The Hall Maxi-Driver Battery System Instruction Manual Rev A Aug 2001

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 Linvatec and/or its licensors. 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 Linvatec. 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 Maxi-Driver are trademarks or registered trademarks of Linvatec Corporation.

© Linvatec Corporation 2001. 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.

Serial No Serial No Serial No Serial No

Date Date Date Date

Page

Table of Contents

1.0

2.0

INTRODUCTION 1.1

Intended Use... 1

1.2

General Warnings... 1

1.3

Symbol Definitions... 2

1.4

Battery Handpiece (L300)... 4

INSTALLATION and OPERATION 2.1

Battery Attachment... 5

2.2

Battery Charging... 6

2.3

Attachments and Accessories... 8 2.3.1

Connecting/Removing Attachments... 9

2.3.2

Automatic Pin Driver Attachment (L111)... 9

2.3.3

Oscillating Saw Attachment (L320A)... 11

2.3.4

Reciprocating Saw Attachment (L140A)... 12

2.3.5

Jacobs Chuck Attachment (L110)... 13

2.3.6

Trinkle Chuck Attachment (L112)... 14 2.3.6.1

Automatic Screwdrivers for the Trinkle Chuck Attachment (D520/D524)... 15

2.3.7

Hudson Chuck Attachment (L113)... 17

2.3.8

Hudson Reamer Drive Attachment (L150)... 18

2.3.9

Zimmer Chuck Attachment (L115)... 19

2.3.10 Zimmer Reamer Drive Attachment (L153)... 20 2.3.11 ASIF/AO Twist Drill Chuck Attachment (L513)... 21 2.3.12 ASIF/AO Flexible Chuck Attachment (L514)... 22 2.3.13 ASIF/AO Reamer Drive Attachment (L151)... 23 2.3.14 Aesculap Reamer Drive Attachment (L152)... 24 2.3.15 Aesculap Chuck Attachment (L515)... 25

i

Page

Table of Contents

3.0

MAINTENANCE 3.1

Cleaning and Sterilizing... 28 3.1.1

Cleaning Precautions... 28

3.1.2

Handpiece and Attachment Cleaning Instructions... 28

3.1.3

Battery Cleaning and Maintenance Instructions... 29

3.1.4

Sterilization Information... 29 3.1.4.1

3.2

4.0

5.0

Sterilization Warnings, Precautions and Notes... 29

Troubleshooting... 32

TECHNICAL SPECIFICATIONS 4.1

Battery Handpiece (L300)... 36

4.2

Battery (L325A)... 37

4.3

System Environmental Requirements... 37

CUSTOMER SERVICE and WARRANTY 5.1

Customer Service... 38

5.2

Handpieces, Attachments and Accessories... 40

5.3

Linvatec® and Hall® Surgical Instrument Warranty... 41

ii

1.0 INTRODUCTION

1.2

t is recommended that personnel study this manual before attempting to operate, clean or sterilize the Hall® Maxi-Driver™ Battery Powered Instrument 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.

I

1.1

Intended Use

he Maxi-Driver Battery Powered Instrument System is designed to provide optimal speed and torque for large bone orthopedic surgery, including cutting, drilling, pinning, sawing, reaming and driving screws. The system attachments are completely interchangeable between the Maxi-Driver battery, electric and pneumatic handpieces.

T

1

General Warnings

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

2.

Eye protection is recommended when operating equipment.

3.

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

4.

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

5.

Prior to each use, perform the following: •

Inspect all equipment for proper operation.

•

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

•

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

6.

Handpieces are factory sealed. Do not disassemble or lubricate.

7.

Oscillating and reciprocating saw blades, and bits are single-use only. Do not resterilize. After use, dispose of properly.

8.

9.

Continually check all handpieces and attachments for overheating. Discontinue use and return equipment for service as necessary. Overheating of the bit or blade may cause damage to the bit or blade and may cause thermal necrosis.

1.3

Symbol Definitions Attention, consult accompanying documents. Electrical hazard symbol

Do not attach, insert or remove accessories or attachments while the handpiece is operating. Place the handpiece safety switch to the appropriate safe position prior to installation or removal of items.

Flammable Anesthetics - Risk of explosion if used in the presence of flammable anesthetics. Type B Equipment: Provides protection against electrical shock and electrical current leakage. In the case of a patient applied part, the equipment is suitable for internal and external application as defined by CSA 601.1, EN 60601-1, and UL 2601

10. Do not short circuit battery terminals or allow them to contact skin or metal objects. This could cause a shock or burn injury and also damage the battery. 11. Do not allow battery leakage or residue to come in contact with skin, eyes or clothing. These materials could contain Potassium Hydroxide (KOH) which is an alkaline and can burn. If leakage contacts skin or eyes, flush affected areas with and abundant amount of water and seek medical assistance immediately.

Indicates the safe or off position (only for a part of equipment) of the handpiece safety switch. Indicates the on or run position (only for a part of equipment) of the handpiece safety switch.

12. Do not expose batteries to fire or incineration. 13. Do Not Exceed the recommended sterilization cycle time for batteries. Battery failure will result. See “Table 2: Sterilization Parameters” on page 31.

F

R 14. Do not use any equipment, especially the battery charger, in the presence of flammable anesthetics, gases, disinfecting agents, cleaning solutions, or any material susceptible to ignition due to electrical sparking. 15. After each use, thoroughly clean the handpiece and attachments (See “3.1 Cleaning and Sterilizing” on page 28).

2

Indicates “on” in the forward, or clockwise, direction of rotation. Indicates “on” in the reverse, or counter-clockwise, direction of rotation.

F

Indicates on in the forward, or clockwise, direction of rotation.

R

Indicates on in the reverse, or counterclockwise, direction of rotation.

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

Indicates battery rack unload/load/carry.

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

Ni-Cd

Indicates product should not be oiled or lubricated. Single Use Only

Eye Protection Required Indicates battery or electric handpiece. Duty Cycle: Applies to battery system.

1 min

3 min

Ni-Cd

Batteries contain nickel cadmium which must be recycled or disposed of properly. The disposal of nickel cadmium batteries as municipal waste is prohibited. Dispose or recycle in accordance with your local, state and governmental regulations. In the U.S. call 1-800-925-4255, or outside the U.S. contact your regional Linvatec representative for additional information on battery disposal or recycling.

Indicates handpiece should not be immersed in any type of fluid.

%

Ni-Cd

Duty Cycle: 1 minute on. Duty Cycle: 3 minutes off.

3

1.4

❹ Safety/Directional Control Knob -

Battery Handpiece (L300)

Used to place the handpiece in the safe or operating mode. Place in the safe/off position prior to connecting or removing the battery, attachments or accessories and during non-use of the handpiece.

❶

❷ ❹

❸

❶ 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.

❷ Activation Trigger - Used to activate the handpiece. Depress when the directional control knob is in either the forward or reverse position.

❸ Battery Release Latch - Slide in the direction of the arrow to remove the battery from the handpiece.

4

F R

2.0

2.1

1.

INSTALLATION and OPERATION

To attach the battery to the handpiece: (a) Place the handpiece safety knob in the off (safe) position.

Battery Attachment

CAUTION: Batteries are shipped non-sterile. Refer to “3.1.4 Sterilization Information” on page 29 for sterilization guidelines and parameters. WARNING: Inspect batteries for damage prior to use, i.e., cracks in battery case. DO NOT use damaged batteries. Discard or recycle properly. Ni-Cd

Ni-Cd

Ni-Cd

(b) Slide the battery onto the handpiece by matching the grooves in the battery to the tracks on the handpiece. Insert the battery firmly until the battery release latch snaps into place.

5

2.

To remove the battery from the handpiece.

2.2 (a) Place the handpiece safety knob in the off (safe) position.

Battery Charging

Reference the appropriate battery charger instruction manual for instructions on how to use the battery charger to charge batteries.

(b) Slide the battery release latch in the direction of the arrow and slide the battery out of the handpiece.

WARNINGS:

3.

4.

With the safety still activated, install the desired attachment and accessory at this time by referencing “2.3.1 Connecting/ Removing Attachments” on page 9.

1.

Batteries may be charged on either the 3M Battery Charger (L375, L376, L377, L378 or L379) or on the Hall Universal Battery Charger (PRO2600 or PRO2600I). Do not attempt to charge batteries on any other battery charger. The use of other battery chargers may shorten the service life of the battery or cause them to vent flammable gas or caustic liquid.

2.

Do not charge batteries unless they are at room temperature.

3.

Do not autoclave batteries above the recommended temperature (reference “3.1.4 Sterilization Information” on page 29).

4.

Do not leave batteries in autoclave longer than recommended.

5.

Any of the above conditions could shorten the life of the batteries and/or compromise the seal integrity, resulting in leakage of Potassium Hydroxide (KOH) which is alkaline and can burn skin, eyes or clothing.

To activate the handpiece: (a) Place the handpiece safety knob in the desired operating position, either forward or reverse and depress the trigger.

F R

6

6.

Do not allow battery leakage or residue to come in contact with your skin, eyes or clothing. If leakage does contact your skin, eyes or clothing, flush affected areas with copious amounts of water and seek medical assistance immediately. If there is any evidence of case cracking, white residue or fluid leakage, follow these guidelines: (a) Handle product with protective gloves. (b) Place absorbent material, such as paper toweling, in a leak-proof double bag containing the battery to absorb leakage. Secure the bag. If battery is damaged, package any loose parts in a separate bag to prevent short circuiting.

NOTES: 1.

New batteries should always be charged before initial use.

2.

Always clean batteries before charging.

3.

Always charge batteries before sterilization.

4.

Store batteries on charger prior to sterilization.

5.

Use charged batteries within 48 hours of charging.

7

❶

❷ ❹

❸

❻

❺

❽ ❿

❼ ❾

12

13

11 14

2.3

15

Attachments and Accessories

❶ Aesculap Reamer Drive Attachment (L152) ❷ Zimmer Reamer Drive Attachment (L153) ❸ Hudson Reamer Drive Attachment (L150) ❹ ASIF/AO Reamer Drive Attachment (L151) ❺ Automatic Pin Drive Attachment (L111) ❻ Reciprocating Saw Attachment (L140A) ❼ Oscillating Saw Attachment (L320A) ❽ ASIF/AO Chuck Attachment (L514) ❾ ASIF/AO Twist Drill Chuck Attachment (L513)

❿ Aesculap Chuck Attachment (L515) 8

11

Jacobs Chuck Attachment (L110)

12

Zimmer Chuck Attachment (L115)

13

Hudson Chuck Attachment (L113)

14

Trinkle Chuck Attachment (L112)

15

Automatic Screwdriver Attachments (D520/D524)

2.3.1

Connecting/Removing Attachments

2.3.2

Automatic Pin Driver Attachment (L111)

All Maxi-Driver Handpiece attachments connect/disconnect in the same manner and are interchangeable between the battery, electric and pneumatic handpieces. See pages 9 through 25 for attachment information. 1.

To connect an attachment:

Nosepiece

(a) Ensure the handpiece is in the safe, or off position.

Adjustment Sleeve Pin Grasping Lever

(b) Twist the lock/release collar to open the attachment receptacle and insert the attachment into the handpiece. Release the lock/release collar to secure the attachment to the handpiece.

The Automatic Pin Driver is designed to drive pins (wires) and drill bits compatible with the specifications below:

(c) Ensure the attachment is secure by pulling it outward.

Through Cannulation: 1.6 - 4.0 mm (0.062 in to 0.156 in.) (1/16 - 5/32 in.)

(d) To remove the attachment, repeat steps 1(a) and 1(b), and pull out the attachment.

9

1.

(d) Loosen the adjustment sleeve one-half turn. The pin should slide freely within the Pin Driver until the grasping lever is depressed.

To insert a pin: (a) Ensure the handpiece is in the safe, or off position before inserting or removing a pin.

(e) For pin sizes that fall between the pin size graduation, loosen the adjustment sleeve one full turn. The pin should slide freely within the Pin Driver until the grasping lever is depressed.

(b) Rotate the adjustment sleeve until the desired pin size graduation appears on the shaft of the nosepiece. Do not turn the adjustment sleeve more than one turn past the marked graduation limits.

2.

To operate the handpiece: (a) Release the safety and place the handpiece in the forward position. (b) To grip and drive the pin, depress the grasping lever until flush with the handpiece and depress the trigger.

3.

To reposition the handpiece on the pin: (a) Release the trigger and grasping lever. (b) Slide the handpiece along the pin. (c) Follow step 2 to further drive the pin.

(c) Insert the pin. While holding the nosepiece, tighten the adjustment sleeve until the pin is held firmly in place.

10

2.3.3

2.

The Oscillating Saw attachment may be placed in any of four positions at 90 degree angles.

3.

To attach a blade:

Oscillating Saw Attachment (L320A)

(a) Ensure the handpiece is in the safe, or off position before attaching or removing blades. (b) While depressing the blade locking button on the attachment, insert the blade in the desired position. Release the locking button. The blade is correctly seated when the locking button clicks up into place.

Specifications: Blade Excursion Arc:

4-1/2° arc

NOTES: 1.

The L320A Oscillating Saw attachment accepts “L” series blades.

2.

For more precise osteotomies, lower cutting temperatures, and reduced instrument wear, use a new blade for each procedure.

3.

Oscillating Saw blades are singleuse only. Dispose of properly after use.

1.

(c) Ensure the blade is secured by pulling outward on the blade.

To attach the Oscillating Saw attachment, reference “2.3.1 Connecting/Removing Attachments” on page 9.

4.

The blade may be placed in five positions within a 180 degree radius.

5.

To remove a blade: (a) Ensure the handpiece is in the safe or off position. (b) Depress the center retaining button, pull the blade forward and lift the blade off the pins.

11

2.3.4

(b) Insert the blade into the blade holder in the desired blade position. Blades may be placed in either of two positions, with the cutting edge facing up or down.

Reciprocating Saw Attachment (L140A)

Specifications: Blade Stroke Length:

6.3 mm (0.25 in.)

NOTES: 1. 2.

3.

The L140A Reciprocating Saw attachment accepts “P” series blades.

(c) Release the twist-lock collar. Ensure the blade is secured by pulling outward on the blade.

For more precise osteotomies, lower cutting temperatures, and reduced instrument wear, use a new blade for each procedure.

4.

(a) Ensure the handpiece is in the safe, or off position.

Reciprocating Saw blades are single-use only. Dispose of properly after use.

1.

To attach the Reciprocating Saw attachment, reference “2.3.1 Connecting/ Removing Attachments” on page 9.

2.

The Reciprocating Saw attachment may be placed in any of four positions at 90 degree angles.

3.

To attach a blade:

To remove a blade:

(a) Turn the twist-lock collar counterclockwise and remove the blade.

(a) Turn the twist-lock collar counterclockwise.

12

2.3.5

1.

To attach the Jacobs Chuck attachment, reference “2.3.1 Connecting/Removing Attachments” on page 9).

2.

Insert the desired accessory into the chuck and secure it with the Chuck Key.

Jacobs Chuck Attachment (L110)

CAUTION: Do Not use burs in any Jacobs Chuck attachment. This attachment is designed to drive plain shank drill bits, pins, and other accessories compatible with the specifications below: Specifications: Jaw Cannulation:

0 - 6.35 mm (0 to 0.250 in.) (0 to 1/4 in.)

Through Cannulation:

6.35 mm (0.250 in.) (1/4 in.)

Associated Chuck Key: REF D298L and 5044-999-52

13

2.3.6

(c) Ensure the accessory is securely seated in the attachment before use by pulling outward on it.

Trinkle Chuck Attachment (L112) 3.

This attachment is designed to drive drill bits, automatic screwdrivers, and other accessories with Trinkle fittings. Specifications: Through Cannulation:

4.8 mm (0.187 in.) (3/16 in.)

1.

To attach a Trinkle Chuck attachment, reference “2.3.1 Connecting/Removing Attachments” on page 9).

2.

To insert a Trinkle Shank accessory into the Trinkle Chuck attachment: (a) Pull the locking sleeve chuck back. Insert the accessory and release the locking sleeve. (b) Turn the accessory in the chuck until it locks.

14

To remove accessory, pull back the locking sleeve chuck and remove the accessory.

1. 2.3.6.1

Automatic Screwdrivers for the Trinkle Chuck Attachment (D520/D524)

To insert a bit into the screwdriver. (a) Unscrew the bit retainer section (counterclockwise) from the screwdriver. (b) Insert the bit into the back of the screwdriver, tip first.

❶ ❷ ❸ ❹

❺ ❻ (c) Slide the bit retainer over the bit and thread the retainer back on the screwdriver by turning it clockwise until tight.

❶ Screwdriver (D520) ❷ Slotted Bit (D521) ❸ Cruciate Bit (D522) ❹ Phillips Bit (D523) ❺ Screwdriver (D524) ❻ Hex Bit for AO type screws (D525)

15

(d) While retracting the locking sleeve on the Trinkle Chuck attachment, insert the screwdriver into the chuck and release the locking sleeve. (e) Turn the accessory in the chuck until it locks.

3.

(f) Ensure the attachment is secure by pulling outward on it. CAUTION: Ensure that the screwdriver is securely seated in the Trinkle Chuck before use. 2.

To engage the screwdriver bit into the screw head. (a) Insert the head of the screw into the screwdriver. (b) Hold the screw firmly and press the knurled portion of the screwdriver body forward so the teflon collar snaps over the head of the screw.

16

To remove the screw, retract the teflon collar and remove the screw.