1
CE0120
Hingmed
Wearable Ambulatory Blood Pressure Monitor
User Manual
(Apply to：WBP-03D for home use)
Shenzhen Hingmed Medical Instrument Co., Ltd.
VER：A/0
Date: March 15, 2015
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About this Manual
The manual mainly introduces the installation and application method of
Wearable Ambulatory Blood Pressure Monitor. Users should read
carefully before application (include warnings, contraindications and
notes).
Manufacturer
Shenzhen Hingmed Medical Instrument Co., Ltd.
Manufacturing address: 4th Floor, Zhonghangfeixiang Building, NO. 371,
Guangshen Road, Bao’an District, Shenzhen, People’s Republic of
China
Tel: +86 755 23720600
Fax: +86 755 23720602
Post code: 518102
After-sales service
Company: Shenzhen Hingmed Instruments Co., Ltd.
Address: 4th Floor, Zhonghangfeixiang Building, NO. 371, Guangshen
Road, Bao’an District, Shenzhen, People’s Republic of China
Tel: +86 755 23720600
Fax: +86 755 23720602
Post code: 518102
European Representative
Company Name: Well Kang Limited
Company Address: The Black Church, St. Mary's Place, Dublin 7,
Ireland
Tel: +353(1)4433560
Fax: +353(1)6864856
Web: www.CE-marking.com
Email: AuthRep@CE-marking.eu
Version Information
This manual may upgrade due to software upgrading. User will not be notified
further.
■ Version: A/0
■ Issue date: March 2015
Shenzhen Hingmed Medical Instruments Co., Ltd. owns and reserves the
copyright.
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Table of Content
Chapter 1 Preface ..................................................................................................................5
1.1 Brief Introduction to Ambulatory Blood Pressure Monitoring ...................................5
Chapter 2 Safety Requirements ............................................................................................7
2.1 Intended use .............................................................................................................7
2.2 Contraindication ........................................................................................................8
2.3 Warnings ...................................................................................................................8
2.4 Notice ........................................................................................................................9
2.4.1 Battery ............................................................................................................9
2.4.2 Blood pressure measurement ........................................................................9
2.4.4 Energy conservation and environment protection .........................................9
2.4.5 Maintenance ...................................................................................................9
Chapter 3 Product Introduction ........................................................................................... 10
3.1 Product composition: ............................................................................................. 10
3.2 Name and Function of Each Component .............................................................. 10
3.2.1 Host Introduction ......................................................................................... 10
3.2.2 OLED screen displays and icon implication ................................................. 11
3.2.3 Symbols ........................................................................................................ 11
Chapter 4 Product Installation and Use .............................................................................. 12
4.1 Battery installation ................................................................................................. 12
4.2 Wear the monitor ................................................................................................... 12
4.2.1 Wear cuff correctly ...................................................................................... 12
4.2.2 Start for single measurement ...................................................................... 12
4.2.3 Ready for use .............................................................................................. 12
4.3 Installing System (PC terminal) ............................................................................. 13
4.3.1 Hardware requirements ................................................... 错误！未定义书签。
4.3.2 Software requirements .................................................... 错误！未定义书签。
4.3.3 Install the software .......................................................... 错误！未定义书签。
4.4 Execute Ambulatory Blood Pressure Study (PC terminal) ........ 错误！未定义书签。
4.4.1 Communication with Hingmed ABPM ............................. 错误！未定义书签。
4.4.2 Connect monitor to computer .......................................... 错误！未定义书签。
4.4.3 Continuous measurement programming ........................ 错误！未定义书签。
4.4.4 Start monitoring ............................................................... 错误！未定义书签。
4.4.5 Finish measuring ............................................................. 错误！未定义书签。
4.4.6 Derive data ...................................................................... 错误！未定义书签。
4.5 Install system (Smart mobile terminal) .................................................................. 13
4.5.1 Hardware requirements: .............................................................................. 13
4.5.2 Installation of software................................................................................. 13
4.5.3 The Bluetooth matching and connection ............................................................ 13
4.6 Execute Ambulatory Blood Pressure study (Smart mobile terminal). ................... 14
4.6.1 Communicate with Household Ambulatory Blood Pressure Monitor .......... 14
4.6.2 Program Ambulatory Blood Pressure Monitor software .............................. 14
4.6.3 Start ambulatory blood pressure measurement .......................................... 14
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4.6.4 Store and extract measurement data .......................................................... 15
4.6.5 Finish measurement and data derive.......................................................... 15
Chapter 5 Troubleshooting and Maintenance .................................................................... 15
5.1 Troubleshooting ..................................................................................................... 15
5.2 Maintenance .......................................................................................................... 16
5.2.1 Maintenance inspection and safety management ...................................... 16
5.2.2 Host Maintenance ....................................................................................... 16
Chapter 6 Product specifications ........................................................................................ 18
Chapter 7 EMC information ................................................................................................ 19
Chapter 8 Warranty Card .................................................................................................... 23
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Chapter 1 Preface
1.1 Brief Introduction to Ambulatory Blood Pressure Monitoring
Ambulatory blood pressure monitoring is an instrument for monitoring human’s blood
pressure continuously during certain period (normally 1-2 days) with certain interval that
is based on actual situation. Blood pressure readings in different periods and under
different life conditions can be judged according to the measuring results, thus blood
pressure diagnosis would be given.
During 24 hours in a day, human blood pressure is not fixed but fluctuates within a certain
scope. The diagnosis made by clinical blood pressure data collected randomly in
sickroom may miss some patient whose blood pressure is abnormal in a certain period in
a whole day due to neglecting the fluctuation of blood pressure. The 24-hour ambulatory
blood pressure monitoring can detect those patients in time.
It is also important to conduct 24-hour ambulatory blood pressure measuring for those
patients who were diagnosed hyperpietic. Research shows half of hyperpietic patients
who believe their blood pressures were controlled well have unstable blood pressures
through 24-hour ambulatory blood pressure monitoring, their blood pressures rise up in
the morning and/or in the afternoon, or rises up at night, so their blood pressure
controlling measures are not ideal. That is one of the answers to that why some
hypertension patients who stick to take medicine and feel good in blood pressures control
still suffer from renal damage. 24-hour ambulatory blood pressure monitoring can help
patients to realize the rules and characters of their blood pressure fluctuation. Accordingly,
patients could take short, medium or long-term antihypertensive drugs to control their
blood pressure and avoid damage of target organs e.g. cardio, brain and kidney.
Obviously, Ambulatory blood pressure monitoring is superior to clinical blood pressure
measurement, and gradually becomes an important method to evaluate the treatment
effect of ant-hypertension gradually.
Compare to clinical or home occasional blood pressure measuring, the ambulatory blood
pressure monitoring is superior in the following aspects:
(1) Eliminate the contingency in measuring and some affecting factors i.e mood, sports,
food, smoking, drinking, and others.
(2) Could attain more blood pressure data that could reflect practical variation rule
during a whole day.
(3) Could increase detection rate and help those slight or borderline hypertension
patients to get timely treatment, these patients may have not any symptom at early stage.
(4) May used to guide drug therapy. In many cases it could be used to evaluate drug
treatment effect, help to select drugs, and adjust dosage and drug administration time.
(5) To judge if there were target organs damage (especially organs which are
susceptible to hypertension). For the hypertension patients with myocardial hypertrophy,
fundus dynamic vascular lesions or renal function change, the blood pressure values
between day and night are usually small.
(6) To predict the time of sudden attack of cardiovascular and cerebrovascular disease in
a day. Generally, it is most frequent that before dawn the disease attacks due to a
sudden blood pressure rising.
(7) Ambulatory blood pressure has an important significance for prognosis. Compare with
normal blood pressure, patients with high blood pressure in 24 hours have higher
mortality and incidence of cardiovascular disease than those with low blood pressure in
24 hours.
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For the following hypertension types, it is only ambulatory blood pressure monitoring that
could diagnose easily.
1. white-coat hypertension
White-coat hypertension is the blood pressure that is high when measured at health care
site but normal in daily activity. The high pressure at health care site is repeatable in
different days. The white-coat hypertension accounts for about 15% in all clinic patients, it
is not rare.
2. Masked hypertension
Masked hypertension is that the clinical measuring value is less than the standard, but
the value from ambulatory blood pressure monitoring is high (135/85mmHg). It is
reported that population of masked hypertension accounts for about 10% of the general
crowd and about 40% of the patients undergoing antihypertensive therapy. It has to apply
ambulatory blood pressure monitoring on those masked hypertension patients who are
undergoing antihypertensive treatment.
3. Morning peak hypertension
Morning peak hypertension is defined that the average of matutinal blood pressure is
more than 135/85mmHg. It may be divided into 2 types-"matutinal peak" and
"reverse-dippers/non dipper". The morning peak type is characterized by sudden rise of
blood pressure early in the morning, and the reverse-dipper/non-dipper is characterized
by continuous rise of blood pressure in early morning and at night. Both of them are the
risk factors of cardiovascular disease. ABPM can identify the two types of hypertension.
4. Large circadian rhythm of blood pressure
The circadian rhythm of blood pressure is subject to relationship of daytime blood
pressure and nighttime blood pressure. In daytime patients are active and in nighttime
patients are sleeping, it is also influenced by external causes (i.e. sleep-wake cycle) and
internal cause (i.e. biological clock). Specific circadian rhythm variability is the average
change rate of blood pressure during nighttime and daytime. Although the circadian
rhythm is common for normal people and primary hypertension patients, some special
hypertension patients or few primary hypertension patients may occur disorder,
disappearance, even reversion to circadian rhythm.
5. Secondary hypertension
Circadian rhythm variability of secondary hypertension patients may be disturbed.
Because the disturbed circadian rhythm variability on secondary hypertension patients
may play a role on the target organ damage progress, an appropriate antihypertensive
treatment strategy should be made to recognize the circadian rhythm variability.
6. Hypotension
Ambulatory blood pressure monitoring is very useful not only to diagnose hypertension
but also diagnose hypotension. Especially, the hypotension could cause dizziness or
fainting on elder people who have exhaustion of autonomic nervous when standing, after
a meal or after a bath.
Hypotension is divided into primary hypotension and secondary hypotension. Primary
hypotension is common in women, which could reduce the patient's life quality usually.
However, just few primary hypotensions will be treated considering long-term prognosis,
because primary hypotension just leads to few vascular disorders. On the other hand,
secondary hypotension is usually caused by some normal diseases and is accompanied
with dangerous syndromes such as syncope and vertigo, so patients need prevention
and therapeutic measures. The ambulatory blood pressure monitoring is useful to
diagnose secondary hypotension.
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1.2 Brief Introduction of Hingmed Wearable ABPM
Blood Pressure Monitor with Body Position Information
Hingmed ambulatory blood pressure monitor has an outstanding feature that it could
provide the user's body position when taking blood pressure measurement, which is of
significance in clinical research. Some symptoms of hypertensive patients, such as
dizziness, nausea, brain death, are caused under dynamic environment of working or
other life. Therefore, monitoring patient’s blood pressure could not be confined to a quiet
condition. It is the best that patients who are wearing ambulatory blood pressure monitor
live a daily life and work. The data would reflect the actual daily blood pressure. That is
helpful to clinical judgments.
Different postures have a great influence on blood pressure. 24-hour monitoring shows
the blood pressure is fluctuant at distinct time. If a monitor can reflect the user's position
at the same time, it would be helpful for doctors to find the causes of the blood pressure
fluctuations, and then distinguish effectively natural change, fluctuation or fluctuation
caused by position changing and moving.
In addition, blood pressure data with position information can help doctors to make a
good judgment on orthostatic hypertension. Position hypertension is that the pressure is
high at standing or sitting posture, but normal at lying flat. Orthostatic hypertension
accounts for 4.2% in domestic hypertension patients and 10% in abroad report.
Orthostatic hypertension is characterized by that there is not hypertension in normal and
just being found occasionally or in physical examination. Diastolic pressure rising-up and
large fluctuation would represent in orthostatic hypertension and the individual could be
accompanied by serious palpitation, tiredness, sleep quickly etc. In blood examination,
the plasma rennin activity in orthostatic hypertension is higher than that of normal people,
even than that of general hypertension patient.
Scope of application
Hingmed Ambulatory blood pressure monitor is designed to assist in diagnosis. Doctor
could give advice to use this medical device by his or her judgment if patient is:
● Hypertension;
● Hypotension;
● Borderline hypertensive (BH), renal inadequacy;
● Control and evaluate the anti-hypertension efficacy, etc.
Chapter 2 Safety Requirements
2.1 Intended use
Wearable Blood pressure monitor is mainly used to measure blood pressures, which
include systolic pressure, diastolic pressure and pulse rate, of patients in different setting
intervals within 24 hours (not applicable to children under 3 years), and the measurement
data can be transmitted by Bluetooth for medical personnel’s reference and analysis at
home or in the open air.
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Product composition: Main unit, Noninvasive blood pressure cuff, USB data wire and
Hingmed PC software.
The device is inner power source with one piece of Lithium battery; Electric shock
protection degree: CF type applied part; Operation mode: continuous mode.
The service life of this product is five years.
2.2 Contraindication
● Do not use the monitor near X-ray tomography device.
● Do not use the monitor in the places where inflammable anesthetic exist, it may lead to
explode.
● Do not wrap the cuff on the limb being used for IV injection as cuff inflation may block
infusion and hurt patient.
● Do not immerse the monitor in any liquid or any detergent, which would cause electrical
hazard.
2.3 Warnings
● Cuff shall not be worn on the wound, because inflation pressure may cause further
damage;
● When patients carry the monitor, pull out the data wire from PC or other devices;
● Never apply the device to patient under 3 years old and patient who can’t express their
thoughts.
● The instrument can’t be used in conjunction with defibrillation equipment.
● It may cause measurement error by using parts not included in the supply listing.
● Make sure the pressure is suitable for the patient. If any abnormity occurs in the
monitoring process, please stop measuring immediately, and remove the cuff from the
patient or shortly press start/stop button to stop inflating. If the cuff fails to deflate,
please remove it properly and safely.
● If this device is dampened by accident, put it in a well-ventilated place for drying prior to
use.
● Only professional physicians can explain the measured blood pressure values.
● Don’t service/maintenance while the medical equipment is in use
● The patient is an intended operator. The patient can only measure, transmit data under
normal circumstances and maintain the device and its accessories according to the
User Manual.
● Not intended to be sterilized.
● Not for use in an oxygen rich environment.
● No modification of this equipment is allowed.
● It is not intended for use with neonate.
● It is not intended for use with pregnant or pre-eclamptic patients.
● Do not apply the cuff over a wound; otherwise it can cause further injury.
● The application of the cuff and its pressurization on any wrist/arm where intravascular
access or therapy, or an arterio-venous(A-V) shunt, is present.
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● Inflate the cuff on the side of a mastectomy.
● Do not inflate the cuff on the same limb which other monitoring ME equipment is
applied around simultaneously, because this could cause temporary loss of function of
those simultaneously-used monitoring ME equipment.
● Please check that operation of the device does not result in prolonged impairment of
patient blood circulation.
● The device cannot be used with HF surgical equipment at the same time.
● Keep out of the reach of children after use.
2.4 Notice
2.4.1 Battery
● The monitor uses built-in battery, do not replace it without authorization.
●Connect monitor host to computer USB port through USB data wire for recharging,
alternatively, connect host to USB port of adapter, and then connect adapter to power
socket for recharging. The adapter should be with 3C compulsory certification or other
compulsory certifications (such as FCC or CE). The specifications of adapter should be:
input: 100-240V, 50/60HZ; output: 5V, 1A.
● Keep the monitor away from high-temperature places, and avoid direct-sunlight in
summer, also, the environmental temperature shall not be over 60 Celsius degree.
● For security, consult after-sale supporter quickly, if the Li-ion cannot be charged or its
discharge speed is fast.
2.4.2 Blood pressure measurement
● Patient with anticoagulant or patient with coagulation disorder may extravasate on the
position wrapping cuff, in the process of measuring blood pressure even the cuff is
worn correctly. In fact, no matter what type of the monitor is, such patients would
extravasate during the measuring process.
● If cuff fails to inflate in 150 seconds, guide patients to remove the cuff manually,
excessive inflation may block patient's blood flow that makes patient uncomfortable.
● Keep still during measuring, especially do not move their cuffed arms, and it is better to
keep quiet, and make the cuff as the same horizontal position as the heart.
● Operating or storing the monitor beyond the specified environmental conditions in
Chapter 6 would cause damage.
2.4.4 Energy conservation and environment protection
● Please power the monitor off in time after using.
● Please properly handle the scrapped batteries, cuff, data wires and main units in
compliance with local environmental regulations.
2.4.5 Maintenance
● Please use the accessories supplied by Hingmed, otherwise it may cause measuring
errors.
● Maintenance should be conducted only by trained personnel or personnel authorized
by Hingmed.
● Displaying method of faults: corresponding codes will display on the screen in
malfunction state, see 5.1 troubleshooting for details.
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Chapter 3 Product Introduction
3.1 Product composition:
Prior to use please confirm if accessories are complete, and if there is any damage on
main unit and accessories, any problem above is found, please contact distributors or
Hingmed customer service hotline for help.
Main unit, accessories include blood pressure cuff, and USB wire for charging.
Other accessories:
User Manual
Quality Certification/warranty card
Hingmed ABPM Packing List
Accessories Items Name Qty
Hingmed Wearable ABPM Monitor 1
Portable box for monitor 1
USB data wire 1
Adult cuff (26-36 cm) 1
User Manual 1
Quality Certification 1
*The product packaging should contain above items, any item misses, please contact
Hingmed or distributors immediately.
Optional accessories
Number Accessories Name
1 Small Adult cuff (18-26cm)
2 Middle Adult cuff (22-32cm)
3 Large Adult cuff (33-43cm)
3.2 Name and Function of Each Component
3.2.1 Host Introduction
1
2
3
4
5
6
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1 OLED screen; 2 Cuff; 3 Backward button; 4 Power on/off button (Closing state) and
Start/stop button (Open state); 5 Forward button; 6 USB port.
3.2.2 OLED screen displays and icon implication
Diastolic pressure
Systolic pressure
Diastolic and systolic pressure values indicated
after measuring
Unit of diastolic and systolic pressure
Heart rate value indicated after measuring
Heart rate unit (times per minute)
Indicate current time when not measuring, after
powering on.
indicate battery capacity
3.2.3 Symbols
Symbol Description Symbol Description
CF type applied part
Series number
Manufacturer
Attention, refer to
accompanying documents
Keep away from rain
This way up
Fragile
Complying with WEEE
standard
Stacking limit by
number
Temperature limits
Refer to user manual
It means the device could
protected against solid foreign
objects of 12.5mm and
greater, and against vertical
falling water drop 15°
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Chapter 4 Product Installation and Use
4.1 Battery installation
The monitor adopts built-in Li-ion battery which is unable-dismantled, and do not replace it
without authorization, when the capacity of battery is going to run out, please recharge the
monitor by using USB.
4.2 Wear the monitor
Hingmed wearable ABPM is integration design, it suggests wearing the cuff on left arm,
click the power on/off button (the middle button) to open the monitor, and press it for about
5 seconds to close the monitor.
4.2.1 Wear cuff correctly
Wear cuff correctly, the bottom of the cuff should be 2-3 cm above
the fossa cubitalia. Make sure that the artery sign is against
the artery brachialis and points to fossa cubitalis, adjust the position
of monitor to outside place, see the picture right:
Note: 1 Improper size of cuff will lead to error of readings and
affect the accuracy of measuring.
2. Do not wrap the cuff on the diseased skin directly,
wrap a partition like cloth or film before wrapping the
cuff, to avoid cross-infection.
4.2.2 Start for single measurement
Press “start/stop” button to start measuring (the middle button), it
only measures for one time, after measuring, user can read the data on OLED screen,
also, user can click forward button or backward button to read history data.
For programming measurement, please refer to sections 4.3-4.4 of this user manual.
4.2.3 Ready for use
For ambulatory blood pressure study, a good preparation of patient is important.
● Patient should avoid overstress, excitement and tightened muscle.
● When start inflating, patient should keep the measuring arm away from body slightly,
and keep quiet and still as soon as possible.
● During programming monitoring, patient may press the button of “start/stop” to
start/stop measuring at any time.
● Never remove the cuff in the process of measuring, if the cuff slips below the elbow or
falls off, patient could take it off and rewrap.
● Data would not be lost if battery is run down, or monitoring program is interrupted, or,
monitor is manually force closed.
●Guidepatienttorecordtheeventsthataffectbodypositionobviouslyduringmeasuring;
● Make sure that patient know how to check the monitor. The monitor should be dry and
avoid falling and bumping.
● If monitor or cuff causes excessive pain or abnormal pain, patient should remove the
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cuff and power off the monitor.
4.3 Install system (Smart mobile terminal)
4.3.1 Hardware requirements:
Operating system requirements：Android system 2.3.1 or higher versions，Apple IOS
system IOS 6.0 or higher versions.
Handhold terminal requirements: Iphone 4S or above versions for Apple mobile phone,
Ipad Mini, Ipad 3 or higher versions, Ipad Touch 5 or higher versions; With handhold
terminal of Android system, e.g. Samsung, Lenovo, Huawei, Xiaomi, Coolpad phone with
480X800 or above resolution of the display screen
Memory requirements: software size is about 1.64M and need about 3.74M installing
EMS memory.
4.3.2 Installation of software
For Android system handhold terminal, users could log on
Hingmed website http:// www.hingmed.com or Android APP
platform, download and install “Hingmed blood pressure”
software.
For Apple IOS system handhold terminal, Users log on App
Store, download and install “Hingmed blood pressure” software.
The icon appears on the screen of handhold terminal
means a successful software installation.
4.3.3 The Bluetooth matching and connection
For Android phone, enter “Setting”---“Bluetooth” (at the time, keep the Bluetooth of
monitor open), search the Bluetooth of monitor (“Hingmed WBP”) and make pairing. Click
to open software APP and enter “More” ---“Bluetooth setting” and choose “Hingmed
WBP” to connect monitor and mobile phone. After successful connection, click to exit
and click ”Measurement” to log in measurement interface. See Fig 4.
For Apple phone, open software App directly and enter “More” ---“Bluetooth setting” and
choose “Hingmed WBP” to connect monitor and mobile phone. After successful
connection, click to exit and click ”Measurement” to log in measurement interface.
See Fig 4.
Fig 4
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4.4 Execute Ambulatory Blood Pressure study (Smart mobile
terminal).
4.4.1 Communicate with Household Ambulatory Blood Pressure Monitor
Connect monitor and handhold terminal through Bluetooth, program the software of
handhold terminal and start monitoring to execute 24-hour Ambulatory Blood Pressure
study. Monitor will measure the pressure according to the set interval.
4.4.2 Program Ambulatory Blood Pressure Monitor software
Program software after successful connection as followings:
Click on top righ to enter programming interface (see Fig 5). User could set Daytime
/ nighttime measurement model, monitoring frequency, time
and maximum inflation pressure by sliding or clicking the
interface.
Parameter setting:
1. Daytime / nighttime continuous measurement interval: Define
start time, end time and measurement interval in daytime or
nighttime. The data will be stored automatically in term with the
defined time.
2. Measurement interval: measurement interval is the time of
two successive measurements. The options may be 15, 30, 45,
60, 90, and 120 (min).
3. Maximum inflation pressure: Maximum inflation pressure is the maximum one in a
measurement. Usually the range is set from 200mmHg to 280mmHg.Possible maximum
systolic pressure plus 40mmHg is recommended. The actual inflation pressure setting
should not reach up to the maximum pressure, which may cause user discomfort. You
can set the pressure with last measurement plus 40mmHg. The setting of Maximum
inflation pressure is for protecting few users who could not bear excessive cuff pressure.
4. Fill in or choose other options truthfully and click “Program” to upload these setting to
monitor. Screen will display “Successful programming” if the programming is
accomplished.
4.4.3 Start ambulatory blood pressure measurement
After successful software programming, click the button on monitor to start the first
measurement. The monitor will perform following measurements till to the end time
according to the setting. Data will be stored automatically and user could click “Statistic”
and “History” to review the history data and chart or send the information to medical staff
by E-mail for further analysis.
Fig 5
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4.4.4 Store and retrieve measuring data
If keeping connection between monitor and handhold terminal through Bluetooth, the
data will be transmitted to handhold terminal continuously from monitor. If Bluetooth is
disconnected and reconnected, the lost data will be transmitted automatically.
User can click “Data backup” on “More” interface to backup the data on SD card (Note:
IOS system has not this function).
4.4.5 Finish measurement and data derive
Press “start/stop” button for 5 seconds to finish measurement if user wants to finish the
measurement before end time. Power indicator light of host and the light of Bluetooth
also close.
Note:
1. Operation details of Mobile phone software of Hingmed Wearable Ambulatory
Blood Pressure Monitor, please refer to < User Guide of APP software >;
2. The monitor could store maximum 300 hundred records. When storage is full,
the monitor can’t save data normally until programming it from smart mobile
phone.
Chapter 5 Troubleshooting and Maintenance
5.1 Troubleshooting
E
rror
Code
Description Resolution
EC01
Cuff is too loose, maybe loose winding or
disconnected cuff
Retighten cuff or keep proper arm
position when inflation
EC02
Air leakage, maybe valve leakage or gas
path leakage
Tighten metal connector and check
the cuff. If leakage is not still
resolved, contact agent or dealer
EC03
Air pressure error, maybe unable to open of
valve
Check whether the valve can work
normally
EC04
weak signal，maybe week pulse or loose
cuff
Check whether the cuff is too loose,
tighten it if necessary.
EC05
beyond the limit，maybe the pressure of
subject beyond the limitation
Press “start/stop” button to measure
again. If not valid still, change the
monitor of larger rang
EC06
Excessive exercise，maybe there is too
much motion artifact or interference
Keep quiet when measured and do
not move the arm with cuff
EC07
overpressure，cuff pressure beyond
290mmHg in adult mode, 247mmHg in child
mode and 145mmHg in neonatal mode
Press “start/stop” button to measure
again.
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EC08
Signal saturation，The amplitude of the
signal is too large due to activity or other
reason
Keep quiet, Press “start/stop” button
to measure again.
EC09
overtime：measuring time beyond 120s in
adult/child mode, 90s in neonatal mode.
Keep quiet, Press “start/stop” button
to measure again.
EC10 manual de-activation
Keep quiet, Press “start/stop” button
to measure again.
EC11 System error
Restart， If the error occur frequently,
professional Maintenance may be
necessary
EC16
Cuff pressure beyond the max pressure
setting
Reprogramming in PC software and
up-regulate the max inflation
pressure setting
EC32 The handshake communication fail
Press “start/stop” button to measure
again.
EC33
safe pressure beyond 15mmHg，
immeasurable
Gassing and remeasure when the
cuff pressure decline to below
15mmHg
EC34
Measurement finish ,and restart the
measuring when the pressure is still above
15mmHg
Gassing and remeasure when the
cuff pressure decline to below
15mmHg
EC35
No answer when the measurement
command is sent.
Press “start/stop” button to measure
again.
EC36 Measurement result is not available
Press “start/stop” button to measure
again.
EC37 Overtime (beyond 180s) remeasure
EC48 Memory is full, can no longer measure Upload and empty the data
* If the errors can be revised, please call distributor or after-sale department of Hingmed
for help.
5.2 Maintenance
5.2.1 Maintenance inspection and safety management
Visually inspect the broken or damages on enclosure and cuff. If any damage is found,
do not use the monitor. Please contact the distributor or the after-sale service department
of Hingmed.
5.2.2 Host Maintenance
After use, it is important to perform preventative maintenance to ensure the safe and
efficient operation of the monitor for long-term.
● It is recommended that the performance should be checked every 2 years and after
maintenance and repair, by retesting at least the requirements in limits of the error of the
cuff pressure indication and Air leakage (testing at least at 50 mmHg and 200 mmHg).
● Do not disinfect. DO NOT immerse the monitor in any fluid, or attempt to clean with any
liquid detergents, cleaning agents, or solvents. You may use a soft, damp cloth to remove
dirt and dust from the monitor. If the unit does become immersed in water, do not use
and contact the distributor or our service department.
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● Do not clean the enclosure and cuff with strong alkali or acid or strong disinfectant.
● May use a mild detergent to clean the cuff, belt and bladder; alternatively, may also
wash them in a washing machine. Remove the bladder from the cuff before machine
washing. Wash them by using warm water and a mild detergent, then hang it for drying.
Any problem, please contact local distributors or Hingmed (see Chapter 8 for
information).
● Take down the monitor from the cuff, use a mild detergent to clean the cuff and bladder,
remove the bladder (with fixing board on it) from the cuff before washing, then hang them
for drying. After drying, put the bladder into the cuff, then install the monitor onto the cuff.
See the following steps to take down the cuff:
a) Dismantle
NO.
Picture Description NO.
Picture Description
1
Hold the positions
shown in the
picture, and give
force by following
the red arrows.
2
Pull out the top
two fixing clips
3
Then move down
along the unit, hold
the positions shown
in the picture, and
give force by
following the red
arrows.
4
Pull out the
middle two
fixing clips
5
Hold the same
positions in step 3,
and give force by
following the red
arrow.
6
Then the main
unit and the
cuff are
detached.
b) Assemble
NO.
Picture Description NO.
Picture Description
1
Put the bottom
fixing clip and
minimized hose into
relevant holes, and
push the unit by
following the red
arrow.
2
The bottom
fixing clip and
hose are
pressed into
place.
18
3
Hold the positions
shown in the
picture, and press
simultaneously, then
press around the
edges of main unit
4
The monitor is
installed well
Chapter 6 Product specifications
Name Wearable Ambulatory Blood Pressure Monitor
Model WBP-03D
measuring method Oscillometric method
Systolic blood pressure
measurement range
40-260 mmHg
Diastolic blood pressure
measurement range
20-210 mmHg
Pulse rate measurement
range
40-200 bpm
Resolution Blood pressure: 1mmHg or 0.1Kpa; pulse rate: 1BPM
Repeatability
The difference of repeated readings of each point is within
4mmHg in the statically continuous low-pressure mode
Accuracy Static Accuracy: ±3 mmHg; Pulse rate: ±3BPM
Pressure testing American Freescale pressure sensor
Working power supply Built-in Li-ion battery
Data memory Flash memory stores up to 300 readings
Calibration frequency At least one time two years
Security system The rated range of cuff pressure: 0~290mmHg
Sampling period Multiple independent programming cycle
Size About 119×52×21mm
Net weight About 105g，including battery
Work environment T: 5℃-40℃; HR: 10%-95%; gas pressure: 70KPa-106KPa
Condition of storage
Stored under the condition of temperature (-20℃-+55℃), HR
(no more than 95%) and atmospheric pressure
(70KPa-106Kpa), no corrosive gases and well-ventilated.
Data transmitted by USB data wire, Bluetooth connection
Protection against
harmful ingress of water
IP22
19
Software version
Embedded software: 1.0
PC software: 1.0
* There is not further notice if product specification changes.
Chapter 7 EMC information
This product needs special precautions regarding EMC and needs to be installed and put
into service according to the EMC information provided, and this unit can be affected by
portable and mobile RF communications equipment.
Do not use a mobile phone or other devices that emit electromagnetic fields, near
the unit. This may result in incorrect operation of the unit.
Caution: This unit has been thoroughly tested and inspected to assure proper
performance and operation!
Caution: this machine should not be used adjacent to or stacked with other
equipment and that if adjacent or stacked use is necessary, this machine should be
observed to verify normal operation in the configuration in which it will be used.
Guidance and manufacture’s declaration – electromagnetic emission
The WBP-03D is intended for use in the electromagnetic environment specified below. The customer of
the user of the WBP-03D should assure that it is used in such an environment.
Emission test Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1
The WBP-03D use RF energy only for its
internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emission
CISPR 11
Class B
The WBP-03D is suitable for use in all
establishments, including domestic
establishments and those directly connected to
the public low-voltage power supply network
that supplies buildings used for domestic
purposes.
Harmonic emissions
IEC 61000-3-2
Not applicable
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Not applicable
20
Guidance and manufacture’s declaration – electromagnetic immunity
The WBP-03D is intended for use in the electromagnetic environment specified below. The customer or
the user of WBP-03D should assure that it is used in such an environment.
Immunity test
IEC 60601 test
level
Compliance
level
Electromagnetic environment
- guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood,
concrete or ceramic tile. If floor
are covered with synthetic
material, the relative humidity
should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for
input/output
lines
Not applicable Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
Not applicable Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips, short
interruptions and
voltage variations
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 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 sec
Not applicable Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the WBP-03D requires
continued operation during
power mains interruptions, it is
recommended that the WBP-03D
be powered from an
uninterruptible power supply or
a battery.
Power frequency
(50Hz/60Hz)
magnetic field IEC
61000-4-8
3 A/m 3 A/m Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical commercial
or hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
21
Guidance and manufacture’s declaration – electromagnetic immunity
The WBP-03D is intended for use in the electromagnetic environment specified below. The
customer or the user of the WBP-03D should assure that it is used in such an environment.
Immunity
test
IEC 60601
test level
Compliance
level
Electromagnetic environment - guidance
Conducted
RF
IEC
61000-4-6
3 V
rms
150 kHz to 80
MHz
Not
applicable
Portable and mobile RF communications
equipment should be used no closer to any part of
the WBP-03D, including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended separation distance
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended
separation distance in metres (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,a
should be less than the compliance level in each
frequency range.b
Interference may occur in the vicinity of equipment
marked with the following symbol:
Radiated RF
IEC
61000-4-3
3 V/m
80 MHz to 2.5
GHz
3 V/m
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 WBP-03D is used
22
exceeds the applicable RF compliance level above, the
WBP-03D
should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or
relocating the WBP-03D.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between
portable and mobile RF communications equipment and the WBP-03D .
The WBP-03D is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the WBP-03D can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the WBP-03D as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum
output power of
transmitter
(W)
Separation distance according to frequency of transmitter
(m)
150 KHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
0.01
0.12 0.12 0.23
0.1
0.38 0.38 0.73
1 1.2 1.2 2.3
10
3.8 3.8 7.3
100
12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in metres (m) can be estimated 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.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for 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.
23
Chapter 8 Warranty Card
Warranty Card
Product model and SN code： Name：
Purchase Date： Address：
Dealer： Tel：
Postal Code： Dealer stamp：
The limited liability of guarantee
Hingmed provides the original purchaser the following limited warranty from the date of
invoicing.
Hingmed Wearable ambulatory blood pressure monitor………………………… 12 months
Accessories except cuff…………………………………………………………………90 days
Cuff..………………………………………………………………..……………………6 months
Hingmed warrants each monitor to be free from defects in material and workmanship.
Liability under this warranty covers servicing of the returning monitor from customer
prepaying to the prospective factory (depending on location). Hingmed will repair any
defective component(s) or part(s) during the period of this limited warranty.
Should a defect become apparent, the original purchaser should notify Hingmed of the
suspected defect; the monitor should be carefully packaged and be prepaid shipped to:
Shenzhen Hingmed Medical Instrument Co., Ltd.
Address: 4th Floor, Zhonghangfeixiang Building, NO. 371, Guangshen Road, Bao’an
District, Shenzhen, People’s Republic of China
Tel: +86 755 23720600
Fax: +86 755 23720602
Postal code: 518102
Email: info@Hingmed.com
The monitor will be repaired as soon as possible, and be returned by the same shipping
method as received by the factory if it is prepaid.
This limited warranty is invalid if the monitor has been damaged due to accidents, misuse,
negligence, or maintained by any person not authorized by Hingmed.
This limited warranty contains the entire obligations of Hingmed, exclud other expressed,
implied or regulated warranties. Representatives or employees without authorized by
Hingmed will assume any further liability or grant any further warranties except as set
herein.
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