SONOPET Universal Handpieces Instructions for Use Rev AA March 2022

EN

5450-820-700 Rev-AA

Contents Introduction... 3 Indications For Use... 3 Contraindications... 3 For Use With... 3 User/Patient Safety... 3 Accessories... 4 Features... 5 Definitions... 5 Instructions... 6 To Install Handpiece Cover... 6 To Install Ultrasonic Tip... 6 To Install Tip Cover... 7 To Operate Handpiece... 7 To Remove Tip Cover... 8 To Remove Ultrasonic Tip... 8 To Remove Handpiece Cover... 8 Processing Instructions... 9 Point of Use... 9 Transport to Decontamination Processing Area... 9 Preparation for Cleaning... 9 Detergents... 9 Water ... 10 Cleaning... 10 Recommended Equipment... 10 To Clean the Handpiece and Attachments... 10 Inspection and Testing...11 Limitations of Processing...11 Visual and Functional Inspection... 12 Consumable Parts... 13 Preparation for Sterilization... 14 Packaging... 14 Sterilization ... 14 Storage and Handling Before Use... 16 Sterile Equipment... 16 Non-sterile Equipment... 16 Troubleshooting... 16 Disposal/Recycle... 16 Specifications... 17 Appendix... 18 To Install Ultrasonic Tip Using Wrench... 18 To Remove Ultrasonic Tip Using Wrench... 18

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5450-820-700 Rev-AA

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Introduction

For Use With

This instructions for use manual contains information intended to ensure the safe, effective and compliant use of your product. This manual may be used by in-service trainers, physicians, nurses, surgical technologists, and biomedical equipment technicians. Keep and consult this reference manual during the life of the product. 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. For additional information, including safety information, in-service training, or current literature, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary. Trademarks that are not the property of Stryker Corporation are the property of their respective owners.

This section identifies required components intended to be used with the equipment to obtain a safe combination.

Indications For Use The Stryker Sonopet Universal Handpiece (handpiece), when used with the appropriate ultrasonic tip, is intended for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, plastic and reconstructive surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and thoracoscopic surgery.

Contraindications This ultrasonic surgical aspirator device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids. NOTE: The Japanese version of the Indications For Use and Contraindications statements appears on a package insert for customers in the Japanese market, and may vary due to the content of the Ministry of Health, Labor, and Welfare (MHLW) approval. The Japanese translated equivalent of this IFU states, “See the information provided on the package insert.”

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DESCRIPTION

REF

Sonopet Ultrasonic Surgical System Console

5450-850-000 (110 VAC)

25 kHz Disposable Universal Tips

See the Accessories section for part number information.

5450-852-000 (230 VAC)

User/Patient Safety WARNINGS: • Before using this equipment, or any component compatible with this equipment, read and understand the instructions for use. Pay particular attention to safety information. Become familiar with the equipment before use. • Only trained and experienced healthcare professionals should use this equipment. • The healthcare professional performing any procedure is responsible for determining the appropriateness of this equipment and the specific technique used for each patient. Stryker, as a manufacturer, does not recommend surgical procedure or technique. • Upon initial receipt and before each use, clean and sterilize the equipment as indicated. Equipment includes the handpiece, wrenches, cleaning wire, and all reusable components and accessories related to the handpiece. See the Processing Instructions section for care information. • Upon initial receipt and before each use, inspect each component for damage. See the Inspection and Testing section for inspection criteria. DO NOT use any equipment if damage is apparent. • DO NOT use this equipment in areas in which flammable anesthetics or flammable agents are mixed with air, oxygen, or nitrous oxide.

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5450-820-700 Rev-AA

Accessories This section identifies accessories that may be purchased to replace consumed, worn, or damaged equipment. Optional accessories may also be purchased to aid in operation. WARNINGS: • Use only Stryker-approved system components and accessories, unless otherwise specified. Using other electronic components and accessories may result in increased electromagnetic emissions, decreased electromagnetic immunity of the system, increased total leakage current, or degradation of system performance and potential overheating. • DO NOT modify this equipment without the authorization of the manufacturer. • All disposable accessories are intended for single use only. DO NOT reuse, reprocess, or repackage a single use device. A single use device is intended for a 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 serious risk of contamination and may compromise the structural integrity of the single use device resulting in operational failure. Critical product information may be lost if the single use device is repackaged. Failure to comply may lead to infection or cross infection and result in patient and/or healthcare staff injury. • ALWAYS use an ultrasonic tip of the correct frequency for the handpiece. See the Specifications section. Failure to comply may result in loss of power to the handpiece during use. NOTES: • Each disposable universal tip is supplied with a matching disposable tip cover. • For a complete list of accessories, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary. DESCRIPTION

REF

25 kHz Disposable Universal Tips, QTY 5

5450-800-3XX Series 5450-815-XXX Series

4

Wrench (7 mm)

5450-800-029

Torque Wrench (7 mm)

5450-800-039

Sterilization Cap

5450-800-275

Cleaning Wire

5450-800-276

Sterilization and Assembly Tray (7 mm)

5450-800-278

Handpiece Cover (angled)

5450-820-016

Handpiece Cover (straight)

5450-840-013

Blu62™ and ProClean Instrument Detergent® Products

3000-00X-000 Series

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Features B D

A

D

G F C E

J I

E

H

A

Tip Cover (applied part)

F

Handpiece

B

Irrigation Port

G

Suction Port

C

Ultrasonic Tip (applied part)

H

Sterilization Cap

D

Handpiece Cover (angled or straight)

I

Handpiece Connector

E

Tip Joint (angled or straight)

J

Handpiece Cord

NOTE: The designated applied parts are defined by the manufacturer. See the Product Safety Certification standards listed in the Specifications section of the instructions for use supplied with the Sonopet Ultrasonic Surgical System Console.

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

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DEFINITION

SYMBOL

DEFINITION

When positioning the torque wrench on an ultrasonic tip, this symbol must face the distal end of the tip.

CAUTION: DO NOT grasp the handpiece by hand to install or remove the ultrasonic tip.

When installing an ultrasonic tip, rotate the torque wrench in this direction to apply the appropriate torque.

General warning sign

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5450-820-700 Rev-AA

Instructions WARNINGS: • ALWAYS observe proper sterile technique when handling the sterile handpiece and its cord and connector. • ALWAYS assemble the sterile handpiece in the sterile field. • Before assembling the handpiece, inspect each component for damage. See the Inspection and Testing section for inspection criteria. DO NOT use any equipment if damage is apparent. • Before operating the handpiece, verify that all components are fully and securely installed on the handpiece as directed. • DO NOT remove the sterilization cap from the handpiece connector within the sterile field. • ALWAYS follow the recommended duty cycle to prevent the equipment from overheating. See the Specifications section. • Follow the current local regulations governing the prevention and transmission of bloodborne infections when handling any blood-related product. CAUTIONS: • ALWAYS handle the handpiece with care. DO NOT drop the handpiece. DO NOT place objects on top of the handpiece. • DO NOT grasp the handpiece by hand to install or remove the ultrasonic tip.

To Install Handpiece Cover Align the notch on the handpiece cover with the notch on the handpiece and securely press the handpiece cover onto the handpiece (figure 1).

To Install Ultrasonic Tip WARNINGS: • ALWAYS use torque wrench REF 5450800-039 to install the ultrasonic tip onto the handpiece. Failure to comply may result in product damage, loss of power, and/or overheating of the handpiece during use. • DO NOT over tighten the ultrasonic tip during installation. Stop tightening immediately when the wrench handle pivots out of alignment with the wrench head. Failure to comply may result in product damage, loss of power, and/or overheating of the handpiece during use. NOTES: • If you do not have a sterilization and assembly tray, see the Appendix to install the ultrasonic tip using a wrench. • When used correctly, the wrench handle will pivot out of alignment with the wrench head during installation.

1. Thread the ultrasonic tip onto the handpiece. NOTE: There is no need to remove the handpiece cover. 2. Place the handpiece tip joint into the notched bracket on the sterilization and assembly tray (figure 2).

Figure 1 – Install Handpiece Cover

Figure 2 – Place Handpiece in Tray

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3. Place the torque wrench on the ultrasonic tip as shown. The side of the torque wrench with the symbols must face the distal end of the tip (figure 3).

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To Install Tip Cover NOTES: • When installing the tip cover, you should feel a frictional drag as the o-ring inside the tip cover slides against the mating surfaces of the tip and handpiece. If there is no frictional drag, replace the tip and tip cover with a new set. • To provide a better line of sight, deeper access through narrow approaches, and/or different irrigation scatter or mist, the distal end of the tip cover may be shortened by cutting the sleeve at one of the frangible score marks. Securely press the tip cover onto the handpiece. Rotate the tip cover to the desired position, if necessary (figure 5).

Figure 3 – Position Torque Wrench 4. Hold the handpiece in place and rotate the torque wrench in the direction of the arrow to tighten the ultrasonic tip. Stop tightening immediately when the wrench handle pivots out of alignment with the wrench head, indicating that adequate force has been applied (figure 4).

Figure 5 – Install Tip Cover

To Operate Handpiece WARNINGS: • Applied part may generate heat. Use care to avoid tissue damage due to unintended contact. ALWAYS provide adequate irrigation to the tip. • If frangible sections have been removed from the tip cover, ALWAYS provide adequate irrigation to the tip. Failure to comply may lead to excessive heat and result in patient injury. See the instructions for use supplied with the Stryker Sonopet Ultrasonic Surgical System Console for handpiece connection, preparation, and operation instructions.

Figure 4 – Install Ultrasonic Tip

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Instructions (continued) To Remove Tip Cover 1. Loosen and remove the tip cover from the handpiece cover by hand (figure 6). 2. Discard the tip cover. See the Disposal/ Recycle section.

2. Place the torque wrench on the ultrasonic tip as shown. The side of the torque wrench with the symbols must face the distal end of the tip (figure 3). 3. If necessary, reset the head of the torque wrench to its proper position by rotating the handle in the opposite direction of the arrow until it clicks into alignment with the head (figure 8). 4. Hold the handpiece in place and rotate the torque wrench in the opposite direction of the arrow to loosen and remove the ultrasonic tip (figure 8).

Figure 6 – Remove Tip Cover

To Remove Ultrasonic Tip CAUTION: When removing the ultrasonic tip, DO NOT remove the tip joint. NOTES: • If you do not have a sterilization and assembly tray, see the Appendix to remove the ultrasonic tip using a wrench. • There is no need to remove the handpiece cover. Removing the tip cover alone will expose the tip joint. 1. Place the handpiece tip joint into the notched bracket on the sterilization and assembly tray (figure 7).

Figure 8 – Remove Ultrasonic Tip 5. Discard the ultrasonic tip. See the Disposal/ Recycle section.

To Remove Handpiece Cover Loosen and remove the handpiece cover from the handpiece by hand (figure 9).

Figure 9 – Remove Handpiece Cover

Figure 7 – Place Handpiece in Tray

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Processing Instructions

Preparation for Cleaning

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.

Detergents

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. 2. Discard waste into an appropriate container; use a puncture-resistant container for sharps. See the Disposal/Recycle section. 3. Remove gross soil from the equipment using absorbent wipes.

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.

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WARNINGS: • Read, understand, and follow the indications, instructions, and safety information supplied with the detergent for correct handling and use of the product. Pay particular attention to the concentration used and the total dispersion. • ALWAYS provide personal protective equipment (PPE) for processing personnel according to the instructions and safety data sheets (SDS) supplied with the detergent. • To clean the equipment, use specifically formulated detergents only. CAUTIONS: • To clean the equipment, a mild alkaline detergent (neutral up to pH 10.5) is preferred. • ALWAYS use a detergent that is suitable for use on aluminum, stainless steel, plastic, rubber, and titanium surfaces. The following detergents were used by Stryker during validation of the manual cleaning process described in these instructions. Supplier

Designation

Suitability

Process

Stryker

ProClean Instrument Detergent

All materials

Manual Cleaning

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

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Processing Instructions (continued) 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.

Cleaning WARNINGS: • Prior to cleaning and sterilization, separate all detachable components and disposable accessories from the handpiece. Detachable components include the disposable tip cover, handpiece cover, disposable ultrasonic tip, and disposable suction and irrigation tubing. See the Disposal/Recycle section. DO NOT remove the tip joint. • Clean the equipment as indicated before first and every use. The equipment includes the handpiece, wrenches, cleaning wire, and all the reusable components and accessories related to the handpiece. • Use the cleaning methods as indicated in these instructions. Using other cleaning methods may prevent proper sterilization of the equipment. • Use PPE at all times during processing. CAUTIONS: • DO NOT use solvents, lubricants, or other chemicals, unless otherwise specified. • DO NOT use a washer-disinfector device to perform automated cleaning/disinfection on the equipment.

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• DO NOT use ultrasonic cleaning equipment. • DO NOT use glutaraldehyde or similar chemical cleaners on the handpiece connector. • DO NOT immerse or soak any equipment in liquid. Equipment may be placed briefly under running water to ensure thorough wetting and contact with liquid. • DO NOT allow moisture or liquid to soak into electrical connectors, receptacles, or openings. Moisture or liquid may cause corrosion and damage the equipment. • DO NOT use pipe cleaners or cotton swabs to clean lumens. • ALWAYS make sure the 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.

Recommended Equipment The following equipment is required to process devices per the instructions in this manual: • PPE as recommended by the detergent supplier • Warm, filtered or deionized water (See the Water section.) • Prepared detergent solution (See the Detergents section.) • Absorbent wipes • Soft, lint-free cloth • Syringe • Non-abrasive, soft, flexible, synthetic bristle brushes • Medical-grade compressed air, < 140 kPa [< 20 psi]

To Clean the Handpiece and Attachments 1. 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. 2. Make sure all surfaces of the equipment are thoroughly wetted using warm water.

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3. Use suitable brushes and detergent solution to clean all surfaces. Pay particular attention to rough surfaces, crevices, and difficult-toreach areas where soil may be shielded from brushing. Use a syringe filled with detergent solution to flush difficult-to-reach areas. See the Special Cleaning Considerations table. 4. Use soft brushes of appropriate diameters to clean the entire length of each lumen. If a lumen passes all the way through a device, make sure that the brush cleans the whole length of the lumen. See the Special Cleaning Considerations table. SPECIAL CLEANING CONSIDERATIONS Component

Moving Parts

Critical Areas

Brush Sizes

Handpiece

No

Lumen

3 mm

Handpiece cover (angled)

No

Lumen

12 mm

Handpiece cover (straight)

No

Lumen

10 mm

5. Hold the equipment on an incline, distal end pointing down, and thoroughly rinse the equipment in warm running water until all traces of detergent solution are removed. Pay particular attention to rough surfaces, lumens, hinges, blind holes, and joints between mating parts. 6. For equipment with lumens, hold the equipment on an incline, distal end pointing up, and rinse the lumen under warm running water. NOTE: A final rinse of the equipment using deionized or filtered water is recommended. 7. 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. 8. Allow the equipment to drain on absorbent wipes. 9. Dry the equipment with a soft, lint-free cloth or medical-grade compressed air. 10. After cleaning, inspect and test the equipment immediately. See the Inspection and Testing section.

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Inspection and Testing WARNINGS: • Only individuals trained and experienced in the maintenance of reusable medical devices should inspect and test this equipment. • Perform recommended inspection and testing as indicated in these instructions. • Upon initial receipt and before each use, inspect each component for damage. DO NOT use any equipment if damage is apparent or the inspection criteria are not met. • DO NOT disassemble, modify, or service this equipment, unless otherwise specified. 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 and functional testing are the best methods for determining the serviceable life span of the equipment. • For service, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary.

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

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Processing Instructions (continued) Visual and Functional Inspection COMPONENT

INTERVAL

CRITERIA

Handpiece

Before each use

Inspect, operate, and test the handpiece to make sure it is working properly. Make sure there are no loose or missing components. Make sure the surface of the handpiece cord is not cut or frayed and there is no damage to the handpiece connector. Inspect the o-rings for cracks, punctures, and general integrity. Make sure no o-rings are missing. Make sure the o-rings provide a friction seal between the handpiece components.

Ultrasonic Tip

12

Every six months

Replace the o-rings. See the Consumable Parts section.

Every year

Return handpiece to Stryker for service.

Before and during each use

Inspect the tip for damage or signs of wear. Make sure that the tip is not bent, scratched, or cracked, and that no part of the tip is broken or missing.

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COMPONENT

INTERVAL

CRITERIA

Tip Cover

Before and during each use

Inspect the sleeve for damage or signs of wear. Make sure that the sleeve is not bent, scratched, or cracked, and that no part of the sleeve is broken or missing. If the ultrasonic tip has a suction hole on the side, make sure that the hole is not exposed when the sleeve is fully installed.

Torque Wrench

Before each use

Activate the torque wrench head by hand to verify free movement of parts.

Torque Wrench

Every year

Return torque wrench to Stryker for service.

Wrench

Before each use

Inspect the wrench for damage or signs of wear.

Sterilization Cap

Before each use

Inspect the cap for damage or signs of wear. Make sure that the cap fits securely on the handpiece connector.

Cleaning Wire

Before each use

Inspect the cleaning wire for damage or signs of wear.

Consumable Parts WARNING: O-rings are designed to fit in specific locations on each individual handpiece. ALWAYS use the correct o-rings for your handpiece configuration, and install each o-ring as shown. Failure to comply may result in loss of power to the handpiece during use and/or cause product damage. NOTES: • Gradually insert the o-rings into the grooves of the handpiece cover. Make sure the o-rings are fully seated. • Moisten the o-rings and the handpiece cover with filtered water to facilitate insertion, if necessary.

A

B

DESCRIPTION

QUANTITY

REF

A

O-Ring

1

0045-001-049

B

O-Ring

2

0045-001-047

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Processing Instructions (continued)

Sterilization

Preparation for Sterilization

• Sterilize the equipment as indicated before first and every use. Equipment includes the handpiece, wrenches, cleaning wire, and all reusable components and accessories related to the handpiece. • All disposable accessories are intended for single use only. DO NOT reuse or resterilize. • Use the sterilization methods as indicated in these instructions. Using other sterilization methods may prevent proper sterilization of the equipment and/or may damage the equipment and cause a handpiece to overheat during use. • Follow the recommended dry times to prevent moisture from accumulating inside the equipment. Moisture may prevent proper sterilization and/or damage the equipment. Moisture may also cause a handpiece to overheat during use. • 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 to the equipment. NOTES: • Stryker has validated several sterilization 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 trays or equipment are discovered after sterilization, a change in the product load configuration or a longer dry time may be necessary.

WARNINGS: • ALWAYS use a chemical indicator within every sterilization load to make sure the proper sterilization conditions of time, temperature, and saturated steam are achieved. • Prior to sterilization, remove all detachable components and disposable accessories from the handpiece. Detachable components include the disposable tip cover, handpiece cover, disposable ultrasonic tip and disposable suction and irrigation tubing. See the Disposal/ Recycle section. DO NOT remove the tip joint. CAUTIONS: • ALWAYS fully install the sterilization cap onto the handpiece connector to protect the connector during sterilization.

• ALWAYS make sure the equipment is clean and completely dry before sterilization. 1. Load the equipment into an appropriate sterilization tray. See the Accessories section. 2. Place a chemical indicator in a corner of the tray.

Packaging WARNING: ALWAYS use a new sterilization wrap to enclose the equipment. DO NOT reuse sterilization wrap. 1. Enclose the equipment using a sterilization wrap that is suitable for the equipment, such as a grade 500 or higher, before sterile processing. 2. Follow the AAMI and the Association of periOperative Registered Nurses (AORN) recommended guidelines for appropriate wrapping configurations. NOTE: The packaging material will maintain the sterility of the equipment after exposure.

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WARNINGS:

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• 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 Perform one of the following validated steam sterilization cycles: Wrapping Method

Cycle

Wrapped

Dynamic Air Removal (Pre-vacuum)

Aesculap Rigid Container

Dynamic Air Removal (Pre-vacuum)

Sterilization Temperature

Minimum Exposure Time

132 °C [270 °F]

4 minutes

134 °C [273 °F]

3 minutes

132 °C [270 °F]

4 minutes

134 °C [273 °F]

3 minutes

Minimum Dry Time

30 minutes

30 minutes

WARNINGS: • DO NOT place equipment into an insert tray, sterilization case, or sterilization container for immediateuse steam sterilization. • After cooling to room temperature, ALWAYS immediately use equipment sterilized by immediate-use steam sterilization. Sterility assurance 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

Unwrapped

Dynamic Air Removal (Pre-vacuum) Gravity

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Sterilization Temperature

Minimum Exposure Time

132 °C [270 °F]

4 minutes

134 °C [273 °F]

3 minutes

132 °C [270 °F]

10 minutes

Minimum Dry Time

No dry time

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Processing Instructions (continued) Storage and Handling Before Use Sterile Equipment 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. NOTE: See the instructions for use supplied with the sterilization wrap for maximum shelf-life information.

Non-sterile Equipment CAUTION: ALWAYS store the equipment within the specified environmental condition values throughout its useful life. See the Specifications section.

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Troubleshooting See the instructions for use supplied with the Stryker Sonopet Ultrasonic Surgical System Console for handpiece troubleshooting information.

Disposal/Recycle WARNINGS: • ALWAYS 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. • 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. 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.

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Specifications The following specifications apply to the handpiece: Sonopet Universal Handpiece REF 5450-820-000 Sonopet Straight Universal Handpiece REF 5450-840-000

Model:

Length: 153 mm [6.0 inches]

Dimensions:

Diameter:

23 mm [0.9 inches]

Mass:

120 grams [4.2 ounces]

Frequency:

25 kHz

Handpiece Cord Length:

4.0 m [13 feet] Non-continuous Operation

Mode of Operation:

Duty Cycle: 1 minute on/1 minute off, 5 times Rest Between Cycles:

30 minutes IPX0 Ordinary Equipment

Ingress Protection: Environmental Conditions:

Operation

Storage and Transportation

Temperature Limitation:

Humidity Limitation:

Atmospheric Pressure Limitation:

NOTE: The following specifications apply to the handpiece when the handpiece is connected to a specific model Stryker Sonopet Ultrasonic Surgical System Console: Model:

Equipment Type: Model:

Equipment Type:

UST-2001 REF 5450-850-000 Type BF Applied Part UST-2001 REF 5450-852-000 Type BF Applied Part

NOTE: See the instructions for use supplied with the Stryker Sonopet Ultrasonic Surgical System Console for additional specifications.

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Appendix NOTE: When installing and removing the ultrasonic tip, there is no need to remove the handpiece cover. Removing the tip cover alone will expose the tip joint.

To Install Ultrasonic Tip Using Wrench 1. Thread the ultrasonic tip onto the handpiece. 2. Place the wrench on the handpiece tip joint (figure 10). 3. Place the torque wrench on the ultrasonic tip as shown. The side of the torque wrench with the symbols must face the distal end of the tip (figure 10).

To Remove Ultrasonic Tip Using Wrench CAUTION: When removing the ultrasonic tip, DO NOT remove the tip joint. 1. Place the wrench on the handpiece tip joint (figure 10). 2. Place the torque wrench on the ultrasonic tip as shown. The side of the torque wrench with the symbols must face the distal end of the tip (figure 10). 3. If necessary, reset the head of the torque wrench to its proper position by rotating the handle in the opposite direction of the arrow until it clicks into alignment with the head (figure 12). 4. Hold the wrench and handpiece in place and rotate the torque wrench in the opposite direction of the arrow to loosen and remove the ultrasonic tip (figure 12).

Figure 10 – Position Wrenches 4. Hold the wrench and handpiece in place and rotate the torque wrench in the direction of the arrow to tighten the ultrasonic tip. Stop tightening immediately when the torque wrench handle pivots out of alignment with the torque wrench head, indicating that adequate force has been applied (figure 11).

Figure 12 – Remove Ultrasonic Tip 5. Discard the ultrasonic tip. See the Disposal/ Recycle section.

Figure 11 – Install Ultrasonic Tip

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