Medtronic 2340000 Instructions for Use

Integrated Power Console (IPC®) System

Rx Only

MODEL: 2340000

User’s Guide

The information contained in this document is accurate at time of publication. Medtronic reserves the right to make changes to the product described in this manual without notice and without incorporating those changes to products already sold. Released documents are available to view or print at manuals.medtronic.com.

The following are trademarks or registered trademarks of Medtronic, Inc. in the United States and other countries: CD HORIZON®, Endo-Scrub®, Hydrodebrider®, Indigo™, Intelliow®, IPC®, Legend®, Legend EHS®, Legend EHS Stylus©, Magnum®, Midas Rex®, Mednext®, NIM®, NIM-Eclipse®, Powerease™, Skeeter®, SOLERA®, StraightShot®, Stylus Touch®, Triton®, TSRH® 3Dx™ , Visao® and XPS®. All other trademarks, service marks, registered trademarks, or registered service marks are the property of their respective owners in the United States and other countries.

TABLE OF CONTENTS

SYMBOLS ......................................................................................................................................... 1-1

GLOSSARY........................................................................................................................................ 1-1

CUSTOMER SERVICE ....................................................................................................................... 1-1

INDICATIONS FOR USE ................................................................................................................... 1-2

DEVICE DESCRIPTION .................................................................................................................... 1-2

CONTRAINDICATIONS .................................................................................................................... 1-2

WARNINGS ....................................................................................................................................... 1-2

PRECAUTIONS ................................................................................................................................. 1-4

SYSTEM REQUIREMENTS AND SPECIFICATIONS.........................................................................1-5

SYSTEM SOUNDS AND FIGURES ................................................................................................... 1-6

PRE-OPERATING INSTRUCTIONS .................................................................................................. 1-8

When the System Arrives .............................................................................................................................................................................1-8

Set up the IPC ...................................................................................................................................................................................................1-8

Install the Pump Cartridges or Irrigation Tubing .................................................................................................................................1-8

Prepare the IPC for Use .................................................................................................................................................................................1-8

Calibrate Touchscreen ...................................................................................................................................................................................1-8

Change System Settings ..............................................................................................................................................................................1-8

Set up and Prime Pumps ..............................................................................................................................................................................1-9

Conrm System Operation ....................................................................................................................................................................... 1-10

IPC COMPONENTS ........................................................................................................................ 1-10

Multifunction Footpedal............................................................................................................................................................................1-10

IntelliFlow Irrigation Remote Control ................................................................................................................................................... 1-10

Auxillary Power Console ............................................................................................................................................................................ 1-10

POST-OPERATIVE INSTRUCTIONS .............................................................................................. 1-10

Disconnect Accessory Cable from Console ........................................................................................................................................1-10

Clean the Multifunction Footpedal ....................................................................................................................................................... 1-10

GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY ....... 1-11

LIMITED WARRANTY ..................................................................................................................... 1-13

FOR ITEMS CONTAMINATED WITH TSE AGENTS ....................................................................... 1-13

TRITON ELECTRIC HIGH-TORQUE HANDPIECE ............................................................................ 2-1

SUCTION IRRIGATOR ...................................................................................................................... 3-1

ENDO-SCRUB 2 ................................................................................................................................ 4-1

SPINE SHAVER (SC1) HANDPIECE ................................................................................................. 5-1

STRAIGHTSHOT M4, STRAIGHTSHOT MAGNUM II AND STRAIGHTSHOT III ............................ 6-1

LEGEND EHS AND LEGEND EHS STYLUS ...................................................................................... 7-1

STYLUS TOUCH ................................................................................................................................ 8-1

LEGEND EHS, LEGEND EHS STYLUS AND STYLUS TOUCH ATTACHMENTS .............................. 9-1

SKEETER ULTRA-LITE OTO-TOOL ................................................................................................ 10-1

VISAO HIGH-SPEED DRILL ........................................................................................................... 11-1

INDIGO HIGH-SPEED OTOLOGIC DRILL ...................................................................................... 12-1

MIDAS REX MICROSAWS .............................................................................................................. 13-1

POWEREASE DRIVER .................................................................................................................... 14-1

TROUBLESHOOTING AND ERROR CODES .................................................................................... A-1

CLEANING AND STERILIZATION .................................................................................................... B-1

Triton Electric High-Torque Handpiece ............................................................................................................................M000030A322

Endo-Scrub 2 ......................................................................................................................................................................................... 68E4005

Midas Rex Spine Shaver, StraightShot M4, StraightShot Magnum II or StraightShot III ............................................ 68E3282

Legend EHS and Legend EHS Stylus .................................................................................................................................M000030A234

Stylus Touch ...........................................................................................................................................................................................68E4132

Legend Attachments ..............................................................................................................................................................M000030A235

Skeeter Oto-ex Burs .......................................................................................................................................................................... 68E3968

Skeeter Handpiece ..............................................................................................................................................................................68E3969

Visao .........................................................................................................................................................................................................68E3281

Indigo High-Speed Otologic Drill ..................................................................................................................................................68E4187

Indigo High-Speed Otologic Drill Attachments .......................................................................................................................68E4188

Microsaws ...................................................................................................................................................................................M000030A231

POWEREASE Driver ..............................................................................................................................................................................68E4189

SYMBOLS

Accessory

Adapter

Attachment

Bone Mill

Brush

The following symbols can appear on this device and related packaging.

INTEGRATED POWER CONSOLE (IPC)

ACC

STERILE

>120 VAC

OFF

<120s

>180s

Do Not Dispose Of This Product In The Unsorted Municipal Waste Stream. Dispose Of This Product Accordingto Local Regulations. See Recycling. Medtronic.Com For Instructions On Proper Disposal Of This Product.

Pump Head 1

Pump Head 2

Fuse

Accessory

AC Power

Output

Is Approximately Equal To

Non-Sterile

Quantity

RoHS - Environmental Friendly Use Period - China (SJ/T11364-2006)

Not Greater than 120vac

Applied Part Duty Cycle

IPX1

IPX7

BUR

NIM

EHS

Package Contents

Equaipotential Ground Connector

Protected Against Vertical Water Drops

Protected Against The Eects Of Temporary Immersion In Water

Type BF Applied Part

Start/Stop

RF Transmitter (Interference May Occur)

Precaution: Pinch Hazard. Keep Fingers Clear Of Rollers

Stim Bur Connector

NIM Console Connector

Electrical High Speed Handpiece Connector

World Wide Standard for Medical Tubing Diameter

On O Button

Use With

Oscillate

Forward

Reverse

Foot Pedal Connector

Fine Irrigant Adjustment

Left Foot Control Unit Button / Mode Button

Right Foot Control Unit Button / Control Button

Top Foot Control Unit Button / Handpiece Button

Locked

Unlocked

Handpiece

Skeeter

Conforms to ANSI/AAMI ES 60601-1, IEC/EN 60601-1. Certied to CSA C22.2 No.601.1

Control Unit

Dissecting Tool

Instrument Case

Lubricant/Diuser

Motor

Multi-Use Disposable Attachment

Refurbished

Regulator

EUR · USA · JPN · AUS

PHT

DEHP

EMC Compliance Mark

Protective Earth

Contains DEHP (di-2-ethyl hexyl phthalate)

Follow Instructions For Use

GLOSSARY

The following words and acronyms may be used in this guide.

FCU Foot Control Unit IPC Integrated Power Console I.V. Intravenous NIM Nerve Integrity Monitor - One or all of the Nerve Integrity Monitor units: NIM-Response 2.0, NIM-Neuro 2.0, NIM-Response 3.0

and NIM-Neuro 3.0 NIM-ECLIPSE Nerve Integrity Monitor for spinal surgeries XPS Xomed Power System FWD Forward - Rotation is clockwise OSC Oscillate REV Reverse - Rotation is counter-clockwise

CUSTOMER SERVICE

Medtronic Spinal and Biologics Business Worldwide Headquarters 2600 Sofamor Danek Drive Memphis, TN 38132 1800 Pyramid Place Memphis, TN 38132 www.myspinetools.com

US Help Line 901-396-3133 800-876-3133 Customer Service: 800-933-2635

International Service International Customers should contact their local Medtronic Xomed oce.

1-1

INTEGRATED POWER CONSOLE (IPC)

INDICATIONS FOR USE

The IPC POWEREASE System is indicated for drilling, tapping and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. The IPC POWEREASE System is also used in the placement of screws, or cutting of screws, posts, and rods.

The IPC is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.

DEVICE DESCRIPTION

The IPC POWEREASE System consists of a driver specically designed for drilling, tapping and driving screws in the pedicle during spinal surgery. The driver is driven by the Integrated Powered Console (IPC) equipped with the appropriate software to operate the handpiece. The driver is used to drive working end instruments capable of breaking setscrews, cutting posts, and cutting rods during spinal surgery.

The IPC POWEREASE System provides the power for tapping the pedicle and insertion of the pedicle screws is currently done manually using an existing ratcheting handle which connects to the taps and drivers.

The POWEREASE Driver also has nerve stimulation capabilities when connected to the Medtronic NIM-Eclipse system. An external cable that connects the NIM-Eclipse System to the driver enables the driver to have nerve stimulating capability.

The driver is equipped with a quick connect feature which allows for easy and secure attachment of working end instruments to perform the various functions mentioned above.

CONTRAINDICATIONS

The IPC POWEREASE system is contraindicated for arthroscopic microdiscectomy in individuals with the following:

• Severe/progressive neurological decits

• Cauda equine syndrome

• Active infection

Arthroscopic microdiscectomy is not indicated for individuals with sequestered disc fragments, discogenic pain, internal disc destruction, or lumbago.

WARNINGS

System Warnings

W1 It is important that the IPC system operator be familiar with the system User’s Guide, its precautions, procedures and safety issues. W2 Do not use the IPC POWEREASE system in the presence of ammable anesthetics. Avoid potential ignition or explosion of gases. W3 When not operating handpiece, eliminate accidental foot control activation. Control energy to and through the handpiece to prevent

unintended tissue, bone, or nerve resection. W4 Disconnect power to the IPC system before cleaning the unit to avoid electrical macro shock. W5 Do not attach unapproved components to the IPC system to avoid electrical macro shock. W6 To avoid the risk of electrical shock, achieve electrical grounding reliability with proper connections. Connect the IPC system to hospital

grade receptacles only. W7 This medical device complies with EN60601-1-2 safety standard for electromagnetic compatibility, requirements and test. However, if this

equipment is operated in the presence of high levels of electromagnetic interference (EMI) or highly sensitive equipment, interference may

be encountered and the user should take whatever steps are necessary to eliminate or reduce the source of the interference. Diminished

performance may lengthen operating time for anesthetized patient. W8 Medical Electrical Equipment needs special Precautions regarding EMC and needs to be installed and put into service according to the EMC

information provided in this Guide. W9 Portable and mobile RF communications equipment can aect Medical Electrical Equipment. W10 Do not operate the IPC POWEREASE system in the presence of Magnetic Resonance Imaging devices. W11 Use of accessories and cables other than those specied and sold by Medtronic may result in increased emissions and decreased immunity

of this unit. W12 The IPC system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the IPC system

should be observed to verify normal operation in the conguration in which it will be used. W13 Do not attempt to run the IPC POWEREASE system handpiece immediately after autoclaving. Allow an adequate “cool down” period

(Typically 1 hour). W14 Consult the Legend Bone Mill product insert before use with the Integrated Power Console system. W15 For metal transection, observe the following safety precautions:

W15a Eye wear protection is essential. W15b Irrigate well to cool the cutting surfaces. W15c Protect the wound site from metal debris.

W15d Use a clamp or grasping device to control loose fragments during transection of any metal component. W16 Do not operate the IPC POWEREASE system without eye protection.

W17 All service must be performed by Medtronic qualied personnel only. W18 Repair and/or modication to the IPC system by anyone other than qualied service personnel may signicantly compromise the unit’s

ability to perform eectively and/or void the equipment warranty.

Component Warnings

W19 Do not use any parts other than Medtronic system components as damage or substandard performance could result. W20 Always inspect the components before and after use for any damage. If damage is observed, do not use damaged part until it is repaired or

replaced. Damaged parts may deposit metal shavings on surgical site.

W21 When precise location of blade tip is required, engage the rotation lock on the handpiece, then calibrate and verify the blade tip on Image

1-2

INTEGRATED POWER CONSOLE (IPC)

Guided Surgery (IGS) system. Always lock M4 handpiece when driving non-rotatable blades to maintain their IGS calibration.

W22 Employ visualization, including use of imaging techniques (e.g., uoroscopy, image guided surgery) when using rotating powered

accessories. Discontinue powered application in the event of lack of visualization of surgical site.

W23 Midas Rex Variable Exposure attachments. Surgeons should familiarize themselves with the performance of dissecting tools before use,

and should explore the eect of various levels of tool exposure on dissection stability. If the tool exhibits excessive chatter, vibration, or movement, decrease the tool exposure.

W24 Motors and attachments may fail due to extended use and allow a component to detach and fall from the motor or attachment, causing

patient injury. W25 Electrical contacts must be dry prior to use. W26 Heavy side loads and/or long operating periods may cause the device to overheat. W27 Do not use an overheated device, as it may cause thermal injury to the patient or operator. W28 Use adequate irrigation. The use of a tool without irrigation may cause an inordinate amount of heat buildup resulting in a thermal injury

to tissue. Depending on the amount of irrigation used, the drill bits and saw blades can achieve temperatures in excess of 50°C. W29 Do not attempt to change a dissecting tool, saw blade, or attachment while the motor is running, or when the motor or attachment is in an

overheated state. W30 Do not immerse the system components, except as noted. W31 Do not place motor, attachment and tool on the patient or in an unsecured location during surgery. W32 A system that is not functioning properly should not be used until all necessary repairs have been made and the unit is tested to ensure

that it is functioning in accordance with Medtronic specications. W33 Match the nomenclature and color code on the tool packaging to the same nomenclature and color code on the Attachment. W34 Make sure that the attachment is still in the locked position after each adjustment of the tool exposure, as attempting to increase the tool

exposure too far, may result in the attachment accidentally being unlocked. W35 Midas Rex Legend EHS Motor and Midas Rex Legend EHS Stylus Motor should only be operated when the attachment is in the locked

position. W36 Smoke may be generated if attachment is not in the locked position. W37 The Indigo and Legend EHS motors will not run properly unless the attachment is in the locked position. W38 DO NOT change accessory with handpiece running to prevent laceration of user and cross-contamination through compromised glove. W39 Remove Legend Footed Attachments cautiously and slowly as per instructions to avoid injury to the operator. W40 DO NOT modify accessories used with the handpiece. Performance could be diminished with modied accessories. W41 The safe use of the Endo-Scrub 2 System in procedures where surgical lasers are also employed has not been clinically demonstrated. W42 In order to ensure compliance with requirements of IEC 60601-1, use a Medtronic approved power cable. W43 To avoid the risk of electric shock, this equipment must only be connected to a supply main with protective earth. W44 Keep NIM Muting Probe cable away from IPC system cables. W45 Verify reusable device was sterilized prior to use. If not sterilized, do not use.

Disposable Warnings

W46 Tools are available for resection of soft tissue and bone for surgical procedures. Use of tools depends on the intended application and

patient needs. Sharp-cutting powered tools induce bleeding and removal of signicant tissue and bone. W47 Use methods at the operative site to control bleeding that do not compromise patient safety during at-risk surgery. W48 Always keep the cutting area of the tool/saw blade away from ngers and loose clothing. Prevent laceration of user and cross-

contamination through compromised glove. W49 Operate the tool only after the appropriate anatomical landmarks and the intended surgical site have been conrmed. W50 Use care in application of the moving cutting end to only appropriate anatomical landmarks and the intended surgical site when using

powered accessories. W51 Insertion of metal objects in accessory tip may cause the accessory to break leaving fragments in the wound. The fragments may be

dicult to remove, causing irritation, inammation and foreign-body response at surgical site. W52 Bending or prying may break the accessory, causing harm to patient or sta. W53 Do not use excessive force to pry or push bone with the attachment, tool or blade during dissection. W54 A tool’s size and geometry may create excessive vibration at certain speeds. Increase or decrease speed on console. Change to a new tool

to prevent unintended tissue removal from patient. W55 Test for wobble at desired speed prior to use. Discontinue use of accessory if tip begins to wobble and replace accessory to prevent

unintended tissue removal from patient. W56 Eccentricity of the tool can cause tool vibration and may result in excess tissue and bone destruction and hearing damage. W57 Excessive noise from the tool when drilling close to the cochlea or ossicular chain may cause hearing damage. W58 CONSULT the cranial perforator device labeling for the recommended speed specications. W59 Tools with “L” identication are longer tools intended for light bone dissection. The increased tool head/stem conguration may aect

dissection stability. W60 Tool utes and blade teeth are sharp and may perforate surgical gloves. Tools/blades may be grasped with a hemostat to aid in installation

and removal. W61 DO NOT attempt to resharpen used tools. Worn tools should be replaced with new ones frequently to ensure eective cutting and control. W62 Carefully inspect tool both prior to and following each use for signs of excessive wear, fragmentation, eccentricities or other defects.

Replace any suspicious tools with a new one prior to use. W63 Excessive pressure applied to bur may cause bur fracture. Should a tool fracture in use, extreme care must be exercised to ensure that all

fragments of the tool are retrieved and removed from the patient. Unremoved tool fragments may cause tissue damage to the patient. W64 Do not use metal-cutting tools on bone. W65 Use only rotary tools specically designed for use with this drill system. W66 When using non-rotatable tools, ensure rotation lock is engaged to prevent inadvertent rotation.

1-3

INTEGRATED POWER CONSOLE (IPC)

W67 The use of powered reciprocating instruments may result in vibration / related injury. W68 Powered blades should be operated in the oscillate mode only. Operating in the forward mode may cause damage to the blade. W69 Do not attempt to sterilize disposable devices. The disposables are packed sterile and are not intended for repeat use. To prevent

contamination, use only once. W70 Any tubing or other tip protectors used during shipping must be removed prior to cleaning and sterilization. W71 Do not use accessory if package is opened or damaged. Broken seal oers no protection against cross-contamination. W72 Properly dispose of single-use devices removed from sterile packages. Devices lose sterility upon removal from packaging. W73 Do not use dull, damaged or bent tools. Use of dull tools can reduce handpiece eectiveness and cause the handpiece temperature to

increase. W74 T&A Blades: Gently remove the inner tube from the outer tube. The inner tube may elongate upon removal from the outer tube. If this

occurs, the inner tube may not lock properly into the handpiece or the blade may not work properly. W75 T&A Blades: Rotate the inner tube when removing and inserting it in the outer tubes to prevent damage to the internal seal. If the seal is

damaged, the blade will leak at the handpiece. W76 Always ensure that the drill is securely engaged into the handpiece prior to operating the system. W77 Always examine operation of each tool in a handpiece before use. W78 Powered burs and drills should be operated in the forward mode only. W79 This system requires insulated connectors for the StraightShot M4 Microdebrider, StraightShot Magnum II Microdebrider, StraightShot III

Microdebrider, Midas Rex SC1, Visao, or Skeeter handpieces and the Multi Function Foot Control Unit. W80 Sterilize and dry reusable device before storing the system. Decrease likelihood of cross-contamination with timely sterilization. W81 After each procedure, properly clean all reusable system components. W82 Auxiliary Power Outlet with protective cover is for use with the Hydrodebrider or Bone Mill consoles only. W83 Place Stylus Touch in safe mode while not in use. W84 Do not place Stylus Touch handpiece in the proximity of magnetic eld, such as magnetic drape and MRI equipment, to avoid inadvertent

handpiece activation. W85 Do not apply excessive side loading. Excessive side loading could cause angled attachments to unlock accidentally from motor.

PRECAUTIONS

P1 PRIME/FLUSH Priming is a feature designed to purge air out of the tubing set(s) during setup. The rst time a Prime or Flush button is

pressed it will turn on pump 1 and/or 2 long enough to purge air out of the tubing set(s). Turning power O and On resets the PRIME

feature. Once pressed all Prime buttons will change to Flush buttons. P2 To prevent damage to curved tools, disconnect suction tube prior to changing tool during procedure. P3 When using an angled attachment, hold the handpiece assembly by the attachment so that the attachment does not inadvertently loosen

from the handpiece. P4 For Legend tools only: If a tool package is opened, but the tool is not used or contaminated, the tool can be re-sterilized. Remove tool from original packaging

and place into an approved autoclave package. Steam sterilize as follows: High-Vacuum Steam 132°C for 5 minutes Gravity Displacement 132°C for 15 minutes The re-sterilized tool must be used promptly following re-sterilization. If rust or corrosion is encountered after re-sterilization, do not use

the re-sterilized tool. P5 DO NOT run the 16-MF attachment with operating speed above 62,000 rpm. This may cause over heating and damage to internal gears of

attachment. P6 DO NOT use twist drill or Contra-Angle tool at an operating speed over 62,000 rpm. P7 Do not attempt to disconnect the cable from the Midas Rex Legend EHS Stylus Motor. P8 Do not kink cables. Inspect cables and pins for cracks, tears or corrosion. P9 Do not use anti-fog on scope or sheath, as weeping or leaking may result. P10 Disconnect cable from Midas Rex Legend EHS motor prior to sterilization. P11 The use of a washer-disinfector for cleaning may cause a pre-mature degradation in performance. P12 Remove devices from instrument case before placing into washer disinfector and allow devices to drain. P13 Orient devices in the washer-disinfector by following manufacturer recommendations. P14 DO NOT use low-temperature hydrogen peroxide gas plasma sterilization due to the lumen internal diameter and length restrictions. P15 DO NOT use low-temperature liquid peracetic acid sterilization due to immersion procedure. P16 DO NOT steam or EO sterilize the Legend Attachment Cleaning Nozzle. P17 Remove and discard accessories following local regulations for proper disposal of contaminated materials. P18 Disposable devices are for single-use only. P19 Clean the motor and cable while still connected together. This will help to reduce ingress of debris. P20 Use ONLY recommended cleaning agents. P21 Do not use excessive force to insert the endoscope into the Endo-Scrub 2 sheath. This will damage the endoscope as well as the Endo-

Scrub 2 sheath. P22 If the endoscope tip can be seen extending beyond the tip of the Endo-Scrub 2 sheath, then the sheath has been damaged. Damaged

product must be immediately discarded.

1-4

INTEGRATED POWER CONSOLE (IPC)

SYSTEM REQUIREMENTS AND SPECIFICATIONS

Console Specications

Functional Standards for Electrical Systems

ANSI/AAMI ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance 2005

IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance 2005

EN 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

(IEC 60601-1:2005)

IEC 60601-1-4 Medical electrical equipment - Part 1: General Requirements for Safety, Part 4: Programmable Electrical Medical Systems 2000

EN 60601-1-2 Medical electrical equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic

Compatibility - Requirements and Tests

CSA-C22.2 No. 601.1 Medical Electrical Equipment - Part 1: General Requirements for Safety 2005

Physical Dimensions

Size 277 mm W x 353 mm H x 267 mm D

Weight 7.3 kg

Operational Environment

Temperature +10°C to +33°C

Humidity 30% to 75% RH

Barometric Pressure 700 - 1060 hPa

Transport and Storage Environment

Temperature -40°C to +70°C

Humidity 10% to 95% RH

Barometric Pressure 500 to 1060 hPa

Display / Touchscreen

Type High contrast, digital, graphic color, visible in complete darkness

Resolution Display 21 cm diagonal, resolution 480 X 640 pixels

Audio Output

Baseline Audio Sound Level 60 dBA minimum SPL (1 m)

Electrical

Input Voltage 100 V-240 V ± 10%

Frequency 50/60 Hz

Power Consumption 500 VA

Auxiliary AC output 200 VA Max.

Internal Fuse 5 x 20 mm T. L. 5 A, 250 V

Medtronic Xomed P/N 11270066

Duty Cycle for Applied Part Maximum On Time 120 Seconds

Minimum O Time 180 Seconds

Power Cord Product Numbers

2006

2001/ A1: 2006

North America:

USA, Barbados, Belize, Bolivia, Canada,

Columbia, Ecuador, Venezuela

Standard P/N EA600 or 1895820

6 meter P/N EA650 or 189721

China

P/N EA604

Argentina

P/N EA608

Australia, New Zealand

P/N EA605

United Kingdom,

Ireland, Hong Kong, Malaysia, Singapore

P/N EA606 or 1895821

India, South Africa

P/N EA607

Israel

P/N EA609

Japan

P/N EA603 or 1895823

Continental Europe:

Austria, Belgium, Finland, France, Germany,

Greece, Korea, Luxembourg, Netherlands,

Norway, Portugal, Spain, Sweden

P/N EA602 or 1895822

Switzerland

P/N EA601

Denmark

P/N EA610 Italy, Chile

P/N EA611

1-5

INTEGRATED POWER CONSOLE (IPC)

(5)

(1)

(3)

(4)

(2)

SYSTEM SOUNDS AND FIGURES

Audible Alarms and Tones

The following alarms and tones can sound while using the IPC Console.

Audible Alarm

When the system detects an error, a message appears on the touchscreen and the system emits a sequence of three tones.

Audible Tones

IPC Tone Cause(s) 1 Tone • Conrmation of change button pressed.

• Change from forward to oscillate.

• Change of active handpiece.

2 Tones Change from oscillate to forward. 3 Tones • Audible Alarm. Error detected. See screen for error message.

• Active handpiece is in reverse and foot pedal pressed.

• First time accessory changes from forward to reverse.

Long Tone Change from handpiece to drill.

System Figures

Figure 1-1. IPC Console Front

1 Pump 1: Coolant, lense cleaning or

irrgation 2 Pump 2: Irrigation or lense cleaning 3 Console Connector Panel for peripheral

devices

4 Power On/O 5 Touchscreen

Figure 1-2. IPC Console Back

(1)

(2)

(3) (4)

(5)

(6)

(7)

1 Pole Clamp 2 Compact Flash Card Port (Medtronic Use) 3 Manual Start/Stop 4 Fuse Access 5 Auxiliary Power Outlet

(8)

6 Endo-Scrub 2 Connector 7 Hospital Grade Power Cord Connector 8 Equipotential. Apply potential equalization

conductor.

Figure 1-3. IPC Console Connector Panel

(1) (2) (3) (4) (5) (6) (7) (8)

1 Legend EHS Motor 2 Legend EHS Stylus Motor 3 Spine Shaver Handpiece StraightShot M4

Microdebrider

StraightShot Magnum II

Microdebrider

StraightShot III

Microdebrider

Stylus Touch Motor Visao Drill Indigo Drill Midas Rex Microsaws Triton Drill 4 Stimulus input from

Patient Interface (NIM or NIM-Eclipse)

5 Stimulus output to Stim

Bur Guard or POWEREASE 6 Skeeter Handpiece 7 Endo-Scrub 2 Finger

Switch Endo-Scrub 2 Footpedal

Intelliow Irrigation

Remote Control 8 Multifunction Footpedal

1-6

Figure 1-4. Multifunction Footpedal

(1)

(2)

(3)

1 Mode Button 2 Foot Pedal 3 Slip-resistant Foot Pad

4 Control Button 5 Handpiece Button

(4)

Figure1-5. IPC Touchscreen

(1)

INTEGRATED POWER CONSOLE (IPC)

(1)

Speed

(2)

Acceleration

Irrigation

(3)

(4)

Pumps

(5)

1 Displays Active Accessory 2 Accessory Control Panel 3 Footpedal Variable Control 4 Opens Pumps Screen

Help

Accessory Name

60000

RPM

100

cc/min

Flow

Prime

(Handpiece Name)

EndoScrub 2

Flow

Mode

Setting

5 Opens Help Screen 6 Irrigation Accessory Panel 7 Inactive Handpiece

Finger

Control

FWD

REV

Foot

Both

PrimeOn

(7)

(6)

Figure 1-6. IPC Pumps Screen

Pump 1

None

(3)

Pump 2

None

(4)

1 Prime/Flush Pump 2 Close Pumps panel 3 Pump 1 Panel Available Accessories 4 Pump 2 Panel Available Accessories

None

M4 Irrigation

Irrigation

Prime

Endo-Scrub® 2

Prime

Endo-Scrub® 2

Figure 1-7. IntelliFlow Remote Control

(2)

(1)

(2)

(3)

1 Pause/On-O 2 Increase/Decrease Fine Adjustment 3 Increase/Decrease Coarse Adjustment

OR Select Stainless Steel Tubing Size (French Size) for Suction Irrigatior

1-7

INTEGRATED POWER CONSOLE (IPC)

PREOPERATING INSTRUCTIONS

The following are general IPC pre-operating instructions. “Accessories or Additional Devices Operating Instructions” contains individual accessory operating instructions.

When the System Arrives

• Verify the contents of the box match the packing slip. If incomplete or damaged, notify Medtronic Customer Service.

• If container is damaged, or cushioning material shows stress, notify carrier and Medtronic Customer Service. Keep shipping materials for

carrier inspection.

• Save the cartons and packing material. If the instrument is to be shipped the shipping package will provide proper protection.

Set up the IPC

Refer to the related topics for detailed instruction.

1. Install pump cartridges or irrigation tubing.

2. Prepare IPC for use.

3. Calibrate touchscreen, if necessary.

4. Change system settings, if necessary.

5. Set up and prime pumps.

6. Conrm system operation.

7. Press the manual start/stop button on the back of the console (Figure 1-2) and verify you can start/stop the handpiece, irrigiation and/or coolant ow.

Install the Pump Cartridges or Irrigation Tubing

1. Locate the correct pump and lift up the lock (Figure 1-8). Pump 1: Coolant, lens cleaning or irrgation Pump 2: Irrigation Important: The number on the pump must match the number on the cartridge (either 1/1 or 2/2). If the cartridge does not have a pump designator number, use the Pump Setup Screen to install the pump cartridge.

2. Insert the pump cartridge.

3. Snap the pump lock shut.

Warning: Ensure the pump cartridge does not crimp the tubing.

Prepare IPC for Use

1. Verify the wheels are locked on the IPC cart.

2. Inspect all components for damage and determine if the system is ready for use.

3. Mount the IPC and irrigation/coolant bags on the IV pole. Important: Mount irrigant and coolant bags above the IPC to ensure adequate ow.

4. Plug the IPC into the power source. Position the IPC so that it does not obstruct the power source for the purpose of disconnecting the Main voltage by the power cord.

5. Locate the correct footpedal or accessory connection port on the connector panel (Figure 1-3) and insert the connector. Note: To insert multi-pin connectors (indicated by a silver or red mark on the connector), align the mark on the connector to the mark on the console, then insert the connector.

6. Connect suction, cooling and/or irrigation tubing.

7. Turn on the IPC and verify the system passes the self-test. Note: If the IPC does not detect a handpiece, footpedal, or Endo-Scrub connection, the Connect Handpiece/Connect Footswitch screen appears. Do one or all of the following:

• Verify the cable is connected to the correct connection port.

• Press [OK] in the Connect Footswitch or Endo-Scrub 2 message window to continue use of the IPC without the footpedal or Endo-

Scrub 2.

Calibrate Touchscreen

Note: This step is optional.

1. Turn on the IPC console.

2. While the system starts, on the Splash screen, press [Settings].

3. On the Settings screen, press Touch Screen Calibration and follow the screen prompts.

Figure 1-8. Install Pump Cartridge

Change System Settings

Note: During surgery, system settings can be overwritten.

1. Turn on the IPC console.

2. While the system starts, on the Splash screen, press [Settings].

3. To change the language, press the appropriate language.

4. To change the default settings, press [Default].

• On the Default screen, press the forward or backward arrow to change the accessory.

• Make changes to the default settings.

• To conrm system settings and return to the Splash screen, press [OK].

5. To conrm system settings and continue to the IPC touchscreen, press [OK].

Handpiece Default Settings

The system conguration is dependent on the handpiece(s) connected to the console. The following table denes the default congurations,

1-8

INTEGRATED POWER CONSOLE (IPC)

default settings (X) and default options (O).

Table 1. IPC Touchscreen Default Congurations

Speed Mode or Mode Select Switch

Handpiece rpm cpm % Forward Oscillate Reverse Acceleration Size Flow Irrigation Control

Visao 80000 X O 30

Indigo 60000 X O 30

Midas Rex SC1 3400 O X 60

StraightShot M4 5000 O X 30

StraightShot III, Magnum II 5000 O X 30

Legend EHS Stylus 60000 X O 45% 0

Legend EHS 70000 X O 0

Stylus Touch 60000 X O 100% 0 Finger

Skeeter 16000 X O 0

Endo-Scrub 2 3

Suction Irrigator 8 50%

Triton 100 X

100 X

Midas Rex Microsaws 100 0

Powerease 120 X

250 X

120 X

Set up and Prime Pumps

• The IPC turns on pump 1 and/or 2 long enough to purge air out of the tubing set(s) the rst time the prime button is pressed.

• The IPC resets the prime feature when you turn IPC power O and On.

• After you prime the pump, the prime button and functionality become ush functionality.

1. Connect tubing from an IPC cartridge to irrigation or coolant tubing on an accessory.

2. On the irrigation tubing, turn the clamp to OPEN.

3. If an accessory uses the clear drip chamber (Visao), ll the clear drip chamber with coolant. To ll, squeeze and release the chamber until full.

4. On the IPC touchscreen (Figure 1-5), press the pumps button.

5. On the IPC pumps screen (Figure 1-6), select the accessory for each pump.

6. For each pump, press the prime button and verify the following:

• Pump(s) run until air is completely purged from tubing.

• Small amount of lubricate ows at the tip of the irrigation device.

• Pump(s) turns o.

7. Press the close button.

Pump Default Congurations

The pump conguration is dependent on the handpiece(s) connected to the console. The following table denes the pump default settings (X) and default options (O).

Table 2. IPC Pumps Screen Default Congurations

Pump 1 Pump 2 Endo-Scrub 2 Suction Irrigator

Handpiece Cooling Irrigation Irrigation Pump 1 Pump 2 Pump 1 Pump 2

Visao X X O O

Indigo O X O O O O

Midas Rex SC1 O X O O

StraightShot M4 O X* X O

StraightShot III, Magum II O X* X O

Legend EHS Stylus X O* O O O O

Legend EHS X O O O O O

Stylus Touch X O O O O O

Skeeter O O O O

1-9

INTEGRATED POWER CONSOLE (IPC)

Table 2. IPC Pumps Screen Default Congurations

Endo-Scrub 2 X O X O

Suction Irrigator O O O O

Midas Rex Microsaws O X O O O O

Powerease O O O O

O O O O

* When the IPC detects both the Straightshot M4 and the Legend EHS Stylus Touch handpiece, by default, the system sets pump 2 as a “shared” irrigation pump. You must manually connect the irrigation tubing to the active handpiece.

Conrm System Operation

1. Conrm the irrigation pedal starts handpiece and irrigation ow. Verify the speed changes from white to yellow in the Speed box on the touchscreen.

2. Conrm the footpedal buttons operate. Refer to “Operate Multifunction Footpedal” for details.

3. On the touchscreen, verify you can do all of the following:

• Adjust Speed: In the Speed box, press the plus and minus buttons.

• Change Modes: In a Mode box, press any mode button.

• Adjust Flow Rate: In the Irrigation box, press the plus and minus buttons.

IPC COMPONENTS

Multifunction Footpedal

You can use the multifunction footpedal (Figure 1-4) to start/stop the handpiece, control handpiece speed, handpiece selection and mode of operation. Refer to the Multifunction Footpedal Controls topic for each handpiece for specic use and control.

Multifunction Footpedal Failure

Use the manual start/stop button (Figure 1-2) on the back of the IPC Console to operate the handpiece if the multifunction footpedal fails during a procedure.

IntelliFlow Irrigation Remote Control

Use the IntelliFlow irrigation remote control (Figure 1-7) to start/stop and change irrigation ow while in the sterile eld.

If you are using handpiece irrigation:

• To pause irrigation ow, press the Pause/On-O button.

• To adjust ow rate, press the Fine Adjustment or Coarse Adjustment Increase/Decrease button.

If you are using the Suction Irrigator:

• To pause or turn on/o the Suction Irrigator, press the Pause/On-O button.

• To adjust ow rate, press the Fine Adjustment Increase/Decrease button.

• To select the stainless steel tubing size (French size), press the Stainless Steel Tubing Size button.

Auxillary Power to Console

Warning: The auxillary power outlet is available for use with the Hydrodebrider and Bone Mill IPC consoles only (see W 82).

The auxillary power outlet is for use at grid voltage ≤120 VAC only.

POSTOPERATIVE INSTRUCTIONS

Disconnect Accessory Cable from Console

To disconnect non-sillicone multi-pin cables from the console, push the cable towards the console and then pull out by the lock ring. Note: Silicone insulated multi-pin and single pin cable connectors do not have a lock ring (1). Remove these types of cable connectors straight from the connector panel.

Warning: After disconnecting insulated connectors (see W79) from the console, connectors that have debris under the insulator must be cleaned according to Cleaning and Sterilization instructions. If debris is still present after cleaning and sterilization, return for warranty servicing.

Clean the Multifunction Footpedal

Important: If debris is present under the footpedal’s boot, return for warranty service.

DO NOT immerse or sterilize the footpedal. DO NOT use alcohol, other solvents or abrasive cleaners.

1. On the slip resistant foot pad ONLY, spray a neutral enzymatic detergent, pH 6.0-8.0, or a phenol based disinfectant, mixed according to manufacturer’s instructions.

2. Leave the solution on the foot pad for approximately 10 minutes.

3. Dampen a cloth with a neutral enzymatic detergent, pH 6.0-8.0, or a phenol based disinfectant, mixed according to manufacturer’s instructions.

4. Wipe the footpedal with the damp cloth until visually clean.

5. Dry the unit with a clean, non-abrasive cloth.

1-10

INTEGRATED POWER CONSOLE (IPC)

GUIDANCE AND MANUFACTURER’S DECLARATION  ELECTROMAGNETIC IMMUNITY

Part I

The IPC is intended for use in the electromagnetic environment specied below. The customer or the user of the IPC should assure that it is used in such

Immunity test

Electrostatic discharge (ESD) ±6kV contact ±6kV contact IEC 61000-4-2 ±8kV air ±8kV air Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Power frequency (50/60 Hz) magnetic eld IEC 61000-4-8 Note: UT is the a.c. mains voltage prior to application of the test level.

The IPC is intended for use in the electromagnetic environment specied below. The customer or the user of the IPC should assure that it is used in such an envi-

Emissions test Compliance Electromagnetic environment - guidance

RF emissions

CISPR 11

RF emissions

CISPR 11

Harmonic emissions

IEC 61000-3-2

Voltage uctuations

IEC 61000-3-3

Guidance and manufacturer’s declaration – electromagnetic immunity – Part I

IEC/EN60601-1-2

test level

±2kV for power supply lines ±1kV for input/output lines ±1kV dierential mode ±2 kV common mode <5 % UT (>95 % dip in UT) for 0.5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 %UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 sec

3 A/m 3 A/m

Guidance and manufacturer’s declaration – electromagnetic emissions

Group 1

Class A

Complies

±2kV for power supply lines ±1kV for input/output lines ±1kV dierential mode ±2kV common mode <5 % UT (>95 % dip in UT) for 0.5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 sec

an environment.

Compliance level Electromagnetic environment - guidance

Floors should be wood, concrete, or ceramic tile. If oors are covered with synthetic material, the relative humidity should be at least 30 %. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the IPC requires continuous operation during power mains interruptions, it is recommended that the IPC be powered from an uninterruptible power supply or a battery.

Power frequency magnetic elds should be at levels characteristic of a typical location in a typical commercial or hospital environment.

ronment.

The IPC uses RF energy only for its internal function. Therefore, its RF emissions are very

low and are not likely to cause any interference in nearby electronic equipment

The IPC is suitable for use in all establishments, other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings for

domestic purpose.

Recommended separation distances between portable and mobile RF communications equipment and the IPC

The IPC is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the IPC can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the IPC as recommended below, according to the maximum output power of the communications equipment.

Rated maximum power

of transmitter

0.01 0.12 0.12 0.23

0.10 0.38 0.38 0.73

1.00 1.20 1.20 2.30

10.00 3.80 3.80 7.30

100.00 12.00 12.00 23.0

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from structures, objects and

people.

150 kHz to 80 MHz

d = 1.2√P

Separation distance according to frequency of transmitter meters

80 MHz to 800 MHz

d = 1.2√P

800 MHz to 2.5 GHz

d = 2.3√P

1-11

INTEGRATED POWER CONSOLE (IPC)

Part II

The IPC is intended for use in the electromagnetic environment specied below.

The customer or the user of the IPC should assure that it is used in such an environment.

Immunity test IEC/EN60601-1-2 test

level

Conducted RF 3Vrms 3Vrms d = 1.2√P

IEC 61000-4-6 150kHz to 80MHz

Radiated RF 3V / m 3V / m d = 1.2√P 80MHz to 800MHz

IEC 61000-4-3 80MHz to 2.5GHz d = 2.3√P 800MHz to 2.5GHz

Compliance level Electromagnetic environment - guidance

Portable and mobile RF communications equipment should be used no closer to any part of the IPC , including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from xed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from structures, objects and

people.

NOTE 3 When operating the IPC with Stylus Touch, the compliance level is 3 V/m except from 88 MHz to 91 MHz where it is 1 V/m. The formula for separation

distance for the IPC with Stylus Touch will be d = 3.5 √P in that frequency range.

a Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio

broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in which the IPC is used exceeds the applicable RF compliance level above, the IPC should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the IPC .

b Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.

1-12

INTEGRATED POWER CONSOLE (IPC)

LIMITED WARRANTY

A. This Limited Warranty provides the following assurance for the customer who purchases a Medtronic IPC System. This Limited Warranty is ex-

tended only to the buyer purchasing the IPC System directly from Medtronic or from its aliate or its authorized distributor or representative. The IPC System includes the console, motor or handpiece, foot control, motor cables, instrumentation cases and trays (hereafter referred to as System Components), straight and angled motor attachments (hereinafter referred to as “Attachments”), bur guards and telescoping tubes (hereinafter referred to as Semi-reusable Components) and dissecting tools, irrigation and coolant tubing, and Intelliow remote control (hereinafter referred to as Single Use Components) and jointly referred to as the IPC System, unless specically noted. i. Should a System Component fail to function to Medtronic’s published specications during the term of this Limited Warranty (one year

from the date of sale of a new System Component or 90 days from the date of sale of a refurbished or used System Component), Medtronic will either repair or replace the Motor Component or any portion thereof.

ii. Should an Attachment fail to function to Medtronic’s published specications during the term of this Limited Warranty (90 days from the

date of sale of a new Attachment), Medtronic will either repair or replace the Attachment or any portion thereof.

iii. Should a Semi-reusable Component fail to function to Medtronic’s published specications during the term of this Limited Warranty (30

days from the date of sale of a new Semi-reusable Component), Medtronic will replace the Semi-reusable Component or any portion thereof.

iv. Should a Single Use Component fail to function to Medtronic’s published specications prior to its “use by” date Medtronic will replace the

Single Use Component.

B. To qualify for this Limited Warranty, the following conditions must be met:

i. The Product must be used on or before its “Use By” or “Use Before” date, if applicable. ii. The Product must be used in accordance with its labeling and may not be altered or subjected to misuse, abuse, accident or improper

handling.

iii. Medtronic must be notied in writing within thirty (30) days following discovery of a defect. iv. The Product must be returned to Medtronic within thirty (30) days of Medtronic receiving notice as provided for in (3) above. v. Upon examination of the Product by Medtronic, Medtronic shall have determined that: (i) the Product was not repaired or altered by any-

one other than Medtronic or its authorized representative, (ii) the Product was not operated under conditions other than normal use, and (iii) the prescribed periodic maintenance and services, if applicable, have been performed on the Product.

C. This Limited Warranty is limited to its express terms. THIS LIMITED WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED

WHETHER STATUTORY OR OTHERWISE, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. In no event shall Medtronic be liable for any consequential, incidental, prospective or other similar damage resulting from a defect, failure, or malfunction of the IPC System, whether a claim for such damage is based upon the warranty, contract, negligence or otherwise.

D. The exclusions and limitations set out above are not intended to, and should not be construed so as to, contravene mandatory provisions of

applicable law. Users may benet from statutory warranty rights under legislation governing the sale of consumer goods. If any part or term of this Limited Warranty is held by any court of competent jurisdiction to be illegal, unenforceable, or in conict with applicable law, the validity of the remaining portion of the Limited Warranty shall not be aected, and all rights and obligations shall be construed and enforced as if this Limited Warranty did not contain the particular part or term held to be invalid.

FOR ITEMS CONTAMINATED WITH TSE AGENTS

Medtronic ENT/NT Transmissible Spongiform Encephalopathy (TSE) Return Policy Medtronic will not authorize or accept the return of products that directly contact patients or is contaminated with a patient’s body uids

suspected or conrmed with a Transmissible Spongiform Encephalopathy / Creutzfeldt-Jakob Disease (TSE/CJD) diagnosis. The following are recommended guidelines and may vary according to specic policy and procedures among hospitals. Hospital personnel

should contact their infection control personnel for current procedures and policy for reusable equipment processing when suspected of contamination with Creutzfeldt-Jakob Disease (CJD) or other Transmissible Spongiform Encephalopathy (TSE) agent.

Medtronic dissecting tools, burs, or blades used on a patient suspected of a TSE/CJD diagnosis should be incinerated. Reusable equipment that has been used on patients with suspected Creutzfeldt-Jakob Disease (CJD) or other Transmissible Spongiform Encephalopathy (TSE) should be quarantined and not reused until diagnosis is conrmed or excluded. Reusable equipment should be quarantined after having been cleaned, decontaminated, sterilized and packed in a rigid sealed container until nal diagnosis. If TSE/CJD is excluded as a diagnosis, the quarantined reusable equipment may be returned for use after appropriate cleaning, decontamination and sterilization.

Medtronic recommends that all Medtronic products used directly on a patient conrmed with a TSE diagnosis be incinerated. Contact your Sales Representative to purchase replacement products or secure loaner equipment.

For additional information contact your Customer Service Representative.

1-13

TRITON ELECTRIC HIGH-TORQUE HANDPIECE

DEVICE DESCRIPTION

The Triton Electric High-Torque Handpiece is capable of removing hard and soft tissue, drilling pilot holes, and driving screws, wires, and pins during spinal, cranial, and small-bone surgical procedures performed in an operating-room environment by surgeons trained in its use.

The following instructions for the Triton Electric High-Torque Handpiece are in addition to “Set up the IPC” general assembly instructions. Complete IPC setup, then continue to the instructions below.

TRITON SAGITTAL SAW ASSEMBLY

Warning: Triton saw attachments should only be used with Medtronic Triton saw blades. Refer to the Triton Quick Reference Saw Blade Guide

(LIT200017) for additional information on Triton saw blades.

1. Insert the Sagittal Saw Attachment into the hand piece in a position to allow easy in ser tion of the Sagittal Saw Key (Figure 2-1). Note: You can install the attachment in 12 di er ent po si tions to facilitate proper surgical ac cess.

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

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

4. Turn the Sagittal Saw Key clockwise to lock the blade. Run briey, then retighten blade.

Caution: Do not over-tighten.

Figure 2-1. Sagittal Saw Assembly

TRITON SAGITTAL SAW DISASSEMBLY

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

TRITON RECIPROCATING SAW ASSEMBLY

Warning: Triton saw attachments should only be used with Medtronic Triton saw blades. Refer to the Triton

Quick Reference Saw Blade Guide (LIT200017) for additional information on Triton saw blades.

1. Loosen the collet nut then insert the blade until it is ful ly seat ed (Figure 2-2). Note: You can install the attachment in di er ent po si tions to facilitate proper surgical ac cess.

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

TRITON RECIPROCATING SAW DISASSEMBLY

To remove the Triton Reciprocating Saw blade, unscrew the collet nut.

TRITON AO/SYNTHES CHUCK AND TRINKLE CHUCK ASSEMBLY

1. To install a drill bit, pull back on the attachment collar (Figure 2-3).

2. Insert the drill bit and release the attachment collar.

TRITON AO/SYNTHES CHUCK AND TRINKLE CHUCK DISASSEMBLY

1. To remove a drill bit, pull back on the attachment collar.

2. Remove the drill bit and release the attachment collar.

Figure 2-2. Reciprocatting Saw Assembly

Figure 2-3. AO/Synthes Chuck and Trinkle Chuck Assembly

TRITON JACOBS CHUCK ASSEMBLY

1. To install a drill bit, turn the key to open the chuck or spin the collar if using a keyless chuck attachment (Figure 2-4).

2. Insert the drill bit.

TRITON JACOBS CHUCK DISASSEMBLY

1. To remove a drill bit, turn the key to open the chuck or spin the collar if using a keyless chuck attachment.

2. Remove the drill bit.

Figure 2-4. Jacobs Chuck Assembly

2-1

TRITON ELECTRIC HIGH-TORQUE HANDPIECE

TRITON HUDSON AND ZIMMER CHUCK ASSEMBLY

To install an instrument, pull back on the attachment collar, then insert the male end of the instrument into the chuck.

Figure 2-5. Hudson and Zimmer Chuck Assembly

TRITON HUDSON AND ZIMMER CHUCK DISASSEMBLY

To remove an instrument, pull back on the attachment collar, then remove the instrument from the chuck.

TRITON WIRE AND PIN COLLET ASSEMBLY

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

1. Insert the Wire or Pin Collet (Figure 2-6) while the handpiece is in the SAFE position (Figure 2-7).

2. Screw the Cannulated Extension in the back of the handpiece to protect the op er a tor from the point of the wire or pin, as necessary.

3. Insert the wire or pin into the front or back of the handpiece.

4. Put the instrument in the RUN position by po si tion ing the trigger control vertically.

5. Turn the Mode select switch at the base of the handle to the FORWARD position.

6. Squeeze the Wire/Pin Advance lever and hold it down.

7. Press the trigger control to drive the wire/pin. The pressure-sensitive trigger allows vari able speed operation.

8. To obtain additional wire/pin length, release the wire/pin.

9. Advance the lever and trigger control.

10. Pull back on the in stru ment.

11. Squeeze the Wire/Pin Advance lever and trigger control to drive the wire.

Figure 2-6. Wire and Pin Collet Assembly

TRITON WIRE AND PIN COLLET DISASSEMBLY

To remove threaded wire/pin, put the Mode select switch in REVERSE, squeeze the Wire/Pin Advance lever and press the trigger control.

TRITON ELECTRIC HIGHTORQUE HANDPIECE OPERATION

You can preload attachments before insertion into the handpiece.

Caution: Insert all attachments into the handpiece with the handpiece in the SAFE po si tion (Figure 2-7). Note: The handpiece has an Extension Handle that screws into the back of the handpiece. The handle extension provides bal ance and two-

hand ed con trol for various drilling and cutting applications.

1. With the handpiece in the SAFE position (Figure 2-7), insert a preloaded attachment by pressing the quick-release button on top of the handpiece. Snap the attachment into the handpiece with a slight twisting motion un til it is seated.

2. Place the handpiece in the RUN position, with the trigger control vertical. The Mode select switch at the base of the handle should be in the FORWARD position.

3. After use, return the trigger control to the SAFE position prior to removing the attachment.

4. Remove the attachment by pressing the quick-release but ton on top of the handpiece.

2-2

Safe Position

(2)

(4)

(5)

(1)

(3)

The handpiece will not op er ate in the SAFE position. To operate the handpiece, activate and press the trigger control.

TRITON ELECTRIC HIGH-TORQUE HANDPIECE

Figure 2-7. Triton Handpiece Safe and Run Positions











SAFE: Turn trigger control to either side to lock handpiece in SAFE mode.

CONNECT TRITON ELECTRIC HIGHTORQUE HANDPIECE TO IPC

Locate the Triton Electric High-Torque Handpiece connection port on the connector panel (Figure 2-8) and insert the connector. Note: To insert multi-pin connectors (indicated by a silver or red mark on the connector), align the mark on the connector to the mark on the console, then insert the connector.

Figure 2-8. IPC Triton Connection Ports

1 Triton Connection 2 Footpedal Connection

TRITON ELECTRIC HIGHTORQUE HANDPIECE TOUCHSCREEN CONTROLS

To adjust Triton Electric High-Torque Handpiece variable speed, on the IPC touchscreen, in the FWD Speed or REV Speed control box (Figure 2-9), press the plus button to increase variable speed or the minus button to decrease variable speed.

RUN: Trigger control in the vertical position will allow activation of the handpiece.

(1) (2)

Figure 2-9. Triton Touchscreen

TRITON

FWD Speed

100

REV Speed

TRITON ELECTRIC HIGHTORQUE HANDPIECE MODE SELECT SWITCH

Use the mode select switch to change the handpiece from forward to reverse when the handpiece is the active handpiece. When the handpiece is the inactive handpiece, use the mode select switch to activate the handpiece.

TRITON ELECTRIC HIGHTORQUE HANDPIECE MULTIFUNCTION FOOTPEDAL CONTROLS

Important: By default, press each button on the footpedal for at least 100 mS for the selection to

become active. Use the IPC touchscreen Settings screen to change the default value. To use the multifunction footpedal (Figure 12-9) to control the handpiece do the following:

• To toggle between the start/stop mode and variable speed mode, press the control button.

• To change the handpiece, press the handpiece button.

Triton Electric High-Torque Handpiece Reverse Footpedal Control

When you connect the optional foot pedal to the IPC console, the pedal can be used as an alternative method of activating Reverse mode (without manipulating the Mode select switch at the bottom of the handpiece). When the pedal is connected, the Reverse Pedal control box appears on the screen (Figure 2-11). Note: By default, pedal functionality is turned OFF.

1. To use the pedal, press ON in the Reverse Pedal control box on the IPC touch screen.

2. With the pedal turned on, step on the foot pedal to put the handpiece into Reverse mode (regardless of what position

the Mode select switch is in). NOTE: The trigger control must be pressed to activate the handpiece, even when you are stepping on the foot pedal.

3. Remove your foot from the pedal to return the handpiece to the mode currently dened by the Mode select switch on

the handpiece.

Figure 2-10. Multifunction Footpedal

1 Mode Button 2 Foot Pedal 3 Slip-resistant foot pad

4 Control Button 5 Handpiece Button

Figure 2-11. Reverse Pedal Control Box

Reverse Pedal

OFF

REV REV

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TRITON ELECTRIC HIGH-TORQUE HANDPIECE

TRITON ELECTRIC HIGHTORQUE HANDPIECE CLEANING AND STERILIZATION INSTRUCTIONS

Refer to document M000030A322 in the Cleaning and Sterilization section.

TRITON ELECTRIC HIGHTORQUE HANDPIECE TECHNICAL SPECIFICATIONS

Triton Electric High-Torque Handpiece ED500

Size 3.5 in L x 5.4 in H x 1.1 in W

Weight 2.1 lbs

Speed 400-18000 cpm (actual speed depends on attachment used)

Duty Cycle for Applied Part Cycle Time: 20 seconds on maximum / 20 seconds o minimum

Maximum number of cycles before resting handpiece: 6 Maximum number of cycles before resting attachment: 3 Minumum rest period: 25 minutes

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SUCTION IRRIGATOR

The following instructions for the Suction Irrigator are in addition to “Set up the IPC” general assembly instructions. Complete IPC setup, then continue to the instructions below.

SUCTION IRRIGATOR ASSEMBLY

Figure 3-1. Suction Irrigator

1. Connect suction tubing from a suction source to the suction tting on the Suction Irrigator (Figure 3-1).

2. On the IPC touchscreen (Figure 1-5), press the pumps button.

3. On the IPC pumps screen (Figure 1-6), select a pump for the Suction Irrigator. Note: When using a handpiece that connects to a pump, the IPC automatically incorporates the Suction Irrigator at the pump not in use by the handpiece.

4. Connect irrigation tubing from the IPC cartridge (Figure 1-8) to irrigation tting on

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the Suction Irrigator (Figure 3-1).

5. On the irrigation tubing, turn the clamp to OPEN.

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SUCTION IRRIGATOR ADAPTER KIT

1. Connect an adapter to the high-speed irrigation tubing (blue adapter) or the IPC tubing (white adapter).

2. Connect an adapter to the irrigation connector tube (Figure 3-2).

3. Connect an irrigation connector tube to the irrigation tting on the Suction Irrigator.

Figure 3-2. Suction Irrigator Adapter Kit

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1 Suction Tube 2 Irrigation Tube 3 Tube Size 4 Irrigation Fitting 5 Suction Fitting

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SUCTION IRRIGATOR TOUCHSCREEN CONTROLS

To set or adjust Suction Irrigator controls, on the IPC touchscreen, in the Suction Irrigator control box (Figure 3-3), do the following:

• To set the tubing size, in the Size control box, press the plus and minus buttons.

Note: The system defaults to size 8.

• To enable or disable the irrigation ow, in the Flow control box, select the On/O box.

• To adjust the ow rate, in the Flow control box, press the plus and minus buttons.

Figure 3-3. Suction Irrigator Touchscreen

Suction Irrigator

Size

Flow

IIIIIIIII

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ENDO-SCRUB 2

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ENDO-SCRUB 2

The following instructions for the Endo-Scrub 2 are in addition to “Set up the IPC” general assembly instructions. Complete IPC setup, then continue to the instructions below. Refer to the Endo-Scrub 2 System Instructions for Use, Endo-Scrub Sheaths Instructions for Use and EndoScrub 2 Finger Switch Instructions for Use for additional information.

The IPC System incorporates Endo-Scrub 2 functionality by using irrigation pump number one (1) and controlling operation with the touch screen and an external footswitch or nger switch.

DO NOT use the Endo-Scrub 2 for infusion, for disinfection or sterilization of an endoscope, or for suction removal of blood and debris. Use the Endo-Scrub 2 sheath only with an endoscope listed on the sheath product label, as malfunction or poor performance could result.

Figure 4-1. Endo-Scrub 2 Fingerswitch

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1 Fingerswitch 2 Endo-Scrub 2 sheath 3 Irrigation Connection

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4 Light Connection 5 Fingerswitch Cable

ENDOSCRUB 2 ASSEMBLY

1. Wet the endoscope.

2. Slowly, slide the approved endoscope into the Endo-Scrub 2 sheath (Figure 4-3).

3. Connect the irrigation tubing and a light source (Figure 4-4).

Figure 4-3. Endo-Scrub 2 Assembly

Figure 4-2. Endo-Scrub 2 Footpedal

Figure 4-4. Endo-Scrub 2 Assembly

ENDOSCRUB 2 FINGERSWITCH ASSEMBLY

If using the Endo-Scrub 2 ngerswitch, complete the following:

1. Slide the ngerswitch onto the Endo-Scrub 2 sheath (Figure 4-1). Align the cutout section of the ring with the luer connector of the tubing set. The ngerswitch is properly installed when the cutout section of the ring is rmly seated against the luer connector.

2. Activate the pump by pressing the actuator button located on the ngerswitch.

ENDOSCRUB 2 ACTIVATION

Note: The procedure below also applies if using the multifunction footpedal.

1. To activate the Endo-Scrub wash cycle, press and release the ngerswitch.

2. To initiate a continuous ow of irrigant, press and hold the ngerswitch.

CONNECT ENDOSCRUB 2 TO IPC CONSOLE

1. Locate the Endo-Scrub 2 connector cover on the back of the IPC console (Figure 1-2).

2. Insert a small screwdriver in the notch on the cable connector cover and pull.

3. Connect the control switch cable to the cable connector.

4. Connect the Endo-Scrub 2 ngerswtich (Figure 4-1) or the footpedal (Figure 4-2) to the console (Figure 4-5).

Figure 4-5. IPC Endo-Scrub 2 Connection Port

1 Fingerswitch or Footpedal Connection Port

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4-1

ENDO-SCRUB 2

ENDOSCRUB 2 TOUCHSCREEN CONTROLS

To set or adjust Endo-Scrub 2 controls, on the IPC touchscreen, in the Flow section of the Endo-Scrub 2 control box (Figure 4-6), do the following:

• To enable the Endo-Scrub 2 , press the On/O check-box.

• To adjust the ow rate, press the plus button to increase ow rate or the minus button to

decrease ow rate.

• To prime the pump, press the prime button.

Figure 4-6. Endo-Scrub 2 Touchscreen

EndoScrub 2

Flow

Setting

PrimeOn

ENDOSCRUB 2 CLEANING AND STERILIZATION INSTRUCTIONS

Refer to document 68E4005 in the Cleaning and Sterilization section.

Endo-Scrub 2 Foot Pedal Cleaning

Important: If debris is found under the foot pedal boot, return for warranty service.

DO NOT emerse or sterilize the foot pedal unit. DO NOT use alcohol, other solvents or abrasive cleaners.

1. Wipe down the Endo-Scrub 2 foot pedal with a cloth dampened with a neutral enzymatic detergent, pH 6.0-8.0 or phenol based disinfectant.

2. Dry the unit with a clean, non-abrasive cloth.

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SPINE SHAVER (SC1) HANDPIECE

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SPINE SHAVER (SC1) HANDPIECE

DEVICE DESCRIPTION

The following instructions for the Spine Shaver (SC1) Handpiece are in addition to “Set up the IPC” general assembly instructions. Complete IPC setup, then continue to the instructions below. Refer to the Midas Rex User’s Guide for additional information.

The IPC incorporates the Midas Rex Spine Shaver (SC1) at pump 2. Control operation of the Midas Rex Spine Shaver (SC1) with the IPC touchscreen and the multifunction footpedal.

Figure 5-1. Spine Shaver (SC1) Handpiece

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1 Finger Wheel 2 Irrigation Tubing Groove 3 Suction Barb 4 Locking Collar 5 Finger Wheel Lock

SPINE SHAVER (SC1) BLADE OR BUR ASSEMBLY

1. Insert the tool aligning the tabs with the notches (Figure 5-2). Orientate the irrigation barb to the left or right side.

Note: The StraightShot M4 uses a four-tab alignment system.

• For rotating straight blades, orient the irrigation barb at the 3 o’clock position for right-handed surgeons and 9 o’clock for left-handed surgeons.

• For rotating curved blades, orient the irrigation barb at 3 o’clock.

2. Press the locking collar (Figure 5-3).

3. Release the locking collar.

Note: If collar does not return to full out position adjust the nger wheel with small back-and-forth motions until collar pops out.

4. Pull on the blade or bur to ensure engagement and visually check to make sure the distal tip of the inner blade is in contact with the distal tip of the outer cannula (Figure 5-4).

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Figure 5-2. Spine Shaver (SC1) Assembly

Figure 5-3. Spine Shaver (SC1) Assembly

Figure 5-4. Spine Shaver (SC1) Assembly

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+ 63 hidden pages

Medtronic 2340000 Instructions for Use

Specifications and Main Features

Frequently Asked Questions

User Manual