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Instruction for Use
OPTIVAC VACUUM MIXING SYSTEM
REF 417000, 417100, 417200, 417300
REF 418000, 418100, 418200, 418300
Before using the OPTIVAC Vacuum Mixing System, this insert should be read through.
DESCRIPTION
OPTIVAC is a vacuum mixing and application system for PMMA "polymethylmethacrylate" bone cement. This system is for single use only and sup-
plied sterile.
OPTIVAC consists of:
• Cartridge(s); available in 3 sizes
• Breakaway nozzle(s) and/or breakaway knee nozzle(s)
• Funnel, sterile line set with charcoal filters
These components are plastic parts in accordance with NF EN ISO 16061 and NF EN ISO 10993-1.
OPTIVAC is available in 8 versions (4 for normal capacity and 4 for maximum capacity):
OPTIVAC
Total Hip Kit
40 g single mix
80 g double mix
40 g, Single mix kit
80 g, Double Mix Kit
120 g, Triple Mix Kit
The breakaway knee nozzle is intended to be used during knee surgery.
The breakaway knee nozzle enables the user to apply an even layer of cement. The flat portion of the nozzle can be manually removed (no need to
use the nozzle cutter). By breaking it off, the remaining round nozzle can be used to fill the cavities.
All components are packed in an inner blister pack, where the bottom of the tray serves as a tool tray. The blister pack is placed in a polyethylene-
Tyvek pouch.
ASSOCIATED MEDICAL DEVICES
Name
OPTIVAC Nozzles
Slim
Revision
Right Angled
Knee
Small Diameter Cement
OPTIGUN
OPTIGUN RATCHET
VACUUM PUMP
0459
Patents U.S. 5 328 262 , U.S. 5 501 520
OPTIVAC Normal capacity
OPTIVAC Maximum capacity
Reference
Specific
Reference
Cartridge(s)
417000
Long + Short
418000
417100
Short
418100
417200
Long
418200
417300
Short +
418300
Extender
Reference
4154
4155
414900
4312
414991
419300
419500
422800
Specific nozzles
Specific
Cartridge(s)
Long + Short
2 breakaway nozzles
+ Extender
Long
1 breakaway nozzle
1 knee nozzle breakaway
Short +
1 breakaway nozzle
Extender
1 knee nozzle breakaway
Long +
1 breakaway nozzle
Extender
I-417000-15
ECR 20121201
Last revision 2013/01
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Summary of Contents for BIOMET OPTIVAC VACUUM MIXING SYSTEM
- Page 1 REF 417000, 417100, 417200, 417300 REF 418000, 418100, 418200, 418300 Before using the OPTIVAC Vacuum Mixing System, this insert should be read through. DESCRIPTION OPTIVAC is a vacuum mixing and application system for PMMA “polymethylmethacrylate” bone cement. This system is for single use only and sup- plied sterile.
- Page 2 Temperature and humidity: No special storage requirements. Before removal of the blue plug, the vacuum pump shall always be disconnected. If in doubt as to the use of OPTIVAC Vacuum Mixing Systems or related products, please contact Biomet. DISPOSAL OPTIVAC components must be disposed of after use and never reused.
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