IPC Model 1898001 Users Guide Rev J Aug 2014

CUSTOMER SERVICE For further information regarding the use of this product or to report any problems, please contact Medtronic using the appropriate information provided on the blue and white contact information card packaged with each device; or contact your local distributor. Medtronic Xomed 6743 Southpoint Drive North Jacksonville, Florida 32216 USA www.medtronicENT.com

US Help Line 1-800-874-5797 International Service International Customers should contact their local Medtronic Xomed office.

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™, Intelliflow®, IPC®, Legend®, Legend EHS®, Legend EHS Stylus©, Magnum®, Midas Rex®, Mednext®, NIM®, NIM-Eclipse®, Powerease™, Skeeter®, SOLERA®, StraightShot®, Stylus Touch®, Triton®, TSRH® 3Dx™ , Visao® and XPS®. All other trademarks, service marks, registered trademarks, or registered service marks are the property of their respective owners in the United States and other countries.

TABLE OF CONTENTS SYMBOLS ... 1-1 GLOSSARY... 1-2 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 ... 1-9 When the System Arrives... 1-9 Set up the IPC... 1-9 Install the Pump Cartridges or Irrigation Tubing ... 1-9 Prepare the IPC for Use ... 1-9 Calibrate Touchscreen... 1-9 Change System Settings ...1-10 Set up and Prime Pumps ...1-11 Confirm System Operation ...1-11

IPC COMPONENTS ...1-12 Auxillary Power Console ...1-12 Multifunction Footpedal ...1-12 Y-Splitter ...1-12 IntelliFlow Irrigation Remote Control ...1-12

GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY ...1-13 LIMITED WARRANTY...1-15 FOR ITEMS CONTAMINATED WITH TSE AGENTS ...1-15 TRITON ELECTRIC HIGH-TORQUE HANDPIECE... 2-1 SUCTION IRRIGATOR ... 3-1 ENDO-SCRUB 2 ... 4-1 SPINE SHAVER (SC1) HANDPIECE ... 5-1 STRAIGHTSHOT M5, STRAIGHTSHOT M4, STRAIGHTSHOT MAGNUM II AND STRAIGHTSHOT III ... 6-1 LEGEND EHS AND LEGEND EHS STYLUS ... 7-1 STYLUS TOUCH ... 8-1 LEGEND EHS, LEGEND EHS STYLUS AND STYLUS TOUCH ATTACHMENTS ... 9-1 SKEETER ULTRA-LITE OTO-TOOL ...10-1 VISAO HIGH-SPEED DRILL ...11-1 INDIGO HIGH-SPEED OTOLOGIC DRILL ...12-1 MIDAS REX MICROSAWS ...13-1 POWEREASE DRIVER ...14-1

TROUBLESHOOTING AND ERROR CODES ...A-1 CLEANING AND STERILIZATION ...B-1 Post-Operative Instructions ... B-1 Triton Electric High-Torque Handpiece ... M000030A322 Endo-Scrub 2 ... 68E4005 Midas Rex Spine Shaver, StraightShot M5, StraightShot M4, StraightShot Magnum II or StraightShot III ... 68E3282 Legend EHS and Legend EHS Stylus... M000030A234 Stylus Touch ... 68E4132 Legend Attachments ... M000030A235 Skeeter Oto-flex 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

INTEGRATED POWER CONSOLE (IPC)

SYMBOLS The following symbols can appear on this device and related packaging. On Off Button

Package Contents

Follow Instructions For Use

Conforms to ANSI/AAMI ES 60601-1, IEC/EN 60601-1. Certified to CSA C22.2 No.601.1 105345

EMC Compliance Mark

Do Not Oil

Do Not Immerse

Oscillate

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

EUR · USA · JPN · AUS

ACC

Fuse

IPX1

Protected Against Vertical Water Drops

Use By Date

IPX7

Protected Against The Effects Of Temporary Immersion In Water

F

Forward

Accessory

Type BF Applied Part

R

Reverse

AC Power

Start/Stop

Foot Pedal Connector

Protective Earth

Output

RF Transmitter (Interference May Occur)

Fine Irrigant Adjustment

Equaipotential Ground Connector

Is Approximately Equal To

Consult Instructions for Use

Left Foot Control Unit Button / Mode Button

Use With

EC REP

Authorized Representative in the European Communicty Precaution: Pinch Hazard. Keep Fingers Clear Of Rollers

PHT

Contains DEHP (di-2-ethyl hexyl phthalate)

DEHP

STERILE

>120 VAC

Non-Sterile

BUR

Stim Bur Connector

Right Foot Control Unit Button / Control Button

RoHS - Environmental friendly use period - China (SJ/ T11364-2006)

Quantity

NIM

NIM Console Connector

Top Foot Control Unit Button / Handpiece Button

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.

EHS

Electrical High Speed Handpiece Connector

Locked

World Wide Standard for Medical Tubing Diameter

Unlocked

If the single use symbols is on the device label then this device is designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death.

Date of Manufacture

Handpiece

Not Greater Than 120vac

Caution

ON <120s

OFF >180s

REF

Fr

Applied Party Duty Cycle

Accessory Adapter Attachment

Catalog Number

Manufacturer

Skeeter

Bone Mill Brush

LOT

Lot Number

SN

Serial Number

STERILE R <XX° C XX° C

Sterilized by Radiation

1

Pump Head 1

Temperature Limitation

2

Pump Head 2

Control Unit Dissecting Tool Instrument Case Lubricant/Diffuser

XX° C >X° C

Motor

!USA

USA Only

Ergonomically Engineered

REFURBISHED

Refurbished

Multi-Use Disposable Attachment Regulator

1-1

INTEGRATED POWER CONSOLE (IPC)

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

INDICATIONS FOR USE The IPC is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone in Head & Neck/ENT (Otologic, Neurologic, Neurotologic, Sinus, Rhinologic, Nasopharyngeal/Laryngeal), Oral/Maxillofacial and Plastic/Reconstructive/Aesthetic surgical procedures.

DEVICE DESCRIPTION The IPC System is a powered microdebrider, drill and saw system that will remove soft tissue, hard tissue and bone during surgical procedures. The system consists of a power control console, footpedal, connection cables and assorted handpieces to drive various burs, blades, drills, rasps, cannulae and saws. It includes integrated irrigation pumps for irrigation of blades, burts and for motor coolant. In addition to the handpieces and pumps there is a connection for continuous stimulation of the Visao straight burs that enables nerve integrity monitoring during surgical procedures. The Nerve Integrity Monitor (NIM) is a separate device that stimulates and monitors the nerve. This system has connections that allow the NIM to be connected with the Visao handpiece and Stimulating Bur Guard, enabling the NIM to stimulate and monitor the nerve at the surgical site. This device is intended for use by physicians trained in the procedures described. The system can be used to clear the end of a rigid rod endocscope in order to maintain good visualization of endoscopic procedures without having to remove the scope from the surgical site.

CONTRAINDICATIONS None.

WARNINGS System Warnings W1 W2 W3 W4 W5 W6 W7

W8 W9 W10 W11 W12 W13 W14 W15

W16 W17 W18

1-2

It is important that the IPC system operator be familiar with the system User’s Guide, its precautions, procedures and safety issues. Do not use the IPC POWEREASE system in the presence of flammable anesthetics. Avoid potential ignition or explosion of gases. When not operating handpiece, eliminate accidental foot control activation. Control energy to and through the handpiece to prevent unintended tissue, bone, or nerve resection. Disconnect power to the IPC system before cleaning the unit to avoid electrical macro shock. Do not attach unapproved components to the IPC system to avoid electrical macro shock. To avoid the risk of electrical shock, achieve electrical grounding reliability with proper connections. Connect the IPC system to hospital grade receptacles only. 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. 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. Portable and mobile RF communications equipment can affect Medical Electrical Equipment. Do not operate the IPC POWEREASE system in the presence of Magnetic Resonance Imaging devices. Use of accessories and cables other than those specified and sold by Medtronic may result in increased emissions and decreased immunity of this unit. 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 configuration in which it will be used. Do not attempt to run the IPC POWEREASE system handpiece immediately after autoclaving. Allow an adequate “cool down” period (Typically 1 hour). Consult the Legend Bone Mill product insert before use with the Integrated Power Console system. 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. Do not operate the IPC POWEREASE system without eye protection. All service must be performed by Medtronic qualified personnel only. Repair and/or modification to the IPC system by anyone other than qualified service personnel may significantly compromise the unit’s ability to perform effectively and/or void the equipment warranty.

INTEGRATED POWER CONSOLE (IPC)

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 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., fluoroscopy, 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 effect 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 specifications. 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. Attempting to operate the Midas Rex Legend EHS Stylus Motor when the attachment is in the unlocked position may result in the motor stalling. W36 Smoke and/or excessive heat may be generated if attachment is not in the fully locked position. This may result in thermal injury to the surgeon or staff. 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 modified 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. Sharpcutting powered tools induce bleeding and removal of significant 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 fingers 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 confirmed. 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 difficult to remove, causing irritation, inflammation and foreign-body response at surgical site. W52 Bending or prying may break the accessory, causing harm to patient or staff. 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 specifications. W59 Tools with “L” identification are longer tools intended for light bone dissection. The increased tool head/stem configuration may affect dissection stability. W60 Tool flutes 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 effective 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 specifically designed for use with this drill system. W66 When using non-rotatable tools, ensure rotation lock is engaged to prevent inadvertent rotation. 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 offers no protection against cross-contamination. W72 Properly dispose of single-use devices removed from sterile packages. Devices lose sterility upon removal from packaging.

1-3

INTEGRATED POWER CONSOLE (IPC)

W73 Do not use dull, damaged or bent tools. Use of dull tools can reduce handpiece effectiveness 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 field, 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

P2 P3 P4

P5 P6 P7 P8 P9 P10 P11 P12 P13 P14 P15 P16 P17 P18 P19 P20 P21 P22 P23 P24 P25

1-4

PRIME/FLUSH Priming is a feature designed to purge air out of the tubing set(s) during setup. The first 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 Off and On resets the PRIME feature. Once pressed all Prime buttons will change to Flush buttons. To prevent damage to curved tools, disconnect suction tube prior to changing tool during procedure. When using an angled attachment, hold the handpiece assembly by the attachment so that the attachment does not inadvertently loosen from the handpiece. 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. 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. DO NOT use twist drill or Contra-Angle tool at an operating speed over 62,000 rpm. Do not attempt to disconnect the cable from the Midas Rex Legend EHS Stylus Motor. Do not kink cables. Inspect cables and pins for cracks, tears or corrosion. Do not use anti-fog on scope or sheath, as weeping or leaking may result. Disconnect cable from Midas Rex Legend EHS motor prior to sterilization. The use of a washer-disinfector for cleaning may cause a pre-mature degradation in performance. Remove devices from instrument case before placing into washer disinfector and allow devices to drain. Orient devices in the washer-disinfector by following manufacturer recommendations. DO NOT use low-temperature hydrogen peroxide gas plasma sterilization due to the lumen internal diameter and length restrictions. DO NOT use low-temperature liquid peracetic acid sterilization due to immersion procedure. DO NOT steam or EO sterilize the Legend Attachment Cleaning Nozzle. Remove and discard accessories following local regulations for proper disposal of contaminated materials. Disposable devices are for single-use only. Clean the motor and cable while still connected together. This will help to reduce ingress of debris. Use ONLY recommended cleaning agents. 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. 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. When using a Y-Splitter, only one Multifunction Footpedal shall be active at a time. Only one Y-Splitter shall be used at a time. Ensure the blade or bur is fully engaged in the microdebrider. For blades, verify the tip is fully engaged with the outer cannula prior to use.

INTEGRATED POWER CONSOLE (IPC)

SYSTEM REQUIREMENTS AND SPECIFICATIONS Console Specifications 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)

2006

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

2001/ A1: 2006

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 Off Time 180 Seconds

Power Cord Product Numbers North America: USA, Barbados, Belize, Bolivia, Canada, Columbia, Ecuador, Venezuela Standard P/N EA600 or 1895820 6 meter P/N EA650 or 189721 China P/N EA604 Argentina P/N EA608 Australia, New Zealand P/N EA605

United Kingdom, Ireland, Hong Kong, Malaysia, Singapore P/N EA606 or 1895821

India, South Africa P/N EA607 Israel P/N EA609 Japan P/N EA603 or 1895823

Continental Europe: Austria, Belgium, Finland, France, Germany, Greece, Korea, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden P/N EA602 or 1895822 Switzerland P/N EA601 Denmark P/N EA610 Italy, Chile P/N EA611 1-5

INTEGRATED POWER CONSOLE (IPC)

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

• Confirmation 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

Figure 1-2. IPC Console Back

1

1

2

2 3 4

3

5 6

4 5

7

1-6

8

1

Pump 1: Coolant, lense cleaning or irrigation

1

Pole clamp

2

Touchscreen

2

Compact flash card port (Medtronic Use)

3

Power on/off

3

Manual start/stop

4

Pump 2: Irrigation or lense cleaning

4

Fuse access

5

Console connector panel for peripheral devices

5

Auxillary power outlet

6

Endo-Scrub 2 connector

7

Hospital grade power cord connector

8

Equipotential. Apply potential equalization conductor.

INTEGRATED POWER CONSOLE (IPC)

Figure 1-4. Multifunction Footpedal & Y-Splitter

Figure 1-3. IPC Console Connector Panel

2

1

6

3

1

2

3

4

5

6

7

4

1

Legend EHS motor

4

Stimulus input from patient interface (NIM or NIM-Eclipse)

2

Legend EHS Stylus motor

5

Stimulus output to stim bur guard or Powerease

3

Spine shaver handpiece, StraightShot M5 microdebrider, StraightShot M4 microdebrider, StraightShot Magnum II microdebrider, StraightShot III microdebrider, Stylus Touch motor, Visao drill, Indigo drill, Midas Rex microsaws, Triton drill

6

Skeeter handpiece

7

Endo-Scrub 2 finger switch, Endo-Scrub 2 footpedal, Intelliflow irrigation remote control

8

8

2

1 3 5 4

Multifunction footpedal

Figure 1-5. IPC Touchscreen 1

7

5

8

1

Mode button

5

Foot pedal

2

Handpiece button

6

Y-Splitter

3

Control button

7

Port 1

4

Slip-resistant foot pad

8

Port 2

Figure 1-6. IPC Pumps Screen

Handpiece Name

+ 60000 RPM

FWD

Prime

None

REV

Acceleration

2

Pump 1

Mode

Speed

Endo-Scrub® 2

1 2

3

+

100 % Pump 2

Control

0

cc/min

Finger Foot

+

Both

Prime

3

Pump 2

8

(Handpiece Name)

7

Prime

None None

4

Endo-Scrub® 2

M4 M4 Irrigation Irrigation

4

EndoScrub 2 Pumps

5

Flow

?

3 On

Setting

6

+ Prime

Help

1

Displays active handpiece

5

Opens Help screen

2

Accessory control panel

6

Irrigation accessory panel

3

Footpedal variable control

7

Inactive handpiece

4

Opens Pumps screen

8

Set active handpiece settings as default settings

1

Close Pumps screen

3

Pump 1 panel available accessories

2

Prime/Flush pump

4

Pump 2 panel available accessories

1-7

INTEGRATED POWER CONSOLE (IPC)

Figure 1-7. Operating Room Setup

Figure 1-8. IPC System Configuration

3

2

5

4

1

6

10

1

2

11

3

9 7

8 1

Mode anesthesia equipment

6

Microscope

2

IPC system

7

Surgeon

3

Nursing supplies/Surgical instruments

8

Electro-Surgical unit

4

Scrub nurse

9

Anesthesiologist

5

NIM Monitor

10

Patient

4 10

9

5

Figure 1-9. IntelliFlow Remote Control 6 8

1

2 7 3

Irrigation and coolant bags

7

Minimum base diameter is 53 cm.

2

Irrigation pole

8

Irrigation pole basket

IPC console

9

Power cord

1

Pause/On-Off

3

2

Increase/Decrease Fine Adjustment

4

Console connector panel

10

Pump 2

Increase/Decrease Coarse Adjustment OR Select stainless steel tubing size (French size) for suction irrigator.

5

Accessory cables

11

Pump 1

6

Maximum height from floor is 89 cm.

3

1-8

1

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 the related topics for detailed instruction. 1. 2. 3. 4. 5. 6. 7.

Install pump cartridges or irrigation tubing. Prepare IPC for use. Calibrate touchscreen, if necessary. Change system settings, if necessary. Set up and prime pumps. Confirm system operation. 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 flow. Figure 1-10. Install Pump Cartridge

Install the Pump Cartridges or Irrigation Tubing 1. Locate the correct pump and lift up the lock (Figure 1-10). 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.

1

2

3

Prepare IPC for Use 1. 2. 3. 4. 5. 6. 7. 8.

Verify Operation Room set up (Figure 1-7). The surgeon may have preferences to the location and visibility. Verify the wheels are locked on the IPC cart. Inspect all components for damage and determine if the system is ready for use. Mount the IPC and irrigation/coolant bags on the IV pole (Figure 1-8). Important: Mount irrigant and coolant bags above the IPC to ensure adequate flow. 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. Locate the correct footpedal or accessory connection port on the connector panel (Figure 1-3), align the mark on the connector to the mark on the console, and then insert the connector. Connect suction, cooling and/or irrigation tubing. Turn on the IPC and verify the system passes the self-test. Note: If the IPC does not detect a handpiece or footpedal the Connect Handpiece/Connect Footswitch screen appears. Do the following: • Verify the cable is connected to the correct connection port. • Press [OK] in the Connect Handpiece/Connect Footswitch message window to continue use of the IPC without the handpiece or footpedal.

Calibrate Touchscreen Note: This step is optional. 1. Turn on the IPC console. 2. When the system starts, on the Splash screen, press [Settings]. 3. On the Settings screen, press Touch Screen Calibration and follow the screen prompts.

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INTEGRATED POWER CONSOLE (IPC)

Change System Settings Note: During surgery, system settings can be overwritten. 1. 2. 3. 4.

Turn on the IPC console. While the system starts, on the Splash screen, press [Settings]. To change the language, press the appropriate language. 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 confirm system settings and return to the Splash screen, press [OK]. 5. For accessories with audible tones, press the REV Audible Tones button to control the following: • The system delivers one set of reverse beeps when the reverse mode is activated. • The system delivers one set of reverse beeps the first time the drill is used in reverse mode after the reverse mode has been activated. 6. To confirm system settings and continue to the IPC touchscreen, press [OK]. 7. To restore settings to factory default, press [Restore]. Handpiece Default Settings The system configuration is dependent on the handpiece(s) connected to the console. The following table defines the default configurations, default settings (X) and default options (O). Note: During use, update the default settings for the active handpiece by pressing the set active handpiece settings as default settings button (Figure 1-5). Table 1. IPC Touchscreen Default Configurations Speed Handpiece

rpm

Visao

80000

Indigo

52000

Midas Rex SC1

cpm

Mode or Mode Select Switch %

Forward

Oscillate

X X 3400

Reverse

Acceleration

Deceleration

Size

Flow

Irrigation

O

30

O

30

O

X

60

StraightShot M5

5000

O

X

05

StraightShot M4

5000

O

X

05

StraightShot III, Magnum II

5000

O

X

Legend EHS Stylus

60000

X

O

Legend EHS

70000

X

O

Stylus Touch

60000

X

Skeeter

16000

X

30 45%

45%

0

O

80%

100%

0

O

v

0

0

Endo-Scrub 2

3

Suction Irrigator

8

Triton

100

Powerease

200 250

1-10

X

100 120

50%

X

100 Midas Rex Microsaws

Control

0 X X X

Finger

INTEGRATED POWER CONSOLE (IPC)

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 first time the prime button is pressed. • The IPC resets the prime feature when you turn IPC power Off and On. • After you prime the pump, the prime button and functionality become flush 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), fill the clear drip chamber with coolant. To fill, squeeze and release the chamber until full. 4. On the IPC touchscreen (Figure 1-5), press the pumps button. Note: The IPC pumps screen is also available from the Connect Handpiece/Connect Footswitch screen which the system displays during IPC preparation for use if a handpiece or footswitch is not detected by the system. 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 flows at the tip of the irrigation device. • Pump(s) turns off. 7. Press the close button. Pump Default Configurations The pump configuration is dependent on the handpiece(s) connected to the console. The following table defines the pump default settings (X) and default options (O). Table 2. IPC Pumps Screen Default Configurations Pump 1 Handpiece

Cooling

Visao

Pump 2

Irrigation

X

Irrigation

Endo-Scrub 2 Pump 1

X

Pump 2

Suction Irrigator Pump 1

O

Indigo

O

X

O

O

Midas Rex SC1

O

X

O

O

StraightShot M5

O

X*

X

O

StraightShot M4

O

X*

X

O

StraightShot III, Magum II

O

X*

X

O

Legend EHS Stylus

X

O*

O

O

Pump 2 O

O

O

O

O

Legend EHS

X

O

O

O

O

O

Stylus Touch

X

O

O

O

O

O

O

O

O

O

Endo-Scrub 2

X

O

X

O

Suction Irrigator

O

O

O

O

Midas Rex Microsaws

O

X

O

O

O

O

O

O

O

O

Skeeter

Powerease

* When the IPC detects both the Straightshot M4 or StraightShot M5 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.

Confirm System Operation 1. Confirm the irrigation pedal starts handpiece and irrigation flow. Verify the speed changes from white to yellow in the Speed box on the touchscreen. 2. Confirm 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. +

1-11

INTEGRATED POWER CONSOLE (IPC)

IPC COMPONENTS 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.

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 specific use and control.

Y-Splitter Y-Splitter (Figure 1-4) allows using a maximum of two multifunction footpedals connected to a single IPC (see P23 & P24). In this configuration, the Y-Splitter shall be connected to the IPC, and the Multifunction Footpedal(s) shall be connected to the Y-Splitter. When connecting a single footpedal to the Y-Splitter, you may connect to either Port 1 or 2.

IntelliFlow Irrigation Remote Control Use the IntelliFlow irrigation remote control (Figure 1-9) to start/stop and change irrigation flow while in the sterile field. If you are using handpiece irrigation: • To pause irrigation flow, press the Pause/On-Off button. • To adjust flow rate, press the Fine Adjustment or Coarse Adjustment Increase/Decrease button. If you are using the Suction Irrigator: • To pause or turn on/off the Suction Irrigator, press the Pause/On-Off button. • To adjust flow rate, press the Fine Adjustment Increase/Decrease button. • To select the stainless steel tubing size (French size), press the Stainless Steel Tubing Size button.

1-12

INTEGRATED POWER CONSOLE (IPC)

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY Part I Guidance and manufacturer’s declaration – electromagnetic immunity – Part I The IPC is intended for use in the electromagnetic environment specified below. The customer or the user of the IPC should assure that it is used in such an environment. IEC/EN60601-1-2 Immunity test Compliance level Electromagnetic environment - guidance test level Floors should be wood, concrete, or ceramic tile. If floors are covered Electrostatic discharge (ESD) ±6 kV contact ±6 kV contact IEC 61000-4-2 ±8 kV air ±8 kV air with synthetic material, the relative humidity should be at least 30 %. Electrical fast transient/burst ±2 kV for power supply lines ±2 kV for power supply lines Mains power quality should be that of a typical commercial or hospiIEC 61000-4-4 ±1 kV for input/output lines ±1 kV for input/output lines tal environment. Surge ±1 kV differential mode ±1 kV differential mode Mains power quality should be that of a typical commercial or hospiIEC 61000-4-5 ±2 kV common mode ±2 kV common mode tal environment. <5 % UT (>95 % dip in UT) <5 % UT (>95 % dip in UT) for 0.5 cycle for 0.5 cycle Voltage dips, short interrup40 % UT (60 % dip in UT) for 40 % UT (60 % dip in UT) for Mains power quality should be that of a typical commercial or hospitions and voltage variations on 5 cycles tal environment. If the user of the IPC requires continuous operation 5 cycles 70 %UT (30 % dip in UT) for 70 % UT (30 % dip in UT) for during power mains interruptions, it is recommended that the IPC be power supply input lines 25 cycles 25 cycles IEC 61000-4-11 powered from an uninterruptible power supply or a battery. <5 % UT (>95 % dip in UT) <5 % UT (>95 % dip in UT) for 5 sec for 5 sec Power frequency (50/60 Hz) Power frequency magnetic fields should be at levels characteristic of magnetic field 3 A/m 3 A/m a typical location in a typical commercial or hospital environment. IEC 61000-4-8 Note: UT is the a.c. mains voltage prior to application of the test level. Guidance and manufacturer’s declaration – electromagnetic emissions The IPC is intended for use in the electromagnetic environment specified below. The customer or the user of the IPC should assure that it is used in such an environment. Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions CISPR 11

Group 1

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

RF emissions CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations IEC 61000-3-3

Complies

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 W

Separation distance according to frequency of transmitter meters 150 kHz to 80 MHz d = 1.2√P

80 MHz to 800 MHz d = 1.2√P

800 MHz to 2.5 GHz d = 2.3√P

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 affected by absorption and reflection from structures, objects and people.

1-13

INTEGRATED POWER CONSOLE (IPC)

Part II The IPC is intended for use in the electromagnetic environment specified 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

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

Conducted RF

3 Vrms

IEC 61000-4-6

150 kHz to 80 MHz

Radiated RF

3V/m

IEC 61000-4-3

80 MHz to 2.5 GHz

3 Vrms

d = 1.2 √P

3V/m

d = 1.2 √P 80 MHz to 800 MHz d = 2.3 √P 800 MHz to 2.5 GHz 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 fixed 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 affected by absorption and reflection 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 fixed 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 fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field 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, field strengths should be less than 3 V/m.

1-14

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 extended only to the buyer purchasing the IPC System directly from Medtronic or from its affiliate 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 Intelliflow remote control (hereinafter referred to as Single Use Components) and jointly referred to as the IPC System, unless specifically noted. i. Should a System Component fail to function to Medtronic’s published specifications 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 specifications 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 specifications 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 specifications 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 notified 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 anyone 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 benefit 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 conflict with applicable law, the validity of the remaining portion of the Limited Warranty shall not be affected, 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 fluids suspected or confirmed with a Transmissible Spongiform Encephalopathy / Creutzfeldt-Jakob Disease (TSE/CJD) diagnosis. The following are recommended guidelines and may vary according to specific 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 confirmed or excluded. Reusable equipment should be quarantined after having been cleaned, decontaminated, sterilized and packed in a rigid sealed container until final 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 confirmed with a TSE diagnosis be incinerated. Contact your Sales Representative to purchase replacement products or secure loaner equipment. For additional information contact your Customer Service Representative.

1-15

TRITON ELECTRIC HIGH-TORQUE HANDPIECE

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.

BEFORE USE Clean and sterilize the device, prior to first use. Refer to the reprocessing instructions contained in this manual for additional information.

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 handpiece in a position to allow easy insertion of the Sagittal Saw Key (Figure 2-1). Note: You can install the attachment in 12 different positions to facilitate proper surgical access. 2. Insert the Sagittal Saw Key into the attachment and turn counterclockwise until there is slight resistance. 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 briefly, 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 counterclockwise.

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.

Figure 2-2. Reciprocatting Saw Assembly

1. Loosen the collet nut then insert the blade until it is fully seated (Figure 2-2). Note: You can install the attachment in different positions to facilitate proper surgical access. 2. Finger-tighten the collet nut. Run briefly, 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.

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

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.

2-1