Yuwell YE680B Blood Pressure Monitor Medical Grade

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User Manual

This is the main product document for model YE680B.

The file format is pdf, 24 pages, you can download this manual here .

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User's Manual
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO.,LTD.
Sales Center Address: Huanyuan East Road No.1,Xuzhuang
Software Park, Nanjing, Jiangsu Province, P.R. China, 210000
Manufacturing Address: YunYang Industrial Park
DanYang, Jiangsu Province, P.R. China, 212300
http://www.yuwell.com
Please read the user's manual closely before using!
YE680B
Electronic Blood Pressure Monitor
1530173-0A
Shanghai International Holding Corp.GmbH(Europe)
Eiffestrasse 80,20537 Hamburg Germany
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Before using
Product features....................................................
Operation guide......................................................
Parts..........................................................................
Important notes......................................................
Maintenance............................................................
Battery installation................................................
Time and date setting...........................................
Voice/Unit setting..................................................
Measuring method
Using method of cuff............................................
Measuring posture.................................................
Start measuring......................................................
Blood pressure range indicator...........................
Memory function....................................................
Auxiliary measuring function..............................
Static mode.............................................................
Common problems
Common questions of blood ..Pressure measurement...... ..
Common fault and trouble shooting..................
Technical parameters............................................
Health diary.............................................................
Electromagnetic compatibility information..........
01
Contents
Product Features
01
02
05
08
13
14
15
17
18
20
21
25
26
29
30
32
36
38
40
44
Body Movement
Detection
IHB (Irregular
Heartbeat)
Prompt
Cuff
Detection
Wrapping
OK
Voice broadcast
function
Data storage
Backlit display
M
D
A
M
P
M
m
M
E
MB
ER
A/B
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0302
Operation guide
This device uses the oscillometric method of
blood pressure measurement。
Please follow the steps as shown below
Or install four AA batteries
Connect the power source
(Please turn to page 14 for details)
Open the
battery cover
Install the batteries
properly
Close the
battery cover
Power-on
Operation guide
1. Using method of cuff
Wearing the cuff and make the lower edge
2~3cm above the elbow, keep the air tube
inside of the arm.
(Please turn to page 19 for details)
2-3cm
Measurement
2 Measuring posture
Sit straightly, keep the center of cuff and heart
at the same level.
(
.
Please turn to page 20 for details)
3 Start measuring
Sit still for 5 minutes and then Press the
" " Button to measure.
.
(Please turn to page 21 for details)
1.5V
LR6(
AA
)
1
.5V
LR6(
AA
)
1.
5V
LR6
(AA)
1
.
5V
LR6
(AA)
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0504
Check the records
Operation guide
Parts
ME
M
B
ER
m
S
YS
m
m
H
g
D
I
A
m
mH
g
P/m
i
n
A/
B
Plug port
Press the button of " " check the measuring
records.
This monitor can display the average
measurement and store 99 records.
(Please turn to page 24 for details)
1. Main part
Display
Member
button
Memory
button
Start/Pulse
button
m
MEMBER
SYS
mmHg
DIA
mmHg
P/min
M
D
AM
PM
A/B
Power adapter
socket
Battery cover
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0706
2. Cuff:
Parts
Parts
The suitable upper-arm circumference:
22cm~45cm
22~45cm
Air plug
Rubber air
tube
Cuff
2~3cm
3. Adapter
AC adapter
INPUT:100~240Vac,50/60Hz,0.15A
OUTPUT:6Vdc 600mA
MFR:JIANGSU CHENYANG ELECTRON CO LTD
US Model:CYSM06-060060-UL-C
EU Model:CYSM06-060060-CE-C
4. User's manual,Warranty card,
4xAA batteries
SYS(systolic)
Pulse rate
Low voltage
Blood pressure
level display
Cuff
Detection
Wrapping
Deflation/Inflation
Time and date
Movement
Indication
Error
Memory
Records
number
HeartbeatIHB Prompt,
Pressure unit
DIA(diastolic)
Member
M
D
AM
PM
Display
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0908
Pay attention with the symbols shown here to
prevent harm or damage to the user.
Important notes
signs and symbols
Caution
Note on important information
Type BF application part
Follow instructions for use
Temperature range
Humidity range
Manufacture
Date of manufacture
EC-Representative
Atmospheric pressure range
Symbol for the marking of electrical and electronics
devices according to Directive 2002/96/EC
Safety and environmental protection use period
for 10 years
Important notes
IP Classification
IP 21
Class II Device
DC Current
AC Current
1. Range of application
2. Warning
This product is intended to measure the blood
pressure and pulse rate of adult at household or
medical center(not suitable for neonate,
pregnancy or pre-eclampsia.
Pay attention to the following points when
measuring or it may cause the incorrect
results.Sit still for 5 minutes before measuring
to ensure quiet and stable mode.
Do not take the measurement within 1 hour of
eating ,smoking, drinking wine or coffee (black tea).
Do not measure while standing, walking or
having body pressed.
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.
Do not take the measurement in a moving
vehicle.
Shelf Life
Shelf Life (Limited by Battery): 1 Year.
The shelf life of the device depend on the life
expectance of AA battery, the AA battery could
be replaced by user at home.
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Important notes Important notes
1110
Do not measure continuously. (5 minutes or
more should be spared between two
measurements).
Please reinstall the batteries and start again if
cannot measure.
For patient of arrhythmia, measuring results
may not be accurate.
Do not keep the cuff in the inflated state for a
long time.
The patient is an intended operator,this
monitor is used for adult whom more than 12
years old.
The AC adapter cable may cause accidental
strangulation in infants.
Do not swallowed small parts that may cause
choking hazard.
The device must not be used with high
frequency surgical equipments.
It will affect the measurement accuracy if the
arm circumference is out of the given value.
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 arterio-venous (A-V) shunt.
Do not use the cuff on the arm where the side
of a mastectomy.
Note that It will lose function on the same limb
while cuff inflating.
Do not allowed frequent measurements the
resulting restriction of the blood flow may
cause injury.
Avoid compression or bending of the cuff
connection tubing while using the device.
Please use the alkaline battery,do not use the
rechargeable battery.
According to the local laws and regulations to
deal with device and battery.
The patient operator could not touch the
battery and DC socket. Or the operator could
not touch the patient and the battery and DC
socket at the same time.
The different type battery might result in
measurement error. Please follow the battery
requirement of manufacturer.
To report unexpected operation or events.
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1312
Important notes Maintenance
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 modify the device without authorization.
Do not replace the parts without authorization.
Please clean the monitor with soft dry cloth. If
it's necessary, please use wiped soft cloth with
water or 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.
75% alcohol
Please observe the following items to protect
the device and ensure the accuracy of
measurement.
We suggest to calibrate the monitor (at least
once a year) according to local laws and
regulations. Please contact the manufacturer
or agent if need.
Tips!
Please disconnect the plug of adapter with
mains when you need to safely terminate
operation of ME EQUIPMENT.
When it is dirty in single patient daily use,
clean the monitor with soft dry cloth. If it is
necessary, please use wiped soft cloth with
water before cleaning by soft cloth. Then clean
the device with 75% alcohol.
When multiple patients use between uses on
different patients, cleaning with 75% alcohol
must be conducted after each use.
Do not let the alcohol flow into the monitor
and arm cuff.
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.
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The" "icon displayed means the battery is low.
The" "icon twinkled means the battery is
running out. Please replace all the batteries.
Please take out the batteries if the monitor
will not be used for a long time (over three
months).
Note: 6V/600mA DC external power can be
connected to the monitor. (Please use the
power adapter supplied by us.)
Please take out the batteries if use the DC
external power for a long time(more than one
month).
Time and date setting
1514
Battery installation
Open the
battery cover
Install the batteries
properly
Close the
battery cover
1. Year setting: Press the " " button and
“ ”for more than 3 seconds till the number
starts flashing.
2. The year increase once press the " "
button.
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 or connecting to DC
power. Please operate as following steps. (For
example: setting the date as 2018-1-15 and
time as 08:28)
1.5V
LR6
(AA)
1
.5V
LR6(
AA)
1
.5V
LR6(
A
A)
1
.5V
LR6
(
AA
)
Open the battery cover and install four AA
batteries properly. Then close the cover with a
click sound.
Aligning the +ve and poles of each battery
with the +ve and -ve signs imprinted on the
battery housing of the device.
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16 17
Time and date setting
Voice/Unit setting
Year character blink Month character blink
Date character Hour character blink
Minute character blink
M
D
M
D
the " " button to enter the mmHg/kPa
unit setting. Press the " " button to
switch between these two pressure units.
Finish by pressing the " " button.
After finishing the volume setting, pressing
After unit setting, press the " "button
to shut down.
Pressing the " " button to enter the voice
setting. The size of the sound ranges from 01
to 05 and OFF. Press " "choose the volume.
Attention:
In the condition of kPa unit, measurement
without voice prompt.
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Using method of cuff
Tips!
Either of arms can be measured.
Cuff connecting
Connect the air connector of the cuff to the
socket which on the left side of the monitor.
18 19
Using method of cuff
Sit straight and flat
the arm on table with
palm up, also keep
the center of cuff and
heart at the same
level. Also please
ensure the air tube
not twisted.
Using method of cuff
Wind the cuff around the upper arm. ( as shown
Stick the cuff tightly.
Note: The cuff
should be wearing
comfortably, avoiding
too tight or loose.
In the picture) Keep
the lower edge of the
cuff at the position
above 2-3cm to the
elbow joint and keep
the air inlet which
insert to the cuff at
the inner side of arm.
2~3
m
c
ME
MB
ER
m
S
Y
S
m
m
Hg
D
I
A
mmH
g
P
/
m
in
A/
B
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Measuring posture
Sit straight
Keep the upper
arm bareness or
wearing thin clothes
Keep the center
of cuff and heart
at the same level
Wrong measurement postures
Do not bend down or body
bend forward.
Do not sit with legs crossed.
Do not sit on a sofa.(Belly
pressure may increase the
blood pressure)
Do not put the arm on the
low table.(May increase the
blood pressure)
20
21
The ideally height
difference between
table and chair is
25-30cm,back and
arm being supported.
Sit on a chair with your
feet flat on the floor
Don't eat, smoke, drink, take bath or do any
high impact sport within half an hour before
measuring. Measurements shall be taken at the
same time every day.
Start measuring
Sit still for 5 minutes before the
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.
1. Measurement
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Start measuring
22 23
Start measuring
The monitor starts measuring automatically
after inflation finished, and the measuring
icon " " starts to flicker, pressure release
value starts to decrease gradually.
2. Measurement finished
After measurement, the monitor will show the
SYS, DIA and pulse rate, then inflate the air
automatically.
m
MEMBER
SYS
mmHg
DIA
mmHg
P/min
M
D
AM
PM
A/B
Full screen display state
The zeroing state
Inflate state
Cuff wear state
measurement state
mmHg display kPa display
AM AM
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24 25
If the SYS is higher than 139mmHg or DIA
higher than 89mmHg means having high blood
pressure. Please contact with doctor for advice.
Also the Blood pressure range indicator can
show the blood pressure intuitively.
Tips!
The time interval between two measurements
should be at least 5 minutes or longer.
Estimate the blood pressure condition
according to the BP classification table, and
consult the doctor.
Blood pressure range indicator
Start measuring
4. Shut down
Press the" "button to shut down. Also it
will power off automatically in 3 mins without
any operation.
3. Take off the cuff
Higher than 139mmHg
Higher than 89mmHg
m
MEMBER
SYS
mmHg
DIA
mmHg
P/min
M
D
AM
A/B
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Tips!
The monitor will store the measurement data
automatically (including time, date, blood
pressure and pulse), and the upper limit of
records is 99. Press the " "button to check
the records.
Warning: Upper limit pressure of air inflation
is 300mmHg/40.0kPa. Don't keep the
inflated state for a long time to avoid
damage.
Memory function
26
27
Memory function
Emergency stop during measurement
If the measurement need stoping for
uncomfortableness or other reasons,
please press the " " button, the
measurement will stop immediately and
air releases fast. Take off the cuff
manually if the " " button is not
working.
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 "1~99".
The average value The 1st group of memory
The th data may be replaced by the th
when the memory capacity is full.The 1st data
may be replaced by the new data.
99 98
Tips!
AM
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Memory function
28 29
Auxiliary measuring function
Press the both " " and " " button until
the display shown as the following picture,
which means the recorded data is cleared.
Press the " " button
to turn off the monitor
after deleting.
Note: This operation will delete all the
recorded data.
C. Read the recorded data by pressing the
" "button as the sequence: "1", "2"
......"99"(max).
D. Press the " " button to shut off the
monitor.
2. Delete the recorded data
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. (Please
refer to page 18 to 19 for how to properly
wrap the cuff.)
It will show the " " icon, if body moves
when measuring. Please measure again or it
will show inaccurate results.
Cuff Wrapping Detection
Body Movement Detection
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30
31
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.
Press the" "button after battery
installation, then the screen will show the " "
icon, which means the system is in restore
testing. Several seconds later, the " " icon
disappears and the air pump starts inflating at
the same time, which indicates the test ended.
Then press the " "button to stop
inflating and take out the batteries to enter
the next step.
System restores
Static mode
Press the " "button and hold, meanwhile
install the batteries. Hold on for about 3
seconds then release the" " button. Then
screen will show the pressure value " " , the
date and time. Now the system has restored
and entered the static mode. Now can take
the static test.
Entering the static mode
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.
Tips!
Note: It must restore the system before
entering the static mode, otherwise it may
cause inaccurate results.
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32
33
kPa/mmHg k a/mmHgP
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
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34
35
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.
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.
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The " "icon
twinkle
36
37
(300mmHg)
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Technical parameters
Technical parameters
38
39
YE680B
LCD digital display
Oscillation mensuration
0-300mmHg
0-450mmHg
40-200 time/min
Pressure:±3mmHg(±0.4kPa)
Pulse:±5% of reading value
=Class II (optional AC adapter)
=Type BF application part
4X1.5v AA batteries
or 6V/ 600mA AC adapter
300 times
22~45cm
IP 21
Approx.330g
Approx.127x93x74 (mm)
+5℃ to +40℃/15% to 90%
RH (non-condensing)
-20℃ to +55℃/15% to 90%
RH (non-condensing)
5 years or 50 thousand times
Model
Display
Measuring
method
Measuring range
Cuff Pressure
Pulse rate
Precision
Electric
classification
Power supply
Battery life
Cuff size
IP Classification
Service life
Weight
Dimension
Operating
temperature
/Humidity
Storage temper-
ature /Humidity
Operating/Storage
atmospheric
pressure
70kPa to 106kPa
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 product away from the
interferential devices.
Part
Material
Rear Cover
Top Cover
ABS
PC
Magic paster
edge cloth
Cuff
Air tube
Air plug connect
PVC
ABS
Nylon
Polyester cotton
The contact materials detail of product
Statement!
The SPHYGMOMANOMETER was clinically
investigated according to the requirement of
ISO 81060-2:2013.
The SPHYGMOMANOMETER complies with
IEC 80601-2-30.
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Guidance and manufacture s declaration- electromagnetic emission'
The YE680B is intended for use in the electromagnetic environment
specified below. The customer or the user of the YE680B
should assure that it is used in such and environment.
Emission test
Compliance
Group 1
RF emissions
CISPR 11
Class B
RF emissions
CISPR 11
Class A
Complies
Harmonic
emissions
IEC 61000-3-2
Voltage
fluctuations/
flicker emissions
IEC 61000-3-3
Group1
For all ME EQUIPMENT and ME SYSTEMS
Table 1
For all ME EQUIPMENT and ME SYSTEMS
Table 2
Guidance and manufacture s declaration-electromagnetic emission'
The is intended for use in the electromagnetic
environment specified below. The customer or the user of the
YE680B should assure that it is used in such and environment.
YE680B
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
Surge IEC
61000-4-5
±1 kV line(s)to line(s)
±2 kV line(s)to earth
±8 kV contact
±15 kV air
<5 % UT (>95 % dip in UT)
for 0.5 cycle
40 % UT (60 % dip in UT)
for 5 cycles
70 % UT (30 % dip in UT)
for 25 cycles
<5 % UT (>95 % dip in UT)
for 5 s
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines 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
±8 kV contact
±15 kV air
±2 kV
100kHz repetition
frequency
±1 kV line(s)to line(s)
<5 % UT (>95 % dip in UT)
for 0.5 cycle
40 % UT (60 % dip in UT)
for 5 cycles
70 % UT (30 % dip in UT)
for 25 cycles
<5 % UT (>95 % dip in UT)
for 5 s
30A/m
50Hz or 60Hz
Electromagnetic compatibility information
Electromagnetic compatibility information
40
41
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Electromagnetic compatibility information
For ME EQUIPMENT and ME SYSTEMS that are
not LIFE-SUPPORTING
Table 3
Guidance and manufacture s declaration-electromagnetic immunity'
The YE680B is intended for use in the electromagnetic environment
specified below. The customer or the user of YE680B should assure
that it is used in such an environment.
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 YE680B is used exceeds the applicable RF
compliance level above, the YE680B should be observed to verify
normal operation. If abnormal performance is observed,additional
measures may be necessary, such as reorienting or relocating the
YE680B.
b
Over 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
a)
Band
(MHz)
a)
Service
(MHz)
Modulation
b)
Maximum
power
(MHz)
IMMUNITY
TEST LEVEL
(V/m)
Distance
(m)
380-390
TETRA 400
Pulse
b)
modulation
18 Hz
1,8
0,3
27
385
430-470
FM
±5 kHz deviation
1 kHz sine
2
28
450
GMRS 460,
FRS 460
0,3
710
704-787
LTE Band 13,
17
0,3
9
745
780
Pulse
b)
modulation
217 Hz
0,2
810
800-960
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
0,3
28
930
Pulse
b)
modulation
18 Hz
2
1720
1700-1990
GSM 1800;
TETRA 1900;
GSM 1900;
DECT;
LTE Band 1,3,
4,25; UMTS
0,3
28
1970
Pulse
b)
modulation
217 Hz
2
870
1845
Bluetooth,
WLAN,
802.11 b/g/n
RFID 2450,
LTE Band 7
0,3
2450
Pulse
b)
modulation
217 Hz
2400-2570
2
28
WLAN
802.11a/n
0,3
Pulse
b)
modulation
217 Hz
5240
5500
5785
5100-5800
0,2
9
NOTE If necesary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting
antenna and theME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by
IEC61000-4-3.
b
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
frequency
(MHz)
Test
Table 4-Test specifications for ENCLOSURE PORT
IMMUNITY to RF wireless communications
equipment
Electromagnetic compatibility information
42
43
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44
45
Health diaryHealth diary

Specifications

Yuwell YE680B Questions and Answers

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