45R5914634 /00 MDSC-8527
RoHS
Directive 2011/65/EC on the restriction of certain hazardous substances in electrical and electronic
equipment.
According to what declared by our components suppliers, this product is RoHS compliant.
6.4 Biological hazard and returns
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.
6.5 Regulatory compliance information
Indications for use
The device is intended to display medical images from medical systems such as endoscopic or laparoscopic
cameras, surgical microscopes, room and boom cameras, ultrasound, image guided therapy and intervention,
PACS, anesthesiology, patient information and other compatible medical image systems.
The device is suitable for use in hospital operating rooms, surgical centres, clinics, doctors’ offices and similar
medical environments.
The device 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.
Intended users
Surgical displays are intended to be used by trained medical practitioners.
Notice to the user and/or patient
Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the
competent authority of the Member State in which the user and/or patient is established.
Important information
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