User Manual
Blood Pressure Monitor
Version:1.0
TMB-1580-BT
Wrist Type
Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, No.105 ,Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
Thank you very much for selecting TRANSTEK Blood Pressure
Monitor TMB-1580-BT.
To use the monitor correctly and safely, please read the manual
thoroughly.
Please keep this manual well in order to reference in future.
CATALOGUE CATALOGUE
INTRODUCTION
BEFORE YOU START
MEASUREMENT
DATA MANAGEMENT 16
INFORMATION FOR USER
ABOUT BLOOD PRESSURE
TROUBLESHOOTING
SPECIFICATIONS
CONTACT INFORMATION
FCC STATEMENT
COMPLIED STANDARDS LIST
EMC GUIDANCE
...............................................................
General Description
Indications for Use
Safety Information
LCD Display Signal
Monitor Components
Installing and Replacing the Batteries
Setting Date, Time and Measurement Unit
Pair-up the Blood Pressure Monitor with Your Device
Tie the Cuff
Select the User ID
Start the Measurement
Recall the Records
Delete the Records
Tips for Measurement
Maintenance
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 wrist?
..........................................................
...............................................................
..........................................................
.....................................................
....................................................
.........................................................
.............................................................
......................................................
.............................................................
.....................................................................
......................................................
2
5
12
18
20
22
23
24
24
26
27
1
INTRODUCTION INTRODUCTION
General Description
Thank you for selecting TRANSTEK Blood Pressure Monitor (TMB-1580-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-1580-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:
Systolic blood pressure
Diastolic blood pressure
Pulse rate
60 records per each user
Indications for Use
The Transtek Blood Pressure Monitor is digital monitors intended for use in
measuring blood pressure and heartbeat rate with wrist circumference ranging
from 13.5 cm to 21.5 cm ( about 5⅓˝-8½˝ ).
It is intended for adult indoor use only.
Safety Information
The signs below might be in the user manual, labeling or other component.
They are the requirement of standard and using.
2
Symbol for “THE OPERATION
GUIDE MUST BE READ”
The Bluetooth Combination Mark
Symbol for “MANUFACTURER”
Symbol for “SERIAL NUMBER”
Symbol for “DIRECT CURRENT”
Symbol for “MANUFACTURE
DATE”
Symbol for “KEEP DRY”
Symbol for “TYPE BF APPLIED
PARTS”
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 “Including RF
transmitter”
Caution: These notes must be
observed to prevent any damage
to the device.
CAUTION
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 wrist 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.
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 wrist and press the START/STOP
button to stop inflation.
To avoid measurement errors, carefully read this manual before using the product.
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 and the patient simultaneously.
Do not use the monitor under the conditions of strong electromagnetic field (e.g. medical RFequipment) that
radiates interference signal or electrial 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.
Please use ACCESSORIES and detachable partes specified/ authorised by MANUFACTURE. Otherwise, it
may cause damage to the unit or danger to the user/patients.
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 wrist 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 alergic
reaction or contact injury.
The device doesn’t need to be calibrated whith the two years of reliable service.
Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local
guidelines.
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.
This device is contraindicated for any female subject who may be suspected of, or is pregnant. Besides
providing inaccurate readings, the effects of this device on the fetus are unknown.
Please keep the unit out of reach of infants, children or pets, since inhalation or swallowing of small parts is
dangerous or even fatal.
Too frequent and consecutive measurements could cause disturbances in blood circulation and injuries.
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 wrist where intravascular
access or therapy, or an arterio-venous (A-V) shunt, is present; Inflating the cuff on the wrist on the side of a
mastectomy.
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.
blood flow and result in harmful injury to the PATIENT.
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.”
Using it in case to result in prolonged impairment of the circulation of the blood of the PATIENT.
Don’t kink the connection tube, otherwise, the cuff pressure may continuously increase which can prevent
The device has been evaluated clinically using manual cuff/stethoscope auscultation as the reference. Blood
3
INTRODUCTION INTRODUCTION
LCD Display Signal
SYMBOL DESCRIPTION EXPLANATION
Systolic
blood pressure
Diastolic
blood pressure
Pulse Pulse/minute; heartbeats/minute
Shocking
remainding
Low battery
kPa
mmHg
Current time
Grade The grade of the blood pressure
Heartbeat
User 1
4
User 2
High pressure result
Low pressure result
Shocking will result in inaccurate
Batteries are low and need to be replaced
Measurement unit of the blood pressure
(1kPa=7.5mmHg)
Measurement unit the blood pressure
(1mmHg=0.133kPa)
Irregular heartbeat detectionIrregular heartbeat
Month/Day/Year,Hour/Minute
Heartbeat detection during the measurement
Start measurement and save the
measuring results for user 1.
Start measurement and save the
measuring results for user 2.
Monitor Components
LCD DISPLAY
GRADE
TIME
MEM BUTTON
Component List:
1. PCBA;
2. Air Pipe;
3. Pump;
4. Valve;
5. Cuff.
BATTERY
COMPARTMENT
List
1) Blood Pressure Monitor
2) 2×AAA batteries
3) User manual
TMB-1580-BT
SYSTOLIC
DIASTOLIC
PULSE RATE
SET BUTTON
START/STOP BUTTON
CUFF
(Type BF applied part)
5
BEFORE YOU START BEFORE YOU START
Installing and Replacing the Batteries
• .Slide off the battery cover.
• .In stall the ba tterie s b y ma tching the corr ect polari ty, a s
shown below. Always use the correct battery type (2 x AAA batteries).
• .Replace the cover.
Replace the batteries whenever the below happen
The shows
The display dims
The display does not light up
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.
Do not dispose of batteries in fire. Batteries may explode or leak.
6
Setting Date, Time and Measurement Unit
It is im portant to set t he clo ck be fore using your blood pressure
monitor, so that a time stamp can be assigned to each record that is
stored in the memory.
1.
When the monitor is off, hold pressing
“S” button for about 3 seconds to set
the time format.
2. Press the “M” button to change
the [TIME FORMAT] between
12 hours and 24 hours.
3.
When you get the right time format,
press “S” button to confirm your
selection and it will turn to the next
step.
(year :2014—2054,time format:24 H/12 H)
7