Welch Allyn Duet CO2 Module - User Manual - Manual (Page 52)

Duet CO
2
Module OEM Implementation Manual
Page 52 Confidential Welch Allyn OEM Technologies
Requirements
Electromagnetic Interference
The Duet Module meets the following EMC requirements without enclosure.
§ Radiated Emissions - tested per CISPR 11, 1990
§ Magnetic Field Emissions - tested per RE101
Electromagnetic Susceptibility
The Duet Module meets the following EMC requirements without enclosure.
§ Electrostatic Discharge - tested per IEC 1000-4-2, 1995
§ Fast Transient Bursts - tested per IEC 1000-4-4 (EN61000-4-4,1995)
§ Radiated Electromagnetic Fields - tested per IEC 1000-4-3 with dwell time adjusted to 3
seconds (80 MHz - 1000 MHz)
§ Radiated Electromagnetic Fields - tested per IEC 1000-4-3 with dwell time adjusted to 3
seconds (26 MHz - 80 MHz)
§ Conducted Electromagnetic Energy - tested per CS114 (MIL-STD-462D)
§ Magnetic Fields - RS101 (MIL-STD-462D)
Compliance Testing Summary
The Duet Module meets the specifications put forth in the FDA Reviewer Guidance for pre-market
notification submissions of Anesthesiology and Respiratory Devices Branch, November 1993 and IEC
601-1-2, Second Edition, Draft 1, 1996 (EN60601-1-2). The test sample was evaluated in accordance
with specifications put forth in the following:
§ CISPR 11, 1990 (EN 55011, 1991)
§ IEC 1000-4-2, 1992 (EN 61000-4-2, 1995)
§ IEC 1000-4-3, 1995 (ENV 50204)
§ IEC 1000-4-4, 1995 (EN 61000-4-4, 1995)
§ MIL-STD-461D, 11 January 1993
§ RE101, RS101, CS114
ISO 9918 and EN 864
The Duet Module, when implemented according to this manual, meets or exceeds the requirements
outlined in Section 8, Clauses 50.3 through 50.9 and Section 11, Clauses 60 and 61 of the ISO 9918
Standard and equivalent sections of EN 864.