Arthrex Synergy AR-9800, User Manual

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General Warnings, Training and Safety Notices - Read
This First
Synergy
RF™
User’s Guide
DFU-0221-6r0_fmt_en-US
Page 7 of 58
cover may introduce an electric shock hazard by exposing you to
dangerously high voltages or other risks. If the system malfunctions,
return it for service immediately.
8. To avoid the RISK of electric shock, this equipment must only be connected
to a SUPPLY MAIN with Protective Earth Terminal.
9. DO NOT stack or place equipment adjacent to the AR-9800 console, if
possible. If such a configuration is necessary, carefully observe the
configuration in question to ensure that electromagnetic interference does not
degrade performance.
10. Use only Arthrex approved 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.
11. DO NOT use in the presence of flammable anesthetics or oxidizing gases
such as nitrous oxide, oxygen, or endogenous gases. All oxygen connections
must be leak free for the duration of the surgical procedure.
12. Do not have the device in direct contact with the patient, if the patient
requires defibrillation.
13. The safety and effectiveness of the AR-9800 is verified and documented;
however, the AR-9800 must be used with an awareness of the risk of damage
to surrounding tissue through iatrogenic injury.
14. Always start with the lowest possible power setting to achieve the desired
effect.
15. Small electric arcs between the active electrode and tissue being resected can
produce low-frequency current that may produce local neuromuscular
stimulation. Per standard of care, ensure that the patient’s arms and/or legs
are supported appropriately.
16. Biohazard waste, such as explanted devices, needles and contaminated
surgical equipment, should be safely disposed of in accordance with the
institutions policy.
17. Serious incidents should be reported to Arthrex Inc., or an in-country
representative, and to the health authority where the incident occurred.