MIXIGUN®Bone Cement

Mixing and Dispensing

System

The Combination of Mixing and Delivery

Vacuum Mixing of Bone CementSince the introduction of bone cement to ortho-pedics, many advancements have been made in terms of improving the quality of the cement mantle surrounding the implant.

Improved Cement QualityStudies1,2,3 have shown that bone cement fail-ure in a total joint replacement most often re-sults from cracks propagating from pores in the cement mantle. Therefore, major efforts have been dedicated to the reduction of bone cement porosity.

Through their documented ability to reduce bone cement porosity, vacuum mixing systems are today recognized as a means to increase the longevity of the cement mantle.4,5

Improved Working EnvironmentBy eliminating the amount of methyl-meth-acrylate fumes that are released into the OR,⁵ the use of vacuum mixing systems provides a safer working environment for OR staff.

The Combinationof Mixing and DeliveryWhile traditional vacuum mixing systems rely on the re -processing of metal cement guns, the-MIXIGUN Bone Cement Mixing and Dispensing System introduces a unique two-in -one design. MIXIGUN Bone Cement Mixing and Dispensing System combines the clinical benefits of vacuum mixing with the convenience of one single use, fully disposable product.

This new mixing/injecting design concept helps reduce both time and cost. With MIXIGUN Bone Cement Mixing andDispensing System, there is no time and cost as-sociated with the handling, cleaning and sterile re-processing of a reusable metal cement gun after the procedure. Furthermore, the logistical organization prior to surgery to ensure the avail-ability of the reusable gun as well as cement gun maintenance are eliminated.

The MIXIGUN Bone Cement Mixing and Dis-pensing System is designed to mix acrylic bone cements under vacuum. The vacuum hose is connected and vacuum pump activated pri-or to the insertion of the cement components into the system. The suction created draws the methyl-methacrylate fumes into the active car-bon filter rather than released into the operating theatre.

Design RationaleAt a Glance

Vacuum Mixing System • Suction applied prior to introduction of both

bone cement components (powder and liquid)

Provides flexibility in choice of bone cement• Mixes high, medium and low viscosity

bone cement• Up to 80g of bone cement

Ergonomic• Lightweight design• Metal mixing handle provides a high stabili-

ty during mixing• High cement injection pressure achieved

with low effort

Fully Disposable• Unique Mixing/Injection Design• No logistical handling of separate metal gun• No sterile processing required (reduced

costs)• Vallidated industrial sterilization

Adaptable to various application areas• Available in 3 configurations

Hip, Knee and Hybrid• Separate nozzles available

Short, Long and Slim

Limited environmental impact• Made entirely of recyclable materials• No detergents needed for cleaning of a

metal reusable gun

Inner Funnel(Liquid)

Outer Funnel(Powder)

Vaccum Tube

Cylinder

Mixing Handle

Base

Piston Release Pin

Locking Pinn

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Instructions for UseStep 1

Step 5

Step 9

Step 2

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Step 10

Step 3

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Step 11

Step 4

Step 8

Step 12

Step 1:Start - Position:Pull out the mixing rod 5cm-7cm. Set the mixing rod into the base and lock into position using the support. Unscrew the top plug and set aside for later use.

Caution: Make sure that the base rests on a flat and steady surface.

Step 5: Powder - Filling:Detach and dispose the funnel. Thread the plug into cylinder top until tight.

Caution: Ensure the plug is tight.

Step 9:Dispense Mode - Engage Pull the mixing rod to its rearmost position. Remove and dispose piston release pin.

Step 2: Funnel -Vacuum Tubing:Put the dual funnel into place. Connect the vacuum tube fitting to the top of the cylinder.

Caution: Make sure that the out-er funnel is securely seated into the cylinder top.

Step 6:Mixing - Start:Detach MIXIGUN System from the base. Usingthe mixing han-dle, move the mi xing rod back and forth with rotating action.

Step 10: Dispense Mode - En-gageWhile holdingthe Mixigun, rotate the cylinder (either direction) to a full stop.

Step 3: Monomer - Filling: Start the vacuum pump. Fill the monomer.

Caution: Use vacuum during filling monomer. This significantly reduces exposure to monomer fumes.

Step 7:Nozzle - Select:Stop the vacuum pump and remove the vacuum tube fitting. Unscrew and dispose the plug.

Step 11: Dispensing - ReadyRemove and dispose the locking pin.

Caution: Make sure that the mix-ing rod is parked at its rearmost position before removing the locking pin.

Step 4: Powder - Filling:Detach the inner funnel. Fill the cylinder with bone cement powder.

Step 8:Nozzle - Select:Select nozzle and screw firmly in place.

Step 12:Dispensing - ReadyThe gun is now ready for dis-pensing.

Caution: The bone cement must be extruded wellwithin the work-ing phase period. Injection of bone cement at or near set time may cause cartridge to fracture.

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Product Family Mixigun Sets

Knee HybridHip

Contents• 2 mixing/dispensing systems• 2 dual funnels• 1 short nozzle• 1 long nozzle• 1 femoral pressurizer• 1 obturator• 1 base• 1 vacuum tubing set with charcoal filter

Separate NozzlesMIXIGUN Nozzles are packaged sterile individually and·sold in boxes of 5 nozzles. Available in Short, Long, Slim

ShortLength: 80 mmD: 11.9 mm

Vacum PumpsMIXIGUN Bone Cement Mixing and Dispensing System is designed to be used with the Promixa Vacuum Foot Pump.

LongLength: 210 mmD: 12 mm

SlimLength: 130 mmD: 8.5 mm

Contents• 1 mixing/ dispensing system• 1 dual funnel• 1 short nozzle• 1 obturator• 1 base• 1 vacuum tubing set with charcoal filter

Contents• 1 mixing/dispensing system• 1 dual funnel• 1 lo ng nozzle• 1 femoral pressurizer• 1 obturator• 1 base• 1 vacuum tubing set with charcoal filter

Ordering Information

MIXIGUN® Sets

MIXIGUN® Nozzles

MIXIGUN® Vaccum Pumps

Contact or Visit us at www.promixa.eu

Promixa Medical AB Traktorvägen 15226 60 Lund Sweden

Phone: +46 (0)46 245 50 00e-mail: info@promixa.eu

REF. NO Description Unit of Quantity50350 MIXIGUN ® System Hip 1/ Ea.50360 MIXIGUN ® System Knee 1/ Ea.50370 MIXIGUN ® System Hybrid 1/ Ea.

REF. NO Description Unit of Quantity50381 MIXIGUN ® Nozzle - Short 5/ Ea.50382 MIXIGUN ® Nozzle - Long 5 / Ea.50383 MIXIGUN ® Nozzle - Slim 5/ Ea.

REF. NO Description Unit of Quantity 50390 Promixa Pump with Schrader wall coupling 1/ Ea.

References1 McCormack BAO, Prendergast, PJ. Microdamage accumulation in the cement layer of hip replacements under flexural loading. Journal of Biome chanics 32 (1999) 467- 47522 James S, Jatsy M, Davies J, Piehler H, and Harris W. A fractographic investigation of PMMA bone cement focusing on the relationship between porosity reduction and increased fatigue life. Journal of Biomedical Materials Research ,Vol. 26 1992,651-66323 Topolesk i LDT, Ducheyne P, Cuckler JM. A fractographic analysis of in vivo poly(methyl methacrylate) bone-cement failure mechanisms. Journal of Biomedical Materials Research 24 (2) 1990, 135-154⁴ Malchau H, Herberts P (1996) Prognosis of total hip replacement; surgica t and cementing technique in THR: a revision-risk study of 134 056 primary operations. 63 rd Annual Meeting of the AAOS, February 22-26, Atlanta, USA⁵ Horas U, Seidel P, Baumann G, Kilian 0, Dingeldein E, Schnettler R. Factors Influencing the App licatio n of Vacuum Mixing Systems for Bone Cement Completion. Osteo TraumaCare 2002; 10; 106-112

* MlXIGUN® is a trademark of Promixa Medical AB, Sweden

Disclaimer

This documentation is intended exclusively for physicians and is not intended for lay persons.Information on the products and procedures contained in this document is of a general nature and does not represent and does not constitute medical advice or recommendations. Because this information does not purport to constitute any diagnostic or therapeutic statement with regard to any individual medical case, each patient must be examined and advised individually, and this document does not replace the need for such examination and/ or advice in whole or in part.Please refer to the package inserts for important product information, including, but not limited to, contraindications, warnings, precautions, and adverse effects.

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