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Technical Information

NOTE: This product complies with ISO 10993-1, Biological Evaluation of

Medical Devices Part 1: Evaluation and Testing.

Manufacturer’s Declaration

Refer to the following table for specific information regarding this device’s

compliance to IEC 60601-1-2.

CAUTION: A functional tester cannot be used to assess the

accuracy of a pulse oximeter monitor or sensor.

CAUTION: All parts and accessories connected to the serial port

of this device must be certified according to at least IEC Standard

EN 60950 or UL 1950 for data-processing equipment.

CAUTION: Portable and mobile RF communications equipment

can affect medical electrical equipment.

Table 1: Electromagnetic Emissions

Emissions Test Compliance

Electromagnetic

Environment—Guidance

This device is intended for use in the electromagnetic environment specified below.

The user of this device should ensure that it is used in such an environment.

RF Emissions

CISPR 11

Group 1

This device 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.

RF Emissions

CISPR 11

Class B

This device is suitable for use in all

establishments, including domestic

and those directly connected to the

public low-voltage power supply

network that supplies buildings used

for domestic purposes.

Harmonic Emissions

IEC 61000-3-2

N/A

Voltage Fluctuations/

Flicker Emissions

IEC 61000-3-3

N/A

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Respironics 920M Betreibershandbuch Seite 37