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The Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are intended to enclose and organize Stryker Endoscopy reusable medical instruments during sterilization at a healthcare facility. The trays are optional accessories to the Stryker Endoscopy instruments for which they are not intended to mantain sterlity; they are intended to be used in conjunction with legally marketed, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices. The Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are intended for use in any of the following standard sterilization machines / cycles: | No | Method | Cycle | |----|-----------------------|----------------------------| | 1 | Ethylene Oxide (EtO) | Preconditioning Parameters | | | | Temperature (°C) | | | | 55°C (131°F) | | | | Chamber Humidity | | | | 70% RH | | | | Vacuum Set Points | | | | 1.3 psia | | | | Time | | | | 30 minutes | | | | Exposure | | | | Concentration | | | | 725 mg/L, 100% EO | | | | Temperature (°C) | | | | 55°C ±2°C (131°F ±5°F) | | | | Time | | | | 1 hour | | | | Chamber Humidity (%) | | | | 70% RH (50-80%) ±5% | | | | Aeration | | | | Aeration Time | | | | 12 hours | | | | Temperature | | | | 35°C - 54°C (95°F - 129°F) | | 2 | Prevacuum Steam | Cycle 1 | | | | Cycle 2 | | | | Wrapping | | | | Double | | | | Double | | | | Temperature | | | | 132°C (270°F) | | | | 134°C (273°F) | | | | Sterilization Time | | | | 4 minutes | | | | 3 minutes | | | | Dry Time | | | | 30 minutes | | | | 30 minutes | | 3 | Gravity Steam | Cycle 1 | | | | Cycle 2 | | | | Wrapping | | | | Double | | | | Double | | | | Temperature | | | | 132°C (270°F) | | | | 134°C (273°F) | | | | Sterilization Time | | | | 15 minutes | | | | 10 minutes | | | | Dry Time | | | | 30 minutes | | | | 30 minutes | | 4 | STERIS® V-PRO® 1 | Standard | | 5 | STERIS® V-PRO® 1 Plus | Non-Lumen or Lumen | | 6 | STERIS® V-PRO® maX | Non-Lumen or Lumen | | 7 | STERRAD® 100S | Standard | | 8 | STERRAD® NX® | Standard | | 9 | STERRAD® 100NX® | Standard | In addition, the Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are validated for the following Immediate Use Steam Sterilization cycles for emergency situations ONLY. | Method | Cycle | Cycle 1 | Cycle 2 | |-------------------------------------------------------------------|--------------------|------------------|------------------| | Immediate Use Steam<br>Sterilization (“Flash”)<br>Prevacuum Steam | Wrapping | None | None | | | Temperature | 132°C<br>(270°F) | 134°C<br>(273°F) | | | Sterilization Time | 4 minutes | 3 minutes | | | Dry Time | None | None | The maximum product loads for the trays are as follows: | Tray Description | Catalog Number | Maximum Tray<br>Product Load | Total Loaded<br>Tray Weight | |----------------------------------------------------|----------------|---------------------------------------------------------------------------------------------------|-----------------------------| | Advanced Imaging Modality (AIM) Sterilization Tray | 0233-032-301 | Camera (Qty. 1)<br>Light Cable (Qty. 1)<br>Coupler (Qty. 1)<br>Scope (Qty. 2)<br>Adapter (Qty. 2) | 10.58 lbs | | Endoscope and Camera Sterilization Tray | 233-032-302 | Camera (Qty. 1)<br>Light Cable (Qty. 1)<br>Coupler (Qty. 1)<br>Scope (Qty. 2)<br>Adapter (Qty. 2) | 10.58 lbs | | Camera Sterilization Tray | 0233-410-002 | Camera (Qty. 1)<br>Light Cable (Qty. 1)<br>Coupler (Qty. 1) | 8.83 lbs | * Validated worst case loading configuration included the Advanced Imaging Modality (AIM) Sterilization Tray containing a camera (Qty. 1), light cable (Qty. 1), coupler (Qty. 2), scope (Qty. 3) and adapter (Qty. 3).

The Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are stainless steel, perforated sterilization trays to allow sterilization gases to penetrate the tray and sterilize the enclosed devices. They are used to enclose and protect particular Stryker endoscopy products during sterilization. The tray is compatible with the following sterilization methods: - Ethylene Oxide (EtO) - Prevacuum Steam, Immediate Use Prevacuum Steam, and Gravity Steam . - Steris V-PRO 1 (Standard Cycle), Steris V-PRO 1 Plus (Non-Lumen or Lumen Cycles), Steris V-. PRO maX (Non-Lumen or Lumen Cycles) - STERRAD 100S, STERRAD NX, and STERRAD 100NX (all with Standard Cycle) . The trays are not intended to maintain sterility; they are intended to be used in conjunction with legally marketed, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices. The trays are comprised of a stainless steel base and removable stainless steel lid. The base includes silicone brackets for Stryker endoscopy device fixation within the tray and two (2) latches to affix the lid to the base. Handles on the sides of the base facilitate carrying of the trays are reusable and provided in a non-sterile condition.

Paragon Medical's Surgical Instrument Delivery Systems are containment devices for medical device sterilization, The Systems are constructed of metal and/or plastic with perforations to facilitate steam penetration. They are to be used with an approved sterilization wrap. Sterilization Cycle: Prevacuum 132°C for 4 minutes Dry Time 20-40 minutes

Paragon Medical Surgical Instrument Delivery Systems consist of various sizes of metal, plastic, and combination cases and trays with removable lids. The devices are intended to hold and protect medical instrumentation or devices during steam sterilization processes and subsequent storage and transportation. The products are constructed of durable materials and designed with perforations or slots to allow for steam penetration. They are to be used with an appropriate sterilization wrap.