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Standard compliance

The provisions of the Council Directive 93/42/EEC concerning medical devices were complied with. The standards in the table below were complied with.

Standard compliance
Reference numberDescription
EN 60601-1:2006/ A1:2013Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN 60601-1-2:2015Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
EN 60601-1-6:2010/ A1:2015Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
EN 80601-230:2010/A1:2015Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
EN 10603:1997+A2:2009Non-invasive sphygmomanometers. Supplementary requirements for electromechanical blood pressure measuring systems
EN 1060-4:2004Non-invasive sphygmomanometers. Test procedures to determine the overall system accuracy of automated noninvasive sphygmomanometers
EN ISO 152231:2016Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
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 62366:2008Medical devices - Application of usability engineering to medical devices
EN 62304:2006/ A1:2015Medical device software - Software lifecycle processes
EN ISO 109931:2009/AC:2010Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
EN ISO 14971:2012Medical devices – Application of risk management to medical devices
EN ISO 13485:2016Medical devices – Quality management systems – Requirements for regulatory purposes

11.1. MANUFACTURER DECLARATION ON EMC

MESI mTABLET ABI 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.

Manufacturer declaration on EMC
Emissions test ComplianceElectromagnetic environment - guidance
RF emissions CISPR 11Group 1The above listed models use RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11Class BMESI mTABLET ABI is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2N/AMESI mTABLET ABI is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Voltage fluctuations / flicker emissions IEC 61000-3-3CompliesMESI mTABLET ABI is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

MESI mTABLET ABI 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.

Patient coupling PORT

Patient coupling PORT
Immunity TestTest ConditionIEC 60601 Compliance level Electromagnetic environment - guidance
Electrostatic discharge (ESD) according to IEC 61000-4-2± 8 kV Contact ± 2, 4, 8, 15 kV Air± 8 kV contact discharge ± 2, 4, 8, 15 kV air dischargeFloors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
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 1kHzExempt from this requirement - cable length is less than 3 m-

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.

MESI mTABLET ABI 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.

Enclosure Port

Enclosure Port
Immunity TestTest ConditionIEC 60601 Compliance level Electromagnetic environment - guidance
Electrostatic discharge (ESD) IEC 61000-4-2±,8 kV Contact ± 2, 4, 8, 15 kV Air±8 kV Contact ± 15 kV Air*Floors 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 1 kHz3 V/m 80 MHz – 2.7 GHzMains 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 (18Hz Pulse Modulation)27 V/mMains 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/mMains 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/mMains 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/mMains 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/mMains 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/mMains 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/mMains 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/mMains 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/mMains 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/mMains 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/mMains 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/mMains 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/mMains 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/mMains 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/mMains 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/mPower frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital 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 1kHz3 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) (5 s)Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. If the user of the above listed models requires continued operation during power mains interruptions, it is recommended that MESI mTABLET ABI 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.

MESI mTABLET ABI 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.

Signal input/output parts PORT

Signal input/output parts PORT
Immunity TestTest ConditionIEC 60601 Compliance level Electromagnetic 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 100 kHz Repetition frequency± 1 kVMains power quality should be that of a professional healthcare facility environment and Home healthcare environment.
Surges IEC 61000-4-5 (b)±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 1kHz3 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.

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.

Guidance and manufacturer’s declaration - electromagnetic immunity

MESI mTABLET ABI 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.

Guidance and manufacturer’s declaration - electromagnetic immunity
Immunity testIEC 60601 Test level Compliance 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/mPortable and mobile RF communications equipment should not be used no 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 MESI mTABLET ABI 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 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.

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

Separation distance according to frequency of transmitter m

Separation distance according to frequency of transmitter m
Rated maximum output power of transmitter W150 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.

11.2 ESSENTIAL PERFORMANCE

MESI ABI MODULE is a part of MESI mTABLET ABI whose essential performance is performing an ABI measurement in specified operating conditions. The measurement is defined as measurement process and data storage to MESI mTABLET.

Due to the devices high sensitivity, intended use and operating modes the device is susceptible to EM interferences. If the device essential performance is degraded, the device will notify operator with error messages of any issues, while the cuffs (if in use during the event) will deflate and cause no harm to the patient.

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