Samsung GH17ASAB/EDC, NB17ASCB Medical Requirement Classifications, Video In / RS 232 / Video Out

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Regulatory

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Mercury is sometimes found in batteries, relays and switches. It damages the nervous system and is toxic in high doses. The relevant TCO'99 requirement states that batteries may not contain any mercury. It also demands that mercury is not present in any of the electrical or electronics components associated with the labelled unit. There is however one exception. Mercury is, for the time being, permitted in the back light system of flat panel monitors as today there is no commercially available alternative. TCO aims on removing this exception when a Mercury free alternative is available.

CFCs (freons)

The relevant TCO'99 requirement states that neither CFCs nor HCFCs may be used during the manufacture and assembly of the product. CFCs (freons) are sometimes used for washing printed circuit boards. CFCs break down ozone and thereby damage the ozone layer in the stratosphere, causing increased reception on earth of ultraviolet light with e.g. increased risks of skin cancer (malignant melanoma) as a consequence.

Lead**

Lead can be found in picture tubes, display screens, solders and capacitors. Lead damages the nervous system and in higher doses, causes lead poisoning. The relevant TCO'99 requirement permits the inclusion of lead since no replacement has yet been developed.

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:

zReorient or relocate the receiving device.

zIncrease the separation between the equipment.

zConnect the equipment into an outlet on a circuit different from that to which the other device

(s) are connected.

zConsult 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.