Description
Product Description and Intended Use
The Arthrex AR-8305 Synergy Resection Shaver System is a motorized,
suction/cutting device used for the resection and aspiration of soft tissue,
cartilage and bone during arthroscopic surgical procedures.
The console is microprocessor controlled and features two fully functional
channels that allow optional simultaneous handpiece operation. Both channels
can be operated with a single foot switch or individually when a second foot
switch is attached to the console. The Synergy Resection has a maximum speed
of 8,000 revolutions per minute providing precise burr control during surgical
procedures.
The Synergy Resection console is designed for continuous operation. The
handpieces are individually protected by a resetting thermal fuse. In the event of
a motor overload fault (e.g., excess current) the fuse heats up and the device is
deactivated. When the fault is removed and the fuse cools down (typically about
30 seconds) operation resumes at the pre-failure settings.
The cable and all handpieces can be sterilized, so handpieces can be changed
during the surgical procedure without endangering surgical sterility.
Technical Specifications
Console
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AR-8305 Console Specifications
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Width 40.64cm(16.00 inches)
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Height 13.335cm (5.250 inches)
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Depth 30.686cm (12.081 inches)
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Weight 6.8kg (15 lbs.)
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Water protection IP22
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Mains cable 10A/250 V
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Power entry module IEC 320/C13
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Fuse value 6.3 A, 250 V~, 50/60Hz, 6.3A
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Applied Part Type BF
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Cleaning, disinfecting and Refer to sections 6.0 Cleaning and Disinfecting
sterilization and 7.0 Sterilization
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Standard Footswitch Specifications
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Functions Reverse, Forward, Oscillation, Speed Increase,
and Toggle
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Width 23.6cm (9.3 inches)
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Height 2.5cm (1.0 inches)
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Depth 20.8cm (8.2 inches)
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Weight 2.2kg(5 lbs.)
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Water protection IP68
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Cleaning, disinfecting and Refer to sections 6.0 Cleaning and Disinfecting
sterilization and 7.0 Sterilization
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AR-8305 Ambient Conditions for Operation
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Temperature 10° to 40°C (50° to 104°F)
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Relative humidity 30 % to 75 %
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Air Pressure 700 hPa to 1060 hPa (21 in. Hg to 31.3 in. Hg)
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AR-8305 Ambient Conditions for Storage
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Temperature -30° to 70°C (-22° to 158°F)
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Relative humidity 10 % to 90 %, non-condensing
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Air Pressure 500 hPa to 1060 hPa (15 in. Hg to 31.3 in. Hg)
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Safety, EMC, and Regulatory Requirements
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Parameter
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Parameter Value
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System
Classification
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FDA Class
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Class 1
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EU Class
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Class IIA
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Health Canada Class
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Class 2
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Safety
Certifications
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Domestic Certification
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UL 60601-1:2003
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Canadian Certification
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CAN/CSA C22.2 No. 60601-1-2008-02
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EU Certification
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EN 60601-1:2006
IEC 60601-1 3rd Ed. + AM1 (2012)
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EMC
Certifications
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CISPR 11 EMC Class
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Class A
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CISPR 11 EMC Group
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Group 1
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EMC Certification
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IEC 60601-1-2:2014 Class A
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CE Markings
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MDD Classification
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CE Marking for MDD93/43/EEC
Class IIA
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MDD Marking
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Rule 9
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Ready to ship in 1-3 business days
from United States (US)
Shipping Policy
All of our products are professionally packaged to assure your items arrive safely.
