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
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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
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