Ewellix CAMT20, Installation, Operation And Maintenance Manual

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2 .0 S afety
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2.7 Modifications of
device
WARNING
To avoid hazardous situations and to ensure optimal
performance, do not make changes or modifications to the
device unless they have been specifically authorized by Ewellix.
2.7.1 Warning labels
The following symbols and information decals can be found
in the danger zone. They refer to the immediate vicinity
around their location.
WARNING
Danger of injurt because of illegible symbols
Over the course of time stickers and decals may bcome dirty or
illegible for some other reason.
Therefore:
• Keep any safety, warning and operation related decals in
legible condition at all time
• Replace damaged decals or stickers immediately
2.8 Manufacturer’s
declaration of EMC
compliance
EN 60601-1-2:2015 (IEC 60601-1-2:2014) Medical Electrical
Equipment -
Part 1-2: General requirements for basic safety and essential
performance –
Collateral Standard: Electromagnetic disturbances –
Requirements and tests
2.8.1 Instructions for use
General
Professional healthcare facility environment
Physician offices, dental offices, clinics, limited care facili-
ties, freestanding surgical centers, freestanding birthing
centers, multiple treatment facilities, hospitals (emergency
rooms, PATIENT rooms, intensive care, surgery rooms, ex-
cept near HF SURGICAL EQUIPMENT, an MR system out-
side a RF shielded room of an ME SYSTEM for magnetic
resonance imaging).
Essential performance
The essential performance about the linear actuator CAMT
is to keep, hold and move weights, loads.
The risk management (Document L5672,0048) identify the
functions about safety of these linear actuators. All features
or functions are performed properly. Unacceptable risks for
patients, operators or others are performed and assessed to
prevent or reduce harm.
The follow points identify and describe the EMC-risks about
the Telescopic pillar CAMT according the EMC-measurements:
Warning against the stacking of equipment
WARNING
Stacked with other equipment
Use of this equipment adjacent to or stacked with other
equipment should be avoided because it could result in improper
operation. If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operationg
normally
List of cables, length of cables, accessories
WARNING
Use of accessories, transducers and cable
The use of accessories, transducers and cable other then those
spacified or provided by the manufacturer of this equipment
could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and
result in
improper operation.