0459
I-417000-15
ECR 20121201
Last revision 2013/01
OPTIVAC VACUUM MIXING SYSTEM
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 lters
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 OPTIVAC Normal capacity OPTIVAC Maximum capacity Specic nozzles
Reference Specic
Cartridge(s)
Reference Specic
Cartridge(s)
Total Hip Kit
40 g single mix
80 g double mix
417000 Long + Short 418000 Long + Short
+ Extender
2 breakaway nozzles
40 g, Single mix kit 417100 Short 418100 Long 1 breakaway nozzle
1 knee nozzle breakaway
80 g, Double Mix Kit 417200 Long 418200 Short +
Extender
1 breakaway nozzle
1 knee nozzle breakaway
120 g, Triple Mix Kit 417300 Short +
Extender
418300 Long +
Extender
1 breakaway nozzle
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 at 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 ll 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 Reference
OPTIVAC Nozzles Slim 4154
Revision 4155
Right Angled 414900
Knee 4312
Small Diameter Cement 414991
OPTIGUN 419300
OPTIGUN RATCHET 419500
VACUUM PUMP 422800
REF 417000, 417100, 417200, 417300
REF 418000, 418100, 418200, 418300
Patents U.S. 5 328 262 , U.S. 5 501 520
Instruction for Use
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