Yuwell W10 User manual

1630207-0A
http://www.yuwell.com
Tell: +86-0511-86900833 User's Manual
W1 、W10S、W10T、W10F 0
Electronic Blood Pressure Monitor
Please read the user's manual closely before using!
SYS
mmHg
mmHg
DIA
P/min
m
Shanghai International Holding Corp.GmbH(Europe)
Eiffestrasse 80,20537 Hamburg Germany
Date of :2021.05issue
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO.,LTD.
Yunyang Industrial Park 212300 Danyang jiangsu
PEOPLE'S REPUBLIC OF CHINA

Using method
Measuring posture
Start Measuring
Soft pillow
Press the " " button to measure.
Do not speak or move while measuring.
Don't eat, smoke, drink, take bath or do any high impact sport
within half an hour before measuring.
Wear the monitor on the wrist as the following picture.
The suitable circumference for wrist is 13.5cm~19.5cm.
Contents
Cautions ……………………………………………………01
Important notes…………………………………………02
………………………………………………05
Parts ………………………………………………………06
Product charging …………………………………………08
……………………………………10
Voice and unit setting……………………………………11
Using method of cuff ……………………………………12
Measuring posture ………………………………………13
Start measuring …………………………………………15
Memory function…………………………………………19
Auxiliary function of measurement……………………21
Static mode ………………………………………………22
Common questions of blood Pressure measurement… 24
Common fault and trouble shooting……………………29
Features and technical parameters……………………31
Electromagnetic compatibility information……………33
Maintenance
Time and date setting
SYS
mmHg
mmHg
DIA
P/min
m
Sit still for 5 minutes.
Keep the monitor and heart
at the same level.
m

1. Range of application
Cautions Important notes
02
Pay attention with the symbols shown here to prevent harm or damage to the user.
If accidentally strayed the electrolyte of battery into eyes, skin or cloth, please
rinse with plenty of water.
The" "icon appearing means the battery is running out. Please replace both
the batteries.
Please take out the batteries if the monitor will not be used for
a long time (over three months).
Please do not mix new batteries with old batteries .
Please dispose batteries in accordance with the local environmental law.
If accidentally strayed the electrolyte of battery into eyes, skin or cloth, please
rinse with plenty of water.
The" "icon appearing means the battery is running out. Please replace both
the batteries.
Please take out the batteries if the monitor will not be used for
a long time (over three months).
Please do not mix new batteries with old batteries .
Please dispose batteries in accordance with the local environmental law.
If accidentally strayed the electrolyte of battery into eyes, skin or cloth, please
rinse with plenty of water.
The" "icon appearing means the battery is running out. Please replace both
the batteries.
Please take out the batteries if the monitor will not be used for
a long time (over three months).
Please do not mix new batteries with old batteries .
Please dispose batteries in accordance with the local environmental law.
2. Attention items
Sit still for 5 minutes before measuring to ensure quiet and stable mode.
Do not take the measurement while standing, walking or having body
pressed.
Do not take the measurement after smoking, drinking wine or coffee
(black tea).
Do not take the measurement after sport or bath.
Do not speak, move, shake arm or bend fingers while measuring.
Do not take the measurement at extreme temperature condition or the
varied severely environment.
The incorrect measurements of the equipment may be caused by
external interference, such as accelerating during transportation or
transportation.
01
This product is intended to measure the blood pressure and pulse rate of
adult whom more than 12 years old at household or medical center (not
suitable for neonate, pregnancy or pre-eclampsia.)
IP 22
Date of manufacture
Manufacturer
EC-Representative
Symbol for the marking of electrical and electronics
devices according to Directive 2002/96/EC
Temperature range
Humidity range
Atmospheric pressure range
Safety and environmental protection use period
for 10 years
IP Classification
CE marking and notify
body number
Class II Device
DC Current
AC Current
Follow instructions for use
Type BF application part
Note on important information
Attention
Serial Number
Statement:the device is a medical device.
Pay attention to the following points when measuring or it may cause
the incorrect results.
Indicates the item is a medical device

03
04
It will affect the measurement accuracy if the wrist circumference is out
of the given value.
Do not measure continuously. (2~3 minutes or more should be spared
between two measurements).
Do not use mobile phone near the monitor.
Do not keep the cuff in the aerated state for a long time.
The patient is an intended operator, this monitor is used for adult whom
more than 12 years old.
Do not swallowed small parts that may cause choking hazard.
The device must not be used with high frequency surgical equipments.
Do not use the CUFF over a wound arm or being on an intravenous drip.
Consult your doctor if using the device on the arm with an arteriovenous
(A-V) shunt.
Do not use the cuff on the arm where the side of a mastectomy or lymph
node clearance.
Note that It will lose function of other device on the same limb while
cuff inflating.
Do not allowed frequent measurements, the resulting restriction of the
blood flow may cause injury.
Please using soft dry cloth stained with 75% ethanol to clean the device
in the case of many people use it,but do not let the ethanol flow into the
monitor and cuff.
Please report serious incident that has occurred in relation to the device
to the manufacturer and the competent authority of the Member State.
Important notes
m
2. Adapter
1. There is no adapter in the accessories of this product, the user can
it using the complimentary USB cable.
2. If you need to buy the yuwell special adapter that matches this product,
please contact the local dealer for consultation.
charge
adapter
USB cable
Tips!
Please turn off the device and unplug the adapter before cleaning.
The AC adapter cable may cause accidental strangulation in infants.
Please pay attention to product storage to prevent damage caused by pets,
pests or children.
Operator can't touch the accessible part of adapter/main unit and patient
at the same time.
According to the local laws and regulations to deal with battery.
Don't interconnect this device to other equipment not described in the
user's manual.
Note: Do not diagnose with the measurement, Please follow doctor's
instruction.
Statement: If the monitor has not been stored in the required temperature
and humidity range, it may not conformance to specification.
Important notes
Please take attention that changes or modification not expressly approved
by the party responsible for compliance could void the user's authority to
operate the equipment.
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.
Tips!

Maintenance Parts
05 06
Please observe the following items to protect the device and ensure the
accuracy of measurement.
Please store the monitor and accessories properly after use.
Do not place the monitor and accessories in high temperature, moisture,
dust, or exposure to sunshine.
The cuff contains an airbag inside, please care in applications, do not fold,
pull or twist it.
Do not disassemble or repair the device without authorization or
Don't service or maintain while the device is in use.
Please clean the monitor with soft dry cloth. If it's necessary, please use
wiped soft cloth with water or neutral detergent before cleaning by soft
dry cloth.
Using absorbent cotton to wipe gently with rubbing alcohol, disinfection
of the machine when it necessary. Do not use detergent to clean.
Do not let water seep into the device.
Manufacture will make available on request circuit diagrams, component
part lists, descriptions, calibration instructions, or other information that
will assist service person to repair those parts of ME EQUIPMENT that are
designated by the manufacture as repairable by service person.
Degraded sensors and electrodes, or loosened electrodes can degrade
performance.
We advice to calibrate the monitor according to local laws and regulations
(at least once a year) .
modify
the device without authorization.
Tips!
1. Main part
Memory button
Display Start/Stop button
Cuff
m
SYS
mmHg
mmHg
DIA
P/min
2. AC adapter and USB cable
AC adapter
(optional)
USB cable
(optional)
Bluetooth icons is only
applicable to the model
with bluetooth function.
AC adapter
INPUT: 100-240V~
50/60Hz 0.35A MAX
OUTPUT: 5V 1000mA
MFR: WEIHAI HITAI ELECTRONICS Co.,LTD.
US Model: HT-C38B-0510WW
EU Model: HT-C38B-0510EW

Us er's manual、Warranty card
07 08
Parts
4. Accessories
Product charging
This product is powered by lithium battery. Please make sure the battery
is sufficient when using the product.
Power-on
1. Connect the power source for charging as shown below.
3. Display
SYS(systolic)
DIA(diastolic)
Time and date
kPa/mmHg unit
Pulse rate
Cuff Wrapping Detection
Movement Error Indication
Records number
Heartbeat
IHB Prompt
Inflation/Deflation
Indication of measuring
position
2. The icon stops flashing
when the battery is fully charged.
3. Please unplug the power adapter from the socket after charging.
" " icon flashs during charging, and the " "
The showing 25% or less mean the battery is
and needs to be charged.
The " " icon appearing and showing 5% or less mean the battery is
running out. Please charge before using.
" " icon appearing and low
Note: Do not measure blood pressure when charging , so as not to cause
abnormal measurement.
1. There is no adapter in the accessories of this product, the user can
it using the complimentary USB cable.
2. Please use the yuwell special adapter matching with this product to
charge, you can contact the local dealer for consultation about the relevant
information.
charge
Tips!
Please use only the authorized yuwell AC Adapter (output DC 5V 1A) to
charge, and you can contact the local dealer for consultation about the
relevant information.
Tips!
bluetooth icon
Bluetooth icons is only
applicable to the model
with bluetooth function.
Note: Please charge the device in a position where it is easy to disconnect
from supply mains.

09 10
Year character blink Month character blink Date character
Hour character blink Minute character blink
H M
H M
M D
M D
Y
Time and date setting
1. Year setting: Press the " m" button and " " button for more than 3
seconds till the number starts flashing.
2. Press the " m " button to advance by increments of one year.
3. Press the " " button to switch to the month setting.
4. Using the same way for other settings.
The monitor will store the measuring results automatically by the management system.
It is necessary to reset time and date after installing new batteries. Please
operate as following steps. (For example: setting the date as 2020-8-11 and
and time as 08:18)
Time and date setting
Product charging
Do not place equipment with lithium batteries near the fire source.
Do not remove and replace the battery or squeeze the battery with
hard objects.
Please charge the device in time when the battery is low.
In order to extend the service life of lithium battery, it is recommended
to maintain more than half of the power.
When the equipment is not used for a long time (more than 6 months),
it is easy to cause the passivation of the electrode material and lead to
the decline of the battery performance. It is recommended to make it
frequently.
Please dispose of waste batteries in accordance with local
environmental protection regulations.
Tips!

11 12
Voice and unit setting
Auxiliary function of measurement
After unit setting, press the " " button to shut down.
Attention:
In the condition of kPa unit, there is no voice prompt for measurement
result.
After finishing the time and date setting, pressing the " " button to enter
the voice volume setting. The size of the sound ranges from 01 to 04 and
OFF. Press the " " to choose the sound which you need.
After finishing the voice volume setting, pressing the " " button to enter
the measuring unit setting. Press the " " button to choose unit between
mmHg and kPa. Press" " to finish setting.
M-D M-D
Using method of cuff
3. Please stick the cuff firmly, or it may get loose while measurement and
affect the measurement results.
4. Wind the spare part of cuff properly.
Both wrists can be measured.
About 1~1.5cm
13.5-19.5cm
Tips!
1.
2. The distance between palm and the end of monitor should be about
1.0cm~1.5cm.
Please wear the cuff on bare wrist not too loose or too tight, do not leave
cloth inside of the cuff.
SYS
mmHg
mmHg
DIA
P/min
m
Voice volume setting
Unit setting
This section applies only to models with voice function.
Tips!

13 14
Measuring posture
Figure 1
Soft pillow
1. Sit straightly and keep relax. (as Figure 1)
Do not bend down or body bend forward.
2. Take 3~4 deeply breath then relax shoulder and arm before measurement.
3. Keep the monitor and heart at the same level. Do not talk, move,
shake hand or bend fingers while measurement.
We suggest supporting the arm with a soft pillow.
Measuring posture
Wrong measurement postures
1. Do not clench fists, or may cause higher blood pressure.
2. Do not hold the cuff with another hand.
3. Do not hold the arm hard while measurement. If it is necessary please
support the arm with a soft pillow.
Figure 2
The correct wrist posture(as Figure 2)
NOTE: Relax fingers and keep a natural extension of state.
About 1~1.5cm
13.5-19.5cm
SYS
mmHg
mmHg
DIA
P/min
m
SYS
mmHg
mmHg
DIA
P/min
m
This icon means that the
monitor is higher than
heart level.
This icon means that
monitor and heart is
at the same level.
This icon means that
the monitor is lower
than heart level.
The correct posture for measuring blood pressure:
1) comfortably seated,
2) legs uncrossed,
3) feet flat on the floor,
4) back and arm supported, and
5) middle of the CUFF at the level of the right
atrium of the heart;

15 16
Start measuring Start measuring
1. Do not move and keep quiet until measurement finished.
2. Keep the monitor and heart at the same level.
3. Restart if the cuff got loose while measurement.
4. Press the " " button to stop measurement. If it does not work,
please take off the cuff.
Warning: Upper limit pressure of air inflation is 300mmHg/40.0kPa.
Don't keep the inflated state for a long time to avoid damage.
5. The time interval between two measurements should be at least 2~3
minutes or longer.
SYS
mmHg
mmHg
DIA
P/min
m
Sit still for 5 minutes before the measurement
Full screen display state
1. Measurement
All icons on screen appear for 1 sec after pressing the " " button, then
disappear. After that the deflation " " icon flickers which means the
system is in zero testing. Several seconds later the inflation icon" "flashes
which means the zero testing is finished. Then inflation starts.
The zeroing state The inflation state
Cuff detection icon
Increase with the pressure
The monitor starts measuring automatically after pressing " " button,
and the icon" " starts to flicker, Pressure rises gradually.

17 18
Start measuringStart measuring
Please maintain the position during the measurement and don't speak or
move body or hand.
The measuring state
2. Measurement finished
After measurement, the monitor will show the SYS, DIA and pulse rate,
then daflate the air automatically.
mmHg display kPa display
Press the" "button to shut down. Then it will power off automatically in
3 minutes without any operation.
3. Take off the cuff
4. Shut down
Please contact with doctor for advice if the SYS is higher than 139mmHg
or DIA is higher than 89mmHg.
Also the blood pressure range indicator can show the blood pressure
intuitively.
Higher than 139mmHg
Higher than 89mmHg
SYS
mmHg
mmHg
DIA
P/min
m
Please measure again or consult your doctor if unexpected readings are
obtained.
Tips!

19 20
Memory function Memory function
1. Press the " " button for the records.
A. Press the " " button to show the average value of the latest 3 times
measurement.
B. Repress the " " button to display the 1st group of memory, the serial
number is displayed as "1" to "74". "1" is the latest group and the "74" is the
earliest one.
SYS
mmHg
mmHg
DIA
P/min
m
SYS
mmHg
mmHg
DIA
P/min
mm
SYS
mmHg
mmHg
DIA
P/min
M D M D
The 74th data may be replaced by the 73rd when the memory
capacity is full.
Tips!
Press the both " " button and " m " button in memory display until the
d isplay shown as the following picture, which means the recorded values
will be cleared.
C. Read the recorded data by pressing the" m " button as the sequence:
"1", "2" ......"74"(max). Then return to the 1st.
D. Holding the " m " button to search the data quickly.
2. Delete the recorded data
SYS
mmHg
mmHg
DIA
P/min
m
Note: This operation will delete all the recorded values.

21 22
Auxiliary measuring function
Cuff detection
If the cuff winded properly, it will show the '' '' icon. Otherwise it will
show the '' '' icon, then press the '' '' button to stop and wind
properly to measure again.
It will show the '' '' icon, if body moves when measuring. Please measure
again or it will show inaccurate results.
Wrong operation indication
When the sphygmomanometer is in the correct position, it shows the " "
icon. When the sphygmomanometer is higher than the heart, it displays the
" " icon, please lower the sphygmomanometer height at this time. When
the sphygmomanometer is lower than the heart, it shows " " icon, Please
raise the sphygmomanometer at this time.
Prompt for correct measurement of position
Static mode
This function is mainly for professional personnel to enter the static mode
to test the monitor through standard pressure gauge.
Warning: normal users don't need to know this function and also do not
operate. The company will not take any responsibility for damage
caused by this operation.
Note: It must restore the system before entering the static mode,
otherwise it may cause inaccurate results.
1. System restores
Press the '' '' button, the screen will show the '' '' icon, which means
the system is in restore testing. Several seconds later, the '' '' icon
indicates the test ended. Then press the '' '' button to stop inflating
and take out the batteries to enter the next step.
disappears and the air pump starts inflating at the same time, which
If irregular pulse signal is detected during a measurement, it will flash the
'' '' icon. If it continues to appear during several measurements, we
recommend you to consult with and follow the directions of your physician.
Indication for irregular heartbeats

23 24
2. Entering the static mode
Press the '' '' button and hold, meanwhile
m
p oke the side reset key with the tool. Hold
on the '' m '' for about 3 seconds then release
button. Then screen will show the pressure
the syste m has restored and entered the static
mode. Now can take the static test.
After entering the static mode, if the screen still doesn't show '' '',
please operate again as the system restore. Please contact with the
local distributor if it still does not work.
The monitor will automatically power off if there is no operation in
4 minutes.
value '' '' , the date and time, mmHg. Now
Tips!
H M
Static mode Common questions of blood Pressure measurement
About the blood pressure on wrist and upper-arm
D iabetes, high blood lipids, hypertension will accelerate atherosclerosis and
cause nerve ending dysaemia.
The blood pressure on wrist and upper-arm
may
have a significant difference on these patients. Even if in unsuitable
conditions, healthy persons may cause about 20 mmHg( 2.6kPa) difference.
So suggest do not diagnose by oneself, please consult the doctor. Normally,
we
the blood pressure on wrist and upper-arm are same. But circulatory system
disorders may have a significant difference. Please manage your blood
pressure with experts. Healthy persons have a 20 mmHg(2.6kPa) difference
between blood pressure on wrist and upper-arm.
About measuring posture
If wrist and heart are not at a same level, the blood pressure will change as
a result of the weight of blood. When the wrist is higher than the heart, the
value measured will be lower, and vice-versa. Every 10cm about 8mmHg(1kPa)
difference. Of course the value is more closely related to the measuring
posture.

25 26
1. What is blood pressure?
Blood pressure is the force exerted by blood against the walls of the arteries.
Systolic pressure occurs when the heart contracts. Diastolic pressure occurs
when the heart expands. Blood pressure is measured in millimetres of
mercury (mmHg). One's natural blood pressure is represented by the
fundamental morning while one pressure, which is measured first thing in the
is still at rest and before eating.
2. What is Hypertension and how is it controlled?
Hypertension, an abnormally high arterial blood pressure, if left unattended can
cause many health problems including stroke and heart attack. Hypertension
can be controlled by altering lifestyle, avoiding stress, and with medication
under a doctor's supervision. To prevent Hypertension or keep it under control:
Do not smoke, exercise regularly, reduce salt and fat intake, have regular
3. Why measure Blood Pressure at home?
Blood pressure measured at a clinic or doctor's office may cause apprehension
and e an elevated reading, 25~30 mmHg higher than that measured can produc
at home. Home measurement reduces the effects of outside influences on
blood pressure readings, supplements the doctor's readings and provides a
more accurate, complete blood pressure history.
4. WHO Blood Pressure Classification?
Standards to assess high blood pressure, without regard to age, have been
established by the world Health Organization (WHO), as shown below:
kPa/mmHg kPa/mmHg
12.0~18.5kPa
90~139mmHg
18.7~21.2kPa
140~159mmHf
12.0~13.2kPa
90~99mmHg
21.3~23.9kPa
160~179mmHg
13.3~14.5kPa
100~109mmHg
≥24.0kPa
≥180mmHg
≥14.7kPa
≥110mmHg
8.0~11.9kPa
60~89mmHg
Common questions of blood Pressure measurement Common questions of blood Pressure measurement
physical checkups, maintain proper weight.

27 28
5. Blood pressure variations?
An individual's blood pressure varies greatly on a daily and seasonal basis.
It may vary by 30 to 50 mmHg due to various conditions during the day. In
hypertensive individuals variations are even more pronounced. Normally, the
blood pressure rises while at work or play and falls to its lowest levels during
sleep. So do not be overly concerned by the results of one measurement.
Take measurements at the same time every day using the procedure described
in this manual to get to know your normal blood pressure. Regular readings
give a more comprehensive blood pressure history. Be sure to note date and
time when recording your blood pressure. Consult doctor to interpret the blood
pressure data.
6. When is the best time to measure blood pressure?
After urination, before breakfast in the morning.
Before sleeping at night.
Before taking medicine.
Please keep a stable body state and mind every time measuring.
We suggest taking measurements at a same time every day.
Note: There is no definition about hypopiesia, and generally SYS
(systolic pressure) less than 90mmHg or DIA (diastolic pressure) less than
60mmHg is called hypotension.
Common questions of blood Pressure measurement Common questions of blood Pressure measurement

29 30
Common fault and trouble shooting Common fault and trouble shooting
Common fault Solutions
It doesn't work after pressing the
'' '' button.
Multiple occurrences of measuring
failure, or measured value is
low (or high)
Please try again after charging
Check the connection and winding of cuff
Check if the cuff winded too tight or too
loose. Take off your clothes if rolled too tight
Please ensure a quiet, relaxed body state o.
Deep breathing to relax yourself before
measurement
Please read the "blood pressure variations"
carefully
Write down the value every day,
and consult a doctor
Check whether the cuff has connected well
The monitor is in good condition,
but the each measuring result are
different
The value is different from that
measured at a clinic or doctor's office
Pump works, but the pressure
doesn't rise
Wrong
indication
Err 4
Err 5
Err 6
Err 7
The table below shows the possible fault displaying icon, possible reason,
and solutions.
Unable to measure pressure
Pressurizing error
Pressurizing error caused by arm or
body motion
Cuff is too loose or fall off
Battery is low
Fasten cuff correctly
before measurement
Check if there is air
leakage from the cuff
Keep arm and body still
and measure again
Fasten cuff tightly
Err 8 Pressure exceeds the maximum
value (300mmHg) Measure again please
Connect the power adapter for
charging
Fault cause Solution
Err 3 The pressure value did not reach
5mmHg within 4s
Please check the for tightness
or leakage
cuff
Showing low
voltage icon
" "
Showing low
voltage icon
" "
Battery is running out Connect the power adapter for
charging
Warning: If the situations cannot be solved or unexpected problem
happens, please consult the local distributor.

31 32
Features and technical parametersFeatures and technical parameters
1. Features
Small delicate design
74 groups of memory
Average value display of three times measurement
kPa & mmHg units display
Automatically shut down in 3 minutes after measurement.
2. Technical parameters
Displaying: LCD digital display
Measuring method: oscillation mensuration
Measuring range
0~300mmHg
Cuff Pressure: 0-450mmHg
Pulse rate: 40~200 beats/min
Precision
Pressure: within ±3mmHg(±0.4kPa)
Pulse rate: within 5% of reading value
Working system: continuous operation
IP Classification: IP22
Electric classification: Class II, type BF application part
Service life: 5 years or 50 thousand times
Power supply
battery:DC 3.7V
AC adapter:input 100-240V~ 50/60Hz 0.35A MAX
output 5V 1000mA
Maximum battery life: the battery can be used about 250 times on a full charge
Pressure:
Diastolic: 40-210mmHg
Systolic: 60-260mmHg
Suitable wrist circumference: 13.5-19.5cm
Dimensions:Approx.L89 mm x W62 mm x H21 mm
Wight: about 109g
4. Operation and storage conditions:
Operating temperature/humidity: +5℃~+40℃/15%~90%RH(no-condensation)
Storage temperature/humidity: -20℃~ +55℃/15%~90%RH(no-condensation)
Operating and storage atmospheric pressure: 70kPa ~ 106kPa
Operation environment:
Avoid electromagnetic interference, violent shock and noise environment.
The contact materials detail of product
Part
Rear Cover ABS
ABS
Magic paster
cloth
PC
Dacron
Panel
The SPHYGMOMANOMETER was clinically investigated according to the
requirement of ISO 81060-2.
The SPHYGMOMANOMETER complies with IEC 80601-2-30.
Statement!
Nylon
Top Cover
Cuff
Material
against ingress of solid foreign objects: ≥12.5mm diamater
against ingress of water with harmful effects: dripping (15°tilted)

33 34
Electromagnetic compatibility information
There is the potentia risk of radio frequency interference between the device
and other devices. If there is, please find out the problems and take the
following measures:
(1) Turn off the device, and turn on again,
(2) Change the direction of the device,
(3) Keep the produc t away from the interferential devices.
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 SPHYGMOMANOMETER, including cables
specified by the manufacturer. Otherwise, degradation of the
performance of this equipment could result.
This equipment might not offer adequate protection to radio-frequency
communication services. The user might need to take mitigation
measures, such as relocating or re-orienting the equipment.
When the instrument is in use,never put it near other instruments or
stack it on other instrument. if you have to put it near other instruments
or instruments, please inspect and verify if the instrument could run
normally.
Electromagnetic compatibility information
Guidance and manufacture s declaration- electromagnetic emission'
Emission test Compliance
Class B
RF emissions
CISPR 11
Class A
Complies
Harmonic
emissions
IEC 61000-3-2
Voltage
fluctuations/
flicker emissions
IEC 61000-3-3
RF emissions
CISPR 11 Group1
The W10/W10S/W10T/W10F is intended for use in the
electromagnetic environment specified below. The customer or the user of
W10/W10S/W10T/W10F should assure that it is used
in such an environment.
Electronic Blood Pressure Monitor
Electronic Blood Pressure Monitor
Table 1 For all ME EQUIPMENT and ME SYSTEMS
Essential performance:
Limits of the error of the manometer, and Reproducibility of the BLOOD
PRESSURE DETERMINATION.
a) no component failures.
b) no changes in settings.
c) do not reset to default settings.
d) change in the reading for the measurement of the CUFF pressure at any
point of the NOMINAL measurement range no more than 2 mmHg (0,3 kPa):
1) during and after exposure to non-transient phenomena; and
2) after exposure to transient phenomena.
e) The maximum error of repeated BLOOD PRESSURE DETERMINATION is
±3mmHg.

35 36
Electromagnetic compatibility information Electromagnetic compatibility information
Table 2
Immunity
test
IEC 60601
test level Compliance level
30A/m
50Hz or 60Hz 3A/m
50Hz or 60Hz
Guidance and manufacturere' s declaration-electromagnetic immunity
Electrostatic
discharge(ESD)
IEC 61000-4-2
Power
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
±8 kV
contact
±15
kV air
±8 kV
contact
±15
kV air
Guidance and manufacture s declaration-electromagnetic emission'
Immunity test IEC 60601
test level Compliance level
Electrostatic
discharge
(ESD) IEC
61000-4-2
Electrical
fasttransient
/burst IEC
61000-4-4
±2 kV
100kHz repetition
frequency
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
±2 kV
100kHz repetition
frequency
Surge IEC
61000-4-5
±1 kV line(s)to line(s)
±2 kV line(s)to earth ±1 kV line(s)to line(s)
0% U ; 0.5 cycle
T
o o o o o o
At 0 , 45 , 90 , 135 , 180 , 225 ,
o o
270 and 315
Voltage dips
IEC 61000-4-11
NOTE: UT is the a.c. mains voltage prior to application of the test level.
30A/m
50Hz or 60Hz
Power frequency
(50/60 Hz)
magnetic
field IEC
61000-4-8
0% U ; 0.5 cycle
T
o o o o o o
At 0 , 45 , 90 , 135 , 180 , 225 ,
o o
270 and 315
30A/m
50Hz or 60Hz
The is intended for use in the
electromagnetic environment specified below. The customer or the user of the
should assure that it is used in
such an environment.
W10/W10S/W10T/W10F
W10/W10S/W10T/W10F
Electronic Blood Pressure Monitor
Electronic Blood Pressure Monitor
For all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacture s declaration-electromagnetic immunity'
Immunity test IEC 60601 test level Compliance level
3 Vrms
0,15 MHz-80 MHz
6 V rms in ISM and amateur
radio bands between
0,15 MHz and 80 MHz
80 % Am at 1 kHz
Conducted RF
IEC 61000-4-6
NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE2 These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.
a Field 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 is used exceeds the applicable RF W10/W10S/W10T/W10F
compliance level above, the should be observed to verify normal operation. W10/W10S/W10T/W10F
If abnormal performance is observed,additional measures may be necessary, such as reorienting
or relocating the .W10/W10S/W10T/W10F
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to
2.7 GHz
3 Vrms
0,15 MHz-80 MHz
6 V rms in ISM and amateur
radio bands between
0,15 MHz and 80 MHz
80 % Am at 1 kHz
10 V/m
80 MHz to
2.7 GHz
The is intended for use in the
electromagnetic environment specified below. The customer or the user of the
W10/W10S/W10T/W10F should assure that it is used in
such an environment.
W10/W10S/W10T/W10F Electronic Blood Pressure Monitor
Electronic Blood Pressure Monitor
Table 3 For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
0% U ; 1 cycle and 70% U ;
T T o
25/30 cycles Single phase: at 0
0% U ; 250/300 cycles
T
Voltage interruptions
IEC 61000-4-11
0% UT; 1 cycle and 70% UT;
o
25/30 cycles Single phase: at 0
0% U ; 250/300 cycles
T
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