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FDA 电子血压计 YE670D 730194-0A

The YE670D Electronic Blood Pressure Monitor is designed for measuring blood pressure and pulse rates in adults, featuring a user-friendly interface and memory function for storing up to 60 records. It includes essential instructions for setup, operation, and maintenance, as well as important safety notes and contraindications. The device is equipped with features like cuff wrapping detection and body movement detection to ensure accurate measurements.

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0% found this document useful (0 votes)
31 views24 pages

FDA 电子血压计 YE670D 730194-0A

The YE670D Electronic Blood Pressure Monitor is designed for measuring blood pressure and pulse rates in adults, featuring a user-friendly interface and memory function for storing up to 60 records. It includes essential instructions for setup, operation, and maintenance, as well as important safety notes and contraindications. The device is equipped with features like cuff wrapping detection and body movement detection to ensure accurate measurements.

Uploaded by

kabadi435
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 24

YE670D

Electronic Blood Pressure Monitor

JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO.,LTD.


Sales Center Address: Huanyuan East Road No.1,Xuzhuang
User's Manual
Software Park, Nanjing, Jiangsu Province, P.R. China, 210000
Manufacturing Address: YunYang Industrial Park
DanYang, Jiangsu Province, P.R. China, 212300
730194-0A
http://www.yuwell.com Please read the user's manual closely before using!
Contents Product Features

Before using
Product features.................................................... 01 Clock Display
Operation guide..................................................... 02 Function
Product structure.................................................. 05
Parts......................................................................... 06
Important notes..................................................... 09
Maintenance........................................................... 13
Battery installation............................................... 14
140
Range of
Time and date setting.......................................... 15
90
Blood
Voice function setting......................................... 17 pressure
mmHg/kPa setting................................................ 18 display
Measuring method
Using method of cuff........................................... 19
Measuring posture................................................ 21
IHB (Irregular
Start measuring..................................................... 22
Heartbeat)
Blood pressure range indicator.......................... 26 Body Movement
Prompt
Memory function................................................... 27 Detection
Auxiliary measuring function............................. 30
LCD display ............................................................ 31
Static mode............................................................ 32
Common problems Common questions of blood Cuff
OK
Wrapping Detection Voice function
Pressure measurement....................................... 34
Common fault and trouble shooting................ 35
Technical parameters.......................................... 37
Electromagnetic compatibility information........ 39
Health diary........................................................... 44
01
Operation guide Operation guide

Please follow the steps as shown below Measurement


1. Using method of cuff
Power-on
Wearing the cuff and make the lower edge
Install four AA batteries 2~3cm above the elbow, keep the air tube
inside of the arm.
(Please turn to page 20 for details)

2-3c
m

Open the Install the batteries Close the


battery cover properly battery cover 2. Measuring posture
Sit straightly, keep the center of cuff and
(Please turn to page 14 for details) heart at the same level.
(Please turn to page 21 for details)
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.
3. Start measuring
Sit still for 5 minutes and then Press the
" " Button to measure.
(Please turn to page 22 for details)
02 03
Operation guide Product structure

Check the records 1. Main part

Press the button of " " to check the


measuring records.

This monitor can display the average


measurement and store 60 records.
(Please turn to page 28 for details)

2. Cuff

22~32cm

3. Accessories

User's manual, Warranty card, 4 AA batteries

04 05
Parts Parts

1. Main part

Display

Battery cover

Setting Memory Start/Pulse


button button button
2. Cuff
The suitable upper-arm circumference:
22cm~32cm .

Rubber air
Plug port
tube

22~32cm
Air plug

06 07
Parts Important notes

3. Display signs and symbols


Pay attention with the symbols shown here to
Time and date prevent harm or damage to the user.
Attention
Note on important information
Type BF application part
SYS(systolic) Consult the manual
Manufacture
Inflation Blood pressure
level display Date of manufacture
DIA(diastolic)
EC-Representative
Deflation
Replace the Symbol for the marking of electrical
Memory batteries and electronics devices according to Directive
2002/96/EC
Cuff Wrapping
Detection Low voltage
Temperature range

Records Pulse rate


number Humidity range
Body Movement Heartbeat,IHB Prompt
Detection Heartbeat IHB Prompt Atmospheric pressure range

Safety and environmental protection use period


for 10 years

IP 21 IP Classification

This device fulfils the provisions of EC directive


93/42/EEC (Medical Device Directive).

08 09
Important notes Important notes

1. Range of application Do not measure continuously. (5 minutes or


This product is intended to measure the blood more should be spared between two
pressure and pulse rate of adult at household or measurements).
medical center(not suitable for neonate, Please reinstall the batteries and start again if
pregnancy or pre-eclampsia.) cannot measure.
Product contraindication:No use contraindication For patient of arrhythmia, measuring results
may not be accurate.
2. Attention items
Do not keep the cuff in the inflated state for a
Pay attention to the following points when
long time.
measuring or it may cause the incorrect
The patient is an intended operator.
results.Sit still for 5 minutes before measuring
Do not swallowed small parts that may cause
to ensure quiet and stable mode.
choking hazard.
Do not take the measurement within 1 hour of
The device must not be used with high
eating ,smoking, drinking wine or coffee (black tea).
frequency surgical equipments.
Do not measure while standing, walking or
It will affect the measurement accuracy if the
having body pressed.
arm circumference is out of the given value.
Do not take the measurement after sport or bath.
Do not use the CUFF over a wound arm or
Do not speak, move, shake arm or bend fingers
being on an intravenous drip.
while measuring.
Consult your doctor if using the device on the
Do not take the measurement at extreme
arm with an arterio-venous (A-V) shunt.
temperature condition or the varied severely
Do not use the cuff on the arm where the side
environment.
of a mastectomy.
Do not take the measurement in a moving
vehicle.
10 11
Important notes Maintenance

Note that It will lose function on the same limb Please observe the following items to protect
while cuff inflating. the device and ensure the accuracy of
Do not allowed frequent measurements the measurement.
resulting restriction of the blood flow may Please store the monitor and accessories
cause injury. properly after use.
Avoid compression or bending of the cuff Do not place the monitor and accessories in
connection tubing while using the device. high temperature, moisture, dust, or exposure
Please using soft dry cloth stained with 75% to sunshine.
ethanol to clean the device in the case of many The cuff contains an bladder inside, please care
people use,but do not let the ethanol flow into in applications, do not fold, pull or twist it.
Do not modify the device without authorization.
the monitor and arm cuff.
Do not replace the parts without authorization.
Please use the alkaline battery,do not use the
Please clean the monitor with soft dry cloth. If
rechargeable battery.
it's necessary, please use wiped soft cloth with
According to the local laws and regulations to water or neutral detergent before cleaning by
deal with battery. soft dry cloth.
Using absorbent cotton to wipe gently with
Note: Do not diagnose with the measurement,
rubbing alcohol, disinfection of the machine when
Please follow doctor's instruction.
it necessary. Do not use detergent to clean.
Statement: If the monitor has not been stored
Do not let water seep into the device.
in the required temperature and humidity
range, it may not conformance to specification. Tips!
We suggest to calibrate the monitor (at
least once a year) according to local laws
and regulations.
12 13
Battery installation Time and date setting

Open the battery cover and install four AA The monitor will store the measuring results
batteries properly. Then close the cover with a automatically by the management system.
click sound. It is necessary to reset time and date after
Aligning the +ve and poles of each battery installing new batteries or connecting to DC
with the +ve and -ve signs imprinted on the power. Please operate as following steps. (For
battery housing of the device. example: setting the date as 2016-1-15 and
time as 08:28)

1. Year setting: Press the" " button for


more than 3 seconds till the number starts
flashing.
Open the Install the batteries Close the
2. The year increase once press the " "
battery cover properly battery cover
button.
The" "icon appearing means the battery is
low. 3. Press the " " button to switch to the
The" "icon appearing means the battery is month setting.
running out. Please replace all the batteries.
4. Using the same way for other settings.
Please take out the batteries if the monitor
will not be used for a long time (over three
months).

14 15
Time and date setting Voice function setting

After finishing the date and time setting,

pressing the " " button to enter the voice

function setting,The voice volume value is

Appeared on the screen(range: 01-05). The

volume value increase once press the " "

Year character blink Month character blink button,When the volume reaches the

maximum volume 05, then press the " "

button, you can turn off the voice

function.Finish by pressing the" "button.

Date character Hour character blink


...

Minute character blink


16 17
mmHg/kPa setting Using method of cuff

After finishing the Voice function setting, Tips!


pressing the " " button to enter the Either of arms can be measured.
mmHg/kPa unit setting. Press the " " button
Cuff connecting
to switch between these two units. Finish by
Connect the air connector of the cuff to the
pressing the " "button. socket which on the left side of the monitor.

After unit setting, press the " "button


to shut down.

18 19
Using method of cuff Measuring posture

Using method of cuff Keep the upper


arm bareness or
Wind the cuff around the upper arm. ( as shown

Sit straight
wearing thin clothes
In the picture) Keep
2~3cm
the lower edge of the Keep the center
of cuff and heart
cuff at the position at the same level
above 2-3cm to the
elbow joint and keep
the air inlet which
insert to the cuff at
the inner side of arm. The ideally height
difference between Sit on a chair with your
Stick the cuff tightly. table and chair is feet flat on the floor
25-30cm,back and
Note: The cuff arm being supported.
should be wearing
comfortably, avoiding Wrong measurement postures
too tight or loose. Do not bend down or body
bend forward.
Sit straight and flat Do not sit with legs crossed.
the arm on table with Do not sit on a sofa.(Belly
palm up, also keep pressure may increase the
the center of cuff blood pressure)
and heart at the Do not put the arm on the
same level. Also low table.(May increase the
please ensure the air blood pressure)
tube not twisted.
20 21
Start measuring Start measuring

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.

Sit still for 5 minutes before the


measurement
1. Measurement
All icons on screen appear for 1 sec after
pressing the" "button, then disappear. Full screen display state
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.

Increase with
the pressure
The zeroing state The inflation state
The monitor starts measuring automatically
after inflation finished, and the measuring
icon " " starts to flicker, pressure release
value starts to decrease gradually.
22 23
Start measuring Start measuring

Please maintain the position during the 3. Take off the cuff
measurement and don't speak or move body
4. Shut down
or hand.
Press the" "button to shut down. Also it
will power off automatically in 30 seconds
without any operation.

The measuring state

2. Measurement finished
After measurement, the monitor will show the
SYS, DIA and pulse rate, then inflate the air
automatically.

mmHg display kPa display

24 25
Blood pressure range indicator Memory function

If the SYS is higher than 140mmHg or DIA Tips!


higher than 90mmHg means having high
The monitor will store the measurement data
blood pressure. Please contact with doctor for
automatically (including time, date, blood
advice.
Also the Blood pressure range indicator can pressure and pulse), and the upper limit of
show the blood pressure intuitively. records is 60. Press the " "button to
check the records.

Emergency stop during measurement


Higher than 140mmHg If the measurement need stoping for
Higher than 90mmHg 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
Tips!
working.
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
Warning: Upper limit pressure of air inflation
consult the doctor.
is 290mmHg/38.7kPa. Don't keep the inflated
state for a long time to avoid damage.
26 27
Memory function Memory function

1. Press the " "button for the records. C. Read the recorded data by pressing the

A. Press the" "button to show the average " "button as the sequence: "1", "2"

value of the latest 3 times measurement. ......"60"(max). Then return to the 1st.

B. Repress the" "button to display the 1st Holding the " " button to search the data

group of memory, the serial number is quickly.

displayed as "1" to "60". "1" is the latest group D. Press the " " button to shut off the

and the "60" is the earliest one. monitor.

2. Delete the recorded data


press the both " " button and " "

button until the display shown as the

following picture, which means the recorded

data is cleared.
The average value The 1st group of memory Press the " " button

Tips! to turn off the monitor

The 60th data may be replaced by the 59th after deleting.


when the memory capacity is full.The 1st data Note: This operation will delete all the
may be replaced by the new data. recorded data.

28 29
Auxiliary measuring function LCD display

Cuff Wrapping Detection Press the " " button and it will show the
current time, as shown blew:
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.

Body Movement Detection

It will show the " " icon, if body moves


Press the " "button again and it will
when measuring. Please measure again or it
show the current date, time and pressure
will show inaccurate results.
unit, as shown blew:

Press the " " button to shut down the


monitor.

30 31
Static mode Static mode

This function is mainly for professional Entering the static mode


personnel to enter the static mode to test the
monitor through standard pressure gauge. Press the " "button and hold, meanwhile
Warning: Normal users don't need to know install the batteries. Hold on for about 3
this function and also do not operate. The seconds then release the" " button. Then
company will not take any responsibility for
screen will show the pressure value " " , the
damage caused by this operation.
date and time. Now the system has restored
System restores and entered the static mode. Now can take

Press the " " button after battery the static test.

installation, then the screen will show the " " Tips!
icon, which means the system is in restore After entering the static mode, if the screen
testing. Several seconds later, the " " icon still doesn't show " ", please operate again as
disappears and the air pump starts inflating at the System restore. Please contact with the
local distributor if it still does not work.
the same time, which indicates the test ended.
The monitor will
Then press the " "button to stop inflating automatically
and take out the batteries to enter the next power off if there is
step. no operation in 4
Note: It must restore the system before minutes.
entering the static mode, otherwise it may
cause inaccurate results. The static mode
32 33
Common questions of blood pressure Common fault and trouble shooting
measurement
1. What is blood pressure? Common fault Solutions
Blood pressure is the force exerted by blood Check the batteries are installed
It doesn't work after
against the walls of the arteries. Systolic pressing the '' ''button
correctly

pressure occurs when the heart contracts. with batteries installation Replace new batteries

Diastolic pressure occurs when the heart Check the connection and winding of
cuff
expands. Blood pressure is measured in
Multiple occurrences of Check if the cuff winded too tight or
millimetres of mercury (mmHg). One's natural measuring failure, or too loose. Take off your clothes if
blood pressure is represented by the measured value is low rolled too tight of cuff

fundamental pressure, which is measured first (or high) Please ensure a quiet, relaxed body
state o. Deep breathing to relax
thing in the morning while one is still at rest and yourself before measurement
before eating.
The monitor is in good
Please read the "blood pressure
condition, but the each
2. WHO Blood Pressure Classification variations"carefully
measuring result are different
Standards to assess high blood pressure, without
regard to age, have been established by the world The value is different from
Write down the value every day,
that measured at a clinic or
Health Organization (WHO), as shown below: doctor's office and consult a doctor

kPa/mmHg k P a/mmHg Pump works, but the Check whether the cuff has connected
pressure doesn't rise well
12.0~18.5kPa 8.0~11.9kPa
90~139mmHg 60~89mmHg

18.7~21.2kPa 12.0~13.2kPa
140~159mmHg 90~99mmHg

21.3~23.9kPa 13.3~14.5kPa
160~179mmHg 100~109mmHg

≥24.0kPa ≥14.7kPa
≥180mmHg ≥110mmHg

34 35
Common fault and trouble shooting Technical parameters

The table below shows the possible fault Model YE670D


displaying icon, possible reason, and solutions. Display LCD digital display
Measuring Oscillation mensuration
Wrong
indication
Fault cause Solution method
Measuring range 0-280mmHg
Unable to measure Fasten cuff correctly
Err4
pressure before measurement Cuff Pressure 0-450mmHg
Check if there is air
Pulse rate 40-200 time/min
Err5 Pressurizing error
leakage from the cuff Precision Pressure:±3mmHg(±0.4kPa)
Pressurizing error Pulse:±5% of reading value
Keep arm and body still
Err6 caused by arm or Electric =Type BF application part
and measure again
body motion
classification
Cuff is too lose or
Err7 Fasten cuff tightly Power supply 4X1.5v AA batteries
fall off
Battery life 300 times
Pressure exceeds the
Err8 maximum value Measure again please Cuff size 22~32cm
(290mmHg) IP Classification IP21
Showing low Service life 5 years or 50 thousand times
voltage icon Battery is low Replace new batteries
Weight Approx.267g
" "
Dimension Approx.127x93x74 (mm)
Showing the
" "icon
Battery is running out Replace new batteries Operating +10℃ to +40℃/15% to 90%RH
temperature (non-condensing)
Warning: If the situations cannot be solved /Humidity
Storage -20℃ to +55℃/15% to 90%RH
or unexpected problem happens, please
temperature (non-condensing)
consult the local distributor.
/Humidity

36 37
Technical parameters Electromagnetic compatibility information

Operating/Storage 80kPa to 105kPa Table 1


atmospheric For all ME EQUIPMENT and ME SYSTEMS
pressure Guidance and manufacture ' s declaration- electromagnetic emission

There is the potentia risk of radio frequency The YE670D is intended for use in the electromagnetic environment
specified below. The customer of the user of the YE670D should
interference between the device and other assure that it is used in such and environment.
devices. If there is, please find out the Emission test Compliance Electromagnetic environment-
guidance
problems and take the following measures:
The YE670D uses RF energy
(1) Turn off the device, and turn on again. only for its internal function.
Therefore, its RF emissions are
(2) Change the direction of the device. RF emissions Group 1 very low and are not likely to
CISPR 11
(3)Keep the product away from the cause any interference in
nearby electronic equipment.
interferential devices.
RF emissions
Class B
The contact materials detail of product CISPR 11 The YE670D Blood Pressure
Monitor is suitable for use in all
Harmonic
establishments, including
Part Material emissions N/A
domestic establishments and
IEC 61000-3-2
Rear Cover ABS those directly connected to the
public low-voltage power supply
Top Cover PC Voltage
network that supplies buildings
fluctuations/ N/A
Magic paster used for domestic purposes.
Nylon flicker emissions
Cuff IEC 61000-3-3
edge cloth Polyester cotton
Air tube PVC
Air plug connect ABS
Iron loop Iron nickel plating

38 39
Electromagnetic compatibility information Electromagnetic compatibility information

Table 2 Table 3
For all ME EQUIPMENT and ME SYSTEMS For ME EQUIPMENT and ME SYSTEMS that are
Guidance and manufacture ' s declaration-electromagnetic emission not LIFE-SUPPORTING
The YE670D is intended for use in the electromagnetic environment Guidance and manufacture' s declaration-electromagnetic immunity
specified below. The customer of the user of the YE670D should
assure that it is used in such and environment. The YE670D is intended for use in the electromagnetic environment
specified below. The customer or the user of YE670D should assure
Immunity IEC 60601 Compliance Electromagnetic
that it is used in such an environment.
test test level level environment-guidance
Floors should be wood, Immunity IEC 60601 Compliance Electromagnetic
test test level level environment-guidance
Electrostatic concrete or ceramic tile. If
discharge ±8 kV contact floor are covered with Portable and mobile RF
(ESD) IEC ±15 kV air synthetic material, the communications equipment
61000-4-2 relative humidity should be should be used no closer to any
at least 30%. part of the YE670D,including
cables, than the recommended
Electrical ±2 kV for powersupply separation distance calculated
fasttransient lines N/A from the equation applicable to
/burst IEC ±1 kV for input/output the frequency of the transmitter.
61000-4-4 lines Recommended separation
distance:
Surge IEC ±1 kV line(s) to line(s) Conducted 3 Vrms N/A d = 1.2 P
61000-4-5 ±2 kV line(s) to earth N/A RF 150 kHz to d = 1.2 P 80 MHz to 800 MHz
IEC 61000- 80 MHZ d = 2.3 P 800 MHz to 2.5 GHz
4-6 Where P is the maximum output
Voltage dips, <5 % UT (>95 % dip in UT) power rating of the transmitter in
short for 0.5 cycle 3 Vrms watts (W) according to the
interruptions 40 % UT (60 % dip in UT) Radiated RF 10 V/m 10 V/m transmitter manufacturer and d is
and voltage for 5 cycles IEC 61000- 80 MHz to the recommended separation
N/A 3 V/m
variations on 70 % UT (30 % dip in UT) 4-3 2.7 GHz distance in metres (m).
power supply for 25 cycles Field strengths from fixed RF
input lines IEC <5 % UT (>95 % dip in UT) transmitters, as determined by an
61000-4-11 for 5 s electromagnetic site survey,a
should be less than the
Power compliance level in each frequency
frequency range.b
Mains power quality should be Interference may occur in the
(50/60 Hz) that of a typical commercialor
30A/m vicinity of equipment marked with
magnetic hospital environment.
field IEC the following symbol:
61000-4-8
NOTE: UT is the a.c. mains voltage prior to application of the test level.

40 41
Electromagnetic compatibility information Electromagnetic compatibility information

Table 3 Table 4
For ME EQUIPMENT and ME SYSTEMS that are For ME EQUIPMENT and ME SYSTEMS that are
not LIFE-SUPPORTING not LIFE-SUPPORTING
Guidance and manufacture' s declaration-electromagnetic immunity Recommended separation distances between portable and mobile
RF communications equipment and the YE670D
The YE670D is intended for use in the electromagnetic environment
specified below. The customer or the user of YE670D should assure The YE670D is intended for use in an electromagnetic environment
that it is used in such an environment. in which radiated RF disturbances are controlled. The customer or
Immunity IEC 60601 Compliance Electromagnetic the user of the YE670D can help prevent electromagnetic
test test level level environment-guidance interference by maintaining a minimum distance between portable
and mobile RF communications equipment (transmitters) and the
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range YE670D as recommended below, according to the maximum output
applies. power of the communications equipment.
NOTE2 These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and reflection
Rated maximum Separation distance according to frequency of
from structures, objects and people. transmitter(m)
output power
of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
A.Field strengths from fixed transmitters, such as base stations for (W) d = 1.2 d = 1.2 d = 2.3
radio (cellular/cordless) telephones and land mobile radios, amateur
radio, AM and FM radio broadcast and TV broadcast cannot be 0.01 0.12 0.12 0.23
predicted theoretically with accuracy. To assess the electromagnetic 0.1 0.38 0.38 0.73
environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the 1 1.2 1.2 2.3
location in which the YE670D is used exceeds the applicable RF 10 3.8 3.8 7.3
compliance level above, the YE670D should be observed to verify
normal operation. If abnormal performance is observed,additional 100 12 12 23
measures may be necessary, such as reorienting or relocating the
YE670D. For transmitters rated at a maximum output power not listed
B. Over the frequency range 150 kHz to 80 MHz, field strengths above, the recommended separation distance d in meters (m) can
should be less than 3 V/m. be determined 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.
NOTE1 At 80 MHz and 800 MHz, the separation distance for 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.

42 43
Health diary Health diary

44 45

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