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)
Severe Hypertension/High Blood
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.
Attention! Please refer to the accompanying
document (the user manual).
Attention! Please refer to the accompanying
document (the user manual).
Enclosure protection grade
Electromagnetic compatibility
Material code of manufacturer
Fragile, handle with care
Storage atmospheric pressure limitation
Storage temperature limitation
Storage humidity limitation
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.
Interface for connecting cuff
Large movement during measurement
Chapter10 Error Message
When the high pressure position appears "Err" and the low pressure position appears the error number, the measurement
is not normal.
Please replace the battery or link adapter
The cuff is not wrapped correctly.
Wrap the cuff correctly (refer to Chapter 7)
Keep arm, body still, measure again
The pulse signal is too weak or the cuff is loose.
Wrap the cuff correctly (refer to Chapter 7)
Keep arm, body still, measure again
Cuff is blocked or squeezed
Wrap the cuff correctly (refer to Chapter 7)
The signal amplitude is too big owing to the arm
or body moving or other reasons when measuring
Keep arm, body still, measure again
Chapter11 Troubleshooting
BP measurement
values too high or
too low.
Cuff is not connected correctly.
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
The cuff windpipe is not correctly connected
with cuff
Cuff deflate in short
time
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
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.
Stop using the device and contact us.
Pull out the cuff to deflate. Stop using the
device and contact us.
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.
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
Electronic Sphygmomanometer
The degree of protection
against ingress of water
SYS:30~270 mmHg(4~36 kPa)
DIA:10~220 mmHg(1.3~29.3 kPa)
160±5 mmHg(21.33±0.67 kPa)
Pressure: 1 mmHg(0.133 kPa)
Static pressure: ±3 mmHg(±0.4 kPa)
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 by general vehicle or according to the order contract, avoid pounded, shake and
splash by rain and snow in transportation.
Temperature: -20 ºC~+55 ºC; Relative humidity: ≤95 %((no condensation)); No corrosive
gas and drafty.
4 "AA" alkaline batteries, AC Adapter(AC, 100 V-240 V, optional)
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.
300 gram(without batteries)
Class Ⅱ equipment (power supplied by power adapter)/Internally powered equipment
(power supplied by batteries)
Type BF applied part
The service life of the device is five years or 10000 times of BP measurement.
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.
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/flicker emissions
IEC 61000-3-3
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.
Electrostatic discharge
(ESD)
IEC 61000-4-2
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
±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
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.
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
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)
IMMUNIT
Y
TEST
LEVEL
(V/m)
Pulse
modulat
ion b)
18 Hz
FM c)
± 5 kHz
deviatio
n
1 kHz
sine
Pulse
modulat
ion b)
217 Hz
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulat
ion b)
18 Hz
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1,3,4,25;
UMTS
Pulse
modulat
ion b)
217 Hz
Bluetooth,WLAN,802.11
b/g/n,RFID 2450,LTE
Band 7
Pulse
modulat
ion b)
217 Hz
Pulse
modulat
ion b)
217 Hz
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.
The MANUFACTURER should consider reducing the minimum separation distance, based on
RISK MANAGEMENT, and using higher IMMUNITY TEST LEVELS that are appropriate for the reduced minimum
separation distance. Minimum separation distances for higher IMMUNITY TEST LEVELS shall be calculated using the
following equation:
Where P is the maximum power in W, d is the minimum separation distance in m, and E is the IMMUNITY TEST
LEVEL in V/m.