MAKOplasty Partial Knee Instrument Cleaning and Sterilization Guide

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MAKOplasty® Partial Knee Instrument Cleaning and Sterilization Guide

Table of Contents A. INTRODUCTION... 1 B. DOCUMENT REFERENCES... 2 C. INITIAL USE OF INSTRUMENTS ... 2 D. INSTRUMENT MATERIALS... 3 E. DISPOSABLES... 7 F. PRE-CLEANING CONSIDERATIONS... 8 G. INSTRUMENT CLEANING GUIDELINES... 12 H. STERILIZATION TRAYS... 16 I. STERILIZATION GUIDELINES... 16 J. REUSABILITY... 18 K. CONDITIONS FOR STORAGE ... 18

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MAKOplasty® Partial Knee Instrument Cleaning and Sterilization Guide

A. INTRODUCTION 1. About This Manual This manual describes cleaning and sterilization procedures for MAKO Surgical Corp. instrumentation. 2. Support / Feedback Corporate Office Phone +1 (954) 927-2044 Corporate Office Fax +1 (954) 927-0446 makosurgical.com 3. Copyrights and Trademarks The content of this manual is protected under applicable copyright and trademark laws. You agree that you will not copy, distribute, republish, display, post, transmit or modify any content in this manual without MAKO’s prior permission. Any images displayed in this manual are the property of their respective copyright owners. Any reproduction, replication, modification or distribution of any art images in this manual is prohibited. The third-party trademarks in this manual are proprietary to their respective owners. These companies or their agents have granted MAKO the right to use their trademarks. Trademarks registered in the United States. Trademark registrations pending in other jurisdictions. Enzol® is a registered trademark of Johnson & Johnson Services Inc. Renu Klenz® and Steris Hinge Free® are registered trademarks of the Steris Corporation. Steris Liqui-Jet2TM is a trademark of the Steris Corporation. RIO® is a registered trademark of MAKO Surgical Corp. MAKOplasty® is a registered trademark of MAKO Surgical Corp. RESTORIS® is a registered trademark of MAKO Surgical Corp. VIZADISC® is a registered trademark of MAKO Surgical Corp. 4. Governing Law Any legal action or proceeding related to this manual or the information contained in it shall be brought exclusively in a court in Broward County, Florida, and shall be governed by the laws of the State of Florida, without regard to conflicts of laws principles. 5. Manufacturer MAKO Surgical Corp. 2555 Davie Rd. Ft. Lauderdale, FL 33317.USA 6. Symbols used in this manual Useful information or clarification.

Indicates situations or actions which could cause damage to equipment and/or result in user/patient injury. 1

MAKOplasty® Partial Knee Instrument Cleaning and Sterilization Guide

B. DOCUMENT REFERENCES The following reference manuals are available with information pertaining to MAKO products: RIO® Technical User Guide - Electrical safety, preventive maintenance, and technical specification information related to the Robotic Arm Interactive Orthopedic System (RIO®). There are no user serviceable parts in the RIO®, refer to your MAKO authorized personnel for service.

RIO® Knee Application User Guide and RIO® System User Guide - Instructions outlining steps to aid in the clinical implementation of a RIO® Knee procedure.

C. INITIAL USE OF INSTRUMENTS Remove all packaging material from instruments. Open all instrument trays and confirm internal packaging materials are removed. Probe and Array Preparation. Remove plastic caps only. DO NOT disassemble probe tip or posts from probes and arrays.

Plastic Cap

Probe Tip and Body

Plastic Cap and Posts

Plastic Cap and Posts

Array Posts and Caps

Array Posts and Caps Array Body Figure 1. Removal of Packaging Materials

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MAKOplasty® Partial Knee Instrument Cleaning and Sterilization Guide

D. INSTRUMENT MATERIALS Table 1. MAKOplasty® Instrument Tray Material

Tool

Material

Blunt Probe

Al 6061-T6, 17-4 PH Stainless Steel, 303 Stainless Steel

Sharp Probe

Al 6061-T6, 17-4 PH Stainless Steel, Al 6061-T6

Tibial Array

Al 6061 T6, 17-4 PH Stainless Steel

Femoral Array

Al 6061 T6, 17-4 PH Stainless Steel

Base Clamp

316L Stainless Steel, 17-4 PH Stainless Steel, 18-8 Stainless Steel, Nitronic 60 Stainless Steel

Array Clamp

316L Stainless Steel, Nitronic 60 Stainless Steel

Base Array

Al 6061 T6

End Effector

17-4 PH SST, 17-7 PH SST, 305 SST, N3971, Silicone

End Effector Array

Al 6061 T6, 316 Stainless Steel

Drill Guide, Double Barrel

Al 6061 T6, 316L Stainless Steel, 316L Stainless Steel, 316L Stainless Steel

Square Driver

Silicone Stainless Steel 316L

Depth Gauge

304 Stainless Steel

Checkpoint Driver

316L Stainless Steel, Al 6061-T6

Femoral Trial Inserter/ Slaphammer Extractor

316L Stainless Steel or 365C Stainless Steel

Square Drill Adaptor

17-4 PH Stainless Steel

Blunt Introducer

316L Stainless Steel

Cement Removal Tool

17-4 PH Stainless Steel

End Effector Wrench

420 Stainless Steel

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MAKOplasty® Partial Knee Instrument Cleaning and Sterilization Guide Table 2. RESTORIS® Tibial Onlay Instrument Set Materials

Tool

Material

Onlay Tibial Stylus

316 Stainless Steel, Nitronic 60 Stainless Steel, 17-4 PH Stainless Steel

Onlay Baseplate Templates

17-4 PH Stainless Steel

Onlay Trial Baseplates

17-4 PH Stainless Steel

Onlay Trial Inserts

Acetyl Copolymer

Baseplate Keel Cutter

17-4 PH Stainless Steel

Anterior Cut Reference Guide

17-4 PH Stainless Steel

Quick Release Bone Pin

17-4 PH Stainless Steel

Quick Release Fitting

17-4 PH Stainless Steel

Onlay Gap Gauge 9 mm, 10 mm, 11 mm

Acetyl Copolymer

.125" Drill

17-4 PH Stainless Steel

Cement Removal Tool

17-4 PH Stainless Steel

Angled Insert Impactor

17-4 PH Stainless Steel, Acetyl Copolymer

Baseplate Impactor

17-4 PH Stainless Steel, Acetyl Copolymer

Onlay Handle

17-4 PH Stainless Steel

Baseplate Post Drill Guide

17-4 PH Stainless Steel

Extension EM Guide

Nitronic 60 Stainless Steel, 17-4 PH Stainless Steel

Saw Block RM/LL, LM/RL Assembly

Nitronic 60 Stainless Steel, 17-4 PH Stainless Steel

EM Varus/Valgus Ankle Guide

Nitronic 60 Stainless Steel, 17-4 PH Stainless Steel

Insert Impactor

17-4 PH Stainless Steel, Acetyl Copolymer

Post Drill

17-4 PH Stainless Steel

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MAKOplasty® Partial Knee Instrument Cleaning and Sterilization Guide Table 3. RESTORIS® Femoral Instrument Set Materials

Tool

Material

.125 Inch Drill Bit

17-4 PH Stainless Steel

Head and Headless Pin Puller

17-4 PH Stainless Steel

Headed Pins

17-4 PH Stainless Steel

Femoral Templates

17-4 PH Stainless Steel

Peg Drill

17-4 PH Stainless Steel

Femoral Template Handle

17-4 PH Stainless Steel

Uni knee Sizers

17-4 PH Stainless Steel

Femoral Trials (All sizes)

CoCr

Femoral Impactor

17-4 PH Stainless Steel, Acetyl Copolymer or PPSU (Radel R5500)

Headed Pin Pusher

17-4 PH Stainless Steel

Table 4. RESTORIS® Tibial Onlay Instrument Set Materials

Tool Alignment Rod

Material 17-4 PH Stainless Steel

Tibial Leveling Guide (All sizes) 17-4 PH Stainless Steel Tibial Implant Gage

17-4 PH Stainless Steel

Tibial Inlay Implant Trials (All sizes)

Acetyl Copolymer

Tibia Inserter

17-4 PH Stainless Steel

Distractor Assembly

416 Stainless Steel 17-4 PH Stainless Steel, Nitronic 60 Stainless Steel

Distractor Pin

17-4 PH Stainless Steel

4.5 mm Straight Shaft Drill

17-4 PH Stainless Steel

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MAKOplasty® Partial Knee Instrument Cleaning and Sterilization Guide Table 5. RESTORIS® MCK Uni-Instrument Set Materials

Tool

Material

Femoral Trial (All Sizes)

CoCr

Inlay Trials (All Sizes)

PPSU (Radel R5500)

Baseplate Trials (All Sizes)

17-4 PH Stainless Steel

Onlay Insert Trials (All Sizes)

PPSU (Radel R5500)

Impactor Handles

17-4 PH Stainless Steel

Impactor Heads

PPSU (Radel R5500)

One Piece Impactors

PPSU (Radel R5500)

Onlay Insert Extractor

316, 420, 17-4 or 18-8 PH Stainless Steel

Table 6. RESTORIS® MCK Patellofemoral Instrument Set Materials

Tool

Material

PF Trials

CoCr

Patella Dome Trials

PPSU (Radel R5500)

Patella Sizing Guides and Handle

17-4 PH Stainless Steel 316L Stainless Steel

Patellar/Tibial Drill

17-4 PH Stainless Steel

Goelet Retractor

300 Series Stainless Steel

Patella Protector

300 Series Stainless Steel

Townley Caliper

300 and 400 Series Stainless Steel

Impactor Handles

17-4 PH Stainless Steel

Impactor Heads

PPSU (Radel R5500)

Patella Clamp

17-4 PH Stainless Steel and 316L Stainless Steel

Patella Saw Guides

17-4 PH Stainless Steel

Patella Cement Jaw

PPSU (Radel R5500)

Anterior Cut Reference Guide

304, 316, 410 or 17-4 PH Stainless Steel

One Piece Impactors

PPSU (Radel R5500)

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MAKOplasty® Partial Knee Instrument Cleaning and Sterilization Guide Table 7. RESTORIS® MCK Manual Instrument Set Materials

Tool

Material

Femoral Templates

17-4 PH Stainless Steel

PF Templates

17-4 PH Stainless Steel

Baseplate Templates

17-4 PH Stainless Steel

Drills

17-4 PH Stainless Steel

Pin Pusher

17-4 PH Stainless Steel

Pin Puller

17-4 PH Stainless Steel

Pins

17-4 PH Stainless Steel

Onlay Handle

17-4 PH Stainless Steel

E. DISPOSABLES Table 8 lists items that are designated as disposable and should be used for a single MAKOplasty® surgery. These items should NOT be cleaned or sterilized. Table 8. Disposable Instruments

Tool RIO® Drape Kit

Image

Material

N/A

LDPE, HDPE, Tyvek, PE film, EMA

2 mm Fluted Ball Burr

M2 Tool Steel

6 mm Fluted Ball Burr

M2 Tool Steel

2 mm Fluted Router

M2 Tool Steel

1.4 mm Fluted Router

M2 Tool Steel

Irrigation Tube

N/A

Tygon (Latex Free)

Irrigation Clip HD

N/A

304 Stainlees Steel / PEEK

VISADISC

Polycarbonate Resin, 3M 3150A reflective material

Femoral Checkpoint

316L Stainless Steel

Tibial Checkpoint

316L Stainless Steel

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MAKOplasty® Partial Knee Instrument Cleaning and Sterilization Guide Table 8. Disposable Instruments

Tool

Image

Material

Bone Pins

316L Stainless Steel

F. PRE-CLEANING CONSIDERATIONS Any medical equipment that has patient contact in a surgical procedure requires cleaning and sterilization. Before cleaning, some instruments may need to be disassembled. • Remove and discard all disposables (VIZADISC®, bone pins, etc.) from instruments prior to cleaning. When removing VIZADISC®, gently twist the VIZADISC® clockwise and pull. • Disassemble instruments with multiple components before cleaning. Some instruments are not intended to be disassembled. Refer to Table 9. • Before starting the cleaning and sterilization process, visually inspect all instruments for damage. Remove any damaged parts from use and have them returned to MAKO Surgical Corp. after cleaning and sterilizing. Table 9. Instrument Disassembly

Part Name

Image Remove and discard VIZADISC® (four places)

Femoral and Tibial Array Assembly

Captured Screws (2) Discard Bone Pins

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MAKOplasty® Partial Knee Instrument Cleaning and Sterilization Guide Table 9. Instrument Disassembly (continued)

Part Name

Image Disassemble into 3 components (screws remain captured)

Captured Screws (2)

End Effector Assembly

ATTENTION!!

Alignment Plates

DO NOT LOOSEN OR REMOVE

Loosening or removing the alignment plate screws will damage the End Effector

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Alignment Plate Screws (4 places)

MAKOplasty® Partial Knee Instrument Cleaning and Sterilization Guide Table 9. Instrument Disassembly (continued)

Part Name

Image Remove and discard VIZACDISC® (four places)

Base Array Assembly

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MAKOplasty® Partial Knee Instrument Cleaning and Sterilization Guide Table 9. Instrument Disassembly (continued)

Part Name

Image Remove and discard VIZACDISC® (four places) Disassemble Screw

End Effector Array Assembly

Remove and discard VIZACDISC® (three places)

Sharp and Blunt Probes

Discard burr Motor and Attachment

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Disassemble

MAKOplasty® Partial Knee Instrument Cleaning and Sterilization Guide

G. INSTRUMENT CLEANING GUIDELINES To properly clean, disinfect and sterilize MAKO instruments, a cleaning procedure must be completed prior to autoclave sterilization. Manual cleaning methods are to be followed if an ultrasonic cleaner is available. Follow the Automated Cleaning Procedures when using an automated washer system. Use the following general guidelines for all instruments: • Wear eye protection and gloves when cleaning or handling contaminated instruments • Do not immerse electronic equipment or cables in water or other liquids • Unless specified otherwise, do not disassemble instruments during cleaning or sterilization • Use only the indicated solvents on equipment Protect and handle delicate instruments so as to avoid damage during the cleaning process.

Cleaning, disinfecting, and sterilization should be performed by trained personnel only. Do not allow blood and/or bodily fluids to dry on the instruments. The decontamination process should begin immediately after completion of the surgical procedure. Pay particular attention to crevices, serrations, grooves, cannulas, screw holes, screw threads, and other difficult to clean areas until all soil has been removed. Any instruments with moving components should be set in motion during cleaning to ensure all surfaces are cleaned. If damage is detected on any instrument, please contact MAKO Surgical Corp.

Complete removal of soil from crevices depends on instrument construction, exposure time, pressure of delivered solution, and pH of the detergent solution, and thus may require prior brushing.

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MAKOplasty® Partial Knee Instrument Cleaning and Sterilization Guide

Manual Cleaning 1. Disconnect the tools and accessories and disassemble instruments with multiple attachments/components. (e.g., clamp assemblies). 2. Pre-rinse to remove all blood, tissue, and visible soil. 3. Soak tools in a disinfecting solution for a minimum of five (5) minutes (use manufacturer’s recommended dilution rate.) 4. Thoroughly clean each part with a soft bristled brush, pipe cleaner, or syringe while soaking. Actuate handles, hinges, and retractable features. Pay particular attention to crevices, cannulas, threads, and other hard to clean areas. 5. Rinse parts in water for five (5) minutes while continuing to clean with a syringe or pipe cleaner. 6. Ultrasonically clean all parts in disinfecting solution for twenty (20) minutes. 7. Rinse parts in water for five (5) minutes while continuing to clean with a syringe or pipe cleaner. 8. Dry parts using a clean soft cloth.

Cleaning instructions for Cutting Tool Attachment Wear eye protection. DO NOT IMMERSE except as specified below. Do not use ultrasonic equipment or corrosive or harsh chemical soaps. Do not rinse attachment with saline solution.

1. Remove attachment and cutting tool from motor handpiece. 2. Fully immerse attachment in an enzymatic cleaner (Alkaline, non-chlorinated detergent (i.e., Steris Liqui-Jet2TM)), prepared as described on product label, at room temperature, in a suitable container and agitate for 15 seconds. 3. Gently insert and remove Anspach Attachment Cleaning Brush (ACB) wetted with enzymatic cleaner through distal (tip) opening of attachment as many times as necessary to remove any foreign debris. DO NOT FORCE brush into or through attachment. 4. Remove brush (ACB). 5. Rinse attachment in a suitable container filled with water and agitate for 15 seconds. 6. Repeat steps 1 and 2 if there is evidence of soils or residuals on attachment surface. 7. After cleaning and rinsing, fully immerse attachment in instrument milk (non-silicone based medical lubricant (i.e., Steris Hinge Free Medical Instrument Lubricant)) prepared as described on product label, at room temperature, in a suitable container and agitate for 15 seconds.

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MAKOplasty® Partial Knee Instrument Cleaning and Sterilization Guide

8. Remove attachment and allow it to drain. a. DO NOT rinse out instrument milk (lubricant). b. DO NOT apply mineral oil or other lubricants, which may cause attachment to overheat.

Pre-Sterilization Wear eye protection. DO NOT IMMERSE! Do not insert brush into motor housing. Do not use saline solution for cleaning. Do not use cleaners containing chlorinated phenois of any concentration. Using cleaners/disinfecting agents containing chlorinated phenois will result in premature hose failure.

Prior to sterilization, wipe with a clean, water-dampened cloth and mild detergent. Silicon Spray or Instrument Milk may be added to lubricate motor/handpiece knurled knob. Silicon spray may be used on hose to prolong its flexibility and to facilitate foreign particle removal. The motor/handpiece should be tested by running it with an attachment and cutting burr at least every three months for one minute to determine the temperature. If distal tip and main body of motor/handpiece are uncomfortably hot to the touch return instrument to Anspach for servicing. If occlusion of the motor/handpiece outer hose was suspected or if the pressure relief valve was actuated return instrument to Anspach for servicing. Motor/Handpiece must not be exposed to ingress of water or to severe physical trauma; degradation of unit function and/or performance may occur.

Instrument Lubrication For the Onlay Insert Extractor, spray all joints and moving points with Barrier Milk Lubricant (or equivalent) prior to sterilization. Failure to lubricate instrument with Barrier Milk Lubricant (or equivalent) may reduce instrument life and reduce mechanical function.

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MAKOplasty® Partial Knee Instrument Cleaning and Sterilization Guide

Automated Cleaning Initial Cleaning 1. Disconnect the tools and accessories and disassemble instruments with multiple attachments/components. (e.g., clamp assemblies). All caddies must be removed from instrument tray and prepared as an instrument/ tray.

2. Pre-soak the instruments in Enzol for five (5) minutes. Prepare the Enzol bath according to manufacturer’s recommendations using lukewarm water. Fully immerse the instruments in the bath during the pre-soak. All instruments and caddies must be soaked in Enzol separately, then placed within the caddy.

3. Rinse tray and caddy in lukewarm water after presoak. 4. Arrange the instruments in the trays as indicated in the tray laminates provided. The top level of each tray should be placed in the washer separately. All tray lids should be removed. All caddies should be placed in water separately with the caddy lid in the open position. Components must be placed in trays as pictured in applicable tray laminates to achieve proper sterilization.

Washer Cycle 5. Pre-wash with cold water for two (2) minutes. 6. Enzyme Wash with hot water, using a disinfecting (enzymatic) solution, for a minimum of five (5) minutes (use manufacturer’s recommended dilution rate). 7. Wash with Renu-Klenz® or similar detergent for fifteen (15) minutes at set point Temperature of 60 °C / 140 °F. 8. Final Rinse with heated water for five (5) minutes at approximately 43 °C / 109 °F.

Drying 9. Remove the tray from the washer. 10. Dry the tray and its contents using a clean soft cloth or by using pressurized air, not exceeding forty (40) psi. Place caddies back into the tray position as indicated on the tray laminate.

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MAKOplasty® Partial Knee Instrument Cleaning and Sterilization Guide

H. STERILIZATION TRAYS The presence of blood, tissue, soil, or soap residue may prevent the tool(s) from being properly sterilized. Remove all debris and residue prior to sterilization. Failure to comply may prevent the tool(s) from being properly sterilized.

Sterilization trays do not by themselves provide a sterile barrier and must be used in conjunction with sterilization wrap to maintain sterility. Sterilization trays can be cleaned with water and a mild detergent. Cleaned instruments should be assembled into the appropriate instrument tray.

I. STERILIZATION GUIDELINES Ensure all instruments are removed from shipping packaging materials and thoroughly cleaned prior to sterilization.

Place attached protective cap over electical connector on Anspach electrical Motor/ Handpiece prior to sterilization.

Validation of Process and Responsibility The following is a list of MAKO Surgical Corp instrument trays which may be sterilized using the sterilization parameters described in this manual. 1. MAKOplasty® Instrument Tray 2. Motor Instrument Tray 3. RESTORIS® MCK Implant System a. Uni Instrument Set b. Patellofemoral Instrument Set c. Manual Instrument Set 4. RESTORIS® Uni Knee System. a. Onlay Instrument Set b. Inlay Instrument Set c. Femoral Manual Instrument Set d. Tibial Onlay Manual Instrument Set e. Tibial Inlay Manual Instrument Set

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