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Information – Samsung 151S User Manual

Page 61

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User’s Manual

Information

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.

Regulatory