Orthopaedics Cleaning, Sterilization, Inspection and Maintenance of Reusable Medical Devices Reference Guide

Sterilization reference guide

Labeling symbols glossary

Do not reuse

Legal manufacturer

3

Sterilization reference guide

Table of contents Introduction ... 5 Preparation for cleaning (point of use for all instruments) ... 7 Manual cleaning ... 8 Automated cleaning and disinfection... 9 Inspection ... 11 Packaging (preparation for sterilization) ... 12 Sterilization ... 13 Storage before use ... 14 Appendix 1: Instructions for cleaning ... 15 Appendix 2: U.S. parameters rigid container compatibility for complete instruments sets... 18 Appendix 3: U.S. parameters for rigid container compatibility for legacy instrument sets ... 23 Appendix 4: International (non-U.S.) parameters for blue sterilization wrap compatibility for legacy instrument sets ... 30 Appendix 5: International (non-U.S.) parameter rigid container compatibility for complete instruments sets ... 35 Appendix 6: Sterilization of instruments outside the tray configuration ... 40 Appendix 7: Sterilization of instruments in sterilization basket ... 41 References: ... 43

4

Sterilization reference guide

Introduction This document is intended to provide detailed instructions for processing reusable surgical instruments manufactured by Stryker Orthopaedics. All Stryker Orthopaedics reusable instruments must be cleaned and sterilized to prepare them for use. This document also gives instructions for inspection to determine when an instrument has reached the end of its serviceable life and must be replaced. This document provides assembly and disassembly instructions for multicomponent instruments which must be disassembled prior to cleaning and/or sterilization. Stryker Orthopaedics has validated the processes provided in these instructions to be capable of being effective.

Equipment, operators, cleaning agents and procedures all contribute to the efficacy of the processing. The healthcare facility should ensure that the selected processing steps are safe and effective. Alternative methods of processing outside the scope of this document may be suitable for reprocessing; however, these must be validated by the end user. In the event of conflicting national cleaning and sterilization requirements, such requirements shall prevail over Stryker Orthopaedics recommendations. In accordance with ISO 17664, two methods of cleaning Stryker Orthopaedics reusable instruments are provided in these instructions: a fully manual method (see Manual cleaning section on page 8) and a

method using an automated washerdisinfector (see Automated cleaning section on page 9). Whenever possible, the automated method should be used. The automated cleaning process is more reproducible and, therefore, more reliable. Additionally, staff are less exposed to the contaminated devices and the cleaning agents used. Whichever method is used, staff should use suitable protective clothing and equipment at all times. In particular, take note of the instructions provided by the cleaning agent manufacturer for correct handling and use of the product.

Warnings and precautions Please refer to the device label to identify single- or multiple-use devices and components. Single-use devices are intended for single-use only and must not be reused. Some device materials may develop changes in mechanical, physical or chemical characteristics under conditions of repeated use, cleaning and re-sterilization that may compromise the integrity of the design and/or material leading to diminished safety, performance and/or compliance with relevant specifications. Stryker Orthopaedics reusable instruments are not normally used in surgical procedures where they contact TSE infective tissue (Transmissible Spongiform Encephalopathies) as defined by the World Health Organization (WHO).

Therefore, decontamination procedures with highly aggressive agents [e.g., sodium hydroxide (NaOH) or sodium hypochlorite (NaClO)] are not necessary and, for normal processing, are not recommended because material degradation may occur. The sterilization parameters recommended in this document are not intended and not suitable for inactivation of prions.

5

Sterilization reference guide

Reprocessing overview The sequence of steps required to prepare reusable instruments for reuse or to prepare new devices for initial use is summarized in the chart below. More detailed instructions for each step are given on the following pages.

Point of use

Remove gross soil

Transport to processing area

Avoid damage Minimize time before cleaning Avoid drying of soil prior to cleaning

Preparation for cleaning

Remove instruments from transport tray/case Disassemble as required For specific assembly/disassembly instructions, refer to Appendix 1

Manual cleaning

Recommended

Automated cleaning

Pre-cleaning (Manual)

Pre-cleaning (Automated)

Manual cleaning

Washer-disinfector Automated cleaning

Inspection

Check soil traps Check for damage Check operation Check straightness

Packaging and sterilization

Suitable sterile barrier Suitable steam sterilizer

Storage

Controlled environment Verified storage time

Note: The quality of the water used for diluting cleaning agents and/or disinfectants and for rinsing reusable instruments should be carefully considered according to AAMI TIR 34 “Water for reprocessing of medical devices.” Application of critical water for final rinsing purpose with less than 10 CFU/mL and less than 10 EU/mL is highly recommended. Mineral residues from hard water, as well as higher contamination with microorganisms and endotoxins, can result in staining of the device and/or prevent effective cleaning and sterilization.

6

Sterilization reference guide

Preparation for cleaning (point of use for all instruments) Point of use After use (within a maximum of 2 hours postoperatively) remove gross soil using absorbent paper wipes. Intensive rinsing of the reusable instruments with fluent water or transfer of the medical devices into a bath with an aldehyde-free disinfectant solution is highly recommended. Transport to processing area Avoid mechanical damage by ensuring that heavy devices do not get mixed with delicate ones. Pay particular attention to cutting edges, both to avoid personal injury and prevent damage to the reusable instruments. Transport the reusable instruments to the point where cleaning is to be performed as soon as practical. If transfer to the processing area is likely to be delayed, consider covering the instruments with a damp cloth to avoid drying of soil. Preparation for cleaning Appendix 1 provides specific instructions for instruments that require disassembly and for certain instruments that should not be disassembled prior to cleaning.

7

Caution: Stryker Orthopaedics trays and cases are intended for transport and storage of reusable instruments. They are not designed for cleaning and/or disinfection in the fully assembled state. The instruments must be removed from the tray for adequate cleaning results.

Sterilization reference guide

Manual cleaning

Pre-Cleaning Remove gross soil using wipes and solution of cleaning agent. Immerse reusable instrument in solution of cleaning agent. Ensure that all surfaces are thoroughly wetted. Use a syringe or pipette to ensure that the cleaning solution reaches all parts of cannulations. Ensure that air is not trapped within features of the device when immersing in the solution. Soak for minimum recommended time by the detergent manufacturer’s instructions.

Using suitable soft bristle brushes, clean the reusable instrument thoroughly, paying particular attention to rough surfaces and features where soil may be impacted or shielded from the cleaning process. Use a firm bristle brush for cleaning bonecutting features such as drill tips, reamer flutes and the teeth of broaches. Use a bottle brush of appropriate diameter and length for cannulations. Ensure that the brush passes the whole length of each cannulation.

Rinse in running water until all traces of cleaning solution are removed. Pay particular attention to cannulations and blind holes, as well as hinges and joints, between mating parts. Visually inspect for any remaining soil and repeat the steps above if necessary. Allow to drain on absorbent paper or transfer immediately to cleaning step.

Operate articulating devices and those with moving parts.

Manual cleaning Equipment required: • Ultrasonic bath large enough to allow complete immersion of the reusable instrument. (A frequency of 25 – 50 kHz is recommended. Do not exceed the temperature stated by the detergent manufacturer.)

•

•

•

Cleaning agent intended for manual cleaning and suitable for ultrasonic treatment. Do not exceed the concentration specified by the detergent manufacturer. Suitable brushes or cleaning wires to reach all parts of the device. Caution: Never use metal brushes or steel wool for cleaning. Syringes (volumes 1 to 50 mL, depending on the size of the channels to be rinsed).

•

Fresh critical water, highly critical water or sterile water for rinsing purposes.

•

Critical water for final rinsing purpose.

Instructions: Prepare an ultrasonic bath with a cleaning solution at the concentration and temperature specified by the detergent manufacturer. Immerse the device completely and activate the bath for a minimum of 15 minutes. Using suitable brushes or cleaning wires, clean the device paying particular attention to rough surfaces and features that may be shielded from the brushing action. Rinse for at least 1 minute in running water until all traces of cleaning solution are removed. Pay particular attention to cannulations, blind holes, hinges, and joints between mating parts. If, after completion of the cleaning step in the ultrasonic bath, encrusted soil remains on the device, the cleaning step must be repeated as described above.

Note: The guidance provided by the cleaning agent manufacturer concerning concentrations and temperatures should be followed. If these concentrations and temperatures are exceeded significantly, discoloration or corrosion could occur with some materials. This could also happen if rinsing after cleaning and/or disinfecting is insufficient. Only specifically formulated cleaning agents and/or disinfectants should be used for cleaning or disinfecting reusable instruments. As not all cleaning agents and disinfectants may be available around the globe, Stryker Orthopaedics does not recommend any specific cleaning and/or disinfection agent. The end user should verify the selected cleaning agent is appropriate for use on reusable surgical instruments.

8

Sterilization reference guide

Automated cleaning and disinfection

Pre-Cleaning Equipment required: • Ultrasonic bath large enough to allow complete immersion of the reusable instrument. (A frequency of 25 – 50 kHz is recommended. Do not exceed the temperature stated by the detergent manufacturer.)

•

•

Cleaning agent intended for manual cleaning and suitable for ultrasonic treatment. Do not exceed the concentration specified by the detergent manufacturer. Suitable brushes or cleaning wires to reach all parts of the device. Caution: Never use metal brushes or steel wool for cleaning.

Instructions: Prepare an ultrasonic bath with a cleaning solution at the concentration and temperature specified by the detergent manufacturer. Remove gross soil using wipes and solution of cleaning agent. Immerse the device completely and activate the bath for a minimum of 20 minutes. While device is immersed in prepared cleaning solution, using suitable brushes or cleaning wires, clean the device paying particular attention to rough surfaces and features that may be shielded from the brushing action.

•

Syringes (volumes 1 to 50 mL, depending on the size of the channels to be rinsed).

Rinse for at least 1 minute in running water until all traces of cleaning solution are removed.

•

Fresh critical water, highly critical water or sterile water for rinsing purposes.

Pay particular attention to cannulations, blind holes, hinges, and joints between mating parts.

•

Critical water for final rinsing purpose.

9

Note: The guidance provided by the cleaning agent manufacturer concerning concentrations and temperatures should be followed. If these concentrations and temperatures are exceeded significantly, discoloration or corrosion could occur with some materials. This could also happen if rinsing after cleaning and/or disinfecting is insufficient. For cleaning or disinfecting reusable instruments, only specifically formulated cleaning agents and/or disinfectants should be used. As not all cleaning agents and disinfectants may be available around the globe, Stryker Orthopaedics does not recommend any specific cleaning and/or disinfection agent. The end user should verify the selected cleaning agent is appropriate for use on reusable surgical instruments.

Sterilization reference guide

Automated cleaning and disinfection (con’t)

Equipment required: • Washer-disinfector with demonstrated efficiency (e.g., CE mark or FDA clearance and validated in accordance to ISO 15883), properly installed, qualified and regularly subjected to maintenance and testing.

•

•

Approved thermal disinfection program with sufficient rinsing steps (A0 value of at least 600 or application for 1 minute at 90°C OR at least 3000 or application for 5 minutes at 90°C). Cleaning agent intended for use in washer-disinfector. Do not exceed the concentration and temperature recommended by the detergent manufacturer.

Instructions: Load the reusable instruments into the washer-disinfector per required loading configuration. Connect cannulations to the rinsing ports of the washer-disinfector. If no direct connection is possible, locate the cannulations directly on injector jets or in injector sleeves of the injector basket. Avoid contact between devices as movement during washing could cause damage and washing action could be obstructed. Arrange reusable instruments so that cannulations are not horizontal and blind holes incline downwards to assist cleaning and drainage. Articulating devices should be in the open position. Operate the washer-disinfector cycle.

Upon completion, unload the washerdisinfector. Visually inspect each device for remaining soil and dryness. If soil remains, repeat the cleaning process. Remaining wetness may be removed with filtered, compressed air or clean, lint-free wipes. If additional drying is required, arrange instruments in a clean area or heat in an oven below 110°C. Caution: Chemical disinfection programs are not recommended due to the potential for chemical residues to remain on the instruments. These residues could interfere with sterilization efficacy. Caution: Neutral cleaning agents are recommended for Stryker Orthopaedics reusable instruments and cases/trays/lids. An alkaline cleaning agent (up to pH 11) is allowable, but not preferred. Alkaline cleaning agents may cause cosmetic damage or reduce the life of product.

10

Sterilization reference guide

Inspection Before preparing for sterilization, all reusable instruments shall be inspected for cleanliness and integrity (the ability of the reusable instrument to function). Generally unmagnified visual inspection under good light conditions is sufficient. All parts of the devices should be checked for visible soil and/or corrosion. Particular attention should be paid to:

•

Soil “traps” such as mating surfaces, hinges, shafts, rotating gears and lumens;

•

Recessed features (holes, textured surfaces and cannulations);

•

Features where soil may be impacted into the device, such as drill flutes adjacent to the cutting tip and sides of teeth on broaches and rasps;

•

Cutting edges should be checked for sharpness and damage.

11

Mating devices should be checked for proper assembly. Instruments with moving parts should be operated to check correct operation (medical grade lubricating oil suitable for steam sterilization can be applied as required). Rotating instruments, such as multiple- use drill bits and reamers, should be checked for straightness. This can be achieved by simply rolling the instrument on a flat surface. “Flexible” instruments should be checked for damage.

Note: Stryker Orthopaedics does not define the maximum number of uses appropriate for reusable instruments. The useful life of these devices depends on many factors, including the method and duration of each use and the handling between uses. For devices that are impacted during the surgical procedure, check that the device is not damaged to the extent that it malfunctions or that burrs have been produced that could damage tissues or surgical gloves. Careful inspection and functional test of the instrument before use is the best method of determining the end of serviceable life. Refer to reference e-IFU SLI0001 “Instructions for inspection and maintenance of reusable medical devices”, for additional information regarding inspection. This e-IFU is available at ifu.stryker.com.

Sterilization reference guide

Packaging (preparation for sterilization) For blue wrap: Stryker Orthopaedics case/tray configurations should be double wrapped according to AAMI/CSR technique. The packaging for terminally sterilized reusable instruments should be suitable for steam sterilization and the appropriate grade for the weight of the instruments. Additionally, the blue wrap should be compliant to the following requirements:

•

AAMI ST79

•

ISO 11607

•

CE mark

•

FDA 510(k) clearance for specified sterilization parameters

For rigid containers: Stryker Orthopaedics has validated steam sterilization of complete reusable instrument trays with Aesculap SterilContainer System. For a complete list of rigid container compatibility details, reference Appendix 2, Appendix 3, Appendix 5, Appendix 6 and Appendix 7. For all sterilization packaging configurations, Stryker Orthopaedics recommends the use of biological indicators as described in ISO 11138-3 (Geobacillus stearothermophilus) and/ or chemical indicators as described in ISO 11140 for proper monitoring of all sterilization cycles.

Caution: Stryker Orthopaedics has only validated the specific lid/case combinations listed to the parameters listed in the Sterilization section on page 13. While other combinations and parameters may be appropriate, the responsibility for validation and evaluation would be on the end user. Warning: The use of lid/case/tray combinations in a rigid container system that has not been properly validated in accordance with ISO 17665 may result in the inability to meet the required sterility assurance level (SAL) of 10-6.

12

Sterilization reference guide

Sterilization The process parameters shown at the right are validated at minimum time and temperature in accordance with ANSI/AAMI ST79, EN ISO 17665 and HTM-01-01 and recommended for sterilization. Steam autoclave (moist heat) sterilization using a pre-vacuum (forced air removal) cycle is recommended. Autoclaves should comply with the requirements of, and be validated and maintained in accordance with, EN285, EN13060, EN ISO 17665 and ANSI/ AAMI ST79.

U.S.

Stryker Orthopaedics has validated the recommended sterilization cycle for complete reusable instrument cases/ trays.

International (non-U.S.) or O.U.S. Method

Moist heat sterilization according to ISO 17665

Compatibility with rigid container systems for U.S. parameters is provided in Appendix 2, Appendix 3, Appendix 6 and Appendix 7. Instruction for international (non-U.S.) parameters is provided in Appendix 4, Appendix 5, Appendix 6 and Appendix 7.

Cycle

Pre-vacuum (dynamic air removal)

Temperature

134-137°C (273-279°F)

Exposure time*

3 minutes (minimum)

Drying time**

30 minutes (in chamber)

Single instruments, properly double wrapped or double pouched, can be sterilized using the same parameters.

*Exposure time: Period for which the load and entire chamber is maintained at the sterilization temperature.

Method

Moist heat sterilization according to ANSI / AAMI ST 79

Cycle

Pre-vacuum (dynamic air removal)

Temperature

132°C (270°F)

Exposure time*

4 minutes

Drying time**

30 minutes (in chamber)

**Drying time: Period during which steam is removed from the chamber and the chamber pressure is reduced to permit the evaporation of condensate from the load either by prolonged evacuation or by the injection and extraction of hot air or other gases. The drying time varies due to load configuration, wrapping method and material. Caution:

Stryker Orthopaedics does not recommend the use of ‘flash’ sterilization for reusable instruments. Caution:

Longer cycles, such as those recommended for control or elimination of Transmissible Spongiform Encephalopathies, may be utilized; however, instruments should be expected to have reduced functional life (applicable for O.U.S. users only). Warning:

Implants and instruments which are supplied STERILE must not be resterilized as this process has not been validated.

13

Sterilization reference guide

Storage before use An appropriate sterile barrier packaging system and appropriate storage conditions shall be utilized to minimize the risk of microbial contamination and to maintain integrity and cleanliness of sterilized reusable instruments prior to use.

Note: Stryker Orthopaedics recommends storage conditions in accordance with USP (United States Pharmacopeia), EP (European Pharmacopoeia), and JP (Japanese Pharmacopoeia) guidelines for controlled room temperatures

After sterilization, reusable instruments should be stored in the sterilization wrap or rigid container in a dry and dust-free place. The shelf life is dependent on the sterile barrier employed, storage manner, environmental conditions and handling. A maximum shelf life for sterilized reusable instruments should be defined by each healthcare facility based on the recommendations of the wrap or container manufacturer.

14

Sterilization reference guide

Appendix 1: Instructions for cleaning Hip instruments

Instructions for instruments that require disassembly Catalog number

Instrument name

Surgical system

Instructions

6278-1-100

Version Control Stem Inserter

Depress the circular button on the body and pull away from Stem Inserter

6260-4-070

Proximal Body Steady Handle

Unthread the white plastic tip in a counterclockwise manner to separate the tip and handle 1.

6278-9-070

Body/Stem Inserter

2.

Restoration Modular

6278-1-200 D

1.

Distal Stem Inserter 2.

Unthread the split collet from the puller by twisting the collet clockwise; Unthread the jackscrew from the puller by twisting counterclockwise Unthread the handle from the outer sleeve by twisting the outer sleeve in the direction of the arrows laser marked on the instrument while holding the flats on the outer sleeve. Note: Threads between the handle and outer sleeve are lefthanded. Remove the threaded rod from the outer sleeve by holding the hex end and sliding the threaded rod from the outer sleeve.

Unthread the white plastic tip in a counterclockwise manner to separate the tip and handle

6266-0-140

Head Impactor

Restoration Modular Accolade

1104-1000

Femoral Head Impactor

Cutting Edge Advantage

1235-0-008

ADM Press

ADM

2102-0410

Acetabular Reamer Handle

Trident

Remove white plastic sleeve by pulling up and over the end of the metal shaft

2101-0130

Final Cup Impactor

Trident

Remove the impactor tip from the handle

Cutting Edge Advantage

Unthread the cylindrical or tapered distal extensions from the broach by turning counterclockwise

1126-xxxx

15

Cutting Edge Broach

Unthread the black plastic tip in a counterclockwise manner to separate the tip and handle

Sterilization reference guide

Appendix 1: Instructions for cleaning Hip instruments

Instructions for instruments that require disassembly Catalog number

0930-5-000

Instrument name

Stem introducer

Surgical system

Instructions

Exeter

Unthread counter-clockwise the locking bolt at the end of the black handle. Disassemble the black handle and extract the central rod and spring from the shaft. The trigger will then disassemble. Unthread the bullet tip, remove and disassemble the spigot connector from the end of the introducer shaft. Repeat these steps in reverse to assemble.

Instructions for instruments that do not require disassembly Catalog number

Instrument name

Surgical system

Instructions

7003-0000

Trial Insert Hex Containment Screw

Trident II

Do not disassemble*

2230-0010

Acetabular Insert Trial Containment Screw Kit

Cutting Edge Advantage

Do not disassemble*

Trident II

Do not disassemble

2111-30XX (XX=22, 26, 28, 32, 36, Plastic Insert Impactor Tips 40, 44)

*If disassembly occurs, place the Hex Screw in the middle of Insert Trial and secure with retaining ring.

16

Sterilization reference guide

Appendix 1: Instructions for cleaning Knee instruments

Instructions for instruments that require disassembly Catalog number

Instrument name

Surgical system

Instructions

6776-8-210

Stem Punch Extractor

Duracon XCelerate

Remove the hammer from the handle

6778-6-xxx

Offset Adaptor Trials Scorpio TS

Remove the jam nut by turning counterclockwise to separate from body Disassemble locking knob by turning it counterclockwise to separate

8200-0043

Tibial Offset Fixture

6776-8-010

Tibial Impactor

MRH

Disassemble plastic tip by turning counterclockwise

6633-9-995*

Tibial Offset Fixture

Duracon TS

Disassemble locking knob by turning it counterclockwise to separate

Scorpio MIS

Disassemble locking knob by turning it counterclockwise to separate

Surgical system

Instructions

8050-1060 L or R

MIS Tibial Resection Guides

*Product is not currently CE marked

Dall-Miles Cabling instruments

Instructions for instruments that require disassembly Catalog number

Instrument name

1. 6704-9-320

Single-Sided Tensioner

2.

1. 6704-9-350

Double-Sided Tensioner

2. Dall-Miles

6704-9-720

Grip Impactor

17

Cable Cutter

Turn knob clockwise to release the jaws in the tensioner head from the studs; Turn the tensioner heads clockwise until they are removed

Unthread the white plastic tip by turning counterclockwise 1.

6704-9-420

Turn the knob clockwise (as indicated by the arrow) until it spins freely; Twist nose silver portion (threaded into green body) counterclockwise

2.

Using a wrench, turn the retaining nut to remove; Twist the tip counterclockwise to unthread the plunger to remove from outer sleeve

Sterilization reference guide

Appendix 2: U.S. parameters rigid container compatibility for complete instruments sets Stryker Orthopaedics has validated steam sterilization of complete, fully loaded reusable instrument trays with Aesculap SterilContainer System. All trays are screen printed with the words RIGID CONTAINER COMPATIBLE. Other rigid container systems maybe suitable for use, but must be evaluated by the end user. Refer to Aesculap Instructions for Use for Care & Handling of Aesculap SterilContainer Systems (JN442).

Hip instruments

Note: For all trays, compatible Lid number is: 6147-0-100 Accolade II Basic

Tray: 6147-1-101

Accolade II Broaches

Tray: 6147-1-102

Modular Dual Mobility

Tray: 6147-2-101

Acetabular Reamers (36-66 mm)

Tray: 6147-3-101

Trident and Tritanium General Tray

Tray: 6147-3-102

Acetabular Reamers (67-80 mm)

Tray: 6147-3-103

Trident and Tritanium Insert Trials

Tray: 6147-3-104

Trident Window Trials

Tray: 6147-3-105

Tritanium Window Trials

Tray: 6147-3-106

Trident Tritanium Window Trials

Tray: 6147-3-107

Exeter Broach Tray

Tray: 0585-9-900

Exeter Plug Trial Tray

Tray: 0585-9-901

Exeter Retractor Tray

Tray: 0585-9-902

Exeter Extension Broach Tray

Tray: 0585-9-903

ETS Instrument Tray

Tray: 0585-9-904

General Femoral Tray

Tray: 0585-9-905

Trident Constrained Insert Trials Tray

Tray: 6147-3-108

Trident Offset Reamer Tray

Tray: 6147-3-110

Trident II Core Reamers (38-66 mm) Tray

Tray: 7000-0100

Aesculap Configuration Base: JN442 Lid: JK48x

18

Sterilization reference guide

Hip instruments

Appendix 2: U.S. parameters rigid container compatibility for complete instruments sets Trident II General Instruments Tray

Tray: 7000-0101

Trident II Core Trials Tray

Tray: 7000-0102

Trident II Auxiliary Trials Tray

Tray: 7000-0103

Trident II Reamers (38-66 mm) Tray

Tray: 7000-0104

Restoration Modular Starting Instruments Tray

Tray: 6278-9-800

Restoration Modular Conical Distal Reamers Tray #1 (13 mm-20 mm)

Tray: 6278-9-801

Restoration Modular Conical Distal Reamers Tray #2 (21 mm-24 mm)

Tray: 6278-9-802

Restoration Modular Conical Distal Reamers Tray #3 (25 mm-28 mm)

Tray: 6278-9-803

Restoration Modular Proximal Cone Reamers Tray (19 mm-31 mm)

Tray: 6278-9-804

Restoration Modular Cone Body Trials Tray #1 (19 mm-25 mm)

Tray: 6278-9-805

Restoration Modular Cone Body Trials Tray #2 (27 mm-31 mm)

Tray: 6278-9-806

Restoration Modular Finishing Instruments Tray #1 (Head Trials Tray)

Tray: 6278-9-807

Restoration Modular Finishing Instruments Tray #2

Tray: 6278-9-808

Trident Constrained Insert Trials Tray

Tray: 6147-3-108

Trident Offset Reamer Tray

Tray: 6147-3-110

Femoral Instrument Tray - General

Tray: 7000-5520

Insignia Broach Tray – General

Tray: 7000-5521*

Accolade II Broach Tray - General

Tray: 7000-5522

Direct Anterior Femoral Tray

Tray: 7000-5523

Direct Anterior Retractor Tray

Tray: 7000-5524

*Product is not currently CE marked

19

Aesculap Configuration Base: JN442 Lid: JK48x

Sterilization reference guide

Knee instruments

Appendix 2: U.S. parameters rigid container compatibility for complete instruments sets Triathlon CR Insert Trials Tray (Size 1-8)

Tray: 6541-9-100

Triathlon CS Insert Trials Tray (Size 1-8)

Tray: 6541-9-101

Triathlon PS Insert Trials Tray (Size 1-8)

Tray: 6541-9-102

Triathlon Pro Femoral Trials - Left Tray

Tray: 6541-9-103

Triathlon Pro Femoral Trials- Right Tray

Tray: 6541-9-104

Triathlon Pro Miscellaneous Instruments Tray

Tray: 6541-9-106

Triathlon Pro 4:1 and Spacer Blocks Tray

Tray: 6541-9-107

Triathlon Pro Tibial Preparation Tray

Tray: 6541-9-109

Triathlon Pro Patella Preparation Tray

Tray: 6541-9-110

Triathlon Primary and Express Femoral Preparation Tray

Tray: 6541-9-112

Aesculap Configuration Base: JN442 Lid: JK48x

Triathlon Primary/Express/MIS Tibial Preparation Tray: 6541-9-113 Tray Triathlon Primary and MIS Patella Preparation Tray Tray: 6541-9-114 Triathlon PS Box Cutting Guides Tray

Tray: 6541-9-115

Triathlon MIS Femoral Preparation Tray

Tray: 6541-9-116

Triathlon 5511 PS Femoral Trials - Left Tray

Tray: 6541-9-117

Triathlon 5511 PS Femoral Trials – Right Tray

Tray: 6541-9-118

Triathlon Pro CR Insert Trials Tray (Size 0-7)

Tray: 6541-9-200

Triathlon Pro CS Insert Trials Tray (Size 0-7)

Tray: 6541-9-201

Triathlon Pro PS Insert Trials Tray (Size 0-7)

Tray: 6541-9-202

20

Sterilization reference guide

Knee instruments

Appendix 2: U.S. parameters rigid container compatibility for complete instruments sets Triathlon Tritanium Central Femoral Cone Preparation Tray

Tray: 6543-6-960

Triathlon AS-1 Cemented Tray**

Tray: 6556-9-111*

Triathlon AS-1 Cementless Tray**

Tray: 6556-9-222*

Triathlon Revision IM Reamers (8-19mm) Tray

Tray: 6543-6-501

Triathlon Revision General Tray

Tray: 6543-6-502

Triathlon Revision Tibial Prep Tray

Tray: 6543-6-503

Triathlon Revision 100mm Stem Trials (9-25mm) Tray

Tray: 6543-6-504

Triathlon Revision Finishing Tray

Tray: 6543-6-505

Triathlon TS Universal Baseplate Finishing Tray

Tray: 6543-6-506

Triathlon TS Femoral Prep Tray

Tray: 6543-6-507

Triathlon TS Femoral Augment Trials Tray

Tray: 6543-6-508

Triathlon TS Femoral Trials - Left Tray

Tray: 6543-6-509

Triathlon TS Femoral Trials – Right Tray

Tray: 6543-6-510

Triathlon TS Insert Trials (9-19mm) Tray

Tray: 6543-6-511

Triathlon Revision Baseplate Finishing Tray

Tray: 6543-6-512*

Triathlon Hinge Insert Trials Tray

Tray: 6543-6-513

Triathlon Hinge Femoral Prep Tray

Tray: 6543-6-514*

Triathlon Hinge Femoral Trials, Left Tray

Tray: 6543-6-515*

Aesculap Configuration Base: JN442 Lid: JK48x

Aesculap Configuration Base: JN442 Lid: JK48x

*Product is not currently CE marked **To ensure the total weight remains under 25lbs (11.3kg), when sterilizing with Rigid Container system, remove the lid from 6556-9-111/-222 prior to placing into the rigid container. This does not apply to blue wrap sterilization.

21