Transtek Medical Electronics TMB1598-B Bluetooth Blood Pressure Monitor User Manual
Guangdong Transtek Medical Electronics Co.,Ltd Bluetooth Blood Pressure Monitor Users Manual
Contents
- 1. TMB-1598-BA FDA user manual
- 2. TMB-1598-BS FDA user manual
TMB-1598-BS FDA user manual
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| Document ID | 3771672 |
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| Document Description | TMB-1598-BS FDA user manual |
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| Document Type | User Manual |
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| Date Submitted | 2018-03-07 00:00:00 |
| Date Available | 2018-03-07 00:00:00 |
| Creation Date | 2015-10-21 16:43:58 |
| Producing Software | Adobe PDF library 9.90 |
| Document Lastmod | 2018-02-09 08:59:25 |
| Document Title | Users Manual |
| Document Creator | Adobe Illustrator CS5 |
Version:1.0 User Manual Blood Pressure Monitor TMB-1598-BS Wrist 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-1598-BS. Please do read the user manual carefully and thoroughly so as to ensure the safe usage of this product, and keep the manual well for your further reference in case you have problems. Table of Contents Table of Contents INTRODUCTION ............................................................... 2 General Description Measurement Principle Safety Information Indications for Use LCD Display Signal Monitor Components BEFORE YOU START .......................................................... 8 Installing and Replacing the Batteries Setting Date, Time, Positioning Symbol and Measurement Unit Pair up the Blood Pressure Monitor with Your Device Positioning the Cuff Setting the User ID MEASUREMENT ...............................................................15 Start Measurement Data Management .............................................................. 17 Recall the Records Delete the Records INFORMATION FOR USER ......................................................20 Tips for Measurement Maintenance ABOUT BLOOD PRESSURE.....................................................22 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 wrist? TROUBLESHOOTING ......................................................... 24 SPECIFICATIONS ............................................................. 25 CONTACT INFORMATION...................................................... 26 ............... 27 COMPLIED STANDARDS LIST .................................... EMC GUDIANCE ...... ...................................................... 28 INTRODUCTION INTRODUCTION General Description Thank you for selecting TRANSTEK blood pressure monitor (TMB-1598-BS). The monitor features blood pressure measurement, pulse rate measurement and the result storage. The design provides you with two years of lifetime. Readings taken by the TMB-1598-BS 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. Please do read this user manual carefully and thoroughly before use. FEATURES: Systolic Blood Pressure Diastolic Blood Pressure Pulse Rate Memory: Up to 60 pieces of records per user 1 and user 2 Measurement Principle This product uses the Oscillometric Measuring Method to detect blood pressure. Before every measurement, the unit establishes a “zero point” equivalent to the atmospheric pressure. Then it starts inflating the cuff. Meanwhile, the unit detects pressure oscillation generated by beat-to-beat pulsatile, which is used to determine the systolic pressure and diastolic pressure as well as pulse rate. Safety Information The signs below might be in the user manual, labeling or other components. They are the requirement of standard and using. Symbol for “THE OPERATION GUIDE MUST BE READ” Symbol for “TYPE BF APPLIED PARTS” Caution: These notes must be observed to prevent any damage to the device. 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” SN Symbol for “SERIAL NUMBER” The Bluetooth Combination Mark Symbol for “Including RF transmitter” Symbol for “Recycle” Symbol for “DIRECT CURRENT” Indications for Use The Transtek Blood Pressure Monitor is digital monitors intended for use in measuring blood pressure and heartbeat rate with wrist circumference ranging from 13.5 cm to 21.5 cm ( about 5-8.5 inches ). It is intended for adult indoor use only. 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 wrist 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 wrist where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present; inflating the cuff on the side of a mastectomy. Symbol for “MANUFACTURER” 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 * 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 wrist may lead to an ecchymosis. *Please check that operation of the device does not result in prolonged impairment of patient blood circulation. * When measurement, please avoid compression or restriction of the connection tubing. * 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 wrist and fingers will become anaesthetic, swollen and even purple due to a lack of blood. * When not in use, store the device in a dry room and protect it against extreme moisture, heat, lint, dust and direct sunlight. Never place any heavy objects on the storage case. * This device may be used only for the purpose described in this booklet. The manufacturer cannot be held liable for damage caused by incorrect application. *This device comprises sensitive components and must be treated with caution. Observe the storage and operating conditions described in this booklet. * The maximum temperature that the applied part can be achieved is 42.5℃ while the environmental temperature is 40℃. * 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 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. * If you experience discomfort during a measurement, such as pain in the wrist or other complaints, press the START/STOP button to release the air immediately from the cuff. Loosen the cuff and remove it from your wrist. * 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 wrist 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. INTRODUCTION CAUTION * 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 operator shall not touch output of batteries 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. * 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 80 MHz to 5.8 GHz column of Table 4 and Table 9 of IEC 60601-1-2:2014, 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. INTRODUCTION INTRODUCTION LCD Display Signal Monitor Components TIME SYSTOLIC PRESSURE SYMBOL DESCRIPTION Systolic pressure Diastolic pressure EXPLANATION DIASTOLIC PRESSURE PULSE RATE LCD DISPLAY SET BUTTON MEMORY BUTTON START/STOP BUTTON High blood pressure Low blood pressure Pulse display Pulse in beats per minute Motion indicator Motion may result in an inaccurate measurement Batteries are low and need to be replaced Low battery GRADE Measurement unit of the blood pressure (1kPa=7.5mmHg) Measurement unit the blood pressure mmHg (1mmHg=0.133kPa) Irregular heartbeat Blood pressure monitor is detecting an irregular heartbeat during measurement. Component list of pressure measuring system: 1. PCBA; 2. Air Pipe; 3. Pump; 4. Valve; 5. Cuff. CUFF (Type BF applied part) kPa Current time The average value of blood pressure Heartbeat Blood pressure monitor is detecting a heartbeat during measurement. Memory Indicate it is in the memory mode User 1 Start measurement and save the results for user 1 Start measurement and save the results for user 2 User 2 Blood pressure level indicator Year/Month/Day,Hour/Minute Average value Indicate the blood pressure level Positioning symbol The correct position gives you an accurate measurement Bluetooth icon Indicate the Bluetooth is working. Data storage Indicate the data is waiting to be transmitted. BATTERY COMPARTMENT List 1.Blood Pressure Monitor (TMB-1598-BS) 2. 2×AAA batteries 3.User Manual BEFORE YOU START BEFORE YOU START Installing and Replacing the Batteries • Slide off the battery cover. • Install the batteries by matching the correct polarity, as shown below. Always use the correct battery type (2×AAA batteries.) • Replace the cover. The typical service life of the new and unused batteries is 54 measurements for the operation time is 60s. Setting Date, Time, Positioning Symbol and Measurement Unit 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 year is 2016 ~ 2056. Time format: 24H) 1. When the monitor is off, press “ ” button,it will display the time.Then press and 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. Replace the batteries whenever the below happen The shows The display is dim. The display does not light up ” button to change 2. Press “ the [YEAR]. Each press will increase the numeral by one in a cycling manner. 3. When you get the right year, press “ ” button to confirm and it will turn to next step. 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 BEFORE YOU START 4.Repeat steps 2 and 3 to confirm [MONTH] and [DAY]. 5.Repeat steps 2 and 3 to confirm [HOUR] and [MINUTE]. 6.Repeat steps 2 and 3 to confirm the measurement unit. 7.After confirming the meausrement unit, the LCD will display “donE”, then display all the settings you have done one by one and then the monitor will shut off. 5.Repeat steps 2 and 3 to confirm [Positioning symbol] on or off. 10 11 BEFORE YOU START BEFORE YOU START Pair up the Blood Pressure Monitor with Your Device 1.Turn on Bluetooth and the “MedM Health” app. Make sure both are ON when pair-up is proceeding. Tie the Cuff 1. Remove all accessories (watch, bracelet,etc) from your wrist. If your physician has diagnosed you with poor circulation in your wrist, use the other one. 2. Roll or push up your sleeve to expose the skin. 3. Apply the cuff to your wrist with your palm facing up. 2.When the monitor is OFF, press and hold the “ ” button to start pair-up. The symbol and the symbol will be shown on the LCD alternatively, indicating pair-up is proceeding. If SUCCEED, symbol be shown on the LCD. If FAIL , symbol shown on the LCD. will will be 3.The monitor will shut off automatically after Pair-up process is complete. 4. Position the edge of the cuff about 1cm~1.5cm from wrist joints. 5. Fasten the wrist cuff around your wrist, leaving no extra room between the cuff and your skin. If the cuff is too loose, the measurement will not be accurate. 6. Sit comfortably with your tested wrist 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. 7. 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 wrist, or as directed by a physician. Bluetooth Module No.: nRF51822 RF Frequency Range: 2.402 - 2.480 GHz Output Power Range: 4 dBm Supply Voltage: 3.3V Transmitting Distance: 1-10 meters 12 13 MEASUREMENT BEFORE YOU START Select the User ID Start the Measurement Before you start the measurement, please select the desired user ID first. 1. When the blood pressure monitor is off, press and hold “ ” button until the user ID blinks. Then press “ ” button to change the user ID between user 1 and user 2. Press “ ” button to confirm your selection. 1. When the monitor is off, press “ ” button to turn on the monitor, and it will finish the whole measurement. (Take user 1 for example.) LCD display 2. After confirming the user ID, the LCD will display “User ID+donE” and then turn off. Then you can start your measurement now. Inflating and measuring. Adjust the zero. Display and save the result. The year, date and time will dispaly alternately. 2.After finishing the measurement, the LCD displays the blinking icon ‘ ’, and transmits the data. 14 15 MEASUREMENT Note: (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. (3). If you have set the [Positioning Symbol] on, when you start the measurement, the blood pressure monitor will detect the position first. The wrist must beat the angle between 30° and 45°. If it’s out of this angle, the LCD won’t start any measurements and will display blinking symbol “ ” until you have the correct position. If you get the correct position, it will display “ ” for about 3 seconds, and then finish the whole measurement. DATA MANAGEMENT CAUTION Interference may occur in the vicinity of equipment marked with the following symbol . And TMB-1598-BS 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. Recall the Records 3.During the measurement or when the measurement is finished, press “ ” button to turn off the monitor. Otherwise it will power off in one minute. Tips: 1. There are two users in total. Each user has 60 records. 2. You can press “ ” button to stop measuring during the process of the measurement at any time. 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 1. When the monitor is off, press “ ” button to show the average value of the latest three measurement records. If the records are less than 3 groups, it will display the latest record instead. 2. Press “ ” button or “ ” button to get the record you want. The record number is No.1. Six records in total. The corresponding time is 22:36. The corresponding date is 8th May. The record number, time and date of the measurement records will display alternately. 17 DATA MANAGEMENT DATA MANAGEMENT 3. If you want to check the other user’s measurement records, please press “ ” button to turn off the blood pressure monitor. Then press and hold “ ” button to enter the selecting user mode, press “ ” again to change the user, when the desired user ID blinks, press “ ” button to confirm. Then press “ ” button to check the records of the selected user. CAUTION 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. 2. Press “ ” button to confirm deleting , the LCD displays “ User ID+dEL donE” and then turns off. Note: To exit out of delete mode without deleting any records, press “ ” button before pressing “ ” button to confirm any delete commands. 3. If there is no record, when you press “ ” button to check the record, the right display will show. Delete the Records If you did not get the correct measurement, you can delete all the results for the selected user by following steps. (Take user 1 for example.) 1. In the memory mode, hold pressing “ ” button about 3 seconds, the flash display “dEL ALL” +User ID will show. 18 19 INFORMATION FOR USER INFORMATION FOR USER Maintenance Tips for Measurement Measurements may be inaccurate if taken in the following circumstances. In order to get the best performance, please follow the instructions below. Put in a dry place and avoid the sunshine Within 1 hour after dinner or drinking Immediate measurement after tea, coffee, smoking Avoid intense shaking and collisions Within 20 minutes after taking a bath 20 Avoid dusty and unstabletemperature environment When talking or moving your fingers Using wet cloths to remove dirt In a very cold environment Avoid touching water, clean it with a dry cloth in case. Avoid washing the cuff When you want to discharge urine 21 ABOUT BLOOD PRESSURE ABOUT BLOOD PRESSURE What are systolic pressure and diastolic pressure? 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 entering vein blood discharging artery What is the standard blood pressure classification? 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 135 mm Hg 85 mm Hg This chart reflects blood pressure categories defined by American Heart Association. Blood Pressure Category Normal Prehypertension High Blood Pressure (Hypertension) Stage 1 High Blood Pressure (Hypertension) Stage 2 Hypertensive Crisis (Emergency care needed) Systolic mmHg (upper#) Diastolic mmHg (lower#) less than 120 and less than 80 120-139 or 80-89 140-159 or 90-99 160 or higher or 100 or higher Higher than 180 or 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, the monitor records all the pulse intervals and calculate the average ; if there are two or more pulse intervals ,the difference between each interval and the average is more than the average value of ±25% , or there are four or more pulse intervals ,the difference between each interval and theaverage value of ±15%,the irregular heartbeat symbol appears on the display when the measurement results are appear. CAUTION 22 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. 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. 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 wrist. 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. Is the result the same if measuring on the right wrist? It is ok for both wrists, but there will be some different results for different people. We suggest you measure the same wrist every time. 23 TROUBLESHOOTING SPECIFICATIONS 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 Display will not light up. Low batteries Display is dim or display E 01 shows E 02 shows E 03 shows Error message E 04 shows EE XX,shows on the display. “oUt ” shows “E 12 ” shows 24 CHECK THIS REMEDY Batteries are exhausted. Replace with new batteries Batteries are inserted incorrectly. Insert the batteries correctly Batteries are low. Replace with new batteries The cuff is too tight or too loose. The monitor detected motion,talking or the pulse is too poor while measuring. Refasten the cuff and then measure again. Power supply Display mode Measurement mode Measurement range Accuracy Normal working condition Relax for a moment and then measure again. The measurement Loosen the clothing on process does not detect the wrist and then the pulse signal. measure again. Relax for a moment and The treatment of the then measure again. measurement failed. 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.) Retake the measurement. contact the retailer or our If the problem persists, customer service department for further assistance.Refer to the warranty for contact information and return instructions. Out of measurement range. Follow the instructions in user manual and measure again. Please check below items: Failure of pairing up your -Bluetooth is ON. monitor with your mobile -App Collector is ON. device. -Both devices are within the transmission distance of Bluetooth. Battery powered mode: 2*AAA alkaline batteries (3V DC) Digital LCD V.A.45mm×33mm 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°C-40°C 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 Storage & transportation A relative humidity range of ≤ 93%, non-condensing, at a water vapour pressure condition up to 50hPa Measurement perimeter of the wrist Weight External dimensions Attachment Mode of operation Degree of protection Protection against ingress of water Software version Device classification About 13.5cm-21.5cm Approx.100g(Excluding the dry cells) Approx.86mmx66mmx22mm 2×AAA batteries,user manual Continuous operation Type BF applied part IP22: The first number 2: Protected against solid foreign objects of 12,5mm Ф and greater. The second number: Protected against vertically falling water drops when enclosure titled up to 15º. Vertically falling drops shall have no harmful effects when the enclosure is titled at any angle up to 15º on either side of the vertical. A01 Internally Powered ME Equipment WARNING: No modification of this equipment is allowed. 25 CONTACT INFORMATION COMPLIED STANDARDS LIST Complied Standards List Contact Information Risk management 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. Labeling 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 User manual General Requirements for Safety FCC Statement FCC ID: OU9TMB1598-B 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. EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. 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 60601-1-11:2015/ 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 Electromagnetic compatibility EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests Performance requirements 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 Clinical investigation 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 Software life-cycle processes Bio-compatibility 26 EN ISO 14971:2012 / ISO 14971:2007 Medical devices Application of risk management to medical devices 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 62366-1:2015/ IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices EN 62304:2006/AC: 2008 / IEC 62304:2006 Medical device software - Software life-cycle processes 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 27 EMC GUIDANCE EMC GUIDANCE EMC Guidance Table 2 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 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 Electrostatic discharge (ESD) IEC 61000-4-2 ±8 kV contact ±15 kV air Electrical fast transient/burst IEC 61000-4-4 power supply lines: ±2 kV Surge IEC61000-4-5 line(s) to line(s): ±1 kV line(s) to earth: ±2 kV 100 kHz repetition frequency 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 Group 1 Class B Class A Voltage fluctuations/ flicker emissions IEC 61000-3-3 28 Complies Electromagnetic environment - guidance 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. Voltage dips, short interruptions and voltage variations on power supply input lines Compliance level ±8 kV contact ±15 kV air power supply lines: ±2 kV input/output lines: ±1 kV 0%UT; 0.5 cycle At 0°, 45°, 90°, 135°, 180°,225°,270° and 315° 0%UT ; 1 cycle and 70%UT ; 25/30 cycles Single phase: at 0° 0% UT ; 300 cycle IEC 61000-4-11 Electromagnetic environment - guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. line(s) to line(s): ±1 kV Mains power quality should be that of a typical commercial or hospital environment. 100 kHz repetition frequency 0% UT ; 0.5 cycle Mains power quality should be At 0°, 45°, 90°, 135°, that of a typical commercial or 180°,225°,270° and hospital environment. 315° 0% UT ; 1 cycle and 70% UT ; 25/30 cycles Single phase: at 0° 0% UT ;300 cycle The device is suitable for use in all establishments, other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Power frequency (50Hz/60Hz) magnetic field IEC 61000-4-8 NOTE 30 A/m 50Hz/60Hz 30 A/m 50Hz/60Hz 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. 29 EMC GUIDANCE EMC GUIDANCE Table 4 Table 3 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 150 kHz to 80 MHz: 3 Vrms 6Vrms (in ISM and amateur radio bands) 80% Am at 1kHz 10V/m, 80% Am at 1kHz Compliance level 150 kHz to 80 MHz: 3 Vrms 6Vrms (in ISM and amateur radio bands) 80% Am at 1kHz 10V/m, 80% Am at 1kHz 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 appropriate for the frequency of the transmitter. Recommended separation distances: d=0.35 P ; d=1.2 P 80 MHz to 800 MHz: where, P is the maximum output power rating of the d=1.2 P 800 MHz to 2.7 GHz: transmitter in watts (W) according to the d=2.3 P transmitter manufacturer, d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol: 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 = 3.5 P 80 MHz to 800 MHz 800 MHz to 2.7 GHz d = 1.2 P d = 2.3 P 0.01 0.12 0.12 0.23 0.1 0.37 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 80 MHz and 800 MHz, 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. NOTE 1 At 80 MHz and 800 MHz, 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. 30 31 EMC GUIDANCE Table 5 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. Radiated RF Test Band a) Service a) Modulation b) Modulation b) IEC61000-4-3 Frequency (MHz) (W) (Test (MHz) specifications 1.8 for 385 380-390 TETRA Pulse ENCLOSURE 400 modulation b) PORT 18Hz IMMUNITY to GMRS 460，FM c) ± 5kHz RF wireless deviation 1kHz 450 380-390 FRS 460 communicasine tions 710 704-787 LTE Band Pulse equipment) 0.2 modulation b) 13, 745 217Hz 17 780 810 800-960 GSM Pulse 800/900, modulation b) TETRA 800, 18Hz iDEN 820, CDMA 850, LTE Band 5 17001990 GSM 1800; Pulse CDMA 1900; modulation b) GSM 1900; 217Hz DECT; LTE Band 1, 3, 4,25; UMTS 870 930 1720 1845 1970 2450 24002570 5240 51005800 5240 Bluetooth, Pulse modulation b) WLAN, 217 Hz 802.11 b/g/n, RFID 2450, LTE Band 7 WLAN 802.11 a/n Pulse modulation b) 217 Hz Distance (m) IMMUNITY TEST LEVEL (V/m) 0.3 27 0.3 28 0.3 0.3 28 0.3 28 0.3 28 0.2 0.3 5785 NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3. a) For some services, only the uplink frequencies are included. b) The carrier shall be modulated using a 50% duty cycle square wave signal. c) As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case. The MANUFACTURER should consider reducing the minimum separation distance, based on RISK MANAGEMENT, and using higher IMMUNITY TEST LEVELS that are appropriate for the reduced minimum separation distance. Minimum separation distances for higher IMMUNITY TEST LEVELS shall be calculated using the following equation: E= Where P is the maximum power in W, d is the minimum separation distance in m, and E is the IMMUNITY TEST LEVEL in V/m. 32
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