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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.
* Bio-accumulative is defined as substances which accumulate within living organisms.
** Lead, Cadmium and Mercury are heavy metals which are Bio-accumulative.
skin
cancer
(malignant
melanoma)
as
a
consequence
skin cancer (malignant melanoma) as a consequence
Medical Requirement
The relevant TCO'99 demand requires that plastic components weighing more than 25 grams
must not contain flame retardants with organically bound bromine or chlorine. Flame retardants
are allowed in the printed circuit boards since no substitutes are available.
Cadmium**
Cadmium is present in rechargeable batteries and in the colour-generating layers of certain
computer displays. Cadmium damages the nervous system and is toxic in high doses. The
relevant TCO'99 requirement states that batteries, the colour-generating layers of display screens
and the electrical or electronics components must not contain any cadmium.
Mercury**
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
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:
z
Reorient or relocate the receiving device.
z
Increase the separation between the equipment.
z
Connect the equipment into an outlet on a circuit different from that to which the other
device(s) are connected.
z
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.