Maxi Driver Manual
Maxi Driver Manual
Maxi Driver Manual
Maxi-Driver
Pneumatic System
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 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 condential 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. Serial No Date
Handpiece Model No. Serial No Date
Handpiece Model No. Serial No Date
Handpiece Model No. Serial No Date
Table of Contents Page
i
1.0 INTRODUCTION
1.1 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.2 General Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.3 Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.4 Pneumatic Handpiece (L100) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.0 INSTALLATION and OPERATION
2.1 Power Source and Regulator Installation and Operation . . . . . . . . . . . . . . . . . . . . . . . 4
2.2 Attachments and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2.2.1 Connecting/Removing Attachments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.2.2 Automatic Pin Driver Attachment (L111) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.2.3 Oscillating Saw Attachment (L320A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.2.4 Reciprocating Saw Attachment (L140A) . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
2.2.5 Jacobs Chuck Attachment (L110) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.2.6 Trinkle Chuck Attachment (L112) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.2.6.1 Automatic Screwdrivers for the Trinkle Chuck
Attachment (D520/D524) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
2.2.7 Hudson Chuck Attachment (L113) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
2.2.8 Hudson Reamer Drive Attachment (L150) . . . . . . . . . . . . . . . . . . . . . . . . . . 18
2.2.9 Zimmer Chuck Attachment (L115) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
2.2.10 Zimmer Reamer Drive Attachment (L153) . . . . . . . . . . . . . . . . . . . . . . . . . . 20
2.2.11 ASIF/AO Twist Drill Chuck Attachment (L513) . . . . . . . . . . . . . . . . . . . . . 21
2.2.12 ASIF/AO Flexible Chuck Attachment (L514). . . . . . . . . . . . . . . . . . . . . . . . 22
2.2.13 ASIF/AO Reamer Drive Attachment (L151). . . . . . . . . . . . . . . . . . . . . . . . . 23
2.2.14 Aesculap Reamer Drive Attachment (L152) . . . . . . . . . . . . . . . . . . . . . . . . . 24
2.2.15 Aesculap Chuck Attachment (L515) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
ii
Table of Contents Page
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 Handpiece and Attachment Lubrication Instructions . . . . . . . . . . . . . . . . . . 29
3.1.4 Sterilization Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
3.1.4.1 Sterilization Warnings, Precautions and Notes . . . . . . . . . . . . . . . 30
3.2 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
4.0 TECHNICAL SPECIFICATIONS
4.1 Handpiece. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
4.2 System Environmental Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
5.0 CUSTOMER SERVICE and WARRANTY
5.1 Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
5.2 Handpieces, Attachments and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
5.3 Linvatec
and Hall
Surgical Instrument Warranty . . . . . . . . . . . . . . . . . . . . . . . . . 42
1
1.0
INTRODUCTION
t is recommended that personnel study this
manual before attempting to operate, clean
or sterilize the Hall
Maxi-Driver
Pneu-
matic 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.
1.1 Intended Use
he Maxi-Driver Pneumatic Instrument
System is designed to provide optimal
speed and torque for large bone orthope-
dic surgery, including cutting, drilling, pinning,
sawing, reaming and driving screws. The system
attachments are completely interchangeable
between the Maxi-Driver pneumatic, battery,
and electric handpieces.
1.2 General Warnings
1. This equipment is designed for use by med-
ical professionals completely familiar with
the required techniques and instructions for
use of the equipment.
Read and follow all
warning and caution notices and instruc-
tions 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 opera-
tion.
Ensure all attachments, accessories and
hoses are correctly and completely
attached to the handpiece.
Check all pneumatic equipment for any
air or nitrogen leakage. If leakage is
noticed, return for service.
Always inspect pneumatic hoses for
signs of wear or damage.
Do not use
worn or damaged hoses. Replace
immediately
.
Always inspect for bent, dull or
damaged blades or drill bits.
Do not attempt to straighten or
sharpen. Do not use if damaged. After
use, dispose of properly.
I
T
2
6. Oscillating and reciprocating saw
blades, and bits are single-use only.
Do not resterilize. After use, dis-
pose of properly.
7. Handpieces are factory sealed. Do
not disassemble.
8. Do not pressurize hoses until all
ttings have been connected and checked.
9. Never operate pneumatic handpiece above
110 psi (7 kg/cm
2
) dynamic pressure unless
an extension hose is added to the standard
10 foot hose. Excessive pressure may cause
damage to the instrument and exert unusual
stress on the hose.
10. The nitrogen regulator is only for use with
pneumatically powered surgical devices.
11. Continually check all handpieces and
attachments for overheating. Discontinue
use and return equipment for service as nec-
essary. Overheating of the bit or blade may
cause damage to the bit or blade and may
cause thermal necrosis.
12. Do not attach, insert or remove accessories
or attachments while the handpiece is oper-
ating.
Place the handpiece safety to the
appropriate safe position prior to instal-
lation or removal of items
.
13. After each use, thoroughly clean the hand-
piece and attachments (See
3.1 Cleaning
and Sterilizing on page 28
).
1.3 Symbol Denitions
Attention, consult accompany-
ing documents.
No user service recommended.
Refer servicing to qualied Lin-
vatec service personnel.
Indicates product component
should not be sterilized.
Indicates product component
should not be immersed in any
type of uid.
Indicates handpiece should not
be immersed in any type of uid.
Indicates product should not be
oiled or lubricated.
Single Use Only
Eye Protection Required
Caution: Federal Law restricts
this device to sale by or on the
order of a physician
Rx ONLY
3
1.4 Pneumatic Handpiece (L100)
Attachment Collet-Lock
Twist to
release 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.
Direction Button
Press this button
inward to place the handpiece in the for-
ward (clockwise) direction. Press in the
opposite direction for reverse (counter-
clockwise).
Activation Trigger
Used to activate the
handpiece when the direction button is in
either the forward or reverse position.
Safety Slide
Slide the safety slide
upward to place the handpiece in the safe,
or non operative position. Slide downward
to place the handpiece in an operating
mode.
Hose Connector
The air hose attaches
here from the air supply tank. The connec-
tor swivels 360 to help eliminate hose
binding.
Cannulation
Used to stabilize long
wires or pins.
4
2.0
INSTALLATION and
OPERATION
2.1 Power Source and Regulator
Installation and Operation
WARNING: Not for inhalation. Does not
support life. For use with powered surgical
devices only.
Research and experience have shown that water-
pumped dry nitrogen is the ideal source for
pneumatically-powered surgical instruments.
Water-pumped dry nitrogen is 99.97% pure, and
will not support combustion or corrosion. Com-
pressed dry nitrogen is recommended as the
pneumatic power source. It is available in stan-
dard cylinders.
Compressed dry nitrogen must meet the follow-
ing specications 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 specied.
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 110 psi
(7 kg/cm
2
) operating pressure unless a hose
longer than the standard 10 ft. Air Hose
(REF D201) or extension hose is used. Add an
additional 1 psi for every extra foot of hose.
The Maxi-Driver pneumatic handpiece
should be operated at 110 psi (7 kg/cm
2
) for
maximum operating efciency, 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/cm
2
) in the tank. Never run the tank
pressure below 200 psi (14.0 kg/cm
2
).
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.
5
2. Install the regulator with a 1 1/8 inch
wrench.
NOTE: The threaded adaptor of the nitro-
gen regulator is designed to t nitrogen t-
tings 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 PRES-
SURE EXERTED TO THE REGULA-
TOR MAY CAUSE INTERNAL
DAMAGE.
4. Slowly turn the tank valve fully open (coun-
terclockwise). 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. To connect the handpiece to the hose.
(a) Place the handpiece safety slide in the
safe (up) position.
6
(b) Before connecting the hose to the
handpiece, ensure that the O-Ring on
the end of the hose connector is in
place. If damage is present, replace the
O-Ring (REF 8016).
(c) Grasp the hose connector and insert it
into the connector on the bottom of the
handpiece.
(d) Twist the hose coupling to the right
(clockwise) and slightly pull on the
hose so the internal pins securely
engage in the indentations.
(e) To remove the hose from the hand-
piece, reverse steps 6a and 6b.
7. With the safety slide still in the safe posi-
tion, install the desired attachment and
accessory at this time by referencing
2.2.1
Connecting/Removing Attachments on
page 9
.
8. Operating pressure is established by gradu-
ally turning the regulator control knob
clockwise.
ALWAYS establish the desig-
nated pressure on the operating pressure
gauge with the instrument running.
9. To operate the handpiece:
(a) Release the safety by sliding the safety
slide downward.
(b) Place the directional control button to
the desired operating position, either
forward (F) or reverse (R).
(c) Depress the trigger.
10. While, depressing the trigger, adjust the
nitrogen regulator until the gauge indicates
110 psi.
11. 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 coun-
terclockwise until it stops.
(d) Turn the female Schrader to the right to
disengage the male Schrader tting.
a
c
b
7
(e) The hose can then be removed from the
connector. Hold the end of the hose
securely when disengaging the male
Schrader tting to prevent possible
damage to the diffuser.
12. If the Hall Pneumatic Connector* is being
used:
(a) Locate the button marked PRESS.
(b) Depress and hold the button until the
audible release of residual gas is com-
pleted.
(c) Release the button and remove the
hose.
(d) If the hose cannot be easily removed,
depress the PRESS button again,
release it and remove the hose.
* U.S. Patent 4,863,201
8
2.2 Attachments and Accessories
Aesculap Reamer Drive Attachment (L152)
Zimmer Reamer Drive Attachment (L153)
Hudson Reamer Drive Attachment (L150)
ASIF/AO Reamer Drive Attachment (L151)
Automatic Pin Drive Attachment (L111)
Reciprocating Saw Attachment (L140A)
Oscillating Saw Attachment (L320A)
ASIF/AO Chuck Attachment (L514)
ASIF/AO Twist Drill Chuck Attachment
(L513)
Aesculap Chuck Attachment (L515)
Jacobs Chuck Attachment (L110)
Zimmer Chuck Attachment (L115)
Hudson Chuck Attachment (L113)
Trinkle Chuck Attachment (L112)
Automatic Screwdriver Attachments
(D520/D524)
11
12
13
14
15
11
12
13
14
15
9
2.2.1 Connecting/Removing
Attachments
All Maxi-Driver Handpiece attachments con-
nect/disconnect in the same manner and are
interchangeable between the battery and pneu-
matic handpieces. See pages 9 through 25 for
attachment information.
1. To connect an attachment:
(a) Ensure the handpiece is in the safe
position.
(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.
(c) Ensure the attachment is secure by
pulling it outward.
(d) To remove the attachment, repeat steps
1(a) and 1(b), and pull out the attach-
ment.
2.2.2 Automatic Pin Driver
Attachment (L111)
The Automatic Pin Driver is designed to drive
pins (wires) and drill bits compatible with the
specications below:
Through Cannulation: 1.6 - 4.0 mm
(0.062 in to 0.156 in.)
(1/16 - 5/32 in.)
Nosepiece
Pin Grasping Lever
Adjustment Sleeve
10
1. To insert a pin:
(a) Ensure the handpiece is in the safe
position before inserting or removing a
pin.
(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.
(c) Insert the pin. While holding the nose-
piece, tighten the adjustment sleeve
until the pin is held rmly in place.
(d) Loosen the adjustment sleeve one half
turn. The pin should slide freely within
the Pin Driver until the grasping lever
is depressed.
(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.
2. To operate the handpiece:
(a) Release the safety and place the hand-
piece in the forward position.
(b) To grip and drive the pin, depress the
grasping lever until ush 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.
11
2.2.3 Oscillating Saw Attachment
(L320A)
Specications:
Blade Excursion Arc: 4-1/2 arc
NOTES:
1. The L320A Oscillating Saw attachment
accepts L series blades.
2. For more precise osteotomies, lower cut-
ting temperatures, and reduced instru-
ment wear, use a new blade for each
procedure.
3. Oscillating Saw blades are single-
use only. Dispose of properly
after use.
1. To attach the Oscillating Saw attachment,
reference
2.2.1 Connecting/Removing
Attachments on page 9
.
2. The Oscillating Saw attachment may be
placed in any of four positions at 90 degree
angles.
3. To attach a blade:
(a) Ensure the handpiece is in the safe
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 cor-
rectly seated when the locking button
clicks up into place.
(c) Ensure the blade is secured by pulling
outward on the blade.
4. The blade may be placed in ve positions
within a 180 degree radius.
5. To remove a blade:
(a) Ensure the handpiece is in the safe
position.
(b) Depress the center retaining button,
pull the blade forward and lift the blade
off the pins.
12
2.2.4 Reciprocating Saw Attachment
(L140A)
Specications:
Blade Stroke Length: 6.3 mm (0.25 in.)
NOTES:
1. The L140A Reciprocating Saw attach-
ment accepts P series blades.
2. For more precise osteotomies, lower cut-
ting temperatures, and reduced instru-
ment wear, use a new blade for each
procedure.
3. Reciprocating Saw blades are sin-
gle-use only. Dispose of properly
after use.
1. To attach the Reciprocating Saw attach-
ment, reference
2.2.1 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:
(a) Turn the twist-lock collar counter-
clockwise.
(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.
(c) Release the twist-lock collar. Ensure
the blade is secured by pulling outward
on the blade.
4. To remove a blade:
(a) Ensure the handpiece is in the
safe position.
(a) Turn the twist-lock collar counter-
clockwise and remove the blade.
13
2.2.5 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 specications below:
Specications:
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
1. To attach the Jacobs Chuck attachment, ref-
erence
2.2.1 Connecting/Removing
Attachments on page 9
).
2. Insert the desired accessory into the chuck
and secure it with the Chuck Key (D298L).
14
2.2.6 Trinkle Chuck Attachment (L112)
This attachment is designed to drive drill bits,
automatic screwdrivers, and other accessories
with Trinkle ttings.
Specications:
Through Cannulation: 4.8 mm (0.187 in.)
(3/16 in.)
1. To attach a Trinkle Chuck attachment, ref-
erence
2.2.1 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.
(c) Ensure the accessory is securely seated
in the attachment before use by pulling
outward on it.
3. To remove accessory, pull back the locking
sleeve chuck and remove the accessory.
15
2.2.6.1 Automatic Screwdrivers for the
Trinkle Chuck Attachment
(D520/D524)
Screwdriver (D520)
Slotted Bit (D521)
Cruciate Bit (D522)
Phillips Bit (D523)
Screwdriver (D524)
Hex Bit for AO type screws (D525)
1. To insert a bit into the screwdriver.
(a) Unscrew the bit retainer section (coun-
terclockwise) from the screwdriver.
(b) Insert the bit into the back of the screw-
driver, tip rst.
(c) Slide the bit retainer over the bit and
thread the retainer back on the screw-
driver by turning it clockwise until
tight.
16
(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.
(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 rmly and press the
knurled portion of the screwdriver
body forward so the teon collar snaps
over the head of the screw.
3. To remove the screw, retract the teon col-
lar and remove the screw.
17
2.2.7 Hudson Chuck Attachment
(L113)
This attachment is designed to drive intramedul-
lary reamers and other accessories with Hudson
ttings.
Specications:
Through Cannulation: 4.8 mm (0.187 in.)
(3/16 in.)
1. To attach a Hudson Chuck attachment, ref-
erence
2.2.1 Connecting/Removing
Attachments on page 9
).
2. To insert a Hudson Shank accessory into the
Hudson Chuck attachment:
(a) Pull the locking sleeve chuck back.
Insert the accessory and release the
locking sleeve.
(b) Ensure the accessory is securely seated
in the attachment before use.
CAUTION: Operating the intramedullary
exible reamer in reverse may cause the
reamer to jam in the intramedullary canal or
damage the reamer shaft.
3. To remove the accessory, pull back the
locking sleeve of the chuck and remove the
accessory.
18
2.2.8 Hudson Reamer Drive
Attachment (L150)
This attachment is designed to drive acetabular
or intramedullary (exible or rigid) reamers
with Hudson ttings.
Specications:
Through Cannulation: 4.8 mm (0.187 in.)
(3/16 in.)
1. To attach a Hudson Reamer Drive attach-
ment, reference
2.2.1 Connecting/
Removing Attachments on page 9
).
2. If desired, slide the Holding Handle (L296)
accessory over the Reamer Drive attach-
ment. Secure the Holding Handle accessory
in the desired position by turning the handle
clockwise until tight.
3. To insert a Hudson Shank accessory into the
Hudson Reamer Drive attachment:
(a) Pull the locking sleeve chuck back.
Insert the accessory and release the
locking sleeve.
(b) Ensure the accessory is securely seated
in the attachment before use.
CAUTION: Operating the intramedullary
exible reamer in reverse may cause the
reamer to jam in the intramedullary canal or
damage the reamer shaft.
4. To remove the accessory, retract the locking
sleeve of the chuck and remove the acces-
sory.
19
2.2.9 Zimmer Chuck Attachment
(L115)
This attachment is designed to drive exible or
rigid reamers with Zimmer-type ttings.
Specications:
Through Cannulation: 4.8 mm (0.187 in.)
(3/16 in.)
1. To attach a Zimmer Chuck attachment, ref-
erence 2.2.1 Connecting/Removing
Attachments on page 9).
2. To insert a Zimmer Shank accessory into
the Zimmer Chuck attachment:
(a) Pull the locking sleeve chuck back.
Insert the accessory and release the
locking sleeve.
(b) Ensure the accessory is securely seated
in the attachment before use.
CAUTION: Operating the intramedullary
exible reamer in reverse may cause the
reamer to jam in the intramedullary canal or
damage the reamer shaft.
3. To remove the accessory, retract the locking
sleeve of the chuck and remove accessory.
20
2.2.10 Zimmer Reamer Drive
Attachment (L153)
This attachment is designed to drive acetabular
or intramedullary (exible or rigid) reamers
with Zimmer-type ttings.
Specications:
Through Cannulation: 4.8 mm (0.187 in.)
(3/16 in.)
1. To attach a Zimmer Reamer Drive attach-
ment, reference 2.2.1 Connecting/
Removing Attachments on page 9).
2. If desired, slide the Holding Handle (L296)
accessory over the Reamer Drive attach-
ment. Secure the Holding Handle accessory
in the desired position by turning the handle
clockwise until tight.
3. To insert a Zimmer Shank accessory into
the Zimmer Reamer Drive attachment:
(a) Pull the locking sleeve chuck back.
Insert the accessory and release the
locking sleeve.
(b) Ensure the accessory is securely seated
in the attachment before use.
CAUTION: Operating the intramedullary
exible reamer in reverse may cause the
reamer to jam in the intramedullary canal or
damage the reamer shaft.
4. To remove the accessory, retract the locking
sleeve of the chuck and remove the acces-
sory.
21
2.2.11 ASIF/AO Twist Drill Chuck
Attachment (L513)
This attachment is designed to drive drill bits
with ASIF/AO (Synthes) type ttings.
Specications:
Through Cannulation: 4.8 mm (0.187 in.)
(3/16 in.)
1. To attach an ASIF/AO Twist Drill Chuck
attachment, reference 2.2.1 Connecting/
Removing Attachments on page 9).
2. To insert an ASIF/AO drill bit into the
ASIF/AO Twist Drill Chuck attachment:
(a) Pull the locking sleeve chuck back.
Insert the accessory and release the
locking sleeve.
(b) Ensure the accessory is securely seated
in the attachment before use.
3. To remove the accessory, retract the locking
sleeve of the chuck and remove accessory.
22
2.2.12 ASIF/AO Flexible Chuck
Attachment (L514)
This attachment is designed to drive intramedul-
lary (exible or rigid) reamers with ASIF/AO
(Synthes) type ttings.
Specications:
Through Cannulation: 4.8 mm (0.187 in.)
(3/16 in.)
1. To attach an ASIF/AO Flexible Chuck
attachment, reference 2.2.1 Connecting/
Removing Attachments on page 9).
2. To insert an ASIF/AO accessory into the
ASIF/AO Flexible Chuck attachment:
(a) Pull the locking sleeve chuck back.
Insert the accessory and release the
locking sleeve.
(b) Ensure the accessory is securely seated
in the attachment before use.
CAUTION: Operating the intramedullary
exible reamer in reverse may cause the
reamer to jam in the intramedullary canal or
damage the reamer shaft.
3. To remove the accessory, retract the locking
sleeve of the chuck and remove the acces-
sory.
23
2.2.13 ASIF/AO Reamer Drive
Attachment (L151)
This attachment is designed to drive acetabular
or intramedullary (exible or rigid) reamers
with ASIF/AO (Synthes) type ttings.
Specications:
Through Cannulation: 4.8 mm (0.187 in.)
(3/16 in.)
1. To attach an ASIF/AO Reamer Drive
attachment, reference 2.2.1 Connecting/
Removing Attachments on page 9).
2. If desired, slide the Holding Handle (L296)
accessory over the Reamer Drive attach-
ment. Secure the Holding Handle accessory
in the desired position by turning the handle
clockwise until tight.
3. To insert an ASIF/AO accessory into the
ASIF/AO Reamer Drive attachment:
(a) Pull the locking sleeve chuck back.
Insert the accessory and release the
locking sleeve.
(b) Ensure the accessory is securely seated
in the attachment before use.
CAUTION: Operating the intramedullary
exible reamer in reverse may cause the
reamer to jam in the intramedullary canal or
damage the reamer shaft.
4. To remove the accessory, retract the locking
sleeve of the chuck and remove the acces-
sory.
24
2.2.14 Aesculap Reamer Drive
Attachment (L152)
This attachment is designed to drive acetabular
or intramedullary (exible or rigid) reamers
with Aesculap ttings.
Specications:
Through Cannulation: 4.8 mm (0.187 in.)
(3/16 in.)
1. To attach an Aesculap Reamer Drive attach-
ment, reference 2.2.1 Connecting/
Removing Attachments on page 9).
2. If desired, slide the Holding Handle (L296)
accessory over the Aesculap Reamer Drive
attachment. Secure the Holding Handle
accessory in the desired position by turning
the handle clockwise until tight.
3. To insert an Aesculap accessory into the
Aesculap Reamer Drive attachment:
(a) Pull the locking sleeve chuck back.
Insert the accessory and release the
locking sleeve.
(b) Ensure the accessory is securely seated
in the attachment before use.
CAUTION: Operating the intramedullary
exible reamer in reverse may cause the
reamer to jam in the intramedullary canal or
damage the reamer shaft.
4. To remove the accessory, retract the locking
sleeve of the chuck and remove the acces-
sory.
25
2.2.15 Aesculap Chuck Attachment
(L515)
This attachment is designed to drive intramedul-
lary reamers and other accessories with Aescu-
lap ttings.
Specications:
Through Cannulation: 4.8 mm (0.187 in.)
(3/16 in.)
1. To attach an Aesculap Chuck attachment,
reference 2.2.1 Connecting/Removing
Attachments on page 9).
2. To insert an Aesculap accessory into the
Aesculap Chuck attachment:
(a) Pull the locking sleeve chuck back.
Insert the accessory and release the
locking sleeve.
(b) Ensure the accessory is securely seated
in the attachment before use.
CAUTION: Operating the intramedullary
exible reamer in reverse may cause the
reamer to jam in the intramedullary canal or
damage the reamer shaft.
3. To remove accessory, retract the locking
sleeve of the chuck and remove accessory.
26
3.0 MAINTENANCE
This section explains the importance of keeping
your Maxi-Driver Pneumatic System well main-
tained. It contains a maintenance schedule to
assist you in determining the maintenance inter-
val requirements of your instruments.
Regular and proper maintenance of your pow-
ered surgical instruments are the best way to
protect your investment. It is essential that you
have your powered surgical instruments ser-
viced as scheduled so as to retain their optimum
performance and reliability, which will reward
you with safer, less problematic product perfor-
mance over time. The following maintenance
schedule species which instruments need atten-
tion and how often you should have them ser-
viced.
The service and time intervals shown in the
maintenance schedule assume you will use the
instruments as indicated in this manual, includ-
ing proper day-to-day operation, cleaning, and
sterilization. Proper care and handling of the
instruments on a day-to-day basis are extremely
important to ensure safe and efcient operation.
Refer to section 2.0 of this instruction manual
for information on proper system installation
and operation and section 3.0 for proper day-to-
day maintenance.
Your authorized Linvatec Service Department is
the most knowledgeable about the instruments
and will provide competent and efcient service.
Service at Linvatec at the indicated service inter-
vals is mandatory to keep your product warran-
ties in effect. Any services and/or repairs done
by any unauthorized repair facility may result in
reduced performance of the instruments or
instrument failure and is not recommended. See
5.3 Linvatec and Hall
Surgical Instrument
Warranty on page 42 for more information on
product warranties.
27
Table 1: Maintenance Schedule
Catalog
Number
Product Description
6
Months
12
Months
L100 Maxi-Driver Pneumatic Handpiece
L110 Jacobs Chuck Attachment
L111 Automatic Pin Drive Attachment
L112 Trinkle Chuck Attachment
L113 Hudson Chuck Attachment
L115 Zimmer Chuck Attachment
L140 Reciprocating Saw Attachment
L150 Hudson Reamer Drive Attachment
L151 ASIF/AO Reamer Drive Attachment
L152 Aesculap Reamer Drive Attachment
L153 Zimmer Reamer Drive Attachment
L320A Oscillating Saw Attachment
L513 ASIF/AO Twist Drill Chuck Attachment
L514 ASIF/AO Chuck Attachment
L515 Aesculap Chuck Attachment
D520/D524 Automatic Screwdriver Attachments
28
3.1 Cleaning and Sterilizing
3.1.1 Cleaning Precautions
1. Follow universal precautions for protective
apparel when handling and cleaning con-
taminated instruments.
2. Saw blades are single-use only.
Dispose of properly after use.
3. Never immerse handpiece,
pressure regulator, or
attachments.
4. Never sterilize the regulator.
5. Never clean handpieces with bleach,
chlorine-based detergents, liquid or chemi-
cal disinfectants, or any products containing
sodium hydroxide (i.e., INSTRU-KLENZ,
Buell Cleaner). They will degrade the anod-
ized aluminum coating.
6. Do not allow any uids such as water or
Blitz II Surgical Instruments Cleaner and
Lubricant (M105A) to enter handpiece.
Fluid contacting internal parts will cause
corrosion. Surface cleaning with Blitz II
Cleaner is recommended.
7. Never clean equipment in an ultrasonic
cleaner or combination washer/sterilizer.
3.1.2 Handpiece and Attachment
Cleaning Instructions
Clean the handpieces and attachments as soon as
possible after use.
1. Leave the hose attached to the handpiece,
but remove all attachments (i.e., chucks,
saws) and accessories (i.e., saw blades, bits)
prior to cleaning.
2. Thoroughly scrub handpiece with a clean,
soft brush dampened with a mild, pH-bal-
anced detergent. Likewise, clean the hand-
piece hose and attachments. Remove all
traces of blood, coagulated material, stains,
etc. Do not immerse equipment in soap
solution or rinse water.
3. Thoroughly clean the cannulation with a
cleaning brush. Feed the wire end of the
brush through the back of the handpiece.
Repeat until all debris is removed.
4. Manipulate all moving parts of the hand-
piece and attachments to ensure all debris is
removed. If not, clean again until all debris
is removed.
5. Keep the nose of the handpiece pointed
downward and rinse under a ne spray of
water to remove all traces of soap. Like-
wise, rinse all attachments. Flush the sur-
faces free of tap water with distilled water
to prevent metal discoloration.
6. Shake the equipment free of water and wipe
the surfaces with a clean, lint-free towel.
29
3.1.3 Handpiece and Attachment
Lubrication Instructions
1. Spray Blitz II Surgical Instruments Cleaner
and Lubricant liberally over exposed sur-
faces of handpiece and attachments, espe-
cially all moving parts.
2. Wipe the surfaces with a clean, lint-free
towel.
3. Disconnect the hose from the handpiece.
While depressing the trigger, apply three
(3) drops of Lubricant (M317) into the
handpiece standpipe.
4. Reconnect the hose to the handpiece and
operate at full speed for ve seconds to dis-
perse lubricant.
Blitz
Blitz
Blitz
Blitz
Oil (3 drops in standpipe)
30
3.1.4 Sterilization Information
team sterilization is safe and effective and
has no contraindications for its use in ster-
ilizing powered surgical handpieces,
accessories and attachments.
3.1.4.1 Sterilization Warnings,
Precautions and Notes
WARNING: The use of disinfecting solu-
tions for an exterior instrument wipe will not
sterilize equipment and is not recommended.
1. Do not sterilize with Ethylene Oxide (EtO).
2. Do not sterilize handpieces or attachments
in cold sterilants like CIDEX.
3. Never sterilize any handpiece in a Washer/
Sterilizer, STERIS System, STERRAD
System, Abtox Plazlyte or comparable
sterilization methods.
4. Do Not Peel Pack handpieces or attach-
ments for sterilization. Sterilization in a
sealed pouch traps moisture which can
cause damage.
5. Remove the hose from the handpiece before
sterilizing.
6. Use of an autoclave case is recommended.
7. 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.
NOTES:
1. The following guidelines do not guaran-
tee the device is sterile after the proce-
dure. Your institution is still responsible
for the normal sterility assurance valida-
tion.
2. Additional drying time may be required
for complete heat and moisture dissipa-
tion. Operation of a handpiece that is not
completely cool or dry may decrease per-
formance and/or reliability
3. Sterilization validation is based on AAMI
guidelines (Association for the Advance-
ment of Medical Instrumentation).
All handpieces and attachments may be pro-
cessed in a pre-vacuum steam sterilizer (Steam
Pre-vacuum) or in a gravity (downward) dis-
placement sterilizer (Steam Gravity).
Before Sterilization:
Remove all accessories (e.g., drill bits,
blades) from attachments.
Remove all attachments (e.g., chucks, saws,
and/or hoses) from the handpiece.
Ensure all attachments were cleaned.
Lubricate, as necessary, equipment requir-
ing lubrication, per guidelines in 3.1.2
Handpiece and Attachment Cleaning
Instructions on page 28, prior to steriliza-
tion.
S
31
Recommended sterilization exposure times of individual handpieces and attachments are as follows:
Table 2: Sterilization Parameters
Sterilization Type Temperature
Exposure
Time
Dry Time
Maxi-Driver Handpieces and Attachments
Steam Pre-vacuum 270 - 272F (132 - 133C) 4 minutes 8 minutes minimum *
Steam Gravity 270 - 272F (132 - 133C) 25 minutes 8 minutes minimum *
Steam Gravity 250 - 254F (121 - 123C) 50 minutes 8 minutes minimum *
* CAUTION: An eight (8) minute minimum dry cycle must be run on handpieces and
attachments every time the product is sterilized. Failure to use a dry cycle may lead to
reduced product performance or premature product failure. Operation of a handpiece that is
not completely cool or dry may decrease performance and/or reliability.
32
3.2 Troubleshooting
Table 3: Troubleshooting
Symptom Possible Cause Corrective Action
Maxi-Driver Pneumatic (L100) Handpiece
Lack of handpiece
power.
Forward/Reverse button not in
full operating position.
Regulator malfunction.
Operating pressure incorrect.
Hose not fully or properly seated
in regulator and/or handpiece.
Restrictions in hose.
Tank pressure below 500 psi.
Tank valve not completely open.
Ensure nitrogen is being used.
Push button fully into position.
Run handpiece on another regu-
lator to see if the problem is the
handpiece or regulator. Replace/
repair appropriate piece of equip-
ment.
Set pressure to recommended
operating pressure.
If using an extension hose or a
hose longer than 10 ft., add an
additional one psi of pressure per
each additional foot of hose.
Check hose connections, ensure
they are completely seated.
Remove any hose restrictions.
Do not start procedure if tank
pressure is below 500 psi.
Replace tank.
Completely open tank valve.
Compressed air (especially if
contaminated) may reduce per-
formance.
33
Maxi-Driver Pneumatic (L100) Handpiece (continued)
Lack of handpiece
power (continued).
Lack of lubrication in motor. Follow lubrication instructions
(reference 3.1.2 Handpiece
and Attachment Cleaning
Instructions on page 28).
If malfunction persists, return for
service.
Excessive noise and
heat.
Debris lodged in motor.
Lack of lubrication.
Worn bearings
Clean and/or lubricate the hand-
piece according to 3.1.2 Hand-
piece and Attachment Cleaning
Instructions on page 28.
Clean and/or lubricate the hand-
piece according to 3.1.2 Hand-
piece and Attachment Cleaning
Instructions on page 28.
Return handpiece for service.
Forward/Reverse
button stuck.
Debris lodged around button. Apply Blitz II Cleaner and
Lubricant or M317 Lubricant and
work back and forth.
Hose leaking at
hose/handpiece
connection.
Missing or worn O-Ring on hose
connector.
Replace O-Ring (REF 8016).
Table 3: Troubleshooting
Symptom Possible Cause Corrective Action
34
Maxi-Driver Pneumatic (L100) Handpiece (continued)
Air leakage
between air control
dial and hose swivel
connector of hand-
piece.
Debris around ball seal of hose
connector at handpiece end.
Remove hose. Depress and spray
ball seal with Blitz II Cleaner
and Lubricant. Reconnect hose.
If problem persists, replace hose.
Hose has tears and/
or cuts.
Improper storage. Replace hose.
To prevent recurrence, discon-
nect hose from handpiece before
placing in autoclave case.
When placing in case, take care
not to pinch hose.
Return hose for repair or replace
hose.
All Attachments
Attachments do not
lock into handpiece.
Attachment not oriented cor-
rectly.
Debris in handpiece locking col-
lar or in attachment.
Attachment and/or handpiece
bent.
Will only attach in correct posi-
tion (reference 2.2.1 Connect-
ing/Removing Attachments on
page 9).
Clean thoroughly with Blitz II
Cleaner and Lubricant (refer-
ence 3.1.2 Handpiece and
Attachment Cleaning Instruc-
tions on page 28).
Return for service.
Table 3: Troubleshooting
Symptom Possible Cause Corrective Action
35
Automatic Pin Driver
Will not adjust to
hold pins.
Internal debris. Possibly
immersed in uid.
Adjustment sleeve rotated more
than one turn past graduation
limits.
Return for service.
Excessive noise or
heat.
Worn or dry bearings. Clean and/or lubricate the hand-
piece according to 3.1.2 Hand-
piece and Attachment Cleaning
Instructions on page 28.
Return for service.
Reamer Drives or Chuck Attachments
Chucks are stuck,
sleeves will not
retract.
Dried blood or debris lodged in
chuck.
Clean and/or lubricate the hand-
piece according to 3.1.2 Hand-
piece and Attachment Cleaning
Instructions on page 28.
Return for service.
Oscillating Saw Attachments
Blade does not cut
properly.
Dull blade. Use a new blade for each proce-
dure. Cut with light pressure and
steady oscillation of blade.
Table 3: Troubleshooting
Symptom Possible Cause Corrective Action
36
Oscillating Saw Attachments (continued)
Blade difcult to
insert or remove
from saw.
Trying to insert a non-Linvatec
approved blade.
Debris lodged in blade holder.
Blade locking button jammed.
Use Linvatec approved blades
only.
Clean thoroughly with Blitz II
Cleaner and Lubricant to remove
debris (see 3.1.2 Handpiece
and Attachment Cleaning
Instructions on page 28).
Return for service.
Handpiece/attach-
ment stops operat-
ing/sawing.
Loose handpiece/cord connec-
tion.
Reconnect cord to handpiece if
sterility is not compromised.
Oscillating Saw should not be
used in a vertical orientation with
the Maxi-Driver Electric hand-
piece.
Use only Maxi-Driver Battery or
Pneumatic handpiece for proce-
dures requiring an oscillating
saw in a vertical orientation.
Table 3: Troubleshooting
Symptom Possible Cause Corrective Action
37
Reciprocating Saw Attachment
Blade does not cut
properly
Dull blade. Use a new blade for each proce-
dure. Cut with light pressure and
steady oscillation of blade.
Blade difcult to
insert or remove
from saw.
Debris lodged in twist-lock col-
lar.
Collar may be bent.
Clean and/or lubricate the hand-
piece according to 3.1.2 Hand-
piece and Attachment Cleaning
Instructions on page 28.
Return for service.
Table 3: Troubleshooting
Symptom Possible Cause Corrective Action
38
4.0 TECHNICAL SPECIFICATIONS
Linvatec Corporation is certied by TV Product Service to EN ISO 9001 and EN 46001, and to the
Medical Device Directive 93/42/EEC with certicates for Annex II, Clause 3; Annex II, section 4; and
Annex V.
4.1 Handpiece
Typical Operating Requirements:
Motor: Vane (Variable Speed)
Through Cannulation: 6.5 mm (0.255 in.)
Forward/Reverse: 0 - 950 rpm
Operating Pressure: 760 kPa (110 psi)
Nitrogen Consumption: 12 scfm (0.0057 m
3
/sec.)
Torque: 28 in-lbf (3.16 N-m)
Weight: 37 oz. (1052 g)
Material: Aluminum and Stainless Steel
NOTE: There are no toxic components used in the manufacture of the Maxi-Driver Pneumatic
System. After the useful life of the product, dispose of components and service parts properly.
4.2 System Environmental Requirements
Operating:
Ambient Operating Temperature: + 50F to 77F (+ 10C to + 25C)
Relative Humidity: 30% to 75%
Atmospheric Pressure: 700 hPa to 1060 hPa
Transport and Storage:
Ambient Temperature: - 40F to 158F (- 40C to + 70C)
Relative Humidity: 10% to 100% including condensation
Atmospheric Pressure: 500 hPa to 1060 hPa
39
5.0 CUSTOMER SERVICE and WARRANTY
5.1 Customer Service
If 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 or your
Hall Surgical Sales Representative. Outside the U.S. contact your Linvatec/Hall Representative.
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/Lot 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 dis-
played 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 any product for repair:
Product Number
Serial/Lot Number - if applicable
Original Invoice Number
Date of Purchase
Detailed description of the problem
Purchase Order Number
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.
40
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 veri-
ed.
Whenever it is required to return your product for repairs, be sure to package it in a protective carton.
We recommend that you save 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
Products must be returned within 45 days of ship date. Returned products are subject to a restocking
fee of fteen percent (15%) of the purchase price (minimum charge $25). Products returned as a
result of errors attributable to Linvatec are exempt from this fee.
Returns must have an authorized Return Goods (R.G.) number 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
decontaminated and sterilized before returning. Products that are contaminated with biohaz-
ardous materials will be immediately returned to you for proper decontamination and steriliza-
tion.
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
41
5.2 Handpieces, Attachments and Accessories
REF Description
Maxi-Driver Attachments and Accessories
L100 Pneumatic Handpiece
D201 Universal Air Hose, 10 ft.
L110 Jacobs Chuck Attachment
L111 Automatic Pin Driver Attachment
L112 Trinkle Chuck Attachment
L113 Hudson Chuck Attachment
L115 Zimmer Chuck Attachment
L140 Reciprocating Saw Attachment
L150 Hudson Reamer Drive Attachment
L151 ASIF/AO Reamer Drive Attachment
L152 Aesculap Reamer Drive Attachment
L153 Zimmer Reamer Drive Attachment
L513 ASIF/AO Twist Drill Chuck Attachment
L514 ASIF/AO Chuck Attachment
L320A Oscillating Saw Attachment
L515 Aesculap Chuck Attachment
D520 Automatic Screwdriver Attachment
D524 Automatic Screwdriver Attachment
D521 Slotted Bit
D522 Cruciate Bit
D523 Phillips Bit
D525 Hex Bit for AO type screws
M105A Blitz II Surgical Instrument Cleaner and Lubricant
M317 Lubricant
42
5.3 Linvatec and Hall
Surgical
Instrument Warranty
invatec Corporation, (the Company),
warrants to the rst purchaser or lessee
(Customer) that the Linvatec and Hall
Surgical instruments, attachments and parts
manufactured by or for the Company (hereinaf-
ter collectively Instruments) have been tested,
inspected, and shipped in proper working order.
The Company warrants all new Instruments to
be free from defects in materials and workman-
ship for the following periods, measured from
Customers 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
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
13. APEX Autoclavable Camera Heads - 500
use service program (prorated credit after
250 uses)
14. Envision 1/4 Autoclavable Camera Heads -
500 use or Twelve (12) months, whichever
comes rst
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 Specic Instruments -
Twelve (12) Months
The Maxi-Driver handpiece and attachments
described in this manual are to be returned to the
factory or a Linvatec authorized service facility
for routine maintenance according to the Main-
tenance Schedule Table starting on page 27.
Failure to follow this routine maintenance
schedule may result in damage to the handpiece
and/or console, and may invalidate the product
warranty.
If within the specied warranty period the Cus-
tomer discovers that an Instrument has a defect
in material and/or workmanship, it must
promptly notify the Company. If it becomes nec-
essary to return the Instrument to the Company,
the Customer must (a) acquire a Returned
Goods authorization from the Company Cus-
tomer Service, (b) pack the unit carefully, and
(c) return it to the Company via air freight, pre-
paid.
L
43
Within a reasonable time after receipt of Instru-
ment, the Company will investigate and shall
correct any defect covered by warranty by pro-
viding, at its option, one of the following: ser-
vice or repair of the Instrument, a replacement
of the Instrument, or a refund of the purchase
price of the Instrument. These remedies are the
Customers exclusive remedies under this war-
ranty.
The Company warrants that all parts and assem-
blies used in the repair or service of Instruments
meet new part functional specications,
although some parts or assemblies may have
been remanufactured.
All parts and assemblies replaced by the Com-
pany shall become the property of the Company.
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 warn-
ings contained in the Company instruction
manuals and package inserts.
5. Instruments which were last serviced, refur-
bished, reprocessed or reconditioned by a
nonauthorized service entity.
6. Instruments which did not have their afore-
mentioned routine maintenance schedule
followed.
The foregoing limited warranties are in lieu
of all other warranties, expressed or implied,
including, but not limited to, the implied
warranties of merchantability and tness 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 war-
ranties, or on remedies, and, in such jurisdic-
tions, 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 with-
out 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.
44
All rights reserved. Printed in USA W41-062-004 Rev. A 08/2001
Hall
Surgical
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
2001 Linvatec Corporation, a subsidiary of ConMed Corporation