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UK
INSTRUCTIONS FOR USE FOR POSITIONING AID FOR FIBE-
ROPTIC PAD SYSTEMS BILISWADDLER
WARNING:
The instructions for use of the basic machine must be strictly observed!
WARNING:
For a full understanding of the performance characteristics of this medical
device, the user should carefully read this manual before use of the medical device.
DEFINITIONS
WARNING:
A WARNING statement provides important information about a potentially hazar-
dous situation which, if not avoided, could result in death or serious injury.
CAUTION:
A CAUTION statement provides important information about a potentially hazar-
dous situation, which, if not avoided, may result in a minor or moderate injury to the user or
patient or in a damage to the equipment or other property.
NOTE:
A NOTE provides additional information intended to avoid inconvenience during
operation of the medical device.
INTENDED USE
Positioning aid for phototherapy with fiberoptic pads for added warmth and comfort. During
the therapy session the baby can be breast fed or held without impairing the bonding between
the infant and its parents.
PREPARATION AND OPERATION
WARNING:
Inspect for defects and damage before using positioning aid BiliSwaddler. Use
only undamaged products, otherwise filling material may escape. Danger of suffocation! If
the product is damaged dispose in accordance with local regulations.
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WARNING:
Ensure that breathing is not obstructed by positioning aid BiliSwaddler. Danger
of suffocation!
WARNING:
Use only new or cleaned and dried parts. Risk of cross infection! Contaminated
positioning aids BiliSwaddler should be replaced and cleaned.
CAUTION:
When not in use, store positioning aids BiliSwaddler so that they are protected
against contamination and soiling.
CAUTION:
Please use appropriate eye-protection during photo therapy sessions.
NOTE:
We recommend to use translucent disposable covers for fiberoptic light pads or
mattresses.
CLEANING AND DISPOSAL
CAUTION:
Even reusable accessories ( e.g. after processing) have a limited life time. A
number of factors may increase wear and reduce product life time considerably. When
external signs of wear become apparent, (such as cracks, discoloration, peeling, etc.) these
parts should be replaced.
Following use, the product must be disposed of in accordance with the local hospital, hygiene
and waste disposal regulations. Cleaning should be performed in accordance with the
washing labels using a tested and recognized washing disinfection process, preferably in a
cleaning/disinfecting machine. Velcro fasteners should be closed before washing!
CAUTION:
Do not feed positioning aid BiliSwaddler through a wringer or mangle!
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