PowerPro Attachments Instructions for Use

ENGLISH/INSTRUCTIONS FOR USE

PowerPro® Attachments DESCRIPTION The PowerPro Attachments are quick connect attachments that facilitate drilling, reaming, tapping, sawing and wire/ pin driving functions when used with PRO5000 and PRO6000 series handpieces.

INTENDED USE PowerPro attachments are designed to be used in conjunction with all PowerPro, PowerProMax™, MPower ® and MPower ® 2 handpieces to perform bone cutting, reaming, drilling, driving screws, and sawing. Most drilling, reaming and sawing attachments are interchangeable between the battery, pneumatic, and electrically operated PowerPro, PowerProMax, MPower and MPower 2 handpieces, with the exception of the PRO2045 Reciprocating Saw attachment, and pin and wire drivers. See the associated Hall® PowerPro Attachment Instruction Manual for more information. The fields of application for the attachments used with the associated PowerPro, PowerProMax, MPower and MPower 2 handpieces include: Orthopedic, Osteotomy, Total Joint Arthroplasty, Trauma, Medial Sternotomy, ACL reconstruction, and small bone surgeries.

WARNINGS 1. Eye protection is always necessary when operating equipment. Eye injury may result without protection. 2. Continually check all handpieces and attachments for overheating. If overheating is sensed, immediately discontinue use and return equipment for service. Overheating may cause damage to the bur, bit or blade and may cause thermal necrosis. 3. Do not attach, insert or remove accessories or attachments while the handpiece is operating. Serious injury may occur. Place the handpiece in safe mode prior to installation or removal of items. 4. The instruments are supplied non-sterile, and must be sterilized before the first use, and after every use.

PRECAUTIONS 1. This equipment is designed for use by medical professionals completely familiar with the required techniques and instructions for use of the equipment. Read and follow all warnings, precautionary notices and instructions marked on the product and included in this insert. 2. Use only associated Hall Surgical and CONMED accessories and attachments as defined in the description of each attachment in the manual. 3. Handle all equipment carefully. If an attachment is dropped or damaged in any way, return it immediately for service. 4. Prior to each use, inspect all equipment for proper operation and ensure all attachments and accessories are correctly and completely attached to the handpiece. 5. Attachments are factory sealed. Do not disassemble or lubricate. Damage will occur. 6. Always inspect for bent, dull or damaged burs, blades or drill bits before each use. Do not attempt to straighten or sharpen. After use, dispose of properly. 7. Reaming and saw attachments are not designed to be used in any screw, tap or oscillate drill modes. They are only to be operated in the drill/ream mode. 8. After each use, thoroughly clean the attachments. See “Cleaning and Sterilization” section below. 9. United States Federal law restricts sale of this device to or on the order of a physician.

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MAINTENANCE CONMED recommends that all PowerPro attachments be returned for preventive maintenance every 24 months, except for certain attachments indicated in Section 3.0 in the Hall PowerPro Attachment Manual, which have a recommended service schedule of every 12 months. WARNING: Failure to follow the maintenance schedule could result in reduced instrument performance or overheating of the handpiece or attachment. In addition, heavy use of the handpiece exceeding the recommended duty cycle can cause the handpiece or attachment to overheat. Overheating can lead to possible burn injury to the patient or medical personnel. Rotation of handpiece and attachment usage per day will assist with proper performance.

CLEANING AND STERILIZATION Cleaning Precautions 1. Follow universal precautions for protective apparel when handling and cleaning contaminated instruments. 2. Do not lubricate any attachments. 3. Do not immerse attachments or accessories. 4. Never clean attachments with bleach, chlorine-based detergents, liquid or chemical disinfectants, or any product containing sodium hydroxide (i.e., INSTRU-KLENZ, Buell Cleaner). They will degrade the anodized aluminum coating.

Cleaning Instructions 1. Clean attachments as soon as possible after use. 2. Remove attachments from handpiece prior to cleaning. 3. Remove all accessories (i.e., saw blades, burs) from the attachments prior to cleaning. 4. Thoroughly scrub the attachments with a clean, soft brush dampened with a mild, pH-balanced detergent cleaner of your choice. Remove all traces of blood, debris and stains. DO NOT IMMERSE equipment in soap solution or rinse water. 5. To clean the cannulated section of the attachment: •

Feed the wire end of a cleaning brush through the back of the attachment.

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Pull the brush through the attachment. Repeat until all debris is removed.

6. Manipulate all moving parts of the attachments to ensure all debris is removed. If not, clean again until all debris is removed. 7. Rinse under running water to remove all traces of soap. 8. Flush all surfaces free of tap water with distilled water to prevent metal discoloration. 9. To dry, shake the equipment free of water and wipe the surfaces with a clean, lint-free towel.

Washer / Sanitizer Instructions (Optional) 1. Rinse the device with tap water at a minimum temperature of 25°C (77°F), to remove all visible traces of debris. 2. Use a minimum of 54 liters of tap water and rinsing for 9 minutes to remove visible debris. 3. While rinsing each device perform manipulation, opening and closing any movable part of the device. 4. The device can be loaded into a washer/sanitizer and operate according to machine manufacturer’s instructions. It is recommended to use a neutral pH cleaner.

PRECAUTIONS •

Clean instruments within 30 minutes after use to minimize the potential for drying prior to cleaning.

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For aluminum surfaces, a neutral-pH agent should be used. To prevent corrosion, avoid contact with strong alkaline solutions (pH over 10.5) or agents containing iodine or chlorine.

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Attachments are factory sealed. DO NOT lubricate. DO NOT disassemble attachment. Damage will occur. 2

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Do not clean attachments with bleach, chlorine-based detergent, or caustic solutions that contain phenol. Chlorine or bleach will corrode metal contacts.

1. After Manually cleaning the attachment(s), carefully inspect for any signs of residual soil. Repeat cleaning until no residual soils remain. 2. Allow devices to drain. Remove excess moisture with a lint-free absorbent wipe.

Sterilization Information Steam sterilization is safe and effective and has no contraindications for its use in sterilizing powered surgical handpieces and attachments.

Sterilization Warnings, Precautions and Notes 1. Do not sterilize with Ethylene Oxide (EtO). 2. Do not “peel pack” handpieces or attachments for sterilization. Sterilization in a sealed pouch traps moisture which can cause damage. 3. Always sterilize attachments with the collet mechanism in the FULLY OPEN position. 4. DO NOT run attachments while warm. Allow adequate time for cooling prior to surgery. DO NOT IMMERSE in liquid or cover with a damp cloth to cool. Cool by exposure to room temperature. WARNING: The use of disinfecting solutions for an exterior instrument wipe will not sterilize the equipment and is not recommended.

Presterilization Inspection Recommendations 1. Inspect device prior to sterilization 2. Generally, unmagnified visual inspection under good light conditions is sufficient. All parts of the devices should be checked for visible soil and/or corrosion. 3. Functional checks should be performed where possible. 4. Mating devices should be checked for proper assembly. 5. Remove and repair damaged instruments / containers. Double wrap instrument tray or case using FDA cleared sterilization wrap. Sterilizing Attachments in the PowerPro Small System Sterilization Case (PRO5095) and the Hall Sterilization Tray (PRO6000) Method

Cycle

Minimum Temperature

Minimum Exposure

Minimum Dry Cycle

Steam

Pre-vacuum

270°F (132°C)

4 minutes

25 minutes

Steam

Gravity

270°F (132°C)

15 minutes

35 minutes

PRECAUTION: The recommended dry cycle must be run on all attachments every time they are sterilized. Failure to use a dry cycle may lead to reduced product performance or premature product failure. Operation of an attachment that is not completely cool and dry may decrease performance and/or reliability. PRECAUTION: Testing demonstrates that a minimum dry time of 35 minutes is required to prevent wet packs when using the gravity cycle.

CONTACT INFORMATION For more information, consult the PowerPro Attachment Instruction Manual, as well as the appropriate handpiece manual. For more information or a product demonstration, contact your regional CONMED sales representative, or call 1-866-426-6633 in the U.S.

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MDSS GmbH Schiffgraben 41 D-30175 Hannover, Germany

CONMED Corporation 525 French Road Utica, NY 13502-5994 USA Customer Service: 1-866-426-6633 USA FAX: (727) 399-5256 International FAX: +1(727) 397-4540 email: [email protected] www.conmed.com ©2021 CONMED Corporation. All rights reserved.

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Rev A

09/2021