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1.5
End of Life, Environmental
Directives
WEEE Directive [2012/19/EU] on Waste
Electrical and Electronic Equipment
The Directive on Waste Electrical and Electronic
Equipment obliges manufacturers, importers,
and/or distributors of electronic equipment to
provide for recycling of the electronic equipment
at the end of its useful life.
Do not dispose of WEEE in unsorted municipal
waste.
The WEEE symbol on the product or its
packaging indicates that this product must not
be disposed of with other waste. Instead, it is
your responsibility to dispose of your waste
equipment by handing it over to a designated
collection point for the recycling of Waste
Electrical and Electronic Equipment. The
separate collection and recycling of your waste
equipment at the time of disposal will help
conserve natural resources and ensure that it is
recycled in a manner that protects human health
and the environment. For more information
about where you can drop off your medical
endoscopic video equipment at the end of its
useful life for recycling, please contact Arthrex
Customer Service Department.
The Camera Control Unit (CCU)
contains a Lithium Coin BATTERY. The
BATTERY must be recycled or disposed
of properly.
NOTE for State of California, USA:
State of California Requirement: Lithium
Batteries contain Perchlorate Material -special
handling may apply. See
www.dtsc.ca.gov/HazardousWaste/Perchlorate
In the US a list of recyclers in your area can be
1.6
Initial Use of the Device
WARNINGS:
1. The device is only completely isolated
from the mains if the power plug is
disconnected from the device’s power
inlet module. Avoid positioning
equipment such that removal of plug is
difficult.
2. The electrical installation of the operating
room where the device is used must
comply with applicable national
requirements.
3. Loss of the Mains Voltage may result in
an unacceptable risk due to loss of
Clinical Function. An Uninterruptable
Power Supply [UPS] is recommended to
mitigate this risk.
4. The device is not intended for use in
areas of explosion hazards. If explosive
nitrous gases are used the Camera
Control Unit may not be operated in the
danger zone.
5. Do not simultaneously touch the Camera
Control Unit and the patient. Camera
Control Unit is intended to be used
outside the Patient Vicinity.
6. Additional peripheral equipment
connected as part of the Endoscopic
Video System must meet the
requirements of the following
specifications:
•
IEC 60950 for Information
Technology Equipment.
•
IEC 60601-2-18 for endoscopic
devices.
•
IEC 60601-1 for medical electrical
equipment.
7. All final Endoscopic Video Systems must
meet the requirements of IEC 60601-1.
8. Whoever connects additional equipment
to signal input or signal output is
obligated to meet the requirements of the
IEC 60601-1 standard.