ConMed PRO2030, PRO2041, PRO2029, PRO2042, PRO2043 Instruction Manual

...
The Hall
Instruction Manual
®
P
ower
®
Attachment
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 r eserves the right to r evise this publication and to make changes fr om time to time in the contents hereof without obligation to notify any person of such revision or changes, unless otherwise required by law.
Linvatec, Hall and PowerPro are trademarks or registered trademarks of Linvatec Corporation.
©
Linvatec Corporation 2002. All Rights Reserved. Printed in USA
Record the Model and Serial Numbers of all attachments, and date received. Retain for future reference.
Attachment Model No. Serial No Date Attachment Model No. Serial No Date Attachment Model No. Serial No Date Attachment Model No. Serial No Date Attachment Model No. Serial No Date Attachment Model No. Serial No Date Attachment Model No. Serial No Date Attachment Model No. Serial No Date Attachment Model No. Serial No Date
Table of Contents
1.0 INTRODUCTION
1.1 Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
1.2 General Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
1.3 Symbol Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
2.0
owerPro
P
2.1 Connecting and Removing Attachments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
®
ATTACHMENT OPERATION
2.1.1 Reaming Attachments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.1.1.1 AO Reamer (PRO2040) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
2.1.1.2 Aesculap Reamer (PRO2060). . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
2.1.1.3 Zimmer/Hudson Reamer (PRO2047) . . . . . . . . . . . . . . . . . . . . . . .4
2.1.2 Drilling Attachments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
2.1.2.1 Zimmer/Hudson Drill (PRO2046) . . . . . . . . . . . . . . . . . . . . . . . . . 5
2.1.2.2 AO Drill (PRO2070). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2.1.2.3 AO Attachment - Small (PRO2038) . . . . . . . . . . . . . . . . . . . . . . . . 5
2.1.2.4 Trinkle /AO Attachment (PRO2029) . . . . . . . . . . . . . . . . . . . . . . .6
2.1.3 Jacobs Chucks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.1.3.1 5/32” Jacobs Chuck (PRO2030) . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.1.3.2 1/4” Jacobs Chuck (PRO2041) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2.1.3.3 1/4” High Torque Jacobs Chuck (PRO2042) . . . . . . . . . . . . . . . . .8
2.1.4 Keyless Chucks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2.1.4.1 1/8” Keyless Chuck (PRO2050) . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2.1.4.2 1/4” Keyless Chuck (PRO2250) . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.1.4.3 3/8” Keyless Chuck (PRO2375) . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.1.4.4 Radiolucent Drive Adaptor (PRO2514) . . . . . . . . . . . . . . . . . . . . .9
Page
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Table of Contents
2.0
owerPro
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ATTACHMENT OPERATION (Continued)
2.1.5 Wire and Pin Driving Attachments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.1.5.1 Wire Driver (PRO5028) for Battery Handpieces . . . . . . . . . . . . . 10
2.1.5.2 Pin Driver (PRO5032) for Electric Handpieces . . . . . . . . . . . . . . 10
2.1.6 Sawing Attachments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.1.6.1 Sagittal Saw Attachment (PRO2043) . . . . . . . . . . . . . . . . . . . . . . 11
2.1.6.2 Reciprocating Saw Attachment (PRO2045). . . . . . . . . . . . . . . . . 11
3.0 MAINTENANCE
3.1 Cleaning and Sterilizing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.1.1 Cleaning Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.1.2 Attachment Cleaning Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
3.1.3 Sterilization Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3.1.3.1 Sterilization Warnings, Precautions and Notes. . . . . . . . . . . . . . . 14
Page
4.0 CUSTOMER SERVICE, REPAIRS and WARRANTY
4.1 Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
4.2 Handpieces, Attachments and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
4.3 Linvatec and Hall
®
Surgical Instrument Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . 19
ii
1.0
I
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.
INTRODUCTION
t is recommended that personnel study this manual before attempting to operate, clean or sterilize Hall
®
PowerPro
®
attachments.
1.1 Intended Use
he PowerPro attachments are inter­changeable between the battery operated
T
and electric PowerPro handpieces. These
attachments are used in conjunction with the
PowerPro handpieces to perform bone cutting,
reaming, drilling, driving screws, and sawing. The fields of application for this handpiece
include: Osteotomies, Trauma, Orthopedic, Total Joint Arthroplasties, Neurosurgical proce­dures, and Medial Sternotomy.
1.2 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. Do not disassemble or lubricate attachments, as this may void your war­ranty. There are no user-serviceable parts inside.
3. Eye protection is recommended when operating equipment.
4. Use only associated Hall Linvatec accessories (saw blades, bits, etc.) as defined within the descriptions of each attachment.
5. Handle all equipment carefully. If an attach­ment is dropped or damaged in any way, return it immediately for service.
®
Surgical and
6. 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.
7. Always inspect for bent, dull or dam­aged blades or drill bits before each use. Do not attempt to straighten or sharpen. Do not use if damaged. After use, dispose of properly.
1
2
8. Continually check all attachments for over­heating. If overheating is noticed, discon­tinue use and return equipment for service.
9. Do not attach, insert or remove accessories or attachments while the handpiece is oper­ating. Place the handpiece safety button
to the safe position prior to installation or removal of items .
10. All reaming attachments have a red colored ring and are not designed to be used in the screw or oscillate modes.
11. Do not operate any saw attachment (Reciprocating Saw - PRO2045, Sagittal Saw - PRO2043) in the oscillate mode. They are only to be operated in the drill mode.
12. After each use, thoroughly clean attach­ments (See “3.1 Cleaning and Sterilizing”
on page 12 ).
1.3 Symbol Definitions
Attention, consult accom­panying documents.
Single Use Only.
No user service recom­mended. Refer servicing to qualified Linvatec service personnel.
Indicates product compo­nent should not be steril­ized.
Indicates product compo­nent should not be immersed in any type of fluid.
Indicates product should not be oiled or lubricated.
Rx ONLY
Eye Protection Required.
Caution: Federal Law restricts this device to sale by or on the order of a phy­sician.
2.0
owerPro
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ATTACHMENT
OPERATION
PowerPro attachments, which are interchange-
able between the battery operated and electric
PowerPro handpieces, and are color coded by
function for easy identification, consist of the following:
AO Drill (PRO2070)
AO Reamer (PRO2040)
Reciprocating Saw (PRO2045)
1/8” Keyless Chuck (PRO2050)
1/4” Keyless Chuck (PRO2250)
Aesculap Reamer (PRO2060)
Zimmer/Hudson Reamer (PRO2047)
Zimmer/Hudson Drill (PRO2046)
Sagittal Saw (PRO2043)
5/32” Jacobs Chuck (PRO2030)
2.1 Connecting and Removing Attachments
All attachments for the PowerPro handpieces connect/disconnect in the same manner.
1. To connect an attachment:
(a) Place the handpiece in the safe posi-
tion.
(b) Orient the attachment shaft with the
handpiece opening. Insert the shaft and press them until they snap together.
1/4” Jacobs Chuck (PRO2041)
1/4” High Torque Jacobs Chuck (PRO2042)
Trinkle/AO (PRO2029)
AO Attachment - Small (PRO2038)
Radiolucent Drive Adapter Attachment (PRO2514)
3/8” Keyless Chuck Attachment (PRO2375)
Wire Driver for Battery Handpieces (PRO5028)
Pin Driver for Battery Handpieces (PRO5032)
2. To disconnect an attachment twist the attachment collet-lock in the direction of the arrow. Remove the attachment.
3
4
2.1.1 Reaming Attachments
All reaming attachments are geared down to provide higher torque levels for acetabulum and femoral reaming, hip screws, or any procedure where high torque is necessary. All PowerPro reaming attachments are easily recognized by the red-colored proximal ring.
NOTE: Reaming and sawing attachments should only be used in the “Drill” mode and are not indicated to be used in the screw or oscillating drill modes.
All reaming attachments have the following specifications in the “Drill” mode:
Variable Speed: 0-420 rpm Torque (forward and reverse): 100 in. lbs.
1. To attach accessories to Reamer attach­ments:
(a) Place the handpiece in the safe posi-
tion.
(b) Pull the collet sleeve back and insert
the accessory shank into the collet. Release the collet sleeve.
2.1.1.2 Aesculap Reamer (PRO2060)
Specifications: Collet: Accepts Aesculap Reamers Cannulation: 5.1 mm Color Ring: Brown/Red
2.1.1.3 Zimmer/Hudson Reamer (PRO2047)
2.1.1.1 AO Reamer (PRO2040)
Specifications: Collet: Accepts large hex AO reamers Cannulation: 5.1 mm Color Ring: Teal/Red
Specifications: Collet: Accepts Zimmer, Hall Series 3,
Hall Series 4, and Hudson
accessories Cannulation: 5.1 mm Color Ring: Blue/Red
5
2.1.2 Drilling Attachments
All drilling attachment modes and specifications are as follows:
Speed Torque (in. lbs.)
Mode Range (FWD/REV)
Drill 0-1250 rpm 35/35 Screw 0-250 rpm 20/35
Speed Oscillation
Mode Range Degrees
Oscillating Drill 0-500 cpm 270°
1. To attach accessories to Drill and AO attachments:
(a) Place the handpiece in the safe posi-
tion.
(b) Pull the collet sleeve back and insert
the accessory shank into the collet. Release the collet sleeve.
2.1.2.2 AO Drill (PRO2070)
Specifications: Collet: Accepts large hex style AO drill
bits for Synthes DHS and DCS
systems Cannulation: 5.1 mm Color Ring: Teal
2.1.2.3 AO Attachment - Small
(PRO2038)
2.1.2.1 Zimmer/Hudson Drill (PRO2046)
Specifications: Collet: Accepts Zimmer, Hall Series 3,
Hall Series 4, and Hudson
accessories Cannulation: 5.1 mm Color Ring: Blue
Specifications: Collet: Accepts small ASIF / AO type
accessories Cannulation: 3.25 mm Color Ring: Brown
2.1.2.4 Trinkle /AO Attachment (PRO2029)
Specifications: Collet: Accepts Trinkle and ASIF/AO
accessories
6
Trinkle Shank Accessories for the Trinkle/AO Attachment
1. To attach accessories to the Trinkle/AO attachment:
(a) Place the handpiece in the safe posi-
tion.
(b) Pull the collet sleeve back.
Cannulation: 3.4 mm Color Ring: Purple
(c) Align the dimple on the Trinkle shank
with the black arrow on the outer collet sleeve. Totally insert the T rinkle shank. The spring-loaded inner sleeve will retract.
(d) Release the collet sleeve and rotate the
accessory until it is completely engaged. Pull the accessory firmly to ensure proper engagement.
(e) To remove the accessory, pull back the
outer collet sleeve and remove the accessory.
AO/ASIF Drill Bits for the Trinkle/AO Attachment
7
2.1.3 Jacobs Chucks
1. Align the flat portion of the drill bit shank with the black arrow on the outer collet sleeve.
2. Insert the drill bit shank into the collet as far as it will go without pulling back the collet sleeve. Twist the shank to make sure it is aligned properly, it should not spin in the collet.
3. Pull back on the collet sleeve while pushing the shank completely into the collet.
1. To attach accessories to the Jacobs Chuck attachments:
(a) Place the handpiece in the safe posi-
tion.
(b) Insert the accessory shank into the
chuck. Secure the chuck with the Jacobs Chuck Key.
2.1.3.1 5/32” Jacobs Chuck
(PRO2030)
Specifications: Collet: 5/32” Jacobs Chuck
4. Release the collet sleeve. The shank is now locked into the collet. Pull the drill bit firmly to verify it is properly seated.
5. To remove the drill bit, pull back on the col­let sleeve and remove the bit.
Cannulation: 3.9 mm Color Ring: Green Replacement Key: 999-53
8
2.1.3.2 1/4” Jacobs Chuck (PRO2041)
Specifications: Collet: 1/4” Jacobs Chuck Cannulation: 5.1 mm Color Ring: Gold Replacement Key: 999-53
2.1.3.3 1/4” High Torque Jacobs Chuck (PRO2042)
2.1.4 Keyless Chucks
1. To attach accessories to Keyless Chuck attachments:
(a) Place the handpiece in the safe posi-
tion. (b) Insert accessory shank into chuck. (c) While holding the knurled ring below
the chuck, turn the knurled portion of
the chuck and secure the accessory.
NOTE: The K eyless Chuck will loosen if the handpiece is operated in the reverse or oscil­lating drill modes.
2.1.4.1 1/8” Keyless Chuck (PRO2050)
Specifications: Collet: 1/4” Jacobs Chuck Cannulation: 5.1 mm Color Ring: Gold/Red Replacement Key: 999-53
Specifications: Collet: 1/8” Keyless Chuck Cannulation: 2.0 mm Color Ring: Green
9
2.1.4.2 1/4” Keyless Chuck (PRO2250)
Specifications: Collet: 1/4” Keyless Chuck Cannulation: 4.1 mm Color Ring: Copper
2.1.4.3 3/8” Keyless Chuck (PRO2375)
2.1.4.4 Radiolucent Drive Adaptor (PRO2514)
1. To attach a radiolucent drive attachment:
(a) Place the handpiece in the safe posi-
tion.
(b) Slide the radiolucent drive attachment
onto the adaptor until it is completely seated against the collar of the adaptor.
Specifications: Collet: 3/8” Keyless Chuck Cannulation: 4.1 mm Color Ring: Copper
NOTE: Refer to the manufacturer’s instructions on the proper use of the radiolu­cent drive.
CAUTION: Do not drive screws or tap holes with this adaptor.
10
Advancement Lever
Wire Driver (PRO5028)
for Battery Handpieces
2.1.5 Wire and Pin Driving Attachments
NOTES:
1. See the appropriate PowerPro handpiece
instruction manual for information to insert and drive wires and pins.
2. The Wire and Pin Driving attachments
should only be used in DRILL or Oscil­lating Drill setting and are not indicated to be used in the SCREW setting.
Wire and Pin Driving attachments have the fol­lowing specifications in the DRILL setting:
Advancement Lever
Pin Driver (PRO5032)
for Battery Handpieces
2.1.5.1 Wire Driver (PRO5028) for Battery Handpieces
Specifications: Collet: Wire Driver Cannulation: Accepts wires from 0.028 in.
(0.71 mm) to 0.062 in. (1.57 mm)
Equipped with a Gold advancement lever
2.1.5.2 Pin Driver (PRO5032) for Electric Handpieces
Specifications:
Variable Speed: 0-1250 rpm Torque (forward and reverse): 35 in. lbs.
Insertion of pins and wires, and the functionality of the handpiece with either pins or wires is the same with either attachment.
Collet: Pin Driver Cannulation: Accepts wires from 0.062 in.
(1.57 mm) to 0.157 in. (3.9 mm) Color Ring: Black Equipped with a Gold advancement lever
11
2.1.6 Sawing Attachments
NOTES:
1. See the appropriate PowerPro handpiece instruction manual for information to insert and drive wires and pins.
2. Do not operate any saw attachment (Reciprocating Saw - PRO2045, Sagittal Saw - PRO2043) in the oscillate mode. They are only to be operated in the drill mode.
3. Operating speed will vary based on the power source in use.
2.1.6.1 Sagittal Saw Attachment
(PRO2043)
2.1.6.2 Reciprocating Saw Attachment (PRO2045)
Specifications: Operating Speed: 0 - 26,000 cpm
Cutting Stroke: 0.125 inch (3.2mm)
NOTE: The r eciprocating saw attachment is designed to accept Hall 5052-058 thru -061, ­073, -179, -258 thru -261, -273, -276 and -279 series blades. Refer to the Hall Catalog for blade information.
Specifications: Operating Speed: 0 - 26,000 cpm Stroke: 4° arc
NOTE: The sagittal saw attachment accepts only Hall 5023 Series Sagittal Saw blades.
3.0
Regular and proper maintenance of your Power-
Pro attachments are the best way to protect your
investment. It is essential that you have your powered surgical instruments serviced as sched­uled so as to retain their optimum performance and reliability, which will re ward you with safer , less problematic product performance over time. The recommended maintenance interval for ser­vice of your PowerPro attachments is every 24 months.
Proper care and handling of the instruments on a day-to-day basis, which includes proper day-to­day operation, cleaning, and sterilization, are extremely important to ensure safe and efficient operation.
Your authorized Hall Surgical service depart­ment is the most knowledgeable about the Pow-
erPro attachments and will provide competent
and efficient service. Service at Hall Surgical at the recommended service intervals 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 attachments or attachment failure and is not recommended. See “4.3 Lin-
vatec and Hall ranty” on page 19 for more information on
product warranties.
MAINTENANCE
®
Surgical Instrument War-
3.1 Cleaning and Sterilizing
3.1.1 Cleaning Precautions
1. Follow universal precautions for protective apparel when handling and cleaning con­taminated instruments.
2. Do not lubricate any attachments.
3. Never immerse attachments.
4. Never clean attachments with bleach, chlorine-based detergents, liquid or chemical disinfectants, or any products con­taining sodium hydroxide (such as INSTRU-KLENZ or Buell Cleaner). They will degrade the anodized aluminum coat­ing.
5. Never clean equipment in an ultrasonic cleaner or a combination washer/sanitizer.
6. Saw blades and bits are single-use only. Do not resterilize. Dispose of properly after use.
12
3.1.2 Attachment Cleaning Instructions
Clean attachments as soon as possible after use.
1. Remove the attachment from the handpiece
prior to cleaning.
2. Thoroughly scrub attachments with a clean,
soft brush dampened with a mild, pH-balanced detergent. Remove all traces of blood, debris and stains. Do Not
immerse equipment in soap solution or
rinse water.
13
3. Clean the cannulated section of the attach-
ment by performing the following: (a) Feed the wire end of a cleaning brush
through the attachment.
(b) Pull the brush completely through the
attachment. Repeat until all debris is removed.
4. Manipulate all moving parts of attachments
to ensure all debris is removed. If not, clean again until all debris is removed.
5. Rinse attachments under running water to
remove all traces of soap.
6. Flush all surfaces free of tap water with dis-
tilled water to prevent metal discoloration.
7. Gently shake attachments free of water and
wipe the surfaces with a clean, lint-free towel.
3.1.3 Sterilization Information
S
team sterilization is safe and effective and has no contraindications for its use in ster­ilizing attachments.
3.1.3.1 Sterilization Warnings, Precautions and Notes
WARNING: The use of disinfecting solu­tions for an exterior instrument wipe will not sterilize equipment and is not recommended.
1. Do not sterilize attachments with Ethylene
Oxide (EtO).
2. Never sterilize in a washer/sanitizer,
STERIS System, STERRAD System, Abtox Plazlyte™ or comparable steriliza­tion methods.
3. Do not sterilize attachments in cold ster-
ilants like CIDEX.
4. Do Not “Peel Pack” attachments for steril-
ization. Sterilization in a sealed pouch traps moisture which can cause damage.
NOTES:
1. The following guidelines do not guarantee that the device is sterile after the procedure. Your institution is still responsible for the normal sterility assurance validation.
2. Additional drying time may be required for complete heat and moisture dissipa­tion. Operation of attachments that are not completely cool or dry may decrease performance and/or reliability.
3. Sterilization validation is based on AAMI guidelines (Association for the Advance­ment of Medical Instrumentation).
All attachments may be processed in a pre-vac­uum steam sterilizer (Steam Pre-vacuum) or in a gravity (downward) displacement sterilizer (Steam Gravity). Place attachments in an appro­priate instrument tray or a fully perforated, wrapped container, when applicable.
PowerPro sterilization cases are sold separately.
Consult the sterilization guidelines on the fol­lowing page or the information insert supplied with that particular tray.
14
5. Attachments with collet mechanisms must be sterilized with the collet fully open .
6. Do not use attachments 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.
Minimum recommended sterilization exposure times are as follows:
Table 1: Sterilization Parameters
Minimum
Sterilization T ype Temperature
Sterilization Guidelines for Sterilizing PowerPro Attachments Individually or in the PowerPro PRO5090 System Sterilization Case
Steam Pre-vacuum 270 - 272°F (132 - 133°C) 4 minutes 8 minutes minimum * Steam Gravity 270 - 272°F (132 - 133°C) 10 minutes 8 minutes minimum * Steam Gravity 250 - 254°F (121 - 123°C) 40 minutes 8 minutes minimum *
Exposure
Time
Dry Cycle
Sterilization Guidelines for Sterilizing P Sterilization Case (Lid - PRO2091/Tray - PRO2092)
Steam Pre-vacuum 270 - 272°F (132 - 133°C) 4 minutes 8 minutes minimum * Steam Gravity 270 - 272°F (132 - 133°C) 15 minutes 8 minutes minimum * Steam Gravity 250 - 254°F (121 - 123°C) 40 minutes 8 minutes minimum *
Sterilization Guidelines for Sterilizing PowerPro Attachments in the PowerPro Complete Sterilization Case (PRO2090)
Steam Pre-vacuum 270 - 272°F (132 - 133°C) 4 minutes 10 minutes minimum * Steam Gravity 270 - 272°F (132 - 133°C) 15 minutes 10 minutes minimum * Steam Gravity 250 - 254°F (121 - 123°C) 40 minutes 10 minutes minimum *
* CAUTION: The recommended dry cycle must be run on all attachments every time they are sterilized. Failure to use a dry cycle may lead to reduced product performance or prema­ture product failure. Operation of an attachment that is not completely cool and dry may decrease performance and/or reliability.
owerPro Attachments in the PowerPro Basic
15
4.0 CUSTOMER SERVICE, REPAIRS and WARRANTY
4.1 Customer Service
f you need technical assistance regarding the use or application of this product, or you encounter a problem that requires servicing or repair, contact Linvatec Customer Service at 800-925-4255
I
or your Hall Surgical Representative. Outside the U.S. contact your local Linvatec Hall Repre-
sentative. Report any events involving injuries or malfunctions to the Linvatec Regulatory Affairs Department. Returning products for any reason requires a Return Goods (R.G.) number that can be obtained by
contacting Linvatec Customer Service. Please provide the following information:
Product Number
Serial Number
Reason for Return
Original Invoice Number
Date of Purchase
Repairs
Products returned for repair must have an authorized Return Goods (R.G.) number prominently dis­played on the box and included on all paperwork. Refer to this number if making inquiries about the repair status. Please call Linvatec Customer Service and provide the following information to obtain an R.G. number prior to returning a product for repair:
Product Number
Serial/Lot Number - if applicable
Original Invoice Number
Date of Purchase
Detailed description of the problem
If you require a quote - Notify Customer Service when requesting your R.G. number, or on the paperwork returned with the product indicate that a quote is required. If a quote is not requested the repair will be processed and your account billed accordingly - provided the repair is not covered under warranty.
16
Minimum repair charge - There is a minimum repair charge (except for products covered under warranty). This charge also applies to products returned for repair in which a problem cannot be veri­fied.
Whenever it is required to return your product for repairs, be sure to package it in a protective carton. W e recommend that you sa ve the original shipping container for this purpose. In-transit damage is not covered by the warranty, therefore, it is best to always insure shipments.
Returned Goods
If it becomes necessary to return a product after purchase, the product must be returned within 45 days of ship date. Returned products are subject to a restocking fee of fifteen percent (15%) of the purchase price (minimum charge $25 U.S. Dollars). Products returned as a result of errors attributable to Linvatec are exempt from this fee.
All returns must be accompanied by an authorized Return Goods (R.G.) number which must be prom­inently displayed on the box and included on all paperwork.
Returns must be shipped prepaid freight, otherwise they will not be accepted. Products must be cleaned, decontaminated, and sterilized, if applicable, before returning. Products that are contami­nated with biohazardous materials will be immediately returned to you for proper decontamination and sterilization.
Products Not Eligible for Credit
Single-use, sterile products returned with the outer packaging seal(s) broken
Products damaged by customer misuse
Products purchased through a sales promotion
Products damaged during return due to inadequate packaging
Less than full packages - all products must be returned in original packaging
Obsolete products
Linvatec Attn.: Customer Service Dept. 11311 Concept Boulevard Largo, Florida 33773-4908 USA
Customer Service (within U.S.) Phone: 800-925-4255
FAX: 727-399-5256
(outside U.S.) Phone: 727-392-6464
FAX: 727-397-4540 Linvatec Regulatory Affairs (within U.S.) Phone: 800-237-0169
(outside U.S.) Phone: 727-399-6620
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4.2 Handpieces, Attachments and Accessories
REF Description
PowerPro Handpieces
PRO5100 PowerPro Battery Modular Handpiece PRO5200 PowerPro Battery Two-Trigger Handpiece PRO5250 PowerPro Battery Two-Trigger Handpiece (International) PRO5300 PowerPro Battery Oscillator Handpiece
PowerPro Handpiece Attachments
PRO2029 Trinkle/A O Attachment PRO2030 5/32” Jacobs Chuck Attachment w/key PRO2038 AO Small Attachment PRO2040 AO Reamer Attachment PRO2041 1/4” Jacobs Chuck Attachment PRO2042 1/4” High Torque Jacobs Chuck Attachment PRO2043 Sagittal Saw Attachment PRO2045 Reciprocating Saw Attachment PRO2046 Zimmer/Hudson Drill Attachment PRO2047 Zimmer/Hudson Reamer Attachment PRO2050 1/8” Keyless Chuck Attachment PRO2250 1/4” Keyless Chuck Attachment PRO2375 3/8” Keyless Chuck Attachment PRO2060 Aesculap Reamer Attachment PRO2070 AO Drill Attachment PRO2514 Radiolucent Drive Adaptor Attachment PRO5028 Wiredriver Attachment for Battery Handpieces PRO5032 Pin Driver Attachment for Battery Handpieces PRO5090 System Sterilization Case
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4.3 Linvatec and Hall® Surgical
Instrument Warranty
13. APEX Autoclavable Camera Heads - 500 use service program (prorated credit after 250 uses)
invatec Corporation, (“the Company”), warrants to the first purchaser or lessee
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(“Customer”) that the Linvatec and Hall Surgical instruments, attachments and parts manufactured by or for the Company (hereinaf­ter collectively “Instruments”) hav e been tested, inspected, and shipped in proper working order.
The Company warrants all new Instruments to be free from defects in materials and workman­ship for the following periods, measured from Customer’s receipt:
1. Powered Surgical Equipment (battery, elec-
tric, pneumatic) - Twelve (12) Months
2. Battery Chargers - Twelve (12) Months
3. Battery Packs - Three (3) Months
4. Burs and Blades - Upon receipt
5. Bur Guards, Blade Guards, and Attach-
ments - Six (6) Months
6. Skull Perforators - Six (6) Months
14. Envision 1/4” Autoclav able Camera Heads ­500 uses or Twelve (12) months, whichever comes first
15. Envision Autoclavable 3CCD Camera Heads - Twelve (12) Months
16. Shutt SLG Instruments - Lifetime
17. Shutt Non-SLG Instruments - Twelve (12) Months
18. Footswitches - Twelve (12) Months
19. Irrigation Systems - Twelve (12) Months
20. Reusable Procedure Specific Instruments ­Twelve (12) Months
Linvatec recommends that the Hall P attachments described in this manual be returned to the factory for routine maintenance every 24 months.
Failure to follow this routine maintenance schedule may result in damage to the attach­ments and may invalidate the product warranty.
owerPro
7. Pneumatic Hoses - Six (6) Months
8. Handpiece Cords and Power Cords - Six (6) Months
9. Camera Consoles - Twenty-four (24) Months
10. Video Components - Twelve (12) Months
11. Video Cables and Light Guides - Three (3) Months
12. Non-autoclavable Camera Heads - Twelve (12) Months
If within the specified original warranty period, or within the service warranty period for a repaired product, the Customer discovers that an Instrument has a defect in material and/or work­manship, the Customer must promptly notify the Company. If it becomes necessary to return the Instrument to the Company, the Customer must (a) acquire a “Returned Goods” authorization from the Company Customer Service Depart­ment, (b) pack the unit carefully, and (c) return it to the Company via express courier service freight, prepaid.
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Within a reasonable time after receipt of the Instrument, the Company will investigate and shall correct any defect covered by warranty by providing, at its option, one of the following: service or repair of the Instrument, a replace­ment of the Instrument, or a refund of the pur­chase price of the Instrument. All parts and assemblies replaced by the Company shall become the property of the Company. These remedies are the Customer’s e xclusive remedies under this warranty.
The Company warrants that all parts and assem­blies used in the repair or service of Instruments meet new part functional specifications, although some parts or assemblies may have been remanufactured.
The foregoing limited warranties do not apply to:
1. Instruments which have been tampered with, altered, abused or misused.
2. Instruments damaged through use with other than Company authorized accessories, attachments, burs or blades.
3. Instruments not manufactured by or for the Company.
4. Instruments used for purposes other than those for which they were designed and manufactured, including use in any way inconsistent with the instructions and warn­ings contained in the Company instruction manuals and package inserts.
5. Instruments which were last serviced, refur­bished, reprocessed or reconditioned by a non-authorized service entity.
6. Instruments which did not have their afore­mentioned routine maintenance schedule followed.
The foregoing limited warranties are in lieu of all other warranties, express or implied, including, but not limited to, the implied war­ranties of merchantability and fitness for a particular purpose.
Except claims for personal injury, in no case shall the Company be liable for any special, incidental or consequential damages based upon breach of warranty or any other legal theory. Some jurisdictions do not allow limits on war­ranties, or on remedies, and, in such jurisdic­tions, the limits in this and the preceding paragraphs may not apply.
The Company reserves the right (a) to make design changes to Instruments at anytime with­out notice to Customer and without incurring any obligation to incorporate those changes into Instruments previously purchased or leased, and (b) to make changes from time to time in the contents of any publication, instruction manual or package insert without any obligation to notify Customers of such revisions or changes.
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Hall® Surgi cal
11311 Concept Boulevard Largo, Florida 33773-4908
Phone: (727) 392-6464
Customer Service: (800) 925-4255
USA Fax: (727) 399-5256
International Fax: (727) 397-4540
www.linvatec.com
© 2002 Linvatec Corporation, a subsidiary of ConMed Corporation
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All rights reserved. Printed in USA W41-065-004 Rev. C 02/2002
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