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Mako Instrument Cleaning and Sterilization Guide
TABLE OF CONTENTS A. INTRODUCTION... 1 B. DOCUMENT REFERENCES... 2 C. INITIAL USE OF INSTRUMENTS ... 3 D. INSTRUMENT MATERIALS... 4 E. STERILE DISPOSABLES ... 8 F. PRE-CLEANING CONSIDERATIONS... 12 G. INSTRUMENT CLEANING GUIDELINES... 22 H. STERILIZATION TRAYS... 28 I. STERILIZATION GUIDELINES... 28 J. REUSABILITY... 30 K. CONDITIONS FOR STORAGE ... 30 APPENDIX A. DISINFECTION STRATEGY... 31 APPENDIX B. EXTENDED DRY TIME TABLE ... 33
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Mako Instrument Cleaning and Sterilization Guide
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Mako Instrument Cleaning and Sterilization Guide
A. INTRODUCTION 1. About This Manual This manual describes the cleaning and sterilization for instrumentation used with Mako Hip, and Knee applications, as well as the Stryker Leg Positioner. The information provided herein, in conjunction with the application of a predetermined customer disinfection strategy, allows for cleaning and sterilization of reusable medical instrumentation in accordance with the applicable domestic and international guidelines. 2. Support / Feedback Customer Service +1 (855) 303-6256 www.stryker.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 Stryker’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 Stryker the right to use their trademarks. Refer to product label for CE mark status and legal manufacturer. The CE mark is only valid if found on the product label.
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 Bergen County, New Jersey, and shall be governed by the laws of the State of New Jersey, without regard to conflicts of laws principles. 5. Manufacturer MAKO Surgical Corp. 3365 Enterprise Avenue Weston, FL 33331 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.
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Mako Instrument Cleaning and Sterilization Guide
B. DOCUMENT REFERENCES There are no user serviceable parts in the Mako, refer to your Mako (Stryker) authorized personnel for service.
In case of serious incident, please notify the Manufacturer and Competent Authority in your region.
The following external references help to develop and maintain the recommended information: BS EN ISO15883 Sections 1-7
EN 554
BS EN ISO17664
EN 556-1
BS EN ISO17665 Sections 1-3
EN 556-2
ANSI/AAMI ST79
HTM01-01 Parts A-D
ANSI/AAMI ST58
United States/European/Japanese Pharmacopoeia (USP/EP/JP)
ANSI/AAMI ST77
Corin Cleaning of Surgical Instruments
ANSI/AAMI ST8
Corin Instructions for Re-Processing Reusable Devices
Additional information about electronic Instructions for Use (eIFU) can be found below.
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Mako Instrument Cleaning and Sterilization Guide
C. INITIAL USE OF INSTRUMENTS Remove all packaging material from instruments. Open all instrument kits and confirm internal packaging materials are removed. Probe and Array Preparation Remove plastic caps only. DO NOT disassemble probe tip or posts from probe bodies and posts from array bodies. Plastic Cap
Probe Tip and Body
Plastic Cap and Posts
Plastic Cap and Posts
Array Posts and Caps
Array Posts and Caps
Figure 1. Removal of Packaging Materials
Orthopaedic surgical instruments generally have a long service life; however, mishandling or inadequate protection can quickly diminish their life expectancy. Mako surgical instruments have the ability to function as intended and are considered acceptable and verified over an expected lifetime of 250 surgeries in a 1-year period without loss of function. Instruments which no longer perform properly because of long use, mishandling, or improper care should be returned to MAKO Surgical Corp. (Stryker) to be discarded. Notify your Mako Representative of any instrument problems.
Safe Disposal If a device is being returned for evaluation, please contact your local Mako representative for shipping and handling information. If the device is not being returned to MAKO Surgical Corp., it is to be disposed of in accordance with applicable laws, rules, and regulations for the disposal of biohazardous waste. Follow all guidelines for biohazardous waste in accordance with the Centers for Disease Control and Prevention guidelines as well as applicable federal, national, state and local regulations.
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Mako Instrument Cleaning and Sterilization Guide
D. INSTRUMENT MATERIALS Table 1. Mako Knee Instrument Kit
Instrument
Material
2-Pin Clamp
Stainless Steel
Angled Saw Attachment
Stainless Steel, Ceramic
Array Stabilizer (3.2 short or 4.0 long)
Stainless Steel
Blunt Probe
Stainless Steel, Aluminum
Burr Guard Assembly
Stainless Steel, Ceramic
Cement Removal Tool
Stainless Steel
Femoral Trial Slaphammer
Stainless Steel
High Speed Rotary Attachment
Stainless Stell, Ceramic
Knee Checkpoint Driver
Silicone, Stainless Steel
Knee End Effector Array
Stainless Steel, Aluminum
Knee Femoral Array
Stainless Steel, Aluminum
Knee Tensioner
Stainless Steel
Knee Tibial Array
Stainless Steel, Aluminum
Lamina Spreader
Stainless Steel
Mako (RIO) System Quick Connect Base Array
Stainless Steel, Aluminum
MICS Attachment Wrench
Stainless Steel
MICS Handpiece
Stainless Steel, Aluminum, PPSU, Silicone
Pelvic Array Adaptor
Stainless Steel, Nitronic 60
Planar Probe
Stainless Steel
Registration Tool
Stainless Steel
Right Angle Saw Attachment
Stainless Steel, Titanium, Viton, Ceramic
Sharp Probe
Stainless Steel, Aluminum
Spacer Block (16/18 mm, 20/22 mm)
Stainless Steel
Spacer Paddle (1 mm x 2 mm, 3 mm x 4 mm, 5 mm x 6 mm)
Stainless Steel
Spacer Shim, 5 mm
Polyphenylsulfone (PPSU)
Square Drill Adaptor
Stainless Steel
Square Driver
Silicone, Stainless Steel
Straight Saw Attachment (Sagittal)
Stainless Steel, Titanium, Viton, Ceramic Table 2. Mako THA Instrument Kit
Instrument
Material
2-Pin Clamp
Stainless Steel
3-Pin Pelvic Clamp
Stainless Steel
Accolade II 127° or 132°, 27mm Neck Trial
Stainless Steel
Accolade II 127° or 132°, 30mm Neck Trial
Stainless Steel 4
Mako Instrument Cleaning and Sterilization Guide Instrument
Material
Accolade II 127° or 132°, 35mm Neck Trial
Stainless Steel
Accolade II 127° or 132°, 37mm Neck Trial
Stainless Steel
Accolade II 127° or 132°, 40mm Neck Trial
Stainless Steel
Acetabular Reamer Case Base Assembly
Stainless Steel
Anato Neutral Neck Trial, Anteverted
Stainless Steel
Anato Neutral Neck Trial, Left
Stainless Steel
Anato Neutral Neck Trial, Right
Stainless Steel
Bone Pin Adaptor
Stainless Steel
Broach Array (V40 Postero-Lateral and Antero-Lateral)
Stainless Steel, Aluminum and Polyphenylsulfone
Checkpoint Driver (Pelvic)
Stainless Steel
Crest Pin Clamp
Stainless Steel
Crest Drill guide
Stainless Steel
Cup Impaction Platform
Stainless Steel and Aluminum
Drivers and Handle Attachments
Stainless Steel, Aluminum and Silicon
Femoral Array
Stainless Steel and Aluminum
Femoral Array Extended Post
Stainless Steel
Fixed Driver Handle
Stainless Steel, Silicone
Hex Driver, 3.5mm
Stainless Steel
Hip End Effector (Parallel and Variable Angle)
Stainless Steel, Aluminum
Hip Probe
Stainless Steel, Aluminum
Mako (Trident RIO) Inline-Offset Shell Impactor
Stainless Steel
Mako Integrated Cutting System (MICS)
Stainless Steel, Aluminum, PPSU, Silicone
Mako Offset Reamer Handle
Stainless Steel
Mako (RESTORIS RIO) Shell Impaction Platform
Stainless Steel
Mako Straight Reamer Handle
Stainless Steel
Mako (Trident RIO) Straight Shell Impactor
Stainless Steel
Mako (RIO) System Quick Connect Base Array
Stainless Steel, Aluminum
MicroAire Adaptor
Stainless Steel
MicroAire 7005 Series Drill/Reamer
Stainless Steel and Aluminum
MicroAire Power Cable
Silicone
MICS Adapter Cover
Polyphenylsulfone
MICS Reamer Attachment
Stainless Steel, Aluminum, PEEK
Pelvic Array
Stainless Steel and Aluminum
Pelvic Array Adaptor
Stainless Steel and Aluminum
Pelvic Checkpoint Driver
Stainless Steel, Silicone
Reamer Handle Sleeve
PTFE
Registration Array (RIO)
Stainless Steel and Aluminum 5
Mako Instrument Cleaning and Sterilization Guide Instrument
Material
Screw Holding Forceps
Stainless Steel
Square Driver
Stainless Steel Table 3. Mako PKA Instrument Kit
Instrument
Material
2-Pin Clamp
Stainless Steel
Anterior Cut Reference Guide
304, 316, 410 or 17-4 PH Stainless Steel
Array Stabilizer (3.2 short or 4.0 long)
Stainless Steel
Blunt Introducer
Stainless Steel
Blunt Probe
Aluminum, Stainless Steel
Burr Guard Assembly
Stainless Steel, PEEK
Caddy Saw Guide (RESTORICS MCK PFJ)
17-4 PH Stainless Steel
Cement Clamp Jaw
PPSU (Radel R5550)
Cement Removal Tool
Stainless Steel
Clamp Assembly, Patella Resection
17-4 PH Stainless Steel, 316L Stainless Steel
Clamp, Patella Saw Guide (8.25 mm, 9.25 mm, 10.25 mm)
17-4 PH Stainless Steel
Collet Nut
Stainless Steel
Depth Gauge
Stainless Steel
Double Angle Collet
Stainless Steel
Double Barrel Drill Guide
Aluminum, Stainless Steel
Femoral Impactor
17-4 PH Stainless Steel, Acetyl copolymer or PPSU (Radel R5500)
Femoral Peg Drill
17-4 PH Stainless Steel
Femoral Trial Slaphammer
Stainless Steel
Goelet Retractor
300 Series Stainless Steel
High Speed Rotary Attachment
Aluminum, Stainless Steel, PEEK
Inlay Impactor, Tibial Insert Assembly
17-4 PH Stainless Steel
Knee Checkpoint Driver
Aluminum, Stainless Steel
Knee End Effector
N3971, Silicone, Stainless Steel
Knee End Effector Array
Aluminum, Stainless Steel
Knee Femoral Array
Aluminum, Stainless Steel
Knee Tibial Array
Aluminum, Stainless Steel
Mako (RIO) System Quick Connect Base Array
Stainless Steel, Aluminum
MICS Attachment Wrench
Stainless Steel
MICS Handpiece
Stainless Steel, Aluminum, PPSU, Silicone
Onlay Insert Extractor
316, 420, 17-4 or 18-8 PH Stainless Steel
Onlay Insert Impactor
17-4 PH Stainless Steel, Acetyl Copolymer 6
Mako Instrument Cleaning and Sterilization Guide Instrument
Material
Patella Impactor
17-4 PH Stainless Steel, Acetyl Copolymer or PPSU (Radel R5500)
Patella Protector
300 Series Stainless Steel
Pelvic Array Adaptor
Stainless Steel
Registration Tool
Stainless Steel
Sagittal Saw Attachment
Aluminum, Stainless Steel, Viton Rubber, Titanium
Sharp Probe
Aluminum, Stainless Steel
Short Collet Nut Wrench
Stainless Steel
Spacer Paddles (1mm x 2mm, 3mm x 4mm, 5 mm x 6 mm)
Stainless Steel
Square Drill Adapter
Stainless Steel
Square Driver
Silicone, Stainless Steel
Townley Caliper (4”)
300 and 400 Series Stainless Steel Table 4. Stryker Leg Positioner Instrument Kit
Instrument
Material
Rail Clamp
Aluminum, Stainless Steel, Bronze
Base Bar
Carbon Fiber, Aluminum, Stainless Steel
Sled
Aluminum, Stainless Steel, Bronze
Boot
Carbon Fiber, Aluminum, Stainless Steel, Bronze, Ceramic, PEEK
Extension Bar
Carbon Fiber, Aluminum, Stainless Steel, Bronze
Short Antler
Aluminum
Long Antler
Stainless Steel
Bent Hohmann Retractor
Stainless Steel
Rake Retractor
Stainless Steel
Smiley Retractor
Stainless Steel
PCL Retractor
Stainless Steel
Patella Retractor
Stainless Steel
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Mako Instrument Cleaning and Sterilization Guide
E. STERILE DISPOSABLES Table 5 lists items that are designated as disposable and should be used for a single Mako surgery.
Disposables should not be cleaned or sterilized.
Table 5. Disposable Instruments Mako TKA, THA, PKA, and Leg Positioner
TKA Disposable
Image
Material
Mako (RIO) Drape Kit
LDPE, HDPE, Tyvek, PE film, EMA
Mako Blade (Standard, Narrow)
420 Stainless Steel
VIZADISC
Polycarbonate Resin, reflective material
Knee Femoral Checkpoint
316L Stainless Steel
Knee Tibial Checkpoint
316L Stainless Steel
Bone Pins (3.2 mm, 4.0 mm)
316L Stainless Steel
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Mako Instrument Cleaning and Sterilization Guide
THA Disposable
Image
Material
Mako (RIO) Drape Kit
LDPE, HDPE, Tyvek, PE film, EMA
Checkpoint 3.5 Hex X 15mm
316LVM Stainless Steel
Checkpoint 3.5mm Hex, IMPACTION
316L Stainless Steel
Tibial Checkpoint
316LVM Stainless Steel
Cortical Screw
316LVM Stainless Steel
4.0 Bone Pins (80, 110, 140, 170mm lengths)
316LVM Stainless Steel
Polycarbonate Resin, reflective material
VIZADISC Hip Procedure Tracking Kit
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Mako Instrument Cleaning and Sterilization Guide
PKA Disposable
Image
Material
Mako (RIO) Drape Kit
LDPE, HDPE, Tyvek, PE film, EMA
6mm Fluted Ball Burr
M2 Tool Steel
Mako (RIO) System Irrigation Tube
N/A
Tygon (Latex Free)
Irrigation Clip HD (Anspach)
N/A
304 Stainless Steel / PEEK
VIZADISC
Polycarbonate Resin, reflective material
Knee Femoral Checkpoint
316L Stainless Steel
Knee Tibial Checkpoint
316L Stainless Steel
Bone Pins 3.2mm/4.0mm
316L Stainless Steel
MICS Irrigation Clip
316LVM Stainless Steel
Mako Ball Burr (116041-57)
440C Stainless Steel
Mako Ball Burr (110135)
M42 Tool Steel
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Mako Instrument Cleaning and Sterilization Guide PKA Disposable
Image
Mako Saw Blade (Narrow)
Material
440C Stainless Steel
Leg Positioner Disposable
Image
Material
Silicone Retractor Cord
Platinum Silicone 6.35mm Dia x 610mm Long
Foam Pad
9.5mm Thick Gray Polyurethane Open Cell Memory Foam
Coban Wrap
Black Coban Adhesive Tape
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Mako Instrument Cleaning and Sterilization Guide
F. PRE-CLEANING CONSIDERATIONS Any Mako instrumentation that has patient contact in a surgical procedure requires cleaning and sterilization. Prior to initiating cleaning and disinfection, a user/facility appropriate disinfection strategy should be chosen from Appendix A. The chosen strategy should be based on the disinfection agents and equipment available. Before cleaning, some instruments may need to be disassembled. • • •
Remove and discard all disposables (VIZADISCs, bone pins, etc.) from instruments prior to cleaning. When removing VIZADISCs, gently twist the VIZADISCs clockwise and pull. Disassemble instruments with multiple components before cleaning; reference Table 6. Some instruments are not intended to be disassembled, reference Table 6. Before starting the cleaning and sterilization process, visually inspect all instruments for damage. Remove any damaged parts from use and return them to MAKO Surgical Corp. after cleaning and sterilizing. Table 6. Instrument Disassembly
TKA Part Name
Image Remove and discard all VIZADISC (four places) Captured Screws
Knee Femoral and Knee Tibial Array Assembly
Captured Screws
Discard Bone Pins
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Mako Instrument Cleaning and Sterilization Guide TKA Part Name
Image Remove and discard all VIZADISC (four places)
RIO (Mako) Base Array Assembly
Remove and discard all VIZADISC (four places)
Knee End Effector Array Assembly
Disassemble Screw
Remove and discard all VIZADISC (three places)
Sharp and Blunt Probes
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Mako Instrument Cleaning and Sterilization Guide TKA Part Name
Image Remove Spacer Shim from Knee Tensioner
Knee Tensioner and Spacer Shim
Remove and discard Mako Saw Blade
MICS Handpiece Assembly
Disconnect Saw Attachment
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Mako Instrument Cleaning and Sterilization Guide
THA Part Name
Image Remove and discard all VIZADISC
Pelvic Array Assembly (3-Pin Clamp)
Thumbscrew
Array Clamp
Thumbscrew Discard All Bone Pins
Remove and discard all VIZADISC Pelvic Array
O Clamp
Pelvic Array Assembly (O Clamp) Optional Discard All Bone Pins
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Mako Instrument Cleaning and Sterilization Guide THA Part Name
Image
Hip End Effector and Variable End Effector Assembly
Captured Screws (2)
Femoral Array Assembly Remove and discard all VIZADISC
Remove and discard all VIZADISC RIO Base Array
Remove and discard all VIZADISC RIO Registration Array
Remove and discard all VIZADISC Hip Probe
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Mako Instrument Cleaning and Sterilization Guide THA Part Name
Image
Straight Reamer Handle Assembly Push up and turn clockwise to unlock for sterilization
Broach Array Postero-Lateral
Remove and discard all VIZADISC
Broach Array Antero-Lateral Remove and discard all VIZADISC
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Mako Instrument Cleaning and Sterilization Guide
PKA Part Name
Image Remove and discard all VIZADISC (four places)
Femoral and Tibial Array Assembly
Captured Screws (2) Discard Bone Pins
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