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User Manual
version:1.0
Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, No.105 ,Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
Blood Pressure Monitor
TMB-1591
Arm Type
Thank you very much for selecting TRANSTEK Blood Pressure
Monitor TMB-1591.
To use the monitor correctly and safely, please read the manual
thoroughly.
Please keep this manual well in order to reference in future.
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CATALOGUE
CATALOGUE
Table of Contents
INTRODUCTION........................................................................................2
General Description
Safety Information
Indications for Use
LCD Display Signal
Monitor Components
BEFORE YOU START................................................................................7
The Choice of Power Supply
Installing and Replacing the Batteries
MEASUREMENT.......................................................................................8
Pairing
Tie the Cuff
Start the Measurement
INFORMATION FOR USER......................................................................13
Tips for measurement
Maintenances
ABOUT BLOOD PRESSURE....................................................................15
What are systolic pressure and diastolic pressure?
What is the standard blood pressure classification?
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..............................................................................17
SPECIFICATIONS.....................................................................................18
AUTHORIZED COMPONENT ..................................................................19
CONTACT INFORMATION........................................................................19
COMPLIED STANDARDS LIST.................................................................20
FCC STATEMENT......................................................................................21
IC STATEMENT..........................................................................................22
EMC GUIDANCE.......................................................................................23
1
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INTRODUCTION
INTRODUCTION
General Description
Thank you for selecting TRANSTEK arm type blood pressure
monitor (TMB-1591). 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 TMB-1591 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:
68mm*90mm Digital LCD display with White backlight
Maximum 99 records
Measuring during inflation technology
Indications for Use
The Transtek Blood Pressure Monitor is digital monitors intended
for use in measuring blood pressure and heartbeat rate with arm
circumference ranging from 22cm to 42cm(about 8¾˝-16½˝).
It is intended for adult indoor use only.
Measurement Principle
This product uses the Oscillometric Measuring method to
detect blood pressure. Before every measurement, the unit
establishes a “zero pressure” equivalent to the air 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.
The device also compares the longest and the shortest time
intervals of detected pulse waves to mean time interval then
calculates standard deviation. The device will display a warning
signal with the reading to indicate the detection of irregular
heartbeat when the difference of the time intervals is over 25%.
Safety Information
The signs below might be in the user manual, labeling or other
component. They are the requirement of standard and using.
Symbol for “THE OPERATION
GUIDE MUST BE READ”
The Bluetooth Combination
Mark
Symbol for “MANUFACTURER”
For indoor use only
F1
T1A/250V Φ3.6*10CCC
WARNING:These warning notes
must be observed to preventany
injury to the user.
The ingress protection: the device could protected against solid foreign
objects of 12.5mm and greater, and against vertically falling water drops
IP22
when ENCLOSURE tilted up to 15°
Symbol for “KEEP DRY”
WARNING
1. The device is not suitable for measuring the blood pressure of children. Ask your
doctor before using it on older children.
2. The device is not suitable for use on pregnant women, patients with implanted,
electrocical devices, patients with pre-elcampsia, premature ventricular beats, atrial
fibrillation, peripheral, arterial disease and patients undergoing intravascular 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
3.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.
4.Please keep the unit out of reach of infants, children or pets, since inhalation or
swallowing of small parts is dangerous or even fata.
Do not dispose of batteries in fire. Batteries may explode or leak.
5.
Symbol for “TYPE BF APPLIED
PARTS”
Symbol for “ENVIRONMENT
PROTECTION – Electrical waste
products should not be disposed
of with household waste. Please
followlocal guidelines.”
Symbol for “DIRECT CURRENT”
Symbol for “Class II Equipment”
Caution: These notes must be
observed to prevent any damage
to the device.
Symbol for “SERIAL NUMBER”
SN
32
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INTRODUCTIONINTRODUCTION
CAUTION
This device is intended only for adult use in homes.
This device is intended for non-invasive measuring and monitoring of arterial blood pressure.
It is not intended for use on extremities other than arm or for functions other than obtaining a
blood pressure measurement.
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.
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.
Too frequent and consecutive measurements could cause disturbances in blood circulation
and injuries.
Do not wrap the cuff on the same arm which other monitoring ME EQUIPMENT is applied
simultaneously, because this could cause temporary loss of function of those
simultaneously-used monitoring ME EQUIPMENT.
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.
The equipment is not AP/APG equipment and not suitable for use in the presence of a
flammable anesthetic mixture with air of with oxygen or nitrous oxide.
This unit is not suitable for continuous monitoring during medical emergencies or operations.
This device cannot be used with HF surgical equipment at the same time.
This device is not intended for patient transports outside a healthcare facility.
To avoid measurement errors, please avoid the condition of strong electromagnetic field
radiated interference signal or electrical fast transient/burst signal.
The operator shall not touch output of batteries/adapter and the patient simultaneously.
Manufacturer will make available on request circuit diagrams, component parts list etc.
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 sensization or irritation
reaction.Never apply the cuff over hurt skin.
Do not use the unit in case of existing polyester resp. synthetic allergies.
Be careful to strangulation due to cables and hoses, particularly due to excessive length.
Do not connect the air hose to other medical equipment, as this could cause air to be pumped
into intravascular systems or high pressure, what could lead to dangerous injuries.
Before use, make sure the device functions safely and is in proper working condition.
Please use the device under the environment which was provided in the user manual.
Otherwise, the performance and lifetime of the device will been impacted and reduced.
Please use ACCESSORIES and detachable partes specified/ authorised by
MANUFACTURE. Otherwise, it may cause damage to the unit or danger to the user/patients.
Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to
the local guidelines.
Please do not attempt to repair the unit yourself in the event of malfunctions. Only have
repairs carried out by authorized service centers.
Please report to Manufacturer if any unexpected operation or events occur.
The device doesn’t need to be calibrated in two years of reliable service.
Please use the soft cloth to clean the whole unit. Don’t use any abrasive or volatile cleaners.
The patient is an intended operator.The patient can measure and change battery under
normal circumstances and maintain the device and its accessories according to the user
manual.
Don't press or restrict the connection tubing during measurement. The device is not intended
for public use.
LCD Display Signal
SYMBOL DESCRIPTION
Systolic blood pressure High pressure result
Diastolic blood pressure Low pressure result
Pulse
mmHg Measurement Unit of the blood pressure
Irregular heartbeat
Battery Indicator Indicate the current battery
Grade
Shocking reminder
Data transmission error
Heartbeat
SYS
mmHg
DIA
mmHg
PULSE
/MIN
EXPLANATION
Pulse/minute
Irregular heartbeat detection
The grade of the blood pressure
Shocking will result in inaccurate
Data transmission error
Heartbeat dectetion during measurement
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