Arthrex SynergyRF AR-9800, Руководство по обслуживанию

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General Warnings, Training and Safety Notices - Read This First
Synergy
RF ™
System Service Guide
DFU-0276-4r0_fmt_en-US Page 4 of 50
19. Refer to the Instructions for Use package insert Apollo
RF®
disposable devices
(DFU-0242-XX) for detailed device cleaning and sterilization instructions
included with each device Additional copies of this insert can be obtained
from the Arthrex website at www.arthrex.com , or by contacting your local
Arthrex Representative.
NOTE : This identifies information and training that can simplify the setup
and operation of this device.
1. If required by local regulations connect the console to the hospital equalization
connector with an equipotential cable. Connect the power cord to a wall outlet
having the correct voltage. Otherwise, product damage may result.
(The equipotential connector provided complies with IEC 60601-1:2005/A1:2012. The proper
use of equipotential cables and equipotential earthing systems must be governed by local
hospital and regulatory requirements)
2. The AR-9800 console incorporates a universal AC input power supply. A voltage
selection switch is not required.
3. AR-9800 has been designed to maintain safe operation when subjected to
Electromagnetic Interference from other devices within the limitations as described in
section 10.
4. Setup for a footswitch is the same for all models. The console detects which version is
attached and allows appropriate functions.
5. Surgeons are advised to review the product specific surgical technique prior to
performing any surgery. Arthrex provides detailed surgical techniques in print,
video, and electronic formats. The Arthrex website also provides detailed surgical
technique information and demonstrations. Or, contact your Arthrex representative
for an onsite demonstration.
1.2 Information
In EU Only : Procedures carried out using these devices may be used on the
general population.
In EU Only: The clinical benefits associated with the use of these devices
outweigh the known clinical risks.
In EU Only: There are no unacceptable residual risks or uncertainties associated
with the clinical use of these devices.