The Hall Maxi-Driver™ Pneumatic System Instruction Manual

The Hall® 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 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
Pneumatic Handpiece (L100) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
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
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
Handpiece and Attachment Lubrication Instructions . . . . . . . . . . . . . . . . . . 29
3.1.4
Sterilization Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
3.1.4.1
3.2
4.0
5.0
Sterilization Warnings, Precautions and Notes . . . . . . . . . . . . . . . 30
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
TECHNICAL SPECIFICATIONS
4.1
Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
4.2
System Environmental Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
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
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™ Pneumatic 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 Pneumatic 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 pneumatic, battery,
and electric 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, 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.
6.
Oscillating and reciprocating saw
blades, and bits are single-use only.
Do not resterilize. After use, dispose of properly.
7.
Handpieces are factory sealed. Do
not disassemble.
8.
Do not pressurize hoses until all
fittings have been connected and checked.
9.
Never operate pneumatic handpiece above
110 psi (7 kg/cm2) 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.
1.3
Symbol Definitions
Attention, consult accompanying documents.
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 handpiece should not
be immersed in any type of fluid.
10. The nitrogen regulator is only for use with
pneumatically powered surgical devices.
Indicates product should not be
oiled or lubricated.
11. 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.
Single Use Only
Eye Protection Required
12. Do not attach, insert or remove accessories
or attachments while the handpiece is operating. Place the handpiece safety to the
appropriate safe position prior to installation or removal of items.
Rx ONLY
13. After each use, thoroughly clean the handpiece and attachments (See “3.1 Cleaning
and Sterilizing” on page 28).
2
Caution: Federal Law restricts
this device to sale by or on the
order of a physician
1.4
❺ Hose Connector — The air hose attaches
Pneumatic Handpiece (L100)
here from the air supply tank. The connector swivels 360° to help eliminate hose
binding.
❶
❻ Cannulation — Used to stabilize long
wires or pins.
❷
❸
❹
❻
❺
❶ 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.
❷ Direction Button — Press this button
inward to place the handpiece in the forward (clockwise) direction. Press in the
opposite direction for reverse (counterclockwise).
❸ Activation Trigger — Used to activate the
handpiece when the direction button is in
either the forward or reverse position.
❹ 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.
3
2.0
2.1
CAUTION: Do not exceed 110 psi
(7 kg/cm2) 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.
INSTALLATION and
OPERATION
The Maxi-Driver pneumatic handpiece
should be operated at 110 psi (7 kg/cm2) for
maximum operating efficiency, and should be
monitored by the operating pressure gauge of
the regulator. Lower pressure setting can be
set for lower speed and torque requirements.
Pressure must be set with the instrument
running to ensure proper operating pressure.
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 waterpumped 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. Compressed dry nitrogen is recommended as the
pneumatic power source. It is available in standard cylinders.
Never start a procedure if the operating
pressure gauge indicates less than 500 psi
(35.1 kg/cm2) in the tank. Never run the tank
pressure below 200 psi (14.0 kg/cm2).
The tank should be thoroughly wiped off with
disinfectant and draped prior to placement in
the operating room. Always have the tank
securely fastened to a stable object.
Compressed dry nitrogen must meet the following specifications to ensure optimum safety for
both patient and instrument.
1.
Nitrogen Content: 99.97% pure, dry nitrogen.
Quality Assurance: To obtain the quality of gas
needed, “water-pumped dry nitrogen, or liquid
nitrogen, pumped dry” should be specified.
Nitrogen is readily available from gas supply
houses in H cylinders holding slightly more than
300 cubic feet (8.50 cubic meters). Initial set-up
costs are relatively inexpensive as compared to
compressed air. Nitrogen can be placed in the
operating room or in a storage area and piped
into the operating room. Manifold systems are
available to eliminate frequent tank changes.
4
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.
2.
Install the regulator with a 1 1/8 inch
wrench.
NOTE: The threaded adaptor of the nitrogen regulator is designed to fit nitrogen fittings only. Incompatibility of the regulator
and tank indicates a gas source other than
nitrogen or an improper regulator for use
with a nitrogen tank.
3.
4.
Slowly turn the tank valve fully open (counterclockwise). This will allow nitrogen to
pressurize the regulator.
5.
Insert the male Schrader end of the hose
into the female Schrader on the regulator
with an upward thrust.
6.
To connect the handpiece to the hose.
Once the regulator is securely installed,
ensure the regulator knob is in the full off
position by turning the regulator control
knob counterclockwise. SUDDEN PRESSURE EXERTED TO THE REGULATOR MAY CAUSE INTERNAL
DAMAGE.
(a) Place the handpiece safety slide in the
safe (up) position.
5
(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).
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) Grasp the hose connector and insert it
into the connector on the bottom of the
handpiece.
(c) Depress the trigger.
(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 handpiece, reverse steps 6a and 6b.
7.
8.
a
With the safety slide still in the safe position, install the desired attachment and
accessory at this time by referencing “2.2.1
Connecting/Removing Attachments” on
page 9.
b
c
Operating pressure is established by gradually turning the regulator control knob
clockwise. ALWAYS establish the designated pressure on the operating pressure
gauge with the instrument running.
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 counterclockwise until it stops.
(d) Turn the female Schrader to the right to
disengage the male Schrader fitting.
6
(e) The hose can then be removed from the
connector. Hold the end of the hose
securely when disengaging the male
Schrader fitting 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 completed.
(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
7
❶
❷
❹
❸
❻
❺
❽
❿
❼
❾
12
13
11
14
2.2
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)
2.2.1
Connecting/Removing
Attachments
2.2.2
Automatic Pin Driver
Attachment (L111)
All Maxi-Driver Handpiece attachments connect/disconnect in the same manner and are
interchangeable between the battery 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
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.
To insert 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.
(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.
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.
(d) Loosen the adjustment sleeve one half
turn. The pin should slide freely within
the Pin Driver until the grasping lever
is depressed.
10
2.2.3
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
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 “2.2.1 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
position.
(b) Depress the center retaining button,
pull the blade forward and lift the blade
off the pins.
11
2.2.4
(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 position.
Reciprocating Saw blades are single-use only. Dispose of properly
after use.
1.
To attach the Reciprocating Saw attachment, 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:
To remove a blade:
(a) Turn the twist-lock collar counterclockwise and remove the blade.
(a) Turn the twist-lock collar counterclockwise.
12
2.2.5
1.
To attach the Jacobs Chuck attachment, reference “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).
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
2.2.6
(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 “2.2.1 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.
14
To remove accessory, pull back the locking
sleeve chuck and remove the accessory.
1.
2.2.6.1
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.
2.2.7
(b) Ensure the accessory is securely seated
in the attachment before use.
Hudson Chuck Attachment
(L113)
CAUTION: Operating the intramedullary
flexible reamer in reverse may cause the
reamer to jam in the intramedullary canal or
damage the reamer shaft.
3.
This attachment is designed to drive intramedullary reamers and other accessories with Hudson
fittings.
Specifications:
Through Cannulation:
4.8 mm (0.187 in.)
(3/16 in.)
1.
To attach a Hudson Chuck attachment, reference “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.
17
To remove the accessory, pull back the
locking sleeve of the chuck and remove the
accessory.
3.
2.2.8
Hudson Reamer Drive
Attachment (L150)
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.
This attachment is designed to drive acetabular
or intramedullary (flexible or rigid) reamers
with Hudson fittings.
Specifications:
Through Cannulation:
1.
2.
4.8 mm (0.187 in.)
(3/16 in.)
(b) Ensure the accessory is securely seated
in the attachment before use.
CAUTION: Operating the intramedullary
flexible reamer in reverse may cause the
reamer to jam in the intramedullary canal or
damage the reamer shaft.
To attach a Hudson Reamer Drive attachment, reference “2.2.1 Connecting/
Removing Attachments” on page 9).
4.
If desired, slide the Holding Handle (L296)
accessory over the Reamer Drive attachment. Secure the Holding Handle accessory
in the desired position by turning the handle
clockwise until tight.
18
To remove the accessory, retract the locking
sleeve of the chuck and remove the accessory.
2.2.9
(b) Ensure the accessory is securely seated
in the attachment before use.
Zimmer Chuck Attachment
(L115)
CAUTION: Operating the intramedullary
flexible reamer in reverse may cause the
reamer to jam in the intramedullary canal or
damage the reamer shaft.
3.
This attachment is designed to drive flexible or
rigid reamers with Zimmer-type fittings.
Specifications:
Through Cannulation:
4.8 mm (0.187 in.)
(3/16 in.)
1.
To attach a Zimmer Chuck attachment, reference “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.
19
To remove the accessory, retract the locking
sleeve of the chuck and remove accessory.
3.
2.2.10 Zimmer Reamer Drive
Attachment (L153)
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.
This attachment is designed to drive acetabular
or intramedullary (flexible or rigid) reamers
with Zimmer-type fittings.
Specifications:
Through Cannulation:
(b) Ensure the accessory is securely seated
in the attachment before use.
4.8 mm (0.187 in.)
(3/16 in.)
CAUTION: Operating the intramedullary
flexible reamer in reverse may cause the
reamer to jam in the intramedullary canal or
damage the reamer shaft.
1.
To attach a Zimmer 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 attachment. Secure the Holding Handle accessory
in the desired position by turning the handle
clockwise until tight.
4.
20
To remove the accessory, retract the locking
sleeve of the chuck and remove the accessory.
(b) Ensure the accessory is securely seated
in the attachment before use.
2.2.11 ASIF/AO Twist Drill Chuck
Attachment (L513)
3.
This attachment is designed to drive drill bits
with ASIF/AO (Synthes) type fittings.
Specifications:
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.
21
To remove the accessory, retract the locking
sleeve of the chuck and remove accessory.
(b) Ensure the accessory is securely seated
in the attachment before use.
2.2.12 ASIF/AO Flexible Chuck
Attachment (L514)
CAUTION: Operating the intramedullary
flexible reamer in reverse may cause the
reamer to jam in the intramedullary canal or
damage the reamer shaft.
3.
This attachment is designed to drive intramedullary (flexible or rigid) reamers with ASIF/AO
(Synthes) type fittings.
Specifications:
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.
22
To remove the accessory, retract the locking
sleeve of the chuck and remove the accessory.
3.
2.2.13 ASIF/AO Reamer Drive
Attachment (L151)
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.
This attachment is designed to drive acetabular
or intramedullary (flexible or rigid) reamers
with ASIF/AO (Synthes) type fittings.
Specifications:
Through Cannulation:
(b) Ensure the accessory is securely seated
in the attachment before use.
4.8 mm (0.187 in.)
(3/16 in.)
CAUTION: Operating the intramedullary
flexible reamer in reverse may cause the
reamer to jam in the intramedullary canal or
damage the reamer shaft.
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 attachment. Secure the Holding Handle accessory
in the desired position by turning the handle
clockwise until tight.
4.
23
To remove the accessory, retract the locking
sleeve of the chuck and remove the accessory.
3.
2.2.14 Aesculap Reamer Drive
Attachment (L152)
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.
This attachment is designed to drive acetabular
or intramedullary (flexible or rigid) reamers
with Aesculap fittings.
Specifications:
Through Cannulation:
1.
2.
4.8 mm (0.187 in.)
(3/16 in.)
(b) Ensure the accessory is securely seated
in the attachment before use.
CAUTION: Operating the intramedullary
flexible reamer in reverse may cause the
reamer to jam in the intramedullary canal or
damage the reamer shaft.
To attach an Aesculap Reamer Drive attachment, reference “2.2.1 Connecting/
Removing Attachments” on page 9).
4.
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.
24
To remove the accessory, retract the locking
sleeve of the chuck and remove the accessory.
(b) Ensure the accessory is securely seated
in the attachment before use.
2.2.15 Aesculap Chuck Attachment
(L515)
CAUTION: Operating the intramedullary
flexible reamer in reverse may cause the
reamer to jam in the intramedullary canal or
damage the reamer shaft.
3.
This attachment is designed to drive intramedullary reamers and other accessories with Aesculap fittings.
Specifications:
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.
25
To remove accessory, retract the locking
sleeve of the chuck and remove accessory.
3.0
Your authorized Linvatec Service Department is
the most knowledgeable about the instruments
and will provide competent and efficient service.
Service at Linvatec at the indicated 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 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.
MAINTENANCE
This section explains the importance of keeping
your Maxi-Driver Pneumatic System well maintained. It contains a maintenance schedule to
assist you in determining the maintenance interval requirements of your instruments.
Regular and proper maintenance of your powered surgical instruments 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 reward
you with safer, less problematic product performance over time. The following maintenance
schedule specifies which instruments need attention and how often you should have them serviced.
The service and time intervals shown in the
maintenance schedule assume you will use the
instruments as indicated in this manual, including 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 efficient 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-today maintenance.
26
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
•
27
3.1
Cleaning and Sterilizing
3.1.1
Cleaning Precautions
1.
Follow universal precautions for protective
apparel when handling and cleaning contaminated 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 chemical disinfectants, or any products containing
sodium hydroxide (i.e., INSTRU-KLENZ,
Buell Cleaner). They will degrade the anodized aluminum coating.
6.
7.
3.1.2
Handpiece and Attachment
Cleaning Instructions
Clean the handpieces and attachments as soon as
possible after use.
Do not allow any fluids 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.
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-balanced detergent. Likewise, clean the handpiece 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 handpiece 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 fine spray of
water to remove all traces of soap. Likewise, rinse all attachments. Flush the surfaces 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.
Never clean equipment in an ultrasonic
cleaner or combination washer/sterilizer.
28
3.
3.1.3
1.
Handpiece and Attachment
Lubrication Instructions
Disconnect the hose from the handpiece.
While depressing the trigger, apply three
(3) drops of Lubricant (M317) into the
handpiece standpipe.
Spray Blitz II Surgical Instruments Cleaner
and Lubricant liberally over exposed surfaces of handpiece and attachments, especially all moving parts.
Blitz
Blitz
Blitz
Oil (3 drops in standpipe)
Blitz
4.
2.
Wipe the surfaces with a clean, lint-free
towel.
29
Reconnect the hose to the handpiece and
operate at full speed for five seconds to disperse lubricant.
NOTES:
3.1.4
Sterilization Information
1.
The following guidelines do not guarantee 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 a handpiece that is not
completely cool or dry may decrease performance and/or reliability
WARNING: The use of disinfecting solutions for an exterior instrument wipe will not
sterilize equipment and is not recommended.
3.
Sterilization validation is based on AAMI
guidelines (Association for the Advancement of Medical Instrumentation).
1.
Do not sterilize with Ethylene Oxide (EtO).
2.
Do not sterilize handpieces or attachments
in cold sterilants like CIDEX.
All handpieces and attachments may be processed in a pre-vacuum steam sterilizer (Steam
Pre-vacuum) or in a gravity (downward) displacement sterilizer (Steam Gravity).
3.
Never sterilize any handpiece in a Washer/
Sterilizer, STERIS System, STERRAD
System, Abtox Plazlyte™ or comparable
sterilization methods.
team sterilization is safe and effective and
has no contraindications for its use in sterilizing powered surgical handpieces,
accessories and attachments.
S
3.1.4.1
Sterilization Warnings,
Precautions and Notes
Before Sterilization:
•
Remove all accessories (e.g., drill bits,
blades) from attachments.
Do Not “Peel Pack” handpieces or attachments for sterilization. Sterilization in a
sealed pouch traps moisture which can
cause damage.
•
Remove all attachments (e.g., chucks, saws,
and/or hoses) from the handpiece.
•
Ensure all attachments were cleaned.
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.
Lubricate, as necessary, equipment requiring lubrication, per guidelines in “3.1.2
Handpiece and Attachment Cleaning
Instructions” on page 28, prior to sterilization.
4.
30
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 - 272°F (132 - 133°C)
4 minutes
8 minutes minimum *
Steam Gravity
270 - 272°F (132 - 133°C)
25 minutes
8 minutes minimum *
Steam Gravity
250 - 254°F (121 - 123°C)
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.
31
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.
♦ Push button fully into position.
♦ Regulator malfunction.
♦ Run handpiece on another regulator to see if the problem is the
handpiece or regulator. Replace/
repair appropriate piece of equipment.
♦ Operating pressure incorrect.
♦ 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.
♦ Hose not fully or properly seated
in regulator and/or handpiece.
♦ Check hose connections, ensure
they are completely seated.
♦ Restrictions in hose.
♦ Remove any hose restrictions.
♦ Tank pressure below 500 psi.
♦ Do not start procedure if tank
pressure is below 500 psi.
Replace tank.
♦ Tank valve not completely open.
♦ Completely open tank valve.
♦ Ensure nitrogen is being used.
♦ Compressed air (especially if
contaminated) may reduce performance.
32
Table 3: Troubleshooting
Symptom
Possible Cause
Corrective Action
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.
♦ Clean and/or lubricate the hand-
piece according to “3.1.2 Handpiece and Attachment Cleaning
Instructions” on page 28.
♦ Lack of lubrication.
♦ Clean and/or lubricate the hand-
piece according to “3.1.2 Handpiece and Attachment Cleaning
Instructions” on page 28.
♦ Worn bearings
♦ Return handpiece for service.
Forward/Reverse
button stuck.
♦ Debris lodged around button.
♦ Apply Blitz II Cleaner and
Hose leaking at
hose/handpiece
connection.
♦ Missing or worn O-Ring on hose
Lubricant or M317 Lubricant and
work back and forth.
connector.
33
♦ Replace O-Ring (REF 8016).
Table 3: Troubleshooting
Symptom
Possible Cause
Corrective Action
Maxi-Driver Pneumatic (L100) Handpiece (continued)
Air leakage
between air control
dial and hose swivel
connector of handpiece.
♦ Debris around ball seal of hose
Hose has tears and/
or cuts.
♦ Improper storage.
connector at handpiece end.
♦ Remove hose. Depress and spray
ball seal with Blitz II Cleaner
and Lubricant. Reconnect hose.
♦ If problem persists, replace hose.
♦ 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.
♦ Will only attach in correct posi-
tion (reference “2.2.1 Connecting/Removing Attachments” on
page 9).
♦ Debris in handpiece locking col-
lar or in attachment.
♦ Clean thoroughly with Blitz II
Cleaner and Lubricant (reference “3.1.2 Handpiece and
Attachment Cleaning Instructions” on page 28).
♦ Attachment and/or handpiece
bent.
34
♦ Return for service.
Table 3: Troubleshooting
Symptom
Possible Cause
Corrective Action
Automatic Pin Driver
Will not adjust to
hold pins.
♦ Internal debris. Possibly
♦ Return for service.
immersed in fluid.
♦ Adjustment sleeve rotated more
than one turn past graduation
limits.
Excessive noise or
heat.
♦ Worn or dry bearings.
♦ Clean and/or lubricate the hand-
piece according to “3.1.2 Handpiece 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
♦ Clean and/or lubricate the hand-
chuck.
piece according to “3.1.2 Handpiece 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.
35
Table 3: Troubleshooting
Symptom
Possible Cause
Corrective Action
Oscillating Saw Attachments (continued)
Blade difficult to
insert or remove
from saw.
♦ Trying to insert a non-Linvatec
approved blade.
♦ Use Linvatec approved blades
only.
♦ Debris lodged in blade holder.
Blade locking button jammed.
♦ 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/attachment stops operating/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 handpiece.
♦ Use only Maxi-Driver Battery or
Pneumatic handpiece for procedures requiring an oscillating
saw in a vertical orientation.
36
Table 3: Troubleshooting
Symptom
Possible Cause
Corrective Action
Reciprocating Saw Attachment
Blade does not cut
properly
♦ Dull blade.
♦ Use a new blade for each proce-
Blade difficult to
insert or remove
from saw.
♦ Debris lodged in twist-lock col-
dure. Cut with light pressure and
steady oscillation of blade.
lar.
♦ Clean and/or lubricate the hand-
piece according to “3.1.2 Handpiece and Attachment Cleaning
Instructions” on page 28.
♦ Collar may be bent.
♦ Return for service.
37
4.0
TECHNICAL SPECIFICATIONS
Linvatec Corporation is certified by TÜV Product Service to EN ISO 9001 and EN 46001, and to the
Medical Device Directive 93/42/EEC with certificates 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 m3/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:
+ 50°F to 77°F (+ 10°C to + 25°C)
Relative Humidity:
30% to 75%
Atmospheric Pressure:
700 hPa to 1060 hPa
Transport and Storage:
Ambient Temperature:
- 40°F to 158°F (- 40°C to + 70°C)
Relative Humidity:
10% to 100% including condensation
Atmospheric Pressure:
500 hPa to 1060 hPa
38
5.0
5.1
CUSTOMER SERVICE and WARRANTY
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 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 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.
39
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.
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 fifteen 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 biohazardous materials will be immediately returned to you for proper decontamination and sterilization.
Linvatec
Attn.: Customer Service Dept.
11311 Concept Boulevard
Largo, Florida 33773-4908 USA
Customer Service
(within U.S.)
Phone:
FAX:
800-925-4255
727-399-5256
(outside U.S.)
Phone:
FAX:
727-392-6464
727-397-4540
Phone:
Phone:
800-237-0169
727-399-6620
Linvatec Regulatory Affairs
(within U.S.)
(outside U.S.)
40
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
41
5.3
13. APEX® Autoclavable Camera Heads - 500
use service program (prorated credit after
250 uses)
Linvatec and Hall® Surgical
Instrument Warranty
14. Envision 1/4” Autoclavable Camera Heads 500 use or Twelve (12) months, whichever
comes first
invatec Corporation, (“the Company”),
warrants to the first purchaser or lessee
(“Customer”) that the Linvatec and Hall
Surgical instruments, attachments and parts
manufactured by or for the Company (hereinafter collectively “Instruments”) have been tested,
inspected, and shipped in proper working order.
L
15. Envision Autoclavable 3CCD Camera
Heads - Twelve (12) months
16. Shutt SLG Instruments - Lifetime
17. Shutt Non-SLG Instruments - Twelve (12)
Months
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.
18. Footswitches - Twelve (12) Months
19. Irrigation Systems - Twelve (12) Months
Powered Surgical Equipment (battery, electric, 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 Attachments - 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
20. Reusable Procedure Specific 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 Maintenance 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 specified warranty period the Customer discovers that an Instrument has a defect
in material and/or workmanship, it 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, (b) pack the unit carefully, and
(c) return it to the Company via air freight, prepaid.
10. Video Components - Twelve (12) Months
11. Video Cables and Light Guides - Three (3)
Months
12. Non-autoclavable Camera Heads - Twelve
(12) Months
42
Within a reasonable time after receipt of 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. These remedies are the
Customer’s exclusive remedies under this warranty.
6.
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.
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 foregoing limited warranties are in lieu
of all other warranties, expressed or implied,
including, but not limited to, the implied
warranties of merchantability and fitness for
a particular purpose.
All parts and assemblies replaced by the Company 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 warnings contained in the Company instruction
manuals and package inserts.
5.
Instruments which were last serviced, refurbished, reprocessed or reconditioned by a
nonauthorized service entity.
Instruments which did not have their aforementioned routine maintenance schedule
followed.
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.
43
44
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
All rights reserved. Printed in USA
W41-062-004
Rev. A
08/2001
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