We ve built a STRONG CASE. for changing the way you sterilize. Reusable Sterilization Container System

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Marcus Stewart
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1 We ve built a STRONG CASE for changing the way you sterilize. Reusable Sterilization Container System

Reusable Sterilization Container System Introducing the DePuy Synthes REUSABLE STERILIZATION CONTAINER SYSTEM Discover the solution designed to In a healthcare environment focused on cost

helping to minimize the impact on budget and the environment.

180 days. It is a container system validated to provide effective sterilization for DePuy Synthes Companies (Trauma, CMF, and Spine) instruments and implants.

2 Reusable Sterilization Container System Introducing the DePuy Synthes REUSABLE STERILIZATION CONTAINER SYSTEM Discover the solution designed to In a healthcare environment focused on cost optimization, waste reduction and infection control, the DePuy Synthes Companies of Johnson & Johnson now provide a solution that will meet your facility s sterilization needs while helping to minimize the impact on budget and the environment. This system offers an assortment of reusable containers that allow for the sterilization of the enclosed medical devices and maintain sterility of the devices until used, for a maximum of 180 days. It is a container system validated to provide effective sterilization for DePuy Synthes Companies (Trauma, CMF, and Spine) instruments and implants. Containers are available with either perforated or solid base. Silicone gasket secured with a stainless steel dual action latching mechanism. Single-use disposable filters provide 100% barrier efficacy with each use. Retention Plate Filter Offset perforated retention plates provide no direct path through the lid. Optional Protective Plate Lid Page 2

3 make a MATERIAL DIFFERENCE. Benefits and Cost Savings Compatibility with DePuy Synthes Sets * Blue Wrap Waste Reduction System is comprised of an anodized aluminum rivet-less case assembly. Extended sizes available for large orthopaedic sets. *For DePuy Synthes Companies (Trauma, CMF, and Spine) instrument and implant sets. Page 3

4 Reusable Sterilization Container System Benefits and Cost Savings Blue wrap can rip, which requires the set to be re-sterilized. When tears in blue wrap are discovered at the last minute, re-sterilization could mean more anesthesia time for the patient and additional cost and time added to the case. Over time the cost to purchase blue wrap, plus the labor time needed to wrap sets by hospital personnel, can add up to significant costs for the hospital. Switching to the DePuy Synthes Reusable Sterilization Container System can reduce overall hospital costs. Cost Analysis for the Reusable Sterilization Container System Costs to consider when comparing Reusable Sterilization Containers to Blue Wrap Capital Outlay for DePuy Synthes Containers Quantity X Average Container Price Extended Price Current Cost on Disposables (sterilization wrap, autoclave tape, waste removal) Cost/Processing Cycle X Number of Annual Cycles Total Annual Usage Cost on Current Disposables Disposable Cost for DePuy Synthes Containers (arrows, data cards, filters) Price/Box X Number of Boxes Total Annual Cost for DePuy Synthes Disposables ROI on capital outlay in years* Estimated 5 year savings Estimated 10 year savings Figure 1: Sample cost calculator to guide facility s specific analysis on possible cost reduction using the Reusable Sterilization Container System. This cost analysis is only for those sets that will be put into containers. *Ask your DePuy Synthes Sales Consultant for a detailed cost analysis for your facility. Compatibility with DePuy Synthes Sets Selecting a compatible container for an orthopaedic instrument/implant set involves not only validation testing, but also ensuring the sets are within the cleared indications of the container. The number of indicated lumens, materials, and the volume-to-vent ratio are some of the key considerations when choosing a proper container. The DePuy Synthes Reusable Sterilization Container System reduces the ambiguity of set sterility by ensuring compatibility with all DePuy Synthes Trauma, CMF, and Spine sets. Page 4

Blue Wrap Waste Reduction Reusable Sterilization Containers provide an economical solution by

facilities to achieve cost savings. Did you know?

1 Over the course of about three years, by switching over from blue wrap to sterilization

6 cubic yards of landfill, more than enough to approximately fill a football field!

Do the math The opportunity to decrease waste (and waste-related costs) exists with the DePuy

A full portfolio of sizes is available in both perforated and non-perforated configurations to

5 Blue Wrap Waste Reduction Reusable Sterilization Containers provide an economical solution by reducing the volume of blue wrap disposed of in landfills or incinerated while also allowing facilities to achieve cost savings. Did you know? Approximately 19% of the waste stream generated by surgical services is blue sterile wrap. 1 Over the course of about three years, by switching over from blue wrap to sterilization containers, 2 one hospital estimated a reduction in waste of cubic yards of landfill, more than enough to approximately fill a football field! There are over 5000 hospitals in the US and Canada. Do the math The opportunity to decrease waste (and waste-related costs) exists with the DePuy Synthes Reusable Sterilization Container System. A full portfolio of sizes is available in both perforated and non-perforated configurations to suit your facility s sterilization needs. 1. Reusable totes, blue wrap recycling and composting. Environmental best practices for health care facilities, November 2002 JHACO environment of care standards Going from blue to green. April 2011 Page 5

Reusable Sterilization Container System PRODUCT PART NUMBERS Descriptions and Dimensions DePuy Synthes DePuy Synthes Volume to Vent Weight Outer Dimensions Inner Dimensions* Part Number Part

4 x 4.5 21.0 x 11.4 x 4.2 62.006.002 Full-Two Level, Perforated Base 31 8.8 23.1 x 12.4 x 5.3 21.0 x 11.4 x 5.1 62.006.003 Full-Three Level, Perforated Base 42 9.4 23.1 x 12.4 x 7.0 21.0 x 11.4 x 6.

6 Reusable Sterilization Container System PRODUCT PART NUMBERS Descriptions and Dimensions DePuy Synthes DePuy Synthes Volume to Vent Weight Outer Dimensions Inner Dimensions* Part Number Part Description Ratio (in 3 /in 2 ) (lbs.) (L x W x H), in. (L x W x H), in. PERFORATED BASE CONTAINERS (Require the Use of Lifting Platform) Full-One Level, Perforated Base x 12.4 x x 11.4 x Full-Two Level, Perforated Base x 12.4 x x 11.4 x Full-Three Level, Perforated Base x 12.4 x x 11.4 x Extended-Four Level, Perforated Base x 12.4 x x 11.4 x Extended-Five Level, Perforated Base x 12.4 x x 11.4 x 9.4 SOLID BASE CONTAINERS Full-One Level, Solid Base x 12.4 x x 11.4 x Full-Two Level, Solid Base x 12.4 x x 11.4 x Full-Three Level, Solid Base x 12.4 x x 11.4 x Extended-Four Level, Solid Base x 12.4 x x 11.4 x Extended-Five Level, Solid Base x 12.4 x x 11.4 x 9.4 LIFTING PLATFORMS Lifting Platform for Full Container Not Applicable x 10.6 x x 10.2 x Lifting Platform for Extended Container Not Applicable x 10.6 x x 10.2 x 0.7 * The use of a Lifting Platform will reduce the container inner functional height by 0.5 inch. Page 6

Additional Items Part Number DePuy Synthes Part Description CONSUMABLES 62.010.002 Filters (1,000 pcs) 62.010.004 Tamper Evident Arrows (1,000 pcs) 62.010.005 Data Cards (500 pcs) REPLACEMENT PARTS Lids 62.

006.033 Perforated Base for Full-Three Level Container 62.009.034 Perforated Base for Extended-Four Level Container 62.009.035 Perforated Base for Extended-Five Level Container 62.016.

7 Additional Items Part Number DePuy Synthes Part Description CONSUMABLES Filters (1,000 pcs) Tamper Evident Arrows (1,000 pcs) Data Cards (500 pcs) REPLACEMENT PARTS Lids Lid for Full Sterilization Container Lid for Extended Sterilization Container Bases Perforated Base for Full-One Level Container Perforated Base for Full-Two Level Container Perforated Base for Full-Three Level Container Perforated Base for Extended-Four Level Container Perforated Base for Extended-Five Level Container Solid Base for Full-One Level Container Solid Base for Full-Two Level Container Solid Base for Full-Three Level Container Solid Base for Extended-Four Level Container Solid Base for Extended-Five Level Container Filter Retention Plates Optional Protective Plate Filter Retention Plate, Top Filter Retention Plate, Bottom Page 7

Reusable Sterilization Container System This is the only container system validated for the DePuy Synthes Companies (Trauma, CMF, and Spine) instruments and implant sets that provides: Benefits and

visit www.depuysynthes.com. * For DePuy Synthes Companies (Trauma, CMF, and Spine) instrument and implant sets. Indications (See User s Manual for complete indications.

8 Reusable Sterilization Container System This is the only container system validated for the DePuy Synthes Companies (Trauma, CMF, and Spine) instruments and implant sets that provides: Benefits and Cost Savings Compatibility with DePuy Synthes Sets * Blue Wrap Waste Reduction To learn more about the DePuy Synthes Reusable Sterilization Container System, contact your DePuy Synthes Consultant or visit * For DePuy Synthes Companies (Trauma, CMF, and Spine) instrument and implant sets. Indications (See User s Manual for complete indications.) The DePuy Synthes Reusable Sterilization Container System is a device intended to be used to enclose other medical devices to be sterilized by healthcare facilities. It allows sterilization of the enclosed medical devices and maintains sterility of the devices until used for a maximum of 180 days. DePuy Synthes containers are suitable for dynamic air removal (pre-vacuum) steam sterilization when used according to the instructions for use. Reusable lifting platforms are intended to hold enclosed medical devices above the filter areas of perforated base containers during sterilization and storage of the containers. Data cards are used to record information regarding a specific sterilization process load. Filter media allow ingress and egress of sterilant while providing a microbial barrier. Tamper evident arrows provide a visual indication that the container system has not been inadvertently opened prior to use. Each arrow contains a modalityspecific (pre-vacuum steam) external process indicator that serves as a visual indication that the system has been exposed to a specific sterilization cycle parameter. Data cards, filters, and tamper evident arrows are single use only. Sterilization Method Cycle Parameters Total System Weight Types of Medical Devices and Materials Validated for Use with DePuy Synthes Container Dynamic Air Removal (Pre-Vacuum) Steam Exposure Temperature: 270 F (132 C) Pre-Conditioning Pulses: 3 Exposure Time: 4 Minutes Minimum Dry Time Cycle: 30 Minutes Minimum Cool Time: 60 minutes (may vary according to load contents) Stacking Not Permitted 25 lbs. (Container plus contents) Orthopaedic Medical Devices including Lumen (Cannulated) Devices; Devices or Device Configurations with conjoined surfaces which meet, touch or unite; Mated Surfaces. Materials: Intrinsically stable metals. Composites, thermoplastics and thermosetting polymers with constant use temperatures above 135 C. WARNING: In the USA, this product has labeling limitations. See User s Manual for complete information. CAUTION: Some products listed in this brochure may not have been licensed in accordance with Canadian law and may not be for sale in Canada. Please contact your sales consultant for items approved in Canada. Synthes USA Products, LLC 1302 Wrights Lane East West Chester, PA USA Synthes USA, LLC 1101 Synthes Avenue Monument, CO USA Note: For recognized manufacturer, refer to the product label. To order (USA): (800) To order (Canada): (800) DePuy Synthes All rights reserved. DSUS/MOC/1215/0368 1/16 DV

REUSABLE STERILIZATION CONTAINER SYSTEM.

REUSABLE STERILIZATION CONTAINER SYSTEM. Validated container system for the DePuy Synthes Companies (Trauma, CMF, and Spine) instrument and implant sets. USER'S MANUAL TABLE OF CONTENTS INTRODUCTION Product