TRANSTEK TMB-2084-T Blood Pressure Monitor User Manual

: June 6, 2024
: TRANSTEK

Table of Contents

TRANSTEK TMB-2084-T Blood Pressure Monitor
INTRODUCTION
BEFORE YOU START
MEASUREMENT
TROUBLESHOOTING
AUTHORIZED COMPONENT
COMPLIED STANDARDS LIST
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

TRANSTEK TMB-2084-T Blood Pressure Monitor

INTRODUCTION

General Description
Thank you for selecting TRANSTEK arm type blood pressure monitor (TMB-2084-T). 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-2084-T 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:

61mm×74 mm Digital LCD display with white backlight
Maximum 120 records per each user
3rd technonoly: Measuring during inflation

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

Contraindications

The device is not suitable for use on may be pregnant women or pregnant women.
The device is not suitable for use on patients with implanted,electrical devices, such as cardiac pacemakers, defibrillators.

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 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.

Safety Information
The signs below might be in the user manual, labeling or other component. They are the requirement of standard and using.

LCD display signal

Monitor Components

Component list of pressure measuring system

Cuff
Air Hose
PCBA
Pump
Valve

List

Blood Pressure Monitor
Cuff
User manual
4×AAA batteries

The Choice of Power Supply

Battery powered mode: 6VDC 4×AAA batteries
AC adaptor powered mode: 5V 1A
(Please only use the recommended AC Please unplug the adaptor to depart from the using utility power.

Installing and Replacing the Batteries

Open the battery cover.
Install the batteries by matching the correct polarity, as shown.
Replace the battery cover.

CAUTION

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.

BEFORE YOU START

Setting Date, Time and Measurement Unit
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 :2020—2099)

When the monitor is off, long press “SET” button,it will display [YEAR]. Each press “SET” button will increase the number.
Press the “MEM” to change the [YEAR]. Each press will decrease the numeral by one in a cycling manner.
When you get the right year, press “START/STOP” to set down and turn to next step.
Repeat steps 2 and 3 to set the [MONTH] and [DAY].
Repeat steps 2 and 3 to set the [HOUR] and [MINUTE].
Repeat steps 2 and 3 to set the [UNIT].
After the unit is set,the LCD will display “dOnE” and then it will turn off.

Setting the voice switch
When the monitor is off,press both “STRAT/STOP” and “SET” button, it will enter voice setting mode. The vocie switch will blink, press “MEM” button to decrease the volume, press “SET” button to increase the volume, the press “START/STOP” button to confirm then the monitor will turn off.

Setting the clock

When the monitor is off, long press both “SET” and “MEM” button, it will enter clock setting mode. Press “MEM” or “SET” button to choose turn off or turn on. Press“START/STOP” button to confirm.
When you choose turn on, press “START/STOP” button, the LCD will display the time, Choose “MEM” or “SET” button to set the time, press “START/STOP” button to cofirm, the LCD will display“dOnE” and then the monitor will turn off.

Setting the User ID

When the monitor is off, hold press “SET” button and then the user ID will shows. Press “MEM” or “SET”button to switch the user ID between user 1 and user 2 mode.
Press “START/STOP” button to confirm user ID , the display will show “User ID + dOnE” and then the monitor will turn off.

Install the App and Pair-Up
Download the Transtek Health app from APP Store or Google Play. Install the APP, and register an account.

click “My setting”, choose the device and then bind the device and app

Search your test information
After binding the app, back to the beginning page and click “Blood Pressure” to search your test information.

List of compatible devices:

For iOS devices:
The operating system must be iOS 11.0 or more. For Android devices:
The operating system must be Android 8.0 or more.

Tie the cuff

Remove all jewelry, 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.
Hold your arm with your palm facing up and tie the cuff on your upper arm, then position the tube off-center toward the inner side of arm in line with the little finger. Or position the artery mark over the main artery (on the 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.
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.
Helpful tips for Patients, especially for Patients with Hypertension:
Rest for 5 minutes before first measuring.
Wait at least 3 minutes between measurements.
This allows your blood circulation to recover.
Take the measurement in a silent room.
The patient must relax as much as possible and do not move and talk during the measurement procedure. 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.
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.

MEASUREMENT

Start the Measurement
Before you start the measurement,Download the Transtek Health app from APP Store or Google Play,and turn on the Bluetooth. Install the APP, and register an account. Then set your personal information (Gender, Birthday, Height, Weight, Name and so on).

Please switch the User button to select the user between User 1 and User 2. When the monitor is off,press the “START/STOP” button to turn on the monitor, and it will finish the whole measurement,save and transmit the measurement data for the desired user. (Take User 1 for example)
If the data transmits successful, the symbol and symblo will disappear, and then the monitor will turn off.
If the data transmition fails, the monitor will turn off automatically.
Press the “START/STOP” to power off.

Recall the Records

When the monitor is off, please hold press the “MEM”,it will display the latest record first when the records are less than three groups. When there are three or more than three groups ,it will display the average value of the latest three records first
Press the “MEM” or “SET” to get the record you want.

Delete the Records
If you did not get the correct measurement, you can delete all results for the selected user by following steps below.

Long press “MEM”, when the monitor is in the memory recall mode, the flash display“YES” will show.
Press “SET” or “MEM”,the flash display “ON” or “YES” will show alternatively,choose “YES” to confirm deleting.
Press “START/STOP” button to confirm delete the records, the display will show “User ID + dOnE” and then the monitor will turn off.
If there is no record, press both “START/STOP” and “MEM” button to confirm delete all the records, the following display will show and then the monitor will turn off.

Tips for Measurement
Measurements may be inaccurate if taken in the following circumstances..

Maintenance
In order to get the best performance, please follow the instructions below.

What are systolic pressure and diastolic pressure?

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 1999 is as follows:

Level

Blood

Pressure (mm Hg)

|

Optimal

|

Normal

|

High-normal

|

Mild

|

Moderate

|

Severe

---|---|---|---|---|---|---
SYS| <120| 120-129| 130-139| 140-159| 160-179| 2180
DIA| <80| 80-84| 85-89| 90-99| 100-109| 2110

Irregular Heartbeat Detector
An irregular heartbeat is detected when a heartbeat rhythm varies while the unit is measuring the systolic and diastolic blood pressure.During each measurement, the monitor records all the pulse intervals and calculate the average ; 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%,the irregular heartbeat symbol appears on the display when the measurement results are appeared.

Why does my blood pressure fluctuate throughout the day?

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.
If the person takes medicine, the pressure will vary more.
Wait at least 3 minutes for another measurement.

Why do I get a different blood pressure at home compared to the hospital?
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.
Is the result the same if measuring on the right arm?
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.

TROUBLESHOOTING

This section includes a list of error messages and frequently asked questions for problems you may encounter with your blood pressure monitor. If the products not operating as you think it should, check here before arranging for servicing.

PROBLEM	SYMPTOM	CHECK THIS	REMEDY

No power

| ****

Display will not light up.

| ****

Batteries are exhausted.

| ****

Replace with new batteries

Error message

| ****

E01 shows

| ****

The cuff is too tight or too loose.

| Refasten the cuff and then measure again.

E02 shows

| The monitor detected motion or talking during measuring.| Movement can affect the measurement.Relax for a moment and then measure again

E03 shows

| The measurement process does not detect the pulse signal.| Loosen the clothing on the arm and then measure again.

E04 shows

| The treatment of the measurement failed.| Relax for a moment and then measure again.

H bAt shows

| Adaptor voltage is higher than 7.5V| Replace with new adaptor
E+ ,shows on the display.| ****

Matching failure or transmission timeout.

| ****

Reconnect to the bluetooth and re-upload data

EEx,shows on the display.

| ****

Hardware error

| ****

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.

Warning message| ****

“out ” shows

| ****

Out of measurement range

| Relax for a moment. Refasten the cuff and then measure again. If the problem persists, contact your physician.
Power supply| Battery powered mode: 6VDC 4×AAA batteries AC adaptor powered mode: 5V 1A

(Please only use the recommended AC

adaptor model).

---|---
Display mode| Digital LCD V.A.61mm × 74mm
Measurement mode| Oscillographic testing mode

Measurement range

| 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

Accuracy| Pressure:

5℃-40℃within±3mmHg(0.4kPa) Pulse value:±5%

Normal working condition

| 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

Storage & transportation condition| Temperature:-20°C to +60°C

A relative humidity range of :: 93%, non-condensing,

at a water vapour pressure up to 50hPa

Measurement perimeter

of the upper arm

| About 22 cm ~ 32 cm, 22cm ~ 42cm, 22cm ~ 45cm
Weight| Approx.238g(Excluding the batteries and cuff)
External dimensions| Approx.100.2mm×138.2mm×51mm
Attachment| 4×AAA batteries,user manual,AC adapter
Mode of operation| Continuous operation
Degree of protection| Type BF applied part
Protection against ingress of water| IP21 It means the device could protected against solid foreign objects of 12.5mm and greater, and protect against vertically falling water drops.

Device Classification

| Battery Powered Mode:

Internally Powered ME Equipment

AC Adaptor Powered Mode: Class II ME Equipment

Software Version| A01

AUTHORIZED COMPONENT

Contact Information
For more information about our products, please visit www.transtek.cn.you can get customer service, usual problems and customer download, transtek will serve you anytime.

Authorized European Representative:
Company: MDSS – Medical Device Safety Service GmbH
Address: Schiffgraben 41, 30175 Hannover, Germany

COMPLIED STANDARDS LIST

FCC Statement
FCC ID: OU9TMB2080-B
This device complies with Part 15 of the FCC Rules. Operation issubject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
Caution : The user is cautioned that changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
NOTE : This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions,may cause harmful interference to radio communications. However,
there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna.
Increase the separation between the equipment and receiver.
Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
Consult the dealer or an experienced radio/TV technician for help.

FCC Radiation Exposure Statement:
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.

Complied Standards List

Risk management| EN ISO 14971:2012 / ISO 14971:2007 Medical devices – Application of risk management to medical devices|
---|---|---

Labeling

| 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

User manual| EN 1041:2008 +A1:2013 Information supplied by the manufacturer of medical devices
General Requirements for Safety| EN 60601-1:2006+A1:2013/ 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

Electromagnetic compatibility| 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
Performance requirements| EN ISO 81060-1:2012 Non-invasive sphygmomanometers – Part 1: Requirements and test methods for non-automated measurement type

IEC 80601-2-30:2009+A1:2013 Medical electrical equipment- Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

Clinical investigation

| EN 1060-4:2004 Non-invasive sphygmomanometers – Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers

ISO 81060-2:2018 Non-invasive sphygmomanometers – Part 2: Clinical validation of intermittent automated measurement type

Usability

| 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

|
Software life-cycle processes| EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015 Medical

device software – 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

EMC Guidance

Table 1

Guidance and manufacturer’s declaration – electromagnetic emissions

Emissions test| Compliance
RF emissions CISPR 11|

Group 1

RF emissions CISPR 11

|

Class [ B ]

Harmonic emissions IEC 61000-3-2

|

Class A

Voltage fluctuations/ flicker emissions IEC 61000-3-3|

Comply

Table 2

Guidance and manufacturer’s declaration – electromagnetic Immunity

Immunity Test| IEC 60601-1-2

Test level

|

Compliance level

Electrostatic discharge (ESD) IEC 61000-4-2

|

±8 kV contact

±2 kV, ±4kV, ±8 kV, ±15 kV air

|

±8 kV contact

±2 kV, ±4kV, ±8 kV,

±15 kV air

Electrical fast transient/burst IEC 61000-4-4|

±2 kV for power supply lines

±1 kV signal input/output 100 kHz repetition frequency

| ±2 kV for power supply lines

±1 kV signal input/output 100 kHz repetition frequency

Surge IEC61000-4-5| ±0.5 kV, ±1 kV differential mode

±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

Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

| 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

| 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

Power frequency magnetic field IEC 61000-4-8

| 30 A/m

50Hz/60Hz

| 30 A/m

50Hz/60Hz

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

Radiated RF IEC61000-4-3

| 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

NOTE UT is the a.c. mains voltage prior to application of the test level.

TABLE 3

| Guidance and manufacturer’s declaration – electromagnetic Immunity
---|---
| Immunity Test| IEC 60601-1-2

Test level

|

Compliance level

|

Electrostatic discharge (ESD) IEC 61000-4-2

|

±8 kV contact

±2 kV, ±4kV, ±8 kV, ±15 kV air

|

±8 kV contact

±2 kV, ±4kV, ±8 kV,

±15 kV air

| Electrical fast transient/burst IEC 61000-4-4|

±2 kV for power supply lines

±1 kV signal input/output 100 kHz repetition frequency

| ±2 kV for power supply lines

±1 kV signal input/output 100 kHz repetition frequency

| Surge IEC61000-4-5| ±0.5 kV, ±1 kV differential mode

±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

| Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

| 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

| 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

|

Power frequency magnetic field IEC 61000-4-8

| 30 A/m

50Hz/60Hz

| 30 A/m

50Hz/60Hz

|

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

|

Radiated RF IEC61000-4-3

| 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

| NOTE UT is the a.c. mains voltage prior to application of the test level.
Guidance and manufacturer’s declaration – electromagnetic Immunity|
Radiated RF IEC61000-4-3

(Test specifications for ENCLOSURE PORT IMMUNITY to

RF wireless communica- tions equipment)

| Test Frequency (MHz)| Band

(MHz)

| Service| Modulation| Modulation

(W)

| Distance (m)| IMMUNITY TEST LEVEL

(V/m)

|
385| 380-390| TETRA 400| Pulse modulation b) 18Hz| 1.8| 0.3| 27|

450

|

430-470