Transtek Medical Electronics TMB995-BT Blood Pressure Monitor User Manual
Guangdong Transtek Medical Electronics Co.,Ltd Blood Pressure Monitor Users Manual
Users Manual
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| Document ID | 3624088 |
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| Document Description | Users Manual |
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| Date Submitted | 2017-10-31 00:00:00 |
| Date Available | 2017-10-31 00:00:00 |
| Creation Date | 2017-07-22 10:17:53 |
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| Document Title | TMB-1597-BT(CE)说明书åˆç¨¿-100x140mm(1) |
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| Document Author: | Shuting |
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...................................................................................................................10 Tie the Cuff Start the Measurement DATA MANAGEMENT..........................................................................................................12 Recall the records Pair up the Blood Pressure Monitor with 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? TROUBLESHOOTING........................................................................................................19 SPECIFICATIONS...............................................................................................................20 AUTHORIZED COMPONENT ............................................................................................21 CONTACT INFORMATION..................... ...........................................................................21 COMPLIED STANDARDS LIST...........................................................................................22 FCC STATEMENT................................................................................................................23 EMC GUIDANCE.................................................................................................................24 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. 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: 73mm×49 mm Blue LCD display with white backlight Maximum 60 records per each user 3rd technonoly: Measuring during inflation INTRODUCTION 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. The device also compares the longest and the shortest time intervals of detected pulse waves to mean time interval then calculates standard deviation. The device will display a warning signal with the reading to indicate the detection of irregular heartbeat when the difference of the time intervals is over 25%. Safety Information The signs below might be in the user manual, labeling or other component. They are the requirement of standard and using. Indications for Use Symbol for “THE OPERATION GUIDE MUST BE READ” 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. Symbol for “MANUFACTURER” SN Contraindications This device is contraindicated for any person who is connected to a wearable or implantable electronic device or instrument, such as a pacemaker or defibrillator. This blood pressure monitor is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated. Symbol for “SERIAL NUMBER” Symbol for “DIRECT CURRENT” F1 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 “MANUFACTURE DATE” For indoor use only T1A/250V Φ3.6*10CCC Symbol for “Class II Equipment” The Bluetooth Combination Mark Caution: These notes must be observed to prevent any damage to the device. Symbol for “Including RF transmitter” Symbol for “Recycle” The Green Dot is the license symbol of a European network of industry-funded systems for recycling the packaging materials of consumer goods. 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. INTRODUCTION 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, 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. 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. * 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 caculated by the MANUFACTURER from the 800 MHz to 2.5 GHz column of Table 6 of IEC 60601-1-2:2007,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. SYS mmHg DIA mmHg PUL /min SYMBOL SYS DIA PUL /min DESCRIPTION High pressure Diastolic blood pressure Low pressure Pulse Pulse/minute Deflating CUFF is deflating Current Time Time(year:month:day:hour:minute) Memory kPa mmHg Low battery EXPLANATION Systolic blood pressure If “MEM” shows, the displayed measurement values is from the memory. Measurement Unit of the blood pressure (1kPa=7.5mmHg) Measurement Unit of the blood pressure (1mmHg=0.133kPa) Batteries are low and need to be replaced Irregular heartbeat Blood pressure monitor is detecting an irregular heartbeat during measurement. Shocking reminder Shocking will result in inaccurate Heartbeat Heartbeat dectetion during measurement Bluetooth icon The bluetooth icon blinks when the bluetooth is working Data pending to transmit Measurement data stored in the equipment 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. CAUTION In order to get the best effect and protect your monitor,please use the right battery and special power adaptor which complies with US safety standard. BATTERY COMPARTMENT LCD DISPLAY 1.Slide off the battery cover. 2.Install the batteries by matching the correct polarity, as shown. 3.Replace the cover. START/STOP List 1.Blood Pressure Monitor (TMB-995-BT) Installing and Replacing the Batteries Replace the batteries whenever the below happen 2.Cuff (Type BF applied part) (22cm~42cm) (Please use TRANSTEK authorized cuff. The size of the actual cuff please refer to the label on the attached cuff.) The shows The display dims The display does not light up CAUTION 3. 4×AA batteries 4.User manual 5. AC Adaptor (KH0601000UW) 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. 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. You should be able to insert one finger between the cuff and your arm. 5. Sit comfortably with your tested arm resting on a flat surface. Place your elbow on a table so that the cuff is at the same level as your heart. Turn your palm upwards. Sit upright in a chair, and take 5-6 deep breaths. 6. Helpful tips for Patients, especially for Patients with Hypertension: Rest for 5 minutes before first measuring. Wait at least 3 minutes between measurements. This allows your blood circulation to recover. Take the measurement in a silent room. The patient must relax as much as possible and do not move and talk during the measurement procedure. The cuff should maintain at the same level as the right atrium of the heart. Please sit comfortably. Do not cross your legs and keep your feet flat on the ground. Keep your back against the backrest of the chair. For a meaningful comparison, try to measure under similar conditions. For example, take daily measurements at approximately the same time, on the same arm, or as directed by a physician. 10 Adjust the zero . LCD display 3. Hold your arm with your palm facing up and tie the cuff on your upper arm, then position the tube off-center toward the inner side of arm in line with the little finger. Or position the artery mark over the main artery (on the inside of your arm). Note: Locate the main artery by pressing with 2 fingers approximately 2 cm above the bend of your elbow on the inside of your left arm. Identify where the pulse can be felt the strongest. This is your main artery. SYS SYS DIA DIA PUL PUL mmHg mmHg mmHg mmHg /min /min 2~3cm Inflating and measuring. Display and save the results. The data transmission will proceed. SYS SYS mmHg mmHg DIA DIA mmHg mmHg PUL PUL /min 2.Press “START/STOP” button to power off, otherwise it will turn off within 1 minute. /min START STOP 11 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.When the monitor is off, press and hold the START/STOP button to start pair-up. The symbol and the symbol will be shown on the LCD alternatively, indicating pair-up is proceeding. 3.If succeed, symbol will be shown on the LCD. PUL SYS /min mmHg 2.Press “ START/STOP ” button again to get the record you want. During the process of displaying the results, if there is no operation, the blood pressure montior will turn off in one minute. Or you can hold and press “ START/STOP ” button to turn it off. DIA mmHg PUL /min 4.If fail, symbol will be shown on the LCD. SYS SYS mmHg mmHg DIA mmHg DIA mmHg PUL /min PUL /min The record number will display once, year,date and time will display many times alternately. It means the total records are 10, the current No. is No. 1. The corresponding year is 2017. The corresponding th date is May 8 . 5.The monitor will shut off automatically after pair-up process is complete. The corresponding time is AM 8:08. CAUTION The most recent record (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) 12 Bluetooth Module No.: AW8001 RF Frequency Range: 2402 MHz to 2480 MHz Output Power Range: ≤0 dBm Supply Voltage: 1.8-3.6 V Transmitting Distance: 10 meters List of compatible devices: For iOS devices: The operating system must be iOS 8 or more, such as iPhone 4S, iPhone 5/5C/5S, iPhone 6/6 Plus and so on. For Android devices: The operating system must be 4.3 or more. 13 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. CAUTION Interference may occur in the vicinity of equipment marked with the following symbol . And TMB-995-BT may interfering vicinity electrical equipment. Sensitive people, including pregnant women pre-eclamptic and those who implanted medical electronic instruments, should avoid using the unit whenever possible. Keep the monitor at least 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. Tips for Measurement Measurements may be inaccurate if taken in the following circumstances. Within 1 hour after dinner or drinking Immediate measurement after tea, coffe, smoking How to mitigate possible interference? 1. 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 BT end so as to obtain quality connection and to lower the RF output range. 2. To avoid interference, other electronic devices (particularly those with wireless transmission / Transmitter) should be kept at least 1 meter away from the monitor. Within 20 minutes after taking a bath In a very cold environment 14 When talking or moving your fingers When you want to discharge urine 15 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. Systolic Diastolic press relax blood discharging artery blood entering vein What is the standard blood pressure classification? Put in a dry place and avoid the sunshine Avoid touching water, clean it with a dry cloth in case. The chart on the right is the standard blood pressure classification published by American Heart Association (AHA). AHA Home Guideline for Upper Limit of Normal BP SYS 135 mm Hg DIA 85 mm Hg Avoid intense shaking and collisions Avoid dusty and unstable temperature environment This chart reflects blood pressure categories defined by American Heart Association. Blood Pressure Category Systolic mmHg (upper#) Diastolic mmHg (lower#) less than 120 and less than 80 Prehypertension 120-139 or 80-89 High Blood Pressure (Hypertension) Stage 1 140-159 or 90-99 160 or higher or 100 or higher Higher than 180 or Normal High Blood Pressure (Hypertension) Stage 2 Hypertensive Crisis (Emergency care needed) Higher than 110 CAUTION 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. Irregular Heartbeat Detector An irregular heartbeat is detected when a heartbeat rhythm varies while the unit is measuring the systolic and diastolic blood pressure.During each measurement, this equipment records the heartbeat intervals and works out the standard deviation. If the calculated value is larger than or equal to 25%,the irregular heartbeat symbol appears on the symbol when the measurement results are displayed. Using wet cloths to remove dirt Avoid washing the cuff CAUTION The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heartbeat was detected during measurement. Usually this is NOT a cause for concern. However, if the symbol appears often, we recommend you seek medical advice. Please note that the device does not replace a cardiac examination, but serves to detect pulse irregularities at an early stage. 16 17 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. It is also affected by the way you tie your cuff and your measurement position, so please take the measurement under the same conditions. PROBLEM SYMPTOM No power Display will not light up. What you need to pay attention to when you measure your blood pressure at home: Why do I get a different blood pressure at home If the cuff is tied properly. cuff is too tight or too loose. compared to the hospital? IfIf the the cuff is tied on the upper arm. The blood pressure is different even If you feel anxious. Taking 2-3 deep breaths before throughout the day due to weather, emotion, exercise etc, Also, there is the beginning will be better for measuring. Advice: Relax yourself for 4-5 “white coat” effect, which means blood minutes until you calm down. pressure usually increases in clinical settings. Is the result the same if measuring on the right arm? It is ok for both arms, but there will be some different results for different people. We suggest you measure the same arm every time. Low batteries Display is dim or shows out E01 shows Error message REMEDY Batteries are low. Insert the batteries correctly Insert the AC adaptor tightly Replace with new batteries The results are over the Remeasurement, according measurement range to the user manual The cuff is not secure. Readjust the cuff and relax for a moment and then measure again. Movement can affect the measurement.Relax for a moment and then measure again. E04 shows The monitor detected motion,talking or the pluse is too poor while measuring. The measurement Loosen the clothing on the process does not detect arm and then measure the pulse signal. again The treatment of the Relax for a moment and measurement failed. then measure again. E12 shows Communication error E02 shows E03 shows EExx,shows on the display. 18 Batteries are inserted incorrectly. AC adaptor is inserted incorrectly. 2.If the person takes medicine, the pressure will vary more. 3.Wait at least 3 minutes for another measurement. CHECK THIS Batteries are exhausted. Replace with new batteries A calibration error occurred. Check if the APP is on, operate and send the data again. 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. 19 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 (5.3kPa~17.3kPa) Pulse value: (40-199)beat/minute Pressure: 5℃-40℃ within±3mmHg(0.4kPa) pulse value:±5% Normal working condition 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 greater than 50 hPa An atmospheric pressure range of : 700 hPa to 1060 hPa Storage & transportation condition Temperature:-20°C to +60°C A relative humidity range of ≤ 93%, non-condensing, at a water vapour pressure up to 50hPa Measurement perimeter of the upper arm Weight External dimensions Attachment Mode of operation Degree of protection Protection against ingress of water Device Classification Software Version About 22cm~42cm Approx.260g(Excluding the dry cells) Approx.102mm*143mm*73mm 4*AA batteries, AC adaptor, user manual Continuous operation Type BF applied part Adapter Type：KH0601000UW Input：100~240V~ 50/60Hz, 0.4A Max Output：6V 1000mA Contact Information For more information about our products, please visit www.transtek.cn.you can get customer service, usual problems and customer download, transtek will serve you anytime. Manufactured by: Guangdong Transtek Medical Electronics Co., Ltd. Company: Guangdong Transtek Medical Electronics Co., Ltd. Address: Zone A, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China IP21 It means the device could protected against solid foreign objects of 12.5mm and greater, and protect against vertically falling water drops. Battery Powered Mode: Internally Powered ME Equipment AC Adaptor Powered Mode: Class II ME Equipment A01 WARNING: No modification of this equipment is allowed. 20 21 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. Part 1 : General requirements EN 1041:2008 Information supplied by the manufacturer of medical devices EN 60601-1:2006/ IEC 60601-1:2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance EN 60601-1-11:2010/ IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment EN 60601-1-2:2007/ IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems 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 EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type Usability EN 60601-1-6:2010/IEC 60601-1-6:2010+A1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability EN 62366:2008/ IEC 62366-1:2015 Medical devices - Application of usability engineering to medical devices Software life-cycle processes EN 62304:2006/AC: 2008 / IEC 62304:2006 Medical device software - Software life-cycle processes Bio-compatibility FCC STATEMENT ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization FCC ID: OU9TMB995-BT This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Caution: The user is cautioned that changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on,the user is encouraged to try to correct the interference by one or more of the following measures: -- Reorient or relocate the receiving antenna. -- Increase the separation between the equipment and receiver. -- Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. -- Consult the dealer or an experienced radio/TV technician for help. FCC Radiation Exposure Statement: This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. 23 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. This may result in incorrect operation of the unit. 3)Caution: This unit has been thoroughly tested and inspected to assure proper performance and operation! 4)* Caution: this machine should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, this machine should be observed to verify normal operation in the configuration in which it will be used. Table 1 Guidance and MANUFACTURER’s declaration – ELECTROMAGNETIC EMISSIONS- for all ME EQUIPMENT and ME SYSTEMS Guidance and manufacturer’s declaration – electromagnetic emissions 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 IMMUNITY test Electrostatic discharge (ESD) IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 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. Emissions test RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Compliance Electromagnetic environment - guidance Group 1 The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. Class B Not applicable IEC 61000-4-11 The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Not applicable IEC 61000-4-8 NOTE 24 Compliance level Electromagnetic environment - guidance ±6 kV contact ±8 kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. ±2 kV for power supply lines ±2 kV for power supply lines Mains power quality should be that of a typical commercial or hospital environment. ±1 kV differential mode ±1 kV differential mode ±6 kV contact ±8 kV air <5% UT (>95% dip in UT ) for 0.5 cycle <5% UT (>95% dip in UT ) for 0.5 cycle 40% UT (60% dip in UT ) for 5 cycles 40% UT (60% dip in UT ) for 5 cycles 70% UT (30% dip in UT ) for 25 cycles 70% UT (30% dip in UT ) for 25 cycles <5% U T (>95% dip in UT ) for 5 sec <5% U T (>95% dip in UT ) for 5 sec Power frequency (50Hz/60Hz) magnetic field Voltage fluctuations/ flicker emissions IEC 61000-3-3 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 60601 test level 3A/m 3A/m Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply or a battery. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. UT is the a.c. mains voltage prior to application of the test level. 25 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. IMMUNITY test IEC 60601 TEST LEVEL Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz Recommended separation distance 3 Vrms 3 V/m Recommended separation distances between portable and mobile RF communications equipment and the device. The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmittters) and the device as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter (W) d = 1.2 P d = 2.3 P 800 MHz to 2,5 G Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol: Separation distance according to frequency of transmitter (m) 150 kHz to 80 MHz d = 1.2 d = 1.2 P 80 MHz to 800 MH where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). NOTE 1 NOTE 2 Table 6 Recommended separation distances between portable and mobile RF communications equipment and the ME EQUIPMENT or ME SYSTEM – for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING 80 MHz to 800 MHz d = 1.2 800 MHz to 2.5 GHz d = 2.3 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80MHz and 800MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed 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. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m. 26 27
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83.999997, 77.999997, 0.000000, 57.999998, 100.000000, 40.000001, 7.000000, 0.000000, 10.000000, 0.000000, 30.000001, 7.000000, 25.000000, 16.000000, 5.000000, 50.999999, 0.000000, 74.000001, 42.999998, 30.000001, 82.999998, 67.968297, 60.000002, 87.972802, 0.003100, 72.999603, 0.000000, 6.000000, 40.000001, 100.000000, 76.470602, 0.003100, 74.676102, 74.676102, 87.972802, 0.003100, 94.999999, 34.999999, 0.000000, 0.000000, 74.676102, 87.972802, 0.003100, 1.000000, 74.676102, 87.972802, 0.003100, 74.676102, 0.003100, 87.972802, 0.003100, 76.470602, 74.676102, 0.003100, 87.972802, 0.003100, 76.470602, 0.000000, 3.000000, 87.972802, 78.252798, 0.000000, 87.972802, 55.291098, 72.999996, 67.578101, 66.406298, 62.890601, 57.812500, 51.171899, 42.968798, 34.765601, 24.218798, 14.843798, 6.250000, 2.343798, 44.140601, 32.812500, 70.703101, 78.906298 Swatch Colorant Yellow : 0.000000, 0.000000, 100.000000, 96.093798, 100.000000, 12.500000, 0.000000, 0.000000, 92.187500, 96.875000, 96.484399, 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0.003100, 82.775599, 89.019603, 94.830197, 0.003100, 0.003100, 82.775599, 89.019603, 94.830197, 0.003100, 0.000000, 0.000000, 89.019603, 81.765503, 0.000000, 89.019603, 52.037799, 72.999996, 66.796899, 64.843798, 61.718798, 56.640601, 50.390601, 42.968798, 35.156298, 24.609399, 15.625000, 6.640601, 2.343798, 85.546899, 0.000000, 0.000000, 0.000000 Swatch Colorant Black : 0.000000, 100.000000, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 6.640601, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 3.906298, 25.781298, 0.000000, 0.000000, 0.000000, 0.000000, 0.390601, 24.609399, 0.390601, 0.000000, 10.937500, 0.781298, 0.000000, 0.000000, 6.640601, 23.437500, 41.796899, 1.171899, 9.765601, 22.656298, 35.546899, 48.828101, 67.968798, 0.000000, 20.000000, 0.000000, 0.000000, 0.000000, 100.000000, 0.000000, 0.000000, 69.999999, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 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100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000 Producer : Adobe PDF library 9.90 Page Count : 15 Author : Shuting Keywords : GBF-1251-B Subject : User Manual