Transtek Medical Electronics TMB1014BS User Manual
User Manual
Wrist Blood Pressure Monitor
Version:1.0
TMB-1014-BS
Wrist Type
Guangdong Transtek Medical Electronics Co., Ltd.
Zone B, No.105 ,Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
Thank you very much for selecting TRANSTEK Wrist Blood Pressure Monitor
TMB-1014-BS.
To use the monitor correctly and safely, please read the manual
Please keep this manual well in order to reference in future.
thoroughly.
CATALOGUE
INTRODUCTION .............................................................................................
General Description
Indications for Use
Contraindications
Measurement Principle
Safety Information
LCD Display Symboll
Monitor Components
List
BEFOREYOU START
Installing and Replacing the Batteries
Setting Date, Time and Measurement Unit
Select the User ID
Pair-up the Blood Pressure Monitor with Your Device
MEASUREMENT
Tie the Cuff
Start the Measurement
DATA MANAGEMENT 25
Recalling the Records
Deleting the Records
INFORMATION FOR USER
Tips for Measurement
Maintenance
ABOUT BLOOD PRESSURE
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 wrist?
TROUBLESHOOTING
SPECIFICATIONS
CONTACT INFORMATION
FCC STATEMENT..................................................................................................
COMPLIED STANDARDS LIST ..........................................................................
EMC GUIDANCE
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INTRODUCTION
General Description
Thank you for selecting TRANSTEK Blood Pressure Monitor (TMB-1014-BS).
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-1014-BS 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 for one user
Indications for Use
The Transtek Blood Pressure Monitor is a digital monitor intended for use in
measuring blood pressure and heartbeat rate with a wrist circumference ranging
from 13.5cm to 21.5 cm ( about 5⅓˝-8½˝ ).
It is intended for adult indoor use only.
INTRODUCTION
Contraindications
1.The device should not be used by any person who may be suspected of,or is pregnant .
2.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 point” equivalent to the atmospheric
pressure. Then it starts inflating the cuff. Meanwhile, the unit detects pressure oscillation
generated by beat-to-beat pulsatile, which is used to determine the systolic pressure and
diastolic pressure as well as pulse rate.
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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 “MANUFACTURE
DATE”
Symbol for “MANUFACTURER”
Symbol for “SERIAL NUMBER”
SN
Symbol for “RECYCLE”
The Green Dot is the license symbol of
a European network of industry-funded
systems for recycling the packaging
materials of consumer goods.
4
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 “DIRECT CURRENT”
Caution: These notes must be
observed to prevent any damage
to the device.
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 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.
* 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.
* 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.
5
INTRODUCTION
CAUTION
*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 wrist 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.
* 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 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 wrist and fingers will become anaesthetic, swollen and even purple due to a lack of blood.
* When not in use, store the device 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 maximum temperature that the applied part can be achieved is 42.5℃ while the environmental
temperature is 40℃.
* 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.
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INTRODUCTION
CAUTION
* The patient can measure 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 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 sensization or irritation reaction.
* If you experience discomfort during a measurement, such as pain in the wrist or other complaints, press
the START/STOP button to release the air immediately from the cuff. Loosen the cuff and remove it from
your wrist.
* 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 wrist 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!
* 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).
* Manufacturer will make available on request circuit diagrams, component part lists, descriptions,
calibration instructions,etc., to assist to service personnel in parts repair.
* The operator shall not touch output of batteries and the patient simultaneously.
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INTRODUCTION INTRODUCTION
CAUTION
* 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 d away from the equipment. The distance d is caculated 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 partes specified/ authorised 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.
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LCD Display Symbol
SYMBOL DESCRIPTION EXPLANATION
Systolic Blood Pressure
Diastolic Blood Pressure
Pulse display
Low Battery
Unit
High blood pressure
Low blood pressure
Pulse in beats per minute
Low battery and please replace the batteries.
Measurement unit of blood pressure(1mmHg=0.133kPa)
INTRODUCTION
INTRODUCTION
SYMBOL DESCRIPTION EXPLANATION
Time
IHB Detector
Bluet ooth Successful Bluetooth Connection
Error
User ID
Memory
Heartbeat
Average value
Blood pressure level
indicator
10 11
Hour:Minute (Month/Day/Year)
Blood pressure monitor is detecting an
irregular heartbeat during measurement.
Data communication has failed
The selected User ID
Indicate it is in the memory mode
Blood pressure monitor is detecting a heartbeat during
measurement.
The average value of the latest three groups bood pressure
value
Indicate the blood pressure level
Monitor Components
SYSTOLIC
DIASTOLIC
PULSE RATE
LCD DISPLAY
MEM/UP
BUTTON
START/STOP
BUTTON
TIME
SET/DOWN
BUTTON
INTRODUCTION
Component List
pressure measuring system:
1. PCBA;
2. Air Pipe;
3. Pump;
4. Valve;
5. Cuff.
List
1) Wrist Blood Pressure Monitor TMB-1014-BS
2) 2×AAA Batteries
3) User manual
CUFF
(Type BF applied part)
BATTERY
COMPARTMENT
Installing and Replacing the Batteries
• Open the battery door.
• Insert the batteries according to the polarity indications.
(Always select the authorized / specified battery:
Two AAA-size batteries).
• Replacing the battery door.
The typical service life of the new and unused batteries is 138
measurements for the operation time is 60s.
BEFORE YOU START
1312
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