TRANSTEK TMB-1490-BHJ Blood Pressure Monitor User Manual

: June 6, 2024
: TRANSTEK

Table of Contents

TMB-1490-BHJ Blood Pressure Monitor
Read User Manual Online (PDF format)
Download This Manual (PDF format)

TMB-1490-BHJ Blood Pressure Monitor

‘ZdDZZ> ZEZZZZdZZ Z’Z

sZ
User Manual
Blood Pressure Monitor Model: TMB-1490-BHJ
Arm Type
MEMORY
M S STOSPTART
dZZdZZWDZZW ZZZZ ZZ<Z

CATALOGUE
Table of Contents
IEdZKhd/KE ‘Z /ZZh ZZ DW ^/ZZ >^ DZZZZ >
&KZzKh^dZd dZZWZ^ /Z ^d
D^hZDEd d ^D
dDE’DEd ZZZ ZZ
/E&KZDd/KE&KZh^Z dZ D
Khd>KKWZ^^hZ tZZ tZZZ /Z tZZZZZ tZ/ZZZZZZ /Z
dZKh>^,KKd/E’ ^W/&/d/KE^ hd,KZ/KDWKEEd KEdd/E&KZDd/KE &^ddDEd KDW>/^dEZ^>/^d D’h/E

INTRODUCTION
General Description
dZZZ ZdZZZZ ZZZZZdD,:Z ZZZZZ ZZ dZZZZZ ZZZZZZZ ZZZZ & > DZZZ hZZZZ
Indications for Use
dZZWDZZdD,:ZZZ ZZZ ZZZZ /ZZZZ
Contraindications
dZZZZZZ dZZZ Z
Measurement Principle
dZKZDZZZZ ZZZ Zd ZZZZ ZZZ

INTRODUCTION

Safety Information
dZZZZZd Z

^ZZd,KWZd/KE ‘h/Dh^dZ
/Z ZZZZ ZZZ ZZ ZZ ZZZ Z

^ZZdzW&WW>/ WZd^
^ZZEs/ZKEDEd WZKdd/KE ZZZ ZZZZ W Z ZZZZ

SN ^ZZ^Z/>EhDZ

^ZZZ

^ZZ/ZdhZZEd

&ZZZZ

^ZZDEh&dhZZ
^ZZDEh&dhZ d

^ZZ//

INTRODUCTION
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, electronical devices, patients with pre-eclampsia, 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. 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 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. 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 intravascular 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.

INTRODUCTION
CAUTION

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 81060-2:2018.
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 fetus 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 anesthetic 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, transmit 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 sensitization or irritation reaction. Adapter 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 pressures 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!

INTRODUCTION
CAUTION

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 insulates 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 Transtek. 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 centers. Please report to Transtek 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 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/authorized by MANUFACTURE. 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 intravascular 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.

LCD display signal
MEMORY

INTRODUCTION

M S

TIME/DATE

Pul/min

START STOP

SYMBOL DESCRIPTION

^ZZZ

mmHg kPa

ZZZ , W

Pul/min

W

EXPLANATION
d dZ DhZZZW, DhZZZ,W
DhZWZ

,

/

h/ d

ZZZh ZZZh EKdhhZ
dZZ

ZZ

d

+bAt +

ZZZ >Z

dZZZZZZ ZZ

ZZ

/ZZ

DZ

/ZZZZZ

d

dZZ

INTRODUCTION
Monitor Components
h&& /Z,K^
MEMORY

Component list of pressure measuring system
1 Cuff 2 Air pipe 3 PCBA 4 Pump 5 Valve

/ZKEEdKZW>h’ >/^W>z

M S STOSPTART

WKtZ^K<d h^Z^t/d, DDhddKE ^dhddKE ^dZd^dKWhddKE

ddZzKDWZdDEd

List
ZZWDZZ dD,:
MEMORY
M S STOSPTART

d&

h

BLJ06L060100P-U

BEFORE YOU START

The Choice of Power Supply

ZZ

s

ZZ s

MEMORY

WZZ

M

S
WZZ

ZZ

AC adaptor

CAUTION
/ZZZZZZ ZZZ

Installing and Replacing the Batteries

KZ /Z
Z
WZ
ZZ >Z/ZZZ ZZ

Z

dZZZ

tZZ

Z

d
CAUTION

Z

ZZZ

ZZZZ

ZZZZZ

ZZZZZZ

tZZZZZZ

ZZZZZZZZ

BBEEFFOORREEYYOOUUSSTTAARRTT

Setting Date and Time

/ZZdZZZZ ZZZZ ZZZ dZdZ,
MEMORY

1. tZZZ

^dZ

dZ^d

ZZZZ

M

S

2. zZ DDZDD Z Z

TIME/DATE MEMORY

Pul/min

START STOP

M S

3. tZ ^dZZZ dZ DKEd,

TIME/DATE MEMORY

Pul/min

START STOP

M S

START

STOP

TIME/DATE

Pul/min

BBEEFFOORREEYYOOUUSSTTAARRTT

4. ZZDKEd,z

MEMORY

M

S

START STOP

TIME/DATE

Pul/min

TIME/DATE

Pul/min

5.ZZd/D&KZDd,,

MEMORY

M

S

START STOP

TIME/DATE

Pul/min

TIME/DATE

Pul/min

6. ZZ,KhZD/Ehd

MEMORY

START STOP

M S

TIME/DATE

Pul/min

START STOP

M S

START STOP

TIME/DATE

Pul/min

BEFORE YOU START

7. ZZhE/d

MEMORY

M

S

START STOP

TIME/DATE

Pul/min

TIME/DATE

Pul/min

8. >Z ZZZ

MEMORY

M S

TIME/DATE

Pul/min

START STOP

Tie the cuff
1. ZZ ZZ EZ/ZZZZZZZ ZZZ
2. ZZZZZZ DZZZZ
3. ,ZZZ ZZZZ ZZZ KZZZ ZZZEZ >Z ZZZZZ ZZZ/ ZdZ
4. dZZZZzZ ZZZ Z
5. ^ZZZZ WZZZZ ZdZ ^
6. ,ZWZW ,Z ZZZ t dZZZZZZZ dZZ dZZZ ZZ
dZ Z WZZZZZZ ZZZ <ZZ &ZZZZ ZZ&Z ZZ Z

MEASUREMENT
2~3cm

MEASUREMENT
Start the Measurement
ZZZZDD, ZWW^ZZ’ZZWZZZ/ WWZdZZZZ ‘,tEZZ
1. ^hZZhh ^ZZhZZh
tZZZ^dZd^dKWZZZ ZZZZ Z dhZ

Z
MEMORY

M S

TIME/DATE

Pul/min

START STOP

Z
MEMORY

M S

TIME/DATE

Pul/min

START STOP

/
MEMORY

M S

TIME/DATE

Pul/min

START STOP

MEASUREMENT

MEMORY

M S

TIME/DATE

Pul/min

START STOP

2. dZZ DZZZKE Z
/ZZZZ ZZZ
/ZZZZZ

MEASUREMENT
dZZZ^dZd ^dKWZ
dZhhZZZZ tZZ ZZZ&h>>ZZZZ

ZZ &ZK^ dZK^ZZ &ZZ dZZZZ
CAUTION
/ZZZZ ZdD,: ^ZZZZ ZZZ Z <ZZZZ ZZ dZZZZZZ ZZ’, ,ZZZ ddZZZZ ZWZZd ZZZZZZZZ&Z dZZZZZ ZdZZ ZZdZZZZZZZZ& Z

DATA MANAGEMENT

Recall the Records

MEMORY

1. tZZZ

DDZ

Z

M

Zt

ZZ

S

Z

START STOP

TIME/DATE

Pul/min

2. W^dZDDZZ ZDEZ^dZZ Z

d

MEMORY

M

dZ dZZ

‘Z

:

S

dZZ

START STOP

TIME/DATE

Pul/min

CAUTION

dZZZ ZZZZZ ZZZZZ Z

DATA MANAGEMENT

Delete the Records

/ZZZZ ZZZdhZ

1. tZZZ ZZ^d

MEMORY

Z>>

h/

M

S

2. W^dZZZ Z>> Zh/

TIME/DATE MEMORY

Pul/min

START STOP

/ZZZ Z^dZd^dKW ZZ
3. KZZ Zd> Z
W^dZd^dKWZZ ZZZZ ZZZZ

M S

TIME/DATE MEMORY

Pul/min

START STOP

M S

TIME/DATE

Pul/min

START STOP

INFORMATION FOR USER
Tips for Measurement
DZZ

tZ Z

/ ZZ

t

tZZZ

/ZZ

tZZ

INFORMATION FOR USER
Maintenance
/ZZZZZZZ

MEMORY
M S STOSPTART

WZ

ZZ Z

MEMORY M
S STOSPTART
Z ZZ
MEMORY M
S STOSPTART
hZZZ

MEMORY M
S STOSPTART
Z Z
ZZZ

ABOUT BLOOD PRESSURE

What are systolic pressure and diastolic pressure?

tZZZZZ ZZ Zt ZZ Z

Systolic
blood discharging artery
press

Diastolic
blood entering vein
relax

What is the standard blood pressure classification?
dZZZ tZ,KZt,K /Z^ZZ,Z/^, ZZ
CAUTION
KZZW WZZ ZZWZZ ZZZ ZZ

ZZ W,
^z^

K EZ ,Z D

DZ ^

/

Irregular Heartbeat Detector
ZZZZZZZ ZZZ ZZZZ ZZZ ZZZ
CAUTION
dZ/,ZZ hEKdZZ,Z ZZZZWZ ZZZZ

ABOUT BLOOD PRESSURE
Why does my blood pressure fluctuate throughout the day?
/ZZ /Z ZZZ ZZZ ZZ /Z Z tZZ

S TA R T S TO P
S TA R T S TO P

Why do I get different

tZZZZ

blood pressure at home

ZZZZ Z

compared to the hospital?
/Z

dZZ ZZZ ZZZ ZZZ

/ZZZZZZZ /Z /ZZ dZ Z ZZZ

ZZ

Is the result the same

if measuring on the

right arm?

/ZZZ ZZ ZtZ

TROUBLE SHOOTING

If any abnormality arises during use, please check the following points:

PROBLEM SYMPTOM

CHECK THIS

REMEDY

No power
High power Low batteries
Error message

Z
,Z >Z Z Z Z
Z

Z
Z Z s
Z

Z /Z
/Z
ZZ W

dZ Z ZZ Z ZZZ

,Z ZZ

ZZ

WZ

ZZZZ

Z

d ZZ

Z

,Z yZ Z

dZZZ /Z Z ZZZ

Warning message

ZZ

KZ

ZZZZ /ZZ Z

EKd/ZZZZZdZ^h ZZZZZZ

SPECIFICATIONS

Power supply Display mode

ZZs ZZs WZZ

s

Measurement mode Measurement range
Accuracy Normal working condition

KZZ
Z ,,WW D ^z^,,WW /,,WW W
W ,W W
ZZ ZZ ZZZZ W ZZ WZW

Storage & transportation condition

dZ ZZZ ZZW

Measurement perimeter of the upper arm Weight
External dimensions Attachment
Mode of operation

ZZZZ ZZ
Z Z
ZZZZ

Degree of protection

d&

Protection against ingress of water
Device Classification

/W/ZZ ZZZZ ZZZZZZ
WZDZ /WZD WZDZ//D

Software Version

Bluetooth Module information

ZZDZEZ Z&&ZD,ZD,
KWZZ

^sZs

d

tZE/E’EZZZZZ

AUTHORIZED COMPONENT
Athorized Component
Please use the TRANSTEK authorized adapter.
Adapter Type: BLJ06L060100P-U Input: 100-240 V, 50-60 Hz, 0.2A max Output: 6V 1000 mA
Contact Information
&ZZZZZZZZZ zZZZZZZd Z
D ‘ZdDZZ> Z ‘ZdDZZ> ZEZZZZdZZ
Z’Z

FCC STATEMENT
&^ &/KhdD, dZWZ&ZKZZ ZZZZZZ ZZZdZZ ZZZZZZZZ ZZZZ EKddZZZZ ZWZ&ZdZ ZZZZ ZdZ ZZZ ZZZZ,ZZ ZZZ/Z ZZZZZ ZZZZZZ ZZZZZZ ZZZZ /Z ZZZZZZ Z ZZZdsZ &ZZZ^ dZ&ZZZZ ZZZdZZZZZ ZZZZ

COMPLIED STANDARDS LIST

Complied Standards List

Risk management

EN ISO 14971:2019 / ISO 14971:2019 Medical devices – Application of risk management to medical devices

Labeling User manual

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
EN 1041:2008 +A1:2013 Information supplied by the manufacturer of medical devices

EN 60601-1:2006+A1:2013+A12:2014 / IEC 60601-1:2005+A1:2012

Medical electrical equipment – Part 1: General requirements for basic

safety and essential performance
General Requirements EN 60601-1-11:2015/ IEC 60601-1-11:2015 Medical electrical

for Safety

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
IEC80601-2-30:2018 Medical electrical equipment – Part 2-30: Particular requirements for the basic safety and essential performance of automated non- invasive sphygmomanometers

Clinical investigation

EN ISO 81060-2:2019/ISO 81060-2:2018, Non-invasive sphygmomanometers – Part 2: Clinical validation of automated measurement type

Usability Software life-cycle processes
Bio-compatibility

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

EMC Guidance
The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments.
Warning: Don’t be near the active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high.
Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
Warning: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the equipment TMB-1490-BHJ including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Technical description 1. All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to electromagnetic disturbances for the excepted service life.
2. Guidance and manufacturer’s declaration-electromagnetic emissions and Immunity.

Table 1

Guidance and manufacturer’s declaration – electromagnetic emissions

Emissions test

Compliance

RF emissions CISPR 11
RF emissions CISPR 11

Group 1 Class [ B ]

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations / flicker emissions IEC 61000-3-3

Comply

EMC GUIDANCE

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, ±4 kV, ±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 Not Applicable 100 kHz repetition frequency

Surge IEC61000-4-5

±0.5 kV, ±1 kV differential mode

±0.5 kV, ±1 kV, ±2 kV common mode Not Applicable

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

Power frequency magnetic field IEC 61000-4-8

30 A/m 50 Hz / 60 Hz

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

Radiated RF IEC61000-4-3

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.

EMC GUIDANCE

Table 3

Guidance and manufacturer’s declaration – electromagnetic Immunity

Radiated RF Test

Band