43K5902149 /02 MDSC-8331
According to what declared by our components suppliers, this product is RoHS compliant.
6.3 Biological hazard and returns –
Decommissioning
Decommissioning
When a device becomes obsolete or unusable, or is no longer needed by the health care facility, it enters the
final stage of its life cycle: decommissioning.
Decommissioning is the process of disposing a device, or removing a device from its originally intended use in
the health care facility to an alternative use.
Every health care facility or institution shall have standard operating procedures in place to decommission a
device according to the Occupational Safety and Health Administration (OSHA) regulations or/and the World
Health Organization (WHO) Decommissioning Medical Devices Technical guideline.
The seller / manufacturer of the device has no legal obligation on the device sold in the event that the health
care facility or institution decides to activate the decommissioning process.
Overview
The structure and the specifications of this device as well as the materials used for manufacturing makes it
easy to wipe and clean and therefore suitable to be used for various applications in hospitals and other
medical environments, where procedures for frequent cleaning are specified.
However, normal use shall exclude biological contaminated environments, to prevent spreading of infections.
Therefore use of this device in such environments is at the exclusive risk of Customer. In case this device is
used where potential biological contamination cannot be excluded.
Customer shall implement the decontamination process as defined in the latest edition of the ANSI/AAMI
ST35 standard on each single failed Product that is returned for servicing, repair, reworking or failure
investigation to Seller (or to the Authorized Service Provider). At least one adhesive yellow label shall be
attached on the top site of the package of returned Product and accompanied by a declaration statement
proving the Product has been successfully decontaminated.
Returned Products that are not provided with such external decontamination label, and/or whenever such
declaration is missing, can be rejected by Seller (or by the Authorized Service Provider) and shipped back at
Customer expenses.
6.4 Regulatory compliance information
Indications for use
This device is intended to be used in operation rooms, to display images from endoscopic cameras, room and
boom cameras, ultrasound, cardiology, PACS, anesthesiology and patient information. It is not intended for
diagnosis.
Intended usage environment
• Equipment primarily for use in a health care facility that is intended for use where contact with a patient is
unlikely (no applied part).
• The equipment shall not be used with life support equipment.
• The user should not touch the equipment, nor its signal input ports (SIP)/signal output ports (SOP) and the
patient at the same time.
Contra-indications
This display is not intended to be used for direct diagnosis and therapeutic interventional radiology.
Important information
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