The Hall PowerPro PRO6150, PRO6175, PRO6185 Instruction Manual Rev C July 2005

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Proprietary Information This manual contains information deemed proprietary to Linvatec Corporation. The information contained herein, including all of the designs and related materials, is the sole property of ConMed Linvatec and/or its licensors. ConMed Linvatec and/or its licensors reserve all patent, copyright and other proprietary rights to this document, including all design, manufacturing methodology and reproduction. This document, and any related materials, is confidential and is protected by copyright laws and shall not be duplicated, transmitted, transcribed, stored in a retrieval system, or translated into any human or computer language in any form or by any means, electronic, mechanical, magnetic, manual or otherwise, or disclosed to third parties, in whole or in part, without the prior express written consent of ConMed Linvatec. ConMed Linvatec reserves the right to revise this publication and to make changes from time to time in the contents hereof without obligation to notify any person of such revision or changes, unless otherwise required by law.

Linvatec, Hall and PowerPro are trademarks or registered trademarks of Linvatec Corporation.

© Linvatec Corporation 2005. All Rights Reserved. Printed in USA

Record the Model and Serial Numbers of the handpiece(s), and date received. Retain for future reference. Handpiece Model No. Handpiece Model No. Handpiece Model No. Handpiece Model No. Handpiece Model No.

Serial No Serial No Serial No Serial No Serial No

Date Date Date Date Date

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Page

Table of Contents

1.0

2.0

INTRODUCTION 1.1

Intended Use... 1

1.2

General Warnings... 1

1.3

Symbol Definitions... 3

1.4

PowerPro® Pneumatic Modular Handpiece (PRO6150)... 4

1.5

PowerPro Pneumatic Oscillator Handpiece (PRO6175)... 4

1.6

PowerPro Pneumatic Reciprocator Handpiece (PRO6185)... 5

INSTALLATION and OPERATION 2.1

Power Source and Regulator Installation and Operation... 6

2.2

Connecting and Removing Attachments... 10

2.3

Handpiece Mode Selection and Operation... 10 2.3.1

PowerPro Pneumatic Modular Handpiece (PRO6150) Operation... 10

2.3.2

PowerPro Pneumatic Oscillator Handpiece (PRO6175) Blade Installation and Operation... 11 2.3.2.1 Blade Installation... 11 2.3.2.2 Handpiece Operation... 12

2.3.3

PowerPro Pneumatic Reciprocator Handpiece (PRO6185) Blade Installation and Operation... 13 2.3.3.1 Blade Installation... 13

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Page

Table of Contents

3.0

MAINTENANCE 3.1

Cleaning and Sterilizing... 15 3.1.1

Cleaning Precautions... 15

3.1.2

Handpiece Cleaning Instructions... 15

3.1.3

Sterilization Information... 16 3.1.3.1 Sterilization Warnings, Precautions and Notes... 16

3.2

4.0

Troubleshooting... 18

TECHNICAL SPECIFICATIONS 4.1

Handpiece Environmental Requirements... 19

4.2

PowerPro Pneumatic Modular Handpiece (PRO6150)... 20

4.3

PowerPro Pneumatic Oscillator Handpiece (PRO6175)... 21

4.4

PowerPro Pneumatic Reciprocator Handpiece (PRO6185)... 21

4.5

Accessories... 22

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1.0 INTRODUCTION

1.2

t is recommended that personnel study this manual before attempting to operate, clean, or sterilize PowerPro® Pneumatic Handpieces (PRO6150, PRO6175, PRO66185). The safe and effective use of this equipment requires the understanding of and compliance with all warnings, cautionary notices, and instructions marked on the product, and included in this manual.

I

1.1

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 warning and cautionary notices and instructions marked on the product and included in this manual.

2.

Handpieces are factory sealed. Do not disassemble or lubricate, as this may void your warranty. There are no user-serviceable parts inside.

3.

Eye protection is recommended when operating equipment.

4.

Use only associated Hall® Surgical and Linvatec accessories (saw blades, bits, etc.).

5.

Handle all equipment carefully. If the handpiece is dropped or damaged in any way, return it immediately for service.

6.

Prior to each use, perform the following:

Intended Use

he PowerPro Pneumatic Modular Handpiece, along with an assortment of modular attachments, is designed to perform bone cutting, reaming, drilling, driving screws, sawing, and pin driving functions common to small and large bone orthopedic surgical procedures. This handpiece uses the same attachments as the PowerPro Electric and Battery Systems handpieces.

T

The PowerPro Pneumatic Oscillator Handpiece is designed for sawing in small, large and transverse or longitudinal bone osteotomies, removal of the femoral head and neck, removal of the greater trochanter, resurfacing the tibial plateau and the distal end of the femur such as required in total knee or total hip arthroplasties. The PowerPro Pneumatic Reciprocator Handpiece is designed for sawing in large bone total joint arthroplasties. The fields of application for these handpieces include: Osteotomy, Trauma, Orthopedic and Total Joint Arthroplasty.

1

General Warnings

•

Inspect all equipment for proper operation.

•

Ensure all attachments, accessories and hoses are correctly and completely attached to the handpiece.

•

Always inspect hoses for signs of wear or damage. Do not use worn or damaged hoses. Replace immediately.

•

Check all equipment for any air or nitrogen leakage. If leakage is noticed, return for service.

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7.

Always inspect for bent, dull or damaged blades or drill bits before each use. Do not attempt to straighten or sharpen. Do not use if damaged. After use, dispose of properly.

8.

Do not attach, insert or remove accessories or attachments while the handpiece is operating. Place the handpiece in the safe position, if applicable, prior to installation or removal of items. Accidental activation of the handpiece could cause injury.

9.

Continually check handpiece and attachments for overheating. If overheating is noticed, discontinue use and return equipment for service.

10. Do not pressurize hoses until all fittings have been connected and checked. 11. Never operate the handpiece above 110 psi (7.7 kg/cm2) dynamic pressure unless an extension hose is added to the standard 10 foot hose. Excessive pressure may cause damage to instrument and exert unusual stress on the hose. 12. Do not bind drill bit or reamer during use. Over exertion may cause patient injury, user injury, and / or damage to the instrument. 13. The nitrogen regulator is for use with pneumatically powered surgical devices only. 14. After each use, thoroughly clean handpiece and attachments (See “3.1 Cleaning and Sterilizing” on page 15).

2

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1.3

Symbol Definitions

F

Attention, consult accompanying documents.

Indicates the “open” or “lock” direction for the PRO6175 Oscillator handpiece blade collet mechanism.

Type B equipment.

Single Use Only.

No user service recommended. Refer servicing to qualified Linvatec service personnel. Indicates handpiece should not be immersed in any fluid. Indicates product should not be oiled or lubricated. Eye Protection Required. Rx ONLY

Caution: Federal Law restricts this device to sale by or on the order of a physician.

R

Indicates the reverse position for the PRO6150 Modular Handpiece or the run position for the PRO6175 Oscillator and PRO6185 Reciprocator Handpieces.

S

Indicates the safe position for all handpieces.

Indicates the forward position for the PRO6150 Modular Handpiece.

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PowerPro Pneumatic Modular

1.4

1.5

Handpiece (PRO6150)

PowerPro Pneumatic Oscillator Handpiece (PRO6175)

❶

❶

❷

❷

❸

❹

❸

❺

❹

❶ Attachment Collet-Lock - Twist to

❻

❶ Blade Locking Collet - Holds and locks

release and remove attachments from the handpiece. It is not necessary to twist for insertion of attachment. Simply insert and push attachment to lock in place.

the blade in place.

❷ Rotating Head - Rotates in 90° intervals for appropriate surgical access. To rotate the head, grasp the rotating head, pull it straight out from the handpiece body, and turn it to the desired position.

❷ Activation Trigger - Used to activate the handpiece. Depress when the safety/direction lever is in the forward or reverse position to operate.

❸ Blade Locking Knob - Rotate to open or lock the blade locking collet to insert and lock the blade securely in place.

❸ Safety/Direction Lever - To operate the

❹ Activation Trigger - Depress when the

handpiece, place in either the forward or reverse position. Place in the safe position prior to connecting or removing any attachment or accessory and during non-use of the handpiece.

safety/direction lever is in the “run” position to operate the handpiece.

❺ Safety/Direction Lever - To operate the handpiece, place in the “run” position. Place in the safe position prior to connecting or removing an accessory and during non-use of the handpiece.

❹ Hose Connector - The pneumatic hose (5052-010) connects here.

❻ Hose Connector - The pneumatic hose (5052-010) connects here. 4

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1.6

❸ Activation Trigger - Used to activate the

PowerPro Pneumatic

handpiece. Depress when the safety/direction lever is in the “run” position to operate the handpiece.

Reciprocator Handpiece (PRO6185)

❹ Safety/Direction Lever - To operate the handpiece, place in the “run” position. Place in the safe position prior to connecting or removing an accessory and during non-use of the handpiece.

❶ ❷ ❸

❺ Hose Connector - The pneumatic hose (5052-010) connects here.

❹

❺

The PowerPro Battery Reciprocator Handpiece is designed to accept Hall 5052-058 through 061, -073, -179, -258 through -261, -273, -276 and -279 series blades. Refer to the Hall Catalog for specific blade information.

❶ Blade Collet - Insert a blade here. Also used to rotate the blade to any of four (4) positions at 90° intervals for appropriate surgical access. Blade positioning must be done prior to locking the blade in the collet. To rotate, grasp the blade at the base of the collet and rotate to the desired position.

❷ Blade Locking Knob - Rotate counterclockwise to open the collet to insert a blade. Rotate clockwise to lock the blade securely in place.

5

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2.0

Nitrogen is readily available from gas supply houses in H cylinders holding slightly more than 300 cubic feet (8.50 cubic meters). Initial set-up costs are relatively inexpensive as compared to compressed air. Nitrogen can be placed in the operating room or in a storage area and piped into the operating room. Manifold systems are available to eliminate frequent tank changes.

INSTALLATION and OPERATION

NOTES: 1.

When not in use and prior to connecting or removing attachments and accessories, always place the handpiece in its safe position.

2.

The connected attachment (drill or reaming) determines the speed and torque.

2.1

Power Source and Regulator Installation and Operation

CAUTION: Do not exceed 110 psi (7.7 kg/cm2) operating pressure unless a hose longer than the standard 10 ft. Universal Hose (5052-010) or extension hose is used. Add an additional 1 psi for every extra foot of hose. The PowerPro Pneumatic handpiece should be operated at 110 psi (7.7 kg/cm2) for maximum operating efficiency, and should be monitored by the operating pressure gauge of the regulator. Lower pressure setting can be set for lower speed and torque requirements. Pressure must be set with the instrument running to ensure proper operating pressure.

WARNING: Not for inhalation. Does not support life. For use with powered surgical devices only. Research and experience have shown that waterpumped dry nitrogen is the ideal source for pneumatically-powered surgical instruments. Water-pumped dry nitrogen is 99.97% pure, and will not support combustion or corrosion. Compressed dry nitrogen is recommended as the pneumatic power source. It is available in standard cylinders.

Never start a procedure if the operating pressure gauge indicates less than 500 psi (35.1 kg/cm2) in the tank. Never run the tank pressure below 200 psi (14.0 kg/cm2). The tank should be thoroughly wiped off with disinfectant and draped prior to placement in the operating room. Always have the tank securely fastened to a stable object.

Compressed dry nitrogen must meet the following specifications to ensure optimum safety for both patient and instrument. Nitrogen Content: 99.97% pure, dry nitrogen. Quality Assurance: To obtain the quality of gas needed, “water-pumped dry nitrogen, or liquid nitrogen, pumped dry” should be specified.

6

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1.

Prior to set-up in the operating room, open the tank valve (counterclockwise) slowly and allow enough gas to escape to blow out any debris that may have accumulated in the valve. Stay clear of the opening and the back of the tank during this procedure. Return the valve to the closed position.

3.

Once the regulator is securely installed, ensure the regulator knob is in the full off position by turning the regulator control knob counterclockwise. SUDDEN PRESSURE EXERTED TO THE REGULATOR MAY CAUSE INTERNAL DAMAGE.

2.

Install the regulator with a 1 1/8 inch wrench.

4.

Slowly turn the tank valve fully open (counterclockwise). This will allow nitrogen to pressurize the regulator.

NOTE: The threaded adaptor of the nitrogen regulator is designed to fit nitrogen fittings only. Incompatibility of the regulator and tank indicates a gas source other than nitrogen or an improper regulator for use with a nitrogen tank.

7

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5.

Insert the male Schrader end of the hose into the female Schrader on the regulator with an upward thrust.

7.

To connect the hose to the handpiece. (a) Place the handpiece in the safe position. (b) Insert the coupling end of the hose into the fitting on the bottom of the handpiece.

6.

Operating pressure is established by gradually turning the regulator control knob clockwise. ALWAYS establish the designated pressure on the operating pressure gauge with the instrument running.

(c) Twist the hose coupling to the right (clockwise) and slightly pull on the hose so the internal pins securely engage in the indentations. (d) Attached to the Universal Hose (5052010) is the Hall Hose Handler. This clip allows fixation of the hose to the surgical drape, reducing the problem of the hose slipping off the patient.

(e) The Velcro® strap allows the hose to be coiled, thus reducing excess hose length. In addition, the VELCRO strap may be used with any additional hose and/or cable. 8

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8.

9.

Before removing the instrument from the regulator:

If the Hall Pneumatic Connector* is being used: (a) Locate the button marked “PRESS”.

(a) Close the tank valve by turning it clockwise.

(b) Depress and hold the button until the audible release of residual gas is completed.

(b) Activate the instrument to bleed off line pressure. (c) Turn the pressure regulator knob counterclockwise until it stops. (d) Turn the female Schrader to the right to disengage the male Schrader fitting. (e) The hose can then be removed from the connector. Hold the end of the hose securely when disengaging the male Schrader fitting to prevent possible damage to the diffuser.

(c) Release the button and remove the hose. (d) If the hose cannot be easily removed, depress the “PRESS” button again, release it and remove the hose.

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2.2

Connecting and Removing Attachments

All attachments for the PowerPro Pneumatic Modular Handpiece connect/disconnect in the same manner. For more information, refer to the PowerPro Attachment Instruction Manual or the Information Insert supplied with each attachment. 1.

2.3

Handpiece Mode Selection and Operation

2.3.1

PowerPro Pneumatic Modular Handpiece (PRO6150) Operation

The PowerPro Pneumatic Modular handpiece, in conjunction with numerous attachments, is used for drilling, and wire and pin driving. It has a variable speed of 0-1250 rpm and a minimum torque of 20 in. lbs. with all drilling, and wire and pin driving attachments. A variable speed of 0-250 rpm and torque of 100 in. lbs. with the 5:1 ratio reaming attachment (identified with a bluecolored ring).

To connect an attachment: (a) Place the safety/directional lever in the safe position. (b) Orient the attachment shaft to the handpiece opening. Insert the shaft and press them until they snap together.

1.

To operate the handpiece, place the handpiece safety/direction lever in either the forward or reverse position and depress the trigger. (a) With the safety/direction lever in the forward position, depressing the trigger operates the handpiece in the clockwise direction as viewed from the rear of the handpiece.The speed is variably controlled by the trigger.

2.

(b) With the safety/direction lever in the reverse position, depressing the trigger operates the handpiece in the counterclockwise direction as viewed from the rear of the handpiece. The speed is variably controlled by the trigger.

To disconnect an attachment, twist the attachment collet-locking ring in a clockwise direction and remove the attachment.

10

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2.3.2

(d) Blades can be positioned 45° off the center line in either direction.

PowerPro Pneumatic Oscillator Handpiece (PRO6175) Blade Installation and Operation

2.3.2.1 Blade Installation 1.

To attach a blade: (a) Place the safety/direction lever in the safe position. (b) Rotate the blade locking knob in the direction of the arrow to the open position. The blade locking collet will disengage.

(e) Rotate the blade locking knob in the opposite direction of the arrow to lock the blade into place. WARNING: The blade locking knob must be completely closed to hold the blade firmly in place.

(c) Align the blade shank to the desired angle with the blade locking collet. Insert the blade. 2.

To remove the blade: (a) Ensure the safety/direction lever is in the safe position. (b) Rotate the blade locking knob to the open position. The blade locking collet will disengage. (c) Remove the blade.

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2.

Move the safety/direction lever to the “run” position.

3.

To activate the handpiece, depress the trigger.

2.3.2.2 Handpiece Operation 1.

Position the rotating head to the desired position. The rotating head may be set in any of 4 positions at 90° intervals for the appropriate surgical access. (a) Ensure the safety/direction lever is in the safe position. (b) Pull the rotating head out and away from the handpiece body.

CAUTION: When operating the PowerPro Oscillator Handpiece, let the saw blade do the cutting. Too much force will bind the blade which can damage the handpiece.

(c) Twist the rotating head to the desired position and release the rotating head. Ensure it is locked into place and does not rotate.

12

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(c) Completely insert the blade shank. 2.3.3

PowerPro Pneumatic Reciprocator Handpiece (PRO6185) Blade Installation and Operation

2.3.3.1 Blade Installation 1.

To attach a blade: (a) Place the safety/direction lever in the safe position. (b) Rotate the blade locking knob counterclockwise to open the blade collet.

(d) The rotating head may be set in any of 4 positions at 90° intervals for the appropriate surgical access. Position the blade to the desired position by grasping the blade at the base of the collet and rotating it to the desired position.

(e) Rotate the blade locking knob clockwise to lock the blade into place. WARNING: The blade locking knob must be completely closed to hold the blade firmly in place.

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2.

3.0

To operate the handpiece, move the safety/ direction lever to the “run” position and depress the trigger.

Regular and proper maintenance of your PowerPro Handpieces are the best ways to protect your investment. It is essential that you have your powered surgical instruments serviced as scheduled in order to retain their optimum performance and reliability, which will reward you with safer, less problematic product performance over time. The recommended maintenance interval for service of your PowerPro Handpieces is every 12 months.

CAUTION: Do not operate the Reciprocator Handpiece with the collet in the open position or without a blade locked in the collet. Damage will occur. 3.

MAINTENANCE

To remove the blade: (a) Ensure the safety/direction lever is in the safe position. (b) Rotate the blade locking knob counterclockwise. The blade locking collet will disengage. Remove the blade.

Recommended care and handling of the instruments include proper day-to-day operation, cleaning, and sterilization which are extremely important to ensure safe and efficient operation. Your authorized Hall Surgical service department is the most knowledgeable about the PowerPro instruments and will provide competent and efficient service. Service at Linvatec/ Hall Surgical at the recommended service interval is mandatory to keep your product warranties in effect. Any services and/or repairs done by any unauthorized repair facility may result in reduced performance of the instruments or instrument failure. WARNING: Failure to follow the maintenance schedule above 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 to overheat. Refer to “4.0 TECHNICAL SPECIFICATIONS” on page 19 for the associated handpiece duty cycle. Overheating can lead to possible burn injury to the patient or medical personnel. Rotation of handpiece usage per day will assist with proper performance.

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3.1

Cleaning and Sterilizing

3.1.2

Handpiece Cleaning Instructions

Clean handpieces and attachments as soon as possible after use. 3.1.1

Cleaning Precautions

1.

Follow universal precautions for protective apparel when handling and cleaning contaminated instruments.

2.

Do not lubricate any handpieces.

3.

Never immerse handpieces or attachments.

4.

Never clean equipment in an automatic washer/sanitizer.

5.

Never clean handpieces with bleach, chlorine-based detergents, liquid or chemical disinfectants, or any products containing sodium hydroxide (such as, INSTRUKLENZ or Buell Cleaner). They will degrade the anodized aluminum coating.

6.

Never clean equipment in an ultrasonic cleaner.

7.

Saw blades and bits are single-use only. Do not resterilize. Dispose of properly after use.

1.

Remove all attachments (chucks, saws) and accessories (saw blades, bits) from the handpiece prior to cleaning. Keep the handpiece hose attached.

2.

Thoroughly scrub the handpiece, handpiece hose, and attachments with a clean, soft brush dampened with a mild, pH-balanced detergent. Ensure the blade locking collet on the oscillator handpiece is in the open position and all debris is removed from this area. Remove all traces of blood, debris and stains. Do Not immerse equipment in soap solution or rinse water.

3.

To clean the cannulated section of the handpiece and attachment: (a) Feed the wire end of a cleaning brush through the cannulation of the handpiece or attachment. (b) Pull the brush completely through and repeat until all debris is removed.

15

4.

Manipulate all moving parts of the handpiece and attachments to ensure all debris is removed. If not, clean again until all debris is removed.

5.

Keeping the nose of the handpiece pointed downward, rinse under running water to remove all traces of soap. Rinse all attachments likewise.

6.

Flush all surfaces free of tap water with distilled water to prevent metal discoloration.

7.

Gently shake the equipment free of water and wipe the surfaces with a clean, lint-free towel.

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NOTES: 3.1.3

Sterilization Information 1.

The following guidelines do not guarantee that the device is sterile after the procedure. Your institution is still responsible for the normal sterility assurance validation.

2.

Additional drying time may be required for complete heat and moisture dissipation. Operation of a handpiece that is not completely cool and dry may decrease performance and/or reliability.

WARNING: Use of disinfecting solutions for an exterior instrument wipe will not sterilize equipment and is not recommended.

3.

Sterilization validation is based on AAMI guidelines (Association for the Advancement of Medical Instrumentation).

1.

Do not sterilize handpieces with Ethylene Oxide (EtO).

4.

2.

Never sterilize any handpiece in a STERIS System, STERRAD System, Abtox Plazlyte™ or comparable sterilization methods.

PowerPro handpieces have been validated to be completely sterile using “flash” sterilization techniques.

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

S

3.1.3.1

Sterilization Warnings, Precautions and Notes

3.

Do not sterilize handpieces in cold sterilants like CIDEX.

4.

Do not “Peel Pack” handpieces or attachments for sterilization. Sterilization in a sealed pouch traps moisture which can cause damage.

5.

Attachments with collet mechanisms must be sterilized with the collet fully open.

6.

Remove the hose from the Handpiece prior to sterilization.

7.

Do not use handpieces while warm. Allow adequate time for cooling prior to use. Do not immerse in liquid or cover with a damp cloth to cool. Cool by exposure to room temperature.

Handpieces, attachments, and the hose may be processed in a pre-vacuum steam sterilizer (Steam Pre-vacuum) or in a gravity (downward) displacement sterilizer (Steam Gravity). Place handpiece(s), hose, and/or attachments in a PowerPro Sterilization Case (PRO5090) and follow the recommended minimum sterilization exposure times listed on the following page.

16