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EMC GUIDANCE

Complied Standards List

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 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

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

Requirements and test methods for non-automated measurement type

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

Risk management

Labeling

User manual

General Requirements 
for Safety

Electromagnetic
compatibility

Performance
requirements

Clinical investigation

Usability

Software life-cycle 
processes

Bio-compatibility

ISO 10993-1:2018 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

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

IEC 80601-2-30:2018 Medical electrical equipment- Part 

2-30: Particular requirements for the basic safety and essential 
performance of automated non-invasive sphygmomanometers

ISO 81060-2:2018  Non-invasive sphygmomanometers - Part 2: 

Clinical validation of intermittent automated measurement type

EMC Guidance

The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments

Warning

Don’t near active HF surgical equipment and the RF shielded room of an ME system for magnetic 

resonance imaging, where the intensity of EM disturbances is high.

Warning

 Use of this equipment adjacent to or stacked with other equipment should be avoided because it 

could result in improper operation.  If such use is necessary, this equipment and the other equipment should be 
observed to verify that they are operating normally.

Warning: Use of accessories, transducers and cables other than those specified or provided by the 
manufacturer of this equipment could result in increased electromagnetic emissions or decreased 
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 be used no closer than 30 cm (12 inches) to any part of the equipment TMB-2079, including   
cables   specified   by   the   manufacturer.   Otherwise, degradation of the performance of this equipment could 
result.

Technical description

1

all necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to 

electromagnetic disturbances for the excepted service life.

2

Guidance and manufacturer’s declaration -electromagnetic emissions and Immunity

Table 1 

Guidance and manufacturer’s declaration - electromagnetic emissions

RF emissions 

CISPR 11

Group 1 

Class [ B ]

Class A

Comply

Compliance

Harmonic emissions 

IEC 61000-3-2

Voltage fluctuations/ 

flicker emissions  

IEC 61000-3-3  

RF emissions 

CISPR 11

Emissions test

COMPLIED STANDARDS LIST

32

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Содержание TMB-2079

Страница 1: ...079 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 version 1 0 Guangdo...

Страница 2: ...ENT 20 Recall the Records Delete the Records INFORMATION FOR USER 24 Tips for measurement Maintenances ABOUT BLOOD PRESSURE 26 What are systolic pressure and diastolic pressure What is the standard bl...

Страница 3: ...e 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...

Страница 4: ...t in prolonged impairment of patient blood circulation When measurement please avoid compression or restriction of the connection tubing CAUTION The device cannot be used with HF surgical equipment at...

Страница 5: ...ce 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 st...

Страница 6: ...T 5V 1A Do not use new and used batteries together Do not use different types of batteries together Do not dispose the batteries in fire Batteries may explode or leak Remove batteries if the device is...

Страница 7: ...p can be assigned to each record that is stored in the memory The setting range of the year 2020 2099 time format 24H 1 When the monitor is off Long press MEM button it will display the time Then pres...

Страница 8: ...USER button will decrease time 3 After the trends start time and end time are set the LCD will disply do nE and then it will turn off Select the User ID Before you start the measurement please select...

Страница 9: ...our test information Search your test information BEFORE YOU START BEFORE YOU START Install the App and Pair Up Download the MedM Health app from APP Store or Google Play Install the APP and register...

Страница 10: ...time on the same arm or as directed by a physician 6 Take the measurement in a silent room The cuff should maintain at the same level as the right atrium of the heart Please sit comfortably Do not cro...

Страница 11: ...data for the desired user Take User 1 for example Install the APP and register an account Then set your personal information Gender Birthday Height Weight Name and so on N 5 Press the START STOP butto...

Страница 12: ...ecall the Records 3 Then show the latest measurement records you can press the MEM or SET button to get the record you want The current No is No 2 The corresponding time is A M 06 00 The corresponding...

Страница 13: ...h dE LE YES the display will show dE LE YES User ID 3 Press START STOP button to confrim deleting the LCD will display do nE and then turn off If you did not get the correct measurement you can delete...

Страница 14: ...he reusable cuff with water and never immerse the cuff in water Tips for Measurement Within 1 hour after dinner or drinking Within 20 minutes after taking a bath In a very cold environment Immediate m...

Страница 15: ...andard blood pressure classification Irregular Heartbeat Detector CAUTION The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heart beat was detected during...

Страница 16: ...en measure again Warning message Relax for a moment Refasten the cuff and then measure again If the problem persists contact your physician OUT shows Out of measurement range TROUBLE SHOOTING SPECIFIC...

Страница 17: ...d 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 residen...

Страница 18: ...edical devices Part 10 Tests for irritation and skin sensitization EN ISO 15223 1 2016 ISO 15223 1 2016 Medical devices Symbols to be used with medical device labels labelling and information to be su...

Страница 19: ...differential mode 0 5 kV 1 kV 2 kV common mode Conduced RF IEC61000 4 6 3 V 0 15 MHz 80 MHz 6 V in ISM and amateur radio bands between 0 15 MHz and 80 MHz 80 AM at 1 kHz 3 V 0 15 MHz 80 MHz 6 V in ISM...

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