Medtronic X805011 Instructions for Use

™

TRITON

Power Surgical Instrument System

Instruction Manual

Rx Only

Glossary of Universal Symbols

GLOSSARY OF UNIVERSAL SYMBOLS

w Attention: See Instructions for use

For U.S. audience only
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician

Catalog Number, Reference Number, Reorder Number, Part Number

l Lot Number
n Serial Number

Quantity

k Single use only; do not reuse

= Is approximately equal to

J Non-sterile

q Sterilized by gamma irradiation

f Use by date

m Date of Manufacture

Storage Temperatures

Unlock

Lock

| On

Off

Finger-Operated Control

Foot-Operated Control

Conformité Européene (European Conformity)
This symbol means that the device fully complies with European Council Directive
MDD 93/42/EEC.

Authorized Representative in the European Community

Manufacturer

DO NOT Dispose to unsorted municipal waste

Rx only

REF

! USA

EC REP

GLOSSARY OF UNIVERSAL SYMBOLS

w Attention: See Instructions for use

For U.S. audience only
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician

Catalog Number, Reference Number, Reorder Number, Part Number

l Lot Number
n Serial Number

Quantity

k Single use only; do not reuse

Is approximately equal to

Rx only

REF

! USA

Attention, see Instructions for Use.

Rx Only

=

United States federal law restricts this device to sale by or on the order of a physician.

Reference Number

Lot Number

Serial Number

Quantity

For single patient use only. Do not re-use, re-process, or re-sterilize this product. Re-use, re­processing or re-sterilization may compromise the structural integrity of the device and/or cre­ate a risk of contamination of the device, which could result in patient injury, illness, or death

Approximately equal to

Non-Sterile

Sterilized by Gamma Irradiation

Use by date

Date of manufacture

Temperature Limitations

Compliant with European Council Directive MDD 93/42/EEC.

Authorized Representative in the European Community

USA Only

Do not dispose to unsorted municipal waste.

I

Manufacturer

Consult Instructions for Use

Use with

Table of Contents

TRITON™ Power Surgical Instrument System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Power Source Requirements

“SAFE” Position

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Pre-Operative Procedures

Post-Operative Procedures

TRITON™ Power Surgical Instrument System Sterilization

TRITON™ High Torque Handpiece

TRITON™ High Torque Handpiece Attachments

TRITON™ Compact Micro-Saw Handpieces

TRITON™ Hose

Precautions

........................................................................18

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

................................................................8

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

........................................................11

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Service and Warranty

....................................................................21

General Warning

Before using the TRITON™ Power Surgical Instrument System, it is EXTREMELY im por tant that you read this
instruction manual.

Extreme caution must be observed when using TRITON components near delicate neural and vascular struc tures.
Improper use may cause in ju ry to the patient or hos pi tal sta.

We recommend in-service training by our rep re sen ta tives. If ques tions arise, please call one of our consultants
at 800-643-2773 or 817-788-6400.

Indications for Use

e TRITON™ Power Surgical Instrument System is intended for use during surgical procedures to cut hard tissue,

bone, and so tissue.

Page 1Page 1

TRITON™ Power Surgical Instrument System Components

MIDAS REX® High Speed Motor

• ControlledbyfootpedalonTRITONPneumaticControl.

1 – Motor
2 – Permanently attached hose
3 – Disposable air diuser
4 – Attachment
5 – Dissecting Tool

[Refer to Midas Rex Instrumentation System Instruction Manual for
de tailed op er at ing in struc tions.]

TRITON™ High Torque (HT) Handpiece

1 – “Pistol Grip” Pneumatic Motor
2 – TRITON Hose (removable)
3 – “Quick Release” button (easy installation and re mov al
of TRITON Attachments)
4 – Trigger Control (pressure sensitive to al low vari able
speed operation)
5 – Forward/Reverse Switch (directional)

TRITON™ Compact Micro-Saw Handpieces

1

2

3

• AlluseTRITONHose(removable).

• Eachhasvariablespeed,FingerControlwith

a “Safe ty Slide.”

1 – Micro-Oscillating Saw Handpiece
2 – Micro-Sagittal Saw Handpiece
3 – Micro-Reciprocating Saw Handpiece

Page 2

TRITON™ Power Surgical Instrument System Components

TRITON™ Pneumatic Control

• IndependentoperationofboththeMIDASREX®MotorandtheTRITON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
pres sure, 13.8 bar (200 psi) maximum pressure.

• Internationalversion(part#703003)doesnotincludeinternalregulatorandoperatesatpressures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detailed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

Pneumatic Supply Hose

3 – DISS (Diameter Index Safety
System) tting for Pneumatic
Supply Hose

DISS tting connects the gas source to the
Pneu mat ic Control:

• Standardlength–6.1meters(20feet)

• Optionallength–9.1meters(30feet)

Power Source Requirements

Spec i  ca tions TRITON™ HT Handpiece

TRITON™ Compact
Micro-Saw Handpiece

Operating pressure

Activation method

Forward/Reverse

Lubrication

Detachable hose

Cannulation

Gas Type

Nitrogen or dry, ltered com pressed air.

8.3 to 13.8 bar (120 to 200 psi)
with U.S. version TRITO
PneumaticControl(#703002);
up to 8.3 bar (120 psi) with

internationalversion(#703003)

7 bar (100 psi) if connected

directly to gas source

Trigger Control, variable speed

Yes

None

Yes (blue)

3.2 mm (.125”)

8.3 to 13.8 bar (120 to 200 psi)
with U.S. version TRI TON
PneumaticControl(#703002);
up to 8.3 bar (120 psi) with

internationalversion(#703003)

7 bar (100 psi) if con nect ed

directly to gas source

Finger Control, variable speed

No

None

Yes (blue)

None

Required Pressure

U.S.versionofTRITONPneumaticControlwithinternalregulator(part#703002):8.3to13.8bar
(120 to 200 psi) max i mum, 8.3 bar (120 psi) nominal.

InternationalversionofTRITONPneumaticControlwithoutinternalregulator(part#703003):8.3bar
(120 psi) max i mum.

Gas Source

Nitrogen cylinder used with a Pressure Reg u la tor (CGA 580 tting) or in-house com pressed air.

Page 4

TRITON™ High Torque Handpiece

e TRITON HT Handpiece will not op er ate in the “SAFE” position.

To operate the TRITON HT Handpiece, activate and depress the Trigger Control.

“SAFE” Position

“SAFE”: Turn Trigger Control to
either side.

“SAFE”: Turn directional
Forward/Reverse Switch to
middle position.

“ON”: Trigger Control in vertical
position will allow activation of
handpiece.

“ON”: Forward/Reverse Switch
in forward or reverse position will
allow activation of handpiece.

TRITON™ Compact Micro-Saw Handpieces

e TRITON Compact Micro-Saw Handpieces will not op er ate in the “SAFE” position.

To op er ate Com pact Mi cro-Saw Handpieces, activate and depress the Finger Control.

“SAFE”: Li Finger Control and
push “Safety Slide” away from
“ON” position.

“ON”: To activate, li Fin ger
Con trol and push “Safety Slide”
to “ON” position.

CAUTION: Always install TRITON Handpieces, Attachments, saw blades and other items
with Handpiece in “SAFE” position.

Pre-Operative Procedures

STEP A – Pneumatic Supply Hose Connections (DISS Fittings)

1A. For in-house gas source with
DISS tting, connect one end
of Pneumatic Supply Hose to
wall tting.

1B. For in-house gas source with
Schrader tting, connect one
end of Pneumatic Supply Hose
to DISS-Schrader Adapter.
Connect Adapter to wall tting.

2. Connect the other end of the hose
to the Pneumatic Control.

1C. For nitrogen tank gas source,
connect one end of the
Pneumatic Supply Hose
to the Pressure Regulator.

NOTES: When operating TRITON Handpieces with out the TRITON Pneumatic Control, connect the
male Schrader tting on TRITON Hose directly to a gas source. Set pres sure 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 tting to WF-4 valve. Hand-tighten all DISS ttings – DO NOT use wrench es. If DISS

ttingsareunavailable,contactMIDASREX®foranadapter.

STEP B – TRI TON™ Hose and Hand piece Connections to Pneu mat ic Con trol

1. Connect color-coded blue
TRITON Hose to blue
quick-connect coupler on
the Pneumatic Con trol.

2. Check to see that TRITON
HT Handpiece or Compact
Micro-Saw Handpiece is in
“SAFE” po si tion.

Page 6

3. Connect TRITON HT
Handpiece or Compact
Micro-Saw Handpiece to
TRITON Hose with “J”
lock. Handpieces can be
connected while the TRITON
Hose is pressurized.

STEP C – MIDAS REX® Connections to Pneumatic Control

Pre-Operative Procedures

1. Unscrew Lubricant Reservoir in
“OFF” direction. (If Pneumatic
Control is pressurized, turn
o gas source and depress
foot pedal 3 to 5 times to
remove air from system.)

4. Place alignment pin of Auto
Lubricator into align ment port of
Pneumatic Control. Push Auto
Lubricator into black
quick-con nect cou pler.

2. Check that siphon tube is
seat ed rmly in side hole
un der reservoir cap.

5. Attach Air Diuser to base of

 MIDASREXmotorhose.

3. FillwithMIDASREX

Lu bri cant until lubricant reaches
“FULL” line. Reattach and rm ly
hand-tight en reservoir.
CAUTION: Do not cross-thread

reservoir.UseonlyMIDASREX

Lubricant.

6. ConnectMIDASREXMotorto
gold quick-connect coupler on
the Auto Lubricator.
NOTE:
 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.

7. Pressurize system and adjust
lubricant ow rate. Depress
Pneumatic Control foot pedal
to run motor, then adjust ow
control on Auto Lubricator
(see chart this page).

LUBRICANT DRIP RATES

• MIDASREXClassicMotor
1 drop per 10-12 seconds

• MIDASREXIIIMotor

1 drop per 30-60 seconds

Post-Operative Procedures

Disassembly

1. Discard used dissecting tools and blades.

2A. RemoveMIDASREX®Motor
from Auto Lubricator by
push ing down gold quick­ con nect coupler. Discard Air
Diuser. If Auto Lubricator
is stored separately from
Pneumatic Control, store upright
or remove lubricant from
reservoir before storage.

3. Turn o gas source and depress
foot pedal 3 to 5 times to re move
air from Pneumatic Supply Hose.

2B. Hold TRITON™ Hose rm ly and
remove by turning blue quick­ connect coupler counter­ clockwise.

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™ Hand piece must be con nect ed to the TRITON Hose to keep water out of the Handpiece during
the clean ing process.

1. Clean TRITON HT Handpiece,
TRITON Compact Micro-Saw
Handpieces, TRITON Hose and all
TRITON Attachments immediately
aer use with an appropriate mild
de ter gent solution and brush.

2. Rinse instrumentation under
running water to remove all traces
of de ter gent solution. If possible,
use dis tilled water for the nal
rinse.

1A. Clean central cannulation
sha of the TRI TON HT
Hand piece with a wire driver
can nu la tion brush. Clean
nose of the
TRITON HT Handpiece,
Reciprocating Saw
Attachment and Compact
Micro-Reciprocating Saw
Handpiece with the same
brush.

WARNINGS: DO NOT lubricate or oil the TRI TON
Handpieces or the TRITON Hose. DO NOT immerse.
DO NOT use ultrasonic washer/sterilizer.

1B. Flush the nose of the
TRITON HT Handpiece,
Reciprocating Saw
Attachment and Compact
Micro-Reciprocating
Saw Handpiece with
a water-pik.

3. Disconnect the TRITON Hose
from the TRI TON HT Handpiece
or Compact Micro-Saw Handpiece.
Dry all components with a lint-free
tow el.

If any TRITON Handpiece is AC CI DEN TAL LY
IMMERSED in saline, disinfectant, clean ing uid,
or any other corrosive substance, take the following
steps:

1. Immerse the Handpiece in distilled water for
1 minute to dilute the corrosive uid.

2. Immediately, steam sterilize the Handpiece in
a prevacuum sterilizer at 132° C for 4 minutes.

TRITON™ Power Surgical Instrument System Sterilization

Sterilization Guidelines

1. Remove TRITON™ Hose from TRITON™ Handpiece.

  DONOTattempttoremovehosefromtheMIDASREX®MotororMEDNEXT®Drill.

Exposure Times

Pre-VacuumSteamSterilization
132°C/270°F for 4 minutes.

2. PlacecleanedMIDASREX®Motor
 orMEDNEXT®DrillandTRITON™

Hose in bottom of instrument case.

Gravity Displacement Steam Sterilization
132°C/270°F for 30 minutes.

3. Place TRITON™ Handpieces, attachments,
and accessories in ap pro pri ate depressions
of insert trays.
Set tray in case.
NOTE:
Midas Rex or Mednext attachments
can be placed in their respective insert trays
and positioned in the TRITION instrument
case.

4. Place lid on instrument case and sterilize.

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, dis pos able items.

DO NOT steam sterilize Pneumatic Control, Auto Lubricator, Pneumatic Supply Hose, DISS to
SchraderAdapterorPressureRegulator;thesterilizationprocesscoulddamagecomponentsandvoid
the warranty.

Page 10

TRITON™ High Torque Handpiece Operation

TRITON™ High Torque Handpiece

1. Attachments may be preloaded
before insertion into the TRITON
HT Handpiece.

3. Place the TRITON HT Handpiece
in “RUN” position with the Trigger
Control vertical. e Forward/
Reverse Switch should be in the
“FORWARD” position.

2. With TRITON HT Handpiece in “SAFE”
position, insert preloaded Attachment
by depressing quick-release button on
top of Handpiece. Snap Attachment into
Handpiece with a slight twisting motion
un til seated.

4. Aer use, return Trigger Control to
“SAFE” position prior to removing
Attachment. Turn Forward/
Reverse Switch to middle position.

NOTE: e TRITON HT
Handpiece has a Handle
Extension that screws into
the back of the Handpiece.
e Handle Extension
provides bal ance and
two-hand ed con trol for
various drilling and cutting
applications.

5. Remove Attachment by depressing
quick-release but ton on top of
TRITON HT Handpiece.

CAUTION: Insert all Attachments into TRITON HT Handpiece with Handpiece in “SAFE” po si tion.

TRITON™ High Torque Handpiece Attachments

Sagittal Saw Attachment

1. Insert Sagittal Saw Attachment into TRI TON
HT Hand piece in a position to allow easy
in ser tion of the Sagittal Saw Key. Note that
Attachment may be in stalled in 12 di er ent
po si tions to facilitate proper surgical ac cess.

3. Insert the blade in the space between
the two jaws, ensuring that the blade
is fully seated.

To remove the blade, insert the Sagittal Saw Key into the Attachment and turn coun ter clock wise.

2. Insert the Sagittal Saw Key into the
Attachment and turn coun ter clock wise
until there is slight re sis tance.

4. Turn the Sagittal Saw Key clockwise to
lock the blade. Run briey, then retighten
blade.
CAUTION: Do not over-tighten.

Page 12

Reciprocating Saw Attachment

TRITON™ High Torque Handpiece Attachments

1. Insert Reciprocating Saw Attachment into
TRI TON HT Handpiece while Handpiece is
in “SAFE” positon. e Attachment may be
installed in dierent positions to facilitate
prop er surgical ac cess.

3. Finger-tighten collet nut. Run briey, then
retighten collet nut.

To remove the blade, unscrew the collet nut.

2. With collet nut loosened, insert blade
until ful ly seat ed.

TRITON™ High Torque Handpiece Attachments

AO/Synthes® Chuck and Trinkle Chuck Attachments

AO/Synthes®Chuck(le)
and Trinkle Chuck (right)
Attachments.

To install drill bit, pull back on
Attachment Collar. Insert drill bit
and release Attachment Collar.
Reverse procedure to re move
drill bit.

Jacobs Chuck Attachments

Jacobs Chucks and key
placement for 5/32” and
1/4” HT sizes.

To install drill bit, turn key
to open ridged collar. Insert
drill bit. Reverse procedure
to re move drill bit.

Hudson and Zimmer® Chuck HT Attachments

Keyless Jacobs
Chucks are
available in 1/8”
and 1/4” HT sizes.

Hudson Chuck HT (le) and
Zimmer®ChuckHT(right)
Attachments.

To install instrument, pull back on
Attachment Collar, then insert male
end of instrument into Chuck. Reverse
procedure to re move drill bit.

Page 14

TRITON™ High Torque Handpiece Attachments

Wire and Pin Collet Attachments

Wire Collet accepts wires up to 1.6mm (.062”) in diameter. Pin Collet accepts pins up to 3.2mm (.125”) in di am e ter.

1. Insert Wire or Pin Collet while
TRITON HT Handpiece is in
“SAFE” position.

3. Insert wire or pin into the front
or back of the TRI TON HT
Handpiece.

2. Screw the Cannulated Extension
into back of the TRITON HT
Handpiece to protect op er a tor
from the point of the wire or pin.

4. Put the instrument in the
“RUN” position by po si tion ing
the Trigger Control vertically.
Turn Forward/Reverse Switch to
the “FORWARD” position.

5. Squeeze wire/pin Advance Lever
and hold it down.

6. Depress Trigger Control to drive the wire/pin. e pressure-sensitive trigger allows vari able speed operation.

7. To obtain additional wire/pin length, release the wire/pin Advance Lever and Trigger Control. Pull back on
the in stru ment. Squeeze the wire/pin Advance Lever and Trigger Control to drive the wire.

8. Toremovethreadedwire/pin,puttheForward/ReverseSwitchin“REVERSE,”squeezewire/pinAdvance
Lever and depress Trigger Control.

9. Remove Wire or Pin Collet while TRITON HT Handpiece is in “SAFE” position.

TRITON™ Compact Micro-Saw Handpieces

Compact Micro-Sagittal Saw Handpiece

Insert blade into Compact Micro-Sagittal Saw Handpiece with Safety Slide in the “SAFE” position.

1. To install blade, li Saw Blade
Lever.

4. To activate, depress Finger Control with Safety Slide in “ON” position.

5. To remove blade, push Safety Slide into “SAFE” po si tion and li Saw Blade Lever.

2. Align hole in blade with alignment
pin in vice.

3. Push Saw Blade Lever down to
lock blade in place. DO NOT force
Saw Blade Lever.

CAUTION: Use Micro-Sagittal Saw Blades only. DO NOT USE HT-SAGITTAL SAW BLADES.

Compact Micro-Reciprocating Saw Handpiece*

Insert blade into Compact Micro-Reciprocating Saw Handpiece with Safety Slide in the “SAFE” position.

1. With collet nut loosened, insert
blade until fully seated.

3. To activate, depress Finger Control with Safety Slide in “ON” position.

4. To remove blade, push Safety Slide into “SAFE” po si tion and unscrew collet nut.

2. Finger-tighten collet nut. Run
briey, then retighten collet nut.

Page 16

TRITON™ Compact Micro-Saw Handpieces

Compact Micro-Oscillating Saw Handpiece

Insert blade into Compact Micro-Oscillating Saw Handpiece with Safety Slide in the “SAFE” position.

1. To install blade, use Os cil lat ing
Key to unscrew hex nut.

3. To ac ti vate Micro-Oscillating Saw Handpiece, depress Finger Control with Safety Slide in “ON” position.

4. To remove blade, push Safety
Slide into “SAFE” po si tion and
use Oscillating Key to unscrew
hex nut.

2. Insert blade underneath hex nut
and washer. Tighten hex nut with
Os cil lat ing Key. Run saw briey,
then retighten hex nut.

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.

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. is could restrict the exhaust ow
and cause the hose to explode.

2. Test the TRITON Hose prior to surgery:

 • Wearsafetygogglesorglasses.

 • AttachtheTRITONHosetothePneumaticControl.

 • 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) e hose tting or the handpiece tting may be
bent or damaged. Try another hose and handpiece to see if the damaged part can be identied.
It must be returned for service. 2) e 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. is could result in the hose exploding and whipping about, possibly causing an injury. is
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operation.
Check all components for gas leakage and return for servicing if necessary.

• DO NOT OPERATE power system if the TRITON Hose is damaged.

• 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 ow and cause the hose to rupture. If the TRITON Hose is dam aged, send it in for
repair.

• ReturntheTRITONHoseatleastonceperyearforroutineinspectionandservice.Normalaging,repeatedusage,
and sterilization will gradually deteriorate the hose materials, causing cracks and breakage under
pres sure.

• 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. e hose tting or the Handpiece tting may be bent or damaged. Try another hose and Handpiece to see if the

damaged part can be identied. Return damaged parts for service.

2. e o-ring in the Handpiece connector may be dried out. It can be lubricated with a small amount of ster ile

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rmly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 t of blades is essential for stability and proper operation of equipment.

Warnings

Warnings

• DO NOT operate the TRITON™ Power Surgical Instrument System unless you have been trained by an
ocial 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 power system if TRITON Hose is damaged.

• 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 rmly 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 t of blades is essential for stability and
proper operation of equipment.

• Alwaysinstallanewbladepriortouse.

Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

/

Page 20

Service and Warranty

Contact: Medtronic Midas Rex
Technical Support: 800-643-2773
817-788-6400

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 aer 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 aer 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 aer 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 aer
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 aer 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 aer the date of purchase. Medtronic Midas Rex will service or replace
any accessories found to be defective on receiving the defective part.

Service and Warranty (continued)

is warranty does not apply to any instrument or part, which has been:

1. Damaged by accident, abuse, misuse, or tampering.

2. Modied without written permission of Medtronic Midas Rex.

3. Used contrary to the instructions and warnings specied 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.

is warranty does not include any implied warranties or any warranty of any type including without limitation
merchantability or tness for a particular purpose, other than those expressly contained herein. is warranty is
exclusive and in lieu of other warranties, whether written, oral or implied.

LIABILITY IN CLINICAL APPLICATIONS

While Medtronic Midas Rex guarantees complete compatibility among its products within a specic product line, it
disclaims any responsibility should a surgical procedure be complicated by a misadventure if:

1. eMIDASREX®MotorsareusedwithdissectingtoolsotherthanMIDASREX®DissectingToolsthatare
manufactured, authorized, or quality controlled by the Medtronic Midas Rex.

2. MIDASREX®DissectingToolsmanufactured,authorized,orqualitycontrolledbytheMedtronicMidasRexare
 usedwithanyMotorotherthantheappropriateMIDASREX®motor.

3. eMEDNEXT®DrillsareusedwithbursotherthanMEDNEXT®Bursthataremanufactured,authorized,or

quality controlled by the Medtronic Midas Rex.

4. MEDNEXT®Bursmanufactured,authorized,orqualitycontrolledtheMedtronicMidasRexareusedwithanydrill
 otherthantheappropriateMEDNEXT®Drill.

5. e TRITON™ HT Handpiece is used with attachments or saw blades other than TRITON™ attachments or saw
blades that are manufactured, authorized, or quality controlled by the Medtronic Midas Rex.

6. e TRITON™ Compact Micro-Saws are used with saw blades other than TRITON™ saw blades that are
manufactured, authorized, or quality controlled by the Medtronic Midas Rex.

7. TRITON™ saw blades manufactured, authorized, or quality controlled by the Medtronic Midas Rex are used with
any handpiece/attachment other than the appropriate TRITON™ handpiece/attachment.

Note: e Limited Warranty does not apply to services required as the result of damage caused by the use of non-genuine

MIDASREX®,MEDNEXT®orTRITON™manufacturedcuttingtools.Peakperformance,reliabilityandmaximumservice
lifefromyourMIDASREX®,MEDNEXT®orTRITON™instrumentationmaybeassuredbyusingonlythoseproducts

that are manufactured by and sold through Medtronic Midas Rex, Fort Worth, Texas.

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 eort, Medtronic Midas Rex oers several
Hands-On Workshops. Contact your local Medtronic Neurologic Technologies Sales Representative or Medtronic Midas
Rex for schedules.

Page 22

Notes

GLOSSARY OF UNIVERSAL SYMBOLS

w Attention: See Instructions for use

For U.S. audience only
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician

Catalog Number, Reference Number, Reorder Number, Part Number

l Lot Number
n Serial Number

Quantity

k Single use only; do not reuse

= Is approximately equal to

J Non-sterile

q Sterilized by gamma irradiation

f Use by date

m Date of Manufacture

Storage Temperatures

Unlock

Lock

| On

Off

Finger-Operated Control

Foot-Operated Control

Conformité Européene (European Conformity)
This symbol means that the device fully complies with European Council Directive
MDD 93/42/EEC.

Authorized Representative in the European Community

Manufacturer

DO NOT Dispose to unsorted municipal waste

Rx only

REF

! USA

EC REP

GLOSSARY OF UNIVERSAL SYMBOLS

w Attention: See Instructions for use

For U.S. audience only
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician

Catalog Number, Reference Number, Reorder Number, Part Number

l Lot Number
n Serial Number

Quantity

k Single use only; do not reuse

Is approximately equal to

Rx only

REF

! USA

Glossaire des symboles universels

Attention, voir mode d’emploi..

Rx Only

La loi fédérale des États-Unis réserve cet appareil àla vente sur ordonnance de ou par un mé­decin.

Numéro de référence

Numéro de lot

Numéro de série

Quantité

Usage unique.Ne pas réutiliser, retraiter ou stériliser une nouvelle fois ce produit. La réutilisa­tion, le retraitement ou une nouvelle stérilisation peut compromettre l’intégrité structurelle de
l’appareil et/ou créer un risque de contamination de l’appareil pouvant entraîner des blessures,
desmaladies ou lamort du patient.

Approximativement égal à

=

Non stérile

Stérilisé par rayons gamma

Utiliser avant (date)

Date de fabrication

Limitations de température

Conforme à la directive DDM 93/42/CEE du Conseil européen

I

Représentant autorisé au sein de la
Communauté européenne

États-Unis
uniquement

Ne pas jeter avec les déchets municipaux non triés.

Fabricant

Consulter Le Mode D’emploi

Utiliser avec

Français

Table des matières

Composants du système d’instrumentation chirurgicale TRITON™ ........................................................2

Exigences en termes de sources d’alimentation ............................................................................................4

Position de sécurité ............................................................................................................................................5

Procédures préopératoires ................................................................................................................................6

Procédures postopératoires ..............................................................................................................................8

Stérilisation du système d’instrumentation chirurgicale TRITON™ ........................................................10

Pièce à main à couple élevé TRITON™..........................................................................................................11

Accessoires pour pièce à main à couple élevé TRITON™ ..........................................................................12

Microscies compactes TRITON™ ..................................................................................................................16

Tuyau TRITON™ ..............................................................................................................................................18

Précautions ........................................................................................................................................................19

Avertissements ................................................................................................................................................20

Réparation et garantie......................................................................................................................................21

Avant toute utilisation du système d’instrumentation chirurgicale TRITON™, il est EXTREMEMENT important de
lire ce manuel d’instructions.

Une grande prudence doit être observée lors de l’utilisation des composants TRITON à proximité de structures neurales
et vasculaires fragiles. Une utilisation incorrecte peut entraîner des blessures au patient ou au personnel soignant.

Nous recommandons d’avoir recours à la formation interne proposée par nos représentants. En cas de doute, appeler l’un
de nos conseillers au 1-800-643-2773 ou au 1-817-788-6400.

Page 1

Avertissement général

Composants du système d’instrumentation chirurgicale TRITON™

Moteur à grande vitesse MIDAS REX®

• Commandé par la pédale de commande pneumatique TRITON.

1 – Moteur
2 – Tuyau fixe
3 – Diffuseur d’air jetable
4 – Accessoire
5 – Outil de dissection

1 – Moteur pneumatique à poignée pistolet
2 – Tuyau TRITON (amovible)
3 – Bouton de dégagement rapide (installation et retrait faciles

des accessoires TRITON)

4 – Commande par gâchette (sensible à la pression afin

de permettre un fonctionnement à vitesse variable)

5 – Interrupteur de marche avant-arrière (directif)

1 – Microscie oscillante
2 – Microscie sagittale
3 – Microscie alternative

[Se référer au manuel d’instructions du système d’instrumentation
Midas Rex pour des consignes d’utilisation détaillées.]

Pièce à main à couple élevé (HT) TRITON™

Microscies compactes TRITON™

• Elles utilisent toutes le tuyau TRITON (amovible).

• Chaque microscie fonctionne à vitesse variable, avec
commande digitale et curseur de sécurité.

Page 2

1

2

3

Français

1 – Raccord rapide pour tuyau TRITON
2 – Raccord rapide pour lubrificateur automatique TRITON

avec moteur MIDAS REX ou pour foret MEDNEXT

Le connecteur DISS doit être branché à la source de gaz de
la commande pneumatique :

• Longueur standard – 6,1 mètres (20 pieds)

• Longueur optionnelle – 9,1 mètres (30 pieds)

Composants du système d’instrumentation chirurgicale TRITON™

• Fonctionnement autonome du moteur MIDAS REX® et de la pièce à main HT TRITON ou d’une microscie
compacte TRITON.

• La version américaine (référence nº 703002) comprend un régulateur interne et fonctionne à une pression nominale
de 8,3 bars (120 psi) et une pression maximale de 13,8 bars (200 psi).

• La version internationale (référence nº 703003) n’est pas dotée de régulateur interne et fonctionne à des pressions
allant jusqu’à 8,3 bars (120 psi).

• La pression maximale du moteur MIDAS REX est de 8,3 bars (120 psi), 10,3 bars (150 psi) ou 13,8 bars (200 psi),
selon les exigences en termes de pression du moteur utilisé.

• Elle est également adaptée au foret MEDNEXT®. La pression maximale du foret MEDNEXT est de 10,3 bars (150 psi).
[Se référer au manuel d’instructions du dispositif de dissection osseuse Mednext (nº 913001) pour des instructions
détaillées.]

• Raccords rapides pour lubrificateur automatique TRITON (à utiliser avec le moteur MIDAS REX) et tuyau TRITON.
Raccorder le moteur MIDAS REX au raccord rapide doré du lubrificateur automatique TRITON. Utiliser le raccord
rapide de couleur noire pour le foret MEDNEXT.

3 – Connecteur DISS (Diameter-

Index Safety System) pour tuyau
d’alimentation pneumatique

Commande pneumatique TRITON™

Tuyau d’alimentation pneumatique

Page 3

Type de gaz

Azote ou gaz sec, air comprimé filtré.

Pression requise

Version américaine de la commande pneumatique TRITON avec régulateur interne (pièce nº 703002) :
maximale 8,3 à 13,8 bars (120 à 200 psi), nominale 8,3 bars (120 psi).

Version internationale de la commande pneumatique TRITON sans régulateur interne (pièce nº 703003) :
maximale 8,3 bars (120 psi).

Source de gaz

Bouteille d’azote utilisée avec un régulateur de pression (raccord CGA 580) ou de l’air comprimé interne.

Exigences en termes de sources d’alimentation

Page 4

Microscie compacte TRITON™

Spécifications Pièce à main HT TRITON™

Pression de fonctionnement

8,3 à 13,8 bars (120 à 200 psi) avec 8,3 à 13,8 bars (120 à 200 psi) avec

la version américaine TRITON la version américaine TRITON
Commande pneumatique (nº 703002) ;

Commande pneumatique

jusqu’à 8,3 bars (120 psi) avec la

(nº 703002) ;

jusqu’à 8,3 bars

version internationale (nº 703003) (120 psi) avec laversion

internationale (nº 703003)

7 bars (100 psi) si connectée 7 bars (100 psi) si connectée

directement à la source de gaz directement à la source de gaz

Méthode d’activation Commande par gâchette, vitesse Commande digitale, vitesse variable

variable

Marche avant-arrière Oui Non

Lubrification Aucune Aucune

Tuyau amovible Oui (bleu) Oui (bleu)