Medtronic 2340000 Instructions for Use

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Integrated Power Console (IPC®) System

Rx Only

MODEL: 2340000

User’s Guide

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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.

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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

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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

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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.

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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

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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.

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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.

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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

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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

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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)

Page 11

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

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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,

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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

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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.

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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

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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.

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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.

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Page 19

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

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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.

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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

2-3

Page 22

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

2-4

Page 23

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

(3)

the Suction Irrigator (Figure 3-1).

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

(4)

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

(1)

(2)

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

(5)

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

3-1

Page 24

Page 25

ENDO-SCRUB 2

(5)

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

(1)

(2)

1 Fingerswitch 2 Endo-Scrub 2 sheath 3 Irrigation Connection

(3)

(4)

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

(1)

4-1

Page 26

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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Page 27

SPINE SHAVER (SC1) HANDPIECE

(1)

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

(2) (3)

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).

(4) (5)

Figure 5-2. Spine Shaver (SC1) Assembly

Figure 5-3. Spine Shaver (SC1) Assembly

Figure 5-4. Spine Shaver (SC1) Assembly

5-1

Page 28

SPINE SHAVER (SC1) HANDPIECE

(1) (2)

SPINE SHAVER (SC1) SUCTION AND IRRIGATION TUBE ASSEMBLY

1. Attach a suction tube to the suction source (Figure 5-5) and an irrigation tube on the irrigation barb (Figure 5-5).

2. Secure suction and irrigation in the irrigation groove on the handpiece (Figure 5-6).

Figure 5-5. Spine Shaver (SC1) Suction and Irrigation Assembly

Figure 5-6. Spine Shaver (SC1) Suction and Irrigation Assembly

CONNECT SPINE SHAVER (SC1) TO IPC CONSOLE

Locate the Spine Shaver (SC1) connection port on the connector panel (Figure 5-7) 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 5-7. Spine Shaver (SC1) IPC Connection Ports

1 Spine Shaver (SC1) Handpiece Connection Port 2 Multifunction Footpedal Connection Port

MICRODEBRIDER BLADE CONTROL

Important: If airway blade becomes clogged during use, 1-5cc of irrigant could be aspirated by

the patient before you detect the clog.

Note: Periodically submerse blade tip in sterile water, with suction on, to keep blades clear during the procedure.

• To rotate the outer blade (Figure 5-8), use the nger wheel (Figure 5-1).

• To rotate the inner blade, use the Blade Position control box on the IPC touchscreen. Refer to

the related accessory Controls topic for further information.

Figure 5-8. Blade Dissection

(4)

(1) (2) (3)

1 Outer Blade 2 Inner Blade 3 Outer Sleeve 4 Suction Flow in through inner blade

Irrigation Flow between inner and outer blades

5-2

Page 29

SPINE SHAVER (SC1) HANDPIECE

(5)

SPINE SHAVER (SC1) TOUCHSCREEN CONTROLS

To set or adjust Spine Shaver (SC1) controls, on the IPC touchscreen, in the control box (Figure 5-9), do the following:

• To change rotation mode, in the Mode control box select OSC (oscillating) or FWD (forward).

• To adjust speed, in the Speed control box, press the plus button to increase speed and the

minus button to decrease.

Forward Mode: Default, 12000 rpm; variable adjustment from 50 to 12000 rpm. Oscillate Mode: Default, 3400 cpm; variable adjustment from 50 to 5000 rpm.

• To adjust ow rate for blade irrigation, in the Irrigation control box, press the plus and minus buttons. Forward Mode: Default, 30cc per minute. Oscillate Mode: Default, 60cc per minute. Note: To adjust ow rate, you can use the touchscreen or the IntelliFlow Irrigation remote control.

Figure 5-9. Spine Shaver (SC1) Touchscreen

SC1 Handpiece

Speed

3400

Blade Position

Irrigation

cc/min

Flow

CPM

180°

Prime

Mode

OSC

FWD

• In oscillating mode only, you can use the Blade Position control box to do any of the following:

To rotate the inner blade 180 press the delta button.

180º

To rotate the inner blade in small increments, press the clockwise or counter-clockwise buttons. Note: The motion indicator indicates rotation direction of the blade.

• To rotate the outer blade, use the nger wheel (Figure 5-1).

SPINE SHAVER (SC1) 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 touch screen

Settings screen to change the default value.

To use the multifunction footpedal (Figure 5-10) to control the handpiece do the following:

• To select forward or oscillating mode, press the mode button.

• To start or adjust the speed of a handpiece in variable mode, press the foot pedal.

• To rotate the inner blade (180) press the control button.

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

SPINE SHAVER (SC1) CLEANING AND STERILIZATION INSTRUCTIONS

Refer to document 68E3282 in the Cleaning and Sterilization section.

SPINE SHAVER (SC1) TECHNICAL SPECIFICATIONS

Spine Shaver (SC1) ED100

Size 14.3 cm legnth x 1.8 cm width (1898200T)

Weight 228g 1898200T

240g 1897200, 1897201 254g 1897200T

Speed 50-5000 rpm oscillate

50-12000 rpm forward

Duty Cycle for Applied Part Maximum on time = 60 seconds. Minimum o time = 30 seconds.

Figure 5-10. Multifunction Footpedal

(1)

(2)

(3)

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

4 Control Button 5 Handpiece Button

(4)

5-3

Page 30

Page 31

STRAIGHTSHOT M4, STRAIGHTSHOT MAGNUM II and STRAIGHTSHOT III

(1)

(2)

STRAIGHTSHOT M4, STRAIGHTSHOT MAGNUM II AND STRAIGHTSHOT III

DEVICE DESCRIPTION

Note: The StraightShot III is not for sale in the United States.

The following instructions for the StraightShot M4, the StraightShot Magnum II and the StraightShot III are in addition to “Set up the IPC” general assembly instructions. Complete IPC setup, then continue to the instructions below.

The IPC incorporates the microdebrider at pump 2. Control operation of the microdebrider with the IPC touchscreen and the multifunction footpedal.

When the IPC detects both the StraightShot M4 and the Legend EHS Stylus handpieces, the system defaults Pump 2 to the Shared conguration. You must manually move the irrigation tubing from the inactive to the active handpiece. Use the pumps screen to override the

Shared default by selecting the StraightShot M4 or the Legend EHS Stylus for Pump 1. Refer to “Set up and Prime Pumps” for more information. Note: The Endo-Scrub 2 is available to all microdebriders. The system automatically turns on the Endo-Scrub 2 only when it also detects the

StraightShot M4. You must manually set the Endo-Scrub 2 for all other microdebriders. Refer to “Set up and Primp Pumps” for details.

Figure 6-1. StraightShot M4 Handpiece

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

(4) (5)

(2) (3)

Figure 6-2. StraightShot Magnum II and III Handpiece

(1)

1 Suction Barb 2 Locking Collar

STRAIGHTSHOT M4 BLADE OR BUR ASSEMBLY

1. Insert the tool aligning the tabs with the notches (Figure 6-3). 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.

• For the M4 rotating blade, adjust the nger wheel with small back-and-forth motions.

2. Press the locking collar (Figure 6-4).

3. Release the locking collar.

Note: If the 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 the 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 6-5).

Figure 6-3. M4 Blade or Bur Assembly

Figure 6-4. M4 Blade or Bur Assembly

Figure 6-5. M4 Blade or Bur Assembly

6-1

Page 32

STRAIGHTSHOT M4, STRAIGHTSHOT MAGNUM II and STRAIGHTSHOT III

STRAIGHTSHOT M4 SUCTION AND IRRIGATION TUBE ASSEMBLY

1. Attach a suction tube to the suction source and an irrigation tube on the irrigation barb (Figure 6-6).

2. Secure suction and irrigation in the irrigation groove on the handpiece (Figure 6-7).

Figure 6-6. M4 Suction and Irrigation Assembly

Figure 6-7. M4 Suction and Irrigation Assembly

STRAIGHTSHOT MAGNUM II AND STRAIGHTSHOT III BLADE AND BUR ASSEMBLY

1. Press the collet and insert blade in collet (Figure 6-8).

2. Release the collet (Figure 6-8).

3. Pull on the tool to ensure engagement and check distal tip of inner blade is in contact with the distal tip of the outer cannula.

Figure 6-8. StraightShot II and III Blade and Bur Assembly

STRAIGHTSHOT MAGNUM II AND STRAIGHTSHOT III SUCTION AND IRRIGATION ASSEMBLY

1. Attach a suction tube to the suction source and an irrigation tube on the irrigation barb (Figure 6-9).

2. Secure suction and irrigation tubing with tubing clips.

Figure 6-9. StraightShot II and III Suction and Irrigation Assembly

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Page 33

STRAIGHTSHOT M4, STRAIGHTSHOT MAGNUM II and STRAIGHTSHOT III

(4)

CONNECT STRAIGHTSHOT TO IPC CONSOLE

Locate the StraightShot connection port on the connector panel (Figure 6-10) 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 6-10. M4 and Magnum II and III IPC Connection Ports

1 M4 and Magnum II and III Handpiece Connection Port 2 Multifunction Footpedal Connection Port

(1) (2)

MICRODEBRIDER BLADE CONTROL

Important: If airway blade becomes clogged during use, 1-5cc of irrigant could be aspirated by

the patient before you detect the clog.

Note: Periodically submerse blade tip in sterile water, with suction on, to keep blades clear during the procedure.

• To rotate the outer blade (Figure 5-8), use the nger wheel (Figure 6-11).

• To rotate the inner blade, use the Blade Position control box on the IPC touchscreen. Refer to

the related accessory Controls topic for further information.

Figure 6-11 Blade Dissection

(1) (2) (3)

1 Outer Blade 2 Inner Blade 3 Outer Sleeve 4 Suction Flow in through inner blade

Irrigation Flow between inner and outer blades

STRAIGHTSHOT M4, STRAIGHTSHOT MAGNUM II AND STRAIGHTSHOT III TOUCHSCREEN CONTROLS

Note: The StraightShot M4, StraightShot Magnum II and StraightShot III handpiece screens feature the same controls as those shown on the

StraightShot M4 Control Box. Note: When you stop the blade, one of the following occurs:

• If the IPC button is visible on the touchscreen, the inner blade returns to the same position it began.

• If the XPS button is visible on the touchscreen, the inner blade stops the current position.

To set or adjust StraightShot controls, on the IPC touchscreen, in the StraightShot Handpiece control box (Figure 6-12), do the following:

• To change rotation mode, select OSC (oscillating) or FWD (forward). Note: The system displays the default oscillating or forward mode speed.

• To adjust speed, in the Speed control box, press the plus button or minus buttons.

Forward Mode: Default, 12000 rpm; variable adjustment from 50 to 12000 rpm. Oscillate Mode: Default, 5000 rpm; variable adjustment from 50 to 5000 rpm.

• To adjust ow rate for blade irrigation, in the Irrigation control box, press the plus or minus buttons. Forward Mode: Default, 30cc per minute. Oscillate Mode: Default, 60cc per minute.

Note: To adjust ow rate, you can use the touchscreen or the IntelliFlow Irrigation remote control.

Figure 6-12. StraightShot IPC Touchscreen

• To rotate outer blade, use the nger wheel (Figure 6-1).

• In oscillating mode only, you can use the Blade Position control box to do any of the following:

Note: The motion indicator indicates rotation direction of the blade.

To enable the multifunction footpedal to change rotation displacement, press the delta button.

To rotate inner blade in small increments, press the counter-clockwise buttons.

60º 180º

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Page 34

STRAIGHTSHOT M4, STRAIGHTSHOT MAGNUM II and STRAIGHTSHOT III

(5)

STRAIGHTSHOT M4, STRAIGHTSHOT MAGNUM II AND STRAIGHTSHOT III 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 touch screen

Settings screen to change the default value.

To use the multifunction footpedal (Figure 6-13) to control the handpiece do the following:

Figure 6-13. Multifunction Footpedal

• To select forward or oscillate mode, press the mode button.

(1)

• To start or adjust the speed of a handpiece in variable mode, press the foot pedal.

• To rotate the inner blade (60 or 180), press the control button.

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

(2)

(3)

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

4 Control Button 5 Handpiece Button

(4)

STRAIGHTSHOT M4, STRAIGHTSHOT MAGNUM II AND STRAIGHTSHOT III CLEANING AND STERILIZATION INSTRUCTIONS

Refer to document 68E3282 in the Cleaning and Sterilization section.

STRAIGHTSHOT M4 TECHNICAL SPECIFICATIONS

StraightShot M4 1898200T

Size 14.3 cm legnth x 1.8 cm width (1898200T)

Weight 228g 1898200T

240g 1897200, 1897201 254g 1897200T

Speed 50-5000 rpm oscillate

50-12000 rpm forward

Duty Cycle for Applied Part The StraightShot M4 handpiece under full load is rated for intermittent operation per the following:

Maximum On Time: 60 seconds Minimum O Time: 30 seconds

STRAIGHTSHOT MAGNUM II AND STRAIGHTSHOT III TECHNICAL SPECIFICATIONS

StraightShot Magnum II 1897200 StraightShot III 1897201

Size 17 cm legnth x 1.6 cm width (1897200/1897201)

Weight 240g 1897200, 1897201

Speed 50-5000 rpm oscillate

50-12000 rpm forward

Duty Cycle for Applied Part Under full load is rated for intermittent operation per the following:

Maximum On Time: 60 seconds Minimum O Time: 30 seconds

6-4

Page 35

LEGEND EHS and LEGEND EHS STYLUS

LEGEND EHS AND LEGEND EHS STYLUS

The Legend EHS motor (Figure 7-1) is a high speed, high torque, reversible electric motor used to dissect bone and biomaterial at selectable speeds from 200 to 75000 rpm.

The Legend EHS Stylus motor (Figure 7-2) is a smaller, compact, high speed, high torque, reversible electric motor used to dissect bone and biomaterials at selectable speeds from 200 to 75000 rpm.

The following instructions for the Legend EHS and Legend EHS Stylus are in addition to “Set up the IPC” general assembly instructions. Complete IPC setup, then continue to the instructions below.

Figure 7-1. Legend EHS Motor

(3)

(1) (2)

1 Rotating Collet 2 Stationary Collet 3 4-pin Cable Connection

Figure 7-2. Legend EHS Stylus Motor

(1)(2)

(3)

(4)

(5)

1 Stationary Collet 2 Rotating Collet 3 Ground Connector 4 4-pin Cable Connection 5 Locking Sleeve

LEGEND EHS AND LEGEND EHS STYLUS ATTACHMENT ASSEMBLY

Refer to “Legend EHS, Legend EHS Stylus and Stylus Touch Attachments” for attachment assembly instructions.

CONNECT LEGEND EHS CABLE TO MOTOR

Note: The Legend EHS Stylus motor cable is integrated in the handpiece and cannot be removed from the motor.

To connect the Legend EHS cable to the Legend EHS motor, align the mark on the cable to the red mark on the motor (Figure 7-3) and connect the two pieces.

Figure 7-3. Legend EHS Motor Cable Connection

REMOVE LEGEND EHS CABLE FROM MOTOR

Note: The Legend EHS Stylus motor cable is integrated in the handpiece and cannot be removed from the motor.

To remove the Legend EHS cable from the Legend EHS motor, (1) push the cable towards the motor, then (2) pull out the cable by the locking ring ONLY (Figure 7-4).

Figure 7-4. Disconnect Legend EHS Cable from Motor

(1)(2)

7-1

Page 36

LEGEND EHS and LEGEND EHS STYLUS

(5)

Mode

CONNECT LEGEND EHS OR LEGEND EHS STYLUS TO IPC

Locate the Legend EHS or Legend EHS Stylus connection port on the connector panel (Figure 7-5) 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.

The IPC incorporates the Legend EHS or Legend EHS Stylus irrigation at pump 1. When

Figure 7-5. Legend EHS and Legend EHS Stylus Connection Ports

the system detects the Legend EHS or Legend EHS Stylus, pump 2 defaults to None. When the IPC detects both the Legend EHS Stylus handpieces and the StraightShot M4,

the system defaults Pump 2 to the Shared conguration. You must manually move the irrigation tubing from the inactive to the active handpiece. Use the pumps screen to override the Shared default by selecting the StraightShot M4 or the Legend EHS Stylus for Pump 1. Refer to “Set up and Prime Pumps” for more information.

Control operation of the Legend EHS or Legend EHS Stylus with the IPC touchscreen and the multifunction footpedal.

(1) (2) (3)

1 Legend EHS Motor Connection Port 2 Legend EHS Stylus Motor Connection Port 3 Multifunction Footpedal Connectoin Port

LEGEND EHS AND LEGEND EHS STYLUS TOUCHSCREEN CONTROLS

To set or adjust Legend EHS or Legend EHS Stylus controls, on the IPC touchscreen, in the control box (Figure 7-6), do the following:

• To change rotation mode, in the Mode control box, select FWD (forward) or REV (reverse). Important: System conguration may be dierent from the default. If the REV (reverse) button appears raised (Figure 7-7) and does not have a selectable radio button, you cannot select the reverse mode. If the REV button appears concave (Figure 7-7) and has a selectable radio button, you can select the reverse mode via the touchscreen or the multifunction footpedal.

• To adjust speed in forward (FWD) or reverse (REV) mode, in the Speed control box, press

the plus button to increase speed or the minus button to decrease speed.

Default, 70000 rpm; variable adjustment from 200 to 75000 rpm.

• To adjust ow rate for optional irrigation, in the Irrigation control box, press the plus button to increase ow or the minus button to decrease ow. Default, 0cc per minute in forward or reverse mode. Note: To adjust ow rate, you can use the touchscreen or the IntelliFlow Irrigation remote control.

• Legend EHS Stylus ONLY: To adjust the rate of the motor’s acceleration and deceleration, in the Acceleration control box, press the plus button to increase acceleration or the minus button to decrease acceleration.

Figure 7-6. Legend EHS Stylus Touchscreen

Speed

Stylus

60000

Acceleration

100

Irrigation

cc/min

Flow

Figure 7-7. Legend EHS or Legend EHS Stylus Mode

FWD

RPM

Prime

Mode

FWD

REV

FWD

LEGEND EHS AND LEGEND EHS STYLUS 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 touch screen Settings screen to change the default value.

To use the multifunction footpedal (Figure 7-8) to control the handpiece do the following:

• To select forward or reverse mode, press the mode button.

• To start or adjust the speed of a handpiece in variable mode, press the foot pedal.

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

button.

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

Figure 7-8. Multifunction Footpedal

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

REV

(1)

(4)

(2)

(3)

4 Control Button 5 Handpiece Button

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LEGEND EHS and LEGEND EHS STYLUS

LEGEND EHS AND LEGEND EHS STYLUS CLEANING AND STERILIZATION INSTRUCTIONS

Refer to documents M000030A234 and M000030A235 in the Cleaning and Sterilization section.

LEGEND EHS TECHNICAL SPECIFICATIONS

Legend EHS EM100-A

Size 9.02 cm length x 2.03 cm diameter

Weight 180g

Speed 75000 rpm forward/reverse

Duty Cycle for Applied Part For use in operating room temperatures up to 400C (1040F), the Legend EHS Motor is rated for a cutting time

of 3 minutes at 70000 rpm. For normal operating room temperatures (typically 200C/680F), the Legend EHS Motor is rated for cutting

time of 10 minutes followed by 25 minutes or rest. The Legend EHS Motor is rated for intermittent use of 20 seconds ON / 20 seconds OFF, indenitely at 70000

rpm.

LEGEND EHS STYLUS TECHNICAL SPECIFICATIONS

Legend EHS EM200

Size 7.77 cm length x 1.65 cm diameter

Weight 90g

Speed 75000 rpm forward/reverse

Duty Cycle for Applied Part For use in operating room temperatures up to 400C (1040F), the Legend EHS Stylus Motor is rated for 3

minutes at 60000 rpm followed by 25 minutes or rest. For normal operating room temperatures (typically 200C/680F), the Legend EHS Stylus Motor is rated for

cutting indenintely at 60000 rpm.

7-3

Page 38

Page 39

STYLUS TOUCH

(1) (2)

STYLUS TOUCH

The Stylus Touch (Figure 8-1) is a small, compact, high-speed, high-torque, reversible electric motor used to dissect bone and biomaterials at variable speeds from 200 to 75000 rpm. The Stylus Touch motor includes a rotating nger lever that emulates the functions of the multifunction footpedal.

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

Figure 8-1. Stylus Touch Motor

(1)

(5) (6)

1 Telescoping Finger Rest 2 Finger Lever 3 Finger Lever Safe Mode Switch

(2)

(3)

4 Control Lever Ring 5 Stationary Collet 6 Rotating Collet

(4)

STYLUS TOUCH ATTACHMENT ASSEMBLY

Refer to “Legend EHS, Legend EHS Stylus and Stylus Touch Attachments” for attachment assembly instructions.

ROTATE STYLUS TOUCH FINGER LEVER

1. Press the control lever ring forward (Figure 8-2).

2. Rotate the lever clockwise or counter clockwise until the lever locks in a new position.

Figure 8-2. Stylus Touch Finger Lever Rotation

(1)

(2)

CONNECT STYLUS TOUCH TO IPC CONSOLE

Locate the Stylus Touch connection port on the connector panel (Figure 8-3) 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.

The IPC incorporates the Stylus Touch at pump 1. If you do not use irrigation for the Stylus Touch, manually change the Pump 1 to None. Refer to “Set up and Prime Pumps” for more information.

Control operation of the Stylus Touch with the IPC touchscreen and the multifunction footpedal.

Figure 8-3. Stylus Touch Connection Ports

1 Stylus Touch Connection Port 2 Multifunction Footpedal Connection Port

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Page 40

STYLUS TOUCH

Speed

(5)

STYLUS TOUCH TOUCHSCREEN CONTROLS

To set or adjust Stylus Touch controls, on the IPC touchscreen, in the control box (Figure 8-4), do the following:

• To change rotation mode, in the Mode control box, select FWD (forward) or REV (reverse). Important: To set the Stylus Touch to Safe Mode, on the Stylus Touch handpiece, switch the Safe Mode nger lever (Figure 8-1) to on.

• To adjust speed, in the Speed control box, press the plus button to increase speed or the minus button to decrease speed.

Default, 60000 rpm; variable adjustment from 200 to 75000 rpm. Important: The handpiece does not operate in Safe Mode. If the Stylus Touch is in Safe Mode, SAFE appears in the the Speed control box (Figure 8-5).

• To adjust rate of the motors acceleration and deceleration, in the Acceleration control box, press the plus button to increase acceleration or the minus button to decrease acceleration.

• To adjust ow rate for optional irrigation, in the Irrigation control box, press the plus button to increase ow or the minus button to decrease ow. Default, 0cc per minute. Note: To adjust ow rate, you can use the touchscreen or the IntelliFlow Irrigation remote control.

STYLUS TOUCH SAFETY SWITCH

Use the Stylus Touch safety switch to activate or deactivate the safe mode when the Stylus Touch is the active handpiece. When the handpiece is the inactive handpiece, use the safety switch to activate the handpiece.

Figure 8-4. Stylus Touch Touchscreen

Speed

60000

Acceleration

100 %

Irrigation

cc/min

Flow

Figure 8-5. Stylus Touch Safe Mode

SAFE

Stylus Touch

RPM

Prime

RPM

Control

Finger

Mode

FWD

REV

Foot

Both

STYLUS TOUCH 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 touch screen Settings screen to change the default value.

To use the multifunction footpedal (Figure 8-6) to control the handpiece do the following:

• To select forward or reverse mode, press the mode button.

• To start or adjust the speed of a handpiece in variable mode, press the foot pedal.

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

button.

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

Figure 8-6. Multifunction Footpedal

(1)

(2)

(3)

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

4 Control Button 5 Handpiece Button

STYLUS TOUCH CLEANING AND STERILIZATION INSTRUCTIONS

Refer to documents 68E4132 and M000030A235 in the Cleaning and Sterilization section.

STYLUS TOUCH TECHNICAL SPECIFICATIONS

Stylus Touch EM210

Size 15.26 cm length x 1.65 cm diameter

Weight 130g

Speed 75000 rpm forward/reverse

Duty Cycle for Applied Part For use in operating room temperatures up to 400C, the Legend EHS Stylus Touch Motor is rated for 3

minutes at 60000 rpm followed by 25 minutes or rest. For normal operating room temperatures (typically 200C), the Legend EHS Stylus Touch Motor is rated for

cutting indenitely at 60000 rpm.

(4)

8-2

Page 41

LEGEND EHS, LEGEND EHS STYLUS, and STYLUS TOUCH ATTACHMENTS

LEGEND EHS, LEGEND EHS STYLUS AND STYLUS TOUCH ATTACHMENTS

The following instructions for the Legend EHS, Legend EHS Stylus and Stylus Touch attachments are in addition to “Set up the IPC” and motorspecic general instructions. Complete IPC setup, motor specic instructions and then continue to the instructions below.

DISSECTING TOOLS NOMENCLATURE

Note: Match the nomenclature and color code on the dissecting tool packaging to the same nomenclature and color code on the attachment.

Part numbers for dissecting tools follow a standard naming convention (Figure 9-1). A basic part number consists of ve characters, representing the associated attachment length, the tool-head shape, and the tool-head diameter. Part numbers can also include a variety of prexes to identify specic attachment types, as well as a variety of suxes to provide additional information about the dissecting tool. Tools that use a design taken from the Mednext line are designated by an additional “-MN” sux.

Figure 9-1. Dissecting Tool Nomenclature Naming Convention

9 M H 3 0

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

1 Optional Prex 2 Attachment Length 3 Tool Head Shape

4 Tool Head Diameter (x.x millimeters) 5 Optional Sux 6 Optional “-MN” Sux

Tool Number Prexes

F For use with footed attachments.

MC For use with metal-cutting attachments.

T For use with telescoping attachments.

Tool Number Suxes

Tool Head Shapes

AC Acorn MH Match Head L Long S Spiral BA Ball OV Oval D Diamond SH Short

CY Cylinder RT Reverse Taper X Extra

HM Hole Maker TA Tapered F Fine DC Diamond Coarse

HS Hole Saw TD Twist Drill C Carbide DX Diamond Extra Coarse

Note: More than one sux can be combined in a single part number.

ALIGN MOTOR COLLET

Note: An attachment will not seat on the Legend EHS, Legend EHS Stylus or Stylus Touch motor if the arrows on the collet ats are not aligned.

1. Verify alignment of arrows on motor collet ats. Prior to installation of an

attachment and dissecting tool on the Legend EHS, Legend EHS Stylus or Stylus Touch motor, ensure that arrows on the motor collet ats are in proper alignment. (Figure 9-2).

Figure 9-2. Correct Alignment

2. If the arrows are not aligned (Figure 9-3), use the motor wrench (Figure 9-4) to

turn the rotational collet until its arrow is aligned with the arrow on the stationary collet. Note: DO NOT use any other components except for the motor wrench to align arrows on motor collet.

Figure 9-3. Incorrect Alignment

Figure 9-4. Motor Wrench

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LEGEND EHS, LEGEND EHS STYLUS, and STYLUS TOUCH ATTACHMENTS

STRAIGHT ATTACHMENT ASSEMBLY

Warnings: Refer to warnings W36 and W54. Caution: Match the nomenclature and color code on the tool packaging to the same nomenclature and color code on the attachment.

Notes:

• An attachment will not seat on the motor if the arrows on the collet ats are not in alignment.

• The Legend EHS motors will not run properly unless the attachment is in the locked position.

• Smoke may be generated if attachment is not in the locked position.

1. Slide a straight attachment over the motor collet aligning triangular arrows on the attachment and the motor case (Figure 9-5). An

audible click, heard and perceptible by touch, conrms that the tool is fully seated.

Figure 9-5. Straight Attachment Assembly

2. Insert the tool into the attachment with a slight rotational motion (Figure 9-6). An audible click, heard and perceptible by touch, conrms

that the tool is fully seated.

Figure 9-6. Straight Attachment Assembly

3. Rotate the attachment in the direction indicated by arrow until the attachment alignment mark is directly in line with the locked symbol

(Figure 9-7).You will hear two clicks as the attachment is rotated.

Figure 9-7. Straight Attachment Assembly

4. Gently pull on the tool to ensure that it is locked into the handpiece.

Note: Tool should rotate freely, if not, unlock the attachment, re-seat the tool, and re-lock the attachment.

STRAIGHT ATTACHMENT DISASSEMBLY

1. Hold the motor in palm of hand. Rotate the attachment to the unlocked position.

2. Remove the dissecting tool from the attachment and discard the tool.

3. Use thumb and index nger to lift the attachment o of the motor.

ANGLED ATTACHMENT ASSEMBLY

Caution: When using an angled attachment, hold the handpiece assembly by the attachment so that the attachment does not inadvertently

loosen from the handpiece.

Notes:

• A dissecting tool may be installed and locked in the attachment before the angled attachment is installed onto the motor.

• Angled and straight attachments with the same length, marking and color band share the same dissecting tools.

• The Legend EHS Motors will not run properly unless the attachment is in the locked position.

• Smoke may be generated if attachment is not in the locked position.

1. With the tool lock in the unlocked position, insert a tool into the angled attachment with a slight rotational motion (Figure 9-8). An

audible click, heard and perceptible by touch, conrms that the tool is fully seated.

9-2

Figure 9-8. Angled Attachment Assembly

Page 43

LEGEND EHS, LEGEND EHS STYLUS, and STYLUS TOUCH ATTACHMENTS

2. Rotate the tool lock in the direction indicated by arrow until the tool lock alignment mark is directly in line with the locked symbol (Figure

9-9).

Figure 9-9. Angled Attachment Assembly

3. Gently pull on the tool to ensure that it is locked into the handpiece.

Note: Tool should rotates freely, if not, unlock the attachment, re-seat the tool, and re-lock the attachment.

4. Slide the angled attachment over the motor collet aligning triangular arrows on the attachment and the motor case. An audible click,

heard and perceptible by touch, conrms that the tool is fully seated.

5. Rotate the attachment in the direction indicated by the arrow until attachment alignment mark is directly in line with the locked symbol.

You will hear two clicks as the attachment is rotated.

6. Verify that both the attachment to motor alignment mark and the tool lock alignment mark are directly in line with the locked symbol

(Figure 9-10).

Figure 9-10. Angled Attachment Assembly

ANGLED ATTACHMENT DISASSEMBLY

1. Rotate the Tool Lock to the unlocked position to remove the tool from the attachment.

2. Rotate the attachment to the unlocked position and lift attachment o of the motor.

FIXED FOOTED ATTACHMENT ASSEMBLY

Warning: Refer to Warning W37.

1. Insert a dissecting tool into the motor collet with a slight rotational motion (Figure 9-11). An audible click, heard and perceptible by

touch, conrms that the tool is fully seated.

Figure 9-11. Footed Attachment Assembly

2. Slide the footed attachment over the dissecting tool onto the motor aligning triangular arrows on the attachment and the motor case

(Figure 9-12).

Figure 9-12. Footed Attachment Assembly

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LEGEND EHS, LEGEND EHS STYLUS, and STYLUS TOUCH ATTACHMENTS

3. Pull the footed attachment towards the motor and rotate the attachment to the locked position on the motor case (Figure 9-13).

Figure 9-13. Footed Attachment Assembly

FIXED FOOTED ATTACHMENT DISASSEMBLY

1. To remove the footed attachment, hold the motor in the palm of your hand. Push the sleeve on the footed attachment distally while

rotating the attachment to the unlocked position on the motor case. Release the sleeve (Figure 9-14).

Figure 9-14. Footed Attachment Disassembly

2. To avoid injury from the dissecting tool, use thumb and index nger to cautiously and slowly lift the attachment o of the motor and

away from the dissecting tool (Figure 9-15).

Figure 9-15. Footed Attachment Disassembly

3. Pull the dissecting tool out of the motor collet and discard the tool (Figure 9-16).

Figure 9-16. Footed Attachment Disassembly

ROTATING FOOTED ATTACHMENT ASSEMBLY

Warnings: Refer to Warnings, W20 and W52. Notes:

• Rotating and xed footed attachments with the same length, marking and color band share the same dissecting tools.

• The footed end of the attachment has 360˚ of unrestricted rotation.

Attach the Rotating Footed attachment using the Fixed Footed Attachment Assembly Instructions.

ROTATING FOOTED ATTACHMENT DISASSEMBLY

Remove the Rotating Footed attachment using the Fixed Footed Attachment Disassembly Instructions.

CONTRAANGLE ATTACHMENT 16MF ASSEMBLY

1. On the IPC Touchscreen, adjust the speed setting to 62,000 rpm using the speed control buttons.

2. Slide the Contra-Angle Attachment over the motor collet aligning triangular arrows on the attachment and the motor case. An audible

click, heard and perceptible by touch, conrms that the tool is fully seated.

3. Rotate the attachment to the locked position on the motor case (Figure 9-17).

Figure 9-17. Contra-Angle Attachment Assembly

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LEGEND EHS, LEGEND EHS STYLUS, and STYLUS TOUCH ATTACHMENTS

4. Rotate the attachment head’s lever laterally to the open position and insert a dissecting tool (Figure 9-18).

5. Close lever (Figure 9-19).

6. Gently pull on the dissecting tool shaft to ensure proper installation.

Figure 9-18. Contra-Angle Attachment Assembly Figure 9-19. Contra-Angle Attachment Assembly

CONTRAANGLE ATTACHMENT 16MF DISASSEMBLY

1. Rotate the lever on the attachment head laterally to remove the dissecting tool.

2. Discard the dissecting tool.

3. Rotate the 16-MF attachment to the unlocked position and lift the attachment o of the motor.

METAL CUTTING ATTACHMENT ASSEMBLY

Warning: Refer to Warning W15. Important: The Metal Cutting attachment uses the tungsten carbide or diamond wheel dissecting

tools. All metal cutting dissecting tools have an “MC” attachment prex in their nomenclature, e.g., MC254, MC30. Metal cutting dissecting tools cannot be installed into any other Attachment.

1. Slide the Metal Cutting attachment over the motor collet aligning triangular markers on the

attachment and the motor case. An audible click, heard and perceptible by touch, conrms that the tool is fully seated.

2. Rotate the attachment to the locked position on the motor case.

3. With the tool lock unscrewed several turns and holding the attachment UPRIGHT, insert a

dissecting tool into attachment (Figure 9-20).

4. Rotate the dissecting tool until it drops into position and is fully seated. You will feel a tactile

click indicating that the tool is fully seated (Figure 9-20).

METAL CUTTING ATTACHMENT DISASSEMBLY

1. Unscrew the tool lock with several turns, then withdraw the dissecting tool.

2. Rotate the attachment to the locked position on the motor case and lift attachment o of the

motor.

VARIABLE EXPOSURE ATTACHMENT ASSEMBLY

Warnings: Refer to Warnings W23, W34, W53 and W57.

The Variable Exposure attachments can be distinguished from standard attachments by the dual color bands on the attachment. Match the color band on the attachment to the color code on the dissecting tool packaging.

1. Assemble the attachment using the Straight Attachment Assembly Instructions.

2. After assembly, use the TUBE adjustment ring to adjust the exposure of the dissecting tool

(Figure 9-21). With the tool pointing away from you, turn the ring to the right to increase the length of the tube, thereby decreasing the exposure of the tool. Turn the ring to the left to decrease the length of the tube, thereby increasing the exposure of the tool.

Figure 9-20. Metal Cutting Attachment Assembly

Figure 9-21. Variable Exposure Attachment

VARIABLE EXPOSURE ATTACHMENT DISASSEMBLY

Remove the Variable Exposure Attachment using the Straight Attachment Disassembly Instructions.

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LEGEND EHS, LEGEND EHS STYLUS, and STYLUS TOUCH ATTACHMENTS

(1) (2)

TELESCOPING STRAIGHT ATTACHMENT AT10 ASSEMBLY

1. Assemble the attachment using the Straight Attachment Assembly Instructions.

2. Insert the base end of the selected telescoping tube into the attachment.

3. To lock tube in place, turn the TUBE Locking Ring clockwise until nger tight (Figure 9-22).

Note: DO NO T over tighten.

Figure 9-22. Telescoping Straight Attachment Assembly

(3)

1 Tube Locking Ring 2 Tool Locking Ring 3 Base

4. Be sure that the TOOL Locking Ring is in the unlocked position. Insert the dissecting tool into the telescoping tube (Figure 9-23). Tactile

feedback is felt when the dissecting tool is fully seated.

Figure 9-23. Telescoping Straight Attachment Assembly

5. Turn the TOOL Locking Ring to the locked position (Figure 9-24).

Figure 9-24. Telescoping Straight Attachment Assembly

6. Verify that the tool is in place by gently pulling on the tool.

7. If the tube position needs to be changed, rotate the TUBE Locking Ring towards the unlocked position, re-position the tube, then rotate

the TUBE Locking Ring towards locked.

8. Gently pull on the dissecting tool, then the tube, to ensure proper installation.

TELESCOPING CURVED ATTACHMENT AT10 ASSEMBLY

1. Assemble the attachment using the Straight Attachment Assembly Instructions.

2. Insert the base end of the curved bur into the attachment until the hub is fully seated. To lock in place, turn the TUBE Locking Ring until

nger tight (Figure 9-25).

Note: DO NOT over tighten.

Figure 9-25. Telescoping Curved Attachment Assembly

3. Verify that the hub is in place by gently pulling on the tool.

4. Seat the tool in the tool Locking Ring by applying a slight amount of inward pressure on the bur (Figure 9-26). An audible click, heard and

perceptible by touch, conrms that the tool is fully seated.

Figure 9-26. Telescoping Curved Attachment Assembly

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LEGEND EHS, LEGEND EHS STYLUS, and STYLUS TOUCH ATTACHMENTS

5. Rotate the Tool Locking Ring until the tool lock alignment mark is directly in line with the locked symbol (Figure 9-27).

Figure 9-27. Telescoping Curved Attachment Assembly

6. Verify that the bur is in place by gently pulling on the bur.

Curved Bur Cooling

1. Prior to initial use, soak the cooling sleeve by dipping it into a cup of saline or DI water (Figure 9-28).

Figure 9-28. Curved Bur Cooling

2. During use, maintain copious irrigation of the cooling sleeve and bur by dribbling saline or DI water along the entire

length of the cooling sleeve.

TELESCOPING ATTACHMENT AT10 DISASSEMBLY

1. Rotate the TUBE Locking Ring towards the unlocked position.

2. Rotate the TOOL Locking Ring to the unlocked position.

3. Pull the telescoping tube out of the attachment.

4. Rotate the attachment to the unlocked position on the motor case and lift the attachment o the motor.

PERFORATOR ATTACHMENT AD01 & AD03 ASSEMBLY

Warning: Refer to Warning W56. Note: A cranial perforator device may be installed in the attachment before the perforator attachment is installed on the motor.

Maximum Speed

Console Setting AD01 Output Speed (MAX) AD03 Output Speed (MAX)

60000 rpm 645 rpm 830 rpm 70000 rpm 745 rpm 965 rpm 72000 rpm 770 rpm 995 rpm 74000 rpm 790 rpm 1020 rpm 75000 rpm 805 rpm 1035 rpm

Figure 9-29. Perforator Attachment Hudson Shank Assembly

1. Assemble the attachment using the Straight Attachment Assembly Instructions.

2. To install a cranial perforator device with a Hudson shank, pull back proximally on the collar of

the Perforator Attachment. Insert a device and release the collar to its original position (Figure 9-29).

PERFORATOR ATTACHMENT AD01 & AD03 DISASSEMBLY

Pull back proximally on the collar of the Perforator Attachment to remove the cranial perforator device. Rotate the Perforator Attachment to the unlocked position and lift the attachment o of the motor.

JACOBS CHUCK ATTACHMENT ASSEMBLY

1. Assemble the attachment using the Straight Attachment Assembly Instructions.

2. To install a drill bit, turn Jacobs key to open ridged collar. Insert drill bit and tighten collar with key (Figure 9-30).

Figure 9-30. Jacobs Chuck Tool Assembly

JACOBS CHUCK ATTACHMENT DISASSEMBLY

Use the Jacobs key to open the collar. Remove and discard the drill bit in an appropriate container. Rotate the Jacobs Chuck Attachment to the unlocked position and lift the attachment o of the motor.

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LEGEND EHS, LEGEND EHS STYLUS, and STYLUS TOUCH ATTACHMENTS

ANGLED DOUBLE LOCK ATTACHMENT ASSEMBLY

Notes:

• Angled attachments with the same length, marking, and color band share the same dissecting tools.

• You can insert and lock a tool in the attachment before the angled attachment is installed on the motor.

1. Assemble the attachment using the Straight Attachment Assembly Instructions.

2. Insert the tool into the attachment with a slight rotational motion. An audible click, perceptible by touch, conrms that the tool is fully

seated (Figure 9-31).

Figure 9-31. Angled Double Lock Attachment Assembly

3. Rotate the tool lock in direction indicated by arrow until the tool lock alignment mark is directly in line with the locked symbol (Figure

9-32).

Figure 9-32. Angled Double Lock Attachment Assembly

4. Pull on the tool to ensure that it is locked into the handpiece.

5. The tool should rotate freely. If not, unlock the attachment, re-seat the tool, and re-lock the attachment.

6. Verify that both the attachment to motor and the tool-lock alignment mark is directly in line with the locked symbol.

ANGLED DOUBLE LOCK ATTACHMENT DISASSEMBLY

1. To remove the attachment, hold the motor in the palm of your hand, and push the sleeve on the attachment distally while turning the

attachment to the unlocked position (Figure 9-33).

2. Release the sleeve and remove the attachment.

Figure 9-33. Angled Double Lock Attachment Disassembly

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LEGEND EHS, LEGEND EHS STYLUS, and STYLUS TOUCH ATTACHMENTS

(1)

TRANSNASAL SKULL BASE BUR ATTACHMENT ASSEMBLY

1. Slide the perforator attachment over the motor collet aligning triangular arrows on the attachment and the motor case. An audible click,

heard and perceptible by touch, conrms that the tool is fully seated.

2. Rotate the perforator attachment to the locked position on the motor case (Figure 9-34).

Figure 9-34. Trans-Nasal Skull Base Bur Assembly

3. Attach irrigation tubing (Figure 9-35).

Figure 9-35. Trans-Nasal Skull Base Bur Assembly

1 I rrigation Tubing Connection

TRANSNASAL SKULL BASE BUR ATTACHMENT DISASSEMBLY

1. Remove irrigation tubing.

2. Rotate the perforator attachment to the unlocked position on the motor case.

3. Remove the perforator attachment from the motor.

IRRIGATION ASSEMBLY

NOTE: Clip may not fasten to small bore attachment after having been used on large bore attachment.

1. Adjust the plastic clip on the stainless-steel irrigation tube (Figure 9-36).

2. Bend the irrigation tube to the desired angle.

3. Snap the clip onto the handpiece near the tool.

Figure 9-36. Irrigation Assembly

LEGEND EHS, LEGEND EHS STYLUS AND STYLUS TOUCH CLEANING AND STERILIZATION INSTRUCTIONS

Refer to documents M000030A234, 68E4132 and M000030A235 in the Cleaning and Sterilization section.

Variable Exposure Attachment Cleaning

When cleaning, clean the attachment completely. First without adjusting the tube length, then with the tube fully extended, and nally with the tube fully retracted.

9-9

Page 50

Page 51

SKEETER

SKEETER ULTRA-LITE OTO-TOOL

The following instructions for the Skeeter Ultra-Lite Oto-Tool are in addition to “Set up the IPC” general assembly instructions. Complete the IPC setup, then continue to the instructions below. Refer to the Skeeter Ultra-Lite Oto-Tool System Instructions for Use for additional information.

SKEETER ASSEMBLY

1. Press the bur release button (Figure 10-1).

2. Load the desired bur for the procedure into the handpiece by

inserting the bur shaft through the distal end of the handpiece with a slight twisting motion while simultaneously pressing the bur release button.

3. The bur is locked into place when a “click” is noted. Locking of the bur

should be checked prior to use by rmly pulling on the bur after the “click” is noted.

4. Tug the bur to ensure it ts securely in the handpiece.

5. To remove the bur from the handpiece, press the bur release button

on the handpiece and pull the bur out.

CONNECT SKEETER HANDPIECE TO IPC CONSOLE

On the IPC Console, locate the Skeeter accessory connection port on the connector panel (Figure 10-2) and insert the connector. Note: To insert the 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.

The Skeeter does not use irrigation. By default, the system sets both pumps to None. Control the operation of the Skeeter with the IPC touchscreen and the multifunction

footpedal.

Figure 10-1. Skeeter Handpiece Assembly

(6)

(4)

(3)

(2)

(5)

(1)

1 Bur at Distal End 2 Bur Color Code 3 PTFE Bearing

4 Bur Shaft 5 Bur Release Button

Figure 10-2. IPC Skeeter Connection Port

SKEETER TOUCHSCREEN CONTROLS

To set or adjust Stylus Touch controls, on the IPC touchscreen, in the Stylus Touch control box (Figure 10-3), do the following:

• To change rotation mode, in the Mode control box, select FWD (forward) or REV (reverse).

• To adjust speed, in the Speed control box, press the plus button to increase speed or

the minus button to decrease speed.

Default, 16000 rpm; variable adjustment from 1000 to 16000 rpm.

SKEETER 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 touch screen Settings screen to change the default value.

To use the multifunction footpedal (Figure 10-4) to control the handpiece do the following:

• To select forward or reverse mode, press the mode button.

• To start or adjust the speed of a handpiece in variable mode, press the foot pedal.

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

button.

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

1 Skeeter Connection Port 2 Multifunction Footpedal Connection Port

Figure 10-3. Skeeter Touchscreen

(3)

Skeeter

RPM

4 Control Button 5 Handpiece Button

(5)

Speed

16000

Figure 10-4. Multifunction Footpedal

(1)

(2)

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

(1) (2)

Mode

FWD

REV

(4)

10-1

Page 52

SKEETER

SKEETER CLEANING AND STERILIZATION INSTRUCTIONS

Refer to documents 68E3968 and 68E3969 in the Cleaning and Sterilization section.

SKEETER TECHNICAL SPECIFICATIONS

Skeeter 3055601

Size 17cm length x 1.6cm diameter

Weight 57g

Speed 1000-16000 rpm forward/reverse

Duty Cycle for Applied Part Continuous run

Storage Temperature -400C to +700C

Humidity 10% to 100% RH

Barometric Pressure 500 to 1060 hPa

10-2

Page 53

VISAO

VISAO HIGH-SPEED DRILL

DEVICE DESCRIPTION

The IPC incorporates the Visao coolant at pump 1 and irrigation at pump 2. The Visao coolant pump cartridge uses both a pump tube and a drip chamber return tube. If you will not use irrigation, select None for pump 2. Refer to “Set up and Prime Pumps”. Control operation of the Visao with the IPC touchscreen and the multifunction footpedal.

Important: During use, maintain free ow irrigation to the cooling sleeve and bur by dribbling saline or DI water along the entire length of the cooling sleeve.

The following instructions are specic for the use of the Visao with the IPC. They are in addition to “Set up the IPC” general accessory instructions.

SET UP VISAO PUMP

Fill the clear-drip chamber with coolant before you prime the coolant system. Refer to “Set up and Prime Pumps” for instruction.

VISAO BUR GUARD ASSEMBLY

Important: On the Visao, a bur guard (Figure 11-2) is required for use with all burs.

Slide bur guard over the front end of the Visao until fully seated (Figure 11-1).

Figure 11-1: Bur Guard Assembly

Figure 11-2. Visao Bur Guards

Visao Reusable Bur Guards with and without irrigation

Visao Single Use Bur Guard with irrigation

VISAO STRAIGHT BUR ASSEMBLY

Important: On the Visao, a bur guard (Figure 11-2) is required for use with all burs.

1. Align the alignment point on the Visao locking collar with the unlock symbol (Figure 11-3).

2. Insert the tool until fully seated.

3. Move the locking collar so that the alignment point aligns with the lock symbol.

4. To ensure a secure t, gently pull the tool.

Figure 11-3. Visao Straight Tool Assembly

Visao Single Use STIM Bur Guard with and without irrigation. The STIM Bur Guard also provides nerve stimulation to standard burs in static and dynamic modes when used with both the Medtronic Nerve Integrity Monitor (NIM) and the IPC System.

11-1

Page 54

VISAO

(1)

VISAO CURVED BUR ASSEMBLY

Important: On the Visao, a bur guard (Figure 11-2) is required for use with all

burs.

1. Align the alignment point on the Visao locking collar with the unlock

symbol (Figure 11-4).

2. Align the notch on the tool with the notch on the Visao collar.

3. Gently press on the tool until full seated.

4. Align the alignment point on the Visao locking collar with the lock

symbol.

5. To ensure a secure t, gently pull the tool.

VISAO IRRIGANT AND COOLING TUBE ASSEMBLY

Caution: Do not confuse the coolant tube with irrigation tube.

1. Connect one coolant tube to each coolant port (Figure 11-5). The

coolant can ow in the left or right port if you connect the return tubing to the opposite port.

2. Connect the free end of the irrigation tube to the irrigation barb.

3. Conrm the coolant pedal starts the handpiece and coolant ow.

Note: The coolant pump runs for 1 minute after you release the pedal

4. Prior to initial use, soak the cooling sleeve in a cup of saline or DI

water.

5. During use, maintain copious irrigation of the cooling sleeve and bur

by dribbling saline or DI water along the entire length of the cooling sleeve.

Figure 11-4. Visao Curved Bur Assembly

Figure 11-5. Visao Irrigant and Cooling Assembly

(2)

1 Coolant Tubing 2 Irrigation Tubing

CONNECT VISAO TO IPC CONSOLE

Figure 11-6. IPC Visao Connection Port

Locate the Visao connection port on the connector panel (Figure 11-6) 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.

1 Visao Connection Port 2 NIM STIM Bur Connection Port

VISAO TOUCHSCREEN CONTROLS

To set or adjust Visao controls, on the IPC touchscreen, in the Visao control box (Figure 11-7), do the following:

• To change rotation mode, in the Mode control box, select FWD (forward) or REV (reverse).

• To adjust speed, in the Speed control box, press the plus button to increase speed or the minus button to decrease speed.

Default, 80000 rpm; variable adjustment from 200 to 80000 rpm.

• To adjust ow rate for blade irrigation, in the Irrigation control box, press the plus button to increase ow rate or the minus button to decrease ow rate. Forward Mode: Default, 30cc per minute. Note: To adjust ow rate, you can use the touchscreen or the IntelliFlow Irrigation remote control.

Figure 11-7. Visao Touchscreen

Speed

80000

Irrigation

cc/min

Flow

(1) (2) (3) (4)

3 Irrigation Connection Port 4 Multifunction Footpedal Port

Visao

Mode

RPM

Prime

FWD

REV

11-2

Page 55

VISAO MULTIFUNCTION FOOTPEDAL CONTROLS

(2)

(4)

(5)

(1)

(3)

Important: By default, press each button on the footpedal for at least 100 mS for the selection to become active. Use the IPC touch screen Settings screen to change the default value.

To use the multifunction footpedal (Figure 11-8) to control the handpiece do the following:

• To select forward or reverse mode, press the mode button.

• To start or adjust the speed of a handpiece in variable mode, press the foot pedal.

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

button.

Figure 11-8. Multifunction Footpedal

VISAO

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

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

4 Control Button 5 Handpiece Button

VISAO CLEANING AND STERILIZATION INSTRUCTIONS

Refer to document 68E3281 in the Cleaning and Sterilization section.

VISAO TECHNICAL SPECIFICATIONS

Visao 3334800

Size 16.0 cm length x 2.0 cm diameter

Weight 148g

Speed 200-80000 rpm forward/reverse. Visao High-Speed Drill, water cooled

Duty Cycle for Applied Part The Visao High-Speed Drill under full load is rated for intermient operaon per the following:

Maximum On Time: 60 seconds

Maximum O Time: 30 seconds

VISAO USE WITH IPC AND NIM

To use the NIM with the IPC use the Stim Bur Guard (Figure 11-2). The Stim Bur Guard connects the IPC to the NIM via the Stim bur stimulus output port (Figure 11-6). The Stim Bur Guard carries stimulating current to the tool’s tip and provides nerve stimulation to standard burs in static and dynamic modes. Refer to the NIM User’s Manual and Stim Bur Guard Product Information and Instructions for further information.

11-3

Page 56

Page 57

INDIGO

(1) Correct Alignment

INDIGO HIGH-SPEED OTOLOGIC DRILL

DEVICE DESCRIPTION

Note: The Indigo drill is not for sale in the United States.

The Indigo drill is a small, compact high-speed, high-torque, reversible electric drill that can be used to dissect bone and biomaterial at variable speeds from 200 to 60000 rpm. The cable cannot be removed from the drill.

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

Figure 12-1. Indigo Alignment

Indigo™

High-Speed Otologic Drill

(3)

(4) (5) (6)

(2) Incorrect Alignment

Indigo™

High-Speed Otologic Drill

1 Correct Alignment 2 Incorrect Alignment 3 Stationary Collet

4 Rotating Collet 5 Indigo Motor 6 Cable

INDIGO DRILL STRAIGHT ATTACHMENT ASSEMBLY

Important: The Indigo High-speed Otologic drill is designed to work only with Medtronic Xomed burs and Indigo attachments. The use of

other burs and attachments may result in sub-standard performance and will void the manufacturer’s warranty. Do not use with Midas Rex attachments or burs.

1. Verify the alignment marks on the motor collet are in alignment (Figure 12-1).

Note: If the marks are misaligned, turn the collet until the marks are aligned.

Figure 12-2. Indigo Straight Attachment Assembly

Indigo™

High-Speed Otologic Drill

2. Slide the attachment over the motor collet (Figure 12-2) so that the alignment

mark on the attachment aligns with the alignment mark (unlocked symbol) on the motor collet.

3. Insert the bur with a slight twisting motion until you feel it seat into position.

4. Turn the attachment so the alignment mark aligns with the locked symbol on

the motor collet. You will hear two clicks while rotating the attachment.

Indigo™

High-Speed Otologic Drill

5. To ensure a secure t, gently pull the tool.

Important: The Indigo motor will not run correctly unless the attachment is in

High-Speed Otologic Drill

the locked position. Warning: Smoke may be generated if attachment is not in the locked position (W 36).

INDIGO DRILL ANGLED ATTACHMENT ASSEMBLY

Important: The Indigo High-speed Otologic drill is designed to work only with Medtronic Xomed burs and Indigo attachments. The use of

other burs and attachments may result in sub-standard performance and will void the manufacturer’s warranty. Do not use with Midas Rex attachments or burs.

1. Verify the alignment marks on the motor collet are in alignment (Figure 12-1).

Note: If the marks are misaligned, turn the collet until the marks are aligned.

2. Slide the attachment over the motor collet (Figure 12-3) so that the alignment

mark on the attachment aligns with the alignment mark (unlocked symbol) on the motor collet.

3. Turn the attachment so the alignment mark aligns with the locked symbol on

the motor collet. You will hear two clicks while rotating the attachment.

4. Verify the alignment marks on the tool lock ring align with the unlocked

symbol on the attachment.

5. Insert the bur with a slight twisting motion until you feel it seat into position.

6. Turn the lock ring so the alignment mark aligns with the locked symbol on the

attachment. You will hear two clicks while rotating the attachment.

7. To ensure a secure t, gently pull the tool.

Important: The Indigo motor will not run correctly unless the attachment and lock ring is in the locked position.

Warning: Smoke may be generated if attachment is not in the locked position (W 36).

Figure 12-3. Indigo Angled Attachment Assembly

Indigo™

High-Speed Otologic Drill

Indigo™

High-Speed Otologic Drill

(1)

(1) Tool Lock Ring

12-1

Page 58

INDIGO

Flow

INDIGO DRILL IRRIGATION AND TUBING CLIP ASSEMBLY

1. Snap or slide the irrigation clip on to the attachment (Figure 12-4).

Note: The irrigation clip is designed with two nodules that t in the grooves on the attachment.

2. Bend the irrigation tube to a desirable angle and adjust the clip closer to or farther

from the bur, as necessary.

3. Snap the tubing clip on the handpiece or angled attachment.

CONNECT INDIGO DRILL TO IPC

Locate the Indigo drill connection port on the connector panel (Figure 12-5) 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.

The IPC incorporates Indigo on-drill irrigation at pump 2. If you do not use drill irrigation, select None for pump 2. If you will use a suction irrigator, you must manually select it for pump 1 or pump 2.

Control operation of the Indigo drill with the IPC touchscreen and the multifunction footpedal.

Figure 12-4. Irrigation and Tubing Clip Assembly

Figure 12-5. IPC Indigo Connection Port

(1) (2)

1 Indigo Connection Port 2 Multifunction Footpedal Port

INDIGO DRILL TOUCHSCREEN CONTROLS

To set or adjust Indigo drill controls, on the IPC touchscreen, in the control box (Figure 12-6), do the following:

• To change rotation mode, in the Mode control box, select FWD (forward) or REV (reverse). Important: System conguration may be dierent from the default. If the REV (reverse) button appears raised and does not have a selectable radio button (Figure 12-7), you cannot select the reverse mode. If the REV button appears concave (Figure 12-7) and has a selectable radio button, you can select the reverse mode via the touchscreen or the multifunction footpedal.

• To adjust speed, in the Speed control box, press the plus button to increase speed or

the minus button to decrease speed.

Default, 60000 rpm; variable adjustment from 200 to 60000 rpm in increments of 200, 500 and then 1000 until 60000.

Note: The speed you set remains constant when you switch between modes. Warning: 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 (W 54).

• To adjust ow rate for optional on-drill irrigation, in the Irrigation control box, press the plus button to increase ow or the minus button to decrease ow. Default, 30cc per minute. Note: To adjust ow rate, you can use the touchscreen or the IntelliFlow Irrigation remote control.

• The system provides the option to select either intermittent or continuous ow of irrigation at 5, 10, 15 and 20 cc per minute ow rates. The system defaults to Intermittent. To modify intermittent or continuous ow for irrigation, in the Flow control box, select the appropriate option. Note: The Flow control box (Figure 12-8) is available only at 5, 10, 15 and 20 cc per minute.

Figure 12-6. Indigo Touchscreen

Indigo

Speed

60000

RPM

Irrigation

cc/min

Flow

Figure 12-7. Indigo Mode

Mode

FWD

REV

Figure 12-8. Indigo Flow

Prime

Intermittent

Continuous

Mode

FWD

REV

Mode

FWD

REV

12-2

Page 59

INDIGO DRILL 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 select forward or reverse mode, press the mode button.

• To start or adjust the speed of a handpiece in variable mode, press the foot pedal.

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

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

Figure 12-9. Multifunction Footpedal

(5)

(1)

(2)

(3)

INDIGO

(4)

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

4 Control Button 5 Handpiece Button

INDIGO DRILL CLEANING AND STERILIZATION INSTRUCTIONS

Refer to documents 68E4187 and 68E4188 in the Cleaning and Sterilization section.

INDIGO DRILL TECHNICAL SPECIFICATIONS

Indigo Drill 1845000

Size 11.9 cm length x 1.53 cm diameter

Weight 102 g

Speed 60000 rpm forward/reverse

Duty Cycle for Applied Part For continuous use in operating room temperatures up to 400C, the Indigo motor is rated for 3 minutes at

60000 rpm, followed by 25 minutes of rest. For normal operating room temperatures (typically 200C), the Indigo motor is rated for continuous cutting

indenitely at 60000 rpm.

12-3

Page 60

Page 61

MICROSAWS

(1)

MIDAS REX MICROSAWS

DEVICE DESCRIPTION

Use Midas Rex Microsaws to remove hard tissue and bone during surgical procedures. Operate the saws through the IPC using the multifunction footpedal to drive the motor. Use proprietary blades as well as single-use components for irrigation with the saws.

The IPC incorporates microsaws at pump 2. If you do not use irrigation, select None for pump 2. Control operation of the microsaws with the IPC touchscreen and the multifunction footpedal.

Figure 13-1. Microsaw Handpieces

(2)

(3)

(4)

1 Reciprocating Saw Collet 2 Sagittal Saw Blade Release

Button

3 Oscillating Saw Head 4 Oscillating Saw Collet 5 Color Band

(5)

BLADE AND RASP NOMENCLATURE

Important: You can only use reciprocating blades with the reciprocating saw. You can use sagittal and oscillating blades interchangeably.

Saw blade part numbers follow a standard naming convention.

1 Cut Depth Limit XX.X mm*

* Blade depth markings are approximate and should be used for reference only.

2 Saw Type S Sagittal / Oscillating

R Reciprocating 3 Cut Width / Length X.X mm 4 Blade Thickness X.X mm 5 Other Identiers F Fine PT Pointed Blade

ARC Rounded Blade ST Straight Rasp

BAY Bayoneted Blade CC Crosscut Rasp

1 2 0 S 9 7 - 0 3 F

(1) (2) (3) (4) (5)

RECIPROCATING MICROSAW ASSEMBLY

Important: Verify the color code on the blade package matches the color band on the handpiece (Figure 13-1).

1. On the reciprocating handpiece (red band), verify the collet is in the unlocked position (Figure 13-2).

2. Insert the reciprocating tool into the collet.

3. Rotate the collet knob 90 to the locked position.

4. To ensure a secure t, gently pull the blade.

SAGITTAL MICROSAW ASSEMBLY

Important: Verify the color code on the blade package matches the color band on the handpiece (Figure 13-1).

1. On the sagittal handpiece (yellow band), press the blade release button (Figure 13-3).

2. Insert the blade at the desired angle.

3. Release the blade release button.

4. To ensure a secure t, gently move the blade from side to side.

Figure 13-2. Reciprocating Saw Assembly

Figure 13-3. Sagittal Saw Assembly

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Page 62

MICROSAWS

OSCILLATING MICROSAW ASSEMBLY

Important: Verify the color code on the blade package matches the color band on the handpiece (Figure 13-1).

1. On the oscillating handpiece (blue band), verify the collet is in the unlocked position (Figure 13-4).

2. Insert the blade into the collet. The blade “clicks” into place. Note: You can insert the blade every 45 in a 360 circle in up to 8 locations (Figure 13-5).

3. Rotate the collet to the locked position (Figure 13-4).

4. To ensure a secure t, gently move the blade from side to side.

Figure 13-4. Oscillating Saw Assembly

Figure 13-5. Oscillating Pin Alignment

MICROSAW IRRIGATION AND TUBING CLIPS ASSEMBLY

Note: Saw irrigation is optional.

1. Snap the irrigation clip on to the attachment (Figure 13-6).

2. Disengage the front of the irrigation clip to adjust the irrigation length, as necessary.

3. Snap the tubing clip on to the handpiece.

Figure 13-6. Microsaw Irrigation and Tubing Clip Assembly

CONNECT MICROSAW HANDPIECE TO IPC

On the IPC Console, locate a 12 pin accessory connection port on the connector panel (Figure 13-7) 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 13-7. IPC Microsaws Connection Ports

(1) (2)

1 M icrosaws Connec tion 2 Footpedal Connection

MICROSAWS TOUCHSCREEN CONTROLS

Important: The IPC recognizes the connected saw then displays the appropriate name and color band ring.

To set or adjust saw controls, on the IPC touchscreen, in the saw control box (Figure 13-8), do the following:

• To adjust speed, in the Speed control box, press the plus button to increase maximum speed and minus button to decrease maximum speed. Variable adjustment ranges from 0% to 100%.

• To adjust ow rate for blade irrigation, in the Irrigation control box, press the plus button to increase ow rate or minus button to decrease ow rate. Default: 0cc per minute. Maximum ow rate is 50cc per minute. Note: To adjust ow rate, you can use the touchscreen or the IntelliFlow Irrigation remote control.

Figure 13-8. Microsaws Touchscreen

Sagittal Saw

Speed

100%

Irrigation

cc/min

13-2

Page 63

MICROSAWS

(2)

(4)

(5)

(1)

(3)

MICROSAW 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 touch screen

Settings screen to change the default value.

To use the multifunction footpedal (Figure 13-9) to control the handpiece do the following:

• To start or adjust the speed of a handpiece in variable mode, press the foot pedal.

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

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

Figure 13-9. Multifunction Footpedal

MICROSAWS CLEANING AND STERILIZATION INSTRUCTIONS

Refer to document M000030A231 in the Cleaning and Sterilization section.

MICROSAWS TECHNICAL SPECIFICATIONS

Microsaw Reciprocating ES200 Microsaw Sagittal ES300 Microsaw Oscillating ES100

Size Reciprocating: 2.3 cm W x 20.3 cm L

Sagittal: 2.3cm W x 17.3 cm L Oscillating: 2.3 cm W x 19.8 cm L

Weight Reciprocating: 300 g

Sagittal: 250 g Oscillating: 300 g

Speed Reciprocatting: 1400-14000 cpm

Sagittal: 2000-20000 cpm Oscillating: 1600-16000 cpm

Duty Cycle ≤ 20°C Ambient (one cut period = 20 seconds on / 20 seconds o) Reciprocating: ≤ 15 cut periods Oscillating: ≤ 4 cut periods Sagittal: ≤ 6 cut periods

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

4 Control Button 5 Handpiece Button

> 20°C Ambient (one cut period = 20 seconds on / 40 seconds o) Reciprocating: ≤ 5 cut periods Oscillating: ≤ 3 cut periods Sagittal: ≤ 6 cut periods

Time for cool down after maximum number of cut periods listed above: 25 minutes.

5 periods with Light Force (0.8 Lbf), 5 periods with Medium Force (2.1 Lbf ), 5 periods with Heavy Force (3.9 Lbf ) 2 periods with Light Force (0.8 Lbf), 2 periods with Medium Force (1.5 Lbf ), 2 periods with Heavy Force (3.0 Lbf ) 1 period with Light Force (0.7 Lbf), 2 periods with Medium Force (1.5 Lbf ), 1 period with Heavy Force (2.6 Lbf ) 1 period with Light Force (0.8 Lbf), 2 periods with Medium Force (2.1 Lbf ), 2 periods with Heavy Force (3.9 Lbf ) 2 periods with Light Force (0.8 Lbf), 2 periods with Medium Force (1.5 Lbf ), 2 periods with Heavy Force (3.0 Lbf ) 1 period with Light Force (0.7 Lbf), 1 period with Medium Force (1.5 Lbf ), 1 period with Heavy Force (2.6 Lbf )

13-3

Page 64

Page 65

POWEREASE

POWEREASE DRIVER

DEVICE DESCRIPTION

The IPC POWEREASE System is specically designed for drilling, tapping, and driving screws during spine surgery.

The IPC POWEREASE system consists of a POWEREASE Driver (Figure 14-1) that is powered by the IPC, along with the following POWEREASE driver compatible working end instruments:

• Taps

• Drill Bits

• Screw Drivers

• Rod Cutter

• Post Cutter

• Set Screw Break-o Instrument (SSBO)

The POWEREASE System and accessories are compatible with the following implant systems:

• CD HORIZON SOLERA Spinal System

• TSRH 3Dx Spinal System

ASSEMBLE THE IPC

Important: The manual start/stop button on the IPC console (Figure 1-2) does not function with

the POWEREASE driver. Note: The POWEREASE driver does not use the IPC pump system. The pumps are available for use with other accessories requiring irrigation or cooling.

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/collant bags on the IV pole.

Important: Mount the 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 POWEREASE connection port on the IPC connector panel (Figure 14-2) and

insert the connector from the POWEREASE driver.

6. If using the NIM-Eclipse with the IPC POWEREASE, assemble the IPC POWEREASE and the

NIM-Eclipse system.

7. Turn on the IPC and do the following:

• Verify the system passes the self-test.

• Verify the POWEREASE screen appears on the IPC monitor.

8. Conrm the IPC POWEREASE System Operation.

Figure 14-1. POWEREASE Driver

(1)

(2)

(3)

(4)

(5)

1 Quick Disconnec t Unlocked 2 Quick Disconnec t Locked 3 Mechanized Working Collar

Locking Pins (2)

4 Variable Speed Trigger

Figure 14-2. IPC POWEREASE Connection Ports

(1) (2) (3)

1 POWEREASE Connection 2 Stimulus I nput from NIM-

Eclipse

(8)

(7) (7)

(6)

5 Finger Sensor Trigger 6 NIM -Eclipse Cable Connector 7 M ode Select Switch 8 Flat Side Indicators

3 Stimulus Output to

POWEREASE

IPC POWEREASE MODE SELECT SWITCH

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

IPC POWEREASE SYSTEM OPERATION

1. On the POWEREASE driver, rotate the mode select switch (Figure 14-3) to F (forward).

2. On the IPC touchscreen, verify the following:

• The FWD Speed box is active and the default speed appears in white.

• The Trigger Status is Ready For Use.

Note: If the trigger status is Locked, release and press the trigger to disengage the lock. Contact Customer Service if the trigger status does not change to Ready For Use.

3. On the POWEREASE driver, touch the trigger (Figure 14-4) and verify the speed in the FWD

Speed box on the IPC touchscreen turns green.

4. On the POWEREASE driver, press the trigger and verify the following:

• The speed increases as you increase pressure on the trigger.

• The speed in the FWD Speed box on the IPC touchscreen turns yellow.

5. Remove nger from the POWEREASE driver trigger and verify the following:

• The driver rotation stops.

• The speed in the FWD Speed box on the IPC touchscreen turns white.

6. Repeat steps 1 through 5 for the reverse (R) and oscillate modes.

Figure 14-3. POWEREASE Mode Select Switch

Figure 14-4. IPC POWEREASE Touchscreen

14-1

Page 66

POWEREASE

POWEREASE TOUCHSCREEN CONTROLS

To adjust the maximum speed of the driver using the IPC POWEREASE touchscreen (Figure 14-4), in the relevent speed control box, press the plus button to increase maximum speed or minus button to decrease maximum speed.

• Variable speed control: FWD Speed: variable adjustment from 10 to 250 rpm in increments of 10 rpm. REV Speed: variable adjustment from 10 to 250 rpm in increments of 10 rpm. OSC Speed: variable adjustment from 10 to 200 rpm in increments of 10 rpm.

• IPC POWEREASE touchscreen color codes: White: active speed at idle, nger o trigger. Green: active speed at idle, nger on trigger. Yellow: active speed in use. Gray: inactive

• Trigger Status: Ready For Use: Device is ready for use. Locked: In the case of a trigger control anomaly, the trigger is locked until the anomaly has cleared and use of the POWEREASE may resume. To disengage the lock, release and press the trigger. Contact customer service if the device does not return to Ready For Use.

Figure 14-4. IPC POWEREASE Touchscreen

CLASSIC WORKING END ASSEMBLY AND OPERATION

NOTE: Please see the POWEREASE System Working Ends User’s Manual and IFU for a

complete listing of compatible working ends and further details regarding their proper use. Contact customer service or your sales representative for the most up-to-date version of the package insert or manual.

1. On the POWEREASE driver, pull back on and hold the quick disconnect to unlock the

collet (Figure 14-1, 1). Note: The quick disconnect must be held in the unlocked position when inserting or removing tools.

2. Insert the classic working end drive shaft (Figure 14-5, 1) into the collet until fully

seated. Fully seated is on or near the drive shaft shoulder (Figure 14-6). Note: If using a two sided shaft, align the at sides on the drive shaft with the marks on the collet (Figure 14-1, 8).

3. Release the quick disconnect to place the working end in the locked position (Figure

14-1, 2).

4. To set the mode on the POWEREASE driver, rotate the mode select switch (Figure 14-3)

to F (forward), R (reverse) or (oscillate)

• Place mode select switch in forward to drill, tap or insert screw.

• Place mode select switch in reverse to back out drill, back out tap or back out screw.

• Place mode select switch in oscillate to lock the tool in its current position. Refer to

POWEREASE Driver Electronic Ratcheting for additional information.

5. To adjust the speed of the driver, increase pressure to increase speed or decrease

pressure to decrease speed. NOTE: The IPC touchscreen displays the maximum speed for the selected mode.

6. Reverse procedure to remove the classic working end accessory.

Figure 14-5. Classic Working End

(1) (2) (3) (4)

1 Four sided drive shaft 2 Flat Side

3 Drive shaft shoulder 4 Shaft

Figure 14-6. Classic Working End Seating

POWEREASE Driver Electronic Ratcheting

Ratcheting is intended to permit manual motion in one direction only.

• FWD Mode: With the trigger released, the handpiece functions as a ratchet allowing the handpiece to be turned in a clockwise direction while ratcheting in a counter clockwise direction.

• REV Mode: With the trigger released, the handpiece functions as a ratchet allowing the handpiece to be turned in a counter clockwise direction while ratcheting in a clockwise direction.

• OSC Mode: With trigger released, the handpiece locks the tool in its current position, and the surgeon can manually rotate the handpiece in a clockwise or counter-clockwise direction.

POWEREASE Ratchet Test

1. Load a drill, tap or screwdriver in the collet. Refer to Classic Working End Assembly and Operation for details.

2. On the POWEREASE driver, set the mode select switch to F (forward, Figure 14-3).

3. Hold the POWEREASE driver shaft rmly and verify the following:

Important: DO NOT hold by the tool. DO NOT touch the trigger sensor.

• The driver ratchets when rotated counter clockwise.

• The driver does not ratchet when rotated clockwise.

4. Set the mode select switch to R (reverse) and verify the following:

• The driver ratchets when rotated clockwise.

• The driver does not ratchet when rotated counter clockwise.

5. Set the mode select switch to oscillate and verify the driver does not ratchet when rotated clockwise or counter clockwise.

14-2

Page 67

POWEREASE

MECHANIZED WORKING END ASSEMBLY AND OPERATION

NOTE: Please see the POWEREASE System Working Ends User’s Manual and IFU for a complete

listing of compatible working ends and further details regarding their proper use. Contact customer service or your sales representative for the most up-to-date version of the package insert or manual.

1. On the POWEREASE driver, pull back on and hold the quick disconnect (Figure 14-1, 1) to

unlock the collet. Note: The quick disconnect must be held in the unlocked position when inserting or removing tools.

2. Align the slots on the working end collar with the mechanized working collar locking pins

(Figure 14-7).

3. To set the mode on the POWEREASE driver, rotate the mode select switch (Figure 14-3) to F

(forward), R (reverse) or (oscillate).

• Place the mode select switch in forward to cut/shear implantable rods, cut vertical posts, break set screws.

• Place the mode select switch in reverse to open the tool.

• Oscillate is intended as a rotational lock for classic working ends and has no function

with mechanized working ends. However, if the trigger is pulled, the tool shaft will oscillate 60° clockwise and counter-clockwise.

4. To adjust the speed of the driver, increase pressure to increase speed or decrease pressure to decrease speed. NOTE: The IPC touchscreen displays the maximum speed for the selected mode.

5. Reverse this procedure to remove the classic working end accessory.

Figure 14-7. Mechanical Working End Seating

POWEREASE CLEANING AND STERILIZATION INSTRUCTIONS

Refer to document 68E4189 in the Cleaning and Sterilization section.

POWEREASE DRIVER TECHNICAL SPECIFICATIONS

POWEREASE Driver 234000

Size 175mm x 160mm x 42mm

Weight 900g (1200g including cable)

Speed 0 to 250 rpm (variable)

Torque 7Nm

Cable Length (Driver) 4.5m

Cable Length (IPC to Patient

Interface Box)

Cable Length (Driver to IPC) 4.5m

Duty Cycle for Applied Part For continuous operating room temperatures up to 33C, the POWEREASE driver rates for continuous operation.

4.5m

For normal operating room temperatures (below 25C), the POWEREASE driver rates for continuous operation.

IPC POWEREASE WITH THE NIMECLIPSE SYSTEM

Important: Do not use the IPC POWEREASE - NIM-Eclipse System with multiple portable socket-outlet or extension cord.

The POWEREASE System is equipped with two cables that connect the IPC to the NIM-Eclipse. Wires within the POWEREASE make contact with the uncoated tool and carry stimulating current to the tool’s tip for nerve monitoring. Contact to your local NIM-Eclipse representative for more information.

Important: Only taps, screws and drills are available for nerve stimulation. When the IPC POWEREASE driver is used in combination with the NIM-Eclipse, the combination creates a medical electrical system. The system

components are as follows:

• IPC

• POWEREASE with accessories

• NIM-Eclipse

• NIM cable set

14-3

Page 68

POWEREASE

Assemble IPC POWEREASE and NIM-Eclipse System

Important: Refer to the NIM-Eclipse Users Guide for set up and use of the NIM-Eclipse system, including the laptop computer. Warnings:

• Only the POWEREASE handpiece with its accessories are intended to be used within the patient environment. The NIM-Eclipse cannot be used in the patient vicinity (1.5 meter radius from patient).

• Do not touch the patient and the enclosure parts of the NIM-Eclipse simultaneously.

• Dispose of the single-use NIM cables after each procedure.

• Any peripheral devices connected to the system must meet IEC60601-1 requirements. Consult with your biomedical engineering department

to determine if the external devices meet this requirement.

1. Assemble the IPC and conrm IPC POWEREASE system operation.

2. Assemble the NIM-Eclipse according to the instructions in the NIM-Eclipse Users Guide. Verify the laptop computer power cord is plugged

into the NIM-Eclipse 945ECLC Controller.

3. On the NIM-Eclipse stimulator extender, connect one end of the black NIM cable to the Stimulus Output connection port (Figure 14-8).

4. On the IPC connector panel, connect the other end of the black NIM cable to the Stimulus Input connection port (Figure 14-8).

Important: Route the wire so that it does not interfere with operating room personnel.

5. Connect one end of the blue NIM cable to the Stimulus Output IPC connector panel (Figure 14-8).

6. Connect the other end of the blue NIM cable to the NIM Stim Input on the POWEREASE driver.

Important: Route the wire so that it does not interfere with operating room personnel.

Figure 14-8. POWEREASE, IPC, NIM-Eclipse Connection

Main Powerease Cable

Preamplifier Module

POWEREASE™

NIM Cable 2 (blue)

Mouse

Notebook

Power Supply

INTEGRATED POWER

C O N S O L E

EHS

BUR

NIM

USB Interface Cable

IPC

NIM Cable (black)

Stimulator Extender

14-4

NIM-ECLIPSE® System

68L2120 A

Controller

NIM-Eclipse

NIM-ECLIPSE® System

68L2125 A

Page 69

INTEGRATED POWER CONSOLE (IPC) TROUBLESHOOTING AND ERROR CODES

TROUBLESHOOTING

For any troubleshooting items not corrected by the actions below, contact Customer Service.

IPC and Multifunction Footpedal

Issue Possible Cause Action

Pump(s) does not run. Failed internal components. Contact Customer Service

Moisture in cable conicts with handpiece recognition.

Little or no irrigation ow. Tubing Set improperly seated in pump. Reposition tubing in pump, verify pump lid is fully

Tubing is pinched or kinked. Check tubing at side of pump, see Irrigation/

Tubing clamps are restricting ow. Set tubing clamps in “open” position.

Irrigation ow rate setting low. Adjust irrigation ow rate.

Irrigator obstructed. Replace irrigator.

Pump stall error. Tubing set imporerly placed in pump. Reposition tubing in pump, verify pump lid is fully

Tubing is pinched or kinked. Check tubing is not pinched or kinked on side of

Console default parameters incorrect. Moisture in cable conicts with handpiece

Handpiece connected but console reads “Connect Handpiece”

Handpiece connected but console displays incorrect handpiece.

Console does not power up. Power cord not properly connected. Connect power cord.

Power switch light is on but Touchscreen does not come on.

Console does not power down. Power switch failure. Unplug power cord, Contact Customer Service.

Touchscreen does not respond. Screen gasket displaced or failed internal

Touchscreen does not work properly. Touchscreen not calibrated. Calibrate Touchscreen.

Console displays wrong handpiece / motor type. Console misidentied the handpiece / motor. Disconnect and reconnect the motor cable.

recognition.

No power. Check power available (i.e. power strip is on, circuit

Power Inlet Fuses blown. Replace fuses with 5.00 A, 250V, time delayed fuses

Failed internal components. Contact Customer Service.

components.

Run a dry cycle when sterilizing.

closed with the uid ow from left to right.

Coolant Pumps

Check remaining tubing for pinched or kinked areas, if necessary replace tubing.

closed with the uid ow from left to right.

pump (see section on “Irrigation/Coolant Pumps”).

Run a dry cycle when sterilizing.

breaker is closed etc.)

(P/N 11270066 Fuse Kit 1898125 )

Contact Customer Service.

Turn console o then on.

Change motor, motor cable, or console to isolate the problem.

Moisture in cable conicts with handpiece recognition.

Foot control unit buttons or pedal does not respond.

Handpiece fails to rotate Failed footswitch. Disconnect footswitch, use manual start/stop

Incorrect use. Press and hold buttons for at least 1 second, wait

Top button does not respond. One (1) handpiece connected (top button has no

Connector not fully inserted. Disconnect and reconnect the FCU cable

Internal component failure. Contact Customer Service.

Failed handpiece motor or motor driver. Contact Customer Service.

Run a dry cycle when sterilizing.

for console conrmation beep.

function with 1 handpiece connected).

connector.

Try dierent FCU or console to isolate the problem.

rocker switch on rear of console.

A-1

Page 70

INTEGRATED POWER CONSOLE (IPC) TROUBLESHOOTING AND ERROR CODES

XOMED Blades or Burs

Issue Possible Cause Action

Appears to be damaged or defective. Damaged or defective. Remove and replace.

Tool vibrates excessively, abnormal noise movement.

No suction. Blade opening is obstructed. Use stylet to clear blade.

Tool is leaking irrigant. Tool not seated correctly in collet. Check for proper tool insertion by pulling back

Tool wobbles in handpiece. Tool wobbles in handpiece. Reduce handpiece operating speeds.

Tool is not rmly seated. Microdebriders, pull back locking collet and re-seat

the tool.

Visao, unlock collar, check/re-seat notch, lock collar.

Remove blade from surgical site and submerse the blade tip in sterile water with suction connected to the handpiece to evacuate the obstruction.

Tubing obstructed. Remove and inspect suction tubing, and if

obstructed, remove obstruction, reconnect tubing.

locking collet, and re-seating tool.

Low or no suction. See Possible Cause, No Suction.

Use tools that are rated for the console speed selected.

If necessary, use bur guard with burs medium, long and X-long.

Operate handpiece at 50% of full speed for medium, long and X-long burs.

Select a new tool.

Legend EHS, Legend EHS Stylus and Indigo Motors

Issue Possible Cause Action

Motor is too hot to touch/hold Inadequate cool down period following

sterilization.

Attachment transferring heat to the motor. Switch attachments to determine whether the heat

Heavy side loading during dissection. Discontinue use and rest the motor by using it

Inadequate irrigation. Ensure adequate irrigation to surgical site during

Tool is dicult to remove from attachment Aging of attachment Contact Customer Service.

Use of reprocessed tools

Use of an unauthorized refurbisher

Improper cleaning Clean the attachment thoroughly according to the

Attachment will not seat properly on the motor Motor collet ats are not aligned. Use the Legend motor wrench to rotate the at

Motor does not run. Cables not properly connected. Ensure motor and foot control cables are properly

Speed setting is too low. Ensure that a speed greater than 10000 rpm (EHS)

Attachment not properly installed and locked onto the motor.

Internal failure of motor and/or console. Change motor or console to isolate the problem.

Foot control not properly functioning. Check for obstruction under the foot pedal.

Cables damaged Check cables for cracks, splits, or bent connector

Motor must be allowed to cool down following steam sterilization.

is being generated by the motor or the attachment.

intermittently or wrap the motor with a moist sterile towel.

bone dissection.

instructions in this manual.

Change tool.

closest to the motor case until its marker is aligned with the marker on the at farthest away from the motor case.

connected.

or 3000 rpm (Stylus) is selected.

Remove and reinstall the attachment and dissecting tool to ensure proper installation.

pins.

A-2

Page 71

INTEGRATED POWER CONSOLE (IPC) TROUBLESHOOTING AND ERROR CODES

Issue Possible Cause Action

Motor with attachment rotates, but an abnormal noise is heard.

Bearings are worn. Change the attachment to isolate the location of

the problem.

Poor electrical connection Check all connections from electrical source to

console.

Ensure motor and foot control cables are properly connected.

Internal failure of motor, console, or cable. Change motor, console, or cable to isolate the

failing component.

Attachment not properly installed. Remove and reinstall the attachment and

dissecting tool.

Stylus Touch Motors

Issue Possible Cause Action

Motor does not run. Finger switch not reaching maximum speed. Check that the control lever ring is properly seated

Finger switch not responding. Safety switch in safe mode.

Finger control damaged. Contact Customer Service.

in one of the four possible positions.

Place switch in run mode.

Legend EHS, Legend EHS Stylus and Stylus Touch Attachments and Telescoping Tubes

Issue Possible Cause Action

Attachment or Telescoping Tube has uncomfortable temperature to touch/hold

Attachment/telescoping tube is bent, loose, damaged or missing a component

Color band on Attachment/Telescoping Tube fades or discolors

Attachment has excess lubrication Over lubrication during cleaning process Visually inspect and wipe excess lubrication.

Footed attachment has a component missing from leg/foot area or foot is bent

16-MF contra-angle attachment is overheating The contra-angle attachment operates by a set of

Smoke is generated by the attachment or motor Attachment is not in the locked position. Make sure the attachment is in the locked position.

Heat from worn attachment/tube bearings

Attachment/tube unclean due to improper cleaning procedures

Heavy side loading during dissection Discontinue use and rest the attachment by using

Attachment mishandled, failed due to extended use or excessive force applied during use

Incorrect cleaning or sterilization method Use nomenclature markings on the attachment

Use of chlorine based or corrosive agents

Aging Telescoping Tubes are multi-use disposable.

Attachment damaged by dissecting tool drilling out part or all of leg/foot area.

Bend caused by incorrect use.

internal gears to engage the drive shaft. It is normal for some heat to be generated approximately 2 cm from the distal end of the attachment and at the right of the angle head.

DO NOT use. Try another attachment/tube.

Telescoping Tubes are multi-use disposable. If problem is resolved with a new Telescoping Tube, discard the over-heated tube.

Check that appropriate cleaning procedures are being followed.

intermittently, try another identical attachment or wrap the attachment interface with a moist sterile towel.

DO NOT use. Dispose of telescoping tube. Telescoping Tubes are multi-use disposable. Contact Customer Service.

to match with a corresponding dissecting tool or Contact Customer Service.

DO NOT use. Contact Customer Service.

If heat continues or is excessive, Contact Customer Service.

A-3

Page 72

INTEGRATED POWER CONSOLE (IPC) TROUBLESHOOTING AND ERROR CODES

Legend EHS, Legend EHS Stylus and Stylus Touch Tools

Issue Possible Cause Action

Tool wobbles A non-Legend tool is being used. Replace with a Legend tool.

Worn attachment or tube bearings. Try another attachment or tube to isolate the

Attachment/tube and tool are not compatible. Match color code on the tool packaging to the

Motor is damaged. Contact Customer Service.

Tool’s size and geometry may contribute to wobbling at certain speeds.

Tool vibrates excessively Tool’s size and geometry may create excessive

Tool dull Extended use Change to a new tool

Tool will not seat properly in the motor or attachment collet

vibration at certain speeds.

Reprocessed tool was used

Incorrect geometry Contact Customer Service.

Debris in collet of attachment or motor. Clean the attachment or motor thoroughly

A non-Legend tool is being used. Replace with a Legend tool.

location of the problem.

If the attachment is failing, Contact Customer Service

If the tube is failing, dispose of it and use a new tube.

color code on the attachment/tube.

Adjust the speed by changing the pressure setting or foot/nger control. Do not use if wobbling persists. Change tool.

Adjust the speed.

Change tools.

according to the instructions in this manual.

If cleaning does not correct the problem, Contact Customer Service.

A-4

Page 73

INTEGRATED POWER CONSOLE (IPC) TROUBLESHOOTING AND ERROR CODES

ERROR CODES

Code # Title Cause Description

1 MCB does not report that it booted within 5 seconds of AI telling it to start and

subsequent reattempts fail.

2 NOT USED NOT USED NOT USED

3 UI-MCB Com Failure - Max resends exceeded System Error Power o. Wait 10 seconds. Power on. If error persists,

4 UI-MCB Com Failure - Get answer failed

5 UI-MCB Com Failure - No status message received

6 UI-MCB Com Failure - Serilization ID error

7 UI-MCB Com Failure - Timeout exception

8 UI-MCB Com Failure - Variable not recognized

9 Pump 1 stalled (no transitions on opto sensor) Pump #1 stalled Check tubing connection.

10 Pump 2 stalled (no transitions on opto sensor) Pump #2 stalled Check tubing connection.

11 Unrecognized/damaged handpiece plugged in on port 1 (rst 12 pin) Handpiece Unplug handpiece and plug back in. If error persists,

12 Unrecognized/damaged handpiece plugged in on port 2 (second 12 pin)

13 Unrecognized/damaged handpiece plugged in on port 3 (4 pin)

14 Unrecognized/damaged handpiece plugged in on port 4 (Skeeter)

15 Handpiece stalled Handpiece stalled Check accessory

16 MCB motor overcurrent detected. Motor overcurrent Unplug handpiece and plug back in. If error persists,

17 Unrecognized/damaged multifunction footpedal plugged in Footpedal

18 Damaged handpiece or nger lever base out of position. Finger Control error Stylus Touch - A nger control error has been detected.

System Error Power o. Wait 10 seconds. Power on. If error persists,

Connection error

call Customer Service.

replace handpiece.

Unplug footpedal and plug back in. If error persists, replace footpedal or switch to manual control.

Check that the control lever ring is properly seated in one of the four possible positions. If error persists contact Medtronic support. Press OK to use alternate control method. Triton/Powerease - Please check mode select switch to ensure a mode has been selected by rotating mechanism until it rests in a detent. If error persists contact Medtronic support.

19 UI self test failure - culture (language) registry entry Self Test Failed Power o. Wait 10 seconds. Power on. If error persists,

20 UI self test failure - sector conguration registry entry

21 UI self test failure - corrupt usage data le or unable to create usage data le

22 NOT USED NOT USED NOT USED

23 MCB non-specic self test failure Self Test Failed Power o. Wait 10 seconds. Power on. If error persists,

24 MCB self test failure - port 1

25 MCB self test failure - port 2

26 MCB self test failure - port 3

27 MCB self test failure - port 4

28 MCB self test failure - bridge transitor 1 shorted

29 MCB self test failure - bridge transitor 2 shorted

30 MCB self test failure - bridge transitor 3 shorted

31 MCB self test failure - bridge transitor 4 shorted

32 MCB self test failure - bridge transitor 5 shorted

33 MCB self test failure - bridge transitor 6 shorted

34 MCB self test failure - A/D converter

35 MCB self test failure - motor error

36 MCB self test failure - 3.3 volt supply

37 MCB self test failure - 12 volt supply

38 MCB self test failure - 48 volt supply

39 MCB self test failure - FCU port

call Customer Service.

A-5

Page 74

Page 75

CLEANING AND STERILIZATION

Reprocessing Instructions are subject to change without notice. Refer to manuals.medtronic.com for current reprocessing instructions.

CLEANING AND STERILIZATION FOR UNITED KINGDOM & EUROPE

Reference: U.K. Health Technical Memorandum 2030 Washers-disinfectors U.K. Health Technical Memorandum 2010 Sterilization

EQUIPMENT: MPS/POWERFORMA Drill Handpieces; Visao; Xcalibur Drill Handpieces, Handpiece Attachments, Motor Assembly, Irrigation Sleeve and Extended Bur Guards; Straightshot , Straightshot Magnum, and Straightshot M4 Drill Handpieces; Skeeter Otologic Drill Handpiece.

ACCESSORIES: POWERFORMA/MICRO-CRAFT, HELIX or Skeeter Oto-Flex Reusable Drill Burs, Bur Racks, Handpiece Cable Clips and Sterilization Trays.

The following guidelines have been validated for eective cleaning and sterilization with the listed surgical equipment and accessories referenced above. These guidelines serve as an addendum to the sterilization and re-use instructions originally provided with the particular device and are intended to provide compliance to HTM 2030 and HTM 2010 cleaning and sterilization recommendations set in the United Kingdom.

CLEANING: (Do NOT use ultrasonic washer)

1. Treat all devices presented for cleaning, disinfection, and sterilization as contaminated with infectious material.

2. Remove instruments and equipment from any sterilization trays before placing into washer baskets.

3. For drill handpiece cleaning, cover handpiece cable connector end with Handpiece Cable Cap, Small, catalog no. 3318510 or Handpiece

Cable Cap, Large, catalog no. 3318515. (Note: Use 3318515 for Straightshot M4, Visao, and Xcalibur Hi-Speed with angled cable. Use 3318510 for other handpieces.) (Note: the Skeeter Handpiece does not require a Handpiece Cable Cap during cleaning).

4. Orient devices in washer baskets or racks following recommendations of washer/disinfector manufacturers.

5. Use low foaming, alkaline or neutral pH, detergent recommended by washer/disinfector or detergent manufacturers.

6. These products have been validated for eective cleaning using automatic washers/disinfectors.

STERILIZATION:

1. After completion of the cleaning steps, remove Handpiece Cable Cap or other protective components installed prior to cleaning.

2. Return instruments and equipment to appropriate sterilization trays.

3. Sterilize using the following Porous Load Cycle for Autoclave conforming to local practices within the limits set below:

Porous Load Cycle Cycle: Porous Load (Pre-vacuum) Temperature: 134°C to 137°C Time: 3.5 minutes Drying: 3 minutes minimum vacuum drying

B-1

Page 76

Reprocessing Instructions

Triton Electric High-Torque Handpiece

Reprocessing Instructions (Per ISO17664)

Cleaning and Sterilization instructions are subject to change without notice. Up to date instructions are available online at manuals.medtronic.com.

M000030A322 A

Warnings and Precautions

Limitations Verify func tionality prior to re-use.

Point of Use Follow hospital procedures.

Containment and Transportation

Preparation for Decontaimination

Cleaning: Automated (Do NOT use ultrasonic washer)

Cleaning: Manual Handpiece and Attachments

Disinfection Follow hospital procedures.

Packaging For sterilization, place devices in instrument tray. Devices may be unwrapped, or wrapped with up to two layers of 1-ply polypropylene wrap

Sterilization (Temperatures are minimum required, times are minimum required)

Maintenance, Inspection and Testing

Storage Store in a clean, dry area.

Additional Information None

Note: The instructions provided above have been validated by the manufac turer as being CAPABLE of preparing the product for re-use. It remains the responsibility of the processor to ensure that the reprocessing is

actually performed using equipment, materials and personnel in the reprocessing facility to achieve the desired result. This normally requires validation and routine monitoring of the process.

Note: All validations performed per current AAMI TIR12, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers.

Medtronic recommends incineration of devices that have directly contacted patients suspected or conrmed with Transmissible Spongiform Encephalopathy (TSE)/ CJD diagnosis. NHS Estates HTM 2010 Parts 4 & 6: Appendix 2, Items contaminated with TSE Agents and WHO I nfec tion Control Guidelines for Transmissible Spongiform Encephalopathies refers to a TSE decontamination cycle using a steam autoclave at a temperature of 134-137°C for a single cycle of 18 minutes or repeated for a total of six 3-minute cycles.

• Do not soak/submerge devices.

• Do not use ultrasound to clean Midas Rex Microsaw devices.

• Do not use chlorine based or corrosive cleaning agents such as bleach, lye, acetone, sodium hydroxide, formic acid, or solutions containing glutaraldehyde.

• Allow an adequate cooling period after steam sterilization.

• The use of a washer-disinfector for cleaning may cause a pre-mature degradation in peformanace.

It is recommended that devices are reprocessed as soon as is practical following use.

Follow hospital procedures.

Handpiece and Attachments

• Prior to placing devices in the automated washer, manually rinse under tap water, until no visible soil is noticed.

• Move any movable parts back and forth to allow water to reach hard-to-rinse areas.

• Transfer the devices into the washer for processing. Place the devices in the washer to facilitate drainage.

• Verify that devices are visually clean after automated cleaning.

Recommended Washer Cycle Phase Recirculation Time Water Temperature Detergent Type and Concentration

Pre-Wash 2 minutes Cold tap water not applicable

Wash 5 minutes 66C Neutral enz ymatic detergent, pH 6.0-8.0

Rinse 1 minute Hot tap waterC not applicable

1. Rinse the entire device, including cable, thoroughly under running water.

2. Wipe all external surfaces of the device and cable with a cloth dampened with a neutral enzymatic detergent pH 6.0-8.0 (henceforth referred to as “cleaning solution”).

3. Scrub the device thoroughly with a soft bristled brush that has been dampened with the cleaning solution, paying close attention to rough surfaces, crevices, and dicult to reach areas. Move any moveable parts, to allow the solution to reach all areas.

4. Clean central cannulation shaft of the handpiece with a cleaning brush (P/N 120-028-1 or equivalent) dampened with the cleaning solution.

5. Insert the cleaning brush into the cannulation from the front and make at least 6 passes with the brush. If residual soil is seen on the cleaning brush in between strokes, rinse it o in the cleaning solution.

6. Repeat the step above from the back side of the handpiece.

7. Flush approximately 30 mL of cleaning solution from a syringe into the central cannulation shaft.

8. Flush approximately 30 mL of cleaning solution from a syringe into the trigger and Forward / Reverse switch, while moving moveable parts.

9. Repeat the ushing in steps 7 and 8, using water instead of cleaning solution.

10. Rinse the entire device under running water. Move any moveable parts, to allow the water to reach all areas. Also, allow water to thoroughly clean the central cannulation shaft. Rinse until there is no visible evidence of soil or debris.

11. Dry the entire device with a towel.

Sagittal and Reciprocating Saw Attachments

1. Rinse the entire device thoroughly under running water.

2. Wipe all external surfaces of the device with a cloth dampened with a neutral enzymatic detergent pH 6.0-8.0 (henceforth referred to as “cleaning solution”).

3. Scrub the device thoroughly with a soft bristled brush that has been dampened with the cleaning solution, paying close attention to rough surfaces, crevices, and dicult to reach. Ensure to brush the blade opening, the gaps/details between and around the blade jaws.

4. Dip the distal end of the saw body (up to approximately 1.25” from the distal end) into cleaning solution and agitate it for 10-15 seconds.

5. Flush approximately 30 mL of cleaning solution from a syringe into the blade opening and the gaps and details between and around two jaws. Repeat the ushing using water, instead of cleaning solution.

6. Repeat the previous step one more time.

7. Rinse the device under running water. Allow water to thoroughly rinse the gaps and details between and around blade jaws. Rinse until there is no visible evidence of soil or debris.

8. Dry the device with a towel.

Steam Sterilization

Cycle Gravity Pre -Vac Pre-Vac (FR/WHO) Pre-Vac (UK)

Temperature 132C 132C 134C 134C

Time 25 minutes 4 minutes 18 minutes 3 minutes

Drying 30 minutes 20 minutes 30 minutes 22 minutes

STERRAD Do not use low temperature hydrogen peroxide gas plasma sterilization due to lumen internal diameter and length restrictions.

STERIS Not applicable.

100% EtO Sterilization Parameters

Preconditioning 51-59°C, 70 ±5% relative humidity, 30 min.

Sterilization Temperature 51-59°C

Relative Humidity 70 +/- 5%

Ethylene oxide concentration 725 +/- 25 mg/L

Gas exposure time (full-cycle) 4 hours

Aeration 51-59°C, 18 hours

• Inspect devices for any damage before and after each use. If damage is observed, do not use the device until it is repaired.

• Verify functionality prior to re-use.

Page 77

Reprocessing Instructions (Per ISO17664)

Cleaning and Sterilization instructions are

Reprocessing Instructions

Endo-Scrub 2 Fingerswitch

Warnings and Precautions

Limitations After cleaning and sterilization, verify functionality prior to re-use.

Point of Use • This product is provided non-sterile and must be cleaned and sterilized before the rst use and any reuse.

Containment and Transportation

Preparation for Decontaimination

Cleaning: Automated (Do NOT use ultrasonic washer)

Cleaning: Manual • Dip the nger switch housing in a diluted mixture of mild (pH 7.0 - 8.5) enzymatic detergent. (Follow detergent manufacturer’s instructions for proper

Disinfection Do not cold soak in glutaraldehyde, chlorine, or ammonium solutions, or dry heat sterilize, as damage to the instrument nish may occur.

Packaging • A standard, sterilization wrap may be used. In the US, an FDA approved surgical wrap must be used. Ensure that the pack is large enough to contain the

Sterilization (Temperatures are minimum required, times are minimum required)

Maintenance, Inspection and Testing

Storage Store in a clean, dry area.

Additional Information

Note: The instructions provided above have been validated by the manufacturer as being CAPABLE of preparing the product for re-use. It remains the responsibility of the processor to

ensure that the reprocessing is actually performed using equipment, materials and personnel in the reprocessing facility to achieve the desired result. This normally requires validation and routine monitoring of the process.

Note: All validations performed per current AAMI TIR12, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers.

Medtronic recommends incineration of devices that have directly contacted patients suspected or conrmed with Transmissible Spongiform Encephalopathy (TSE)/ CJD diagnosis. NHS Estates HTM 2010 Parts 4 & 6: Appendix 2, Items contaminated with TSE Agents and WHO Infection Control Guidelines for Transmissible Spongiform Encephalopathies refers to a TSE decontamination cycle using a steam autoclave at a temperature of 134-137°C for a single cycle of 18 minutes or repeated for a total of six 3-minute cycles.

Disconnect the nger switch from the Endo-Scrub 2 pump before cleaning.

• After use, remove the nger switch from the sheath and dissconect the plug from the pump.

• Thoroughly rinse with water following use.

It is recommended that devices are reprocessed as soon as is practical following use.

Promptly and thoroughly rinse with deionized water after each use.

Not validated

dilution.)

• Thoroughly clean the housing with a soft instrument brush to remove any blood and tissue.

• Rinse the housing thoroughly with tap water and wipe dry.

• Note: If wiping the cord dry, be sure to hold the cord and not the housing to avoid stressing or breaking the electrical connections located inside the

housing.

instrument without stressing the seals.

• In sets: Instruments may be loaded into dedicated instruments trays or general purpose sterilization trays. Ensure that cutting edges are protected. Wrap trays using appropriate method.

• Check the cleanliness and operation of the instrument. Clean again if debris is present and remove from use any damaged instrument. Close instruments with catches and racks on the rst notch. Arrange the instruments in sterilization containers with perforations on the top and bottom, and on supports such as those used in microsurgery. Follow the appropriate cycle listed in the table below.

• The sterilization parameters given below should be used for devices that are fully disassembled when disassembly is possible. Use basic aseptic technique during post-sterilization assembly to maintain the sterility of the instruments.

• All steam cycles have been validated in the wrapped conguration and can be sterilized wrapped or unwrapped. These devices have only been validated for steam sterilization methods.

Steam Sterilization

Cycle Gravity Pr e-Vac Pre-Vac (FR/WHO) Pre-vac (UK)

Temperature 132C 132C 132C 134C

Time 10 minutes 10 minutes 4 minutes 3 minutes

Drying 15-30 minutes, or until visibly dry.

STERRAD Not validated.

100% EtO Sterilization Parameters Not validated.

• Inspect nger switch for any damage before and after each use. If damage is observed do not use the nger switch until it is repaired or replaced.

• After cleaning and sterilization, verify functionality prior to re-use.

None

subject to change without notice. Up to date instructions are available online at manuals. medtronic.com.

68E4005 B

Page 78

Reprocessing Instructions

Microdebriders

Spine Shaver, StraightShot M4, StraightShot Magnum II or StraightShot III

Warnings and Precautions

Limitations After cleaning and sterilization, verify functionality prior to re-use.

Point of Use • This product is provided non-sterile and must be cleaned and sterilized before the rst use and any reuse.

Containment and Transportation

Preparation for Decontaimination

Cleaning: Automated (Do NOT use ultrasonic washer)

Cleaning: Manual • Do not immerse the handpiece.

Disinfection Do not cold soak in gluteraldehyde.

Packaging • A standard, sterilization wrap may be used. In the US, an FDA approved surgical wrap must be used. Ensure that the pack is large enough to contain the

Sterilization (Temperatures are minimum required, times are minimum required)

Maintenance, Inspection and Testing

Storage It is extremely important that the handpiece be rapidly and completely vacuum dried before storage to prevent corrosion and residue deposits in the bearing

Additional Information

Note: The instructions provided above have been validated by the manufacturer as being CAPABLE of preparing the product for re-use. It remains the responsibility of the processor to

Note: All validations performed per current AAMI TIR12, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers.

• Disconnect the power before cleaning.

• Do not fully immerse, or ultrasonically clean, this instrument.

• Do not cold soak sterilize this instrument in glutaraldehyde. This will void the warranty.

• Do not use organic solvents to clean the bur chuck.

• For drill handpiece cleaning, cover handpiece cable connector end with Handpiece Cable Cap, Small, catalog no. 3318510 or Handpiece Cleaning Cap,

Universal, catalog no. 3318520. (Note: Use 3318520 for Straightshot M4, Visao, and Xcalibur Hi-Speed with angled cable. Use 3318510 for other handpieces.)

• After completion of the cleaning steps, remove Handpiece Cable Cap or other protective components installed prior to cleaning.

• To remove occasional residual buildup on handpiece cable connector, use a soft brush and isopropyl alcohol.

It is recommended that instruments are reprocessed as soon as is practical following use.

Remove the bur from the handpiece, otherwise disassembly is not required.

• Remove instruments and equipment from any sterilization trays before placing into washer baskets.

• Orient devices following recommendations of washer/disinfector manufacturers.

• Use alkaline or neutral pH detergent recommended by washer/disinfector or detergent manufacturers.

• These products have been validated for eective cleaning using an automatic washer/disinfector cycle consisting of a minimum 44 minutes total time,

including a pre-wash, main wash & rinse, and thermal rinse. The thermal rinse shall be at least 10 minutes long at a minimum temperature of 60°C.

• Wipe the handpiece and cable with disinfectant applied to a clean, non-abrasive cloth.

• Gently clean the handpiece with a moistened soft bristle brush or pipe cleaner, making sure to clean all passages. Use an enzymatic detergent solution to

loosen and remove collected tissues from the unit.

• Hold the handpiece with the front end pointed downward during rinsing.* * Additional Cleaning Instructions for XPS Straightshot M4/Spine Shaver Microdebrider:

• During the normal cleaning cycle, run a gentle stream of warm water into the collet (front end), and into the lock lever of the Straightshot M4/Spine Shaver handpiece.

• While warm water is running into the collet, rotate the mechanism for several revolutions (rotate the wheel); and while water is running into the lock lever, actuate the lock lever several times (locking and unlocking).

• Shake excess water from the handpiece.

• PRECAUTION: Ensure the use of a very gentle stream of warm clean water during this additional cleaning step.

• Dry the handpiece and cable with a lint-free towel. Make sure to dry o the electrical connection on the cable ends.

• Apply a small amount of silicone spray into the front-end collet and outside of the handpiece.

• Sterilize the handpiece immediately after cleaning.

instrument without stressing the seals.

• In sets: Instruments may be loaded into dedicated instrument trays or general purpose sterilization trays. Wrap trays using appropriate method.

The sterilization parameters given below should be used for devices that are fully disassembled when disassembly is possible. Use basic aseptic technique during post-sterilization assembly to maintain the sterility of the instrument(s). All steam sterilization cycles have been validated in the wrapped conguration and instruments can be sterilized wrapped or unwrapped.

Steam Sterilization

Cycle Gravity Pre -Vac Pre-Vac (FR/WHO) Pre-vac (UK)

Temperature 121C 132C 134C 134C

Time 40 minutes 4 minutes 18 minutes 3 minutes

Drying 8 minutes, or until visibly dry

STERRAD 100S Compatible

100% EtO Sterilization Parameters

Preconditioning 54±2°C, 60±5% relative humidity, 30 minutes

Sterilization Temperature 54-55C

Relative Humidity 60 +/- 5%

Ethylene oxide concentration 600 +/- 25 mg/L

Gas exposure time (full-cycle) 120 minutes

Aeration 48-52C, 8 hours

• Inspect components for any damage before and after each use. If damage is observed do not use the instrument until it is repaired.

• After cleaning and sterilization, verify functionality prior to re-use.

and motor.

Increase temperatures higher than those stated when necessary to satisfy governmental or health care facility requirements so long as the temperature does not exceed 149° C. Heating above 149° C may damage the handpiece and will void the warranty.

Reprocessing Instructions (Per ISO17664)

Cleaning and Sterilization instructions are subject to change without notice. Up to date instructions are available online at manuals.medtronic.com.

68E3282 C

Page 79

Reprocessing Instructions

Legend EHS and Legend EHS Stylus

Reprocessing Instructions (Per ISO17664)

Cleaning and Sterilization instructions are subject to change without notice. Up to date instructions are available online at manuals.medtronic.com.

M000030A234 A

Warnings and Precautions

Limitations Verify functionality prior to re-use.

Point of Use Follow hospital procedures.

Containment and Transportation

Preparation for Decontaimination

Cleaning: Automated (Do NOT use ultrasonic washer)

Cleaning: Manual • Wipe all external surfaces of the motor and cable with a cloth dampened with a neutral enzymatic detergent, pH 6.0-8.0.

Disinfection Follow hospital procedures.

Packaging For sterilization, place devices in instrument tray. Devices may be unwrapped, or wrapped with up to two layers of 1-ply polypropylene wrap

Sterilization (Temperatures are minimum required, times are minimum required)

Maintenance, Inspection and Testing

Storage Store with other sterile devices.

Additional Information

Note: The instructions provided above have been validated by the manufacturer as being CAPABLE of preparing the product for re-use. It remains the responsibility of the processor to

Note: All validations performed per current AAMI TIR12, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers.

Medtronic recommends incineration of devices that have directly contacted patients suspected or conrmed with Transmissible Spongiform Encephalopathy (TSE)/ CJD diagnosis. NHS Estates HTM 2010 Parts 4 & 6: Appendix 2, Items contaminated with TSE Agents and WHO Infection Control Guidelines for Transmissible Spongiform Encephalopathies refers to a TSE decontamination cycle using a steam autoclave at a temperature of 134-137°C for a single cycle of 18 minutes or repeated for a total of six 3-minute cycles.

• Do not soak/submerge devices.

• Do not use ultrasound to clean devices.

• Do not use chlorine based or corrosive cleaning agents such as bleach, lye, acetone, sodium hypochlorite/bleach, sodium hydroxide, formic acid, or solutions

containing glutaraldehyde.

• The use of a washer-disinfector for cleaning may cause a degradation in performance.

• Allow an adequate cooling period after steam sterilization.

It is recommended that devices are reprocessed as soon as is practical following use.

Follow hospital procedures.

• Review the washer-disinfector warning above, before using this cleaning method.

• Remove devices from instrument trays before placing into washer baskets.

• Orient devices following recommendations of the washer/disinfector manufacturers.

Recommended Washer Cycle Phase Recirculation Time Water Temperature Detergent Type and Concentration

Pre-Wash 5 minutes 35C not applicable

Wash 30 minutes 93C not applicable

Neutralize 2 minutes

Final Rinse 10 minutes 65C not applicable

• Brush motor case and collet with a nylon brush dampened with a neutral enzymatic detergent.

• Rinse motor thoroughly under running water, collet end pointed down. Dry collet and motor with towel.

• Verify that devices are visually clean after manual cleaning.

• Rinse thoroughly with tap water.

Steam Sterilization

Cycle Gravity Pre -Vac Pr e-Vac

Temperature 132C 132C 134C

Time 25 minutes 4 minutes 3 minutes

Drying 15 minutes 15 minutes 10 minutes

STERRAD Do not use low temperature hydrogen peroxide gas plasma sterilization due to lumen internal diameter and length restrictions.

STERIS Do not use liquid peracetic acid sterilization due to immersion procedure.

100% EtO Sterilization Parameters

Preconditioning 51-59°C, 70 ±5% relative humidity, 30 min.

Sterilization Temperature 51-59°C

Relative Humidity 70 +/- 5%

Ethylene oxide concentration 725 +/- 25 mg/L

Gas exposure time (full-cycle) 4 hours

Aeration 51-59°C, 18 hours

• Inspect devices for any damage before and after each use. If damage is observed, do not use the device until it is repaired.

• Verify functionality prior to re-use.

None

Page 80

Reprocessing Instructions

Reprocessing Instructions (Per ISO17664)

Cleaning and Sterilization instructions are subject to change without notice. Up to date instructions are available online at manuals.medtronic.com.

68E4132 B

Warnings and Precautions

Limitations

Point of Use

Containment and

Stylus Touch

• Do not soak/submerge devices.

• Do not use ultrasound to clean devices.

• Do not use chlorine based or corrosive cleaning agents such as bleach, lye, acetone, sodium hypochlorite/bleach, sodium hydroxide, formic acid, or solutions

containing glutaraldehyde.

• The use of a washer-disinfector for cleaning may cause a degradation in performance.

• Allow an adequate cooling period after steam sterilization.

Verify functionality prior to re-use.

This product is provided non-sterile and must be cleaned and sterilized before the rst use and any reuse.

It is recommended that devices are reprocessed as soon as is practical following use.

Transportation

Preparation for

Follow hospital procedures.

Decontaimination

Cleaning: Automated (Do NOT use ultrasonic washer)

Cleaning: Manual

Disinfection

Packaging

Review the washer-disinfector warning above, before using this cleaning method. Remove devices from instrument trays before placing into washer baskets. Orient devices following recommendations of the washer/disinfector manufacturers. Verify that devices are visually clean after automated cleaning.

Recommended Washer Cycle Phase Recirculation Time Water Temperature Detergent Type and Concentration

Pre-Wash 2 minutes Cold tap water not applicable

Wash 5 minutes 66C (set point) Neutral enzymatic detergent, pH 6.0-8.0

Rinse 1 minute Hot tap water not applicable

• Wipe all external surfaces with a cloth dampened with a neutral enzymatic detergent, pH 6.0-8.0.

• Brush motor case and collet with a nylon brush dampened with a neutral enzymatic detergent.

• Rinse motor thoroughly under running water, collet end pointed down.

• Dry with towel.

• Verify that devices are visually clean after manual cleaning.

Follow hospital procedures.

For sterilization, place devices in instrument tray. Devices may be unwrapped, or wrapped with up to two layers of 1-ply polypropylene wrap.

Sterilization (Temperatures are minimum required, times are minimum required)

Maintenance, Inspection and

Steam Sterilization

Cycle P re-Vac Gravity Pre -Vac Pr e-Vac Flash (Pre-Vac Unwrapped)

Temperature 132C 132C 134C 134C 132C

Time 4 minutes 25 minutes 3 minutes 18 minutes 4 minutes

Drying 15 minutes 15 minutes 10 minutes 20 minutes not applicable

STERRAD Not validated

100% EtO Sterilization Parameters

Preconditioning 55ºC, 70% relative humdity, Vacuum Set Point: 1.3 psia, Time: 30 minutes

Sterilization Temperature 55ºC +/- 4ºC

Relative Humidity 70 +/- 5%

Ethylene oxide concentration 725 +/- 25 mg/L

Gas exposure time (full-cycle) 4 hours

Aeration 55C +/-4C, 12 hours

• Inspect devices for any damage before and after each use. If damage is observed, do not use the device until it is repaired.

• After cleaning and sterilization, verify functionality prior to re-use.

Testing

Storage

Additional

Store with other sterile devices.

None

Information

Note: The instructions provided above have been validated by the manufacturer as being CAPABLE of preparing the product for re-use. It remains the responsibility of the processor to

Note: All validations performed per current AAMI TIR12, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers.

Page 81

Reprocessing Instructions

Reprocessing Instructions (Per ISO17664)

Cleaning and Sterilization instructions are subject to change without notice. Up to date instructions

Legend Attachments/Tubes

Warnings and Precautions

Limitations Verify functionality prior to re-use.

Point of Use Follow hospital procedures.

Containment and Transportation

Preparation for Decontaimination

Cleaning: Automated (Do NOT use ultrasonic washer)

Cleaning: Manual 1. Wipe all attachments and telescoping tubes with a cloth, dampened with a surgical instrument cleaning solution.

Disinfection Follow hospital procedures.

Packaging For sterilization, place devices in instrument tray. Devices may be unwrapped, or wrapped with up to two layers of 1-ply polypropylene wrap.

Sterilization (Temperatures are minimum required, times are minimum required)

Maintenance, Inspection and Testing

Storage Store with other sterile devices.

Additional Information

Note: The instructions provided above have been validated by the manufacturer as being CAPABLE of preparing the product for re-use. It remains the responsibility of the processor to ensure that

the reprocessing is actually performed using equipment, materials and personnel in the reprocessing facility to achieve the desired result. This normally requires validation and routine monitoring of the process.

Note: All validations performed per current AAMI TIR12, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers.

• Do not soak/submerge devices.

• Do not use ultrasound to clean devices.

• Do not use chlorine based or corrosive cleaning agents such as bleach, lye, acetone, sodium hypochlorite/bleach, sodium hydroxide, formic acid, or solutions

containing glutaraldehyde.

• The use of a washer-disinfector for cleaning may cause a pre-mature degradation in performance.

• Allow an adequate cooling period after steam sterilization.

It is recommended that devices are reprocessed as soon as is practical following use.

Follow hospital procedures.

• Review the washer-disinfector warning above, before using this cleaning method.

• Manually rinse attachments/tubes under tap water, until no visible soil is noticed, before placing them into the automatic washer.

• Remove devices from instrument trays before placing into washer baskets.

• Orient devices following recommendations of the washer/disinfector manufacturers.

Recommended Washer Cycle Phase Recirculation Time Water Temperature Detergent Type and Concentration

Pre-Wash 2 minutes Cold tap water not applicable

Wash 5 minutes 66C (set point) Neutral enzymatic detergent, pH 6.0-8.0

Rinse 1 minute Hot tap water not applicable

2. Immerse the head of Contra-Angle attachments in surgical instrument cleaning solution and run the motor for 1 minute.

3. Other attachments and tubes may be mechanically agitated in cleaning solution, but not soaked or immersed.

4. A nylon brush dampened with a surgical instrument cleaning solution may be used to clean the external surfaces and internal connecting surfaces of the attachments and tubes.

5. Straight attachments, footed attachments and telescoping straight tubes have special cleaning brushes sized to the attachment’s or telescoping tube’s internal diameter. Push the brush wet with surgical instrument cleaning solution through the attachment or telescoping tube from rear to front to loosen and remove debris trapped inside.

6. Move any moveable parts back and forth to allow solution to thoroughly clean attachment, e.g., sleeve on footed attachment, perforator attachment.

7. Rinse thoroughly with tap water.

8. Thoroughly dry attachments. An air gun may be used to blow moisture out from rear to front of attachment.

Note: Medtronic no longer recommends using the Legend attachment cleaning nozzle (PA120), as this may cause some attachments to overheat.

9. Using an aerosol spray lubricant (such as Pana Spray), perform the following steps to lubricate attachments:

• Holding the can approximately 10-15 cm (3-6 in.) away from the attachment, spray all components that move, rotate, or slide with three quick squirts.

• Articulate movable components to ensure proper lubrication.

• Remove excess lubricant with a clean cloth.

Steam Sterilization

Cycle Gravity P re-Vac Pre-Vac (FR/WHO) Pre -vac (UK)

Temperature 132C 132C 134C 134C

Time 25 minutes 4 minutes 18 minutes 3 minutes

Drying 15 minutes 15 minutes 20 minutes 10 minutes

STERRAD Do not use low temperature hydrogen peroxide gas plasma sterilization due to lumen internal diameter and length restrictions.

STERIS Do not use liquid peracetic acid sterilization due to immersion procedure.

100% EtO Sterilization Parameters

Preconditioning 51-59°C, 70 ±5% relative humidity, 30 min

Sterilization Temperature 51-59°C

Relative Humidity 70 ±5%

Ethylene oxide concentration 725 +/- 25 mg/L

Gas exposure time (full-cycle) 4 hours

Aeration 51-59°C, 18 hours

• Inspect devices for any damage before and after each use. If damage is observed, do not use the device until it is repaired.

• Verify functionality prior to re-use.

None

are available online at manuals.medtronic.com.

M000030A235 A

Page 82

Reprocessing Instructions

Reprocessing Instructions (Per ISO17664)

Cleaning and Sterilization instructions are subject to change without notice. Up to date instructions are

Skeeter Oto-ex Burs

Warnings and Precautions

Limitations Discard any burs that show signs of damage or wear.

Point of Use • Remove burs from the handpiece before cleaning and sterilizing.

Containment and Transportation

Preparation for Decontaimination

Cleaning: Automated • Remove burs from any sterilization trays before placing into washer baskets.

Cleaning: Manual • Soak in lukewarm*, mild* enzymatic detergent (less than 43°C; pH 7.0 - 8.5), and deionized water for a minimum of two minutes.

Disinfection Do not cold soak in gluteraldehyde.

Packaging • A standard, sterilization wrap may be used. In the US, an FDA approved surgical wrap must be used. Ensure that the pack is large enough to contain the

Sterilization (Temperatures are minimum required, times are minimum required)

Maintenance, Inspection and Testing

Storage Store in a clean, dry area.

Additional Information

Note: The instructions provided above have been validated by the manufacturer as being CAPABLE of preparing the product for re-use. It remains the responsibility of the processor to

Note: All validations performed per current AAMI TIR12, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers.

Medtronic recommends incineration of devices that have directly contacted patients suspected or conrmed with Transmissible Spongiform Encephalopathy (TSE)/ CJD diagnosis. NHS Estates HTM 2010 Parts 4 & 6: Appendix 2, Items contaminated with TSE Agents and WHO Infection Control Guidelines for Transmissible Spongiform Encephalopathies refers to a TSE decontamination cycle using a steam autoclave at a temperature of 134-137°C for a single cycle of 18 minutes or repeated for a total of six 3-minute cycles.

• Before sterilization, carefully inspect the bur tips.

• Burs exhibiting the following conditions should be replaced:

• nicks on cutting surfaces

• noticeable wear on PTFE bearings

• severe bends or crimps on bur shaft

• Cold soak in glutaraldehyde, chlorine, or ammonium solutions, or dry heat sterilization is not recommended as damage to the bur may occur.

• Promptly and thoroughly rinse instruments with deionized water after each use.

It is recommended that instruments are reprocessed as soon as is practical following use.

Promptly and thoroughly rinse instruments with deionized water after each use.

• Orient burs following recommendations of washer/disinfector manufacturers.

• Use alkaline or neutral pH detergent recommended by washer/disinfector or detergent manufacturers.

• These products have been validated for eective cleaning using an automatic washer/disinfector cycle consisting of a minimum 44 minutes total time,

including a pre-wash, main wash & rinse, and thermal rinse. The thermal rinse shall be at least 10 minutes long at a minimum temperature of 60°C.

• Following cleaning, apply a light coating of silicone spray or Pana Spray in the following manner: grasp the PTFE bearing and rotate the bur to assure application of the spray inside the bearing.

• Then clean ultrasonically in lukewarm* solution of mild* detergent (less than 43°C; pH 7.0 - 8.5) and deionized water for at least 30 seconds.

• Rinse thoroughly with deionized water and wipe dry.

• Following cleaning, apply a light coating of silicone spray or Pana Spray in the following manner: grasp the PTFE bearing and rotate the bur to assure

application of the spray inside the bearing.

• Note: When using an ultrasonic cleaner or a spray washing machine, follow the manufacturer’s recommendations, particularly with regard to articulated instruments and positioning of instruments.

instrument without stressing the seals.

• In sets: Instruments may be loaded into dedicated instrument trays or general purpose sterilization trays. Wrap trays using appropriate method.

• The sterilization parameters given below should be used for devices that are fully disassembled when disassembly is possible. Use basic aseptic technique

during post-sterilization assembly to maintain the sterility of the instrument(s).

• All steam sterilization cycles have been validated in the wrapped conguration and instruments can be sterilized wrapped or unwrapped.

Steam Sterilization

Cycle Gravity Gravity Pre-vac Pre-vac (FR/WHO) Pre-vac (UK

Temperature 121C 132C 132C 134C 134C

Time 30 minutes 10 minutes 4 mninutes 18 minutes 3 minutes

Drying 8 minutes, or until visibly dry.

STERRAD Not validated.

100% EtO Sterilization Parameters

Preconditioning

Sterilization Temperature 54 +/- 2C

Relative Humidity 60 +/- 5%

Ethylene oxide concentration 600 +/- 25 mg/L

Gas exposure time (full-cycle) 120 minutes

Aeration 48-52C, 8 hours

Discard any burs that show signs of damage or wear.

None

available online at manuals.medtronic.com.

68E3968 D

Page 83

Reprocessing Instructions

Reprocessing Instructions (Per ISO17664)

Cleaning and Sterilization instructions are subject to change without notice. Up to date instructions are

Skeeter Handpiece

Warnings and Precautions

Limitations After cleaning and sterilization, verify functionality prior to re-use.

Point of Use • This product is provided non-sterile and must be cleaned and sterilized before the rst use and any reuse.

Containment and Transportation

Preparation for Decontaimination

Cleaning: Automated (Do NOT use ultrasonic washer)

Cleaning: Manual • Carefully clean with an enzymatic detergent. Do not fully immerse.

Disinfection Do not cold soak in gluteraldehyde.

Packaging • A standard, sterilization wrap may be used. In the US, an FDA approved surgical wrap must be used. Ensure that the pack is large enough to contain the

Sterilization (Temperatures are minimum required, times are minimum required)

Maintenance, Inspection and Testing

Storage It is extremely important that the handpiece be rapidly and completely dried before storage to prevent corrosion and residue deposits in the bearing and motor.

Additional Information

Note: The instructions provided above have been validated by the manufacturer as being CAPABLE of preparing the product for re-use. It remains the responsibility of the processor to

Note: All validations performed per current AAMI TIR12, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers.

• Disconnect the power before cleaning.

• Do not fully immerse, or ultrasonically clean, this instrument.

• Do not use any cleaning instruments in the cannulated shaft of the handpiece.

• Do not cold soak sterilize this instrument in glutaraldehyde. This will void the warranty.

• Do not use organic solvents to clean the bur chuck.

• To remove occasional residual buildup on handpiece cable connector, use a soft brush and isopropyl alcohol.

It is recommended that instruments are reprocessed as soon as is practical following use.

Disassembly not required, other than removal of the bur.

• Remove instruments and equipment from any sterilization trays before placing into washer baskets.

• Orient devices following recommendations of washer/disinfector manufacturers.

• Use alkaline or neutral pH detergent recommended by washer/disinfector or detergent manufacturers.

• These products have been validated for eective cleaning using an automatic washer/disinfector cycle consisting of a minimum 44 minutes total time,

including a pre-wash, main wash & rinse, and thermal rinse. The thermal rinse shall be at least 10 minutes long at a minimum temperature of 60°C.

• The cannulated needle nose should be cleaned by immersing in the detergent solution up to the level of the Bur Release button. Do not use any cleaning instruments in the cannulated shaft of the handpiece.

• Rinse by immersing the distal end of the handpiece (up to the Bur Release button) in distilled water, using a gentle swirling motion to ush away residual cleaning solution. Avoid water accumulation in the motor housing by shaking excess water out with a downward motion.

• Silicone spray or Pana Spray should be sprayed into the cannulated shaft of the handpiece prior to sterilization. Apply silicone spray or Pana Spray until surplus lubricant is noted on the outside of the Bur Release Button. Wipe away excess lubricant from the handpiece. Following this procedure will insure that the bur release mechanism is well lubricated for proper functioning.

• Sterilize the handpieces immediately after cleaning.

instrument without stressing the seals.

• In sets: Instruments may be loaded into dedicated instrument trays or general purpose sterilization trays. Wrap trays using appropriate method.

• The sterilization parameters given below should be used for devices that are fully disassembled when disassembly is possible. Use basic aseptic technique

during post-sterilization assembly to maintain the sterility of the instrument(s).

• All steam sterilization cycles have been validated in the wrapped conguration and instruments can be sterilized wrapped or unwrapped.

Steam Sterilization

Cycle Gravity Gravity Pre-vac Pre-vac (FR/WHO) Pre-vac (UK)

Temperature 121C 132C 132C 134C 134C

Time 30 minutes 10 minutes 4 minutes 18 minutes 3 minutes

Drying 8 minutes, or until visibly dry.

STERRAD 100S Compatible

100% EtO Sterilization Parameters

Preconditioning

Sterilization Temperature 54 +/- 2C

Relative Humidity 60 +/- 5%

Ethylene oxide concentration 600 +/- 25 mg/L

Gas exposure time (full-cycle) 120 minutes

Aeration 48-52C, 8 hours

• Inspect components for any damage before and after each use. If damage is observed do not use the instrument until it is repaired.

• After cleaning and sterilization, verify functionality prior to re-use.

None

available online at manuals.medtronic.com.

68E3969 E

Page 84

Reprocessing Instructions (Per ISO17664)

Cleaning and Sterilization instructions are subject to change without notice. Up to date instructions are available online at manuals.medtronic.com.

68E3281 D

Warnings and Precautions

Limitations

Point of Use

Containment and

Reprocessing Instructions

Visao

• Disconnect the power before cleaning.

• Do not fully immerse, or ultrasonically clean, this instrument.

• Do not cold soak sterilize this instrument in glutaraldehyde. This will void the warranty.

• Do not use organic solvents to clean the bur chuck.

• For drill handpiece cleaning, cover handpiece cable connector end with Handpiece Cable Cap, Small, catalog no. 3318510 or Handpiece Cleaning Cap,

Universal, catalog no. 3318520. (Note: Use 3318520 for Straightshot M4, Visao, and Xcalibur Hi-Speed with angled cable. Use 3318510 for other handpieces.)

• After completion of the cleaning steps, remove Handpiece Cable Cap or other protective components installed prior to cleaning.

After cleaning and sterilization, verify functionality prior to re-use.

• This product is provided non-sterile and must be cleaned and sterilized before the rst use and any reuse.

• To remove occasional residual buildup on handpiece cable connector, use a soft brush and isopropyl alcohol.

It is recommended that instruments are reprocessed as soon as is practical following use.

Transportation

Preparation for

Remove the bur from the handpiece, otherwise disassembly is not required.

Decontaimination

Cleaning: Automated

Cleaning: Manual

Disinfection

Packaging

Sterilization (Temperatures are minimum required, times are minimum required)

Maintenance, Inspection and

• Remove instruments and equipment from any sterilization trays before placing into washer baskets. Orient devices following recommendations of washer/ disinfector manufacturers.

• Use alkaline or neutral pH detergent recommended by washer/disinfector or detergent manufacturers.

• These products have been validated for eective cleaning using an automatic washer/disinfector cycle consisting of a minimum 44 minutes total time,

including a pre-wash, main wash & rinse, and thermal rinse. The thermal rinse shall be at least 10 minutes long at a minimum temperature of 60°C.

• After surgery, clean the irrigation sleeves and bur guards with an enzymatic detergent solution. Wipe the handpiece and cable with disinfectant applied to a clean, non-abrasive cloth.

• A chuck brush cleaner (REF 3112500) or an appropriately sized small (plastic bristle) bore brush may be inserted into the distal end of the Visao handpiece, irrigation sleeves and bur guards to assist in removing uids, tissue, or bone fragments, making sure to clean all passages. Use an enzymatic detergent solution to loosen and remove collected tissues from the unit.

• Rinse out the distal end of the handpiece. Shake excess water from the handpiece.

• Ensure all water is drained from the cooling housing. If saline was used for cooling during surgery, use distilled water to rinse the housing prior to

draining.

• Using distilled water, rinse saline from the irrigation nozzles. Drain the nozzle of all water.

• Sterilize the handpiece immediately after cleaning.

Do not cold soak in gluteraldehyde.

• A standard, sterilization wrap may be used. In the US, an FDA approved surgical wrap must be used. Ensure that the pack is large enough to contain the instrument without stressing the seals.

• In sets: Instruments may be loaded into dedicated instrument trays or general purpose sterilization trays. Wrap trays using appropriate method.

Steam Sterilization

Cycle Gravity Pre -Vac Pre-Vac (FR/WHO) Pre-vac (UK)

Temperature 121C 132C 134C 134C

Time 40 minutes 4 minutes 18 minutes 3 minutes

Drying 8 minutes, or until visibly dry

STERRAD 100S Compatible (Handpiece Only)

100% EtO Sterilization Parameters

Preconditioning

Sterilization Temperature 54-55C

Relative Humidity 60 +/- 5%

Ethylene oxide concentration 600 +/- 25 mg/L

Gas exposure time (full-cycle) 120 minutes

Aeration 48-52C, 8 hours

• Inspect components for any damage before and after each use. If damage is observed do not use the instrument until it is repaired.

• After cleaning and sterilization, verify functionality prior to re-use.

Testing

Storage

Additional Information

Note: The instructions provided above have been validated by the manufacturer as being CAPABLE of preparing the product for re-use. It remains the responsibility of the processor to

Note: All validations performed per current AAMI TIR12, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers.

It is extremely important that the handpiece be rapidly and completely vacuum dried before storage to prevent corrosion and residue deposits in the bearing and motor.

Page 85

Reprocessing Instructions

Reprocessing Instructions (Per ISO17664)

Cleaning and Sterilization instructions are subject to change without notice. Up to date instructions are

Indigo High-Speed Otologic Drill

available online at manuals.medtronic.com.

68E4187 A

Warnings and Precautions

Limitations

Point of Use

Containment and

• Do not soak/submerge devices.

• Do not use ultrasound to clean devices.

• Do not use chlorine based or corrosive cleaning agents such as bleach, lye, acetone, sodium hypochlorite/bleach, sodium hydroxide, formic acid, or solutions

containing glutaraldehyde.

• The use of a washer-disinfector for cleaning may cause a pre-mature degradation in performance.

• Allow an adequate cooling period after steam sterilization.

Verify functionality prior to re-use.

This product is provided non-sterile and must be cleaned and sterilized before the rst use and any reuse.

It is recommended that devices are reprocessed as soon as is practical following use.

Transportation

Preparation for

Follow hospital procedures.

Decontaimination

Cleaning: Automated (Do NOT use ultrasonic washer)

Cleaning: Manual

Disinfection

Packaging

• Remove devices from instrument trays before placing into washer baskets.

• Prior to cleaning, cover the drill cable connector end with Handpiece Cleaning Cap, catalog no. 3318520.

• Orient devices following recommendations of the washer/disinfector manufacturers.

• After comploetion of the cleaning steps, remove Handpiece Cleaning Cap or other protective components prior to sterilization.

Recommended Washer Cycle Phase Recirculation Time Water Temperature Detergent Type and Concentration

Pre-Wash 2 minutes Cold tap water not applicable

Wash 5 minutes 66 (set point) Neutral enzymatic detergent, pH 6.0-8.0

Rinse 1 minute Hot tap water not applicable

• Prior to cleaning, cover the drill cable connector end with Handpiece Cleaning Cap, catalog no. 3318520.

• Wipe all external surface of the motor and cable with a cloth dampened with a neutral enzymatic detergent, pH 6.0-8.0 prepared with lukewarm tap water.

• Brush motor case and collet with a nylon brush dampened with a neutral enzymatic detergent.

• Rinse motor thoroughly under running water, collet end pointed down.

• Dry collet and motor with lint free towel

• After comploetion of the cleaning steps, remove Handpiece Cleaning Cap or other protective components prior to sterilization.

• Verify that devices are visually clean after manual cleaning

Follow hospital procedures.

Place devices in instrument tray, and double wrap instrument case with 1-ply polypropylene wrap. In the US, an FDA approved surgical wrap must be used.

Sterilization (Temperatures are minimum required, times are minimum required)

Maintenance, Inspection and

Steam Sterilization

Cycle Gravity Pre -Vac Pre-Vac (FR/WHO) Pre-vac

(UK)

Temperature 132C 132C 134C 134C

Time 25 minutes 4 minutes 18 minutes 3 minutes

Drying 20 minutes

STERRAD Not validated

100% EtO Sterilization Parameters

Preconditioning 55C, 70% relative humidity, 30 minutes

Sterilization Temperature 55C

Relative Humidity 70%

Ethylene oxide concentration 725 mg/L

Gas exposure time (full-cycle) 240 minutes

Aeration 53-57C, 18 hours

• Inspect components for any damage before and after each use. If damage is observed do not use the instrument until it is repaired.

• After cleaning and sterilization, verify functionality prior to re-use.

Testing

Storage

Additional

Store with other sterile devices.

None

Information

Note: The instructions provided above have been validated by the manufacturer as being CAPABLE of preparing the product for re-use. It remains the responsibility of the processor to

Note: All validations performed per current AAMI TIR12, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers.

Page 86

Reprocessing Instructions

Indigo High-Speed Otologic Drill Attachments

Reprocessing Instructions (Per ISO17664)

Cleaning and Sterilization instructions are subject to change without notice. Up to date instructions are available online at manuals.medtronic.com.

68E4188 A

Warnings and Precautions

Limitations Verify functionality prior to re-use.

Point of Use This product is provided non-sterile and must be cleaned and sterilized before the rst use and any reuse.

Containment and Transportation

Preparation for Decontaimination

Cleaning: Automated (Do NOT use ultrasonic washer)

Cleaning: Manual • Use a neutral enzymatic detergent, pH 6.0 – 8.0, prepared with lukewarm tap water for the cleaning process.

Packaging Place devices in instrument tray, and double wrap instrument case with 1-ply polypropylene wrap. In the US, an FDA approved surgical wrap must be used.

Sterilization (Temperatures are minimum required, times are minimum required)

Maintenance, Inspection and Testing

Storage Store with other sterile devices.

Additional Information None

actually performed using equipment, materials and personnel in the reprocessing facility to achieve the desired result. This normally requires validation and routine monitoring of the process.

Note: All validations performed per current AAMI TIR12, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers.

Medtronic recommends incineration of devices that have directly contacted patients suspected or conrmed with Transmissible Spongiform Encephalopathy (TSE)/ CJD diagnosis. NHS Estates HTM 2010 Parts 4 & 6: Appendix 2, Items contaminated with TSE Agents and WHO I nfec tion Control Guidelines for Transmissible Spongiform Encephalopathies refers to a TSE decontamination cycle using a steam autoclave at a temperature of 134-137°C for a single cycle of 18 minutes or repeated for a total of six 3-minute cycles.

• Do not soak/submerge devices.

• Do not use ultrasound to clean devices.

• Do not use chlorine based or corrosive cleaning agents such as bleach, lye, acetone, sodium hypochlorite/bleach, sodium hydroxide, formic acid, or solutions containing

glutaraldehyde.

• The use of a washer-disinfector for cleaning may cause a pre-mature degradation in performance.

• Allow an adequate cooling period after steam sterilization.

It is recommended that devices are reprocessed as soon as is practical following use.

Follow hospital procedures.

• All attachments must be thoroughly rinsed manually with tap water, ensuring all hard to reach areas are rinsed, prior to transfer to automatic washer for processing.

• Remove devices from instrument trays before placing into washer baskets.

• Orient devices following recommendations of the washer/disinfector manufacturers.

Recommended Washer Cycle Phase Recirculation Time Water Temperature Detergent Type and Concentration

Pre-Wash 2 minutes Cold tap water not applicable

Wash 5 minutes 66 (set point) Neutral enzymatic detergent, pH 6.0-8.0

Rinse 1 minute Hot tap water not applicable

• Thoroughly wipe the straight and angled attachments with a cloth dampened with the enzymatic detergent.

• Wipe entire attachment until all gross soil has been removed.

• Using a brush wetted with the enzymatic detergent, brush the attachments to clean the external surfaces and internal connecting surfaces.

• For the angled attachment: Wet an appropriately sized cleaning brush (Ø 2.4mm) with the enzymatic detergent. Insert the brush into the bore at the front of the

attachment. Brush the bore to loosen debris trapped inside. Rinse the bore to remove debris.

• For the straight attachment: Wet an appropriately sized cleaning brush (Ø 2.4mm) with the enzymatic detergent. Push the brush through the straight attachment from the rear to front to loosen and remove debris trapped inside. Rinse bore to remove debris.

• Place one half of the straight or angled attachment into the enzymatic detergent. Do not immerse the entire attachment. Gently agitate the attachments in the detergent and actuate any moveable parts.

• Place the other half of the attachment into the detergent and repeat. Do not immerse the entire attachment.

• Rinse the attachment thoroughly with tap water. Flush both ends to remove detergent.

• Thoroughly dry the attachments. An air gun may be used on the straight attachment to blow moisture out from the rear to front.

• Using an aerosol spray lubricant (such as Pana Spray), perform the following steps to lubricate attachments:

• Holding the can approximately 10-15 cm (3-6 in) away from the attachment, spray all components that move, rotate, or slide with three quick squirts.

• Articulate movable components to ensure proper lubrication.

• Remove excess lubricant with a clean cloth.

Follow hospital procedures.

Steam Sterilization

Cycle Gravity P re-Vac Pre-Vac (FR/WHO) Pre-vac (UK)

Temperature 132C 132C 134C 134C

Time 25 minutes 4 minutes 18 minutes 3 minutes

Drying 20 minutes

STERRAD Not validated

100% EtO Sterilization Parameters

Preconditioning 55C, 70% relative humidity, 30 minutes

Sterilization Temperature 55C

Relative Humidity 70%

Ethylene oxide concentration 725 mg/L

Gas exposure time (full-cycle) 240 minutes

Aeration 53-57C, 18 hours

• Inspect components for any damage before and after each use. If damage is observed do not use the instrument until it is repaired.

• After cleaning and sterilization, verify functionality prior to re-use.

Page 87

Reprocessing Instructions

Reprocessing Instructions (Per ISO17664)

Cleaning and Sterilization instructions are subject to change without notice. Up to date instructions are

Microsaws

available online at manuals.medtronic.com. M000030A231 A

Warnings and Precautions

Limitations Verify functionality prior to re-use.

Point of Use Follow hospital procedures.

Containment and Transportation

Preparation for Decontaimination

Cleaning: Automated (Do NOT use ultrasonic washer)

Cleaning: Manual • Rinse the device thoroughly under running water, with the collet end pointed down.

Disinfection Follow hospital procedures.

Packaging For sterilization, place devices in instrument tray. Devices may be unwrapped, or wrapped with up to two layers of 1-ply polypropylene wrap.

Sterilization (Temperatures are minimum required, times are minimum required)

Maintenance, Inspection and Testing

Storage Store with other sterile devices.

Additional Information None

actually performed using equipment, materials and personnel in the reprocessing facility to achieve the desired result. This normally requires validation and routine monitoring of the process.

Note: All validations performed per current AAMI TIR12, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers.

Medtronic recommends incineration of devices that have directly contacted patients suspected or conrmed with Transmissible Spongiform Encephalopathy (TSE)/ CJD diagnosis. NHS Estates HTM 2010 Parts 4 & 6: Appendix 2, Items contaminated with TSE Agents and WHO I nfec tion Control Guidelines for Transmissible Spongiform Encephalopathies refers to a TSE decontamination cycle using a steam autoclave at a temperature of 134-137°C for a single cycle of 18 minutes or repeated for a total of six 3-minute cycles.

• Do not soak/submerge devices.

• Do not use ultrasound to clean Midas Rex Microsaw devices.

• Do not use chlorine based or corrosive cleaning agents such as bleach, lye, acetone, sodium hypochlorite/bleach, sodium hydroxide, formic acid, or solutions containing

glutaraldehyde.

• Allow an adequate cooling period after steam sterilization.

• The use of a washer-disinfector for cleaning may cause a pre-mature degradation in performance.

It is recommended that devices are reprocessed as soon as is practical following use.

• Disconnect handpiece from console.

• Remove irrigation tubing/clips, saw blade, and cable management clamps.

• Prior to placing the saws in the automated washer, manually rinse the saw body with the distal end pointed down under tap water, until no visible soil is noticed.

• Move any movable parts back and forth to allow water to reach hard-to -rinse areas.

• Transfer the devices into the washer for processing, making sure that the oscillating saw collet is open . Place the devices in the washer to facilitate drainage.

• Verify that devices are visually clean after automated cleaning.

Recommended Washer Cycle Phase Recirculation Time Water Temperature Detergent Type and Concentration

Pre-Wash 2 minutes Cold tap water not applicable

Wash 5 minutes 66 (set point) Neutral enzymatic detergent, pH 6.0-8.0

Rinse 1 minute Hot tap water not applicable

• Wipe the saw body and cable with a cloth dampened with a neutral enzymatic detergent, pH 6.0-8.0 (henceforth referred to as “cleaning solution”).

• With the collet end pointed down, brush saw body and blade-release button with a nylon brush that has been dipped in cleaning solution.

• Sagittal Only:

1. Dip the distal end of the saw in cleaning solution and agitate for 10-15 seconds.

2. Press and hold the blade-release button, then repeat step 1.

3. With the blade-release button pressed, ush approximately 15 mL of cleaning solution from a syringe into the blade opening.

4. Flus all ports with 15 mL of cleaning solution.

5. Repeat steps 1-4 using water instead of cleaning solution.

• Reciprocating Only:

1. With the distal end facing up, squeeze 30 mL of cleaning soultion from a syringe into the distal end of the device so that the solution thoroughly reaches the inside of the collet.

2. While the device is in the vertical position, rotate the collet knob back and forth three times.

3. Dump the solution from the device.

4. Repeat steps 1-3 a second time with cleaning solution.

5. Repeat steps 1-3 a third time with water.

• Rinse the device under running water, ensuring that water enters all ports/openings. Move any moveable parts to allow the solution to reach all areas. Rinse until there is no visible evidence of soil or debris.

• Dry the entire device with a lint-free towel.

• Reciprocating and Oscillating Only: If desired, complete the following steps using Pana Spray to lubricate the saw collet:

1. Holding the can approximately 10-15 cm (4-6 in) away from the saw collet, spray into the hole of the shaf t (reciprocating saw) or onto the proximal/bottom portion of the

collet near the locked/unlocked indicators (oscillating saw) with three quick squirts.

2. Articulate the collet to ensure proper lubrication.

3. Remove excess lubricant with a clean cloth.

Steam Sterilization

Cycle Gravity Pre -Vac Pre-Vac (FR/WHO) Pre-vac (UK)

Temperature 132C 132C 134C 134C

Time 25 minutes 4 minutes 18 minutes 3 minutes

Drying 30 minutes 20 minutes 30 minutes 22 minutes

STERRAD Do not use low temperature hydrogen peroxide gas plasma sterilization due to lumen internal diameter and length restrictions.

SETERIS Do not use liquid peracetic acid sterilization due to immersion procedure.

100% EtO Sterilization Parameters

Preconditioning 51-59C, 70% relative humidity, 30 minutes

Sterilization Temperature 51-59C

Relative Humidity 70 +/- 5%

Ethylene oxide concentration 725 +/- 25mg/L

Gas exposure time (full-cycle) 4 hours

Aeration 51-59C, 18 hours

• Inspect components for any damage before and after each use. If damage is observed do not use the instrument until it is repaired.

• After cleaning and sterilization, verify functionality prior to re-use.

Page 88

Reprocessing Instructions

Reprocessing Instructions (Per ISO17664)

Cleaning and Sterilization instructions are subject to change without notice. Up to date instructions are available online at manuals.medtronic.com. 68E4189 A

Warnings and Precautions

Limitations

Point of Use

Containment and

POWEREASE Driver

• Do not soak/submerge devices.

• Do not use ultrasound to clean devices.

• Do not use chlorine based or corrosive cleaning agents such as bleach, lye, acetone, sodium hypochlorite/bleach, sodium hydroxide, formic acid, or solutions

containing glutaraldehyde.

• The use of a washer-disinfector for cleaning may cause a pre-mature degradation in performance.

• Allow an adequate cooling period after steam sterilization.

Verify functionality prior to re-use.

No particular requirements.

It is recommended that devices are reprocessed as soon as is practical following use.

Transportation

Preparation for

Disconnect handpiece from console.

Decontaimination

Cleaning: Manual

Cleaning: Automated (Do NOT use ultrasonic washer)

Disinfection

Packaging

• Rinse tap water through the open lumen of the handpiece, collet pointed down, until all evidence of soil and debris is removed. Actuate and rinse collet.

• Wipe external surface of the motor and cable with a cloth dampened with neutral enzymatic detergent, pH 6.0-8.0.

• Thoroughly clean the motor case, collet, and trigger area with a nylon brush dampened with neutral enzymatic detergent, pH 6.0-8.0. Actuate the collet and

trigger while brushing.

• Use a lumen brush to brush the entire length of the lumen.

• Rinse entire device, with collet pointed down, under running tap water.

• Immerse the collet portion of the device into neutral enzymatic detergent, pH 6.0-8.0 for a minimum of 2 minutes. Actuate and thoroughly brush the collet

while immersed. A syringe should be used to ush hard to reach areas.

• Rinse entire device, with collet pointed down, under running tap water. A syringe should be used to rinse hard to reach areas.

• Dry with lint free cloth.

• Verify that device is visually clean.

The POWEREASE must undergo the manual cleaning process prior to processing in a washer/disinfector.

1. Rinse tap water through the open lumen of the handpiece, collet pointed down until all evidence of soil and debris is removed. Actuate and rinse collet.

2. Wipe external surface of the motor and cable with a cloth dampened with neutral enzymatic detergent.

3. Brush motor case, collet, and trigger area with a nylon brush dampened with neutral enzymatic detergent. Actuate the collet and trigger while brushing.

4. Use a lumen brush to brush the entire length of the lumen.

5. Rinse entire device, with the collet pointed down, under running tap water

6. Immerse the collet portion of the device into neutral enzymatic detergent for a minimum of 2 minutes. Actuate and brush the collet while immersed. A syringe should be used to ush hard to reach areas.

7. Rinse entire device, with the collet pointed down, under running tap water. A syringe should be used to rinse hard to reach areas.

8. Place POWEREASE into a suitable washer/disinfector basket and process through a washer/disinfector cycle.

Recommended Washer Cycle Phase Recirculation Time Water Temperature Detergent Type and Concentration

Pre-Wash 2 minutes Cold tap water not applicable

Wash 5 minutes 66C (set point) Neutral enzymatic detergent, pH 6.0-8.0

Rinse 1 minute Hot tap water not applicable

Follow hospital procedures.

Steam sterilization may be performed wrapped or unwrapped. If wrapped, in the US, an FDA approved surgical wrap must be used.

Sterilization (Temperatures are minimum required, times are minimum required)

Maintenance, Inspection and

Steam Sterilization

Cycle Gravity P re-Vac Pre-Vac (FR/WHO) Pre-Vac (UK)

Temperature 132C 132C 134C 134C

Time 25 minutes 4 minutes 3 minutes 18 minutes

Drying 40 minutes

STERRAD Not validated

STERIS Not validated

100% EtO Sterilization Parameters

• Inspect devices for any damage before and after each use. If damage is observed, do not use the device until it is repaired.

• After cleaning and sterilization, verify functionality prior to re-use.

Not validated

Testing

Storage

Additional

Store with other sterile devices.

None

Information

Note: The instructions provided above have been validated by the manufacturer as being CAPABLE of preparing the product for re-use. It remains the responsibility of the processor to

Note: All validations performed per current AAMI TIR12, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers.

Page 89

Page 90

M726750B246 A

EC REP

01/2012

medtronic.com manuals.medtronic.com

Medtronic Xomed, Inc. 6743 Southpoint Drive North Jacksonville, Florida USA 32216

800.874.5797

Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands

011.31.45.566.8000