Stryker
Pneumatic and Electric Systems
Heavy Duty Battery Powered and Electric Systems Care Instructions Rev L Feb 2017
Care Instructions
47 Pages
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Heavy Duty Battery Powered and Electric Heavy Duty Systems
Care Instructions
ENGLISH (EN) 2017-02
7200-001-700 Rev-L
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7200-001-700 Rev-L
Contents Introduction... 3 Audience... 3 Conventions... 4 Contact Information... 4 Intellectual Property... 4 Definitions... 4 Description... 5 Safety Directives... 5 Limitations of Processing... 6 Processing Equipment... 6 Water... 8 Detergents... 8 Preparation for Cleaning... 10 Point of Use (Post-Surgery)... 10 Transport to Decontamination Processing Area... 10 Cleaning... 11 Manual Cleaning... 13 Automated Cleaning... 17 Inspection... 22 Visual and Functional Inspection... 23 Lubrication... 23 Preparation for Sterilization... 24 Packaging... 25 Stacking and Constraints... 25
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Sterilization... 26 Handpieces and Attachments... 28 Battery Packs... 30 System 8 Battery Packs... 32 Storage and Handling... 36 Sterile Equipment... 36 Non-sterile Equipment... 36 Disposal/Recycle... 37 Appendix A: Special Cleaning Considerations Table... 38 Appendix B: Inspection Table... 43 Appendix C: Lubrication Table... 45 Appendix D: Extended Dry Time Table... 46
Introduction This care instructions manual contains information intended to ensure the safe, effective, and compliant sterile processing of your product. Processing equipment, operators, detergents, 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.
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.
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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.
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
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Description This comprehensive reference provides care instructions and recommendations for Stryker Heavy Duty Systems (Battery Powered and Electric) components and equipment, including battery packs and aseptic battery housings.
Safety Directives WARNINGS: • Before processing this equipment, read and understand the care instructions. Pay particular attention to safety information. • Only individuals trained and experienced in the processing of reusable medical devices should process this equipment. • ALWAYS provide personal protective equipment (PPE) for processing personnel according to the instructions and safety data sheets (SDS) supplied with the detergent. Wear PPE at all times during processing. • 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.
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Limitations of Processing Repeated processing has a minimal effect on this equipment. See the Inspection section for additional guidance on evaluating device functionality.
Processing Equipment 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: • PPE as recommended by the detergent manufacturer • Warm, filtered or deionized water (See the Water section.) • Prepared, specially formulated detergents (See the Detergents section.) • Absorbent wipes • Soft, lint-free cloth • Syringe • Non-abrasive, soft, flexible, synthetic bristle brushes • Washer-disinfector • Detergents and rinsing agents as required by the washerdisinfector • Medical-grade compressed air, < 140 kPa [< 20 psi] • Oven • Sterilization wrap, grade 500 or higher • Chemical indicators • Sterilizer
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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
ProClean 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
Sterilization Container Bottoms and Lids
7102-55X-0X0 series 7102-65X-0X0 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.
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Water WARNING: Use filtered water for diluting detergents and for rinsing the equipment. Mineral residues from hard water can stain the equipment and/or prevent effective cleaning and decontamination. 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.
Detergents WARNINGS: • To clean the equipment, use specifically formulated detergents only. • Read, understand, and follow the indications, instructions, and safety information supplied with the detergent for correct handling and use of the product. • ALWAYS prepare the detergent solution according to the manufacturer’s recommendations. Pay particular attention to the concentration used and the total dispersion.
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CAUTIONS: • To clean the equipment, a mild alkaline detergent (neutral up to pH 10.5) is preferred. If a washer-disinfector is used, see the instructions for use supplied with the washer-disinfector machine to select the recommended detergent. • ALWAYS use a detergent that is suitable for use on aluminum, stainless steel, plastic, rubber, and titanium surfaces. NOTE: Stryker recommends the specified validated detergent (if available) for manual cleaning; however, other products may perform equally or better. Alternative detergents must be verified by referencing the information provided by the product supplier and/or physical testing. Stryker used the following detergents to validate the manual and automated (washer-disinfector) cleaning processes described in these instructions: Supplier
Product
Suitability
Process
Stryker
ProClean 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 detergent solution according to the manufacturer's recommendations.
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Preparation for Cleaning Point of Use (Post-Surgery) CAUTIONS: • DO NOT use saline to wet or soak the equipment before transport to the decontamination processing area. • 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. The pretreatment foam will minimize the drying of soil and facilitate later decontamination processing. DO NOT allow pretreatment foam to dry on the equipment. 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.
Transport to Decontamination Processing 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.
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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. 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. • Use PPE at all times during cleaning. CAUTIONS: • ALWAYS handle the equipment with care. DO NOT drop the equipment. • DO NOT use solvents, lubricants, or other chemicals, unless otherwise specified. • DO NOT use ultrasonic cleaning equipment. • DO NOT immerse or soak any equipment 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.
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• 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. • 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 detergent solution is completely rinsed from the interior and exterior of the equipment before drying the equipment. • Use of compressed air is only recommended for drying of equipment. NOTES: • Two methods of cleaning are described, a manual cleaning method and an automated cleaning method. Manual removal of all gross soil is required for both cleaning methods. • Automated cleaning may reduce the useful life of battery packs. Manual cleaning per these instructions is preferred.
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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. Remove non-sterile batteries from the aseptic housings. 4. Remove all gross soil from the equipment using absorbent wipes or a soft, lint-free cloth moistened with the prepared detergent solution. 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 detergent solution 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 detergent solution to flush difficult-to-reach areas. • 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 detergent solution 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 the prepared detergent solution 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 deionized or filtered 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 detergent solution. If soil or detergent solution remains, repeat the cleaning procedure using freshly prepared detergent solution. 9. Allow the equipment to drain on absorbent wipes. If possible, orient the equipment vertically to assist in drainage. CAUTION: DO NOT dry battery packs in an oven. Drying battery contacts with compressed air is recommended. Residual moisture from cleaning may lead to oxidation of the contacts. 10. Dry the equipment with a soft, lint-free cloth or medical-grade compressed air, or by heating the equipment in an oven below 110 °C [230 °F]. 11. After manual cleaning, inspect and charge battery packs as required. See the instructions for use supplied with the battery pack. 12. After manual cleaning, inspect the equipment immediately (see the Inspection section), or perform the steps in the Automated Cleaning section.
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Automated Cleaning 1. Perform all manual cleaning steps. See the Manual Cleaning section. CAUTION: Automated cleaning may reduce the useful life of battery packs. Manual cleaning is preferred. See the Manual Cleaning section. NOTE: The drying step after manual cleaning may be skipped. 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 Processing Equipment 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. • ALWAYS separate the sterilization tray components before loading into the washer-disinfector Load each tray component separately. • ALWAYS check the clearance in the automated washerdisinfector to prevent the sprayer wand from striking the equipment.
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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 Processing Equipment section), a wire basket, or other washer-disinfector equipment holder. • Avoid contact between components. • If possible, orient the equipment vertically to assist in drainage. Placing the equipment in a horizontal position is also acceptable. • Place moving parts in the open position.
Example tray loading configuration for System 7/System 8
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Example basket loading configuration for System 6 • If possible, orient battery packs on their sides with the battery latches pointing down. CAUTION: DO NOT allow the battery contacts to touch the wire basket or any metal objects inside the basket. Failure to comply may short circuit the battery pack.
Example basket loading configuration for battery packs
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• When cleaning an empty insert tray or sterilization case, orient the equipment vertically to assist in drainage.
Example loading configuration for empty sterilization case and insert tray CAUTIONS: • DO NOT use any type of lubricant in the automated washerdisinfector. Lubrication is not required and may leave residue on the equipment after cleaning. • ALWAYS select the lowest possible spray pressure setting when cleaning battery packs in a washer-disinfector. Use a gentle or low impingement setting to prevent damage. • DO NOT use the dry phase when cleaning battery packs in an automated washer-disinfector. The dry phase will shorten the life of the battery packs. Devices that require a dry phase should be processed separately from the battery packs.
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