Precautions - Arthrex AR-3210-0006 Instrucciones De Uso

General Information
EN
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WARNING!
Device defect
If a device defect is suspected or confirmed, do not use it. Make sure the device
can no longer be used until a qualified service technician conducts the appropri-
ate tests and repairs.
WARNING!
Hot surface on the endoscope
The fiber optic cable connector on the endoscope may become very hot. Always
use fiber optic cables with a cross sectional area matching the endoscope.
WARNING!
Endoscopes and peripheral devices
The device may only be connected with endoscopes and additional accessories
designed for and featuring the technical specification permitting such a com-
bined use. Endoscopes and related accessories must comply with requirements
of the standards IEC 60601-2-18 / EN 60601-2-18, and ISO 8600 for endoscopy
devices and IEC 60601-1 / EN 60601-1 for electrical medical devices in the most
recently amended version.
Persons connecting additional devices to signal outputs or signal inputs is con-
figuring a medical system and as such is responsible for complying with require-
ments of the standard IEC 60601-1 / EN 60601-1 in the most recently amended
version.
3.4.2

Precautions

CAUTION!
Do not use the video lens in a strongly magnetic environment (e.g., open MRI)!
CAUTION!
Compatibility check of the endoscopic system
The compatibility of the endoscopic device with all accessories and with any
electrically operated endotherapy devices with regard to the safety criteria de-
fined in the instructions for use must be checked before each use.
CAUTION!
Endoscopes and accessories
The outer surface of the endoscope and each endoscopically usable piece of ad-
ditional equipment has to be checked to ensure that the area is free of rough
spots and/or sharp edges that could harm the patient.