medtronic

Medtronic Endoscopic Endo-Scrub System

Endoscrub 2 IPC System Service Manual for Console and Attachments Rev B May 2010

Service Manual

22 Pages

File Type: PDF

File Size: 6.68 MB

File Name: endoscrub_2_ipc_system_service_manual_for_console_a.pdf

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Page 1

Integrated Power Console (IPC™) Models EC300 and 1898001

Service Manual for Console and Attachments Rx Only

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, all repairs must be undertaken by Medtronic Xomed or its authorized representative.

Released documents are available for viewing/printing @ www.medtronicENT-TechComms.com ™ are trademarks and ® are registered marks of Medtronic, Inc. 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.

Symbols...4 General...5 Definitions ...5 Warnings and Precautions...5 Warnings... 5 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 Console Front... 6 Connector Panel... 6 Connector Panel Cable Connection... 6 Connector Panel Cable Disconnection (multi pin)... 6 Cable Disconnection (single pin)... 6 Console Rear... 7 Power Cords... 7 Console Pump Designator... 7 Irrigation/Coolant Pumps... 7 Pump Cartridge Set-up... 7 Visao® Pump Cartridge... 7 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 To Rotate the Finger Lever... 12 Technical Specifications... 12 Splash Screen... 12 Settings Screen... 12 Handpiece Default Settings Table... 13 Console Set-Up ... 13 Connect Handpiece/Footswitch Screen... 13 Console Set-Up Instructions... 13 Power Down... 14 Cleaning... 14 Console Specifications... 14

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

Manufacturer Date of Manufacture

>120 VAC

ON <120s

OFF >180s

<XX° C XX° C XX° C >X° C

Pump Head 2 105345

Use by Date Do not Reuse Lot Number

REF REF

Use with

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

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

Dissecting Tool

Attachment Attachment Control Unit Control Unit

Protective Earth

Refurbished Refurbished

Accessory Accessory

Consult instructions for use

Sterilized by ethylene oxide. STERILE EO Do not use if package is open or damaged Authorized representative E C R E P in the european community 0123

Conforms to ANSI/AAMI ES 60601-1, IEC/EN 606011. Certified to CSA C22.2 No.601.1 Handpiece Skeeter® handpiece

EUR · USA · JPN · AUS

AC power

On/Off (main power)

Catalog Number

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

Unlocked

Recommended storage temperature and limits.

Equipotential

Is approximately equal to

Locked

Applied part duty cycle

Accessory

Output

Top foot control unit button

Not greater than 120VAC

EMC compliance mark

Fuse

ACC

Right foot control unit button

ROHS - Environmental friendly use period - China (SJ/T113642006.)

Pump Head 1

LOT

Left foot control unit button

Attention see instructions for use IPX1 IPX7

Protected against vertical water drops Protected against the effects of temporary immersion in water Type BF applied part Manual Start/Stop RF transmitter (interference may occur) 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

Regulator Regulator Bone Mill Bone Mill

Motor

Brush

Adapter

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. W6 Sterilize and dry reusable device before storing the system. Decrease likelihood of cross-contamination with timely sterilization. W7 After each procedure, properly clean all reusable system components. W8 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.

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.

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, 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.

Console Front

Connector Panel Cable Disconnection (multi pin) To Remove Midas Rex® : To Remove Midas Rex® Legend EHS® Motor and Legend EHS Stylus® Motor, Cable from motor or console: A A

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:

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

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

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.

Connector Panel E

Port # A B

D E F G H

Component Midas Rex® Legend EHS® motor Midas Rex® Legend EHS® Stylus motor StraightShot® M4 Microdebrider Midas Rex® Legend EHS® Stylus Touch™ motor Midas Rex® SC1 StraightShot® Magnum® II and StraightShot® III Visao® Stimulus input from Patient Interface connection (NIM). Stimulus output to STIM Bur Guard Skeeter® Handpiece Endo-Scrub® 2 Finger Switch Endo-Scrub® 2 Footpedal IntelliFlow Irrigation Remote Control Foot Control Unit (FCU)

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).

Quantity 1 1 2 1

1 1 1 1 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. 6

To Remove cables (multi pin) with silicone insulating boots:

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

Console Pump Designator

C D E

G H I

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, 250 V fuse. E. Auxiliary power outlet with protective cover: • For use at grid voltage < 120 VAC only. • 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 sppendix 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.

Power Cords North America: United Kingdom, Continental Europe: USA, Barbados, Ireland, Hong Austria, Belgium, Finland, Belize, Bolivia, Kong, Malaysia, France, Germany, Greece, Canada, Columbia, Singapore Korea, Luxembourg, Ecuador, Venezuela P/N EA606 or Netherlands, Norway, Standard P/N EA600 1895821 Portugal, Spain, Sweden or 1895820 P/N EA602 or 1895822 6 meter P/N EA650 or 189721 China India, South Switzerland P/N EA604 Africa P/N EA601 P/N EA607 Argentina Israel Denmark P/N EA608 P/N EA609 P/N EA610 Australia, New Japan Italy, Chile P/N EA611 Zealand P/N EA603 or P/N EA605 1895823

A. Pump 1: Coolant, lens cleaning, or irrigation. B. Pump 2: Irrigation or lens cleaning. C. Pump 1 Designator – This designator number is used to coordinate the pump (by number) with the cartridge number and/or pump setup screen number listed on the touch screen. When setting up the console these numbers must match. D. Pump 2 Designator. 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.

Irrigation/Coolant Pumps Pump Cartridge Set-up The Pump Cartridge snaps onto the lower section of the pump. 1

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

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

Standard Pump Set-up

Microdebrider A. Pedal: Start/stop, variable speed (start/stop, or variable speed selectable via FCU button on Main Screen). B. Right Button: In OSC Mode this button will rotate inner blade 60°/180º (touchscreen selected). In FWD Mode this button will select Pedal function (Start/stop, or variable speed). C. Top Button: Active handpiece selection. D. Left Button: Mode/RPM selection 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 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 NOTE: If any of these condition are different check your set-up, if still incorrect contact Customer Service.

Intelliflow Irrigation Remote Control 3

Tips on loading the pump

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

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

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. B2

1 A

A 4 D

Buttons and Pedal NOTE: Each button must be depressed and held for a definable amount of time (100 mS by default). 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).

A. Endo-Scrub® 2 Sheath. B. Endoscope. C. Light source connection. D. Irrigation connection. E5

E. Endo-Scrub® 2 Finger switch. F. Finger switch cable.

Suction Irrigator Adapter Kit 7 G

8 H

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

4 D

Endo-Scrub® 2 Assembly 1

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.

Handpieces Microdebriders and SC1

1. Wet. 2. Slowly insert. 3

StraightShot® M4, Microdebriders, and Midas Rex® SC1 2 B

1 A

3. Attach irrigation and light source.

Suction Irrigator

7 G

4 D

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.

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

A. Suction Tube. B. Irrigation tube. C. Suction Fitting. D. Irrigation Fitting. E. Tube Size. NOTE: The Suction Irrigator shown here is available for all drills provided a microdebrider is not attached to the console. 9

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.

StraightShot® Magnum® II and StraightShot® III Microdebriders

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

Technical Specifications 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

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

3 C

5 E

B2 A1

4 D

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

4 D

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

Technical Specifications

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

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

Handpieces Drills

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

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

4 D

A. Handpiece 10

2 B

A. Midas Rex® Legend EHS® Motor. B. 4-pin cable connection. C. Rotational collet. D. Stationary collet.

Midas Rex® Legend EHS Stylus® Motor

Legend EHS® Motor Cable Connects the motor to the console. B2

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

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

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.

Technical Specifications 2

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

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.

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.

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.

Midas Rex® Legend EHS® Stylus Touch™ Motor

A. Range of motion B. Range of motion C. Telescoping Finger Rest (pull out/push in). D. Finger Lever E. Finger Lever Safe Mode Switch F. Control Lever Ring G. Stationary Collet H. Rotational Collet I. Midas Rex® Legend EHS® Stylus Motor J. 12-pin Connector and Boot

To Rotate the Finger Lever

Splash Screen

The Splash Screen is displayed while the system is starting up and executing its self tests.

Settings Screen

During the boot up/self-test operation the Splash Screen will display the Setting button for about 5 seconds. To change language, default settings, or calibrate the touch screen you must depress this button while it is displayed.

1. Firmly push the “Control Lever Ring” forward and rotate slightly in a clockwise or counter-clockwise direction as shown in figure. 2. Continue rotating the finger lever until lever locks in new position.

Technical Specifications Legend EHS® Stylus Touch™ Part No. EM210 Speed: 75,000 rpm forward/reverse Size: 15.26 cm length x 1.65 cm diameter Weight 130 g Duty Cycle (To avoid overheating): • For continuous use in operating room temperatures up to 40°C, the Legend EHS® 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 EHS® Stylus Motor is rated for continuous cutting indefinitely at 60,000 rpm.

A. This area is used to select desired language. 12

B. “Touch Screen Calibration” button will open the calibration screen. To calibrate follow the on screen instructions C. The “Default” button will open the default screens.

Connect Handpiece/Footswitch Screen

a. The operator can cycle through handpieces to locate desired handpiece. b. The operator may change any of the default settings to those most frequently used or view default settings. c. OK or Cancel button will accept or void changes and return to previous screen. D. OK or Cancel button will accept or void changes and return to previous screen. NOTE: Changing the default setting of any handpiece in no way affects the operator’s ability to change settings during surgery.

When the IPC® detects no handpiece the Connect Handpiece screen will open. By pressing the OK button in the Connect Footswitch panel the handpiece function will be allowed without the use of a footswitch. By pressing the OK button in the Endo-Scrub® 2 panel the Endo-Scrub® 2 function will be allowed without the use of a hand piece.

Handpiece Default Settings Table

Console Set-Up Instructions

Handpiece

Mode Speed Setting

Visao® 80000 Midas Rex® SC1 3400 StraightShot® M4, 12000 StraightShot® III, 5000 Magnum® II Midas Rex® Legend 70000 EHS® motor. Midas Rex® Legend 60000 EHS® Stylus motor Midas Rex® Legend 60000 EHS® Stylus Touch™ Skeeter® Handpiece 16000 Endo-Scrub® 2 Suction Irrigator Device FCU Delay Endo-Scrub® 2 Pump Endo-Scrub® 2 Setting

Fwd

X X

Pumps

Osc

X X

Pump 1 Coolant Endo-Scrub® 2

Irrigant Irrigant Irrigant

Endo-Scrub® 2

Irrigant

X X

Pump 2

Irrigant X Optional

Setting 100 mS Pump 1 3

Optional

Console Set-Up General instructions: for set-up and use of the Integrated Power Console. See “Accessories” for instructions specific to the peripheral being used. NOTE: Use sterile water or saline for irrigation and cooling. 1. Locate cart and lock wheels. 2. Inspect components for damage and determine if system is ready to use. 3. On IV pole, mount IPC® and irrigation/coolant bag(s). NOTE: Irrigant and coolant bags should be placed above the console to ensure adequate flow. 4. 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. 5. Connect footswitch. 6. Connect the sterilized accessories to console. 7. Tubing • Connect tubing as needed (suction, cooling, irrigation). 8. Turn power switch ON and verify: • System passes self test • Default screen opens. If “Attach Handpiece / Attach Footpedal” screen opens, return to steps 4 and 5. 9. 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. 13

•

A small amount of irrigant is observed flowing at the tip of irrigation device(s). • Pump(s) turns off. 10. 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 to yellow. • Pedal Buttons: Please refer to “Multifunction Foot Control Unit”. 11. Depress the intraoperative button on the back of the console. Verify: • Starts and stops the handpiece, irrigation and/or coolant flow. 12. 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.

Console Specifications Functional Standards for Electric Systems

ANSI / Medical electrical equipment -- Part 1: General 2005 AAMI: - ES requirements for basic safety and essential performance 60601-1 IEC Medical electrical equipment -- Part 1: General 2005 60601-1 requirements for basic safety and essential performance EN - 60601- Medical electrical equipment -- Part 1: General 2006 1 requirements for basic safety and essential performance (IEC 60601-1:2005)) IEC - 60601- Medical Electrical Equipment – Part 1: General 2000 1-4 Requirements for Safety, Part 4: Programmable Electrical Medical Systems EN - 60601- Medical Electrical Equipment – Part 1-2: General 2001/ 1-2 Requirements for Safety – Collateral Standard: A1: Electromagnetic Compatibility – Requirements and Tests 2006 CSA - C22.2 Medical Electrical Equipment - Part 1: General 2005 No. 601.1 Requirements for Safety.

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 / Touch Screen 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 Electrical Input Voltage Frequency Power Consumption: Auxiliary AC output: Internal Fuse

60 dBA minimum SPL (1 m)

100 V-240 V ± 10% 50/60 Hz 500 VA 200 VA Max. 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 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

Troubleshooting IPC® and Foot Control Unit Symptom

Pumps don’t run.

Issue Action Failed internal components. Contact Customer Care. Moisture ingress in cable conflicts with Run a dry cycle when sterilizing, If problem persists, contact Customer handpiece recognition. Care. tubing in pump, verify pump lid is fully closed with the fluid Tubing Set improperly seated in pump. Reposition flow from left to right.

Little or no irrigation flow.

Tubing is pinched or kinked.

Check tubing at side of pump, see Irrigation/Coolant Pumps Check remaining tubing for pinched or kinked areas, if necessary replace tubing.

Tubing clamps are restricting flow.

Set tubing clamps in “open” position.

Irrigation flow rate setting low. Irrigator obstructed. Pump stall error. Console default parameters incorrect. Handpiece connected but console reads “Connect Handpiece” Handpiece connected but console displays incorrect handpiece.

Adjust irrigation flow rate Replace irrigator tubing in pump, verify pump lid is fully closed with the fluid Tubing Set improperly seated in pump. Reposition flow from left to right. If problem persists, contact Customer Care. Check tubing is not pinched or kinked on side of pump (see section on Tubing is pinched or kinked. “Irrigation/Coolant Pumps”). If problem persists, contact Customer Care. Moisture ingress in cable conflicts with Run a dry cycle when sterilizing, If problem persists, contact Customer handpiece recognition. Care. Power cord not properly connected.

Console doesn’t power up.

No power. Power Inlet Fuses blown.

Failed internal components. Power switch light is on but Touch Failed internal components. Screen doesn’t come on. Console doesn’t power down. Power switch failure. Screen gasket displaced or failed Touch Screen doesn’t respond. internal components. Touch Screen doesn’t work Touch Screen not calibrated. properly.

Connect power cord. Check power available (i.e. power strip is on, circuit breaker is closed etc.) Replace fuses with 5.00 A, 250V, time delayed fuses (P/N 11270066) Contact Customer Care. Contact Customer Care. Unplug power cord, contact Customer Care. Contact Customer Care. Calibrate Touch Screen. If problem persists, contact Customer Care. Disconnect and reconnect the motor cable.

Console displays wrong handpiece / motor type.

Console misidentified the handpiece / motor.

Turn console off then on. Change motor, motor cable, or console to isolate the problem.

Moisture ingress in cable conflicts with Run a dry cycle when sterilizing, if problem persists, contact Customer handpiece recognition. Care. Incorrect use. Top button doesn’t respond. Foot control unit buttons or pedal doesn’t respond.

Connector not fully inserted.

Press and hold buttons for at least 1 second, wait for console confirmation beep. One (1) handpiece connected (top button has no function with 1 handpiece connected). Disconnect and reconnect the fcu cable connector. Try different fcu or console to isolate the problem. Contact Customer Care.

Internal component failure. Handpiece fails to rotate

Failed footswitch. Failed handpiece motor or motor driver.

Contact Customer Care. Disconnect footswitch, use manual start/stop rocker switch on rear of console. Contact Customer Care.

Non EHS Blades or Burs Symptom Appears to be damaged or defective. Tool Vibrates Excessively, Abnormal Noise movement.

Issue

Damaged or defective. Tool is not firmly seated. Blade opening is obstructed.

No suction.

Tubing obstructed. Tool is leaking irrigant.

Tool wobble in Handpiece.

Tool not seated correctly in collet. Low or no suction.

Tool wobbles in Handpiece.

Action Remove and replace. Microdebriders, pull back locking collet and re-seat the tool. Visao®, unlock collar, check/re-seat notch, lock collar. Use stylet to clear blade. Remove blade from surgical site and submerse the blade tip in sterile water with suction connected to the handpiece to evacuate the obstruction. Remove and inspect suction tubing, and if obstructed, remove obstruction, reconnect tubing. Check for proper tool insertion by pulling back locking collet, and reseating tool. See SYMPTOM, no suction. Reduce handpiece operating speeds. Use tools that are rated for the console speed selected If necessary, use bur guard with burs medium, long and X-long. Operate handpiece at 50% of full speed for medium, long and X-long burs. Select a new tool. Contact Customer Care.

Midas Rex® Legend EHS® motors Symptom

Issue Action Inadequate cool down period following Motor must be allowed to cool down following steam sterilization. sterilization. Switch attachments to determine whether the heat is being generated by Attachment transferring heat to the the motor or the attachment. motor. Contact Customer Care. Motor is too hot to touch/hold Discontinue use and rest the motor by using it intermittently or wrap the Heavy side loading during dissection. motor with a moist sterile towel. If overheating continues, contact Customer Care. Inadequate irrigation. Ensure adequate irrigation to surgical site during bone dissection. Aging of attachment Use of reprocessed tools Contact Customer Care. Tool is difficult to remove from Use of an unauthorized refurbisher attachment Clean the attachment thoroughly according to the instructions in this manual. Improper cleaning Change tool. Use the Legend motor wrench to rotate the flat closest to the motor case Attachment will not seat properly Motor collet flats are not aligned. until its marker is aligned with the marker on the flat farthest away from on the motor the motor case. Cables not properly connected. Ensure motor and foot control cables are properly connected. Ensure that a speed greater than 10,000 rpm (EHS) or 3,000 rpm (Stylus) Speed setting is too low. is selected. Attachment not properly installed and Remove and reinstall the attachment and dissecting tool to ensure locked onto the motor. proper installation. Motor does not run. Change motor or console to isolate the problem. Internal failure of motor and/or console. Contact Customer Care. Check for obstruction under the foot pedal. Foot control not properly functioning. If problem persists, contact Customer Care. Cables damaged Check cables for cracks, splits, or bent connector pins. Change the attachment to isolate the location of the problem. Bearings are worn. Contact Customer Care. Check all connections from electrical source to console. Motor with attachment rotates, but Poor electrical Connection Ensure motor and foot control cables are properly connected. an abnormal noise is heard Change motor, console, or cable to isolate the failing component. Internal failure of motor, console, or cable. Contact Customer Care. Attachment not properly installed Remove and reinstall the attachment and dissecting tool

Midas Rex® Legend EHS® Stylus Touch™ motors Symptom

Motor does not run.

Issue Finger switch not reaching maximum speed Finger switch not responding. Safety switch in safe mode Finger control damaged.

Action Check that the control lever ring is properly seated in one of the four possible positions. Place switch in run mode. Contact Customer Service.

Midas Rex® Legend EHS®Attachments or Telescoping Tubes Symptom

Issue

Heat from worn attachment/tube bearings Attachment or Telescoping Tube has uncomfortable temperature to Attachment/tube unclean due to improper cleaning procedures touch/hold

Action DO NOT use. Try another attachment/tube. Contact Customer Care. Telescoping Tubes are multi-use disposable. If problem is resolved with a new Telescoping Tube, discard the over-heated tube. Check that appropriate cleaning procedures are being followed.

Discontinue use and rest the attachment by using intermittently, try another identical attachment or wrap the attachment interface with a moist sterile towel. If attachment continues to overheat, Contact Customer Care. Attachment/telescoping tube is Attachment mishandled, failed due to DO NOT use. Contact Customer Care. bent, loose, damaged or missing a extended use or excessive force applied Dispose of telescoping tube. Telescoping Tubes are multi-use disposable. component during use Incorrect cleaning or sterilization method Use nomenclature markings on the attachment to match with a Color band on Attachment/ corresponding dissecting tool or Contact Customer Care. of chlorine based or corrosive Telescoping Tube fades or discolors Use agents Aging Telescoping Tubes are multi-use disposable. Over lubrication during cleaning Attachment has excess lubrication process Visually inspect and wipe excess lubrication. Attachment damaged by dissecting Footed attachment has a tool drilling out part or all of leg/foot component missing from leg/foot area. DO NOT use. Contact Customer Care. area or foot is bent Bend caused by incorrect use. The contra-angle attachment operates by a set of internal gears to engage the 16-Mf contra-angle attachment is drive shaft. It is normal for some heat If heat continues or is excessive, contact Customer Care. overheating to be generated approximately 2 cm from the distal end of the attachment and at the right of the angle head. Smoke is generated by the Attachment is not in the locked Make sure the attachment is in the locked position. attachment or motor position. Heavy side loading during dissection

Midas Rex® Legend EHS® Tools Symptom

Issue A non-Legend tool is being used.

Action Replace with a Legend tool. Try another attachment or tube to isolate the location of the problem.

Worn attachment or tube bearings.

If the attachment is failing, contact Customer Care. If the tube is failing, dispose of it and use a new tube.

Tool fails

Tool vibrates excessively Tool dull Tool will not seat properly in the motor or attachment collet

Attachment/tube and tool are not compatible. Motor is damaged. Tool’s size and geometry may contribute to flailing at certain speeds. Tool’s size and geometry may create excessive vibration at certain speeds.

Match color code on the tool packaging to the color code on the attachment/tube. Contact Customer Care. Adjust the speed by changing the pressure setting or foot/finger control. Do not use if flailing persists. Change tool. Adjust the speed. Change tools.

Extended use Reprocessed tool was used Incorrect geometry

Change to a new tool

Debris in collet of attachment or motor. A non-Legend tool is being used.

Contact Customer Care. Clean the attachment or motor thoroughly according to the instructions in this manual. If cleaning does not correct the problem, contact Customer Care. Replace with a Legend tool.

Error Code

15 16

MCB motor overcurrent detected

Motor Overcurrent

Unrecognized/damaged FCU plugged in

Foot Control Connection Error

Damaged handpiece or finger lever base out of position.

Finger Control Error

UI self test failure - culture (language) registry entry UI self test failure - sector configuration Self Test Failed registry entry UI self test failure - corrupt usage data file or unable to create usage data file Not Used N/A MCB non-specific self test failure MCB self test failure - Port 1 MCB self test failure - Port 2 MCB self test failure - Port 3 MCB self test failure - Port 4 MCB self test failure - bridge transistor 1 shorted MCB self test failure - bridge transistor 2 shorted MCB self test failure - bridge transistor 3 shorted MCB self test failure - bridge transistor 4 Self Test Failed shorted MCB self test failure - bridge transistor 5 shorted MCB self test failure - bridge transistor 6 shorted MCB self test failure - A/D converter MCB self test failure - motor error MCB self test failure - 3.3 volt supply MCB self test failure - 12 volt supply MCB self test failure - 48 volt supply MCB self test failure - FCU port

1 2 3 4 5 6 7 8 9 10 11 12 13 14

20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39

Error Code

Cause Error Message Title MCB does not report that it is booted within 5 seconds of AI telling it to start and System Error subsequent reattempts fail. Not Used N/A UI-MCB Com Failure - Max resends exceeded UI-MCB Com Failure - Get answer failed UI-MCB Com Failure - No status message System Error received UI-MCB Com Failure - Serialization ID error UI-MCB Com Failure - Timeout exception Not Used N/A Pump 1 stalled (no transitions on opto Pump #1 Stalled sensor) Pump 2 stalled (no transitions on opto Pump #2 Stalled sensor) Unrecogonized/damaged handpiece plugged in on port 1 (first 12 pin) Unrecogonized/damaged handpiece plugged in on port 2 (second 12 pin) Handpiece Unrecogonized/damaged handpiece plugged in on port 3 (4 pin) Unrecogonized/damaged handpiece plugged in on port 4 (Skeeter) Handpiece Stalled Handpiece Stalled

Error Message Description Power off. Wait 10 seconds. Power on. If error persists, call Technical Services. N/A Power off. Wait 10 seconds. Power on. If error persists, call Technical Services. N/A Check tubing connection.

Unplug handpiece and plug back in. If error persists, replace handpiece.

Check accessory. Unplug handpiece and plug back in. If error persists, replace handpiece. Unplug Foot Control and plug back in. If error persists, replace Foot Control or switch to manual control. A finger control error has been detected. Check that the control lever ring is properly seated in one of the four possible positions. If error persists contact Medtronic support. Press OK to use alternate control method. Power off. Wait 10 seconds. Power on. If error persists, call Technical Services. N/A

Power off. Wait 10 seconds. Power on. If error persists, call Technical Services.

Changing the Fuse 0

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