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EMC Information Tables per EN60601-1-2:2001-09 Section 6. In accordance with EN 60601-1-2:2001 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility Requirements and tests 1) “Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the Accompanying Documents” (the following tables). 2) “Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment.” 3) “The equipment or system should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the equipment or system should be observed to verify normal operation in the configuration in which it is used.” The following tables provide information regarding the EMC characteristics of this Medical Electrical Equipment. * The compliance levels of immunity referred to in tables 202 and 204 have not been arrived at by testing, but by declaration on the basis that the Thoracic suction pump contains no electronic components and is inherently immune to the specified levels of electromagnetic disturbance. The performance of all functions of the Thoracic suction pump are considered essential performance for the purpose of electromagnetic immunity.

Table 201 - Guidance and manufacturer’s declaration - electromagnetic emissions - all equipment and systems Guidance and manufacturer’s declaration - electromagnetic emissions The Thoracic suction pump is intended for use in the electromagnetic environment specified below. The customer or user of the Thoracic suction pump should assure that it is used in such an environment. Emissions Test

Compliance

Electromagnetic environment - guidance

Harmonic Emissions IEC 61000-3-2

Class A

Voltage fluctuations / flicker emissions IEC 61000-3-3

Complies

The Thoracic suction pump 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.

RF emissions CSIPR 14-1

Complies

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The Thoracic suction pump is not suitable for interconnection with other equipment.

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Table 202 - Guidance and manufacturer’s declaration - electromagnetic immunity - for all equipment and systems Guidance and manufacturer’s declaration - electromagnetic immunity The Thoracic suction pump is intended for use in the electromagnetic environment specified below. The customer or user of the Thoracic suction pump should assure that it is used in such an environment. Immunity Test

IEC 61000 test level

Compliance level (not tested) *

Electromagnetic environment - guidance

Electrostatic discharge (ESD) IEC 61000-3-4

±6 kV contact ±8 kV air

±6 kV contact ±8 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%.

Electrical fast transient/burst IEC 61000-4-4

±2 kV for power supply lines ±1 kV for input/ output lines

±2 kV for power supply lines ±1 kV for input/ output lines

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

Surge IEC 61000-4-5

±1 kV line(s) to line(s) ±2 kV line(s) to earth

±1 kV line(s) to line(s) ±2 kV line(s) to earth

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

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

<5 % UT (>95% dip in UT for 0.5 cycle) 40 % UT (60% dip in UT for 5 cycles) 70 % UT (30% dip in UT for 25 cycles) <5 % UT (>95% dip in UT for 5 sec)

<5 % UT (>95% dip in UT for 0.5 cycle) 40 % UT (60% dip in UT for 5 cycles) 70 % UT (30% dip in UT for 25 cycles) <5 % UT (>95% dip in UT for 5 sec)

Mains power quality should be that of a typical commercial or hospital environment. The unit shut off during the >95% dip for 5 sec disturbance. If the user of the Thoracic suction pump requires continued operation during power mains interruptions, it is recommended that the Thoracic suction pump be powered from an uninterruptible power supply or battery.

Power frequency (50/60Hz) magnetic field IEC 61000-4-8

3 A/m

3 A/m

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

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Table 204 - Guidance and manufacturer’s declaration - electromagnetic immunity - for equipment and systems that are NOT life-supporting. Guidance and manufacturer’s declaration - electromagnetic immunity The Thoracic suction pump is intended for use in the electromagnetic environment specified below. The customer or user of the Thoracic suction pump should assure that it is used in such an environment. Immunity Test

IEC 61000 test level

Compliance level (not tested) *

Electromagnetic environment guidance Portable and mobile communications equipment should be used no closer to any part of the Thoracic suction pump, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

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Conducted RF

3 Vrms

IEC 61000-4-6

150 kHz to 80 MHz

Radiated RF

3 V/m

IEC 61000-4-3

80MHz to 2.5 GHz

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3 Vrms

d = [3.5/V1] P

3 V/m

d = [3.5/E1] P 80 MHz to 800MHz d = [7/E1] P 800 MHz to 2.5GHz 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 metre (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol

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