BIOMET OPTIVAC VACUUM MIXING SYSTEM User manual

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 Specic nozzles
Reference Specic
Cartridge(s)
Reference Specic
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

0459
I-417000-15
ECR 20121201
Last revision 2013/01
INTENDED USE
• Mixing and collecting PMMA “polymethylmethacrylate” bone cement under vacuum
• Deliver the PMMA “polymethylmethacrylate” bone cement
Mixing takes place in a partial vacuum (0.15 bar), resulting in an almost non-porous cement with improved fatigue strength. The closed system mini-
mizes the amount of free monomer in the operating theatre; the application method eliminates direct contact with the cement.
WARNINGS:
Do not use with any instruments other than those dened in the chapter ASSOCIATED MEDICAL DEVICES.
Do not use knee nozzle breakaway for hip femoral surgery.
The application of an excessive force on the nozzles may lead to unexpected breaking of the removable part.
USER INFORMATION
See operating instructions on the lid of the blister.
SHELF LIFE AND STERILITY
OPTIVAC Vacuum Mixing Systems are delivered sterilized by beta irradiation, min 25 kGy.
The expiration date is printed on the label.
SAFETY PRECAUTIONS
Do not use products after the expiration date.
This product is for single use only and has not been designed or tested for re-use.
Do not attempt to clean or re-sterilize the product due to the risk of cross infection and/ or possible alterations in the product performance.
Packaging must not show signs that could indicate a defect in the sterility and/or integrity of the medical device.
Never use a damaged product.
When handling products in the operating room, all necessary precautions must be taken to avoid damaging them.
This system must be used by a trained orthopaedic surgeon or trained nurse taking into account the step by step IFU on the lid.
The non-used products without initial packaging must be thrown out.
Optivac and its components must not be used in conjunction with other companies mixing systems.
Before using Optivac, the user must be thoroughly familiar with its properties, handling and use and should have read the instructions for use as well
as the instructions for use for the chosen bone cement.
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.
Once used, the system must be handled by the proper disposal channel for infectious health care wastes
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
Manufacturer: Biomet France
Plateau de Lautagne, BP75
26903 Valence Cedex 9, FRANCE
Tel: [phone] Fax: [phone]
Distributor: Biomet Orthopedics, Inc., P.O. Box 587, Warsaw, IN 46581-0587
Tel: [phone], Fax: [phone]
Web site: www.biomet.com, email: [email protected]
All trademarks herein are the property of Biomet Inc or one of its subsidiaries unless otherwise indicated.
Patents U.S. 5 328 262, U.S. 5 501 520
Warning, see instruction leaet
Do not reuse
Batch code
Catalogue reference
Use by
Sterilized by irradiation