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COMPLIED STANDARDS LIST

COMPLIED STANDARDS LIST

Complied Standards List

EN 60601-1:2006+A1:2013/ IEC 60601-1:2005+A1:2012 Medical 

electrical equipment - Part 1: General requirements for basic safety 

and essential performance

EN 60601-1-11:2015/ IEC 60601-1-11:2015 Medical electrical 

equipment - Part 1-11: General requirements for basic safety and 

essential performance - Collateral standard: Requirements for 

medical electrical equipment and medical electrical systems used in 

the home healthcare environment

EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical 

equipment - Part 1-2: General requirements for basic safety and 

essential performance - Collateral standard: Electromagnetic 

disturbances - Requirements and tests

Risk management

Labeling

User manual

General Requirements 

for Safety

Electromagnetic

compatibility

EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 

1: Requirements and test methods for non-automated measurement 

type

Performance

requirements

EN ISO 14971:2012 / ISO 14971:2007 Medical devices - 

Application of risk management to medical devices

EN 1041:2008 +A1:2013 Information supplied by the 

manufacturer of medical devices

EN ISO 15223-1:2016 / ISO 15223-1:2016  Medical devices. 

Symbols to be used with medical device labels, labelling and 

information to be supplied. Part 1 : General requirements

EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers - 

Part 3: Supplementary requirements for electro-mechanical blood 

pressure measuring systems

EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test 

procedures to determine the overall system accuracy of automated 

non-invasive sphygmomanometers

EN 60601-1-6:2010+A1:2015/IEC 60601-1-6:2010+A1:2013 

Medical electrical equipment - Part 1-6: General requirements for 

basic safety and essential performance - Collateral standard: 

Usability

IEC 62366-1:2015 Medical devices - Part 1: Application of 

usability engineering to medical devices

EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015   Medical 

device software - Software life-cycle processes

Clinical investigation

Usability

Software life-cycle 

processes

Bio-compatibility

ISO 10993-1:2009 Biological evaluation of medical devices- 

Part 1: Evaluation and testing within a risk management process

ISO 10993-5:2009 Biological evaluation of medical devices - 

Part 5: Tests for in vitro cytotoxicity

ISO 10993-10:2010 Biological evaluation of medical devices - 

Part 10: Tests for irritation and skin sensitization

IEC 80601-2-30:2009+A1:2013 Medical electrical equipment- 

Part 2-30: Particular requirements for the basic safety and 

essential performance of automated non-invasive 

sphygmomanometers

ISO 81060-2:2013  Non-invasive sphygmomanometers - Part 2: 

Clinical validation of automated measurement type

Содержание Medel Soft TMB-1581-S

Страница 1: ...Co Ltd Zone A No 105 Dongli Road Torch Development District Zhongshan 528437 Guangdong China To use the monitor correctly and safely please read the manual thoroughly Thank you very much for selectin...

Страница 2: ...tenance ABOUT BLOOD PRESSURE 26 What are systolic pressure and diastolic pressure What is the standard blood pressure classification Irregular heartbeat detector Why does my blood pressure fluctuate t...

Страница 3: ...rement pulse rate measurement and the result storage The design provides you with two years of reliable service Readings taken by the TMB 1581 S are equivalent to those obtained by a trained observer...

Страница 4: ...d 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 in...

Страница 5: ...ore and after use Don t use any abrasive or volatile cleaners The device doesn t need to be calibrated within two years of reliable service Warning Do not apply the cuff over a wound otherwise it can...

Страница 6: ...s and their base stations walkie talkies can affect this equipment and should be kept at least a distance d away from the equipment The distance d is calculated by the MANUFACTURER from the 80 MHz to...

Страница 7: ...ar Hour Minute Heartbeat Blood pressure monitor is detecting an irregular heartbeat during measurement Blood pressure level indicator Indicate the blood pressure level Blood pressure monitor is detect...

Страница 8: ...A 2 Air Pipe 3 Pump 4 Valve 5 Cuff List 1 Wrist Blood Pressure Monitor TMB 1581 S 2 2 AAA batteries 3 User manual Slide off the battery cover Install the batteries by matching the correct polarity as...

Страница 9: ...mful to the environment Do not dispose with daily garbage Remove the old batteries from the device following your local recycling guidelines Setting Date Time and Measurement Unit It is important to s...

Страница 10: ...lection and it will turn to the next step 4 Repeat step 2 and 3 to confirm MONTH and DAY 5 6 Repeat step 2 and 3 to confirm HOUR and MINUTE Repeat step 2 and 3 to confirm the MEASUREMENT UNIT After co...

Страница 11: ...measurement please sit comfortably with legs uncrossed feet flat on the floor back and wrist supported Rest for 5 minutes before measuring Wait at least 3 minutes between measurements This allows you...

Страница 12: ...it will display the next record and so on During the process of displaying the results if there is no operation the blood pressure monitor will turn off in one minute Or you can press START STOP butt...

Страница 13: ...the right display will be shown Note To exit out of delete mode without deleting any records press START STOP button before pressing MEM to confirm any delete commands 1 2 Press MEM to confirm deletin...

Страница 14: ...a very cold environment When you want to discharge urine Maintenance To obtain the best performance please follow the instructions below INFORMATION FOR USER INFORMATION FOR USER TROUBLESHOOTING Avoi...

Страница 15: ...n the heart relaxes between heartbeats the lowest blood pressure is diastolic pressure Irregular Heartbeat Detector CAUTION The appearance of the IHB icon indicates that a pulse irregularity consisten...

Страница 16: ...s but there will be some different results for different people We suggest you measure the same wrist every time The cuff is not secure Refasten the cuff and then measure again This section includes a...

Страница 17: ...0 C within 3mmHg 0 4kPa Pulse value 5 Rated cuff pressure 0mmHg 299mmHg 0kPa 39 9kPa Measurement pressure SYS 60mmHg 230mmHg 8 0kPa 30 7kPa DIA 40mmHg 130mmHg 5 3kPa 17 3kPa Pulse value 40 199 beat mi...

Страница 18: ...ectronics Co Ltd SPECIFICATIONS CONTACT INFORMATION A01 Internally Powered ME Equipment IP22 The first number 2 Protected against solid foreign objects of 12 5mm and greater The second number Protecte...

Страница 19: ...labelling and information to be supplied Part 1 General requirements EN 1060 3 1997 A2 2009 Non invasive sphygmomanometers Part 3 Supplementary requirements for electro mechanical blood pressure measu...

Страница 20: ...eased electromagnetic immunity of this equipment and result in improper operation Warning Portable RF communications equipment including peripherals such as antenna cables and external antennas should...

Страница 21: ...4 11 Electrical fast transient burst IEC 61000 4 4 Surge IEC61000 4 5 IEC 60601 1 2 Test level 2 kV 4kV 8 kV 15 kV air Not application Not application Not application Not application Not application N...

Страница 22: ...odulation b 18Hz 1 8 450 430 470 GMRS 460 FRS 460 FM c 5kHz deviation 1kHz sine 2 0 3 28 710 704 787 745 780 LTE Band 13 17 Pulse modulation b 217Hz 0 2 0 3 9 810 870 930 800 960 GSM 800 900 TETRA 800...

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