Yuwell YHT107 Infrared Ear Thermometer User Manual

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YUWELL®

Infrared ear thermometer

YHT107

Instructions for Use

Please read the instructions for use carefully and follow the instructions

before use. For date of manufacture, please refer to the packaging.

The picture is for reference only, please refer to the actual product.

Safety and environmental protection use period

for 10 years

Protected against solid foreign objects of 12.5

mmφ and greater. Protection against vertically

falling water drops when ENCLOSURE tilted

up to 15°

Refer to instructions manual

(Background: Blue; Symbol: White)

Waste from electrical and electronic equipment

(WEEE)

SYMBOL

Type BF applied part

Caution

DEFINITION

MR Unsafe (Background color: white; Circular

frame and diagonal bar: red; Letters 'MR': black)

Temperature limit

Humidity limitation

Atmospheric pressure limitation

This way up

Fragile, handle with care

Keep dry

Date of manufacture

Serial number

Batch code

Medical device

Unique device identifier

Recyclable

Manufacturer

Bluetooth

1. From the date of purchase, the device will enjoy a free one-year warranty

with the purchase invoice. During warranty service, if you need to be provided

with circuit diagram, components, necessary materials and electrical circuit

maintenance, please contact the manufacturer.

2. The infrared ear thermometer is calibrated initially when manufactured. There

is no need for readjustment if it is used according to the instruction. If anytime

you question the accuracy of the temperature measurement, please contact the

manufacturer.

Adjusted mode is for general public; calibration mode is for after-sale person

only.

3. Free warranty service will not be provided for faults caused by the following

personal reasons:

●The following conditions are not covered by the warranty:

A. Vulnerable and consumable parts: cover, battery and probe cover;

B. Breakdown caused by unauthorized disassembly and assembly of the

device;

C. Breakdown caused by operation not in accordance with the instructions;

D. Breakdown caused by lack of reasonable maintenance;

E. Fault caused by device falling carelessly;

XI. Guidance and manufacturers declaration on EMC

EMC compliance

1.This device has been tested and found to comply with the Class B limits for

medical devices according to the IEC 60601-1-2.

2.The thermometer is suitable to be used in professional use environment and

home use environment except for near active HF SURGICAL EQUIPMENT and

the RF shielded room of an ME SYSTEM for magnetic resonance imaging.

3.The essential performance of the thermometer is measurement range

34.0℃‒42.2℃ (93.2℉‒108.0℉),Within the temperature display range of

35.0℃‒42.0℃ (95.0℉‒107.6℉), it is ±0.2℃ (±0.4℉); beyond the temperature

display range of 35.0℃‒42.0℃ (95.0℉‒107.6℉), it is ±0.3℃ (±0.5℉). When

used directly near strong electromagnetic interference (for example: near

mobile phones, microwave ovens, etc.), it may be temporarily inaccurate. If so,

please keep the product away from interfering devices.

4.WARNING: Use of the thermometer adjacent to or stacked with other

equipment should be avoided because it could result in improper operation.

5.WARNING: Portable RF communications equipment (including peripherals

such as antenna cables and external antennas) should be used no closer than

30 cm (12 inches) to any part of the thermometer. Otherwise, degradation of the

performance of the thermometer could result.

Table 1. Electromagnetic emissions

YY-THM0107D-01(A/0)

Revision date: Oct. 2024

JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO.,LTD.

No.1 Baisheng Road Development Zone, Danyang,

Jiangsu 212300 CHINA

www.yuwell.com

If you have any questions, you can contact us at the following phone

number or email.

Contact number: (86-511) 8690 0890

E-mail: yuwellsales@yuyue.com.cn / sales@yuyue.com.cn

XII. Abbreviations Deﬁnition

Personal Computer

RFID

Radio Frequency Identification Devices

MRI

Magnetic resonance imaging

FCC

℃

environment

℉

Fahrenheit degree

Electromagnetic

environment

App

Application

ME equipment

Medical electrical

equipment

HF SURGICAL

EQUIPMENT

High-frequency surgery

equipment

Celsius degree

Federal Communications Commission

Radio Frequency

Frequency Range

Bandwidth

Modulation

ITEM

Dimensions

Weight without battery

Frequency characteristics

Max Conducted TX Power

Recommended Range

FCC ID

2402 MHz-2480 MHz

1 MHz, 2 MHz

GFSK

UHF

3.12 dBm

~10 feet (~3 meters) line-of-sight

2A2JJ-YHT107

PARAMETER

153 mm×59 mm×37.5 mm

About 80 g

Mode of Operation

Environment

Continuous operation

Not for use in an OXYGEN RICH

ENVIRONMENT

3.Physical Characteristics

ITEM

Operating temperature range

Transport and storage temperature range

DESCRIPTION

+10℃‒+40℃ (50℉‒104℉)

-20℃‒+55℃ (-4℉‒131℉)

Humidity

Atmospheric pressure

15% to 90%, no condensation

70kPa‒106kPa

5.Environment

7.Compliance

4.Bluetooth Technology Information

EQUIPMENT CLASSIFICATIONS PER IEC 60601-1

Degree of protection against electric

shock

6.Clinical accuracy

The clinical thermometer uses

adjusted mode.

The clinical accuracy was

conducted according to the

requirements of ISO 80601-2-56.

Take the result measured by

mercury thermometer from oral

cavity as the reference. Test three

groups, the minimum number of

subjects in an age group shall be

at least 35. The test results are

shown in the table below.

REFERENCE BODY SITE Oral

Measuring site of

infrared ear thermometer

Ear canal

CLINICAL

BIAS(

Δcb)

LIMITS OF

AGREEMENT

（

）

CLINICAL

REPEATABI

-LITY(

σr

)

Less than

1 year of age

0.14

℃

0.76℃

0.16

℃

Aged

1-5 years

0.28

℃

1.06℃

0.19

℃

Older than

5 years

0.00

℃

0.88℃

0.19

℃

Internally powered ME equipment Type

bf applied part, applied part is the probe.

Degree of Protection from Liquid

Ingress

IP22

IX. Symbols

X. After-sales Service

F. Damage caused by external force;

4. Maintenance services beyond the

scope of warranty will be charged

according to regulations.

5. If the situations cannot be solved or

unexpected problem happens, please

consult the local distributor.

Warranty card

Product name:

Infrared ear thermometer

Model:

YHT107

Phenomenon and standard

RF emissions CISPR 11

Harmonic Current Disturbance

IEC 61000-3-2

Limit

Class B Group 1

Class A

Test result

PASS

Not applicable

Voltage Fluctuations & Flicker

IEC 61000-3-3

–

Not applicable

Phenomenon

and standard

Immunity test levels

Test result

PASS

Professional

healthcare

facility

environment

Home

healthcare

Environment

± 8 kV contact

± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air

Electrostatic

discharge

IEC 61000-4-2

Table 2. Electromagnetic Immunity

Table 3. Test speciﬁcations for ENCLOSURE PORT IMMUNITY to RF wireless

communications equipment.

5240

5500

5785

If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting

antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance

is permitted by IEC 61000-4-3.

a) For some services, only the uplink frequencies are included.

b) The carrier shall be modulated using a 50 % duty cycle square wave signal.

c) As an alternative to FM modulation, the carrier may be pulse modulated using a 50 % duty cycle

square wave signal at 18 Hz. While it does not represent actual modulation, it would be worst case.

2450

2400-2570

5100-5800

Bluetooth,

WLAN,

802.11 b/g/n

RFID 2450,

LTE Band 7

WLAN 802.11

a/n

Pulse

modulation

217 Hz

Pulse

modulation

217 Hz

710

745

780

810

870

930

450

704-787

800-960

430-470

1700-1990

LTE Band

13,17

GSM 800/900,

TETRA 800,

iDEN 820,

CDMA 850,

LTE Band 5

GMRS 460,

FRS 460

GSM 1800;

CDMA 1900;

GSM 1900;

DECT;

LTE Band 1, 3,

4, 25; UMTS

1720

1845

1970

Pulse

modulation

217 Hz

Pulse

modulation

18 Hz

±5 kHz

deviation

1 kHz sine

Pulse

modulation

217 Hz

Test

frequency

(MHz)

385

Band

(MHz)

380-390

Service

TETRA 400

Modulation

Pulse

modulation

18 Hz

IMMUNITY

Test LEVEL

(V/m)

PASS

3 V/m

80 MHz – 2,7 GHz

80 % AM at 1 kHz

10 V/m

80 MHz – 2,7 GHz

80 % AM at 1 kHz

Radiated RF EM

Fields

IEC 61000-4-3

Not applicable

± 2 kV

100 kHz repetition

frequency

Electrical fast

transient/burst

IEC 61000-4-4

PASS

8 A/m for 30 kHz, 65 A/m for 134.2

kHz,75 A/m for 13.56 kHz

Proximity

magnetic fields

IEC 61000-4-39

Not applicable

Voltage dips: 0 % U

; 0,5 cycle, 0 %

; 1 cycle, 70 % U

; 25/30 cycles

Voltage interruptions: 0 % U

;

250/300 cycle

Voltage dips,

short interrupts

and voltage

variations on

power supply

input lines

IEC 61000-4-11

Not applicable

± 0,5 kV, ± 1 kV (Line-to-line)

± 0,5 kV, ± 1 kV, ± 2 kV

(Line-to-ground)

Surge

IEC 61000-4-5

PASS

30 A/m

50 Hz and 60 Hz

Power frequency

magnetic field

IEC 61000-4-8

Not applicable

–

Electrical transient

conduction along

supply lines

ISO 7637-2

Test specifications for ENCLOSURE

PORT IMMUNITY to RF wireless

communications equipment

Proximity fields

from RF wireless

communications

equipment

IEC 61000-4-3

Not applicable

3 V

0,15 MHz–80 MHz

6 V in ISM bands

between 0,15 MHz

and 80 MHz

80 % AM at 1 kHz

3 V

0,15 MHz–80 MHz

6 V in ISM and

amateur radio

bands between

0,15 MHz and 80

MHz

80 % AM at 1 kHz

Conducted

disturbances

induced by RF

IEC 61000-4-6

This infrared thermometer meets requirements established in ASTM Standard E

1965-98. Full responsibility for the conformance of this product to the standard is

assumed by JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO.,LTD. ASTM

laboratory accuracy requirements in the display range of 37℃

to 39℃ (98℉ to 102℉) for

IR thermometers is 土0.2 ℃ (土0.4℉), whereas for mercury-in-glass and electronic

thermometers, the requirement per ASTM Standards E667-86 and E1112-86 is 土0.1 ℃

(土0.2℉).

FCC Radiation Exposure Statement:

Any Changes or modifications not expressly approved by the party responsible for

compliance could void the user’s authority to operate the equipment.

This equipment complies with FCC radiation exposure limits set forth for an uncontrolled

environment .

01 02 04 05 06 07 0803

4. Gently pull on the patient's ear, then fit the probe snuggly into the ear canal.

patients over one year of age, pulled back and up as in Figure 5;

Patients under one year of age, pulled back as in Figure 6.

NOTE: Do not move while measuring.

5. Press and release the measure button " ", after about one second, the

device will beep to prompt the end of measurement and display the measure-

ment results.

NOTE: When the measurement is completed, the device will display " ",

When " " appears, the next measurement can be taken.

Time interval of each measurement less than 12s.

6. To take the next temperature measurement, press the probe cover replace-

ment button to remove and discard probe cover, and put on a new, clean and

undamaged probe cover.

7. If there is no need to perform the next measurement, please take off the used

probe cover, put on the cover and put in the protective case.

2. Attach probe cover.

Take a new, clean probe cover, align

the center of the probe cover with the

center of the probe and insert it to the

end to ensure that the probe cover is in

place, as shown in figure 2.

NOTE: Please use the designated probe

cover, otherwise the accuracy of the

measurement will be affected. Please

contact the agent or manufacturer to

purchase special probe cover.

NOTE: Probe cover is single-use.

Please use clean and undamaged new

probe cover before each measurement.

Please make sure the sensor lens is

clean and intact before wearing the

probe cover.

3. Press the measure button " " to

switch on. During an internal

self-check, the display shows all

segments as shown in figure 3. After

self-check, it displays the pending test

status as in Figure 4, and the indicator

light is on.

1. High temperature reminder

When in use, if the temperature measurement is over 37.5℃, there will be a long

beep followed by three short beeps to remind the user.

2. Memory mode

Press the memory button " ", memory value inquiry can be carried out. The

device can store 10 groups of memory values. When the number of groups

exceeds the specified number, the latest memory value will cover the earliest

memory value.

In memory mode, press and hold the Memory button " " for about 5s, when

CLr is displayed on the screen, the memory value is cleared.

3. Power off

Manual power off: Long press the Measure button " " to switch off.

Automatic power off: The device will power off automatically without any

operation after 60s±10s.

4. Temperature unit switch

In power off state, press the measure button" " and hold for about 8s‒12s to

enter the temperature unit switching state, press the memory button " " to

select "℃" or "℉" temperature units, then press the measure button " " to

confirm.

5. Bluetooth

(1) Download & Install

Method 1: Search and download Yuwell HealthCare+ app in App Store or

Google Play store.

Method 2: Scan the QR codes below to download and install.

(2) Measurement

Launch the Yuwell HealthCare+ app, choose temperature measuring interface,

and ensure the Bluetooth is enabled on the smart device. Then attach a new,

clean probe cover and take a measurement.

NOTE: Thermometer will automatically search for and connect to smart device

when switched on.

NOTE: When using thermometer with a smart device, keep both devices within

the recommended range of each other (see Bluetooth technology information

for details); moving outside of this range may cause a loss in connection with the

IV. Operation

V. Functions

VI.Care and Cleaning

II. Device Structure and Composition

I. Indications for use and Working Principle

III. Warnings and Cautions

Proper use is critical to be obtaining accurate temperatures. Therefore, read the

instructions for use carefully and thoroughly.

Safety Warnings and Cautions

WARNING: Do not use in the presence of flammable anesthetics or other

flammable substances, oxygen-enriched environments, or nitrous oxide to

avoid the risk of explosion.

WARNING: Device application component materials are certified for biological

compatibility.

CAUTION: Due to the limited size of the label, the font is too small, please put it

at a suitable location for viewing.

CAUTION: Do not inhale or swallow small parts. Please pay attention to device

storage to prevent damage caused by pets and pests.

CAUTION: Please replace the probe cover before each use to ensure measure-

ment accuracy and avoid cross-infection.

CAUTION: Do not leave the thermometer unattended around children. Small

items such as probe cover may become choking hazards.

Performance Warnings and Cautions

WARNING: Avoid dropping the thermometer from a height, as damage to the

probe may affect the accuracy of the measurement.

WARNING: The ear thermometer should not be transported without packaging,

so as to avoid the influence of mechanical vibration on temperature measure-

ment accuracy.

WARNING: This device contains sensitive electronic components and should be

avoided in the environment with strong electromagnetic interference (such as

mobile phones, microwave ovens, etc.) to prevent temporary impact on its

accuracy.

CAUTION: In order to measure the accurate temperature value, when measur-

ing, please make sure that the probe is aligned with the eardrum and closely

contacted with the ear canal.

CAUTION: The temperature of left and right ears of the same person is usually

slightly different. It is better to measure the same ear every time for comparison.

CAUTION: The measurement results are only for reference and cannot replace

the diagnosis of doctors. Some people do not have fever when they are ill. If you

feel unwell, whatever the measurement results are, it is recommended to see a

doctor immediately.

CAUTION: Sleep on one side can cause the temperature of the pressed ear to

rise. It is better to wait a few minutes before measuring.

CAUTION: The ear canal should be kept clean, because too much earwax in the

ear canal will affect the accuracy.

CAUTION: Do not try to measure when the device is wet, which may lead to

inaccurate measurement results.

CAUTION: Do not measure the body temperature within 30 minutes after

exercise, bathing or eating. At these moments, the body temperature is

deviated from the normal body temperature.

CAUTION: Do not use the thermometer if there is blood or drainage in the

external ear canal.

CAUTION: Use the untreated ear if prescription ear drops or other ear medica-

tions have been placed in the ear canal.

CAUTION: Patients who have deformities of the face and/or ear may not be able

to have a temperature taken with the ear thermometer.

CAUTION: Complete ear canal occlusion due to cerumen (ear wax) can result in

lower temperature readings.

CAUTION: If there is a temperature difference between the device storage place

and the measuring environment, the device shall be placed in the using

environment for more than 30 minutes, otherwise the measurement results may

have errors.

CAUTION: If multiple measurements are required for the same person, remove

the thermometer from the ear canal after each measurement, and follow the

measurement steps to re-test.

CAUTION: Limitation, the device could not instead of rectal thermometer for

rectal temperature.

CAUTION: When using the thermometer with a smart device, keep both devices

within the recommended range of each other (see Specifications for details);

moving outside of this range may cause a loss in connection with the smart

device.

CAUTION: When using the thermometer with a smart device, relocate the

devices away from sources that may interfere with the Bluetooth connection.

The presence of other devices that may create radio frequency interference

(RFI) may result in loss of Quality of Service (see Specifications for details) of

the Bluetooth connection. Devices that may cause RFI include but are not

limited to the following: electrocautery equipment, diathermy equipment, other

cellular telephones, wireless PC and tablets, pagers, RFID devices, MRI, and

electromagnetic security systems.

Care and Cleaning Warnings and Cautions

WARNING: Do not immerse this device in medical alcohol or other liquids.

WARNING: Avoid liquid contact with device metal parts.

WARNING: The cleaned devices shall be stored in a dust-free and dry place,

please avoid direct sunlight; do not store the device in a place with high

temperature, humidity, dust or corrosive gas.

WARNING: This device is suitable for multiple people. In order to prevent

cross-infection, new probe cover needs to be replaced before each measure-

ment. It is recommended to clean this device before use.

WARNING: The sensor lens is an infrared optical component, which is the most

frequently damaged and stained part. To ensure the measurement accuracy,

the cover must be worn after the measurement.

WARNING: Patient can use the thermometer to take the measurement by

Installing the AA batteries

1. Pull and remove the battery cover.

2. Put the battery into the battery compartment according to

the instructions of the positive and negative poles in the battery

compartment. (The device will carry out internal self-check,

the display shows all segments as shown in figure 3)

NOTE: The thermometer will not work if the batteries are

inserted in the incorrect orientation.

3. Install the battery cover.

NOTE: The battery attached to this device is for trial use.

Please replace them with new batteries when testing.

4.Battery Reminder

The state of the internal electrical power source will display a

●Indications for use: The Infrared ear thermometer is indicated for the intermit-

tent measurement of human body temperature from ear canal for people of all

ages except for pre-term babies or small for gestational age babies in

professional use and home use environment. Not for emergency clinical

condition. The probe cover is used as a sanitary barrier between the infrared

ear thermometer and the ear canal.

●Working Principle: The infrared ear thermometer is equipped with an infrared

sensor, which can transform the infrared light released by human ear

membrane into corresponding electrical signal. The signal is corrected by the

amplifier and signal processing circuit according to the internal algorithm of the

instrument and the targeted emissivity, and then transformed into the tempera-

ture value of the measured human body. The YUWELL® Infrared ear thermom-

eter is a non-contact thermometer according to the working principle.

●Contraindications:

Do not use ear thermometer, if there is inflammation in the ear canal.

Do not use an ear thermometer if you have not fully recovered from surgery or

ear canal trauma

VII. Troubleshooting Instructions

Memory mark

Battery level

Probe cover

prompt

Measurement

status

Temperature

units

Display area of

measuring

℉℃

Thermometer has been

turned off automatically

Blank screen

The batteries were wearing out

Screen is still blank

Restart

Check whether the battery is

installed correctly

Replace with new batteries

Please contact the dealer

for repair

No probe cover is attached or

probe cover is not in place

Attach the probe cover in place

Low power unable to use

Possible cause Troubleshooting methods

Replace with new batteries

Phenomenon

of breakdown

Battery not correctly installed

Operating temperature is

lower than the set value

Put the thermometer at room

temperature of 10℃~40℃(50℉～

104℉) stand for 30 minutes

before use

Please contact the dealer for

repair

Sensor error

Operating temperature is

higher than the set value

Put the thermometer at room

temperature of 10℃~40℃(50℉

～104℉) stand for 30 minutes

before use

The use environment

temperature has a large

change compared to the

storage temperature

Put the thermometer at the use

environment temperature for 30

minutes before use

Please measure again according

to the instructions

Please measure again

according to the instructions

The temperature of the

measured object is higher

than the measuring range

of the device

The temperature of the

measured object is lower

than the measuring

range of the device

VIII. Technical Speciﬁcation

Support version iOS 10.0

and above

Support version Android 5.0

and above

smart device.

(3) Measurement records

Click the "Data" on the main interface of Yuwell

HealthCare+ app to open the history records. Tempera-

ture records and curve are available.

NOTE: The Bluetooth communication is only available to

smart devices using the Yuwell HealthCare+ app. The

thermometer can only communicate to a single smart

device at one time to minimize the risk of unauthorized

access.

himself, or someone else can use the thermometer to measure the patient.

Either way, the use and maintenance methods are the same.

WARNING: All the servicing and maintenance should be operated before or after

use.

WARNING: Please takeout the battery when the thermometer will not be used for

a long period, and take the battery out of the children's reach.

WARNING: Please keep the probe clean before and after use. When the sensor

lens becomes dirty, gently wipe it with a soft dry cloth or cotton swab. Do not

wipe it with other objects, or blow the infrared sensor with your mouth.

Otherwise it may cause the sensor mirror scratch or device failure.

Compliance Warnings and Cautions

WARNING: Do not modify the device without authorization of the manufacturer.

WARNING: This device contains batteries and recyclable electronic waste. To

protect the environment, do not dispose of it in household waste, and dispose of

used batteries at an appropriate collection location in accordance with national

or local regulations.

NOTE: This device complies with part 15 of the FCC Rules. Operation is subject

to the following two conditions: (1) This device may not cause harmful interfer-

ence, and (2) This device must accept any interference received, including

interference that may cause undesired operation.

NOTE: This equipment has been tested and found to comply with the limits for a

Class B digital device, pursuant to part 15 of the FCC Rules. These limits are

designed to provide reasonable protection against harmful interference in a

residential installation. This equipment generates, uses and can radiate radio

frequency energy and, if not installed and used in accordance with the

instructions, may cause harmful interference to radio communications. Howev-

er, there is no guarantee that interference will not occur in a particular installa-

tion. If this equipment does cause harmful interference to radio or television

reception, which can be determined by turning the equipment off and on, the

user is encouraged to try to correct the interference by one or more of the

following measures:

●Reorient or relocate the receiving antenna.

●Increase the separation between the equipment and receiver.

●Consult the dealer or an experienced radio/TV technician for help

●The infrared ear thermometer consists of the main engine, probe cover and

the cover.

●Detachable parts and materials for use: Probe cover (PP), Cover (PP),

Protective case (ABS), 2 AA alkaline batteries.

●Appendix: Instruction for use, 2 AA alkaline batteries, Protective case, APP

Quick Guide, Probe cover (Box of 20).

Measure

button

Indicator

light

Display

area

Memory

button

Battery cover

Probe cover

replacement

button

Infrared

sensor probe

Probe cover Cover

Sensor lens

Protective

case

different icon depending on the battery capacity. When the screen only displays

the symbol " ", prompt to replace the battery as soon as possible; when the

symbol " " is displayed, replace the battery immediately. Replace with 2 new

AA batteries, slide open the battery cover and remove old batteries. Replace the

batteries being sure to align properly as indicated inside the battery compart-

ment. Replace with new batteries, making sure the poles are in the right

direction.

Using infrared ear thermometer

1. Take the infrared ear thermometer out from the protective case, as shown in

figure 1, then remove the cover.

figure(4)

figure(3)

figure(6)figure(5)

figure(1) figure(2)

1. Before each use, check whether the sensor lens is dirty. If it is dirty, please

use a clean and dry soft cloth or cotton swab to gently wipe the sensor lens.

2. Use a clean and soft cloth with clean water to gently wipe the LCD screen and

the shell.

3. Allow the device to air dry until it is visually dry, or dry thoroughly with a soft,

clean, non-linting cloth. Drying times may vary based on the environmental

conditions.

Post-cleaning inspection

Inspect device visually after cleaning and prior to disinfection for cleanliness,

damage, and missing or illegible device labeling or markings:

1. If there is any visible soil present, repeat the cleaning procedure.

2. Damaged device shall be removed from use. Damage may include but is not

limited to corrosion, discoloration, excessive scratches, flaking, cracks, and

wear.

3. Device that has missing or illegible device labeling or marking shall be

removed from use.

Cleaning procedure

1. Display and Maximum allowable error of temperature measurement:

2. Battery Life

ITEM

Measurement range

Temperature units

Minimum discernible value

Maximum allowable error of

temperature measurement

PARAMETER

34.0℃‒42.2℃ (93.2℉‒108.0℉)

℃/℉

ITEM

Power supply

Battery life

DESCRIPTION

DC 3V (2 x 1.5V AA alkaline batteries)

New battery enables more than 3000

times measurements.

0.1℃ (0.1℉)

Within the temperature display range

of 35.0℃‒42.0℃(95.0℉-107.6℉), it

is ±0.2℃ (±0.4℉); beyond the

temperature display range of 35.0℃

‒42.0℃ (95.0℉‒107.6℉), it is±0.3℃

(±0.5℉)

NOTE: According to ISO 80601-2-56, Rated output range:34.0℃‒42.0℃

(93.2℉‒107.6℉),Rated extended output range: 42.1℃‒42.2℃ (107.6℉

‒108.0℉).

NOTE: Normal body temperature is a range. It varies by sites of measure-

ment, and it tends to decrease with age. It also varies from person to person

and fluctuates throughout the day.

The normal body temperature of most people is: Tympanic temperature:

35.5℃‒37.5℃( 95.9℉‒99.5℉), the range is just for reference.

NOTE: This thermometer meets requirements established in ASTM Standard

E 1965-98. Full responsibility for the conformance of this device to the

standard is assumed by JIANGSU YUYUE MEDICAL & SUPPLY CO.,LTD..

ASTM laboratory accuracy requirements in the display range of 37℃‒39℃

(98℉‒102℉) for infrared ear thermometers is ±0.2℃ (±0.4℉), whereas for

mercury-in-glass and electronic thermometers, the requirement per ASTM

Standards E667-86 and E1112-86 is ±0.1℃ (±0.2℉).