Arthrex AR-3200-1018, Instructions For Use Manual

Page: 11 / 28

DFU-0331r0_fmt_en-US Page 8 of 25
• 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.
CAUTION: Do not install the device
in a location near heat sources such
as air ducts or radiators and do not
expose the device to direct sunlight,
excessive dust, or mechanical vibration.
1.7 Unpacking and Inspecting the
Device
Upon receipt, carefully unpack the Synergy
Laser Light Source and accessories. Ensure
contents are complete and are free from
damage. If any damage is noted contact your
Arthrex Customer Service. Contact the
Manufacturer for Return Authorization PRIOR to
shipping your device for service. Save ALL
packaging materials; they may be needed to
verify any claims of damage by the shipper.
1.8 Returning the Device
If it becomes necessary to return the device,
always use the original packaging. The
manufacturer does not take responsibility for
damage that has occurred during transportation
if the damage was caused by inadequate
transport packaging. Please make sure that all
required information has been supplied. Call
Arthrex for an RMA Number for the device return
for service.
• Owner’s Name
• Owner’s Address
• Owner’s Daytime Telephone Number
• Device type and model.
• Serial Number
• Detailed explanation of the damage.
NOTE:
The device shall be cleaned per section
Cleaning and Sterilization prior to returning for
service.
Equipment will not be repaired unless
decontaminated as stated above prior to return
to the manufacturer.