version:1.0 User Manual Blood Pressure Monitor TMB-995-BT Arm Type Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China 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.
CATALOGUE CATALOGUE 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.......................
INTRODUCTION General Description 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.
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.
INTRODUCTION CAUTION INTRODUCTION LCD display signal * 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.
INTRODUCTION BEFORE YOU START The Choice of Power Supply Monitor Components 1.Battery powered mode: Component list of pressure measuring system 1 Cuff 2 Air pipe 3 PCBA 4 Pump 5 Valve CUFF AIR HOSE AIR CONNECTOR PLUG 6VDC 4*AA batteries 2.AC adaptor powered mode: 6V 1A (Can be supplied by AC adaptor model KH0601000UW !) Right picture is the hole in for power adaptor.
MEASUREMENT MEASUREMENT Start the Measurement Tie the Cuff 1.When the monitor is off, press “START/STOP” button to turn it on, it will finish the whole measurement. 1. Remove all jewelry, such as watches and bracelets from your left arm. Note: If your doctor has diagnosed you with poor circulation in your left arm, use your right arm. START STOP 2. Roll or push up your sleeve to expose the skin. Make sure your sleeve is not too tight. 4. The cuff should be snug but not too tight.
DATA MANAGEMENT DATA MANAGEMENT Recall the records 1.When the monitor is off, press and hold the “ START/STOP ” button to enter bluetooth pair-up mode. Press and hold “ START/STOP ” button again to enter query mode, the monitor will show the average value of the latest three records. Pair up the Blood Pressure Monitor with Your Device START STOP SYS mmHg DIA mmHg 1.Turn on Bluetooth and the app. Make sure both are on when pair-up is proceeding. 2.
INFORMATION FOR USER DATA MANAGEMENT Data Transmission 1.With TMB-995-BT successfully pair-up, the measurement data will be automatically transmitted to your mobile device via Bluetooth. 2.The symbol will disappear after successful data transmission, and you may check your personal health data stored in your mobile device. 3.If the data transmission fails, the symbol will remain. The pending measurement data will be transmitted to your mobile device when next measurement is complete.
ABOUT BLOOD PRESSURE INFORMATION FOR USER What are systolic pressure and diastolic pressure? Maintenance In order to get the best performance, please follow the instructions below. When ventricles contract and pump blood out of the heart, the blood pressure reaches its maximum value in the cycle, which is called systolic pressure. When the ventricles relax, the blood pressure reaches its minimum value in the cycle, which is called diastolic pressure.
TROUBLESHOOTING ABOUT BLOOD PRESSURE This section includes a list of error messages and frequently asked 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. Why does my blood pressure fluctuate throughout the day? 1. Individual blood pressure varies multiple times everyday.
SPECIFICATIONS AUTHORIZED COMPONENT Battery powered mode: 6VDC 4*AA batteries Power supply AC adaptor powered mode: 6V 1A (Can be supplied by AC adaptor model Authorized Component 1.please use the TRANSTEK authorized adapter. KH0601000UW !) Display mode Measurement mode Measurement range Accuracy Blue LCD with white backlight V.A.60mm*80mm Oscillographic testing mode Rated cuff pressure: 0mmHg~299mmHg(0kPa ~ 39.9kPa) Measurement pressure: SYS: 60mmHg~230mmHg (8.0kPa~30.7kPa) DIA: 40mmHg~130mmHg (5.
COMPLIED STANDARDS LIST Complied Standards List Risk management Labeling User manual General Requirements for Safety Electromagnetic compatibility Performance requirements Clinical investigation 22 FCC Statement EN ISO 14971:2012 / ISO 14971:2007 Medical devices - Application of risk management to medical devices EN 980:2008 Symbols for use in the labelling of medical devices ISO 15223-1:2012 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied.
EMC GUIDANCE EMC GUIDANCE Table 2 Guidance and MANUFACTURER’s declaration – electromagnetic IMMUNITY – for all ME EQUIPMENT and ME SYSTEMS EMC Guidance 1)This product needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided, and this unit can be affected by portable and mobile RF communications equipment. 2)* Do not use a mobile phone or other devices that emit electromagnetic fields, near the unit.
EMC GUIDANCE EMC GUIDANCE Table 4 Guidance and MANUFACTURER’s declaration – electromagnetic IMMUNITY – for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacturer’s declaration – electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.
