Battery Power and Electric Systems Heavy Duty Processing Instructions Oct 2019

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Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Audience . . . . . . . . . . . . . . . . . . . . . . . . . 4 Conventions . . . . . . . . . . . . . . . . . . . . . . . . 4 Contact Information . . . . . . . . . . . . . . . . . . . . 5 Intellectual Property . . . . . . . . . . . . . . . . . . . . 5 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Description . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Safety Directives . . . . . . . . . . . . . . . . . . . . . . . . 6 Limitations of Processing . . . . . . . . . . . . . . . . . . . . 6 Preparation for Cleaning . . . . . . . . . . . . . . . . . . . . 7 Equipment and Materials . . . . . . . . . . . . . . . . . . 7 Accessories . . . . . . . . . . . . . . . . . . . . . . . . 8 Water Quality . . . . . . . . . . . . . . . . . . . . . . . 9 Cleaning Agents . . . . . . . . . . . . . . . . . . . . . 10 Point of Use (Post-Surgery) . . . . . . . . . . . . . . . 11 Transport to Decontamination Area . . . . . . . . . . . . 12 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Manual Cleaning . . . . . . . . . . . . . . . . . . . . . 14 Automated Cleaning . . . . . . . . . . . . . . . . . . . 19 Disinfection (optional) . . . . . . . . . . . . . . . . . . . . 24 Drying . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Visual Inspection . . . . . . . . . . . . . . . . . . . . . 25 Lubrication . . . . . . . . . . . . . . . . . . . . . . . . 25

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Preparation for Sterilization . . . . . . . . . . . . . . . . . . 26 Equipment and Materials . . . . . . . . . . . . . . . . . 26 Loading and Packaging . . . . . . . . . . . . . . . . . . 27 Stacking and Constraints . . . . . . . . . . . . . . . . . 28 Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . 28 Handpieces and Accessories . . . . . . . . . . . . . . . 30 Steam Sterilization . . . . . . . . . . . . . . . . . 30 Immediate-Use Steam Sterilization . . . . . . . . . . 31 Sterrad Gas Plasma Sterilization . . . . . . . . . . . 31 Steris Vaporized Hydrogen Peroxide Sterilization . . . 32 Battery Packs . . . . . . . . . . . . . . . . . . . . . . 32 Steam Sterilization (Battery Packs) . . . . . . . . . . 33 Sterrad Gas Plasma Sterilization . . . . . . . . . . . 34 Steris Vaporized Hydrogen Peroxide Sterilization . . . 34 System 8 Battery Packs . . . . . . . . . . . . . . . . . 34 Steam Sterilization (System 8 Battery Packs ONLY) . . 35 Immediate-Use Steam Sterilization (System 8 Battery Packs ONLY) . . . . . . . . . . . . . . . . . . . . 36 Steris Vaporized Hydrogen Peroxide Sterilization . . . 37 Storage and Transportation . . . . . . . . . . . . . . . . . . 38 Sterile Equipment . . . . . . . . . . . . . . . . . . . . 38 Non-sterile Equipment . . . . . . . . . . . . . . . . . . 38 Disposal/Recycle . . . . . . . . . . . . . . . . . . . . . . 38 Appendix A: Special Cleaning Considerations Table . . . . . . 40 Appendix B: Inspection Table . . . . . . . . . . . . . . . . . 46 Appendix C: Lubrication Table . . . . . . . . . . . . . . . . 48 Appendix D: Extended Dry Time Table . . . . . . . . . . . . 49

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Introduction This processing instructions manual contains information intended to ensure the safe, effective, and compliant sterile processing of your product. Processing equipment, operators, cleaning agents, and procedures all contribute to the efficacy of medical device processing. The healthcare facility should make sure that the combination used results in a medical device that is safe for use. Alternative methods of processing may be equally suitable. NOTE: The user/processor should comply with local laws and ordinances in countries where processing requirements are more stringent than those detailed in these instructions.

Audience This manual is intended for in-service trainers, biomedical equipment technicians, and central supply/sterile processing technicians. Keep and consult this reference manual during the life of the product.

Conventions The following conventions are used in this manual: • A WARNING highlights a safety-related issue. ALWAYS comply with this information to prevent patient and/or healthcare staff injury. • A CAUTION highlights a product reliability issue. ALWAYS comply with this information to prevent product damage. • A NOTE supplements and/or clarifies procedural information.

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Contact Information For additional information, including safety information, inservice training, or current literature, contact your Stryker sales representative or call Stryker customer service at 1-269-323-7700 or 1-800-253-3210. Outside the US, contact your nearest Stryker subsidiary.

Intellectual Property Trademarks not the property of Stryker Corporation are the property of their respective owners.

Definitions The symbols located on the equipment and/or labeling are defined in this section or in the Symbol Definition Chart. See the Symbol Definition Chart supplied with the equipment. SYMBOL

DEFINITION General warning sign

Description This comprehensive reference provides processing instructions and recommendations for Stryker Heavy Duty Systems (Battery Powered and Electric) components and equipment, including battery packs and aseptic battery housings.

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Safety Directives WARNINGS: • Before processing this equipment, read and understand the processing instructions. Pay particular attention to safety information. • Only individuals trained and experienced in the processing of reusable medical devices should process this equipment. • DO NOT reuse, reprocess, or repackage a device that is intended for single use only. -- A single use device may not withstand chemical, chemical vapor, or high temperature sterilization reprocessing. -- Design features may make cleaning difficult. -- Reuse may create a contamination risk and compromise structural integrity resulting in operational failure or fragmentation during use. -- Critical product information may be lost during repackaging. Failure to comply may lead to infection or cross infection and result in patient and/or healthcare staff injury.

Limitations of Processing Repeated processing has a minimal effect on this equipment. See the Inspection section for additional guidance on evaluating device functionality.

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Preparation for Cleaning Equipment and Materials WARNING: Use only Stryker-approved equipment, unless otherwise specified. DO NOT modify any system component or accessory. The following equipment is required to process devices per the instructions in this manual: • Warm water (See the Water Quality section.) • Prepared, specially formulated cleaning agents (See the Cleaning Agents section.) • Absorbent wipes • Soft, nonlinting cloth • Syringe • Non-abrasive, soft, flexible, synthetic bristle brushes • Washer-disinfector (complies with ISO 15883 series) • Cleaning agents as required by the washer-disinfector manufacturer • Instrument air1 < 140 kPa [< 20 psi] • Oven Instrument air is medical gas that falls under the general requirements for medical gases as defined by the National Fire Protection Association (NFPA) Health Care Facilities Code, is not respired, is compliant with the American National Standards Institute (ANSI)/ International Society of Automation (ISA) Quality Standard for Instrument Air, and is filtered to 0.01 microns, free of liquids and hydrocarbon vapors, and dry to a dew point of -40 °C [-40 °F]. 1

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Accessories The following optional equipment may be purchased to aid in processing: DESCRIPTION

REF

Light Mineral Oil

1605-010-000

Blu62® Pretreatment Foam

3000-00X-000 series

Blu62 Instrument Detergent

3000-00X-000 series

Cordless Driver Sterilization Container

4100-451-000

Cordless Driver Sterilization Cases

4X00-465-000 series

Cordless Driver Aseptic Battery Kit Sterilization Cases

422X-450-000 series

Sports Medicine/Small Bone Trauma (SMT) Sterilization Case

4300-452-000

Battery Powered Micro (BPM) Sterilization Case

4300-462-000

Cordless Driver 4/Sabo®2 Insert Trays

4405-45X-0X0 series

Trauma Insert Tray

4405-451-010

System 6 Sterilization Cases

6102-45X-000 series

EZout Insert Tray

7102-459-010

Insert Trays and Sterilization Cases

7102-45X-0X0 series 7102-55X-0X0 series

Aesculap Rigid Sterilization Containers and Accessories

7102-XXX-XXX series

Hybrid Insert Tray

1900-375-010

®

NOTE: For a complete list of components or ordering information, contact your Stryker sales representative or call Stryker customer service. See the Contact Information section. Outside the US, contact your nearest Stryker subsidiary. 8

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Water Quality WARNING: Use the appropriate water quality for each stage of the cleaning process. Mineral residues from hard water can stain the equipment and/or prevent effective cleaning and decontamination. • Use utility water for flushing, washing, and rinsing the equipment. Utility water is water that comes from the tap. • Use potable water for diluting cleaning agents. Potable water is water that is treated and delivered in a manner so that it meets United States (US) Environmental Protection Agency (EPA) or local guidelines as suitable for drinking. • Use critical water for final rinsing of the equipment prior to sterilization. Critical water is water that is extensively treated usually by a multistep treatment process that could include a carbon bed, softening, deionization, and reverse osmosis or distillation to ensure that the microorganisms and the inorganic and organic material are removed from the water. A final submicron filtration could also be part of the treatment process. CAUTION: Poor water quality can adversely affect the life of medical devices. ALWAYS follow the water quality requirements per Association for the Advancement of Medical Instrumentation (AAMI) TIR 34. Warm water with an optimum temperature range of 27 to 44 °C [80 to 110 °F] is recommended for manual cleaning. The water should not exceed 60 °C [140 °F] and should be warm to the touch.

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Cleaning Agents WARNINGS: • To clean the equipment, use specifically formulated cleaning agents only. • Read, understand, and follow the indications, instructions, and safety information supplied with the cleaning agent for correct handling and use of the product. CAUTIONS: • Alkaline agents may be used to clean instruments in countries where required by law or local ordinances, or where prion diseases such as Transmissible Spongiform Encephalopathy (TSE) and Creutzfeldt-Jakob Disease (CJD) are a concern. It is critical that alkaline cleaning agents are thoroughly neutralized and completely rinsed from devices. • ALWAYS prepare the cleaning agent according to the manufacturer’s recommendations. Pay particular attention to the concentration used and the total dispersion. • To clean the equipment, a neutral cleaning agent is preferred. • An alkaline cleaning agent (neat, up to pH 11) is allowable, but not preferred. Alkaline cleaning agents may cause cosmetic damage or reduce the life of the product. • If a washer-disinfector is used, make sure the cleaning agent used is suitable for use in a washer-disinfector. • ALWAYS use a cleaning agent that is suitable for use on aluminum, stainless steel, plastic, rubber, and titanium surfaces.

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Stryker validated the manual and automated (washer-disinfector) cleaning processes using the following cleaning agents: Supplier

Product

Suitability

Process

Stryker

Blu62 Instrument Detergent

All materials

Manual Cleaning

Steris

Prolystica 2x Aluminum, Concentrate Enzymatic stainless steel, soft metals, Prolystica 2x and plastics Concentrate Neutral

Automated Cleaning

Prepare the cleaning agent according to the manufacturer's recommendations.

Point of Use (Post-Surgery) CAUTIONS: • Dry, soiled surgical instruments are more difficult to clean. Do not allow contaminated devices to dry prior to processing. All subsequent cleaning and sterilization steps are facilitated by not allowing blood, body fluids, bone and tissue debris, saline, or disinfectants to dry on used instruments. • DO NOT use saline to wet or soak the equipment before transport to the decontamination processing area. • Pretreatment foam will minimize the drying of soil and facilitate later processing. DO NOT allow pretreatment foam to dry on the equipment.

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1. Separate reusable equipment from disposable waste. 2. Discard waste into an appropriate container; use a punctureresistant container for sharps. See the Disposal/Recycle section. 3. Use absorbent wipes to remove gross soil from the equipment. 4. If transport to the decontamination processing area is delayed, cover the equipment with a damp cloth or spray the equipment with a pretreatment foam as often as necessary to maintain moisture.

Transport to Decontamination Area WARNING: During transport, pay particular attention to sharp, cutting edges to avoid injury. CAUTION: Avoid mechanical damage during transport. DO NOT mix heavy devices with delicate devices. Clean the equipment as soon as practical, typically within two hours, to preclude extended or repeat cleaning procedures.

Cleaning NOTE: These cleaning instructions are appropriate for handpieces, attachments, battery packs, cords, aseptic battery housings, sterilization cases, EZout accessories, and non-sterile single use cutting accessories (e.g., K-wires). To properly clean a console, see the instructions for use supplied with the console.

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WARNINGS: • Clean the equipment as indicated before first and every use. Use the cleaning methods as indicated in these instructions. Other cleaning methods may prevent proper sterilization of the equipment. • Prior to cleaning, separate all detachable components and remove single use cutting accessories from the handpieces. Detachable components include attachments, battery packs, and cords. Remove non-sterile batteries from the aseptic housings. CAUTIONS: • ALWAYS handle the equipment with care. DO NOT drop the equipment. • DO NOT use solvents, lubricants, rinse aids, or other chemicals, unless otherwise specified. • DO NOT use ultrasonic cleaning equipment. • DO NOT immerse or soak any equipment, including non-sterile batteries, in liquid unless otherwise specified. Equipment may be placed briefly under running water to ensure thorough wetting and contact with liquid while actuating moving parts. • DO NOT allow moisture or liquid to enter electrical plugs, receptacles, or openings. Moisture or liquid may cause corrosion and damage the equipment. • DO NOT allow fluid to remain inside the recesses of the aseptic housing.

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• DO NOT use pipe cleaners or cotton swabs to clean lumens or connector receptacles. • DO NOT bend connector pins during cleaning. • ALWAYS make sure the prepared cleaning agent is completely rinsed from the interior and exterior of the equipment before drying the equipment. • Use of instrument air is only recommended for drying of equipment. NOTES: • Two methods of cleaning are described, a manual cleaning method and an automated cleaning method. Removal of all gross soil is required for both cleaning methods. Select the desired cleaning method per facility protocol. • Automated cleaning may reduce the useful life of battery packs. Manual cleaning per these instructions is preferred.

Manual Cleaning 1. Remove the lid and insert tray(s) from the base of the sterilization case. 2. Remove all soiled medical devices from the insert tray(s) and base. 3. Wipe all soil from the external surfaces of the aseptic housing. Unlock the aseptic housing, and remove the non-sterile battery from the aseptic housing. Set aside the non-sterile battery. NOTE: The non-sterile battery may be wiped with a clean, dry cloth. Do not rinse, spray, or wipe the non-sterile battery with a saturated cloth.

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4. Remove all traces of pretreatment foam and any remaining gross soil from the equipment using absorbent wipes or a soft, nonlinting cloth moistened with the prepared cleaning agent. Devices may be placed briefly under running water or flushed with a water-filled syringe to assist in the removal of gross soil. 5. Thoroughly clean the equipment. • Use suitable brushes and the prepared cleaning agent to clean all surfaces. Pay particular attention to rough surfaces, crevices, and difficult-to-reach areas where soil may be shielded from brushing. • Use soft brushes of appropriate diameters to clean the entire length of each lumen. For dead-ended lumens, use light pressure and do not force the brush any farther after you feel resistance. • Use a syringe filled with the prepared cleaning agent to flush difficult-to-reach areas. For the universal collet, flush the lumen from the back of the collet. • Actuate all moving parts to clean hidden surfaces. Actuate all holding, clamping, and latching mechanisms on sterilization cases, lids, and insert trays. NOTES: • See the Special Cleaning Considerations Table (Appendix A) for critical areas and brush sizes. • (For System 8 handpieces only): System 8 handpieces may be held under the surface of the prepared cleaning agent during manual cleaning. Do not soak any equipment.

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CLEAN THE EQUIPMENT

6. Thoroughly rinse the equipment with warm, running water until all traces of cleaning agent are removed. • For equipment with lumens, hold the equipment on an incline, distal end pointing up, and rinse the lumen. • For dead-ended lumens, once the water comes back out of the equipment, immediately point the distal end of the equipment down to allow the water to drain out. Repeat this step one or two more times until the water draining from the equipment is clear. • For all other equipment, hold the equipment on an incline, distal end pointing down.

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RINSE THE EQUIPMENT

• Pay particular attention to rough surfaces, lumens, hinges, blind holes, battery contacts, and joints between mating parts. • Actuate all moving parts to rinse hidden surfaces. For sterilization cases and insert trays, actuate all holding, clamping, and latching mechanisms. NOTE: A final rinse of the equipment using critical water is recommended.

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7. (For System 6 handpieces only): If water leaks into the handpiece, tip the handpiece back as shown to allow drainage from the small opening in the battery pack contact area.

8. Visually inspect the equipment for any remaining soil or cleaning agent. If soil or cleaning agent remains, repeat the cleaning procedure using freshly prepared cleaning agent. 9. Allow the equipment to drain on absorbent wipes. If possible, orient the equipment vertically to assist in drainage. 10. After manual cleaning, dry the equipment immediately (see the Drying section), or proceed with step 2 in the Automated Cleaning section.

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Automated Cleaning CAUTIONS: • Automated cleaning may reduce the useful life of battery packs. Manual cleaning is preferred. See the Manual Cleaning section. • ALWAYS ensure the aseptic housing lid stays open during automated cleaning. • DO NOT immerse or sterilize non-sterile batteries. 1. Perform the following pre-cleaning steps: • Remove the equipment from the insert trays. • Remove all visible soil from the equipment using the prepared cleaning agent. Pay particular attention to lumens and moving parts, using brushes as necessary. • Rinse the equipment to remove all excess cleaning agent. WARNINGS: • ALWAYS load the equipment carefully to prevent movement that may inhibit proper cleaning during the automated washerdisinfector cycle. • Only System 7, Cordless Driver 4, and EZout insert trays may be used to hold equipment in the washer-disinfector (see the Accessories section). All other insert trays and sterilization cases are for use with the sterilization process only and must be washed separately. • When using the Trauma Insert Tray or the Hybrid Insert Tray during automated washing, be sure the top and bottom trays are separated when placed in the washer-disinfector to ensure products receive adequate exposure to the washer-disinfector cycle.

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• ALWAYS separate the sterilization tray components before loading into the washer-disinfector. Load each tray component separately. NOTE: The equipment illustrated is representational only and may not reflect the actual configuration. See the instructions for use supplied with the insert tray for device-specific loading configurations. 2. Load the equipment into the washer-disinfector in an appropriate insert tray (see the Accessories section). • Avoid contact between components. • Orient the handpieces vertically or at an angle to assist in drainage. • Place moving parts in the open position.

Example tray loading configuration for System 7/System 8 CAUTION: Placing handpieces horizontally in a wire basket or similar holder may increase the potential for trapped moisture.

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