User manual

FCC ID: OU9TMB1014BS

Users Manual

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FCCID_4068604

Version:1.0 User Manual Wrist Blood Pressure Monitor TMB-1014-BS Wrist Type Thank you very much for selecting TRANSTEK Wrist Blood Pressure Monitor Guangdong Transtek Medical Electronics Co., Ltd. Zone B, No.105 ,Dongli Road, Torch Development District, TMB-1014-BS. Zhongshan,528437,Guangdong,China To use the monitor correctly and safely, please read the manual thoroughly. Please keep this manual well in order to reference in future.

CATALOGUE INTRODUCTION ............................................................................................. 2 General Description Indications for Use Contraindications Measurement Principle Safety Information LCD Display Symboll Monitor Components List BEFOREYOU START ...................................................................................... 13 Installing and Replacing the Batteries Setting Date, Time and Measurement Unit Select the User ID Pair-up the Blood Pressure Monitor with Your Device MEASUREMENT .............................................................................................. 21 Tie the Cuff Start the Measurement DATA MANAGEMENT ...................................................................................... 25 Recalling the Records Deleting the Records INFORMATION FOR USER ................................................................................ 27 Tips for Measurement Maintenance ............................................................................... 29 ABOUT BLOOD PRESSURE 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 wrist? TROUBLESHOOTING ..................................................................................... 32 SPECIFICATIONS ........................................................................................... 34 CONTACT INFORMATION ................................................................................. 36 FCC STATEMENT.................................................................................................. 37 COMPLIED STANDARDS LIST .......................................................................... 38 1 EMC GUIDANCE ............................................................................................. 40

INTRODUCTION INTRODUCTION General Description Contraindications Thank you for selecting TRANSTEK Blood Pressure Monitor (TMB-1014-BS). 1.The device should not be used by any person who may be suspected of,or is pregnant . The monitor features blood pressure measurement, pulse rate measurement 2.The device is not suitable for use on patients with implanted,electrical devices, and the result storage. The design provides you with two years of reliable such as cardiac pacemakers, defibrillators. service. Readings taken by the TMB-1014-BS are equivalent to those obtained by a trained observer using the cuff and stethoscope auscultation method. Measurement Principle This manual contains important safety and care information, and provides This product uses the Oscillometric Measuring Method to detect blood pressure. Before every measurement, the unit establishes a “zero point” equivalent to the atmospheric step by step instructions for using the product. pressure. Then it starts inflating the cuff. Meanwhile, the unit detects pressure oscillation Read the manual thoroughly before using the product. generated by beat-to-beat pulsatile, which is used to determine the systolic pressure and Features: diastolic pressure as well as pulse rate. Systolic blood pressure Diastolic blood pressure Pulse rate 60 records for one user Indications for Use The Transtek Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and heartbeat rate with a wrist circumference ranging from 13.5cm to 21.5 cm ( about 5⅓˝-8½˝ ). It is intended for adult indoor use only. 2 3

INTRODUCTION INTRODUCTION Safety Information CAUTION The signs below might be in the user manual, labeling or other component. They are the requirement of standard and using. * 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, Symbol for “THE OPERATION Symbol for “TYPE BF APPLIED electronical devices, patients with pre-eclampsia, premature ventricular beats, atrial fibrillation, peripheral, arterial disease and patients undergoing intravascular therapy or arterio-venous shunt or GUIDE MUST BE READ” PARTS” people who received a mastectomy. Please consult your doctor prior to using the unit if you suffer from Symbol for “ENVIRONMENT illnesses. Symbol for “MANUFACTURE * The device is not suitable for measuring the blood pressure of children. Ask your doctor before using it DATE” PROTECTION - Electrical waste on older children. products should not be disposed of with * The device is not intended for patient transport outside a healthcare facility. household waste. Please recycle where * The device is not intended for public use. Symbol for “MANUFACTURER” facilities exist. Check with your local * This device is intended for no-invasive measuring and monitoring of arterial blood pressure. It is not authority or retailer for recycling advice” intended for use on extremities other than the wrist or for functions other than obtaining a blood pressure measurement. SN Symbol for “SERIAL NUMBER” Symbol for “DIRECT CURRENT” * 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. Caution: These notes must be * If you are taking medication,consult your physician to determine the most appropriate time to measure Symbol for “RECYCLE” observed to prevent any damage your blood pressure. Never change a prescribed medication without consulting your physician. to the device. * 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 The Green Dot is the license symbol of pressure. a European network of industry-funded * When the device was used to measure patients who have common arrhythmias such as atrial or systems for recycling the packaging ventricular premature beats or atrial fibrillation, the best result may occur with deviation. Please consult materials of consumer goods. your physician about the result. * Warning: Do not apply the cuff over a wound;otherwise it can cause further injury. 4 *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. 5

INTRODUCTION INTRODUCTION CAUTION CAUTION * The patient can measure data and change batteries under normal circumstances and maintain the device *On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, open the cuff and its accessories according to the user manual. immediately. Prolonged high pressure (cuff pressure ＞ 300mmHg or constant pressure ＞ 15mmHg for * To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated more than 3 minutes) applied to the wrist may lead to an ecchymosis. interference signal or electrical fast transient/burst signal. *Please check that operation of the device does not result in prolonged impairment of patient blood * The blood pressure monitor and the cuff are suitable for use within the patient environment. If you are circulation. allergic to polyester, nylon or plastic, please don't use this device. * When measurement, please avoid compression or restriction of the connection tubing. * During use, the patient will be in contact with the cuff. The materials of the cuff have been tested and * The device cannot be used with HF surgical equipment at the same time. found to comply with requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not cause any * The ACCOMPANYING DOCUMENT shall disclose that the SPHYGMOMANOMETER was clinically potential sensization or irritation reaction. investigated according to the requirements of ISO 81060-2:2013. * If you experience discomfort during a measurement, such as pain in the wrist or other complaints, press * To verify the calibration of the AUTOMATED SPHYGMOMANOMETER, please contact the manufacturer. the START/STOP button to release the air immediately from the cuff. Loosen the cuff and remove it from * This device is contraindicated for any female who may be suspected of, or is pregnant. Besides providing your wrist. inaccurate readings, the effects of this device on the fetus are unknown. * If the cuff pressure reaches 40 kPa (300 mmHg), the unit will automatically deflate. Should the cuff not * Too frequent and consecutive measurements could cause disturbances in blood circulation and injuries. deflate when pressures reaches 40 kPa (300 mmHg), detach the cuff from the wrist and press the * This unit is not suitable for continuous monitoring during medical emergencies or operations.Otherwise, START/STOP button to stop inflation. the patient’s wrist and fingers will become anaesthetic, swollen and even purple due to a lack of blood. * Before use, make sure the device functions safely and is in proper working condition. Check the device, * When not in use, store the device in a dry room and protect it against extreme moisture, heat, lint, dust do not use the device if it is damaged in any way. The continuous use of a damaged unit may cause injury, and direct sunlight. Never place any heavy objects on the storage case. improper results, or serious danger. * This device may be used only for the purpose described in this booklet. The manufacturer cannot be held * Do not wash the cuff in a washing machine or dishwasher! liable for damage caused by incorrect application. * The service life of the cuff may vary by the frequency of washing, skin condition, and storage state. The *This device comprises sensitive components and must be treated with caution. Observe the storage and typical service life is 10000 times. operating conditions described in this booklet. * It is recommended that the performance should be checked every 2 years and after maintenance and * The maximum temperature that the applied part can be achieved is 42.5℃ while the environmental repair, by retesting at least the requirements in limits of the error of the cuff pressure indication and air temperature is 40℃. leakage (testing at least at 50mmHg and 200mmHg). * The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable * Manufacturer will make available on request circuit diagrams, component part lists, descriptions, anesthetic mixture with air of with oxygen or nitrous oxide. calibration instructions,etc., to assist to service personnel in parts repair. * Warning: No servicing/maintenance while the ME equipment is in use. * The operator shall not touch output of batteries and the patient simultaneously. * The patient is an intended operator. 6 7

INTRODUCTION INTRODUCTION LCD Display Symbol CAUTION * Cleaning :Dust environment may affect the performance of the unit. Please use the soft cloth to clean the whole unit before and after use. Don’t use any abrasive or volatile cleaners. * The device doesn’t need to be calibrated within two years of reliable service. * If you have any problems with this device, such as setting up, maintaining or using, please contact the SERVICE PERSONNEL of Transtek. Don’t open or repair the device by yourself in the event of malfunctions. 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; SYMBOL DESCRIPTION EXPLANATION * Wireless communications equipment such as wireless home network devices, mobile phones, cordless Systolic Blood Pressure High blood pressure telephones and their base stations, walkie-talkies can affect this equipment and should be kept at least a Diastolic Blood Pressure Low blood pressure distance d away from the equipment. The distance d is caculated 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. Pulse display Pulse in beats per minute * Please use ACCESSORIES and detachable partes specified/ authorised by MANUFACTURE. Otherwise, it may cause damage to the unit or danger to the user/patients. Low Battery Low battery and please replace the batteries. * 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 Unit Measurement unit of blood pressure(1mmHg=0.133kPa) 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. 8

INTRODUCTION INTRODUCTION SYMBOL DESCRIPTION EXPLANATION Monitor Components Time Hour:Minute (Month/Day/Year) Blood pressure monitor is detecting an IHB Detector irregular heartbeat during measurement. Bluet ooth Successful Bluetooth Connection Error Data communication has failed MEM/UP SYSTOLIC BUTTON User ID The selected User ID Memory Indicate it is in the memory mode DIASTOLIC Heartbeat Blood pressure monitor is detecting a heartbeat during START/STOP PULSE RATE BUTTON measurement. Average value The average value of the latest three groups bood pressure LCD DISPLAY TIME value SET/DOWN BUTTON Blood pressure level Indicate the blood pressure level indicator 10 11

INTRODUCTION BEFORE YOU START Component List Installing and Replacing the Batteries pressure measuring system: • Open the battery door. CUFF 1. PCBA; (Type BF applied part) • Insert the batteries according to the polarity indications. 2. Air Pipe; (Always select the authorized / specified battery: 3. Pump; Two AAA-size batteries). 4. Valve; • Replacing the battery door. 5. Cuff. BATTERY COMPARTMENT List 1) Wrist Blood Pressure Monitor TMB-1014-BS 2) 2×AAA Batteries 3) User manual The typical service life of the new and unused batteries is 138 measurements for the operation time is 60s. 12 13

BEFORE YOU START BEFORE YOU START Setting Date and Time Replace the batteries whenever the below happen Please proceed to time setting before your initial use so as to The shows ensure each piece of record are labled with a time stamp. The display is dim. (Year Range: 2018-2058; Time Format: 12 Hours) The display does not light up 1.When the monitor is off, hold pressing “SET” button for about 3 seconds to enter into setting mode. The blinking numeral MEM represents [HOUR]. 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. SET 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. 2. Press “MEM” button to change the [HOUR] . Each press will MEM increase the numeral by one in a cycling manner. SET 14 15

BEFORE YOU START BEFORE YOU START 3.When you get the right hour,Press “SET” button again to confirm [HOUR]. Then it will 5.Repeat step 2 and 3 to confirm [MONTH], [DAY] and [YEAR]. turn to the next step. MEM MEM MEM MEM SET SET SET SET 4.Repeat step 2 and 3 to confirm [MINUTE]. 6.After confirming [YEAR], the LCD will display “donE” then the monitor will turn off . MEM SET 16 17

BEFORE YOU START BEFORE YOU START Select the User ID Pair-up the Blood Pressure Monitor Before you start the measurement, please select the suitable user ID first. with Your Device 1.When the blood pressure monitor is off, press the 1.Turn on Bluetooth and the app. Make sure both are ON when pair-up is proceeding. MEM button for 3 seconds, then the user ID will blink. MEM 2.When the monitor is OFF, press and hold the START/STOP button to start pair-up. The symbol “ + ”and user ID will be shown on the LCD alternatively, indicating pair-up is proceeding. SET 2. Press the MEM button shortly to change the user ID between User 1 and User 2 . MEM If SUCCEED, the symbol “ + ”and user ID will be shown on the LCD. SET 3. After selecting the suitable user ID, press SET button to confirm then the LCD will turn off. 18 19

BEFORE YOU START MEASUREMENT Tie the Cuff 1. Remove all accessories (watch, bracelet,etc) from your wrist. If your physician has diagnosed you with If FAIL, the symbol “ + ” will be shown on the LCD. 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. 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. Patients with Hypertension: The middle of the cuff should be at the level of the right atrium of the heart; Before starting measurement, please sit comfortably with legs uncrossed, feet flat on the floor, back and wrist supported. Rest for 5 minutes before measuring. 3.The monitor will turn off after Pair-up process is complete. Wait at least 3 minutes between measurements. This allows your blood circulation to recover. Take the measurement in a silent room. Bluetooth Module No.: LS51802 The patient must relax as much as possible and do not move and talk RF Frequency Range: 2402 MHz to 2480 MHz during the measurement procedure. Output Power Range: ≤4dBm The cuff should maintain at the same level as the right atrium of the heart. Supply Voltage: 2 V to 3.6V Do not cross your legs and keep your feet on the ground. Transmitting Distance: 10 meters 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. 20 21

MEASUREMENT MEASUREMENT Start the Measurement 1.When the monitor is off, press the START/STOP button 2.This device will proceed to data transmission after measurement. The Bluetooth symbol START will blink. to turn on the monitor, and it will finish the whole measurement.(Take user 1 for example.) STOP Adjust to zero. Inflating and measuring. 3.If the data transmission succeeds, the Bluetooth symbol will light on , the LCD will display as pictured to the right,then the device will turn off. Display and save the measuring result. 22 23

MEASUREMENT DATA MANAGEMENT If the data transmission fails,the LCD will display “ ” Recalling the Records MEM as pictured to the right, then the device will turn off. 1. When the monitor is off, please press the “MEM” to show the average value of the latest three records.If the records are less than three groups,it will display the latest record first. SET CAUTION MEM Interference may occur in the vicinity of equipment marked with the following symbol . And TMB-1014-BS may interfering vicinity electrical equipment. 2. Press “MEM” button or “SET” button to rotate the history UP Sensitive people, including pregnant women pre-eclamptic and those who implanted medical records.“MEM” to go forward;“SET” to go backward. 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 SET GHz. How to mitigate possible interference? DOWN 1. The range between the device and BT end should be reasonably close, from 1 meter to 10 meters. CAUTION Please ensure no obstacles between the device and BT end so as to obtain quality connection and to lower the RF output range. The most recent record (1) is shown first. Each new measurement is 2. To avoid interference, other electronic devices (particularly those with wireless transmission / assigned to the first (1) record. All other records are pushed back one Transmitter) should be kept at least 1 meter away from the monitor. digit (e.g., 2 becomes 3, and so on), and the last record (60) is dropped from the list. 24 25

DATA MANAGEMENT INFORMATION FOR USER Deleting the Records Tips for Measurement ABOUT If you did not BLOOD get the PRESSURE correct measurement, you can delete all results Measurements may be inaccurate if taken in the following circumstances. by following steps below. 1.Hold pressing “MEM” for 3 seconds when the monitor is in the memory recall mode ,the “dEL ALL” will blink on the display. 2.Press “SET” to confirm deleting and the monitor will display Within 1 hour Immediate measurement Within 20 minutes after dinner or drinking after tea, coffee, smoking “dEL donE” then turn off. after taking a bath MM 3.If you don’t want to delete the records, press START/STOP” to escape. START STOP 4. If there is no record, the right display will be showed. SET When talking or In a very cold environment When you want to moving your fingers discharge urine 26 27

INFORMATION FOR USER ABOUT BLOOD PRESSURE Maintenance What are systolic pressure and diastolic pressure? When ventricles contract and pump blood out of the heart, blood pressure reaches its maximum To obtain the best performance, please follow the instructions below. value, the highest pressure in the cycle is known as systolic pressure. When the heart relaxes between heartbeats, the lowest blood pressure is diastolic pressure. What is the standard blood pressure classification? The chart on the right is the This chart reflects blood pressure categories defined by American Heart Association. standard blood pressure Systolic Diastolic classification published by Blood Pressure Category mmHg (upper#) mmHg (lower#) American Heart Association No symbol Put in a dry place and Avoid immersing it in the water. Avoid shaking and collision. (AHA). Normal displayed less than 120 and less than 80 avoid the sunshine Clean it with a dry cloth in case. Elevated 120-129 and less than 80 TROUBLESHOOTING AHA Home Guideline for High Blood Pressure 130-139 or 80-89 Upper Limit of Normal BP (Hypertension) Stage 1 SYS 135 mm Hg High Blood Pressure (Hypertension) Stage 2 140 or higher or 90 or higher DIA 85 mm Hg Hypertensive Crisis Higher than 180 and/or (Emergency care needed) Higher than 120 Avoid dusty environment and Use the slightly damp cloth Avoid washing the cuff CAUTION unstable temperature surrounding to remove the dirt. 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. 28 29

ABOUT BLOOD PRESSURE ABOUT BLOOD PRESSURE Irregular Heartbeat Detector Why does my blood pressure fluctuate throughout the day? An irregular heartbeat is detected when a heartbeat rhythm varies while the device is measuring 1. Individual blood pressure varies multiple times everyday. It is also systolic pressure and diastolic pressure. During each measurement, blood pressure monitor will affected by the way you tie your cuff and your measurement position, so keep a record of all the pulse intervals and calculate the average value of them. If there are two or please take the measurement under the same conditions. more pulse intervals , the difference between each interval and the average is more than the 2.If the person takes medicine, the pressure will vary more. 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%, then the irregular heartbeat 3.Wait at least 3 minutes for another measurement. symbol will appear on the display with the measurement result. Why do I get a different blood CAUTION pressure at home compared 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. to the hospital? However, if the symbol appears often, we recommend you seek medical advice. Please What you need to pay attention The blood pressure is different even throughout the day to when you measure your blood note that the device does not replace a cardiac examination, but serves to detect pulse due to weather, emotion, exercise etc, Also, there is the pressure at home: irregularities at an early stage. “white coat” effect, which means blood pressure usually increases in clinical settings. If the cuff is tied properly. If the cuff is too tight or too loose. Is the result the same if If the cuff is tied on the wrist. measuring on the right If you feel anxious. Taking 2-3 deep breaths before wrist? beginning will be better for It is ok for both wrists, but there will be measuring. some different results for different Advice: Relax yourself for 4-5 people. We suggest you measure the minutes until you calm down. same wrist every time. 30 31

TROUBLESHOOTING TROUBLESHOOTING This section includes a list of error messages and frequently asked questions for problems you may encounter with your blood PROBLEM SYMPTOM CHECK THIS REMEDY pressure monitor. If the products not operating as you think it Make sure that phone’s Bluetooth is on or Error + Data communication should, check here before arranging for servicing. Error has failed within the distance range shows message EExx,shows on A calibration error Retake the measurement.If the problem PROBLEM SYMPTOM CHECK THIS REMEDY the display. occurred. persists,contact the retailer or our customer Batteries are exhausted. Replace with new batteries service department for further assistance. Display is dim or Refer to the warranty for contact information No power Batteries are inserted Insert the batteries correctly and return instructions. will not light up. incorrectly. Relax for a moment. Low Show on Warning Out of measurement Refasten the cuff and then Batteries are low. Replace with new batteries “out ” shows batteries the display message range measure again. If the problem persists, contact E 01 shows Refasten the cuff and then measure again. your physician. The cuff is not secure. Refasten the cuff and then measure again. E 02 shows The cuff is very tight The pressure of the E 03 shows Relax for a moment and then measure again. cuff is excess. The monitor detected motion, movement can affect the measurement. E 10 or talking,or the pulse is too poor Relax for a moment and then measure E 11 shows while measuring. again. The measurement process Loosen the clothing on the arm and then Error E 20 shows does not detect the pulse measure again. signal. message E 21 shows Measure incorrectly. Relax for a moment and then measure again. 32 33

EMC GUIDANCE SPECIFICATIONS SPECIFICATIONS Power supply Battery powered mode: 2*AAA batteries Mode of operation Continuous operation Display mode Digital LCD V.A.36mmx41mm Measurement mode Oscillographic testing mode Degree of protection Type BF applied part Rated cuff pressure: Device Classification Internally Powered ME Equipment 0mmHg~299mmHg(0kPa ~ 39.9kPa) Measurement range Measurement pressure: IP22: The first number 2: Protected against solid foreign SYS: 60mmHg~230mmHg (8.0kPa~30.7kPa) objects of 12,5mm Ф and greater. The second number: DIA: 40mmHg~130mmHg (5.3kPa~17.3kPa) Protected against vertically falling water drops when enclosure Pulse value: (40-199)beat/minute IP Classification titled up to 15º. Vertically falling drops shall have no harmful effects when the enclosure is titled at any angle up to 15º on Accuracy Pressure:5°C-40°C within±3mmHg(0.4kPa) either side of the vertical. Pulse value:±5% A temperature range of :+5°C to +40°C Software Version A01 A relative humidity range of 15% to 90%, non-condensing, Working condition but not requiring a water vapour partial pressure greater than 50 hPa WARNING: No modification of this equipment is allowed. 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, condition at a water vapour pressure up to 50hPa Measurement perimeter About 13.5cm-21.5cm of the upper arm Weight Approx.120g(Excluding the batteries) External dimensions Approx.80mm×65mm×22mm(Excluding the cuff) Attachment 2*AAA batteries,user manual 34 35

CONTACT INFORMATION FCC Statement Contact Information FCC Statement FCC ID:OU9TMB1014BS 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. 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 Manufactured by: Guangdong Transtek Medical Electronics Co., Ltd. cautioned that changes or modifications not expressly approved by the party responsible for Company: Guangdong Transtek Medical Electronics Co., Ltd. compliance could void the user's authority to operate the equipment. Address: Zone B, No.105 ,Dongli Road, Torch Development District, NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, Zhongshan,528437,Guangdong,China pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection Authorized European Representative: against harmful interference in a residential installation. This equipment generates, uses and can Company: MDSS - Medical Device Safety Service GmbH radiate radio frequency energy and, if not installed and used in accordance with the instructions, may Address: Schiffgraben 41, 30175 Hannover, Germany 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. 36 37

COMPLIED STANDARDS LIST COMPLIED STANDARDS LIST Complied Standards List EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood EN ISO 14971:2012 / ISO 14971:2007 Medical devices - Risk management Application of risk management to medical devices pressure measuring systems IEC 80601-2-30:2009+A1:2013 Medical electrical equipment- Part 2-30: Particular requirements for the basic safety and EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices. essential performance of automated non-invasive Symbols to be used with medical device labels, labelling and Labeling information to be supplied. Part 1 : General requirements sphygmomanometers EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test EN 1041:2008 Information supplied by the manufacturer of procedures to determine the overall system accuracy of automated User manual medical devices Clinical investigation non-invasive sphygmomanometers ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: EN 60601-1:2006+A1:2013/ IEC 60601-1:2005+A1:2012 Medical Clinical validation of automated measurement type electrical equipment - Part 1: General requirements for basic safety and essential performance EN 60601-1-6:2010+A1:2015/IEC 60601-1-6:2010+A1:2013 General Requirements EN 60601-1-11:2015/ IEC 60601-1-11:2015 Medical electrical Medical electrical equipment - Part 1-6: General requirements for for Safety equipment - Part 1-11: General requirements for basic safety and Usability basic safety and essential performance - Collateral standard: essential performance - Collateral standard: Requirements for Usability medical electrical equipment and medical electrical systems used in IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices the home healthcare environment EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical Software life-cycle EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015 Medical device software - Software life-cycle processes Electromagnetic equipment - Part 1-2: General requirements for basic safety and processes compatibility essential performance - Collateral standard: Electromagnetic ISO 10993-1:2009 Biological evaluation of medical devices- disturbances - Requirements and tests Part 1: Evaluation and testing within a risk management process ISO 10993-5:2009 Biological evaluation of medical devices - Performance EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part Part 5: Tests for in vitro cytotoxicity 1: Requirements and test methods for non-automated measurement Bio-compatibility ISO 10993-10:2010 Biological evaluation of medical devices - requirements type Part 10: Tests for irritation and skin sensitization 38 39

EMC GUIDANCE EMC GUIDANCE Table 1 EMC Guidance Guidance and manufacturer’s declaration – electromagnetic emissions 1)This product needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided, The device is intended for use in the electromagnetic environment specified below. The customer or the and this unit can be affected by portable and mobile RF communications user of the device should assure that it is used in such an environment. equipment. Emissions test Compliance Electromagnetic environment - guidance 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. RF emissions The device uses RF energy only for its internal 3)Caution: This unit has been thoroughly tested and inspected to assure Group 1 function. Therefore, its RF emissions are very low CISPR 11 proper performance and operation! and are not likely to cause any interference in nearby 4)* Caution: This machine should not be used adjacent to or stacked with electronic equipment. other equipment and that if adjacent or stacked use is necessary, this RF emissions machine should be observed to verify normal operation in the configuration in CISPR 11 Class B The device is suitable for use in all establishments, which it will be used. other than domestic and those directly connected to the public low-voltage power supply network that Harmonic emissions supplies buildings used for domestic purposes. Class A IEC 61000-3-2 Voltage fluctuations/ flicker emissions Complies IEC 61000-3-3 40 41

EMC GUIDANCE EMC GUIDANCE Table 2 Guidance and manufacturer’s declaration – electromagnetic immunity Voltage dips, 0%UT; 0.5 cycle 0% UT ; 0.5 cycle Mains power quality should be short interruptions At 0°, 45°, 90°, 135°, At 0°, 45°, 90°, 135°, that of a typical commercial or The device is intended for use in the electromagnetic environment specified below. The customer or the and voltage 180°,225°,270° and 315° 180°,225°,270° and hospital environment. user of the device should assure that it is used in such an environment. variations on 0%UT ; 1 cycle 315° power supply and 0% UT ; 1 cycle input lines 70%UT ; 25/30 cycles and Electromagnetic Single phase: at 0° 70% UT ; 25/30 cycles Immunity test IEC 60601 test level Compliance level IEC 61000-4-11 environment - guidance 0% UT ; 300 cycle Single phase: at 0° 0% UT ;300 cycle Floors should be wood, concrete Electrostatic or ceramic tile. If floors are Power frequency Power frequency magnetic fields ±8 kV contact should be at levels characteristic discharge (ESD) ±8 kV contact covered with synthetic material, (50Hz/60Hz) ±15 kV air the relative humidity should be at magnetic field 30 A/m 30 A/m of a typical location in a typical IEC 61000-4-2 ±15 kV air commercial or hospital least 30%. 50Hz/60Hz 50Hz/60Hz IEC 61000-4-8 environment. Electrical fast power supply lines: power supply lines: Mains power quality should be NOTE UT is the a.c. mains voltage prior to application of the test level. transient/burst ±2 kV ±2 kV that of a typical commercial or IEC 61000-4-4 input/output lines: hospital environment. ±1 kV Surge line(s) to line(s): ±1 kV line(s) to line(s): ±1 kV Mains power quality should be line(s) to earth: ±2 kV IEC61000-4-5 that of a typical commercial or 100 kHz repetition 100 kHz repetition hospital environment. frequency frequency 42 43

EMC TableGUIDANCE 5 EMC GUIDANCE Table 3 Guidance and manufacturer’s declaration – electromagnetic immunity determined by an electromagnetic site The device is intended for use in the electromagnetic environment specified below. The customer or the survey, a should be less user of the device should assure that it is used in such an environment. than the compliance levelb in each frequency range. Immunity test IEC 60601 Compliance Electromagnetic environment - guidance Interference may occur in Test level level the vicinity of equipment marked with the following Conducted RF 150 kHz to 150 kHz to Portable and mobile RF communications symbol: IEC 61000-4-6 80 MHz: 80 MHz: equipment should be used no closer to any part 3 Vrms 3 Vrms of the device, including cables, than the 6Vrms (in ISM 6Vrms (in ISM recommended separation distance calculated and amateur and amateur from the equation appropriate for the frequency radio bands) radio bands) of the transmitter. NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. 80% Am at 1kHz 80% Am at 1kHz Recommended separation distances: NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by d=0.35 P ; absorption and reflection from structures, objects and people. d=1.2 P a Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) Radiated RF 10V/m, 80% Am 10V/m, 80% Am 80 MHz to 800 MHz: where, P is the maximum IEC 61000-4-3 at 1kHz at 1kHz d=1.2 P output power rating of the telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast 800 MHz to 2.7 GHz: transmitter in watts (W) cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to d=2.3 P according to the fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field transmitter manufacturer, strength in the location in which the device is used exceeds the applicable RF compliance level d is the recommended above, the device should be observed to verify normal operation. If abnormal performance is separation distance in observed, additional measures may be necessary, such as re-orienting or relocating the device. meters (m). Field b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m. strengths from fixed RF transmitters, as 45 44

Table 5 EMC GUIDANCE EMC GUIDANCE Table 4 Recommended separation distances between portable and mobile RF communications Guidance and manufacturer’s declaration - electromagnetic immunity equipment and the device. The device is intended for use in an electromagnetic environment in which radiated RF disturbances are The device is intended for use in the electromagnetic environment specified below. The customer or the controlled. The customer or the user of the device can help prevent electromagnetic interference by user of the device, should assure that it is used in such an environment. 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 Radiated RF Test Band a) Service a) Modulation b) Modulation b) Distance (m) IMMUNITY IEC61000-4-3 Frequency (MHz) (W) TEST communications equipment. LEVEL (Test (MHz) (V/m) Rated maximum output Separation distance according to frequency of transmitter (m) specifications power of transmitter for 385 380-390 TETRA Pulse (W) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7 GHz ENCLOSURE 400 modulation b) 1.8 0.3 27 d = 3.5 P d = 1.2 P d = 2.3 P PORT 18Hz IMMUNITY to GMRS 460， FM c) ± 5kHz 0.01 0.12 0.12 0.23 RF wireless 2 0.3 28 450 380-390 FRS 460 deviation 1kHz communicatio 0.1 0.37 0.38 0.73 sine ns equipment) 1 1.2 1.2 2.3 710 704-787 LTE Band Pulse 745 13, modulation b) 0.2 0.3 9 10 3.8 3.8 7.3 17 217Hz 780 100 12 12 23 GSM Pulse 810 800-960 For transmitters rated at a maximum output power not listed above, the recommended separation 800/900, modulation b) 2 0.3 28 TETRA 800, 18Hz distance d in metres (m) can be estimated using the equation applicable to the frequency of the 870 iDEN 820, transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the CDMA 850, transmitter manufacturer. 930 LTE Band 5 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 46 absorption and reflection from structures, objects and people. 47

Table 5 EMC GUIDANCE 1720 1700- GSM 1800; Pulse CDMA 1900; 2 0.3 28 1990 modulation b) GSM 1900; 217Hz 1845 DECT; LTE Band 1, 3, 1970 4,25; UMTS 2450 2400- Bluetooth, Pulse 2 0.3 28 2570 WLAN, modulation b) 802.11 217 Hz b/g/n, RFID 2450, LTE Band 7 5240 5100- WLAN Pulse 0.2 0.3 9 5800 802.11 modulation b) 5240 a/n 217 Hz 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 48 TEST LEVEL in V/m. 47


Document Created: 2018-10-30 16:31:35
Document Modified: 2018-10-30 16:31:35
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