User's Manual

Do not use the cuff in the area where the treatment is being performed inside blood vessel or the arteriovenous
connection. This may cause temporary blockage of blood flow and cause injury to the patient.
Do not use the cuff on the side of the mastectomy.
When using the cuff to pressurize, some of the body’s functions may temporarily weaken. Do not use the measurement
medical electrical equipment at the appropriate arm position.
Do not move during measurement, it will have a delayed effect on the patient’s blood flow.
The device need to be placed for 2 hours from the minimum storage temperature to being ready for its intended use.
The device need to be placed for 4 hours from the highest storage temperature to being ready for its intended use.
Note
The following conditions may also cause changes in the blood pressure measurement value.
Take the measurement in one hour after meal or after drinking alcohol, coffee or after smoking, exercise, bathing;
Using incorrect posture such as standing or lying down, etc;
The patient speak or move his body during measurement;
When measuring, the patient is nervous, excited, emotional instability;
The room temperature rise or fall sharply, or the environment of measurement often changes;
Measuring in a moving vehicle;
The high and low location of cuff will cause changes in measurement results;
Continuous measurement for a long time.
7.2 Applying the Cuff
Both left and right arm can be measured.
Bare your arm or cloth close-fitting clothing during measurement.
Carry out the operation in a room with comfortable temperature.
When measuring, take the thick clothes off instead of rolling up the sleeves.
In order to measure accurately, pay attention to applying the cuff properly (left arm).
① Insert the arm cuff air plug in the cuff socket of sphygmomanometer.
② Stretch cuff into a barrel for the arm can conformable enter into the barrel
③ Left arm penetrate through the cuff, the air tube of the cuff will pass the top of your palm.
④ Wrap the cuff to your upper arm. Make the air tube inside the forearm and aligned with your middle finger.
⑤ The bottom of the cuff should be approximately 2cm~3cm above your elbow.
⑥ Be fixed with cloths, and wrapped tight cuff, the arm and the cuff should not have gaps.
① ② ③
④ ⑤ ⑥
7.3 Measurement BP
①Under “OFF” state, press “START/STOP” button to start measuring.
During measurement, please keep correct pose and quiet state, the body could not move.The “Movement” icon appears
if patient moves, and continue measuring may lead to inaccurate measurement.
If you want to abort the measurement
Press【START/STOP】button, the device will stop inflating, and release the air from the cuff.
Display the measurement results after finishing measuring.The pressure bar on the right side visually demonstrates the
pressure level.
7.4 Confirm the Measurement Value
①The World Health Organization has established globally accepted standards for the assessment of hypertension readings.(In the
clinic environment)
Blood pressure level
Systolic pressure
Diastolic pressure
Normal
Pressure＜130mmHg
Pressure＜85mmHg
Normal Systolic Value
130mmHg≤Pressure≤139mmHg
85mmHg≤Pressure≤89mmHg
Mild Hypertension
140mmHg≤Pressure≤159mmHg
90mmHg≤Pressure≤99mmHg
Moderate Hypertension
160mmHg≤Pressure≤179mmHg
100mmHg≤Pressure≤109mmHg
Severe Hypertension/High Blood
Pressure
180mmHg≤Pressure
110mmHg≤Pressure
Pressure bar at the right side
The SYS higher than 135mmHg or the DIA higher than 85mmHg are used as the criteria of hypertension(In the home environment),
and the pressure bar at the right side lights up in red.
The SYS lower than 135mmHg and the DIA lower than 85mmHg are used as the criteria of normal pressure, and the pressure bar
at the right side lights up all in green.
The number of lights represents the blood pressure range.
*Self-diagnosis and treatment using measured results may be dangerous. Follow the instructions of your physician.
7.5 Upload date(optional for devices with Bluetooth function)
①The data stored can be uploaded to master device by Bluetooth
Time sync icon lights up if the device time is not synced, and the measured data cannot be uploaded to the terminal
equipment via the Bluetooth. After syncing the time by Bluetooth connection of the device, Time sync icon goes off,
and the measured data can be uploaded
③After uploading the data to the master device, the local data will be deleted.
Note
Wait at least 4-5 minutes between measurements.
 When repeatedly measuring, the accurate blood pressure value may not be measured due to congestion in the arm.
Please measure after the blood flow is smooth.
 When the screen displays Err, the measure can't be carried out correctly.
 Irregular pulse icon is displayed in the measurement results if the pulse internal is irregular during measuring,
which may cause it is unable to take measurement correctly. Please keep quiet and remeasure. If the irregular
pulse icon appears frequently, please consult a doctor.
 The minimum value of the patient’s physiological signal is the minimum limit that the device can measure. The
device may obtain inaccurate measurement results when it is operated below the minimum amplitude or minimum
value of the patient’s physiological signal.
*The device will automatically turn off after five minutes in which there is no operation to the device, even if you
forget to turn the power off.
Chapter8 Memory Function
The device can store NIBP values automatically, display up to 199 set of measurement results.
If 199 set of measurement data have been stored in current device, when saving the 200th set of data, the earliest set of
data will be overwritten. If no measurement values, the memory values can be not numerated.
Memory function can not be used during measuring.
When there is no measurement values, “---” will display on the review interface.
8.1 Review the Memory Value
1.Under “OFF” state, press “M” button to display the average value of the latest three set of data, when the number of
measurement data is less than three groups, it will supplement automatically. Continue to press “M” button in current
interface to view all measurement records.
8.2 Delete Memory Values
1.Users can delete all memory values of the current user instead of separately delete one memory value
2.Under the memory interface, press “M” button and “START/STOP” button simultaneously for more than 5 s, after
“DEL” appears on the screen, all memory values will be deleted.
Caution
When querying the measurement records, please press “M” button continuously to query one by one.
Chapter9 Key and Symbols
Your device may not contain all the following symbols.
Signal
Description
Signal
Description
Attention! Please refer to the accompanying
document (the user manual).
Attention! Please refer to the accompanying
document (the user manual).
SYS
Systolic pressure
DIA
Diastolic pressure
MAP
Mean blood pressure
PUL
Pulse rate (bpm)
IP20
Enclosure protection grade
EMC
Electromagnetic compatibility
Recyclable
P/N
Material code of manufacturer
Batch code
Use by date
This way up
Fragile, handle with care
Keep dry
Storage atmospheric pressure limitation
Storage temperature limitation
Storage humidity limitation
Manufacturer
Date of manufacture
Batteries Power
SN
Serial number
Flating
Deflating
Waste disposal mark, this symbol indicates
that the waste of electrical and electronic
equipment can not be disposed as an
unclassified municipal waste and must be
recovered separately.
This item is compliant with Medical Device
Directive 93/42/EEC of June 14, 1993,a directive
of the European Economic Community.
Class II equipment
Type BF applied parts
European Representative
Irregular pulse
Socket for power adapter
Interface for connecting cuff
Voice closed
Voice enabled
Large movement during measurement
Cuff tied properly
Artery indicator label
Bluetooth
time sync icon
Chapter10 Error Message
When the high pressure position appears "Err" and the low pressure position appears the error number, the measurement
is not normal.
Error Mark
Causes
Solutions
Err2
Err15
Function abnormal
Please contact us
Err4
Low battery
Please replace the battery or link adapter
Err6
The cuff is not wrapped correctly.
Wrap the cuff correctly (refer to Chapter 7)
Err7
Cuff leakage
Replace with a new cuff
Err8
Air pressure error
Keep arm, body still, measure again
Err9
The pulse signal is too weak or the cuff is loose.
Wrap the cuff correctly (refer to Chapter 7)
Err10
Out of measure range
Keep arm, body still, measure again
Err12
Cuff is blocked or squeezed
Wrap the cuff correctly (refer to Chapter 7)
Err11
Err13
The signal amplitude is too big owing to the arm
or body moving or other reasons when measuring
Keep arm, body still, measure again
Err16
Err19
It takes too much time
Chapter11 Troubleshooting
Abnormal
Phenomenons
Causes
Solutions
BP measurement
values too high or too
low.
Cuff is not connected correctly.
Correctly connect cuff.
Talk or move arm in measurement
Keep quiet and restart a measurement.
The turnup close oppress the arm
Take off the clothes, and restart a measurement
No pressure
Cuff leakage
Buy a new cuff.
The cuff windpipe is not correctly
connected with cuff
Correctly connect.
Cuff not inflate
Contact us.
Cuff deflate in short
time
Loose cuff
Correctly tangle cuff.
It can not carry on measurement ,even if press the measurement
button
Return on the power and restart a
measurement.
Abruptly turn the
power off in adding
pressure
No use for a long time, the batteries can be
exhausted owing to the changed
temperature
Replace all four batteries with new ones.
Hold the on/off button
but can not start the
device
Batteries are worn
Replace all four batteries with new ones.
The battery polarities is reversed
Check the battery installation for proper
placement of the battery polarities.
Cuff inflation start before press the measurement button
Stop using the device and contact us.
Cuff never deflation
Stop using the device and contact us.
Air pressure error
Deflation error
Pull out the cuff to deflate. Stop using the
device and contact us.
Others
Keep arm, body still, measure again.
No press value displayed or the value unaltered when cuff inflating
Pull out the cuff to deflate. Stop using the
device and contact us.
Other phenomenon
Switch on the power once again and restart an
operation.
Replace the batteries.
If no, please contact us.
Chapter12 Maintenance, Cleaning and Keeping
*Please do obey the precautions and correct operating methods in this user manual. Otherwise, we will not responsible for
any fault.
Warning
Remove the batteries before cleaning. The accessories and main unit must be separated for cleaning.
Maintenance is not allowed during device using.
Do not squeeze the rubber tube on the cuff.
Caution
 High pressure disinfection to the device and accessories is not allowed.
 Do not let water or cleaning agent flow into the socket to avoid device damage.
 Do not soak the device and accessories in liquid.
 If any damage or deterioration of the device and accessories is found, please do not use it.
Maintenance:
 Clean the device and accessories regularly. It is recommended to clean them every one month. When the device or
accessory gets dirty, use a dry and soft cloth to wipe. If they are very dirty, it is available to dip the soft cloth into
water or mild detergent, and wring out, then use the cloth for cleaning.
 The device shall be inspected and calibrated regularly (or according to inspection standard of hospital). The
inspection can be carried out in appointed institutions, or by professional personnel or contact us for inspection.
Under the setting interface, Press the “START/STOP” button once, after “CAL” appears on the screen, press “M”
button for more than 15 s to enter the static pressure interface.
Advice
 Do not use gasoline, volatile oil, diluent, etc. to wipe the device.
 Do not clean or wet the cuff.
Storage:
Advice
 Do not expose the device in direct sunlight for long time, otherwise the display screen maybe damaged.
 The basic performance and safety of the device are not affected by the dust or cotton wool in home
environment,while the device shall not be placed where with high temperature, humidity or dusty.
 Aged cuff may result in inaccurate measurement, please replace the cuff periodically according to the user manual.
 To avoid device damage, keep the device out the reach of children and pets.
 Avoid the device close to extreme high temperature such as fireplace, otherwise the device performance may be affected.
 Do not store the device with chemical medicine or corrosive gas.
 Do not place the device where there is water.
 Do not place the device where with slope, vibration or impact
 Take the batteries out if the device is not to be used for three months or longer.
Chapter13 NIBP Specification
Name
Electronic Sphygmomanometer
The degree of protection
against ingress of water
IP20
Display
LED
NIBP Specifications
Measurement Method
Oscillometric method
Working mode
Automatic
Operation mode
Continuous operation
Pressure Range
0~297 mmHg(0~39.6 kPa)
Measurement range
Pressure
SYS：30～270 mmHg(4～36 kPa)
DIA：10～220 mmHg(1.3～29.3 kPa)
Pulse: 40~240/min
Inflation
160±5 mmHg(21.33±0.67 kPa)
Overpressure protect
297±3 mmHg(39.6±0.4 kPa)
Resolution
Pressure: 1 mmHg(0.133 kPa)
Accuracy
Static pressure: ±3 mmHg(±0.4 kPa)
Error
The BP value measured by the device is equivalent with the measurement value of
Stethoscopy, perform clinical verification in accordance with the requirements in ISO
81060-2: 2013, whose error meets the followings:
Maximum mean error: ±5 mmHg
Maximum Standard deviation: 8 mmHg
Operating Temperature/
Humidity
+5ºC~40 ºC . 15%RH~85%RH(no condensation)
Transport
Transport by general vehicle or according to the order contract, avoid pounded, shake and
splash by rain and snow in transportation.
Storage
Temperature: -20 ºC~+55 ºC; Relative humidity: ≤95 %((no condensation)); No corrosive
gas and drafty.
Atmospheric pressure
700 hPa~1060 hPa
Power supply
4 "AA" alkaline batteries, AC Adapter(AC, 100 V-240 V, optional)
Rated current
≤ 600 mA
Battery life
When the temperature is 23 ºC, limb circumference is 270 mm, the measured blood
pressure is normal, 4 "AA" alkaline batteries cab be used about 300 times.
Main Unit Dimensions
122*110*83mm
Main Unit Weight
300 gram(without batteries)
Safety classification
Class Ⅱ equipment (power supplied by power adapter)/Internally powered equipment
(power supplied by batteries)
Type BF applied part
Service life
The service life of the device is five years or 10000 times of BP measurement.
Date of manufacturer
See the label
Accessories
Standard Configure:
Adult Cuff: limb circumference 22-32 cm (upper arm center)
User Manual, four "AA" alkaline batteries
Optional Configure：
AC Adapter:
Input: voltage: AC 100 V~240 V frequency: 50 Hz/60 H Rated current: AC 150 mA
Output: DC 5.0 V±0.2 V 1.0 A
Extra large adult Cuff: the range of limb circumference is 18-26 cm (middle part of upper
arm)
the range of limb circumference is 22-30 cm (middle part of upper arm)
the range of limb circumference is 22-43 cm (middle part of upper arm)
the range of limb circumference is 32-43 cm (middle part of upper arm)
Appendix
Table 1:
Guidance and manufacturer’s declaration –electromagnetic emission
The device is intended for use in the electromagnetic environment specified below. The purchaser or the user of the
device should assure that it is used in such environment.
Emission test
Compliance
RF emissions CISPR 11
Group 1
RF emissions CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/flicker emissions
IEC 61000-3-3
Applicable
Table 2:
Guidance and manufacturer’s declaration-electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The purchaser or the user of the
device should assure that it is used in such environment.
Immunity test
IEC60601 test level
Compliance level
Electrostatic discharge
(ESD)
IEC 61000-4-2
±8kV contact
± 15 kV air
±8kV contact
±15kV air
Electrical fast
transient/burst
IEC 61000-4-4
±2kV for power supply lines
± 1 kV for input/output line
±2kV for power supply lines
Not Applicable
Surge
IEC 61000-4-5
±1 kV lines to lines
±2 kV lines to earth
±1 kV lines to lines
Not Applicable
Voltage dips, short
interruptions and voltage
vatiations on power supply
input lines
IEC 61000-4-11
<5%UT(>95%dip in UT) for 0.5 cycle
40% UT(60%dip in UT) for 5 cycle
70%UT(30%dip in UT) for 25 cycle
<5%UT(>95%dip in UT) for 5 sec
<5%UT(>95%dip in UT) for 0.5 cycle
40% UT(60%dip in UT) for 5 cycle
70%UT(30%dip in UT) for 25 cycle
<5%UT(>95%dip in UT) for 5 sec
Power frequency (50 /
60Hz) magnetic field
IEC 61000-4-8
30 A/m
30A/m
Table 3:
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer the user of the
device should assure that it is used in such environment.
Immunity test
IEC 60601 test level
Compliance level
Conducted RF
IEC61000-4-6
3 V
0,15 MHz – 80 MHz
6 V in ISM bands between
0,15 MHz and 80 MHz
3 V
0,15 MHz – 80 MHz
6 V in ISM bands between
0,15 MHz and 80 MHz
Radiated RF
IEC61000-4-3
10 V/m 80 MHz- 2.7 GHz
10 V/m80 MHz- 2.7 GHz
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.
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 the device is used exceeds the
applicable RF compliance level above, the the device should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or relocating the the device.
Table 4：
Guidance and manufacturer’s declaration - electromagnetic Immunity
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
Radiated RF
IEC61000-4-3
(Test
specifications
for
ENCLOSUR
EPORT
IMMUNITY
to RF wireless
communicatio
ns equipment)
Test
Frequency
(MHz)
Band a)
(MHz)
Service a)
Modulat
ion b)
Modulat
ion b)
(W)
Distan
ce
(m)
IMMUNIT
Y
TEST
LEVEL
(V/m)
385
380–
390
TETRA 400
Pulse
modulat
ion b)
18 Hz
1,8
0,3
27
450
380–
390
GMRS 460,
FRS 460
FM c)
± 5 kHz
deviatio
n
1 kHz
sine
2
0,3
28
710
704–
787
LTE Band 13,
17
Pulse
modulat
ion b)
217 Hz
0,2
0,3
9
745
780
810
800–
960
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulat
ion b)
18 Hz
2
0,3
28
870
930
1720
1700–199
0
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1,3,4,25;
UMTS
Pulse
modulat
ion b)
217 Hz
2
0,3
28
1845
1970
2450
2400–257
0
Bluetooth,WLAN,802.11
b/g/n,RFID 2450,LTE
Band 7
Pulse
modulat
ion b)
217 Hz
2
0,3
28
5240
5100–580
0
WLAN 802.11a/n
Pulse
modulat
ion b)
217 Hz
0,2
0,3
9
5500
5785
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.
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.