MAKO Instrument Cleaning and Sterilization Guide

Mako Instrument Cleaning and Sterilization Guide

iv

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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