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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.

Содержание TMB-995-BT

Страница 1: ...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 ...

Страница 2: ...th 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 TR...

Страница 3: ... 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 8 16 It...

Страница 4: ...ecome 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 appli...

Страница 5: ...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 sign...

Страница 6: ...uff Type BF applied part 22cm 42cm 3 4 AA batteries Please use TRANSTEK authorized cuff The size of the actual cuff please refer to the label on the attached cuff Component list of pressure measuring system 1 Cuff 2 Air pipe 3 PCBA 4 Pump 5 Valve AIR HOSE AIR CONNECTOR PLUG LCD DISPLAY START STOP 5 AC Adaptor KH0601000UW CUFF The Choice of Power Supply 1 Battery powered mode 6VDC 4 AA batteries 2 ...

Страница 7: ...and take 5 6 deep breaths Rest for 5 minutes before first measuring Wait at least 3 minutes between measurements This allows your blood circulation to recover The patient must relax as much as possible and do not move and talk during the measurement procedure For a meaningful comparison try to measure under similar conditions For example take daily measurements at approximately the same time on th...

Страница 8: ...cord 1 is shown first Each new measurement is assigned to the first 1 record All other records are pushed one digit e g 2 becomes 3 and so on and the last record 60 CAUTION Pair up the Blood Pressure Monitor with Your Device 1 Turn on Bluetooth and the app Make sure both are on when pair up is proceeding 2 When the monitor is off press and hold the START STOP button to start pair up The symbol and...

Страница 9: ... 20 centimeters away from the human body especially the head when the data transmission is proceeding after measurement To enable the data transmission function this product should be paired to Bluetooth end at 2 4 GHz How to mitigate possible interference The range between the device and BT end should be reasonably close from 1 meter to 10 meters Please ensure no obstacles between the device and ...

Страница 10: ...ac examination but serves to detect pulse irregularities at an early stage Only a physician can tell your normal BP range Please contact a physician if your measuring result falls out of the range Please note that only a physician can tell whether your blood pressure value has reached a dangerous point The chart on the right is the standard blood pressure classification published by American Heart...

Страница 11: ...ed questions for problems you may encounter with your blood pressure monitor If the products not operating as you think it should check here before arranging for servicing TROUBLESHOOTING PROBLEM SYMPTOM CHECK THIS REMEDY No power Low batteries Error message Display will not light up Batteries are exhausted Replace with new batteries Insert the batteries correctly Replace with new batteries Batter...

Страница 12: ...ly Powered ME Equipment AC Adaptor Powered Mode Class II ME Equipment IP21 It means the device could protected against solid foreign objects of 12 5mm and greater and protect against vertically falling water drops Pressure 5 40 within 3mmHg 0 4kPa pulse value 5 A temperature range of 5 C to 40 C A relative humidity range of 15 to 90 non condensing but not requiring a water vapour partial pressure ...

Страница 13: ... 1 General requirements IEC 80601 2 30 2013 Medical electrical equipment Part 2 30 Particular requirements for the basic safety and essential performance of automated non invasive sphygmomanometers ISO 81060 2 2013 Non invasive sphygmomanometers Part 2 Clinical validation of automated measurement type EN 60601 1 2 2007 IEC 60601 1 2 2007 Medical electrical equipment Part 1 2 General requirements f...

Страница 14: ...will be used Guidance and manufacturer s declaration electromagnetic immunity IMMUNITY test 6 kV contact 8 kV air 6 kV contact 8 kV air 2 kV for power supply lines 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec 3A m NOTE UT is the a c mains voltage prior to application of the test level Table 2 Guidance and MANUFACTURER ...

Страница 15: ... RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above the device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the device Over the frequency range 150 kH...

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