Medical Requirement Classifications, Emc

Guide de l'utilisateur

Information

Regulatory

•Medical Requirement

Classifications:

In accordance with UL 2601-1/IEC 60601-1, the product is cssified 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.

EMC

This equipment has been tested and found to comply with the limits for medical devices to the IEC 601-1-2:1994. 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 950 for data processing equipment and IEC 601-1 for medical equipment.) Furthermore all configurations shall comply with the system standard IEC 601-1-1. Everybody 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 601-1-1. If in doubt, consult the technical services department or your local representative.

Transport and Storage Limitations:

Temperature Range of -40°C to +70°C

Relative Humidity of 10 -95%, non-condensing

*Bio-accumulative is defined as substances which accumulate within living organisms.

**Lead, Cadmium and Mercury are heavy metals which are Bio-accumulative.

GG15MSAN/EDC, GH15LSAN, GH15LSAN/EDC, GG15MSAS/EDC, GG15ASAS specifications

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