Transtek Medical Electronics TMB1491 B User Manual
version:1.0
User Manual
Blood Pressure Monitor
TMB-1491-BT
Arm Type
Thank you very much for selecting TRANSTEK Blood Pressure Monitor
TMB-1491-BT.
Please do read the user manual carefully and thoroughtly so as to ensure
the safe usage of this product, and 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,
Zhongshan,528437,Guangdong,China
Table of Contents
CATALOGUE CATALOGUE
INTRODUCTION...................................................................................................................2
General Description
Indications for Use
Safety Information
LCD Display Signal
Monitor Components
BEFORE YOU START...........................................................................................................6
The Choice of Power Supply
Installing and Replacing the Batteries
Measurement Principle
Setting Date, Time and Measurement Unit
Select the User
Pair-up the Blood Pressure Monitor with Your Device
MEASUREMENT...................................................................................................................13
Tie the Cuff
Start the Measurement
DATA MANAGEMENT..........................................................................................................16
Recall the Records
Delete the Records
INFORMATION FOR USER................................................................................................18
Tips for measurement
Maintenances
ABOUT BLOOD PRESSURE..............................................................................................20
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........................................................................................................22
SPECIFICATIONS..............................................................................................................23
AUTHORIZED COMPONENT ...........................................................................................24
CONTACT INFORMATION.................................................................................................24
COMPLIED STANDARDS LIST..........................................................................................25
FCC STATEMENT...............................................................................................................26
EMC GUIDANCE................................................................................................................27
INTRODUCTION INTRODUCTION
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”
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”
Symbol for “MANUFACTURE
DATE”
Thank you for selecting TRANSTEK arm type blood pressure Monitor
(TMB-1491-BT). 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-1491-BT 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: Maximum 60 records
General Description
For indoor use only
F1
7$9ĭ&&& Symbol for “Class II Equipment”
3rd technonoly: Measuring during inflation
(The updated technology in the world)
60mm×40.5 mm Digital LCD display
The Bluetooth Combination Mark
Symbol for “Including RF
transmitter”
This device is intended for adult use only.
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.
When the device was 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.
If the cuff pressure exceeds 40 kPa (300 mmHg), the unit will automatically deflate. Should the cuff not
deflate when pressures exceeds 40 kPa (300 mmHg), detach the cuff from the arm and press the
START/STOP button to stop inflation.
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.
The operator shall not touch output of batteries/AC adaptor and the patient simultaneously.
To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated
interference signal or electrical fast transient/burst signal.
The user must check that the equipment functions safely and see that it is in proper working
condition before being used.
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 fetus are unknown.
Manufacturer will make available on request circuit diagrams, component parts list etc.
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.
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.
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 sensization or irritation reaction.
The device has been evaluated clinically using manual cuff/stethoscope auscultation as the reference.
Blood pressure measurements determined with this device are equivalent to those obtained by a trained
observer using the cuff/stethoscope auscultatory method, within the limits prescribed by the American
National Standard, Manual, electronic, or automated sphygmomanometers.”
The patient is an intended operator. The patient can measure under normal circumstances and maintain
the device and its accessories according to the user manual.
The blood pressure monitor, and the cuff are suitable for use within the patient environment. If you are
allergic to dacron or plastic, please don’t use this device.
Please keep the unit out of reach of infants, children or pets, since inhalation or swallowing of small parts is
dangerous or even fata.
If Luer lock connectors are used in the construction of tubing, there is a possibility that they might be
inadvertently connected to intravascular fluid systems, allowing air to be pumped into a blood vessel.
The device is not suitable for public use.
The device is not intended for PATIENT transport outside a healthcare facility.
This device cannot be used with HF surgical equipment at the same time.
Be careful to strangulation due to cables and hoses, particularly due to excessive length.
CAUTION
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
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It is intended for adult indoor use only.
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INTRODUCTION INTRODUCTION
LCD display signal
SYMBOL DESCRIPTION
Systolic blood pressure High pressure result
Diastolic blood pressure Low pressure result
EXPLANATION
Pulse per minute Beats per minute, BPM
Deflating CUFF air is exhausting of deflating
Memory
The displayed measurement values
is from the memory.
mmHg
kPa
Measurement Unit of the blood pressure
Measurement Unit of the blood pressure
Low battery
Batteries are low and need to be replaced
Irregular heartbeat
Arrhythmia
Grade
The grade of the blood pressure
Current Time
Year/Month/Day, Hour/Minute
Monitor Components
List
1.Blood Pressure Monitor
(TMB-1491-BT)
4.User manual
2.Cuff (Type BF applied part) (22~32cm or 22~42cm)
Component list of
pressure measuring system
1 Cuff
2 Air pipe
3 PCBA
4 Pump
5 Valve
5. AC Adaptor
(Model : KH0601000UW)
3. 4×AAA alkaline batteries
BATTERY COMPARTMENT
(1kPa=7.5mmHg)
(1mmHg=0.133kPa)
Heartbeat
Heartbeat detection during the
measurement
User 1
Start measurement,save and transmit the
measuring results for User 1
User 2
Start measurement,save and transmit the
measuring results for User 2
Bluetooth icon
The bluetooth icon blinks when the
bluetooth is working
MEM BUTTON
START/STOP BUTTON
SET BUTTON
CUFF
AIR HOSE
LCD DISPLAY
AIR CONNECTOR PLUG
BEFORE YOU START BEFORE YOU START
In order to get the best effect and protect your monitor,please use the right
battery and special power adaptor which complies with U.S. safety standard.
Open the battery cover.
Install the batteries by matching
the correct polarity, as shown.
Replace the cover.
Installing and Replacing the Batteries
CAUTION
Remove batteries if the device is not likely to be used for some time.
The old batteries are harmful to the environment, do not dispose with other daily trash.
Remove the old batteries from the device and follow your local recycling guidelines.
CAUTION
Replace the batteries whenever the below happen
The shows
The display dims
The display does not light up
Do not dispose of batteries in fire. Batteries may explode or leak.
AC adaptor
The Choice of Power Supply
1.Battery powered mode:
6VDC 4×AAA alkaline batteries
2.AC adaptor powered mode:
6V 1A
(Please only use the recommended AC
adaptor model).
Please unplug the adaptor to depart from
the using utility power.
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%.
1: 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:
too frequent and consecutive multiple measurements; the application of the CUFF and its
pressurization on any arm where intravascular access or therapy, or an arterio-venous (A-V)
shunt, is present; Inflating the cuff on the upper arm on the side of a mastectomy.
2. Do not apply the cuff over a wound, otherwise it can cause further injury.
3. 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.
4. Using it in case to result in prolonged impairment of the circulation of the blood of the
PATIENT.
5: Don’t kink the connection tube, otherwise, the cuff pressure may continuously increase which
can prevent blood flow and result in harmful injury to the PATIENT.
CAUTION
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