Transtek Medical Electronics TMB1597BN Blood Pressure Monitor User Manual

Guangdong Transtek Medical Electronics Co.,Ltd Blood Pressure Monitor

User Manual

version:1.0User ManualBlood Pressure Monitor TMB-1597-BNArm TypeThank you very much for selecting TRANSTEK Blood Pressure MonitorTMB-1597-BN.Please do read the user manual carefully and thoroughtly so as to ensure the safe usage of this product, and keep the manual well for further reference in case you have problems.Guangdong Transtek Medical Electronics Co., Ltd.Zone B, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China
Table of ContentsINTRODUCTION..................................................................................................................2General DescriptionIndications for UseContraindicationsMeasurement PrincipleSafety InformationLCD Display SignalMonitor ComponentsList BEFORE YOU START..........................................................................................................8The Choice of Power SupplyInstalling and Replacing the BatteriesSetting Date, Time and Measurement UnitSelect the UserPair-up the Blood Pressure Monitor with Your DeviceMEASUREMENT................................................................................................................15Tie the CuffStart the MeasurementDATA MANAGEMENT........................................................................................................18Recall the RecordsDelete the RecordsINFORMATION FOR USER...............................................................................................21Tips for measurementMaintenancesABOUT BLOOD PRESSURE.............................................................................................23What are systolic pressure and diastolic pressure?What is the standard blood pressure classification?Irregular heartbeat detectorWhy 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........................................................................................................25SPECIFICATIONS..............................................................................................................26AUTHORIZED COMPONENT ...........................................................................................27CONTACT INFORMATION.................................................................................................27COMPLIED STANDARDS LIST..........................................................................................28FCC STATEMENT...............................................................................................................29EMC GUIDANCE................................................................................................................301CATALOGUE CATALOGUE
Safety InformationThe signs below might be in the user manual, labeling or other component. They are the requirement of standard and using.Symbol for “THE OPERATION GUIDE MUST BE READ”Symbol for “MANUFACTURER”Symbol for “SERIAL NUMBER”Symbol for “TYPE BF APPLIED PARTS”Symbol for “DIRECT CURRENT”Symbol for “ENVIRONMENT PROTECTION - Electrical waste products should not be disposed of with household waste. Please recycle where facilities exist. Check with your local authority or retailer for recycling advice”Symbol for “MANUFACTURE DATE”Features: Maximum 60 records per each userGeneral DescriptionFor indoor use onlyF1T1A/250V Φ3.6*10CCC Symbol for “Class II Equipment”3rd technonoly: Measuring during inflation 73mm×49 mm Blue LCD display with white backlight Indications for UseMeasurement Principle This product uses the Oscillometric Measuring method to detect blood pressure. Before every measurement, the unit establishes a “zero pressure” equivalent to the air pressure. Then it starts inflating the arm cuff, meanwhile, the unit detects pressure oscillations generated by beat-to-beat pulsatile, which is used to determine the systolic and diastolic pressure, and also pulse rate. The device also compares the longest and the shortest time intervals of detected pulse waves to mean time interval then calculates standard deviation. The device will display a warning signal with the reading to indicate the detection of irregular heartbeat when the difference of the time intervals is over 25%.Caution: These notes must be observed to prevent any damage to the device.SN Thank you for selecting TRANSTEK arm type blood pressure monitor (TMB-1597-BN). The monitor features blood pressure measurement, pulse rate measurement and the result storage. The design provides you with two years of reliable service. Readings taken by the TMB-1597-BN are equivalent to those obtained by a trainedobserver using the cuff and stethoscope auscultation method. This manual contains important safety and care information, and providesstep by step instructions for using the product. Read the manual thoroughly before using the product. 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.The Bluetooth Combination MarkSymbol for “Including RFtransmitter”ContraindicationsThis device is contraindicated for any person who is connected to a wearable or implantable electronic device or instrument, such as a pacemaker or defibrillator.This blood pressure monitor is not intended to be a diagnostic device.Contact your physician if hypertensive values are indicated.23INTRODUCTION INTRODUCTION
CAUTION* This device is intended for adult use only. It is not intended for use with neonatal patients, pregnant or pre-eclamptic patients.* The device is not intended for patient transport outside a healthcare facility. * The device is not intended for public use.* This device is intended for no-invasive measuring and monitoring of arterial blood pressure. It is not intended for use on extremities other than the arm or for functions other than obtaining a blood pressure measurement.* Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood pressure.Do not begin or end medical treatment without asking a physician for treatment advice.* If you are taking medication,consult your physician to determine the most appropriate time to measure your blood pressure. Never change a prescribed medication without consulting your Physician.* When the device was used to measure patients who have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, the best result may occur with deviation. Please consult your physician about the result.* If the cuff pressure exceeds 40 kPa (300 mmHg), the unit will automatically deflate. Should the cuff not deflate when pressures exceeds 40 kPa (300 mmHg), detach the cuff from the arm and press the START/STOP button to stop inflation.* The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable anesthetic mixture with air of with oxygen or nitrous oxide.* The operator shall not touch output of batteries /adapter and the patient simultaneously.* To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated interference signal or electrical fast transient/burst signal.* The user must check that the equipment functions safely and see that it is in proper working condition before being used.* This device is contraindicated for any female who may be suspected of, or is pregnant. Besides providing inaccurate readings, the effects of this device on the fetus are unknown.* Manufacturer will make available on request circuit diagrams, component parts list etc.* This unit is not suitable for continuous monitoring during medical emergencies or operations. Otherwise, the patient’s arm and fingers will become anaesthetic, swollen and even purple due to a lack of blood.* Please use the device under the environment which was provided in the user manual. Otherwise, the performance and lifetime of the device will be impacted and reduced.* During use, the patient will be in contact with the cuff. The materials of the cuff have been tested and found to comply with requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not cause any potential sensization or irritation reaction.* Please use ACCESSORIES and detachable partes specified/ authorised by MANUFACTURE. Otherwise, it may cause damage to the unit or danger to the user/patients.* The device doesn’t need to be calibrated within two years of reliable service.* Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local guidelines.CAUTION* If you have any problems with this device, such as setting up, maintaining or using, please contact the SERVICE PERSONNEL of Transtek. Don’t open or repair the device by yourself. * Please report to Transtek if any unexpected operation or events occur.* Please use the soft cloth to clean the whole unit. Don’t use any abrasive or volatile cleaners. * Warning: No servicing/maintenance while the ME equipment is in use. * The patient is an intended operator. The patient can measure,transmit data and change battery under normal circumstances and maintain the device and its accessories according to the user manual.* Adaptor is specified as a part of ME EQUIPMENT.* The plug/adapter plug pins insulates the device from the main supply. Do not position the device in a position where it is difficult to disconnect from the supply mains to safely terminate operation of ME EQUIPMENT. * Before every use, check the device, do not use the device or an electrode if it is damaged in any way. The continuous use of a damaged unit may cause injury, improper results, or serious danger.* Be careful to strangulation due to cables and hoses, particularly due to excessive length.* Keep unit out of the reach of young children / pets to avoid inhalation or swallowing of small parts. The cord/tube can cause strangulation.* At least 30 min required for ME equipment to warm from the minimum storage temperature between uses until it is ready for intended use. At least 30 min required for ME equipment to cool from the maximum storage temperature between uses until it is ready for intended use.* When not in use, store the device with the adapter in a dry room and protect it against extreme moisture, heat, lint, dust and direct sunlight. Never place any heavy objects on the storage case.* Warning: Be careful to regarding the effect of blood flow interference and resulting harmful injury to the patient caused by continuous cuff pressure due to connection tubing.*When using this device, please pay attention to the following situation which may interrupt blood flow and influence blood circulation of the patient, thus cause harmful injury to the patient: connection tubing kinking too frequent and consecutive multiple measurements; the application of the cuff and its pressurization on any arm where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present; inflating the cuff on the side of a mastectomy.* Warning: Do not apply the cuff over a wound;otherwise it can cause further injury.* Do not inflate the cuff on the samb limb which other monitoring ME equipment is applied around simultaneously, because this could cause temporary loss of function of those simultaneously-used monitoring ME equipment.* Please check that operation of the device does not result in prolonged impairment of patient blood circulation.* When measurement, please avoid compression or restriction of the connection tubing.* The device cannot be used with HF surgical equipment at the same time.* The ACCOMPANYING DOCUMENT shall disclose that the SPHYGMOMANOMETER was clinically investigated according to the requirements of ISO 81060-2:2013.* To verify the calibration of the AUTOMATED SPHYGMOMANOMETER, please contact the manufacturer.*This device may be used only for the purpose described in this booklet. The manufacturer cannot be held liable for damage caused by incorrect application.* This device comprises sensitive components and must be treated with caution. Observe the storage and operating conditions described in this booklet.* Do not wash the cuff in a washing machine or dishwasher!* It is recommended that the performance should be checked every 2 years and after maintenance and repair, by retesting at least the requirements in limits of the error of the cuff pressure indication and air leakage (testing at least at 50mmHg and 200mmHg).* There is no luer lock connectors are used in the construction of tubing, there is a possibility that they might be inadvertently connected to intravascular fluid systems, allowing air to be pumped into a blood vessel.* This equipment needs to be installed and put into service in accordance with the information provided in the ACCOMPANYING DOCUMENTS;• Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies can affect this equipment and should be kept at least a distance d away from the equipment. The distance d is caculated by the MANUFACTURER from the 800 MHz to 2.5 GHz column of Table 6 of IEC 60601-1-2:2007,as appropriate.45INTRODUCTIONINTRODUCTION
LCD display signalSYMBOL DESCRIPTIONSystolic blood pressureDiastolic blood pressureEXPLANATIONMemorymmHgkPaMeasurement Unit of the blood pressureMeasurement Unit of the blood pressureLow battery Batteries are low and need to be replacedCurrent Time Year/Month/Day, Hour/Minute(1kPa=7.5mmHg)(1mmHg=0.133kPa)HeartbeatUser 1 Start measurement,save and transmit the measuring results for User 1User 2Irregular heartbeat Monitor ComponentsList1.Blood Pressure Monitor (TMB-1597-BN)4.User manual2.Cuff (Type BF applied part) (22cm~32cm or 22cm~42cm)3. 4×AA alkaline batteries(Please use TRANSTEK authorized cuff. The size of the actual cuff please refer to the label on the attached cuff.)Start measurement, save and transmit the measuring results for User 2Component list of pressure measuring system1 Cuff 2 Air pipe3 PCBA4 Pump5 ValveCUFF AIR HOSEAIR CONNECTOR PLUGLCD DISPLAYDC POWER SOCKETMEM BUTTONSTART/STOPSET BUTTONBATTERY COMPARTMENT5. AC Adaptor(KH0601000UW!)Average value The average value of blood pressureMotion indicator Motion may result in an inaccuratemeasurementBluetooth iconData storageIndicate the Bluetooth is workingIndicate the data is waiting to be transmittedHigh blood pressure Low blood pressurePulse in beats per minutePulse displayDeflation symbol The cuff is deflating.Indicate it is in the memory mode and which group of memory it is.Blood pressure monitor is detecting an irregular heartbeat during measurement.Blood pressure level indicator Indicate the blood pressure levelBlood pressure monitor is detecting a heartbeat during measurement.76INTRODUCTION INTRODUCTION
In order to get the best effect and protect your monitor,please use the right battery and special power adaptor which complies with U.S. safety standard.•.Open the battery cover.•.Install the batteries by matching the correct polarity, as shown.•.Replace the battery cover.Installing and Replacing the BatteriesCAUTIONReplace the batteries whenever the below happenThe showsThe display is dimThe display does not light up The Choice of Power Supply1.Battery powered mode: 6VDC 4×AA alkaline batteries2.AC adaptor powered mode: 6V 1A(Please only use the recommended AC adaptor model). Please unplug the adaptor to depart fromthe using utility power.Setting Date, Time and Measurement Unit1.2. AC adaptor It is important to set the clock before using your blood pressure monitor, so that a time stamp can be assigned to each record that is stored in the memory. (The setting range of the year :2016—2056; Time format:24H)When the monitor is off, press “ ”button,it will display the time.Then press and hold “ ” button to enter the mode for year setting.(Notes: 1.During the process of setting, you can press “ ” button to stop setting at any time. 2. If there is no operation during the process of setting, it will turn off within 1 minute.)Press “ ” button to change the [YEAR]. Each press will increase the numeral by one in a cycling manner. CAUTIONDo not use new and used batteries together. Do not use different types of batteries together.Do not dispose the batteries in fire. Batteries may explode or leak.Remove batteries if the device is not likely to be used for some time.Worn batteries are harmful to the environment. Do not dispose with daily garbage.Remove the old batteries from the device following your local recycling guidelines.The typical service life of the new and unused batteries is 300 measurements for the operation time is 60s.98BEFORE YOU START BEFORE YOU START
3.4.Repeat steps 2 and 3 to set the [MONTH] and [DAY]. 7.6.Repeat steps 2 and 3 to set the [UNIT]..Repeat steps 2 and 3 to set the [HOUR] and [MINUTE]. 5When you get the right year, press “ ” button to set down and turn to next step. After the unit is set,the LCD will display “done” first, then display all the settings you have done and then turn off.1110BEFORE YOU START BEFORE YOU START
Select the User1.2.3.When the monitor is off, press and hold “ ”button to enter user setting mode. The user ID will blink.Then press “ ” button again, select the user ID between user 1 and user 2.After selecting the suitable user ID, press “ ” button to confirm. It will display User ID+ donE” and then turn off.1.2.If SUCCEED, symbol + will be shown on the LCD.If FAIL, only bluetooth symbol “E12”will be shown on the LCD.3.Pair - up the Blood Pressure Monitor with Your DeviceBefore you start pairing, please download the MedM Health app from APP Store or Google Play in your device which supports Bluetooth 4.0 technology first.Turn on Bluetooth and the app. Make sure both are ON when pair-up is proceeding. If this is the first time you use “MedM Health”, please register an account first. Enter your account and password to log in.Please enter “My Profile” to set your pernal information. Please enter Settings infterface,click “My Devices”, select “Add the Device”.When the monitor is OFF, press and hold the button to start pair-up. The symbol and will display alternatively, indicating pair-up is proceeding. After detecting the blood pressure monitor, “MedM Health” will display the product’s information. Click and select the device which you want to bind with your mobile device. Click “bind the device”, then click “User Profile” to select the user you want to connect with your mobile device on the app to continute the pair-up. After binding the device, it only can transmit the data of the bound user.1312BEFORE YOU START BEFORE YOU START
Tie the cuff1.2.3.2~3cm4.Tie the cuff on your upper arm, then position the tube off-center toward the inner side of arm in line with the little finger. Or position the artery mark over the main artery (on the inside of your arm). Note: Locate the main artery by pressing with 2 fingers approximately 2 cm above the bend of your elbow on the inside of your left arm. Identify where the pulse can be felt the strongest. This is your main artery.The cuff should be snug but not too tight. You should be able to insert one finger between the cuff and your arm.Sit comfortably with your tested arm resting on a flat surface.Patients with Hypertension:The middle of the cuff should be at the level of the right atrium of the heart; Before starting measurement, please sit comfortably with legs uncrossed, feet flat on the floor, back and arm supported.Rest for 5 minutes before measuring.Wait at least 3 minutes between measurements. This allows your blood circulation to recover.For a meaningful comparison, try to measure under similar conditions. For example, take daily measurements at approximately the same time, position of upper arm, or as directed by a physician. 4.The monitor will shut off after Pair-up process is complete.Bluetooth Module No.: AW51822RF Frequency Range: 2402 MHz to 2480 MHzOutput Power Range: 4 dBmSupply Voltage: 1.8V-3.6 VTransmitting Distance: 10 metersCAUTION 1. 2. List of compatible devices:For iOS devices:The operating system must be iOS 8 or more, such as iPhone4S, iPhone 5/5C/5S, iPhone 6/6 Plus and so on.For Android devices:The operating system must be 4.3 or more.Interference may occur in the vicinity of equipment marked with the following symbol . And TMB-1597-BN may interfering vicinity electrical equipment.Sensitive people, including pregnant women pre-eclamptic and those who implanted medical electronic instruments, should avoid using the unit whenever possible.Keep the monitor at least 20 centimeters away from the human body (especially the head) when the data transmission is proceeding after measurement.To enable the data transmission function, this product should be paired to Bluetooth end at 2.4 GHz.How to mitigate possible interference?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.To avoid interference, other electronic devices (particularly those with wireless transmission / Transmitter) should be kept at least 1 meter away from the monitor. 1514MEASUREMENTBEFORE YOU START
1.Adjust the zero. LCD displayInflating and measuring. Start the Measurement4.When the monitor is off, press “ ” button to turn on the monitor, and it will finish the whole measurement.(Take user 1 for example.)Display and save the measurement results. The year, date and time will display alternately. Press the “ ” button to power off, otherwise it will turn off within 1 minute. Tips: 1. There are two users in total. Each user has 60 records.2. You can press “ ” button at any time to stop measuring during the process of measurement.3. If the measurement result is out of the measurement range (SYS: 60mmHg to 230mmHg; or DIA: 40mmHg to 130mmHg;or Pulse: 40-199 pulse/minute), the LCD will display “out”.3.With TMB-1597-BN successfully pair-up with your mobile device, the measurement data will be automatically transmitted to your mobile device via Bluetooth. (1).The symbol will disappear after successful data transmission, and you may check your personal health data stored in your mobile device.(2).If the data transmission fails, the symbol will remain. The pending measurement data will be transmitted to your mobile device when next measurement is complete.2.This device will proceed to data transmission after measurement. The Bluetooth symbol blinks on the LCD indicates data is transmitting.Transmitting Complete1716MEASUREMENT MEASUREMENT
Recall the Records1.2.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.The current No. is No. 1.Seven records in total.The corresponding time is A.M. 7:00.The corresponding date is December 1 .CAUTION3.stWhen the monitor is off, please press “ ” button to show the average value of the latest three records. (Take user 1 for example.)Press “ ” button or “ ” button to get the records you want.The record number, date and time of the measurement records will display alternately. If you want to check another user’s records, press “ ” button to turn off the monitor when the blood pressure monitor is in the memory inquiry mode. Press and hold “ ” button to enter into the selecting user ID mode, press “ ” button again to select the user ID between user 1 and user 2, press “ ” button to confirm the user ID , then press “ ” button to check the selected user’s measurement records.1918DATA MANAGEMENT DATA MANAGEMENT
Delete the Records Tips for MeasurementWithin 1 hour after dinner or drinkingWithin 20 minutes after taking a bathIn a very cold environmentImmediate measurement after tea, coffee, smoking When talking or moving your fingersWhen you want to discharge urineMeasurements may be inaccurate if taken in the following circumstances.If you did not get the correct measurement, you can delete all results for the selected user by following steps. (Take User 1 for example.)Hold pressing “ ” button about 3 seconds when the monitor is in the memory recall mode, the flash display “ dEL ALL”+ User ID will show.1. Press “ ” button to confirm deleting and the monitor will display “User ID+dEL dOnE” and then turn off.2.Note: To exit out of delete mode without deleting any records, press “ ” button before pressing " " button to confirm any delete commands.If there is no record, when you press “ ” button to check the record, the following display will show.3.2120DATA MANAGEMENT INFORMATION FOR USER
MaintenanceIn order to get the best performance, please follow the instructions below.What are systolic pressure and diastolic pressure? pressartery veinblood dischargingSystolicrelaxblood enteringDiastolic 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.What is the standard blood pressure classification?Irregular Heartbeat DetectorCAUTIONThe appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heart-beat was detected during measurement. Usually this is NOT a cause for concern. However, if the symbol appears often, we recommend you seek medical advice. Please note that the device does not replace a cardiac examination, but serves to detect pulse irregularities at an early stage.Put in a dry place and avoid the sunshineAvoid intense shakingand collisionsUsing wet cloths to remove dirtAvoid touching water,clean it with a dry cloth in case.Avoid dusty and unstabletemperature environmentDo not attempt to clean the reusable cuff with water and never immerse the cuff in water.An irregular heartbeat (IHB) is detected when a heartbeat rhythm varies while the unit is measuring the systolic and diastolic blood pressure.During each measurement, the monitorrecords the heartbeat intervals and calculates the average. If any average is larger than or equal to 25%,the irregular heartbeat symbol appears on the display when the measurement results appear.The chart on the right is thestandard blood pressureclassification published byAmerican Heart Association (AHA).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.CAUTIONAHA Home Guideline for Upper Limit of Normal BPSYS 135 mm HgDIA 85 mm HgBlood Pressure CategoryNormalPrehypertensionHigh Blood Pressure(Hypertension) Stage 1High Blood Pressure(Hypertension) Stage 2Hypertensive Crisis(Emergency care needed)SystolicmmHg (upper#)DiastolicmmHg (lower#)less than 120120-139140-159160 or higherHigher than 180andororororless than 8080-8990-99100 or higherHigher than 110This chart reflects blood pressure categories defined by American Heart Association.22 23INFORMATION FOR USER ABOUT BLOOD PRESSURE
Why does my blood pressure fluctuate throughout the day?Is the result the same if measuring on the right arm?Why do I get a different blood pressure at home compared to the hospital?1. Individual blood pressure varies multiple times everyday. It is also affected by the way you tie your cuff and your measurement position, so please take the measurement under the same conditions.2.If the person takes medicine, the pressure will vary more.3.Wait at least 3 minutes for another measurement.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.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. 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 CHECK THIS REMEDYNo powerLowbatteriesErrormessageDisplay will not light up.Batteries are exhausted. Replace with new batteriesInsert the batteries correctlyReplace with new batteriesBatteries are insertedincorrectly.Display is dim or show Batteries are low.E 01 showsE 03 showsE 04 showsEExx,shows on the display.A calibration erroroccurred. (XX canbe some digital symbol,such as 01, 02,etc., if this similar situation appear, all belong to calibration error.)Retake the measurement.If the problem persists,contact the retailer or ourcustomer service department for further assistance.Refer to the warranty for contact information and return instructions.The treatment of themeasurement failed.AC adaptor is insertedincorrectly.Insert the AC adaptor tightlyE 02 showsThe cuff is too tight or too loose.Refasten the cuff and thenmeasure again.The monitor detected motion while measuring.Movement can affect themeasurement.Relax for a moment and then measure again.Relax for a moment andthen measure again.The measurement process does not detect the pulse signal.Loosen the clothing onthe arm and then measure again. WarningmessageRelax for a moment.Refasten the cuff and thenmeasure again. If theproblem persists, contactyour physician.“out ” shows Out of measurementrangeData communication is failed.Check if the App/Bluetoothis on or not,try datatransmission again.E 12 shows24 25ABOUT BLOOD PRESSURE TROUBLESHOOTING
About 22cm~32cm or 22cm~42cmType BF applied partWARNING: No modification of this equipment is allowed.Power supplyBattery powered mode: 6VDC 4×AA alkaline batteriesAC adaptor powered mode: 6V 1A(Please only use the recommended AC adaptor model). Display modeMeasurement mode Oscillographic testing modeMeasurement rangeMeasurement perimeterof the upper armWeight Approx.258g(Excluding the dry cells and cuff)External dimensionsAttachmentMode of operation Continuous operationDegree of protectionProtection against ingress of waterAccuracyNormal working conditionStorage & transportationconditionSoftware Version A01Pressure:5℃-40℃within±3mmHg(0.4kPa) Pulse value:±5%Blue LCD display with white backlightV.A.73mm×49mmApprox.118mm×126mm×72mm4×AA alkaline batteries,user manual Contact InformationFor 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:Company:Address:Authorized Component1.please use the TRANSTEK authorized adapter.Guangdong Transtek Medical Electronics Co., Ltd.Zone B, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China Guangdong Transtek Medical Electronics Co., Ltd.Rated cuff pressure: 0mmHg~300mmHg(0kPa ~ 40kPa)Measurement pressure: SYS: 60mmHg~230mmHg (8.0kPa~30.7kPa) DIA: 40mmHg~130mmHg (5.3kPa~17.3kPa)Pulse value: (40-199)beat/minuteIP21 It means the device could protected against solid foreign objects of 12.5mm and greater, and protect against vertically falling water drops.AdapterModel：KH0601000UWInput：AC 100-240V50/60Hz 0.4A MaxOutput：6V 1000mA26 27SPECIFICATIONS AUTHORIZED COMPONENTA 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 hPaAn atmospheric pressure range of : 700 hPa to 1060 hPaTemperature:-20°C to +60°CA relative humidity range of ≤ 93%, non-condensing, at a water vapour pressure up to 50hPa
Complied Standards List FCC StatementThis 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. FCC ID: OU9TMB1597BNISO 14971:2007 Medical devices - Application of risk management to medical devicesEN 1041:2008 Information supplied by the manufacturer of medical devicesIEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and testsIEC 62304:2006/AC: 2008 Medical device software - Software life-cycle processesRisk managementLabelingUser manualGeneral Requirements for SafetyElectromagneticcompatibilityPerformancerequirementsClinical investigationUsabilitySoftware life-cycle processesISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1 General requirementsIEC 60601-1: 2005+A1：2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performanceIEC 60601-1-11 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environmentIEC 80601-2-30:2009 Medical electrical equipment- Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometersIEC 62366 Medical devices - Application of usability engineering to medical devices (IEC 62366:2007)IEC 60601-1-6 Medical electrical equipment - Part 1 -6 : General requirements for basic safety and essential performance - collateral standard : UsabilityISO 81060-2:2009 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement typeMODIFICATION: Any changes or modifications not expressly approved by the grantee of this device could void the user’s authority to operate the device.28 29COMPLIED STANDARDS LIST FCC STATEMENT
EMC Guidance1)This product needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided,and this unit can be affected by portable and mobile RF communications equipment.2)* Do not use a mobile phone or other devices that emit electromagnetic fields, near the unit. This may result in incorrect operation of the unit.3)Caution: This unit has been thoroughly tested and inspected to assure proper performance and operation!4)* Caution: this machine should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, this machine should be observed to verify normal operation in the configuration in which it will be used.Table 1 Guidance and MANUFACTURER’s declaration – ELECTROMAGNETIC EMISSIONS- for all ME EQUIPMENT and ME SYSTEMS Guidance and manufacturer’s declaration – electromagnetic emissionsRF emissions CISPR 11 Group 1 Class B Class ACompliesComplianceThe 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.Harmonic emissions IEC 61000-3-2Voltage fluctuations/ flicker emissions IEC 61000-3-3 RF emissions CISPR 11Emissions test Electromagnetic environment - guidanceThe device uses RF energy only for its internal function. Therefore, its RFemissions are very low and are not likelyto cause any interference in nearby electronic equipment.The device is suitable for use in all establishments,including domestic establishments and those directlyconnected to the public low-voltage power supplynetwork that supplies buildings used for domestic purposes. Guidance and manufacturer’s declaration – electromagnetic immunity IMMUNITY test ±6 kV contact±8 kV air ±6 kV contact±8 kV air ±2 kV for power supply lines ±1 kV line(s) to line(s)±2 kV line(s) to earth <5% UT(>95% dip in UT)for 0.5 cycle40% UT(60% dip in UT)for 5 cycles70% UT(30% dip in UT)for 25 cycles<5% UT(>95% dip in UT)for 5 sec3A/mNOTE UT is the a.c. mains voltage prior to application of the test level. Table 2 Guidance and MANUFACTURER’s declaration – electromagnetic IMMUNITY – for all ME EQUIPMENT and ME SYSTEMS IEC 60601 test level Compliance levelElectrostatic discharge (ESD) IEC 61000-4-2 Electromagnetic environment - guidanceFloors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.Power frequency magnetic fields should be at levels characteristic of a typicallocation in a typical commercial or hospital environment.3A/mPower frequency (50Hz/60Hz) magnetic field IEC 61000-4-8 Voltage dips, short interruptionsand voltagevariations on power supply input linesIEC 61000-4-11 Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5The 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 anenvironment±1 kV for input/output linesMains power quality shouldbe that of a typicalcommercial or hospitalenvironment.Mains power quality shouldbe that of a typicalcommercial or hospitalenvironment.Mains power quality shouldbe that of a typicalcommercial or hospitalenvironment. If the user ofthe device requires continued operation duringpower mains interruptions,it is recommended that thedevice be powered from anuninterruptible power supplyor a battery.±2 kV for powersupply lines±1 kV differential mode<5% UT(>95% dip in UT)for 0.5 cycle40% UT(60% dip in UT)for 5 cycles70% UT(30% dip in UT)for 25 cycles<5% UT(>95% dip in UT)for 5 sec30 31EMC GUIDANCE EMC GUIDANCE
Table 4 Guidance and MANUFACTURER’s declaration – electromagnetic IMMUNITY –for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacturer’s declaration – electromagnetic immunityIMMUNITY test3 Vrms3 V/m Compliance levelIEC 60601 TEST LEVELConducted RFIEC 61000-4-6 Radiated RF IEC 61000-4-33 V/m80 MHz to2.5 GHz 3 Vrms150 kHz to80 MHz Electromagnetic environment - guidancePortable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.Recommended separation distanceThe 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.where P is the maximum output powerrating of the transmitter in watts (W) according to the transmitter manufacturerand d is the recommended separationdistance in metres (m).Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should beless than the compliance level in eachfrequency range.abInterference may occur in the vicinity of equipment marked with the following symbol:P=dP=d 80 MHz to 800 MHz P=d 2.3 800 MHz to 2,5 GHz 1.2 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.aField strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones and land mobile radios, amateur radio, AM and FM radio broad-cast 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.Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.b1.2 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz Table 6 Recommended separation distances between portable and mobile RF communications equipment and the ME EQUIPMENT or ME SYSTEM –for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the device.The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the devicecan 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 outputpower of transmitter(W) Separation distance according to frequency of transmitter (m)For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.NOTE 1 At 80MHz and 800MHz, the separation distance for the higher frequency range applies.NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.0.010.11101000.12 0.120.381.23.8120.230.732.37.323P=d P=d 1.2 2.3 P=d0.381.23.8121.232 33EMC GUIDANCE EMC GUIDANCE

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