zewa UAM-710 User manual

Version:1.0
User Manual
Blood Pressure Monitor UAM-710
Arm Type
Thank you very much for selecting Zewa Blood Pressure Monitor
UAM-710
Please do read the user manual carefully and thoroughtly so as to ensure
the safe usage of this product, and keep the manual well for further
reference in case you have problems.
Manufactured for Zewa, Inc.
12960 Commerce Lakes Drive#29
Fort Myers, FL 33913 USA
www.zewa.com
Toll Free Customer Service:
1-888-993-3592
[email protected]
2018-07-12
技术要求：
1、黏合不可露胶
2、保持印刷面板上的清洁
3、注意套印的准确性
4、表面处理不可爆开
5、结构工艺以结构受控图为准
6、颜色参考：
产品型号 材质
尺寸
70G书写纸
100*140 mm
单黑
产品名称 血压计
-
TMB-1491-DS-022
李秋燕 2018-07-12
罗佳钰 2018-07-12
谭文昊 2018-07-12
TMB-1491-DS-022-GB-09
PO#2F3242-TMB-1491-DS-022-GB-09-说明书-A0
共 16 张 第 1 张
A/0
对应结构图纸 印色
1:1 -表面处理

1
CATALOGUE
Table of Contents
CATALOGUE
INTRODUCTION...................................................................................................................2
General Description
Indications for Use
Contraindications
Measurement Principle
Safety Information
LCD Display Signal
Monitor Components
List
BEFORE YOU START...........................................................................................................9
The Choice of Power Supply
Installing and Replacing the Batteries
Setting Date, Time and Measurement Unit
Select the User
MEASUREMENT..................................................................................................................13
Tie the Cuff
Start the Measurement
DATA MANAGEMENT..........................................................................................................15
Recall the Records
Delete the Records
INFORMATION FOR USER................................................................................................17
Tips for measurement
Maintenances
ABOUT BLOOD PRESSURE..............................................................................................19
What are systolic pressure and diastolic pressure?
What is the standard blood pressure classification?
Irregular heartbeat detector
Why does my blood pressure fluctuate throughout the day?
Why do I get a different blood pressure at home compared to the hospital?
Is the result the same if measuring on the right arm?
TROUBLESHOOTING.......................................................................................................21
SPECIFICATIONS..............................................................................................................22
AUTHORIZED COMPONENT ...........................................................................................23
CONTACT INFORMATION.................................................................................................23
FCC STATEMENT...............................................................................................................23
COMPLIED EUROPEAN STANDARDS LIST.....................................................................24
EMC GUIDANCE................................................................................................................29

INTRODUCTION INTRODUCTION
2 3
The signs below might be in the user manual, labeling or other component.
They are the requirement of standard and using.
Safety Information
Measurement Principle
Thank you for selecting Zewa arm type blood pressure monitor
(UAM-710). The monitor features blood pressure measurement, pulse
rate measurement and the result storage. The design provides you with
years of reliable service.
Readings taken by the UAM-710 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:
Maximum 60 records
General Description
3rd technonoly: Measuring during inflation
60mm×40.5 mm digital LCD display
Indications for Use
The Zewa Blood Pressure Monitor is digital monitors intended for use in
measuring blood pressure and heartbeat rate with arm circumference ranging
from 22cm to 42cm(about 8¾˝-16½˝).
It is intended for adult indoor use only.
1.The device is not suitable for use on pregnant women.
2.The device is not suitable for use on patients with implanted,electrical devices,
such as cardiac pacemakers, defibrillators.
Contraindications
This product uses the Oscillometric Measuring method to detect blood pressure.
Before every measurement, the unit establishes a “zero pressure” equivalent to the air
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.
The Green Dot is the license
symbol of a European
network of industry-funded
systems for recycling the
packaging materials of
consumer goods.
Symbol for “Recycle”
Symbol for “THE OPERATION
GUIDE MUST BE READ”
Symbol for “MANUFACTURER”
Symbol for “SERIAL NUMBER”
Symbol for “TYPE BF APPLIED
PARTS”
Symbol for “DIRECT CURRENT”
Symbol for “ENVIRONMENT
PROTECTION - Electrical waste
products should not be disposed of
with household waste. Please
recycle where facilities exist. Check
with your local authority or retailer
for recycling advice”
Caution: These notes must
be observed to prevent any
damage to the device.
SN
Symbol for “MANUFACTURE
DATE”

INTRODUCTION
INTRODUCTION
45
CAUTION CAUTION
* This device is intended for adult use in homes only.
* The device is not suitable for use on neonatal patients, pregnant women,patients with
implanted, electronical devices, patients with pre-eclampsia, premature ventricular beats,
atrial fibrillation, peripheral, arterial disease and patients undergoing intravascular therapy or
arterio-venous shunt or people who received a mastectomy. Please consult your doctor
prior to using the unit if you suffer from illnesses.
* The device is not suitable for measuring the blood pressure of children. Ask your doctor
before using it on older children.
* The device is not intended for patient transport outside a healthcare facility.
* The device is not intended for public use.
* This device is intended for no-invasive measuring and monitoring of arterial blood
pressure.It is not intended for use on extremities other than the arm or for functions other
than obtaining a blood pressure measurement.
* Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your
blood pressure.Do not begin or end medical treatment without asking a physician for
treatment advice.
* If you are taking medication,consult your physician to determine the most appropriate time
to measure your blood pressure. Never change a prescribed medication without consulting
your physician.
* Do not take any therapeutic measures on the basis of a self measurement. Never alter the
dose of a medicine prescribed by a doctor. Consult your doctor if you have any question
about your blood pressure.
* When the device was used to measure patients who have common arrhythmias such as
atrial or ventricular premature beats or atrial fibrillation, the best result may occur with
deviation. Please consult your physician about the result.
* Don't kink the connection tube during use, otherwise, the cuff pressure may continuously
increase which can prevent blood flow and result in harmful injury to the PATIENT.
* When using this device, please pay attention to the following situation which may interrupt
blood flow and influence blood circulation of the patient, thus cause harmful injury to the
patient: connection tubing kinking too frequent and consecutive multiple measurements; the
application of the cuff and its pressurization on any arm where intravascular access or
therapy, or an arterio-venous (A-V) shunt, is present; inflating the cuff on the side of a
mastectomy.
* Warning: Do not apply the cuff over a wound;otherwise it can cause further injury.
*Do not inflate the cuff on the same limb which other monitoring ME equipment is applied
around simultaneously, because this could cause temporary loss of function of those
simultaneously-used monitoring ME equipment.
*On the rare occasion of a fault causing the cuff to remain fully inflated during
measurement, open the cuff immediately. Prolonged high pressure (cuff pressure ＞
300mmHg or constant pressure ＞ 15mmHg for more than 3 minutes) applied to the arm
may lead to an ecchymosis.
*Please check that operation of the device does not result in prolonged impairment of
patient blood circulation.
* When measurement, please avoid compression or restriction of the connection tubing.
* The device cannot be used with HF surgical equipment at the same time.
* The ACCOMPANYING DOCUMENT shall disclose that the SPHYGMOMANOMETER was
clinically investigated according to the requirements of ISO 81060-2:2013.
* To verify the calibration of the AUTOMATED SPHYGMOMANOMETER, please contact the
manufacturer.
* This device is contraindicated for any female who may be suspected of, or is pregnant.
Besides providing inaccurate readings, the effects of this device on the fetus are unknown.
* Too frequent and consecutive measurements could cause disturbances in blood circulation
and injuries.
* This unit is not suitable for continuous monitoring during medical emergencies or
operations.Otherwise, the patient’s arm and fingers will become anaesthetic, swollen and
even purple due to a lack of blood.
* When not in use, store the device with the adapter in a dry room and protect it against
extreme moisture, heat, lint, dust and direct sunlight. Never place any heavy objects on the
storage case.
* This device may be used only for the purpose described in this booklet. The manufacturer
cannot be held liable for damage caused by incorrect application.
*This device comprises sensitive components and must be treated with caution. Observe the
storage and operating conditions described in this booklet.
* The equipment is not AP/APG equipment and not suitable for use in the presence of a
flammable anesthetic mixture with air of with oxygen or nitrous oxide.
* Warning: No servicing/maintenance while the ME equipment is in use.
* The patient is an intended operator.
* The patient can measure data and change batteries under normal circumstances and
maintain the device and its accessories according to the user manual.
* To avoid measurement errors, please avoid the condition of strong electromagnetic field
radiated interference signal or electrical fast transient/burst signal.
* The blood pressure monitor, and the cuff are suitable for use within the patient
environment. If you are allergic to polyester, nylon or plastic, please don't use this device.
* During use, the patient will be in contact with the cuff. The materials of the cuff have been
tested and found to comply with requirements of ISO 10993-5:2009 and ISO
10993-10:2010. It will not cause any potential sensization or irritation reaction.
* If you experience discomfort during a measurement, such as pain in the arm or other
complaints, press the START/STOP button to release the air immediately from the cuff.
Loosen the cuff and remove it from your arm.
* If the cuff pressure reaches 40 kPa (300 mmHg), the unit will automatically deflate. Should
the cuff not deflate when pressures reaches 40 kPa (300 mmHg), detach the cuff from the
arm and press the START/STOP button to stop inflation.
* Before use, make sure the device functions safely and is in proper working condition.
Check the device, do not use the device if it is damaged in any way. The continuous use of
a damaged unit may cause injury, improper results, or serious danger.

7
6
INTRODUCTIONINTRODUCTION
LCD display signal
SYMBOL DESCRIPTION
Systolic blood pressure High blood pressure
Diastolic blood pressure Low blood pressure
EXPLANATION
Memory
mmHg
kPa
Measurement Unit of the blood pressure
Measurement Unit of the blood pressure
Low battery Batteries are low and need to be replaced
Current Time Year/Month/Day, Hour/Minute
Pulse in beats per minute
Pulse display
Deflation symbol The cuff is deflating.
Indicate it is in the memory mode and
which group of memory it is.
Blood pressure monitor is detecting an
irregular heartbeat during measurement.
Irregular heartbeat
Blood pressure
level indicator Indicate the blood pressure level
CAUTION
* Do not wash the cuff in a washing machine or dishwasher!
* The service life of the cuff may vary by the frequency of washing, skin condition, and
storage state. The typical service life is 10000 times.
* It is recommended that the performance should be checked every 2 years and after
maintenance and repair, by retesting at least the requirements in limits of the error of the
cuff pressure indication and air leakage (testing at least at 50mmHg and 200mmHg).
* Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT
according to the local guidelines.
* Manufacturer will make available on request circuit diagrams, component part lists,
descriptions, calibration instructions,etc., to assist to service personnel in parts repair.
* The plug/adapter plug pins insulates the device from the main supply. Do not position the
device in a position where it is difficult to disconnect from the supply mains to safely
terminate operation of ME equipment.
* The operator shall not touch output of batteries /adapter and the patient simultaneously.
* Cleaning :Dust environment may affect the performance of the unit. Please use the soft
cloth to clean the whole unit before and after use. Don’t use any abrasive or volatile
cleaners.
* The device doesn’t need to be calibrated within two years of reliable service.
* If you have any problems with this device, such as setting up, maintaining or using,
please contact the SERVICE PERSONNEL of Zewa. Don’t open or repair the device by
yourself in the event of malfunctions. The device must only be serviced, repaired and
opened by individuals at authorized sales/service centers.
* Please report to Zewa if any unexpected operation or events occur.
* Keep the unit out of reach of infants, young children or pets to avoid inhalation or
swallowing of small parts. It is dangerous or even fatal.
* Be careful to strangulation due to cables and hoses, particularly due to excessive length.
* At least 30 min required for ME equipment to warm from the minimum storage
temperature between uses until it is ready for intended use. At least 30 min required for
ME equipment to cool from the maximum storage temperature between uses until it is
ready for intended use.
* This equipment needs to be installed and put into service in accordance with the
information provided in the ACCOMPANYING DOCUMENTS;
* Wireless communications equipment such as wireless home network devices, mobile
phones, cordless telephones and their base stations, walkie-talkies can affect this
equipment and should be kept at least a distance d away from the equipment. The
distance d is calculated by the MANUFACTURER from the 80MHz to 5.8 GHz column of
Table 4 and Table 9 of IEC 60601-1-2:2014, as appropriate.
* Please use ACCESSORIES and detachable partes specified/ authorised by
MANUFACTURE. Otherwise, it may cause damage to the unit or danger to the
user/patients.
* There is no luer lock connectors are used in the construction of tubing, there is a
possibility that they might be inadvertently connected to intravascular fluid systems,
allowing air to be pumped into a blood vessel.
* Please use the device under the environment which was provided in the user manual.
Otherwise, the performance and lifetime of the device will be impacted and reduced.
Heartbeat Blood pressure monitor is detecting a
heartbeat during measurement.
User 1/ User 2 Start measurement for User 1/User 2

9
8
BEFORE YOU START
INTRODUCTION
List
1.Blood Pressure Monitor
(UAM-710)
2.Cuff (Type BF applied part)
( 22cm~42cm)
(Please use ZEWA
authorized cuff. The size
of the actual cuff please
refer to the label on the
attached cuff.)
In order to get the best effect and protect your monitor,please use the right
battery which complies with CE safety standard.
•Open the battery cover.
•Install the batteries by matching
the correct polarity, as shown.
•Replace the battery cover.
Installing and Replacing the Batteries
CAUTION
CAUTION
Replace the batteries whenever the below happen
The shows
The display is dim.
The display does not light up
AC adaptor
The Choice of Power Supply
1.Battery powered mode:
6VDC 4×AAA batteries.
2.AC adaptor powered mode (Not included):
6V 1A
(Please only use the recommended AC
adaptor model).
Please unplug the adaptor to depart from
the using utility power.
Do not use new and used batteries together.
Do not use different types of batteries together.
Do not dispose the batteries in fire. Batteries may explode or leak.
Remove batteries if the device is not likely to be used for some time.
Worn batteries are harmful to the environment. Do not dispose with daily garbage.
Remove the old batteries from the device following your local recycling guidelines.
Monitor Components
Component list of
pressure measuring system
1 Cuff
2 Air pipe
3 PCBA
4 Pump
5 Valve
BATTERY COMPARTMENT
CUFF
AIR HOSE
AIR CONNECTOR PLUG
LCD DISPLAY
MEM BUTTON
START/STOP BUTTON
SET BUTTON
DC POWER SOCKET
4.User manual
3. 4×AAA batteries

11
10
BEFORE YOU START
BEFORE YOU START
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 :2018—2058
time format:24H)
1.When the monitor is off,
hold pressing “SET”
for 3 seconds to enter
the mode for year
setting.
Or when the monitor is off,
press “SET” button shortly,
it will display the time. Then
hold pressing “SET” button
to enter the mode for year
setting.
2.Press the “MEM” to
change the [YEAR].
Each press will increase the
numeral by one in a cycling manner.
3.When you get the right
year, press “SET” to set
down and turn to next
step.Repeat steps 2 and
3 to set the [MONTH] and [DAY].
.Repeat steps 2 and 3 to set the [HOUR]
and [MINUTE].
7.After the unit is set,the LCD will display
“donE”first,then display all the settings you
have done and then it will turn off.
6.Repeat steps 2 and 3 to set the [UNIT].
5

13
12
Tie the Cuff
2~3cm
MEASUREMENT
1.
4.
Hold your arm with your palm facing up and tie the cuff
on your upper arm, then position the tube off-center toward
the inner side of arm in line with the little finger. Or position
the artery mark over 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.
This is your main artery.
The cuff should be snug but not too tight. You should be able to
insert one finger between the cuff and your arm.
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.
Roll or push up your sleeve to expose the skin.
Make sure your sleeve is not too tight.
2.
3.
Sit comfortably with your tested arm resting on
a flat surface. Place your elbow on a table
so that the cuff is at the same level as your heart.
Turn your palm upwards. Sit upright in a chair,
and take 5-6 deep breaths.
Rest for 5 minutes before first measuring.
Wait at least 3 minutes between measurements.
This allows your blood circulation to recover.
The patient must relax as much as possible 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.
5.
6.
Take the measurement in a silent room.
The cuff should maintain at the same level as the right atrium
of the heart.
Please sit comfortably. Do not cross your legs and
keep your feet flat on the ground.
Keep your back against the backrest of the chair.
Helpful tips for Patients, especially for Patients
with Hypertension:
START
STOP
START
STOP
STA RT
STO P
BEFORE YOU START
Select the User
1.When the monitor is off , press the SET button shortly
to enter user setting mode.
2.Then press SET button again, select the user ID user 1 , user 2 .
3. After selecting the suitable user ID, press “ ” button to
confirm. Then the LCD will turn off.

15
14
DATA MANAGEMENT
MEASUREMENT
1.When the monitor is off,
press the “START/STOP” to turn on
the monitor, and it will finish the whole
measurement .(Take User 1 for example)
Start the Measurement
2.Press the “START/STOP” to power
off, otherwise it will turn off
within 1 minute.
START
STOP
START
STOP
Recall the Records
1. When the monitor is off,
please press the “MEM” to
show the average value of
the latest three records.If
the records are less than
three groups,it will display
the latest record first.
2. Press the “MEM”
or “SET” to get the
record you want.
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 (60) is dropped
The current No. is No 2. The corresponding
time is 10:08.
The corresponding
date is January 1st.
CAUTION
The date and time
of the record
will be shown
alternately.
Adjust the zero.LCD display
Inflating and measuring. Display and save the
results.
UP
DOWN

17
16
Tips for Measurement
Measurements may be inaccurate if taken in the following
circumstances.
INFORMATION FOR USERDATA MANAGEMENT
Within 1 hour
after dinner or drinking
Within 20 minutes
after taking a bath
In a very cold environment
Immediate measurement
after tea, coffee, smoking
When talking or moving your fingers
When you want to discharge urine
To delete records, follow these steps.
Delete Records
When the monitor is in the
memory recall mode,
hold
pressing “MEM” and “SET”
at the same time for 3
seconds, the
flash display
will show.
2.Press “SET”and “ to
confirm deleting and
the monitor will turn
off.
3.If you don’t want to delete the
records, press “START/STOP”
to escape.
4. If there is no record,
the right display will
show.
START
STOP
1.

19
18
ABOUT BLOOD PRESSURE INFORMATION FOR USER
What are systolic pressure and diastolic pressure?
press
artery vein
blood discharging
Systolic
relax
blood entering
Diastolic
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.
Irregular Heartbeat Detector
CAUTION
The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heart-
beat 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 device does
not replace a cardiac examination, but serves to detect pulse irregularities at an early stage.
An irregular heartbeat is detected when a heartbeat rhythm varies while the unit is measuring
the systolic and diastolic blood pressure.During each measurement, the monitor records all the
pulse intervals and calculate the average ; if there are two or more pulse intervals ,the difference
between each interval and the average is more than the average value of ±25% , or there are four
or more pulse intervals ,the difference between each interval and the average is more than the
average value of ±15%,the irregular heartbeat symbol appears on the display when the
measurement results are appeared.
What is the standard blood pressure classification?
The chart on the right is the
standard blood pressure classifi-
cation published by American
Heart Association (AHA).
Please consult a physician if your measuring result falls outside the range.
Please note that only a physician can tell whether your blood pressure value
has reached a dangerous point.
CAUTION
Blood Pressure Category
Normal
Elevated
High Blood Pressure
(Hypertension) Stage 1
High Blood Pressure
(Hypertension) Stage 2
Hypertensive Crisis
(Consult your doctor immediately)
Systolic
mmHg (upper#)
Diastolic
mmHg (lower#)
less than 120
120-129
130-139
140 or higher
Higher than 180
and
or
or
and/or
less than 80
80-89
90 or higher
Higher than 120
This chart reflects blood pressure categories defined by American Heart Association.
and less than 80
Maintenance
In order to get the best performance, please follow the
instructions below.
Put in a dry place and avoid the sunshine
Avoid intense shaking
and collisions
Using wet cloths to remove dirt
Avoid touching water,
clean it with a dry cloth in case.
Avoid dusty and unstable
temperature environment
Do not attempt to clean the reusable cuff
with water and never immerse the cuff in
water.

20 21
TROUBLESHOOTINGABOUT BLOOD PRESSURE
Why does my blood pressure
fluctuate throughout the
day?
Is the result the same
if measuring on the
right arm?
Why do I get a different
blood pressure at home
compared to the hospital?
START
STOP
START
STOP
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.
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.
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.
It is ok for both arms, but there
will be some different results for
different people. We suggest you
measure the same arm every time.
This section includes a list of error messages and frequently
asked questions for problems you may encounter with your blood
pressure monitor. If the products not operating as you think it
should, check here before arranging for servicing.
PROBLEM SYMPTOM CHECK THIS REMEDY
No power
Low
batteries
Error
message
Display will not
light up.
Batteries are exhausted. Replace with new batteries
Insert the batteries
correctly
Replace with new batteries
Batteries are inserted
incorrectly.
Display is dim or
show Batteries are low.
E 1 shows
E 2 shows
The cuff is too tight or
too loose.
E 3 shows The measurement
process does not detect
the pulse signal.
Loosen the clothing on the
arm and then measure
again
EExx,shows on
the display.
A calibration 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
E 4 shows The treatment of the
measurement failed.
Relax for a moment and
then measure again.
AC adaptor is inserted
incorrectly.
Insert the AC adaptor
tightly
Readjust the cuff ,not too
loose or too tight and then
measure again.
The monitor detected
motion,talking or the
pluse is too poor
while measuring.
Relax for a
moment and then
measure again.
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.

22 23
AUTHORIZED COMPONENT
SPECIFICATIONS
Contact Information
For more information about our products, please visit www.zewa.com.you can get
customer service, usual problems and customer download, Zewa will serve you
anytime.
Manufactured for Zewa, Inc.
12960 Commerce Lakes Drive#29
Fort Myers, FL 33913 USA
www.zewa.com
Toll Free Customer Service:
1-888-993-3592
[email protected]
Authorized Component
1.please use the Zewa
authorized adapter. (Not included)
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
interference, and (2) this device must accept any interference received,
including interference that may cause undesired operation.
FCC Statement
Adapter
Type: BLJ06L060100P-U
Input：100~240V,50~60Hz,0.2A Max
Output：6V 1A
22
Battery powered mode:
6VDC 4*AAA batteries
AC adaptor powered mode: 6V 1A
(Not included)
(Please only use the recommended AC adaptor model).
Battery Powered Mode:
Internally Powered ME Equipment
Approx.174g(Excluding the dry cells)
Blue LCD with white backlight V.A.60mm×40.5mm
Approx.110mm×110mm×41mm
4xAAA batteries, user manual,warranty book
A01
About 22cm~42cm
Type BF applied part
WARNING: No modification of this equipment is allowed.
Power supply
Display mode
Measurement mode
Oscillographic testing mode
Measurement range
Measurement perimeter
of the upper arm
Net Weight
External dimensions
Attachment
Mode of operation Continuous operation
Degree of protection
Protection against
ingress of water
Accuracy
Normal working condition
Storage & transportation
condition
Software Version
Pressure:
5℃-40℃within±0.4kPa(3mmHg)
Pulse value:±5%
IP21 It means the device could protected
against solid foreign objects of 12.5mm and
greater, and protect against vertically falling
water drops.
Device Classification
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
Temperature:-20°C to +60°C
A relative humidity range of ≤ 93%, non-condensing,
at a water vapour pressure up to 50hPa
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

24 25
COMPLIED STANDARDS LIST
Complied Standards List
EN ISO 14971:2012 / ISO 14971:2007 Medical devices -
Application of risk management to medical devices
EN 1041:2008 Information supplied by the manufacturer of medical
devices
EN 60601-1:2006+A1:2013/ IEC 60601-1:2005+A1:2012 Medical
electrical equipment - Part 1: General requirements for basic safety
and essential performance
EN 60601-1-11:2015/ IEC 60601-1-11:2015 Medical electrical
equipment - Part 1-11: General requirements for basic safety and
essential performance - Collateral standard: Requirements for medical
electrical equipment and medical electrical systems used in the home
healthcare environment
EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical
equipment - Part 1-2: General requirements for basic safety and
essential performance - Collateral standard: Electromagnetic
disturbances - Requirements and tests
EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1:
Requirements and test methods for non-automated measurement type
EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers -
Part 3: Supplementary requirements for electro-mechanical blood
pressure measuring systems
EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test
procedures to determine the overall system accuracy of automated
non-invasive sphygmomanometers
EN 60601-1-6:2010+A1:2015/IEC 60601-1-6:2010+A1:2013
Medical electrical equipment - Part 1-6: General requirements for basic
safety and essential performance - Collateral standard: Usability
IEC 62366-1:2015 Medical devices - Part 1: Application of
usability engineering to medical devices
EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015 Medical
device software - Software life-cycle processes
Risk management
Labeling
User manual
General Requirements
for Safety
Electromagnetic
compatibility
Performance
requirements
Clinical investigation
Usability
Software life-cycle
processes
Bio-compatibility
ISO 10993-1:2009 Biological evaluation of medical devices- Part
1: Evaluation and testing within a risk management process
ISO 10993-5:2009 Biological evaluation of medical devices -
Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices -
Part 10: Tests for irritation and skin sensitization
EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices.
Symbols to be used with medical device labels, labelling and
information to be supplied. Part 1 : General requirements
IEC 80601-2-30:2009+A1:2013 Medical electrical equipment- Part
2-30: Particular requirements for the basic safety and essential
performance of automated non-invasive sphygmomanometers
ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2:
Clinical validation of automated measurement type
EMC Guidance
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.
Table 1
Guidance and manufacturer’sdeclaration – electromagnetic emissions
RF emissions
CISPR 11 Group 1
Class B
Class A
Complies
Compliance
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
RF emissions
CISPR 11
Emissions test Electromagnetic environment - guidance
The device is intended for use in the electromagnetic environment specified below. The customer or the
user of the device should assure that it is used in such an environment.
The device uses 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.
The device is suitable for use in all establishments,
other than domestic and those directly connected to
the public low-voltage power supply network that
supplies buildings used for domestic purposes.

EMC GUIDANCE
26 27
Guidance and manufacturer’s declaration – electromagnetic immunity
Immunity test
±8 kV contact
±15 kV air ±8 kV contact
±15 kV air
±2 kV
power supply lines:
line(s) to line(s): ±1 kV
line(s) to earth: ±2 kV
0%U T; 0.5 cycle
At 0°, 45°, 90°, 135°,
180°,225°,270° and 315°
0%U
T ; 1 cycle
and
70%U
T ; 25/30 cycles
Single phase: at 0°
0% U
T ; 300 cycle
30 A/m
50Hz/60Hz
NOTE U
T
is the a.c. mains voltage prior to application of the test level.
Table 2
Compliance level
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electromagnetic
environment - guidance
30 A/m
50Hz/60Hz
Power frequency
(50Hz/60Hz)
magnetic field
IEC 61000-4-8
Voltage dips,
short interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC61000-4-5
input/output lines:
±1 kV
The device is intended for use in the electromagnetic environment specified below. The customer or the
user of the device should assure that it is used in such an environment.
IEC 60601 test level
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30%.
±2 kV
power supply lines:
100 kHz repetition
frequency
line(s) to line(s): ±1 kV
100 kHz repetition
frequency
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment.
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
0% U
T ; 0.5 cycle
At 0°, 45°, 90°, 135°,
180°,225°,270° and
315°
0% U
T ; 1 cycle
and
70% U
T ; 25/30 cycles
Single phase: at 0°
0% U
T ;300 cycle
Table 3
Guidance and manufacturer’s declaration – electromagnetic immunity
Immunity test Compliance
level
IEC 60601
Test level
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
10V/m, 80% Am
at 1kHz
150 kHz to
80 MHz:
3 Vrms
6Vrms (in ISM
and amateur
radio bands)
80% Am at 1kHz
Electromagnetic environment - guidance
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
aField strengths from fixed transmitters, such as base stations for radio (cellular / cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the device is used exceeds the applicable RF compliance level
above, the device should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the device.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
b
The device is intended for use in the electromagnetic environment specified below. The customer or the
user of the device should assure that it is used in such an environment.
150 kHz to
80 MHz:
3 Vrms
6Vrms (in ISM
and amateur
radio bands)
80% Am at 1kHz
Portable and mobile RF communications
equipment should be used no closer to any part
of the device, including cables, than the
recommended separation distance calculated
from the equation appropriate for the frequency
of the transmitter.
Recommended separation distances:
d=0.35 ;
d=1.2
10V/m, 80% Am
at 1kHz
80 MHz to 800 MHz:
d=1.2
800 MHz to 2.7 GHz:
d=2.3
where, P is the maximum
output power rating of the
transmitter in watts (W)
according to the
transmitter manufacturer,
dis the recommended
separation distance in
meters (m). Field
strengths from fixed RF
transmitters, as
determined by an
electromagnetic site
survey, should be less
than the compliance level
in each frequency range.
Interference may occur in
the vicinity of equipment
marked with the following
symbol:
P
P
P
P
EMC GUIDANCE

EMC GUIDANCE
28 29
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7 GHz
Table 4
Recommended separation distances between portable and mobile RF communications
equipment and the device.
Rated maximum output
power of transmitter
(W)
Separation distance according to frequency of transmitter (m)
0.01
0.1
1
10
100
0.12 0.12
0.38
1.2
3.8
12
=d =d 1.2
0.37
1.2
3.8
12
3.5
The device is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the device can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment
(transmittters) and the device as recommended below, according to the maximum output power of the
communications equipment.
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
PP
0.23
0.73
2.3
7.3
23
2.3=d
P
EMC GUIDANCE
Table 5
Guidance and manufacturer’s declaration - electromagnetic immunity
Test
Frequency
(MHz)
385 0.3 27
The device is intended for use in the electromagnetic environment specified below. The customer or the
user of the device, should assure that it is used in such an environment.
NOTE 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.
Radiated RF
IEC61000-4-3
(Test
specifications
for
ENCLOSURE
PORT
IMMUNITY to
RF wireless
communicatio
ns equipment)
Band a)
(MHz)
Service a) Modulation b) Modulation b)
(W)
Distance (m)
IMMUNITY
TEST
LEVEL
(V/m)
380-390 TETRA
400
Pulse
modulation b)
18Hz
1.8
450 380-390
GMRS 460，
FRS 460
FM c) ± 5kHz
deviation 1kHz
sine
20.3 28
710 704-787
745
780
LTE Band
13,
17
Pulse
modulation b)
217Hz
0.2 0.3 9
810
870
930
800-960
GSM
800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulation b)
18Hz
20.3 28
1720
1845
1970
1700-
1990
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1,
3,
4,25; UMTS
Pulse
modulation b)
217Hz
20.3 28
20.3 28
2450 2400-
2570
Bluetooth,
WLAN,
802.11
b/g/n, RFID
2450, LTE
Band 7
Pulse
modulation b)
217 Hz
5240
5240
5785
5100-
5800
WLAN
802.11
a/n
Pulse
modulation b)
217 Hz
0.2 0.3 9
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, 50% pulse modulation at 18 Hz may be used because while it does
not represent actual modulation, it would be worst case.
The MANUFACTURER should consider reducing the minimum separation distance, based on RISK
MANAGEMENT, and using higher IMMUNITY TEST LEVELS that are appropriate for the reduced
minimum separation distance. Minimum separation distances for higher IMMUNITY TEST LEVELS shall be
calculated using the following equation:
E=
Where P is the maximum power in W, d is the minimum separation distance in m, and E is the IMMUNITY
TEST LEVEL in V/m.