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Standard compliance

Product development was carried out in accordance with the Medical Device Regulation (EU) 2017/745, All relevant standards listed in the table below were also met.

Standard compliance
Reference numberDescription
EN 60601-1:2006 + A1:2013 + A12:2014 + A2:2021Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN 60601-1- 2:2015+A1:2021Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
EN 62304:2006/ A1:2015Medical device software - Software life-cycle processes
EN ISO 15223-1:2021Symbols for use in the labelling of medical devices
EN 303 446-1:2017Electromagnetic Compatibility (EMC) standard for combined and/or integrated radio and non-radio equipment; Part 1: Specific conditions for equipment in residential locations.
EN ISO 14971:2019+A1:2021Medical devices – Application of risk management to medical devices
13485:2016/A11:2021Medical devices – Quality management systems – Requirements for regulatory purposes
EN 301 489-17ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 17: Specific conditions for Broadband Data Transmission Systems; Harmonised Standard for ElectroMagnetic Compatibility
EN 301 489-3 V2.3.2ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 3: Specific conditions for Short Range Devices (SRD) operating on frequencies between 9 kHz and 246 GHz; Harmonised Standard for ElectroMagnetic Compatibility

13.1 MANUFACTURER DECLARATION ON EMC

The MESI mTABLET is intended for use in the electromagnetic environment specified below. The customer or the user of the above models should ensure that they are used in such environment.

MANUFACTURER DECLARATION ON EMC
Emissions TestComplianceElectromagnetic Environment - Guidance
RF emissions CISPR 11Group 1The models listed above use RF energy only for their internal function. Therefore, their RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF Emissions CISPR 11Class BThe models listed above use RF energy only for their internal function. Therefore, their RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
Harmonic emissions IEC 61000-3-2N/AThe models listed above use RF energy only for their internal function. Therefore, their RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
Voltage fluctuations / flicker emissions IEC 61000-3-3CompliesThe models listed above use RF energy only for their internal function. Therefore, their RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

The MESI mTABLET is intended for use in the electromagnetic environment specified below. The customer or the user of the above models should assure that they are used in such environment.

Enclosure Port

Enclosure Port
Immunity TestTest ConditionIEC 60601 Compliance LevelElectromagnetic environment – guidance
Electrostatic discharge (ESD) IEC 61000- 4-2± 8 kV contact ± 2,4,8,15 kV air±8 kV contact ± 15 kV airFloors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-33 V/m 80 MHz – 2.7 GHz 80% AM 1kHz3 V/m 80 MHz – 2.7 GHzThe mains power quality should be that of a professional healthcare facility environment and home healthcare environment.
Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3385 MHz (18 Hz Pulse Modulation)27 V/mThe mains power quality should be that of a professional healthcare facility environment and home healthcare environment.
Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3450 MHz (FM+/–5 KHz deviation 1 kHz sine or 18 Hz pulse modulation)28 V/mThe mains power quality should be that of a professional healthcare facility environment and home healthcare environment.
Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3710 MHz (217 Hz PM)9 V/mThe mains power quality should be that of a professional healthcare facility environment and home healthcare environment.
Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3745 MHz (217 Hz PM)9 V/mThe mains power quality should be that of a professional healthcare facility environment and home healthcare environment.
Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3780 MHz (217 Hz PM)9 V/mThe mains power quality should be that of a professional healthcare facility environment and home healthcare environment.
Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3810 MHz (18 Hz PM)28 V/mThe mains power quality should be that of a professional healthcare facility environment and home healthcare environment.
Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3870 MHz (18 Hz PM)28 V/mThe mains power quality should be that of a professional healthcare facility environment and home healthcare environment.
Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3930 MHz (18 Hz PM)28 V/mThe mains power quality should be that of a professional healthcare facility environment and home healthcare environment.
Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-31720 MHz (217 Hz PM)28 V/mThe mains power quality should be that of a professional healthcare facility environment and home healthcare environment.
Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-31845 MHz (217 Hz PM)28 V/mThe mains power quality should be that of a professional healthcare facility environment and home healthcare environment.
Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-31970 MHz (217 Hz PM)28 V/mThe mains power quality should be that of a professional healthcare facility environment and home healthcare environment.
Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-32450 MHz (217 Hz PM)28 V/mThe mains power quality should be that of a professional healthcare facility environment and home healthcare environment.
Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-35240 MHz (217 Hz PM)9 V/mThe mains power quality should be that of a professional healthcare facility environment and home healthcare environment.
Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-35500 MHz (217 Hz PM)9 V/mThe mains power quality should be that of a professional healthcare facility environment and home healthcare environment.
Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-35785 MHz (217 Hz PM)9 V/mThe mains power quality should be that of a professional healthcare facility environment and home healthcare environment.
RATED power frequency magnetic fields IEC 61000-4-850 Hz or 60 Hz30 A/mThe power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Proximity magnetic fields IEC 61000-4-3930 kHz (CW) (a)8 A/ma) This test is applicable only to ME EQUIPMENT and ME SYSTEMS intended for use in the HOME HEALTHCARE ENVIRONMENT. b) The carrier shall be modulated using a 50 % duty cycle square wave signal. c) r.m.s., before modulation is applied.
Proximity magnetic fields IEC 61000-4-39134,2 kHz (2,1 kHz PM)65 A/m (c)a) This test is applicable only to ME EQUIPMENT and ME SYSTEMS intended for use in the HOME HEALTHCARE ENVIRONMENT. b) The carrier shall be modulated using a 50 % duty cycle square wave signal. c) r.m.s., before modulation is applied.
Proximity magnetic fields IEC 61000-4-3913,56 MHz (50 kHz PM)7,5 A/m (c)a) This test is applicable only to ME EQUIPMENT and ME SYSTEMS intended for use in the HOME HEALTHCARE ENVIRONMENT. b) The carrier shall be modulated using a 50 % duty cycle square wave signal. c) r.m.s., before modulation is applied.

The MESI mTABLET is intended for use in the electromagnetic environment specified below. The customer or the user of the above listed models should assure that they are used in such an environment.

Input a.c. power PORT

Input a.c. power PORT
Immunity TestTest ConditionIEC 60601 Compliance LevelElectromagnetic environment – guidance
Electrical fast transient/ bursts IEC 610004-4± 2 kV 100 kHz repetition frequency± 2 kVMains power quality should be that of a professional healthcare facility environment and home healthcare environment.
Surges IEC 61000- 4-5± 0.5 kV, ±1 kV line(s) to line(s) ± 0.5 kV, ±1 kV, ± 2 kV line(s) to ground (a)± 1 kV, differential modeMains power quality should be that of a professional healthcare facility environment and home healthcare environment.
Conducted RF induced by RF fields IEC 61000- 4-63 Vrms 150 kHz – 80 MHz 6 Vrms in ISM bands between 150 kHz – 80 MHz c) 80% AM 1 kHz3 Vrms 150 kHz – 80 MHz 6 Vrms in ISM bands between 150 kHz – 80 MHz c) 80% AM 1 kHzMains power quality should be that of a professional healthcare facility environment and home healthcare environment.
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-110% UT; 0°,45°,90°,135°,180°, 225°,270°,315° 0% UT; 0° 0% UT; 70% 0% UT; 0%0.5 cycles 1 cycle 25/30 cycles (50/60 Hz) 250/300 cycles (50/60 Hz) (5s)Mains power quality should be that of a professional healthcare facility environment and home healthcare environment. If the user of the models listed above requires continued operation during power mains interruptions, it is recommended that the MESI mTABLET is powered from an uninterruptible power supply or battery.

Comment: a) Not applicable to CLASS II ME EQUIPMENT and ME SYSTEMS.

b) The ISM (industrial, scientific and medical) bands between 0.15 MHz and 80 MHz are: 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. The amateur radio bands between 0.15 MHz and 80 MHz are: 1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz, 5.3 MHz to 5.4 MHz, 7 MHz to 7.3 MHz, 10.1 MHz to 10.15 MHz, 14 MHz to 14.2 MHz, 18.07 MHz to 18.17 MHz, 21.0 MHz to 21.4 MHz, 24.89 MHz to 24.99 MHz, 28.0 MHz to 29.7 MHz, and 50.0 MHz to 54.0 MHz.

The MESI mTABLET is intended for use in the electromagnetic environment specified below. The customer or the user of the above listed models should ensure that they are used in such environment.

Signal input/output parts PORT

Signal input/output parts PORT
Immunity TestTest ConditionIEC 60601 Compliance LevelElectromagnetic environment – guidance
Electrostatic discharge (ESD) IEC 61000-4-2± 8 kV contact ± 2,4,8,15 kV air± 8 kV contact ± 15 kV airFloors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient/bursts IEC 610004- 4 (a)± 1 kV 100kHz repetition frequency± 1 kVMains power quality should be that of a professional healthcare facility environment and home healthcare environment.
Conducted RF induced by RF fields IEC 61000-4-6± 2 kV line(s) to groundNot applicable.Mains power quality should be that of a professional healthcare facility environment and home healthcare environment.
Conducted RF induced by RF fields IEC 61000-4- 6 (a)3 Vrms 150 kHz – 80 MHz 6 Vrms in ISM bands between 150 kHz – 80 MHz c) 80% AM 1 kHz3 Vrms 150 kHz – 80MHz 6 Vrms in ISM bands between 150 kHz – 80 MHz c) 80% AM 1 kHzMains power quality should be that of a professional healthcare facility environment and home healthcare environment.

Comment: *Not applicable, unit, without Signal input/output parts PORT

a) SIP/SOPS whose maximum cable length is less than 3 m in length are excluded.

b) This test applies only to output lines intended to connect directly to outdoor cables.

c) The ISM (industrial, scientific and medical) bands between 0.15 MHz and 80 MHz are: 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. The amateur radio bands between 0.15 MHz and 80 MHz are: 1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz, 5.3 MHz to 5.4 MHz, 7 MHz to 7.3 MHz, 10.1 MHz to 10.15 MHz, 14 MHz to 14.2 MHz, 18.07 MHz to 18.17 MHz, 21.0 MHz to 21.4 MHz, 24.89 MHz to 24.99 MHz, 28.0 MHz to 29.7 MHz, and 50.0 MHz to 54.0 MHz.

Guidance and manufacturer’s declaration – electromagnetic immunity

MESI mTABLET is intended for use in the electromagnetic environment specified below. The customer or the user of the above listed models should ensure that they are used in such environment.

Guidance and manufacturer’s declaration – electromagnetic immunity
Immunity TestIEC 60601 Test levelCompliance levelElectromagnetic environment – guidance
Conducted RF induced by RF fields IEC 61000-4-6 Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-33 Vrms 150 kHz – 80 MHz 6 Vrms in ISM bands between 150 kHz – 80 MHz c) 3 V/m 80 MHz – 2.7 GHz3 Vrms 150 kHz – 80 MHz 6 Vrms in ISM bands between 150 kHz – 80 MHz c) 3 V/m 80 MHz – 2.7 GHzPortable and mobile RF communications equipment should not be used any closer to any part of the above listed models, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.2√P d = 1.2√P 80 MHz - 800 MHz d = 2.3√P 800 MHz - 2.7 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range. (b) Interference may occur in the vicinity of equipment marked with the following symbol:

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.

a) Field strengths from fixed transmitters such as base stations for radio (cellular/cordless) telephones, land mobile radios, amateur radio, AM and FM radio broadcast 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 MESI mTABLET is used, exceeds the applicable RF compliance level above, the above listed models should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the above listed models. 

b) Over the frequency range from 150 kHz to 80 MHz, field strength should be less than 3 V/m.  

c) The ISM (industrial, scientific and medical) bands between 0.15 MHz and 80 MHz are: 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. The amateur radio bands between 0.15 MHz and 80 MHz are: 1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz, 5.3 MHz to 5.4 MHz, 7 MHz to 7.3 MHz, 10.1 MHz to 10.15 MHz, 14 MHz to 14.2 MHz, 18.07 MHz to 18.17 MHz, 21.0 MHz to 21.4 MHz, 24.89 MHz to 24.99 MHz, 28.0 MHz to 29.7 MHz, and 50.0 MHz to 54.0 MHz. 

Distanze di separazione consigliate tra le apparecchiature di comunicazione RF portatili e mobili e i modelli sopra elencati.

The MESI mTABLET is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the models listed above can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the models listed above as recommended below, according to the maximum output power of the communication equipment. 

STANDARD COMPLIANCE
Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m: 150 kHz to 80 MHz d = 1.2√P80 MHz to 800 MHz d = 1.2√P800 MHz to 2.5 GHz d = 2.3√P
0.010.120.120.23
0.10.380.380.73
11.21.22.3
103.83.87.3
100121223

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 80 MHz and 800 MHz, 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. 

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