Arthrex SynergyRF AR-9800, Service Manual

Page: 7 / 56

General Warnings, Training and Safety Notices - Read This First
Synergy
RF ™
System Service Guide
DFU-0276-4r0_fmt_en-US Page 1 of 50
1.0 General Warnings, Training and Safety Notices - Read
This First
It is imperative that the symbols and conventions listed below be clearly understood.
The
Synergy
RF
Service Guide identifies critical, important, and useful information using
these symbols and conventions.
1.1 Important Safety Conventions
Warnings and safety conventions follow IEC 60601-1 and IEC 60601-2-2.
Users of this device are encouraged to contact their Arthrex representatives if
they require a more comprehensive surgical technique.
W A R N I N G !
The WARNING! is the most important safety symbol. It identifies critical
information that must be followed precisely to avoid injury or death.
1. Caution: Federal law restricts this device to sale by or on the order of a
physician.
2. This device is intended to be used by a trained medical professional.
3. Failure to follow set up instructions and/or continuing to use the console
(AR-9800) without resolving an alarm could result in a serious patient
adverse event.
4. Failure to adhere to the set up instructions and use of Arthrex certified
devices may result in inaccurate sensing and feedback by the device. It is
imperative that the user is aware of the potential compromise in patient
safety when an alarm on the console is ignored or silenced incorrectly.
NEVER ignore or silence alarms. Follow appropriate troubleshooting
procedures and carefully monitor the patient. Only Arthrex certified devices
must be used.
5. This device is only for use in normal arthroscopic procedures as described in
the User’s Guide, 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.
6. No modification of the console (AR-9800) or accessories are allowed.
7. DO NOT open or attempt to service this system, as this may void your
warranty. There are no user-serviceable parts inside. Removing the
cover may introduce an electric shock hazard by exposing you to