it in household waste as
unsoed municipal waste, but collect separately and take it to
an appropriate local collection center.
The ear thermometer (Model:ET101,ET102,ET103) is
classied as small equipment (5th catego) according to
ANNEX IV of Directive 2012/19/EU.
Before disposing of your ear thermometer (Model:
ET101,ET102,ET103), please take away the batteries from ear
thermometer (Model: ET101,ET102,ET103) and dispose of the
batteries and ear thermometer (Model: ET101,ET102,ET103)
separately.
You can take away the batteries as follows:
＞＞Batte remove diagram
① Open the lid on the back of the device
② Remove the batteries.
Batteries represent a hazard to health and the environment!
Never open, damage, or swallow batteries or allow them to
pollute the environment. They may contain toxic, ecologically
hazardous heavy metals. The removed batteries shall be
disposed of at the point of sale or in the corresponding
containers provided at collection points by local public waste
authorities and treated according to 2006/66/EC.
The batteries and recyclable electronic waste shall be
disposed of in a separate waste container.
Packaging materials must be disposed of according to local
regulations. Consult the authorized collection points for more
information.
In Germany
For the recyclable electronic waste disposal, you can search
the authorized collection points at the following website:
https://www.ear-system.de/ear-verzeichnis/sam-
mel-und-ruecknahmestellen
For batteries, you can search the authorized collection points
at the following website:
https://www.ear-system.de/ear-verzeichnis/battghersteller#-
no-back
Search method: using your postcode or the name of the city
and state where you live to nd collection points near you.
Other countries
For count-specic information on disposal, contact your
local dealers or impoer.
ashes, it reminds you to put on the
probe cover.
To obtain accurate readings, clean
and new disposable probe cover
should be installed before each
measurement.
Inse the ear thermometer probe
into the probe cover box, then pull it
out to t the new probe cover.
Only use this ear thermometer once you have read and
understood the instruction for use.
Only use this ear thermometer for the specic purpose
described in the instruction manual. Any misuse will void the
warranty.
This ear thermometer may be used for professional
purposes or for personal home use.
Using this ear thermometer is no substitute for consulting a
doctor. Do not self-diagnose or self-medicate on the basis
of the measurements without consulting your doctor. In
·
·
·
·
paicular, do not sta taking any new medication or
change the type and/or dosage of any existing medication
without prior approval.
This ear thermometer must be operated by adults, ensure
that children do not use this device unsupeised; some
pas are small enough to be a choking hazard or be
swallowed.
If this thermometer is stored condition that is out of its
using condition, please put it in operation place for at least
30 minutes before taking the measurement.
When the subject enters a warm room from a cold outdoor
environment and wets their ears by swimming or bathing,
the ear canal temperature will temporarily be lower than the
actual temperature. Please wait for 30 minutes before
taking the measurement.
When the subject's ears are covered by heat due to sleeping
on their side, wearing headphones or hearing aids, or long
hair covering, the ear canal temperature will temporarily be
higher than the actual temperature. Please wait for 30
minutes before taking the measurement.
The readings of the left and right ears may dier. When
obseing changes in body temperature, it is recommended
to collect the temperature of the same ear.
The measurement may result in measurement bias when the
subject takes medication that may increase or decrease
body temperature.
The subject may experience temperature uctuations after
engaging in activities such as intense exercise, cing, and
eating. It is recommended to maintain a quiet state for at
least 30 minutes before the measurement.
Dierent types and brands of temperature measurement
products do not have comparative value. It is recommended
that you use the same temperature measurement product
for multiple frequency obseations when obseing body
temperature, in order to better grasp changes in body
temperature.
People with ear diseases such as otitis externa and otitis
media should not use the ear thermometer.
It is recommended to measure about 3 times during
measurement, with a time inteal of 12s or more than 12s
between each measurement, recommend the maximum
temperature as measurement temperature.
Please check the batte level before use, as low batte
voltage may result in inaccurate measurement results.
If you nd that this product cannot achieve the claimed
peormance or if there is a change in product peormance,
please stop using it immediately and contact the manufac-
·
·
·
·
·
·
·
·
·
·
·
·
turer for assistance in time.
To ensure an accurate measurement, this thermometer must
only be used indoors when the ambient temperature range
is between 10℃(50℉) and 40℃（104℉）.
Before measurement, please ensure that the probe is free
from small foreign objects (such as earwax, dandru,
droplets, dust, etc.). After measurement, please place it in a
storage box to protect the probe from di or damage.
When there is a lot of earwax in the ear canal of the subject
(especially young children), please clean the ear canal
before taking the measurement to avoid aecting the
accuracy.
The probe lens is the most vulnerable pa of this product,
so it must be carefully protected. Please do not touch or
blow the probe with your hands. After measuring, please
place the product in the storage box.
Before use, conrm whether the probe lens is diy. If it is
diy, clean it according to the following steps, otherwise it
may cause measurement errors:
(1) Gently wipe the probe with a cotton swab or soft cloth
dipped in 75% alcohol.
(2) D and let the device stand for 30 minutes before use.
·
·
·
·
·
This ear thermometer should not be immersed in water or
directly exposed to sunlight to avoid product malfunctions.
This ear thermometer must be kept d and clean.
Please do not place this ear thermometer in an area with
electric shock to avoid product malfunction.
If any problems are found, please contact customer seice
and do not attempt to repair this product on your own. If
the original components are replaced with pas not
provided by the manufacturer, it may cause measurement
errors.
This ear thermometer is a measuring product. It is
recommended to check the accuracy of the product with a
manufacturer or a qualied third-pay organization at a
one-year inteal.
Please dispose of the waste and residue at the end of the
product's seice life in accordance with local laws and
regulations.
This ear thermometer expected seie life is 5 years.
Please use BERRCOM exclusive disposable probe cover
(model: PC001). If you use other brand’s probe cover, it may
result in inaccurate measurements. To purchase the
disposable probe cover, please contact your agent or
BERRCOM directly.
Do not use accessories, materials, etc. that are not specied
in this manual. Using accessories that are not provided or
specied by the manufacturer may result in the product not
achieving its intended use.
Before and after each use, the thermometer should be
cleaned according to the requirement of this manual to
avoid possible bacterial infections.
Do not expose this thermometer to extreme temperature
conditions of higher than 55℃(131℉) or lower than -20℃（
-4℉）.
Do not use this thermometer in relative humidity higher
than 85%RH.
Do not put this ear thermometer in the place with direct
sunlight, high temperature, high humidity, excessive dust, or
the place where it may contact with corrosive gas or liquid,
and do not use this product in the above environment.
Do not open up this thermometer. It contains small pas
which might be swallowed by children.
Remove the batteries if you do not wish to use the unit for
an extended period of time. Otherwise there is a danger
that the batteries may leak.
Keep the thermometer away from electromagnetic elds
produced by objects such as microwave ovens, arc welders
or induction heaters.
·
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·
·
·
·
·
·
·
·
·
·
·
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·
Please keep this ear thermometer out of reach of children.
Forceful measurement by children may cause ear inju. If
the batte is accidentally swallowed, please contact a
doctor immediately.
Please store the ear thermometer according to its storage
conditions to avoid usage issues and measurement errors.
Please do not forcefully collide, fall, step on, or shake this
product to avoid product malfunction or measurement
deviation.
·
·
Note: Do not use toilet paper or tissue to wipe.
Note: The reference body temperature for the ear thermome-
ter is oral temperature.
1、Guyton A C, Textbook of medical physiology, W.B.
Saunders, Philadelphia, 1996, p919;
eardrum
ear canal
1 2 3
4
5
6
7
8
9
① Probe cover (20 pcs/box)
② Storage box
③ Temperature sensing probe
④ Probe cover detector
⑤ Switch/Measure button
Symbols interpretation:
⑥ Batte cover
⑦ Display screen
⑧ Age selection button
⑨ Memo button
Batte
capacity
Measure
value
Probe notice
Age Groups
Unit
Memo
Last
measurement
value
Mute
AA 1.5V
2.Operate the device
The correct usage method is the key to measurement
accuracy, otherwise it may cause measurement errors. Due to
the high requirements of infrared
temperature measurement on the
surrounding environment, please
follow the prompts below for
operation.
① Take out the ear thermometer
from the storage box.
② Power on and self checking
Press the "Switch/Measure" button,
the ear thermometer will turn on
and sta self checking with a beep
sound. During self inspection, the
screen displays three full color icons.
If the following situations exist,
measurement cannot be suppoed:
1). Operating environment tempera-
ture too low or too high: Er1 is
displayed on the screen.
2). Low batte: The low batte icon
on the screen “ ” ashes to
indicate.
If the probe cover icon “ ” scrolls
Attention: If disposable probe cover is not installed, the ear
thermometer will not operate.
Attention: If the top of the disposable probe cover is found to
be damaged, they need to be replaced with new probe cover.
③ Select age groups
Press the age selection button“ ” to select the age range
of the tested object for temperature measurement. Press the
button to switch age groups.
④ Probe preheating
This product uses preheating temperature measurement
technology. Studies have shown that preheating the ear
thermometer for temperature measurement can avoid
cooling effects, improve temperature
measurement accuracy and comfort.
When the display screen shows
"00.0", it indicates that the preheat-
ing is completed and enters the test
state.
Note: This product defaults to the age range of the last
temperature measurement. If the age group of the tempera-
ture measurement object is dierent from the age group of
the last temperature measurement object, the age group
needs to be selected.
Above 36 months
0 ~ 3 months
3 ~ 36 months
Symbol
White backlight
1 beep
(Normal
temperature)
Orange
backlight
2 beeps
(Moderate fever)
Red backlight
3 beeps
(High fever)
Age
Groups
35.8°C ≤ T≤ 37.4°C
35.4°C ≤ T≤ 37.6°C 37.6°C <T≤ 38.5°C
37.7°C < T≤ 39.4°C
35.4°C ≤ T≤ 37.7°C
/ T
>
37.4°C
T
>
38.5°C
T
>
39.4°C
0 ~ 3
months
3 ~ 36
months
Above 36
months
Notice: The above steps are for use in
beep mode. If the ear thermometer
is in mute mode, the beep will turn
off, there will be mute icon “ ” on
the screen, and other prompts will
keep the same.
Attention: When measuring, the ear thermometer sensor
should be inserted into the ear canal and aligned withthe
eardrum. Otherwisr, the measured temperature will be lower
than the actual temperature.
The method of straightening the ear canal:
When measuring temperature, please fix the head of the
subject, gently pull the auricle, and horizontally insert the
probe into the ear canal and align it with the eardrum to fully
fill the ear canal. Specifically, the method of straightening
the ear canal is as follows:
36.8℃ Low measurement Low measurement
For children under 1
year old：gently pull
the auricle outward
and backward to
keep the ear canal as
straight as possible.
Children over 1 year
old and adults:
gently pullthe auricle
outward and upward
to keep it as straight
as possible.
This product can modify default settings parameters. Facto
settings have been made for dierent sales markets before
leaving the facto. It is recommended not to modify the
facto default values. If modication is necessa, please
follow the steps below.
Beep/mute mode
This product can be set to "beep mode" and "mute mode".
(Facto default is beep mode)
Setting method:
In standby mode, press and hold “Memo” button for 5
seconds, then enter beep/mute mode. And keep to hold the
“Memo” button, the screen will display two modes of with
or without mute symbol “ ” in sequence, each mode will
display about 3 seconds. Release the button when your
desired mode is displayed, then the save the mode and return
to standby mode.
Attention:
1．After each resta, the product is in beep mode；
2. When the device is turned on without wearing probe cover,
beep/mute mode conversion cannot be peormed.
Unit conversion
This product can be set to Fahrenheit (° F) and Celsius (° C).
(Facto default is Celsius)
Setting method:
In standby mode, press and hold the "Age selection" button
for 5 seconds, and the screen will display "° C" and "° F" in
sequence until the desired unit is displayed. Release the "Age
selection" button to complete the unit conversion and return
to full display standby mode.
Attention:
1. Maintain the settings before shutting down after each
resta;
2. When the device is turned on without wearing probe cover,
unit conversion cannot be peormed.
Memo que
This ear thermometer can remember the last 32 sets of body
temperature readings, making it easy to que historical
temperature data.
Setting method:
In standby mode, press the "Memo" button to enter memo
mode. In memo mode, pressing the “Memo” button, the
screen will display “M” and memo number, release the
button, the screen will display temperature data of the
Operational principle Infrared radiation detection
Audible Indicator Yes
Use of Probe Covers Ye s
Unit size Approx. 146×37×37mm (L x W x H)
Trade mark
Do not re-use
Manufacturer
Serial number
Please read the instructions carefully.
Applied pa, Type BF
Direct current
Date of manufacture
Made in China
Unique device identier
Medical device
Use-by date
Model number
Unit weight
(include batte)
Approx. 133g
( Without storage box)
Expected Seice Life 5 years
Applied pa Sensor; Type BF
IP Class IP22
Normal using
condition
Ambient temperature:10°C~40°C(50°F~104°F)
Relative humidity: ≤85%RH
Pressure altitude: 700hPa~1060hPa
Storage and
shipping condition
Essential
Peormance
Ambient temperature:-20°C~55°C(-4°F~131°F)
Relative humidity: ≤95%RH
Pressure altitude: 700hPa to 1060hPa
1.In normal using condition
10°C~40°C (50°F~104°F),
LABORATORY ACCURACY meet:
34.0°C~ 34.9°C(93.2°F~94.8°F):±0.3°C(±0.6°F)
35.0°C~ 42.0°C(95°F~107.6°F):±0.2°C(±0.4°F)
42.1°C~ 43.0°C(107.8°F~109.4°F):±0.3°C(±0.6°F)
2.OUTPUT TEMPERATURE
Display “Hi” when measuring temperature
above 43.0°C (109.4°F) and display “Lo” when
measuring temperature lower than 34.0°C
(93.2°F).
Adjusted mode
Oral
People of all ages
Ear
34.0°C~43.0°C (93.2°F~109.4°F)
≤ ±0.2°C/0.4°F
DC 3V (2pcs AA d batteries)
Approx. 3.5 seconds
LCD screen
0.1°C (0.1°F)
Approx. 60±10 seconds
34.0°C~ 34.9°C(93.2°F~94.8°F): ±0.3°C(±0.6°F)
35.0°C~ 42.0°C(95°F~107.6°F): ±0.2°C(±0.4°F)
42.1°C~ 43.0°C(107.8°F~109.4°F): ±0.3°C(±0.6°F)
OTC
Mode of operation
Patient population
RX/OTC Use
Measurement site
Measuring range
Accuracy
Clinical repeatability
Batteries
Measurement time
Display mode
Display resolution
Automatic power-o
32 sets Memo
Measurement
reference body site
Chocking hazard!
Small children may swallow and choke on batteries. Store
batteries out of the reach of small children.
•If a batte has leaked, put on protective gloves and clean
the batte compament with a d cloth.
•Protect batteries form excessive heat.
Risk of explosion! Do not throw batteries into a re.
•Use identical or equivalent batte types only.
•Always replace all batteries at the same time.
•Do not use rechargeable batteries.
•Do not disassemble, split or crush the batteries.
Ensure that no liquid enters the interior of the thermometer.
Never use abrasive cleaning agents, thinners or benzene for
cleaning and never immerse the Thermometer in water or
other cleaning liquids.
Take care not to scratch the suace of the probe lens and
the display.
If the visual inspection identies unacceptable deterioration
such as corrosion, discoloration, pitting, cracked, then the
device should be stop to use and discard.
If the thermometer is been used for between patients,
please visually inspect the thermometer to determine if
there is stain or oil on the casing or probe after each use,
and follow the instruction of cleaning and disinfection to
cleaning your thermometer.
•
•
•
•
•
GUANGZHOU BERRCOM MEDICAL DEVICE CO., LTD EXPRESSLY
DISCLAIMS ALL WARRANTIES OF MERCHANTABILITY AND
FITNESS FOR A PARTICULAR PURPOSE.
UNDER ON CIRCUMSTANCES SHALL BERRCOM HAVE ANY
OBLIGATION OR LIABILITY FOR ANY LOSS OF PROFIT OR FOR
ANY CONSEQUENTIAL, INCIDENTAL INDIRECT, SPECIAL,
PUNITIVE, OR CONTINGENT DAMAGES WHATSOEVER WITH
RESPECT TO CLAIMS MADE BY ANY CUSTOMER, CONSUMER OR
OTHER USER OF BERRCOM PRODUCTS.
IN THE EVENT THAT ANY APPLICABLE LAWS IMPOSE WARRAN-
TIES, CONDITIONS, OR OBLIGATIONS THAT CANNOT BE
EXCLUDED OR MODIFIED, THIS PARAGRAPH SHALL APPLY TO
THE GREATEST EXTENT ALLOWED BY SUCH LAWS.
•
•
•
Screen
message
Description
No display
Possible causes Solutions
Symbol Description of symbol
Symbol Symbol Description of symbol
Description of symbol
1. System error;
2. The batte is
completely power
o
Attention: If the above measures still cannot solve the problem, please
contact customer seice.
Batte
symbol
ashing, can
not measure
temperature
Batte
symbol
display, last
batte level
ashing.
Probe cover
symbol icker
in an
animated
style
Display Er1
Display“Hi”
or“Lo”
1. Not installing
probe cover,
2. The probe cover
is not properly
installed.
The current
ambient
temperature is too
low or too high,
which is not within
the operating range
specied in the
manual and cannot
be measured.
Place the product at
normal room
temperature (10 ° C to
40 ° C) or wait for a
period of time.
1. Check if the probe lens
is diy. Please clean the
probe lens and operate
again.
2. Please ask the subject
to maintain a stable
posture and measure
again according to the
correct operating method.
3. Place the product at
normal room temperature
(10 ° C to 40 ° C) and wait
for 30 minutes.
1.The measured
temperature exceeds
the measurement
range (34.0℃ to
43.0℃).
2.Unable to collect
stable temperature
values (the
environmental
temperature changes
too quickly and the
product has not yet
reached a stable state).
1. Install probe cover;
2. Remove the probe
cover and reinstall.
The current
batte level is too
low to peorm
temperature
measurement
The current
batte level is to
low, but still
operate correctly
Suggest replacing new
batteries as soon as
possible.
Replace new batteries.
1. Turn o and then
resta;
2. Remove the batte
and replace it or replace
it with a new one;
3. Please contact your
local dealer or customer
seice.
18
Guidance and manufacturer’s declaration - electromagnetic emissions
Indicates the need for the user to consult the instructions
for use for crucial cautiona information such as
warnings and precautions that can not, for a variety of
reasons, be presented on the medical device itself.
Degree of protection against harmful ingress of water
and paiculate matter
2 Protected and against solid foreign objects of 12.5mm
Φ and greater
2 Protection against veically falling water drops when
ENCLOSURE titled up to 15°
DISPOSAL: Do not dispose of this product as unsoed
municipal waste. Collection of such waste separately for
special treatment is necessa.
The CE labelling ceies that the product complies with
the essential requirements of EU regulations on medical
device.
Symbol of European Authorized Representative,
expressly indicate the name and address of European
Authorized Representative after the symbol.
CN
Impoer
(Just for Probe
Cover)
Table 1
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 2
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 3
Emissions test
Immunity Test Compliance level
IEC 60601-1-2
Test level
Harmonic emissions IEC 61000-3-2
RF emissions CISPR 11
RF emissions CISPR 11
Radiated RF
IEC61000-4-3
(Test
specications
for ENCLOSURE
PORT IMMUNITY
to RF wireless
communications
equipment)
Radiated RF
IEC61000-4-39
(Test
specications
for ENCLOSURE
PORT IMMUNITY
to proximity
magnetic elds)
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast transient
/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
±8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 kV air
Not applicable Not applicable
Radiated RF
IEC61000-4-3
10 V/m
80 MHz – 2,7 GHz
80 % AM at 2 Hz
10 V/m
80 MHz – 2,7 GHz
80 % AM at 2 Hz
Not applicable Not applicable
Conducted RF
IEC61000-4-6
Not applicable Not applicable
Not applicable
30 A/m
50Hz/60Hz
30 A/m
50Hz/60Hz
Not applicable
±8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 kV air
Group 1
Group B
Not applicable
Not applicable
Voltage uctuations/ icker emissions
IEC 61000-3-3
Compliance
Voltage dips, sho
interruptions and
voltage variations on
power supply input lines
IEC 61000-4-11
Power frequency
magnetic eld
IEC 61000-4-8
NOTE U
T is the a.c. mians voltage prior to application of the test
level.
Tes t
Frequency
(MHz)
Band
(MHz)
Seice Modulation
IEC
60601-1-2
Test Level
(V/m)
Compli-
ance
level
(V/m)
Tes t
Frequency
Modulation
IEC 60601-1-2
Test Level
(A/m)
Compliance
level
(A/m)
Pulse
modulation
18 Hz
Pulse
modulation
217 Hz
Pulse
modulation
18 Hz
FM ± 5 kHz
deviation
1 kHz sine
385 27 27
28 28
9 9
28 28
28 28
28 28
9 9
380
–390
TETRA 400
GMRS 460,
FRS 460
LTE Band 13,
17
WLAN
802.11
a/n
GSM
800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
430
–470
704
–787
800
–960
450
710
745
780
5240
30 kHz
134,2 kHz
13,56 MHz
CW
Pulse
modulation
2.1 kHz
Pulse
modulation
50 kHz
8 8
65 65
7,5 7,5
5500
5785
810
870
930
Pulse
modulation
217 Hz
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS
1700
–
1990
1720
1845
Pulse
modulation
217 Hz
Pulse
modulation
217 Hz
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
2400
–
2570
5100
–
5800
2450
1970
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 4
AA 1.5V
1
I.Intended Use
II.Warnings And Precautions
III.Principle Of Operation Of Ear Thermometer
IV.Product Description
V. How To Use The Ear Thermometer
VI.Setting Of The Ear Thermometer
VII.Technical Specications
VIII.Batteries
IX.Included In Delive
X.Cleaning and Disinfection
XI.Troubleshooting
XII.Signs And Symbols
XIII.EMC Declaration
XIV.Warranty/seice
02
02
06
07
07
05
13
15
16
16
17
18
19
22
Contents
IV. Product Description VI. Setting Of The Ear ThermometerIII. Principle Of Operation Of
Ear Thermometer
I. Intended Use
II. Warnings And Precautions
02 03 0504 06 07 08 09 10
Instruction Manual
0
m
o
n
t
h
s
+
11 12
13
14 15 16 17 19 20 21 22 23 24
ET101 ET102 ET103
PREHE AT
EAR
THERMOMETER
NOTE:
You must read this instruction manual completely before use and
follow all instructions. Keep the instructions for later use. You must
check the device functions according to this instruction manual
prior to each use and only use this device if it is in proper working
condition.
VII. Technical Specications
VIII. Batteries
IX. Included In Delive
X. Maintainance Of The Product
The Manufacturer Resees The Rightto Alter The Specica-
tions Of Theproduct Without Prior Notication.
Ear thermometer is intended to measure ear temperature of
people of all ages. It can be used by consumers in household
environment and doctor in clinic as reference.
All objects, solid, liquid or gas, emit energy by radiation. The
intensity of this energy depends on the temperature of the
object. The ear thermometer is therefore able to measure the
temperature of a person by the energy the person emits from
ear canal. The infrared sensor located at the front end of the
device collects the infrared radiation emitted from the ear
canal. The sensor conves the received infrared into electrical
signals and transmits them to the device chip. The device chip
calculates the human body temperature based on the
intensity and frequency of the infrared signal received by the
infrared sensor.
The goal of thermomet is to measure core body tempera-
ture which is the temperatures of the vital organs. Clinical
studies showed that the ear is an excellent site of temperature
measurement because the temperatures taked in ear can
sooner and accurately reect core body temperature’s
changes .
1) Hold down the batte cover with your ngers, gently push
down to open the batte compament, and open the batte
cover.
2) Follow the polarity label in the batte compament, place
the new batte into the compament and clamp it tightly.
During installation, pay attention to the polarity and do not
install it upside down.
3) Finally, replace the batte cover in its original state.
V. How To Use The Ear Thermometer
1.Install/replace batteries
Batte installation/replacing method is as follows:
memo number. Note:The rst set of data displayed is the
most recent temperature measurement data, while the other
31 sets of data are displayed in order of temperature
measurement from near to far. In memo mode, if no any
operation within 5 seconds, the device will return to standby
mode automatically.
Over temperature warning function
If the measured body temperature is higher than the set
value, the ear thermometer will have dierent beeps and
backlight prompts.
1. Batteries using attention
1). The product uses two AA batteries.
2). When the batte symbol “ ” appears on the screen and
ashes, it indicates that the batte is low and needs to be
replaced. theoretically it can be used continuously for about
300 times (test conditions: temperature: 25°C, relative
humidity of 65%RH, staing from power on, self-check,
measurement, and automatic shutdown). When the low
batte icon on the screen ashes “ ”, it indicates that the
batte is low and needs to be replaced.
3). If the ambient temperature is low, it will shoen the batte
life.
4). When using batteries other than alkaline batteries, the
usage frequency may be ve sho, so it is recommended to
use alkaline batteries.
5). The voltage of the rechargeable batte is unstable and
can aect measurement. It is recommended not to use it.
6). When not in use for a long time, it is recommended to
remove the batte to avoid batte leakage and damage to
the product.
2. Disposing of batteries
To protect environment, dispose of empty batteries at
appropriate collection sites according to national or local
regulations.
Ear Thermometer 1pc
Instruction Manual 1pc
Quick Reference Guide 1pc
Probe Cover 20pcs(1 box)
The ear thermometer is a multi-patient reusable device, and
the cleaning and disinfection instructions were validated,
please follow the instructions to cleaning/disinfect your
thermometer prior to use.
Cleaning:
1) Use a cotton swab moistened with hot water or neutral
detergent to throughout cleaning the casing of thermometer
and measuring probe to removal of stain or oil.
2) Visual inspection the thermometer after cleaning process,
ensure there is no soil or stain is seen. if the device is
determined not to be visually clean at the end of the cleaning
step, you should either repeat the relevant previous cleaning
steps or safely dispose of the device, so that a visibly soiled
device is not used again.
Disinfection:
1) Use an 75% ethyl alcohol swab or cotton swab moistened
with 75% ethyl alcohol to disinfect the thermometer casing
and the measuring probe about 30 seconds.
2) Repeat the above steps at least 3 times, then wipe suace
and probe d with a clean cloth, and wait about 1 minute for
ding after disinfection process.
Note:
XIII. EMC Declaration XIV. Warranty/seice
The ME EQUIPMENT or ME SYSTEM is suitable for home
healthcare and clinic environments.
Statement: The ear thermometer model ET101,ET102,ET103
was tested according to the recommendations of Technical
Repo IEC TR 60601-4-2: Medical electrical equipment – Pa
4-2: Guidance and interpretation – Electromagnetic
immunity; peormance of medical electrical equipment and
medical electrical systems.
Warning：Don’t near active HF surgical equipment and the
RF shielded room of an ME system for magnetic resonance
imaging, where the intensity of EM disturbances is high.
Warning： Use of this equipment adjacent to or stacked with
other equipment should be avoided because it could result in
improper operation. If such use is necessa, this equipment
and the other equipment should be obseed to verify that
they are operating normally.
Warning: Use of accessories, transducers and cables other
than those specied or provided by the manufacturer of this
equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.”
Warning：Poable RF communications equipment (including
peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any pa
of the equipment ET101,ET102,ET103, including cables
specied by the manufacturer. Otherwise, degradation of the
peormance of this equipment could result.
1，All necessa instructions for maintaining BASIC SAFETY
and ESSENTIAL PERFORMANCE with regard to electromag-
netic disturbances for the excepted seice life.
Poable and mobile RF communication equipment may
aect the peormance of the ET101,ET102,ET103, avoiding
strong electromagnetic inteerence when used, such as near
mobile phones, microwave ovens, etc.
2，Guidance and manufacturer’s declaration -electromag-
netic emissions and Immunity
Guidance and manufacturer’s declaration - electromag-
netic emissions and Immunity
XI. Troubleshooting
XII. Signs And Symbols
If you have problems while using your thermometer, please
refer to this guide to help resolve the problem. If the problem
persists, please contact our customer seice.
Notes on handling batteries
•If your skin or eyes come into contact with batte uid,
rinse the aected area with water and seek medical
assistance.
When the buzzer beeps, it indicates that the temperature
measurement is completed and the temperature value is
displayed on the display screen.
The screens and sound prompts for different temperature
values are as follows:
Attention: The temperature value from the last temperature
measurement is displayed in the lower right corner of the
display screen, making it easier to compare changes in body
temperature.
Reference:Herzog L.Phillips S.Addressing Concerns About
Fever Clinical Pediatrics 2011 50(5) 383‒390
Below the temperature measurement range (T<34.0 ℃):
Display LO, red backlight, 1 beep:
Above the temperature measurement range (T>43.0 ℃):
Display Hi, red backlight, 1 beep.
⑤After inserting the probe into the ear canal and aligning it
with the eardrum, short press the "switch/measure" button
to measure the temperature. During the temperature
measurement process, the screen scrolls to display "- ° C",
" - ° C" and " -° C".
⑥If you need to take the next
temperature measurement, please
remove the used probe cover and
replace the new one and repeat
step ⑤.
⑦If there is no operation for about 60 seconds after the
temperature measurement is completed, the ear thermome-
ter will automatically shut down. You can also press and hold
the "Switch/Measure" button for about 5 seconds to turn off
the device. When the device is turned off, the display screen
will flash OFF for a short time and then turn off.
In accordance with our policy of continual product
improvement, we reserve the right to make technical and
optical changes without notice.
Warranty and repair terms
Warranty: 18 months.
Please contact your dealer or the service center in case of a
claim under the warranty. If you have to return the unit,
please enclose a copy of your receipt and state what the
defect is.
The following warranty terms apply:
1. The warranty period for BERRCOM products is 18 months
from date of purchase. In case of a warranty claim, the date
of purchase has to be proven by means of the sales receipt or
invoice.
2. Defects in material or workmanship will be removed free
of charge within the warranty period.
3. Repairs under warranty do not extend the warranty period
either for the unit or for the replacement parts.
4. The following is excluded under the warranty:
a. All damage which has arisen due to improper treatment,
e.g. nonobservance of the user instructions.
b. All damage which is due to repairs or tampering by the
customer or unauthorised third parties.
c. Damage which has arisen during transport from the
manufacturer to the consumer or during transport to the
service centre.
d. Accessories which are subject to normal wear and tear.
5. Liability for direct or indirect consequential losses caused
by the unit are excluded even if the damage to the unit is
accepted as a warranty claim.
Disposal
It is required that you should not dispose of WEEE as
unsoed municipal waste and collect such WEEE separately.
In accordance with Directive 2012/19/EU and national
disposal regulations regarding old electrical and electronic
devices, please be advised that such items must be disposed
of in a special way within the European Union (EU) .
These regulations require the environmentally friendly
recycling/disposal of old electrical and electronic devices.
Such items must not be disposed of as domestic refuse. This
has been expressed using the icon of the “crossed out trash
can”.
The ear thermometer (Model: ET101,ET102,ET103) contains
batteries and recyclable electronic waste. To protect the
environment, do not dispose of it in household waste as
unsoed municipal waste, but collect separately and take it to
an appropriate local collection center.
The ear thermometer (Model:ET101,ET102,ET103) is
classied as small equipment (5th catego) according to
ANNEX IV of Directive 2012/19/EU.
Before disposing of your ear thermometer (Model:
ET101,ET102,ET103), please take away the batteries from ear
thermometer (Model: ET101,ET102,ET103) and dispose of the
batteries and ear thermometer (Model: ET101,ET102,ET103)
separately.
You can take away the batteries as follows:
＞＞Batte remove diagram
① Open the lid on the back of the device
② Remove the batteries.
Batteries represent a hazard to health and the environment!
Never open, damage, or swallow batteries or allow them to
pollute the environment. They may contain toxic, ecologically
hazardous heavy metals. The removed batteries shall be
disposed of at the point of sale or in the corresponding
containers provided at collection points by local public waste
authorities and treated according to 2006/66/EC.
The batteries and recyclable electronic waste shall be
disposed of in a separate waste container.
Packaging materials must be disposed of according to local
regulations. Consult the authorized collection points for more
information.
In Germany
For the recyclable electronic waste disposal, you can search
the authorized collection points at the following website:
https://www.ear-system.de/ear-verzeichnis/sam-
mel-und-ruecknahmestellen
For batteries, you can search the authorized collection points
at the following website:
https://www.ear-system.de/ear-verzeichnis/battghersteller#-
no-back
Search method: using your postcode or the name of the city
and state where you live to nd collection points near you.
Other countries
For count-specic information on disposal, contact your
local dealers or impoer.
ashes, it reminds you to put on the
probe cover.
To obtain accurate readings, clean
and new disposable probe cover
should be installed before each
measurement.
Inse the ear thermometer probe
into the probe cover box, then pull it
out to t the new probe cover.
Only use this ear thermometer once you have read and
understood the instruction for use.
Only use this ear thermometer for the specic purpose
described in the instruction manual. Any misuse will void the
warranty.
This ear thermometer may be used for professional
purposes or for personal home use.
Using this ear thermometer is no substitute for consulting a
doctor. Do not self-diagnose or self-medicate on the basis
of the measurements without consulting your doctor. In
·
·
·
·
paicular, do not sta taking any new medication or
change the type and/or dosage of any existing medication
without prior approval.
This ear thermometer must be operated by adults, ensure
that children do not use this device unsupeised; some
pas are small enough to be a choking hazard or be
swallowed.
If this thermometer is stored condition that is out of its
using condition, please put it in operation place for at least
30 minutes before taking the measurement.
When the subject enters a warm room from a cold outdoor
environment and wets their ears by swimming or bathing,
the ear canal temperature will temporarily be lower than the
actual temperature. Please wait for 30 minutes before
taking the measurement.
When the subject's ears are covered by heat due to sleeping
on their side, wearing headphones or hearing aids, or long
hair covering, the ear canal temperature will temporarily be
higher than the actual temperature. Please wait for 30
minutes before taking the measurement.
The readings of the left and right ears may dier. When
obseing changes in body temperature, it is recommended
to collect the temperature of the same ear.
The measurement may result in measurement bias when the
subject takes medication that may increase or decrease
body temperature.
The subject may experience temperature uctuations after
engaging in activities such as intense exercise, cing, and
eating. It is recommended to maintain a quiet state for at
least 30 minutes before the measurement.
Dierent types and brands of temperature measurement
products do not have comparative value. It is recommended
that you use the same temperature measurement product
for multiple frequency obseations when obseing body
temperature, in order to better grasp changes in body
temperature.
People with ear diseases such as otitis externa and otitis
media should not use the ear thermometer.
It is recommended to measure about 3 times during
measurement, with a time inteal of 12s or more than 12s
between each measurement, recommend the maximum
temperature as measurement temperature.
Please check the batte level before use, as low batte
voltage may result in inaccurate measurement results.
If you nd that this product cannot achieve the claimed
peormance or if there is a change in product peormance,
please stop using it immediately and contact the manufac-
·
·
·
·
·
·
·
·
·
·
·
·
turer for assistance in time.
To ensure an accurate measurement, this thermometer must
only be used indoors when the ambient temperature range
is between 10℃(50℉) and 40℃（104℉）.
Before measurement, please ensure that the probe is free
from small foreign objects (such as earwax, dandru,
droplets, dust, etc.). After measurement, please place it in a
storage box to protect the probe from di or damage.
When there is a lot of earwax in the ear canal of the subject
(especially young children), please clean the ear canal
before taking the measurement to avoid aecting the
accuracy.
The probe lens is the most vulnerable pa of this product,
so it must be carefully protected. Please do not touch or
blow the probe with your hands. After measuring, please
place the product in the storage box.
Before use, conrm whether the probe lens is diy. If it is
diy, clean it according to the following steps, otherwise it
may cause measurement errors:
(1) Gently wipe the probe with a cotton swab or soft cloth
dipped in 75% alcohol.
(2) D and let the device stand for 30 minutes before use.
·
·
·
·
·
This ear thermometer should not be immersed in water or
directly exposed to sunlight to avoid product malfunctions.
This ear thermometer must be kept d and clean.
Please do not place this ear thermometer in an area with
electric shock to avoid product malfunction.
If any problems are found, please contact customer seice
and do not attempt to repair this product on your own. If
the original components are replaced with pas not
provided by the manufacturer, it may cause measurement
errors.
This ear thermometer is a measuring product. It is
recommended to check the accuracy of the product with a
manufacturer or a qualied third-pay organization at a
one-year inteal.
Please dispose of the waste and residue at the end of the
product's seice life in accordance with local laws and
regulations.
This ear thermometer expected seie life is 5 years.
Please use BERRCOM exclusive disposable probe cover
(model: PC001). If you use other brand’s probe cover, it may
result in inaccurate measurements. To purchase the
disposable probe cover, please contact your agent or
BERRCOM directly.
Do not use accessories, materials, etc. that are not specied
in this manual. Using accessories that are not provided or
specied by the manufacturer may result in the product not
achieving its intended use.
Before and after each use, the thermometer should be
cleaned according to the requirement of this manual to
avoid possible bacterial infections.
Do not expose this thermometer to extreme temperature
conditions of higher than 55℃(131℉) or lower than -20℃（
-4℉）.
Do not use this thermometer in relative humidity higher
than 85%RH.
Do not put this ear thermometer in the place with direct
sunlight, high temperature, high humidity, excessive dust, or
the place where it may contact with corrosive gas or liquid,
and do not use this product in the above environment.
Do not open up this thermometer. It contains small pas
which might be swallowed by children.
Remove the batteries if you do not wish to use the unit for
an extended period of time. Otherwise there is a danger
that the batteries may leak.
Keep the thermometer away from electromagnetic elds
produced by objects such as microwave ovens, arc welders
or induction heaters.
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
Please keep this ear thermometer out of reach of children.
Forceful measurement by children may cause ear inju. If
the batte is accidentally swallowed, please contact a
doctor immediately.
Please store the ear thermometer according to its storage
conditions to avoid usage issues and measurement errors.
Please do not forcefully collide, fall, step on, or shake this
product to avoid product malfunction or measurement
deviation.
·
·
Note: Do not use toilet paper or tissue to wipe.
Note: The reference body temperature for the ear thermome-
ter is oral temperature.
1、Guyton A C, Textbook of medical physiology, W.B.
Saunders, Philadelphia, 1996, p919;
eardrum
ear canal
1 2 3
4
5
6
7
8
9
① Probe cover (20 pcs/box)
② Storage box
③ Temperature sensing probe
④ Probe cover detector
⑤ Switch/Measure button
Symbols interpretation:
⑥ Batte cover
⑦ Display screen
⑧ Age selection button
⑨ Memo button
Batte
capacity
Measure
value
Probe notice
Age Groups
Unit
Memo
Last
measurement
value
Mute
AA 1.5V
2.Operate the device
The correct usage method is the key to measurement
accuracy, otherwise it may cause measurement errors. Due to
the high requirements of infrared
temperature measurement on the
surrounding environment, please
follow the prompts below for
operation.
① Take out the ear thermometer
from the storage box.
② Power on and self checking
Press the "Switch/Measure" button,
the ear thermometer will turn on
and sta self checking with a beep
sound. During self inspection, the
screen displays three full color icons.
If the following situations exist,
measurement cannot be suppoed:
1). Operating environment tempera-
ture too low or too high: Er1 is
displayed on the screen.
2). Low batte: The low batte icon
on the screen “ ” ashes to
indicate.
If the probe cover icon “ ” scrolls
Attention: If disposable probe cover is not installed, the ear
thermometer will not operate.
Attention: If the top of the disposable probe cover is found to
be damaged, they need to be replaced with new probe cover.
③ Select age groups
Press the age selection button“ ” to select the age range
of the tested object for temperature measurement. Press the
button to switch age groups.
④ Probe preheating
This product uses preheating temperature measurement
technology. Studies have shown that preheating the ear
thermometer for temperature measurement can avoid
cooling effects, improve temperature
measurement accuracy and comfort.
When the display screen shows
"00.0", it indicates that the preheat-
ing is completed and enters the test
state.
Note: This product defaults to the age range of the last
temperature measurement. If the age group of the tempera-
ture measurement object is dierent from the age group of
the last temperature measurement object, the age group
needs to be selected.
Above 36 months
0 ~ 3 months
3 ~ 36 months
Symbol
White backlight
1 beep
(Normal
temperature)
Orange
backlight
2 beeps
(Moderate fever)
Red backlight
3 beeps
(High fever)
Age
Groups
35.8°C ≤ T≤ 37.4°C
35.4°C ≤ T≤ 37.6°C 37.6°C <T≤ 38.5°C
37.7°C < T≤ 39.4°C
35.4°C ≤ T≤ 37.7°C
/ T
>
37.4°C
T
>
38.5°C
T
>
39.4°C
0 ~ 3
months
3 ~ 36
months
Above 36
months
Notice: The above steps are for use in
beep mode. If the ear thermometer
is in mute mode, the beep will turn
off, there will be mute icon “ ” on
the screen, and other prompts will
keep the same.
Attention: When measuring, the ear thermometer sensor
should be inserted into the ear canal and aligned withthe
eardrum. Otherwisr, the measured temperature will be lower
than the actual temperature.
The method of straightening the ear canal:
When measuring temperature, please fix the head of the
subject, gently pull the auricle, and horizontally insert the
probe into the ear canal and align it with the eardrum to fully
fill the ear canal. Specifically, the method of straightening
the ear canal is as follows:
36.8℃ Low measurement Low measurement
For children under 1
year old：gently pull
the auricle outward
and backward to
keep the ear canal as
straight as possible.
Children over 1 year
old and adults:
gently pullthe auricle
outward and upward
to keep it as straight
as possible.
This product can modify default settings parameters. Facto
settings have been made for dierent sales markets before
leaving the facto. It is recommended not to modify the
facto default values. If modication is necessa, please
follow the steps below.
Beep/mute mode
This product can be set to "beep mode" and "mute mode".
(Facto default is beep mode)
Setting method:
In standby mode, press and hold “Memo” button for 5
seconds, then enter beep/mute mode. And keep to hold the
“Memo” button, the screen will display two modes of with
or without mute symbol “ ” in sequence, each mode will
display about 3 seconds. Release the button when your
desired mode is displayed, then the save the mode and return
to standby mode.
Attention:
1．After each resta, the product is in beep mode；
2. When the device is turned on without wearing probe cover,
beep/mute mode conversion cannot be peormed.
Unit conversion
This product can be set to Fahrenheit (° F) and Celsius (° C).
(Facto default is Celsius)
Setting method:
In standby mode, press and hold the "Age selection" button
for 5 seconds, and the screen will display "° C" and "° F" in
sequence until the desired unit is displayed. Release the "Age
selection" button to complete the unit conversion and return
to full display standby mode.
Attention:
1. Maintain the settings before shutting down after each
resta;
2. When the device is turned on without wearing probe cover,
unit conversion cannot be peormed.
Memo que
This ear thermometer can remember the last 32 sets of body
temperature readings, making it easy to que historical
temperature data.
Setting method:
In standby mode, press the "Memo" button to enter memo
mode. In memo mode, pressing the “Memo” button, the
screen will display “M” and memo number, release the
button, the screen will display temperature data of the
Operational principle Infrared radiation detection
Audible Indicator Yes
Use of Probe Covers Ye s
Unit size Approx. 146×37×37mm (L x W x H)
Trade mark
Do not re-use
Manufacturer
Serial number
Please read the instructions carefully.
Applied pa, Type BF
Direct current
Date of manufacture
Made in China
Unique device identier
Medical device
Use-by date
Model number
Unit weight
(include batte)
Approx. 133g
( Without storage box)
Expected Seice Life 5 years
Applied pa Sensor; Type BF
IP Class IP22
Normal using
condition
Ambient temperature:10°C~40°C(50°F~104°F)
Relative humidity: ≤85%RH
Pressure altitude: 700hPa~1060hPa
Storage and
shipping condition
Essential
Peormance
Ambient temperature:-20°C~55°C(-4°F~131°F)
Relative humidity: ≤95%RH
Pressure altitude: 700hPa to 1060hPa
1.In normal using condition
10°C~40°C (50°F~104°F),
LABORATORY ACCURACY meet:
34.0°C~ 34.9°C(93.2°F~94.8°F):±0.3°C(±0.6°F)
35.0°C~ 42.0°C(95°F~107.6°F):±0.2°C(±0.4°F)
42.1°C~ 43.0°C(107.8°F~109.4°F):±0.3°C(±0.6°F)
2.OUTPUT TEMPERATURE
Display “Hi” when measuring temperature
above 43.0°C (109.4°F) and display “Lo” when
measuring temperature lower than 34.0°C
(93.2°F).
Adjusted mode
Oral
People of all ages
Ear
34.0°C~43.0°C (93.2°F~109.4°F)
≤ ±0.2°C/0.4°F
DC 3V (2pcs AA d batteries)
Approx. 3.5 seconds
LCD screen
0.1°C (0.1°F)
Approx. 60±10 seconds
34.0°C~ 34.9°C(93.2°F~94.8°F): ±0.3°C(±0.6°F)
35.0°C~ 42.0°C(95°F~107.6°F): ±0.2°C(±0.4°F)
42.1°C~ 43.0°C(107.8°F~109.4°F): ±0.3°C(±0.6°F)
OTC
Mode of operation
Patient population
RX/OTC Use
Measurement site
Measuring range
Accuracy
Clinical repeatability
Batteries
Measurement time
Display mode
Display resolution
Automatic power-o
32 sets Memo
Measurement
reference body site
Chocking hazard!
Small children may swallow and choke on batteries. Store
batteries out of the reach of small children.
•If a batte has leaked, put on protective gloves and clean
the batte compament with a d cloth.
•Protect batteries form excessive heat.
Risk of explosion! Do not throw batteries into a re.
•Use identical or equivalent batte types only.
•Always replace all batteries at the same time.
•Do not use rechargeable batteries.
•Do not disassemble, split or crush the batteries.
Ensure that no liquid enters the interior of the thermometer.
Never use abrasive cleaning agents, thinners or benzene for
cleaning and never immerse the Thermometer in water or
other cleaning liquids.
Take care not to scratch the suace of the probe lens and
the display.
If the visual inspection identies unacceptable deterioration
such as corrosion, discoloration, pitting, cracked, then the
device should be stop to use and discard.
If the thermometer is been used for between patients,
please visually inspect the thermometer to determine if
there is stain or oil on the casing or probe after each use,
and follow the instruction of cleaning and disinfection to
cleaning your thermometer.
•
•
•
•
•
GUANGZHOU BERRCOM MEDICAL DEVICE CO., LTD EXPRESSLY
DISCLAIMS ALL WARRANTIES OF MERCHANTABILITY AND
FITNESS FOR A PARTICULAR PURPOSE.
UNDER ON CIRCUMSTANCES SHALL BERRCOM HAVE ANY
OBLIGATION OR LIABILITY FOR ANY LOSS OF PROFIT OR FOR
ANY CONSEQUENTIAL, INCIDENTAL INDIRECT, SPECIAL,
PUNITIVE, OR CONTINGENT DAMAGES WHATSOEVER WITH
RESPECT TO CLAIMS MADE BY ANY CUSTOMER, CONSUMER OR
OTHER USER OF BERRCOM PRODUCTS.
IN THE EVENT THAT ANY APPLICABLE LAWS IMPOSE WARRAN-
TIES, CONDITIONS, OR OBLIGATIONS THAT CANNOT BE
EXCLUDED OR MODIFIED, THIS PARAGRAPH SHALL APPLY TO
THE GREATEST EXTENT ALLOWED BY SUCH LAWS.
•
•
•
Screen
message
Description
No display
Possible causes Solutions
Symbol Description of symbol
Symbol Symbol Description of symbol
Description of symbol
1. System error;
2. The batte is
completely power
o
Attention: If the above measures still cannot solve the problem, please
contact customer seice.
Batte
symbol
ashing, can
not measure
temperature
Batte
symbol
display, last
batte level
ashing.
Probe cover
symbol icker
in an
animated
style
Display Er1
Display“Hi”
or“Lo”
1. Not installing
probe cover,
2. The probe cover
is not properly
installed.
The current
ambient
temperature is too
low or too high,
which is not within
the operating range
specied in the
manual and cannot
be measured.
Place the product at
normal room
temperature (10 ° C to
40 ° C) or wait for a
period of time.
1. Check if the probe lens
is diy. Please clean the
probe lens and operate
again.
2. Please ask the subject
to maintain a stable
posture and measure
again according to the
correct operating method.
3. Place the product at
normal room temperature
(10 ° C to 40 ° C) and wait
for 30 minutes.
1.The measured
temperature exceeds
the measurement
range (34.0℃ to
43.0℃).
2.Unable to collect
stable temperature
values (the
environmental
temperature changes
too quickly and the
product has not yet
reached a stable state).
1. Install probe cover;
2. Remove the probe
cover and reinstall.
The current
batte level is too
low to peorm
temperature
measurement
The current
batte level is to
low, but still
operate correctly
Suggest replacing new
batteries as soon as
possible.
Replace new batteries.
1. Turn o and then
resta;
2. Remove the batte
and replace it or replace
it with a new one;
3. Please contact your
local dealer or customer
seice.
18
Guidance and manufacturer’s declaration - electromagnetic emissions
Indicates the need for the user to consult the instructions
for use for crucial cautiona information such as
warnings and precautions that can not, for a variety of
reasons, be presented on the medical device itself.
Degree of protection against harmful ingress of water
and paiculate matter
2 Protected and against solid foreign objects of 12.5mm
Φ and greater
2 Protection against veically falling water drops when
ENCLOSURE titled up to 15°
DISPOSAL: Do not dispose of this product as unsoed
municipal waste. Collection of such waste separately for
special treatment is necessa.
The CE labelling ceies that the product complies with
the essential requirements of EU regulations on medical
device.
Symbol of European Authorized Representative,
expressly indicate the name and address of European
Authorized Representative after the symbol.
CN
Impoer
(Just for Probe
Cover)
Table 1
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 2
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 3
Emissions test
Immunity Test Compliance level
IEC 60601-1-2
Test level
Harmonic emissions IEC 61000-3-2
RF emissions CISPR 11
RF emissions CISPR 11
Radiated RF
IEC61000-4-3
(Test
specications
for ENCLOSURE
PORT IMMUNITY
to RF wireless
communications
equipment)
Radiated RF
IEC61000-4-39
(Test
specications
for ENCLOSURE
PORT IMMUNITY
to proximity
magnetic elds)
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast transient
/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
±8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 kV air
Not applicable Not applicable
Radiated RF
IEC61000-4-3
10 V/m
80 MHz – 2,7 GHz
80 % AM at 2 Hz
10 V/m
80 MHz – 2,7 GHz
80 % AM at 2 Hz
Not applicable Not applicable
Conducted RF
IEC61000-4-6
Not applicable Not applicable
Not applicable
30 A/m
50Hz/60Hz
30 A/m
50Hz/60Hz
Not applicable
±8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 kV air
Group 1
Group B
Not applicable
Not applicable
Voltage uctuations/ icker emissions
IEC 61000-3-3
Compliance
Voltage dips, sho
interruptions and
voltage variations on
power supply input lines
IEC 61000-4-11
Power frequency
magnetic eld
IEC 61000-4-8
NOTE U
T is the a.c. mians voltage prior to application of the test
level.
Tes t
Frequency
(MHz)
Band
(MHz)
Seice Modulation
IEC
60601-1-2
Test Level
(V/m)
Compli-
ance
level
(V/m)
Tes t
Frequency
Modulation
IEC 60601-1-2
Test Level
(A/m)
Compliance
level
(A/m)
Pulse
modulation
18 Hz
Pulse
modulation
217 Hz
Pulse
modulation
18 Hz
FM ± 5 kHz
deviation
1 kHz sine
385 27 27
28 28
9 9
28 28
28 28
28 28
9 9
380
–390
TETRA 400
GMRS 460,
FRS 460
LTE Band 13,
17
WLAN
802.11
a/n
GSM
800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
430
–470
704
–787
800
–960
450
710
745
780
5240
30 kHz
134,2 kHz
13,56 MHz
CW
Pulse
modulation
2.1 kHz
Pulse
modulation
50 kHz
8 8
65 65
7,5 7,5
5500
5785
810
870
930
Pulse
modulation
217 Hz
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS
1700
–
1990
1720
1845
Pulse
modulation
217 Hz
Pulse
modulation
217 Hz
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
2400
–
2570
5100
–
5800
2450
1970
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 4
AA 1.5V
1
I.Intended Use
II.Warnings And Precautions
III.Principle Of Operation Of Ear Thermometer
IV.Product Description
V. How To Use The Ear Thermometer
VI.Setting Of The Ear Thermometer
VII.Technical Specications
VIII.Batteries
IX.Included In Delive
X.Cleaning and Disinfection
XI.Troubleshooting
XII.Signs And Symbols
XIII.EMC Declaration
XIV.Warranty/seice
02
02
06
07
07
05
13
15
16
16
17
18
19
22
Contents
IV. Product Description VI. Setting Of The Ear ThermometerIII. Principle Of Operation Of
Ear Thermometer
I. Intended Use
II. Warnings And Precautions
02 03 0504 06 07 08 09 10
Instruction Manual
0
m
o
n
t
h
s
+
11 12
13
14 15 16 17 19 20 21 22 23 24
ET101 ET102 ET103
PREHE AT
EAR
THERMOMETER
NOTE:
You must read this instruction manual completely before use and
follow all instructions. Keep the instructions for later use. You must
check the device functions according to this instruction manual
prior to each use and only use this device if it is in proper working
condition.
VII. Technical Specications
VIII. Batteries
IX. Included In Delive
X. Maintainance Of The Product
The Manufacturer Resees The Rightto Alter The Specica-
tions Of Theproduct Without Prior Notication.
Ear thermometer is intended to measure ear temperature of
people of all ages. It can be used by consumers in household
environment and doctor in clinic as reference.
All objects, solid, liquid or gas, emit energy by radiation. The
intensity of this energy depends on the temperature of the
object. The ear thermometer is therefore able to measure the
temperature of a person by the energy the person emits from
ear canal. The infrared sensor located at the front end of the
device collects the infrared radiation emitted from the ear
canal. The sensor conves the received infrared into electrical
signals and transmits them to the device chip. The device chip
calculates the human body temperature based on the
intensity and frequency of the infrared signal received by the
infrared sensor.
The goal of thermomet is to measure core body tempera-
ture which is the temperatures of the vital organs. Clinical
studies showed that the ear is an excellent site of temperature
measurement because the temperatures taked in ear can
sooner and accurately reect core body temperature’s
changes .
1) Hold down the batte cover with your ngers, gently push
down to open the batte compament, and open the batte
cover.
2) Follow the polarity label in the batte compament, place
the new batte into the compament and clamp it tightly.
During installation, pay attention to the polarity and do not
install it upside down.
3) Finally, replace the batte cover in its original state.
V. How To Use The Ear Thermometer
1.Install/replace batteries
Batte installation/replacing method is as follows:
memo number. Note:The rst set of data displayed is the
most recent temperature measurement data, while the other
31 sets of data are displayed in order of temperature
measurement from near to far. In memo mode, if no any
operation within 5 seconds, the device will return to standby
mode automatically.
Over temperature warning function
If the measured body temperature is higher than the set
value, the ear thermometer will have dierent beeps and
backlight prompts.
1. Batteries using attention
1). The product uses two AA batteries.
2). When the batte symbol “ ” appears on the screen and
ashes, it indicates that the batte is low and needs to be
replaced. theoretically it can be used continuously for about
300 times (test conditions: temperature: 25°C, relative
humidity of 65%RH, staing from power on, self-check,
measurement, and automatic shutdown). When the low
batte icon on the screen ashes “ ”, it indicates that the
batte is low and needs to be replaced.
3). If the ambient temperature is low, it will shoen the batte
life.
4). When using batteries other than alkaline batteries, the
usage frequency may be ve sho, so it is recommended to
use alkaline batteries.
5). The voltage of the rechargeable batte is unstable and
can aect measurement. It is recommended not to use it.
6). When not in use for a long time, it is recommended to
remove the batte to avoid batte leakage and damage to
the product.
2. Disposing of batteries
To protect environment, dispose of empty batteries at
appropriate collection sites according to national or local
regulations.
Ear Thermometer 1pc
Instruction Manual 1pc
Quick Reference Guide 1pc
Probe Cover 20pcs(1 box)
The ear thermometer is a multi-patient reusable device, and
the cleaning and disinfection instructions were validated,
please follow the instructions to cleaning/disinfect your
thermometer prior to use.
Cleaning:
1) Use a cotton swab moistened with hot water or neutral
detergent to throughout cleaning the casing of thermometer
and measuring probe to removal of stain or oil.
2) Visual inspection the thermometer after cleaning process,
ensure there is no soil or stain is seen. if the device is
determined not to be visually clean at the end of the cleaning
step, you should either repeat the relevant previous cleaning
steps or safely dispose of the device, so that a visibly soiled
device is not used again.
Disinfection:
1) Use an 75% ethyl alcohol swab or cotton swab moistened
with 75% ethyl alcohol to disinfect the thermometer casing
and the measuring probe about 30 seconds.
2) Repeat the above steps at least 3 times, then wipe suace
and probe d with a clean cloth, and wait about 1 minute for
ding after disinfection process.
Note:
XIII. EMC Declaration XIV. Warranty/seice
The ME EQUIPMENT or ME SYSTEM is suitable for home
healthcare and clinic environments.
Statement: The ear thermometer model ET101,ET102,ET103
was tested according to the recommendations of Technical
Repo IEC TR 60601-4-2: Medical electrical equipment – Pa
4-2: Guidance and interpretation – Electromagnetic
immunity; peormance of medical electrical equipment and
medical electrical systems.
Warning：Don’t near active HF surgical equipment and the
RF shielded room of an ME system for magnetic resonance
imaging, where the intensity of EM disturbances is high.
Warning： Use of this equipment adjacent to or stacked with
other equipment should be avoided because it could result in
improper operation. If such use is necessa, this equipment
and the other equipment should be obseed to verify that
they are operating normally.
Warning: Use of accessories, transducers and cables other
than those specied or provided by the manufacturer of this
equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.”
Warning：Poable RF communications equipment (including
peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any pa
of the equipment ET101,ET102,ET103, including cables
specied by the manufacturer. Otherwise, degradation of the
peormance of this equipment could result.
1，All necessa instructions for maintaining BASIC SAFETY
and ESSENTIAL PERFORMANCE with regard to electromag-
netic disturbances for the excepted seice life.
Poable and mobile RF communication equipment may
aect the peormance of the ET101,ET102,ET103, avoiding
strong electromagnetic inteerence when used, such as near
mobile phones, microwave ovens, etc.
2，Guidance and manufacturer’s declaration -electromag-
netic emissions and Immunity
Guidance and manufacturer’s declaration - electromag-
netic emissions and Immunity
XI. Troubleshooting
XII. Signs And Symbols
If you have problems while using your thermometer, please
refer to this guide to help resolve the problem. If the problem
persists, please contact our customer seice.
Notes on handling batteries
•If your skin or eyes come into contact with batte uid,
rinse the aected area with water and seek medical
assistance.
When the buzzer beeps, it indicates that the temperature
measurement is completed and the temperature value is
displayed on the display screen.
The screens and sound prompts for different temperature
values are as follows:
Attention: The temperature value from the last temperature
measurement is displayed in the lower right corner of the
display screen, making it easier to compare changes in body
temperature.
Reference:Herzog L.Phillips S.Addressing Concerns About
Fever Clinical Pediatrics 2011 50(5) 383‒390
Below the temperature measurement range (T<34.0 ℃):
Display LO, red backlight, 1 beep:
Above the temperature measurement range (T>43.0 ℃):
Display Hi, red backlight, 1 beep.
⑤After inserting the probe into the ear canal and aligning it
with the eardrum, short press the "switch/measure" button
to measure the temperature. During the temperature
measurement process, the screen scrolls to display "- ° C",
" - ° C" and " -° C".
⑥If you need to take the next
temperature measurement, please
remove the used probe cover and
replace the new one and repeat
step ⑤.
⑦If there is no operation for about 60 seconds after the
temperature measurement is completed, the ear thermome-
ter will automatically shut down. You can also press and hold
the "Switch/Measure" button for about 5 seconds to turn off
the device. When the device is turned off, the display screen
will flash OFF for a short time and then turn off.
In accordance with our policy of continual product
improvement, we reserve the right to make technical and
optical changes without notice.
Warranty and repair terms
Warranty: 18 months.
Please contact your dealer or the service center in case of a
claim under the warranty. If you have to return the unit,
please enclose a copy of your receipt and state what the
defect is.
The following warranty terms apply:
1. The warranty period for BERRCOM products is 18 months
from date of purchase. In case of a warranty claim, the date
of purchase has to be proven by means of the sales receipt or
invoice.
2. Defects in material or workmanship will be removed free
of charge within the warranty period.
3. Repairs under warranty do not extend the warranty period
either for the unit or for the replacement parts.
4. The following is excluded under the warranty:
a. All damage which has arisen due to improper treatment,
e.g. nonobservance of the user instructions.
b. All damage which is due to repairs or tampering by the
customer or unauthorised third parties.
c. Damage which has arisen during transport from the
manufacturer to the consumer or during transport to the
service centre.
d. Accessories which are subject to normal wear and tear.
5. Liability for direct or indirect consequential losses caused
by the unit are excluded even if the damage to the unit is
accepted as a warranty claim.
Disposal
It is required that you should not dispose of WEEE as
unsoed municipal waste and collect such WEEE separately.
In accordance with Directive 2012/19/EU and national
disposal regulations regarding old electrical and electronic
devices, please be advised that such items must be disposed
of in a special way within the European Union (EU) .
These regulations require the environmentally friendly
recycling/disposal of old electrical and electronic devices.
Such items must not be disposed of as domestic refuse. This
has been expressed using the icon of the “crossed out trash
can”.
The ear thermometer (Model: ET101,ET102,ET103) contains
batteries and recyclable electronic waste. To protect the
environment, do not dispose of it in household waste as
unsoed municipal waste, but collect separately and take it to
an appropriate local collection center.
The ear thermometer (Model:ET101,ET102,ET103) is
classied as small equipment (5th catego) according to
ANNEX IV of Directive 2012/19/EU.
Before disposing of your ear thermometer (Model:
ET101,ET102,ET103), please take away the batteries from ear
thermometer (Model: ET101,ET102,ET103) and dispose of the
batteries and ear thermometer (Model: ET101,ET102,ET103)
separately.
You can take away the batteries as follows:
＞＞Batte remove diagram
① Open the lid on the back of the device
② Remove the batteries.
Batteries represent a hazard to health and the environment!
Never open, damage, or swallow batteries or allow them to
pollute the environment. They may contain toxic, ecologically
hazardous heavy metals. The removed batteries shall be
disposed of at the point of sale or in the corresponding
containers provided at collection points by local public waste
authorities and treated according to 2006/66/EC.
The batteries and recyclable electronic waste shall be
disposed of in a separate waste container.
Packaging materials must be disposed of according to local
regulations. Consult the authorized collection points for more
information.
In Germany
For the recyclable electronic waste disposal, you can search
the authorized collection points at the following website:
https://www.ear-system.de/ear-verzeichnis/sam-
mel-und-ruecknahmestellen
For batteries, you can search the authorized collection points
at the following website:
https://www.ear-system.de/ear-verzeichnis/battghersteller#-
no-back
Search method: using your postcode or the name of the city
and state where you live to nd collection points near you.
Other countries
For count-specic information on disposal, contact your
local dealers or impoer.
ashes, it reminds you to put on the
probe cover.
To obtain accurate readings, clean
and new disposable probe cover
should be installed before each
measurement.
Inse the ear thermometer probe
into the probe cover box, then pull it
out to t the new probe cover.
Only use this ear thermometer once you have read and
understood the instruction for use.
Only use this ear thermometer for the specic purpose
described in the instruction manual. Any misuse will void the
warranty.
This ear thermometer may be used for professional
purposes or for personal home use.
Using this ear thermometer is no substitute for consulting a
doctor. Do not self-diagnose or self-medicate on the basis
of the measurements without consulting your doctor. In
·
·
·
·
paicular, do not sta taking any new medication or
change the type and/or dosage of any existing medication
without prior approval.
This ear thermometer must be operated by adults, ensure
that children do not use this device unsupeised; some
pas are small enough to be a choking hazard or be
swallowed.
If this thermometer is stored condition that is out of its
using condition, please put it in operation place for at least
30 minutes before taking the measurement.
When the subject enters a warm room from a cold outdoor
environment and wets their ears by swimming or bathing,
the ear canal temperature will temporarily be lower than the
actual temperature. Please wait for 30 minutes before
taking the measurement.
When the subject's ears are covered by heat due to sleeping
on their side, wearing headphones or hearing aids, or long
hair covering, the ear canal temperature will temporarily be
higher than the actual temperature. Please wait for 30
minutes before taking the measurement.
The readings of the left and right ears may dier. When
obseing changes in body temperature, it is recommended
to collect the temperature of the same ear.
The measurement may result in measurement bias when the
subject takes medication that may increase or decrease
body temperature.
The subject may experience temperature uctuations after
engaging in activities such as intense exercise, cing, and
eating. It is recommended to maintain a quiet state for at
least 30 minutes before the measurement.
Dierent types and brands of temperature measurement
products do not have comparative value. It is recommended
that you use the same temperature measurement product
for multiple frequency obseations when obseing body
temperature, in order to better grasp changes in body
temperature.
People with ear diseases such as otitis externa and otitis
media should not use the ear thermometer.
It is recommended to measure about 3 times during
measurement, with a time inteal of 12s or more than 12s
between each measurement, recommend the maximum
temperature as measurement temperature.
Please check the batte level before use, as low batte
voltage may result in inaccurate measurement results.
If you nd that this product cannot achieve the claimed
peormance or if there is a change in product peormance,
please stop using it immediately and contact the manufac-
·
·
·
·
·
·
·
·
·
·
·
·
turer for assistance in time.
To ensure an accurate measurement, this thermometer must
only be used indoors when the ambient temperature range
is between 10℃(50℉) and 40℃（104℉）.
Before measurement, please ensure that the probe is free
from small foreign objects (such as earwax, dandru,
droplets, dust, etc.). After measurement, please place it in a
storage box to protect the probe from di or damage.
When there is a lot of earwax in the ear canal of the subject
(especially young children), please clean the ear canal
before taking the measurement to avoid aecting the
accuracy.
The probe lens is the most vulnerable pa of this product,
so it must be carefully protected. Please do not touch or
blow the probe with your hands. After measuring, please
place the product in the storage box.
Before use, conrm whether the probe lens is diy. If it is
diy, clean it according to the following steps, otherwise it
may cause measurement errors:
(1) Gently wipe the probe with a cotton swab or soft cloth
dipped in 75% alcohol.
(2) D and let the device stand for 30 minutes before use.
·
·
·
·
·
This ear thermometer should not be immersed in water or
directly exposed to sunlight to avoid product malfunctions.
This ear thermometer must be kept d and clean.
Please do not place this ear thermometer in an area with
electric shock to avoid product malfunction.
If any problems are found, please contact customer seice
and do not attempt to repair this product on your own. If
the original components are replaced with pas not
provided by the manufacturer, it may cause measurement
errors.
This ear thermometer is a measuring product. It is
recommended to check the accuracy of the product with a
manufacturer or a qualied third-pay organization at a
one-year inteal.
Please dispose of the waste and residue at the end of the
product's seice life in accordance with local laws and
regulations.
This ear thermometer expected seie life is 5 years.
Please use BERRCOM exclusive disposable probe cover
(model: PC001). If you use other brand’s probe cover, it may
result in inaccurate measurements. To purchase the
disposable probe cover, please contact your agent or
BERRCOM directly.
Do not use accessories, materials, etc. that are not specied
in this manual. Using accessories that are not provided or
specied by the manufacturer may result in the product not
achieving its intended use.
Before and after each use, the thermometer should be
cleaned according to the requirement of this manual to
avoid possible bacterial infections.
Do not expose this thermometer to extreme temperature
conditions of higher than 55℃(131℉) or lower than -20℃（
-4℉）.
Do not use this thermometer in relative humidity higher
than 85%RH.
Do not put this ear thermometer in the place with direct
sunlight, high temperature, high humidity, excessive dust, or
the place where it may contact with corrosive gas or liquid,
and do not use this product in the above environment.
Do not open up this thermometer. It contains small pas
which might be swallowed by children.
Remove the batteries if you do not wish to use the unit for
an extended period of time. Otherwise there is a danger
that the batteries may leak.
Keep the thermometer away from electromagnetic elds
produced by objects such as microwave ovens, arc welders
or induction heaters.
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
Please keep this ear thermometer out of reach of children.
Forceful measurement by children may cause ear inju. If
the batte is accidentally swallowed, please contact a
doctor immediately.
Please store the ear thermometer according to its storage
conditions to avoid usage issues and measurement errors.
Please do not forcefully collide, fall, step on, or shake this
product to avoid product malfunction or measurement
deviation.
·
·
Note: Do not use toilet paper or tissue to wipe.
Note: The reference body temperature for the ear thermome-
ter is oral temperature.
1、Guyton A C, Textbook of medical physiology, W.B.
Saunders, Philadelphia, 1996, p919;
eardrum
ear canal
1 2 3
4
5
6
7
8
9
① Probe cover (20 pcs/box)
② Storage box
③ Temperature sensing probe
④ Probe cover detector
⑤ Switch/Measure button
Symbols interpretation:
⑥ Batte cover
⑦ Display screen
⑧ Age selection button
⑨ Memo button
Batte
capacity
Measure
value
Probe notice
Age Groups
Unit
Memo
Last
measurement
value
Mute
AA 1.5V
2.Operate the device
The correct usage method is the key to measurement
accuracy, otherwise it may cause measurement errors. Due to
the high requirements of infrared
temperature measurement on the
surrounding environment, please
follow the prompts below for
operation.
① Take out the ear thermometer
from the storage box.
② Power on and self checking
Press the "Switch/Measure" button,
the ear thermometer will turn on
and sta self checking with a beep
sound. During self inspection, the
screen displays three full color icons.
If the following situations exist,
measurement cannot be suppoed:
1). Operating environment tempera-
ture too low or too high: Er1 is
displayed on the screen.
2). Low batte: The low batte icon
on the screen “ ” ashes to
indicate.
If the probe cover icon “ ” scrolls
Attention: If disposable probe cover is not installed, the ear
thermometer will not operate.
Attention: If the top of the disposable probe cover is found to
be damaged, they need to be replaced with new probe cover.
③ Select age groups
Press the age selection button“ ” to select the age range
of the tested object for temperature measurement. Press the
button to switch age groups.
④ Probe preheating
This product uses preheating temperature measurement
technology. Studies have shown that preheating the ear
thermometer for temperature measurement can avoid
cooling effects, improve temperature
measurement accuracy and comfort.
When the display screen shows
"00.0", it indicates that the preheat-
ing is completed and enters the test
state.
Note: This product defaults to the age range of the last
temperature measurement. If the age group of the tempera-
ture measurement object is dierent from the age group of
the last temperature measurement object, the age group
needs to be selected.
Above 36 months
0 ~ 3 months
3 ~ 36 months
Symbol
White backlight
1 beep
(Normal
temperature)
Orange
backlight
2 beeps
(Moderate fever)
Red backlight
3 beeps
(High fever)
Age
Groups
35.8°C ≤ T≤ 37.4°C
35.4°C ≤ T≤ 37.6°C 37.6°C <T≤ 38.5°C
37.7°C < T≤ 39.4°C
35.4°C ≤ T≤ 37.7°C
/ T
>
37.4°C
T
>
38.5°C
T
>
39.4°C
0 ~ 3
months
3 ~ 36
months
Above 36
months
Notice: The above steps are for use in
beep mode. If the ear thermometer
is in mute mode, the beep will turn
off, there will be mute icon “ ” on
the screen, and other prompts will
keep the same.
Attention: When measuring, the ear thermometer sensor
should be inserted into the ear canal and aligned withthe
eardrum. Otherwisr, the measured temperature will be lower
than the actual temperature.
The method of straightening the ear canal:
When measuring temperature, please fix the head of the
subject, gently pull the auricle, and horizontally insert the
probe into the ear canal and align it with the eardrum to fully
fill the ear canal. Specifically, the method of straightening
the ear canal is as follows:
36.8℃ Low measurement Low measurement
For children under 1
year old：gently pull
the auricle outward
and backward to
keep the ear canal as
straight as possible.
Children over 1 year
old and adults:
gently pullthe auricle
outward and upward
to keep it as straight
as possible.
This product can modify default settings parameters. Facto
settings have been made for dierent sales markets before
leaving the facto. It is recommended not to modify the
facto default values. If modication is necessa, please
follow the steps below.
Beep/mute mode
This product can be set to "beep mode" and "mute mode".
(Facto default is beep mode)
Setting method:
In standby mode, press and hold “Memo” button for 5
seconds, then enter beep/mute mode. And keep to hold the
“Memo” button, the screen will display two modes of with
or without mute symbol “ ” in sequence, each mode will
display about 3 seconds. Release the button when your
desired mode is displayed, then the save the mode and return
to standby mode.
Attention:
1．After each resta, the product is in beep mode；
2. When the device is turned on without wearing probe cover,
beep/mute mode conversion cannot be peormed.
Unit conversion
This product can be set to Fahrenheit (° F) and Celsius (° C).
(Facto default is Celsius)
Setting method:
In standby mode, press and hold the "Age selection" button
for 5 seconds, and the screen will display "° C" and "° F" in
sequence until the desired unit is displayed. Release the "Age
selection" button to complete the unit conversion and return
to full display standby mode.
Attention:
1. Maintain the settings before shutting down after each
resta;
2. When the device is turned on without wearing probe cover,
unit conversion cannot be peormed.
Memo que
This ear thermometer can remember the last 32 sets of body
temperature readings, making it easy to que historical
temperature data.
Setting method:
In standby mode, press the "Memo" button to enter memo
mode. In memo mode, pressing the “Memo” button, the
screen will display “M” and memo number, release the
button, the screen will display temperature data of the
Operational principle Infrared radiation detection
Audible Indicator Yes
Use of Probe Covers Ye s
Unit size Approx. 146×37×37mm (L x W x H)
Trade mark
Do not re-use
Manufacturer
Serial number
Please read the instructions carefully.
Applied pa, Type BF
Direct current
Date of manufacture
Made in China
Unique device identier
Medical device
Use-by date
Model number
Unit weight
(include batte)
Approx. 133g
( Without storage box)
Expected Seice Life 5 years
Applied pa Sensor; Type BF
IP Class IP22
Normal using
condition
Ambient temperature:10°C~40°C(50°F~104°F)
Relative humidity: ≤85%RH
Pressure altitude: 700hPa~1060hPa
Storage and
shipping condition
Essential
Peormance
Ambient temperature:-20°C~55°C(-4°F~131°F)
Relative humidity: ≤95%RH
Pressure altitude: 700hPa to 1060hPa
1.In normal using condition
10°C~40°C (50°F~104°F),
LABORATORY ACCURACY meet:
34.0°C~ 34.9°C(93.2°F~94.8°F):±0.3°C(±0.6°F)
35.0°C~ 42.0°C(95°F~107.6°F):±0.2°C(±0.4°F)
42.1°C~ 43.0°C(107.8°F~109.4°F):±0.3°C(±0.6°F)
2.OUTPUT TEMPERATURE
Display “Hi” when measuring temperature
above 43.0°C (109.4°F) and display “Lo” when
measuring temperature lower than 34.0°C
(93.2°F).
Adjusted mode
Oral
People of all ages
Ear
34.0°C~43.0°C (93.2°F~109.4°F)
≤ ±0.2°C/0.4°F
DC 3V (2pcs AA d batteries)
Approx. 3.5 seconds
LCD screen
0.1°C (0.1°F)
Approx. 60±10 seconds
34.0°C~ 34.9°C(93.2°F~94.8°F): ±0.3°C(±0.6°F)
35.0°C~ 42.0°C(95°F~107.6°F): ±0.2°C(±0.4°F)
42.1°C~ 43.0°C(107.8°F~109.4°F): ±0.3°C(±0.6°F)
OTC
Mode of operation
Patient population
RX/OTC Use
Measurement site
Measuring range
Accuracy
Clinical repeatability
Batteries
Measurement time
Display mode
Display resolution
Automatic power-o
32 sets Memo
Measurement
reference body site
Chocking hazard!
Small children may swallow and choke on batteries. Store
batteries out of the reach of small children.
•If a batte has leaked, put on protective gloves and clean
the batte compament with a d cloth.
•Protect batteries form excessive heat.
Risk of explosion! Do not throw batteries into a re.
•Use identical or equivalent batte types only.
•Always replace all batteries at the same time.
•Do not use rechargeable batteries.
•Do not disassemble, split or crush the batteries.
Ensure that no liquid enters the interior of the thermometer.
Never use abrasive cleaning agents, thinners or benzene for
cleaning and never immerse the Thermometer in water or
other cleaning liquids.
Take care not to scratch the suace of the probe lens and
the display.
If the visual inspection identies unacceptable deterioration
such as corrosion, discoloration, pitting, cracked, then the
device should be stop to use and discard.
If the thermometer is been used for between patients,
please visually inspect the thermometer to determine if
there is stain or oil on the casing or probe after each use,
and follow the instruction of cleaning and disinfection to
cleaning your thermometer.
•
•
•
•
•
GUANGZHOU BERRCOM MEDICAL DEVICE CO., LTD EXPRESSLY
DISCLAIMS ALL WARRANTIES OF MERCHANTABILITY AND
FITNESS FOR A PARTICULAR PURPOSE.
UNDER ON CIRCUMSTANCES SHALL BERRCOM HAVE ANY
OBLIGATION OR LIABILITY FOR ANY LOSS OF PROFIT OR FOR
ANY CONSEQUENTIAL, INCIDENTAL INDIRECT, SPECIAL,
PUNITIVE, OR CONTINGENT DAMAGES WHATSOEVER WITH
RESPECT TO CLAIMS MADE BY ANY CUSTOMER, CONSUMER OR
OTHER USER OF BERRCOM PRODUCTS.
IN THE EVENT THAT ANY APPLICABLE LAWS IMPOSE WARRAN-
TIES, CONDITIONS, OR OBLIGATIONS THAT CANNOT BE
EXCLUDED OR MODIFIED, THIS PARAGRAPH SHALL APPLY TO
THE GREATEST EXTENT ALLOWED BY SUCH LAWS.
•
•
•
Screen
message
Description
No display
Possible causes Solutions
Symbol Description of symbol
Symbol Symbol Description of symbol
Description of symbol
1. System error;
2. The batte is
completely power
o
Attention: If the above measures still cannot solve the problem, please
contact customer seice.
Batte
symbol
ashing, can
not measure
temperature
Batte
symbol
display, last
batte level
ashing.
Probe cover
symbol icker
in an
animated
style
Display Er1
Display“Hi”
or“Lo”
1. Not installing
probe cover,
2. The probe cover
is not properly
installed.
The current
ambient
temperature is too
low or too high,
which is not within
the operating range
specied in the
manual and cannot
be measured.
Place the product at
normal room
temperature (10 ° C to
40 ° C) or wait for a
period of time.
1. Check if the probe lens
is diy. Please clean the
probe lens and operate
again.
2. Please ask the subject
to maintain a stable
posture and measure
again according to the
correct operating method.
3. Place the product at
normal room temperature
(10 ° C to 40 ° C) and wait
for 30 minutes.
1.The measured
temperature exceeds
the measurement
range (34.0℃ to
43.0℃).
2.Unable to collect
stable temperature
values (the
environmental
temperature changes
too quickly and the
product has not yet
reached a stable state).
1. Install probe cover;
2. Remove the probe
cover and reinstall.
The current
batte level is too
low to peorm
temperature
measurement
The current
batte level is to
low, but still
operate correctly
Suggest replacing new
batteries as soon as
possible.
Replace new batteries.
1. Turn o and then
resta;
2. Remove the batte
and replace it or replace
it with a new one;
3. Please contact your
local dealer or customer
seice.
18
Guidance and manufacturer’s declaration - electromagnetic emissions
Indicates the need for the user to consult the instructions
for use for crucial cautiona information such as
warnings and precautions that can not, for a variety of
reasons, be presented on the medical device itself.
Degree of protection against harmful ingress of water
and paiculate matter
2 Protected and against solid foreign objects of 12.5mm
Φ and greater
2 Protection against veically falling water drops when
ENCLOSURE titled up to 15°
DISPOSAL: Do not dispose of this product as unsoed
municipal waste. Collection of such waste separately for
special treatment is necessa.
The CE labelling ceies that the product complies with
the essential requirements of EU regulations on medical
device.
Symbol of European Authorized Representative,
expressly indicate the name and address of European
Authorized Representative after the symbol.
CN
Impoer
(Just for Probe
Cover)
Table 1
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 2
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 3
Emissions test
Immunity Test Compliance level
IEC 60601-1-2
Test level
Harmonic emissions IEC 61000-3-2
RF emissions CISPR 11
RF emissions CISPR 11
Radiated RF
IEC61000-4-3
(Test
specications
for ENCLOSURE
PORT IMMUNITY
to RF wireless
communications
equipment)
Radiated RF
IEC61000-4-39
(Test
specications
for ENCLOSURE
PORT IMMUNITY
to proximity
magnetic elds)
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast transient
/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
±8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 kV air
Not applicable Not applicable
Radiated RF
IEC61000-4-3
10 V/m
80 MHz – 2,7 GHz
80 % AM at 2 Hz
10 V/m
80 MHz – 2,7 GHz
80 % AM at 2 Hz
Not applicable Not applicable
Conducted RF
IEC61000-4-6
Not applicable Not applicable
Not applicable
30 A/m
50Hz/60Hz
30 A/m
50Hz/60Hz
Not applicable
±8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 kV air
Group 1
Group B
Not applicable
Not applicable
Voltage uctuations/ icker emissions
IEC 61000-3-3
Compliance
Voltage dips, sho
interruptions and
voltage variations on
power supply input lines
IEC 61000-4-11
Power frequency
magnetic eld
IEC 61000-4-8
NOTE U
T is the a.c. mians voltage prior to application of the test
level.
Tes t
Frequency
(MHz)
Band
(MHz)
Seice Modulation
IEC
60601-1-2
Test Level
(V/m)
Compli-
ance
level
(V/m)
Tes t
Frequency
Modulation
IEC 60601-1-2
Test Level
(A/m)
Compliance
level
(A/m)
Pulse
modulation
18 Hz
Pulse
modulation
217 Hz
Pulse
modulation
18 Hz
FM ± 5 kHz
deviation
1 kHz sine
385 27 27
28 28
9 9
28 28
28 28
28 28
9 9
380
–390
TETRA 400
GMRS 460,
FRS 460
LTE Band 13,
17
WLAN
802.11
a/n
GSM
800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
430
–470
704
–787
800
–960
450
710
745
780
5240
30 kHz
134,2 kHz
13,56 MHz
CW
Pulse
modulation
2.1 kHz
Pulse
modulation
50 kHz
8 8
65 65
7,5 7,5
5500
5785
810
870
930
Pulse
modulation
217 Hz
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS
1700
–
1990
1720
1845
Pulse
modulation
217 Hz
Pulse
modulation
217 Hz
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
2400
–
2570
5100
–
5800
2450
1970
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 4
AA 1.5V
1
I.Intended Use
II.Warnings And Precautions
III.Principle Of Operation Of Ear Thermometer
IV.Product Description
V. How To Use The Ear Thermometer
VI.Setting Of The Ear Thermometer
VII.Technical Specications
VIII.Batteries
IX.Included In Delive
X.Cleaning and Disinfection
XI.Troubleshooting
XII.Signs And Symbols
XIII.EMC Declaration
XIV.Warranty/seice
02
02
06
07
07
05
13
15
16
16
17
18
19
22
Contents
IV. Product Description VI. Setting Of The Ear ThermometerIII. Principle Of Operation Of
Ear Thermometer
I. Intended Use
II. Warnings And Precautions
02 03 0504 06 07 08 09 10
Instruction Manual
0
m
o
n
t
h
s
+
11 12
13
14 15 16 17 19 20 21 22 23 24
ET101 ET102 ET103
PREHE AT
EAR
THERMOMETER
NOTE:
You must read this instruction manual completely before use and
follow all instructions. Keep the instructions for later use. You must
check the device functions according to this instruction manual
prior to each use and only use this device if it is in proper working
condition.
VII. Technical Specications
VIII. Batteries
IX. Included In Delive
X. Maintainance Of The Product
The Manufacturer Resees The Rightto Alter The Specica-
tions Of Theproduct Without Prior Notication.
Ear thermometer is intended to measure ear temperature of
people of all ages. It can be used by consumers in household
environment and doctor in clinic as reference.
All objects, solid, liquid or gas, emit energy by radiation. The
intensity of this energy depends on the temperature of the
object. The ear thermometer is therefore able to measure the
temperature of a person by the energy the person emits from
ear canal. The infrared sensor located at the front end of the
device collects the infrared radiation emitted from the ear
canal. The sensor conves the received infrared into electrical
signals and transmits them to the device chip. The device chip
calculates the human body temperature based on the
intensity and frequency of the infrared signal received by the
infrared sensor.
The goal of thermomet is to measure core body tempera-
ture which is the temperatures of the vital organs. Clinical
studies showed that the ear is an excellent site of temperature
measurement because the temperatures taked in ear can
sooner and accurately reect core body temperature’s
changes .
1) Hold down the batte cover with your ngers, gently push
down to open the batte compament, and open the batte
cover.
2) Follow the polarity label in the batte compament, place
the new batte into the compament and clamp it tightly.
During installation, pay attention to the polarity and do not
install it upside down.
3) Finally, replace the batte cover in its original state.
V. How To Use The Ear Thermometer
1.Install/replace batteries
Batte installation/replacing method is as follows:
memo number. Note:The rst set of data displayed is the
most recent temperature measurement data, while the other
31 sets of data are displayed in order of temperature
measurement from near to far. In memo mode, if no any
operation within 5 seconds, the device will return to standby
mode automatically.
Over temperature warning function
If the measured body temperature is higher than the set
value, the ear thermometer will have dierent beeps and
backlight prompts.
1. Batteries using attention
1). The product uses two AA batteries.
2). When the batte symbol “ ” appears on the screen and
ashes, it indicates that the batte is low and needs to be
replaced. theoretically it can be used continuously for about
300 times (test conditions: temperature: 25°C, relative
humidity of 65%RH, staing from power on, self-check,
measurement, and automatic shutdown). When the low
batte icon on the screen ashes “ ”, it indicates that the
batte is low and needs to be replaced.
3). If the ambient temperature is low, it will shoen the batte
life.
4). When using batteries other than alkaline batteries, the
usage frequency may be ve sho, so it is recommended to
use alkaline batteries.
5). The voltage of the rechargeable batte is unstable and
can aect measurement. It is recommended not to use it.
6). When not in use for a long time, it is recommended to
remove the batte to avoid batte leakage and damage to
the product.
2. Disposing of batteries
To protect environment, dispose of empty batteries at
appropriate collection sites according to national or local
regulations.
Ear Thermometer 1pc
Instruction Manual 1pc
Quick Reference Guide 1pc
Probe Cover 20pcs(1 box)
The ear thermometer is a multi-patient reusable device, and
the cleaning and disinfection instructions were validated,
please follow the instructions to cleaning/disinfect your
thermometer prior to use.
Cleaning:
1) Use a cotton swab moistened with hot water or neutral
detergent to throughout cleaning the casing of thermometer
and measuring probe to removal of stain or oil.
2) Visual inspection the thermometer after cleaning process,
ensure there is no soil or stain is seen. if the device is
determined not to be visually clean at the end of the cleaning
step, you should either repeat the relevant previous cleaning
steps or safely dispose of the device, so that a visibly soiled
device is not used again.
Disinfection:
1) Use an 75% ethyl alcohol swab or cotton swab moistened
with 75% ethyl alcohol to disinfect the thermometer casing
and the measuring probe about 30 seconds.
2) Repeat the above steps at least 3 times, then wipe suace
and probe d with a clean cloth, and wait about 1 minute for
ding after disinfection process.
Note:
XIII. EMC Declaration XIV. Warranty/seice
The ME EQUIPMENT or ME SYSTEM is suitable for home
healthcare and clinic environments.
Statement: The ear thermometer model ET101,ET102,ET103
was tested according to the recommendations of Technical
Repo IEC TR 60601-4-2: Medical electrical equipment – Pa
4-2: Guidance and interpretation – Electromagnetic
immunity; peormance of medical electrical equipment and
medical electrical systems.
Warning：Don’t near active HF surgical equipment and the
RF shielded room of an ME system for magnetic resonance
imaging, where the intensity of EM disturbances is high.
Warning： Use of this equipment adjacent to or stacked with
other equipment should be avoided because it could result in
improper operation. If such use is necessa, this equipment
and the other equipment should be obseed to verify that
they are operating normally.
Warning: Use of accessories, transducers and cables other
than those specied or provided by the manufacturer of this
equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.”
Warning：Poable RF communications equipment (including
peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any pa
of the equipment ET101,ET102,ET103, including cables
specied by the manufacturer. Otherwise, degradation of the
peormance of this equipment could result.
1，All necessa instructions for maintaining BASIC SAFETY
and ESSENTIAL PERFORMANCE with regard to electromag-
netic disturbances for the excepted seice life.
Poable and mobile RF communication equipment may
aect the peormance of the ET101,ET102,ET103, avoiding
strong electromagnetic inteerence when used, such as near
mobile phones, microwave ovens, etc.
2，Guidance and manufacturer’s declaration -electromag-
netic emissions and Immunity
Guidance and manufacturer’s declaration - electromag-
netic emissions and Immunity
XI. Troubleshooting
XII. Signs And Symbols
If you have problems while using your thermometer, please
refer to this guide to help resolve the problem. If the problem
persists, please contact our customer seice.
Notes on handling batteries
•If your skin or eyes come into contact with batte uid,
rinse the aected area with water and seek medical
assistance.
When the buzzer beeps, it indicates that the temperature
measurement is completed and the temperature value is
displayed on the display screen.
The screens and sound prompts for different temperature
values are as follows:
Attention: The temperature value from the last temperature
measurement is displayed in the lower right corner of the
display screen, making it easier to compare changes in body
temperature.
Reference:Herzog L.Phillips S.Addressing Concerns About
Fever Clinical Pediatrics 2011 50(5) 383‒390
Below the temperature measurement range (T<34.0 ℃):
Display LO, red backlight, 1 beep:
Above the temperature measurement range (T>43.0 ℃):
Display Hi, red backlight, 1 beep.
⑤After inserting the probe into the ear canal and aligning it
with the eardrum, short press the "switch/measure" button
to measure the temperature. During the temperature
measurement process, the screen scrolls to display "- ° C",
" - ° C" and " -° C".
⑥If you need to take the next
temperature measurement, please
remove the used probe cover and
replace the new one and repeat
step ⑤.
⑦If there is no operation for about 60 seconds after the
temperature measurement is completed, the ear thermome-
ter will automatically shut down. You can also press and hold
the "Switch/Measure" button for about 5 seconds to turn off
the device. When the device is turned off, the display screen
will flash OFF for a short time and then turn off.
In accordance with our policy of continual product
improvement, we reserve the right to make technical and
optical changes without notice.
Warranty and repair terms
Warranty: 18 months.
Please contact your dealer or the service center in case of a
claim under the warranty. If you have to return the unit,
please enclose a copy of your receipt and state what the
defect is.
The following warranty terms apply:
1. The warranty period for BERRCOM products is 18 months
from date of purchase. In case of a warranty claim, the date
of purchase has to be proven by means of the sales receipt or
invoice.
2. Defects in material or workmanship will be removed free
of charge within the warranty period.
3. Repairs under warranty do not extend the warranty period
either for the unit or for the replacement parts.
4. The following is excluded under the warranty:
a. All damage which has arisen due to improper treatment,
e.g. nonobservance of the user instructions.
b. All damage which is due to repairs or tampering by the
customer or unauthorised third parties.
c. Damage which has arisen during transport from the
manufacturer to the consumer or during transport to the
service centre.
d. Accessories which are subject to normal wear and tear.
5. Liability for direct or indirect consequential losses caused
by the unit are excluded even if the damage to the unit is
accepted as a warranty claim.
Disposal
It is required that you should not dispose of WEEE as
unsoed municipal waste and collect such WEEE separately.
In accordance with Directive 2012/19/EU and national
disposal regulations regarding old electrical and electronic
devices, please be advised that such items must be disposed
of in a special way within the European Union (EU) .
These regulations require the environmentally friendly
recycling/disposal of old electrical and electronic devices.
Such items must not be disposed of as domestic refuse. This
has been expressed using the icon of the “crossed out trash
can”.
The ear thermometer (Model: ET101,ET102,ET103) contains
batteries and recyclable electronic waste. To protect the
environment, do not dispose of it in household waste as
unsoed municipal waste, but collect separately and take it to
an appropriate local collection center.
The ear thermometer (Model:ET101,ET102,ET103) is
classied as small equipment (5th catego) according to
ANNEX IV of Directive 2012/19/EU.
Before disposing of your ear thermometer (Model:
ET101,ET102,ET103), please take away the batteries from ear
thermometer (Model: ET101,ET102,ET103) and dispose of the
batteries and ear thermometer (Model: ET101,ET102,ET103)
separately.
You can take away the batteries as follows:
＞＞Batte remove diagram
① Open the lid on the back of the device
② Remove the batteries.
Batteries represent a hazard to health and the environment!
Never open, damage, or swallow batteries or allow them to
pollute the environment. They may contain toxic, ecologically
hazardous heavy metals. The removed batteries shall be
disposed of at the point of sale or in the corresponding
containers provided at collection points by local public waste
authorities and treated according to 2006/66/EC.
The batteries and recyclable electronic waste shall be
disposed of in a separate waste container.
Packaging materials must be disposed of according to local
regulations. Consult the authorized collection points for more
information.
In Germany
For the recyclable electronic waste disposal, you can search
the authorized collection points at the following website:
https://www.ear-system.de/ear-verzeichnis/sam-
mel-und-ruecknahmestellen
For batteries, you can search the authorized collection points
at the following website:
https://www.ear-system.de/ear-verzeichnis/battghersteller#-
no-back
Search method: using your postcode or the name of the city
and state where you live to nd collection points near you.
Other countries
For count-specic information on disposal, contact your
local dealers or impoer.
ashes, it reminds you to put on the
probe cover.
To obtain accurate readings, clean
and new disposable probe cover
should be installed before each
measurement.
Inse the ear thermometer probe
into the probe cover box, then pull it
out to t the new probe cover.
Only use this ear thermometer once you have read and
understood the instruction for use.
Only use this ear thermometer for the specic purpose
described in the instruction manual. Any misuse will void the
warranty.
This ear thermometer may be used for professional
purposes or for personal home use.
Using this ear thermometer is no substitute for consulting a
doctor. Do not self-diagnose or self-medicate on the basis
of the measurements without consulting your doctor. In
·
·
·
·
paicular, do not sta taking any new medication or
change the type and/or dosage of any existing medication
without prior approval.
This ear thermometer must be operated by adults, ensure
that children do not use this device unsupeised; some
pas are small enough to be a choking hazard or be
swallowed.
If this thermometer is stored condition that is out of its
using condition, please put it in operation place for at least
30 minutes before taking the measurement.
When the subject enters a warm room from a cold outdoor
environment and wets their ears by swimming or bathing,
the ear canal temperature will temporarily be lower than the
actual temperature. Please wait for 30 minutes before
taking the measurement.
When the subject's ears are covered by heat due to sleeping
on their side, wearing headphones or hearing aids, or long
hair covering, the ear canal temperature will temporarily be
higher than the actual temperature. Please wait for 30
minutes before taking the measurement.
The readings of the left and right ears may dier. When
obseing changes in body temperature, it is recommended
to collect the temperature of the same ear.
The measurement may result in measurement bias when the
subject takes medication that may increase or decrease
body temperature.
The subject may experience temperature uctuations after
engaging in activities such as intense exercise, cing, and
eating. It is recommended to maintain a quiet state for at
least 30 minutes before the measurement.
Dierent types and brands of temperature measurement
products do not have comparative value. It is recommended
that you use the same temperature measurement product
for multiple frequency obseations when obseing body
temperature, in order to better grasp changes in body
temperature.
People with ear diseases such as otitis externa and otitis
media should not use the ear thermometer.
It is recommended to measure about 3 times during
measurement, with a time inteal of 12s or more than 12s
between each measurement, recommend the maximum
temperature as measurement temperature.
Please check the batte level before use, as low batte
voltage may result in inaccurate measurement results.
If you nd that this product cannot achieve the claimed
peormance or if there is a change in product peormance,
please stop using it immediately and contact the manufac-
·
·
·
·
·
·
·
·
·
·
·
·
turer for assistance in time.
To ensure an accurate measurement, this thermometer must
only be used indoors when the ambient temperature range
is between 10℃(50℉) and 40℃（104℉）.
Before measurement, please ensure that the probe is free
from small foreign objects (such as earwax, dandru,
droplets, dust, etc.). After measurement, please place it in a
storage box to protect the probe from di or damage.
When there is a lot of earwax in the ear canal of the subject
(especially young children), please clean the ear canal
before taking the measurement to avoid aecting the
accuracy.
The probe lens is the most vulnerable pa of this product,
so it must be carefully protected. Please do not touch or
blow the probe with your hands. After measuring, please
place the product in the storage box.
Before use, conrm whether the probe lens is diy. If it is
diy, clean it according to the following steps, otherwise it
may cause measurement errors:
(1) Gently wipe the probe with a cotton swab or soft cloth
dipped in 75% alcohol.
(2) D and let the device stand for 30 minutes before use.
·
·
·
·
·
This ear thermometer should not be immersed in water or
directly exposed to sunlight to avoid product malfunctions.
This ear thermometer must be kept d and clean.
Please do not place this ear thermometer in an area with
electric shock to avoid product malfunction.
If any problems are found, please contact customer seice
and do not attempt to repair this product on your own. If
the original components are replaced with pas not
provided by the manufacturer, it may cause measurement
errors.
This ear thermometer is a measuring product. It is
recommended to check the accuracy of the product with a
manufacturer or a qualied third-pay organization at a
one-year inteal.
Please dispose of the waste and residue at the end of the
product's seice life in accordance with local laws and
regulations.
This ear thermometer expected seie life is 5 years.
Please use BERRCOM exclusive disposable probe cover
(model: PC001). If you use other brand’s probe cover, it may
result in inaccurate measurements. To purchase the
disposable probe cover, please contact your agent or
BERRCOM directly.
Do not use accessories, materials, etc. that are not specied
in this manual. Using accessories that are not provided or
specied by the manufacturer may result in the product not
achieving its intended use.
Before and after each use, the thermometer should be
cleaned according to the requirement of this manual to
avoid possible bacterial infections.
Do not expose this thermometer to extreme temperature
conditions of higher than 55℃(131℉) or lower than -20℃（
-4℉）.
Do not use this thermometer in relative humidity higher
than 85%RH.
Do not put this ear thermometer in the place with direct
sunlight, high temperature, high humidity, excessive dust, or
the place where it may contact with corrosive gas or liquid,
and do not use this product in the above environment.
Do not open up this thermometer. It contains small pas
which might be swallowed by children.
Remove the batteries if you do not wish to use the unit for
an extended period of time. Otherwise there is a danger
that the batteries may leak.
Keep the thermometer away from electromagnetic elds
produced by objects such as microwave ovens, arc welders
or induction heaters.
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
Please keep this ear thermometer out of reach of children.
Forceful measurement by children may cause ear inju. If
the batte is accidentally swallowed, please contact a
doctor immediately.
Please store the ear thermometer according to its storage
conditions to avoid usage issues and measurement errors.
Please do not forcefully collide, fall, step on, or shake this
product to avoid product malfunction or measurement
deviation.
·
·
Note: Do not use toilet paper or tissue to wipe.
Note: The reference body temperature for the ear thermome-
ter is oral temperature.
1、Guyton A C, Textbook of medical physiology, W.B.
Saunders, Philadelphia, 1996, p919;
eardrum
ear canal
1 2 3
4
5
6
7
8
9
① Probe cover (20 pcs/box)
② Storage box
③ Temperature sensing probe
④ Probe cover detector
⑤ Switch/Measure button
Symbols interpretation:
⑥ Batte cover
⑦ Display screen
⑧ Age selection button
⑨ Memo button
Batte
capacity
Measure
value
Probe notice
Age Groups
Unit
Memo
Last
measurement
value
Mute
AA 1.5V
2.Operate the device
The correct usage method is the key to measurement
accuracy, otherwise it may cause measurement errors. Due to
the high requirements of infrared
temperature measurement on the
surrounding environment, please
follow the prompts below for
operation.
① Take out the ear thermometer
from the storage box.
② Power on and self checking
Press the "Switch/Measure" button,
the ear thermometer will turn on
and sta self checking with a beep
sound. During self inspection, the
screen displays three full color icons.
If the following situations exist,
measurement cannot be suppoed:
1). Operating environment tempera-
ture too low or too high: Er1 is
displayed on the screen.
2). Low batte: The low batte icon
on the screen “ ” ashes to
indicate.
If the probe cover icon “ ” scrolls
Attention: If disposable probe cover is not installed, the ear
thermometer will not operate.
Attention: If the top of the disposable probe cover is found to
be damaged, they need to be replaced with new probe cover.
③ Select age groups
Press the age selection button“ ” to select the age range
of the tested object for temperature measurement. Press the
button to switch age groups.
④ Probe preheating
This product uses preheating temperature measurement
technology. Studies have shown that preheating the ear
thermometer for temperature measurement can avoid
cooling effects, improve temperature
measurement accuracy and comfort.
When the display screen shows
"00.0", it indicates that the preheat-
ing is completed and enters the test
state.
Note: This product defaults to the age range of the last
temperature measurement. If the age group of the tempera-
ture measurement object is dierent from the age group of
the last temperature measurement object, the age group
needs to be selected.
Above 36 months
0 ~ 3 months
3 ~ 36 months
Symbol
White backlight
1 beep
(Normal
temperature)
Orange
backlight
2 beeps
(Moderate fever)
Red backlight
3 beeps
(High fever)
Age
Groups
35.8°C ≤ T≤ 37.4°C
35.4°C ≤ T≤ 37.6°C 37.6°C <T≤ 38.5°C
37.7°C < T≤ 39.4°C
35.4°C ≤ T≤ 37.7°C
/ T
>
37.4°C
T
>
38.5°C
T
>
39.4°C
0 ~ 3
months
3 ~ 36
months
Above 36
months
Notice: The above steps are for use in
beep mode. If the ear thermometer
is in mute mode, the beep will turn
off, there will be mute icon “ ” on
the screen, and other prompts will
keep the same.
Attention: When measuring, the ear thermometer sensor
should be inserted into the ear canal and aligned withthe
eardrum. Otherwisr, the measured temperature will be lower
than the actual temperature.
The method of straightening the ear canal:
When measuring temperature, please fix the head of the
subject, gently pull the auricle, and horizontally insert the
probe into the ear canal and align it with the eardrum to fully
fill the ear canal. Specifically, the method of straightening
the ear canal is as follows:
36.8℃ Low measurement Low measurement
For children under 1
year old：gently pull
the auricle outward
and backward to
keep the ear canal as
straight as possible.
Children over 1 year
old and adults:
gently pullthe auricle
outward and upward
to keep it as straight
as possible.
This product can modify default settings parameters. Facto
settings have been made for dierent sales markets before
leaving the facto. It is recommended not to modify the
facto default values. If modication is necessa, please
follow the steps below.
Beep/mute mode
This product can be set to "beep mode" and "mute mode".
(Facto default is beep mode)
Setting method:
In standby mode, press and hold “Memo” button for 5
seconds, then enter beep/mute mode. And keep to hold the
“Memo” button, the screen will display two modes of with
or without mute symbol “ ” in sequence, each mode will
display about 3 seconds. Release the button when your
desired mode is displayed, then the save the mode and return
to standby mode.
Attention:
1．After each resta, the product is in beep mode；
2. When the device is turned on without wearing probe cover,
beep/mute mode conversion cannot be peormed.
Unit conversion
This product can be set to Fahrenheit (° F) and Celsius (° C).
(Facto default is Celsius)
Setting method:
In standby mode, press and hold the "Age selection" button
for 5 seconds, and the screen will display "° C" and "° F" in
sequence until the desired unit is displayed. Release the "Age
selection" button to complete the unit conversion and return
to full display standby mode.
Attention:
1. Maintain the settings before shutting down after each
resta;
2. When the device is turned on without wearing probe cover,
unit conversion cannot be peormed.
Memo que
This ear thermometer can remember the last 32 sets of body
temperature readings, making it easy to que historical
temperature data.
Setting method:
In standby mode, press the "Memo" button to enter memo
mode. In memo mode, pressing the “Memo” button, the
screen will display “M” and memo number, release the
button, the screen will display temperature data of the
Operational principle Infrared radiation detection
Audible Indicator Yes
Use of Probe Covers Ye s
Unit size Approx. 146×37×37mm (L x W x H)
Trade mark
Do not re-use
Manufacturer
Serial number
Please read the instructions carefully.
Applied pa, Type BF
Direct current
Date of manufacture
Made in China
Unique device identier
Medical device
Use-by date
Model number
Unit weight
(include batte)
Approx. 133g
( Without storage box)
Expected Seice Life 5 years
Applied pa Sensor; Type BF
IP Class IP22
Normal using
condition
Ambient temperature:10°C~40°C(50°F~104°F)
Relative humidity: ≤85%RH
Pressure altitude: 700hPa~1060hPa
Storage and
shipping condition
Essential
Peormance
Ambient temperature:-20°C~55°C(-4°F~131°F)
Relative humidity: ≤95%RH
Pressure altitude: 700hPa to 1060hPa
1.In normal using condition
10°C~40°C (50°F~104°F),
LABORATORY ACCURACY meet:
34.0°C~ 34.9°C(93.2°F~94.8°F):±0.3°C(±0.6°F)
35.0°C~ 42.0°C(95°F~107.6°F):±0.2°C(±0.4°F)
42.1°C~ 43.0°C(107.8°F~109.4°F):±0.3°C(±0.6°F)
2.OUTPUT TEMPERATURE
Display “Hi” when measuring temperature
above 43.0°C (109.4°F) and display “Lo” when
measuring temperature lower than 34.0°C
(93.2°F).
Adjusted mode
Oral
People of all ages
Ear
34.0°C~43.0°C (93.2°F~109.4°F)
≤ ±0.2°C/0.4°F
DC 3V (2pcs AA d batteries)
Approx. 3.5 seconds
LCD screen
0.1°C (0.1°F)
Approx. 60±10 seconds
34.0°C~ 34.9°C(93.2°F~94.8°F): ±0.3°C(±0.6°F)
35.0°C~ 42.0°C(95°F~107.6°F): ±0.2°C(±0.4°F)
42.1°C~ 43.0°C(107.8°F~109.4°F): ±0.3°C(±0.6°F)
OTC
Mode of operation
Patient population
RX/OTC Use
Measurement site
Measuring range
Accuracy
Clinical repeatability
Batteries
Measurement time
Display mode
Display resolution
Automatic power-o
32 sets Memo
Measurement
reference body site
Chocking hazard!
Small children may swallow and choke on batteries. Store
batteries out of the reach of small children.
•If a batte has leaked, put on protective gloves and clean
the batte compament with a d cloth.
•Protect batteries form excessive heat.
Risk of explosion! Do not throw batteries into a re.
•Use identical or equivalent batte types only.
•Always replace all batteries at the same time.
•Do not use rechargeable batteries.
•Do not disassemble, split or crush the batteries.
Ensure that no liquid enters the interior of the thermometer.
Never use abrasive cleaning agents, thinners or benzene for
cleaning and never immerse the Thermometer in water or
other cleaning liquids.
Take care not to scratch the suace of the probe lens and
the display.
If the visual inspection identies unacceptable deterioration
such as corrosion, discoloration, pitting, cracked, then the
device should be stop to use and discard.
If the thermometer is been used for between patients,
please visually inspect the thermometer to determine if
there is stain or oil on the casing or probe after each use,
and follow the instruction of cleaning and disinfection to
cleaning your thermometer.
•
•
•
•
•
GUANGZHOU BERRCOM MEDICAL DEVICE CO., LTD EXPRESSLY
DISCLAIMS ALL WARRANTIES OF MERCHANTABILITY AND
FITNESS FOR A PARTICULAR PURPOSE.
UNDER ON CIRCUMSTANCES SHALL BERRCOM HAVE ANY
OBLIGATION OR LIABILITY FOR ANY LOSS OF PROFIT OR FOR
ANY CONSEQUENTIAL, INCIDENTAL INDIRECT, SPECIAL,
PUNITIVE, OR CONTINGENT DAMAGES WHATSOEVER WITH
RESPECT TO CLAIMS MADE BY ANY CUSTOMER, CONSUMER OR
OTHER USER OF BERRCOM PRODUCTS.
IN THE EVENT THAT ANY APPLICABLE LAWS IMPOSE WARRAN-
TIES, CONDITIONS, OR OBLIGATIONS THAT CANNOT BE
EXCLUDED OR MODIFIED, THIS PARAGRAPH SHALL APPLY TO
THE GREATEST EXTENT ALLOWED BY SUCH LAWS.
•
•
•
Screen
message
Description
No display
Possible causes Solutions
Symbol Description of symbol
Symbol Symbol Description of symbol
Description of symbol
1. System error;
2. The batte is
completely power
o
Attention: If the above measures still cannot solve the problem, please
contact customer seice.
Batte
symbol
ashing, can
not measure
temperature
Batte
symbol
display, last
batte level
ashing.
Probe cover
symbol icker
in an
animated
style
Display Er1
Display“Hi”
or“Lo”
1. Not installing
probe cover,
2. The probe cover
is not properly
installed.
The current
ambient
temperature is too
low or too high,
which is not within
the operating range
specied in the
manual and cannot
be measured.
Place the product at
normal room
temperature (10 ° C to
40 ° C) or wait for a
period of time.
1. Check if the probe lens
is diy. Please clean the
probe lens and operate
again.
2. Please ask the subject
to maintain a stable
posture and measure
again according to the
correct operating method.
3. Place the product at
normal room temperature
(10 ° C to 40 ° C) and wait
for 30 minutes.
1.The measured
temperature exceeds
the measurement
range (34.0℃ to
43.0℃).
2.Unable to collect
stable temperature
values (the
environmental
temperature changes
too quickly and the
product has not yet
reached a stable state).
1. Install probe cover;
2. Remove the probe
cover and reinstall.
The current
batte level is too
low to peorm
temperature
measurement
The current
batte level is to
low, but still
operate correctly
Suggest replacing new
batteries as soon as
possible.
Replace new batteries.
1. Turn o and then
resta;
2. Remove the batte
and replace it or replace
it with a new one;
3. Please contact your
local dealer or customer
seice.
18
Guidance and manufacturer’s declaration - electromagnetic emissions
Indicates the need for the user to consult the instructions
for use for crucial cautiona information such as
warnings and precautions that can not, for a variety of
reasons, be presented on the medical device itself.
Degree of protection against harmful ingress of water
and paiculate matter
2 Protected and against solid foreign objects of 12.5mm
Φ and greater
2 Protection against veically falling water drops when
ENCLOSURE titled up to 15°
DISPOSAL: Do not dispose of this product as unsoed
municipal waste. Collection of such waste separately for
special treatment is necessa.
The CE labelling ceies that the product complies with
the essential requirements of EU regulations on medical
device.
Symbol of European Authorized Representative,
expressly indicate the name and address of European
Authorized Representative after the symbol.
CN
Impoer
(Just for Probe
Cover)
Table 1
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 2
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 3
Emissions test
Immunity Test Compliance level
IEC 60601-1-2
Test level
Harmonic emissions IEC 61000-3-2
RF emissions CISPR 11
RF emissions CISPR 11
Radiated RF
IEC61000-4-3
(Test
specications
for ENCLOSURE
PORT IMMUNITY
to RF wireless
communications
equipment)
Radiated RF
IEC61000-4-39
(Test
specications
for ENCLOSURE
PORT IMMUNITY
to proximity
magnetic elds)
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast transient
/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
±8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 kV air
Not applicable Not applicable
Radiated RF
IEC61000-4-3
10 V/m
80 MHz – 2,7 GHz
80 % AM at 2 Hz
10 V/m
80 MHz – 2,7 GHz
80 % AM at 2 Hz
Not applicable Not applicable
Conducted RF
IEC61000-4-6
Not applicable Not applicable
Not applicable
30 A/m
50Hz/60Hz
30 A/m
50Hz/60Hz
Not applicable
±8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 kV air
Group 1
Group B
Not applicable
Not applicable
Voltage uctuations/ icker emissions
IEC 61000-3-3
Compliance
Voltage dips, sho
interruptions and
voltage variations on
power supply input lines
IEC 61000-4-11
Power frequency
magnetic eld
IEC 61000-4-8
NOTE U
T is the a.c. mians voltage prior to application of the test
level.
Tes t
Frequency
(MHz)
Band
(MHz)
Seice Modulation
IEC
60601-1-2
Test Level
(V/m)
Compli-
ance
level
(V/m)
Tes t
Frequency
Modulation
IEC 60601-1-2
Test Level
(A/m)
Compliance
level
(A/m)
Pulse
modulation
18 Hz
Pulse
modulation
217 Hz
Pulse
modulation
18 Hz
FM ± 5 kHz
deviation
1 kHz sine
385 27 27
28 28
9 9
28 28
28 28
28 28
9 9
380
–390
TETRA 400
GMRS 460,
FRS 460
LTE Band 13,
17
WLAN
802.11
a/n
GSM
800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
430
–470
704
–787
800
–960
450
710
745
780
5240
30 kHz
134,2 kHz
13,56 MHz
CW
Pulse
modulation
2.1 kHz
Pulse
modulation
50 kHz
8 8
65 65
7,5 7,5
5500
5785
810
870
930
Pulse
modulation
217 Hz
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS
1700
–
1990
1720
1845
Pulse
modulation
217 Hz
Pulse
modulation
217 Hz
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
2400
–
2570
5100
–
5800
2450
1970
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 4
AA 1.5V
1
I.Intended Use
II.Warnings And Precautions
III.Principle Of Operation Of Ear Thermometer
IV.Product Description
V. How To Use The Ear Thermometer
VI.Setting Of The Ear Thermometer
VII.Technical Specications
VIII.Batteries
IX.Included In Delive
X.Cleaning and Disinfection
XI.Troubleshooting
XII.Signs And Symbols
XIII.EMC Declaration
XIV.Warranty/seice
02
02
06
07
07
05
13
15
16
16
17
18
19
22
Contents
IV. Product Description VI. Setting Of The Ear ThermometerIII. Principle Of Operation Of
Ear Thermometer
I. Intended Use
II. Warnings And Precautions
02 03 0504 06 07 08 09 10
Instruction Manual
0
m
o
n
t
h
s
+
11 12
13
14 15 16 17 19 20 21 22 23 24
ET101 ET102 ET103
PREHE AT
EAR
THERMOMETER
NOTE:
You must read this instruction manual completely before use and
follow all instructions. Keep the instructions for later use. You must
check the device functions according to this instruction manual
prior to each use and only use this device if it is in proper working
condition.
VII. Technical Specications
VIII. Batteries
IX. Included In Delive
X. Maintainance Of The Product
The Manufacturer Resees The Rightto Alter The Specica-
tions Of Theproduct Without Prior Notication.
Ear thermometer is intended to measure ear temperature of
people of all ages. It can be used by consumers in household
environment and doctor in clinic as reference.
All objects, solid, liquid or gas, emit energy by radiation. The
intensity of this energy depends on the temperature of the
object. The ear thermometer is therefore able to measure the
temperature of a person by the energy the person emits from
ear canal. The infrared sensor located at the front end of the
device collects the infrared radiation emitted from the ear
canal. The sensor conves the received infrared into electrical
signals and transmits them to the device chip. The device chip
calculates the human body temperature based on the
intensity and frequency of the infrared signal received by the
infrared sensor.
The goal of thermomet is to measure core body tempera-
ture which is the temperatures of the vital organs. Clinical
studies showed that the ear is an excellent site of temperature
measurement because the temperatures taked in ear can
sooner and accurately reect core body temperature’s
changes .
1) Hold down the batte cover with your ngers, gently push
down to open the batte compament, and open the batte
cover.
2) Follow the polarity label in the batte compament, place
the new batte into the compament and clamp it tightly.
During installation, pay attention to the polarity and do not
install it upside down.
3) Finally, replace the batte cover in its original state.
V. How To Use The Ear Thermometer
1.Install/replace batteries
Batte installation/replacing method is as follows:
memo number. Note:The rst set of data displayed is the
most recent temperature measurement data, while the other
31 sets of data are displayed in order of temperature
measurement from near to far. In memo mode, if no any
operation within 5 seconds, the device will return to standby
mode automatically.
Over temperature warning function
If the measured body temperature is higher than the set
value, the ear thermometer will have dierent beeps and
backlight prompts.
1. Batteries using attention
1). The product uses two AA batteries.
2). When the batte symbol “ ” appears on the screen and
ashes, it indicates that the batte is low and needs to be
replaced. theoretically it can be used continuously for about
300 times (test conditions: temperature: 25°C, relative
humidity of 65%RH, staing from power on, self-check,
measurement, and automatic shutdown). When the low
batte icon on the screen ashes “ ”, it indicates that the
batte is low and needs to be replaced.
3). If the ambient temperature is low, it will shoen the batte
life.
4). When using batteries other than alkaline batteries, the
usage frequency may be ve sho, so it is recommended to
use alkaline batteries.
5). The voltage of the rechargeable batte is unstable and
can aect measurement. It is recommended not to use it.
6). When not in use for a long time, it is recommended to
remove the batte to avoid batte leakage and damage to
the product.
2. Disposing of batteries
To protect environment, dispose of empty batteries at
appropriate collection sites according to national or local
regulations.
Ear Thermometer 1pc
Instruction Manual 1pc
Quick Reference Guide 1pc
Probe Cover 20pcs(1 box)
The ear thermometer is a multi-patient reusable device, and
the cleaning and disinfection instructions were validated,
please follow the instructions to cleaning/disinfect your
thermometer prior to use.
Cleaning:
1) Use a cotton swab moistened with hot water or neutral
detergent to throughout cleaning the casing of thermometer
and measuring probe to removal of stain or oil.
2) Visual inspection the thermometer after cleaning process,
ensure there is no soil or stain is seen. if the device is
determined not to be visually clean at the end of the cleaning
step, you should either repeat the relevant previous cleaning
steps or safely dispose of the device, so that a visibly soiled
device is not used again.
Disinfection:
1) Use an 75% ethyl alcohol swab or cotton swab moistened
with 75% ethyl alcohol to disinfect the thermometer casing
and the measuring probe about 30 seconds.
2) Repeat the above steps at least 3 times, then wipe suace
and probe d with a clean cloth, and wait about 1 minute for
ding after disinfection process.
Note:
XIII. EMC Declaration XIV. Warranty/seice
The ME EQUIPMENT or ME SYSTEM is suitable for home
healthcare and clinic environments.
Statement: The ear thermometer model ET101,ET102,ET103
was tested according to the recommendations of Technical
Repo IEC TR 60601-4-2: Medical electrical equipment – Pa
4-2: Guidance and interpretation – Electromagnetic
immunity; peormance of medical electrical equipment and
medical electrical systems.
Warning：Don’t near active HF surgical equipment and the
RF shielded room of an ME system for magnetic resonance
imaging, where the intensity of EM disturbances is high.
Warning： Use of this equipment adjacent to or stacked with
other equipment should be avoided because it could result in
improper operation. If such use is necessa, this equipment
and the other equipment should be obseed to verify that
they are operating normally.
Warning: Use of accessories, transducers and cables other
than those specied or provided by the manufacturer of this
equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.”
Warning：Poable RF communications equipment (including
peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any pa
of the equipment ET101,ET102,ET103, including cables
specied by the manufacturer. Otherwise, degradation of the
peormance of this equipment could result.
1，All necessa instructions for maintaining BASIC SAFETY
and ESSENTIAL PERFORMANCE with regard to electromag-
netic disturbances for the excepted seice life.
Poable and mobile RF communication equipment may
aect the peormance of the ET101,ET102,ET103, avoiding
strong electromagnetic inteerence when used, such as near
mobile phones, microwave ovens, etc.
2，Guidance and manufacturer’s declaration -electromag-
netic emissions and Immunity
Guidance and manufacturer’s declaration - electromag-
netic emissions and Immunity
XI. Troubleshooting
XII. Signs And Symbols
If you have problems while using your thermometer, please
refer to this guide to help resolve the problem. If the problem
persists, please contact our customer seice.
Notes on handling batteries
•If your skin or eyes come into contact with batte uid,
rinse the aected area with water and seek medical
assistance.
When the buzzer beeps, it indicates that the temperature
measurement is completed and the temperature value is
displayed on the display screen.
The screens and sound prompts for different temperature
values are as follows:
Attention: The temperature value from the last temperature
measurement is displayed in the lower right corner of the
display screen, making it easier to compare changes in body
temperature.
Reference:Herzog L.Phillips S.Addressing Concerns About
Fever Clinical Pediatrics 2011 50(5) 383‒390
Below the temperature measurement range (T<34.0 ℃):
Display LO, red backlight, 1 beep:
Above the temperature measurement range (T>43.0 ℃):
Display Hi, red backlight, 1 beep.
⑤After inserting the probe into the ear canal and aligning it
with the eardrum, short press the "switch/measure" button
to measure the temperature. During the temperature
measurement process, the screen scrolls to display "- ° C",
" - ° C" and " -° C".
⑥If you need to take the next
temperature measurement, please
remove the used probe cover and
replace the new one and repeat
step ⑤.
⑦If there is no operation for about 60 seconds after the
temperature measurement is completed, the ear thermome-
ter will automatically shut down. You can also press and hold
the "Switch/Measure" button for about 5 seconds to turn off
the device. When the device is turned off, the display screen
will flash OFF for a short time and then turn off.
In accordance with our policy of continual product
improvement, we reserve the right to make technical and
optical changes without notice.
Warranty and repair terms
Warranty: 18 months.
Please contact your dealer or the service center in case of a
claim under the warranty. If you have to return the unit,
please enclose a copy of your receipt and state what the
defect is.
The following warranty terms apply:
1. The warranty period for BERRCOM products is 18 months
from date of purchase. In case of a warranty claim, the date
of purchase has to be proven by means of the sales receipt or
invoice.
2. Defects in material or workmanship will be removed free
of charge within the warranty period.
3. Repairs under warranty do not extend the warranty period
either for the unit or for the replacement parts.
4. The following is excluded under the warranty:
a. All damage which has arisen due to improper treatment,
e.g. nonobservance of the user instructions.
b. All damage which is due to repairs or tampering by the
customer or unauthorised third parties.
c. Damage which has arisen during transport from the
manufacturer to the consumer or during transport to the
service centre.
d. Accessories which are subject to normal wear and tear.
5. Liability for direct or indirect consequential losses caused
by the unit are excluded even if the damage to the unit is
accepted as a warranty claim.
Disposal
It is required that you should not dispose of WEEE as
unsoed municipal waste and collect such WEEE separately.
In accordance with Directive 2012/19/EU and national
disposal regulations regarding old electrical and electronic
devices, please be advised that such items must be disposed
of in a special way within the European Union (EU) .
These regulations require the environmentally friendly
recycling/disposal of old electrical and electronic devices.
Such items must not be disposed of as domestic refuse. This
has been expressed using the icon of the “crossed out trash
can”.
The ear thermometer (Model: ET101,ET102,ET103) contains
batteries and recyclable electronic waste. To protect the
environment, do not dispose of it in household waste as
unsoed municipal waste, but collect separately and take it to
an appropriate local collection center.
The ear thermometer (Model:ET101,ET102,ET103) is
classied as small equipment (5th catego) according to
ANNEX IV of Directive 2012/19/EU.
Before disposing of your ear thermometer (Model:
ET101,ET102,ET103), please take away the batteries from ear
thermometer (Model: ET101,ET102,ET103) and dispose of the
batteries and ear thermometer (Model: ET101,ET102,ET103)
separately.
You can take away the batteries as follows:
＞＞Batte remove diagram
① Open the lid on the back of the device
② Remove the batteries.
Batteries represent a hazard to health and the environment!
Never open, damage, or swallow batteries or allow them to
pollute the environment. They may contain toxic, ecologically
hazardous heavy metals. The removed batteries shall be
disposed of at the point of sale or in the corresponding
containers provided at collection points by local public waste
authorities and treated according to 2006/66/EC.
The batteries and recyclable electronic waste shall be
disposed of in a separate waste container.
Packaging materials must be disposed of according to local
regulations. Consult the authorized collection points for more
information.
In Germany
For the recyclable electronic waste disposal, you can search
the authorized collection points at the following website:
https://www.ear-system.de/ear-verzeichnis/sam-
mel-und-ruecknahmestellen
For batteries, you can search the authorized collection points
at the following website:
https://www.ear-system.de/ear-verzeichnis/battghersteller#-
no-back
Search method: using your postcode or the name of the city
and state where you live to nd collection points near you.
Other countries
For count-specic information on disposal, contact your
local dealers or impoer.
ashes, it reminds you to put on the
probe cover.
To obtain accurate readings, clean
and new disposable probe cover
should be installed before each
measurement.
Inse the ear thermometer probe
into the probe cover box, then pull it
out to t the new probe cover.
Only use this ear thermometer once you have read and
understood the instruction for use.
Only use this ear thermometer for the specic purpose
described in the instruction manual. Any misuse will void the
warranty.
This ear thermometer may be used for professional
purposes or for personal home use.
Using this ear thermometer is no substitute for consulting a
doctor. Do not self-diagnose or self-medicate on the basis
of the measurements without consulting your doctor. In
·
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paicular, do not sta taking any new medication or
change the type and/or dosage of any existing medication
without prior approval.
This ear thermometer must be operated by adults, ensure
that children do not use this device unsupeised; some
pas are small enough to be a choking hazard or be
swallowed.
If this thermometer is stored condition that is out of its
using condition, please put it in operation place for at least
30 minutes before taking the measurement.
When the subject enters a warm room from a cold outdoor
environment and wets their ears by swimming or bathing,
the ear canal temperature will temporarily be lower than the
actual temperature. Please wait for 30 minutes before
taking the measurement.
When the subject's ears are covered by heat due to sleeping
on their side, wearing headphones or hearing aids, or long
hair covering, the ear canal temperature will temporarily be
higher than the actual temperature. Please wait for 30
minutes before taking the measurement.
The readings of the left and right ears may dier. When
obseing changes in body temperature, it is recommended
to collect the temperature of the same ear.
The measurement may result in measurement bias when the
subject takes medication that may increase or decrease
body temperature.
The subject may experience temperature uctuations after
engaging in activities such as intense exercise, cing, and
eating. It is recommended to maintain a quiet state for at
least 30 minutes before the measurement.
Dierent types and brands of temperature measurement
products do not have comparative value. It is recommended
that you use the same temperature measurement product
for multiple frequency obseations when obseing body
temperature, in order to better grasp changes in body
temperature.
People with ear diseases such as otitis externa and otitis
media should not use the ear thermometer.
It is recommended to measure about 3 times during
measurement, with a time inteal of 12s or more than 12s
between each measurement, recommend the maximum
temperature as measurement temperature.
Please check the batte level before use, as low batte
voltage may result in inaccurate measurement results.
If you nd that this product cannot achieve the claimed
peormance or if there is a change in product peormance,
please stop using it immediately and contact the manufac-
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turer for assistance in time.
To ensure an accurate measurement, this thermometer must
only be used indoors when the ambient temperature range
is between 10℃(50℉) and 40℃（104℉）.
Before measurement, please ensure that the probe is free
from small foreign objects (such as earwax, dandru,
droplets, dust, etc.). After measurement, please place it in a
storage box to protect the probe from di or damage.
When there is a lot of earwax in the ear canal of the subject
(especially young children), please clean the ear canal
before taking the measurement to avoid aecting the
accuracy.
The probe lens is the most vulnerable pa of this product,
so it must be carefully protected. Please do not touch or
blow the probe with your hands. After measuring, please
place the product in the storage box.
Before use, conrm whether the probe lens is diy. If it is
diy, clean it according to the following steps, otherwise it
may cause measurement errors:
(1) Gently wipe the probe with a cotton swab or soft cloth
dipped in 75% alcohol.
(2) D and let the device stand for 30 minutes before use.
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This ear thermometer should not be immersed in water or
directly exposed to sunlight to avoid product malfunctions.
This ear thermometer must be kept d and clean.
Please do not place this ear thermometer in an area with
electric shock to avoid product malfunction.
If any problems are found, please contact customer seice
and do not attempt to repair this product on your own. If
the original components are replaced with pas not
provided by the manufacturer, it may cause measurement
errors.
This ear thermometer is a measuring product. It is
recommended to check the accuracy of the product with a
manufacturer or a qualied third-pay organization at a
one-year inteal.
Please dispose of the waste and residue at the end of the
product's seice life in accordance with local laws and
regulations.
This ear thermometer expected seie life is 5 years.
Please use BERRCOM exclusive disposable probe cover
(model: PC001). If you use other brand’s probe cover, it may
result in inaccurate measurements. To purchase the
disposable probe cover, please contact your agent or
BERRCOM directly.
Do not use accessories, materials, etc. that are not specied
in this manual. Using accessories that are not provided or
specied by the manufacturer may result in the product not
achieving its intended use.
Before and after each use, the thermometer should be
cleaned according to the requirement of this manual to
avoid possible bacterial infections.
Do not expose this thermometer to extreme temperature
conditions of higher than 55℃(131℉) or lower than -20℃（
-4℉）.
Do not use this thermometer in relative humidity higher
than 85%RH.
Do not put this ear thermometer in the place with direct
sunlight, high temperature, high humidity, excessive dust, or
the place where it may contact with corrosive gas or liquid,
and do not use this product in the above environment.
Do not open up this thermometer. It contains small pas
which might be swallowed by children.
Remove the batteries if you do not wish to use the unit for
an extended period of time. Otherwise there is a danger
that the batteries may leak.
Keep the thermometer away from electromagnetic elds
produced by objects such as microwave ovens, arc welders
or induction heaters.
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Please keep this ear thermometer out of reach of children.
Forceful measurement by children may cause ear inju. If
the batte is accidentally swallowed, please contact a
doctor immediately.
Please store the ear thermometer according to its storage
conditions to avoid usage issues and measurement errors.
Please do not forcefully collide, fall, step on, or shake this
product to avoid product malfunction or measurement
deviation.
·
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Note: Do not use toilet paper or tissue to wipe.
Note: The reference body temperature for the ear thermome-
ter is oral temperature.
1、Guyton A C, Textbook of medical physiology, W.B.
Saunders, Philadelphia, 1996, p919;
eardrum
ear canal
1 2 3
4
5
6
7
8
9
① Probe cover (20 pcs/box)
② Storage box
③ Temperature sensing probe
④ Probe cover detector
⑤ Switch/Measure button
Symbols interpretation:
⑥ Batte cover
⑦ Display screen
⑧ Age selection button
⑨ Memo button
Batte
capacity
Measure
value
Probe notice
Age Groups
Unit
Memo
Last
measurement
value
Mute
AA 1.5V
2.Operate the device
The correct usage method is the key to measurement
accuracy, otherwise it may cause measurement errors. Due to
the high requirements of infrared
temperature measurement on the
surrounding environment, please
follow the prompts below for
operation.
① Take out the ear thermometer
from the storage box.
② Power on and self checking
Press the "Switch/Measure" button,
the ear thermometer will turn on
and sta self checking with a beep
sound. During self inspection, the
screen displays three full color icons.
If the following situations exist,
measurement cannot be suppoed:
1). Operating environment tempera-
ture too low or too high: Er1 is
displayed on the screen.
2). Low batte: The low batte icon
on the screen “ ” ashes to
indicate.
If the probe cover icon “ ” scrolls
Attention: If disposable probe cover is not installed, the ear
thermometer will not operate.
Attention: If the top of the disposable probe cover is found to
be damaged, they need to be replaced with new probe cover.
③ Select age groups
Press the age selection button“ ” to select the age range
of the tested object for temperature measurement. Press the
button to switch age groups.
④ Probe preheating
This product uses preheating temperature measurement
technology. Studies have shown that preheating the ear
thermometer for temperature measurement can avoid
cooling effects, improve temperature
measurement accuracy and comfort.
When the display screen shows
"00.0", it indicates that the preheat-
ing is completed and enters the test
state.
Note: This product defaults to the age range of the last
temperature measurement. If the age group of the tempera-
ture measurement object is dierent from the age group of
the last temperature measurement object, the age group
needs to be selected.
Above 36 months
0 ~ 3 months
3 ~ 36 months
Symbol
White backlight
1 beep
(Normal
temperature)
Orange
backlight
2 beeps
(Moderate fever)
Red backlight
3 beeps
(High fever)
Age
Groups
35.8°C ≤ T≤ 37.4°C
35.4°C ≤ T≤ 37.6°C 37.6°C <T≤ 38.5°C
37.7°C < T≤ 39.4°C
35.4°C ≤ T≤ 37.7°C
/ T
>
37.4°C
T
>
38.5°C
T
>
39.4°C
0 ~ 3
months
3 ~ 36
months
Above 36
months
Notice: The above steps are for use in
beep mode. If the ear thermometer
is in mute mode, the beep will turn
off, there will be mute icon “ ” on
the screen, and other prompts will
keep the same.
Attention: When measuring, the ear thermometer sensor
should be inserted into the ear canal and aligned withthe
eardrum. Otherwisr, the measured temperature will be lower
than the actual temperature.
The method of straightening the ear canal:
When measuring temperature, please fix the head of the
subject, gently pull the auricle, and horizontally insert the
probe into the ear canal and align it with the eardrum to fully
fill the ear canal. Specifically, the method of straightening
the ear canal is as follows:
36.8℃ Low measurement Low measurement
For children under 1
year old：gently pull
the auricle outward
and backward to
keep the ear canal as
straight as possible.
Children over 1 year
old and adults:
gently pullthe auricle
outward and upward
to keep it as straight
as possible.
This product can modify default settings parameters. Facto
settings have been made for dierent sales markets before
leaving the facto. It is recommended not to modify the
facto default values. If modication is necessa, please
follow the steps below.
Beep/mute mode
This product can be set to "beep mode" and "mute mode".
(Facto default is beep mode)
Setting method:
In standby mode, press and hold “Memo” button for 5
seconds, then enter beep/mute mode. And keep to hold the
“Memo” button, the screen will display two modes of with
or without mute symbol “ ” in sequence, each mode will
display about 3 seconds. Release the button when your
desired mode is displayed, then the save the mode and return
to standby mode.
Attention:
1．After each resta, the product is in beep mode；
2. When the device is turned on without wearing probe cover,
beep/mute mode conversion cannot be peormed.
Unit conversion
This product can be set to Fahrenheit (° F) and Celsius (° C).
(Facto default is Celsius)
Setting method:
In standby mode, press and hold the "Age selection" button
for 5 seconds, and the screen will display "° C" and "° F" in
sequence until the desired unit is displayed. Release the "Age
selection" button to complete the unit conversion and return
to full display standby mode.
Attention:
1. Maintain the settings before shutting down after each
resta;
2. When the device is turned on without wearing probe cover,
unit conversion cannot be peormed.
Memo que
This ear thermometer can remember the last 32 sets of body
temperature readings, making it easy to que historical
temperature data.
Setting method:
In standby mode, press the "Memo" button to enter memo
mode. In memo mode, pressing the “Memo” button, the
screen will display “M” and memo number, release the
button, the screen will display temperature data of the
Operational principle Infrared radiation detection
Audible Indicator Yes
Use of Probe Covers Ye s
Unit size Approx. 146×37×37mm (L x W x H)
Trade mark
Do not re-use
Manufacturer
Serial number
Please read the instructions carefully.
Applied pa, Type BF
Direct current
Date of manufacture
Made in China
Unique device identier
Medical device
Use-by date
Model number
Unit weight
(include batte)
Approx. 133g
( Without storage box)
Expected Seice Life 5 years
Applied pa Sensor; Type BF
IP Class IP22
Normal using
condition
Ambient temperature:10°C~40°C(50°F~104°F)
Relative humidity: ≤85%RH
Pressure altitude: 700hPa~1060hPa
Storage and
shipping condition
Essential
Peormance
Ambient temperature:-20°C~55°C(-4°F~131°F)
Relative humidity: ≤95%RH
Pressure altitude: 700hPa to 1060hPa
1.In normal using condition
10°C~40°C (50°F~104°F),
LABORATORY ACCURACY meet:
34.0°C~ 34.9°C(93.2°F~94.8°F):±0.3°C(±0.6°F)
35.0°C~ 42.0°C(95°F~107.6°F):±0.2°C(±0.4°F)
42.1°C~ 43.0°C(107.8°F~109.4°F):±0.3°C(±0.6°F)
2.OUTPUT TEMPERATURE
Display “Hi” when measuring temperature
above 43.0°C (109.4°F) and display “Lo” when
measuring temperature lower than 34.0°C
(93.2°F).
Adjusted mode
Oral
People of all ages
Ear
34.0°C~43.0°C (93.2°F~109.4°F)
≤ ±0.2°C/0.4°F
DC 3V (2pcs AA d batteries)
Approx. 3.5 seconds
LCD screen
0.1°C (0.1°F)
Approx. 60±10 seconds
34.0°C~ 34.9°C(93.2°F~94.8°F): ±0.3°C(±0.6°F)
35.0°C~ 42.0°C(95°F~107.6°F): ±0.2°C(±0.4°F)
42.1°C~ 43.0°C(107.8°F~109.4°F): ±0.3°C(±0.6°F)
OTC
Mode of operation
Patient population
RX/OTC Use
Measurement site
Measuring range
Accuracy
Clinical repeatability
Batteries
Measurement time
Display mode
Display resolution
Automatic power-o
32 sets Memo
Measurement
reference body site
Chocking hazard!
Small children may swallow and choke on batteries. Store
batteries out of the reach of small children.
•If a batte has leaked, put on protective gloves and clean
the batte compament with a d cloth.
•Protect batteries form excessive heat.
Risk of explosion! Do not throw batteries into a re.
•Use identical or equivalent batte types only.
•Always replace all batteries at the same time.
•Do not use rechargeable batteries.
•Do not disassemble, split or crush the batteries.
Ensure that no liquid enters the interior of the thermometer.
Never use abrasive cleaning agents, thinners or benzene for
cleaning and never immerse the Thermometer in water or
other cleaning liquids.
Take care not to scratch the suace of the probe lens and
the display.
If the visual inspection identies unacceptable deterioration
such as corrosion, discoloration, pitting, cracked, then the
device should be stop to use and discard.
If the thermometer is been used for between patients,
please visually inspect the thermometer to determine if
there is stain or oil on the casing or probe after each use,
and follow the instruction of cleaning and disinfection to
cleaning your thermometer.
•
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•
•
GUANGZHOU BERRCOM MEDICAL DEVICE CO., LTD EXPRESSLY
DISCLAIMS ALL WARRANTIES OF MERCHANTABILITY AND
FITNESS FOR A PARTICULAR PURPOSE.
UNDER ON CIRCUMSTANCES SHALL BERRCOM HAVE ANY
OBLIGATION OR LIABILITY FOR ANY LOSS OF PROFIT OR FOR
ANY CONSEQUENTIAL, INCIDENTAL INDIRECT, SPECIAL,
PUNITIVE, OR CONTINGENT DAMAGES WHATSOEVER WITH
RESPECT TO CLAIMS MADE BY ANY CUSTOMER, CONSUMER OR
OTHER USER OF BERRCOM PRODUCTS.
IN THE EVENT THAT ANY APPLICABLE LAWS IMPOSE WARRAN-
TIES, CONDITIONS, OR OBLIGATIONS THAT CANNOT BE
EXCLUDED OR MODIFIED, THIS PARAGRAPH SHALL APPLY TO
THE GREATEST EXTENT ALLOWED BY SUCH LAWS.
•
•
•
Screen
message
Description
No display
Possible causes Solutions
Symbol Description of symbol
Symbol Symbol Description of symbol
Description of symbol
1. System error;
2. The batte is
completely power
o
Attention: If the above measures still cannot solve the problem, please
contact customer seice.
Batte
symbol
ashing, can
not measure
temperature
Batte
symbol
display, last
batte level
ashing.
Probe cover
symbol icker
in an
animated
style
Display Er1
Display“Hi”
or“Lo”
1. Not installing
probe cover,
2. The probe cover
is not properly
installed.
The current
ambient
temperature is too
low or too high,
which is not within
the operating range
specied in the
manual and cannot
be measured.
Place the product at
normal room
temperature (10 ° C to
40 ° C) or wait for a
period of time.
1. Check if the probe lens
is diy. Please clean the
probe lens and operate
again.
2. Please ask the subject
to maintain a stable
posture and measure
again according to the
correct operating method.
3. Place the product at
normal room temperature
(10 ° C to 40 ° C) and wait
for 30 minutes.
1.The measured
temperature exceeds
the measurement
range (34.0℃ to
43.0℃).
2.Unable to collect
stable temperature
values (the
environmental
temperature changes
too quickly and the
product has not yet
reached a stable state).
1. Install probe cover;
2. Remove the probe
cover and reinstall.
The current
batte level is too
low to peorm
temperature
measurement
The current
batte level is to
low, but still
operate correctly
Suggest replacing new
batteries as soon as
possible.
Replace new batteries.
1. Turn o and then
resta;
2. Remove the batte
and replace it or replace
it with a new one;
3. Please contact your
local dealer or customer
seice.
18
Guidance and manufacturer’s declaration - electromagnetic emissions
Indicates the need for the user to consult the instructions
for use for crucial cautiona information such as
warnings and precautions that can not, for a variety of
reasons, be presented on the medical device itself.
Degree of protection against harmful ingress of water
and paiculate matter
2 Protected and against solid foreign objects of 12.5mm
Φ and greater
2 Protection against veically falling water drops when
ENCLOSURE titled up to 15°
DISPOSAL: Do not dispose of this product as unsoed
municipal waste. Collection of such waste separately for
special treatment is necessa.
The CE labelling ceies that the product complies with
the essential requirements of EU regulations on medical
device.
Symbol of European Authorized Representative,
expressly indicate the name and address of European
Authorized Representative after the symbol.
CN
Impoer
(Just for Probe
Cover)
Table 1
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 2
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 3
Emissions test
Immunity Test Compliance level
IEC 60601-1-2
Test level
Harmonic emissions IEC 61000-3-2
RF emissions CISPR 11
RF emissions CISPR 11
Radiated RF
IEC61000-4-3
(Test
specications
for ENCLOSURE
PORT IMMUNITY
to RF wireless
communications
equipment)
Radiated RF
IEC61000-4-39
(Test
specications
for ENCLOSURE
PORT IMMUNITY
to proximity
magnetic elds)
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast transient
/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
±8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 kV air
Not applicable Not applicable
Radiated RF
IEC61000-4-3
10 V/m
80 MHz – 2,7 GHz
80 % AM at 2 Hz
10 V/m
80 MHz – 2,7 GHz
80 % AM at 2 Hz
Not applicable Not applicable
Conducted RF
IEC61000-4-6
Not applicable Not applicable
Not applicable
30 A/m
50Hz/60Hz
30 A/m
50Hz/60Hz
Not applicable
±8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 kV air
Group 1
Group B
Not applicable
Not applicable
Voltage uctuations/ icker emissions
IEC 61000-3-3
Compliance
Voltage dips, sho
interruptions and
voltage variations on
power supply input lines
IEC 61000-4-11
Power frequency
magnetic eld
IEC 61000-4-8
NOTE U
T is the a.c. mians voltage prior to application of the test
level.
Tes t
Frequency
(MHz)
Band
(MHz)
Seice Modulation
IEC
60601-1-2
Test Level
(V/m)
Compli-
ance
level
(V/m)
Tes t
Frequency
Modulation
IEC 60601-1-2
Test Level
(A/m)
Compliance
level
(A/m)
Pulse
modulation
18 Hz
Pulse
modulation
217 Hz
Pulse
modulation
18 Hz
FM ± 5 kHz
deviation
1 kHz sine
385 27 27
28 28
9 9
28 28
28 28
28 28
9 9
380
–390
TETRA 400
GMRS 460,
FRS 460
LTE Band 13,
17
WLAN
802.11
a/n
GSM
800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
430
–470
704
–787
800
–960
450
710
745
780
5240
30 kHz
134,2 kHz
13,56 MHz
CW
Pulse
modulation
2.1 kHz
Pulse
modulation
50 kHz
8 8
65 65
7,5 7,5
5500
5785
810
870
930
Pulse
modulation
217 Hz
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS
1700
–
1990
1720
1845
Pulse
modulation
217 Hz
Pulse
modulation
217 Hz
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
2400
–
2570
5100
–
5800
2450
1970
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 4
AA 1.5V
1
I.Intended Use
II.Warnings And Precautions
III.Principle Of Operation Of Ear Thermometer
IV.Product Description
V. How To Use The Ear Thermometer
VI.Setting Of The Ear Thermometer
VII.Technical Specications
VIII.Batteries
IX.Included In Delive
X.Cleaning and Disinfection
XI.Troubleshooting
XII.Signs And Symbols
XIII.EMC Declaration
XIV.Warranty/seice
02
02
06
07
07
05
13
15
16
16
17
18
19
22
Contents
IV. Product Description VI. Setting Of The Ear ThermometerIII. Principle Of Operation Of
Ear Thermometer
I. Intended Use
II. Warnings And Precautions
02 03 0504 06 07 08 09 10
Instruction Manual
0
m
o
n
t
h
s
+
11 12
13
14 15 16 17 19 20 21 22 23 24
ET101 ET102 ET103
PREHE AT
EAR
THERMOMETER
NOTE:
You must read this instruction manual completely before use and
follow all instructions. Keep the instructions for later use. You must
check the device functions according to this instruction manual
prior to each use and only use this device if it is in proper working
condition.
VII. Technical Specications
VIII. Batteries
IX. Included In Delive
X. Maintainance Of The Product
The Manufacturer Resees The Rightto Alter The Specica-
tions Of Theproduct Without Prior Notication.
Ear thermometer is intended to measure ear temperature of
people of all ages. It can be used by consumers in household
environment and doctor in clinic as reference.
All objects, solid, liquid or gas, emit energy by radiation. The
intensity of this energy depends on the temperature of the
object. The ear thermometer is therefore able to measure the
temperature of a person by the energy the person emits from
ear canal. The infrared sensor located at the front end of the
device collects the infrared radiation emitted from the ear
canal. The sensor conves the received infrared into electrical
signals and transmits them to the device chip. The device chip
calculates the human body temperature based on the
intensity and frequency of the infrared signal received by the
infrared sensor.
The goal of thermomet is to measure core body tempera-
ture which is the temperatures of the vital organs. Clinical
studies showed that the ear is an excellent site of temperature
measurement because the temperatures taked in ear can
sooner and accurately reect core body temperature’s
changes .
1) Hold down the batte cover with your ngers, gently push
down to open the batte compament, and open the batte
cover.
2) Follow the polarity label in the batte compament, place
the new batte into the compament and clamp it tightly.
During installation, pay attention to the polarity and do not
install it upside down.
3) Finally, replace the batte cover in its original state.
V. How To Use The Ear Thermometer
1.Install/replace batteries
Batte installation/replacing method is as follows:
memo number. Note:The rst set of data displayed is the
most recent temperature measurement data, while the other
31 sets of data are displayed in order of temperature
measurement from near to far. In memo mode, if no any
operation within 5 seconds, the device will return to standby
mode automatically.
Over temperature warning function
If the measured body temperature is higher than the set
value, the ear thermometer will have dierent beeps and
backlight prompts.
1. Batteries using attention
1). The product uses two AA batteries.
2). When the batte symbol “ ” appears on the screen and
ashes, it indicates that the batte is low and needs to be
replaced. theoretically it can be used continuously for about
300 times (test conditions: temperature: 25°C, relative
humidity of 65%RH, staing from power on, self-check,
measurement, and automatic shutdown). When the low
batte icon on the screen ashes “ ”, it indicates that the
batte is low and needs to be replaced.
3). If the ambient temperature is low, it will shoen the batte
life.
4). When using batteries other than alkaline batteries, the
usage frequency may be ve sho, so it is recommended to
use alkaline batteries.
5). The voltage of the rechargeable batte is unstable and
can aect measurement. It is recommended not to use it.
6). When not in use for a long time, it is recommended to
remove the batte to avoid batte leakage and damage to
the product.
2. Disposing of batteries
To protect environment, dispose of empty batteries at
appropriate collection sites according to national or local
regulations.
Ear Thermometer 1pc
Instruction Manual 1pc
Quick Reference Guide 1pc
Probe Cover 20pcs(1 box)
The ear thermometer is a multi-patient reusable device, and
the cleaning and disinfection instructions were validated,
please follow the instructions to cleaning/disinfect your
thermometer prior to use.
Cleaning:
1) Use a cotton swab moistened with hot water or neutral
detergent to throughout cleaning the casing of thermometer
and measuring probe to removal of stain or oil.
2) Visual inspection the thermometer after cleaning process,
ensure there is no soil or stain is seen. if the device is
determined not to be visually clean at the end of the cleaning
step, you should either repeat the relevant previous cleaning
steps or safely dispose of the device, so that a visibly soiled
device is not used again.
Disinfection:
1) Use an 75% ethyl alcohol swab or cotton swab moistened
with 75% ethyl alcohol to disinfect the thermometer casing
and the measuring probe about 30 seconds.
2) Repeat the above steps at least 3 times, then wipe suace
and probe d with a clean cloth, and wait about 1 minute for
ding after disinfection process.
Note:
XIII. EMC Declaration XIV. Warranty/seice
The ME EQUIPMENT or ME SYSTEM is suitable for home
healthcare and clinic environments.
Statement: The ear thermometer model ET101,ET102,ET103
was tested according to the recommendations of Technical
Repo IEC TR 60601-4-2: Medical electrical equipment – Pa
4-2: Guidance and interpretation – Electromagnetic
immunity; peormance of medical electrical equipment and
medical electrical systems.
Warning：Don’t near active HF surgical equipment and the
RF shielded room of an ME system for magnetic resonance
imaging, where the intensity of EM disturbances is high.
Warning： Use of this equipment adjacent to or stacked with
other equipment should be avoided because it could result in
improper operation. If such use is necessa, this equipment
and the other equipment should be obseed to verify that
they are operating normally.
Warning: Use of accessories, transducers and cables other
than those specied or provided by the manufacturer of this
equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.”
Warning：Poable RF communications equipment (including
peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any pa
of the equipment ET101,ET102,ET103, including cables
specied by the manufacturer. Otherwise, degradation of the
peormance of this equipment could result.
1，All necessa instructions for maintaining BASIC SAFETY
and ESSENTIAL PERFORMANCE with regard to electromag-
netic disturbances for the excepted seice life.
Poable and mobile RF communication equipment may
aect the peormance of the ET101,ET102,ET103, avoiding
strong electromagnetic inteerence when used, such as near
mobile phones, microwave ovens, etc.
2，Guidance and manufacturer’s declaration -electromag-
netic emissions and Immunity
Guidance and manufacturer’s declaration - electromag-
netic emissions and Immunity
XI. Troubleshooting
XII. Signs And Symbols
If you have problems while using your thermometer, please
refer to this guide to help resolve the problem. If the problem
persists, please contact our customer seice.
Notes on handling batteries
•If your skin or eyes come into contact with batte uid,
rinse the aected area with water and seek medical
assistance.
When the buzzer beeps, it indicates that the temperature
measurement is completed and the temperature value is
displayed on the display screen.
The screens and sound prompts for different temperature
values are as follows:
Attention: The temperature value from the last temperature
measurement is displayed in the lower right corner of the
display screen, making it easier to compare changes in body
temperature.
Reference:Herzog L.Phillips S.Addressing Concerns About
Fever Clinical Pediatrics 2011 50(5) 383‒390
Below the temperature measurement range (T<34.0 ℃):
Display LO, red backlight, 1 beep:
Above the temperature measurement range (T>43.0 ℃):
Display Hi, red backlight, 1 beep.
⑤After inserting the probe into the ear canal and aligning it
with the eardrum, short press the "switch/measure" button
to measure the temperature. During the temperature
measurement process, the screen scrolls to display "- ° C",
" - ° C" and " -° C".
⑥If you need to take the next
temperature measurement, please
remove the used probe cover and
replace the new one and repeat
step ⑤.
⑦If there is no operation for about 60 seconds after the
temperature measurement is completed, the ear thermome-
ter will automatically shut down. You can also press and hold
the "Switch/Measure" button for about 5 seconds to turn off
the device. When the device is turned off, the display screen
will flash OFF for a short time and then turn off.
In accordance with our policy of continual product
improvement, we reserve the right to make technical and
optical changes without notice.
Warranty and repair terms
Warranty: 18 months.
Please contact your dealer or the service center in case of a
claim under the warranty. If you have to return the unit,
please enclose a copy of your receipt and state what the
defect is.
The following warranty terms apply:
1. The warranty period for BERRCOM products is 18 months
from date of purchase. In case of a warranty claim, the date
of purchase has to be proven by means of the sales receipt or
invoice.
2. Defects in material or workmanship will be removed free
of charge within the warranty period.
3. Repairs under warranty do not extend the warranty period
either for the unit or for the replacement parts.
4. The following is excluded under the warranty:
a. All damage which has arisen due to improper treatment,
e.g. nonobservance of the user instructions.
b. All damage which is due to repairs or tampering by the
customer or unauthorised third parties.
c. Damage which has arisen during transport from the
manufacturer to the consumer or during transport to the
service centre.
d. Accessories which are subject to normal wear and tear.
5. Liability for direct or indirect consequential losses caused
by the unit are excluded even if the damage to the unit is
accepted as a warranty claim.
Disposal
It is required that you should not dispose of WEEE as
unsoed municipal waste and collect such WEEE separately.
In accordance with Directive 2012/19/EU and national
disposal regulations regarding old electrical and electronic
devices, please be advised that such items must be disposed
of in a special way within the European Union (EU) .
These regulations require the environmentally friendly
recycling/disposal of old electrical and electronic devices.
Such items must not be disposed of as domestic refuse. This
has been expressed using the icon of the “crossed out trash
can”.
The ear thermometer (Model: ET101,ET102,ET103) contains
batteries and recyclable electronic waste. To protect the
environment, do not dispose of it in household waste as
unsoed municipal waste, but collect separately and take it to
an appropriate local collection center.
The ear thermometer (Model:ET101,ET102,ET103) is
classied as small equipment (5th catego) according to
ANNEX IV of Directive 2012/19/EU.
Before disposing of your ear thermometer (Model:
ET101,ET102,ET103), please take away the batteries from ear
thermometer (Model: ET101,ET102,ET103) and dispose of the
batteries and ear thermometer (Model: ET101,ET102,ET103)
separately.
You can take away the batteries as follows:
＞＞Batte remove diagram
① Open the lid on the back of the device
② Remove the batteries.
Batteries represent a hazard to health and the environment!
Never open, damage, or swallow batteries or allow them to
pollute the environment. They may contain toxic, ecologically
hazardous heavy metals. The removed batteries shall be
disposed of at the point of sale or in the corresponding
containers provided at collection points by local public waste
authorities and treated according to 2006/66/EC.
The batteries and recyclable electronic waste shall be
disposed of in a separate waste container.
Packaging materials must be disposed of according to local
regulations. Consult the authorized collection points for more
information.
In Germany
For the recyclable electronic waste disposal, you can search
the authorized collection points at the following website:
https://www.ear-system.de/ear-verzeichnis/sam-
mel-und-ruecknahmestellen
For batteries, you can search the authorized collection points
at the following website:
https://www.ear-system.de/ear-verzeichnis/battghersteller#-
no-back
Search method: using your postcode or the name of the city
and state where you live to nd collection points near you.
Other countries
For count-specic information on disposal, contact your
local dealers or impoer.
ashes, it reminds you to put on the
probe cover.
To obtain accurate readings, clean
and new disposable probe cover
should be installed before each
measurement.
Inse the ear thermometer probe
into the probe cover box, then pull it
out to t the new probe cover.
Only use this ear thermometer once you have read and
understood the instruction for use.
Only use this ear thermometer for the specic purpose
described in the instruction manual. Any misuse will void the
warranty.
This ear thermometer may be used for professional
purposes or for personal home use.
Using this ear thermometer is no substitute for consulting a
doctor. Do not self-diagnose or self-medicate on the basis
of the measurements without consulting your doctor. In
·
·
·
·
paicular, do not sta taking any new medication or
change the type and/or dosage of any existing medication
without prior approval.
This ear thermometer must be operated by adults, ensure
that children do not use this device unsupeised; some
pas are small enough to be a choking hazard or be
swallowed.
If this thermometer is stored condition that is out of its
using condition, please put it in operation place for at least
30 minutes before taking the measurement.
When the subject enters a warm room from a cold outdoor
environment and wets their ears by swimming or bathing,
the ear canal temperature will temporarily be lower than the
actual temperature. Please wait for 30 minutes before
taking the measurement.
When the subject's ears are covered by heat due to sleeping
on their side, wearing headphones or hearing aids, or long
hair covering, the ear canal temperature will temporarily be
higher than the actual temperature. Please wait for 30
minutes before taking the measurement.
The readings of the left and right ears may dier. When
obseing changes in body temperature, it is recommended
to collect the temperature of the same ear.
The measurement may result in measurement bias when the
subject takes medication that may increase or decrease
body temperature.
The subject may experience temperature uctuations after
engaging in activities such as intense exercise, cing, and
eating. It is recommended to maintain a quiet state for at
least 30 minutes before the measurement.
Dierent types and brands of temperature measurement
products do not have comparative value. It is recommended
that you use the same temperature measurement product
for multiple frequency obseations when obseing body
temperature, in order to better grasp changes in body
temperature.
People with ear diseases such as otitis externa and otitis
media should not use the ear thermometer.
It is recommended to measure about 3 times during
measurement, with a time inteal of 12s or more than 12s
between each measurement, recommend the maximum
temperature as measurement temperature.
Please check the batte level before use, as low batte
voltage may result in inaccurate measurement results.
If you nd that this product cannot achieve the claimed
peormance or if there is a change in product peormance,
please stop using it immediately and contact the manufac-
·
·
·
·
·
·
·
·
·
·
·
·
turer for assistance in time.
To ensure an accurate measurement, this thermometer must
only be used indoors when the ambient temperature range
is between 10℃(50℉) and 40℃（104℉）.
Before measurement, please ensure that the probe is free
from small foreign objects (such as earwax, dandru,
droplets, dust, etc.). After measurement, please place it in a
storage box to protect the probe from di or damage.
When there is a lot of earwax in the ear canal of the subject
(especially young children), please clean the ear canal
before taking the measurement to avoid aecting the
accuracy.
The probe lens is the most vulnerable pa of this product,
so it must be carefully protected. Please do not touch or
blow the probe with your hands. After measuring, please
place the product in the storage box.
Before use, conrm whether the probe lens is diy. If it is
diy, clean it according to the following steps, otherwise it
may cause measurement errors:
(1) Gently wipe the probe with a cotton swab or soft cloth
dipped in 75% alcohol.
(2) D and let the device stand for 30 minutes before use.
·
·
·
·
·
This ear thermometer should not be immersed in water or
directly exposed to sunlight to avoid product malfunctions.
This ear thermometer must be kept d and clean.
Please do not place this ear thermometer in an area with
electric shock to avoid product malfunction.
If any problems are found, please contact customer seice
and do not attempt to repair this product on your own. If
the original components are replaced with pas not
provided by the manufacturer, it may cause measurement
errors.
This ear thermometer is a measuring product. It is
recommended to check the accuracy of the product with a
manufacturer or a qualied third-pay organization at a
one-year inteal.
Please dispose of the waste and residue at the end of the
product's seice life in accordance with local laws and
regulations.
This ear thermometer expected seie life is 5 years.
Please use BERRCOM exclusive disposable probe cover
(model: PC001). If you use other brand’s probe cover, it may
result in inaccurate measurements. To purchase the
disposable probe cover, please contact your agent or
BERRCOM directly.
Do not use accessories, materials, etc. that are not specied
in this manual. Using accessories that are not provided or
specied by the manufacturer may result in the product not
achieving its intended use.
Before and after each use, the thermometer should be
cleaned according to the requirement of this manual to
avoid possible bacterial infections.
Do not expose this thermometer to extreme temperature
conditions of higher than 55℃(131℉) or lower than -20℃（
-4℉）.
Do not use this thermometer in relative humidity higher
than 85%RH.
Do not put this ear thermometer in the place with direct
sunlight, high temperature, high humidity, excessive dust, or
the place where it may contact with corrosive gas or liquid,
and do not use this product in the above environment.
Do not open up this thermometer. It contains small pas
which might be swallowed by children.
Remove the batteries if you do not wish to use the unit for
an extended period of time. Otherwise there is a danger
that the batteries may leak.
Keep the thermometer away from electromagnetic elds
produced by objects such as microwave ovens, arc welders
or induction heaters.
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
Please keep this ear thermometer out of reach of children.
Forceful measurement by children may cause ear inju. If
the batte is accidentally swallowed, please contact a
doctor immediately.
Please store the ear thermometer according to its storage
conditions to avoid usage issues and measurement errors.
Please do not forcefully collide, fall, step on, or shake this
product to avoid product malfunction or measurement
deviation.
·
·
Note: Do not use toilet paper or tissue to wipe.
Note: The reference body temperature for the ear thermome-
ter is oral temperature.
1、Guyton A C, Textbook of medical physiology, W.B.
Saunders, Philadelphia, 1996, p919;
eardrum
ear canal
1 2 3
4
5
6
7
8
9
① Probe cover (20 pcs/box)
② Storage box
③ Temperature sensing probe
④ Probe cover detector
⑤ Switch/Measure button
Symbols interpretation:
⑥ Batte cover
⑦ Display screen
⑧ Age selection button
⑨ Memo button
Batte
capacity
Measure
value
Probe notice
Age Groups
Unit
Memo
Last
measurement
value
Mute
AA 1.5V
2.Operate the device
The correct usage method is the key to measurement
accuracy, otherwise it may cause measurement errors. Due to
the high requirements of infrared
temperature measurement on the
surrounding environment, please
follow the prompts below for
operation.
① Take out the ear thermometer
from the storage box.
② Power on and self checking
Press the "Switch/Measure" button,
the ear thermometer will turn on
and sta self checking with a beep
sound. During self inspection, the
screen displays three full color icons.
If the following situations exist,
measurement cannot be suppoed:
1). Operating environment tempera-
ture too low or too high: Er1 is
displayed on the screen.
2). Low batte: The low batte icon
on the screen “ ” ashes to
indicate.
If the probe cover icon “ ” scrolls
Attention: If disposable probe cover is not installed, the ear
thermometer will not operate.
Attention: If the top of the disposable probe cover is found to
be damaged, they need to be replaced with new probe cover.
③ Select age groups
Press the age selection button“ ” to select the age range
of the tested object for temperature measurement. Press the
button to switch age groups.
④ Probe preheating
This product uses preheating temperature measurement
technology. Studies have shown that preheating the ear
thermometer for temperature measurement can avoid
cooling effects, improve temperature
measurement accuracy and comfort.
When the display screen shows
"00.0", it indicates that the preheat-
ing is completed and enters the test
state.
Note: This product defaults to the age range of the last
temperature measurement. If the age group of the tempera-
ture measurement object is dierent from the age group of
the last temperature measurement object, the age group
needs to be selected.
Above 36 months
0 ~ 3 months
3 ~ 36 months
Symbol
White backlight
1 beep
(Normal
temperature)
Orange
backlight
2 beeps
(Moderate fever)
Red backlight
3 beeps
(High fever)
Age
Groups
35.8°C ≤ T≤ 37.4°C
35.4°C ≤ T≤ 37.6°C 37.6°C <T≤ 38.5°C
37.7°C < T≤ 39.4°C
35.4°C ≤ T≤ 37.7°C
/ T
>
37.4°C
T
>
38.5°C
T
>
39.4°C
0 ~ 3
months
3 ~ 36
months
Above 36
months
Notice: The above steps are for use in
beep mode. If the ear thermometer
is in mute mode, the beep will turn
off, there will be mute icon “ ” on
the screen, and other prompts will
keep the same.
Attention: When measuring, the ear thermometer sensor
should be inserted into the ear canal and aligned withthe
eardrum. Otherwisr, the measured temperature will be lower
than the actual temperature.
The method of straightening the ear canal:
When measuring temperature, please fix the head of the
subject, gently pull the auricle, and horizontally insert the
probe into the ear canal and align it with the eardrum to fully
fill the ear canal. Specifically, the method of straightening
the ear canal is as follows:
36.8℃ Low measurement Low measurement
For children under 1
year old：gently pull
the auricle outward
and backward to
keep the ear canal as
straight as possible.
Children over 1 year
old and adults:
gently pullthe auricle
outward and upward
to keep it as straight
as possible.
This product can modify default settings parameters. Facto
settings have been made for dierent sales markets before
leaving the facto. It is recommended not to modify the
facto default values. If modication is necessa, please
follow the steps below.
Beep/mute mode
This product can be set to "beep mode" and "mute mode".
(Facto default is beep mode)
Setting method:
In standby mode, press and hold “Memo” button for 5
seconds, then enter beep/mute mode. And keep to hold the
“Memo” button, the screen will display two modes of with
or without mute symbol “ ” in sequence, each mode will
display about 3 seconds. Release the button when your
desired mode is displayed, then the save the mode and return
to standby mode.
Attention:
1．After each resta, the product is in beep mode；
2. When the device is turned on without wearing probe cover,
beep/mute mode conversion cannot be peormed.
Unit conversion
This product can be set to Fahrenheit (° F) and Celsius (° C).
(Facto default is Celsius)
Setting method:
In standby mode, press and hold the "Age selection" button
for 5 seconds, and the screen will display "° C" and "° F" in
sequence until the desired unit is displayed. Release the "Age
selection" button to complete the unit conversion and return
to full display standby mode.
Attention:
1. Maintain the settings before shutting down after each
resta;
2. When the device is turned on without wearing probe cover,
unit conversion cannot be peormed.
Memo que
This ear thermometer can remember the last 32 sets of body
temperature readings, making it easy to que historical
temperature data.
Setting method:
In standby mode, press the "Memo" button to enter memo
mode. In memo mode, pressing the “Memo” button, the
screen will display “M” and memo number, release the
button, the screen will display temperature data of the
Operational principle Infrared radiation detection
Audible Indicator Yes
Use of Probe Covers Ye s
Unit size Approx. 146×37×37mm (L x W x H)
Trade mark
Do not re-use
Manufacturer
Serial number
Please read the instructions carefully.
Applied pa, Type BF
Direct current
Date of manufacture
Made in China
Unique device identier
Medical device
Use-by date
Model number
Unit weight
(include batte)
Approx. 133g
( Without storage box)
Expected Seice Life 5 years
Applied pa Sensor; Type BF
IP Class IP22
Normal using
condition
Ambient temperature:10°C~40°C(50°F~104°F)
Relative humidity: ≤85%RH
Pressure altitude: 700hPa~1060hPa
Storage and
shipping condition
Essential
Peormance
Ambient temperature:-20°C~55°C(-4°F~131°F)
Relative humidity: ≤95%RH
Pressure altitude: 700hPa to 1060hPa
1.In normal using condition
10°C~40°C (50°F~104°F),
LABORATORY ACCURACY meet:
34.0°C~ 34.9°C(93.2°F~94.8°F):±0.3°C(±0.6°F)
35.0°C~ 42.0°C(95°F~107.6°F):±0.2°C(±0.4°F)
42.1°C~ 43.0°C(107.8°F~109.4°F):±0.3°C(±0.6°F)
2.OUTPUT TEMPERATURE
Display “Hi” when measuring temperature
above 43.0°C (109.4°F) and display “Lo” when
measuring temperature lower than 34.0°C
(93.2°F).
Adjusted mode
Oral
People of all ages
Ear
34.0°C~43.0°C (93.2°F~109.4°F)
≤ ±0.2°C/0.4°F
DC 3V (2pcs AA d batteries)
Approx. 3.5 seconds
LCD screen
0.1°C (0.1°F)
Approx. 60±10 seconds
34.0°C~ 34.9°C(93.2°F~94.8°F): ±0.3°C(±0.6°F)
35.0°C~ 42.0°C(95°F~107.6°F): ±0.2°C(±0.4°F)
42.1°C~ 43.0°C(107.8°F~109.4°F): ±0.3°C(±0.6°F)
OTC
Mode of operation
Patient population
RX/OTC Use
Measurement site
Measuring range
Accuracy
Clinical repeatability
Batteries
Measurement time
Display mode
Display resolution
Automatic power-o
32 sets Memo
Measurement
reference body site
Chocking hazard!
Small children may swallow and choke on batteries. Store
batteries out of the reach of small children.
•If a batte has leaked, put on protective gloves and clean
the batte compament with a d cloth.
•Protect batteries form excessive heat.
Risk of explosion! Do not throw batteries into a re.
•Use identical or equivalent batte types only.
•Always replace all batteries at the same time.
•Do not use rechargeable batteries.
•Do not disassemble, split or crush the batteries.
Ensure that no liquid enters the interior of the thermometer.
Never use abrasive cleaning agents, thinners or benzene for
cleaning and never immerse the Thermometer in water or
other cleaning liquids.
Take care not to scratch the suace of the probe lens and
the display.
If the visual inspection identies unacceptable deterioration
such as corrosion, discoloration, pitting, cracked, then the
device should be stop to use and discard.
If the thermometer is been used for between patients,
please visually inspect the thermometer to determine if
there is stain or oil on the casing or probe after each use,
and follow the instruction of cleaning and disinfection to
cleaning your thermometer.
•
•
•
•
•
GUANGZHOU BERRCOM MEDICAL DEVICE CO., LTD EXPRESSLY
DISCLAIMS ALL WARRANTIES OF MERCHANTABILITY AND
FITNESS FOR A PARTICULAR PURPOSE.
UNDER ON CIRCUMSTANCES SHALL BERRCOM HAVE ANY
OBLIGATION OR LIABILITY FOR ANY LOSS OF PROFIT OR FOR
ANY CONSEQUENTIAL, INCIDENTAL INDIRECT, SPECIAL,
PUNITIVE, OR CONTINGENT DAMAGES WHATSOEVER WITH
RESPECT TO CLAIMS MADE BY ANY CUSTOMER, CONSUMER OR
OTHER USER OF BERRCOM PRODUCTS.
IN THE EVENT THAT ANY APPLICABLE LAWS IMPOSE WARRAN-
TIES, CONDITIONS, OR OBLIGATIONS THAT CANNOT BE
EXCLUDED OR MODIFIED, THIS PARAGRAPH SHALL APPLY TO
THE GREATEST EXTENT ALLOWED BY SUCH LAWS.
•
•
•
Screen
message
Description
No display
Possible causes Solutions
Symbol Description of symbol
Symbol Symbol Description of symbol
Description of symbol
1. System error;
2. The batte is
completely power
o
Attention: If the above measures still cannot solve the problem, please
contact customer seice.
Batte
symbol
ashing, can
not measure
temperature
Batte
symbol
display, last
batte level
ashing.
Probe cover
symbol icker
in an
animated
style
Display Er1
Display“Hi”
or“Lo”
1. Not installing
probe cover,
2. The probe cover
is not properly
installed.
The current
ambient
temperature is too
low or too high,
which is not within
the operating range
specied in the
manual and cannot
be measured.
Place the product at
normal room
temperature (10 ° C to
40 ° C) or wait for a
period of time.
1. Check if the probe lens
is diy. Please clean the
probe lens and operate
again.
2. Please ask the subject
to maintain a stable
posture and measure
again according to the
correct operating method.
3. Place the product at
normal room temperature
(10 ° C to 40 ° C) and wait
for 30 minutes.
1.The measured
temperature exceeds
the measurement
range (34.0℃ to
43.0℃).
2.Unable to collect
stable temperature
values (the
environmental
temperature changes
too quickly and the
product has not yet
reached a stable state).
1. Install probe cover;
2. Remove the probe
cover and reinstall.
The current
batte level is too
low to peorm
temperature
measurement
The current
batte level is to
low, but still
operate correctly
Suggest replacing new
batteries as soon as
possible.
Replace new batteries.
1. Turn o and then
resta;
2. Remove the batte
and replace it or replace
it with a new one;
3. Please contact your
local dealer or customer
seice.
18
Guidance and manufacturer’s declaration - electromagnetic emissions
Indicates the need for the user to consult the instructions
for use for crucial cautiona information such as
warnings and precautions that can not, for a variety of
reasons, be presented on the medical device itself.
Degree of protection against harmful ingress of water
and paiculate matter
2 Protected and against solid foreign objects of 12.5mm
Φ and greater
2 Protection against veically falling water drops when
ENCLOSURE titled up to 15°
DISPOSAL: Do not dispose of this product as unsoed
municipal waste. Collection of such waste separately for
special treatment is necessa.
The CE labelling ceies that the product complies with
the essential requirements of EU regulations on medical
device.
Symbol of European Authorized Representative,
expressly indicate the name and address of European
Authorized Representative after the symbol.
CN
Impoer
(Just for Probe
Cover)
Table 1
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 2
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 3
Emissions test
Immunity Test Compliance level
IEC 60601-1-2
Test level
Harmonic emissions IEC 61000-3-2
RF emissions CISPR 11
RF emissions CISPR 11
Radiated RF
IEC61000-4-3
(Test
specications
for ENCLOSURE
PORT IMMUNITY
to RF wireless
communications
equipment)
Radiated RF
IEC61000-4-39
(Test
specications
for ENCLOSURE
PORT IMMUNITY
to proximity
magnetic elds)
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast transient
/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
±8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 kV air
Not applicable Not applicable
Radiated RF
IEC61000-4-3
10 V/m
80 MHz – 2,7 GHz
80 % AM at 2 Hz
10 V/m
80 MHz – 2,7 GHz
80 % AM at 2 Hz
Not applicable Not applicable
Conducted RF
IEC61000-4-6
Not applicable Not applicable
Not applicable
30 A/m
50Hz/60Hz
30 A/m
50Hz/60Hz
Not applicable
±8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 kV air
Group 1
Group B
Not applicable
Not applicable
Voltage uctuations/ icker emissions
IEC 61000-3-3
Compliance
Voltage dips, sho
interruptions and
voltage variations on
power supply input lines
IEC 61000-4-11
Power frequency
magnetic eld
IEC 61000-4-8
NOTE U
T is the a.c. mians voltage prior to application of the test
level.
Tes t
Frequency
(MHz)
Band
(MHz)
Seice Modulation
IEC
60601-1-2
Test Level
(V/m)
Compli-
ance
level
(V/m)
Tes t
Frequency
Modulation
IEC 60601-1-2
Test Level
(A/m)
Compliance
level
(A/m)
Pulse
modulation
18 Hz
Pulse
modulation
217 Hz
Pulse
modulation
18 Hz
FM ± 5 kHz
deviation
1 kHz sine
385 27 27
28 28
9 9
28 28
28 28
28 28
9 9
380
–390
TETRA 400
GMRS 460,
FRS 460
LTE Band 13,
17
WLAN
802.11
a/n
GSM
800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
430
–470
704
–787
800
–960
450
710
745
780
5240
30 kHz
134,2 kHz
13,56 MHz
CW
Pulse
modulation
2.1 kHz
Pulse
modulation
50 kHz
8 8
65 65
7,5 7,5
5500
5785
810
870
930
Pulse
modulation
217 Hz
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS
1700
–
1990
1720
1845
Pulse
modulation
217 Hz
Pulse
modulation
217 Hz
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
2400
–
2570
5100
–
5800
2450
1970
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 4
AA 1.5V
1
I.Intended Use
II.Warnings And Precautions
III.Principle Of Operation Of Ear Thermometer
IV.Product Description
V. How To Use The Ear Thermometer
VI.Setting Of The Ear Thermometer
VII.Technical Specications
VIII.Batteries
IX.Included In Delive
X.Cleaning and Disinfection
XI.Troubleshooting
XII.Signs And Symbols
XIII.EMC Declaration
XIV.Warranty/seice
02
02
06
07
07
05
13
15
16
16
17
18
19
22
Contents
IV. Product Description VI. Setting Of The Ear ThermometerIII. Principle Of Operation Of
Ear Thermometer
I. Intended Use
II. Warnings And Precautions
02 03 0504 06 07 08 09 10
Instruction Manual
0
m
o
n
t
h
s
+
11 12
13
14 15 16 17 19 20 21 22 23 24
ET101 ET102 ET103
PREHE AT
EAR
THERMOMETER
NOTE:
You must read this instruction manual completely before use and
follow all instructions. Keep the instructions for later use. You must
check the device functions according to this instruction manual
prior to each use and only use this device if it is in proper working
condition.
VII. Technical Specications
VIII. Batteries
IX. Included In Delive
X. Maintainance Of The Product
The Manufacturer Resees The Rightto Alter The Specica-
tions Of Theproduct Without Prior Notication.
Ear thermometer is intended to measure ear temperature of
people of all ages. It can be used by consumers in household
environment and doctor in clinic as reference.
All objects, solid, liquid or gas, emit energy by radiation. The
intensity of this energy depends on the temperature of the
object. The ear thermometer is therefore able to measure the
temperature of a person by the energy the person emits from
ear canal. The infrared sensor located at the front end of the
device collects the infrared radiation emitted from the ear
canal. The sensor conves the received infrared into electrical
signals and transmits them to the device chip. The device chip
calculates the human body temperature based on the
intensity and frequency of the infrared signal received by the
infrared sensor.
The goal of thermomet is to measure core body tempera-
ture which is the temperatures of the vital organs. Clinical
studies showed that the ear is an excellent site of temperature
measurement because the temperatures taked in ear can
sooner and accurately reect core body temperature’s
changes .
1) Hold down the batte cover with your ngers, gently push
down to open the batte compament, and open the batte
cover.
2) Follow the polarity label in the batte compament, place
the new batte into the compament and clamp it tightly.
During installation, pay attention to the polarity and do not
install it upside down.
3) Finally, replace the batte cover in its original state.
V. How To Use The Ear Thermometer
1.Install/replace batteries
Batte installation/replacing method is as follows:
memo number. Note:The rst set of data displayed is the
most recent temperature measurement data, while the other
31 sets of data are displayed in order of temperature
measurement from near to far. In memo mode, if no any
operation within 5 seconds, the device will return to standby
mode automatically.
Over temperature warning function
If the measured body temperature is higher than the set
value, the ear thermometer will have dierent beeps and
backlight prompts.
1. Batteries using attention
1). The product uses two AA batteries.
2). When the batte symbol “ ” appears on the screen and
ashes, it indicates that the batte is low and needs to be
replaced. theoretically it can be used continuously for about
300 times (test conditions: temperature: 25°C, relative
humidity of 65%RH, staing from power on, self-check,
measurement, and automatic shutdown). When the low
batte icon on the screen ashes “ ”, it indicates that the
batte is low and needs to be replaced.
3). If the ambient temperature is low, it will shoen the batte
life.
4). When using batteries other than alkaline batteries, the
usage frequency may be ve sho, so it is recommended to
use alkaline batteries.
5). The voltage of the rechargeable batte is unstable and
can aect measurement. It is recommended not to use it.
6). When not in use for a long time, it is recommended to
remove the batte to avoid batte leakage and damage to
the product.
2. Disposing of batteries
To protect environment, dispose of empty batteries at
appropriate collection sites according to national or local
regulations.
Ear Thermometer 1pc
Instruction Manual 1pc
Quick Reference Guide 1pc
Probe Cover 20pcs(1 box)
The ear thermometer is a multi-patient reusable device, and
the cleaning and disinfection instructions were validated,
please follow the instructions to cleaning/disinfect your
thermometer prior to use.
Cleaning:
1) Use a cotton swab moistened with hot water or neutral
detergent to throughout cleaning the casing of thermometer
and measuring probe to removal of stain or oil.
2) Visual inspection the thermometer after cleaning process,
ensure there is no soil or stain is seen. if the device is
determined not to be visually clean at the end of the cleaning
step, you should either repeat the relevant previous cleaning
steps or safely dispose of the device, so that a visibly soiled
device is not used again.
Disinfection:
1) Use an 75% ethyl alcohol swab or cotton swab moistened
with 75% ethyl alcohol to disinfect the thermometer casing
and the measuring probe about 30 seconds.
2) Repeat the above steps at least 3 times, then wipe suace
and probe d with a clean cloth, and wait about 1 minute for
ding after disinfection process.
Note:
XIII. EMC Declaration XIV. Warranty/seice
The ME EQUIPMENT or ME SYSTEM is suitable for home
healthcare and clinic environments.
Statement: The ear thermometer model ET101,ET102,ET103
was tested according to the recommendations of Technical
Repo IEC TR 60601-4-2: Medical electrical equipment – Pa
4-2: Guidance and interpretation – Electromagnetic
immunity; peormance of medical electrical equipment and
medical electrical systems.
Warning：Don’t near active HF surgical equipment and the
RF shielded room of an ME system for magnetic resonance
imaging, where the intensity of EM disturbances is high.
Warning： Use of this equipment adjacent to or stacked with
other equipment should be avoided because it could result in
improper operation. If such use is necessa, this equipment
and the other equipment should be obseed to verify that
they are operating normally.
Warning: Use of accessories, transducers and cables other
than those specied or provided by the manufacturer of this
equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.”
Warning：Poable RF communications equipment (including
peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any pa
of the equipment ET101,ET102,ET103, including cables
specied by the manufacturer. Otherwise, degradation of the
peormance of this equipment could result.
1，All necessa instructions for maintaining BASIC SAFETY
and ESSENTIAL PERFORMANCE with regard to electromag-
netic disturbances for the excepted seice life.
Poable and mobile RF communication equipment may
aect the peormance of the ET101,ET102,ET103, avoiding
strong electromagnetic inteerence when used, such as near
mobile phones, microwave ovens, etc.
2，Guidance and manufacturer’s declaration -electromag-
netic emissions and Immunity
Guidance and manufacturer’s declaration - electromag-
netic emissions and Immunity
XI. Troubleshooting
XII. Signs And Symbols
If you have problems while using your thermometer, please
refer to this guide to help resolve the problem. If the problem
persists, please contact our customer seice.
Notes on handling batteries
•If your skin or eyes come into contact with batte uid,
rinse the aected area with water and seek medical
assistance.
When the buzzer beeps, it indicates that the temperature
measurement is completed and the temperature value is
displayed on the display screen.
The screens and sound prompts for different temperature
values are as follows:
Attention: The temperature value from the last temperature
measurement is displayed in the lower right corner of the
display screen, making it easier to compare changes in body
temperature.
Reference:Herzog L.Phillips S.Addressing Concerns About
Fever Clinical Pediatrics 2011 50(5) 383‒390
Below the temperature measurement range (T<34.0 ℃):
Display LO, red backlight, 1 beep:
Above the temperature measurement range (T>43.0 ℃):
Display Hi, red backlight, 1 beep.
⑤After inserting the probe into the ear canal and aligning it
with the eardrum, short press the "switch/measure" button
to measure the temperature. During the temperature
measurement process, the screen scrolls to display "- ° C",
" - ° C" and " -° C".
⑥If you need to take the next
temperature measurement, please
remove the used probe cover and
replace the new one and repeat
step ⑤.
⑦If there is no operation for about 60 seconds after the
temperature measurement is completed, the ear thermome-
ter will automatically shut down. You can also press and hold
the "Switch/Measure" button for about 5 seconds to turn off
the device. When the device is turned off, the display screen
will flash OFF for a short time and then turn off.
In accordance with our policy of continual product
improvement, we reserve the right to make technical and
optical changes without notice.
Warranty and repair terms
Warranty: 18 months.
Please contact your dealer or the service center in case of a
claim under the warranty. If you have to return the unit,
please enclose a copy of your receipt and state what the
defect is.
The following warranty terms apply:
1. The warranty period for BERRCOM products is 18 months
from date of purchase. In case of a warranty claim, the date
of purchase has to be proven by means of the sales receipt or
invoice.
2. Defects in material or workmanship will be removed free
of charge within the warranty period.
3. Repairs under warranty do not extend the warranty period
either for the unit or for the replacement parts.
4. The following is excluded under the warranty:
a. All damage which has arisen due to improper treatment,
e.g. nonobservance of the user instructions.
b. All damage which is due to repairs or tampering by the
customer or unauthorised third parties.
c. Damage which has arisen during transport from the
manufacturer to the consumer or during transport to the
service centre.
d. Accessories which are subject to normal wear and tear.
5. Liability for direct or indirect consequential losses caused
by the unit are excluded even if the damage to the unit is
accepted as a warranty claim.
Disposal
It is required that you should not dispose of WEEE as
unsoed municipal waste and collect such WEEE separately.
In accordance with Directive 2012/19/EU and national
disposal regulations regarding old electrical and electronic
devices, please be advised that such items must be disposed
of in a special way within the European Union (EU) .
These regulations require the environmentally friendly
recycling/disposal of old electrical and electronic devices.
Such items must not be disposed of as domestic refuse. This
has been expressed using the icon of the “crossed out trash
can”.
The ear thermometer (Model: ET101,ET102,ET103) contains
batteries and recyclable electronic waste. To protect the
environment, do not dispose of it in household waste as
unsoed municipal waste, but collect separately and take it to
an appropriate local collection center.
The ear thermometer (Model:ET101,ET102,ET103) is
classied as small equipment (5th catego) according to
ANNEX IV of Directive 2012/19/EU.
Before disposing of your ear thermometer (Model:
ET101,ET102,ET103), please take away the batteries from ear
thermometer (Model: ET101,ET102,ET103) and dispose of the
batteries and ear thermometer (Model: ET101,ET102,ET103)
separately.
You can take away the batteries as follows:
＞＞Batte remove diagram
① Open the lid on the back of the device
② Remove the batteries.
Batteries represent a hazard to health and the environment!
Never open, damage, or swallow batteries or allow them to
pollute the environment. They may contain toxic, ecologically
hazardous heavy metals. The removed batteries shall be
disposed of at the point of sale or in the corresponding
containers provided at collection points by local public waste
authorities and treated according to 2006/66/EC.
The batteries and recyclable electronic waste shall be
disposed of in a separate waste container.
Packaging materials must be disposed of according to local
regulations. Consult the authorized collection points for more
information.
In Germany
For the recyclable electronic waste disposal, you can search
the authorized collection points at the following website:
https://www.ear-system.de/ear-verzeichnis/sam-
mel-und-ruecknahmestellen
For batteries, you can search the authorized collection points
at the following website:
https://www.ear-system.de/ear-verzeichnis/battghersteller#-
no-back
Search method: using your postcode or the name of the city
and state where you live to nd collection points near you.
Other countries
For count-specic information on disposal, contact your
local dealers or impoer.
ashes, it reminds you to put on the
probe cover.
To obtain accurate readings, clean
and new disposable probe cover
should be installed before each
measurement.
Inse the ear thermometer probe
into the probe cover box, then pull it
out to t the new probe cover.
Only use this ear thermometer once you have read and
understood the instruction for use.
Only use this ear thermometer for the specic purpose
described in the instruction manual. Any misuse will void the
warranty.
This ear thermometer may be used for professional
purposes or for personal home use.
Using this ear thermometer is no substitute for consulting a
doctor. Do not self-diagnose or self-medicate on the basis
of the measurements without consulting your doctor. In
·
·
·
·
paicular, do not sta taking any new medication or
change the type and/or dosage of any existing medication
without prior approval.
This ear thermometer must be operated by adults, ensure
that children do not use this device unsupeised; some
pas are small enough to be a choking hazard or be
swallowed.
If this thermometer is stored condition that is out of its
using condition, please put it in operation place for at least
30 minutes before taking the measurement.
When the subject enters a warm room from a cold outdoor
environment and wets their ears by swimming or bathing,
the ear canal temperature will temporarily be lower than the
actual temperature. Please wait for 30 minutes before
taking the measurement.
When the subject's ears are covered by heat due to sleeping
on their side, wearing headphones or hearing aids, or long
hair covering, the ear canal temperature will temporarily be
higher than the actual temperature. Please wait for 30
minutes before taking the measurement.
The readings of the left and right ears may dier. When
obseing changes in body temperature, it is recommended
to collect the temperature of the same ear.
The measurement may result in measurement bias when the
subject takes medication that may increase or decrease
body temperature.
The subject may experience temperature uctuations after
engaging in activities such as intense exercise, cing, and
eating. It is recommended to maintain a quiet state for at
least 30 minutes before the measurement.
Dierent types and brands of temperature measurement
products do not have comparative value. It is recommended
that you use the same temperature measurement product
for multiple frequency obseations when obseing body
temperature, in order to better grasp changes in body
temperature.
People with ear diseases such as otitis externa and otitis
media should not use the ear thermometer.
It is recommended to measure about 3 times during
measurement, with a time inteal of 12s or more than 12s
between each measurement, recommend the maximum
temperature as measurement temperature.
Please check the batte level before use, as low batte
voltage may result in inaccurate measurement results.
If you nd that this product cannot achieve the claimed
peormance or if there is a change in product peormance,
please stop using it immediately and contact the manufac-
·
·
·
·
·
·
·
·
·
·
·
·
turer for assistance in time.
To ensure an accurate measurement, this thermometer must
only be used indoors when the ambient temperature range
is between 10℃(50℉) and 40℃（104℉）.
Before measurement, please ensure that the probe is free
from small foreign objects (such as earwax, dandru,
droplets, dust, etc.). After measurement, please place it in a
storage box to protect the probe from di or damage.
When there is a lot of earwax in the ear canal of the subject
(especially young children), please clean the ear canal
before taking the measurement to avoid aecting the
accuracy.
The probe lens is the most vulnerable pa of this product,
so it must be carefully protected. Please do not touch or
blow the probe with your hands. After measuring, please
place the product in the storage box.
Before use, conrm whether the probe lens is diy. If it is
diy, clean it according to the following steps, otherwise it
may cause measurement errors:
(1) Gently wipe the probe with a cotton swab or soft cloth
dipped in 75% alcohol.
(2) D and let the device stand for 30 minutes before use.
·
·
·
·
·
This ear thermometer should not be immersed in water or
directly exposed to sunlight to avoid product malfunctions.
This ear thermometer must be kept d and clean.
Please do not place this ear thermometer in an area with
electric shock to avoid product malfunction.
If any problems are found, please contact customer seice
and do not attempt to repair this product on your own. If
the original components are replaced with pas not
provided by the manufacturer, it may cause measurement
errors.
This ear thermometer is a measuring product. It is
recommended to check the accuracy of the product with a
manufacturer or a qualied third-pay organization at a
one-year inteal.
Please dispose of the waste and residue at the end of the
product's seice life in accordance with local laws and
regulations.
This ear thermometer expected seie life is 5 years.
Please use BERRCOM exclusive disposable probe cover
(model: PC001). If you use other brand’s probe cover, it may
result in inaccurate measurements. To purchase the
disposable probe cover, please contact your agent or
BERRCOM directly.
Do not use accessories, materials, etc. that are not specied
in this manual. Using accessories that are not provided or
specied by the manufacturer may result in the product not
achieving its intended use.
Before and after each use, the thermometer should be
cleaned according to the requirement of this manual to
avoid possible bacterial infections.
Do not expose this thermometer to extreme temperature
conditions of higher than 55℃(131℉) or lower than -20℃（
-4℉）.
Do not use this thermometer in relative humidity higher
than 85%RH.
Do not put this ear thermometer in the place with direct
sunlight, high temperature, high humidity, excessive dust, or
the place where it may contact with corrosive gas or liquid,
and do not use this product in the above environment.
Do not open up this thermometer. It contains small pas
which might be swallowed by children.
Remove the batteries if you do not wish to use the unit for
an extended period of time. Otherwise there is a danger
that the batteries may leak.
Keep the thermometer away from electromagnetic elds
produced by objects such as microwave ovens, arc welders
or induction heaters.
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
Please keep this ear thermometer out of reach of children.
Forceful measurement by children may cause ear inju. If
the batte is accidentally swallowed, please contact a
doctor immediately.
Please store the ear thermometer according to its storage
conditions to avoid usage issues and measurement errors.
Please do not forcefully collide, fall, step on, or shake this
product to avoid product malfunction or measurement
deviation.
·
·
Note: Do not use toilet paper or tissue to wipe.
Note: The reference body temperature for the ear thermome-
ter is oral temperature.
1、Guyton A C, Textbook of medical physiology, W.B.
Saunders, Philadelphia, 1996, p919;
eardrum
ear canal
1 2 3
4
5
6
7
8
9
① Probe cover (20 pcs/box)
② Storage box
③ Temperature sensing probe
④ Probe cover detector
⑤ Switch/Measure button
Symbols interpretation:
⑥ Batte cover
⑦ Display screen
⑧ Age selection button
⑨ Memo button
Batte
capacity
Measure
value
Probe notice
Age Groups
Unit
Memo
Last
measurement
value
Mute
AA 1.5V
2.Operate the device
The correct usage method is the key to measurement
accuracy, otherwise it may cause measurement errors. Due to
the high requirements of infrared
temperature measurement on the
surrounding environment, please
follow the prompts below for
operation.
① Take out the ear thermometer
from the storage box.
② Power on and self checking
Press the "Switch/Measure" button,
the ear thermometer will turn on
and sta self checking with a beep
sound. During self inspection, the
screen displays three full color icons.
If the following situations exist,
measurement cannot be suppoed:
1). Operating environment tempera-
ture too low or too high: Er1 is
displayed on the screen.
2). Low batte: The low batte icon
on the screen “ ” ashes to
indicate.
If the probe cover icon “ ” scrolls
Attention: If disposable probe cover is not installed, the ear
thermometer will not operate.
Attention: If the top of the disposable probe cover is found to
be damaged, they need to be replaced with new probe cover.
③ Select age groups
Press the age selection button“ ” to select the age range
of the tested object for temperature measurement. Press the
button to switch age groups.
④ Probe preheating
This product uses preheating temperature measurement
technology. Studies have shown that preheating the ear
thermometer for temperature measurement can avoid
cooling effects, improve temperature
measurement accuracy and comfort.
When the display screen shows
"00.0", it indicates that the preheat-
ing is completed and enters the test
state.
Note: This product defaults to the age range of the last
temperature measurement. If the age group of the tempera-
ture measurement object is dierent from the age group of
the last temperature measurement object, the age group
needs to be selected.
Above 36 months
0 ~ 3 months
3 ~ 36 months
Symbol
White backlight
1 beep
(Normal
temperature)
Orange
backlight
2 beeps
(Moderate fever)
Red backlight
3 beeps
(High fever)
Age
Groups
35.8°C ≤ T≤ 37.4°C
35.4°C ≤ T≤ 37.6°C 37.6°C <T≤ 38.5°C
37.7°C < T≤ 39.4°C
35.4°C ≤ T≤ 37.7°C
/ T
>
37.4°C
T
>
38.5°C
T
>
39.4°C
0 ~ 3
months
3 ~ 36
months
Above 36
months
Notice: The above steps are for use in
beep mode. If the ear thermometer
is in mute mode, the beep will turn
off, there will be mute icon “ ” on
the screen, and other prompts will
keep the same.
Attention: When measuring, the ear thermometer sensor
should be inserted into the ear canal and aligned withthe
eardrum. Otherwisr, the measured temperature will be lower
than the actual temperature.
The method of straightening the ear canal:
When measuring temperature, please fix the head of the
subject, gently pull the auricle, and horizontally insert the
probe into the ear canal and align it with the eardrum to fully
fill the ear canal. Specifically, the method of straightening
the ear canal is as follows:
36.8℃ Low measurement Low measurement
For children under 1
year old：gently pull
the auricle outward
and backward to
keep the ear canal as
straight as possible.
Children over 1 year
old and adults:
gently pullthe auricle
outward and upward
to keep it as straight
as possible.
This product can modify default settings parameters. Facto
settings have been made for dierent sales markets before
leaving the facto. It is recommended not to modify the
facto default values. If modication is necessa, please
follow the steps below.
Beep/mute mode
This product can be set to "beep mode" and "mute mode".
(Facto default is beep mode)
Setting method:
In standby mode, press and hold “Memo” button for 5
seconds, then enter beep/mute mode. And keep to hold the
“Memo” button, the screen will display two modes of with
or without mute symbol “ ” in sequence, each mode will
display about 3 seconds. Release the button when your
desired mode is displayed, then the save the mode and return
to standby mode.
Attention:
1．After each resta, the product is in beep mode；
2. When the device is turned on without wearing probe cover,
beep/mute mode conversion cannot be peormed.
Unit conversion
This product can be set to Fahrenheit (° F) and Celsius (° C).
(Facto default is Celsius)
Setting method:
In standby mode, press and hold the "Age selection" button
for 5 seconds, and the screen will display "° C" and "° F" in
sequence until the desired unit is displayed. Release the "Age
selection" button to complete the unit conversion and return
to full display standby mode.
Attention:
1. Maintain the settings before shutting down after each
resta;
2. When the device is turned on without wearing probe cover,
unit conversion cannot be peormed.
Memo que
This ear thermometer can remember the last 32 sets of body
temperature readings, making it easy to que historical
temperature data.
Setting method:
In standby mode, press the "Memo" button to enter memo
mode. In memo mode, pressing the “Memo” button, the
screen will display “M” and memo number, release the
button, the screen will display temperature data of the
Operational principle Infrared radiation detection
Audible Indicator Yes
Use of Probe Covers Ye s
Unit size Approx. 146×37×37mm (L x W x H)
Trade mark
Do not re-use
Manufacturer
Serial number
Please read the instructions carefully.
Applied pa, Type BF
Direct current
Date of manufacture
Made in China
Unique device identier
Medical device
Use-by date
Model number
Unit weight
(include batte)
Approx. 133g
( Without storage box)
Expected Seice Life 5 years
Applied pa Sensor; Type BF
IP Class IP22
Normal using
condition
Ambient temperature:10°C~40°C(50°F~104°F)
Relative humidity: ≤85%RH
Pressure altitude: 700hPa~1060hPa
Storage and
shipping condition
Essential
Peormance
Ambient temperature:-20°C~55°C(-4°F~131°F)
Relative humidity: ≤95%RH
Pressure altitude: 700hPa to 1060hPa
1.In normal using condition
10°C~40°C (50°F~104°F),
LABORATORY ACCURACY meet:
34.0°C~ 34.9°C(93.2°F~94.8°F):±0.3°C(±0.6°F)
35.0°C~ 42.0°C(95°F~107.6°F):±0.2°C(±0.4°F)
42.1°C~ 43.0°C(107.8°F~109.4°F):±0.3°C(±0.6°F)
2.OUTPUT TEMPERATURE
Display “Hi” when measuring temperature
above 43.0°C (109.4°F) and display “Lo” when
measuring temperature lower than 34.0°C
(93.2°F).
Adjusted mode
Oral
People of all ages
Ear
34.0°C~43.0°C (93.2°F~109.4°F)
≤ ±0.2°C/0.4°F
DC 3V (2pcs AA d batteries)
Approx. 3.5 seconds
LCD screen
0.1°C (0.1°F)
Approx. 60±10 seconds
34.0°C~ 34.9°C(93.2°F~94.8°F): ±0.3°C(±0.6°F)
35.0°C~ 42.0°C(95°F~107.6°F): ±0.2°C(±0.4°F)
42.1°C~ 43.0°C(107.8°F~109.4°F): ±0.3°C(±0.6°F)
OTC
Mode of operation
Patient population
RX/OTC Use
Measurement site
Measuring range
Accuracy
Clinical repeatability
Batteries
Measurement time
Display mode
Display resolution
Automatic power-o
32 sets Memo
Measurement
reference body site
Chocking hazard!
Small children may swallow and choke on batteries. Store
batteries out of the reach of small children.
•If a batte has leaked, put on protective gloves and clean
the batte compament with a d cloth.
•Protect batteries form excessive heat.
Risk of explosion! Do not throw batteries into a re.
•Use identical or equivalent batte types only.
•Always replace all batteries at the same time.
•Do not use rechargeable batteries.
•Do not disassemble, split or crush the batteries.
Ensure that no liquid enters the interior of the thermometer.
Never use abrasive cleaning agents, thinners or benzene for
cleaning and never immerse the Thermometer in water or
other cleaning liquids.
Take care not to scratch the suace of the probe lens and
the display.
If the visual inspection identies unacceptable deterioration
such as corrosion, discoloration, pitting, cracked, then the
device should be stop to use and discard.
If the thermometer is been used for between patients,
please visually inspect the thermometer to determine if
there is stain or oil on the casing or probe after each use,
and follow the instruction of cleaning and disinfection to
cleaning your thermometer.
•
•
•
•
•
GUANGZHOU BERRCOM MEDICAL DEVICE CO., LTD EXPRESSLY
DISCLAIMS ALL WARRANTIES OF MERCHANTABILITY AND
FITNESS FOR A PARTICULAR PURPOSE.
UNDER ON CIRCUMSTANCES SHALL BERRCOM HAVE ANY
OBLIGATION OR LIABILITY FOR ANY LOSS OF PROFIT OR FOR
ANY CONSEQUENTIAL, INCIDENTAL INDIRECT, SPECIAL,
PUNITIVE, OR CONTINGENT DAMAGES WHATSOEVER WITH
RESPECT TO CLAIMS MADE BY ANY CUSTOMER, CONSUMER OR
OTHER USER OF BERRCOM PRODUCTS.
IN THE EVENT THAT ANY APPLICABLE LAWS IMPOSE WARRAN-
TIES, CONDITIONS, OR OBLIGATIONS THAT CANNOT BE
EXCLUDED OR MODIFIED, THIS PARAGRAPH SHALL APPLY TO
THE GREATEST EXTENT ALLOWED BY SUCH LAWS.
•
•
•
Screen
message
Description
No display
Possible causes Solutions
Symbol Description of symbol
Symbol Symbol Description of symbol
Description of symbol
1. System error;
2. The batte is
completely power
o
Attention: If the above measures still cannot solve the problem, please
contact customer seice.
Batte
symbol
ashing, can
not measure
temperature
Batte
symbol
display, last
batte level
ashing.
Probe cover
symbol icker
in an
animated
style
Display Er1
Display“Hi”
or“Lo”
1. Not installing
probe cover,
2. The probe cover
is not properly
installed.
The current
ambient
temperature is too
low or too high,
which is not within
the operating range
specied in the
manual and cannot
be measured.
Place the product at
normal room
temperature (10 ° C to
40 ° C) or wait for a
period of time.
1. Check if the probe lens
is diy. Please clean the
probe lens and operate
again.
2. Please ask the subject
to maintain a stable
posture and measure
again according to the
correct operating method.
3. Place the product at
normal room temperature
(10 ° C to 40 ° C) and wait
for 30 minutes.
1.The measured
temperature exceeds
the measurement
range (34.0℃ to
43.0℃).
2.Unable to collect
stable temperature
values (the
environmental
temperature changes
too quickly and the
product has not yet
reached a stable state).
1. Install probe cover;
2. Remove the probe
cover and reinstall.
The current
batte level is too
low to peorm
temperature
measurement
The current
batte level is to
low, but still
operate correctly
Suggest replacing new
batteries as soon as
possible.
Replace new batteries.
1. Turn o and then
resta;
2. Remove the batte
and replace it or replace
it with a new one;
3. Please contact your
local dealer or customer
seice.
18
Guidance and manufacturer’s declaration - electromagnetic emissions
Indicates the need for the user to consult the instructions
for use for crucial cautiona information such as
warnings and precautions that can not, for a variety of
reasons, be presented on the medical device itself.
Degree of protection against harmful ingress of water
and paiculate matter
2 Protected and against solid foreign objects of 12.5mm
Φ and greater
2 Protection against veically falling water drops when
ENCLOSURE titled up to 15°
DISPOSAL: Do not dispose of this product as unsoed
municipal waste. Collection of such waste separately for
special treatment is necessa.
The CE labelling ceies that the product complies with
the essential requirements of EU regulations on medical
device.
Symbol of European Authorized Representative,
expressly indicate the name and address of European
Authorized Representative after the symbol.
CN
Impoer
(Just for Probe
Cover)
Table 1
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 2
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 3
Emissions test
Immunity Test Compliance level
IEC 60601-1-2
Test level
Harmonic emissions IEC 61000-3-2
RF emissions CISPR 11
RF emissions CISPR 11
Radiated RF
IEC61000-4-3
(Test
specications
for ENCLOSURE
PORT IMMUNITY
to RF wireless
communications
equipment)
Radiated RF
IEC61000-4-39
(Test
specications
for ENCLOSURE
PORT IMMUNITY
to proximity
magnetic elds)
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast transient
/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
±8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 kV air
Not applicable Not applicable
Radiated RF
IEC61000-4-3
10 V/m
80 MHz – 2,7 GHz
80 % AM at 2 Hz
10 V/m
80 MHz – 2,7 GHz
80 % AM at 2 Hz
Not applicable Not applicable
Conducted RF
IEC61000-4-6
Not applicable Not applicable
Not applicable
30 A/m
50Hz/60Hz
30 A/m
50Hz/60Hz
Not applicable
±8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 kV air
Group 1
Group B
Not applicable
Not applicable
Voltage uctuations/ icker emissions
IEC 61000-3-3
Compliance
Voltage dips, sho
interruptions and
voltage variations on
power supply input lines
IEC 61000-4-11
Power frequency
magnetic eld
IEC 61000-4-8
NOTE U
T is the a.c. mians voltage prior to application of the test
level.
Tes t
Frequency
(MHz)
Band
(MHz)
Seice Modulation
IEC
60601-1-2
Test Level
(V/m)
Compli-
ance
level
(V/m)
Tes t
Frequency
Modulation
IEC 60601-1-2
Test Level
(A/m)
Compliance
level
(A/m)
Pulse
modulation
18 Hz
Pulse
modulation
217 Hz
Pulse
modulation
18 Hz
FM ± 5 kHz
deviation
1 kHz sine
385 27 27
28 28
9 9
28 28
28 28
28 28
9 9
380
–390
TETRA 400
GMRS 460,
FRS 460
LTE Band 13,
17
WLAN
802.11
a/n
GSM
800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
430
–470
704
–787
800
–960
450
710
745
780
5240
30 kHz
134,2 kHz
13,56 MHz
CW
Pulse
modulation
2.1 kHz
Pulse
modulation
50 kHz
8 8
65 65
7,5 7,5
5500
5785
810
870
930
Pulse
modulation
217 Hz
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS
1700
–
1990
1720
1845
Pulse
modulation
217 Hz
Pulse
modulation
217 Hz
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
2400
–
2570
5100
–
5800
2450
1970
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 4
AA 1.5V
1
I.Intended Use
II.Warnings And Precautions
III.Principle Of Operation Of Ear Thermometer
IV.Product Description
V. How To Use The Ear Thermometer
VI.Setting Of The Ear Thermometer
VII.Technical Specications
VIII.Batteries
IX.Included In Delive
X.Cleaning and Disinfection
XI.Troubleshooting
XII.Signs And Symbols
XIII.EMC Declaration
XIV.Warranty/seice
02
02
06
07
07
05
13
15
16
16
17
18
19
22
Contents
IV. Product Description VI. Setting Of The Ear ThermometerIII. Principle Of Operation Of
Ear Thermometer
I. Intended Use
II. Warnings And Precautions
02 03 0504 06 07 08 09 10
Instruction Manual
0
m
o
n
t
h
s
+
11 12
13
14 15 16 17 19 20 21 22 23 24
ET101 ET102 ET103
PREHE AT
EAR
THERMOMETER
NOTE:
You must read this instruction manual completely before use and
follow all instructions. Keep the instructions for later use. You must
check the device functions according to this instruction manual
prior to each use and only use this device if it is in proper working
condition.
VII. Technical Specications
VIII. Batteries
IX. Included In Delive
X. Maintainance Of The Product
The Manufacturer Resees The Rightto Alter The Specica-
tions Of Theproduct Without Prior Notication.
Ear thermometer is intended to measure ear temperature of
people of all ages. It can be used by consumers in household
environment and doctor in clinic as reference.
All objects, solid, liquid or gas, emit energy by radiation. The
intensity of this energy depends on the temperature of the
object. The ear thermometer is therefore able to measure the
temperature of a person by the energy the person emits from
ear canal. The infrared sensor located at the front end of the
device collects the infrared radiation emitted from the ear
canal. The sensor conves the received infrared into electrical
signals and transmits them to the device chip. The device chip
calculates the human body temperature based on the
intensity and frequency of the infrared signal received by the
infrared sensor.
The goal of thermomet is to measure core body tempera-
ture which is the temperatures of the vital organs. Clinical
studies showed that the ear is an excellent site of temperature
measurement because the temperatures taked in ear can
sooner and accurately reect core body temperature’s
changes .
1) Hold down the batte cover with your ngers, gently push
down to open the batte compament, and open the batte
cover.
2) Follow the polarity label in the batte compament, place
the new batte into the compament and clamp it tightly.
During installation, pay attention to the polarity and do not
install it upside down.
3) Finally, replace the batte cover in its original state.
V. How To Use The Ear Thermometer
1.Install/replace batteries
Batte installation/replacing method is as follows:
memo number. Note:The rst set of data displayed is the
most recent temperature measurement data, while the other
31 sets of data are displayed in order of temperature
measurement from near to far. In memo mode, if no any
operation within 5 seconds, the device will return to standby
mode automatically.
Over temperature warning function
If the measured body temperature is higher than the set
value, the ear thermometer will have dierent beeps and
backlight prompts.
1. Batteries using attention
1). The product uses two AA batteries.
2). When the batte symbol “ ” appears on the screen and
ashes, it indicates that the batte is low and needs to be
replaced. theoretically it can be used continuously for about
300 times (test conditions: temperature: 25°C, relative
humidity of 65%RH, staing from power on, self-check,
measurement, and automatic shutdown). When the low
batte icon on the screen ashes “ ”, it indicates that the
batte is low and needs to be replaced.
3). If the ambient temperature is low, it will shoen the batte
life.
4). When using batteries other than alkaline batteries, the
usage frequency may be ve sho, so it is recommended to
use alkaline batteries.
5). The voltage of the rechargeable batte is unstable and
can aect measurement. It is recommended not to use it.
6). When not in use for a long time, it is recommended to
remove the batte to avoid batte leakage and damage to
the product.
2. Disposing of batteries
To protect environment, dispose of empty batteries at
appropriate collection sites according to national or local
regulations.
Ear Thermometer 1pc
Instruction Manual 1pc
Quick Reference Guide 1pc
Probe Cover 20pcs(1 box)
The ear thermometer is a multi-patient reusable device, and
the cleaning and disinfection instructions were validated,
please follow the instructions to cleaning/disinfect your
thermometer prior to use.
Cleaning:
1) Use a cotton swab moistened with hot water or neutral
detergent to throughout cleaning the casing of thermometer
and measuring probe to removal of stain or oil.
2) Visual inspection the thermometer after cleaning process,
ensure there is no soil or stain is seen. if the device is
determined not to be visually clean at the end of the cleaning
step, you should either repeat the relevant previous cleaning
steps or safely dispose of the device, so that a visibly soiled
device is not used again.
Disinfection:
1) Use an 75% ethyl alcohol swab or cotton swab moistened
with 75% ethyl alcohol to disinfect the thermometer casing
and the measuring probe about 30 seconds.
2) Repeat the above steps at least 3 times, then wipe suace
and probe d with a clean cloth, and wait about 1 minute for
ding after disinfection process.
Note:
XIII. EMC Declaration XIV. Warranty/seice
The ME EQUIPMENT or ME SYSTEM is suitable for home
healthcare and clinic environments.
Statement: The ear thermometer model ET101,ET102,ET103
was tested according to the recommendations of Technical
Repo IEC TR 60601-4-2: Medical electrical equipment – Pa
4-2: Guidance and interpretation – Electromagnetic
immunity; peormance of medical electrical equipment and
medical electrical systems.
Warning：Don’t near active HF surgical equipment and the
RF shielded room of an ME system for magnetic resonance
imaging, where the intensity of EM disturbances is high.
Warning： Use of this equipment adjacent to or stacked with
other equipment should be avoided because it could result in
improper operation. If such use is necessa, this equipment
and the other equipment should be obseed to verify that
they are operating normally.
Warning: Use of accessories, transducers and cables other
than those specied or provided by the manufacturer of this
equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.”
Warning：Poable RF communications equipment (including
peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any pa
of the equipment ET101,ET102,ET103, including cables
specied by the manufacturer. Otherwise, degradation of the
peormance of this equipment could result.
1，All necessa instructions for maintaining BASIC SAFETY
and ESSENTIAL PERFORMANCE with regard to electromag-
netic disturbances for the excepted seice life.
Poable and mobile RF communication equipment may
aect the peormance of the ET101,ET102,ET103, avoiding
strong electromagnetic inteerence when used, such as near
mobile phones, microwave ovens, etc.
2，Guidance and manufacturer’s declaration -electromag-
netic emissions and Immunity
Guidance and manufacturer’s declaration - electromag-
netic emissions and Immunity
XI. Troubleshooting
XII. Signs And Symbols
If you have problems while using your thermometer, please
refer to this guide to help resolve the problem. If the problem
persists, please contact our customer seice.
Notes on handling batteries
•If your skin or eyes come into contact with batte uid,
rinse the aected area with water and seek medical
assistance.
When the buzzer beeps, it indicates that the temperature
measurement is completed and the temperature value is
displayed on the display screen.
The screens and sound prompts for different temperature
values are as follows:
Attention: The temperature value from the last temperature
measurement is displayed in the lower right corner of the
display screen, making it easier to compare changes in body
temperature.
Reference:Herzog L.Phillips S.Addressing Concerns About
Fever Clinical Pediatrics 2011 50(5) 383‒390
Below the temperature measurement range (T<34.0 ℃):
Display LO, red backlight, 1 beep:
Above the temperature measurement range (T>43.0 ℃):
Display Hi, red backlight, 1 beep.
⑤After inserting the probe into the ear canal and aligning it
with the eardrum, short press the "switch/measure" button
to measure the temperature. During the temperature
measurement process, the screen scrolls to display "- ° C",
" - ° C" and " -° C".
⑥If you need to take the next
temperature measurement, please
remove the used probe cover and
replace the new one and repeat
step ⑤.
⑦If there is no operation for about 60 seconds after the
temperature measurement is completed, the ear thermome-
ter will automatically shut down. You can also press and hold
the "Switch/Measure" button for about 5 seconds to turn off
the device. When the device is turned off, the display screen
will flash OFF for a short time and then turn off.
In accordance with our policy of continual product
improvement, we reserve the right to make technical and
optical changes without notice.
Warranty and repair terms
Warranty: 18 months.
Please contact your dealer or the service center in case of a
claim under the warranty. If you have to return the unit,
please enclose a copy of your receipt and state what the
defect is.
The following warranty terms apply:
1. The warranty period for BERRCOM products is 18 months
from date of purchase. In case of a warranty claim, the date
of purchase has to be proven by means of the sales receipt or
invoice.
2. Defects in material or workmanship will be removed free
of charge within the warranty period.
3. Repairs under warranty do not extend the warranty period
either for the unit or for the replacement parts.
4. The following is excluded under the warranty:
a. All damage which has arisen due to improper treatment,
e.g. nonobservance of the user instructions.
b. All damage which is due to repairs or tampering by the
customer or unauthorised third parties.
c. Damage which has arisen during transport from the
manufacturer to the consumer or during transport to the
service centre.
d. Accessories which are subject to normal wear and tear.
5. Liability for direct or indirect consequential losses caused
by the unit are excluded even if the damage to the unit is
accepted as a warranty claim.
Disposal
It is required that you should not dispose of WEEE as
unsoed municipal waste and collect such WEEE separately.
In accordance with Directive 2012/19/EU and national
disposal regulations regarding old electrical and electronic
devices, please be advised that such items must be disposed
of in a special way within the European Union (EU) .
These regulations require the environmentally friendly
recycling/disposal of old electrical and electronic devices.
Such items must not be disposed of as domestic refuse. This
has been expressed using the icon of the “crossed out trash
can”.
The ear thermometer (Model: ET101,ET102,ET103) contains
batteries and recyclable electronic waste. To protect the
environment, do not dispose of it in household waste as
unsoed municipal waste, but collect separately and take it to
an appropriate local collection center.
The ear thermometer (Model:ET101,ET102,ET103) is
classied as small equipment (5th catego) according to
ANNEX IV of Directive 2012/19/EU.
Before disposing of your ear thermometer (Model:
ET101,ET102,ET103), please take away the batteries from ear
thermometer (Model: ET101,ET102,ET103) and dispose of the
batteries and ear thermometer (Model: ET101,ET102,ET103)
separately.
You can take away the batteries as follows:
＞＞Batte remove diagram
① Open the lid on the back of the device
② Remove the batteries.
Batteries represent a hazard to health and the environment!
Never open, damage, or swallow batteries or allow them to
pollute the environment. They may contain toxic, ecologically
hazardous heavy metals. The removed batteries shall be
disposed of at the point of sale or in the corresponding
containers provided at collection points by local public waste
authorities and treated according to 2006/66/EC.
The batteries and recyclable electronic waste shall be
disposed of in a separate waste container.
Packaging materials must be disposed of according to local
regulations. Consult the authorized collection points for more
information.
In Germany
For the recyclable electronic waste disposal, you can search
the authorized collection points at the following website:
https://www.ear-system.de/ear-verzeichnis/sam-
mel-und-ruecknahmestellen
For batteries, you can search the authorized collection points
at the following website:
https://www.ear-system.de/ear-verzeichnis/battghersteller#-
no-back
Search method: using your postcode or the name of the city
and state where you live to nd collection points near you.
Other countries
For count-specic information on disposal, contact your
local dealers or impoer.
ashes, it reminds you to put on the
probe cover.
To obtain accurate readings, clean
and new disposable probe cover
should be installed before each
measurement.
Inse the ear thermometer probe
into the probe cover box, then pull it
out to t the new probe cover.
Only use this ear thermometer once you have read and
understood the instruction for use.
Only use this ear thermometer for the specic purpose
described in the instruction manual. Any misuse will void the
warranty.
This ear thermometer may be used for professional
purposes or for personal home use.
Using this ear thermometer is no substitute for consulting a
doctor. Do not self-diagnose or self-medicate on the basis
of the measurements without consulting your doctor. In
·
·
·
·
paicular, do not sta taking any new medication or
change the type and/or dosage of any existing medication
without prior approval.
This ear thermometer must be operated by adults, ensure
that children do not use this device unsupeised; some
pas are small enough to be a choking hazard or be
swallowed.
If this thermometer is stored condition that is out of its
using condition, please put it in operation place for at least
30 minutes before taking the measurement.
When the subject enters a warm room from a cold outdoor
environment and wets their ears by swimming or bathing,
the ear canal temperature will temporarily be lower than the
actual temperature. Please wait for 30 minutes before
taking the measurement.
When the subject's ears are covered by heat due to sleeping
on their side, wearing headphones or hearing aids, or long
hair covering, the ear canal temperature will temporarily be
higher than the actual temperature. Please wait for 30
minutes before taking the measurement.
The readings of the left and right ears may dier. When
obseing changes in body temperature, it is recommended
to collect the temperature of the same ear.
The measurement may result in measurement bias when the
subject takes medication that may increase or decrease
body temperature.
The subject may experience temperature uctuations after
engaging in activities such as intense exercise, cing, and
eating. It is recommended to maintain a quiet state for at
least 30 minutes before the measurement.
Dierent types and brands of temperature measurement
products do not have comparative value. It is recommended
that you use the same temperature measurement product
for multiple frequency obseations when obseing body
temperature, in order to better grasp changes in body
temperature.
People with ear diseases such as otitis externa and otitis
media should not use the ear thermometer.
It is recommended to measure about 3 times during
measurement, with a time inteal of 12s or more than 12s
between each measurement, recommend the maximum
temperature as measurement temperature.
Please check the batte level before use, as low batte
voltage may result in inaccurate measurement results.
If you nd that this product cannot achieve the claimed
peormance or if there is a change in product peormance,
please stop using it immediately and contact the manufac-
·
·
·
·
·
·
·
·
·
·
·
·
turer for assistance in time.
To ensure an accurate measurement, this thermometer must
only be used indoors when the ambient temperature range
is between 10℃(50℉) and 40℃（104℉）.
Before measurement, please ensure that the probe is free
from small foreign objects (such as earwax, dandru,
droplets, dust, etc.). After measurement, please place it in a
storage box to protect the probe from di or damage.
When there is a lot of earwax in the ear canal of the subject
(especially young children), please clean the ear canal
before taking the measurement to avoid aecting the
accuracy.
The probe lens is the most vulnerable pa of this product,
so it must be carefully protected. Please do not touch or
blow the probe with your hands. After measuring, please
place the product in the storage box.
Before use, conrm whether the probe lens is diy. If it is
diy, clean it according to the following steps, otherwise it
may cause measurement errors:
(1) Gently wipe the probe with a cotton swab or soft cloth
dipped in 75% alcohol.
(2) D and let the device stand for 30 minutes before use.
·
·
·
·
·
This ear thermometer should not be immersed in water or
directly exposed to sunlight to avoid product malfunctions.
This ear thermometer must be kept d and clean.
Please do not place this ear thermometer in an area with
electric shock to avoid product malfunction.
If any problems are found, please contact customer seice
and do not attempt to repair this product on your own. If
the original components are replaced with pas not
provided by the manufacturer, it may cause measurement
errors.
This ear thermometer is a measuring product. It is
recommended to check the accuracy of the product with a
manufacturer or a qualied third-pay organization at a
one-year inteal.
Please dispose of the waste and residue at the end of the
product's seice life in accordance with local laws and
regulations.
This ear thermometer expected seie life is 5 years.
Please use BERRCOM exclusive disposable probe cover
(model: PC001). If you use other brand’s probe cover, it may
result in inaccurate measurements. To purchase the
disposable probe cover, please contact your agent or
BERRCOM directly.
Do not use accessories, materials, etc. that are not specied
in this manual. Using accessories that are not provided or
specied by the manufacturer may result in the product not
achieving its intended use.
Before and after each use, the thermometer should be
cleaned according to the requirement of this manual to
avoid possible bacterial infections.
Do not expose this thermometer to extreme temperature
conditions of higher than 55℃(131℉) or lower than -20℃（
-4℉）.
Do not use this thermometer in relative humidity higher
than 85%RH.
Do not put this ear thermometer in the place with direct
sunlight, high temperature, high humidity, excessive dust, or
the place where it may contact with corrosive gas or liquid,
and do not use this product in the above environment.
Do not open up this thermometer. It contains small pas
which might be swallowed by children.
Remove the batteries if you do not wish to use the unit for
an extended period of time. Otherwise there is a danger
that the batteries may leak.
Keep the thermometer away from electromagnetic elds
produced by objects such as microwave ovens, arc welders
or induction heaters.
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
Please keep this ear thermometer out of reach of children.
Forceful measurement by children may cause ear inju. If
the batte is accidentally swallowed, please contact a
doctor immediately.
Please store the ear thermometer according to its storage
conditions to avoid usage issues and measurement errors.
Please do not forcefully collide, fall, step on, or shake this
product to avoid product malfunction or measurement
deviation.
·
·
Note: Do not use toilet paper or tissue to wipe.
Note: The reference body temperature for the ear thermome-
ter is oral temperature.
1、Guyton A C, Textbook of medical physiology, W.B.
Saunders, Philadelphia, 1996, p919;
eardrum
ear canal
1 2 3
4
5
6
7
8
9
① Probe cover (20 pcs/box)
② Storage box
③ Temperature sensing probe
④ Probe cover detector
⑤ Switch/Measure button
Symbols interpretation:
⑥ Batte cover
⑦ Display screen
⑧ Age selection button
⑨ Memo button
Batte
capacity
Measure
value
Probe notice
Age Groups
Unit
Memo
Last
measurement
value
Mute
AA 1.5V
2.Operate the device
The correct usage method is the key to measurement
accuracy, otherwise it may cause measurement errors. Due to
the high requirements of infrared
temperature measurement on the
surrounding environment, please
follow the prompts below for
operation.
① Take out the ear thermometer
from the storage box.
② Power on and self checking
Press the "Switch/Measure" button,
the ear thermometer will turn on
and sta self checking with a beep
sound. During self inspection, the
screen displays three full color icons.
If the following situations exist,
measurement cannot be suppoed:
1). Operating environment tempera-
ture too low or too high: Er1 is
displayed on the screen.
2). Low batte: The low batte icon
on the screen “ ” ashes to
indicate.
If the probe cover icon “ ” scrolls
Attention: If disposable probe cover is not installed, the ear
thermometer will not operate.
Attention: If the top of the disposable probe cover is found to
be damaged, they need to be replaced with new probe cover.
③ Select age groups
Press the age selection button“ ” to select the age range
of the tested object for temperature measurement. Press the
button to switch age groups.
④ Probe preheating
This product uses preheating temperature measurement
technology. Studies have shown that preheating the ear
thermometer for temperature measurement can avoid
cooling effects, improve temperature
measurement accuracy and comfort.
When the display screen shows
"00.0", it indicates that the preheat-
ing is completed and enters the test
state.
Note: This product defaults to the age range of the last
temperature measurement. If the age group of the tempera-
ture measurement object is dierent from the age group of
the last temperature measurement object, the age group
needs to be selected.
Above 36 months
0 ~ 3 months
3 ~ 36 months
Symbol
White backlight
1 beep
(Normal
temperature)
Orange
backlight
2 beeps
(Moderate fever)
Red backlight
3 beeps
(High fever)
Age
Groups
35.8°C ≤ T≤ 37.4°C
35.4°C ≤ T≤ 37.6°C 37.6°C <T≤ 38.5°C
37.7°C < T≤ 39.4°C
35.4°C ≤ T≤ 37.7°C
/ T
>
37.4°C
T
>
38.5°C
T
>
39.4°C
0 ~ 3
months
3 ~ 36
months
Above 36
months
Notice: The above steps are for use in
beep mode. If the ear thermometer
is in mute mode, the beep will turn
off, there will be mute icon “ ” on
the screen, and other prompts will
keep the same.
Attention: When measuring, the ear thermometer sensor
should be inserted into the ear canal and aligned withthe
eardrum. Otherwisr, the measured temperature will be lower
than the actual temperature.
The method of straightening the ear canal:
When measuring temperature, please fix the head of the
subject, gently pull the auricle, and horizontally insert the
probe into the ear canal and align it with the eardrum to fully
fill the ear canal. Specifically, the method of straightening
the ear canal is as follows:
36.8℃ Low measurement Low measurement
For children under 1
year old：gently pull
the auricle outward
and backward to
keep the ear canal as
straight as possible.
Children over 1 year
old and adults:
gently pullthe auricle
outward and upward
to keep it as straight
as possible.
This product can modify default settings parameters. Facto
settings have been made for dierent sales markets before
leaving the facto. It is recommended not to modify the
facto default values. If modication is necessa, please
follow the steps below.
Beep/mute mode
This product can be set to "beep mode" and "mute mode".
(Facto default is beep mode)
Setting method:
In standby mode, press and hold “Memo” button for 5
seconds, then enter beep/mute mode. And keep to hold the
“Memo” button, the screen will display two modes of with
or without mute symbol “ ” in sequence, each mode will
display about 3 seconds. Release the button when your
desired mode is displayed, then the save the mode and return
to standby mode.
Attention:
1．After each resta, the product is in beep mode；
2. When the device is turned on without wearing probe cover,
beep/mute mode conversion cannot be peormed.
Unit conversion
This product can be set to Fahrenheit (° F) and Celsius (° C).
(Facto default is Celsius)
Setting method:
In standby mode, press and hold the "Age selection" button
for 5 seconds, and the screen will display "° C" and "° F" in
sequence until the desired unit is displayed. Release the "Age
selection" button to complete the unit conversion and return
to full display standby mode.
Attention:
1. Maintain the settings before shutting down after each
resta;
2. When the device is turned on without wearing probe cover,
unit conversion cannot be peormed.
Memo que
This ear thermometer can remember the last 32 sets of body
temperature readings, making it easy to que historical
temperature data.
Setting method:
In standby mode, press the "Memo" button to enter memo
mode. In memo mode, pressing the “Memo” button, the
screen will display “M” and memo number, release the
button, the screen will display temperature data of the
Operational principle Infrared radiation detection
Audible Indicator Yes
Use of Probe Covers Ye s
Unit size Approx. 146×37×37mm (L x W x H)
Trade mark
Do not re-use
Manufacturer
Serial number
Please read the instructions carefully.
Applied pa, Type BF
Direct current
Date of manufacture
Made in China
Unique device identier
Medical device
Use-by date
Model number
Unit weight
(include batte)
Approx. 133g
( Without storage box)
Expected Seice Life 5 years
Applied pa Sensor; Type BF
IP Class IP22
Normal using
condition
Ambient temperature:10°C~40°C(50°F~104°F)
Relative humidity: ≤85%RH
Pressure altitude: 700hPa~1060hPa
Storage and
shipping condition
Essential
Peormance
Ambient temperature:-20°C~55°C(-4°F~131°F)
Relative humidity: ≤95%RH
Pressure altitude: 700hPa to 1060hPa
1.In normal using condition
10°C~40°C (50°F~104°F),
LABORATORY ACCURACY meet:
34.0°C~ 34.9°C(93.2°F~94.8°F):±0.3°C(±0.6°F)
35.0°C~ 42.0°C(95°F~107.6°F):±0.2°C(±0.4°F)
42.1°C~ 43.0°C(107.8°F~109.4°F):±0.3°C(±0.6°F)
2.OUTPUT TEMPERATURE
Display “Hi” when measuring temperature
above 43.0°C (109.4°F) and display “Lo” when
measuring temperature lower than 34.0°C
(93.2°F).
Adjusted mode
Oral
People of all ages
Ear
34.0°C~43.0°C (93.2°F~109.4°F)
≤ ±0.2°C/0.4°F
DC 3V (2pcs AA d batteries)
Approx. 3.5 seconds
LCD screen
0.1°C (0.1°F)
Approx. 60±10 seconds
34.0°C~ 34.9°C(93.2°F~94.8°F): ±0.3°C(±0.6°F)
35.0°C~ 42.0°C(95°F~107.6°F): ±0.2°C(±0.4°F)
42.1°C~ 43.0°C(107.8°F~109.4°F): ±0.3°C(±0.6°F)
OTC
Mode of operation
Patient population
RX/OTC Use
Measurement site
Measuring range
Accuracy
Clinical repeatability
Batteries
Measurement time
Display mode
Display resolution
Automatic power-o
32 sets Memo
Measurement
reference body site
Chocking hazard!
Small children may swallow and choke on batteries. Store
batteries out of the reach of small children.
•If a batte has leaked, put on protective gloves and clean
the batte compament with a d cloth.
•Protect batteries form excessive heat.
Risk of explosion! Do not throw batteries into a re.
•Use identical or equivalent batte types only.
•Always replace all batteries at the same time.
•Do not use rechargeable batteries.
•Do not disassemble, split or crush the batteries.
Ensure that no liquid enters the interior of the thermometer.
Never use abrasive cleaning agents, thinners or benzene for
cleaning and never immerse the Thermometer in water or
other cleaning liquids.
Take care not to scratch the suace of the probe lens and
the display.
If the visual inspection identies unacceptable deterioration
such as corrosion, discoloration, pitting, cracked, then the
device should be stop to use and discard.
If the thermometer is been used for between patients,
please visually inspect the thermometer to determine if
there is stain or oil on the casing or probe after each use,
and follow the instruction of cleaning and disinfection to
cleaning your thermometer.
•
•
•
•
•
GUANGZHOU BERRCOM MEDICAL DEVICE CO., LTD EXPRESSLY
DISCLAIMS ALL WARRANTIES OF MERCHANTABILITY AND
FITNESS FOR A PARTICULAR PURPOSE.
UNDER ON CIRCUMSTANCES SHALL BERRCOM HAVE ANY
OBLIGATION OR LIABILITY FOR ANY LOSS OF PROFIT OR FOR
ANY CONSEQUENTIAL, INCIDENTAL INDIRECT, SPECIAL,
PUNITIVE, OR CONTINGENT DAMAGES WHATSOEVER WITH
RESPECT TO CLAIMS MADE BY ANY CUSTOMER, CONSUMER OR
OTHER USER OF BERRCOM PRODUCTS.
IN THE EVENT THAT ANY APPLICABLE LAWS IMPOSE WARRAN-
TIES, CONDITIONS, OR OBLIGATIONS THAT CANNOT BE
EXCLUDED OR MODIFIED, THIS PARAGRAPH SHALL APPLY TO
THE GREATEST EXTENT ALLOWED BY SUCH LAWS.
•
•
•
Screen
message
Description
No display
Possible causes Solutions
Symbol Description of symbol
Symbol Symbol Description of symbol
Description of symbol
1. System error;
2. The batte is
completely power
o
Attention: If the above measures still cannot solve the problem, please
contact customer seice.
Batte
symbol
ashing, can
not measure
temperature
Batte
symbol
display, last
batte level
ashing.
Probe cover
symbol icker
in an
animated
style
Display Er1
Display“Hi”
or“Lo”
1. Not installing
probe cover,
2. The probe cover
is not properly
installed.
The current
ambient
temperature is too
low or too high,
which is not within
the operating range
specied in the
manual and cannot
be measured.
Place the product at
normal room
temperature (10 ° C to
40 ° C) or wait for a
period of time.
1. Check if the probe lens
is diy. Please clean the
probe lens and operate
again.
2. Please ask the subject
to maintain a stable
posture and measure
again according to the
correct operating method.
3. Place the product at
normal room temperature
(10 ° C to 40 ° C) and wait
for 30 minutes.
1.The measured
temperature exceeds
the measurement
range (34.0℃ to
43.0℃).
2.Unable to collect
stable temperature
values (the
environmental
temperature changes
too quickly and the
product has not yet
reached a stable state).
1. Install probe cover;
2. Remove the probe
cover and reinstall.
The current
batte level is too
low to peorm
temperature
measurement
The current
batte level is to
low, but still
operate correctly
Suggest replacing new
batteries as soon as
possible.
Replace new batteries.
1. Turn o and then
resta;
2. Remove the batte
and replace it or replace
it with a new one;
3. Please contact your
local dealer or customer
seice.
18
Guidance and manufacturer’s declaration - electromagnetic emissions
Indicates the need for the user to consult the instructions
for use for crucial cautiona information such as
warnings and precautions that can not, for a variety of
reasons, be presented on the medical device itself.
Degree of protection against harmful ingress of water
and paiculate matter
2 Protected and against solid foreign objects of 12.5mm
Φ and greater
2 Protection against veically falling water drops when
ENCLOSURE titled up to 15°
DISPOSAL: Do not dispose of this product as unsoed
municipal waste. Collection of such waste separately for
special treatment is necessa.
The CE labelling ceies that the product complies with
the essential requirements of EU regulations on medical
device.
Symbol of European Authorized Representative,
expressly indicate the name and address of European
Authorized Representative after the symbol.
CN
Impoer
(Just for Probe
Cover)
Table 1
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 2
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 3
Emissions test
Immunity Test Compliance level
IEC 60601-1-2
Test level
Harmonic emissions IEC 61000-3-2
RF emissions CISPR 11
RF emissions CISPR 11
Radiated RF
IEC61000-4-3
(Test
specications
for ENCLOSURE
PORT IMMUNITY
to RF wireless
communications
equipment)
Radiated RF
IEC61000-4-39
(Test
specications
for ENCLOSURE
PORT IMMUNITY
to proximity
magnetic elds)
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast transient
/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
±8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 kV air
Not applicable Not applicable
Radiated RF
IEC61000-4-3
10 V/m
80 MHz – 2,7 GHz
80 % AM at 2 Hz
10 V/m
80 MHz – 2,7 GHz
80 % AM at 2 Hz
Not applicable Not applicable
Conducted RF
IEC61000-4-6
Not applicable Not applicable
Not applicable
30 A/m
50Hz/60Hz
30 A/m
50Hz/60Hz
Not applicable
±8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 kV air
Group 1
Group B
Not applicable
Not applicable
Voltage uctuations/ icker emissions
IEC 61000-3-3
Compliance
Voltage dips, sho
interruptions and
voltage variations on
power supply input lines
IEC 61000-4-11
Power frequency
magnetic eld
IEC 61000-4-8
NOTE U
T is the a.c. mians voltage prior to application of the test
level.
Tes t
Frequency
(MHz)
Band
(MHz)
Seice Modulation
IEC
60601-1-2
Test Level
(V/m)
Compli-
ance
level
(V/m)
Tes t
Frequency
Modulation
IEC 60601-1-2
Test Level
(A/m)
Compliance
level
(A/m)
Pulse
modulation
18 Hz
Pulse
modulation
217 Hz
Pulse
modulation
18 Hz
FM ± 5 kHz
deviation
1 kHz sine
385 27 27
28 28
9 9
28 28
28 28
28 28
9 9
380
–390
TETRA 400
GMRS 460,
FRS 460
LTE Band 13,
17
WLAN
802.11
a/n
GSM
800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
430
–470
704
–787
800
–960
450
710
745
780
5240
30 kHz
134,2 kHz
13,56 MHz
CW
Pulse
modulation
2.1 kHz
Pulse
modulation
50 kHz
8 8
65 65
7,5 7,5
5500
5785
810
870
930
Pulse
modulation
217 Hz
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS
1700
–
1990
1720
1845
Pulse
modulation
217 Hz
Pulse
modulation
217 Hz
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
2400
–
2570
5100
–
5800
2450
1970
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 4
AA 1.5V
1
I.Intended Use
II.Warnings And Precautions
III.Principle Of Operation Of Ear Thermometer
IV.Product Description
V. How To Use The Ear Thermometer
VI.Setting Of The Ear Thermometer
VII.Technical Specications
VIII.Batteries
IX.Included In Delive
X.Cleaning and Disinfection
XI.Troubleshooting
XII.Signs And Symbols
XIII.EMC Declaration
XIV.Warranty/seice
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02
06
07
07
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16
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22
Contents
IV. Product Description VI. Setting Of The Ear ThermometerIII. Principle Of Operation Of
Ear Thermometer
I. Intended Use
II. Warnings And Precautions
02 03 0504 06 07 08 09 10
Instruction Manual
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ET101 ET102 ET103
PREHE AT
EAR
THERMOMETER
NOTE:
You must read this instruction manual completely before use and
follow all instructions. Keep the instructions for later use. You must
check the device functions according to this instruction manual
prior to each use and only use this device if it is in proper working
condition.
VII. Technical Specications
VIII. Batteries
IX. Included In Delive
X. Maintainance Of The Product
The Manufacturer Resees The Rightto Alter The Specica-
tions Of Theproduct Without Prior Notication.
Ear thermometer is intended to measure ear temperature of
people of all ages. It can be used by consumers in household
environment and doctor in clinic as reference.
All objects, solid, liquid or gas, emit energy by radiation. The
intensity of this energy depends on the temperature of the
object. The ear thermometer is therefore able to measure the
temperature of a person by the energy the person emits from
ear canal. The infrared sensor located at the front end of the
device collects the infrared radiation emitted from the ear
canal. The sensor conves the received infrared into electrical
signals and transmits them to the device chip. The device chip
calculates the human body temperature based on the
intensity and frequency of the infrared signal received by the
infrared sensor.
The goal of thermomet is to measure core body tempera-
ture which is the temperatures of the vital organs. Clinical
studies showed that the ear is an excellent site of temperature
measurement because the temperatures taked in ear can
sooner and accurately reect core body temperature’s
changes .
1) Hold down the batte cover with your ngers, gently push
down to open the batte compament, and open the batte
cover.
2) Follow the polarity label in the batte compament, place
the new batte into the compament and clamp it tightly.
During installation, pay attention to the polarity and do not
install it upside down.
3) Finally, replace the batte cover in its original state.
V. How To Use The Ear Thermometer
1.Install/replace batteries
Batte installation/replacing method is as follows:
memo number. Note:The rst set of data displayed is the
most recent temperature measurement data, while the other
31 sets of data are displayed in order of temperature
measurement from near to far. In memo mode, if no any
operation within 5 seconds, the device will return to standby
mode automatically.
Over temperature warning function
If the measured body temperature is higher than the set
value, the ear thermometer will have dierent beeps and
backlight prompts.
1. Batteries using attention
1). The product uses two AA batteries.
2). When the batte symbol “ ” appears on the screen and
ashes, it indicates that the batte is low and needs to be
replaced. theoretically it can be used continuously for about
300 times (test conditions: temperature: 25°C, relative
humidity of 65%RH, staing from power on, self-check,
measurement, and automatic shutdown). When the low
batte icon on the screen ashes “ ”, it indicates that the
batte is low and needs to be replaced.
3). If the ambient temperature is low, it will shoen the batte
life.
4). When using batteries other than alkaline batteries, the
usage frequency may be ve sho, so it is recommended to
use alkaline batteries.
5). The voltage of the rechargeable batte is unstable and
can aect measurement. It is recommended not to use it.
6). When not in use for a long time, it is recommended to
remove the batte to avoid batte leakage and damage to
the product.
2. Disposing of batteries
To protect environment, dispose of empty batteries at
appropriate collection sites according to national or local
regulations.
Ear Thermometer 1pc
Instruction Manual 1pc
Quick Reference Guide 1pc
Probe Cover 20pcs(1 box)
The ear thermometer is a multi-patient reusable device, and
the cleaning and disinfection instructions were validated,
please follow the instructions to cleaning/disinfect your
thermometer prior to use.
Cleaning:
1) Use a cotton swab moistened with hot water or neutral
detergent to throughout cleaning the casing of thermometer
and measuring probe to removal of stain or oil.
2) Visual inspection the thermometer after cleaning process,
ensure there is no soil or stain is seen. if the device is
determined not to be visually clean at the end of the cleaning
step, you should either repeat the relevant previous cleaning
steps or safely dispose of the device, so that a visibly soiled
device is not used again.
Disinfection:
1) Use an 75% ethyl alcohol swab or cotton swab moistened
with 75% ethyl alcohol to disinfect the thermometer casing
and the measuring probe about 30 seconds.
2) Repeat the above steps at least 3 times, then wipe suace
and probe d with a clean cloth, and wait about 1 minute for
ding after disinfection process.
Note:
XIII. EMC Declaration XIV. Warranty/seice
The ME EQUIPMENT or ME SYSTEM is suitable for home
healthcare and clinic environments.
Statement: The ear thermometer model ET101,ET102,ET103
was tested according to the recommendations of Technical
Repo IEC TR 60601-4-2: Medical electrical equipment – Pa
4-2: Guidance and interpretation – Electromagnetic
immunity; peormance of medical electrical equipment and
medical electrical systems.
Warning：Don’t near active HF surgical equipment and the
RF shielded room of an ME system for magnetic resonance
imaging, where the intensity of EM disturbances is high.
Warning： Use of this equipment adjacent to or stacked with
other equipment should be avoided because it could result in
improper operation. If such use is necessa, this equipment
and the other equipment should be obseed to verify that
they are operating normally.
Warning: Use of accessories, transducers and cables other
than those specied or provided by the manufacturer of this
equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.”
Warning：Poable RF communications equipment (including
peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any pa
of the equipment ET101,ET102,ET103, including cables
specied by the manufacturer. Otherwise, degradation of the
peormance of this equipment could result.
1，All necessa instructions for maintaining BASIC SAFETY
and ESSENTIAL PERFORMANCE with regard to electromag-
netic disturbances for the excepted seice life.
Poable and mobile RF communication equipment may
aect the peormance of the ET101,ET102,ET103, avoiding
strong electromagnetic inteerence when used, such as near
mobile phones, microwave ovens, etc.
2，Guidance and manufacturer’s declaration -electromag-
netic emissions and Immunity
Guidance and manufacturer’s declaration - electromag-
netic emissions and Immunity
XI. Troubleshooting
XII. Signs And Symbols
If you have problems while using your thermometer, please
refer to this guide to help resolve the problem. If the problem
persists, please contact our customer seice.
Notes on handling batteries
•If your skin or eyes come into contact with batte uid,
rinse the aected area with water and seek medical
assistance.
When the buzzer beeps, it indicates that the temperature
measurement is completed and the temperature value is
displayed on the display screen.
The screens and sound prompts for different temperature
values are as follows:
Attention: The temperature value from the last temperature
measurement is displayed in the lower right corner of the
display screen, making it easier to compare changes in body
temperature.
Reference:Herzog L.Phillips S.Addressing Concerns About
Fever Clinical Pediatrics 2011 50(5) 383‒390
Below the temperature measurement range (T<34.0 ℃):
Display LO, red backlight, 1 beep:
Above the temperature measurement range (T>43.0 ℃):
Display Hi, red backlight, 1 beep.
⑤After inserting the probe into the ear canal and aligning it
with the eardrum, short press the "switch/measure" button
to measure the temperature. During the temperature
measurement process, the screen scrolls to display "- ° C",
" - ° C" and " -° C".
⑥If you need to take the next
temperature measurement, please
remove the used probe cover and
replace the new one and repeat
step ⑤.
⑦If there is no operation for about 60 seconds after the
temperature measurement is completed, the ear thermome-
ter will automatically shut down. You can also press and hold
the "Switch/Measure" button for about 5 seconds to turn off
the device. When the device is turned off, the display screen
will flash OFF for a short time and then turn off.
In accordance with our policy of continual product
improvement, we reserve the right to make technical and
optical changes without notice.
Warranty and repair terms
Warranty: 18 months.
Please contact your dealer or the service center in case of a
claim under the warranty. If you have to return the unit,
please enclose a copy of your receipt and state what the
defect is.
The following warranty terms apply:
1. The warranty period for BERRCOM products is 18 months
from date of purchase. In case of a warranty claim, the date
of purchase has to be proven by means of the sales receipt or
invoice.
2. Defects in material or workmanship will be removed free
of charge within the warranty period.
3. Repairs under warranty do not extend the warranty period
either for the unit or for the replacement parts.
4. The following is excluded under the warranty:
a. All damage which has arisen due to improper treatment,
e.g. nonobservance of the user instructions.
b. All damage which is due to repairs or tampering by the
customer or unauthorised third parties.
c. Damage which has arisen during transport from the
manufacturer to the consumer or during transport to the
service centre.
d. Accessories which are subject to normal wear and tear.
5. Liability for direct or indirect consequential losses caused
by the unit are excluded even if the damage to the unit is
accepted as a warranty claim.
Disposal
It is required that you should not dispose of WEEE as
unsoed municipal waste and collect such WEEE separately.
In accordance with Directive 2012/19/EU and national
disposal regulations regarding old electrical and electronic
devices, please be advised that such items must be disposed
of in a special way within the European Union (EU) .
These regulations require the environmentally friendly
recycling/disposal of old electrical and electronic devices.
Such items must not be disposed of as domestic refuse. This
has been expressed using the icon of the “crossed out trash
can”.
The ear thermometer (Model: ET101,ET102,ET103) contains
batteries and recyclable electronic waste. To protect the
environment, do not dispose of it in household waste as
unsoed municipal waste, but collect separately and take it to
an appropriate local collection center.
The ear thermometer (Model:ET101,ET102,ET103) is
classied as small equipment (5th catego) according to
ANNEX IV of Directive 2012/19/EU.
Before disposing of your ear thermometer (Model:
ET101,ET102,ET103), please take away the batteries from ear
thermometer (Model: ET101,ET102,ET103) and dispose of the
batteries and ear thermometer (Model: ET101,ET102,ET103)
separately.
You can take away the batteries as follows:
＞＞Batte remove diagram
① Open the lid on the back of the device
② Remove the batteries.
Batteries represent a hazard to health and the environment!
Never open, damage, or swallow batteries or allow them to
pollute the environment. They may contain toxic, ecologically
hazardous heavy metals. The removed batteries shall be
disposed of at the point of sale or in the corresponding
containers provided at collection points by local public waste
authorities and treated according to 2006/66/EC.
The batteries and recyclable electronic waste shall be
disposed of in a separate waste container.
Packaging materials must be disposed of according to local
regulations. Consult the authorized collection points for more
information.
In Germany
For the recyclable electronic waste disposal, you can search
the authorized collection points at the following website:
https://www.ear-system.de/ear-verzeichnis/sam-
mel-und-ruecknahmestellen
For batteries, you can search the authorized collection points
at the following website:
https://www.ear-system.de/ear-verzeichnis/battghersteller#-
no-back
Search method: using your postcode or the name of the city
and state where you live to nd collection points near you.
Other countries
For count-specic information on disposal, contact your
local dealers or impoer.
ashes, it reminds you to put on the
probe cover.
To obtain accurate readings, clean
and new disposable probe cover
should be installed before each
measurement.
Inse the ear thermometer probe
into the probe cover box, then pull it
out to t the new probe cover.
Only use this ear thermometer once you have read and
understood the instruction for use.
Only use this ear thermometer for the specic purpose
described in the instruction manual. Any misuse will void the
warranty.
This ear thermometer may be used for professional
purposes or for personal home use.
Using this ear thermometer is no substitute for consulting a
doctor. Do not self-diagnose or self-medicate on the basis
of the measurements without consulting your doctor. In
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paicular, do not sta taking any new medication or
change the type and/or dosage of any existing medication
without prior approval.
This ear thermometer must be operated by adults, ensure
that children do not use this device unsupeised; some
pas are small enough to be a choking hazard or be
swallowed.
If this thermometer is stored condition that is out of its
using condition, please put it in operation place for at least
30 minutes before taking the measurement.
When the subject enters a warm room from a cold outdoor
environment and wets their ears by swimming or bathing,
the ear canal temperature will temporarily be lower than the
actual temperature. Please wait for 30 minutes before
taking the measurement.
When the subject's ears are covered by heat due to sleeping
on their side, wearing headphones or hearing aids, or long
hair covering, the ear canal temperature will temporarily be
higher than the actual temperature. Please wait for 30
minutes before taking the measurement.
The readings of the left and right ears may dier. When
obseing changes in body temperature, it is recommended
to collect the temperature of the same ear.
The measurement may result in measurement bias when the
subject takes medication that may increase or decrease
body temperature.
The subject may experience temperature uctuations after
engaging in activities such as intense exercise, cing, and
eating. It is recommended to maintain a quiet state for at
least 30 minutes before the measurement.
Dierent types and brands of temperature measurement
products do not have comparative value. It is recommended
that you use the same temperature measurement product
for multiple frequency obseations when obseing body
temperature, in order to better grasp changes in body
temperature.
People with ear diseases such as otitis externa and otitis
media should not use the ear thermometer.
It is recommended to measure about 3 times during
measurement, with a time inteal of 12s or more than 12s
between each measurement, recommend the maximum
temperature as measurement temperature.
Please check the batte level before use, as low batte
voltage may result in inaccurate measurement results.
If you nd that this product cannot achieve the claimed
peormance or if there is a change in product peormance,
please stop using it immediately and contact the manufac-
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turer for assistance in time.
To ensure an accurate measurement, this thermometer must
only be used indoors when the ambient temperature range
is between 10℃(50℉) and 40℃（104℉）.
Before measurement, please ensure that the probe is free
from small foreign objects (such as earwax, dandru,
droplets, dust, etc.). After measurement, please place it in a
storage box to protect the probe from di or damage.
When there is a lot of earwax in the ear canal of the subject
(especially young children), please clean the ear canal
before taking the measurement to avoid aecting the
accuracy.
The probe lens is the most vulnerable pa of this product,
so it must be carefully protected. Please do not touch or
blow the probe with your hands. After measuring, please
place the product in the storage box.
Before use, conrm whether the probe lens is diy. If it is
diy, clean it according to the following steps, otherwise it
may cause measurement errors:
(1) Gently wipe the probe with a cotton swab or soft cloth
dipped in 75% alcohol.
(2) D and let the device stand for 30 minutes before use.
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This ear thermometer should not be immersed in water or
directly exposed to sunlight to avoid product malfunctions.
This ear thermometer must be kept d and clean.
Please do not place this ear thermometer in an area with
electric shock to avoid product malfunction.
If any problems are found, please contact customer seice
and do not attempt to repair this product on your own. If
the original components are replaced with pas not
provided by the manufacturer, it may cause measurement
errors.
This ear thermometer is a measuring product. It is
recommended to check the accuracy of the product with a
manufacturer or a qualied third-pay organization at a
one-year inteal.
Please dispose of the waste and residue at the end of the
product's seice life in accordance with local laws and
regulations.
This ear thermometer expected seie life is 5 years.
Please use BERRCOM exclusive disposable probe cover
(model: PC001). If you use other brand’s probe cover, it may
result in inaccurate measurements. To purchase the
disposable probe cover, please contact your agent or
BERRCOM directly.
Do not use accessories, materials, etc. that are not specied
in this manual. Using accessories that are not provided or
specied by the manufacturer may result in the product not
achieving its intended use.
Before and after each use, the thermometer should be
cleaned according to the requirement of this manual to
avoid possible bacterial infections.
Do not expose this thermometer to extreme temperature
conditions of higher than 55℃(131℉) or lower than -20℃（
-4℉）.
Do not use this thermometer in relative humidity higher
than 85%RH.
Do not put this ear thermometer in the place with direct
sunlight, high temperature, high humidity, excessive dust, or
the place where it may contact with corrosive gas or liquid,
and do not use this product in the above environment.
Do not open up this thermometer. It contains small pas
which might be swallowed by children.
Remove the batteries if you do not wish to use the unit for
an extended period of time. Otherwise there is a danger
that the batteries may leak.
Keep the thermometer away from electromagnetic elds
produced by objects such as microwave ovens, arc welders
or induction heaters.
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Please keep this ear thermometer out of reach of children.
Forceful measurement by children may cause ear inju. If
the batte is accidentally swallowed, please contact a
doctor immediately.
Please store the ear thermometer according to its storage
conditions to avoid usage issues and measurement errors.
Please do not forcefully collide, fall, step on, or shake this
product to avoid product malfunction or measurement
deviation.
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Note: Do not use toilet paper or tissue to wipe.
Note: The reference body temperature for the ear thermome-
ter is oral temperature.
1、Guyton A C, Textbook of medical physiology, W.B.
Saunders, Philadelphia, 1996, p919;
eardrum
ear canal
1 2 3
4
5
6
7
8
9
① Probe cover (20 pcs/box)
② Storage box
③ Temperature sensing probe
④ Probe cover detector
⑤ Switch/Measure button
Symbols interpretation:
⑥ Batte cover
⑦ Display screen
⑧ Age selection button
⑨ Memo button
Batte
capacity
Measure
value
Probe notice
Age Groups
Unit
Memo
Last
measurement
value
Mute
AA 1.5V
2.Operate the device
The correct usage method is the key to measurement
accuracy, otherwise it may cause measurement errors. Due to
the high requirements of infrared
temperature measurement on the
surrounding environment, please
follow the prompts below for
operation.
① Take out the ear thermometer
from the storage box.
② Power on and self checking
Press the "Switch/Measure" button,
the ear thermometer will turn on
and sta self checking with a beep
sound. During self inspection, the
screen displays three full color icons.
If the following situations exist,
measurement cannot be suppoed:
1). Operating environment tempera-
ture too low or too high: Er1 is
displayed on the screen.
2). Low batte: The low batte icon
on the screen “ ” ashes to
indicate.
If the probe cover icon “ ” scrolls
Attention: If disposable probe cover is not installed, the ear
thermometer will not operate.
Attention: If the top of the disposable probe cover is found to
be damaged, they need to be replaced with new probe cover.
③ Select age groups
Press the age selection button“ ” to select the age range
of the tested object for temperature measurement. Press the
button to switch age groups.
④ Probe preheating
This product uses preheating temperature measurement
technology. Studies have shown that preheating the ear
thermometer for temperature measurement can avoid
cooling effects, improve temperature
measurement accuracy and comfort.
When the display screen shows
"00.0", it indicates that the preheat-
ing is completed and enters the test
state.
Note: This product defaults to the age range of the last
temperature measurement. If the age group of the tempera-
ture measurement object is dierent from the age group of
the last temperature measurement object, the age group
needs to be selected.
Above 36 months
0 ~ 3 months
3 ~ 36 months
Symbol
White backlight
1 beep
(Normal
temperature)
Orange
backlight
2 beeps
(Moderate fever)
Red backlight
3 beeps
(High fever)
Age
Groups
35.8°C ≤ T≤ 37.4°C
35.4°C ≤ T≤ 37.6°C 37.6°C <T≤ 38.5°C
37.7°C < T≤ 39.4°C
35.4°C ≤ T≤ 37.7°C
/ T
>
37.4°C
T
>
38.5°C
T
>
39.4°C
0 ~ 3
months
3 ~ 36
months
Above 36
months
Notice: The above steps are for use in
beep mode. If the ear thermometer
is in mute mode, the beep will turn
off, there will be mute icon “ ” on
the screen, and other prompts will
keep the same.
Attention: When measuring, the ear thermometer sensor
should be inserted into the ear canal and aligned withthe
eardrum. Otherwisr, the measured temperature will be lower
than the actual temperature.
The method of straightening the ear canal:
When measuring temperature, please fix the head of the
subject, gently pull the auricle, and horizontally insert the
probe into the ear canal and align it with the eardrum to fully
fill the ear canal. Specifically, the method of straightening
the ear canal is as follows:
36.8℃ Low measurement Low measurement
For children under 1
year old：gently pull
the auricle outward
and backward to
keep the ear canal as
straight as possible.
Children over 1 year
old and adults:
gently pullthe auricle
outward and upward
to keep it as straight
as possible.
This product can modify default settings parameters. Facto
settings have been made for dierent sales markets before
leaving the facto. It is recommended not to modify the
facto default values. If modication is necessa, please
follow the steps below.
Beep/mute mode
This product can be set to "beep mode" and "mute mode".
(Facto default is beep mode)
Setting method:
In standby mode, press and hold “Memo” button for 5
seconds, then enter beep/mute mode. And keep to hold the
“Memo” button, the screen will display two modes of with
or without mute symbol “ ” in sequence, each mode will
display about 3 seconds. Release the button when your
desired mode is displayed, then the save the mode and return
to standby mode.
Attention:
1．After each resta, the product is in beep mode；
2. When the device is turned on without wearing probe cover,
beep/mute mode conversion cannot be peormed.
Unit conversion
This product can be set to Fahrenheit (° F) and Celsius (° C).
(Facto default is Celsius)
Setting method:
In standby mode, press and hold the "Age selection" button
for 5 seconds, and the screen will display "° C" and "° F" in
sequence until the desired unit is displayed. Release the "Age
selection" button to complete the unit conversion and return
to full display standby mode.
Attention:
1. Maintain the settings before shutting down after each
resta;
2. When the device is turned on without wearing probe cover,
unit conversion cannot be peormed.
Memo que
This ear thermometer can remember the last 32 sets of body
temperature readings, making it easy to que historical
temperature data.
Setting method:
In standby mode, press the "Memo" button to enter memo
mode. In memo mode, pressing the “Memo” button, the
screen will display “M” and memo number, release the
button, the screen will display temperature data of the
Operational principle Infrared radiation detection
Audible Indicator Yes
Use of Probe Covers Ye s
Unit size Approx. 146×37×37mm (L x W x H)
Trade mark
Do not re-use
Manufacturer
Serial number
Please read the instructions carefully.
Applied pa, Type BF
Direct current
Date of manufacture
Made in China
Unique device identier
Medical device
Use-by date
Model number
Unit weight
(include batte)
Approx. 133g
( Without storage box)
Expected Seice Life 5 years
Applied pa Sensor; Type BF
IP Class IP22
Normal using
condition
Ambient temperature:10°C~40°C(50°F~104°F)
Relative humidity: ≤85%RH
Pressure altitude: 700hPa~1060hPa
Storage and
shipping condition
Essential
Peormance
Ambient temperature:-20°C~55°C(-4°F~131°F)
Relative humidity: ≤95%RH
Pressure altitude: 700hPa to 1060hPa
1.In normal using condition
10°C~40°C (50°F~104°F),
LABORATORY ACCURACY meet:
34.0°C~ 34.9°C(93.2°F~94.8°F):±0.3°C(±0.6°F)
35.0°C~ 42.0°C(95°F~107.6°F):±0.2°C(±0.4°F)
42.1°C~ 43.0°C(107.8°F~109.4°F):±0.3°C(±0.6°F)
2.OUTPUT TEMPERATURE
Display “Hi” when measuring temperature
above 43.0°C (109.4°F) and display “Lo” when
measuring temperature lower than 34.0°C
(93.2°F).
Adjusted mode
Oral
People of all ages
Ear
34.0°C~43.0°C (93.2°F~109.4°F)
≤ ±0.2°C/0.4°F
DC 3V (2pcs AA d batteries)
Approx. 3.5 seconds
LCD screen
0.1°C (0.1°F)
Approx. 60±10 seconds
34.0°C~ 34.9°C(93.2°F~94.8°F): ±0.3°C(±0.6°F)
35.0°C~ 42.0°C(95°F~107.6°F): ±0.2°C(±0.4°F)
42.1°C~ 43.0°C(107.8°F~109.4°F): ±0.3°C(±0.6°F)
OTC
Mode of operation
Patient population
RX/OTC Use
Measurement site
Measuring range
Accuracy
Clinical repeatability
Batteries
Measurement time
Display mode
Display resolution
Automatic power-o
32 sets Memo
Measurement
reference body site
Chocking hazard!
Small children may swallow and choke on batteries. Store
batteries out of the reach of small children.
•If a batte has leaked, put on protective gloves and clean
the batte compament with a d cloth.
•Protect batteries form excessive heat.
Risk of explosion! Do not throw batteries into a re.
•Use identical or equivalent batte types only.
•Always replace all batteries at the same time.
•Do not use rechargeable batteries.
•Do not disassemble, split or crush the batteries.
Ensure that no liquid enters the interior of the thermometer.
Never use abrasive cleaning agents, thinners or benzene for
cleaning and never immerse the Thermometer in water or
other cleaning liquids.
Take care not to scratch the suace of the probe lens and
the display.
If the visual inspection identies unacceptable deterioration
such as corrosion, discoloration, pitting, cracked, then the
device should be stop to use and discard.
If the thermometer is been used for between patients,
please visually inspect the thermometer to determine if
there is stain or oil on the casing or probe after each use,
and follow the instruction of cleaning and disinfection to
cleaning your thermometer.
•
•
•
•
•
GUANGZHOU BERRCOM MEDICAL DEVICE CO., LTD EXPRESSLY
DISCLAIMS ALL WARRANTIES OF MERCHANTABILITY AND
FITNESS FOR A PARTICULAR PURPOSE.
UNDER ON CIRCUMSTANCES SHALL BERRCOM HAVE ANY
OBLIGATION OR LIABILITY FOR ANY LOSS OF PROFIT OR FOR
ANY CONSEQUENTIAL, INCIDENTAL INDIRECT, SPECIAL,
PUNITIVE, OR CONTINGENT DAMAGES WHATSOEVER WITH
RESPECT TO CLAIMS MADE BY ANY CUSTOMER, CONSUMER OR
OTHER USER OF BERRCOM PRODUCTS.
IN THE EVENT THAT ANY APPLICABLE LAWS IMPOSE WARRAN-
TIES, CONDITIONS, OR OBLIGATIONS THAT CANNOT BE
EXCLUDED OR MODIFIED, THIS PARAGRAPH SHALL APPLY TO
THE GREATEST EXTENT ALLOWED BY SUCH LAWS.
•
•
•
Screen
message
Description
No display
Possible causes Solutions
Symbol Description of symbol
Symbol Symbol Description of symbol
Description of symbol
1. System error;
2. The batte is
completely power
o
Attention: If the above measures still cannot solve the problem, please
contact customer seice.
Batte
symbol
ashing, can
not measure
temperature
Batte
symbol
display, last
batte level
ashing.
Probe cover
symbol icker
in an
animated
style
Display Er1
Display“Hi”
or“Lo”
1. Not installing
probe cover,
2. The probe cover
is not properly
installed.
The current
ambient
temperature is too
low or too high,
which is not within
the operating range
specied in the
manual and cannot
be measured.
Place the product at
normal room
temperature (10 ° C to
40 ° C) or wait for a
period of time.
1. Check if the probe lens
is diy. Please clean the
probe lens and operate
again.
2. Please ask the subject
to maintain a stable
posture and measure
again according to the
correct operating method.
3. Place the product at
normal room temperature
(10 ° C to 40 ° C) and wait
for 30 minutes.
1.The measured
temperature exceeds
the measurement
range (34.0℃ to
43.0℃).
2.Unable to collect
stable temperature
values (the
environmental
temperature changes
too quickly and the
product has not yet
reached a stable state).
1. Install probe cover;
2. Remove the probe
cover and reinstall.
The current
batte level is too
low to peorm
temperature
measurement
The current
batte level is to
low, but still
operate correctly
Suggest replacing new
batteries as soon as
possible.
Replace new batteries.
1. Turn o and then
resta;
2. Remove the batte
and replace it or replace
it with a new one;
3. Please contact your
local dealer or customer
seice.
18
Guidance and manufacturer’s declaration - electromagnetic emissions
Indicates the need for the user to consult the instructions
for use for crucial cautiona information such as
warnings and precautions that can not, for a variety of
reasons, be presented on the medical device itself.
Degree of protection against harmful ingress of water
and paiculate matter
2 Protected and against solid foreign objects of 12.5mm
Φ and greater
2 Protection against veically falling water drops when
ENCLOSURE titled up to 15°
DISPOSAL: Do not dispose of this product as unsoed
municipal waste. Collection of such waste separately for
special treatment is necessa.
The CE labelling ceies that the product complies with
the essential requirements of EU regulations on medical
device.
Symbol of European Authorized Representative,
expressly indicate the name and address of European
Authorized Representative after the symbol.
CN
Impoer
(Just for Probe
Cover)
Table 1
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 2
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 3
Emissions test
Immunity Test Compliance level
IEC 60601-1-2
Test level
Harmonic emissions IEC 61000-3-2
RF emissions CISPR 11
RF emissions CISPR 11
Radiated RF
IEC61000-4-3
(Test
specications
for ENCLOSURE
PORT IMMUNITY
to RF wireless
communications
equipment)
Radiated RF
IEC61000-4-39
(Test
specications
for ENCLOSURE
PORT IMMUNITY
to proximity
magnetic elds)
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast transient
/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
±8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 kV air
Not applicable Not applicable
Radiated RF
IEC61000-4-3
10 V/m
80 MHz – 2,7 GHz
80 % AM at 2 Hz
10 V/m
80 MHz – 2,7 GHz
80 % AM at 2 Hz
Not applicable Not applicable
Conducted RF
IEC61000-4-6
Not applicable Not applicable
Not applicable
30 A/m
50Hz/60Hz
30 A/m
50Hz/60Hz
Not applicable
±8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 kV air
Group 1
Group B
Not applicable
Not applicable
Voltage uctuations/ icker emissions
IEC 61000-3-3
Compliance
Voltage dips, sho
interruptions and
voltage variations on
power supply input lines
IEC 61000-4-11
Power frequency
magnetic eld
IEC 61000-4-8
NOTE U
T is the a.c. mians voltage prior to application of the test
level.
Tes t
Frequency
(MHz)
Band
(MHz)
Seice Modulation
IEC
60601-1-2
Test Level
(V/m)
Compli-
ance
level
(V/m)
Tes t
Frequency
Modulation
IEC 60601-1-2
Test Level
(A/m)
Compliance
level
(A/m)
Pulse
modulation
18 Hz
Pulse
modulation
217 Hz
Pulse
modulation
18 Hz
FM ± 5 kHz
deviation
1 kHz sine
385 27 27
28 28
9 9
28 28
28 28
28 28
9 9
380
–390
TETRA 400
GMRS 460,
FRS 460
LTE Band 13,
17
WLAN
802.11
a/n
GSM
800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
430
–470
704
–787
800
–960
450
710
745
780
5240
30 kHz
134,2 kHz
13,56 MHz
CW
Pulse
modulation
2.1 kHz
Pulse
modulation
50 kHz
8 8
65 65
7,5 7,5
5500
5785
810
870
930
Pulse
modulation
217 Hz
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS
1700
–
1990
1720
1845
Pulse
modulation
217 Hz
Pulse
modulation
217 Hz
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
2400
–
2570
5100
–
5800
2450
1970
Guidance and manufacturer’s declaration - electromagnetic Immunity
Table 4
AA 1.5V
1
