User's Manual Part 1

PART I. User & Installation Manual
8 1417WGC/WCC
1. Safety Information
1.1 Safety Standard
1.1.1 Medical Device Classification
Item Description
Classification by protection type against Electric
Shock
Class I or Internally Powered Equipment
Classification according to the degree of protection
against ingress of water
IPX6
Mode of operation Continuous Operation
Environment of Use
This equipment is not suitable for use in the
presence of flammable anesthetic or oxygen.
1.1.2 Regulations
1. Safety and Electromagnetic Compatibility Information
Item Description
IEC/EN/UL 60601-1
Medical electrical equipment
Part 1: General requirements for safety
IEC/EN 60601-1-2
Medical electrical equipment
Part 2: Electromagnetic compatibility-requirements
and tests
This equipment has been tested and found to comply with the limits for medical devices in IEC
60601-1-2. These limits are designed to provide reasonable protection against harmful
interference in a typical medical installation.
This equipment generates, uses and can radiate radio frequency energy. If not installed and
used in accordance with the instructions, it may cause harmful interference to other devices in
the vicinity. However, there is no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference to other devices, which can be
determined by turning the equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following measures.
 Reorient or relocate the equipment.
 Increase the separation between the equipment.
 Connect the equipment into an outlet on a circuit different from that to which the other
devices are connected.
 Contact Rayence Customer Service team or authorized agent for help.