Jamr Technology W03 User manual

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CONTACT INFORMATION
Wrist Type Blood Pressure Monitor is legal manufactured by:
Company name: Shenzhen Jamr Technology Co., Ltd
Address: A101-301,D101-201, Jamr Science & Technology Park, No. 2 Guiyuan Road,
Guixiang Community,Guanlan Street, Longhua District, Shenzhen 518100,PEOPLE'S
REPUBLIC OF CHINA
Website: www.jiemeirui.com
Telephone: [phone]
Authorized European Representative:
Company Name: Shanghai International Holding Corp. GmbH (Europe)
Contact person: Mr JIN LIANG
Address: Eiffestrasse 80, 20537 Hamburg, Germany.
Telephone: [phone]
FAX: [phone]
E-mail: [e-mail]
Release date: 2021.03.18, Version:B1

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Wrist Type
Blood Pressure Monitor
Model Number: W03
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USER MANUAL

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CONTENTS
1. Introduction and Intended Use..............................................................................................3
2. Important Information on Blood Pressure and its Measurement...........................................5
3. Components of your blood pressure monitor.........................................................................7
4. Using your Monitor for the First Time.....................................................................................8
5. Measurement Procedure..................................................................................................... 9
6. Care and Maintenance........................................................................................................16
7. Warranty...............................................................................................................................16
8. Certifications........................................................................................................................16
9. Technical Specifications..................................................................................................17-18
10. EMC Declaration.......................................................................................................... 19-22
11. Warranty Card..................................................................................................................23

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1.Introduction and Intended Use
The device is intended to measure systolic and diastolic blood pressure as well as the
pulse by wrapping around the wrist with cuff circumference ranging from 13.5cm to
19.5cm .
The device is used for adult that age is more than 12 years old ,and the intended
populations are the patients with hypertension or need blood pressure monitoring.The
device is not used for patients under dialysis therapy or on anticoagulant, antiplatelets, or
steroids.
The device can be used in medical facilities or at home.
Before using, please read this instruction manual carefully and then keep it in a safe place.
Please contact your doctor for further questions on the subject of blood pressure and its
measurement.
Warning：Not suitable for neonatal and infants.
Warning：Not suitable for pregnant, including pre-eclamptic patients, not suitable for self-use
in public areas, Not intended for use in the emergency medical services environment.
Warning：This device can not be used together with HF surgical equipment.
1.1. Remember…
• Only a health-care professional is qualified to interpret blood pressure measurements.
• This device is NOT intended to replace regular medical checkups.
• It is recommended that your physician review your procedure for using this device.
• Blood pressure readings obtained by this device should be verified before prescribing or
making adjustments to any medications used to control hypertension. Under no circumstances
should YOU alter the dosages of any drugs prescribed by your doctor.
• This monitor is intended for use by adults only. Consult with a physician before using this
instrument on a child.
• In cases of irregular heartbeat (Arrhythmia), measurements made with this instrument should
only be evaluated after consultation with your doctor.
• Familiarize yourself with the section titled "Important Information on Blood Pressure and its
Measurement". It contains important information on the dynamics of blood pressure readings
and will help you to obtain the best results.
• Host products, including accessories, shall be processed in accordance with local regulations
after reaching the life cycle.
NOTE!
• This device contains sensitive electronic components. Avoid strong electrical or
electromagnetic fields in the direct vicinity of the device (e.g. mobile telephones, microwave
ovens) during use. These can lead to erratic results.
• Do not attempt to service or repair this device yourself. Should a malfunction occur, refer to
local distributor or the manufacturer.

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Warning：
• Too frequent measurements can cause injury to the PATIENT due to blood flow interference.
• Don’t place the cuff over wound part.
• Pressurization of the CUFF can temporarily cause loss of function of simultaneously used
monitoring ME EQUIPMENT on the same limb.
• Apply CUFF and its pressurization to any limb where intravascular access or arteriovenous
(A-V) shunts exist, can temporarily interfere with blood flow and may cause injury to the
patient.
•Apply CUFF and its pressurization on the side of the patient's mastectomy or lymph node
removal can cause injury.
Contraindication
Use of this instrument on patients under dialysis therapy or on anticoagulant, antiplatelets, or
steroids could cause internal bleeding.
1.2 Warnings and Precautions
Warning: Do not use cuffs, batteries other than those included with this product or
replacement parts supplied by the manufacturer.
Warning: This system may fail to yield specified measurement accuracy if operated or stored
in temperature or humidity conditions outside the limits stated in the specifications section of
this manual.
Warning: Remove the battery if the ME EQUIPMENT is not likely to be used for some time.
Warning: The user must check that the equipment functions safely and see that it is in proper
working condition before being used.
Warning: No modification of this equipment is allowed.
Warning: The device is not suitable for use in the presence of flammable anesthetic mixtures
with air or with oxygen or nitrous oxide.
Warning: Not suitable for use in the presence of flammable agents.
Warning: If having a potential allergic reaction when using the cuff of the device, the user
should immediately remove it and contact the manufacturer or local distributor.
Warning:Regularly checking the operation of the blood pressure monitor to ensure that it does
not cause long-term damage to the patient's blood circulation.
Warning:The performance of the blood pressure monitor could be affected by extreme
temperatures, humidity and altitude.
Warning:The hose of the cuff can only be connected with the manufacturer's blood pressure
monitor,and used in other equipment may cause malfunction.
Warning:Do not bend, squeeze or restrict the connecting hose of cuff during the storage or
operation,, otherwise it will cause injury.
Warning: This equipment shall not be serviced or maintained while in use with the patient.
Warning: The patient is an intended operator, the functions of monitoring blood pressure and
pulse rate can be safely used by patient. The routine clean and changing batteries can be
performed by the patient.
Warning: Do not be prone to water leakage, high temperature, moisture, direct sunlight and
more or more corrosive gas environment. And Do not use this product in the above

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environment.
Caution: To avoid any possibility of accidental strangulation, keep this unit away from children
and do not drape tubing around your neck.
Caution: To avoid damaging the device, keep this unit away from children and pets.
Caution: The standard material used for the bladder and tubing is latex-free.
Attention: Self-measurement means control, not diagnosis or treatment. Unusual values must
always be discussed with your doctor. Under no circumstances should you alter the dosages
of any drugs prescribed by your doctor.
Attention: The pulse display is not suitable for checking the frequency of heart pacemakers!
Attention: In cases of irregular heartbeat, measurements made with this instrument should
only be evaluated after consultation with your doctor.
Note: To obtain the greatest accuracy from your blood pressure instrument, it is recommended
that the instrument be used within the specified temperature and the relative humidity, please
see the Technical Specifications
Note: The cuff is treated as the applied part.The user should contact the manufacturer for
assistance, if needed, in setting up, using or maintaining the device.
2. Important Information on Blood Pressure and its Measurement
2.1. How does high or low blood pressure arise?
Your level of blood pressure is determined in the circulatory center of the brain and adjusts to a
variety of situations through feedback from the nervous system. To adjust blood pressure, the
strength and speed of the heart (Pulse), as well as the width of circulatory blood vessels is
altered.Blood vessel width is controlled by fine muscles in the blood vessel walls.
Your level of arterial blood pressure changes periodically during heart activity: During the
“blood ejection” (Systole) the value is highest (systolic blood pressure value). At the end of the
heart’s “rest period” (Diastole) pressure is lowest (diastolic blood pressure value).
Blood pressure values must lie within certain normal ranges in order to prevent particular
diseases.
2.2. Which values are normal?
Please refer to the diagram below(Picture-01)

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Picture-01
There are six grids in the display of device. Please refer to the picture-01-01. Different grids
represent different interval scales of WHO.
Blood pressure is very high if your diastolic pressure is above 90 mmHg and/or your systolic
blood pressure is over 160 mmHg, while at rest. In this case, please consult your physician
immediately. Long-term values at this level endanger your health due to continual damage to
the blood vessels in your body. If your systolic blood pressure values are between 140 mmHg
and 159mmHg and/or the diastolic blood pressure values between 90 mmHg and 99mmHg,
consult your physician. Regular self-checks are necessary. If you have blood pressure values
that are too low, (i.e., systolic values under 105mmHg and/or diastolic values under 60 mmHg),
consult your physician. Even with normal blood pressure values, a regular self-check with your
blood pressure monitor is recommended. You can detect possible changes in your values
early and react appropriately. If you are undergoing medical treatment to control your blood
pressure, keep a record of values along with time of day and date. Show these values to your
physician. Never use the results of your measurements to independently alter the drug doses
prescribed by your physician.
Further information
• If your values are mostly normal under resting conditions but exceptionally high under
conditions of physical or psychological stress, it is possible that you are suffering from
so-called “labile hypertension.” Consult your doctor.
• Correctly measured diastolic blood pressure values above 120mmHg require immediate

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medical treatment.
2.3. What can be done if regular high or low values are obtained?
1) Consult your doctor.
2) Increased blood pressure values (various forms of hypertension) are associated with
considerable health risks over time. Arterial blood vessels in your body are endangered due to
constriction caused by deposits in the vessel walls (Arteriosclerosis). A deficient supply of
blood to important organs (heart, brain, muscles) can result from arteriosclerosis. Furthermore,
the heart will become structurally damaged with increased blood pressure values.
3) There are many different causes of high blood pressure. We differentiate between the
common primary (essential) hypertension, and secondary hypertension. The latter group can
be ascribed to specific organ malfunctions. Please consult your doctor for information about
the possible origins of your own increased blood pressure values.
4) There are measures which you can take to reduce and even prevent high blood pressure.
3. Components of your blood pressure monitor
3.1. Measuring unit
Picture-02 Picture-03
3.2 The symbols on the LCD display
1. User A 2. User B
3. Bluetooth symbol 4. mute symbol
5. Irregular heartbeat symbol 6.Average value symbol
7. Low battery symbol 8. Date/Time display
9. Heartbeat symbol 10. Pulse display
11.WHO symbol 12. Memory symbol
13. Diastolic blood pressure 14.Systolic blood pressure
3.3. Features of Model W03
1. Talking function 2. Double users: 2 x 120 sets memory 3.Date/time display
4. Irregular heartbeat checking 5. Average value function 6. Low battery display

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7. WHO function 8. Auto power-off 9.Volume adjustment
4. Using your Monitor for the First Time
4.1. System Settings
After you load the battery for the monitor,long press the START/STOP button for more than
3s, and then you can start to set.
A. Setting the Users
Press the MEM button and then you can set the A/B user by shifting the A/B user button.
B. Setting the Year/Month&Date/Time/Volume
Setting the Year:
Initial year is 2019, when the year display is flashing, press the memory button, the year will
increase by I year each, hold the memory button and it will increase continuously 1 by 1, until
2049, and then rollover to 2019, once the year Setting is OK, press SET button to confirm.
Setting Month/Date:
Initial Month/Date is 1/01, when the Month display is flashing, press the memory button, the
month will increase by 1, press SET button to confirm, and do in the same way to set the date.
Press SET button to confirm.
Setting Time :
When the hour display is flashing, press the memory button, the hour will increase by 1, press
START/STOP button to confirm, and do in the same way to set the minute. Press
START/STOP button to confirm.
Setting Volume:
When display with SP is flashing, press memory button to switch volume 1, volume 2, volume
3 or OFF. Press START/STOP button to confirm.
C. Record Delete
When you checking the memory data, long press memory to delete existing user
measurement data.
Note: You can’t delete all measurement record from the monitor storage at one time, if you
decide to delete the all record, please keep the record in another way, in case you need it
some days later. Take the battery out won’t lead to a record missing.
5. Measurement Procedure
Note: You should always be seated and calm before and during measurement.
5.1. Before measurement:
• Avoid eating and smoking as well as all forms of exertion directly before measurement. These

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factors influence the measurement result. Find time to relax by sitting in an wristchair in a quiet
atmosphere for about ten minutes before taking a measurement.
• Remove any gwristent that fits closely to your wrist.
• Always measure on the same wrist (normally left).
• Always compare measurements taken at the same time of day, since blood pressure
changes during the course of the day, as much as 13.5-19.5mmHg.
5.2. Common sources of error:
Note: Comparable blood pressure measurements always require the same conditions!
•Conditions should always be quiet.
•All efforts by the user to support the wrist can increase blood pressure. Make sure you are in a
comfortable, relaxed position and do not flex any of the muscles in the measurement wrist
during the measurement. Use a cushion for support if necessary.
• If the wrist artery lies considerably lower or higher than the heart, an erroneously high or low
blood pressure will be measured !
Note: Only use approved cuffs!
• A loose cuff or a sideways protruding air pocket causes false measurement values.
• With repeated measurements, blood accumulates in the wrist, which can lead to false results.
Consecutive blood pressure measurements should be repeated after a 1 minute pause or after
your wrist has been held up in order to allow the accumulated blood to flow away. If you decide
to take your Averaging Mode measurement again, be sure to wait at least one minute
beforehand.
5.3. Fitting the Cuff
Please refer to picture-04
a) Remove all jewelry and watches. The palm of your hand should be facing you. Apply the cuff
so that the display is facing you.
b) The distance between the cuff and the hand should be 1cm.
c) Secure the cuff with the hook and loop adhesive so that it lies comfortably and not too tight.
It should be comfortable.
d) Lay your wrist on a table with your palm upwards. Support your wrist with a cushion so that
the cuff rests at about the same height as the heart. Remain still for 2 minutes, sitting quietly,
before beginning a measurement.

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Picture-04
5.4. Measure Procedure
Refer to picture 05
The monitor is designed to take measurements and store the measurement values in
memory for two people using User ID A and User ID B.
1. Sit comfortably in a chair with your feet flat on the floor.
2. Select your User ID (A or B).
Stretch your wrist forward on the desk and keep relaxing, make sure the palm of hand is
upturned. Make sure wrist is in correct position, to avoid body movement. Sit still and do not
talk or move during the measurement.
After the cuff has been appropriately positioned on the wrist and connected to the blood
pressure monitor, the measurement can begin:
a) Press the Stop/Start button. The pump begins to inflate the cuff. In the display, the
increasing cuff pressure is continually displayed.
b) After automatically reaching an individual pressure, the pump stops and the pressure slowly
falls. The cuff pressure is displayed during the measurement.
c) When the device has detected your pulse, the heart symbol in the display begins to blink.
d) When the measurement has been concluded, the measured systolic and diastolic blood
pressure values, as well as the pulse will be displayed.
e) The measurement results are displayed until you switch the device off. If no button is
pressed for 60seconds, the device switches off automatically.
Recommended Use Methods
1. Recommendation that the PATIENT relax as much as possible and not talk during the
measurement PROCEDURE
2. Recommendation that 5 min should elapse before the first reading is taken
3. Any reading can be affected by the measurement site, the position of the PATIENT,
exercise, or the PATIENT’S physiologic condition
4. Performance of the AUTOMATED SPHYGMOMANOMETER can be affected by extremes
of temperature, humidity and altitude

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5. To stop the inflation or measurement, push the START/STOP button,the monitor will stop
inflating, start deflating, and will turn off
6. After the monitor has detected your blood pressure and pulse rate, the cuff automatically
deflates. Your blood pressure and pulse rate are displayed.
7. If getting a suspicious reading after finishing measurement,you should consult the doctor.
Self-diagnosis of measurement results are dangerous.
8. The monitor will automatically turn off after one minute.
Picture-05
5.5. Irregular Heartbeat Detector
This symbol - indicates that certain pulse irregularities were detected during the measurement.
In this case, the result may deviate from your normal basal blood pressure – repeat the
measurement.
Information for the doctor on frequent appearance of the Irregular Heartbeat Symbol
This instrument is an oscillometric blood pressure monitor device that also analyzes pulse
frequency during measurement. The instrument is clinically tested.
If pulse irregularities occur during measurement, the irregular heartbeat symbol is displayed
after the measurement. If the symbol appears more frequently (e.g. several times per week on
measurements performed daily) or if it suddenly appears more often than usual, we
recommend the patient to seek medical advice. The instrument does not replace a cardiac
examination, but serves to detect pulse irregularities at an early stage.
5.6. Error Indicates
SYMBOL
CAUSE
CORRECTION

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No display
appears
Weak battery or improper
placement
Replace both batteries with new ones. Check
the battery installation for proper placement of
the battery polarities.
Er1
Sensor abnormal
Check if the pump is working or not. If it is
working, then the problem is sensor abnormal.
Please send it to the local distributor.
Er2
Monitor could not detect
pulse wave or cannot
calculate the blood
pressure data
Check if the air releasing is too slow or not. If it
is too slow, please check if there is any dust in
the tube plug of the cuff and the cuff port in the
device. If yes, please clean and start the
measurement again. If no, please send the
device back to the local distributor.
Er3
Measurement result is
abnormal (SYS≦45mmHg,
DIA≦24mmHg)
Occasionally-measure for one more time/
Always - send it to local distributor
Er4
Too loose cuff or air
leakage (Cannot inflate to
30mmHg within 15s)
Tie the cuff correctly and make sure the air plug
is properly inserted in the unit
Er 5
The air tube is crimped
Correct it and make the measurement again
Er 6
The sensor is sensing great
fluctuation in the pressure
Please keep quiet and don’t move
Er 7
The pressure that the
sensor sensing is over the
limit
Please send back to the local distributor
Er 8
The demarcation is
incorrect or the device has
not been demarcated
Please send back to the local distributor
5.7 Trouble shooting

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5.8 SYMBOL DESCRIPTIONS
The following symbols may appear in this manual, on the Blood Pressure Monitor W03, or on
it's accessories. Some of the symbols represent standards and compliances associated with
the Blood Pressure Monitor W03 and its use.
Authorized Representative in the European Community
CE Mark: conforms to essential requirements of REGULATION (EU) 2017/745
Indicate the item as a medical device
Class II equipment
Date of manufacture.
Manufacturer
SN
Specifies serial number
Type BF applied part
Direct current
DISPOSAL: Do not dispose this product as unsorted municipal waste. Collection
of such waste separately for special treatment is necessary.

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Follow instructions for use
Put up
fragile
Keep dry
Avoid the sun
handle gently
temperature range
5.9. Memory
At the end of a measurement, this monitor automatically stores each result with date and time.
Each unit stores 120 sets measurements for 2 users, totally 240 sets（User A and B）.
Viewing the stored values
With the unit off, press the Memory button. The display first shows "A", then shows an average
of all measurements stored in the unit. Please note: Measurements for each user are
averaged and stored separately. Be certain that you are viewing the measurements for the
correct user. Pressing the Memory button again displays the previous value. To view a
particular stored memory, press and hold the Memory button to scroll to that stored reading.
5.10. Discontinuing a Measurement
If it is necessary to interrupt a blood pressure measurement for any reason (e.g the patient
feels unwell), the Start/Stop button can be pressed at any time. The device then immediately
lowers the cuff pressure automatically.
5.11. Battery Change Indicator
Batteries discharged– replacements required
When the batteries are discharged, the battery symbol will flash as soon as the instrument
is switched on. You cannot take any further measurements and must replace the batteries.
The battery compartment is located on the back side of the unit
a) Remove cover from the bottom plate, as illustrated below picture-06
b) Insert the batteries (2 x size AAA ). Always use AAA long life batteries or alkaline 1.5V
batteries.
c) The memory retains all values although date and time must be reset - the year number
therefore flashes automatically after the batteries are replaced.

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d) To set date and time, follow the procedure described in Section 4.2.
Picture-06
Which batteries and which procedure?
Use two new, longlife 1.5V AAA batteries. Do not use batteries beyond their expiration date. If
the monitor is not going to be used for a prolonged period the batteries should be removed.
Using rechargeable batteries
You can also operate this instrument using rechargeable batteries.
•Only use "NiMH" reusable batteries!
• If the battery symbol the batteries must be removed and recharged! They must not
remain inside the instrument, as they may become damaged through total discharge even
when switched off. The batteries must NOT be discharged in the blood pressure monitor! If you
do not intend to use the instrument for a week or more, always remove the rechargeable
batteries!
• Recharge these batteries using an external charger and follow manufacturer’s instructions
Carefully.
6. Care and Maintenance
Wash hands after each time measurement.
If one device is used by different patients, wash hands before and after each use.
The device,including cuff should be cleaned every week,and the effective repetitive cleaning
times is 390 times during the shelf life.
The device,including cuff should be cleaned every week,and the effective repetitive cleaning
times is 390 times during the shelf life.
a) Do not expose the device to either extreme temperatures, humidity, dust or direct sunlight.
b) The cuff contains a sensitive air-tight bubble. Handle this cuff carefully and avoid all types of
stress through twisting or buckling.
c) Clean the device with a soft, dry cloth. Do not use gas, thinners or similar solvents. Spots on
the cuff can be removed carefully with a damp cloth and soapsuds,if necessary, 70%
isopropanol can also be used. The cuff with bladder must not be washed in a dishwasher,
clothes washer, or submerged in water.
d) Handle the tube carefully. Do not pull on it. Do not allow the tubing to kink and keep it away
from sharp edges.

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e) Do not drop the monitor or treat it roughly in any way. Avoid strong vibrations.
f) Never open the monitor! This invalidates the manufacturer’s warranty.
g) Batteries and electronic instruments must be disposed of in accordance with the locally
applicable regulations, not with domestic waste.
Accuracy test
Sensitive measuring devices must be checked for accuracy from time to time. We recommend
a periodical inspection of your unit by an authorized dealer every 1 years. Please turn to local
distributor or the manufacturer.
7. Warranty
Your blood pressure monitor is guaranteed for 1 years against manufacturers’ defects for the
original purchaser only, from date of purchase. The warranty does not apply to damage
caused by improper handling, accidents, professional use, not following the operating
instructions or alterations made to the instrument by third parties.
Warranty only applies to the instrument. All accessories including the cuff are guaranteed for
one year.
There are no user serviceable parts inside. Batteries or damage from old batteries is not
covered by the warranty.
Note: According to international standards, your monitor should be checked for accuracy every
year.
8. Certifications
Device standard:
This device is manufactured to meet the European blood pressure monitors:
IEC 80601-2-30/ISO81060-1/ISO81060-2/IEC60601-1-11/ IEC60601-1
Electromagnetic compatibility:
Device fulfills the stipulations of the International standard
IEC60601-1-2
9. Technical Specifications
Model: W03
Wight: 101g (batteries and AC adapter is not included)
Display: 49.5 x 41.5mm LCD Digital Display
Size: 68 (W) x 68 (L) x 30 (H) mm
Accessories: 1×Main Device, 1×Cuff, 1×Users manual, 1×Warranty card
Operating Conditions: Temperature: 5℃to 40℃;Humidity: 15% to 93% RH;
Pressure altitude:70KPa~ 106Kpa
Storage And Shipping Conditions:Temperature: -25℃to 70℃; Humidity: 10% to 93% RH;
Pressure altitude: 70KPa~ 106Kpa

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Measuring method: Oscillometric
Operating method: Continuous operation
Pressure sensor: Resistive
Measuring range: DDIA: 15-160mmHg; SYS: 40-240mmHg
Pulse: 40 to 199 per minute
Cuff pressure display range: 0–295 mmHg
Memory: Automatically stores the last 120 measurements for 2 users (total 240)
Measuring resolution: 1 mmHg
Accuracy: Pressure within ± 3 mmHg / pulse ± 5 % of the reading
Power source: 2 AAA batteries, 1.5 V
Accessories: 13.5-19.5cm
Automatically power off : 60 seconds
Users: Adult
Software Version: V1.1.1
Expected service life of the device and accessories: 5 years
Technical alterations reserved!
10. EMC Declaration
1) * This product needs special precautions regarding EMC and needs to be installed and
put into service according to the EMC information provided, and this unit can be affected by
portable and mobile RF communications equipment.
2) * Do not use a mobile phone or other devices that emit electromagnetic fields, near the
unit. This may result in incorrect operation of the unit.
3) * Caution: This unit has been thoroughly tested and inspected to assure proper
performance and operation!
4) * Caution: this machine should not be used adjacent to or stacked with other equipment
and that if adjacent or stacked use is necessary, this machine should be observed to verify
normal operation in the configuration in which it will be used
Guidance and manufacture’s declaration – electromagnetic emission
The device is intended for use in the electromagnetic environment specified below. The customer of the user of the
device should assure that it is used in such an environment.
Emission test
Compliance
Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1
The device use RF energy only for its internal function.
Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic
equipment.

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RF emission
CISPR 11
Class B
The device is suitable for use in all establishments,
including domestic establishments other than domestic
and those directly connected to the public low-voltage
power supply network that supplies buildings used for
domestic purposes.
Hwristonic emissions
IEC 61000-3-2
Not applicable
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Not applicable

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Guidance and manufacture’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the user of device
should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment -
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±2 kV, ±4 kV, ±8 kV,
±15 kV air
±8 kV contact
±2 kV, ±4 kV, ±8 kV,
±15 kV air
Floors should be wood, concrete
or ceramic tile. If floor are covered
with synthetic material, the
relative humidity should be at
least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power supply
lines
±1 kV for input/output
lines
Not applicable
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
Not applicable
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
0 % UT; 0.5 cycle
at 0°,45°,90°,
135°, 180°, 225°,
270°, 315°
0 % UT ; 1 cycle
70 % UT; 25/30 cycle
0% UT; 250/300 cycle
Not applicable
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the device requires continued
operation during power mains
interruptions, it is recommended
that the device be powered from
an uninterruptible power supply or
a battery.
Power frequency
(50Hz/60Hz)
magnetic field IEC
61000-4-8
30 A/m
50/60Hz
30 A/m
50/60Hz
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
NOTE UTis the a.c. mains voltage prior to application of the test level.
Guidance and manufacture’s declaration – electromagnetic immunity