Transtek Medical Electronics TMB1580-B Blood Pressure Monitor User Manual 13 Proposed Labeling

Guangdong Transtek Medical Electronics Co.,Ltd Blood Pressure Monitor 13 Proposed Labeling

User manual

User ManualBlood Pressure Monitor TMB-1580-BTTo use the monitor correctly and safely, please read the manual thoroughly.Thank you very much for selecting TRANSTEK Blood Pressure Monitor TMB-1580-BT.Please keep this manual well in order to reference in future.Wrist TypeVersion:1.0Guangdong Transtek Medical Electronics Co., Ltd.Zone A, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China
INTRODUCTION...............................................................2Safety InformationLCD Display SignalMonitor ComponentsBEFORE YOU START..........................................................5Installing and Replacing the BatteriesSetting Date, Time and Measurement UnitMEASUREMENT...............................................................12Tie the CuffPair-up the Blood Pressure Monitor with Your DeviceStart the MeasurementSelect the User IDDATA MANAGEMENT 16Recall the RecordsDelete the RecordsINFORMATION FOR USER.....................................................18Tips for MeasurementMaintenanceABOUT BLOOD PRESSURE....................................................20What are systolic pressure and diastolic pressure?What is the standard blood pressure classification?Why does my blood pressure fluctuate throughout the day?Why do I get a different blood pressure at home compared to the hospital?Is the result the same if measuring on the right wrist?TROUBLESHOOTING.........................................................22SPECIFICATIONS..........................................................................................................................23CONTACT INFORMATION......................................................2424COMPLIED STANDARDS LISTFCC STATEMENT.....................................................................26EMC GUIDANCE......................................................27..........................................................General DescriptionIndications for Use1CATALOGUE CATALOGUE
The signs below might be in the user manual, labeling or other component. They are the requirement of standard and using.Safety InformationFeatures:Systolic blood pressureDiastolic blood pressurePulse rate60 records per each userSymbol 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”General Description Thank you for selecting TRANSTEK Blood Pressure Monitor (TMB-1580-BT).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-1580-BT 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 Bluetooth Combination MarkSymbol for “Including RFtransmitter”Indications for UseThe Transtek Blood Pressure Monitor is digital monitors intended for use inmeasuring blood pressure and heartbeat rate with wrist circumference rangingfrom 13.5 cm to 21.5 cm ( about 5⅓˝-8½˝ ).It is intended for adult indoor use only.CAUTION This device is intended for adult use only.This device is intended for no-invasive measuring and monitoring of arterial blood pressure. It is not intended for use on extremities other than the wrist or for functions other than obtaining a blood pressure measurement.Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood pressure.Do not begin or end medical treatment without asking a physician for treatment advice.If you are taking medication,consult your physician to determine the most appropriate time to measure your blood pressure. Never change a prescribed medication without consulting your physician.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 wrist and press the START/STOP button to stop inflation.To avoid measurement errors, carefully read this manual before using the product.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 and the patient simultaneously.Do not use the monitor under the conditions of strong electromagnetic field (e.g. medical RFequipment) that radiates interference signal or electrial 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.Please use ACCESSORIES and detachable partes specified/ authorised by MANUFACTURE. Otherwise, it may cause damage to the unit or danger to the user/patients. 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 wrist 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 alergic reaction or contact injury. The device doesn’t need to be calibrated whith the two years of reliable service.Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local guidelines.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.This device is contraindicated for any female subject who may be suspected of, or is pregnant. Besides providing inaccurate readings, the effects of this device on the fetus are unknown.Please keep the unit out of reach of infants, children or pets, since inhalation or swallowing of small parts is dangerous or even fatal.Too frequent and consecutive measurements could cause disturbances in blood circulation and injuries.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: too frequent and consecutive multiple measurements; the application of the CUFF and its pressurization on any wrist where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present; Inflating the cuff on the wrist on the side of a mastectomy.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.Using it in case to result in prolonged impairment of the circulation of the blood of the PATIENT.Don’t kink the connection tube, otherwise, the cuff pressure may continuously increase which can prevent blood flow and result in harmful injury to the PATIENT.The device has been evaluated clinically using manual cuff/stethoscope auscultation as the reference. Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultatory method, within the limits prescribed by the American National Standard, Manual, electronic, or automated sphygmomanometers.”Symbol for “KEEP DRY”32INTRODUCTION INTRODUCTIONCaution: These notes must be observed to prevent any damage to the device.
SYSTOLICDIASTOLICMEM BUTTONSET BUTTONSTART/STOP BUTTONPULSE RATESystolic blood pressure High pressure resultDiastolic blood pressure Low pressure resultPulse Pulse/minute; heartbeats/minutemmHg Measurement unit the blood pressure (1mmHg=0.133kPa)kPa Measurement unit of the blood pressure (1kPa=7.5mmHg)Current timeShocking remainding Shocking will result in inaccurateIrregular heartbeat detectionIrregular heartbeatLow battery Batteries are low and need to be replacedGrade The grade of the blood pressureLCD Display SignalSYMBOL DESCRIPTION EXPLANATIONMonth/Day/Year,Hour/MinuteHeartbeat Heartbeat detection during the measurementCUFF(Type BF applied part)Monitor ComponentsComponent List:1. PCBA;2. Air Pipe;3. Pump;4. Valve; 5. Cuff. List1) Blood Pressure Monitor TMB-1580-BT2) 2×AAA batteries3) User manualLCD DISPLAYGRADETIMEUser 1User 2Start measurement and save the measuring results for user 1.Start measurement and save the measuring results for user 2.BATTERYCOMPARTMENT54INTRODUCTION INTRODUCTION
•.Slide off the battery cover.•.Install the batteries by matching the correct polarity, as shown below. Always use the correct battery type (2 x AAA batteries). •.Replace the cover.Installing and Replacing the BatteriesRemove batteries if the device is not likely to be used for some time.The old batteries are harmful to the environment, do not dispose with other daily trash.Remove the old batteries from the device and follow your local recycling guidelines.Replace the batteries whenever the below happenThe showsThe display dimsThe display does not light upDo not dispose of batteries in fire. Batteries may explode or leak.Setting Date, Time and Measurement Unit It is important to set the clock before using your blood pressure monitor, so that a time stamp can be assigned to each record that is stored in the memory. (year :2014—2054,time format:24 H/12 H)1.2. Press the “M” button to change the [TIME FORMAT] between 12 hours and 24 hours.3.When the monitor is off, hold pressing “S” button for about 3 seconds to set the time format.CAUTIONWhen you get the right time format,press “S” button to confirm yourselection and it will turn to the nextstep.76BEFORE YOU START BEFORE YOU START
4.Repeat steps 2 and 3 to confirm [HOUR] and [MINUTE].5.Then the monitor diverts to date format setting. Select the date format. Repeat steps 2 and 3 to confirm the date format between DM and MD. 6.Repeat steps 2 and 3 to confirm the [MONTH] , [DAY] and [YEAR].8.After confirming the meausrement unit, the LCD will display “dOnE” and then turn off.7.Repeat steps 2 and 3 to confirm the [MEASUREMENT UNIT].98BEFORE YOU START BEFORE YOU START
Pair-up the Blood Pressure Monitor with Your Device 1 .Turn on Bluetooth and the app. Make sure both are ON when pair-up is proceeding.2 .When the monitor is OFF, press and hold START/STOP button about 3 seconds to start pair-up. The symbol and the symbol will be shown on the LCD alternatively, indicating pair-up is proceeding.If SUCCEED, symbol willbe shown on the LCD.If FAIL, symbol will beshown on the LCD.4 .The monitor will shut off automatically after Pair-up process is complete.Bluetooth Module No.: AW2540MV1RF Frequency Range:Output Power Range: Supply Voltage: Transmitting Distance: 10 meters 2402 MHz to 2480 MHz-1 dBm2 V to 3.6V3. Then please select the user ID you want to connect with your smartphone on the app to continute the pair-up.1110BEFORE YOU START BEFORE YOU START
Tie the Cuff Select the User ID1.When the blood pressure monitor is off, press and hold the MEM button until the user ID blinks. Then press “M” button to change the user IDbetween user 1 and user 2. Press “S” button to confirm your selection.Before you start the measurement, please select the desired user ID first.2. After confirming the user ID, the LCD will turn off. Then you can startyour measurement now.1.Remove all accessories (watch, bracelet, etc) from your wrist. If your physician has diagnosed you with poor circulation in your wrist, use the other one.2.Roll or push up your sleeve to expose the skin.3.Apply the cuff to your wrist with your palm facing up.4. Position the edge of the cuff about 1-1.5cm.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.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, on the same wrist, or as directed by a physician.Sit comfortably with your tested wrist 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 wrist supported.6.7.The patient must relax as much as possible and do not talk during themeasurement procedure.1312MEASUREMENT MEASUREMENT
1.When the monitor is off, press “START/STOP” button to turn on the monitor,and it will finish the whole measurement. (Take User 1 for example.) Adjust to zero. LCD displayInflating and measuring. Display and save theresult. Start the Measurement3.2.Press “START/STOP” button to power off, otherwise it will turn off within 1 minute.This device will proceed to data transmission after measurement.The Bluetooth symbol blinks on the LCD indicates data is transmitting.If the data transmission fails, lights all the time.Tips: Maximum 60 records are both for User 1 and User 2.If the data transmission succeeds,the LCD will display “User ID+ + ”. 1514MEASUREMENT DATA MANAGEMENT
1.2.Press “S” to confirm deleting , the LCD displays “ dEL dOnE” and the monitor will turn off. If you did not get the correct measurement, you can delete all results by following steps below . (Take User 1 for example.)Delete the Records3.If there is no record. the right display will show.In the memory mode, holdpressing “M” button for 3 seconds, the flash display “User ID+ dEL All” will show.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.CAUTION3. If you want to check the other user’s measurement records, please press “START/STOP” button to turn off the blood pressure monitor. Then press and hold “M” button to enter the selecting user mode, press “M” again to change the user, when the desired user ID blinks, press “S” button to confirm. Then press “M” button to check the records of the selected user. Recall the Records1.2. The date and time will display alternately.When the monitor is off, press “M” button to show the average value of the latest three measurement records. (Take User 1 for example.)Press “M” button or “S” button to get the record you want.The corresponding time is 9:10.The corresponding date is May 11 .thNote: To exit out of delete mode without deleting any records, press START/STOP button before pressing “S” to confirm any delete commands.1716DATA MANAGEMENT DATA MANAGEMENT
MaintenanceIn order to get the best performance, please follow the instructions below.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 unstable-temperature environmentAvoid washing the cuffTips for MeasurementWait at least 1 hour after dinner or drinkingWait at least 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 urine 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.Measurements may be inaccurate if taken in the following circumstances.1918INFORMATION FOR USERINFORMATION FOR USER
Why does my blood pressure fluctuate throughout theday?What are systolic pressure and diastolic pressure? What is the standard blood pressure classification?pressartery veinblood dischargingSystolicrelaxblood enteringDiastolic CAUTIONIrregular Heartbeat DetectorThe appearance of the IHB icon indicates that a pulse irregularity consistent withan irregular heartbeat was detected during measurement. Usually this is NOT acause for concern. However, if the symbol appears often, we recommend youseek medical advice. Please note that the device does not replace a cardiacexamination, but serves to detect pulse irregularities at an early stage.An irregular heartbeat is detected when a heartbeat rhythm varies while the unit is measuring the systolic and diastolic blood pressure.During each measurement, this equipment records the heartbeat intervals and works out the standard deviation. If the calculated value is larger than or equal to 15,the irregular heartbeat symbol appears on the symbol when the measurement results are displayed.1. Individual blood pressure varies multiple times everyday. It is also affected by the way you tie your cuff and your measurement position, so please take the measurement under the same conditions.2.If the person takes medicine, the pressure will vary more.3.Wait at least 3 minutes for another measurement.Why do I get a differentblood pressure at homecompared to the hospital?The blood pressure is different even throughout the day due to weather, emotion, exercise etc, Also, there is the “white coat” effect, which means blood pressure usually increases in clinical settings.What you need to pay attention to when you measure your blood pressure at home: If the cuff is tied properly. If the cuff is too tight or too loose.If the cuff is tied on the wrist.If you feel anxious.Taking 2-3 deep breaths before beginning will be better for measuring. Advice: Relax yourself for 4-5 minutes until you calm down.Is the result the same ifmeasuring on the rightwrist?It is ok for both wrists, but there will be some different results for different people. We suggest you measure the same wrist every time.When ventricles contract and pump blood out of the heart, blood pressure reaches its maximum 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.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.2120ABOUT BLOOD PRESSUREABOUT BLOOD PRESSURE
Power supply Battery powered mode: 2*AAA batteries (3V DC)Display mode Digital LCD V.A.35mm×46mmMeasurement mode Oscillographic testing modeMeasurement rangeAccuracyNormal working conditionStorage & transportationconditionMeasurement perimeterof the wrist About 13.5cm-21.5cmNet Weight Approx.120g(Excluding the dry cells)External dimensionsAttachmentApprox.64mmx90mmx57mm (Exclude the cuff)2*AAA batteries,user manual Mode of operation Continuous operationDegree of protection Type BF applied partProtection against ingress of water IPX0Software versionDevice classificationV01Internally Powered ME EquipmentWARNING: No modification of this equipment is allowed.This section includes a list of error messages and frequently asked questions for problems you may encounter with your wristblood pressure monitor. If the products not operating as you think it should, check here before arranging for servicing.PROBLEM SYMPTOM CHECK THIS REMEDYNo powerLowbatteriesErrormassageDisplay is dim orwill not light up.Batteries are exhausted. Replace with new batteriesInsert the batteries correctlyReplace with new batteriesBatteries are insertedincorrectly.Show onthe display Batteries are low.Err 1 shows The cuff is too loose. Refasten the cuff and thenmeasure again.Err 2 shows The cuff is very tight Refasten the cuff and thenmeasure again.Err 3 shows The pressure of thecuff is excess.Relax for a momentand then measure again.EExx,shows on the display.A calibration erroroccurred.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.Pressure:5℃-40℃within±0.4kPa(3mmHg) pulse value:±5%Temperature:5℃ to 40℃ Relative humidity: ≤85%RHAtmospheric pressure: 86kPa to 106kPaTemperature:-20℃ to 60℃ Relative humidity: 10%RH to 93%RHAtmospheric pressure: 50kPa to 106kPaRated cuff pressure: 0kPa - 40kPa (0mmHg~300mmHg)Measurement pressure: 5.3kPa-30.7kPa(40mmHg-230mmHg)pulse value: (40-199) beat/minuteData communicationis failed.Check if the Bluetooth function of the smartphoneis on or it is during the range of distanceE 1 shows2322SPECIFICATIONSTROUBLESHOOTING
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:Guangdong Transtek Medical Electronics Co., Ltd.Zone A, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China Guangdong Transtek Medical Electronics Co., Ltd.FCC StatementFCC ID: OU9TMB1580-BFCC StatementThis 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 bedetermined by turning the equipment off and on, the user is encouraged to try to correct theinterference 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 receiveris connected.• Consult the dealer or an experienced radio/TV technician for help.To assure continued compliance, any changes or modifications not expressly approved by theparty responsible for compliance could void the user’s authority to operate this equipment.Radiation Exposure StatementThis equipment complies with FCC radiation exposure limits set forth for an uncontrolledenvironment and it also complies with Part 15 of FCC RF Rules.CAUTION:To comply with the limits of the Class B digital device, pursuant to Part 15 of the FCC Rules, this device is comply with Class B limits. All peripherals must be shielded and grounded. Operation with non-certified peripherals or non-shielded cables may results in interference to radio or reception.MODIFICATION:Any changes or modifications not expressly approved by the grantee of this device could void the user’s authority to operate the device.Label Statement: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.2524CONTACT INFORMATION FCC STATEMENT
EMC GuidanceComplied Standards List1) This equipment needs to be installed and put into service in accordance with the information provided in the user manual;2) 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=3,3m away from the equipment.(Note: As indicated in Table 6 of IEC 60601-1-2:2007 for ME EQUIPMENT, a typical cell phone with a maximum output power of 2 W yields d=3, 3m at an IMMUNITY LEVEL of 3V/m) Risk managementLabelingUser manualGeneral Requirements for SafetyElectromagnetic compatibilityPerformance requirements and Clinical investigationSoftware life-cycle processesISO/EN 14971:2012 Medical devices — Application of risk management to medical devicesISO/EN 15223-1:2012 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirementsEN 1041: 2008 Medical equipment manufacturers to provide informationIEC 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/EN 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard:Electromagnetic compatibility - Requirements and testsIEC 80601-2-30:2009 Medical electrical equipment- Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometersIEC/EN 62304:2006+AC: 2008 Medical device software - Software life cycle processesUsabilityIEC 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 : UsabilityANSI/AAMI SP10:2002/A2: 2008 Manual, electronic, or automated sphygmomanometers26 27EMC GUIDANCECOMPLIED STANDARDS LIST

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