Chapter 1 Important Safety and Compliance Information
Regulatory Compliance Notes and Notices
N-mark for Medical Electrical Equipment
Classifications
In accordance with UL 2601-1/IEC 60601-1, the product is classified as continuous duty Class I equipment, which is not protected against ingress of liquids. The product is not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide.
•Type of protection against electrical shock: Class l.
•Degree of protection against electrical shock (Patient connection): Not applicable.
•Degree of protection against harmful ingress of water: Ordinary equipment.
•Methods of sterilization or disinfection: Not applicable.
•Degree of safety of application in the presence of a flammable anesthetic material with air or with oxygen or nitrous oxide: Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.
•Mode of operation: Continuous.
EMC
This equipment has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2:2001. 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 and, if not installed and used in accordance with the instructions, 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 receiving device.
•Increase the separation between the equipment.
•Connect the equipment into an outlet on a circuit different from that to which the other device (s) are connected.
•Consult the manufacturer or field service technician for help.
Video In / RS 232 / Video Out
Accessories equipment connected to the analog and digital interfaces must be certified to the respective IEC standards (i.e. IEC 60950-1 for data processing equipment and IEC 60601-1 for medical equipment.) Furthermore all configurations shall comply with the system standard IEC 60601-1-1. Anyone who connects additional equipment to the signal input part or signal output part configures a medical system, and is therefore, responsible that the system complies with the requirements of the system standard IEC 60601-1-1. If in doubt, consult the technical services department or your local representative.
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