APPLYING THE CUFF
Only use a cuff that has been approved by the manufacturer for this device model.
Before use, please confirm if it fits your arm circumference.
1. Remove all jewelry, such as watches and bracelets from your
left arm.
Note: If your doctor has diagnosed you with poor circulation in
your left arm, use your right arm.
2. Roll or push up your sleeve to expose the skin. Make sure your
sleeve is not too tight.
3. Hold your arm with your palm facing up and tie the cuff on
your upper arm, align the Artery indicator with the main Artery
(on the inside of your arm). Note: Locate the main Artery by
pressing with 2 fingers approximately 2 cm above the bend of
your elbow on the inside of your left arm. Identify where the
pulse can be felt the strongest, that is your main Artery
4. Make sure the bottom edge of the arm cuff 2 to
3 cm above the inside elbow. Then wrap the cuff
securely. Note: The cuff should be snug but not
too tight. You should be able to insert one finger
between the cuff and your arm.
5. Sit upright in a comfortable chair with your back
against the backrest of the chair. Keep your feet
flat and your legs uncrossed. Place your arm resting
comfortably on a flat table. The cuff worn on your arm
should be placed at the same level as your right atrium
of the heart.
6. Take 5-6 deep breaths and let’s start measuring!
Helpful tips:
• Take the measurement in a silent room.
• Rest for 5 minutes before a measurement.
• Wait at least 3 minutes before another measurement.
This allows your blood circulation to recover.
• Be relaxed and DO NOT move and talk during the
measurement procedure.
• For a meaningful comparison, try to measure
under similar conditions. For example, take daily
measurements at approximately the same time, on the
same arm, or as directed by a physician.
DATA MANAGEMENT
RECALL THE RECORDS
1. When the monitor is off, press the “MEM” button, the user ID will blink, you
can press the “MEM” or “SET” button to switch the user ID between User 1 and
User 2.
2. Press the “START/STOP” button to confirm the selected user ID. Then the LCD
will display the latest record. (Example shown below for User 1)
BPA- 5020-AU
INSTRUCTION MANUAL AND WARRANTY INFORMATION
1-year limited warranty
automatic arm blood
pressure monitor
IMPORTANT SAFETY INSTRUCTIONS
WHEN USING ELECTRICAL PRODUCTS, ESPECIALLY WHEN CHILDREN ARE PRESENT, BASIC
SAFETY PRECAUTIONS SHOULD ALWAYS BE FOLLOWED, INCLUDING THE FOLLOWING:
READ ALL INSTRUCTIONS BEFORE USING.
PRECAUTION
• This device is intended for indoor, home use and is not intended for self-use in
public areas.
• This device is portable, but it is not intended for use during patient transport.
• This device is not suitable for continuous monitoring during medical emergencies
or operations.
• This device is intended for non-invasive measuring and monitoring of arterial blood
pressure.
• It is not intended for use on extremities other than the arm, or for any purpose other
than obtaining a blood pressure measurement.
• This device is for adults. DO NOT use this device on neonates or infants. DO
NOT use it on children and adolescents unless otherwise instructed by a medical
professional.
• Consult with your physician before using this monitor if you suffer from the
following conditions:
• Common arrhythmias such as premature ventricular beats or atrial fibrillation;
peripheral arterial disease; pregnancy; preeclampsia; implantation with electrical
devices; undergoing intravascular therapy; arteriovenous shunt or mastectomy.
• Please note that any of these conditions may affect measurement readings, in
addition to patient motion, trembling or shivering.
• DO NOT use this device for diagnosis or treatment of any health problems or
diseases. Please consult with your physician first whether the blood pressure or
pulse rate readings can be used as an input in determining clinical actions. Please
note that clinical actions can only be determined by the physician, otherwise it may
lead to delayed treatment or other dangerous situations.
• If you are taking medication, consult your physician to determine the proper time to
measure your blood pressure.
• This device may be used only for the intended use described in this manual, the
manufacturer shall have no liability for any incidental, consequential, or special
damages caused by misuse or abuse.
• Please use the device under the environment which is provided in the user manual.
Otherwise, the performance and lifetime of the device will be impacted and reduced.
• The device may require up to 30 minutes to warm up / cool down from the
minimum/ maximum storage temperature before it is ready for use.
• The blood pressure monitor and the cuff are suitable for use within the patient
environment.
• DO NOT wash the cuff in a washing machine or dishwasher.
• The device contains sensitive electronic components. To avoid measurement errors,
avoid taking blood pressure measurements near a strong electromagnetic field
radiated interference signal or electrical fast transient/burst signal.
• Blood Pressure Monitor is intended for use by medical staffs and lay persons, and
patient is also an intended user or operater.
WARNING
• DO NOT apply the cuff on an arm that has an intravenous drip or a blood transfusion
attached.
• DO NOT kink, fold, stretch, compress, or otherwise deform the tube during
measuring, as the cuff pressure might continuously increase, which could prevent
blood flow and result injury.
• Taking blood pressure measurements too frequently could disrupt blood circulation
and cause injuries.
• DO NOT apply cuff to areas on patient where skin is delicate or damaged. Check
cuff site frequently for irritation.
• DO NOT place the cuff on the arm of a person whose arteries or veins are undergoing
medical treatment, i.e. intra-vascular access or intra-vascular therapy or an
arteriovenous (A-V) shunt, which could disrupt blood circulation and cause injuries.
• DO NOT place the cuff on the arm on the same side of a mastectomy (especially
when lymph nodes have been removed). it is recommended to take measurements
on the unaffected side.
• DO NOT wrap the cuff on the same arm to which another monitoring device is
applied. One or both devices could temporarily stop functioning if you try to use
them at the same time.
• Please check (for example, by observation of the limb concerned) that the operation
of the device does not result in prolonged impairment of patient blood circulation.
• On the rare occasion of a fault causing the cuff to remain fully inflated during
measurement, loosen and remove the cuff immediately. Prolonged high pressure
applied to the arm (cuff pressure >300 mmHg or constant pressure >15 mmHg for
more than 3 minutes) might lead to bruising and discolored skin.
• DO NOT use this device with high-frequency (HF) surgical equipment at the same time.
• This device is not used in conjunction with oxygen rich environments, not intended
for use with flammable anaesthetics, not intended for use in conjunction with
flammable agents.
• DO NOT touch output of the batteries and the user simultaneously.
• The power cord is considered the disconnect device for isolating this equipment
from supply mains.
• DO NOT position the equipment so that it is difficult to reach or disconnect.
• DO NOT use this device if you are allergic to polyester, nylon, or plastic.
• Only use accessories approved by manufacturer. Using unapproved accessories
might cause damage to the unit and injure users.
• If you experience discomfort during a measurement, such as pain in the arm or other
complaints, press the Power button immediately to release the air from the cuff.
• DO NOT use the device while under maintenance, or being serviced.
• The air tube poses a risk of strangulation. Furthermore, the small parts of product
and batteries present a choking hazard if swallowed. They should therefore always
be kept away from infants/children.
• Sensor degradation or looseness may reduce performance of device or cause other
problems.
NOTICE
• You can use this device to take your own measurement, no third-party operator is
required.
• At the request of authorized service personnel, circuit diagrams, component
part lists, descriptions, and calibration procedures will be made available by the
manufacturer or distributor.
• The expected lifetime of the cuff may vary by the frequency of washing, skin
condition, and storage state.
• Please report to the manufacturer and the competent authority of the Member
State / the FDA in which you are established about any serious incident that has
occurred in relation to this device.
ABOUT BLOOD PRESSURE
GENERAL DESCRIPTION
Thank you for selecting the Homedics type blood pressure monitor
(BPA-5020-AU). The monitor features blood pressure measurement, pulse rate
measurement and the result storage. The warranty period is two years.
Readings taken by the BPA-5020-AU are equivalent to those obtained by a trained
observer using the cuff and stethoscope auscultation method.
This manual contains important safety and care information, and provides step by step
instructions for using the product.
Read the manual thoroughly before using the product.
Features:
• 59.5 mm×40.5 mm Digital LCD display
• 2 × 99 memory storage, Guest mode available
• Measuring-during-inflation technology
INDICATIONS FOR USE
This Blood Pressure Monitor is a digital monitor intended for use in measuring blood
pressure and pulse rate with arm circumference ranging from 22cm to 32cm (about
8¾*-12½*°) or 22cm to 42cm (about 8¾”-16½*).
It is intended for adult indoor use only.
Date ofmanufacture
Symbol for “TYPE BF
APPLIED PART”
Symbol for
“MANUFACTURER”
Symbol for “SERIAL
NUMBER”
Consult instructions
for use or consult
electronic instructions
for use
Batch Code
Symbol for
“RECYCLE”
Caution
Indicates that caution is
necessary when operating
the device or control close
to where the symbol is
placed, or that the current
situation needs operator
awareness or operator
action in order to avoid
undesirable consequences.
Medical Device
Symbol for “DIRECT
CURRENT”
Refer to instruction
manual/booklet
to signify that the
instruction manual/
booklet must be read.
Note: The background
color of the symbol
is blue.
Authorised representative in
the European Community/
European Union
Australian Regulatory
Compliance mark (RCM)
The symbol indicates
that the product
should not be
discarded as unsorted
waste but must be
sent to separate
collection facilities
for recovery and
recycling.
CE marking indicates that a
product has been assessed
by the manufacturer and
deemed to meet EU safety,
health and environmental
protection requirements.
It is required for products
manufactured anywhere
in the world that are then
marketed in the EU.
Display and save the results.
The current record
is Group 2.
The corresponding
time is 08:01 (a.m.).
The corresponding
date is January 1st.
The corresponding
year is 2023.
“dEL AL” blinks
“dEL no” blinks
Deletion is done
No record
CAUTION:
• DO NOT attempt to repair the unit yourself if it malfunctions. Only have
repairs carried out by authorised service centers.
• It is recommended that the performance should be checked after repair,
maintenance, and every two years of use, by retesting the requirements
in limits of the error of the cuff pressure indication and air leakage (testing
at least at 50 mmHg and 200 mmHg). Please contact manufacturer or
distributor for authorised service personnel.
• Store your device, cuff in a clean and dry place, protect it against extreme
moisture, heat, lint, dust and direct sunlight. Never place any heavy objects on it.
• Make sure the rubber tube of the cuff is not squeezed, stretched, or kinked
during storage.
• Dispose of accessories, detachable parts, and the device according to the
local guidelines.
MEASUREMENT PRINCIPLE
This product uses the Oscillometric Measuring method to detect blood pressure.
Before every measurement, the unit establishes a “zero pressure” equivalent to the
atmospheric pressure. Then it starts inflating the arm cuff, meanwhile, the unit detects
pressure oscillations generated by beat-to-beat pulsatile, which is used to determine
the systolic and diastolic pressure, and also pulse rate.
RECEIVING AND INSPECTING YOUR MONITOR
Check that the device packaging has not been tampered with and make sure that all
contents are present. Before use, ensure that there is no visible damage to the device
or accessories and that all packaging material has been removed.
If you have any doubts,
DO NOT
use the device and contact your retailer or the
specified Customer Services address.
SAFETY INFORMATION
The signs below might be in the user manual, labeling or other component.
They are the requirement of standard and using
LCD DISPLAY SIGNAL
LCD DISPLAY SIGNAL
MONITOR COMPONENTS
Symbol Description Explanation
Systolic blood pressure High blood pressure
Diastolic blood pressure Low blood pressure
Pulse display Pulse in beats per minute
Memory
Indicate it is in the memory mode and
which group of memory it is.
kPa
Measurement Unit of the blood
pressure
Excessive Body
Motion Detector
Motion may result in an inaccurate
measurement.
Low battery
Batteries are low and need to be
replaced
mmHg
Measurement Unit of the blood
pressure
User 1/User G/User 2
Start measurement and save the
measuring results for User 1/ User 2.
Irregular pulse rate
Irregular pulse rate detected during
measurement.
Pulse rate
Blood pressure monitor is detecting a
pulse rate during measurement.
Deflation symbol The cuff is deflating.
Current Time
Time and date (year/month/day;
hour:minute).
Blood pressure level Indicates the blood pressure level.
CUFF
AIR HOSE
AIR CONNECTOR PLUG
LCD DISPLAY
MEM BUTTON
SET BUTTON
START/STOP BUTTON
BATTERY
COMPARTMENT
1. Blood pressure Monitor
(BPA-5020-AU)
2. Cuff
(Type BF Applied part)
Upper arm cuff:22-42cm.
3. 4xAAA Batteries
4. User Manual
INSTALLING AND REPLACING THE BATTERY
• Open the battery cover.
• Install the batteries as indicated in the battery
compartment
• (Always select the authorised / specified battery:
Four AAA-size batteries.
• Replace the battery cover.
Replace the batteries whenever the below happens
• The
shows
• The display is dim
• The display does not light up
SETTING DATE, TIME AND MEASUREMENT UNIT
It is important to set the clock before using your blood pressure monitor, so that a time
stamp can be assigned to each record that is stored in the memory. (The setting range
of the year :2022-2052 time format:12 H/24 H)
CAUTION:
• New and used batteries, or different types of batteries shall not be used
together.
• Remove batteries if the device is not likely to be used for some time.
• DO NOT heat or deform the batteries, or dispose of them in fire.
• Batteries should not be disposed of with household waste.
• Please check with your local authority for battery recycling advice.
2~3cm
START THE MEASUREMENT
1. When the monitor is off, press the “START/STOP” button to
turn on the monitor, and it will finish the whole measurement.
(Take User 1 for example).
2. Press the “START/STOP” button to power off, otherwise it will
turn off within 1 minute.
3. About the irregular pulse rate and excessive body motion during
the measurement. During a measurement, If an irregular pulse
rate is detected, the symbol will display in the measurement
result. See page 20 for more information.
4. During a measurement, when the excessive body motion, the symbol will
flash about 5 seconds and detect again. If it is no longer detected, the symbol will
disappear; If still detected, the symbol will final display in the measurement
result.
Note:
The measured blood pressure reading may not
be accurate if this symbol is displayed.
Note:
Any time if you want to stop the measurement,
press the “START/ STOP” button.
Adjust the zero.
Inflating and measuring
3. Press the “MEM” or “SET” button to get the record you want.
Note
1. For User G (guest), there is no memory space.
2. Both User 1 and User 2 can store maximum 99 groups of record. When you pass
that limit, every time you recall the records, the monitor will show a blinking “FULL”
along with the group number “99”.
Date,Time
and Year
will display
alternately.
DELETE THE RECORDS
If you did not get the
correct measurement, you
can delete all results by
following steps below.
1. Hold pressing the
“START/STOP” button
for about 3 seconds
when the monitor is in
the memory recall mode
, the display will show a
blinking “dEL AL” along
with the user ID.
2. Use the “MEM” or
“SET” button to switch
between “dEL AL” and
“dEL no”, Press “START/
STOP” to confirm the
selection.
3. If “dEL AL” is selected,
it will display “do nE” +
User ID, and delete all
the record of the current
user. Several seconds
later, it will display “---”.
If “dEL no” is selected, it
will stop the deletion.
1. When the monitor is off, hold pressing
the “SET” button for 3 seconds to enter
the mode for year setting. Or when
the batteries are installed for the first
time, it will enter the setting mode
automatically.
2. Press the “MEM” or “SET” button to
change the [YEAR]. Each press will
increase or decrease the numeral by
one in a cycling manner.
3. When you get the right year, press the
“START/STOP” button to set down
and turn to next step. Repeat the same
steps to set the [MONTH] and [DAY].
4. Repeat the same steps to confirm time
format between [12 H] and [24 H]
5. Repeat the same steps to set the [HOUR]
and [MINUTE].
6. Repeat the same steps to set the
[UNIT].
7. After the unit is set,the LCD will
display “donE”, and then it will turn off
automatically.
SELECT THE USER
1. When the monitor is off , short press
the “SET” button to enter user setting
mode. The user ID will blink.
2. Then press the “SET” button again to
select the user ID: User 1 , User 2 or
User G.
Press the “START/STOP” button to confirm the selected user ID, then the User ID
will not flash any more and the monitor will enter the measurement automatically.
CAUTION:
The most recent record (1) is shown first. Each new measurement is assigned to
the first (1) record. All other records are pushed back one digit (e.g., 2 becomes
3, and so on), and the last record (99) is dropped.
We or us means Homedics Australia Pty Ltd ACN 31 103 985 717
and our contact details are set out at the end of this warranty;
You means the purchaser or the original end-user of the Goods.
You may be a domestic user or a professional user;
Supplier means the authorised distributor or retailer of the
Goods that sold you the Goods in Australia and New Zealand;
and
Goods means the product or equipment which was accompanied
by this warranty and purchased in Australia and New Zealand.
For Australia:
Our Goods come with guarantees that cannot be excluded under
the Australian Consumer Law. You are entitled, subject to the
provisions of the Australian Consumer Law, to a replacement
or refund for a major failure and for compensation for any other
reasonably foreseeable loss or damage. You are also entitled,
subject to the provisions of the Australian Consumer Law, to
have the Goods repaired or replaced if the goods fail to be of
acceptable quality and the failure does not amount to a major
failure.
This is not a complete statement of your legal rights as a
consumer.
For New Zealand:
Our Goods come with guarantees that cannot be excluded under
the Consumer Guarantees Act 1993. This guarantee applies
in addition to the conditions and guarantees implied by that
legislation.
The Warranty
Homedics sells its products with the intent that they are free
of defects in manufacture and workmanship under normal use
and service. In the unlikely event that your Homedics product
proves to be faulty within 1 year from the date of purchase due
to workmanship or materials only, we will replace it at our own
expense, subject to the terms and conditions of this guarantee.
The warranty period is limited to 3 months from the date of
purchase for products used commercially/professionally.
Terms and Conditions:
In addition to the rights and remedies that you have under the
Australian Consumer Law, Consumer Guarantees Act of New
Zealand or any other applicable law and without excluding such
rights and remedies warranty against defects:
The Goods are designed to withstand the rigors of normal
household use and are manufactured to the highest standards
using the highest quality components. Whilst unlikely, if, during
the first 12 months (3 months commercial use) from their date of
purchase from the Supplier (Warranty Period), the Goods prove
defective by reason of improper workmanship or materials and
none of your statutory rights or remedies apply, we will replace
the Goods, subject to the terms and conditions of this warranty.
We
DO NOT have to replace the Goods under this Additional
Warranty if the Goods have been damaged due to misuse or
abuse, accident,
the attachment of any unauthorised accessory, alteration to
the product, improper installation, unauthorised repairs or
modifications, improper use of electrical/power supply, loss
of power, malfunction or damage of an operating part from
failure to provide manufacturer’s recommended maintenance,
transportation damage, theft, neglect, vandalism, environmental
conditions or any other conditions whatsoever that are beyond
the control of Homedics.
This Warranty does not extend to the purchase of used, repaired
or second-hand products or to products not imported or supplied
by Homedics Australia Pty Ltd, including but not limited to those
sold on offshore internet auction sites.
This Warranty extends only to consumers and does not extend to
Suppliers.
Even when we
DO NOT have to replace the Goods, we may decide
to do so anyway. In some cases, we may decide to substitute the
Goods with a similar alternative product of our choosing.
All such decisions are at our absolute discretion.
All such replaced or substituted Goods continue to receive the
benefit of this Additional Warranty for the time remaining on
the original Warranty Period (or three months, whichever is the
longest).
This Additional Warranty does not cover items damaged
by normal wear and tear including but not limited to chips,
scratches, abrasions, discolouration and other minor defects,
where the damage has negligible effect on the operation or
performance of the Goods.
This Additional Warranty is limited to replacement or substitution
only. As far as the law permits, we will not be liable for any
loss or damage caused to property or persons arising from any
cause whatsoever and shall have no liability for any incidental,
consequential, or special damages.
This warranty is only valid and enforceable in Australia and New
Zealand.
Making a Claim:
In order to claim under this Warranty, you must return the Goods
to the Supplier (place of purchase) for replacement. If this is not
possible, please contact our Customer Service department by
email:
cservice@Homedics.com.au or at the address below.
All returned Goods must be accompanied by satisfactory proof
of purchase which clearly indicates the name and address of the
Supplier, the date and place of purchase and identifies product.
It is best to provide an original, legible, and unmodified receipt or
sales invoice.
You must bear any expense for return of the Goods or otherwise
associated with making your claim under this Additional
Warranty.
DISTRIBUTED BY
AUSTRALIA: Homedics Australia Pty Ltd,
14 Kingsley Close, Rowville, VIC 3178
NEW ZEALAND: CDB Media Ltd, 4 Lovell Court, Albany, Auck-
land, New Zealand 0800 232 633
Homedics Customer Service:
Email: [email protected]u
Manufactured by:
Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, No. 105, Dongli Road, Torch Development District,
528437 Zhongshan, Guangdong, China
1-YEAR LIMITED WARRANTY
INFORMATION FOR USER
TIPS FOR MEASUREMENT
Measurements may be inaccurate if taken in the following circumstances
Within 1 hour
after dinner or drinking
Immediate measurement
after tea, coee, smoking
Within 20 minutes
after taking a bath
When talking or moving your ngers
In a very cold environment
When you want to discharge urine
MAINTENANCE
In order to get the best performance, please follow the instructions below.
CLEANING PROCESS:
Step 1: Make sure to switch off and unplug the device prior to cleaning
Step 2: Use a soft cloth dampened with soapy water to clean the cuff first, and
then use a soft cloth dampened with clear water to remove residual
soap until there is no visible residual contaminants. Attention shall
be paid to avoid liquid invasion into the cuff.
Step 3: Use a dry soft cloth to wipe the cuff, in order to remove residual
moisture.
Step 4: Dry the cuff at a well-ventilated place after cleaning.
DISINFECTION PROCESS:
Step 1: Make sure to switch off and unplug the device prior to disinfection.
Step 2: Use a soft cloth dampened with 70% isopropanol to disinfect the cuff
for about 3 minutes. Attention shall be paid to avoid liquid invasion
into the cuff.
Step 3: Use a clean dry cloth or towel to wipe off the disinfectant until
there is no visible residue.
Step 4: Dry the cuff at a well-ventilated place after disinfection.
Suggestion:
FREQUENCY OF CLEANING AND DISINFECTION:
For single patient multiple use, it’s recommended to clean the device
surface once a month or whenever it’s necessary,
For multiple patient multiple use, it’s recommended to clean the device every time
before and after usage. Maintenance procedures shall be taken as per instruction
ABOUT BLOOD PRESSURE
WHAT ARE SYSTOLIC PRESSURE AND
DIASTOLIC PRESSURE?
When ventricles contract and pump blood out
of the heart, the blood pressure reaches its
maximum value in the cycle, which is called
systolic pressure. When the ventricles relax,
the blood pressure reaches its minimum value
in the cycle, which is called diastolic pressure.
WHAT IS THE STANDARD BLOOD PRESSURE
CLASSIFICATION?
The blood pressure classification published
by World Health Organization (WHO) and
International Society of Hypertension (ISH) in
1999 is as follows:
press
artery
vein
blood discharging
Systolic
relax
blood entering
Diastolic
Blood Pressure
Category
Systolic mm HG
(upper number)
Diastolic mm Hg
(lower number)
Normal <120 and <80
Elevated 120-129 and <80
High Blood Pressure
(Hypertension) Stage 1
130-139 or 80-89
High Blood Pressure
(Hypertension) Stage 2
≤140 or ≤90
Hypertension Crisis
(Consult your doctor
immediately)
>180 and/or >120
CAUTION
Only a physician can tell your normal BP range. Please contact a physician if
your measuring result falls out of the range. Please note that only a physician
can tell whether your blood pressure value has reached a dangerous point.
IRREGULAR PULSE RATE DETECTOR
An irregular pulse rate will be detected if there is an irregular pulse rhythm while
measuring systolic and diastolic blood pressure. When measurements were
performed, the monitor will record all pulse intervals and calculate the average. If
two or more pulse intervals were recorded, and the difference between each interval
and the average is larger than ±25% of the average; or if four or more pulse intervals
were recorded, and the difference between each interval and the average is larger
than ±15% of the average value, the irregular pulse symbol will be displayed along with
measurement results.
WHY DOES MY BLOOD PRESSURE FLUCTUATE
THROUGHOUT THE DAY?
1. Individual blood pressure varies multiple times
everyday. It is also affected by the way you tie
your cuff and your measurement position, so
please take the measurement under the same
conditions.
2. If the person takes medicine. The pressure will
vary more.
3. Wait at least 3 minutes for another measurement.
CAUTION
The appearance of the IPR icon indicates that a pulse irregularity consistent
with an irregular pulse rate was detected during measurement. Usually
this is NOT a cause for concern. However, if the symbol appears often, we
recommend you seek medical advice. Please note that the irregular pulse rate
detector results cannot be used directly for clinical judgment. Please seek
medical advice from professionals before making any medical decisions.
WHY DO I GET A DIFFERENT BLOOD PRESSURE AT HOME COMPARED TO THE
HOSPITAL?
The blood pressure is different even throughout the day due to weather, emotion,
exercise etc, Also, there is the “white coat” effect, which means blood pressure
usually increases in clinical settings. Is the result the same if measuring on the
right arm?
What you need to pay attention to when you measure your blood pressure at home:
• If the cuff is tied properly.
• If the cuff is too tight or too loose.
• If the cuff is tied on the upper arm.
• If you feel anxious.
• Taking 2-3 deep breaths before beginning will be better for measuring.
• Advice: Relax yourself for 4-5 minutes until you calm down.
IS THE RESULT THE SAME IF MEASURING ON
THE RIGHT ARM?
It is okay for both arms, but there will be some
different results for different people. We suggest
you measure the same arm every time.
TROUBLESHOOTING
If any abnormality arises during use, please check the following points:
Problem Symptom Check This Remedy
No power
Display will
not light up.
Batteries are
exhausted.
Replace with new
batteries.
Batteries are
inserted
incorrectly.
Insert the batteries
correctly.
High
Battery
bAt H shows
The battery is too
high.
Replace with new
batteries
Low
Batteries
Display is dim
or shows
+
bAt Lo
The battery is low.
Replace with new
batteries.
Error
Message
E 1 shows
The cuff is not
wrapped well or the
cuff air plug is loose
Readjust the cuff,
not too loose or
too tight and then
measure again.
E 2 shows
The monitor
detected motion,
talking or the pulse
is too poor while
measuring.
Relax for a moment
and then measure
again.
E 3 shows
The measurement
process does not
detect the pulse
signal.
Loosen the clothing
on the arm and then
measure again.
E 4 shows
The treatment of
the measurement
failed.
Relax for a moment
and then measure
again.
EEx
shows on
the display.
Hardware error
occurred.
Retake the
measurement. If the
problem persists,
contact the retailer
or our customer
service department
for further
assistance. Refer
to the warranty for
contact information
and return.
Warning
Message
“out ” shows
Out of
measurement
range
Relax for a moment.
Refasten the cuff
and then measure
again. If the
problem persists,
contact your
physician.
NOTE: If the product still does not work, contact Customer Service. Under no
circumstance should you disassemble or attempt to repair the unit by yourself.
SPECIFICATIONS
Power supply Battery powered mode: 4× AAA batteries
Display mode Digital LCD display V.A.59.5mm×40.5mm
Measurement mode Oscillographic testing mode
Measurement range
Rated cuff pressure:
0mmHg~299mmHg(0kPa ~ 39.9kPa)
Measurement pressure:
SYS: 60mmHg~230mmHg (8.0kPa~30.7kPa)
DIA: 40mmHg~130mmHg (5.3kPa~17.3kPa)
Pulse value: (40-199)beat/minute
Accuracy
Static Pressure: 5-40°C within ±3mmHg
Pulse value: ±5%
Clinical validation: Mean difference within ±5mmHg;
Standard deviation ≤8mmHg
Normal working
condition
A temperature range of: +5°C to +40°C
A relative humidity range of 15% to 90%,
non-condensing, but not requiring a water vapour
partial pressure greater than 50 hPa
An atmospheric pressure range of 700 hPa to 1060 hPa
Storage &
transportation
Condition
Temperature:-20°C to +60°C
A relative humidity range of ≤ 93%, non-condensing,
at a water vapour pressure up to 50 hPa
An atmospheric pressure range of 500 hPa to 1060 hPa
Measurement
perimeter of the arm
About 22cm~42cm
Net Weight Approx.187g(Excluding the dry cells and cuff)
External
dimensions
Approx.110mm×110mm×42mm
Attachment 4×AAA batteries, user manual
Mode of operation Continuous operation
Degree of protection Type BF applied part
Protection against
ingress of water
IP21 Itmeansthedevicecould be protected against
solid foreign objects of 12,5mm > and greater, and
against vertically falling water drops
Device Classification
Battery Powered Mode:
Internally Powered ME Equipment
Software Version A01
Expected Lifetime
Device: 3 years or 30,000 measurements (may vary
based on usage conditions)
Cuff: 10000 times
Alkaline battery: About 200-300 times
Types of use/reuse Multiple patient multiple use
WARNING: No modification of this equipment is allowed.
EMC GUIDANCE
The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments.
Essential performance: Accuracy of measuring blood pressure
The Basis Safety of the Blood Pressure Monitor (BPA-5020-AU) is as following:
Deviation from normal operation that poses an unacceptable risk to the patient or
operator.
Warning: Don’t be near the 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 necessary,
this equipment and the other equipment should be observed to verify that they are
operating normally.
Warning: Use of accessories, transducers and cables other than those specified
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: 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 equipment including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment could result.
Guidance and manufacturer’s declaration - electromagnetic emissions
Emissions test Compliance
RF emissions
CISPR 11
Group 1
RF emissions
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Not applicable
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Not applicable
TECHNICAL DESCRIPTION
1. All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL
PERFORMANCE with regard to electromagnetic disturbances for the expected
lifetime.
2. Guidance and manufacturer’s declaration -electromagnetic emissions and Immunity
TABLE 01
TABLE 02
TABLE 03
Part 1:
Guidance and manufacturer’s declaration – electromagnetic Immunity
Immunity Test
IEC 60601-1-2
Test level
Compliance level
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±2 kV, ±4kV, ±8 kV, ±15
kV air
±8 kV contact
±2 kV, ±4kV, ±8 kV, ±15
kV air
Electrical fast
transient/burst
IEC 61000-4-4
Not applicable Not applicable
Surge
IEC61000-4-5
Not applicable Not applicable
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Not applicable Not applicable
Power frequency
magnetic field
IEC 61000-4-8
30 A/m
50 Hz / 60 Hz
30 A/m
50Hz/60Hz
Conduced RF
IEC61000-4-6
Not applicable Not applicable
Radiated RF
IEC61000-4-3
10 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
NOTE:
U
T
is the a.c. mains voltage prior to application of the test level.
Guidance and manufacturer’s declaration - electromagnetic Immunity
Radiated RF
IEC61000-
4-3 (Test
specifica
-
tions for
ENCLO
-
SURE PORT
IMMUNITY
to RF wire
-
less commu
-
nicati- ons
equipment)
Test
Frequency
(MHz)
Band
(MHz)
Service Modulation
385 380-390
TETRA
400
Pulse
modulation
18 Hz
450 430-470
GMRS 460,
FRS 460
FM ± 5k Hz
deviation
1 kHz sine
710
704-787
LTE Band
13,
17
Pulse
modulation
217 Hz
745
780
810
800-960
GSM
800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulation
18 Hz
870
930
1720
1700-
1990
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1,
3, 4,25;
UMTS
Pulse
modulation
217 Hz
1845
1970
2450
2400-
2570
Bluetooth,
WLAN,
802.11
b/g/n, RFID
24 50, LTE
Band 7
Pulse
modulation
217 Hz
5240
5100-
5800
WLAN
802.11
a/n
Pulse
modulation
217 Hz
5500
5785
Guidance and manufacturer’s declaration - electromagnetic Immunity
Radiated RF
IEC61000-
4-3 (Test
specifica
-
tions for
ENCLO
-
SURE PORT
IMMUNITY
to RF wire
-
less commu
-
nications
equipment)
Maximum
Power
(W)
Distance
(m)
IEC
60601-1-2
Test Level
(V/m)
Compliance
level
(V/m)
1.8 0.3 27 27
2 0.3 28 28
0.2 0.3 9 9
2 0.3 28 28
2 0.3 28 28
2 0.3 28 28
0.2 0.3 9 9
Part 2:
