Stryker LEIBINGER Cleaning and Sterilization Guide Implants, Instruments, Accessories

1. Important Information

Contents 1. 2. 3. 3.1. 3.2. 3.2.1. 3.2.2. 3.2.3.

Important Information Introduction Cleaning Medical Device Cleaning Groups Cleaning General Notes Safety Notes General Caution Notes Caution Notes for Instruments with Electronics 3.3. Cleaning Methods 3.4. Cleaning Equipment 3.5. Manual Cleaning Instructions 3.5.1. Manual 3.5.1.1. Manual Cleaning Instructions for Instruments with Electronics 3.6. Machine Cleaning Instructions (Recommended) 4. Inspection Recommendations 5. Sterilization Instructions 6. Appendix 1: Cleaning, Rinsing and Washing Agents; and Washing Machine

WARNING - CAUTION – NOTE 2 2 3 3 3 3 3 3 4 4 4 4 5 5 6 6

7

List of Tables Table 1: Medical Device Cleaning Groups Table 2: Cleaning Tools Table 3: Successfully Tested Cleaning Agents for Manual Cleaning Table 4: Successfully Tested Washing Agents for Machine Cleaning Table 5: Successfully Tested Rinsing Agents for Machine Cleaning Table 6: Successfully Tested Washing Machine

3 4 7 7 7 7

List of Flow Diagrams Flow diagram 1: Introduction Flow diagram 2: Manual Cleaning Flow diagram 3: Automated Cleaning

Please read this manual and follow its instructions carefully. The words WARNING, CAUTION and NOTE carry special meanings and should be carefully reviewed. WARNING: The personal safety of the patient and user may be involved. Disregarding this information could result in injury to the patient and/or user. CAUTION: In general, these instructions point out special service procedures or precautions that must be followed to avoid damaging the instrument. In addition, cleaning instruction steps related to a particular group are specified in a caution note. NOTE: This provides special information to make maintenance easier or important instructions clearer.

An exclamation point within a triangle displayed on the product is intended to alert the user to the presence of important operating and maintenance instructions in this manual.

2. Introduction This booklet provides detailed cleaning instructions and general sterilization recommendations of the Stryker Leibinger Implants, Instruments and Accessories. For Navigation Systems and components refer to Cleaning and Sterilization Guide Ref. No. 6000005-750. General information about the maintenance and care are also included. This Cleaning and Sterilization Guide is intended to be used with the Instructions For Use supplied with the devices. These Instructions provide specific information for maintenance and care as well as disassembling instructions if necessary. In addition, refer to the Instructions For Use for technical specifications or special cleaning/ sterilization recommendations related to the product/system. Keep all instructions where they are easily accessible for the persons handling the product. If you have any question or need help during a procedure, contact your Stryker Leibinger Sales Representative or Customer Service at +1-800-962-6558. Outside the U.S.A., contact the nearest Stryker subsidiary or Customer Support at +49-761-4512-0. Medical Device Cleaning Group Definition See chapter 3.1 in this manual for general information See Instructions For Use for instrument classification

2 4 5

Cleaning Safety / Caution Notes See chapter 3.2 in this manual for general information See Instructions For Use for special notes and recommendations related to the device

List of Acronyms AAMI: CSR: HF: TC:

Association for the Advancement of Medical Instrumentation Central Sterilization Room High Frequency Temperature Controlled

Disassembling Instructions Contained in the Instructions For Use if needed

Cleaning Instructions See Instructions For Use for material specification and recommendation of the cleaning method to be used (manual/automated) See cleaning equipment (3.4) and detailed instructions (3.5) in this manual

List of Terms and Definitions

Flow Diagram 1: Introduction

Device: Implant, Instrument, container or accessories Treat: Clean and sterilize

2

Inspection Recommendations See chapter 4 in this manual

Maintenance Recommendations Contained in the Instructions For Use if needed

Sterilization Instructions Unless otherwise specified in the Instructions For Use, follow the instructions in this manual (5)

3. Cleaning 3.1. Medical Device Cleaning Groups For proper handling during cleaning, reusable Stryker Leibinger devices are classified into six groups. Some instruments may belong to more than one group. In this case, the cleaning method should be the most aggressive or combine the instructions outlined for each corresponding group. If an instrument is not included in the list below and you are in doubt about the cleaning group it belongs to, refer to the Instructions For Use supplied with the instrument. Contact Stryker Leibinger Customer Service for clarification purposes. See contact information below.* Group I

Description

Representative Product Samples

II

(Bone) Cutting devices that cut, pierce or scrape

Instruments/Accessories: countersinks, drill bits, taps, osteotomes, bone elevators, curettes, spoons, dissectors, knives, scissors, raspatories, rasps, needles, awls, ear loops, perforators, chisels, scalpels, gouges, pluggers, saw blades, burrs, cutters, separators, cutting cylinders osseous microtome, trephines, trocars, plate deburrers,etc. Implants: one-piece screws, one-piece fixation pins, etc.

III

Cannulated cannulated devices (with cannula or features whose diameter is less, than or equal to 1/6 of the device‘s length)

Instruments/Accessories: drill/pin guides and sleeves, trocars, speculae, ear syringes, cannular gauges, cannulae, fixation sleeve, insertion tool, suction tubes, guiding tubes, catheters, tubes, suction dissectors, etc. Implants: cannulated screws, cannulated fixation pins, etc.

Articulated and MultiComponent articulated devices and those consisting of at least two pieces (with moving or detachable parts)

Instruments/Accessories: articulated bone forceps, articulated tissue forceps, roller benders, clamps, multicomponent retractors, biopsy probes, screwdriver handle, haematom evacuators, needleholder, suture forceps, drill handle, multi-component hooks, probes, multi-component tongue depressors, multi-component mirrors, coagulation instruments, measuring instruments, depth measuring gauges, fascia applicators, razor blade holders, rongeurs, ear snare, bone punches, spreaders, osseous microtome, multi-component or articulated wiring instruments, hand traction system, lag screw target bow, etc. Implants: bone distractors, multi-component screws, multi-component plates, etc. Instruments/Accessories: electrodes (TC string electrodes, TC straight, electrodes, TC needle electrodes, TC electrodes), and connecting cables, IM reamers, fiber optic cables, etc. Implants: distraction rods, etc. implant modules, sterilization trays, screw holders, sterilization containers, instrument trays, etc.

IV

Basic one-piece devices(with no moving or detachable part), devices that do not cut, scrape or pierce bone, non-cannulated, nonarticulated devices

V

Flexible devices with flexible shaft, cables

VI

Storage/Sterilization Boxes, Trays instrument containers

Instruments/Accessories: one-piece screwdrivers, spatulae, femoral clamps, screwdriver blades, one-piece cheek retractors, fixation plates, nonarticulated forceps, one-piece hooks, probes, one-piece tongue depressors, mirrors, suture pushers, tissue picks, rulers, ligature guides, retractor blades, mallets, guide wires, forks, cotton applicators, ear loops, one-piece mouth gags, one-piece mouth openers, mouth props, scalpel handles, strippers, onepiece wiring instruments, arch bars, etc. Implants: one-piece plates, etc.

Table 1: Medical Device Cleaning Groups *For further information, contact your Stryker Leibinger Sales Representative or Customer Service at +1-800-962-6558. Outside the U.S.A., contact the nearest Stryker subsidiary or Customer Support at +49-761-4512-0.

3.2. Cleaning General Notes* 3.2.1. Safety Notes Read carefully the following notes prior to cleaning.

WARNINGS Clean devices before first and every use and before returning them to service. After cleaning, sterilize as directed prior to use. • Only trained personnel should treat devices as instructed in this manual. • Handle sharp-edged and pointed instruments with care • Do not place contaminated devices in containers. • Use protective garments as recommended in the instructions supplied with the cleaning agent. • Whenever possible, disassemble the device and/or loosen all connections prior to treatment. Open hinged/jointed devices as recommended. Refer to the Instructions For Use supplied with the device. • Ensure the devices are completely immersed in the cleaning solution. • To avoid higher risk of corrosion and contamination, treat devices immediately after use. • To avoid contamination and to prevent debris from drying out, transport devices to the cleaning area, covered with a damp cloth or closed in a heat-sealed bag. • For proper cleaning, use preferably a protease-based cleaning agent. Refer to Appendix 1. • Depending on the conditions of use, replace the cleaning solution daily or more frequently. Dirt accumulation and increased concentration due to evaporation may compromise cleaning effectiveness and risk of corrosion. • For proper loading of the washing machine, follow the instructions contained in this manual and the manufacturer’s recommendations. Avoid overloading to ensure that all surfaces are reached by the cleaning solution. • Strictly follow the dosage, temperature, exposure time, material compatibility specifications and, after use, disposal restrictions of the cleaning agent as recommended by the manufacturer. • If medical compressed air is used, a sterile filter must be available.

3.2.2. General Caution Notes CAUTION • • • •

To avoid product damage (pitting, rust, degradation), DO NOT use highly aggressive agents (NaOH, NaOCL), salt solutions and other unsuitable cleaning agents. To avoid surface discoloration or stains, dissolve powders completely if used as cleaning agents. Use suitable cleaning tools as instructed in this anual. Never use metal brushes or metal sponges for debris removal. Rinse thoroughly and carefully. If agents lacking a foam inhibitor are used, take care to remove foam during rinsing. Sterile demineralized water facilitates water spots removal from the surface.

3.2.3. Caution Notes for Instruments with Electronics CAUTION • •

• • •

DO NOT immerse instruments/cables. If water runs into the battery holder or enters the housing, the electronics can fail and the communication with the system will cease. To avoid malfunction of the instrument, DO NOT scratch or damage the Light Emitting Diodes (LEDs) or the transceiver cover. Check them for proper functioning after cleaning. See Instructions For Use supplied with the device. DO NOT use solvents, lubricants, or other chemicals unless otherwise specified. DO NOT use aggressive or scouring agents, or other chemicals. Use a neutral enzymatic cleaner.

*For further information, contact your Stryker Leibinger Sales Representative or Customer Service at +1-800-962-6558. Outside the U.S.A., contact the nearest Stryker subsidiary or Customer Support at +49-761-4512-0 3

3.3. Cleaning Methods

3.5. Manual Cleaning Instructions for Groups I-VI

Both manual and machine cleaning methods can be used. Whenever possible, the washing machine should be used to avoid prolonged contact with contaminated devices and the cleaning agents.

Prepare Cleaning Water Solution At 40°C (104°F), homogenise the solution

3.4. Cleaning Equipment

Prepare for Soaking Disassemble removable parts, loosen connections

Manual Cleaning (and Pre-cleaning Stage Prior to Machine Cleaning) Protective Garments: • Single use shirt • Single use gloves • Safety glasses • Anti-splash mask (see recommendations supplied with cleaner)

Soak in Bath Completely for 15 min

Clean with Proper Tool See table 2

Material Equipment: • Sterile purified water • Running water • Appropriate cleaning agent (Appendix 1) • Soaking pans (preferably stainless steel): Vol. 500 ml at 25 l capacity • Ultrasound bath with adjustable temperature and stainless steel basket (Frequency: 25-50 kHz, min. Power: 238 W), large enough for complete immersion of all devices intended to be cleaned • Sterile syringe (approx. Vol. 50 ml) • Single use drying paper • Medical compressed air • Thermometer • Suitable cleaning tool as follows: Group I

Cleaning Tool

Note

Supple (soft) polishing brush

II

Hard (nylon) bristle brush

III

Flexible bottle brush

IV

Syringe for solution injection into hard-to- reach parts

Diameter and length depending on device Choose appropriate diameter. Carefully clean cutting areas. Choose appropriate diameter. Scrub the inside of the cannulae repeatedly. Use only sterile tools and syringe. Take care to clean articulated parts.

V

Brush with fine stiff bristles

VI.

Supple polishing brush

Rinse in Running Water For II, IV, V apply rinsing solution to hard-to-reach parts with syringe

Drain

For Instruments without Electronics Soak in Ultrasound Bath Completely for 15 min. at 40°C (104°F)

Drain

Dry For III, IV, V with medical compressed air

Flow Diagram 2: Manual Cleaning

Table 2: Cleaning Tools

Sterile purified water Running water Cleaning/washing agent (Appendix 1) Rinsing product (Appendix 1) Washing machine compliant with EN ISO 15883 (Appendix 1)

Dry With medical compressed air if necessary

Rinse in Sterile Running Water Completely at 20°-30°C (68 - 86°F)

Choose appropriate size. Scrub flexible parts. Choose appropriate size. Pay attention to and bottle brush holes and slots.

Machine Cleaning Material Equipment:

For Containers

Inspect Macroscopically for visible soil Repeat procedure if required

Sterilize

3.5.1. Manual CAUTION For Group VI, follow only steps 1 through 6 and step 12. For instruments with electronics refer to section 3.5.1.1 Manual Cleaning Instructions for Instruments Electronics. 1. 1.1. 1.2 2. 2.1. 2.2 2.3 3.

with

Prepare Cleaning Water Solution Dilute the cleaning agent at minimum 40°C (104°F). Read the instructions supplied with the agent carefully. Stir the mixture to homogenise the solution. Prepare Device for Soaking Handle the devices with care. Do not let them collide during transport to the soaking area. Whenever possible, disassemble the device (for the removable parts) and/or loosen connections.See Instructions For Use supplied with the device. Remove heavy or large debris using single use absorbent paper wipes soaked in appropriate cleaning solution. Soak Device

CAUTION Soak immediately after use. To avoid risk of corrosion, DO NOT exceed 15 minute soaking time. 3.1 4

Whenever possible, operate articulated parts and bend

3.2

flexible elements. Using a syringe, aspirate and squirt the solution several times into hard-to-reach areas (cannulae, grooves, holes, joints, flexible parts). Immerse the device in the solution completely for 15 minutes. If articulated or flexible devices are soaked, operate articulated parts and bend flexible elements.

4. Clean Device 4.1. Remove any debris using the suitable cleaning tool (see table 2). Pay attention to reach all areas.

them as required. 10.2.

If debris is still visible on the surface, repeat steps 7 through 10.

11. 11.1.

Drain Instrument Allow to drain on single use blotting paper.

12. 12.1.

Dry Instrument/Container Dry the instruments and containers with single use blotting paper and/or medical compressed air.

Note The cleaning bath has 24-hour effectiveness. For very dirty devices, replace it several times.

CAUTION 5. 5.1.

Rinse Device Rinse thoroughly the device in running water until it is no longer slippery to the touch.

For Group II, IV, V, use a syringe to apply rinsing solution under pressure to hard-to-reach areas (for example cannulae, bending / moving parts) while operating/bending them. 5.2.

Inspect the device for remaining debris, in particular hard-to-reach areas. Repeat steps 3 and 4 for residual debris removal if necessary.

6. 6.1. 6.2.

Drain Device Allow to drain on single use blotting paper. For instruments, proceed to ultrasound cleaning bath. During transport, handle instruments with care. Cover them with a pan or close them in a heat-sealed bag to prevent contamination.

7.

Prepare Ultrasound Bath for Instruments

Note The bath has 24-hour effectiveness. Prior to reusing the bath, inspect it for debris and impurity. When the bath is replaced, it must be ultrasonically degassed for 5 minutes. 7.1. 7.2. 8. 8.1.

9.

Dilute the cleaning agent in the ultrasound bath as required at minimum 40°C (104°F). Stir the mixture to homogenise the solution. Prepare Instrument for Ultrasound Bath Handle instruments with care. Do not let them collide. Avoid mixing instruments of different materials and conditions (operational instruments with damaged ones). Immerse Instrument in Ultrasound Bath for Cleaning

WARNING Ensure the ultrasound bath temperature is at 40°C (104°F). Failure to comply compromises cleaning effectiveness.

CAUTION For Groups III, IV, V, always use medical compressed air to ensure proper treatment of hard-to-reach parts (for example interiors of cannulae). 12.2.

After inspection (follow inspection recommendations), repeat the pre-cleaning stage and the washing cycle if needed.

3.5.1. 1. Manual Cleaning Instructions For Instruments with Electronics 1. 2.

Remove and discard the battery. Check with your local environmental protection agency for special disposal restrictions for lithium batteries. Using a mild detergent that contains NO abrasive materials, remove debris, paying special attention to the LEDs and transceiver unit.

Note For instruments with cannular features (suction tubes, etc), apply the cleaning solution under pressure to the cannula using a syringe. 3.

4. 5. 6.

Using a damp cloth, wipe away detergent. For pointed and flexible/long-shaft instruments (for example pointers, feelers, seekers, electrodes), rinse in addition the long tip and shaft thoroughly with running water. Brush validation disks using a soft bristle brush needed. Be very careful not to damage the electrical contacts when cleaning with a cloth or a towel. Using a lint-free towel, dry the instrument.

3.6. Machine Cleaning Instructions (Recommended) For devices without electronics grouped into III,IV,V

For devices without electronics grouped into I,II

Prepare Cleaning Water Solution At 40°C (104°F) homogenise the solution

Prepare for Soaking Disassemble removable parts, loosen connections

CAUTION For Groups III, IV, V, operate articulated parts and bend flexible elements. Using a syringe, aspirate and squirt the solution several times into hard-to-reach areas (cannulae, grooves, holes, joints, flexible parts). 9.1. 9.2.

10. 10.1.

Ensure that the instruments in the bath are completely submerged for 15 minutes and do not overlap. After 15-minute immersion, brush the instrument vigourously to remove debris from the surface completely. Use proper cleaning tool. See table 2.

Soak in Bath Completely for 15 minutes

Clean with Proper Tool See table 2

Rinse with running water Until no longer slippery to the touch

Rinse after Ultrasound Bath Rinse thoroughly with sterile purified running water at 20° - 30°C (68-86°F).

CAUTION

Load Instrument / Container Do not overload

Load Washing and Rinsing Agent

Flow Diagram 3: Automated Cleaning

Start Washing Cycle

For Groups III, IV, V, use a syringe to apply rinsing solution under pressure to hard-to-reach parts when bending or operating 5

4. Inspection Recommendations CAUTION •

To avoid product damage, DO NOT use machine cleaning method for instruments with Electronics.

WARNING: Perform pre-cleaning stage (step 1) for Groups III, IV, V. 1. 1.1. 1.2. 1.3. 1.4.

Pre-cleaning Stage Whenever possible, disassemble devices (for the removable parts), open joints and/or loosen connections. Dilute the cleaning agent in the ultrasound bath as required at 40 °C (104°F). Read the instructions supplied with the agent carefully. Stir the mixture to homogenise the solution. Place instruments in the ultrasound bath with diluted solution. Take care to immerse the device completely for 15 minutes.

CAUTION Soak immediately after use. To avoid risk of corrosion, DO NOT exceed 15 minute soaking time. 1.5.

Use suitable cleaning tool (see table 2). Whenever possible, use a syringe to apply the cleaning solution under pressure to hard-to-reach parts (cannulae, joints, slots) while operating articulated parts and bending flexible elements.

Note The cleaning bath has 24-hour effectiveness. For very dirty instruments, replace it several times. 1.6.

Rinse thoroughly with running water.

2. 2.1.

Load Devices for Cleaning Place devices so that they do not collide during operation. Place heavy items at the bottom and hollow objects in the washing machine baskets. Ensure that no part is obstructed by large objects (plates, cups). Place articulated instruments in fully open position and cannulated instruments in horizontal position. Place disassembled instruments in the washing machine baskets.

2.2. 2.3. 2.4. 2.5.

WARNING

CAUTION Inspect Device Prior to Sterilization. Before preparing for sterilization all medical devices should be inspected. Generally un-magnified 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: • • • • •

Functional checks should be performed where possible: • mating devices should be checked for proper assembly (see appropriate assembly/disassembly instructions on page 3) • medical devices with moving parts should be operated to check correct operation (medical grade, silicone-free and non-mineral oil based lubricant suitable for steam sterilisation can be applied as required) • rotating devices (e.g. drill bits, reamers) should be checked for straightness (this can be simply achieved by rolling the device on a flat surface), sharpness and damages • „flexible” devices (e.g. distraction rods) should be checked for damage to the spiral element.

CAUTION Remove and repair damaged instruments/containers.

CAUTION Stryker Leibinger does not define the maximum number of uses appropriate for re-usable medical devices. The useful life of these devices is dependent on many factors including the method and duration of each use, and the handling between uses. Careful inspection and functional testing of the device before use is the best method of determining the end of serviceable life for the medical device.

5. Sterilization Instructions

Avoid overloading. Failure to comply compromises cleaning effectiveness. 3. 3.1.

4. 4.1. 4.1.1. 4.1.2. 4.1.3. 4.1.4. 4.2. 4.3. 4.4. 4.5.

6

Load Washing and Rinsing Agents Put the required quantity of washing and rinsing agents into the washing machine as instructed by the manufacturer. Washing Machine and Drying Cycle Operate the washing machine cycle including (4.1.3. not required for aluminum): Washing phase with increasing temperature up to 93°C98°C (200-208°F). Thermal cleaning phase at 93°C-98°C (200-208°F) for 10 minutes (without addition of any particular agent). Neutralisation phase after adding a neutralisation agent if necessary (some agents do not require a neutraliser). Successive rinsing phases with demineralised water. At the end of the cleaning cycle, remove the basket from the washing machine. If the washing process does not include a drying cycle, allow the devices to dry after the cleaning cycle in an oven at a temperature below 110°C (230°F). For cannulated, flexible and articulated instruments, dry in addition with medical compressed air if necessary (depending on the washing machine). After inspection (follow inspection recommendations), repeat the pre-cleaning stage and the washing cycle if needed.

soil „traps” such as mating surfaces, hinges, shafts of flexible devices, e.g. distraction rods recessed features (holes, cannulations) features where soil may be pressed into contact with the device, e.g. drillflutes adjacent to the cutting tip, sides of teeth on broaches and rasps cutting edges should be checked for sharpness and damage for devices that may be impacted 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.

CAUTION Ensure the sterilization procedure for individual devices and systems complies with accepted standard requirements. 1. 1.1. 1.2.

2. • •

Preparation Whenever possible, disassemble instruments (with removable parts), open joints/hinges/locks and/or loosen connections. If heavy loads can not be avoided, place the instruments in different trays/cases to facilitate penetration of the agent transferring heat (steam). In addition, special care should be taken on completion to inspect the instruments for dryness prior to storage. Operation Pre-vacuum cycles are recommended. Pre-vacuum cycles can also be referred to as „forced air removal“. Cycle C is not recommended for instrument cases with multiple cases within them.

CAUTION Sterilization exposure time at 134°-137°C can be extended to 18 minutes. As prolonged exposure time may affect product life, carefully inspect the device for visible damage and malfunction after treatment.

Perform sterilization according to the following parameters unless otherwise specified in the Instructions for Use of the individual product or system. Pre-vacuum Autoclave Cycles - Cycle A • Pre-vacuumed sterilizer • 132°C-137°C (270°F-279°F) - 45 psi (3 bar) • Double wrapped (AAMI CSR technique) • 15-minute minimum exposure time • 5-minute minimum drying time Cycle B • Pre-vacuumed sterilizer • 132°C-137°C (270°F-279°F) - 45 psi (3 bar) • Double wrapped (AAMI CSR technique) • 15-minute minimum pre-heating time • 10-minute minimum exposure time • 5-minute minimum drying time Gravity Displacement Cycles - Cycle C • Gravity displacement sterilizer • 121°C-123°C (250° F-252°F) - 35 psi (2.4 bar) • Double wrapped (AAMI CSR technique) • 15-minute minimum pre-heating time • 40-minute minimum exposure time Cycle D • Gravity Displacement sterilizer • 132°C-137°C (270°F-279°F) - 45 psi (3 bar) • Double wrapped (AAMI CSR technique) • 15-minute minimum pre-heating time • 20-minute minimum exposure time

6. Appendix 1: Cleaning, Rinsing and Washing Agents; and Washing Machine For soaking and manual cleaning, enzymatic agents with both bacteriocidal and fungicidal properties are recommended. For machine cleaning, use only agents recommended by the machine‘s manufacturer. For aluminum surfaces, a neutral-pH agent should be used. To prevent corrosion, avoid contact with strong alkaline solutions (pH over 10.5) or agents containing iodine or chlorine. The agents and washing machines listed below have been used during validation of the processing instructions contained in this manual. We do not recommend them in preference to others which may be equally suitable.

CAUTION To avoid product damage, ensure aluminum surfaces are treated using suitable agents (see tables 3, 4, 5). See material specifications contained in the Instructions For Use supplied with the device .

CAUTION Ensure the washing machine is compliant with EN ISO 15883 (see table 6).

7