System G Care Instructions for Use Rev A

STRYKER SYSTEM G™

Care Instructions

ENGLISH (EN) ESPAÑOL (ES) ITALIANO (IT) PORTUGUÊS (PT) TÜRKÇE (TR) РУССКИЙ (RU) 中文 (ZH) 한국어 (KO)

2017-04

7300-001-700 Rev-B

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EN

7300-001-700 Rev-B

Contents

Introduction

Introduction . . . . . . . . . . . . . . . . . . . . . 2

This Care Instructions manual is part of the Instructions For Use and Technical Description. It is published as a separate, modular book because its contents are common to several components of the system.

Audience . . . . . . . . . . . . . . . . . . . . 2 Conventions . . . . . . . . . . . . . . . . . . . 2 Contact Information . . . . . . . . . . . . . . . 2 Intellectual Property . . . . . . . . . . . . . . . 2 Safety Directives . . . . . . . . . . . . . . . . . . . 3 Limitations of Processing . . . . . . . . . . . . . . . 3 Processing Equipment . . . . . . . . . . . . . . . . 3 Water . . . . . . . . . . . . . . . . . . . . . . 4 Detergents . . . . . . . . . . . . . . . . . . . . 4

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.

Preparation for Cleaning . . . . . . . . . . . . . . . 4 Point of Use . . . . . . . . . . . . . . . . . . . 4 Transport to Decontamination Processing Area . . . 4 Cleaning . . . . . . . . . . . . . . . . . . . . . . . 4 Power Module Cleaning . . . . . . . . . . . . . 5 Manual Cleaning . . . . . . . . . . . . . . . . . 5 Inspection . . . . . . . . . . . . . . . . . . . . . . 6 Preparation for Sterilization . . . . . . . . . . . . . . 7

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

Recommended Placement of Chemical Indicators . 7

The following conventions are used in this manual:

Packaging . . . . . . . . . . . . . . . . . . . . 7

▪▪ A WARNING highlights a safety-related issue. ALWAYS comply with this information to prevent patient and/or healthcare staff injury.

To Package Individual Devices . . . . . . . . 7 To Package a Sterilization Case . . . . . . . 7 Stacking and Constraints . . . . . . . . . . . . . 7 Sterilization . . . . . . . . . . . . . . . . . . . . . 7 Steam Sterilization . . . . . . . . . . . . . . . . 8

▪▪ A CAUTION highlights a product reliability issue. ALWAYS comply with this information to prevent product damage. ▪▪ A NOTE supplements and/or clarifies procedural information.

Immediate-Use Steam Sterilization . . . . . . . . 8 Ethylene Oxide (EO) Sterilization . . . . . . . . . 8 Storage and Handling . . . . . . . . . . . . . . . . . 8 Service . . . . . . . . . . . . . . . . . . . . . . . 9 Disposal/Recycle . . . . . . . . . . . . . . . . . . . 9 Appendix A: Special Cleaning Considerations . . . . . 9 Handpieces . . . . . . . . . . . . . . . . . . . 9 Attachments . . . . . . . . . . . . . . . . . . 10 Care Components . . . . . . . . . . . . . . . . 10 Appendix B: Inspection Criteria . . . . . . . . . . . . 10

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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.

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7300-001-700 Rev-B

Safety Directives WARNINGS:

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Processing Equipment WARNINGS:

▪▪ Before processing this equipment, read and understand the care instructions. Pay particular attention to safety information.

▪▪ Use only Stryker-approved equipment, unless otherwise specified.

▪▪ Only individuals trained and experienced in the processing of reusable medical devices should process this equipment.

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.

▪▪ 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.

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

▪▪ DO NOT modify any system component or accessory.

The following equipment is required to process devices per the instructions in this manual: ▪▪ Warm, filtered or deionized water (See the Water section.) ▪▪ Prepared, specially formulated detergents (See the Detergents section.) ▪▪ PPE as recommended by the detergent manufacturer (minimum: overalls, gloves, face/eye shield) ▪▪ Soft, lint-free cloth ▪▪ Non-abrasive, soft, flexible, synthetic-bristle brushes ▪▪ Syringe ▪▪ Absorbent wipes ▪▪ Medical-grade compressed air, < 140 kPa ▪▪ Oven ▪▪ Sterilization wrap, grade 500 or higher ▪▪ Chemical indicators ▪▪ Steam sterilizer (autoclave) ▪▪ Ethylene Oxide (EO) sterilizer The following optional equipment may be purchased to aid in processing: Description STRYKER SYSTEM G Sterilization Case, 1 Hand Piece STRYKER SYSTEM G Sterilization Case, 2 Hand Pieces

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REF 7302-120-000 7302-130-000

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Preparation for Cleaning

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 is recommended for cleaning. The water should not exceed 60 °C and should be warm to the touch.

Point of Use CAUTION: DO NOT use saline to wet or soak the equipment before transport to the decontamination processing area. NOTE: 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.

Detergents

2. Discard waste into an appropriate container; use a puncture-resistant container for sharps.

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. CAUTIONS: ▪▪ To clean the equipment, a mild alkaline detergent (neutral up to pH 8.5) is preferred. ▪▪ DO NOT use detergent solution with pH levels higher than 8.5. See the detergent SDS to verify the pH range. Failure to comply may damage the equipment. ▪▪ When cleaning handpieces and attachments, ALWAYS use a detergent that is suitable for aluminum and stainless steel surfaces. NOTE: Stryker recommends the specified validated detergent (if available) for manual cleaning; however, other products may perform equally well or better. Alternative detergents must be verified by referencing the information provided by the product supplier and/or physical testing. Stryker used the following detergent to validate the manual cleaning processes described in these instructions: Supplier ASP

Product Enzol

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 repeated cleaning procedures.

Cleaning 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, remove single use cutting and fixation tools, attachments, transfer shields, and power modules from the handpieces.

Suitability Process Aluminum Manual and Stainless Cleaning Steel

Prepare the detergent solution according to the manufacturer’s recommendations.

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CAUTIONS: ▪▪ DO NOT use solvents, lubricants, or other chemicals, unless otherwise specified. ▪▪ DO NOT use automated washers or ultrasonic cleaning equipment. ▪▪ DO NOT immerse or soak any equipment in liquid. Handpieces and attachments 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.

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4. Thoroughly clean the equipment. See Appendix A: Special Cleaning Considerations for critical areas and brush sizes. ▪▪ Use suitable brushes to clean all surfaces. Pay particular attention to rough surfaces, crevices, and difficult-to-reach areas where soil may be shielded from brushing. ▪▪ Thoroughly brush the equipment for a minimum of two minutes. ▪▪ Open the door on the bottom of the handpiece and use suitable, non-abrasive brushes to clean the interior of the power module compartment.

▪▪ DO NOT use pipe cleaners or cotton swabs to clean lumens or connector receptacles. ▪▪ ALWAYS make sure the detergent solution is completely rinsed off before drying the equipment. ▪▪ Use of compressed air is only recommended for drying of equipment.

Power Module Cleaning CAUTION: DO NOT rinse, spray, or wipe the power module with a saturated cloth. NOTE: Keep the power module as clean as possible, as it cannot be sterilized. 1. Wipe all debris from external surfaces of the handpiece door. 2. Remove the power module from the handpiece. Follow the steps in the instructions for use manual supplied with the handpiece. 3. Wipe the power module with a clean, dry cloth.

▪▪ 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 detergent solution to flush difficult-to-reach areas. ▪▪ Actuate all moving parts to clean hidden surfaces. ▪▪ When removing debris from a reciprocating saw, rotate the blade collar to access all surfaces.

4. After cleaning, inspect the power module. See the Inspection section.

Manual Cleaning CAUTION: DO NOT use these instructions to clean power modules. See the Power Module Cleaning section. 1. Remove the lid from the sterilization case. 2. Remove all soiled medical devices from the sterilization case. 3. 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.

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5. Thoroughly rinse the equipment with warm, running water until all traces of detergent solution are removed: ▪▪ For equipment with lumens, hold the equipment on an incline, distal end pointing up, and rinse the lumen.

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▪▪ 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.

▪▪ Actuate all moving parts to rinse hidden surfaces.

NOTE: A final rinse of the equipment using deionized or filtered water is recommended. 6. Visually inspect the equipment for any remaining soil or detergent solution. If soil or detergent solution remains, repeat the cleaning procedure using fresh detergent solution. ▪▪ For all other equipment, hold the equipment on an incline, distal end pointing down.

7. Allow the equipment to drain on absorbent wipes. If possible, orient the equipment vertically to assist in drainage. 8. Dry the equipment with a soft lint-free cloth, medicalgrade compressed air, or by heating the equipment in an oven below 110 °C. 9. After manual cleaning, inspect the equipment. See the Inspection section.

Inspection WARNINGS: ▪▪ Perform recommended inspection as indicated in these instructions.

▪▪ Pay particular attention to rough surfaces, lumens, hinges, blind holes, and joints between mating parts. ▪▪ Open the door on the bottom of the handpiece and rinse the interior of the power module compartment.

▪▪ Only individuals trained and experienced in the inspection of reusable medical devices should inspect this equipment. ▪▪ DO NOT sterilize any equipment if damage is apparent or the inspection criteria are not met. 1. After cleaning, thoroughly inspect the equipment. See Appendix B: Inspection Criteria for inspection criteria. 2. If all of the inspection criteria are met: ▪▪ Charge the power modules. For charging instructions, see the instructions for use supplied with the battery charger. ▪▪ Sterilize the equipment, with the exception of the power module. DO NOT sterilize power modules. See the Sterilization section. NOTE: If the equipment fails to meet the inspection criteria, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary.

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Preparation for Sterilization WARNINGS:

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Stacking and Constraints WARNINGS:

▪▪ Prior to sterilization, remove single use cutting and fixation tools, attachments, transfer shields, and power modules from the handpieces.

▪▪ DO NOT stack multiple sterilization cases during sterile processing. Stacking multiple cases may damage the sterile barrier provided by the sterilization wrap.

▪▪ ALWAYS verify that the power module has been removed from the handpiece before sterilization.

▪▪ ALWAYS stack non-sterile cases in a safe and secure manner.

▪▪ ALWAYS open the door on the bottom of the handpiece before sterilization and take steps to make sure that it will remain open during sterilization.

▪▪ DO NOT stack wrapped or unwrapped sterilization cases during transport.

▪▪ ALWAYS separate the transfer shield from the handpiece before sterilization.

Sterilization

▪▪ ALWAYS make sure the equipment is clean and completely dry before sterilization.

WARNINGS:

Recommended Placement of Chemical Indicators WARNING: ALWAYS use a chemical indicator within every sterilization load to make sure the proper sterilization conditions of time, temperature, and saturated steam are achieved. Place a chemical indicator in a corner of the sterilization case.

Packaging WARNING: When using sterilization wrap, ALWAYS use new sterilization wrap to enclose the equipment. Do not reuse sterilization wrap. NOTES: ▪▪ Follow the AAMI and the Association of periOperative Registered Nurses (AORN) recommended guidelines for appropriate wrapping configurations. ▪▪ The packaging material will maintain the sterility of the equipment after exposure.

To Package Individual Devices Enclose the equipment using a sterilization wrap that is suitable for the equipment, such as a grade 500 or higher, before sterile processing.

To Package a Sterilization Case 1. Place the devices into the base of the sterilization case. 2. Install the lid of the sterilization case and close the latches to secure the lid to the base. 3. Enclose the equipment using a sterilization wrap that is suitable for the equipment, such as a grade 500 or higher, before sterile processing.

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▪▪ Sterilize the equipment as indicated before first and every use. ▪▪ DO NOT sterilize power modules. ▪▪ Use the sterilization methods as indicated in these instructions. Using other sterilization methods may prevent proper sterilization of the equipment and/or damage the equipment. ▪▪ Follow the recommended dry times to prevent moisture from accumulating inside the equipment. Moisture may prevent proper sterilization and/or damage the equipment. ▪▪ After sterilization, allow the equipment to cool to room temperature prior to use. Failure to comply may result in a burn injury and/or damage the equipment. NOTES: ▪▪ Stryker has validated several cycles for the sterilization of this equipment; however, sterilizer design and performance can affect the efficacy of the process. Healthcare facilities should verify the process they use, employing the actual equipment and operators that routinely process the equipment. ▪▪ The final responsibility for verification of sterilization techniques lies directly with the hospital. To ensure the efficacy of hospital processing, all cycles and methods should be verified for different sterilization chambers, wrapping methods, and/or various loading configurations. ▪▪ If wet cases or equipment are discovered after sterilization, a change in the product load configuration or a longer dry time may be necessary. ▪▪ Validation is based on the AAMI protocol. ▪▪ International sterilization parameters are per the following standards: ▪▪ Australia/New Zealand per AS/NZS 4187 ▪▪ Netherlands per Field Standard for Loaner Instruments, Revision 03.02, April 2008. ▪▪ Europe and the United Kingdom per EN ISO 17664. ▪▪ Canada per CSA ISO 17664.

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Steam Sterilization

Ethylene Oxide (EO) Sterilization

Perform one of the following validated steam sterilization cycles:

Wrapping Method: Concentration: Sterilization Temperature: Humidity: Gas Concentration: Exposure Time: Minimum Aeration Time:

Wrapping Method: Cycle: Sterilization Temperature: Minimum Exposure Time: Minimum Dry Time:

Wrapped Dynamic Air Removal (Pre-vacuum) 132 °C

134 °C

Gravity 121 °C

132 °C

4 3 30 15 minutes minutes minutes minutes 30 30 30 30 minutes minutes minutes minutes

Immediate-Use Steam Sterilization WARNINGS: ▪▪ DO NOT place equipment into a sterilization case for immediate-use steam sterilization. ▪▪ After cooling to room temperature, ALWAYS use the equipment immediately. Assurance of sterility cannot be maintained for unwrapped equipment. CAUTION: Stryker does not recommend immediate-use steam sterilization for routine sterilization of medical devices. Immediate-use steam sterilization should only be used when individual devices require immediate sterilization and use. Perform one of the following validated steam sterilization cycles: Wrapping Method: Cycle: Sterilization Temperature: Minimum Exposure Time: Minimum Dry Time:

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Wrapped 100% EO 55 °C 55% 725 mg/L 80 minutes 8 hours

Storage and Handling WARNINGS: ▪▪ ALWAYS transport wrapped equipment with care to prevent damaging the sterile barrier. ▪▪ ALWAYS store wrapped, processed equipment in a controlled environment and avoid extremes in temperature and moisture. ▪▪ Excessive handling of wrapped equipment will increase the likelihood of damaging the sterile barrier and may lead to contamination. CAUTION: ALWAYS transport and store the equipment within the specified environmental condition values: Temperature Limitation

Humidity Limitation

Atmospheric Pressure Limitation

Unwrapped Dynamic Air Removal (Pre-vacuum)

Gravity

132 °C

132 °C

4 minutes

10 minutes

No dry time

No dry time

NOTE: See the instructions for use supplied with the sterilization wrap for maximum shelf-life information.

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Service WARNINGS: ▪▪ DO NOT disassemble, modify, service, or repair this equipment without authorization of the manufacturer. ▪▪ Failure to comply with the stated service interval may compromise the safe and effective use of the equipment. NOTES: ▪▪ The useful life of this equipment is dependent upon many factors including, but not limited to, the method and duration of each use, and the handling of the equipment between uses. ▪▪ Routine and careful inspection of the equipment is the best method for determining the serviceable life span of the equipment. ▪▪ Maintenance documentation for this equipment is available upon request to Stryker-authorized service personnel only. ▪▪ For service information, contact your Stryker sales representative or call Stryker customer service. See the Contact Information section. Outside the US, contact your nearest Stryker subsidiary. Component Rotary Drill Reciprocating Saw Sagittal Saw System G Rotary Drill Attachments Power Module Charger, 2-Bay Sterilization Case

Expected Service Life 5 years 5 years 5 years Non-serviceable Non-serviceable Non-serviceable Non-serviceable

Action Contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary.

To comply with European Community Waste Electrical and Electronic Equipment (WEEE) Directive 2012/19/EU, ALWAYS collect this product separately for recycling. DO NOT dispose of this product as unsorted municipal waste. Contact your local distributor for disposal information. To comply with European Community Batteries Directive 2006/66/EC, power modules have been designed to be recycled at the end-oflife by the end user as complete units. No disassembly is required. Power modules contain Lithium-ion material. Contains no hazardous substances, per China RoHS standard.

Appendix A: Special Cleaning Considerations Handpieces Component

Moving Parts

Rotary Drill

Yes

Reciprocating Saw

Yes

Sagittal Saw

Yes

Disposal/Recycle WARNINGS: ▪▪ Power modules contain Lithium-ion material. Risk of fire, burns, and explosion. DO NOT short circuit, open, crush or incinerate. Consult instructions for use. ▪▪ Follow the current local recommendations and/or regulations governing environmental protection and the risks associated with recycling or disposing of the equipment at the end of its useful life.

Critical Areas Safety switch, release lever, triggers, door, latch, lumen, power module compartment Safety switch, blade chuck, trigger, door, latch, power module compartment Safety switch, blade lock button, blade mount, trigger, door, latch, power module compartment

Brush Sizes

4.4 mm

0.75, 2, and 3 mm

0.75 and 2 mm

▪▪ ALWAYS follow the current local regulations governing the safe handling and disposal of sharps. ▪▪ ALWAYS follow the current local regulations governing biohazard waste to safely handle and dispose of surgical waste.

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Attachments Component Wire Collet

Care Components Moving Parts Yes

Pin Collet, Small

Pin Collet, Large

Keyless Chuck Adaptor 1:1 AO Small Drill 1:1 Hudson 1:1 1/4 inch (6.4 mm) Keyed Chuck Keyless Drill Attachment 1:1 Hudson Modified Trinkle 1:1 Trinkle High Torque 1/4 inch (6.35 mm) Drill with Chuck 2:1 with Key 3.25:1 AO Large Reamer 3.25:1 Hudson 3.25:1 1/4 inch (6.4 mm) Keyed Chuck 3.25:1 Hudson/ Modified Trinkle 3.25:1 Trinkle 4:1 Hudson 4:1 Hudson/ Modified Trinkle

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Yes

Yes

Yes Yes Yes Yes Yes Yes Yes

Yes

Yes Yes Yes Yes Yes Yes Yes

Critical Areas Clamping lever, preadjust knob, lumen Clamping lever, preadjust knob, lumen Clamping lever, preadjust knob, lumen Jaws, lumen Retaining collar, lumen Retaining collar, lumen

Brush Sizes 1.2, 2.5, and 6 mm

2.5 and 6 mm

3.6 and 6 mm 4.1 and 7 mm 2.5 and 5 mm 4.2, 7 and 8 mm

Jaws, lumen

4.2 and 7 mm

Lock switch, jaws, lumen Retaining collar, lumen Retaining collar, lumen

4.2 and 7 mm 4.2, 7 and 8 mm 4.2, 7 and 8 mm

Jaws, lumen

4.2 and 7 mm

Retaining collar, lumen Retaining collar, lumen

4.2, 7 and 8 mm 4.2, 7 and 8 mm

Jaws, lumen

4.2 and 7 mm

Retaining collar, lumen Retaining collar, lumen Retaining collar, lumen Retaining collar, lumen

4.2, 7 and 8 mm 4.2, 7 and 8 mm 4.2, 7 and 8 mm 4.2, 7 and 8 mm

Component Sterilization Cases

Moving Parts Yes

Critical Areas Latches, handles, perforations

Brush Sizes 3, 5, and 15 mm

Appendix B: Inspection Criteria Interval Before sterilization

Activity Inspect the equipment

Criteria No visible soil, damage, signs of wear, and/or corrosion No loose or missing components No cracks or damage No nicks or burrs that may cause injury, damage surgical gloves, or tear the packaging material and damage the sterile barrier Markings on the equipment are clearly legible All moving parts move freely All equipment is completely dry

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