Dabir Surfaces DabirAIR CA-1001, Инструкция по эксплуатации

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• Do not place the Pneumatic Controller in direct sunlight.
• The Pneumatic Controller must be stored and operated within
designed operating conditions specified in this manual.
Operating the Pneumatic Controller outside these
ranges may cause damage to the device which could
result in premature failure.
• The Pneumatic Controller must be used with specified operating
wall currents. All other alternative power sources
and currents may result in irreparable damage to
the system and possible hazardous event to the
patient or caregiver.
• Equipment may be hazardous if misused.
• Modification of the device voids warranty and
may compromise intended function. Service should
be performed exclusively by the manufacturer or
manufacturer’s representative.
• If Pneumatic Controller is damaged during the shipping process,
please contact the manufacturer for appropriate action.
• If Pneumatic Controller is dropped during use with noticeable
damage, please remove from service and contact the manufacturer
for appropriate action.
• Do not transport or carry the Pneumatic Controller with an
Overlay attached.
• This device requires the use of a shielded Power Cord
for compliance with emissions limits. Do not operate
device without manufacturer supplied Power Cord.
• Do not use in an MRI environment.
• Turn Dabir System “OFF” during patient transfer and
before patient positioning.
• It is the responsibility of the caregiver to adequately secure and
protect the patient against patient falls.
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1.3 Labels and Descriptions
UL Mark
ANSI/AAMI ES60601-1 AMD 1 (2012), "Medical
Electrical Equipment - Part 1:
General Requirements for Basic Safety and
Essential Performance, Amendment 1.
CAN/CSA-C22.2 No. 60601-1 (2014), "Medical
Electrical Equipment - Part 1:
General Requirements for Basic Safety and
Essential Performance
Label Description Application
Pneumatic Controller label
The Symbols below appear on the Pneumatic Controller , Overlays, Hose Assembly,
Accessories and/or packaging.
NON
STERILE
Non-Sterile
Indicates a medical device that has not been
subjected to a sterilization process.
Overlay labels & Overlay Box labels
Instructions For Use
Caution
Alerts the reader of a potentially hazardous
situation which, if not avoided, may result in
minor or moderate injury to the user or
patient or damage to the product or other
property. This includes special care neces -
sary for the safe and effective use of the
device and the care necessary to avoid
damage to the device that may occur as a
result of use or misuse.
Separate Collection
Separate collection for electronic waste
required.
Box labels, Overlay Box labels,
Overlay labels, Pneumatic Controller
label, Hose Assembly label
Date of Manufacture
Indicates the date when the medical device
was manufactured.
Box labels, Pneumatic Controller
label, Hose Assembly label,
Overlay labels
YYYY-MM-DD
Manufacturer
Indicates the medical device manufacturer.
Box labels & Pneumatic
Controller label
UL Badge
Indicates UL compliance on marketing,
advertising, and packaging materials
Pneumatic Controller label, Box
labels, Overlay labels, Hose
Assembly label
DOC# R01-0006-00004-AA
NOTE: Provides special information to make important instructions clearer.