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 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
OPTIVAC Normal capacity
OPTIVAC Maximum capacity Specific nozzles
Reference
Specific
Cartridge(s)
Reference
Specific
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 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
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