Notes on electromagnetic compatibility (EMC) for Aesculap Aeos

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Aesculap® Notes on electromagnetic compatibility (EMC) for Aesculap Aeos Contents 1. 2. 2.1 2.1.1 2.1.2 2.1.3 2.2 2.3 2.4 2.5 3.

Scope... Guidance and manufacturer’s declaration... Classification of medical electrical equipment acc. to CISPR 11 Groups... Classes... Set-up environment/set-up location... Electromagnetic emission... Electromagnetic immunity... High frequency conducted disturbance - IEC 61000-4-3... Separation distances... Technical Service...

1.

Scope

2 2 2 2 2 2 3 4 7 8 8

2.

Guidance and manufacturer’s declaration

2.1

Classification of medical electrical equipment acc. to CISPR 11

According to CISPR 11, all medical electrical equipment is divided into groups and classes. Different guidelines concerning electromagnetic emissions apply, depending on which group or class the equipment belongs to. 2.1.1 Groups The group any medical electrical equipment belongs to depends on the way in which it uses RF energy.

Art. no.

Designation

Group 1 Group 1 is the group of “equipment and systems which generate or use RF energy exclusively for their internal functions”, such as camera systems, light sources and motor systems. Group 1 also comprises “equipment that feed energy into the patient, but not energy in the form of high-frequency electromagnetic energy“, e.g. infusion equipment. RF surgery devices also belong to group 1 since, according to IEC 606012-2, they are assessed with the RF output inactive.

PV008 PV010 PV011 PV014 PV031

Aesculap Aeos (Digital Surgical Microscope) Basic hardware configuration

Group 2 Not relevant for Aesculap products.

This information on electromagnetic compatibility (EMC) applies to the following medical electrical device:

Note The use of cables other than those provided by or recommended by Aesculap may result in increased electromagnetic emissions or reduced immunity to interference.

2.1.2 Classes The class to which medical electrical equipment belongs depends on the electromagnetic environment at the site where the equipment is operated. Class A Devices are of Class A if they are identified in the instructions for use as "CISPR Class A". Class B Devices are of Class B if no particular classification is specified in the instructions for use, or if they are identified there as "CISPR Class B". 2.1.3 Set-up environment/set-up location The equipment is intended for use in a specific environment (defined in accordance with IEC 60601-1-2, 4th edition). It may be used in areas in which medical treatments are performed with HF surgical devices. ► Do not place the device in the immediate vicinity of other devices except Aesculap devices. ► Where the device has to be operated in the immediate vicinity of other devices or in conjunction with other devices: Observe the device to ensure normal operation in this configuration. ► Necessary precautions for use in the vicinity of AM, FM and TV transmitters (e.g. at a distance of less than 1.5 km), or other local sources of electromagnetic interference: Observe the device to ensure proper operation over the expected service life.

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en 2.2

Electromagnetic emission

► Always observe guidelines according to the group and class the equip-

ment belongs to. ► For details regarding the meaning of different groups and classes, see

Classification of medical electrical equipment acc. to CISPR 11 in the previous section. Guidance and manufacturer´s declaration - Electromagnetic emission The Aesculap Aeos is intended for use in an environment like the electromagnetic environment specified below. The user of the device shall make sure the system is operated in such an environment. Emissions test

Compliance

Electromagnetic environment - Guidance

RF emissions acc. to CISPR 11

Complies with group 1

The equipment uses 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.

Harmonic emissions acc. to IEC 61000-3-2

Consistent with Class A (IEC 61000-3-2)

–

Voltage fluctuations/flicker emissions acc. to IEC 61000-3-3

Complies

–

RF emissions CISPR 11

Class A

The EQUIPMENT is suitable for use in all establishments other than domestic, and may be used in domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes, provided the following warning is heeded: Warning: The device/system is only intended for use by medical personnel. This is a device/system of class A pursuant to CISPR 11. In the residential area, this device/system can cause radio interference, so that it may be necessary to take suitable corrective measures, such as rearrangement, reorientation or shielding of the device or filtering the connection to the location.

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en 2.3

Electromagnetic immunity

Guidelines and Manufacturer Explanation - Electromagnetic Compatibility - IEC 60601-1-2, 3rd edition The Aesculap Aeos is intended for use in the electromagnetic environment specified below. The user of the Aesculap Aeos shall make sure that it is used in such an environment. Immunity test

Compatibility test level IEC 60601-1-2, 3rd Edition

Compliance level

Electromagnetic environment Guidance

Electrostatic discharge (ESD) acc. to IEC 61000-4-2

±6 kV contact

±6 kV

±8 kV air

±8 kV

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Rapid transient electrically conducted disturbance acc. to IEC 61000-4-4

±2 kV for power supply lines

±2 kV

±1 kV for power supply lines

±1 kV

Surges acc. to IEC 61000-4-5

±1 kV voltage outer conductorouter conductor

±1 kV

±2 kV voltage external conductor earth

±2 kV

<5 % UT1 (>95 % dip in UT) for 0.5 cycle

Complies

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Aesculap Aeos requires continued operation even during power mains interruptions, it is recommended that the Aesculap Aeos be powered from an uninterruptible power source or from a battery.

3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines acc. to IEC 61000-4-11

40 % UT (60 % dip in UT) for 5 cycles

Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment.

70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 sec Magnetic field at power supply fre- 3 A/m quency (50/60 Hz) acc. to IEC 61000-4-8 Note 1 UT is the AC mains voltage prior to application of the test level.

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en Guidelines and Manufacturer Explanation - Electromagnetic Compatibility - IEC 60601-1-2, 4th edition The Aesculap Aeos is intended for use in the electromagnetic environment specified below. The user of the Aesculap Aeos shall make sure that it is used in such an environment. Immunity test

Compatibility test level IEC 60601-1-2, 4th Edition

Compliance level

Electromagnetic environment Guidance

Electrostatic Discharge (ESD) acc. to IEC 61000-4-2

±8 kV contact

±8 kV

±15 kV air

±15 kV

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Electrostatic transient/burst acc. to IEC 61000-4-4

±2 kV for power supply lines

±2 kV

±1 kV for power supply lines Modulation 100 kHz

±1 kV Modulation 100 kHz

Surge acc. to IEC 61000-4-5

±1 kV voltage external conductor external conductor

±1 kV

±2 kV voltage outer conductorprotective earth

±2 kV

0 % UT1 at 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° for 1/2 periods

Complies

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Aesculap Aeos requires continued operation even during power mains interruptions, it is recommended that the Aesculap Aeos be powered from an uninterruptible power source or from a battery.

30 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Voltage dips, short term interruptions and fluctuations in power supply acc. to IEC 61000-4-11

0 % UT; one period 70 % UT 25/30 periods Single phase: at 0°

Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment.

0 % UT; 250/300 periods Magnetic field at power supply fre- 30 A/m quency (50/60 Hz) acc. to IEC 61000-4-8 Note 1

UT is the AC mains voltage prior to application of the test level..

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en Guidance and manufacturer´s declaration – Electromagnetic immunity - For equipment that are not life supporting The Aesculap Aeos is intended for use in the electromagnetic environment specified below. The user of the Aesculap Aeos shall make sure that the Aesculap Aeos is used in such an environment. Immunity test

Test level IEC 60601-1-2 Compliance level

Electromagnetic environment - Guidance2 Portable and mobile RF communications equipment should be used no closer to any part of the Aesculap Aeos, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance1:

Conducted RF acc. to IEC 61000-4-6

Transmitted RF acc. to IEC 61000-4-3

3 Veff 150 kHz to 80 MHz

3 Veff 150 kHz to 80 MHz

6 Veff 80 % AM at 1 kHz for ISM bandsc

6 Veff 80 % AM at 1 kHz for ISM bandsc

3 V/m 80 MHz to 2.7 GHz

3 V/m 80 MHz to 2.7 GHz

d = 1,2 x √P

d = 1,2 x √P 80 MHz to 800 MHz d = 2,3 x √P for 800 MHz to 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 surveya should be less than the compliance level in each frequency rangeb. 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 and land mobile 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 where the Aesculap Aeos is used exceeds the applicable RF compliance level above, the Aesculap Aeos should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Aesculap Aeos. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. c The ISM bands (en: frequency bands used for Industrial, Scientific and Medical purposes) 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 frequency 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.

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High frequency conducted disturbance - IEC 61000-4-3

Test frequency range (MHz)

Band (MHz)

Service

Modulation

Max. output (W) Distance (m)

Conducted disturbance test level (V/m)

385

380–390

TETRA 400

Pulse modulation 18 Hz

1.8

0.3

27

450

430-470

GRMS 460, FRS 460

FM ±5 kHz deviation

2

0.3

28

710

704-787

LTE-Band 13, 17

Pulse modulation 217 Hz

0.2

0.3

9

800-960

GSM 800/900, TETRA 800, IDEN 820, CDMA 850, LTE-Band 5

Pulse modulation 18 Hz

2

0.3

28

1 700–1 990

GSM 1 800, CDMA 1 900, GSM 1 900, DECT, LTEBand 1, 3, 4, 25, UMTS

Pulse modulation 217 Hz

2

0.3

28

2 450

2 400–2 570

Bluetooth, WLAN 802.11 b/g/n, RFID 2 4500, LTEBand 7

Pulse modulation 217 Hz

2

0.3

28

5 240

5 100–5 800

WLAN 802.11 a/n

Pulse modulation 217 Hz

0.2

0.3

9

745 780 810 870 930 1 720 1 845 1 970

5 500 5 785

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en 2.5

Separation distances

Recommended separation distances2 between portable and mobile RF communications equipment and the Aesculap Aeos The Aesculap Aeos is intended for use in an electromagnetic environment in which radiated RF interference is controlled. The user of the Aesculap Aeos can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Aesculap Aeos as recommended below, according to the maximum output power of the communications equipment. Portable RF communications equipment (radios, including peripherals such as antenna cables and external antennae) should be no closer than 30cm from the cables of the Aesculap Aeos. Failure to do so may result in a reduction in the performance of the device. Rated maximum output of trans- Separation distance1 according to frequency of transmitter [m] mitter [W] 150 kHz to 80 MHz 80 MHz to 800 MHz d = 1,2 x √P d = 1,2 x √P

800 MHz to 2.7 GHz d = 2,3 x √P

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters [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 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

3.

Technical Service

► For service and repairs, please contact your national B. Braun/Aesculap

agency. Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 (7461) 95 -1601 Fax: +49 (7461) 14 -939 E-Mail: [email protected] Other service addresses can be obtained from the address indicated above.

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