Arthrex NanoScope, Руководство пользователя, Страница: 6 / 44

General Warnings, Training and Safety Notices – Read This First
NanoScope Manual
DFU-0298-1, Revision 0 Page 2 of 38
4. Maintain a tested and functioning backup NanoScope Console to ensure
procedures can be completed in the event of equipment failure. Always ensure a
backup NanoScope Handpiece Kit is available in the event of damaged parts in
the original package or during use.
5. Do not use in the presence of flammable anesthetics, gases, disinfecting agents,
cleaning solutions, or any material susceptible to ignition due to electrical
sparking.
6. This device is only for use in normal arthroscopic or endoscopic purposes as
described in the User’s Guide.
7. Use this device only under the supervision of a trained and licensed physician.
This device should not be used by untrained personnel or used for indications
other than those described in this User’s Guide.
8.
Use only
Arthrex approved electronic accessories. Other accessories may result
in increased emissions or decreased immunity of the system. Contact your
Arthrex representative for a complete list of accessories.
DO NOT
modify any
accessory. Failure to comply may result in patient and/or operating room staff
injury.
9. Equipment grounding is vital for safe operation. Plug the power cord into a
properly earthed mains supply outlet whose voltage and frequency
characteristics are compatible with those listed on the unit or in this manual.
10. This equipment should not share an electrical outlet or grounding with life
supporting or life sustaining equipment.
11. If one or more mains powered units are connected simultaneously to one socket
by the means of a distribution box, the sum of the individual leakage currents
may exceed the tolerated limits.
12. Do not use if the package is damaged or previously opened.
13. Before use, the outer surfaces of the NanoScope Handpiece, cannula and user
accessories should be checked to ensure there are no unintended rough edges,
sharp edges or protrusions which may cause injury.
14. Applied Parts of other Medical Electrical Equipment used within the
configuration for Endoscopic Application shall be type BF or CF Applied Parts.
15. This equipment/system may cause radio interference or may disrupt the
operation of nearby equipment. It may be necessary to take mitigation measures,
such as re-orienting or relocating the NanoScope System or shielding the
location.
16. This equipment is
NOT
suitable for use in the presence of a flammable
anesthetic mixture with air or with oxygen rich or nitrous oxide environment.
17. No modifications of the NanoScope Console or NanoScope Handpiece Kits are
allowed.