Transtek Medical Electronics TMB995 BS Users manual
User Manual
version:1.0
Blood Pressure Monitor
START
STOP
TMB-995-BS
Arm Type
FCC ID:OU9TMB995-BS
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 Blood Pressure Monitor
TMB-995-BS.
To use the monitor correctly and safely, please read the manual thoroughly.
Please keep well this manual in order to reference in future.
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...........................................................................................................9
The Choice of Power Supply
Installing and Replacing the Batteries
Setting Date and Time
Select the User
MEASUREMENT.................................................................................................................13
Tie the Cuff
Start the Measurement
DATA MANAGEMENT..........................................................................................................15
Recall the Records
Delete the Records
INFORMATION FOR USER................................................................................................19
Tips for measurement
Maintenances
ABOUT BLOOD PRESSURE..............................................................................................21
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........................................................................................................23
SPECIFICATIONS...............................................................................................................24
AUTHORIZED COMPONENT ............................................................................................25
CONTACT INFORMATION..................................................................................................25
COMPLIED STANDARDS LIST...........................................................................................26
FCC STATEMENT................................................................................................................27
EMC GUIDANCE.................................................................................................................28
1
INTRODUCTION INTRODUCTION
General Description
Thank you for selecting TRANSTEK arm type blood pressure Monitor
(TMB-995-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-995-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:
80*60mm Digital LCD display
Maximum 60 records per each user
Measuring during inflation technology
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
1.The device is not suitable for use on may be pregnant women or pregnant women.
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.
Safety Information
The signs below might be in the user manual, labeling or other components.
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”
For indoor use only
F1
T1A/250V Φ3.6*10CCC
Caution: These notes must
be observed to prevent any
damage to the device.
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 “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 “Class II Equipment”
Symbol for “MANUFACTURE
DATE”
Symbol for “Recycle”
2 3
INTRODUCTION 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.
* The device cannot be used with HF surgical equipment at the same time.
CAUTION
* 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 maximum temperature that the applied part can be achieved is 42.8℃ 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.
* The patient can measure,transmit data and charge power 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 any 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 any 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!
4 5
INTRODUCTION
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 d 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 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
LCD Display Signal
SYMBOL DESCRIPTION
Systolic blood pressure High pressure result
Diastolic blood pressure Low pressure result
Pulse Pulse/minute
Deflating CUFF air is exhausting of deflating
Current Time
Memory If “MEM” shows, the displayed measurement
mmHg
Battery Indicator
Grade
Heartbeat Heartbeat dectetion during measurement
User 1
User 2
Data pending to transmit Measurement data stored in the equipment
Shocking reminder Shocking will result in inaccurate
Bluetooth icon
EXPLANATION
Time(year:month:day:hour:minute)
values is from the memory.
Measurement Unit of the blood pressure
Indicate the current battery
Irregular heartbeatIrregular heartbeat
The grade of the blood pressure
Start measurement and transmit the results for User 1
Start measurement and transmit the results for User 2
The bluetooth icon blinks when the bluetooth is
working
7
Monitor Components
CUFF
AIR HOSE
AIR CONNECTOR PLUG
START
STOP
SET/DOWN BUTTON
START/STOP BUTTON
MEM/UP BUTTON
LCD DISPLAY
BATTERY COMPARTMENT
BEFORE YOU STARTINTRODUCTION
The Choice of Power Supply
1.Battery powered mode:
6VDC 4*AA batteries
2.AC adaptor powered mode:
6V 1A
(Please use the AC adaptor which
authorized by the manufacturer!)
Right picture is the hole in for power
adaptor.
CAUTION
In order to get the best effect and protect your monitor,please use the
the right batteries and special power adapter which complies with local
safety standard.
Installing and Replacing the Batteries
Component list of
pressure measuring system:
1 Cuff
2 Air pipe
3 PCBA
4 Pump
5 Valve
List
1. Blood Pressure Monitor
(TMB-995-BS)
START
STOP
4. 4*AA batteries
8
2. Cuff (22~32cm or 22~42cm)
(Type BF applied part)
5. AC adaptor
(BLJ06L060100P-U)
3. User manual
1.Slide off the battery cover.
2.Install the batteries by matching
the correct polarity, as shown.
3.Replace the cover.
Replace the batteries whenever the below happen
The shows
The display dims
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.
9
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