Medicare LIFESENSE MD1814 User manual

User Manual
Version:1.0
A1 Blood Pressure Monitor MD1814 (TMB-1872-A)
Thank you very much for selecting Medicare LifeSense®A1 Blood
Pressure Monitor MD1814 (TMB-1872-A).
Please read the user manual carefully and thoroughly so as to ensure the
safe usage of this product. Keep the manual well for further reference in
case you have problems.
GUANGDONG TRANSTEK MEDICAL
ELECTRONICS CO., LTD.
Zone A, No. 105, Dongli Road,
Torch Development District, 528437
Zhongshan, Guangdong, China
Limerick, V94 K6W4, Ireland
1800 307777 (IRE) 0800 7314315 (UK)
WWW.FLEMINGMEDICAL.IE
FLEMING MEDICAL LTD
Schiffgraben 41, 30175 Hannover, Germany
MEDICAL DEVICE SAFETY SERVICE GmbH
Arm Type
Model: TMB-1872-A
V1.5.210322

Table of Contents
INTRODUCTION ................................................................................................................. 2
• General Description
• Indications for Use
• Contraindications
• Measurement Principle
• Safety Information
• LCD Display Signal
• Monitor Components
• List
BEFORE YOU START.........................................................................................................9
• The Choice of Power Supply
• Installing and Replacing the Batteries
• Setting Date and Time
• Select the User
MEASUREMENT.................................................................................................................13
• Tie the Cuff
• Start the Measurement
DATA MANAGEMENT.........................................................................................................15
• Recall the Records
• Delete the Records
INFORMATION FOR USER................................................................................................18
• Tips for measurement
• Maintenance
ABOUT BLOOD PRESSURE ............................................................................................. 20
• What are systolic pressure and diastolic pressure?
• What is the standard blood pressure classification?
• Irregular heartbeat detector
• Why does my blood pressure fluctuate throughout the day?
• Why do I get a different blood pressure at home compared to the hospital?
• Is the result the same if measuring on the right arm?
TROUBLESHOOTING ........................................................................................................ 22
SPECIFICATIONS ............................................................................................................... 23
AUTHORIZED COMPONENTS .......................................................................................... 24
CONTACT INFORMATION ................................................................................................. 24
COMPLIED STANDARDS LIST.......................................................................................... 25
EMC GUIDANCE................................................................................................................. 26
CATALOGUE CATALOGUE
1

The signs below might be in the user manual, labelling or other component.
They are the requirement of standard and using.
Safety Information
Symbol for “RECYCLE”
Symbol for “MEDICAL DEVICE”
Symbol for “THE OPERATION
GUIDE MUST BE READ”
Symbol for “MANUFACTURER”
Symbol for “SERIAL NUMBER”
Symbol for “TYPE BF APPLIED
PARTS”
Symbol for “DIRECT CURRENT”
Symbol for “ENVIRONMENT
PROTECTION - Electrical waste
products should not be disposed of
with household waste. Please recycle
where facilities exist. Check with your
local authority or retailer for recycling
advice”
Caution: These notes must
be observed to prevent any
damage to the device.
SN
Symbol for “MANUFACTURE
DATE”
Symbol for “COMPLIES WITH
MDD 93/42/EEC REQUIREMENTS”
Symbol for “Authorised
Representative in the European
Community
EC REP
Thank you for selecting Medicare LifeSense® A1 Blood Pressure
Monitor (MD1814 (TMB-1872-A)). The monitor features blood
pressure measurement, pulse rate measurement and the result
storage. The design provides you with two years of reliable service.
Readings taken by the MD1814 (TMB-1872-A) are equivalent to
those obtained by a trained observer using the cuff and stethoscope
auscultation method. This manual contains important safety and care
information, and provides step by step instructions for using the
product. Read the manual thoroughly before using the product.
Features:
60*41mm Digital LCD display
Maximum 60 records per each user
Measuring during inflation technology
General Description
The Medicare LifeSense® Blood Pressure Monitor is a digital monitor intended for use
in measuring blood pressure and heartbeat rate with arm circumference ranging
from 22cm to 32cm(about 8¾˝-12½˝). It is intended for adult indoor use only.
Indications for Use
Measurement Principle
Contraindications
1. The device should not be used by any person who may be suspected of,or is pregnant.
2. The device is not suitable for use on patients with implanted,electrical devices,
such as cardiac pacemakers, defibrillators.
This product uses the Oscillometric Measuring method to detect blood pressure.
Before every measurement, the unit establishes a “zero pressure” equivalent to the
atmospheric pressure. Then it starts inflating the arm cuff, meanwhile, the unit detects
pressure oscillations generated by beat-to-beat pulsatile, which is used to determine
the systolic and diastolic pressure, and also pulse rate.
INTRODUCTION INTRODUCTION
2 3

CAUTION CAUTION
* This device is intended for adult use in homes only.
* The device is not suitable for use on neonatal patients, pregnant women,patients with
implanted, electronic devices, patients with pre-eclampsia, premature ventricular beats,
atrial fibrillation, peripheral, arterial disease and patients undergoing intra-vascular therapy
or arterio-venous shunt or people who received a mastectomy. Please consult your doctor
prior to using the unit if you suffer from illnesses.
* The device is not suitable for measuring the blood pressure of children. Ask your doctor
before using it on older children.
* The device is not intended for patient transport outside a healthcare facility.
* The device is not intended for public use.
* This device is intended for no-invasive measuring and monitoring of arterial blood
pressure. It is not intended for use on extremities other than the arm or for functions other
than obtaining a blood pressure measurement.
* Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your
blood pressure. Do not begin or end medical treatment without asking a physician for
treatment advice.
* If you are taking medication,consult your physician to determine the most appropriate time
to measure your blood pressure. Never change a prescribed medication without consulting
your physician.
* Do not take any therapeutic measures on the basis of a self measurement. Never alter the
dose of a medicine prescribed by a doctor. Consult your doctor if you have any question
about your blood pressure.
* When the device is used to measure patients who have common arrhythmias such as
atrial or ventricular premature beats or atrial fibrillation, the best result may occur with
deviation. Please consult your physician about the result.
* Don't kink the connection tube during use, otherwise, the cuff pressure may continuously
increase which can prevent blood flow and result in harmful injury to the PATIENT.
* When using this device, please pay attention to the following situation which may interrupt
blood flow and influence blood circulation of the patient, thus cause harmful injury to the
patient: connection tubing kinking too frequent and consecutive multiple measurements; the
application of the cuff and its pressurization on any arm where intra-vascular access or
therapy, or an arterio-venous (A-V) shunt, is present; inflating the cuff on the side of a
mastectomy.
* Warning: Do not apply the cuff over a wound;otherwise it can cause further injury.
*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.
*On the rare occasion of a fault causing the cuff to remain fully inflated during measurement,
open the cuff immediately. Prolonged high pressure (cuff pressure ＞300mmHg or constant
pressure ＞15mmHg for more than 3 minutes) applied to the arm may lead to an
ecchymosis.
*Please check that operation of the device does not result in prolonged impairment of
patient blood circulation.
* When measurement, please avoid compression or restriction of the connection tubing.
* The device cannot be used with HF surgical equipment at the same time.
* The ACCOMPANYING DOCUMENT shall disclose that the SPHYGMOMANOMETER
was clinically investigated according to the requirements of ISO 81060-2:2013.
* To verify the calibration of the AUTOMATED SPHYGMOMANOMETER, please contact
the manufacturer.
* This device is contraindicated for any female who may be suspected of, or is pregnant.
Besides providing inaccurate readings, the effects of this device on the foetus are unknown.
* Too frequent and consecutive measurements could cause disturbances in blood
circulation and injuries.
* This unit is not suitable for continuous monitoring during medical emergencies or
operations. Otherwise, the patient’s arm and fingers will become anaesthetic, swollen and
even purple due to a lack of blood.
* When not in use, store the device with the adapter in a dry room and protect it against
extreme moisture, heat, lint, dust and direct sunlight. Never place any heavy objects on the
storage case.
* This device may be used only for the purpose described in this booklet. The manufacturer
cannot be held liable for damage caused by incorrect application.
*This device comprises sensitive components and must be treated with caution. Observe
the storage and operating conditions described in this booklet.
* The equipment is not AP/APG equipment and not suitable for use in the presence of a
flammable anaesthetic mixture with air of with oxygen or nitrous oxide.
* Warning: No servicing/maintenance while the ME equipment is in use.
* The patient is an intended operator.
* The patient can measure data and change batteries under normal circumstances and
maintain the device and its accessories according to the user manual.
* To avoid measurement errors, please avoid the condition of strong electromagnetic field
radiated interference signal or electrical fast transient/burst signal.
* The blood pressure monitor, its adapter, and the cuff are suitable for use within the patient
environment. If you are allergic to polyester, nylon or plastic, please don't use this device.
* During use, the patient will be in contact with the cuff. The materials of the cuff have been
tested and found to comply with requirements of ISO 10993-5:2009 and ISO
10993-10:2010. It will not cause any potential sensation or irritation reaction.
* Adaptor is specified as a part of ME EQUIPMENT.
* If you experience discomfort during a measurement, such as pain in the arm or other
complaints, press the START/STOP button to release the air immediately from the cuff.
Loosen the cuff and remove it from your arm.
* If the cuff pressure reaches 40 kPa (300 mmHg), the unit will automatically deflate.
Should the cuff not deflate when pressure reaches 40 kPa (300 mmHg), detach the cuff
from the arm and press the START/STOP button to stop inflation.
* Before use, make sure the device functions safely and is in proper working condition.
Check the device, do not use the device if it is damaged in any way. The continuous use of
a damaged unit may cause injury, improper results, or serious danger.
* Do not wash the cuff in a washing machine or dishwasher!
INTRODUCTIONINTRODUCTION
4 5

LCD Display Signal
User 1 Start measurement for User 1
User 2 Start measurement for User 2
SYMBOL DESCRIPTION
Systolic blood pressure High blood pressure
Diastolic blood pressure Low blood pressure
EXPLANATION
Memory
mmHg Measurement Unit of the blood pressure
Low battery Batteries are low and need to be replaced
mmHg
Current Time Year/Month/Day, Hour/Minute
Pulse in beats per minute
Pulse display
Blood pressure monitor is detecting an
irregular heartbeat during measurement.
Irregular heartbeat
Blood pressure
level indicator Indicate the blood pressure level
(1mmHg=0.133kPa)
Indicate it is in the memory mode and
which group of memory it is.
Heartbeat Blood pressure monitor is detecting a
heartbeat during measurement.
Motion indicator Motion may result in an inaccurate
measurement
Average value The average value of blood pressure
* The service life of the cuff may vary by the frequency of washing, skin condition, and
storage state. The typical service life is 10000 times.
* 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 50mmHg and 200mmHg).
* Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according
to the local guidelines.
* Manufacturer will make available on request circuit diagrams, component part lists,
descriptions, calibration instructions,etc., to assist to service personnel in parts repair.
* The plug/adapter plug pins insulate the device from the main supply. Do not position the
device in a position where it is difficult to disconnect from the supply mains to safely
terminate operation of ME equipment.
* The operator shall not touch output of batteries/adapter and the patient simultaneously.
* Cleaning :Dust environment may affect the performance of the unit. Please use the soft
cloth to clean the whole unit before and after use. Don’t use any abrasive or volatile
cleaners.
* The device doesn’t need to be calibrated within two years of reliable service.
* If you have any problems with this device, such as setting up, maintaining or using, please
contact the SERVICE PERSONNEL of Fleming Medical Ltd. Don’t open or repair the device
by yourself in the event of malfunctions. The device must only be serviced, repaired and
opened by individuals at authorized sales/service centres.
* Please report to Fleming Medical Ltd. if any unexpected operation or events occur.
* Keep the unit out of reach of infants, young children or pets to avoid inhalation or
swallowing of small parts. It is dangerous or even fatal.
* Be careful to strangulation due to cables and hoses, particularly due to excessive length.
* At least 30 min required for ME equipment to warm from the minimum storage
temperature between uses until it is ready for intended use. At least 30 min required for ME
equipment to cool from the maximum storage temperature between uses until it is ready for
intended use.
* This equipment needs to be installed and put into service in accordance with the
information provided in the ACCOMPANYING DOCUMENTS;
* Wireless communications equipment such as wireless home network devices, mobile
phones, cordless telephones and their base stations, walkie-talkies can affect this
equipment and should be kept at least a distance d away from the equipment. The distance
d is calculated by the MANUFACTURER from the 80MHz to 5.8 GHz column of Table 4 and
Table 9 of IEC 60601-1-2:2014, as appropriate.
* Please use ACCESSORIES and detachable parts specified/ authorised by MANUFAC-
TURE. Otherwise, it may cause damage to the unit or danger to the user/patients.
* There is no luer lock connectors are used in the construction of tubing, there is a
possibility that they might be inadvertently connected to intra-vascular fluid systems,
allowing air to be pumped into a blood vessel.
* Please use the device under the environment which was provided in the user manual.
Otherwise, the performance and lifetime of the device will be impacted and reduced.
CAUTION
INTRODUCTIONINTRODUCTION
76

Monitor Components
List
1. Blood Pressure Monitor
MD1814 (TMB-1872-A)
2. Cuff (Type BF applied part)
(22~32cm)
Component list of
pressure measuring system
1 Cuff
2 Air pipe
3 PCBA
4 Pump
5 Valve
BATTERY COMPARTMENT
The Choice of Power Supply
In order to get the best effect and protect your monitor,please use the right
battery and special power adaptor which complies with local safety standard.
• Slide off the battery cover.
• Install the batteries by matching
the correct polarity, as shown.
• Replace the battery cover.
1.Battery powered mode:
6VDC 4*AAA batteries
2.
Installing and Replacing the Batteries
CAUTION
CAUTION
Replace the batteries whenever the below happens
The shows
The display is dim
The display does not light up
Do not use new and used batteries together.
Do not use different types of batteries together.
Do not dispose the batteries in fire. Batteries may explode or leak.
Remove batteries if the device is not likely to be used for some time.
Worn batteries are harmful to the environment. Do not dispose with daily garbage.
Remove the old batteries from the device following your local recycling guidelines.
MEM BUTTON START/STOP BUTTON
SET BUTTON
CUFF
AIR HOSE
LCD DISPLAY
AIR CONNECTOR PLUG
Please use the AC adaptor and USB
cable just like the following picture:
AC adaptor
AC adaptor powered mode:
5V 1A(Not included)
USB INTERFACE
4. User manual3. 4×AAA batteries
BEFORE YOU STARTINTRODUCTION
98

Setting Date and Time
It is important to set the clock before using your blood pressure
monitor, so that a time stamp can be assigned to each record that
is stored in the memory. (The setting range of the year :2018—2058
time:24H/12 H)
1.When the monitor is off,
press “SET” button shortly
it will display the time. Then
press “SET” button for 3
seconds to enter the mode
for year setting.
3.When you get the right
year, press “SET” button
to set down and turn to next
step.
4.Repeat step 2 and 3 to
set the [MONTH] and [DAY].
5
.Repeat step 2 and 3 to
set the [TIME FORMAT]
between 12h and 24h.
2.Press “MEM” button to
change the [YEAR].
Each press will increase
the numeral by one in a
cycling manner. 6.Repeat step 2 and 3 to
set the [HOUR] and [MINUTE].
.After the [MINUTE] is set,
the LCD will display “donE”
first,then display all the
settings you have done
and then it will turn off.
7
BEFORE YOU START BEFORE YOU START
1110

Tie the Cuff
2~3cm
1.
4.
Hold your arm with your palm facing up and tie the cuff
on your upper arm, then position the tube off-centre toward
the inner side of arm in line with the little finger. Or position
the artery mark over the main artery (on the inside of your arm).
Note: Locate the main artery by pressing with 2 fingers
approximately 2 cm above the bend of your elbow on the inside
of your left arm. Identify where the pulse can be felt the strongest.
This is your main artery.
The cuff should be snug but not too tight. You should be able to
insert one finger between the cuff and your arm.
Remove all jewellery, such as watches and bracelets
from your left arm. Note: If your doctor has diagnosed
you with poor circulation in your left arm, use your right arm.
Roll or push up your sleeve to expose the skin.
Make sure your sleeve is not too tight.
2.
3.
Sit comfortably with your tested arm resting on
a flat surface. Place your elbow on a table
so that the cuff is at the same level as your heart.
Turn your palm upwards. Sit upright in a chair,
and take 5-6 deep breaths.
Rest for 5 minutes before first measurement.
Wait at least 3 minutes between measurements.
This allows your blood circulation to recover.
The patient must relax as much as possible and do not move and talk
during the measurement procedure.
For a meaningful comparison, try to measure under
similar conditions. For example, take daily measurements
at approximately the same time, on the same arm,
or as directed by a physician.
5.
6.
Take the measurement in a silent room.
The cuff should maintain at the same level as the right atrium
of the heart.
Please sit comfortably. Do not cross your legs and
keep your feet flat on the ground.
Keep your back against the backrest of the chair.
Helpful tips for Patients, especially for Patients
with Hypertension:
Select the User
1.
2.
3.
When the monitor is off, press and hold “MEM ”button to
enter user setting mode. The user ID will blink.
Then press “ MEM ” button again, select the user ID between
user 1 and user 2.
After selecting the suitable user ID, press “SET” button to
confirm. It will display “User ID+ donE” and then turn off.
BEFORE YOU START MEASUREMENT
1312

1
Start the Measurement Recall the Records
1. When the monitor is off,
please press “MEM” button
to show the recent record.
If the records are less than
3 groups, it will display the
latest record instead. Take
user 1 for example.
2. Press “MEM” button
or “SET” button to get
the record you want.
The most recent record (1) is shown first. Each new measurement is
assigned to the first (1) record. All other records are pushed back one
digit (e.g., 2 becomes 3, and so on), and the last record (60) is dropped
from the list.
The corresponding
time is 10:38.
CAUTION
The current No.,
date and time
of the record
will be shown
alternately.
The current No. is No. 1.
three records in total.
The corresponding
date is 2019 year
July 1st.
.When the monitor is off, press “Start/Stop” button to turn on
the monitor, and it will finish the whole measurement.
Adjust the zero.LCD display
Inflating and measuring. Display and save the results.
2.Press “Start/Stop” button to power
off, otherwise it will turn off
within 1 minute.
START
STOP
STAR
STO
START
STOP
DATA MANAGEMENTMEASUREMENT
1514

If you did not get the correct measurement, you can delete
results by following steps below.
Delete the Records
A: Delete one record
1. Hold pressing “set” button
for 3 seconds when the
monitor is in the memory
recall mode, the flash
display “dEL one+User
ID” will show.
2. Press and hold “Start/stop”
button to confirm deleting
and the monitor will display
“dEL donE+USER ID” and then
turn off.
Note: To exit out the delete mode
press “Start/Stop” button shortly.
STAR
STO
1. Hold pressing “MEM” button
for 3 seconds when the
monitor is in the memory
recall mode, the flash
display “dEL ALL+User
ID” will show.
2. Press and hold “Start/stop”
button to confirm deleting
and the monitor will display
“dEL donE+USER ID” and then
turn off.
3. If there is no record,
the right display will
show.
START
STOP
B: Delete all records
Note: To exit out the delete mode
press “Start/Stop” button shortly.
START
STOP
START
STOP
DATA MANAGEMENT DATA MANAGEMENT
1716

Please calibrate the blood pressure monitor in specific institute once
every two years to ensure the precise measurement. In order to get the
best performance, please follow the instructions below for storage.
Maintenance
Put in a dry place and
avoid the sunshine.
Avoid intense shaking
and collisions.
Using wet cloths to remove dirt.
Avoid touching water,
clean it with a dry cloth in case.
Do not attempt to clean the
reusable cuff with water and
never immerse the cuff in water.
Tips for Measurement
Measurements may be inaccurate if taken in the following
circumstances.
Immediately after
consuming caffeine
or smoking.Within 1 hour of eating or drinking.
Within 20 minutes of taking a bath.
In a very cold
environment.
When talking or
moving your fingers.
When you need to use the toilet.
Avoid dusty and unstable
temperature environment.
INFORMATION FOR USERINFORMATION FOR USER
1918

Why does my blood
pressure fluctuate
throughout the day?
Is the result the same if
measuring on the right
arm?
Why do I get a different
blood pressure at home
compared to the hospital?
1. Individual blood pressure varies
multiple times everyday. It is also affected
by the way you tie your cuff and your
measurement position, so please take the
measurement under the same conditions.
2. If the person takes medicine, the
pressure will vary more.
3. Wait at least 3 minutes for another
measurement.
The blood pressure is different even
throughout the day due to weather,
emotion, exercise etc., Also, there is the
“white coat” effect, which means blood
pressure usually increases in clinical
settings.
It is ok for both arms, but there will
be some different results for different
people. We suggest you measure
the same arm every time.
What you need to pay attention
to when you measure your
blood pressure at home:
If the cuff is tied properly.
If the cuff is too tight or too loose.
If the cuff is tied on the upper arm.
If you feel anxious.
Taking 2-3 deep breaths before
beginning will be better for measuring.
Advice: Relax yourself for 4-5 minutes
until you calm down.
What are systolic pressure and diastolic pressure?
press
artery vein
blood discharging
Systolic
relax
blood entering
Diastolic
When ventricles contract and pump blood out of the
heart, the blood pressure reaches its maximum value
in the cycle, which is called systolic pressure. When
the ventricles relax, the blood pressure reaches its
minimum value in the cycle, which is called diastolic
pressure.
What is the standard blood pressure classification?
The blood pressure classification published
by World Health Organization (WHO) and
International Society of Hypertension (ISH)
in 1999 is as follows:
Irregular Heartbeat Detector
CAUTION
The appearance of the IHB icon indicates that a pulse irregularity consistent with an
irregular heart-beat was detected during measurement. Usually this is NOT a cause for
concern. However, if the symbol appears often, we recommend you seek medical advice.
Please note that the device does not replace a cardiac examination, but serves to detect
pulse irregularities at an early stage.
SYS
DIA
<120
<80
120-129
80-84
130-139
85-89
140-159
90-99
160-179
100-109
≥180
≥110
Level
Blood
Pressure (mm Hg)
Optimal Normal
High-normal
Mild Moderate Severe
An irregular heartbeat is detected when a heartbeat rhythm varies while the device is
measuring systolic pressure and diastolic pressure. During each measurement, blood
pressure monitor will keep a record of all the pulse intervals and calculate the average
value of them. If there are two or more pulse intervals , the difference between each
interval and the average is more than the average value of ±25% , or there are four or
more pulse intervals ,the difference between each interval and the average is more than
the average value of ±15%, then the irregular heartbeat symbol will appear on the display
with the measurement result.
Only a physician can tell your normal BP range.
Please contact a physician if your measuring
result falls out of the range. Please note that
only a physician can tell whether your blood
pressure value has reached a dangerous point.
CAUTION
ABOUT BLOOD PRESSUREABOUT BLOOD PRESSURE
20 21

Power supply
Battery powered mode:
6VDC 4*AAA batteries
AC adaptor powered mode: 5V 1A
(not included)
(Please only use the recommended AC
adaptor model).
Display mode
Measurement mode
Oscillographic testing mode
Measurement range
Accuracy
Normal working condition
Storage & transportation
condition
Measurement perimeter
of the upper arm
About 22cm~32cm
Net Weight
External dimensions
Attachment user manual,
4*AAA batteries
Mode of operation Continuous operation
Degree of protection
Protection against
ingress of water
Software Version A01
Pressure:
5°C-40°C within±3mmHg(0.4kPa)
Pulse value:±5%
Device Classification
Battery Powered Mode:
Internally Powered ME Equipment
AC Adaptor Powered Mode:
Class II ME Equipment
Rated cuff pressure:
0mmHg~299mmHg(0kPa ~ 39.9kPa)
Measurement pressure:
SYS: 60mmHg~230mmHg (8.0kPa~30.7kPa)
DIA: 40mmHg~130mmHg (5.3kPa~17.3kPa)
Pulse value: (40-199)beat/minute
IP21 It means the device could protected against
solid foreign objects of 12.5mm and greater, and
protect against vertically falling water drops.
Type BF applied part
WARNING: No modification of this equipment is allowed.
Digital LCD display V.A.60mm*41mm
Approx.162g(Excluding the batteries)
Approx.93mm*130mm*32.5mm
A temperature range of :+5°C to +40°C
A relative humidity range of 15% to 90%,
non-condensing, but not requiring a water
vapour partial pressure greater than 50 hPa
An atmospheric pressure range of :
700 hPa to 1060 hPa
Temperature:-20°C to +60°C
A relative humidity range of ≤ 93%, non-condensing,
at a water vapour pressure up to 50hPa
This section includes a list of error messages and frequently
asked questions for problems you may encounter with your blood
pressure monitor. If the product is not operating as you think it
should, check here before arranging for servicing.
PROBLEM SYMPTOM CHECK THIS REMEDY
No power
Low
batteries
Error
message
Display will not
light up.
Batteries are exhausted. Replace with new batteries
Insert the batteries
correctly
Replace with new batteries
Batteries are inserted
incorrectly.
Display is dim or
show Batteries are low.
EExx,shows on
the display.
Retake the measurement.
If the problem persists,
contact the retailer or our
customer service
department for further
assistance. Refer to the
warranty for contact
information and return
instructions.
AC adaptor is inserted
incorrectly.
Insert the AC adaptor
tightly
Warning
message
“out ” shows Out of measurement
range
E01 shows
E03 shows
E04 shows The treatment of the
measurement failed.
E02 shows
The cuff is too tight
or too loose.
Refasten the cuff and then
measure again.
The monitor detected
motion, talking,or the
pulse is too poor
during measurement.
Relax for a moment and
then measure again.
Relax for a moment and
then measure again.
The measurement
process does not
detect the pulse
signal.
Loosen the clothing on
the arm and then
measure again.
Relax for a moment.
Refasten the cuff and then
measure again. If the
problem persists, contact
your physician.
A calibration error occurred.
(XX could be some digital
symbol,such as 01,02,etc.,
if this similar situation
appear, all belongs to
calibration error.)
SPECIFICATIONSTROUBLESHOOTING
22 23

Contact Information
For more information about our products, please visit
www.flemingmedical.ie. Fleming Medical Ltd. will serve you anytime.
Distributed By: Fleming Medical Ltd.
Address: Corcanree Business Park, Dock Road
Limerick, V94 K6W4, Ireland
Phone (ROI): 1800 307777
Phone (UK): 0800 7314315
Manufactured By: Guangdong Transtek Medical Electronics Co., Ltd.
Address: Zone A, No.105 ,Dongli Road, Torch Development District,
528437 Zhongshan,Guangdong,China
Authorised EC REP: Medical Device Safety Service GmbH
Address: Schiffgraben 41, 30175 Hannover, Germany
Authorized Components
1.Please use the Fleming Medical Ltd. authorised adapter (not included).
Adapter
Type：BLJ06L050100U-V
Input：100~240V, 50/60Hz,0.2A MAX
Output：5V 1000mA
Complied Standards List
EN ISO 14971:2012 / ISO 14971:2007 Medical devices -
Application of risk management to medical devices
EN 1041:2008 +A1:2013 Information supplied by the manufacturer
of medical devices
EN 60601-1:2006+A1:2013+A12:2014 / IEC 60601-1:2005+A1:2012
Medical electrical equipment - Part 1: General requirements for basic
safety and essential performance
EN 60601-1-11:2015/ IEC 60601-1-11:2015 Medical electrical
equipment - Part 1-11: General requirements for basic safety and
essential performance - Collateral standard: Requirements for medical
electrical equipment and medical electrical systems used in the home
healthcare environment
EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical
equipment - Part 1-2: General requirements for basic safety and
essential performance - Collateral standard: Electromagnetic
disturbances - Requirements and tests
EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1:
Requirements and test methods for non-automated measurement type
EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers -
Part 3: Supplementary requirements for electro-mechanical blood
pressure measuring systems
EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test
procedures to determine the overall system accuracy of automated
non-invasive sphygmomanometers
EN 60601-1-6:2010+A1:2015/IEC 60601-1-6:2010+A1:2013
Medical electrical equipment - Part 1-6: General requirements for basic
safety and essential performance - Collateral standard: Usability
IEC 62366-1:2015 Medical devices - Part 1: Application of
usability engineering to medical devices
EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015 Medical
device software - Software life-cycle processes
Risk management
Labelling
User manual
General Requirements
for Safety
Electromagnetic
compatibility
Performance
requirements
Clinical investigation
Usability
Software life-cycle
processes
Bio-compatibility
ISO 10993-1:2018 Biological evaluation of medical devices- Part
1: Evaluation and testing within a risk management process
ISO 10993-5:2009 Biological evaluation of medical devices -
Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices -
Part 10: Tests for irritation and skin sensitization
EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices.
Symbols to be used with medical device labels, labelling and
information to be supplied. Part 1 : General requirements
IEC 80601-2-30:2018 Medical electrical equipment- Part
2-30: Particular requirements for the basic safety and essential
performance of automated non-invasive sphygmomanometers
ISO 81060-2:2018 Non-invasive sphygmomanometers - Part 2:
Clinical validation of intermittent automated measurement type
AUTHORISED COMPONENTS COMPILED STANDARDS LIST
24 25

EMC Guidance
The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments
Warning：Don’t near active HF surgical equipment and the RF shielded room of an ME system for magnetic
resonance imaging, where the intensity of EM disturbances is high.
Warning：Use of this equipment adjacent to or stacked with other equipment should be avoided because it
could result in improper operation. If such use is necessary, this equipment and the other equipment should be
observed to verify that they are operating normally.
Warning: Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation.”
Warning：Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to any part of the equipment MD1814 (TMB-1872-A),
including cables specified by the manufacturer. Otherwise, degradation of the performance of this
equipment could result.
Technical description：
1，All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to
electromagnetic disturbances for the excepted service life.
2，Guidance and manufacturer’s declaration -electromagnetic emissions and Immunity
Table 1
Guidance and manufacturer’s declaration - electromagnetic emissions
RF emissions
CISPR 11 Group 1
Class [ B ]
Class A
Comply
Compliance
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
RF emissions
CISPR 11
Emissions test
Table 2
Guidance and manufacturer’s declaration – electromagnetic Immunity
Immunity Test
±8 kV contact
±2 kV, ±4kV, ±8 kV, ±15 kV air
±8 kV contact
±2 kV for power supply lines
±0.5 kV, ±1 kV differential mode
0 % UT; 0,5 cycle. At 0°, 45°, 90°, 135°,
180°, 225°, 270° and 315°.0 % UT;
1 cycle and 70 % UT; 25/30 cycles;
Single phase: at 0°.0 % UT; 250/300 cycle
30 A/m
50Hz/60Hz
NOTE UT is the a.c. mains voltage prior to application of the test level.
Compliance level
Electrostatic
discharge (ESD)
IEC 61000-4-2
30 A/m
50Hz/60Hz
Power frequency
magnetic field
IEC 61000-4-8
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC61000-4-5
±1 kV signal input/output
100 kHz repetition frequency
IEC 60601-1-2
Test level
0 % UT; 0,5 cycle. At 0°, 45°, 90°, 135°,
180°, 225°, 270° and 315°.
0 % UT; 1 cycle and 70 % UT;
25/30 cycles; Single phase: at 0°.
0 % UT; 250/300 cycle
±2 kV, ±4kV, ±8 kV,
±15 kV air
±2 kV for power supply lines
±1 kV signal input/output
100 kHz repetition frequency
±0.5 kV, ±1 kV,±2 kV common mode
±0.5 kV, ±1 kV differential mode
±0.5 kV, ±1 kV,±2 kV common mode
Conduced RF
IEC61000-4-6
3 V
0,15 MHz – 80 MHz
6 V in ISM and amateur radio bands
between 0,15 MHz and 80 MHz
80 % AM at 1 kHz
3 V
0,15 MHz – 80 MHz
6 V in ISM and amateur radio bands
between 0,15 MHz and 80 MHz
80 % AM at 1 kHz
10 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
10 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
Radiated RF
IEC61000-4-3
EMC GUIDANCE EMC GUIDANCE
26 27

Table 3
Guidance and manufacturer’s declaration - electromagnetic Immunity
Test
Frequency
(MHz)
385 0.3 27
Radiated RF
IEC61000-4-3
(Test
specifications
for
ENCLOSURE
PORT
IMMUNITY to
RF wireless
communica-
tions
equipment)
Band
(MHz)
Service Modulation Modulation
(W)
Distance (m)
IMMUNITY
TEST
LEVEL
(V/m)
380-390 TETRA
400
Pulse
modulation b)
18Hz
1.8
450 430-470
GMRS 460，
FRS 460
FM c) ± 5kHz
deviation 1kHz
sine
20.3 28
710 704-787
745
780
LTE Band
13,
17
Pulse
modulation b)
217Hz
0.2 0.3 9
810
870
930
800-960 GSM
800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulation b)
18Hz
20.3 28
1720
1845
1970
1700-
1990
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1,
3,
4,25; UMTS
Pulse
modulation b)
217Hz
20.3 28
20.3 282450 2400-
2570
Bluetooth,
WLAN,
802.11
b/g/n, RFID
2450, LTE
Band 7
Pulse
modulation
217 Hz
5240
5500
5785
5100-
5800
WLAN
802.11
a/n
Pulse
modulation
217 Hz
0.2 0.3 9
EMC GUIDANCE
28 29