Navigator Surgical Gamma Probes Sterilization Instructions

PROBE MODEL:

SP-2A14, 67, SP-2S14-67, SP-2S11-53, SP-2S10-31, SP-2S10-19, SP-2S10-31D, WP-9000-14; WP-9000-14S Only model numbers manufactured October 30, 2015, and later are sterilizable.

Preparation of probes and cables

CABLE MODEL: GP-4001-00

WARNING: To avoid permanent damage of the Navigator Control Unit, do not sterilize the Navigator Control Unit or immerse it in fluids. WARNING: To avoid permanent damage of the probes and cables, prior to cleaning and sterilization, always inspect them for cracks, wear or other damages. WARNING: To avoid permanent damage to the wireless probe, do not clean with the battery cap open or not securely tightened. PREPARATION STEPS: Ensure the following for wireless probes, wired probes, and cables: 1. The probes are free of any damage. 2. The cables are free of cracks or cuts. 3. The connectors of the probe and cable are completely dry. 4. The cable is detached from the probe and the Navigator Control Unit. 5. (If available) The top gun collimator is removed from the probe. For wireless probe only: 1. After cleaning of the wireless probe, and prior to each sterilization, insert a new CR2 DURACELL battery. 2. Ensure the cap is securely tightened to the Wireless Pilot Probe. The O-ring on the cap should not be visible.

Cleaning

Equipment: Enzymatic detergent Instructions: 1. Prepare enzymatic cleaner, suitable for surgical instruments, according to the manufacturer's recommendation. 2. Rinse the outside surfaces of the probe with a brisk stream of lukewarm tap water (98°F to 105°F / 36.5°C to 40.5°C). Wipe with soft cloth or sponge soaked in enzymatic cleaner. Repeat separately for collimator cleaning, if used. 3. Visually inspect device(s) for contaminated areas. 4. Repeat steps 1 & 2 until visual inspection reveals instrument(s) is clean. 5. Rinse equipment with a brisk stream of lukewarm tap water (98°F to 105°F / 36.5°C to 40.5°C) for 30-seconds. 6. Air-dry or dry with clean towel.

141-00005-001 Rev 06

Revised 24Jan2020

OPTION 1. Sterilization Equipment: Wireless probe, wired probe, and cable: • • •

STERRAD® NX - Standard Cycle STERRAD® 100NX - Standard Cycle STERRAD® 100S - Short Cycle

• • • •

Steris V-PRO® 1 Plus - Non-Lumen Cycle Steris V-PRO® maX - Non-Lumen Cycle Steris V-PRO® 60 - Non-Lumen Cycle Steris V-PRO® maX - Flexible Cycle

• • • •

Steris System 1E® (US use only) Steris System 1® (International use Only) Steris System 1® Express (International use Only) Steris System 1® Plus (International use Only)

•

STERIZONE® VP4 Sterilizer - Cycle 1

Additional methods for wireless probe and wired probe (not for use on cable): • • • •

Steris V-PRO® 1 - Standard Cycle Steris V-PRO® 1 Plus – Lumen Cycle Steris V-PRO® maX – Lumen Cycle Steris V-PRO® 60 – Lumen Cycle

WARNING: To avoid permanent damage of the cable, do not process the cable in the V-PRO 1 Standard Cycle or the VPRO-1 Plus, VPRO maX, or V-PRO 60 Lumen Cycles because the cable contains polyurethane. Instructions: 1.

Please refer to the manufacturer’s instructions to properly conduct the sterilization procedure. The probe cable can be loosely coiled and then placed together with the probe. 2. After the sterilization procedure is completed, handle and store the probes and cables per your facility’s guidelines in packaging and storing sterile products. 3. The wireless probe with battery inside has a two-week shelf life of storage and no use after sterilization WARNING: Do not exceed the two-week shelf life after sterilization for a wireless probe with battery inside. A wireless probe with a shelf life longer than two weeks may not function properly due to a drained battery. If the probe has a shelf life of storage that is longer than two weeks, replace the battery and re-sterilize the probe.

141-00005-001 Rev 06

Revised 24Jan2020

OPTION 2. High-Level Desinfection High-level disinfection

Equipment: High-level disinfection APO Instructions: 1. 2. 3.

4.

5.

Please refer to the manufacturer’s instructions to properly prepare the sterilization mixture. Immerse both the probe and cable in the solution for at least 12 minutes at 68°F or more to destroy all pathogenic microorganisms. Rinse the outside surfaces of the probe with a brisk stream of lukewarm tap water (98°F to 105°F / 36.5°C to 40.5°C) for 1 minute. Rinse twice more. Air-dry or wipe with soft cloth. Do not exceed 60°C. Air-dry or wipe with soft cloth. Rinse the probe connector with isopropyl or ethyl alcohol than air-dry. Make sure both cable ends are properly dried before storing them. The cable can take up to 24 hours before being completely dry. The wireless probe with battery inside has a two-week shelf life of storage and no use after sterilization

WARNING: To avoid health hazards, follow the instructions of the disinfectant manufacturer WARNING: Do not exceed the two-week shelf life after sterilization for a wireless probe with battery inside. A wireless probe with a shelf life longer than two weeks may not function properly due to a drained battery. If the probe has a shelf life of storage that is longer than two weeks, replace the battery and re-sterilize the probe. NOTE: The instructions provided above have been validated by the medical device manufacturer as being capable of preparing the Navigator probe for re-use. It remains the responsibility of the facility to ensure that the probes and cables have been properly cleaned and sterilized. This requires validation and routine monitoring of the process. Any deviation by the facility from the instructions provided should be properly evaluated for effectiveness and potential adverse consequences. Manufactured by: Dilon Technologies, Inc. 12050 Jefferson Avenue Suite 340 Newport News, VA 23606 USA Phone: 1-844-DILONNAV

141-00005-001 Rev 06

Revised 24Jan2020