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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 Cleaning and disinfection
Instructions
•
Be sure to unplug the power cord from the mains when cleaning your LCD monitor.
•
Take care not to scratch the front surface with any hard or abrasive material.
•
Dust, finger marks, grease etc. can be removed with a soft damp cloth (a small amount of mild detergent
can be used on the damp cloth).
•
Wipe off water drop immediately.
Possible cleaning solutions
•
70 percent isopropyl alcohol
•
1.6 percent aqueous ammonia
•
Cidex® (2.4 percent glutaraldehyde solution)
•
Sodium hypochlorite (bleach) 10 percent
•
"Green soap" (USP)
•
0.5 percent Chiorhexidine in 70 percent isopropyl alcohol.
•
Like Cleansafe® optical cleaning liquid
6.5 Regulatory compliance information
Indications for use
This device is a color high-resolution liquid crystal display especially designed for medical imaging
applications.
The monitor is used in a hospital environment and remain physically attached, upright, as part of a fixed,
stationary, indoor system. For the use in control room an optional stand can be provided. 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.
Intended users
Surgical displays are intended to be used by trained medical practitioners.
Important information
K5902150 (451920612554) /03
MDSC-8358
37
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