3M Maxi Battery Manual
3M Maxi Battery Manual
3M Maxi Battery Manual
Battery 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.
Record the Model and Serial Numbers of the handpiece(s), and date received. Retain for
future reference.
1.0 INTRODUCTION
i
Table of Contents Page
3.0 MAINTENANCE
ii
1.0 INTRODUCTION 1.2 General Warnings
t is recommended that personnel study this 1. This equipment is designed for use by med-
I manual before attempting to operate, clean
or sterilize the Hall® Maxi-Driver™ Battery
ical professionals completely familiar with
the required techniques and instructions for
use of the equipment. Read and follow all
Powered Instrument System. The safe and effec-
tive use of this equipment requires the under- warning and caution notices and instruc-
standing of and compliance with all warnings, tions marked on the product and
caution notices and instructions marked on the included in this manual.
product and included in this manual.
2. Eye protection is recommended
when operating equipment.
1
8. Continually check all handpieces and
attachments for overheating. Discontinue 1.3 Symbol Definitions
use and return equipment for service as nec-
essary. Overheating of the bit or blade may Attention, consult accompany-
cause damage to the bit or blade and may ing documents.
cause thermal necrosis.
Electrical hazard symbol
9. Do not attach, insert or remove accessories
or attachments while the handpiece is oper-
ating. Place the handpiece safety switch Flammable Anesthetics - Risk of
to the appropriate safe position prior to explosion if used in the presence
installation or removal of items. of flammable anesthetics.
2
No user service recommended. Indicates battery rack
Refer servicing to qualified Lin- unload/load/carry.
vatec service personnel.
Indicates product component
should not be sterilized.
3
❹ Safety/Directional Control Knob -
1.4 Battery Handpiece (L300) Used to place the handpiece in the
safe or operating mode. Place in the
safe/off position prior to connecting
❶ or removing the battery, attachments
F
or accessories and during non-use of
R
the handpiece.
❷
❹
4
2.0 INSTALLATION and
1. To attach the battery to the handpiece:
WARNING: Inspect
batteries for damage
Ni-Cd Ni-Cd
prior to use, i.e., cracks Ni-Cd
5
2. To remove the battery from the handpiece.
2.2 Battery Charging
(a) Place the handpiece safety knob
in the off (safe) position. Reference the appropriate battery
(b) Slide the battery release latch in the charger instruction manual for instruc-
direction of the arrow and slide the bat- tions on how to use the battery charger
tery out of the handpiece. to charge batteries.
WARNINGS:
3. With the safety still activated, install the 2. Do not charge batteries unless they are at
desired attachment and accessory at this room temperature.
time by referencing “2.3.1 Connecting/ 3. Do not autoclave batteries above the rec-
Removing Attachments” on page 9. ommended temperature (reference “3.1.4
4. To activate the handpiece: Sterilization Information” on page 29).
(a) Place the handpiece safety knob 4. Do not leave batteries in autoclave longer
F than recommended.
in the desired operating position,
either forward or reverse and 5. Any of the above conditions could
R
depress the trigger. shorten the life of the batteries and/or
compromise the seal integrity, resulting
in leakage of Potassium Hydroxide
(KOH) which is alkaline and can burn
skin, eyes or clothing.
6
6. Do not allow battery leakage or residue
to come in contact with your skin, eyes or
clothing. If leakage does contact your
skin, eyes or clothing, flush affected areas
with copious amounts of water and seek
medical assistance immediately. If there
is any evidence of case cracking, white
residue or fluid leakage, follow these
guidelines:
NOTES:
7
❶ ❷
❹
❸
❻
❺
❽
❼ ❿
❾
12
13
11
14 15
8
2.3.1 Connecting/Removing 2.3.2 Automatic Pin Driver
Attachments Attachment (L111)
1. To connect an attachment:
Nosepiece
(a) Ensure the handpiece is in the
safe, or off position. Adjustment Sleeve
(c) Ensure the attachment is secure by The Automatic Pin Driver is designed to drive
pulling it outward. pins (wires) and drill bits compatible with the
specifications below:
9
1. To insert a pin: (d) Loosen the adjustment sleeve one-half
turn. The pin should slide freely within
(a) Ensure the handpiece is in the the Pin Driver until the grasping lever
safe, or off position before insert- is depressed.
ing or removing a pin.
(e) For pin sizes that fall between the pin
(b) Rotate the adjustment sleeve until the size graduation, loosen the adjustment
desired pin size graduation appears on sleeve one full turn. The pin should
the shaft of the nosepiece. Do not turn slide freely within the Pin Driver until
the adjustment sleeve more than one the grasping lever is depressed.
turn past the marked graduation
limits. 2. To operate the handpiece:
10
2. The Oscillating Saw attachment may be
2.3.3 Oscillating Saw Attachment placed in any of four positions at 90 degree
(L320A) angles.
3. To attach a blade:
5. To remove a blade:
11
(b) Insert the blade into the blade holder in
2.3.4 Reciprocating Saw Attachment the desired blade position. Blades may
(L140A) be placed in either of two positions,
with the cutting edge facing up or
down.
Specifications:
Blade Stroke Length: 6.3 mm (0.25 in.)
NOTES:
3. To attach a blade:
12
1. To attach the Jacobs Chuck attachment, ref-
2.3.5 Jacobs Chuck Attachment (L110) erence “2.3.1 Connecting/Removing
Attachments” on page 9).
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
(c) Ensure the accessory is securely seated
2.3.6 Trinkle Chuck Attachment (L112) in the attachment before use by pulling
outward on it.
3. To remove accessory, pull back the locking
sleeve chuck and remove the accessory.
14
1. To insert a bit into the screwdriver.
2.3.6.1 Automatic Screwdrivers for the
Trinkle Chuck Attachment (a) Unscrew the bit retainer section (coun-
(D520/D524) terclockwise) from the screwdriver.
❷
❸
❹
❻
(c) Slide the bit retainer over the bit and
thread the retainer back on the screw-
❶ Screwdriver (D520) driver by turning it clockwise until
tight.
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.
16
(b) Ensure the accessory is securely seated
2.3.7 Hudson Chuck Attachment in the attachment before use.
(L113)
CAUTION: Operating the intramedullary
flexible reamer in reverse may cause the
reamer to jam in the intramedullary canal or
damage the reamer shaft.
Specifications:
Through Cannulation: 4.8 mm (0.187 in.)
(3/16 in.)
17
3. To insert a Hudson Shank accessory into the
2.3.8 Hudson Reamer Drive Hudson Reamer Drive attachment:
Attachment (L150)
(a) Pull the locking sleeve chuck back.
Insert the accessory and release the
locking sleeve.
Specifications:
Through Cannulation: 4.8 mm (0.187 in.)
(3/16 in.) (b) Ensure the accessory is securely seated
in the attachment before use.
18
(b) Ensure the accessory is securely seated
2.3.9 Zimmer Chuck Attachment in the attachment before use.
(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. To remove the accessory, retract the locking
sleeve of the chuck and remove accessory.
Specifications:
Through Cannulation: 4.8 mm (0.187 in.)
(3/16 in.)
19
3. To insert a Zimmer Shank accessory into
2.3.10 Zimmer Reamer Drive the Zimmer Reamer Drive attachment:
Attachment (L153)
(a) Pull the locking sleeve chuck back.
Insert the accessory and release the
locking sleeve.
Specifications:
Through Cannulation: 4.8 mm (0.187 in.) (b) Ensure the accessory is securely seated
(3/16 in.) in the attachment before use.
20
(b) Ensure the accessory is securely seated
2.3.11 ASIF/AO Twist Drill Chuck in the attachment before use.
Attachment (L513)
3. To remove the accessory, retract the locking
sleeve of the chuck and remove accessory.
Specifications:
Through Cannulation: 4.8 mm (0.187 in.)
(3/16 in.)
21
(b) Ensure the accessory is securely seated
2.3.12 ASIF/AO Flexible Chuck in the attachment before use.
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.
Specifications:
Through Cannulation: 4.8 mm (0.187 in.)
(3/16 in.)
22
3. To insert an ASIF/AO accessory into the
2.3.13 ASIF/AO Reamer Drive ASIF/AO Reamer Drive attachment:
Attachment (L151)
(a) Pull the locking sleeve chuck back.
Insert the accessory and release the
locking sleeve.
Specifications:
Through Cannulation: 4.8 mm (0.187 in.) (b) Ensure the accessory is securely seated
(3/16 in.) in the attachment before use.
1. To attach an ASIF/AO Reamer Drive 4. To remove the accessory, retract the locking
attachment, reference “2.3.1 Connecting/ sleeve of the chuck and remove the acces-
Removing Attachments” on page 9). sory.
23
3. To insert an Aesculap accessory into the
2.3.14 Aesculap Reamer Drive Aesculap Reamer Drive attachment:
Attachment (L152)
(a) Pull the locking sleeve chuck back.
Insert the accessory and release the
locking sleeve.
Specifications:
Through Cannulation: 4.8 mm (0.187 in.)
(3/16 in.)
(b) Ensure the accessory is securely seated
in the attachment before use.
24
(b) Ensure the accessory is securely seated
2.3.15 Aesculap Chuck Attachment in the attachment before use.
(L515)
CAUTION: Operating the intramedullary
flexible reamer in reverse may cause the
reamer to jam in the intramedullary canal or
damage the reamer shaft.
Specifications:
Through Cannulation: 4.8 mm (0.187 in.)
(3/16 in.)
25
3.0 MAINTENANCE
Your authorized Linvatec Service Department is
the most knowledgeable about the instruments
and will provide competent and efficient service.
This section explains the importance of keeping Service at Linvatec at the indicated service inter-
your Maxi-Driver Battery System well main- val is mandatory to keep your product warran-
tained. It contains a maintenance schedule to ties in effect. Any services and/or repairs done
assist you in determining the maintenance inter- by any unauthorized repair facility may result in
val requirements of your equipment. reduced performance of the instruments or
instrument failure and is not recommended. See
Regular and proper maintenance of your pow-
“5.3 Linvatec and Hall® Surgical Instrument
ered surgical instruments is the best way to pro-
Warranty” on page 41 for more information on
tect your investment. It is essential that you have
product warranties.
your powered surgical instruments serviced as
scheduled so as to retain their optimum perfor-
mance and reliability, which will reward you
with safer, less problematic product perfor-
mance over time. The following maintenance
schedule specifies which instruments need atten-
tion and how often you should have them ser-
viced.
26
Table 1: Maintenance Schedule
Catalog 6 12
Product Description
Number Months Months
27
3.1 Cleaning and Sterilizing 3.1.2 Handpiece and Attachment
Cleaning Instructions
28
3.1.3 Battery Cleaning and 3.1.4 Sterilization Information
Maintenance Instructions
team sterilization is safe and effective and
CAUTIONS:
2. Do not rinse under running water. WARNING: The use of disinfecting solu-
tions for an exterior instrument wipe will not
sterilize equipment and is not recommended.
29
NOTES:
Before Sterilization:
30
Recommended sterilization exposure times of individual handpieces, batteries, attachments and
accessories are as follows:
Exposure
Sterilization Type Temperature Dry Time
Time
Batteries
Steam Gravity 270 - 272°F (132 - 133°C) 3 minutes None
(Unwrapped)
* 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
♦ Battery did not accept charge. ♦ Try charging the battery again. If
battery still does not accept a
charge, battery possibly faulty.
Replace battery. Dispose of prop-
erly (reference “3.1.3 Battery
Cleaning and Maintenance
Instructions” on page 29.
♦ Improper connection between ♦ Check connection and reattach.
handpiece and battery. Check for any debris in battery
receptacle.
32
Table 3: Troubleshooting
Battery
Battery will not ♦ Debris in battery receptacle. ♦ Remove debris with a damp
connect to the hand- cloth. Do not immerse in liquid.
piece.
♦ Damaged handpiece grip. ♦ Return handpiece for service.
All Attachments
Attachments do not ♦ Attachment not oriented cor- ♦ Will only attach in correct posi-
lock into handpiece. rectly. tion (reference “2.3.1 Connect-
ing/Removing Attachments” on
page 9).
♦ Debris in handpiece locking col- ♦ Clean thoroughly with Blitz II
lar or in attachment. Cleaner (reference “3.1.2 Hand-
piece and Attachment Cleaning
Instructions” on page 28).
33
Table 3: Troubleshooting
Chucks are stuck, ♦ Dried blood or debris lodged in ♦ Clean the handpiece according to
sleeves will not chuck. “3.1.2 Handpiece and Attach-
retract. ment Cleaning Instructions”
on page 28.
Blade does not cut ♦ Dull blade. ♦ Use a new blade for each proce-
properly. dure. Cut with light pressure and
steady oscillation of blade.
34
Table 3: Troubleshooting
Blade does not cut ♦ Dull blade. ♦ Use a new blade for each proce-
properly dure. Cut with light pressure and
steady oscillation of blade.
Blade difficult to ♦ Debris lodged in twist-lock col- ♦ Clean the handpiece according to
insert or remove lar. “3.1.2 Handpiece and Attach-
from saw. ment Cleaning Instructions”
on page 28.
♦ Collar may be bent. ♦ Return for service.
35
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.
36
4.2 Battery (L325A)
NOTE: There are no toxic components used in the manufacture of the Maxi-Driver System.
After the useful life of the product, dispose of components and service parts properly.
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
37
5.0 CUSTOMER SERVICE and WARRANTY
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.
38
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-
fied.
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 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
39
5.2 Handpieces, Attachments and Accessories
REF Description
40
13. APEX® Autoclavable Camera Heads - 500
5.3 Linvatec and Hall® Surgical use service program (prorated credit after
Instrument Warranty 250 uses)
The Company warrants all new Instruments to 17. Shutt Non-SLG Instruments - Twelve (12)
be free from defects in materials and workman- Months
ship for the following periods, measured from
18. Footswitches - Twelve (12) Months
Customer’s receipt:
19. Irrigation Systems - Twelve (12) Months
1. Powered Surgical Equipment (battery, elec-
tric, pneumatic) - Twelve (12) Months 20. Reusable Procedure Specific Instruments -
Twelve (12) Months
2. Battery Chargers - Twelve (12) Months
The Maxi-Driver handpiece and attachments
3. Battery Packs - Three (3) Months
described in this manual are to be returned to the
4. Burs and Blades - Upon receipt factory or a Linvatec authorized service facility
for routine maintenance according to the Main-
5. Bur Guards, Blade Guards, and Attach- tenance Schedule Table starting on page 27.
ments - Six (6) Months
Failure to follow this routine maintenance
6. Skull Perforators - Six (6) Months schedule may result in damage to the handpiece
and/or attachments, and may invalidate the
7. Pneumatic Hoses - Six (6) Months
product warranty.
8. Handpiece Cords and Power Cords - Six (6)
If within the specified warranty period the Cus-
Months
tomer discovers that an Instrument has a defect
9. Camera Consoles - Twenty-four (24) in material and/or workmanship, it must
Months promptly notify the Company. If it becomes nec-
essary to return the Instrument to the Company,
10. Video Components - Twelve (12) Months the Customer must (a) acquire a “Returned
Goods” authorization from the Company Cus-
11. Video Cables and Light Guides - Three (3)
tomer Service, (b) pack the unit carefully, and
Months
(c) return it to the Company via air freight, pre-
12. Non-autoclavable Camera Heads - Twelve paid.
(12) Months
41
Within a reasonable time after receipt of Instru- 6. Instruments which did not have their afore-
ment, the Company will investigate and shall mentioned routine maintenance schedule
correct any defect covered by warranty by pro- followed.
viding, at its option, one of the following: ser-
vice or repair of the Instrument, a replacement The foregoing limited warranties are in lieu
of the Instrument, or a refund of the purchase of all other warranties, expressed or implied,
price of the Instrument. These remedies are the including, but not limited to, the implied
Customer’s exclusive remedies under this war- warranties of merchantability and fitness for
ranty. a particular purpose.
The Company warrants that all parts and assem- Except claims for personal injury, in no case
blies used in the repair or service of Instruments shall the Company be liable for any special,
meet new part functional specifications, incidental or consequential damages based upon
although some parts or assemblies may have breach of warranty or any other legal theory.
been remanufactured. Some jurisdictions do not allow limits on war-
ranties, or on remedies, and, in such jurisdic-
All parts and assemblies replaced by the Com- tions, the limits in this and the preceding
pany shall become the property of the Company. paragraphs may not apply.
The foregoing limited warranties do not The Company reserves the right (a) to make
apply to: design changes to Instruments at anytime with-
out notice to Customer and without incurring
1. Instruments which have been tampered any obligation to incorporate those changes into
with, altered, abused or misused. Instruments previously purchased or leased, and
2. Instruments damaged through use with (b) to make changes from time to time in the
other than Company authorized accessories, contents of any publication, instruction manual
attachments, burs or blades. or package insert without any obligation to
notify Customers of such revisions or changes.
3. Instruments not manufactured by or for the
Company.
42
Hall Surgical
®