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1. 4 Repeat step 2 and 3 to confirm MONTH and DAY Then the monitor diverts to YEAR setting automatically gt a E oe a Wt Fan MONTH x DAY 3 5 Repeat step 2 and 3 to confirm YEAR 6 After confirming the YEAR the LCD will display dOnE and the monitor will shut off automatically m T CT v Select User ID NOTE The monitor will shut off automatically in 60 seconds after last operation when under User ID selection mode 4 When the monitor is OFF press and hold MEM button to enter User ID selection mode ro 2 The current User ID 14 blinks NS 3 Press MEM button to switch between User 1 and User 2 a CI Te 4 Press SET button to a confirm the selected User ID CI Ne BEFORE YOU START Start Mearsurement BEFORE YOU START v Pair up the Blood Pressure Monitor v Start Mearsurement with Your Device After correctly positioning the cuff and selecting User ID press START STOP button to turn on the monitor and it will complete the measurement process 1 Turn on Bluetooth Smart automatically and the app Make sure both are ON when pair up 1 LCD display 18 is proceeding m Z5 co 2 When the monitor is OFF press and hold the START 18 2 Adjus
2. User manual 5 AC Adaptor Detector a a UEO8WCP 060100SPA a BEFORE YOU START v The Choice of Power Supply 1 Battery powered mode 6VDC 4 AAA alkaline batteries 2 AC adaptor powered mode 100 240V 50 60HZ 400mA Can be supplied by AC adaptor model UEO8WCP 060100SPA only Please unplug the adaptor to depart from the p 4 using utility power CAUTION In order to achieve the best performance and protect you monitor please use the authorized specified battery and power adaptor v Installing and Replacing the Batteries 1 Open the battery door 2 Insert the batteries according to the polarity indications 3 Close the battery door Battery Life Approx 44 days Battery capacity 600 mAH If measured three times per day each measurement takes 35s measuring result display takes 20s and data transmission takes 10s The current for measurement is 400 mA and that for records display and data transmission is 50 mA and 50 mA separately while the current when shutdown is 35 uA Replace the batteries under following circumstances i displays on the LCD The LCD display dims e When powering on the monitor the LCD doesn t light up CAUTION e Remove batteries if the device is not likely to be used for some time e Worn batteries are harmful to the environment Do not dispose with daily garbage e Remove the old batteries from the device following your local recy
3. 00 240V 50 60Hz 400mA Output 6V 1A Expected Service Life 50 000 Hours v Contact Information For more information about our products please visit BodyGauge Postbus 654 3720 AR Bilthoven The Netherlands Tel 31 858769819 email info bodygauge eu Manufactured by GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO LTD Company GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO LTD Address Zone A 5 F Investment Building No 12 Huizhan East Rd Torch Development District Zhongshan Guangdong 528437 China Authorized European Representative Company MDSS Medical Device Safety Service GmbH Address Schiffgraben 41 30175 Hannover Germany v Complied European Standards List Risk Management EN ISO 14971 2007 Labeling EN 980 2008 User Manual EN 1041 2008 Generl Requirements EN 60601 1 2006 A1 2012 for Safety EN 62304 2006 AC 2008 EN 60601 1 6 2010 EN 60601 1 11 2010 Non invasive EN 1060 1 1995 A2 2009 Sphygmomanometers Carera EN 1060 3 1997 A2 2009 Requirements EN 1060 4 2004 Electromagnetic EN 60601 1 2 2007 AC 2010 Compatibility 20 v EMC Guidance Table 1 Guidance and manufacturer s declaration electromagnetic emissions for all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic emission The TMB 1018 BT is intended for use in the electromagnetic environment specified below The customer of the user of the TMB 1018 BT should ass
4. 018 BT The monitor features blood pressure measurement pulse rate measurement and auto save the result The design provides you with two years of reliable service Reading taken by the TMB 1018 BT are equivalent to those obtained by a trained observer using the cuff and stethoscope auscultation method This manual contains important safety and care information and provides step by step instruction for using the product Read the manual thoroughly before using the product Features e 141mm x 36mm Blue LCD display with white backlight e Up to 60 pieces of record stored for each user e Measure during inflating Technology Bluetooth Smart data transmitting function v Indications For Use The BodyGauge 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 8 7 12 6 inches It is intended for adult indoor use only v Measurement 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 int
5. 3 5 2009 and ISO 10993 10 2010 It will not cause any potential alergic reaction or contact injury Please make sure the unit functions safely and it is in proper working conditions before use INTRODUCTION INTRODUCTION ne See Signa v Monitor Components f 1 SYS mmHg E DIA mmHg x Puli A aD 00 ae gt Sp aon gt D 0D 4 ae 910 0 0 00 00 eZ oT D P o GD LAST 3 AVG m2 0 SYS Systolic Blood Pressure High blood pressure ine CF 37 wi bd a yi D IA Diastolic Blood Pressure Low blood pressure DC POWER SOCKET Pulimin Puls Beat minute I ILI ud SET UP BUTTON START STOP BUTTON MEM DOWN BUTTON D measuring result automatically 1 a User 1 Start measurement for user 1 and transmit the a Start measurement for user 2 and transmit the 2 User 2 measuring result automatically Memory Review Mode The query log and a few memories Successful Bluetooth x Smart Connection Bluetooth Smart is turned on a aia Average Value Average value of last three measurements Error The monitor detects error List Low Battery Low battery and please replace the batteries TOGOA ie WOM 2 Cuff 3 4 AAA alkaline batteries TMB 1018 BT See Unit Measurement unit of blood pressure Current Time Month Day Hour Minute Irregular Heartbeat Detects i eee 4
6. Mistakes and changes are reserved BodyGauge is a registered trademark C 0123 Bluetooth SMART BodyGauge Postbus 654 3720 AR Bilthoven The Netherlands Tel 31 858769819 email info bodygauge eu GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO LTD e EE A 5 F Investment Building No 12 Huizhan East Rd Torch Development District Zhongshan Guangdong 528437 China MDSS Medical Device Safety Service GmbH Schiffgraben 41 30175 Hannover Germany Version 1 0 a5nvpaqdoag GJ D BODYGAUGE User Manual Blood Pressure Monitor TMB 1018 BT Arm Type 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 This blood pressure monitor could also easily be used seperately All functions will be available without the usage of a Bluetooth Smart device with BodyGauge app isn t necessary Bluetooth SMART TABLE OF CONTENTS Table of Contents INTRODUCTION twos cetcoct ates sedate ENE E AEE ences teens EE e eet 2 e General Description e Indications For Use e Measurement Principle e Safety Information e LCD Display Signal e Monitor Components BEFORE VOW SIAR 255462 eet anes dg hoses eee ct eae Gane enbee ee eeueisdat ceed 6 e The Choise of Power Supply e Installing and Rep
7. Records 1 When under data enquiry mode press and hold both MEM button and SET button for 3 seconds to clear memory The LCD will display AEL dOnE indicating that the memory is cleared 12 DIA mmHg Pulimin Z IC DJ q x SYS nmns DIA wn ud oc No Record found for User 2 JIC t GCL m Cox Lx Data Management v Data Transmission Automatic Data Transmission With the advanced Bluetooth Smart technology applied the mobile or portable equipments which are equipped with Bluetooth Smart function in line with BLE Technical Specifications as well as BLP Protocol established by global organization App and Bluetooth SIG are capable to receive your personal health data When both BodyGauge App and Bluetooth Smart are ON TMB 1018 BT will automatically transmit measurement data to your mobile via Bluetooth Smart 1 After measurement the symbol lights 12 SYS mms DIA mmng Pulimin up indicating the measuring result is being imu CI 74 automatically transmitted to BodyGauge app 4 0 oe ere 16 2 f SUCCEED the LCD will display dOnE 30 3 If FAIL the LCD will display ERROR CAUTION Interference may occur in the vicinity of equipment marked with the following symbol a And TMB 1018 BT may interfering vicinity electrical equipment Sensitive people i
8. cling guidelines v Apply the Cuff 1 Insert the plug of cuffs air pipe into the interface located on the right side of the monitor 2 As pictured on the right wear the cuff on your upper arm 3 Tighten the cuff up Make sure the cuff is fixed 2 to 3 centimeters above your elbow Appropriate to insert one finger when the cuff is tightened around your upper arm 4 Correct Posture Bare your arm or wear tights only when starting measurement Sit comfortably and relaxed on a proper size chair The central of the cuff should maintain at the same level as your heart Legs relaxed with the feet falling outwards Palms up BEFORE YOU START BEFORE YOU START Y Settings Please proceed to time setting before your initial use so as to ensure each piece of record is labeled with a time stamp The range of the year is 2000 to 2050 Time Format 24 Hours NOTE The monitor will shut off automatically in 60 seconds after last operation when in Setting Interface 4 When the monitor is OFF press and hold SET button to enter HOUR and MINUTE setting 2 Press MEM button to oe x change the numeral Each press will increase the numeral by one ina c cycling manner HOUR 3 Press SET button to confirm the HOUR and MINUTE Then the monitor diverts to MONTH and DAY q setting automatically MINUTE taf qv a z gaa 5 oun I cp e gt 1
9. de Measurement mode Measurement range Accuracy Working condition Storage amp transportation condition Measurement perimeter of the upper arm Net Weight External dimensions Attachment Mode of operation Degree of protection Device Classification IP Classification Software Version WARNING No modification of this equipment is allowed SPECIFICATIONS Battery Powered Mode 6V 4 x AAA size alkaline battery AC Adaptor Powered Mode 100 240 V 50 60 Hz 400 Ma Can be supplied by AC adaptor model UEO8WCP 060100SPA only Blue LCD with White Backlight V A 141mm L x 36mm W Oscillographic testing mode Pressure 0 40kpa 0 300mmHg pulse value 40 199 times minute Pressure 15C 25 C within 0 4 kPa 3 mm Hg 10C 40C out of 15 C 25C within 0 7 kPa 5 mm Hg Pulse Value 5 Temperature 10 C 40 C Relative Humidity 15 90 RH Atmospheric Pressure 80 105 kPa Temperature 20 C 60 C Relative Humidity 10 93 RH Atmospheric Pressure 50 106 kPa About 22cm 32cm Approx 340g Excluding the dry cells Approx 180 100 40mm 4 AAA alkaline batteries user manual Continuous operation Type BF applied part Battery Powered Mode Internally Powered ME Equipment AC Adaptor Powered Mode Class I ME Equipment IP22 V01 AUTHORIZED COPMONENT v The Matched Components 1 Please use the BodyGauge 2 Storage bag authorized adaptor E m Adaptor Type UE08WCP 060100SPA Input 1
10. e slightly damp cloth to remove the dirt Avoid washing the cuff Cleaning Before Use Pick out the whole unit of the storage bag Use the soft cloth to remove the dirt on the monitor and apply some alcohol to disinfect the cuff before tying the cuff After Use Use the soft cloth to wipe the unit and apply some alcohol to disinfect the cuff before putting the whole unit back in the bag Please always disinfect the cuff before applying to another patient Please follow the instructinos for correct replacement of interchangeable or detachable parts specified by BodyGauge as replaceable Disposal Degraded sensors may result in inaccurate measurement while loosened electrodes may cause the monitor s failure to power on The expected life of the monitor is two years Please dispose of ACCESSORIES detachable parts and the ME EQUIP MENT according to the local guidelines 15 ABOUT BLOOD PRESSURE v What are systolic pressure and diastolic pressure When ventricles contract and pump blood out of the heart the blood pressure reaches its maximum value in the cycle which is called systolic pressure When the ventricles relax the blood pressure reaches its minimum value in the cycle which is called diastolic pressure Diastolic blood entering vein Systolic blood discharging artery v What is the standard blood pressure classification The blood pressure classification published by World Health O
11. ears 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 16 ABOUT BLOOD PRESSURE v Why my blood pressure IS varies even in one day 1 Individual blood pressure varies every in one day it also affected by the way you tie your cuff and the your measurement position so please take the measurement at the same condition 2 The varies of the pressure is greater if the person take medicine 3 Waiting at least 4 5 minutes for another measurement Why the blood pressure The attention need to pay I get from the hospital is when you measure you 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 upperarm If you feel anxious pressured You had better take deep breath 2 3 times before beginning different from home The blood pressure is different even during24hourbecauseofthe weather emotion exercise etc specially the white coat in hospital which makes the results are higher than the ones at home Advice adjust yourself for 4 5 minutes until you calm down v If the result is the same if measuring onthe right arm It is ok for both arms but there will be some different results for different arm so suggest you measure the same arm every time TROUBLESHOOTING No power Low batteries Er
12. erval 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 over INTRODUCTION v Safety Information The below signs might be in the user manual labeling or other component they are the requirement of standard and using Symbol for THE OPERATION Symbol for TYPE BF APPLIED GUIDE MUST BE READ PARTS 7 Symbol for ENVIRONMENT C 0123 Symbol for COMPLIES WITH PROTECTION Waste electrical MDD93 42 EEC products should not be disposed of REQUIREMENTS with household waste Please follow local guidelines gsi Symbol for MANUFACTURER for DIRECT CURRENT Symbol for SERIAL NUMBER Ec rer Symbol for Authorised Representa SN y tive in the European Community cy For indoor use only m for Class Il Equipment Bluetoot The Bluetooth Smart Mark Ft riazsov 3 6 10CCC Symbol for MANUFACTURE DATE CAUTION Please do read this user manual carefully and thoroughly before use This device is intended for adult use in the home domestic only This device is intended for non invasive measuring and monitoring of arterial blood pressure It is not intended for use on extremities other than the upper arm or for functions other than obtaining a blood pressure measurement Do not confuse self monitoring with self diagnosis This unit allows
13. lacing the Batteries Data Transmission via Bluetooth Smart Apply the Cuff Settings Select User ID Pair up the Blood Pressure Monitor with Your Device START MEASUREMENT ican ns eeee eed Ekt Ere Er da eee ose Shaheed eee E 11 e Start Measurement DATA MANAGEMENT 000 cece cece eee e eee e eee beeen been nee nnes 12 e Recall the Records e Delete the Records e Data Transmission INFORMATION FOR USER c2teveuscetensce ona ahvemeneennaeewetee en ees a EKER R E 14 e Tips for Measurement e Maintenance ABOUT BLOOD PRESSURE satir ere a EPa EAEE EAER Ee Ra anne ePowscerenadepesnetes 16 e What are systolic pressure and diastolic pressure e What is the standard blood pressure classification e Why does my blood pressure fluctuate throughout the day e Why the blood pressure get from the hospital is different from home e The result is different that you measuring on the different arm TROUBLESHOOTING s 12 24 austas cute ce oheetedtaes nfetes epee cnatesesosuserassue le SPECIFICATIONS sepcaceetacameheacy ese shuns nace nesent heer he leesteaeusyeaseaues 19 AUTHORIZED COPMONENT sorse inersersrisi Gane gb Si cote acnrde eda dts andi Eae a Eaa 20 COMPLIED EUROPEAN STANDARDS LIST 2c c0ccoueeeeadueestuseteneced tucee eee 20 EMC GUDIANCE ctcseuesaceredaary ecetehteseececetesenevesneneeaceedeiseatas 21 INTRODUCTION v General Description Thank you for selecting BodyGauge arm type Blood Pressure Monitor TMB 1
14. ld transient burst power supply lines power supply lines be that of a typical IEC 61000 4 4 commercial or hospital environment Surge IEC 1 kV line s 1 kV Mains power quality should 61000 4 5 to line s differential mode be that of a typical commercial or hospital environment Voltage dips lt 5 Ut lt 5 Ut Mains power quality should short interruptions gt 95 dip in UT gt 95 dip in Uy be that of a typical and voltage for 0 5 cycle for 0 5 cycle commercial or hospital variations on 40 U7 40 U7 environment If the user of power supply 60 dip in Ur 60 dip in Ur TMB 1018 BT requires input lines for 5 cycles for 5 cycles Conine operator caning IEC 61000 4 11 power mains interruptions 70 UT 70 UT it is recommended that 30 dip in UT 30 dip in UT TMB 1018 BT be powered for 25 cycles for 25 cycles from an interruptible power lt 5 Ut lt 5 Ur supply or a battery gt 95 dip in UT gt 95 dip in UT for 5 sec for 5 sec Power frequency 3A m Power frequency magnetic 50Hz magnetic fields should be at levels field characteristic of a typical IEC 61000 4 8 location in a typical commercial or hospital environment NOTE Ur is the a c mains voltage prior to application of the test level Table 4 Guidance and manufacturer s declaration electromagnetic immunity for ME EQUIPMENT and ME SYSTEMS that are not LIFE SUPPORTING Guidance and manufacture s declaration electromagnetic immunit
15. ncluding pregnant women and those who implanted medical elec tronic 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 Smart end at 2 4 GHz How to mitigate possible interference 1 The range between the device and Bluetooth Smart end should be reasonably close 1 10 meter Please ensure no obstacles between device and Bluetooth Smart end so as to obtain quality connection and to lower the RF output range 2 To avoid interference other electronic devices particularly those with wireless transmission Transmitter should be kept at least 1 meter away from the monitor 13 INFORMATION FOR USER v Tips for Measurement It can cause inaccuracy if the measurement is taken in the following circumstances xX Immediate measurement after tea coffe smoking Within 20 minutes X after taking a bath In a very cold eae 4 When you want to discharge urine 14 v Maintenance To obtain the best performance please follow below instructions Put in a dry place 4 nd Avoid immersing it in the water avoid the sunshine Clean it with a dry cloth in case Avoid dusty environment and Avoid shaking and collision unstable temperature surrounding Use th
16. put Separation distance according to frequency of transmitter m power of transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 167 p d 1 167 p d 2 333 p 0 233 0 738 100 11 67 11 67 23 33 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be determined 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 4 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 29
17. rganization WHO and International Society of Hypertension ISH in 1999 is as follows CAUTION Only a physician can tell your normal BP range Please contact a physician if your measuring result falls out of the range Kindly note that only a physician could tell whether your blood pressure value has reached a dangerous point Grade 3 hypertension severe S 110 100 mH Grade 2 hypertension moderate Grade 1 hypertension mild Subgroup borderline High normal Blood Pressure Normal Blood Pressure Diastolic blood pressure Optimal Blood Pressure 120 130 140 150 160 180 Systolic blood pressure mmHg Optimal Normal High normal Mild Moderate Severe Pressure mm Hg SYS lt 120 120 129 130 139 140 159 160 179 2180 DIA lt 80 80 84 85 89 90 99 100 109 2110 v Irregular Heartbeat Detector This Blood Pressure Monitor is equipped with an intelligent function of Irregular Heartbeat IHB Detector 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 this equipment will light up the IHB symbol on the screen when displaying the measuring result CAUTION The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heartbeat was detected during measurement Usually this is NOT a cause for concern However if the symbol app
18. ror massage Display is dim or will not light up to the display E 1 shows E 2 shows E 3 shows E 10 or E 11 shows E 20 or E 21 shows Eexx shows on the display Batteries are exhausted Batteries are inserted incorrectly Batteries are low Data Communication Failure The cuff is very tight The pressure of the cuff is excess The monitor detected motion while measuring Measure incorrectly A calibration error occurred Data Transmission Failure Bluetooth Smart is OFF The device is too far away from your mobile Replace with new batteries Insert the batteries correctly Replace with new batteries Please check below items 1 Bluetooth Smart is ON 2 Both devices are within the transmission distance of Bluetooth Smart Refasten the cuff and then measure again Relax for a moment and then measure again movement can affect the measurement Relax for a moment and then measure again Relax for a moment and then measure again Retake the measurement If the problem persists contact the retailer or our customer service department for further assistance Refer to the warranty for contact information and return instructions Press and hold START STOP button to start manual data transmission Turn ON Bluetooth Smart and try again Keep the distance of Blood Pressure Monitor and the mobile within 2 to 3 meters Power supply Display mo
19. rs such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broad cast 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 TMB 1018 BT is usedexceeds the applicable RF compliance level above the TMB 1018 BT should be observed to verify normal operation If abnormal performance is observed additional measuresmay be necessary such as re orienting or relocating the TMB 1018 BT Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3V m 24 Table 6 Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM for ME EQUIPMENT or ME SYSTEM that are not LIFE SUPPORTING Recommended separation distances between portable and mobile RF communications equipment at the TMB 1018 BT The TMB 1018 BT is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the TMB 1018 BT can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmittters and the TMB 1018 BT as recommended below according to the maximum output power of the communications equipment Rated maximum out
20. t to zero automatically l button to start pair up The 16 ag symbol yp blinks ep S a indicating pair up is C is 10 08 proceeding 3 Inflating and measuring automatically E Eo SYS yina DIA mmn Pumin If SUCCEED symbols maa ee UE C A ia will be shown on the LCD 1 D DD og just like the picture on the ooo dB RE right 4 Display and save the results will ie W oai Da E Pa automatically transmitted to the app m Y 7 a 93 If FAIL symbols will be shown on x l The icon XR blinks TED mc i a the LCD just like the picture on the ee right 5 Press START STOP button to turn off the monitor Otherwise the monitor will shut off within 1 minute after last operation 3 The monitor will shut off automatically after Pair up process is complete Tips A when finish the whole measurement press another button Then the blood monitor will begin measuring again B Maximum 60 records are both for user 1 and user 2 10 11 Data Management v Recall the Records 1 When the monitor is OFF press MEM button to retrieve the memory The monitor will display the average value of last three measurements 2 Press MEM button again to rotate the records Up to 60 records will be stored under each user ID The measurement date and time will be displayed alternatively 3 If you would like to check another user ID s history please follow the instructions in Select User ID to change to another User ID first v Delete the
21. ure that it is used in such anenvironment Emission test Compliance Electromagnetic environment guidance The TMB 1018 BT uses RF energy only RF emissions nee for its internal function Therefore its RF CISPR 11 up emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emission CISPR 11 Class B The TMB 1018 BT is suitable for use in all establishments other than domestic and Harmonic emissions those directly connected to the public IEC 61000 3 2 Not applicable low voltage power supply network that supplies buildings used for domestic Voltage fluctuations Purposes flicker emissions IEC Not applicable 61000 3 3 21 Table 2 Guidance and manufacturer s declaration electromagnetic immunity for all ME EQUIPMENT and ME SYSTEMS Guidance and manufacture s declaration electromagnetic immunity The TMB 1018 BT is intended for use in the electromagnetic environment specified below The customer of the user of the TMB 1018 BT should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic 6 kV contact 6 kV contact Floors should be wood discharge ESD 8 kV air 8 kV air concrete or ceramic tile If IEC 61000 4 2 floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast 2 kV for 2kV for Mains power quality shou
22. y The TMB 1018 BT is intended for use in the electromagnetic environment specified below The customer of the user of the TMB 1018 BT should assure that it is used in such an environment Immunity test IEC 60601 Compliance Electromagnetic environment test level level guidance Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHZ to 2 5 GHz Portable and mobile RF communications equipment should be used no closer to any part of the TMB 1018 BT including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 167 J P d 1 167 P 80 MHz to 800 MHz d 2 333 p 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacture and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Co At 80 MHz and 800 MHz the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitte
23. you to monitor your blood pressure Please start or end medical treatment basing solely on physician s treatment advice If you are taking medication consult your physician to determine the most appropriate time for your measurement Never change a prescribed medication without your physician s consent This unit is not suitable for continuous monitoring during medical emergencies or operations If the pressure of the cuff exceeds 40 kPa 300 mmHg the unit will automatically deflate Should the cuff not deflate when its pressure exceeds 40 kPa 300 mmHg detach the cuff from the upper arm and press the homologous button to stop inflation Do not use the monitor under the conditions of strong electromagnetic field e g mobile that radiates interference signal or electrical fast transient burst signal especially when the AC adaptor is applied Do not touch the output of AC adapter and the patient simultaneously The device is not AP APG equipment It is not suitable for use in the presence of a flammable anesthetic mixture with air or oxygen nitrous oxide Please keep the unit out of reach of infants or children since inhalation or swallowing of small parts is dangerous or even fatal Please use ACCESSORIES and detachable parts specified authorised by MANUFACTURER Otherwise it may cause damage to the unit or danger to the user patient The materials of the cuff have been tested and found to comply with requirements of ISO 1099

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