Manual de Triton
Manual de Triton
Instruction Manual
Rx Only
! USA Rx only For U.S. audience only
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician
Glossary
REF of Universal Symbols
Catalog Number, Reference Number, Reorder Number, Part Number
l Lot Number
GLOSSARY OF UNIVERSAL SYMBOLS
n Serial Number
Attention, see Instructions for Use.
Quantity
kw Rx Only Attention:
Single See
United States Instructions
do not reusefor use
federal
use only;
law restricts this device to sale by or on the order of a physician.
! USA Rx only For U.S. audience only
= IsReference Numberequal to
approximately
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician
J
REF
Lot Number
Non-sterile
Catalog Number, Reference Number, Reorder Number, Part Number
q
l Sterilized
Serial
Lot by gamma irradiation
Number
Number
nf Use byNumber
date
Quantity
Serial
m Date of Manufacture
Quantity
For single patient use only. Do not re-use, re-process, or re-sterilize this product. Re-use, re-
processing or re-sterilization may compromise the structural integrity of the device and/or cre-
Storage Temperatures
k Single use
ate a risk of only; do not reuse
contamination of the device, which could result in patient injury, illness, or death
Approximately equal to
Unlock
= Is approximately equal to
Non-Sterile
Lock
J Non-sterile
|
q On
Sterilized by Gamma Irradiation
Sterilized by gamma irradiation
Off
f Use by
Use by date
date
Finger-Operated Control
m Date Manufacture
Date of manufacture
Foot-Operated
Storage Control
Temperatures
Temperature Limitations
Conformité
Unlock Européene (European Conformity)
Compliant with European
This symbol means thatCouncil Directive
the device fullyMDD 93/42/EEC.
complies with European Council Directive
MDD
Lock 93/42/EEC.
Authorized Representative in the European Community
EC REP
| Authorized
On Representative in the European Community
USA Only
Manufacturer
Off
Do not dispose to unsorted municipal waste.
DO NOT DisposeControl
Finger-Operated to unsorted municipal waste
Manufacturer
TOOL Tool Control Control
Foot-Operated
TUBE Tube ControlEuropéene (European Conformity)
Conformité
PHT Contains DEHP (di-2-ethyl hexyl phthalate)
This symbol means that the device fully complies with European
Midas RexCouncil Directive
Legend High Speed Pneumatic System
DEHP
MDD 93/42/EEC.
EC REP
Authorized Representative in the European Community
Manufacturer
“SAFE” Position. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Pre-Operative Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Post-Operative Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
TRITON™ Hose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
General Warning
Before using the TRITON™ Power Surgical Instrument System, it is EXTREMELY important that you read this
instruction manual.
Extreme caution must be observed when using TRITON components near delicate neural and vascular structures.
Improper use may cause injury to the patient or hospital staff.
We recommend in-service training by our representatives. If questions arise, please call one of our consultants
at 800-643-2773 or 817-788-6400.
The TRITON™ Power Surgical Instrument System is intended for use during surgical procedures to cut hard tissue,
bone, and soft tissue.
Page 1
TRITON™ Power Surgical Instrument System Components
1 – Motor
2 – Permanently attached hose
3 – Disposable air diffuser
4 – Attachment
5 – Dissecting Tool
Page 2
TRITON™ Power Surgical Instrument System Components
• Independent operation of both the MIDAS REX® Motor and the TRITON HT Handpiece or a TRITON Compact
Micro-Saw Handpiece.
• U.S. version (part #703002) includes internal regulator and operates at 8.3 bar (120 psi) nominal
pressure, 13.8 bar (200 psi) maximum pressure.
• International version (part #703003) does not include internal regulator and operates at pressures up
to 8.3 bar (120 psi).
• Maximum pressure for the MIDAS REX Motor is either 8.3 bar (120 psi), 10.3 bar (150 psi), or 13.8 bar (200 psi),
depending on the pressure requirements of the MIDAS REX Motor being used.
• Also operates MEDNEXT® Drill. Maximum pressure for MEDNEXT Drill is 10.3 bar (150 psi). [Refer to Mednext
Bone Dissecting System Instruction Manual (#913001) for detailed operating instructions.]
• Quick-connect couplers for TRITON Auto Lubricator (for use with the MIDAS REX Motor) and for TRITON Hose.
Connect MIDAS REX Motor to gold quick-connect coupler on TRITON Auto Lubricator. Use black quick-connect
coupler for MEDNEXT Drill.
1 – Quick-connect coupler for TRITON Hose
2 – Quick-connect coupler for TRITON Auto Lubricator
with MIDAS REX Motor or for MEDNEXT Drill
Page 3
Power Source Requirements
TRITON™ Compact
Specifications TRITON™ HT Handpiece Micro-Saw Handpiece
Operating pressure 8.3 to 13.8 bar (120 to 200 psi) 8.3 to 13.8 bar (120 to 200 psi)
with U.S. version TRITO with U.S. version TRITON
Pneumatic Control (#703002); Pneumatic Control (#703002);
up to 8.3 bar (120 psi) with up to 8.3 bar (120 psi) with
international version (#703003) international version (#703003)
7 bar (100 psi) if connected 7 bar (100 psi) if connected
directly to gas source directly to gas source
Activation method Trigger Control, variable speed Finger Control, variable speed
Forward/Reverse Yes No
Gas Type
Nitrogen or dry, filtered compressed air.
Required Pressure
U.S. version of TRITON Pneumatic Control with internal regulator (part #703002): 8.3 to 13.8 bar
(120 to 200 psi) maximum, 8.3 bar (120 psi) nominal.
International version of TRITON Pneumatic Control without internal regulator (part #703003): 8.3 bar
(120 psi) maximum.
Gas Source
Nitrogen cylinder used with a Pressure Regulator (CGA 580 fitting) or in-house compressed air.
Page 4
“SAFE” Position
To operate the TRITON HT Handpiece, activate and depress the Trigger Control.
The TRITON Compact Micro-Saw Handpieces will not operate in the “SAFE” position.
To operate Compact Micro-Saw Handpieces, activate and depress the Finger Control.
CAUTION: Always install TRITON Handpieces, Attachments, saw blades and other items
with Handpiece in “SAFE” position.
Page 5
Pre-Operative Procedures
1A. For in-house gas source with 1B. For in-house gas source with 1C. For nitrogen tank gas source,
DISS fitting, connect one end Schrader fitting, connect one connect one end of the
of Pneumatic Supply Hose to end of Pneumatic Supply Hose Pneumatic Supply Hose
wall fitting. to DISS-Schrader Adapter. to the Pressure Regulator.
Connect Adapter to wall fitting.
NOTES: When operating TRITON Handpieces without the TRITON Pneumatic Control, connect the
male Schrader fitting on TRITON Hose directly to a gas source. Set pressure at 7 bar (100 psi).
When connecting TRITON Pneumatic Supply Hose to a MIDAS REX Safety Valve Regulator (SVR),
remove in-line oiler assembly from SVR. Wrench-tighten WF-4 valve to SVR, then hand-tighten Pneumatic
Supply Hose DISS fitting to WF-4 valve. Hand-tighten all DISS fittings – DO NOT use wrenches. If DISS
fittings are unavailable, contact MIDAS REX® for an adapter.
Page 6
Pre-Operative Procedures
1. Unscrew Lubricant Reservoir in 2. Check that siphon tube is 3. Fill with MIDAS REX
“OFF” direction. (If Pneumatic seated firmly in side hole Lubricant until lubricant reaches
Control is pressurized, turn under reservoir cap. “FULL” line. Reattach and firmly
off gas source and depress hand-tighten reservoir.
foot pedal 3 to 5 times to CAUTION: Do not cross-thread
remove air from system.) reservoir. Use only MIDAS REX
Lubricant.
4. Place alignment pin of Auto 5. Attach Air Diffuser to base of 6. Connect MIDAS REX Motor to
Lubricator into alignment port of MIDAS REX motor hose. gold quick-connect coupler on
Pneumatic Control. Push Auto the Auto Lubricator.
Lubricator into black NOTE:
quick-connect coupler. Connect MEDNEXT® Drill
directly to black quick-connect
coupler on TRITON™ Pneu-matic
Control. Refer to the MEDNEXT®
Bone Dissecting System Manual
for lubrication, cleaning and
maintenance of the Mednext Drill
System.
Page 7
Post-Operative Procedures
Disassembly
2A. Remove MIDAS REX® Motor 2B. Hold TRITON™ Hose firmly and
from Auto Lubricator by remove by turning blue quick-
pushing down gold quick- connect coupler counter-
connect coupler. Discard Air clockwise.
Diffuser. If Auto Lubricator
is stored separately from
Pneumatic Control, store upright
or remove lubricant from
reservoir before storage.
4. Remove Pneumatic Supply Hose from Pneumatic Control and gas source.
Page 8
Post-Operative Procedures
Cleaning
Clean the MIDAS REX® Motor according to instructions in the MIDAS REX Instrumentation System Operative Manual.
CAUTION: A TRITON™ Handpiece must be connected to the TRITON Hose to keep water out of the Handpiece during
the cleaning process.
1. Clean TRITON HT Handpiece, 1A. Clean central cannulation 1B. Flush the nose of the
TRITON Compact Micro-Saw shaft of the TRITON HT TRITON HT Handpiece,
Handpieces, TRITON Hose and all Handpiece with a wire driver Reciprocating Saw
TRITON Attachments immediately cannulation brush. Clean Attachment and Compact
after use with an appropriate mild nose of the Micro-Reciprocating
detergent solution and brush. TRITON HT Handpiece, Saw Handpiece with
Reciprocating Saw a water-pik.
Attachment and Compact
Micro-Reciprocating Saw
Handpiece with the same
brush.
Page 9
TRITON™ Power Surgical Instrument System Sterilization
Sterilization Guidelines
Exposure Times
Pre-Vacuum Steam Sterilization
132°C/270°F for 4 minutes.
WARNINGS:
Following steam sterilization, the instrumentation must be allowed to cool to room temperature prior
to use.
Dissecting tools and saw blades are single use, disposable items.
DO NOT steam sterilize Pneumatic Control, Auto Lubricator, Pneumatic Supply Hose, DISS to
Schrader Adapter or Pressure Regulator; the sterilization process could damage components and void
the warranty.
Page 10
TRITON™ High Torque Handpiece
CAUTION: Insert all Attachments into TRITON HT Handpiece with Handpiece in “SAFE” position.
Page 11
TRITON™ High Torque Handpiece Attachments
1. Insert Sagittal Saw Attachment into TRITON 2. Insert the Sagittal Saw Key into the
HT Handpiece in a position to allow easy Attachment and turn counterclockwise
insertion of the Sagittal Saw Key. Note that until there is slight resistance.
Attachment may be installed in 12 different
positions to facilitate proper surgical access.
3. Insert the blade in the space between 4. Turn the Sagittal Saw Key clockwise to
the two jaws, ensuring that the blade lock the blade. Run briefly, then retighten
is fully seated. blade.
CAUTION: Do not over-tighten.
To remove the blade, insert the Sagittal Saw Key into the Attachment and turn counterclockwise.
Page 12
TRITON™ High Torque Handpiece Attachments
1. Insert Reciprocating Saw Attachment into 2. With collet nut loosened, insert blade
TRITON HT Handpiece while Handpiece is until fully seated.
in “SAFE” positon. The Attachment may be
installed in different positions to facilitate
proper surgical access.
Page 13
TRITON™ High Torque Handpiece Attachments
Page 14
TRITON™ High Torque Handpiece Attachments
Wire Collet accepts wires up to 1.6mm (.062”) in diameter. Pin Collet accepts pins up to 3.2mm (.125”) in diameter.
3. Insert wire or pin into the front 4. Put the instrument in the
or back of the TRITON HT “RUN” position by positioning
Handpiece. the Trigger Control vertically.
Turn Forward/Reverse Switch to
the “FORWARD” position.
6. Depress Trigger Control to drive the wire/pin. The pressure-sensitive trigger allows variable speed operation.
7. To obtain additional wire/pin length, release the wire/pin Advance Lever and Trigger Control. Pull back on
the instrument. Squeeze the wire/pin Advance Lever and Trigger Control to drive the wire.
8. To remove threaded wire/pin, put the Forward/Reverse Switch in “REVERSE,” squeeze wire/pin Advance
Lever and depress Trigger Control.
Page 15
TRITON™ Compact Micro-Saw Handpieces
Insert blade into Compact Micro-Sagittal Saw Handpiece with Safety Slide in the “SAFE” position.
1. To install blade, lift Saw Blade 2. Align hole in blade with alignment
Lever. pin in vice.
CAUTION: Use Micro-Sagittal Saw Blades only. DO NOT USE HT-SAGITTAL SAW BLADES.
Page 16
TRITON™ Compact Micro-Saw Handpieces
Insert blade into Compact Micro-Oscillating Saw Handpiece with Safety Slide in the “SAFE” position.
3. To activate Micro-Oscillating Saw Handpiece, depress Finger Control with Safety Slide in “ON” position.
CAUTION: When connecting any Compact Micro-Saw Handpiece to the TRITON Hose, ensure the
Safety Slide is in the “SAFE” position. Insert blades into, or remove blades from, any Compact Micro-Saw
Handpiece with Safety Slide in the “SAFE” position.
Page 17
TRITON™ Hose
TRITON™ Hose:
1. Inspect TRITON Hose before each use: Check carefully for any punctures, tears, or worn areas. Also check the
metal bands at each end of the hose for looseness or wear. Do not use a hose that has any of these conditions.
WARNING: Do not attempt to repair a torn hose by wrapping tape around it. This could restrict the exhaust flow
and cause the hose to explode.
• Slowly open the nitrogen control valve (nitrogen tank with regulator or “in-house” nitrogen). Listen for any
sounds of leakage. Leakage indicates a worn or damaged hose. Do not use hose if there is any evidence of
pressure leakage.
• Attach the TRITON Handpiece to the hose and test for normal operation. Note: if the air hose does not easily
insert into the handpiece there are two possible problems: 1) The hose fitting or the handpiece fitting may be
bent or damaged. Try another hose and handpiece to see if the damaged part can be identified.
It must be returned for service. 2) The O-ring in the handpiece connector may be dried out. It can be lubricated
with a small amount of STERILE petroleum jelly or sterile water (not saline).
• Ensure that the hose does not slip loose from the handpiece when in use. It could whip about, possibly causing
an injury.
3. Return the TRITON Hose at least once per year for routine inspection and service. Aging and repeated
usage/sterilization will gradually deteriorate the hose materials. Eventually, the materials may crack and break under
pressure. This could result in the hose exploding and whipping about, possibly causing an injury. This
is why it is important to routinely return the hose for inspection and service.
Page 18
Precautions
Precautions
• Prior to each use, the entire TRITON™ Power Surgical Instrument System must be inspected for proper operation.
Check all components for gas leakage and return for servicing if necessary.
• Inspect the TRITON Hose before each use for any punctures, tears, or worn areas. Also check the metal bands at
each end of the hose for looseness or wear. Do not attempt to repair a torn hose by wrapping tape around it; such
taping could restrict the exhaust flow and cause the hose to rupture. If the TRITON Hose is damaged, send it in for
repair.
• Return the TRITON Hose at least once per year for routine inspection and service. Normal aging, repeated usage,
and sterilization will gradually deteriorate the hose materials, causing cracks and breakage under
pressure.
• Attach the TRITON Handpieces to the hose and test for normal operation. NOTE: If the TRITON Hose does not
insert easily into the Handpieces, there are two possible problems:
1. The hose fitting or the Handpiece fitting may be bent or damaged. Try another hose and Handpiece to see if the
damaged part can be identified. Return damaged parts for service.
2. The o-ring in the Handpiece connector may be dried out. It can be lubricated with a small amount of sterile
petroleum jelly or sterile water (not saline).
• Wear safety goggles or glasses when using the TRITON Power Surgical Instrument System.
• DO NOT initiate patient contact without testing instruments completely. Test for vibration, heat, etc. in the
Handpieces, Attachments, and hoses.
• ALWAYS change Handpieces and Attachments with instrument in the “SAFE” position.
• DO NOT operate Saw Attachments or Compact Micro-Saws if blades cannot be firmly secured.
• DO NOT use excessive force during surgery. Using excessive force may cause vibration or breakage, which may
result in serious injury.
• Use ONLY TRITON saw blades with the TRITON HT Handpiece Saw Attachments and Compact Micro-Saw
Handpieces. Exact fit of blades is essential for stability and proper operation of equipment.
Page 19
Warnings
Warnings
• DO NOT operate the TRITON™ Power Surgical Instrument System unless you have been trained by an
official Medtronic Midas Rex representative.
• Prior to each use, the entire TRITON Power Surgical Instrument System must be inspected for proper operation.
Check all components for air leakage and return for servicing if leakage is noticed.
• DO NOT initiate patient contact without testing instruments completely: test for vibration, heat, etc. in the
handpiece, hose, and attachments.
• Eye protection should be worn by operating room personnel and surgeons during use of the TRITON Power
Surgical Instrument System.
• Following steam sterilization, the components must be allowed to cool to room temperature prior to use.
• DO NOT operate handpiece without making sure the proper attachment is used.
• DO NOT use an attachment that gets hot or an attachment that is damaged in any way.
• DO NOT operate the Sagittal Saw Attachment, Reciprocating Saw Attachment, Compact Micro-Sagittal Saw,
Compact Micro-Oscillating Saw, or Compact Micro-Reciprocating Saw if blades cannot be firmly secured.
• DO NOT use excessive force during surgery. Excessive force may lead to vibration or breakage which may
result in serious injury.
• Use ONLY blades manufactured by Medtronic Midas Rex. Exact fit of blades is essential for stability and
proper operation of equipment.
/ Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
Page 20
Service and Warranty
CAUTION ABOUT REPAIRS
When MIDAS REX®, MEDNEXT® or TRITON™ equipment requires servicing or repair, it is strongly urged that the
equipment be returned to MEDTRONIC MIDAS REX, Fort Worth, TX, for quality assured service by factory-trained
personnel who will utilize genuine parts as required.
LIMITED WARRANTY
Medtronic Midas Rex warrants that the instruments and parts sold by Medtronic Midas Rex have been tested, inspected
and shipped from the factory in proper working condition, free of visible defects.
Medtronic Midas Rex warrants the following to be free from defects in material and workmanship for a period
of one (1) year after the date of purchase:
MIDAS REX® Motors* TRITON™ Pneumatic Controls
MIDAS REX® Hoses TRITON™ Attachments
MIDAS REX® Foot Controls Bur Storage Cabinets
MEDNEXT® Handpieces Bur Racks
MEDNEXT® Hoses Pressure Regulators
MEDNEXT® Foot Controls Sterilization Trays
TRITON™ Handpieces Pneumatic Supply Hoses
TRITON™ Hoses
Any service or repair work done by Medtronic Midas Rex on the equipment listed above, following the one (1) year
warranty period, will be free from defects in materials and workmanship for a period of six (6) months after the date of
shipment back to the customer.
*MIDAS REX® Driver Motor
Medtronic Midas Rex warrants the MIDAS REX® Driver Motor (Product Number: MRDM) to be free from defects in
material and workmanship for a period of six (6) months after the date of purchase.
Any service or repair work done by Medtronic Midas Rex on the MIDAS REX® Driver Motor (MRDM), following the six
(6) month warranty period, will be free from defects in materials and workmanship for a period of ninety (90) days after
the date of shipment back to the customer.
Medtronic Midas Rex warrants the following to be free from defects in material and workmanship for a period of ninety
(90) days after the date of purchase:
• MIDAS REX® Attachments and Tubes
• MEDNEXT® Attachments
Medtronic Midas Rex warrants all other accessories not listed above to be free from any defects in material or
workmanship for a period of ninety (90) days after the date of purchase. Medtronic Midas Rex will service or replace
any accessories found to be defective on receiving the defective part.
Page 21
Service and Warranty (continued)
This warranty does not apply to any instrument or part, which has been:
1. Damaged by accident, abuse, misuse, or tampering.
2. Modified without written permission of Medtronic Midas Rex.
3. Used contrary to the instructions and warnings specified in the Medtronic Midas Rex instruction manuals for
MIDAS REX®, MEDNEXT® or TRITON™ equipment.
4. Serviced or repaired by anyone other than Medtronic Midas Rex.
5. Damaged by the use of accessories other than genuine MIDAS REX® Tools and Attachments, MEDNEXT® Burs and
Attachments, or TRITON™ Blades and Attachments.
This warranty does not include any implied warranties or any warranty of any type including without limitation
merchantability or fitness for a particular purpose, other than those expressly contained herein. This warranty is
exclusive and in lieu of other warranties, whether written, oral or implied.
MANUFACTURER’S RECOMMENDATION
It is strongly recommended that Surgeons and Operating Room Personnel become thoroughly familiar with all
Medtronic Midas Rex equipment prior to use in surgery. To assist in this effort, Medtronic Midas Rex offers several
Hands-On Workshops. Contact your local Medtronic Neurologic Technologies Sales Representative or Medtronic Midas
Rex for schedules.
Page 22
Notes
Page 23
Notes
Page 24
©2009 Medtronic, Inc.
All rights reserved.
Printed in the USA
10/09
913004EN.R2
Manufactured by:
Medtronic Powered Surgical Solutions
4620 North Beach Street
Fort Worth, TX 76137 USA
Telephone: 817-788-6400
Toll-Free: 1-800-643-2773
Fax: 817-788-6401
www.medtronic.com
Orders:
Telephone: 817-788-6400
Toll-Free: 1-800-433-7080
Fax: 817-788-6489
Repairs:
Telephone: 817-788-6440
Toll-Free: 1-800-335-9557
Fax: 817-788-6441
EC Authorized Representative:
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands