Electromagnetic Compatibility (Emc); Declaration Of Compliance; It Security; Disposal Of The Analyzer - Siemens Healthineers Atellica VTLi User Manual

Immunoassay analyzer
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Electromagnetic Compatibility (EMC)

This product complies with relevant international and national laws and standards on EMC
(electromagnetic compatibility) for this type of product when used as intended. Such laws
and standards define both the permissible electromagnetic emission levels from the product
and its required immunity to electromagnetic interference from external sources.
Other electronic products exceeding the limits defined in such EMC standards could, under
unusual circumstances, affect the operation of the product.
Medical electrical products need special precautions regarding EMC, and need to be
installed and put into service according to EMC information provided in the accompanying
documents.
The use of accessories and cables other than those specified, may result in increased
emission or decreased immunity levels.
The product should not be used adjacent to or stacked with other products and that if
adjacent or stacked use is necessary, it should be observed to verify normal operation.

Declaration of compliance

This device complies with United States FCC part 15 Rules and Industry Canada license-
exempt RSS standard(s). Operation is subject to the following two conditions:
(1) this device may not cause interference, and
(2) this device must accept any interference, including interference that may cause
undesired operation of the device.
Changes or modifications not expressly approved by the party responsible for compliance
could void the user's authority to operate the equipment.
Portable and mobile RF communications can affect medical electrical equipment.
Use caution when using such communication devices within the specified range of
medical electrical devices.

IT Security

See the product's Security White Paper and Manufacturer Disclosure Statement (MDS2) for
additional information about specifications for software, hardware, network characteristics,
and security controls. This technical information is not part of the operator guide, and is
intended for the information technology or security professional. Security White Paper and
MDS2 can be found at siemens-healthineers.com/poc or contact your local technical service
provider.

Disposal of the Analyzer

The instrument must be treated as biological contaminated hazardous waste. Proper
disposal of old instruments (including its plastic parts, electrical components) prevents
potential negative consequences for the environment and human health. All electrical and
electronic products and other components of the analyzer should be disposed of separately
from the municipal waste system. Final disposal must be organized in a way that does not
endanger waste handlers. As a rule, such equipment must be sterile before it is passed for
final disposal. For more information about disposal of such product, please contact your city
office, waste disposal service, or your local safety officer.
Appendix A - Specifications
43

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