Welch Allyn Duet CO2 Module - User Manual - Manual (Page 51)

Duet CO
2
Module OEM Implementation Manual
Welch Allyn OEM Technologies Confidential Page 51
Regulatory
Overview
Welch Allyn OEM Technologies and Compliance with IEC 601-1
The Duet Module meets the requirements of IEC 601-1 (EN 60601-1).
Although sidestream devices do not require patient isolation, the host system must not bridge the
isolation barrier with any sub components of the Duet Module. All components with electrical
connections to the CO
2
main processor board must be properly insulated from non-isolated power.
OEM Responsibilities
The responsibilities of the manufacturer of the OEM host system include (but are not limited to) the
following:
• The end-use product (the host system) must comply with all appropriate safety requirements of
IEC 60601-1 (EN60601-1), it’s amendments and applicable standards.
• It is recommended that the power supplied to the Duet Module be fused or provided similar
protection in the event a short circuit.
• Creepage and clearance distances from primary to ground and secondary circuits, as defined in
IEC 60601-1 (EN60601-1), must be maintained after installation to preserve the intended safety.
• Minimum isolation/insulation clearances specified in IEC 60601-1 (EN60601-1) when mounting the
Duet Module and all off board components must be maintained after installation to preserve the
intended safety.
• The exhaust tubing must be single fault protected to protect against oxygen buildup in the event of
an exhaust tube malfunction.
• The end-user Operator Manual must include instructions for decontaminating, cleaning and/or safe
disposal of sidestream accessories.
• ISO 9918 and all Regulatory testing after full implementation into the final form or device.