SI-BONE iFuse Implant System®Instruments Hospital Cleaning and

SI-BONE iFuse Implant System® Instruments
Hospital Cleaning and Sterilization Instructions
0344
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 15883 and ISO 17665.
CLEANING THE INSTRUMENTS:
Clean Using Automated or Manual Process as Indicated Below
AUTOMATED CLEANING PROCESS
Pre-Cleaning Instructions:
1.
2.
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).
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.
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 soft-bristled, nylon
brush. Pay particular attention to crevices, lumens, mated
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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 1.
12.
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.
ECN 21648
Effective Date:11/28/2017
SI-BONE iFuse Implant System® Instruments
Hospital Cleaning and Sterilization Instructions
0344
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.
2.
3.
4.
5.
6.
7.
8.
9.
MANUAL CLEANING PROCESS
bristled, nylon brush to gently scrub the instruments
Clean instruments as soon as possible after use,
until all visible soil has been removed. Pay particular
thoroughly rinsing the instruments under running
attention to crevices, lumens, mated surfaces,
warm tap water to remove gross contamination. Do
connectors and other hard-to-clean areas. Lumens
not allow blood and debris to dry on the instruments.
and hard to reach areas should be cleaned with a long,
Disassemble Navigation Impactor/Removal Adapter
narrow, soft-bristled brush (i.e. pipe cleaner brush). Do
(see Figure 15).
not use metal scouring pads.
DO NOT disassemble the “pinned” soft tissue protector
10. After brushing, use an appropriately sized syringe to
assembly (see Figure 1).
thoroughly flush the prepared detergent through all
lumens, holes and other difficult-to-reach areas.
DO NOT disassemble the screw from the Adjustable
Parallel Pin Guide (see Figure 5).
11. Thoroughly rinse the instruments under running tap
water for a minimum of 1 minute. Flush all lumens,
Dispose of any pins (e.g., guide wires, Steinmann pins,
holes and hard to reach areas using an appropriately
K-wires) and drill bits used in the procedure.
sized syringe filled with tap water.
Prepare a neutral pH enzymatic detergent or
12. Thoroughly dry the instruments using a clean lint-free
equivalent such as Enzol® per manufacturer’s
cloth.
directions at 1 oz/gallon using lukewarm tap water.
13. Visually inspect the instruments for cleanliness. If soil
Fully immerse the instruments in the prepared
is visible, repeat the cleaning procedures outlined
detergent.
above.
Flush all hard to reach areas of the instruments with
14. Return instruments to their designated locations in
the prepared detergent using an appropriately sized
the tray as applicable.
syringe and allow them to soak for a minimum of 10
minutes.
Following the minimum 10 minute soak, use a softEND OF MANUAL CLEANING PROCESS
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ECN 21648
Effective Date:11/28/2017
SI-BONE iFuse Implant System® Instruments
Hospital Cleaning and Sterilization Instructions
0344
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.
•
Check the inner canal and threads of the Soft Tissue Protector, Drill/Pin
Sleeve and Broach (See Figures 2, 3 and 11).
•
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
Figure 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 (See Figures 12 and 16).
•
Check the inner cannula and threads for the Navigation
Impactor/Removal Adapter (See Figure 13, 14 and 15).
For all instruments:
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
ECN 21648
Effective Date:11/28/2017
SI-BONE iFuse Implant System® Instruments
Hospital Cleaning and Sterilization Instructions
0344
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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ECN 21648
Effective Date:11/28/2017
SI-BONE iFuse Implant System® Instruments
Hospital Cleaning and Sterilization Instructions
0344
TABLE 2: STANDARD INSTRUMENTS / RADIOLUCENT INSTRUMENTS /
REVISION INSTRUMENTS (7.5 MM & 10.75 MM IMPLANTS) / 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.
Headquarters
SI-BONE, INC.
3055 Olin Avenue, Suite 2200
San Jose, CA 95128 USA
t +1 408.207.0700
f +1 408.557.8312
info@si-bone.com
www.si-bone.com
SI-BONE UK
105-107 Monkswell House
Manse Lane
Knaresborough, North Yorkshire
HG5 8NQ, UK
SI-BONE S.r.l.
Via Postcastello, 6
21013 Gallarate (VA), Italy
t +39 0331 1561179
f +39 0331 1561180
infoeurope@si-bone.com
SI-BONE Deutschland GmbH
Soldnerstraße 11
D - 68219 Mannheim, Germany
t +49 (621) 976860 00
f +49 (621) 976860 99
infodeutschland@si-bone.com
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.
© 2017 SI-BONE, Inc. All rights reserved. Patents: www.si-bone.com
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ECN 21648
Effective Date:11/28/2017