TRANSTEK TMB-995-BT User Manual
version:1.0
User Manual
Blood Pressure Monitor
TMB-995-BT
Arm Type
Thank you very much for selecting TRANSTEK Blood Pressure Monitor
TMB-995-BT.
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.
Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, No.105 ,Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
Table of Contents
INTRODUCTION...................................................................................................................2
General Description
Indications for Use
Contraindications
Measurement Method
Safety Information
LCD Display
Monitor Components
List
BEFORE YOU START...........................................................................................................9
Power Supply
Installing and Replacing the Batteries
MEASUREMENT...................................................................................................................10
Tie the Cuff
Start the Measurement
DATA MANAGEMENT..........................................................................................................12
Recall the records
Pair up the Blood Pressure Monitor with Your Device
Data Transmission
INFORMATION FOR USER................................................................................................ 15
Tips for measurement
Maintenances
ABOUT BLOOD PRESSURE..............................................................................................17
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 arm?
TROUBLESHOOTING........................................................................................................19
SPECIFICATIONS...............................................................................................................20
AUTHORIZED COMPONENT ............................................................................................21
CONTACT INFORMATION..................... ...........................................................................21
COMPLIED STANDARDS LIST...........................................................................................22
FCC STATEMENT................................................................................................................23
EMC GUIDANCE.................................................................................................................24
1
CATALOGUE CATALOGUE
Safety Information
The signs below might be in the user manual, labeling or other component.
They are the requirement of standard and using.
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%.
Features:
Maximum 60 records per each user
General Description
3rd technonoly: Measuring during inflation
73mm×49 mm Blue LCD display with white backlight
Indications for Use
Thank you for selecting TRANSTEK arm type blood pressure monitor (TMB-995BT). 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-995-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.
The Transtek Blood Pressure Monitor is digital monitors intended for use in measuring
blood pressure and heartbeat rate with arm circumference ranging from 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.
Symbol for “THE OPERATION
GUIDE MUST BE READ”
Symbol for “MANUFACTURER”
Symbol for “SERIAL NUMBER”
Symbol for “TYPE BF APPLIED
PARTS”
Symbol for “DIRECT CURRENT”
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 “MANUFACTURE
DATE”
For indoor use only
F1
T1A/250V Φ3.6*10CCC
Symbol for “Class II Equipment”
Caution: These notes must be
observed to prevent any damage
to the device.
SN
The Bluetooth Combination Mark
Symbol for “Including RF
transmitter”
2
3
INTRODUCTION
INTRODUCTION
The Green Dot is the license
symbol of a European network of
industry-funded systems for
recycling the packaging materials
of consumer goods.
Symbol for “Recycle”
4
5
INTRODUCTION
INTRODUCTION
CAUTION
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.
* 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 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 adaptor, 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.
* Adaptor 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!
* 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.
CAUTION
* 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 800
MHz to 2.5 GHz column of Table 6 of IEC 60601-1-2:2007,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.
6
7
INTRODUCTION
LCD display signal
INTRODUCTION
SYMBOL DESCRIPTION
Systolic blood pressure High pressure
Diastolic blood pressure Low pressure
EXPLANATION
Pulse Pulse/minute
Deflating
CUFF is deflating
Current Time
Time(year:month:day:hour:minute)
Memory
If “MEM” shows, the displayed measurement
values is from the memory.
mmHg
Measurement Unit of the blood pressure
Heartbeat Heartbeat dectetion during measurement
Data pending to transmit
Measurement data stored in the equipment
Shocking reminder
Shocking will result in inaccurate
Bluetooth icon
The bluetooth icon blinks when the
bluetooth is working
Measurement Unit of the blood pressure
(1kPa=7.5mmHg)
kPa
(1mmHg=0.133kPa)
PUL
/min
DIA
mmHg
SYS
mmHg
DIA
SYS
PUL
/min
Low battery
Batteries are low and need to be replaced
Blood pressure monitor is detecting an
irregular heartbeat during measurement.
Irregular heartbeat
Loading...