IPC Models EC300 and 1898001 Service Manual Console and Attachments March 2009

Notice This manual is provided primarily for information purposes. Although there are certain troubleshooting actions that may be attempted by the customers as specifically listed in this manual, the majority of repairs must be undertaken by Medtronic Xomed or its authorized representative it otherwise being unsafe to maintain or repair this device.

Released documents are available for viewing/printing @ www.medtronicENT-TechComms.com ™ are trademarks and ® are registered marks of Medtronic, Inc. Jacobs Chuck® is a registered mark of Jacobs Chuck Manufacturing Company The information contained in this document was accurate at time of publication. Medtronic reserves the right to make changes in the product described in this manual without notice and without incorporating those changes in any products already sold. 2

Symbols...4 General...4 Definitions ...4 Warnings and Precautions...4 Warnings... 4 Precaution... 5 System Description...5 Sales and Customer Care...5 U.S. Customers... 5 Medtronic Xomed, Inc. . ... 5 U.S. Help Line... 5 Medtronic Powered Surgical Solutions... 5 U.S. Help Line... 5 International Service... 5 Components...5 Integrated Power Console... 5 Console Front... 5 Connector Panel... 6 Connector Panel Cable Connection... 6 Connector Panel Cable Disconnection (multi pin)... 6 Cable Disconnection (single pin)... 6 Console Rear... 6 Console Pump Designator... 7 Console Specifications... 7 Irrigation/Coolant Pumps... 7 Pump Cartridge Set-up... 7 Visao® Pump Cartridge... 8 Visao® Coolant Pump Set-Up... 8 Standard Pump Set-up... 8 Accessories/attachments...8 Multifunction Foot Control Unit (FCU)... 8 Intelliflow Irrigation Remote Control... 8 Endo-Scrub® 2 ... 8 Endo-Scrub® 2 Assembly... 9 Suction Irrigator... 9 Suction Irrigator Adapter Kit... 9 Handpieces Microdebriders and SC1...9 Straightshot® M4, Microdebriders, and Midas Rex® SC1.9 Technical Specifications... 10 Straightshot® Magnum® II and Straightshot® III Microdebriders... 10 Technical Specifications... 10 Handpieces Drills...10 Visao® High-Speed Otologic Drill (Water-Cooled)... 10 Technical Specifications... 10 Skeeter® Ultra-Lite Oto-Tool System Set-Up and Use. 10 Technical Specifications... 10 Midas Rex® Legend EHS® Motor... 10 Technical Specifications... 11 Midas Rex® Legend EHS Stylus® Motor ... 11 Technical Specifications... 11 System Overview...11 Set-Up...12 Inspect:... 12 Configure System:... 12 Functional Test... 12 Main Screen... 12 Power Down... 13 Cleaning... 13 Calibration... 13 Settings Screen... 13 Console Test-Electrical Safety Specifications ... 13 Troubleshooting...15 Error Code... 16 Changing the Fuse ... 17

Symbols N

Serial Number Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See http://recycling.Medtronic.Com for instructions on proper disposal of this product. Do not use if package is open or damaged

Package Contents

1 2

Pump Head 1 Pump Head 2 Use by Date Do not Reuse

LOT

Lot Number Fuse

ACC

REF REF

Accessory Catalog Number

AC power Output Is approximately equal to

STERILE R Sterilized by radiation. Do not use if package is open or damaged

STERILE

Non sterile

STERILE EO Sterilized by ethylene oxide. Do not use if package is

EC REP 0123

Table of Contents

open or damaged Authorized representative in the european community

This device complies with medical device directive 93/42/EEC

0086 Rx Only

Caution: federal law (U.S.A.) Restricts this device to sale by or on the order of a physician

! USA

Usa Only Quantity Manufacturer Date of manufacture Rohs - Environmental friendly use period - China (sj/ t11364-2006.)

3

>120 VAC

ON <120s

OFF >180s

Unlocked

Not greater than 120vac

On/Off (main power)

Applied part duty cycle

Use with <XX° C XX° C XX° C >X° C

Recommended storage temperature and limits. Conforms to ansi/aami es 60601-1, iec/en 606011. Certified to csa C22.2 No.601.1

Instrument Case Instrument case Lubricant/Diffuser Lubricant/Diffuser Dissecting Tool

105345

Handpiece Skeeter® handpiece

Attachment Attachment

Emc compliance mark

Refurbished Refurbished

EUR · USA · JPN · AUS

Equipotential

IPX7

M

Bone Mill Bone Mill Motor

Consult instructions for use

Brush

Brush

Attention see instructions for use

Adapter

Adapter

Protected against vertical water drops Protected against the effects of temporary immersion in water Type bf applied part Manual Start/Stop

Precaution: Pinch hazard. Keep fingers clear of rollers

BUR

Stim bur connector

NIM

Nim® console connector

EHS

Electrical high speed handpiece connector Foot pedal connector World Wide Standard for medical tubing diameter. Fine irrigant adjustment Left foot control unit button Right foot control unit button Top foot control unit button Locked

4

Regulator Regulator

Motor

Rf transmitter (interference may occur)

Fr

Control Unit Control Unit

Accessory Accessory Protective Earth

IPX1

Dissecting Tool

TOOL TUBE

Tool control Tube control

Multi-Use Disposable Attachment Multi-Use Disposable Attachment NOTE IT IS IMPORTANT THAT THE OPERATOR BE FAMILIAR WITH THIS MANUAL AND THE USER’S GUIDE WITH THEIR WARNINGS, PRECAUTIONS, PROCEDURES AND SAFETY ISSUES.

General

Uppercase Alphabetic list (A. B. C. etc.) contain introductory information where Numeric list (1. 2. 3. etc.) are “How To” instructions.

Definitions

Explaining the essential meaning of a word or acronym as used in this manual. Also explains changes in words or phrases variations from one product generation to the next. FCU – Foot Control Unit IPC™ Integrated Power Console I.V. Intravenous NIM® Nerve Integrity Monitor - One or all of the following units: NIM-Response®, NIM-Pulse®, NIM-Response® 2.0, NIM-Pulse® 2.0, NIM-Neuro® 2.0, NIM-Response® 3.0, NIM-Pulse® 3.0, NIM-Neuro® 3.0 Nomenclature The act or process or an instance of naming

Warnings and Precautions Warnings W1 The IPC™ shall only be serviced by trained technicians at an authorized Medtronic service facility W2 The IPC™ contains live circuitry that can cause injury or death if the enclosure is opened.

W3 The IPC™ contains live circuitry that can cause injury or death to operators or patients if assembled incorrectly. This document and the documents referenced herein are not sufficient to guarantee correct assembly and operation of the device. Product specific training and product specific test equipment is required to ensure the correct operation and assembly of the IPC™. W4 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. W5 Auxiliary Power Outlet with protective cover is for use with the HydroDebrider™, or Bone Mill consoles only.

Precaution

P1 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.

System Description

The IPC™ System is a powered microdebrider, drill and saw system that will remove soft tissue, hard tissue, bone, and biomaterials during surgical procedures. The system consists of a power control console, footswitch, connection cables, and assorted handpieces to drive various burs, blades, drills, rasps, cannulae, and saws. It includes integrated irrigation pumps for irrigation of blades, burs and for motor coolant. 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. The system can be used to clear the end of a rigid rod endoscope in order to maintain good visualization of endoscopic procedures without having to remove the scope from the surgical site. This device is intended for use by physicians trained in the procedures described.

Medtronic will contact your facility promptly with a repair cost estimate if requested. The customer will be responsible for freight charges on non-warranted units. 6. When you have loaner equipment and you receive your repaired unit, please package the loaner equipment as safely as possible using the foam provided with your repaired equipment. Include paperwork indicating the unit is a loaner, and Medtronic will credit your account. 7. Loaner equipment not received by Medtronic within 30 days from the date that repaired equipment is shipped will be invoiced at full purchase price.

Medtronic Xomed, Inc. 6743 Southpoint Drive North Jacksonville, FL 32216 USA www.medtronicENT.com

U.S. Help Line (800)-874-5797.

Medtronic Powered Surgical Solutions 4620 North Beach Street Fort Worth, TX 76137 USA www.medtronic.com

U.S. Help Line (800) 468-9710

International Service

International customers should contact their local Medtronic representative.

Components Integrated Power Console Console Front

Sales and Customer Care

Medtronic is committed to provide the highest standard of workmanship in manufacturing its products. Your system requires minimal maintenance and calibration. Servicing and/or modification to the system, or any accessory/ attachment by anyone other than qualified service personnel may significantly compromise the systems performance and void the equipment warranty. For best performance, it is recommended that all service be performed by Medtronic Xomed service personnel. Medtronic recommends preventative maintenance and screen calibration scheduled at yearly intervals. Comprehensive testing and calibration should be performed by returning the entire system to Medtronic Customer Service.

A

B

U.S. Customers

Should your console or related equipment malfunction, Medtronic provides, at no charge, loaner equipment shipped to your facility by UPS or Federal Express for use while your equipment is being serviced by Medtronic. Please adhere to the following guidelines: 1. When a loaner console is ordered, please reuse the shipping material and carton when you return your console to Medtronic. Insure the unit. 2. When a loaner is not ordered, please package the console as safely as possible and insure. 3. A return goods authorization number is required on repairs. A copy of your purchase order is required. Make certain the purchase order includes the following: • Shipping and billing information • Purchase order number • Contact person • Phone number • Description of malfunction • Your Medtronic account number 4. Please indicate preferred method of return shipment. Otherwise the unit will be shipped back via UPS ground. 5. When the malfunctioning unit is not covered by warranty,

C

E

D

A. Touchscreen – User interface. B. Pump 1 – Coolant, lens cleaning, or irrigation. C. Pump 2 – Irrigation. D. Connector Panel - peripheral devices. E. Power Switch – System On/Off switch.

5

Connector Panel

To Remove cables (multi pin) with polymer insulating boots: E

1

2

A

A

Port # A B

C

B

D

G

F

Component

H

Quantity

Midas Rex® Legend EHS® motor.

1

Midas Rex® Legend EHS Stylus® motor.

1

StraightShot® M4 Microdebrider Straightshot® Magnum® II Microdebrider C

Straightshot® III Microdebrider

1

Midas Rex® SC1

NOTE: Confirm handpieces contain polymer insulating boot (A). If handpiece contain missing or cracked polymer boots, contact Medtronic Customer Care for upgrade. NOTE, If units with polymer insulating boots have debris under the insulator: • Reclean according to Cleaning and Sterilization instructions. • If debris was not removed return for warranty servicing. See warning W4. 1. Push the cable towards the console. 2. Then pull out by the polymer insulating boot (A). To Remove cables (multi pin) with silicone insulating boots:

Visao® D

Stimulus input from Patient Interface connection (NIM).

1

E

Stimulus output to STIM Bur Guard.

1

F

Skeeter® Handpiece

1

Endo-Scrub® 2 Finger Switch G

Endo-Scrub® 2 Footpedal

1

IntelliFlow Irrigation Remote Control. H

Foot Control Unit (FCU)

1

Connector Panel Cable Connection

Cable to console connection red/silver dot Red or silver dot connections are multi pin and must be correctly aligned (oriented). Cable to console connection without dot Connectors without the red or silver dot are single pin and may be inserted without regard to orientation.

Silicone insulated connectors do not have a locking device (ring) and may be removed by pulling straight out on the connector.

Cable Disconnection (single pin)

Single pin connectors do not have a locking device (ring) and may be removed by pulling straight out on the connector.

Console Rear

A

Connector Panel Cable Disconnection (multi pin)

To Remove Midas Rex® Legend EHS® Motor and Legend EHS Stylus® Motor, Cable from motor or console: A

2

1

1. Push the cable towards the motor or console. 2. Then pull out by locking ring (A). To Remove Midas Rex® Legend EHS Stylus® Cable from console:

B

C D E

G H I

A F

Push the cable towards the console, then pull by locking ring (A)

A. Pole Clamp. B. Compact Flash Card port (factory use only). C. Manual Start Stop Button D. Fuse Access – Replace only with 5 x 20 T. L. 5A, 250V fuse. E. Auxiliary Power Outlet with protective cover: • For use at grid voltage < 120VAC only. 6

• HydroDebrider™, or Bone Mill consoles only. See Warning W5. F. To remove cover, place small screwdriver in notch at bottom and pull/pry off. G. Endo-Scrub® 2 - power connector. H. Power Cord Connector: See Appendix B for part numbers. • Hospital grade power cord connects here. • Means of disconnecting device from Mains voltage by the power cord. I. Equipotential: • Uniform potential. • Means for eliminating noise or interference with sensitive equipment by application of a POTENTIAL EQUALIZATION CONDUCTOR.

Console Pump Designator

A

C

B D

Pump Setup Irrigation Method HANDPIECE

SUCTION IRRIGATOR D

C

Pump 1

Pump 2

Visao

Cooling

Suction Flush

Irrigator

Flush

Pumps

A. Pump 1– Coolant, lens cleaning, or irrigation. B. Pump 2 – Irrigation. C. Pump 1 Designator – This designator number is used to coordinate the “Pump Task” (pump setup panel pump number) with the “Pump Number” (number on the side of the pump) and the “Irrigation/ Coolant Cartridge” (number on the cartridge). When setting up the console all of these numbers must be the same. D. Pump 2 Designator – This designator number is used to coordinate the “Pump Task” (pump setup panel pump number) with the “Pump Number” (number on the side of the pump) and the “Irrigation/ Coolant Cartridge” (number on the cartridge). When setting up the console all of these numbers must be the same. NOTE: Not all Pump Cartridges have pump designator numbers. For these cartridges the operator should view the Pump Setup Screen prior to installing the cartridge.

Console Specifications Functional Standards for Electric Systems

ANSI / Medical electrical equipment -- Part 1: General AAMI: - ES requirements for basic safety and essential performance 60601-1 IEC Medical electrical equipment -- Part 1: General 60601-1 requirements for basic safety and essential performance EN - 60601- Medical electrical equipment -- Part 1: General 1 requirements for basic safety and essential performance (IEC 60601-1:2005)) IEC - 60601- Medical Electrical Equipment – Part 1: General 1-4 Requirements for Safety, Part 4: Programmable Electrical Medical Systems EN - 60601- Medical Electrical Equipment – Part 1-2: General 1-2 Requirements for Safety – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests CSA - C22.2 Medical Electrical Equipment - Part 1: General No. 601.1 Requirements for Safety.

2005 2005 2006 2000 2001/ A1: 2006 2005

Physical Dimensions Size: 277mm W x 353mm H x 267mm D Weight: 7.3kg 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 / Touch Screen Type: High contrast, digital, graphic Color, visible in complete darkness. Resolution: Display 21cm diagonal, resolution 480 X 640 pixels Audio Output Baseline Audio Sound Level 60dBA minimum SPL (1m) Electrical Input Voltage 100V-240V ± 10% Frequency 50/60 Hz Power Consumption: 500VA Auxiliary AC output: 200VA Max. Internal Fuse 5 x 20mm T. L. 5A, 250V Medtronic Xomed P/N 11270066 Duty Cycle for Applied Part Maximum On Time 120 Seconds Minimum Off Time 180 Seconds

Irrigation/Coolant Pumps Pump Cartridge Set-up

The Pump Cartridge snaps onto the lower section of the pump. 1

2

3

7

Visao® Pump Cartridge

The Visao® Pump Cartridge has both a pump tube and a return tube. B

A

C

A. Pump tubing. B. Pump tubing is clipped into the Pump Cartridge. C. Return tube.

Visao® Coolant Pump Set-Up

The Pump Cartridge snaps onto the lower section of pump # 1. 1

3

2

Standard Pump Set-up

Drills A. Foot Pedal - Start/Stop, Variable speed. Aa. Non-Slip Foot Pad. B. Right Button - Pedal function, (Start-Stop or Variable speed). C. Top Button - Active handpiece selection D. Left Button - Mode selection, (FWD/REV). Microdebrider A. Pedal Start-Stop, Variable speed (Start/Stop, or Variable speed selectable via FCU button on Main Screen). B. Right Button - IF Mode is set to OSC this button will, rotate inner tube on blades 180º. IF Mode is set to FWD this button will, select Pedal function (Start/Stop, or Variable speed). C. Top Button - Active handpiece selection. D. Left Button - Mode/RPM selection - FWD/OSC (FWD @ 12000) (OSC @ 5000, 3000, 1500, or 300). SC1 A. Pedal Start-Stop, Variable speed (Start/Stop, or Variable speed selectable via FCU button on Main Screen). B. Right Button - IF Mode is set to OSC or CUT this button will, rotate inner tube on blades 180º. IF Mode is set to FWD this button will, select Pedal function (Start/Stop, or Variable speed). C. Top Button - Active handpiece selection. D. Left Button - Mode selection -FWD/OSC/CUT. NOTE: If any of these condition are different check your set-up, if still incorrect contact Customer Service.

Intelliflow Irrigation Remote Control

3

2

1

Buttons and Pedal NOTE: Each button must be depressed and held for one (1) second to activate its function.

Tips on loading the pump

A. Pause/On-Off: • Pause if used with handpiece irrigation (Flow rate will flash yellow). • On-Off/Pause if used with Suction A Irrigator. B. Increase/Decrease: B • Handpiece Irrigation - fine adjustment for irrigation rate. C • Suction Irrigator - fine adjustment for irrigation rate. C. Increase/Decrease: • Handpiece Irrigation - coarse adjustment for irrigation rate. • Suction Irrigator - selects stainless steel (Fr) tubing size.

Endo-Scrub® 2

Accessories/attachments Multifunction Foot Control Unit (FCU) Part No. 1898430 or EF200

NOTE: Can be used only with a microdebrider. 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 finger switch. It is not to be used for infusion, for disinfection or sterilization of an endoscope, or for suction removal of blood and debris. NOTE: Use the Endo-Scrub® 2 sheath only with an endoscope listed on the sheath product label, as malfunction or poor performance could result.

4 D

C

A

Aa

8

B2

1 A

D

B

A. Endo-Scrub® 2 Sheath. B. Endoscope. C. Light source connection. D. Irrigation connection.

C3

E5

F6

C. Suction Fitting. D. Irrigation Fitting. E. Tube Size. NOTE: The Suction Irrigator shown here is available to all drills provided a microdebrider is not attached to the console.

Suction Irrigator Adapter Kit E. Endo-Scrub® 2 Finger switch. F. Finger switch cable. 7 G

8 H

C3

B2

A1

4 D

G. Endo-Scrub® 2 Footswitch. H. Endo-Scrub® 2 Footswitch cable.

Endo-Scrub® 2 Assembly

A. Blue Irrigation Tube Adapter fits high speed irrigation tubing 3318503. B. White Irrigation Tube Adapter fits IPC™ Visao® irrigation tubing 3318603. C. Irrigation Connector Set is used to adjust the Blue or White Adapter to the stainless steel Irrigation Fitting. D. Irrigation Fitting.

1

2

Handpieces Microdebriders and SC1 Straightshot® M4, Microdebriders, and Midas Rex® SC1

1. Wet. 2. Slowly insert. 3

2 B

1 A 7 G

C3

4 D

E5

3. Attach irrigation and light source.

Suction Irrigator

The Suction Irrigator may be selected via the radio button within the Irrigation Method box. NOTE: The suction irrigator is NOT available for microdebrider handpieces. Suction Irrigator Handpiece. A1

B2

F6

A. Handpiece. B. Finger wheel. C. Locking collar. D. Irrigation-tubing groove. E. Finger-wheel lock. F. Cable. G. Suction barb.

E5 4 D

C3

A. Suction Tube. B. Irrigation tube. 9

Technical Specifications

Technical Specifications

StraightShot® M4 Microdebrider Part No. 1898200T Midas Rex® SC1 Part No. ED100 Speed 50-5,000 RPM oscillate 50-12,000 RPM forward Size 14.3 cm length x 1.8 cm width (1898200T) Weight 228 g 1898200T 240 g 1897200 254 g 1897200T 240 g 1897201 Duty Cycle The StraightShot®, M4, and SC1 Handpiece under full load are rated for intermittent operation per the following: Maximum On Time 60 seconds Minimum Off Time 30 seconds NOTE: If any of these condition are different check your set-up, if still incorrect contact Customer Service.

Visao® High-Speed Otologic Drill Part No. 3334800 Speed 200-80,000 RPM forward/reverse, Water-Cooled Size 16.0 cm length x 2.0 cm diameter Weight 148 g Duty Cycle The Visao® High-Speed Otologic Drills under full load are rated for intermittent operation per the following: Maximum On Time: 60 seconds Minimum Off Time: 30 seconds

Straightshot® Magnum® II and Straightshot® III Microdebriders 3 C

B2 A1

Skeeter® Ultra-Lite Oto-Tool System Set-Up and Use 1 A

B2

C3 5 E

4 D

A. Tool B. Tool’s color code. C. Tool lock/release button. D. Cannulated shaft. E. PTFE Bearing.

Technical Specifications

4 D

A. Basic handpiece B. Suction barb C. Locking collar D. Cable

Technical Specifications

Handpiece - Straightshot® Magnum® II, Part No. 1897200 Straightshot® III Part No. 1897201 Size 17 cm length x 1.6 cm diameter (1897200) Speed 50-5,000 RPM oscillate 50-12,000 RPM forward Size 17 cm length x 1.6 cm diameter Weight 240 g Duty Cycle Under full load are rated for intermittent operation per the following: Maximum On Time 60 seconds Minimum Off Time 30 seconds

Handpieces Drills

Caution: do not use Xcalibur or Powerforma handpieces with the IPC™ console.

Visao® High-Speed Otologic Drill (Water-Cooled) B2

Part No. Speed Size Weight Duty Cycle Storage Temperature: Humidity: Barometric Pressure:

3055601 1,000-16,000 RPM forward/reverse 17 cm length x 1.6 cm diameter 57 g Continuous run -40°C to +70°C 10% to 100% RH 500 to 1060 hPa

Midas Rex® Legend EHS® Motor

High speed, high torque, reversible electric motor used to dissect bone and biomaterial at selectable speeds from 200 to 75,000 RPM. A1 2 B

C3

D4

A. Midas Rex® Legend EHS® Motor. B. 4-pin cable connection. C. Rotational collet. D. Stationary collet. Legend EHS® Motor Cable Connects the motor to the console. B2

A1

C3

A1 4 D

4 D

C3

A. Handpiece B. Cable C. Cable clip D. Cooling barbs E. Locking collar

10

E5

B2

C3

A. 4-pin connector. B. Locking sleeve. C. Green boot. D. Cable.

Motor Collet Prior to installing an attachment, ensure that arrows on the motor collet are in proper alignment. 1

2

Technical Specifications Legend EHS Stylus® Motor Part No. EM200 Speed 200-75000 RPM forward/reverse Size 7.77 cm length x 1.65 cm diameter Weight 90 g Duty Cycle (To avoid overheating): • For continuous use in operating room temperatures up to 40°C, the Legend Stylus™ Motor is rated for 3 minutes at 60,000 RPM, followed by 25 minutes of rest. • For normal operating room temperatures (typically 20°C) the Legend Stylus™ Motor is rated for continuous cutting indefinitely at 60,000 RPM.

System Overview

3

1. Improperly aligned collets. 2. Properly aligned collets. 3. Motor side attachment alignment arrow.

B

If the arrows are not aligned, use the Motor Wrench to turn the rotational collet until its arrow is aligned with the arrow on the stationary collet.

A

Technical Specifications

Part No. EM100-A Speed 200-75000 RPM forward/reverse Size 9.02 cm length x 2.03 cm diameter Weight 180 g Duty Cycle (To avoid overheating): • For continuous use in operating room temperatures up to 40°C , the Legend EHS® Motor is rated for a cutting time of 3 minutes, at 70,000 RPM. • For normal operating room temperatures (typically 20°C ) the Legend EHS® Motor is rated for a continuous cutting time of 10 minutes followed by 25 minutes of rest. • The Legend EHS® Motor is rated for intermittent use of 20 seconds ON / 20 seconds OFF, indefinitely at 70,000 RPM.

D

E H

Midas Rex® Legend EHS Stylus® Motor

F

A smaller compact high speed, high torque, reversible electric motor used to dissect bone and biomaterials at selectable speeds from 200 to 75,000 RPM. The Midas Rex® Legend EHS Stylus® Motor cable is integral with the Handpiece and is not removable from the motor. 1 A

4 D

C

I

J

B2

G

C3

K

E5

F6

7 G

8 H

A. Midas Rex® Legend EHS Stylus® Motor. B. Cable. C. Rotational collet. D. Stationary collet. E. Ground connector. F. 4-pin connect G. Locking sleeve. H. Black boot.

A. Irrigation and Coolant Bags. B. Irrigation Pole. C. Integrated Power Console™. D. Pump 1 coolant, lens cleaning, or irrigation. E. Pump 2 irrigation. F. Power Cord. G. Irrigation Pole Basket for Footswitch. H. Console Connector Array (see also Accessories/Attachments and Handpieces Drills). I. Accessory Cables. J. Maximum height from floor 89cm. K. Minimum base diameter 53cm.

11

Set-Up

Main Screen

During the boot up/self-test operation the IPC™ will identify attachments such as handpiece(s) foot pedal etc. Actual screen displayed is dependent on attachment found. The following generalized screen is meant to familiarize the technician with adjustments available.

1. Visually inspect: • the entire console for signs of cracks or other damage. • the front and back connector panel for damaged or loose connectors • air inlet and exhaust on the bottom and rear of console is clean and free of debris. 2. Check that the handle is securely attached to console and slowly rotate the IPC™ to an inverted position while listening for loose material inside the enclosure. 3. Ensure pole clamp is securely attached to console and knob spins freely.

Ac

60

cc/min

12000

Prime

Stylus

B

Skeeter

C Da

D

Db

EndoScrub 2

Pumps

?

Flow

Help

+

3

Dc

On

Setting

Flush

A. Handpiece Panel - This panel shows the active handpiece. Aa Speed - Variable adjustment on most handpices. Default value is handpiece specific. Ab Blade Position - Handpiece specific, allows the user to rotate the inner cutting tip of specially designed rotatable blades. Ac Irrigation - Adjust the flow rate of irrigation. Default value is handpiece specific. Ad Mode - Handpiece specific cutting mode selection. B. Augment Area - Shows supplemental information such as inactive handpiece(s), special function panel, pump panel etc. C. Special Function Panel - Shows Suction Irrigator or Endo-Scrub® 2 panel. D. Main Screen subsection Da Foot Control Unit (FCU) Button - changes foot pedal from variable speed control to On/Off. Db Pumps - Opens pump panel. Dc Help - Opens help screens.

Midas Rex SC1

SC1 Handpiece

5000 12000 1 5000 12000

StraightShot M4 StraightShot 50-5000 50-12000 Microdebrider M4 EndoScrub 2 Optional 5000 Straightshot III StraightShot 50-5000 Microdebrider M4 50-12000 12000 EndoScrub 2 Optional Straightshot 50-5000 5000 StraightShot Magnum II M4 50-12000 12000 Microdebrider EndoScrub 2 Optional Midas Rex Legend EHS 200-75000 70000 EHS® motor. Suction Irrigator Optional Midas Rex Legend Stylus 200-75000 60000 EHS Stylus motor Suction Irrigator Optional Skeeter Handpiece Skeeter 1000-16000 16000 Suction Irrigator Optional

X X

X

X

X

X

Suction Irrigator

50-5000 50-12000

X

X

Pump 2

Irrigation

X

EndoScrub 2

80000 80000

Irrigation

200-80000 200-80000

Cooling

Visao

Pump 1 Cut (1 revolution)

Visao

Mode Osc (Oscillate)

Touchscreen Display Name

RPMs

Rev (Reverse)

Handpiece Name

Suction Irrigator Optional

12

Fwd Mode

+

Flow

Initialization in Progress...

1. Turn power switch ON and verify: • the power switch operates smoothly • switch lamp illuminates • fan on bottom of device is turning by listening for fan noise. • The Splash Screen is displayed while the system is starting up and executing its self tests • System passes self test • Default screen opens.

300

Irrigation

Handpiece Touchscreen Default Value Table

Setting

1500 180°

Fwd (Forward)

C O N S O L E

3000

Default RPMs

INTEGRATED POWER

5000

+ 5000 RPM

Blade Position

Ab

Configure System:

Functional Test Splash Screen

Speed

Aa

Inspect:

4. On Irrigation pole, mount IPC™ and irrigation/coolant bag(s). Note: Irrigant and coolant bags should be placed above the console to ensure adequate flow. 5. Position the IPC™ in a manner that does not obstruct the power inlet for the purpose of disconnecting the Mains voltage by the power cord. Plug unit into power source. 6. Connect FCU. 7. Connect the accessories to console (test all accessories available one at a time). 8. Irrigation/Coolant Pumps • Connect tubing as needed (suction, cooling, irrigation).

StraightShot M4 Ad Osc Mode

A

RPM Range

General instructions for set-up, inspection, and use of the Integrated Power Console. The IPC™ is designed to require no regular maintenance or service. The following recommended sustaining care may be performed annually or at more frequent intervals to extend the life of the IPC™. NOTE: Use sterile water or saline for irrigation and cooling.

X

X

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1. Prime irrigation and cooling. See Precaution P1. a. Adjust clamp on the irrigation tubing to OPEN. b. Manually prime the clear drip chamber (if used). c. Depress and release the prime button on the touch screen panel. Verify: • Pump(s) run until all air has been purged out of the tubing. • A small amount of irrigant is observed flowing at the tip of irrigation device(s). • Pump(s) turns off. 2. Confirm system operation. Verify: • Pedal (Coolant): Starts handpiece and coolant flow (coolant pump continues to run for 1 minute after pedal is released). • Pedal (Irrigation): Starts and stops the handpiece and irrigation flow (At this step you should also verify that the characters on the SPEED display changed from white (set RPMs) to yellow (actual RPMs)). • Left Button: Changes Mode selection (FWD, REV, OSC, or CUT/ Cut Direction). • Top Button: Change Handpiece Selection if there are additional handpieces. • Right Button: Changes pedal operation from Start/Stop or Variable speed. 3. Disconnect the FCU and press OK on the touchscreen. 4. Depress the intraoperative button on the back of the console. Verify: • Starts and stops the handpiece, irrigation and/or coolant flow. 5. Touch Screen Verify: • Speed can be adjusted. • Mode can be changed. • In oscillate and cut modes check: • The Blade Position panel opens. • The clockwise and counterclockwise buttons move the position indicator and blade in the appropriate direction. • Depressing the 180° button moves the position indicator and blade 180°. • Flow rate for irrigation is adjustable.

Power Down

1. Turn power switch Off. 2. Disconnect: a. Accessories. b. Suction, irrigation, and coolant tubing. c. Power cord. 3. Discard disposables following health-care facility guidelines on contaminated materials. NOTE: If any of these condition are different check your set-up, if still incorrect contact Customer Service.

Cleaning IPC™, Foot Control Unit, and Endo-Scrub® 2 Footswitch • Do not immerse or sterilize the units. • Do not use alcohol, other solvents, or abrasive cleaners. 1. Wipe down the IPC™, Foot Control Unit, and Endo-Scrub® 2 Footswitch with a cloth dampened with a neutral enzymatic detergent, pH 6.0-8.0 or phenol based disinfectant. Non-Slip Pad ONLY 1a. Spray a neutral enzymatic detergent, pH 6.0 – 8.0, or a phenol based disinfectant, mixed to manufactures instructions, directly onto foot pad. 1b. Allow the solution to remain in contact with the surface for approximately 10 minutes. 1c. Wipe the solution or disinfectant off the foot pedal until visually clean. 2. Dry the units with a clean, non-abrasive cloth. NOTE: If debris is found under the Foot Control Unit’s boot, return for warranty service.

Calibration Settings Screen Settings Language

English Français Italiano Deutsch Español

Touch Screen Calibration

OK

Cancel

During the boot up/self-test operation the Splash Screen will display the Setting button for about 5 seconds. To change language or calibrate the touch screen you must depress this button while it is displayed. 1. To calibrate the screen: a. Depress the large “Touch Screen Calibration” button in center of the screen. b. Follow on screen instructions.

Console Test-Electrical Safety Specifications

See also Block Diagram Precaution Each IPC™ has been factory tested to the dielectric and ground bond test levels described within this section. These levels are in accordance with IEC/AAMI/EN 60601-1 Third Edition. Only technicians familiar with the 60601-1 standard and adequately trained in performing testing to the 60601-1 standard shall perform the dielectric and ground bond tests described within this section. Protectively Earthed Exposed Metal Applicable components: Equalization Terminal (PN 11190620) and Components in direct contact with the Back Panel (PN 11683316). Applicable test: 25 Ampere/60Hz ground bond for 5 seconds, (per IEC 60601-1 Clause 8.6.4.a) Applicable result: <100 milli-Ohm impedance Floating Metal Applicable components: Pole Clamp (PN 66320173) and bezel of irrigation port in Connector Panel (PN 44681784 or PN 11249350) Applicable test: 4000VAC high potential, 60Hz, 60 seconds, 10 second ramp-up (per IEC 60601-1 Clause 8.8.3) Applicable result: <10mA leakage Metal Shells of Type BF Electrical Connectors Applicable components: Shells of footswitch, 12-position handpiece, and 4-position handpiece connectors of Connector Panel (PN 44681784 or PN 11249350) Applicable test: 2500VAC high potential, 60Hz, 60 seconds, 10 second ramp-up (per IEC 60601-1 Clause 8.8.3) Applicable result: <10mA leakage

13

Symptom Enclosure, pump, or touchscreen is cracked Loose material inside enclosure Handle is loose or damaged Pole clamp is loose or damaged Air inlet is blocked Mains switch is damaged/non-functional/does not latch Mains switch lamp does not illuminate, unit functional Fan does not turn Console does not power on (power lamp on)

Troubleshooting

Cause Solution (Customer) Mechanical impact to affected component Loose or damaged component due to Contact customer care. mechanical impact or vibration Mechanical damage to handle Mechanical damage to pole clamp Screen is obstructed with debris Use a dry soft bristle brush to dislodge debris (vacuum) Component cracked, worn, obstructed by debris Hardware fault.

Contact customer care.

Console does not power on (power lamp off)

Blown Fuse Replace fuses. REF 1898125 - Fuses, 5A/250V 2/Pack Mains cable not connected properly or Check mains connection, replace faulty mains cable if damaged necessary

Display not visible (power lamp on) Display contains horizontal/vertical lines or color streaks

Hardware fault.

Incorrect language displayed

Language set incorrectly.

Touchscreen does not respond correctly

Touchscreen not calibrated.

Touchscreen not responsive (cannot be calibrated) Pump does not turn Pump is noisy (erratic motion) Pump is noisy, but functional

Hardware fault.

Contact customer care.

Incompatible tubing

Use only Medtronic approved tubing sets

Hardware fault.

Contact customer care

Incompatible or incorrect tubing Incorrect irrigation setting Tubing occluded

Use only Medtronic approved tubing sets Verify correct settings in “Pump” set-up screen Ensure tubing is not pinched or occluded by roller/slide clamps, or tissue. Ensure fluid source is above pump.

Mechanical damage to panel

Contact customer care.

Little or no irrigation/cooling flow Damaged or loose connector on connector panel Damaged or loose connector on back panel

Contact customer care. Cycle power on console. Press “Settings” button on display during initial boot up and select desired language. Cycle power on console. Press “Settings” button on display during initial boot up and perform touchscreen calibration.

Mechanical damage to component Mains cable not connector properly or damaged Blown fuse Hardware fault.

Contact customer care. Check mains connection, replace faulty mains cable if necessary No line voltage on AC outlet Replace fuses. REF 1898125 - Fuses, 5A/250V 2/Pack Contact customer care. Verify handpiece/accessory plug is not damaged. Verify Handpiece or accessory will not connect Damaged connector correct boot is installed. Handpiece not recognized See Error Code 11 through 14 troubleshooting Check faulty FCU by using manual switch on back of Handpiece or FCU fault console. Handpiece recognized, but does not run Hardware fault. Contact customer care. Handpiece fault FCU pedal obstructed Check for obstructions below/near pedal Handpiece does not reach full speed FCU fault Contact customer care. Hardware fault. (Console) Contact customer care. Handpiece does not reach full speed or is noisy Collet unlocked Lock collet Handpiece fault Wrong handpiece identified Contact customer care Hardware fault. Footswitch not recognized See Error Code 17 Hardware fault. Contact customer care Footswitch buttons not correctly recognized FCU fault Disconnect FCU. Manual switch is disabled when FCU FCU connected is connected. Manual switch does not run handpiece Hardware fault. Contact customer care Console fails 4kVAC hi-pot Hardware fault. Contact customer care Console fails 2.5kVAC hi-pot Hardware fault. Contact customer care

15

Symptom Error Code 1 displayed Error Code 3 displayed Error Code 4 displayed Error Code 5 displayed Error Code 6 displayed Error Code 7 displayed Error Code 9 displayed Error Code 10 displayed Error Code 11 displayed Error Code 12 displayed Error Code 13 displayed Error Code 14 displayed Error Code 15 displayed Error Code 16 displayed Error Code 17 displayed Error Code 19 displayed Error Code 20 displayed Error Code 21 displayed Error Code 23 displayed Error Code 24 displayed Error Code 25 displayed Error Code 26 displayed Error Code 27 displayed Error Code 28 displayed Error Code 29 displayed Error Code 30 displayed Error Code 31 displayed Error Code 32 displayed Error Code 33 displayed Error Code 34 displayed Error Code 35 displayed Error Code 36 displayed Error Code 37 displayed Error Code 38 displayed Error Code 39 displayed

16

Cause Internal communication fault

Error Code

Solution (Customer)

Contact customer care

Pump 1 stalled Check tubing / contact customer care Pump 2 stalled Unrecognized/damaged handpiece plugged in on Port 1 (left most 12 position) Unrecognized/damaged handpiece plugged in on Port 2 (right most 12 position 12 pin) Unrecognized/damaged handpiece plugged in on Port 3 (4 position) Possible handpiece or console problem, contact customer care Unrecognized/damaged handpiece plugged in on Port 4 (Skeeter®) Handpiece Stalled Excessive current or heat detected Unrecognized/damaged FCU plugged in

Self test failure

Contact customer care

Changing the Fuse 0

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1

2

5

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