SI-BONE ifuse Implant System Instruments Hospital Cleaning and Sterilization Instructions 0344

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Isabel Walters
5 years ago
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1 HOW SUPPLIED The SI-BONE instruments are supplied non-sterile and must be cleaned and sterilized prior to use. The ifuse Implant is provided separately and supplied sterile. Please refer to the ifuse System Instructions for Use. SI-BONE INSTRUMENT STERILIZATION SI-BONE Instruments are provided non-sterile and must be cleaned and sterilized prior to use. The following instructions apply to instrument cleaning and sterilization. Note: Single-use devices that have been used should be disposed of immediately after use. WARNINGS 1. Follow the instructions and warnings issued by the suppliers of any cleaning solutions and equipment used. 2. Avoid exposure to hypochlorite solutions and solutions containing iodine or high chlorine content, as these will promote corrosion. 3. Cleaning agents with a ph of 7 9 are recommended. 4. Highly alkaline conditions (ph > 11) can damage instruments (esp. aluminum parts). 5. Manual Pre-cleaning must be performed prior to Automated Cleaning for all instruments. 6. Soiled or used devices should not be loaded into the instrument tray for cleaning in a mechanical washer. Soiled instruments must be processed separate from trays and cases. SI-BONE instrument trays are designed to be an organization tool for steam sterilization process, a storage tool for all medical devices and an organizational tool for surgery. 7. The parameters listed are only valid for properly installed, maintained, calibrated and compliant reprocessing equipment in accordance with ISO and ISO CLEANING THE INSTRUMENTS: Clean Using Automated or Manual Process as Indicated Below Pre-Cleaning Instructions: 1. Clean instruments as soon as possible after use, thoroughly rinsing the instruments with warm tap water to remove gross contamination. Do not allow blood and debris to dry on the instruments. 2. Disassemble Navigation Impactor/Removal Adapter (see Figure 15). 3. DO NOT disassemble the pinned soft tissue protector assembly (see Figure 1). 4. DO NOT disassemble the screw from the Adjustable Parallel Pin Guide (see Figure 5). 5. Dispose of any pins (e.g., guide wires, Steinmann pins, K-wires) and drill bits used in the procedure. 6. Fully immerse all instruments in a mildly alkaline, enzymatic cleaner, such as MediClean at 0.5-2%, at < 40 C. Remove gross soil using a soft bristled brush. 7. Soak instruments for minutes. Flush all lumens and hard to reach areas of the instruments with the prepared detergent using an appropriately sized syringe or pipette filled with the prepared cleaning solution a minimum of 3 times. 8. Rinse the instruments with cold tap water for 1 minute. Remove remaining gross soil using a soft-bristled, nylon brush. Pay particular attention to crevices, lumens, mated AUTOMATED CLEANING PROCESS surfaces, connectors and other hard-to-clean areas. Lumens and hard to reach areas should be cleaned with a long, narrow, soft-bristled brush (i.e. pipe cleaner brush). Do not use metal scouring pads. 9. Flush lumens with water a minimum of 3 times using a syringe or pipette. Automated Cleaning Process Instructions: 10. Load the instruments so that the lumens/blind holes can drain. 11. Using a validated washer disinfector and a mildly alkaline enzymatic cleaning agent intended for use in an automated cleaning process, use the minimum cycle parameter set points below in Table After the completion of the washer cycle, visually inspect the instruments for remaining soil in a well-lit area; no visible soil should be left on the device. 13. If devices are still wet after the automated cleaning cycle, thoroughly dry the devices using a clean, lint-free cloth. If needed, use filtered pressurized air at <40 psi to aid in drying. 14. Return instruments to their designated locations in the tray as applicable. Page 1 of 5

2 Table 1: Automated Washer/Disinfector Cleaning Cycle Parameters Time Cycle (minutes:seconds) Temperature Type of Detergent/ Water Pre-Cleaning 2:00 Cold Tap Cleaning 5:00 Rinse 2:00 Thermal Rinse 1:00 Dry 26:00 Tap (55 C) (70 C) (90 C) (85 C) END OF AUTOMATED CLEANING PROCESS MediClean (per the manufacturer s instructions) Reverse Osmosis (RO) Water RO Water NA 1. Clean instruments as soon as possible after use, thoroughly rinsing the instruments under running warm tap water to remove gross contamination. Do not allow blood and debris to dry on the instruments. 2. Disassemble Navigation Impactor/Removal Adapter (see Figure 15). 3. DO NOT disassemble the pinned soft tissue protector assembly (see Figure 1). 4. DO NOT disassemble the screw from the Adjustable Parallel Pin Guide (see Figure 5). 5. Dispose of any pins (e.g., guide wires, Steinmann pins, K-wires) and drill bits used in the procedure. 6. Prepare a neutral ph enzymatic detergent or equivalent such as Enzol per manufacturer s directions at 1 oz/gallon using lukewarm tap water. 7. Fully immerse the instruments in the prepared detergent. 8. Flush all hard to reach areas of the instruments with the prepared detergent using an appropriately sized syringe and allow them to soak for a minimum of 10 minutes. MANUAL CLEANING PROCESS 9. Following the minimum 10 minute soak, use a softbristled, nylon brush to gently scrub the instruments until all visible soil has been removed. Pay particular attention to crevices, lumens, mated surfaces, connectors and other hard-to-clean areas. Lumens and hard to reach areas should be cleaned with a long, narrow, soft-bristled brush (i.e. pipe cleaner brush). Do not use metal scouring pads. 10. After brushing, use an appropriately sized syringe to thoroughly flush the prepared detergent through all lumens, holes and other difficult-to-reach areas. 11. Thoroughly rinse the instruments under running tap water for a minimum of 1 minute. Flush all lumens, holes and hard to reach areas using an appropriately sized syringe filled with tap water. 12. Thoroughly dry the instruments using a clean lint-free cloth. 13. Visually inspect the instruments for cleanliness. If soil is visible, repeat the cleaning procedures outlined above. 14. Return instruments to their designated locations in the tray as applicable. END OF MANUAL CLEANING PROCESS Page 2 of 5

VERIFY THAT THE INSTRUMENTS ARE CLEAN PRIOR TO STERILIZATION A.

discoloration or cracking, which might indicate excessive wear.

SI-BONE will replace the instrument(s). B.

dispose if parts show signs of prior use. C.

tissue D. Check the assembly of mating parts as follows.

Drill/Pin Sleeve and Broach (See Figures 2, 3 and 11).

the handle (See examples in Figures 4 and 6).

Sleeve, Adjustable Parallel Pin Guide, Variable Parallel Pin

Guide, Orientation Guide, Broach Stop and Pin Sleeve (See Figures

Check the threads of the Triangular and Circular s and Dilators.

and Navigation Broach 7.0 (See Figures 12 and 16).

Impactor/Removal Adapter (See Figure 13, 14 and 15). E.

3 VERIFY THAT THE INSTRUMENTS ARE CLEAN PRIOR TO STERILIZATION A. Visually inspect the instruments for corrosion, pitting, discoloration or cracking, which might indicate excessive wear. If an instrument is damaged or shows signs of unusual wear, SI-BONE will replace the instrument(s). B. For disposable parts (Pins and Drill Bits), visually inspect and dispose if parts show signs of prior use. C. Visually inspect the tray and content surfaces for dry blood and tissue D. Check the assembly of mating parts as follows. For all instruments: Check the inner canal and threads of the, Drill/Pin Sleeve and Broach (See Figures 2, 3 and 11). For Radiolucent instruments: For Revision instruments (7.5 mm and mm implants): For Navigation instruments: Check the inside of the handle (See examples in Figures 4 and 6). Check sliding mechanisms and/or actuating parts of the Drill/Pin Sleeve, Adjustable Parallel Pin Guide, Variable Parallel Pin Guide, Orientation Guide, Implant Orientation Guide. (See Figures 3, 5, 7, 8, 9, 12). Check the slot and cutting surfaces of the Broach (See example in Figure 11 and 16). Check the inner canal and threads of the, Variable Parallel Pin Guide, Orientation Guide, Broach Stop and Pin Sleeve (See Figures 6 10). Check the threads of the Triangular and Circular s and Dilators. Check the inner canal and threads of the Implant Orientation Guide and Navigation Broach 7.0 (See Figures 12 and 16). Check the inner cannula and threads for the Navigation Impactor/Removal Adapter (See Figure 13, 14 and 15). E. Return instruments to their designated locations in the tray as applicable. F. Instruments not stored in the tray should be sterilized individually per validated hospital procedures. STANDARD, XL AND NAVIGATION INSTRUMENTS Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Pinned Soft Tissue Protector inner canal Drill/Pin Sleeve Inner & Outer threads Handle Adjustable Parallel Pin Guide RADIOLUCENT INSTRUMENTS Figure 6 Figure 7 Figure 8 Figure 9 Figure 10 Variable Parallel Pin Guide (View 1) Variable Parallel Pin Guide (View 2) Orientation Guide Adjustable Broach Stop Page 3 of 5

instrument set should be covered in a wrap

INSTRUMENTS / REMOVAL SYSTEM INSTRUMENTS

4 Figure 11 Broach NAVIGATION INSTRUMENTS Figure 12 Figure 13 Figure 14 Nav. Implant Orientation Guide Nav. Impactor/ Removal Adapter, Tube Nav. Impactor/Removal Adapter, Cap Figure 15 Nav. Impactor/Removal Adapter Assembly Figure 16 Nav. Broach STERILIZATION PROCEDURE The SI-BONE instrument set should be covered in a wrap and the instruments must be steam sterilized prior to use, using the following parameters: TABLE 1: XL INSTRUMENTS / REMOVAL SYSTEM INSTRUMENTS Sterilizer Type Preconditioning Pulses Temperature Full Cycle Time Dry Time Pre Vacuum C 3 minutes 40 minutes Page 4 of 5

TABLE 2: STANDARD INSTRUMENTS / RADIOLUCENT INSTRUMENTS / REVISION INSTRUMENTS (7.5 MM & 10.

ifuse Implant System is intended for sacroiliac joint fusion. Headquarters SI-BONE, INC. 3055 Olin Avenue, Suite 2200 San Jose, CA 95128 USA t +1 408.207.0700 f +1 408.557.

com SI-BONE Deutschland GmbH Soldnerstraße 11 D - 68219 Mannheim, Germany t +49 (621) 976860 00 f +49 (621) 976860 99 infodeutschland@si-bone.

5 TABLE 2: STANDARD INSTRUMENTS / RADIOLUCENT INSTRUMENTS / REVISION INSTRUMENTS (7.5 MM & MM IMPLANTS) / NAVIGATION INSTRUMENTS Sterilizer Type Preconditioning Pulses Temperature Full Cycle Time Dry Time Pre Vacuum C 3 minutes 30 minutes Indications for Use: The ifuse Implant System is intended for sacroiliac joint fusion. Headquarters SI-BONE, INC Olin Avenue, Suite 2200 San Jose, CA USA t f info@si-bone.com SI-BONE S.r.l. Via Postcastello, Gallarate (VA), Italy t f infoeurope@si-bone.com SI-BONE Deutschland GmbH Soldnerstraße 11 D Mannheim, Germany t +49 (621) f +49 (621) infodeutschland@si-bone.com SI-BONE UK Monkswell House Manse Lane Knaresborough, North Yorkshire HG5 8NQ, UK Authorized Representative MedPass International Ltd. Windsor House Bretforton, Evesham Worcs.WR11 7JJ United Kingdom SI-BONE and ifuse Implant System are registered trademarks of SI-BONE, Inc SI-BONE, Inc. All rights reserved. Patents: Page 5 of 5

M6-C Artificial Cervical Disc Surgical Instruments

M6-C Artificial Cervical Disc Surgical Instruments CARE AND HANDLING INSTRUCTIONS Orthofix Inc. 3451 Plano Parkway Lewisville, Texas 75056-9453 U.S.A. 1-214-937-3199 1-888-298-5700 www.orthofix.com OSI-CustomerService@Orthofix.com Spinal Kinetics LLC,