Transtek Medical Electronics LS808-B-S Bluetooth Blood Pressure Monitor User Manual LS808 BS FDA
Guangdong Transtek Medical Electronics Co.,Ltd Bluetooth Blood Pressure Monitor LS808 BS FDA
LS808-BS FDA
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| Document ID | 3831775 |
| Application ID | 8mVhSb7X9sVuMOQwEAhgPg== |
| Document Description | LS808-BS FDA |
| Short Term Confidential | No |
| Permanent Confidential | No |
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| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 502.23kB (6277916 bits) |
| Date Submitted | 2018-04-27 00:00:00 |
| Date Available | 2018-04-27 00:00:00 |
| Creation Date | 2017-07-27 10:36:04 |
| Producing Software | Adobe PDF library 9.90 |
| Document Lastmod | 2018-04-11 10:03:56 |
| Document Title | LS808-B（ce）A3å议说明书 更改低电é‡æ˜¾ç¤º |
| Document Creator | Adobe Illustrator CS5 |
Version:1.0 User Manual Blood Pressure Monitor LS808-BS Arm Type FCC ID: OU9LS808-B-S 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 LS808-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 Indications for Use Contraindications Measurement Principle Safety Information LCD Display Signal Monitor Components List BEFORE YOU START ........................................................... 9 Power Supply and Charge Power Setting the Time,Date and Unit Pair up with Your Device Tie the Cuff MEASUREMENT ............................................................... 16 Start Measurement DATA MANAGEMENT........................................................... 18 Recall the Records Delete the Records INFORMATION FOR USER ...................................................... 22 Tips for Measurement Maintenance ABOUT BLOOD PRESSURE..................................................... 24 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 .......................................................... 26 SPECIFICATIONS .............................................................. 27 ATHORIZED COMPONENT ................................................ 28 CONTACT INFORMATION....................................................... 28 ................ 29 COMPLIED EUROPEAN STANDARDS LIST ........................ FCC STATEMENT.............................................................. 30 EMC GUDIANCE ...... ....................................................... 31 INTRODUCTION General Description * Thank you for selecting TRANSTEK blood pressure monitor (LS808-BS). The monitor features blood pressure measurement, pulse rate measurement and the result storage. The design provides you with two years of lifetime. * This manual contains important safety information and caution, and provides step by step instructions for using the product. * Please do read this user manual carefully and thoroughly before use. INTRODUCTION Safety Information The signs below might be in the user manual, labeling or other components. They are the requirement of standard and using. FEATURES: 86.1mm×24mm Blue LCD Display with White Backlight Measure-during-inflating Technology SN Symbol for “MANUFACTURE DATE” 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 “SERIAL NUMBER” Symbol for “DIRECT CURRENT” Indications for Use Contraindications Symbol for “TYPE BF APPLIED PARTS” Symbol for “MANUFACTURER” Up to 60 pieces of record stored per each user 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. Symbol for “THE OPERATION GUIDE MUST BE READ” Symbol for “Class II Equipment” F1 T1A/250V Φ3.6*10CCC Symbol for “Recycle” Caution: These notes must be observed to prevent any damage to the device. The Green Dot is the license symbol of a European network of industry-funded systems for recycling the packaging materials of consumer goods. For indoor use only 1.The device is not suitable for use on may be pregnant women or pregnant women. 2.The device is not suitable for use on patients with implanted,electrocical devices, such as cardiac pacemakers, defibrillators. 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. INTRODUCTION 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. CAUTION * 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. * 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 charge power 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 any 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 any 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! INTRODUCTION INTRODUCTION CAUTION * 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. * 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 calculated by the MANUFACTURER from the 80MHz 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. LCD Display Signal Systolic Blood Pressure High blood pressure Diastolic Blood Pressure Low blood pressure Pulse display Pulse in beats per minute Low Battery Low battery and please charge the power. Unit Measurement unit of blood pressure Irregular heartbeat Blood pressure monitor is detecting an irregular heartbeat during measurement. Data pending to transmit Data transmitting Measurement data stored in the device Memory Query Indicate it is in the memory mode and which group of memory it is. User ID Start measurement for selected user, and transmit the measuring result Current time Year/Month/Day(Hour:Minute) Motion indicator Heartbeat Data transmission succeeds. Motion may result in an inaccurate measurement. Blood pressure monitor is detecting a heartbeat during measurement. BEFORE YOU START INTRODUCTION Monitor Components Power Supply and Charge Power DC POWER SOCKET ON/OFF BUTTON 1. The battery of LS808-BS is built-in rechargeable li-polymer battery, the battery current is 1000 mAh. 2. Please use the AC adaptor to charge the battery, just like the following picture: SYSTOLIC PRESSURE DIASTOLIC PRESSURE PULSE RATE QUERY/UP BUTTON AC adaptor USER 1/SET BUTTON Component list of pressure measuring system 1 PCBA 2 Air pipe 3 Pump 4 Valve 5 Cuff 3.User Manual displays on the LCD The LCD display is dim. When powering on the monitor, the LCD doesn’t light up. CUFF (Type BF applied part) CAUTION * The List 1.Blood Pressure Monitor (LS808-BS) Charging the power under following circumstances: USER 2/ACTIVATION BUTTON 2.AC Adaptor ( Model: BLJ06L060100P-U) 4. Cuff (22cm-32cm or 22cm-42cm) (Type BF Applied Part) (Please use TRANSTEK authorized cuff. The size of the actual cuff please refer to the label on the attached cuff.) battery of LS808-BS is built-in rechargeable lithium-ion battery, please do not disassemble it by the unauthorized maintenance personel. * Under the normal using, it can charge power about 300 times, if the battery cannot charge the power normally or the blood pressure monitor cannot use normally, please connect with the authorized maintenance personel.If measured three times per day, and the battery is fully charged, it can be used for about 20 days. * Storge and use the blood pressure monitor at the cool, dry and ventilated environment. Avoid to approach to the fire and the heat source, or it will cause the battery explode. * Only can use the Transtek’s authorized AC Adaptor (Model: BLJ06L060100P-U) to charge the power. You cannot use the blood pressure monitor during the process of charging. * During the process of charging, the blood pressure monitor display When the charging is finished, please pull the plug in time. * When charging, shall not touch charging connector and the patient simultaneously. BEFORE YOU START CAUTION • Do not attempt to replace your blood pressure monitor’s battery. It is built-in and not changeable. • Only charge the battery in accordance with the user instructions supplied with the blood pressure monitor. • Avoid charging your blood pressure monitor in extremely high or low temperatures. • Do not use your blood pressure monitor while you are charging it. • Do not attempt to disassemble the blood pressure monitor or force open the built-in battery. • Do not clean the blood pressure monitor when it is being charged. Always unplug the charger first before cleaning the blood pressure monitor. • Do not dispose of your blood pressure monitor in a fire. The battery could explode causing injury or death. • Batteries (battery pack or batteries installed) shall not be exposed to excessive heat such as sunshine, fire or the like. BEFORE YOU START (2) As pictured in the right, the blinking numeral representing [HOUR]. Press “Query” button to change the numeral. Each press will increase the numeral by one in a cycling manner. Setting the Time, Date and Unit To ensure the stored measurement result has correct time record, please set time and unit before device is used. Before use,switch the button to the “ON” side to turn on the monitor. Note: If the button is on the “OFF” side, there is no reaction when you press any button. (1) When the monitor is off, press and hold User 1 button for 3s to enter Time Setting Mode. 10 (3) Press “User 1” button again to confirm [HOUR]. Then the numeral representing [MINUTE] blinks. 11 BEFORE YOU START 12 BEFORE YOU START (4) Repeat steps 2 and 3 to confirm [MINUTE]. (6) Repeat steps 2 and 3 to confirm the measurement unit. (5) Repeat steps 2 and 3 to confirm[MONTH], [DAY] and [YEAR]. (7) After confirming the measurement unit, the LCD will display “dOnE” and the monitor will shut off. 13 BEFORE YOU START BEFORE YOU START Pair up the Blood Pressure Monitor with Your Device Tie the Cuff (1) Turn on Bluetooth and the app. Enter to “MedM Health” then press “My Setting” ,the app will display My Setting tap. (2)Press “My devices”,the app will display My Devices tap. (3)When the moniter is off,press press“User 1” to measure, the will show and will blink after measuring,then the datas are transmitting. (4) Press in “MedM Health to reseach,then select “808A0” to connect the monitor. (5)After selecting the device,select the “account” and return;then enter device to “Set device” .When the app display“Receive data automatically”，please choose “Yes”. (6)When the monitor is connected,the datas will transmit to “MedM”, if transmit successfully,the symbel and will disappear,then the monitor turn off;or not,it will turn off within one minute. 1. Remove all accessories (watch, bracelet,etc) from your arm. If your physician has diagnosed you with poor circulation in your arm, use the other one. 2. Roll or push up your sleeve to expose the skin. 3. Apply the cuff to your arm with your palm facing up. 4. Position the edge of the cuff about 2cm~3cm from elbow. 5. Fasten the cuff around your arm, 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 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. 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 arm, or as directed by a physician. Bluetooth Module No. : LS51802 Frequency Range 2.402 - 2.480 GHz Supply Voltage 1.8-3.6 V Output Power Range ≤0 dBm 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. 14 15 MEASUREMENT MEASUREMENT Start Measurement Inflating and measuring. Display and save the results. The data transmission will proceed. When the monitor is off, press User 1 button to turn on the monitor and it will finish the whole measurement, and then save the measure data for User 1. The same to the User 2. (Take User 1 for example.) (Note: Select the same user on your app and BPM to take the measurement, or the measurement data won’t be transmitted to the app.) (1) When the monitor is off, press the User 1 button to turn on the monitor. LCD display Adjust to zero. (2) Press User 1 button to power off, otherwise it will turn off within one minute. Tips: A. When finish the whole measurement, press another user button, the blood monitor will begin measuring again. B. Maximum 60 records are both for user 1 and user 2. CAUTION 1.With LS808-BS successfully pair-up with your mobile device, 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. 16 17 DATA MANAGEMENT DATA MANAGEMENT Recall the Records (1) When the monitor is off, press “Query” button to access the memory. (4) When in the memory mode, press the User 1 button to recall the measurement history of User 1, or press the User 2 button to recall the measurement history. (2) The LCD will display the latest measuring result of the user ID which completes the last measurement. The record number, measuring date and measuring time will be displayed alternatively. (5) When no history stored for the specific user in the monitor, press “Query” button and the LCD will display as pictured to the right. (3) Press “Query” button to rotate the history records. 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. 18 19 DATA MANAGEMENT DATA MANAGEMENT Delete the Records (3) The LCD will display “dEL dONE” and then shut off. (1) When under the query mode, press and hold “Query” button for 3 seconds to clear the memory. (2) When the LCD display “dEL ALL”, press “Query” button to confirm. (4) If you wish to stop clearing the memory, you may press the other button, rather than “Query” button to turn off the monitor, or wait until the monitor shuts off. CAUTION • Interference may occur in the vicinity of equipment marked with the following symbol . .And LS808-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. 20 21 INFORMATION FOR USER INFORMATION FOR USER Tips for Measurement Maintenance Measurements may be inaccurate if taken in the following circumstances. To obtain the best performance, please follow instructions below. Within 1 hour after dinner or drinking Immediate measurement after tea, coffee, smoking Put in a dry place and avoid the sunshine Avoid intense shaking and collisions. Within 20 minutes after taking a bath 22 Avoid dusty environment and unstable temperature surrounding When talking or moving your fingers Use the slightly damp cloth to remove the dirt. In a very cold environment Avoid immersing it in the water. Clean it with a dry cloth in case. Avoid washing the cuff When you want to discharge urine 23 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 discharging artery blood entering vein 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 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. 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 Please consult a physician if your measuring result falls outside 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 the average is more than the average value of ±15%,the irregular heartbeat symbol appears on the display when the measurement results are appear. CAUTION Why does my blood pressure fluctuate throughout the day? 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 24 examination, but serves to detect pulse irregularities at an early stage. 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 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. 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. 25 SPECIFICATIONS TROUBLESHOOTING 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 shows E1 shows E 3 shows E 10 or E 11 shows Error message E 20 shows E 21 shows EExx,shows on the display. Warning message 26 “out ” shows CHECK THIS Charge the power AC adaptor is inserted incorrectly. Insert the AC adaptor tightly Power is low. Charge the power The pressure of the cuff is excess. The monitor detected motion,talking or the pulse is too poor while measuring. A calibration error occurred. Out of measurement range Measurement range Accuracy Refasten the cuff and then measure again. Relax for a moment and then measure again. Relax for a moment and then measure again. The measurement Loosen the clothing on process does not detect the arm and then the pulse signal. measure again. The treatment of the measurement failed. Display mode Measurement mode REMEDY Power is exhausted. The cuff is not secure. Power supply Relax for a moment and then measure 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. the measurement result is out of the measurement range (SYS: 60mmHg to 230mmHg; or DIA: 40mmHg to 130mmHg;or Pulse: 40-199 pulse/minute) Normal working condition Storage & transportation condition Measurement perimeter of the arm Weight External dimensions Attachment Mode of operation Degree of protection Protection against ingress of water Software version Device classification 3.7V 1000mAH Built-in rechargeable li-polymer battery, 6V 1A AC Adaptor Blue LCD with White Backlight V.A.= 86.1mm(L) x24mm(W) 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 A relative humidity range of ≤ 93%, non-condensing, at a water vapour pressure up to 50hPa About 22cm-32cm or 22cm-42cm Approx.285g Approx.130.9mm×73mm×29.4mm AC Adaptor,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 Battery Powered Mode: Internally Powered ME Equipment AC Adaptor charged Mode: Class II ME Equipment WARNING: No modification of this equipment is allowed. 27 COMPLIED STANDARDS LIST ATHORIZED COMPONENT Athorized Component Please use the TRANSTEK authorized adaptor Complied Standards List Risk management Labeling User manual General Requirements for Safety Adaptor Type: BLJ06L060100P-U Input: 100-240V 50-60Hz,0.2Amax 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 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+A1:2013/ 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 80601-2-30:2009+A1:2013 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 28 EN ISO 14971:2012 / ISO 14971:2007 Medical devices Application of risk management to medical devices EN 60601-1-6:2010+A1:2015/IEC 60601-1-6:2010+A1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015 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 29 FCC STATEMENT FCC Statement FCC ID: OU9LS808-B-S 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. EMC GUIDANCE 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 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 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. 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. Class A Voltage fluctuations/ flicker emissions IEC 61000-3-3 30 Complies 31 EMC GUIDANCE EMC GUIDANCE Table 3 Table 2 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 IEC 60601 test level ±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 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 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 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 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: 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. Power frequency (50Hz/60Hz) magnetic field IEC 61000-4-8 NOTE 32 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. 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. 33 EMC GUIDANCE EMC GUIDANCE Table 5 Table 4 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 d = 1.2 P 800 MHz to 2.7 GHz d = 2.3 P 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 communicatio sine ns equipment) 710 704-787 LTE Band Pulse 0.2 modulation b) 13, 745 217Hz 17 780 810 17001990 GSM 1800; Pulse CDMA 1900; modulation b) GSM 1900; 217Hz DECT; LTE Band 1, 3, 4,25; UMTS 870 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 1845 100 12 12 23 1970 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. 800-960 GSM Pulse 800/900, modulation b) TETRA 800, 18Hz iDEN 820, CDMA 850, LTE Band 5 930 1720 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. 34 35
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