SI-BONE
Soft Tissue Protector - Stainless Steel
iFuse Implant System Instruments Hospital Cleaning and Sterilization Instructions
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SI-BONE iFuse Implant System® Instruments Hospital Cleaning and Sterilization Instructions
0344
HOW SUPPLIED • •
The instruments are supplied non-sterile and must be cleaned and sterilized prior to use. The iFuse Implant is provided separately and supplied sterile. Refer to the iFuse implant System Instructions for Use. 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 15883 and ISO 17665. CLEANING THE INSTRUMENTS: Clean Using Automated or Manual Process as Indicated Below AUTOMATED CLEANING PROCESS Pre-Cleaning Instructions: 1.
2. 3.
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. Disassemble Navigation Impactor/Removal Adapter (see Figure 15).
crevices, lumens, mated surfaces, connectors and other hard-to-clean areas. Lumens and hard to reach areas should be cleaned with a long, narrow, softbristled brush (i.e. pipe cleaner brush). Do not use metal scouring pads. 9.
DO NOT disassemble the “pinned” soft tissue protector assembly (see Figure 1).
Flush lumens with water a minimum of 3 times using a syringe or pipette. Automated Cleaning Process Instructions:
4.
DO NOT disassemble the screw from the Adjustable Parallel Pin Guide (see Figure 5).
10.
Load the instruments so that the lumens/blind holes can drain.
5.
Dispose of any pins (e.g., guide wires, Steinmann pins, K-wires) and drill bits used in the procedure.
11.
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.
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 in Table 1.
12.
After the completion of the washer cycle, visually inspect the instruments for remaining soil in a welllit 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 (275,80 kPa) to aid in drying.
14.
Return instruments to their designated locations in the tray as applicable.
7.
8.
Soak instruments for 10-30 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. Rinse the instruments with cold tap water for 1 minute. Remove remaining gross soil using a softbristled, nylon brush. Pay particular attention to
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SI-BONE iFuse Implant System® Instruments Hospital Cleaning and Sterilization Instructions
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Table 1: Automated Washer/Disinfector Cleaning Cycle Parameters
Cycle
Time (minutes:seconds)
Minimum Temperature
Type of Detergent/ Water
Pre-Cleaning
2:00
Cold
Tap
Cleaning
5:00
MediClean® (per the manufacturer’s instructions)
Rinse
2:00
Thermal Rinse
1:00
Dry
26:00
Heated Tap (55°C) Heated (70°C) Heated (90°C) Heated (85°C)
Reverse Osmosis (RO) Water RO Water NA
END OF AUTOMATED CLEANING PROCESS
1.
MANUAL CLEANING PROCESS narrow, soft-bristled brush (i.e. pipe cleaner brush). Do Clean instruments as soon as possible after use, not use metal scouring pads. 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). 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 8 mL/L (1 oz/gallon)using lukewarm tap water.
8.
9.
thoroughly flush the prepared detergent through all lumens, holes and other difficult-to-reach areas. 11. Thoroughly rinse the instruments under running tap
3.
7.
10. After brushing, use an appropriately sized syringe to
Fully immerse the instruments in the prepared detergent.
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. Prepare an enzymatic detergent such as Enzol® per
manufacturer’s directions at 1 oz/gallon using lukewarm tap water in a sonication unit. 13. Completely submerge the instruments in the prepared
detergent. 14. Flush all hard to reach areas of the instruments with the
prepared detergent using an appropriately sized syringe, and sonicate for 10 minutes at 45-50 kHz. 15. Minimum 1 minute rinse under running tap water.
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. 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,
Thoroughly flush lumens, holes and other difficult-toreach areas using an appropriately sized syringe filled with tap water. 16. Thoroughly dry the instruments using a clean lint-free
cloth. 17. Visually inspect the instruments for cleanliness. If soil
is visible, repeat the cleaning procedures outlined above. 18. Return instruments to their designated locations in
the tray as applicable.
END OF MANUAL CLEANING PROCESS
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SI-BONE iFuse Implant System® Instruments Hospital Cleaning and Sterilization Instructions
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INSTRUMENT VERIFICATION 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 or excessive wear, SI-BONE will replace the instrument(s). Note: Sterilize damaged parts separately and prior to shipment to SIBONE for replacement. 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. • Check the inner canal and threads of the Soft Tissue Protector, Drill/Pin Sleeve and Broach (See Figures 2, 3 and 11).
For all instruments:
• Check the inside of the Soft Tissue Protector 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 Figures 11 and 16). For Radiolucent instruments:
• Check the inner canal and threads of the Soft Tissue Protector, Variable Parallel Pin Guide, Orientation Guide, Broach Stop and Pin Sleeve (See Figures 6 – 10).
For Revision instruments (7.5 mm and 10.75 mm implants):
• Check the threads of the Triangular and Circular Soft Tissue Protectors and Dilators.
For Navigation instruments:
• Check the inner canal and threads of the Implant Orientation Guide and Navigation Broach 7.0 mm (See Figures 12 and 16). • Check the inner cannula and threads for the Navigation Impactor/Removal Adapter (See Figures 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
Soft Tissue Protector inner canal
Drill/Pin Sleeve Inner & Outer threads
Soft Tissue Protector Handle
Adjustable Parallel Pin Guide
RADIOLUCENT INSTRUMENTS
Figure 6 Soft Tissue Protector
Figure 7 Variable Parallel Pin Guide (View 1)
Figure 8 Variable Parallel Pin Guide (View 2)
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Figure 9
Figure 10
Orientation Guide
Adjustable Broach Stop
SI-BONE iFuse Implant System® Instruments Hospital Cleaning and Sterilization Instructions
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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
Minimum Temperature
Full Cycle Time
Minimum Dry Time
Pre Vacuum
3
134°C
3 minutes
40 minutes
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SI-BONE iFuse Implant System® Instruments Hospital Cleaning and Sterilization Instructions
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TABLE 2: STANDARD INSTRUMENTS / RADIOLUCENT INSTRUMENTS / REVISION INSTRUMENTS / NAVIGATION INSTRUMENTS
Sterilizer Type
Preconditioning Pulses
Minimum Temperature
Full Cycle Time
Minimum Dry Time
Pre Vacuum
3
134°C
3 minutes
30 minutes
Indications for Use: The iFuse Implant System® is intended for sacroiliac joint fusion. GRAPHIC SYMBOLS Caution: Refer to Instructions for Use Non-sterile, Sterilize Prior to Use Lot Number Use by Catalog Number Do not use if package is damaged Federal Law (USA) restricts this device to sale by or on the order of a physician. For Instructions for Use & symbols glossary www.si-bone.com/label Manufacturer Authorized European Representative
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SI-BONE iFuse Implant System® Instruments Hospital Cleaning and Sterilization Instructions
Manufactured for: SI-BONE, INC. 471 El Camino Real, Suite 101 Santa Clara, CA 95050 U.S.A T +1 408.207.0700 fF+1 408.557.8312 [email protected]
Authorized Representative: MedPass SAS 95 bis Boulevard Pereire 75017 Paris - France T +33 (0)1 42 12 83 30
0344
Australian Sponsor: Device Technologies Australia Pty Ltd. 1 Garigal Rd. Belrose NSW 2085 Australia P +61 2 9972 8200
New Zealand Sponsor: Device Technologies New Zealand Ltd. 47 Arrenway Drive Albany Auckland 0632 New Zealand T +64 9 913 2000
SI-BONE UK 1st Floor Unit 7b, St. James Business Park Knaresborough, North Yorkshire HG5 8QB, UK
Si-BONE 6 rue des Merisiers 68920 WETTOLSHEIM LES ERLEN – FR T +33 09 73 79 03 92 F +33 09 70 19 0132 [email protected]
www.si-bone.com Importers: SI-BONE S.r.l. Via Postcastello, 6 21013 Gallarate (VA), Italy T +39 0331 1561179 F +39 0331 1561180 [email protected]
SI-BONE Deutschland GmbH Soldnerstraße 11 D - 68219 Mannheim, Germany T +49 (621) 976860 00 F +49 (621) 976860 99 [email protected]
T +441423860025 [email protected]
SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. © 2019 SI-BONE, Inc. All rights reserved. Patents: www.si-bone.com
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