Transtek TMB-1597-BN User Manual
User Manual
version:1.0
Guangdong Transtek Medical Electronics Co., Ltd.
Zone B, No.105 ,Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
Blood Pressure Monitor
TMB-1597-BN
Arm Type
Thank you very much for selecting TRANSTEK Blood Pressure Monitor
TMB-1597-BN.
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.
CATALOGUE CATALOGUE
Table of Contents
INTRODUCTION..................................................................................................................2
General Description
Indications for Use
Contraindications
Measurement Principle
Safety Information
LCD Display Signal
Monitor Components
List
BEFORE YOU START..........................................................................................................8
The Choice of Power Supply
Installing and Replacing the Batteries
Setting Date, Time and Measurement Unit
Select the User
Pair-up the Blood Pressure Monitor with Your Device
MEASUREMENT................................................................................................................15
Tie the Cuff
Start the Measurement
DATA MANAGEMENT........................................................................................................18
Recall the Records
Delete the Records
INFORMATION FOR USER...............................................................................................21
Tips for measurement
Maintenances
ABOUT BLOOD PRESSURE.............................................................................................23
What are systolic pressure and diastolic pressure?
What is the standard blood pressure classification?
Irregular heartbeat detector
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........................................................................................................25
SPECIFICATIONS..............................................................................................................26
AUTHORIZED COMPONENT ...........................................................................................27
CONTACT INFORMATION.................................................................................................27
COMPLIED STANDARDS LIST..........................................................................................28
FCC STATEMENT...............................................................................................................29
EMC GUIDANCE................................................................................................................30
1
INTRODUCTION INTRODUCTION
General Description
Thank you for selecting TRANSTEK arm type blood pressure monitor
(TMB-1597-BN). 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-1597-BN 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:
73mm×49 mm Blue LCD display with white backlight
Maximum 60 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 from 22 cm to 32 cm
( about 8¾˝-12½˝ ) or 22cm to 42cm(about 8¾˝-16½˝).
It is intended for adult indoor use only.
Contraindications
This device is contraindicated for any person who is connected to a wearable or
implantable electronic device or instrument, such as a pacemaker or defibrillator.
This blood pressure monitor is not intended to be a diagnostic device.
Contact your physician if hypertensive values are indicated.
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”
Symbol for “MANUFACTURER”
Symbol for “SERIAL NUMBER”
SN
Symbol for “DIRECT CURRENT”
Symbol for “MANUFACTURE
DATE”
F1
T1A/250V Φ3.6*10CCC
The Bluetooth Combination Mark
Symbol for “Including RF
transmitter”
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”
For indoor use only
Symbol for “Class II Equipment”
Caution: These notes must be
observed to prevent any damage
to the device.
2
3
CAUTION
* This device is intended for adult use only. It is not intended for use with neonatal patients, pregnant or
pre-eclamptic patients.
* 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.
* 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 /adapter 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.
* Please use ACCESSORIES and detachable partes specified/ authorised by MANUFACTURE.
Otherwise, it may cause damage to the unit or danger to the user/patients.
* The device doesn’t need to be calibrated within two years of reliable service.
* Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local
guidelines.
4
INTRODUCTIONINTRODUCTION
CAUTION
* 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.
* Please report to Transtek if any unexpected operation or events occur.
* Please use the soft cloth to clean the whole unit. Don’t use any abrasive or volatile cleaners.
* 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 battery under
normal circumstances and maintain the device and its accessories according to the user manual.
* Adaptor is specified as a part of ME EQUIPMENT.
* 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.
* Before every use, check the device, do not use the device or an electrode if it is damaged in any way. The
continuous use of a damaged unit may cause injury, improper results, or serious danger.
* Be careful to strangulation due to cables and hoses, particularly due to excessive length.
* Keep unit out of the reach of young children / pets to avoid inhalation or swallowing of small parts. The
cord/tube can cause strangulation.
* 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.
* 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.
* Warning: Be careful to regarding the effect of blood flow interference and resulting harmful injury to the
patient caused by continuous cuff pressure due to connection tubing.
*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 samb 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.
* 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.
* 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 81060-2:2013.
* To verify the calibration of the AUTOMATED SPHYGMOMANOMETER, please contact the manufacturer.
*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.
* Do not wash the cuff in a washing machine or dishwasher!
* 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).
* 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.
* 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 d away from the equipment. The distance d is caculated by the MANUFACTURER from the 800
MHz to 2.5 GHz column of Table 6 of IEC 60601-1-2:2007,as appropriate.
5
INTRODUCTION
INTRODUCTION
LCD display signal
SYMBOL DESCRIPTION
6
Systolic blood pressure
Diastolic blood pressure
Pulse display
Deflation symbol
Memory
kPa
mmHg
Low battery Batteries are low and need to be replaced
Irregular heartbeat
Blood pressure
level indicator
Current Time
Heartbeat
User 1
User 2
Motion indicator
Average value The average value of blood pressure
Bluetooth icon
Data storage
EXPLANATION
High blood pressure
Low blood pressure
Pulse in beats per minute
The cuff is deflating.
Indicate it is in the memory mode and
which group of memory it is.
Measurement Unit of the blood pressure
(1kPa=7.5mmHg)
Measurement Unit of the blood pressure
(1mmHg=0.133kPa)
Blood pressure monitor is detecting an
irregular heartbeat during measurement.
Indicate the blood pressure level
Year/Month/Day, Hour/Minute
Blood pressure monitor is detecting a
heartbeat during measurement.
Start measurement,save and transmit the
measuring results for User 1
Start measurement, save and transmit the
measuring results for User 2
Motion may result in an inaccurate
measurement
Indicate the Bluetooth is working
Indicate the data is waiting to be
transmitted
Monitor Components
CUFF
AIR HOSE
AIR CONNECTOR PLUG
LCD DISPLAY
List
1.Blood Pressure Monitor
(TMB-1597-BN)
3. 4×AA alkaline batteries
Component list of
pressure measuring system
1 Cuff
2 Air pipe
3 PCBA
4 Pump
5 Valve
MEM BUTTON
SET BUTTON
START/STOP
DC POWER SOCKET
2.Cuff (Type BF applied part)
(22cm~32cm or 22cm~42cm)
4.User manual
(Please use TRANSTEK
authorized cuff. The size
of the actual cuff please
refer to the label on the
attached cuff.)
5. AC Adaptor
(KH0601000UW!)
BATTERY COMPARTMENT
7
BEFORE YOU START BEFORE YOU START
The Choice of Power Supply
1.Battery powered mode:
6VDC 4×AA 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.
AC adaptor
CAUTION
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.
Installing and Replacing the Batteries
• .Open the battery cover.
• .Install the batteries by matching
the correct polarity, as shown.
• .Replace the battery cover.
The typical service life of the new and
unused batteries is 300 measurements
for the operation time is 60s.
Replace the batteries whenever the below happen
The shows
The display is dim
The display does not light up
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.
8
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 :2016—2056;
Time format:24H)
When the monitor is off, press “ ”button,it will display the time.Then press and
1.
hold “ ” button to enter the mode for year setting.
(Notes:
1.During the process of setting, you can press “ ” button to stop setting at
any time.
2. If there is no operation during the process of setting, it will turn off within 1
minute.)
2.
Press “ ” button to change
the [YEAR]. Each press will
increase the numeral by one in a
cycling manner.
9
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