Welch Allyn LC101 CO2 Module - User Manual - Manual (Page 53)

LC101 CO
2
Module OEM Implementation Manual
Welch Allyn OEM Technologies Confidential Page 53
Section 6
Regulatory
IEC 601-1-2 (EN 60601-1-2)
Welch Allyn OEM Technologies
The LC101 Module meets the requirements of IEC 601-1-2 (EN 60601-1-2).
Although sidestream devices do not require patient isolation, the host system must not bridge the
isolation barrier with any subcomponents of the LC101 Module. All components with electrical
connections to the Main Board must be properly insulated from non-isolated power.
OEM
The responsibilities of the OEM 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 (EN 60601-1) and applicable standards.
• It is recommended that the power supplied to the LC101 Module be fused or provided
similar protection in the event of a short circuit.
• Creepage and clearance distances from primary to ground and secondary circuits, as
defined in IEC 60601-1 (EN 60601-1), must be maintained after installation to
preserve the intended safety.
• Minimum isolation/insulation clearances specified in IEC 60601-1 (EN 60601-1) when
mounting the LC101 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.