The Hall Sternum Saw Instruction Manual

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 Corporation 2021. All Rights Reserved.

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

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Handpiece Model No.

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Handpiece Model No.

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Handpiece Model No.

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Table of Contents

1.0

2.0

3.0

Page

INTRODUCTION 1.1

Intended Use... 1

1.2

Warnings and Cautions... 1 1.2.1

Warnings... 2

1.2.2

Cautions... 3

INSTALLATION and OPERATION 2.1

Power Source and Regulator Installation and Operation... 4

2.2

Sternum Saw... 8

2.3

Equipment Installationand Operation... 9 2.3.1

Hose Installation... 9

2.3.2

Attaching a Blade and Guard... 11

MAINTENANCE 3.1

Cleaning and Sterilizing... 16 3.1.1

Care and Cleaning Precautions... 16

3.1.2

Cleaning Instructions... 17

3.1.3

Sterilization... 21

3.2

Troubleshooting... 23

3.3

Specifications... 25

3.4

Attachments and Accessories... 26

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1.0 INTRODUCTION It is recommended that personnel study this manual before attempting to operate, clean or sterilize the Hall® Sternum Saw. 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.

1.1

Intended Use

The Hall Sternum Saw is designed for use in thoracic surgical procedures. The Hall Sternum Saw is not intended for use in repeat sternotomy applications.

1.2

Warnings and Cautions

This equipment is designed for use only by medical professionals who are completely familiar with the required techniques and instructions for use of the equipment. Read and follow all warnings and caution notices and instructions marked on the product and included in this manual. Regular service is required to keep the Sternum Saw at its optimum operating performance. Refer to page 15 for details on service intervals.

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1.2.1

Warnings

1.

Eye protection is recommended when operating equipment. Eye injury may result.

2.

Prior to each use, perform the following: •

Inspect all equipment for proper operation.

•

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

•

Inspect pneumatic hoses for signs of wear or damage prior to use. Discontinue use and replace immediately if any signs of wear or damage are detected.

•

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

3.

Put the instrument in the “SAFE” position before changing blades, accessories or hoses, and when the instrument is not in use. Accidental activation of the instrument could cause injury.

4.

Dull blades may cause heat build-up in the handpiece and the bone. It is recommended that single-use blades be used. If reusable blades are used, inspection with a magnifying glass should be performed to check for dulled and chipped cutting surfaces.

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1.2.2

Cautions

1.

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

2.

Use only ConMed Linvatec and Hall accessories and attachments.

3.

Handle all equipment carefully. Should a handpiece or attachment be dropped or damaged in any way, return it immediately for service.

4. Always use the proper blade guard and the correct blade for the surgical procedure being performed. 5.

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

6.

Continually check all parts of the instrument or its attachments for overheating. If overheating is noticed, discontinue use and return the equipment for service.

7.

Before activating pressure to the hose, connect and check all hose fittings.

8.

Do not move the foot control using the hoses. Such action may cause damage to the fittings and/ or hoses.

9.

The nitrogen regulator is only for use with pneumatically powered surgical devices.

10. Never operate the instrument above 100 psi (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. 11. After each use, thoroughly clean and sterilize the handpiece and accessories (See 3.1 “Cleaning and Sterilizing” on page 16).

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2.0 INSTALLATION and OPERATION 2.1

Power Source and Regulator Installation and Operation

WARNING: Not for inhalation. Does not support life. For use with powered surgical devices only. Research and experience have shown that water-pumped dry nitrogen is the ideal power 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. 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. 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. CAUTION: Do not exceed 100 psi (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 Sternum Saw should be operated at 100 psi (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. 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.

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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.

2.

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

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. 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.

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4.

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

5.

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

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.

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7.

Before removing the instrument from the regulator: (a) Close the tank valve by turning it clockwise. (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.

  

 

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

2.2

Sternum Saw

The Hall Sternum Saw is used for primary sternotomies and provides smooth, reliable power with variable speed from 0 to 16,000 cpm.

 Sternum Guard - Used to support and guide the cutting blade.  Collet Nut* - Accepts and locks a blade into the handpiece.  Guard Locking Sleeve - Used to lock the sternum guard to the handpiece.  Trigger - Depress to activate the handpiece when the activation lever is in the “ON” position.  Activation Lever - Used to place the handpiece in the operating or safe mode. Slide the activation lever to the “SAFE” position when changing attachments or accessories. To activate the handpiece, place the activation lever to the “ON” position.

 Quick Disconnect Coupling - Used to quickly attach/detach the air hose to the handpiece. * NOTE: Use only the new 5059-09 collet nut. This catalog number, along with the ConMed logo, should appear on the collet nut.

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2.3

Equipment Installationand Operation

2.3.1

Hose Installation

1.

Put the handpiece in the safe mode by moving the activation lever to the “SAFE” position.

2.

To connect the handpiece to the hose: (a) Insert the coupling end of the hose into the quick disconnect coupling on the handpiece.

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(b) Push together and twist the hose coupling clockwise so the internal pins of the handpiece are secured in the indentations of the hose coupling.

(c) Pull gently on the hose to ensure it is securely fastened to the handpiece. 3.

The automatic check valve in the end of the hose permits removal of the hose under pressure. After use, the hose should be removed from the regulator. Use care to prevent dirt or debris from entering the end of the handpiece when the handpiece and hose are separated.

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2.3.2

Attaching a Blade and Guard

WARNINGS: 1.

Never operate the Sternum Saw without the collet nut locked securely in place.

2.

Never operate the Sternum Saw without the Sternum Guard in place.

1.

Place the handpiece in the “SAFE” position.

2.

To install a blade: (a) Using the Locking Wrench (5059-007), loosen the collet nut by placing the locking wrench over the flats of the collet and turning counterclockwise one or two revolutions. (b) Completely insert the flat blade shank into the collet.

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(c) The blade may be inserted in either of two positions to allow cutting in a push (blade teeth pointing downward - bottom left photo) or pull direction (blade teeth pointing upward - photo below).

3.

Place the opening of the locking wrench over the flats on the collet nut. Turn in a clockwise direction and tighten the collet nut securely.

4. After the blade has been completely seated and locked, move the activation lever to the “ON” position. 5.

Briefly activate the handpiece by depressing the trigger. Return the activation lever to the “SAFE” position.

6.

Using the locking wrench, retighten the collet nut. Pull on the blade to ensure there is no movement in the blade. If there is movement, tighten the collet nut more securely.

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7.

To attach the Sternum Guard: (a) Slide the locking sleeve towards the back of the handpiece.

(b) Slide the Sternum Guard over the blade. Always align the support strut on the guard with the non-cutting side of the blade. (c) Align the slots on the connecting portion of the guard with the pins inside the guard locking sleeve. Insert the guard completely into the guard locking sleeve. (d) With the guard in the proper position, release the locking sleeve. It will snap into place, locking the guard to the handpiece.

(e) If operating the handpiece with the blade in the pull direction, attach the guard with the support strut positioned downward, along the non-cutting side of the blade.

8.

To activate the handpiece, slide the activation lever to the “ON” position and depress the trigger.

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9.

To remove the Sternum Guard and blade: (a) Ensure the handpiece is in the “SAFE” position. (b) Slide the locking sleeve towards the back of the handpiece.

(c) Pull the Sternum Guard out and away from the handpiece. Release the locking sleeve. (d) Place the opening of the locking wrench over the flats on the collet nut. Turn the wrench in a counterclockwise direction and loosen the collet nut. Do not turn the collet nut more than two or three revolutions. (e) Remove the blade.

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3.0 MAINTENANCE This section explains the importance of keeping your Hall Sternum Saw well maintained. Regular and proper maintenance of your Hall Sternum Saw are the best ways to protect your investment. It is essential that you have your Hall Sternum Saw serviced every twelve (12) months so as to retain its optimum performance and reliability, which will reward you with safer, less problematic product performance over time. This recommended service and time interval assumes you will use your Hall Sternum Saw as indicated in this manual, including proper day-to-day operation, cleaning, and sterilization. Proper care and handling of your sternum saw on a day-to-day basis are extremely important to ensure safe and efficient operation. Your authorized ConMed Linvatec service department is the most knowledgeable about your Hall Sternum Saw and will provide competent and efficient service. Service at ConMed Linvatec at the indicated 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.

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3.1

Cleaning and Sterilizing

3.1.1

Care and Cleaning Precautions

1.

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

2.

Saw blades are single-use only. Do not resterilize. Dispose of properly after use in the sharps container. The ability to effectively clean and re-sterilize these singleuse devices has not been established and subsequent re-use may adversely affect the performance, safety and/or sterility of the device.

2

STERILIZE

3.

ConMed Linvatec does not recommend immersing the sternum saw or attachments, as this may affect long-term reliability.

4.

The use of bleach, chlorine-based, or sodium hydroxide based liquid or chemical disinfectants, detergents, enzymatic cleaners, or soaps may cause degradation of the aluminum coating on the outside of your sternum saw.

5.

Never clean sternum saw in an ultrasonic cleaner or combination washer/sterilizer.

6.

Never sterilize or immerse the regulator in any solution.

7.

Steam sterilize only (except regulator). Follow instructions starting on page 21.

8.

Do not lubricate the sternum saw or attachments.

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3.1.2

Cleaning Instructions

Clean handpieces and attachments as soon as possible after use. NOTE: Care should be taken to keep the nose of the handpieces pointed down while cleaning and rinsing. 1.

Remove attachments and accessories from the handpiece prior to cleaning.

2.

With the hose attached, thoroughly scrub the handpiece and attachments with a clean, soft brush and mild, pH-balanced detergent. Remove all traces of blood, coagulated material, stains, etc.

3.

Remove the collet nut from the handpiece using the locking wrench and rotating counterclockwise.

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