IPC Console User Guide

0123

MEDTRONIC XOMED INC. 6743 Southpoint Drive North Jacksonville, FL 32216 USA

Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel.: 011-31-45-566-8000 Fax: 011-31-45-566-8668

EC REP

™ are trademarks and ® are registered marks of Medtronic Xomed, Inc. Midas Rex® Legend EHS® motor, Midas Rex® Legend EHS Stylus™ motor and the Mednext® are trademarks and registered marks of Medtronic, Inc. Jacobs Chuck® is a registered mark of Jacobs Chuck Manufacturing Company © 2008 Medtronic, Inc. Released documents are available for viewing/printing @ www.medtronicENT-TechComms.com

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.

TABLE OF CONTENTS

Page Symbols...3 Definitions...5 Warnings And Precautions...5 When the System Arrives...7 System Description... 7 Intended Use / Indications for Use...7 Sales and Customer Care...7 medtronic xomed, inc. ...7 Components...7 Console Front...7 Connector Panel...7 Cable Connection...8 Console Rear...8 Console Specifications...8

Irrigation/COOLANT Pumps...8 Pump Set-Up Cartridge...8 Visao® Pump Cartridge...8 Visao® Coolant Pump Set-Up...9 Visao® Clear Drip Chamber...9 Pump Set-Up Standard...9 Tubing Management...9 System Overview...9 Operating Room Set-Up...10 Audio – Understanding What You Hear...10 Set-up instructions...10 Post-Operative Procedure...10 Cleaning...10 Touch screen...10 Splash Screen...10 Settings Screen...11 Connect Handpiece/Footswitch Screen...11 Touch Screen User Interface...11 Push Buttons And Indicators...11 Panels...12 Microdebriders And Pump Panels ...12 Drills And Pump Panels...13 Pump Panels With Multiple Handpieces...15 Accessories...16 Multifunction Footswitch...16 Intelliflow Irrigation Remote Control...16 Endo-Scrub® 2...16 Suction Irrigator...17 Handpieces Microdebriders...17 Microdebrider Straightshot® M4, And Midas Rex® Sc1...17 Blade Position And Finger Wheel...17 Keyed Rotatable Blade...17 Straightshot® M4 And Midas Rex® Sc1 Set-Up...17 Technical Specifications Straightshot® M4 Microdebrider and Midas Rex® Sc1...18

Straightshot® Magnum® II And Straightshot® III Microdebrider...18 Handpieces Drills...18 Visao® High-Speed Otologic Drill (Water-Cooled)...18 Visao® burs and bur guards...19 Visao® Curved Tool Installation...19 Visao® Bur Guards...19 Visao® Stim Bur Guard Installation...19 Visao® Bur Guard And Straight Tool Installation...20 Visao® tubing...20 Visao® Motor Coolant Tubing...20 VisaO® Irrigation Tubing...20 Visao® Cleaning And Sterilization...20

Midas Rex® Legend EHS® Motor, Midas Rex® Legend EHS Stylus™ Motor, And Attachments...22 Motor Collet...22

Medtronic Powered Surgical Solutions Tool Nomenclature...22 Installing Attachments...22 Straight Attachment...22 Angled Attachments...23 Irrigation Clip (Straight Bur)...23 Fixed Footed Attachment...23 Rotating Footed Attachment...24 Contra-Angle Attachment 16-Mf...24 Metal-Cutting Attachment...24 Variable-Exposure Attachment...24 Telescoping Attachment...24 Perforator Attachments (Ad01 & Ad03)...25 Cleaning...26

Troubleshooting...27 IPC™ And Foot Control Unit...27 Non Legend EHS® Blades Or Burs...27 Midas Rex® Legend EHS® Motors, . ...28 Midas Rex® Legend EHS®Attachments...28 Midas Rex® Legend EHS® Tools...29 Error Codes...29 Guidance And Manufacturer’s Declaration – Electromagnetic Immunity And Emissions...30 Limited Warranty...32 Transmissible Spongiform Encaphalopathies (Tse) Return Policy...32 Appendix A Cleaning And Sterilization...33 Appendix B power cords...45

Symbols

N

DO NOT USE IF PACKAGE IS OPEN OR DAMAGED

Package Contents

1 2

LOT

LOT NUMBER FUSE

Skeeter® Ultra-Lite Oto-Tool System Set-Up And Use...20

REF

Technical Specifications...20

REF

Skeeter® Ultra-Lite Oto-Tool...20

PUMP HEAD 2

DO NOT REUSE

ACC

Instructions For Use...20 Skeeter® Cleaning And Sterilization...20

PUMP HEAD 1

USE BY DATE

Technical Specifications...20 Visao® High-Speed Otologic Drill...20

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.

ACCESSORY CATALOG NUMBER

Midas Rex® Legend EHS® Motors...21 Legend EHS® Motor...21 Legend EHS® Motor Cable...21

Connect Midas Rex® Legend EHS® Motor Cable, And Console...21 Technical Specifications...21

AC POWER OUTPUT

Legend EHS® Motor...21

IS APPROXIMATELY EQUAL TO

Midas Rex® Legend EHS Stylus™ Motor...21

STERILE R STERILIZED BY RADIATION. DO NOT USE IF PACKAGE IS OPEN OR DAMAGED

Midas Rex® Legend EHS Stylus™ Motor...21 Technical Specifications...21 Legend EHS Stylus™ Motor...21

3

STERILE

NON STERILE

RF TRANSMITTER (INTERFERENCE MAY OCCUR)

STERILE EO STERILIZED BY ETHYLENE OXIDE. DO NOT USE

IF PACKAGE IS OPEN OR DAMAGED AUTHORIZED REPRESENTATIVE IN THE EUROPEAN COMMUNITY

0123

EC REP

THIS DEVICE COMPLIES WITH MEDICAL DEVICE DIRECTIVE 93/42/EEC 0086

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

Rx Only

CAUTION: FEDERAL LAW (U.S.A.) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN

! USA

USA ONLY

FINE IRRIGANT ADJUSTMENT

QUANTITY

LEFT FOOT CONTROL UNIT BUTTON

Fr

MANUFACTURER

RIGHT FOOT CONTROL UNIT BUTTON

DATE OF MANUFACTURE

TOP FOOT CONTROL UNIT BUTTON

ROHS - ENVIRONMENTAL FRIENDLY USE PERIOD - CHINA (SJ/T11364-2006.) >120 VAC

ON <120s

OFF >180s

<XX° C XX° C XX° C >X° C

WORLD WIDE STANDARD FOR MEDICAL TUBING DIAMETER.

LOCKED

NOT GREATER THAN 120VAC

UNLOCKED

APPLIED PART DUTY CYCLE

ON/OFF (MAIN POWER)

RECOMMENDED STORAGE TEMPERATURE AND LIMITS.

USE WITH Instrument Case INSTRUMENT CASE

CONFORMS TO ANSI/AAMI ES 60601-1, IEC/EN 60601-1. Certified to CSA C22.2 NO.601.1 105345

Lubricant/Diffuser LUBRICANT/DIFFUSER Dissecting Tool

HANDPIECE SKEETER® HANDPIECE EMC COMPLIANCE MARK EUR · USA · JPN · AUS

PROTECTIVE EARTH

DISSECTING TOOL

Attachment ATTACHMENT Control Unit CONTROL UNIT Refurbished REFURBISHED

Accessory ACCESSORY Regulator REGULATOR

EQUIPOTENTIAL

CONSULT INSTRUCTIONS FOR USE ATTENTION SEE INSTRUCTIONS FOR USE IPX1 IPX7

M 4

PROTECTED AGAINST VERTICAL WATER DROPS PROTECTED AGAINST THE EFFECTS OF TEMPORARY IMMERSION IN WATER TYPE BF APPLIED PART MANUAL START/STOP

Bone Mill BONE MILL

Motor

MOTOR

Brush

BRUSH

Adapter

ADAPTER

TOOL TUBE

TOOL CONTROL TUBE CONTROL

Multi-Use Disposable Attachment MULTI-USE DISPOSABLE ATTACHMENT

Definitions (used in this manual)

FCU – IPC™ I.V. NIM® -

Nomenclature Panel XPS® -

Foot Control Unit Integrated Power Console Intravenous Nerve Integrity Monitor - One or all of the following units: NIM-Response®, NIM-Response® 2.0, NIM-Neuro® 2.0 The act or process or an instance of naming Sub group of the Touch Screen controls Xomed Power System

WARNINGS AND Precautions

It is important that the IPC™ operator be familiar with this manual: its Warnings, Precautions, procedures and safety issues. Three labels are used in this manual to identify important concerns, conditions, or procedures: Warnings: Describes serious adverse reactions and potential safety hazards that can occur during the proper or improper use of a device. Precautions: Any special care to be exercised by a practitioner or patient for the safe and effective use of the device. Note: Identifies special information or to clarify/emphasize important instructions.

WARNINGS

System Warnings W1 It is important that the IPC™ operator be familiar with the system User’s Guide, its precautions, procedures and safety issues. W2 Do not use the IPC™ System in the presence of flammable anesthetics. Avoid potential ignition or explosion of gases W3 When not operating handpiece, eliminate accidental foot control activation. Control energy to and through the handpiece to prevent unintended tissue, bone, or nerve resection. W4 Disconnect power to the IPC™ before cleaning the unit to avoid electrical macro shock. W5 Do not attach unapproved components to the IPC™ to avoid electrical macro shock. W6 To avoid the risk of electrical shock, achieve electrical grounding reliability with proper connections. Connect the IPC™ to hospital grade receptacles only. W7 This medical device complies with EN60601-1-2 safety standard for electromagnetic compatibility, requirements and test. However, if this equipment is operated in the presence of high levels of electromagnetic interference (EMI) or highly sensitive equipment, interference may be encountered and the user should take whatever steps are necessary to eliminate or reduce the source of the interference. Diminished performance may lengthen operating time for anesthetized patient. W8 Medical Electrical Equipment needs special Precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this Guide. W9 Portable and mobile RF communications equipment can affect Medical Electrical Equipment. W10 Do not operate the IPC™ System in the presence of Magnetic Resonance Imaging devices. W11 Use of accessories and cables other than those specified and sold by Medtronic may result in increased emissions and decreased immunity of this unit. W12 The IPC™ should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the IPC™ should be observed to verify normal operation in the configuration in which it will be used. W13 Do not attempt to run the IPC™ System handpiece immediately after autoclaving. Allow an adequate “cool down” period (Typically 1 hour). W14 Consult the Legend® Bone Mill product insert before use with the Integrated Power Console™. W15 For metal transection, observe the following safety precautions: W 15a Eye wear protection is essential. W 15b Irrigate well to cool the cutting surfaces. W 15c Protect the wound site from metal debris. W 15d Use a clamp or grasping device to control loose fragments during transection of any metal component. W16 Do not operate the IPC™ System without eye protection. W17 All service must be performed by Medtronic qualified personnel only.

W18 Repair and/or modification to the IPC™ by anyone other than qualified service personnel may significantly compromise the unit’s ability to perform effectively and/or void the equipment warranty. Component Warnings W19 Do not use any parts other than Medtronic system components as damage or substandard performance could result. W20 Always inspect the components before and after use for any damage. If damage is observed, do not use damaged part until it is repaired or replaced. Damaged parts may deposit metal shavings on surgical site. W21 When precise location of blade tip is required, engage the rotation lock on the handpiece, then calibrate and verify the blade tip on Image 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 can achieve temperatures in excess of 50° C. W29 Do not attempt to change a dissecting tool 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. 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. W36 Smoke may be generated if attachment is not in the locked position. W37 The 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 mains with protective earth. W44 Keep NIM® Muting Probe cable away from IPC™ system cables. 5

Disposable Warnings W45 Verify reusable device was sterilized prior to use. If not sterilized, do not use. W46 Tools are available for resection of soft tissue and bone for surgical procedures. Use of tools depends on the intended application and patient needs. Sharp-cutting powered tools induce bleeding and removal of 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 tip of the tool away from fingers and loose clothing. Prevent laceration of user and crosscontamination 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 or tool 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 are sharp and may perforate surgical gloves. Tools 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. 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.

PRECAUTIONS

P1

P2 P3 P4

P5 P6 P7 P8 P9 P10 P11 P12 P13 P14 P15 P16 P17 P18 P19 P20

6

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 270°F (132°C) for 5 minutes Gravity Displacement 270°F (132°C) for 15 minutes The re-sterilized tool must be used promptly following re-sterilization. If rust or corrosion is encountered after resterilization, 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 premature 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.

P21 P22

Do not use excessive force to insert the endoscope into the EndoScrub® 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.

COMPONENTS Integrated Power Console Console Front

WHEN THE SYSTEM ARRIVES

UNPACKING AND INSPECTION Check off the contents of the box against packing slip. If incomplete or damaged, notify Customer Care. If container is damaged, or cushioning material shows stress, notify carrier and Customer Care. Keep shipping materials for carrier inspection. After unpacking, save the cartons and packing material. If the instrument is to be shipped the shipping package will provide proper protection.

B A

System 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, 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.

Intended Use / 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.

sales and customer care MEDTRONIC XOMED, INC.

6743 Southpoint Drive North Jacksonville, FL 32216 USA www.medtronicENT.com U.S. HELP LINE (800)-874-5797.

INTERNATIONAL SERVICE International customers should contact their local MEDTRONIC XOMED office.

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. Cable connection NOTE, If units with insulated connectors have debris under the insulator: • Reclean according to Cleaning and Sterilization instructions. • if debris was not removed return for warranty servicing. See warning W79. 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. To disconnect the cables from the console: 1

2

A

1. Push the cable towards the console. 2. Then pull out by the insulating boot (A).

7

CONNECTOR PANEL

• 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.

5

Console Specifications 1

3

2

4

6

7

8

1. RECEPTACLE for - Midas Rex® Legend EHS® motor. 2. RECEPTACLE for - Midas Rex® Legend EHS Stylus™ motor. 3. RECEPTACLE for - : • StraightShot® M4 Microdebrider • Straightshot® Magnum® II Microdebrider • Straightshot® III Microdebrider • Midas Rex® SC1 • Visao®. NOTE, Connector #3 only one (1) handpiece may be attached to the console at a time. 4. RECEPTACLE - Stimulus input from Patient Interface connection (NIM). 5. RECEPTACLE - Stimulus output to STIM Bur Guard. 6. RECEPTACLE - Skeeter® Handpiece. 7. RECEPTACLE : • Endo-Scrub® 2 Finger Switch • Endo-Scrub® 2 Footpedal • IntelliFlow Irrigation Remote Control. 8. RECEPTACLE for - Foot Control Unit. Console Rear

A

B

C D E

G

Functional Standards for Electric Systems ANSI / AAMI: - ES 60601-1 IEC 60601-1 EN 60601-1

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

Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005)) IEC Medical Electrical Equipment – Part 1: General 60601-1-4 Requirements for Safety, Part 4: Programmable Electrical Medical Systems EN Medical Electrical Equipment – Part 1-2: General 60601-1-2 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 (+50°F to +91°F) Humidity: 30% to 75% RH Barometric Pressure: 700 - 1060 hPa Transport and Storage Environment Temperature: -40°C to +70°C (-40°F to +158°F) 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

H

Pump Cartridge Set-up The Pump Cartridge snaps onto the lower section of the pump.

I

F

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. • HydroDebrider™, or Bone Mill consoles only. See warning W82. 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. 8

1

2

3

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

Tubing Management 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

A variety of clips exist for securing tubing. Refer to your tubing set for type included.

System Overview VISAO® Clear Drip Chamber The clear drip chamber must be filled with coolant before priming the coolant system.

1

2

B A

3

D

C

E H F

standard Pump Set-up

I

J

G

1

2

3

Tips on loading the pump K

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 Acessaries and Handpieces). I. Accessory Cables. J. Maximum height from floor 35 inches (89cm). K. Minimum base diameter 21 inches (53cm). 9

Operating Room Set-Up

The surgeon may have preferences as to location and visibility. Typical Set-Up B

C

D

E F

A

I H

G

A Anesthesia Equipment B IPC™ System C Nursing Supplies / Surgical Instruments D Scrub Nurse E NIM Monitor

F Microscope G Surgeon H Electro Surgical Unit I Anesthesiologist

Audio – Understanding What You Hear Audible Alarm A sequence of three short beeps are issued when an error is detected and an error message is displayed on the screen. Audible Tones A confirmation beep is issued anytime a change button is depressed. Three long beeps are issued when the active handpiece is in reverse mode and the foot pedal is depressed. Error conditions see Troubleshooting for additional information.

Set-up instructions

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. Inspect components for damage and determine if system is ready to use. 2. 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. 3. 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. 4. Connect footswitch. 5. Connect the sterilized accessories to console. 6 Tubing • Connect tubing as needed (suction, cooling, irrigation). 7 Turn power switch ON and verify: • System passes self test • Default screen opens. If Attach Handpiece/Attach Footpedal screen opens return to step 4 and 5. 8. 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. 9. 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. 10

· Right Button

Changes pedal operation from Start/Stop or Variable speed. 10. Depress the intraoperative button on the back of the console. • Verify: Starts and stops the handpiece, irrigation and/or coolant flow. 11. 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. Post-operative Procedure 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. CLEANING IPC™ and Foot Control Units • DO NOT immerse or sterilize the units. • Wipe down the units with a cloth dampened with a neutral enzymatic detergent, pH 6.0-8.0 or phenol based disinfectant. • Do not use alcohol, other solvents, or abrasive cleaners. • Dry the units with a clean, non-abrasive cloth. NOTE: If debris is found under the Foot Control Unit’s connector, return for warranty service. Handpiece/Accessory See Appendix A for cleaning/sterilization instructions specific to the accessory being used.

Touch screen

The touch-sensitive screen provides information and control options.

Splash Screen

Is displayed while the system is starting up and executing its self tests.

INTEGRATED POWER C O N S O L E

Setting

Initialization in Progress...

Self test An internal system test is automatically performed each time the system is turned on.

Settings Screen

Touch Screen User Interface

Settings

StraightShot M4

Speed

+ 5000 RPM

Language

English Français Italiano Deutsch Español

3000

Blade Position

A

1500 180°

300

Irrigation 60

cc/min

Flow

Touch Screen Calibration

Osc Mode 5000

Fwd Mode

+

12000

Prime

Stylus

B

Skeeter

C

D

EndoScrub 2

E Pumps

F

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. 2. To change language setting select desired language then press OK.

Connect handpiece/footswitch screen

Press OK to continue without Footswitch

+

Setting

Flush

Push Buttons and Indicators

In this section all buttons used on the “Touch Screen User Interface” are displayed with an explanation of how they work. Setting

Cancel

OK

3 On

A. Handpiece Panel - This panel shows the active handpiece. B. Inactive Handpiece Buttons - Shows connected (inactive) handpieces. C. Special Function Panel - Shows Suction Irrigator or Endo-Scrub® 2. D. Foot Control Unit (FCU) Button - changes foot pedal from variable speed control to On/Off. E. Pumps - Opens pump panel. F. Help - Opens help screens.

<Graphic here>

<Graphic here>

? Help

Connect Handpiece(s)

Connect Footswitch

Flow

Located on Splash Screen used to open Setting Screen.

Direction indicator

Direction is clockwise.

Direction indicator

Direction is counter-clockwise.

on Setting Screen used to cancel Cancel Button Located any changes that were selected.

OK

OK Button

Located on Setting Screen used to accept any changes that were selected.

+

Large Increment Button Large Decrement Button

Decrease / Increase a given value with each depression. Typically used for speed adjustment.

No accessory connected (handpiece/footswitch), footswitch optional.

FCU Variable Speed Select I/ O

+

FCU On/Off Select Small Increment Button Small Decrement Button

Changes foot pedal function on Foot Control Unit between variable control and On/Off.

Decrease / Increase a given value with each depression. Typically used for flow rate or size adjustment. Radio Button for option selection (center is white when selected). 11

Check Box used to show if an option is turned On or Off (green with check mark is On).

?

180º

Help Button

Opens help screen.

Pumps Button

Opens pump options panel.

Prime Button

See Precaution P1.

Flush Button

Depressing the Flush Button will turn on pump as long as button is held. See Precaution P1.

Exit Button

Exits or closes a screen or panel.

Attention Icon

Used to indicate a problem to the user.

Clockwise Rotation Button CounterClockwise Rotation Button

Used in Blade Position Panel only.

A. The microdebriders consist of three (3) handpieces (StraightShot® M4 Microdebrider, Straightshot® Magnum® II Microdebrider, and the Straightshot® III Microdebrider) all of which use this title. B. Speed panel. Default speed is 5000 rpm. C. Mode Panels cutting mode selection. • Osc Mode - tool oscillates • Fwd Mode - tool cuts in forward direction. D. The Microdebrider Handpiece allows the user to rotate the inner cutting tip of specially designed rotatable blades (see “Blade Position And Finger Wheel”). 1. Look at the position of the cutting tool (the indicator is there to show the blade is moving not the blades position). 2. Using the clockwise or counter-clockwise buttons move the blade to the desired starting position. 3. The 180° button will move the cutting tool to the opposite position. 4. Visually confirm the tools position. E. Irrigation Panel - used to adjust the flow rate of irrigation. Default is 60 cc per minute in Oscillate Mode. Prime/Flush button: See Precaution P1. Microdebriders (Forward Mode)

Manually rotates the microdebrider blades to any desired starting position.

Rotates the microdebrider blades one hundred and eighty degrees (180º). Shows blade is in motion only when Blade Rotating manually positioning blade. Does NOT indicator indicate blades orientation. 180º Button

+ 12000 RPM

1500

G

300 Irrigation 30

cc/min

English Français Italiano Deutsch Español

Pump Setup Irrigation Method HANDPIECE

(Error Name)

HANDPIECE / ENDOSCRUB 2

Displays Handpiece Error Opens Error Message.

Error Button

Pump 2

(Handpiece Name)

Panels

Microdebriders and pump Panels Microdebriders (Oscillate Mode (default)) A

Speed B

D

StraightShot M4

+ 5000 RPM

Blade Position

60

cc/min

Flow

12

Flush

This is the default screen for the Microdebrider. Pump 2 is the default pump with no pump configuration options. See Precaution P1. Microdebrider Pump Set-up Panel (Endo-Scrub® 2) The Endo-Scrub® 2 is only available when a microdebrider is connected.

Pump Setup

Osc 5000

Irrigation Method HANDPIECE

3000

HANDPIECE / ENDOSCRUB 2

1500 180°

Irrigation

E

Irrigation

Pumps

In this section panels used on the “Touch Screen User Interface” are displayed with an explanation of how they work.

C

M4

Displays Inactive Handpiece Makes Inactive Handpiece Active.

Inactive Handpiece

12000

Prime

F. Default speed is 12000 rpm in Forward Mode. G. Default is 30 cc per minute in Forward Mode. Microdebrider Pump Set-up Panel (Handpiece)

Located on setting screen and used to select language.

Language Buttons

Fwd Mode

+

Flow

Located on Help Screen. Left and right buttons allow user to cycle through help screens. Center bar shows current help screen.

Osc Mode 5000 3000

F

Handpiece Irrigation

Cycle Bar

StraightShot M4

Speed

Pump 1

300

Prime

12000

M4

EndoScrub 2

Fwd

+

Pump 2

Flush

Irrigation

Flush

Pumps

This is the default screen for the Microdebrider with Endo-Scrub® 2

selection. Pump 1 will operate in the same fashion as an Endo-Scrub® 2 with pump 2 remaining the default for irrigation. See Precaution P1. Endo-Scrub® 2 Panel

EndoScrub 2

Mode OSC

H

Flow

FWD

+

3 On

SC1 Handpiece Cut Direction

Blade Position

Prime

Setting

180°

CUT

Flow panel: • Enable/disable pump 1 using the check button. • Adjust the flow rate (Setting). • Prime button (See Push Buttons and Indicators).

Midas Rex® SC1 and pump Panels Midas Rex® SC1 Handpiece (Oscillate Mode (default)) A

SC1 Handpiece

Speed

+ 5000 RPM

B

C D

Blade Position 180°

H.Cut Direction panel operator selectable cut direction. Midas Rex® SC1 Pump Set-up Panel (Handpiece)

Pump Setup

Mode OSC

Irrigation Method HANDPIECE

FWD CUT

Pump 2 SC1

Irrigation

E

60

cc/min

Irrigation

Flush

+ Prime

Flow

Pumps

A. The Midas Rex® SC1 handpiece. B. Speed panel - Default speed is 5000 rpm in Oscillate Mode. C. Mode Panel used for Midas Rex® SC1 cutting mode selection. • OSC Mode - tool oscillates. • FWD Mode - tool cuts in forward direction. • CUT Mode - tool cuts one cut at a time in a backward or forward direction. D. See Microdebriders (Oscillate Mode (default)) D. E. Irrigation Panel - adjust the flow rate of irrigation. Default is 60 cc per minute in Oscillate Mode. Prime/Flush button: (See Precaution P1). Midas Rex® SC1 Handpiece (Forward Mode) Speed F

SC1 Handpiece

+ 12000 RPM

Mode OSC FWD CUT

Irrigation

G

30

cc/min

Flow

+ Prime

F. Default speed is 12000 rpm in Forward Mode. G. Default is 30 cc per minute in Forward Mode. Midas Rex® SC1 Handpiece (Cut Mode)

This is the default screen for the Midas Rex® SC1. Pump 2 is the default pump with no configuration options. See Precaution P1.

Drill and Pump Panels Visao® (Forward Mode (default))

Visao

A

Speed B

+ 80000 RPM

Mode FWD REV

C

Irrigation D

0

cc/min

Flow

+ Prime

A. Visao® drill. B. Speed Panel - Default speed is 80000 rpm in both FWD and REV Mode. C. Mode Panel - cutting mode selection. • FWD Mode - tool cuts in forward direction. • REV Mode - tool cuts in the reverse or opposite direction. D Irrigation Panel - used to adjust the flow rate for on-drill irrigation. Default is 0 cc per minute in FWD/REV Modes.

13

Visao® Pump Set-up (default) NOTE: The Suction Irrigator shown here is available to all drills provided a microdebrider is not attached to the console.

Pump Setup Irrigation Method

• REV Mode - tool cuts in the reverse direction. D. Irrigation Panel - used to adjust the flow rate for on-drill irrigation. Default is 0 cc per minute in FWD/REV Modes (not available with Suction Irrigator selected). See Precaution P1. Midas Rex® Legend EHS® Pump Set-up (default) Panel

Pump Setup

SUCTION IRRIGATOR

HANDPIECE

Pump 1

Irrigation Method

Pump 2

Cooling

Pump 1

Visao

Visao

Irrigation

Flush

EHS

Flush

Irrigation

Pumps

This is the default screen for the Visao® drill. Pump 1 will default to coolant and Pump 2 is the default pump for irrigation. See Precaution P1. Visao® Pump Set-up (Suction Irrigator)

Pump Setup

Pumps

This is the default screen for the Midas Rex® Legend EHS® Motor. Midas Rex® Legend EHS® Pump Set-up Panel (Suction Irrigator) Irrigation Method

SUCTION IRRIGATOR

HANDPIECE

Pump 1 Visao

Cooling

Flush

Pump 2

Pump 2

Suction

Suction Irrigator

Irrigator

Flush

Pumps

Suction Irrigator Fr

Flow

+

On

IIIIIIIII

+

1. Size Panel - used to select the suction tube size. 2. Flow Panel - used to turn the irrigation on/off and adjusting the flow rate. Midas Rex® Legend EHS® Drill Panel (default) A

EHS

Speed B

+ 70000 RPM

0

cc/min

Pumps

This is the default screen for the Midas Rex® Legend EHS® Motor with Suction Irrigator selected. • For Suction Irrigator panel instructions see, “DRILLS - Visao® Suction Irrigator Panel”. Midas Rex® Legend EHS Stylus™ Drill Panel (default) A

Stylus

Speed B

+ 60000 RPM

Mode FWD REV

Mode Irrigation

FWD REV

Irrigation

Flow

Flush

C

C

D

SUCTION IRRIGATOR

HANDPIECE

• When Suction Irrigator is selected, pump assignment by default is pump 2. See Precaution P1. Visao® Suction Irrigator Panel

8

Flush

Pump Setup

Irrigation Method

Size

SUCTION IRRIGATOR

HANDPIECE

+ Prime

A. EHS® Motor Drill. B. Speed Panel - Default speed is 70000 RPM in both FWD and REV Mode. C. Mode Panel - used for cutting-mode selection. • FWD Mode - tool cuts in forward direction. 14

D

0

cc/min

Flow

+ Prime

A. EHS Stylus™ Drill. B. Speed Panel -Default speed is 60000 rpm in both FWD and REV Mode. C. Mode Panel - cutting mode selection. • FWD Mode - cutting tool cuts in forward direction. • REV Mode - tool cuts in the reverse direction. D. Irrigation Panel - adjust the flow rate for on-drill irrigation. Default is 0 cc per minute in FWD/REV Modes. Midas Rex® Legend EHS® Stylus™ Pump Set-up (default) Panel See, Midas Rex® Legend EHS® Pump Set-up (default and Suction Irrigator) Panel.

Skeeter® Drill Panel (default) Speed B

Pump Setup

Skeeter

A

Irrigation Method

Mode

16000 +

HANDPIECE

FWD

RPM

HANDPIECE / ENDOSCRUB 2

REV

C

Pump 1

Pump 2

EndoScrub 2

M4

Irrigation

Irrigation

Flush

Flush Pumps

A. Handpiece title. B. Speed Panel - Default speed is 16000 rpm in both FWD and REV Mode. C. Mode Panel - used for cutting mode selection. • FWD Mode - tool cuts in forward direction. • REV Mode - tool cuts in the reverse direction. Skeeter® Drill Pump Set-up (Suction Irrigator) Panel.

Pump 1 will default to Endo-Scrub® 2 irrigation and pump 2 to the Microdebrider with no EHS Drill options. See Precaution P1. Midas Rex® Legend EHS® Drill Motors and Visao® (Pump Set-up Panel)

Pump Setup Irrigation Method HANDPIECE

Pump Setup Irrigation Method HANDPIECE

SUCTION IRRIGATOR

SUCTION IRRIGATOR

Pump 1

Pump 2

Visao

Visao

Irrigation

Cooling

Flush

EHS

Irrigation

Flush

Pumps

Pumps

• There are no pump options for the Skeeter® drill. • For Suction Irrigator panel instructions see, DRILLS Visao® Pump Set-up (Suction Irrigator) and Visao® Suction Irrigator Panel.

Pump 1 will default to Visao® Cooling and pump 2 to the Visao® irrigation with a configuration option to use pump 2 for EHS irrigation. (same for the EHS Stylus™ Motor). See Precaution P1. Midas Rex® Legend EHS® Drill Motors and Visao® (Suction Irrigator)

Pump Setup

Pump Panels with Multiple Handpieces

Irrigation Method

Midas Rex® Legend EHS® Drill Motors and Microdebrider Pump Setup Panel

HANDPIECE

SUCTION IRRIGATOR

Pump Setup Irrigation Method

Pump 1

HANDPIECE

Pump 2

Visao

Cooling

HANDPIECE / ENDOSCRUB 2 Pump 1

Pump 2

EHS

M4

Irrigation

Flush

Irrigator

Flush

Pumps

Irrigation

Flush

Suction

Flush

Pump 1 will default to Visao® Cooling and pump 2 to the Suction Irrigator with no irrigation options. See Precaution P1.

Pumps

Pump 1 will default to EHS irrigation (or Stylus irrigation) and pump 2 to the Microdebrider with no irrigation configuration options. See Precaution P1. Midas Rex® Legend EHS® Drill Motors and Microdebrider with EndoScrub® 2 selected:

15

Accessories

connected).

Multifunction Footswitch

Part No. 1898430 or EF200 The multifunction footswitch allows control of handpiece selection, handpiece speed, and mode selection. 4

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 3

1

4 D 2

C3

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

Multifunction Foot Control Unit (FCU) Buttons and Pedal NOTE: Each button must be depressed and held for one (1) second to activate its function. Drills 1. Pedal - Start/Stop, Variable speed 2. Right Button - Pedal function, (Start-Stop or Variable speed). 3. Top Button - Active handpiece selection 4. Left Button - Mode selection, (FWD/REV). Microdebrider 1. Pedal Start-Stop, Variable speed (Start/Stop, or Variable speed selectable via FCU button on Main Screen). 2. 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). 3. Top Button - Active handpiece selection. 4. Left Button - Mode/rpm selection - FWD/OSC (FWD @ 12000) (OSC @ 5000, 3000, 1500, or 300). SC1 1. Pedal Start-Stop, Variable speed (Start/Stop, or Variable speed selectable via FCU button on Main Screen). 2. 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). 3. Top Button - Active handpiece selection. 4. Left Button - Mode selection -FWD/OSC/CUT.

F6

E. Endo-Scrub® 2 Finger switch. F. Finger switch cable. 7 G

8 H

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

1

IntelliFlow Irrigation Remote Control

The IntelliFlow Irrigation Remote Control is designed to set and change the flow rates from the sterile field. A. Pause/On-Off: • Pause if used with handpiece irrigation (Flow rate will flash yellow). • On-Off/Pause if used with Suction Irrigator. B. Increase/Decrease: • Handpiece Irrigation - fine adjustment for irrigation rate. • 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.

1. Wet. 2. Slowly insert. A 3

B C

Endo-Scrub® 2 (can be used only when a microdebrider is 16

2

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.

C3 1 A

A1

B2

C3

1 A

B2

2 B

4 D

4 D 5 E

55 E

E5

A. Outer blade - rotated by Finger Wheel (Straightshot® M4 and Midas Rex® SC1). B. Inner blade - rotated by the Blade Position panel (Straightshot® M4, Straightshot® Magnum® II, Straightshot® III, and the Midas Rex® SC1). C. Outer Sleeve. D. Irrigation flow is between the inner and outer blades. E. Suction flow is through the inner blade.

4 D

C3

A. Suction Tube. B. Irrigation tube. C. Suction Fitting. D. Irrigation Fitting. E. Tube Size.

keyed rotatable Blade Suction irrigator handpiece.

Handpieces Microdebriders and sc1 STRAIGHTSHOT® M4, microdebriders, and Midas Rex® SC1

2 B

1 A 7 G

Rotating Outer Blade: 1. Align the arrow on the indexing tool with the window opening and apply axial pressure to disengage the tip . 2. Rotate to the desired position. 3. Release the axial pressure and verify the tip is fully engaged. StraightShot® M4 and Midas rex® sc1 set-up NOTE: The Straightshot® M4 uses cutting tools with a four (4) tab alignment system where the Midas Rex® SC1 uses cutting tools with a three- (3) tab alignment system.

C3

4 D 1

E5

F6

A. Handpiece. B. Finger wheel. C. Locking collar. D. Irrigation-tubing groove. E. Finger-wheel lock. F. Cable. G. Suction barb. Blade Position and finger wheel Blades NOTE on keeping blades clear: During the procedure, it is recommended to periodically submerse the blade tip in sterile water with suction connected to the handpiece. NOTE For Airway Blades: Should the blade become clogged during use, risk assessment has determined 1-5 cc of irrigant could be aspirated by the patient before detection by the user.

M4

1

2

2

SC1

Blade or bur installation (3 & 4-tab) Straightshot® M4 1. Insert tool aligning the tabs with the notches (1) and orientate the irrigation barb (2) to the left or right side. 3

2. Depress the locking collar(3).

17

2

3. Release the locking collar. (If collar does not return to full out position adjust the finger wheel with small back-andforth motions until collar pops out). 4. Pull on the blade or bur to ensure engagement and visually check to make sure distal tip of inner blade is in contact with the distal tip of the outer cannula.

1

Tubing (Straightshot® M4, and the Midas Rex® SC1).

3

1. Depress collet(1). 2. Insert blade in collet and release collet (2 and 3). 3. Pull on the tool to ensure engagement and check distal tip of inner blade is in contact with the distal tip of the outer cannula.

4 5

1. Push the free end of the irrigation tubing onto the irrigation barb on the blade until fully seated. 2. Attach suction tubing securely to the suction port on the handpiece.

3. Secure the irrigation tubing. 4. Secure the suction and irrigation tubing (see Tubing Management).

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 Handpiece 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

Tubing 4. Attach suction tubing. 5. Push irrigation tubing onto the irrigation barb. 6. Secure the suction and irrigation tubing (see Tubing Management). MICRODEBRIDERs and sc1 CLEANING and Sterilization See Appendix A Technical Specifications Handpiece - Straightshot® Magnum® II, Part No. 1897200 Straightshot® III 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 handpieces with the IPC console.

Visao® High-speed Otologic Drill (WATERCOOLED) B2

A1

4 D

C3

3 C

B2 A1

4 D

A. Basic handpiece B. Suction barb C. Locking collar D. Cable 18

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

Visao® Hi-Speed Drill

E5

Visao® burs and bur guards

Visao® STIM Bur Guard installation.

Visao® curved tool installation

The STIM Bur Guard locks onto any Visao® handpiece.

1

2

2

1. Unlock. 2. Insert the curved tool.

1

3

4

1. Unlock. 2. Insert STIM Bur Guard. 4

5

3. Engage notch. 4. Push in tool. 5. Lock collar. 6. Gently Pull on the tool to ensure it is locked. 7. Remove in the reverse order. Visao® curved tool cooling 1. Prior to initial use, soak the cooling sleeve by dipping it into a cup of saline or DI water, as shown. 2. During use, maintain copious irrigation of the cooling sleeve and bur by dribbling saline or DI water along the entire length of the cooling sleeve.

3

3. Ensure notch is engaged. 4. Insert tool.

5

Visao® bur guards Visao® Bur Guard.

5. Lock. 6. Gently pull on tool to ensure it is locked. 7. Remove in the reverse order.

Visao® STIM Bur Guard provides nerve stimulation to standard burs in static and dynamic modes when used with both the Medtronic Nerve Integrity Monitor (NIM™) and the IPC™ or XPS® 3000 (REF 1897102BF only) Drill System.

The STIM Bur Guard cable connects to the BUR jack on the Integrated Power Console™. A separate cable then connects the IPC™ (NIM® Jack) to the Medtronic Nerve Integrity Monitor (NIM®) Patient Interface Box. Wires within the STIM Bur Guard make contact with the uncoated tool and carry the stimulating current to the tool’s tip. For more information related to the STIM Bur Guard system contact your local Medtronic ENT representative. 19

Visao® Bur Guard and straight tool installation. Bur Guard is required for use with all burs. NOTE: Multi-use Bur Guard shown. Single-use installs in the same fashion.

1

Visao® STIM Bur with irrigation Bur Guards irrigation tubing instructions 1. Push the free end of the irrigation tubing onto the irrigation barb until fully seated. NOTE Prime only when both cooling and irrigation systems are ready.

1. Insert 2

Visao® CLEANING and Sterilization See Appendix A

Technical Specifications 3

2. Unlock. 3. Insert tool.

4

4. Lock. 5. Gently pull on tool to ensure it is locked. 6. Remove in the reverse order.

Visao® High-Speed Otologic Drill Part No. 3334800 Speed 200-80,000 rpm forward/reverse, Visao® High-Speed Otologic Drill, Water-Cooled Size 16.0 cm length x 2.0 cm diameter Weight 148 g Duty Cycle The Visao® High-Speed Otologic Drill 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 B2

1 A

C3 5 E

Visao® tubing Visao® motor coolant Tubing The Visao® utilizes saline or DI water to cool the motor. The coolant may flow in the left or right port as long as return tubing is connected to the opposite port. NOTE: Be careful not to confuse the coolant with irrigation.

4 D

A. Tool B. Tool’s color code. C. Tool lock/release button. D. Cannulated shaft. E. PTFE Bearing. INSTRUCTIONS FOR USE 1

1. Connect one tube to each port.

2

Visao® irrigation Tubing

3

2

Visao® multi-use Bur Guard with irrigation

1. Press the bur release button. 2. Insert the bur shaft using a slight twisting motion. 3. When a “click” is noted release the bur release button. 4. Gently pull on bur to ensure it is locked. 5. Remove in the reverse order. Skeeter® CLEANING and Sterilization See Appendix A

Visao® single-use Bur Guard with irrigation 20

Technical Specifications Skeeter® Ultra-Lite oto-Tool Part No. 3055601 Speed 1,000-16,000 rpm forward/reverse