Version:1.0 User Manual Arm Blood Pressure Monitor Model: TMB-2085 Wrist Type Guangdong Transtek Medical Electronics Co., Ltd. Zone B, No.105, Dongli Road, Torch Development District, Zhongshan, 528437, Guangdong, China Thank you for selecting Transtek Blood Pressure Monitor. Please read the user manual carefully and thoroughly so as to ensure the safe usage of this product. Keep this manual for further reference in case any issues arise.
CATALOGUE INTRODUCTION General Description Indications for Use Contraindications Measurement Principle Safety Information LCD Display Symboll Monitor Components List BEFOREYOU START Installing and Replacing the Batteries Setting Date, Time and Measurement Unit Select the User ID Install the App and Pair-Up Search your test inform
INTRODUCTION INTRODUCTION General Description This product features blood pressure measurement, pulse rate measurement and the result storage. The design provides you with two years of reliable service. Readings taken by this blood pressure monitor TMB-2085 is 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 this blood pressure monitor.
INTRODUCTION INTRODUCTION Safety Information CAUTION The signs below might be in the user manual, labeling or other component. They are the requirement of standard and using. Symbol for “THE OPERATION GUIDE MUST BE READ” Symbol for “MANUFACTURE DATE” Symbol for “MANUFACTURER” SN Symbol for “SERIAL NUMBER” Symbol for “RECYCLE” Symbol for “TYPE BF APPLIED PARTS” Symbol for “ENVIRONMENT PROTECTION - Electrical waste products should not be disposed of with household waste.
INTRODUCTION INTRODUCTION CAUTION *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 wrist 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.
INTRODUCTION CAUTION * 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.
INTRODUCTION SYMBOL INTRODUCTION DESCRIPTION EXPLANATION Battery Indicator Indicate the current battery Irregular heartbeat Irregular heartbeat Data transmitting Data is transmitting Postion Adjust your hand to correct position Blood pressure level Indicate blood pressure level Bluetooth icon The bluetooth icon blinks when the bluetooth is working Monitor Components SYSTOLIC LCD DISPLAY START/STOP BUTTON DIASTOLIC MEM BUTTON CUFF kPa mmHg Average value The average value of the late
INTRODUCTION BEFORE YOU START Installing and Replacing the Batteries CUFF (Type BF applied part) Slide off the battery cover. Install the batteries as indicated in the battery compartment. Always use the correct battery type (2× AAA batteries). Replace the battery cover. The typical service life of the new and unused batteries is about 45 measurements for the operation time is 60s.
BEFORE YOU START BEFORE YOU START Setting Date and Time Replace the batteries whenever the below happen The shows The display is dim The display does not light up It is important to set the Date and Time before using your blood pressure monitor, so that a time stamp can be assigned to each record that is stored in the memory. (Year Range: 2020-2099; Time Format: 24 Hours) 1.When the monitor is off, Long press “MEM” button, the display will show a blinking number representing the [YEAR].
BEFORE YOU START BEFORE YOU START 3.When you get the right year, press the “START STOP” button to confirm the entry. The screen will then show a blinking number representing the [MONTH]. 5. Repeat steps 2 and 3 to confirm [HOUR] and [MINUTE]. 4.Repeat steps 2 and 3 to set the [MONTH] and [DAY]. 6.Repeat steps 2 and 3 to set the [UNIT].
BEFORE YOU START BEFORE YOU START 7.After confirming the measurement unit, the LCD will display “dOnE” and then the monitor will turn off. Set the User ID Before you start the measurement, please set your desired user ID. 1.When the blood pressure monitor is off, hold press “START/STOP” button and then the user ID shows. Then press “MEM” button to switch the user ID between user A, user B and Guest mode. 2.
BEFORE YOU START BEFORE YOU START Install the App and Pair-Up Download the Transtek Health app from APP Store or Google Play. Install the APP, and register an account.
BEFORE YOU START BEFORE YOU START Search your test information After binding the app, back to the beginning page and click “Blood Pressure” to search your test information. Bluetooth Module No.: LS51802 RF Frequency Range: 2402 MHz to 2480 MHz Output Power Range: G%P Supply Voltage: 1.8-3.6 V Transmitting Distance: 10 meters List of compatible devices： For iOS devices: The operating system must be iOS 11.0 or more. For Android devices The operating system must be Android 8.
MEASUREMENT Tie the Cuff Start the Measurement 1. Remove all accessories (watch, bracelet,etc) from your wrist. If your physician has diagnosed you with poor circulation in your wrist, use the other one. 2. Roll or push up your sleeve to expose the skin. 3. Apply the cuff to your wrist with your palm facing up. 1.When the monitor is off, press the START/STOP button to turn on the monitor, and it will complete the whole measurement automatically.(Take user A for example.) 4.
DATA MANAGEMENT MEASUREMENT DATA MANAGEMENT Inflating and measuring. 3. If the data transmits successful, the symbol and symblo will disappear, and then the monitor will turn off. mmHg mmHg Display and save the 4. If the data transmition fails, the monitor will turn off automatically. measuring result. After the measurement was finished, the symbol will start blinking, and the data will start transmitting. 2.Press “START/STOP” button to power off, otherwise it will turn off within 1 minute.
DATA MANAGEMENT DATA MANAGEMENT 1. When it is in the memory mode, hold pressing “START/STOP” button for 3 seconds, it will display “dEL ALL”+User ID. 2. Press MEM button to get the record you want. Date and time will display alternately. Note: To exit delete mode, press START/STOP button before pressing MEM button to confirm any delete commands. mmHg The corresponding year is 2020. The corresponding date is 1st January. The corresponding time is 9:00.
INFORMATION FOR USER INFORMATION FOR USER Tips for Measurement Maintenance Measurements may be inaccurate if taken in the following circumstances. To obtain the best performance, please follow the instructions below. Within 1 hour after dinner or drinking Immediate measurement after tea, coffee, smoking Put in a dry place and avoid the sunshine Within 20 minutes after taking a bath Avoid immersing it in the water. Clean it with a dry cloth in case. Avoid shaking and collision.
ABOUT BLOOD PRESSURE ABOUT BLOOD PRESSURE What are systolic pressure and diastolic pressure? When ventricles contract and pump blood out of the heart, blood pressure reaches its maximum value, the highest pressure in the cycle is known as systolic pressure. When the heart relaxes between heartbeats, the lowest blood pressure is diastolic pressure.
ABOUT BLOOD PRESSURE TROUBLESHOOTING Why does my blood pressure fluctuate throughout the day? 1. Individual blood pressure varies multiple times everyday. It is also affected by the way you tie your cuff and your measurement position, so please take the measurement under the same conditions. If any abnormality arises during use, please check the following points: PROBLEM SYMPTOM 2.If the person takes medicine, the pressure will vary more. 3.Wait at least 3 minutes for another measurement.
SPECIFICATIONS TROUBLESHOOTING PROBLEM SYMPTOM Error message Warning message EExx,shows on the display. “out ” shows CHECK THIS A calibration error occurred. Out of measurement range REMEDY Retake the measurement.If the problem persists,contact the retailer or our customer service department for further assistance. Refer to the warranty for contact information and return instructions. Relax for a moment. Refasten the cuff and then measure again. If the problem persists, contact your physician.
EMC GUIDANCE SPECIFICATIONS FCC STATEMENT FCC Statement FCC ID: OU9TMB2085-K Mode of operation Continuous operation Degree of protection Type BF applied part Device Classification Internally Powered ME Equipment IP Classification Software Version IP22: The first number 2: Protected against solid foreign REMHFWV RI PP Ɏ DQG JUHDWHU 7KH VHFRQG QXPEHU Protected against vertically falling water drops when enclosure titled up to 15º.
COMPLIED STANDARDS LIST COMPLIED STANDARDS LIST Complied Standards List Risk management EN ISO 14971:2012 / ISO 14971:2007 Medical devices Application of risk management to medical devices Labeling EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied.
EMC GUIDANCE EMC Guidance The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments. Warning: Don’t be near the active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high. Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation.
EMC GUIDANCE Table 5 EMC GUIDANCE Table 2 Guidance and manufacturer’s declaration – electromagnetic Immunity Immunity Test IEC 60601-1-2 Test level Compliance level Electrostatic discharge (ESD) IEC 61000-4-2 ±8 kV contact ±2 kV, ±4kV, ±8 kV, ±15 kV air ±8 kV contact Electrical fast transient/burst IEC 61000-4-4 Not applicable Not applicable Surge IEC61000-4-5 ±2 kV, ±4kV, ±8 kV, ±15 kV air Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Powe
TableGUIDANCE 5 EMC EMC GUIDANCE Table 3 Guidance and manufacturer’s declaration - electromagnetic Immunity 1720 Radiated RF Test Band Service Modulation Modulation IEC61000-4-3 Frequency (MHz) (W) (Test (MHz) specifications 1.8 for 385 380-390 TETRA Pulse ENCLOSURE 400 modulation b) PORT 18Hz IMMUNITY to GMRS 460，FM c) ± 5kHz RF wireless 2 deviation 1kHz 450 430-470 FRS 460 communicatio sine ns equipment) 710 704-787 LTE Band Pulse 0.
