Hall Titan Battery Handpieces Instruction Manual

Proprietary Information This manual contains information deemed proprietary to CONMED Corporation. The information contained herein, including all of the designs and related materials, is the sole property of CONMED and/or its licensors. CONMED 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. CONMED 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. HALL, Titan, M-Class, Intrex, SureCharge, Primecut, Primecut+, PowerPro and PowerPro MAX are trademarks or registered trademarks of CONMED Corporation. © CONMED Corporation 2022. All Rights Reserved.

Record the Model and Serial Numbers of all handpieces and date received. Retain for future reference.

Handpiece Model No. 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. Serial No.

Date Date Date Date Date Date

Contents 1.0

2.0

INTRODUCTION  1.1 Operating Principle  1.2 Indications for Use  1.3 Intended Use  1.4 Contraindications  1.5 Warnings and Precautions 

1 1 1 1 1 2

1.6 1.7 1.8

4 4 4

1.5.1 1.5.2

Warnings  Precautions 

1.8.1 1.8.2

Product Symbols  Warnings and Information Symbols 

Environmental Directives  Product Photographs and Drawings  Symbol Definitions 

4 5

SYSTEM INSTALLATION AND OPERATION  2.1 Single and Double Trigger Battery Handpiece Installation and Operation 

7 7

2.2

10

2.1.1 2.1.2 2.1.3 2.1.4 2.1.5

PRO9100B HALL® Titan™ Single Trigger Battery Handpiece  Connecting and Removing Attachments to the Handpiece (PRO9100B/PRO9200B)  PRO9100B HALL® Titan™ Single Trigger Battery Handpiece Operation  PRO9200B HALL® Titan™ Dual Trigger Battery Handpiece  PRO9200B HALL® Titan™ Dual Trigger Battery Handpiece Operation 

2.2.1

PRO9300B and PRO9350B HALL® Titan™ Oscillating and Primecut+™ Oscillating Saw Battery Handpiece  Connecting and Removing Blades to the Oscillating and Primecut+ Oscillating Handpieces (PRO9300B and PRO9350B)  PRO9300B and PRO9350B HALL® Titan™ Oscillating and Primecut+™ Oscillating Saw Battery Handpiece Operation 

Oscillating Saw Battery Handpiece Installation and Operation 

2.2.2 2.2.3

2.3

2.4

2.5 2.6 3.0

2 3

7 7 8 8 9

10 10 11

Reciprocating Saw Battery Handpiece Installation and Operation 

12

Sternum Saw Battery Handpiece Installation and Operation 

14

Battery Installation  Preoperative Functional Test 

16 16

2.3.1 2.3.2 2.3.3

PRO9400B HALL® Titan™ Reciprocating Saw Battery Handpiece  Connecting and Removing Blades to the Reciprocator Handpiece (PRO9400B)  PRO9400B HALL® Titan™ Reciprocating Saw Battery Handpiece Operation 

2.4.1 2.4.2 2.4.3

PRO9450B HALL® Titan™ Sternum Saw Battery Handpiece  Connecting and Removing Blade and Blade Guard to the Sternum Saw (PRO9450B)  PRO9450B HALL® Titan™ Sternum Saw Battery Handpiece Operation 

12 13 14

14 14 16

MAINTENANCE  3.1 Cleaning Information 

17 17

3.2

Disinfection Information 

19

Sterilization Information 

19

Troubleshooting  Maintenance Schedule 

21 21

3.3

3.4 3.5

3.1.1 3.1.2 3.1.3 3.1.4

Warnings, Precautions and Notes  Manual Cleaning Instructions (PRO9100B, PRO9200B, PRO9300B, PRO9350, and PRO9400B) Manual Cleaning Instructions (PRO9450B)  Automated Cleaning Instructions 

3.2.1 3.2.2

Manual Disinfection Instructions  Automated Disinfection Instructions 

3.3.1 3.3.2 3.3.3

Warnings, Precautions and Notes  Inspection Recommendations  Sterilization Instructions 

I

17 17 18 18

19 19

19 19 19

4.0

TECHNICAL SPECIFICATIONS  4.1 Product Technical Specifications 

22 22

4.2

Product Environmental Requirements 

23

Accessories 

26

CUSTOMER SERVICE  5.1 Assistance and Repair 

28 28

4.3 5.0

4.1.1 4.1.2 4.1.3 4.1.4 4.1.5 4.1.6

PRO9100B HALL® Titan™ Single Trigger Battery Handpiece  PRO9200B HALL® Titan™ Dual Trigger Battery Handpiece  PRO9300B HALL® Titan™ Oscillating Saw Battery Handpiece  PRO9350B HALL® Titan™ Primecut+™ Oscillating Saw Battery Handpiece  PRO9400B HALL® Titan™ Reciprocating Saw Battery Handpiece  PRO9450B HALL® Titan™ Sternum Saw Battery Handpiece 

4.2.1 4.2.2

Environmental Technical Specifications  Electromagnetic Requirements 

II

22 22 22 22 23 23

23 24

1.0

INTRODUCTION

It is recommended that personnel study this manual before attempting to operate, clean, or sterilize this or associated equipment. The safe and effective use of this equipment requires the understanding of and compliance with all warnings, precautionary notices, and instructions marked on the product, and included in this manual. This equipment is designed for use by medical professionals completely familiar with the required techniques and instructions for use of the equipment. Service intervals, as listed in Section “3.5 Maintenance Schedule” , are required to keep the equipment at its optimum operating performance.

1.1

Operating Principle

The HALL® Titan™ Battery Handpieces (PRO9100B, PRO9200B, PRO9300B, PRO9350B, PRO9400B, and PRO9450B) are powered by a detachable, rechargeable battery to provide rotary, reciprocating, or oscillating force to the accessory (drill bits, saw blades, reamers, drivers or other attachments) for bone cutting, drilling, driving and soft tissue resection. The handpieces are controlled by an activation trigger and mode lever on the handpiece. The handpieces and accessories (including the batteries) may come into physical contact with the patient (applied part).

1.2

Indications for Use

The PRO9100B HALL® Titan™ Single Trigger Battery Handpiece, the PRO9200B HALL® Titan™ Dual Trigger Battery Handpiece, and their accessories, perform cutting of soft tissue and bone. The fields of application include: orthopedic, arthroscopic, hand and foot surgical procedures. The PRO9300B HALL® Titan™ Oscillating Saw Battery Handpiece, PRO9350B HALL® Titan™ Primecut+™ Oscillating Saw Battery Handpiece, and their accessories, perform cutting of soft tissue and bone. The fields of application include: orthopedic, arthroscopic, hand and foot surgical procedures. The PRO9400B HALL® Titan™ Reciprocating Saw Battery Handpiece and its accessories, perform cutting of soft tissue and bone. The fields of application include: orthopedic, and arthroscopic surgical procedures. The PRO9450B HALL® Titan™ Sternum Saw Battery Handpiece and its accessories, perform cutting of soft tissue and bone. The fields of application include: orthopedic, and arthroscopic surgical procedures. Specific Indications for European Union and Australia: The HALL® Titan™ Battery Handpieces are intended for drilling and cutting of soft tissue and bone in the following orthopedic surgical procedures including, but not limited to: • Sports Medicine procedures (ACL, PCL, labral and rotator cuff repair), • Total joint arthroplasties (small and large joints), • Osteotomies (small and large bone), • Trauma procedures (small and large bone), and • Sternotomies.

1.3

Intended Use

Same as Indications for Use above.

1.4

Contraindications

The PRO9450B HALL® Titan™ Sternum Saw Battery Handpiece is not intended for use in repeat sternotomy applications.

1

1.5

Warnings and Precautions

Do not bypass this section. It contains warnings and precautions that must be thoroughly understood before operating any of the equipment. Lack of understanding or adherence to these warnings and precautions may result in injury or even death to the patient and/or surgical staff. The words WARNING, PRECAUTION, and NOTE carry special meanings and they must be read carefully. WARNING: A warning contains critical information regarding serious adverse reactions and potential safety hazards that can occur in proper use or misuse of the equipment. Failure to observe the information or procedures presented in a Warning may result in injury or other serious adverse reactions to the patient and/or surgical staff. PRECAUTION: A precaution contains instructions for any special care to be exercised by the practitioner for the safe and effective use of the equipment. Failure to observe the information or procedures presented in a Precaution may result in damage to the equipment. NOTE: A note is added to provide additional focused information. This information has no critical effect on the patient or equipment.

1.5.1

Warnings

1. United States Federal law restricts sale of this device to or on the order of a physician. 2. Eye protection is recommended when operating equipment. Eye injury may result. 3. It is the surgeon’s responsibility to be familiar with the appropriate surgical techniques prior to use of the equipment and its associated accessories. Do not use equipment other than intended use. 4. Do not use equipment if, upon receipt, package is opened, damaged, or shows any signs of tampering. 5. Use only associated CONMED approved equipment and accessories. Using unapproved accessories may result in improper operation and may result in non-compliance to medical standards. 6. Follow universal precautions for protective apparel when handling and cleaning contaminated instruments. 7. Always inspect handpiece and accessories prior to use. Do not use damaged equipment. 8. Handpieces and batteries are supplied non-sterile. Clean and sterilize prior to each use. 9. Disposable blades are supplied sterile and are for single-use only. Do not resterilize or reuse. The ability 2 STERILIZE to effectively clean and resterilize these single use devices has not been established and subsequent reuse may adversely affect the performance, safety and/or sterility of the devices. 10. Do not use sterile equipment beyond the expiration date listed on the label. Sterility of the product cannot be assured beyond the expiration date. 11. Inspect battery pack for damage (e.g., cracks in battery case) prior to use. Do not use damaged battery packs. If battery pack is damaged and leakage or residue is noticed, do not allow it to come in contact with skin, eyes or clothing. Burns may result. If contact occurs, flush area with copious amounts of water and seek medical attention immediately. Dispose of or recycle properly. 12. Do not use equipment in the presence of flammable anesthetics, gases, disinfecting agents, cleaning solutions, or any material susceptible to ignition due to electrical sparking. 13. While handpiece is not in use, do not place on patient/surgical drapes. Place handpiece on mayo stand. 14. Always place the mode lever in the “safe” position when not in use and prior to repositioning the rotating head on the Oscillating Saws or connecting or removing blades and batteries. 15. Always place the handpiece in the “safe” position when not in use and prior to repositioning the rotating head on the Oscillating Saw and Reciprocating Saw or connecting or removing attachments and accessories. Injury to the operator and/or damage to the equipment may occur. Place the handpiece mode lever in the “safe” position prior to installation or removal of accessories. 16. Do not operate the Oscillating, Reciprocating or Sternum Saw with the collet in the “open” position or without a blade locked in the collet. Damage to the handpiece may occur. 17. Avoid contact with cutting tip of blade when locking into handpiece. Tips are sharp and may cause injury. 18. Do not contact the moving parts on the handpieces. Injury to the operator may occur. 19. Continually check handpiece for overheating. If overheating is sensed, immediately discontinue use and return equipment for service. Overheating of the blade may cause damage to the blade and may cause burns or thermal necrosis. 20. Never pinch the HALL Primecut Cassettes. Overheating of the blade may cause damage to the cassette and may cause burns or thermal necrosis. 21. Avoid contact of blades with cutting blocks, retractors or other instrumentation. Damage to blade or instrumentation may occur. Metal fragments may cause injury to patient or user. 2

22. Do not use burs for plunge cutting. Injury or damage may occur. 23. When using the PowerPro Sagittal Saw attachment (PRO2043), placing excessive bending or twisting force on the sagittal saw blade may cause the collet to open and release the saw blade. 24. Do not use saw blades to pry, remove bone grafts, or as a leverage point. Do not apply excessive bending or twisting force to blade. Patient or user injury may occur. 25. Do not short circuit battery terminals or allow them to contact metal objects. This could cause a shock or burn injury and damage the battery. 26. Do not expose batteries to fire or incineration. Exposure may cause injuries. 27. After use, blades, burs and tubing sets may be a potential biohazard and should be handled and disposed in accordance with acceptable medical practice and applicable local and national requirements. 28. Failure to follow the 12 month service interval could result in reduced instrument performance or overheating of the handpiece. Overheating can lead to possible burn injury to the patient or medical personnel. Rotation of handpiece usage per day will assist with proper performance. (Refer to section “3.5 Maintenance Schedule”). 29. Clean, disinfect and sterilize all equipment and associated accessories according to instructions for use. (Refer to section “3.1 Cleaning Information”, section “3.2 Disinfection Information” and section “3.3 Sterilization Information”) 30. Do not use HALL Reciprocating Blade 5052-260 with HALL Titan Reciprocating Saw PRO9400B. Blade vibrates during use.

1.5.2

Precautions

1. This device should only be used in compliance with its intended use. 2. Handle all equipment carefully. If any equipment is dropped or damaged in any way, return it immediately for service. 3. The warranty becomes void and the manufacturer is not liable for direct or resulting damage if: • The device or the accessories are improperly used, prepared or maintained; • The instructions in the manual are not adhered to; • Non-authorized persons perform repairs, adjustments or alterations to the device or accessories. 4. There are no user-serviceable parts inside. No modification of this equipment is allowed. 5. Prior to each use, perform the following: • Ensure all accessories are correctly and completely attached. • Perform the required Preoperative Functional Tests for the equipment and accessories. (Refer to Section “2.6 Preoperative Functional Test”). 6. Handpieces are factory sealed. Do not disassemble or lubricate, as this may void the warranty. 7. Always inspect for bent, dull or damaged blades or burs before each use. Do not attempt to straighten or sharpen. Do not use if damaged. 8. After each use, thoroughly clean and inspect the handpiece and accessories. (Refer to Section “3.0 MAINTENANCE”). 9. Do not stall handpieces, damage can occur. 10. Do not operate the PRO2045 Reciprocating Saw attachment with the PRO9100B and PRO9200B Battery Handpieces. Damage will occur to the attachment. 11. When using a saw attachment (Reciprocating Saw-PRO6045 or Sagittal Saw-PRO2043) or reaming attachment, do not operate in the screw, tap or oscillate mode. Handpieces should only be operated in the drill/ream mode when used with these attachments. 12. Depletion of the battery charge will result if the battery pack is attached to a handpiece while the handpiece is stored or is not being used. 13. Battery packs contain materials which must be recycled or disposed of properly. The disposal of nickel cadmium or nickel metal hydride batteries as municipal waste is prohibited. Dispose or recycle in accordance with your local, state and government regulations. In the U.S. call 1-866-426-6633 for additional information on battery pack disposal or recycling. Outside the U.S. contact your local CONMED representative. 14. Avoid contact of blades and burs with cutting blocks, retractors or other instrumentation. Damage to blade, bur or instrumentation may occur.

3

1.6

Environmental Directives

WEEE Directive [2002/96/EC] on Waste Electrical and Electronic Equipment. This statement only applies to European countries with regard to the Waste Electrical and Electric Equipment (WEEE) European Directive. The WEEE symbol on the product or its packaging indicates that this product must not be disposed of with other waste. Instead, it is your responsibility to dispose of your waste equipment by handing it over to a designated collection point for the recycling of Waste Electrical and Electronic Equipment. The separate collection and recycling of your waste equipment at the time of disposal will help conserve natural resources and ensure that it is recycled in a manner that protects human health and the environment. For more information about where you can drop off your medical equipment at the end of its useful life for recycling, please contact CONMED.

1.7

Product Photographs and Drawings

The pictures in this manual are for reference only. Items shown may not represent the actual product. However, procedural steps are identical, unless otherwise specified. When necessary, the actual pictures will be represented.

1.8

Symbol Definitions

1.8.1

Product Symbols “Safe” or “Off” position.

“Reverse” position of the PRO9100B handpiece.

“Forward” position of the PRO9100B handpiece.

“Run” position of the PRO9400B and PRO9450B handpieces.

Drill/ream operating mode for the PRO9200B handpiece.

Screw/tap operating mode for the PRO9200B handpiece.

Open and close direction for the collet for the PRO9300B and PRO9350B handpieces.

Fast speed of the PRO9300B and PRO9350B handpieces.

Standard speed of the PRO9300B and PRO9350B handpieces.

4

1.8.2

Warnings and Information Symbols

REF

Catalog Number

SN

Serial Number

Manufacturer

Date of Manufacture

Consult Instructions for Use

Refer to Instruction Manual/Booklet (for critical safety instruction).

Caution

DEHP Symbol DEHP

EC REP

Authorized Representative in the European Community

CE Mark of Conformity

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

No User Service Recommended. Refer servicing to qualified CONMED service personnel

Non Sterile

STERILE EO

2

STERILE

Sterile - Sterilized Using EO

STERILE

R

Sterile Sterile - Sterilized Using Irradiation

Do Not Steam Sterilize

Do Not Sterilize

Do Not Resterilize

Do Not Reuse (for Single Use Only)

Do Not Use Oil

Do Not Use for Plunge Cutting

Eye Protection Required

Biohazard Risk

STERILIZE

Do Not Immerse

~

QTY

Quantity

Type B Applied Part

Type BF Applied Part

UL Classification Mark

UL Recognized Components

Rating Fuse

Fuse Location

Alternating Current

Protective Earth Ground

Equipotentiality (Equipment Potential)

Non-Ionizing Electromagnetic Radiation (RF Symbol)

Temperature Limitation

Humidity Limitation

5

Atmospheric Pressure Limitation

Use by Date

Fragile

This Side Up

Do Not Use if Package is Damaged

Keep Dry

Warning: Corrosive Substance

Warning: Electrical Hazard/High Voltage

Waste Electrical and Electronic Equipment (WEEE) Symbol. Regarding European Union end-of-life of product, indicating separate collection for electrical and electronic equipment

Lithium

Recycle . Batteries contain materials which must be recycled or disposed of properly. The disposal of batteries as municipal waste is prohibited. Dispose or recycle in accordance with your local, state and governmental regulations. In the U.S. call 1-866-426-6633, or outside the U.S. contact your local CONMED representative for additional information on battery disposal or recycling.

6

2.0

SYSTEM INSTALLATION AND OPERATION

2.1

Single and Double Trigger Battery Handpiece Installation and Operation

2.1.1

PRO9100B HALL® Titan™ Single Trigger Battery Handpiece 1

2 3

5

4

6

1. Attachment Collet-Lock - Twist to unlock 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. 2. Activation Trigger - Used to activate the handpiece. Depress when the mode lever is in the “forward” or “reverse” position to operate. Trigger will not depress when mode lever is in “safe” position. 3. Mode Lever - To operate 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. 4. Battery Receptacle - The battery attaches here. 5. Battery Release Lever - Depress this lever to remove the battery from the handpiece. 6. Battery Pack - Refer to section “4.3 Accessories” for compatible batteries.

2.1.2

Connecting and Removing Attachments to the Handpiece (PRO9100B/PRO9200B)

All attachments for the HALL Titan single and dual trigger handpieces connect/disconnect in the same manner. For more information, refer to the PowerPro Attachment Instruction Manual or the Information Insert supplied with each attachment. NOTE: The connected attachment (drill or reamer) determines the speed and torque of the Titan handpiece. To attach an attachment: 1. Place the mode lever in the “safe” position. 2. Orient the attachment shaft to the handpiece opening. Insert the shaft and press them until they snap together.

To disconnect an attachment: 1. Place the mode lever in the “safe” position. 2. Twist the attachment collet-lock. Remove the attachment.

7

2.1.3

PRO9100B HALL® Titan™ Single Trigger Battery Handpiece Operation

To operate the handpiece, place the handpiece mode lever in either the “forward” or “reverse” position and depress the trigger. 1. With the mode 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 with the trigger. 2. With the mode 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 with the trigger.

2.1.4

PRO9200B HALL® Titan™ Dual Trigger Battery Handpiece 1

2 3 4

6

5

7

1. Attachment Collet-Lock - Twist to unlock 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. 2. Top Activation Trigger - Used to activate the handpiece. Trigger will not depress when mode lever is in “safe” position. Refer to section “2.1.5 PRO9200B HALL® Titan™ Dual Trigger Battery Handpiece Operation” for detailed information on the functionality of this trigger. 3. Bottom Activation Trigger - Used to activate the handpiece. Trigger will not depress when mode lever is in “safe” position. Refer to section “2.1.5 PRO9200B HALL® Titan™ Dual Trigger Battery Handpiece Operation” for detailed information on the functionality of this trigger. 4. Mode Lever - To operate the handpiece, place in either the “drill/ream” or “screw/tap” position. Place in the “safe” position prior to connecting or removing any attachment or accessory and during non-use of the handpiece. 5. Battery Receptacle - The battery attaches here. 6. Battery Release Lever - Depress this lever to remove the battery from the handpiece. 7. Battery Pack - Refer to section “4.3 Accessories” for compatible batteries. See section 2.1.2 for connecting and removing attachments.

8

2.1.5

PRO9200B HALL® Titan™ Dual Trigger Battery Handpiece Operation

A matrix that describes the functionality of the two triggers, alone or in combination, is located below. DRILL/REAM Position Place the handpiece mode lever in the “drill/ream” position. The handpiece operates as follows: 1. Depress the bottom trigger only to operate in the forward, or clockwise direction as viewed from the rear of the handpiece. The speed is variably controlled with the trigger. 2. Depress the top trigger only to operate in the reverse, or counterclockwise direction as viewed from the rear of the handpiece. The speed is variably controlled with the trigger. 3. Depress both triggers simultaneously to operate in oscillate mode (three-quarter turn clockwise, three-quarter turn counterclockwise). The speed is variably controlled with the bottom trigger. SCREW/TAP Position NOTE: Do not use reaming attachments in the SCREW mode. Place the handpiece mode lever in the “screw/tap” position. The handpiece operates as follows: 1. Depress the bottom trigger only to operate in the forward screw direction to drive screws. The speed is variably controlled with the trigger and torque is limited to approximately 20 in. lbs. (2.26 Nm). 2. Depress the top trigger only to operate in the reverse screw direction for removing screws. The speed is variably controlled with the trigger. Torque is not limited. 3. Depress both triggers to operate in tap mode. The handpiece will rotate 720° clockwise, then 360° counterclockwise (2 turns CW, 1 turn CCW). The speed is variably controlled with the bottom trigger. Table 1: PRO9200B HALL® Titan™ Dual Trigger Battery Handpiece Operating Matrix Lever Position

Operating Mode

Top Trigger Position

Bottom Trigger Position

Handpiece Action

Drill/Ream

Not Pressed

Pressed

Forward

Pressed

Not Pressed

Reverse

Pressed

Pressed

Oscillating mode*

Not Pressed

Pressed

Screw Forward *

Pressed

Not Pressed

Screw Reverse*

Pressed

Pressed

Tap Mode*

Screw/Tap

* NOTE: Do not operate any saw attachment (Sagittal Saw - PRO2043, Reciprocating Saw - PRO6045) or reaming attachment in the screw, tap or oscillate mode. They are only to be operated in the forward/reverse mode.

9

2.2

Oscillating Saw Battery Handpiece Installation and Operation

2.2.1

PRO9300B and PRO9350B HALL® Titan™ Oscillating and Primecut+™ Oscillating Saw Battery Handpiece 1

1

2

2

3

3

4

4

5

5

7

7

6

6

8

8

PRO9300B PRO9350B Titan Oscillating Saw (PRO9300B) is designed to accept M-Class, HALL Pro, Intrex, and Series V HALL Classic blades. Titan Primecut+ Oscillating Saw (PRO9350B) is designed to accept HALL Primecut Cassettes, M-Class, HALL Pro, Intrex, and Series V HALL Classic blades. 1. Blade Locking Collet - Holds and locks the blade in place. 2. Rotating Head - The rotating head gives the surgeon the ability to position the cutting blade for appropriate surgical access. The oscillating handpiece contains an 8 position, 45° indexing head. To position the rotating head, grasp the rotating head, pull it out from the handpiece body, and turn it to the desired position. 3. Blade Locking Knob - Rotate to the “open” position to insert a blade. Rotate in the opposite direction to lock the blade securely in place. 4. Activation Trigger - Used to activate the handpiece. Depress when the mode lever is in the “run” position to operate the handpiece. Trigger will not depress when mode lever is in “safe” position. 5. Mode Lever - To operate the handpiece, place in the “fast” or “standard” speed position. Place in the “safe” position prior to connecting or removing an accessory and during non-use of the handpiece. Two speeds standard and fast. 6. Battery Receptacle - The battery attaches here. 7. Battery Release Lever - Depress this lever to remove the battery from the handpiece. 8. Battery Pack - Refer to section “4.3 Accessories” for compatible batteries.

2.2.2

Connecting and Removing Blades to the Oscillating and Primecut+ Oscillating Handpieces (PRO9300B and PRO9350B)

To attach a blade: 1. Place the mode lever in the “safe” position. 2. Rotate the blade locking knob to the “open” position. The blade locking collet will disengage.

10

3. Align the blade shank with the blade locking collet. Insert the blade.

4. Rotate the blade locking knob in the opposite direction to lock the blade into place. 5. Carefully pull on the blade to ensure it is securely in place. WARNING: The blade locking knob must be completely closed to hold the blade firmly in place. WARNING: HALL Primecut Cassettes are not designed for use in PRO9300B HALL Titan Oscillating Saw.

To remove the blade: 1. Ensure the mode lever is in the “safe” position. 2. Rotate the blade locking knob to the “open” position. The blade locking collet will disengage. 3. Remove and dispose of blade properly.

2.2.3

PRO9300B and PRO9350B HALL® Titan™ Oscillating and Primecut+™ Oscillating Saw Battery Handpiece Operation

Position the rotating head to the desired position for the appropriate surgical access. 1. Ensure the mode lever is in the “safe” position. 2. Carefully pull the rotating head out and away from the handpiece body.

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

4. Move the mode lever to the “standard” or “fast” position. • “Fast” mode is recommended for use in short durations when extra power is needed. • “Standard” mode is recommended for extended use. 5. To activate the handpiece, depress the trigger.

11

2.3

Reciprocating Saw Battery Handpiece Installation and Operation

2.3.1

PRO9400B HALL® Titan™ Reciprocating Saw Battery Handpiece 1

1

2 3

3

4

4

5

5

7

7

6

6

8

8

PRO9400B (With Collet Sleeve, Old Design)

PRO9400B (Without Collet Sleeve, New Design)

1. Blade Collet - Insert a blade here. Blade can be positioned in one of two positions, either vertical or horizontal. See “Collet Locking Button” below. 2. Collet Sleeve - Slide toward blade collet to release collet locking button (old design only). 3. Collet Locking Button - Allows collet to rotate and blades to be inserted/removed. 4. Activation Trigger - Used to activate the handpiece. Depress when the mode lever is in the “run” position to operate the handpiece. Trigger will not depress when mode lever is in “safe” position. 5. Mode 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. 6. Battery Receptacle - The battery attaches here. 7. Battery Release Lever - Depress this lever to remove the battery from the handpiece. 8. Battery Pack - Refer to section “4.3 Accessories” for compatible batteries.

12

2.3.2

Connecting and Removing Blades to the Reciprocator Handpiece (PRO9400B)

To attach a blade: 1. Place the mode lever in the “safe” position. 2. Pull collet sleeve out and away from the handpiece body (old design only) (a). Press and hold collet locking button to open the blade collet (b).

a

b

b

PRO9400B (With Collet Sleeve, Old Design) 3.

PRO9400B (Without Collet Sleeve, New Design)

Completely insert the blade shank.

PRO9400B (With Collet Sleeve, Old Design)

PRO9400B (Without Collet Sleeve, New Design)

4. The blade collet may be rotated 90° counterclockwise for the appropriate surgical access. Twist the blade while the blade collet is open (see step 2 above).

PRO9400B (With Collet Sleeve, Old Design)

PRO9400B (Without Collet Sleeve, New Design)

5. Release the collet locking button when the collet is in the desired position.

PRO9400B (With Collet Sleeve, Old Design)

PRO9400B (Without Collet Sleeve, New Design)

6. Carefully pull on the blade to ensure it is securely in place. WARNING: Do not use HALL Reciprocating Blade 5052-260. 13

To operate the handpiece, move the mode lever to the “run” position and depress the trigger. To remove the blade: 1. Ensure the mode lever is in the “safe” position. 2. Pull collet sleeve out and away from handpiece body (old design only). Press and hold collet locking button. Remove the blade. Release the collet locking button.

2.3.3

PRO9400B HALL® Titan™ Reciprocating Saw Battery Handpiece Operation

1. Move the mode lever to the “run” position. 2. To activate the handpiece, depress the trigger.

2.4

Sternum Saw Battery Handpiece Installation and Operation

2.4.1

PRO9450B HALL® Titan™ Sternum Saw Battery Handpiece 1 2 3 4

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5

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1. Collet Nut - Accepts and locks a blade into the handpiece. 2. Blade Guard Locking Sleeve - Used to lock the sternum saw blade guard to the handpiece. 3. Activation Trigger - Used to activate the handpiece. Depress when the mode lever is in the “run” position to operate. Trigger will not depress when mode lever is in “safe” position. 4. Mode Lever - To operate the handpiece, place in the “run” position. Place in the “safe” position prior to connecting or removing any attachment or blade and during non-use of the handpiece. 5. Battery Receptacle - The battery attaches here. 6. Battery Release Lever - Depress this lever to remove the battery from the handpiece. 7. Battery Pack - Refer to section “4.3 Accessories” for compatible batteries.

2.4.2

Connecting and Removing Blade and Blade Guard to the Sternum Saw (PRO9450B)

WARNING: Never operate the Sternum Saw without the saw blade, collet nut, and blade guard locked securely in place. To install a blade: 1. Place the handpiece in the “safe” position. 2. 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. 3. Completely insert the flat blade shank into the collet.

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4. The blade may be inserted in either of two positions to allow cutting in a push (blade teeth pointing upwards - photo above) or pull direction (blade teeth pointing downwards - photo below).

5. 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.

6. After the blade has been completely seated and locked, move the mode lever to the “run” position. 7. Briefly activate the handpiece by depressing the trigger. Return the mode lever to the “safe” position. 8. Carefully pull on the blade to ensure there is no movement in the blade. If there is movement, tighten the collet nut more securely. To attach the sternum saw blade guard: NOTE: Ensure the O-Ring is present on the blade guard prior to installing. 1. Carefully slide the sternum saw blade guard over the blade. Always align the support strut on the blade guard with the non-cutting side of the blade.

2. Align the slots on the connecting portion of the blade guard with the pins inside the blade guard locking sleeve. Pull the locking sleeve back (see above picture) and insert the blade guard completely into the blade guard locking sleeve. 3. With the blade guard in the proper position, release the locking sleeve. It will snap into place, locking the blade guard to the handpiece.

CORRECT

CORRECT

WARNING: Make sure the blade is inserted inside the slot of the blade guard, not outside. Otherwise damage or injury may occur.

INCORRECT To remove the sternum saw blade guard and blade: 1. Place the handpiece in the “safe” position. 2. Slide the locking sleeve towards the back of the handpiece.

3. Pull the blade guard out and away from the handpiece. Release the locking sleeve. 4. 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. 15

5. Remove the blade and dispose of blade properly.

2.4.3

PRO9450B HALL® Titan™ Sternum Saw Battery Handpiece Operation

1. Move the mode lever to the “run” position. 2. To activate the handpiece, depress the trigger.

2.5

Battery Installation

To attach the desired battery pack to the handpiece: 1. Align the contacts on the top of the battery pack with the connector on the handpiece. 2. Slide the battery pack until it snaps into place.

To remove the battery pack from the handpiece: 1. Depress the release lever and pull the battery pack from the handpiece.

2.6

Preoperative Functional Test

Prior to each use, perform the following preoperative functional test: 1. Attach battery to handpiece. 2. Insert an attachment or blade into the handpiece. Gently pull on the attachment or cutting accessory to ensure it is properly seated. 3. Run the handpiece for less than 5 seconds to observe any abnormal noises, vibrations or heat rise. 4. If any operating difficulties occur, return the handpiece for service.

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