Transtek Medical Electronics TMB1597BN Blood Pressure Monitor User Manual
Guangdong Transtek Medical Electronics Co.,Ltd Blood Pressure Monitor
User Manual
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| Document ID | 3411126 |
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| Document Description | User Manual |
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| Document Type | User Manual |
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| Filesize | 392.21kB (4902567 bits) |
| Date Submitted | 2017-06-01 00:00:00 |
| Date Available | 2017-11-25 00:00:00 |
| Creation Date | 2016-10-20 15:21:41 |
| Producing Software | Adobe PDF library 9.90 |
| Document Lastmod | 2017-05-15 13:41:44 |
| 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-1597-BN Arm Type Guangdong Transtek Medical Electronics Co., Ltd. Zone B, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China Thank you very much for selecting TRANSTEK Blood Pressure Monitor TMB-1597-BN. 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 Principle Safety Information LCD Display Signal Monitor Components List BEFORE YOU START..........................................................................................................8 The Choice of Power Supply Installing and Replacing the Batteries Setting Date, Time and Measurement Unit Select the User Pair-up the Blood Pressure Monitor with Your Device MEASUREMENT................................................................................................................15 Tie the Cuff Start the Measurement DATA MANAGEMENT........................................................................................................18 Recall the Records Delete the Records INFORMATION FOR USER...............................................................................................21 Tips for measurement Maintenances ABOUT BLOOD PRESSURE.............................................................................................23 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........................................................................................................25 SPECIFICATIONS..............................................................................................................26 AUTHORIZED COMPONENT ...........................................................................................27 CONTACT INFORMATION.................................................................................................27 COMPLIED STANDARDS LIST..........................................................................................28 FCC STATEMENT...............................................................................................................29 EMC GUIDANCE................................................................................................................30 INTRODUCTION General Description Thank you for selecting TRANSTEK arm type blood pressure monitor (TMB-1597-BN). 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-1597-BN 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 Indications for Use 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. The Transtek Blood Pressure Monitor is digital monitors intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22 cm to 32 cm ( about 8¾˝-12½˝ ) or 22cm to 42cm(about 8¾˝-16½˝). It is intended for adult indoor use only. 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 “THE OPERATION GUIDE MUST BE READ” Symbol for “MANUFACTURER” SN 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” INTRODUCTION INTRODUCTION CAUTION CAUTION * This device is intended for adult use only. It is not intended for use with neonatal patients, pregnant or pre-eclamptic patients. * 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. * 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. * If the cuff pressure exceeds 40 kPa (300 mmHg), the unit will automatically deflate. Should the cuff not deflate when pressures exceeds 40 kPa (300 mmHg), detach the cuff from the arm and press the START/STOP button to stop inflation. * 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. * The operator shall not touch output of batteries /adapter and the patient simultaneously. * To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated interference signal or electrical fast transient/burst signal. * The user must check that the equipment functions safely and see that it is in proper working condition before being used. * 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. * Manufacturer will make available on request circuit diagrams, component parts list etc. * 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. * 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. * 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. * Please use ACCESSORIES and detachable partes specified/ authorised by MANUFACTURE. Otherwise, it may cause damage to the unit or danger to the user/patients. * The device doesn’t need to be calibrated within two years of reliable service. * Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local guidelines. * 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. * Please report to Transtek if any unexpected operation or events occur. * Please use the soft cloth to clean the whole unit. Don’t use any abrasive or volatile cleaners. * 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 battery under normal circumstances and maintain the device and its accessories according to the user manual. * Adaptor is specified as a part of ME EQUIPMENT. * 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. * Before every use, check the device, do not use the device or an electrode if it is damaged in any way. The continuous use of a damaged unit may cause injury, improper results, or serious danger. * Be careful to strangulation due to cables and hoses, particularly due to excessive length. * Keep unit out of the reach of young children / pets to avoid inhalation or swallowing of small parts. The cord/tube can cause strangulation. * 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. * 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. * Warning: Be careful to regarding the effect of blood flow interference and resulting harmful injury to the patient caused by continuous cuff pressure due to connection tubing. *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 samb 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. * 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 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. * Do not wash the cuff in a washing machine or dishwasher! * 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). * 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. * 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. INTRODUCTION INTRODUCTION LCD display signal Monitor Components Component list of pressure measuring system 1 Cuff 2 Air pipe 3 PCBA 4 Pump 5 Valve CUFF AIR HOSE MEM BUTTON AIR CONNECTOR PLUG SYMBOL DESCRIPTION SET BUTTON EXPLANATION START/STOP Systolic blood pressure High blood pressure Diastolic blood pressure Low blood pressure Pulse in beats per minute Pulse display Deflation symbol Memory kPa mmHg Low battery Batteries are low and need to be replaced Blood pressure monitor is detecting an irregular heartbeat during measurement. Current Time Heartbeat User 1 User 2 Motion indicator Average value The cuff is deflating. Indicate it is in the memory mode and which group of memory it is. Measurement Unit of the blood pressure (1kPa=7.5mmHg) Measurement Unit of the blood pressure (1mmHg=0.133kPa) Irregular heartbeat Blood pressure level indicator DC POWER SOCKET LCD DISPLAY BATTERY COMPARTMENT Indicate the blood pressure level List Year/Month/Day, Hour/Minute 1.Blood Pressure Monitor (TMB-1597-BN) 2.Cuff (Type BF applied part) (22cm~32cm or 22cm~42cm) 3. 4×AA alkaline batteries 4.User manual Blood pressure monitor is detecting a heartbeat during measurement. Start measurement,save and transmit the measuring results for User 1 Start measurement, save and transmit the measuring results for User 2 Motion may result in an inaccurate measurement The average value of blood pressure Bluetooth icon Indicate the Bluetooth is working Data storage Indicate the data is waiting to be transmitted (Please use TRANSTEK authorized cuff. The size of the actual cuff please refer to the label on the attached cuff.) 5. AC Adaptor (KH0601000UW!) BEFORE YOU START BEFORE YOU START The Choice of Power Supply Setting Date, Time and Measurement Unit 1.Battery powered mode: It is important to set the clock before using your blood pressure monitor, so that a time stamp can be assigned to each record that is stored in the memory. (The setting range of the year :2016—2056; Time format:24H) 6VDC 4×AA alkaline batteries 2.AC adaptor powered mode: 6V 1A (Please only use the recommended AC adaptor model). Please unplug the adaptor to depart from the using utility power. AC 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 U.S. safety standard. ”button,it will display the time.Then press and 1. When the monitor is off, press “ hold “ ” button to enter the mode for year setting. (Notes: 1.During the process of setting, you can press “ ” button to stop setting at any time. 2. If there is no operation during the process of setting, it will turn off within 1 minute.) Installing and Replacing the Batteries • .Open the battery cover. • .Install the batteries by matching the correct polarity, as shown. • .Replace the battery cover. The typical service life of the new and unused batteries is 300 measurements for the operation time is 60s. Replace the batteries whenever the below happen The shows 2. Press “ ” button to change the [YEAR]. Each press will increase the numeral by one in a cycling manner. The display is dim The display does not light up CAUTION 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. BEFORE YOU START 3. When you get the right year, press “ BEFORE YOU START ” button to set down and turn to next step. 5 .Repeat steps 2 and 3 to set the [HOUR] and [MINUTE]. 6.Repeat steps 2 and 3 to set the [UNIT]. 4.Repeat steps 2 and 3 to set the [MONTH] and [DAY]. 7. After the unit is set,the LCD will display “done” first, then display all the settings you have done and then turn off. 10 11 BEFORE YOU START BEFORE YOU START Select the User 1. When the monitor is off, press and hold “ user setting mode. The user ID will blink. ”button to enter Pair - up the Blood Pressure Monitor with Your Device Before you start pairing, please download the MedM Health app from APP Store or Google Play in your device which supports Bluetooth 4.0 technology first. 1. Turn on Bluetooth and the app. Make sure both are ON when pair-up is proceeding. If this is the first time you use “MedM Health”, please register an account first. Enter your account and password to log in.Please enter “My Profile” to set your pernal information. Please enter Settings infterface,click “My Devices”, select “Add the Device”. 2. When the monitor is OFF, press and hold the button to start pair-up. The symbol and will display alternatively, indicating pair-up is proceeding. ” button again, select the user ID between 2. Then press “ user 1 and user 2. 3. After selecting the suitable user ID, press “ ” button to confirm. It will display User ID+ donE” and then turn off. 12 3. After detecting the blood pressure monitor, “MedM Health” will display the product’s information. Click and select the device which you want to bind with your mobile device. Click “bind the device”, then click “User Profile” to select the user you want to connect with your mobile device on the app to continute the pair-up. After binding the device, it only can transmit the data of the bound user. If SUCCEED, symbol + will be shown on the LCD. If FAIL, only bluetooth symbol “E12” will be shown on the LCD. 13 BEFORE YOU START MEASUREMENT Tie the cuff 4.The monitor will shut off after Pair-up process is complete. Bluetooth Module No.: AW51822 RF Frequency Range: 2402 MHz to 2480 MHz Output Power Range: 4 dBm Supply Voltage: 1.8V-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. CAUTION Interference may occur in the vicinity of equipment marked with the following symbol . And TMB-1597-BN 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. 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. 1. 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. 2. The cuff should be snug but not too tight. You should be able to insert one finger between the cuff and your arm. 3. Sit comfortably with your tested arm resting on a flat surface. 2~3cm 4. Patients with Hypertension: The middle of the cuff should be at the level of the right atrium of the heart; Before starting measurement, please sit comfortably with legs uncrossed, feet flat on the floor, back and arm supported. Rest for 5 minutes before measuring. Wait at least 3 minutes between measurements. This allows your blood circulation to recover. For a meaningful comparison, try to measure under similar conditions. For example, take daily measurements at approximately the same time, position of upper arm, or as directed by a physician. 14 15 MEASUREMENT MEASUREMENT Start the Measurement 1. When the monitor is off, press “ will finish the whole measurement. (Take user 1 for example.) LCD display ” button to turn on the monitor, and it 2.This device will proceed to data transmission after measurement. The Bluetooth symbol blinks on the LCD indicates data is transmitting. Adjust the zero. Transmitting Inflating and measuring. Display and save the measurement results. The year, date and time will display alternately. Complete 3.With TMB-1597-BN successfully pair-up with your mobile device, the measurement data will be automatically transmitted to your mobile device via Bluetooth. (1).The symbol will disappear after successful data transmission, and you may check your personal health data stored in your mobile device. (2).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. ” button to power off, otherwise it will turn off 4. Press the “ within 1 minute. Tips: 1. There are two users in total. Each user has 60 records. 2. You can press “ ” button at any time to stop measuring during the process of measurement. 3. If the measurement result is out of the measurement range (SYS: 60mmHg to 230mmHg; or DIA: 40mmHg to 130mmHg;or Pulse: 40-199 pulse/minute), the LCD will display “out”. 16 17 DATA MANAGEMENT DATA MANAGEMENT Recall the Records 1. When the monitor is off, please press “ value of the latest three records. (Take user 1 for example.) 2. Press “ ” button or “ ” button to show the average 3. If you want to check another user’s records, press “ ” button to turn off the monitor when the blood pressure monitor is in the memory inquiry mode. Press and hold “ ” button to enter into the selecting user ID mode, press “ ” button again to select the user ID between user 1 and user 2, press “ ” button to confirm the user ID , then press “ ” button to check the selected user’s measurement records. ” button to get the records you want. CAUTION The current No. is No. 1. The corresponding Seven records in total. date is December 1st . The record number, date and time of the measurement records will display alternately. 18 The corresponding time is A.M. 7:00. The most recent record (1) is shown first. Each new measurement is assigned to the first (1) record. All other records are pushed back one digit (e.g., 2 becomes 3, and so on), and the last record (60) is dropped from the list. 19 INFORMATION FOR USER DATA MANAGEMENT Delete the Records If you did not get the correct measurement, you can delete all results for the selected user by following steps. (Take User 1 for example.) 1. Hold pressing “ ” button about 3 seconds when the monitor is in the memory recall mode, the flash display “ dEL ALL”+ User ID will show. Note: To exit out of delete mode without deleting any records, press “ ” button before pressing " " button to confirm any delete commands. Tips for Measurement Measurements may be inaccurate if taken in the following circumstances. 2. Press “ ” button to confirm deleting and the monitor will display “User ID+dEL dOnE” and then turn off. 3. If there is no record, when you press “ ” button to check the record, the following display will show. Within 1 hour after dinner or drinking Immediate measurement after tea, coffee, smoking Within 20 minutes after taking a bath When talking or moving your fingers In a very cold environment 20 When you want to discharge urine 21 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 DIA Avoid intense shaking and collisions Avoid dusty and unstable temperature environment 135 mm Hg 85 mm Hg This chart reflects blood pressure categories defined by American Heart Association. Blood Pressure Category Normal 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 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 Using wet cloths to remove dirt Do not attempt to clean the reusable cuff with water and never immerse the cuff in water. An irregular heartbeat (IHB) is detected when a heartbeat rhythm varies while the unit is measuring the systolic and diastolic blood pressure.During each measurement, the monitor records the heartbeat intervals and calculates the average. If any average is larger than or equal to 25%,the irregular heartbeat symbol appears on the display when the measurement results appear. CAUTION The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heart-beat 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. 22 23 TROUBLESHOOTING ABOUT BLOOD PRESSURE 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. 2.If the person takes medicine, the pressure will vary more. 3.Wait at least 3 minutes for another measurement. Why do I get a different blood pressure at home compared to the hospital? The blood pressure is different even throughout the day due to weather, emotion, exercise etc, Also, there is the “white coat” effect, which means blood pressure usually increases in clinical settings. 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. PROBLEM SYMPTOM No power Low batteries What you need to pay attention to when you measure your blood pressure at home: If the cuff is tied properly. If the cuff is too tight or too loose. If the cuff is tied on the upper arm. If you feel anxious. Taking 2-3 deep breaths before beginning will be better for measuring. Advice: Relax yourself for 4-5 minutes until you calm down. Error message Is the result the same if measuring on the right arm? Display will not light up. 24 REMEDY Batteries are inserted incorrectly. Insert the batteries correctly AC adaptor is inserted incorrectly. Insert the AC adaptor Batteries are low. Replace with new batteries E 01 shows The cuff is too tight or too loose. Refasten the cuff and then measure again. E 02 shows The monitor detected motion while measuring. Movement can affect the measurement.Relax for a moment and then measure again. E 03 shows The measurement process does not detect the pulse signal. Loosen the clothing on the arm and then measure again. E 04 shows The treatment of the measurement failed. Relax for a moment and then measure again. E 12 shows Data communication is failed. EExx,shows on the display. A calibration error occurred. (XX can be some digital symbol, such as 01, 02,etc., if this similar situation appear, all belong to calibration error.) “out ” shows Out of measurement range Display is dim or show 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. Warning message CHECK THIS Batteries are exhausted. Replace with new batteries tightly Check if the App/Bluetooth is on or not,try data transmission 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. Relax for a moment. Refasten the cuff and then measure again. If the problem persists, contact your physician. 25 SPECIFICATIONS Power supply Display mode Measurement mode Measurement range Accuracy Normal working condition Storage & transportation condition Measurement perimeter of the upper arm Weight External dimensions Attachment Mode of operation AUTHORIZED COMPONENT Battery powered mode: 6VDC 4×AA alkaline batteries AC adaptor powered mode: 6V 1A (Please only use the recommended AC adaptor model). Blue LCD display with white backlight V.A.73mm×49mm Oscillographic testing mode Rated cuff pressure: 0mmHg~300mmHg(0kPa ~ 40kPa) 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% 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 Temperature:-20°C to +60°C A relative humidity range of ≤ 93%, non-condensing, at a water vapour pressure up to 50hPa About 22cm~32cm or 22cm~42cm authorized adapter. Adapter Model：KH0601000UW Input：AC 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 B, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China Approx.258g(Excluding the dry cells and cuff) Approx.118mm×126mm×72mm 4×AA alkaline batteries,user manual Continuous operation Degree of protection Type BF applied part Protection against ingress of water IP21 It means the device could protected against solid foreign objects of 12.5mm and greater, and protect against vertically falling water drops. Software Version Authorized Component 1.please use the TRANSTEK A01 WARNING: No modification of this equipment is allowed. 26 27 COMPLIED STANDARDS LIST FCC STATEMENT Complied Standards List FCC ID: OU9TMB1597BN Labeling ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1 General requirements User manual EN 1041:2008 Information supplied by the manufacturer of medical devices 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. Risk management General Requirements for Safety Electromagnetic compatibility Performance requirements Clinical investigation Usability Software life-cycle processes 28 FCC Statement ISO 14971:2007 Medical devices - Application of risk management to medical devices IEC 60601-1: 2005+A1：2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC 60601-1-11 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 IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests IEC 80601-2-30:2009 Medical electrical equipmentPart 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers ISO 81060-2:2009 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type IEC 62366 Medical devices - Application of usability engineering to medical devices (IEC 62366:2007) IEC 60601-1-6 Medical electrical equipment - Part 1 -6 : General requirements for basic safety and essential performance - collateral standard : Usability IEC 62304:2006/AC: 2008 Medical device software Software life-cycle processes 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. MODIFICATION: Any changes or modifications not expressly approved by the grantee of this device could void the user’s authority to operate the device. 29 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 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 Class A flicker emissions IEC 30 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 Complies IEC 60601 test level ±6 kV contact ±8 kV air Electrical fast transient/burst IEC 61000-4-4 ±2 kV for power supply lines ±1 kV for input/output lines Surge IEC 61000-4-5 ±1 kV line(s) to line(s) ±2 kV line(s) to earth Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Compliance level IEC 61000-4-8 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 Mains power quality should be that of a typical commercial or hospital environment. ±1 kV differential mode <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 NOTE 3A/m Electromagnetic environment - guidance ±6 kV contact ±8 kV air Power frequency (50Hz/60Hz) magnetic field Voltage fluctuations/ 61000-3-3 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. Guidance and manufacturer’s declaration – electromagnetic immunity 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. 31 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 Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 IEC 60601 TEST LEVEL 3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz 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. Recommended separation distance 3 Vrms d = 1.2 P 3 V/m d = 1.2 P 80 MHz to 800 MHz d = 2.3 P 800 MHz to 2,5 GHz 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). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a 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: NOTE 1 NOTE 2 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. 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 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) Separation distance according to frequency of transmitter (m) 150 kHz to 80 MHz d = 1.2 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. 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. 32 33
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100.000000, 100.000000, 100.000000, 100.000000, 100.000000 Producer : Adobe PDF library 9.90 Page Count : 18 Author : Shuting Keywords : GBF-1251-B Subject : User Manual