Hall Repeat Sternotomy 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.

Ó 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

Page

INTRODUCTION 1.1

Intended Use... 1

1.2

Warnings and Cautions... 1 1.2.1 Warnings... 1 1.2.2 Cautions... 2

1.3. Symbol Definitions... 3 1.4. System Indicators... 4

2.0

INSTALLATION and OPERATION 2.1

Power Source and Regulator Installation and Operation... 5

2.2

Equipment Installation and Operation... 8 2.2.1 Hose Installation... 8 2.2.2 Foot Control Installation and Operation... 9 2.2.3 Saw Blade Installation... 10

3.0

MAINTENANCE 3.1

Cleaning and Sterilizing... 13 3.1.1 Care and Cleaning Precautions... 13 3.1.2 Cleaning Instructions... 13 3.1.3 Sterilization... 15

3.2

Troubleshooting... 17

3.3

Specifications... 18

3.4

Accessories... 19

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Table of Contents

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1.0 INTRODUCTION It is recommended that personnel study this manual before attempting to operate, clean or sterilize the Hall® Repeat Sternotomy Saw System. The safe and effective use of this equipment requires the understanding of and compliance with all warnings, caution notices and instructions marked on the product and included in this manual.

1.1

Intended Use

The intended use of the Hall Repeat Sternotomy Saw System is for thoracic surgery.

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 Repeat Sternotomy Saw at its optimum operating performance. Refer to 12 for details on service intervals. 1.2.1 Warnings 1. Eye protection is always necessary when operating equipment. Eye injury may result without protection. 2. Prior to each use, perform the following: • Inspect all equipment for proper operation. • Ensure all attachments, accessories and hoses are able to be 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 bone. It is recommended that single-use blades are used.

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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 be dropped or damaged in any way, return it immediately for service. 4. Always inspect for bent, dull or damaged blades before each use. Gradually accelerate the saw with the blade in place and visually observe if the blade does not appear straight or if it tends to vibrate. Do not use excessive force on any blade. Do not attempt to straighten or sharpen. Do not use if damaged. After use, dispose of properly. 5. Continually check all parts of the instrument for overheating. If overheating is noticed, discontinue use and return the equipment for service. 6. Do not pressurize hoses until all fittings have been connected and checked. 7. Do not move the foot control using the hose. Such action may cause damage to the fittings and/or hose. 8. Do not restrict exhaust vents on hose, or severely bend or kink hose, or roll equipment over hose. Damage will occur. 9. 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. 10. The nitrogen regulator is only for use with pneumatically powered surgical devices. 11. After each use, thoroughly clean and sterilize the handpiece (See “3.1 Cleaning and Sterilizing” on page 13).

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1.3. Symbol Definitions

!

Attention, consult accompanying documents. Single Use Only. Eye Protection Required.

No user service recommended. Refer servicing to qualified CONMED Linvatec service personnel.

2

STERILIZE

Indicates product component should not be sterilized.

Indicates product component should not be immersed in any type of fluid.

Indicates handpiece should not be immersed in any fluid. Indicates product should not be oiled or lubricated. Caution: Federal Law restricts this device to sale by or on the order of a physician

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1.4. System Indicators

Í

Ì

Ë

Î

Ï

Ê

Ê Blade Collet - Insert the blade between the washers within the collet. Ë Collet Lock Screw - Tighten to lock a blade in place. Ì Throttle Lever - Depress to activate the handpiece when the safety lock is in the “ON” position.

Í Safety Lock - Used to place the handpiece in the operating mode or to place it in the safe mode.

Slide the safety lock to the “SAFE” position when changing accessories. To activate the handpiece, place the safety lock in the “ON” position.

Î Quick Disconnect Coupling - Used to quickly attach/detach the air hose to the handpiece. Ï 360° Swivel - Allows the handpiece to swivel independently for easy positioning of the handpiece in the surgical site.

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2.0 INSTALLATION and OPERATION 2.1

Power Source and Regulator Installation and Operation

WARNING: Nitrogen is 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 Repeat Sternotomy 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. 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.

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2. Install the regulator with a 1 1/8 inch wrench, or adjustable wrench.

NOTE: The threaded adapter 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 while the instrument is 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 Schrader fitting to prevent possible damage to the diffuser.

2.2

Equipment Installation and Operation

2.2.1 Hose Installation 1. Place the handpiece in the “SAFE” position. (a) Slide the safety lock on the throttle lever toward the tip of the instrument. The word “SAFE” should be visible on the throttle lever.

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2. To connect the handpiece to the hose. (a) Place the coupling end of the hose over the swivel fitting on the handpiece.

(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.

3. The quick-disconnect coupling allows the handpiece to be removed from the hose for easy cleaning and/or packaging for sterilization and service. 4. 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.

5. To activate the handpiece: (a) Lift the throttle lever and slide the safety lock to the “ON” position.

(b) Depress the throttle lever to activate the handpiece. 9

2.2.2 Foot Control Installation and Operation 1. To use the optional Foot Control (1375-028) attach accordingly: (a) Attach the Foot Control hose to the nitrogen regulator. (b) Insert the male end of the Universal Hose (5052-010) into the Foot Control.

2. Attach the hose to the handpiece (See “2.2.1 Hose Installation” on page 8). 3. After the hose is connected, lift the throttle lever and slide the safety lock to the “ON” position. (c) Place the Throttle Clip (5053-074) over the handpiece throttle lever.

4. Depress the Foot Control pedal to activate the handpiece.

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2.2.3 Saw Blade Installation 1. To attach a saw blade: (a) Place the blade in the center slot at the end of the handpiece.

NOTE: Ensure the blade is inserted between the washers. (b) Securely tighten the lock screw with the hex wrench (1365-005).

2. Briefly activate the handpiece: (a) Slide the handpiece safety lock to the “ON” position. (b) Depress the throttle lever or Foot Control pedal. 3. Retighten the lock screw to ensure the blade is securely attached. NOTE: The blade may be positioned anywhere within a 180° arc.

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3.0 MAINTENANCE Regular and proper maintenance of your Repeat Sternotomy Saw and related equipment 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 is listed in the table below. 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 Repeat Sternotomy Saw and related equipment and will provide competent and efficient service. Service at CONMED Linvatec 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.

Table 1: Maintenance Schedule (Months) Catalog Number

Product Description

6

12

5057-040

Repeat Sternotomy Saw

•

1375-028

Foot Control

•

Hoses * (See page 19 for associated hose catalog numbers)

•

24

* To ensure proper functioning and reduce the risk of a burst hose, it is recommended that hoses be replaced after four years. The date of manufacture for each hose is imprinted on the metal sealing ring located below the hose handpiece connector. Please contact CONMED Linvatec customer service or your local sales representative. WARNING: Failure to follow the maintenance schedule above could result in reduced instrument performance or overheating of the handpiece or attachment. 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

3.1.1 Care and Cleaning Precautions 1. Follow universal precautions for protective apparel when handling and cleaning contaminated instruments. 2. Dispose of all burs labeled as “single use only” after use. 3. The ability to clean and resterilize single use devices has not been established and subsequent reuse may adversely affect the performance, safety, and/or sterility of the device. 4. CONMED Linvatec does not recommend immersing handpieces, as this may affect long-term reliability. 5. 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 Repeat Sternotomy Saw. 6. Never clean the handpiece with liquid or chemical disinfectants. 7. Never clean equipment in an ultrasonic cleaner or combination washer/sterilizer. 8. Never sterilize or immerse the regulator in any solution.

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STERILIZE

9. Steam sterilize only (except regulator). Follow instructions starting on page 15. 10. Do not lubricate the Repeat Sternotomy Saw. Damage will result. 3.1.2 Cleaning Instructions Clean handpieces and hoses as soon as possible after use. NOTE: Care should be taken to keep the nose of the handpiece pointed down while cleaning and rinsing. 1. Remove blades from the handpiece. 2. With the hose attached, thoroughly scrub the handpiece and hose with a soft, clean brush and mild, pH-balanced detergent. Remove all traces of blood, coagulated material, stains, etc. DO NOT IMMERSE handpiece in soap solution or rinse water.

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3. Manipulate all moving parts of the handpiece to ensure all debris is removed. If debris is detected, continue cleaning until it is removed. 4. Keeping the nose of the handpiece pointed downward, and with the hose still attached, rinse under running water to remove all traces of soap from the equipment. Flush the surfaces free of tap water with distilled water to prevent metal discoloration. Do Not immerse handpiece.

5. Shake the handpiece free of water and wipe the surfaces with a clean, lint-free towel.

6. Detach the hose prior to sterilization.

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3.1.2.1

Foot Control Cleaning Instructions

1. Disconnect all hoses from the foot control. 2. Wipe the foot control with a clean, soft cloth dampened with a mild, pH-balanced detergent. Be sure to thoroughly wipe the underside of the foot control to ensure no metal objects have attached themselves. 3. Wipe foot control again with distilled or sterilized water to prevent metal discoloration. 3.1.3 Sterilization Steam sterilization is safe and effective, and there are no contraindications for sterilizing Hall instruments, attachments and accessories.

3.1.3.1

Sterilization Warnings, Precautions and Notes

WARNING: Use of disinfecting solutions for an exterior instrument wipe will not sterilize the instrument, and cannot be recommended. 1. Ethylene Oxide Gas sterilization is not recommended for powered surgical instruments, as gas is used primarily for heat sensitive products. 2. Do not sterilize handpieces in cold sterilants like CIDEX. 3. Remove the hose from the handpiece. Do not crimp the hose when closing the lid of the sterilization container. 4. Do not run handpieces 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. 5. Place the cleaned instruments in an instrument tray. The 5052-12 Sterilization Container is recommended. If the sterilization container is used, add an additional 5 minutes to the dry time. 6. If instruments are to be wrapped, two double thicknesses of #140 thread count wrappers should be utilized. Do not use Tyvek bags, as they retain moisture and may damage the handpiece. Exposure times are the same for wrapped or unwrapped instruments. NOTES: 1. Sterilization validation has been conducted in accordance with the requirements of AAMI TIR12. 2. Flash sterilization is a process of sterilizing the product unwrapped and without a dry cycle. The Repeat Sternotomy Saw can be “flash” sterilized using the sterilization parameters listed below, and eliminating the recommended dry time. 15

Table 2: Sterilization Parameters Sterilization parameters for Repeat Sternotomy Saw Method

Cycle

Recommended Temperature

Minimum Exposure

Minimum Dry Time

Steam

Pre-vacuum

270°-272°F (132°-133°C)

4 minutes

8 minutes

Steam

Gravity

270°-272°F (132°-133°C)

35 minutes

8 minutes

Steam

Gravity

250°-254°F (121°-123°C)

80 minutes

8 minutes

NOTES: 1. For Sterilization Containers with filters, add FIVE (5) minutes to the Gravity cycle. 2. Dry times are extremely important for reliability and durability of handpieces and attachments. If eight minutes in your autoclave does not completely dry the handpiece and attachment, additional dry time is recommended.

Sterilization parameters for hoses Method

Cycle

Recommended Temperature

Minimum Exposure

Minimum Dry Time

Steam

Pre-vacuum

270°-272°F (132°-133°C)

4 minutes

8 minutes

Steam

Gravity

270°-272°F (132°-133°C)

20 minutes

8 minutes

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