Kimguard Smart-Fold Sterilization Wrap

KIMGUARD* Smart Fold* Sterilization Wrap (KC450 and KC650) is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using:

Advanced Sterilization Products’ STERRAD® Sterilization Systems that include:

STERRAD® 100S

STERRAD® NX® [Standard Cycle, Advanced Cycle]

STERRAD® 100NX®). [Standard Cycle, Flex Cycle, EXPRESS cycle, DUO Cycle]

KIMGUARD* Smart Fold* Sterilization Wraps (KC450 and KC650) are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.

Test results validated that KIMGUARD* Smart Fold* Sterilization Wrap (KC450 and KC650) allowed sterilization of the enclosed devices by the Advanced Sterilization Products STERRAD® Sterilization Systems (STERRAD® 100S, NX® [Standard Cycle and Advanced Cycle], and 100NX®. [Standard Cycle, Flex Cycle, EXPRESS cycle, DUO Cycle]). (Refer to the STERRAD® Sterilization System User’s Guide for complete instructions on load(s) and cycle(s), including chamber loading instructions.)

The KC450 and KC650 models of the KIMGUARD* Smart Fold* Sterilization Wrap have been validated for use with the STERRAD® 100S, STERRAD® NX®, and STERRAD® 100 NX® cycles in Table 1.

TABLE 1: Validated Advanced Sterilization Products (ASP) STERRAD® 100S, STERRAD® NX®, and STERRAD® 100NX® Cycles

ASP STERRAD® System and Cycle — Intended Load

STERRAD® 100S: Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load:

An inside diameter of 1 mm or larger and a length of 125 mm or shorter of single-channel stainless steel lumens.

An inside diameter of 2 mm or larger and a length of 250 mm or shorter of single-channel stainless steel lumens.

An inside diameter of 3 mm or larger and a length of 400 mm or shorter of single-channel stainless steel lumens.

An inside diameter of 6 mm or larger and a length of 310 mm or shorter of single-channel Teflon/Polyethylene lumens.

STERRAD® NX® Standard Cycle: Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load:

An inside diameter of 1 mm or larger and a length of 150 mm or shorter of single-channel stainless steel lumens.

An inside diameter of 2 mm or larger and a length of 400 mm or shorter of single-channel stainless steel lumens.

STERRAD® NX® Advanced Cycle: Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load:

An inside diameter of 1 mm or larger and a length of 500 mm or shorter of single-channel stainless steel lumens.

OR

One single-channel Flexible Endoscope with or without a silicone mat and no additional load. The flexible endoscope may contain:

A single-channel Teflon®/Polyethylene lumen with an inside diameter of 1 mm or larger and a length of 850 mm or shorter.

STERRAD® 100NX® Standard Cycle: Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load:

An inside diameter of 0.7 mm or larger and a length of 500 mm or shorter of single-channel stainless steel lumens. (A maximum of two flexible endoscopes, one per tray per sterilization cycle.)

STERRAD® 100NX® Flex Cycle: One or two single-channel Flexible Endoscope with or without a silicone mat and no additional load. The flexible endoscope may contain:

A single-channel Teflon®/Polyethylene lumen with an inside diameter of 1 mm or larger and a length of 850 mm or shorter. (A maximum of two flexible endoscopes, one per tray per sterilization cycle).

STERRAD® 100NX® EXPRESS Cycle: Non-lumened reusable metal and non-metal devices requiring surface sterilization, and sterilization of diffusion-restricted spaces such as the hinged portions of forceps and scissors, and rigid or semi-rigid endoscopes without lumens.

STERRAD® 100NX® DUO Cycle: One or two single-channel Flexible Endoscope with accessory devices that are normally connected to it, with or without a silicone mat. The flexible endoscope may contain:

A single-channel Teflon®/Polyethylene lumen with an inside diameter of 2 mm or larger and a length of 250 mm or shorter.

Accessory devices that are normally connected to a flexible endoscope during use.

Flexible endoscopes without lumens.

KIMGUARD* Smart Fold* Sterilization Wrap Recommendations for Use with the Advanced Sterilization Products STERRAD® Sterilization Systems are provided in Table 2.

TABLE 2: Recommended Loads for KIMGUARD* Smart-Fold* Sterilization Wrap for use with Advanced Sterilization Products (ASP) STERRAD® Sterilization Systems (STERRAD® 100S, NX® [Standard Cycle, Advanced Cycle], and 100NX® [Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle])

KIMGUARD* Smart Fold* Sterilization Wrap Models — Intended Loads — Maximum Wrapped Package Content Weights Used in Sterility Maintenance Validation Study — Description of Loads Used in Sterility Maintenance Validation Study

KC450 — Moderate to heavy weight package (e.g., general use medical instruments) — 10.7 lbs. — APTIMAX® Instrument Tray (23 in. x 11 in. x 4in.) with Tray Mat; Metal and non-metal instruments.

KC650 — Very heavy weight package (e.g., general use medical instruments) — 10.7 lbs. — APTIMAX® Instrument Tray (23 in. x 11 in. x 4in.) with Tray Mat; Metal and non-metal instruments.

Intended loads include: Medical Instruments with and without lumens that include telescopes, endoscopes, cameras, light cords, and general use medical instruments.