TRANSTEK TMB-1591-BS User Manual
User Manual
Blood Pressure Monitor
TMB-1591-BS
To use the monitor correctly and safely, please read the manual
thoroughly.
Thank you very much for selecting TRANSTEK Blood Pressure
Monitor TMB-1591-BS.
Please keep this manual well in order to reference in future.
Arm Type
version:1.0
Guangdong Transtek Medical Electronics Co., Ltd.
Zone B, No.105 ,Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
FCC ID:OU9TMB1591BS
Table of Contents
INTRODUCTION........................................................................................2
General Description
Safety Information
Indications for Use
Contraindications
Measurement Principle
LCD Display Signal
Monitor Components
BEFORE YOU START................................................................................8
The Choice of Power Supply
Installing and Replacing the Batteries
MEASUREMENT.......................................................................................9
Pairing
Tie the Cuff
Start the Measurement
INFORMATION FOR USER......................................................................14
Tips for measurement
Maintenances
ABOUT BLOOD PRESSURE....................................................................16
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..............................................................................18
SPECIFICATIONS.....................................................................................19
AUTHORIZED COMPONENT ..................................................................20
CONTACT INFORMATION........................................................................20
FCC STATEMENT......................................................................................21
COMPLIED STANDARDS LIST.................................................................22
EMC GUIDANCE.......................................................................................23
CATALOGUE
CATALOGUE
1
Thank you for selecting TRANSTEK arm type blood pressure
monitor (TMB-1591-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-1591-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.
The signs below might be in the user manual, labeling or other
component. They are the requirement of standard and using.
Safety Information
Features:
68mm*90mm Digital LCD display with White backlight
Maximum 99 records
Measuring during inflation technology
T1A/250V Φ3.6*10CCC
F1
For indoor use only
Symbol for “MANUFACTURER”
Symbol for “SERIAL NUMBER”
Symbol for “TYPE BF APPLIED
PARTS”
Symbol for “ENVIRONMENT
PROTECTION – Electrical waste
products should not be disposed
of with household waste. Please
followlocal guidelines.”
Symbol for “DIRECT CURRENT”
Symbol for “Class II Equipment”
Symbol for “THE OPERATION
GUIDE MUST BE READ”
General Description
Caution: These notes must be
observed to prevent any damage
to the device.
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 22cm to 42cm(about 8¾˝-16½˝).
It is intended for adult indoor use only.
IP22
The ingress protection: the device
could protected against solid foreign
objects of 12.5mm and greater, and
against vertically falling water drops
when ENCLOSURE tilted up to 15°
SN
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 calculated by the MANUFACTURER from the 80
MHz 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.
INTRODUCTION
INTRODUCTION
32
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.
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.
Contraindications
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.
* 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.
CAUTION
* 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 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.
INTRODUCTION
54
LCD Display Signal
SYMBOL DESCRIPTION
Systolic blood pressure High pressure result
Diastolic blood pressure Low pressure result
EXPLANATION
Pulse
Pulse/minute
mmHg Measurement Unit of the blood pressure
Battery Indicator Indicate the current battery
Irregular heartbeat detection
Irregular heartbeat
Grade
Heartbeat
Heartbeat dectetion during measurement
The grade of the blood pressure
Component list of
pressure measuring system
1 Cuff
2 Air pipe
3 PCBA
4 Pump
5 Valve
Monitor Components
BATTERY COMPARTMENT
ON/STANDBY BUTTON
LCD DISPLAY
AIR HOSE
AIR CONNECTOR PLUG
CUFF
List
1. Blood Pressure Monitor
(TMB-1591-BS)
4. User manual3. 4*AA alkaline batteries
2. Cuff (about 22cm~42cm)
(Type BF applied part)
5. AC adaptor (UE08WCP-060100SPA)
Data transmission error
Shocking reminder
Shocking will result in inaccurate
SYS
mmHg
PULSE
/MIN
mmHg
DIA
Data transmission error
DC POWER SOCKET
INTRODUCTION
INTRODUCTION
76
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