Medtronic 3334800 Instructions for Use

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User’s Guide

REF

Integrated Power Console (IPC™) System

1898001

Symbols

EUR · USA · JPN · AUS

IPX1

EC REP

IPX7

ACC

IPX8

DEHP

STERILE

NIM

Accessory

REF

LOT

REFURBISHED

!USA

On/O Button Package Contents Follow

EMC Compliance Mark

Instructions For Use

Do Not Oil Do Not Immerse

105345

Conforms to ANSI/AAMI ES60601-1, Certied to CAN/CSA-C22.2 No.60601-1, IEC/EN 60601-1

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

>120 VAC

<120s

Fuse

Use By Date

Accessory

AC Power Type BF Applied Part Foot Pedal

Output Start/Stop Fine Irrigant

Is Approximately Equal To

Non-Sterile Consult Instructions

Non-Sterile

Quantity

Not Greater Than 120vac

Caution

Applied Part

OFF

Duty Cycle

>180s

Catalog Number Manufacturer

Lot Number

Serial Number Ergonomically

XX° C >X° C

BUR

EHS

Protected Against Vertical Water Drops

Protected Against The Eects Of Temporary Immersion In Water

RF Transmitter (Interference May Occur)

for Use

Stim Bur Connector

NIM Console Connector

Electrical High Speed Handpiece Connector

World Wide Standard for Medical Tubing Diameter

Date of Manufacture Handpiece

<XX° C

Temperature

XX° C

Limitation Outer Limits =

Transport Inner Limits = Use

Engineered

Oscillate

Forward

Reverse

Connector

Adjustment

Left Foot Control Unit Button / Mode Button

Right Foot Control Unit Button / Control Button

Top Foot Control Unit Button / Handpiece Button

Locked

Unlocked

Pump Head 1

Pump Head 2

Refurbished

Authorized Representative in the European Community

Precaution: Pinch Hazard. Keep Fingers Clear Of Rollers

PHT

Contains DEHP (di-2-ethyl hexyl phthalate)

Protective Earth

Equipotential Ground Connector

Use With

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

Do Not Dispose Of This Product In The Unsorted Municipal Waste Stream. Dispose Of This Product According to Local Regulations. See

Recycling.Medtronic.com for Instructions On Proper Disposal Of This Product.

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

Adapter

Attachment

Bone Mill

Brush

Control Unit

Dissecting Tool

Instrument Case

Lubricant/Diuser

Motor

Multi-Use Disposable Attachment

Regulator

USA Only Speed Range

<NNNN

min

For use up to “NNNN” RPM

Table of Contents

Symbols .......................................................................................................................................................... 2

IPC™ System .................................................................................................................................................... 4

Glossary ............................................................................................................................................................................................................................... 4

Indications for use ...........................................................................................................................................................................................................4

Device description ........................................................................................................................................................................................................... 4

Contraindications ............................................................................................................................................................................................................4

Additional IPC™ congurations ..................................................................................................................................................................................4

Warnings .............................................................................................................................................................................................................................4

Precautions .........................................................................................................................................................................................................................6

System requirements and specications ................................................................................................................................................................6

System sounds ..................................................................................................................................................................................................................7

System gures ...................................................................................................................................................................................................................8

Pre-and Post-operating instructions ...................................................................................................................................................................... 11

IPC™ components ......................................................................................................................................................................................................... 13

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity ............................................................................................... 15

Limited warranty ........................................................................................................................................................................................................... 17

For items contaminated with TSE agents ............................................................................................................................................................ 17

Endo-Scrub™ 2 .............................................................................................................................................. 18

StraightShot™ M5, StraightShot™ M4, StraightShot™ Magnum™ II, and StraightShot™ III .................... 21

Skeeter™ Ultra-Lite Oto-Tool ....................................................................................................................... 26

Indigo™ High-Speed Otologic Drill ............................................................................................................. 28

Visao™ High-Speed Drill ............................................................................................................................... 32

Troubleshooting ........................................................................................................................................... 35

Error codes .................................................................................................................................................... 37

Cleaning and sterilization ............................................................................................................................ 39

Reprocessing Instructions - Endo-Scrub™ 2 Finger Switch ........................................................................................................................... 40

Reprocessing Instructions - StraightShot™ M5, StraightShot™ M4, StraightShot™ Magnum™ II, StraightShot™ III .................. 41

Reprocessing Instructions - Skeeter™ Oto-Flex Burs ........................................................................................................................................ 43

Reprocessing Instructions - Skeeter™ Handpiece ............................................................................................................................................. 44

Reprocessing Instructions - Indigo™ High-Speed Otologic Drill ................................................................................................................. 45

Reprocessing Instructions - Indigo™ High-Speed Otologic Drill Attachments ...................................................................................... 46

Reprocessing Instructions - Visao™ Handpiece .................................................................................................................................................. 47

Reprocessing Instructions - Frontal Sinus 2mm Mini Trephine Drill ........................................................................................................... 48

Reprocessing Instructions - Medtronic Burs ....................................................................................................................................................... 49

Customer service .......................................................................................................................................... 50

Integrated Power Console (IPC™) System

IPC™ SYSTEM

IPC™ System Glossary

The following words and acronyms may be used in this guide.

FCU Foot Control Unit FWD Forward - Rotation is clockwise I.V. Intravenous IPC™ Integrated Power Console NIM™ Nerve Integrity Monitor - One or all of the Nerve Integrity Monitor units: NIM-Response™ 2.0, NIM-Neuro™ 2.0, NIM-

Response™ 3.0 and NIM-Neuro™ 3.0 NIM-Eclipse™ Nerve Integrity Monitor for spinal surgeries OSC Oscillate REV Reverse - Rotation is counter-clockwise XPS Xomed Power System Tool Surgical cutting device Motor Handpiece/drill Accessory Any compatible product that can be used with the IPC™ Attachment Any compatible product that can be secured to a handpiece

Indications for use

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

Device description

The IPC™ System is a powered microdebrider, drill and saw system that will remove soft tissue, hard tissue and bone during surgical procedures. The system consists of a power control console, foot pedal, 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.

In addition to the handpieces and pumps there is a connection for continuous stimulation of the Visao™ straight burs that enables nerve integrity monitoring during surgical procedures. The Nerve Integrity Monitor (NIM™) is a separate device that stimulates and monitors the nerve. This system has connections that allow the NIM™ to be connected with the Visao™ handpiece and stimulating bur guard, enabling the NIM™ to stimulate and monitor the nerve at the surgical site.

This device is intended for use by physicians trained in the procedures described.

Contraindications

None.

Additional IPC™ congurations

Additional IPC™ congurations are available. Refer to the following User’s Guides for related information.

• IPC™ POWEREASE™ System Model: 2340000 (IPC™ User’s Guide)

• Neurosurgical IPC™ System Model: EC300 (IPC™ User’s Guide CFN 175027)

Consult the appropriate User’s Guide for indications, contraindications, warnings, and component information specic to each system.

Warnings

System warnings

W1 It is important that the IPC™ system operator be familiar with the system User’s Guide, its precautions, procedures and safety issues. W2 Do not use the IPC™ system in the presence of ammable anesthetics. Avoid potential ignition or explosion of gases. W3 To avoid the risk of electric shock, this equipment must only be connected to a supply main with protective earth. W4 To avoid the risk of electrical shock, achieve electrical grounding reliability with proper connections. Connect the IPC™ system to hospital

grade receptacles only.

W5 Do not attach any system component or accessory other than Medtronic approved components to the IPC™ system as this may result in

electrical shock, component damage, substandard performance, increased emissions, or decreased immunity.

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Integrated Power Console (IPC™) System

IPC™ SYSTEM

W6 Disconnect power to the IPC™ system before cleaning the unit to avoid electrical shock. 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 the anesthetized patient. W8 Do not operate the IPC™ system in the presence of Magnetic Resonance Imaging devices. W9 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 User’s Guide. W10 The IPC™ system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the IPC™ system

should be observed to verify normal operation in the conguration in which it will be used. W11 Portable and mobile RF communications equipment can aect Medical Electrical Equipment. W12 Keep NIM™ Muting Probe cable away from IPC™ system cables to prevent unintended EMG interference or muting. W13 After each procedure, properly clean all reusable system components. W14 All service must be performed by Medtronic qualied personnel only. Repair and/or modication to the IPC™ system by anyone other than

qualied service personnel may signicantly compromise the unit’s ability to perform eectively and/or void the equipment warranty. W15 Auxiliary Power Outlet with protective cover is for use with the Hydrodebrider or Bone Mill only. Consult Hydrodebrider and Bone Mill

instructions prior to use.

Component Warnings

W16 Always inspect the components before and after use for any damage or malfunction. If damage or malfunction is observed, do not use

damaged part until it is repaired or replaced. Use of damaged or malfunctioning parts can increase risk of injury. W17 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. W18 Do not use an overheated device as it may cause thermal injury. Smoke and/or excessive heat may be caused by:

• Applying excessive force while cutting (e.g. side loading)

• Long operating periods (exceeding handpiece duty cycle)

• Attachment not fully locked in handpiece

• Inadequate or loss of irrigation

• Component failure or wear W19 The handpieces will not run properly unless the attachment is in the locked or secured position. W20 Do not change accessory with handpiece running to prevent laceration of user and cross-contamination through compromised glove. W21 Do not place motor, attachment and tool on the patient or in an unsecured location during surgery. W22 Do not activate foot pedal without conrming the safe position and handling of the handpiece. Accidental handpiece activation could

result in unintended tissue, bone, or nerve resection. W23 Verify reusable device was cleaned and sterilized prior to use. If not sterilized, do not use. W24 For warnings & precautions related to reprocessing, refer to Cleaning and sterilization instructions. W25 This system requires insulated connectors for the StraightShot™ M4 Microdebrider, StraightShot™ Magnum™ II Microdebrider,

StraightShot™ III Microdebrider, Midas Rex™ Spine Shaver (SC1), Visao™, or Skeeter™ handpieces and the multifunction foot pedal. W26 When using StraightShot™ microdebrider handpieces with non-rotatable tools, ensure rotation lock is engaged to prevent inadvertent

rotation. When using with optical Image Guided Surgery (IGS), engage the rotation lock prior to calibration and verication of the tip.

Disposable Warnings

W27 Tools are available for resection of soft tissue and bone for surgical procedures. Use of tools depends on the intended application and

patient needs. Sharp cutting powered tools induce bleeding and removal of signicant tissue and bone. W28 Do not use accessory if package is opened or damaged. Broken seal oers no protection against cross-contamination. W29 Operate the tool only after the appropriate anatomical landmarks and the intended surgical site have been conrmed. Ensure adequate

visualization when using powered accessories. Discontinue powered application in the event of lack of visualization of the surgical site. W30 Use methods at the operative site to control bleeding that do not compromise patient safety during at-risk surgery. W31 Always keep the cutting area of the tool away from ngers and loose clothing to prevent laceration of user and cross-contamination

through compromised glove. W32 Excessive noise from the tool when drilling close to the cochlea or ossicular chain may cause hearing damage. W33 Improper use of high speed burs can result in damage to the eye and/or orbit, vascular damage, nerve damage, and/or cerebral damage.

Use appropriate caution when operating this device in the vicinity of critical anatomy. W34 Excessive pressure applied to tool may cause tool 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. W35 Do not use excessive force to pry or push bone with the attachment, tool or blade during dissection. W36 Do not apply excessive side loading. Excessive side loading could cause angled attachments to unlock accidentally from motor.

Integrated Power Console (IPC™) System

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IPC™ SYSTEM

W37 Do not modify any system components or accessories. Use of modied components or accessories may increase risk of injury or diminish

performance of the system. W38 Insertion of metal objects in accessory tip may cause the accessory to break leaving fragments in the wound. The fragments may be

dicult to remove, causing irritation, inammation and foreign-body response at surgical site. W39 Bending or prying may break the accessory, causing harm to patient or sta. W40 Inspect tools prior to and during use for signs of wear, fragmentation, eccentricities, or other defects. Replace and discard damaged tools.

Do not attempt to re-sharpen tools. W41 Test attachments for excessive vibration at desired speed before use. Vibration may be caused by eccentricity of the tool or worn

components. Replace tool, attachment, or handpiece, or change handpiece speed. W42 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. W43 Powered blades should be operated in the Oscillate mode only. Operating in the Forward mode may cause damage to the blade. W44 Do not use the burs above the speed indicated on the bur label. W45 If an airway blade becomes clogged during use, 1-5 cc of irrigant could be aspirated by the patient before detection by the user. W46 Do not attempt to sterilize disposable devices. The disposables are packed sterile and are intended for single use. Devices lose sterility

upon removal from packaging.

Precautions

P1 Do not kink cables. Inspect cables and pins for cracks, tears or corrosion. P2 When using a Y-Splitter, only one multifunction foot pedal shall be active at a time. P3 Do not connect multiple Y-Splitters. P4 StraightShot™ handpieces are intended to operate at speeds greater than 6,000 rpm only when used with the high speed bur line. P5 Do not use anti-fog on scope or sheath, as weeping or leaking may result. P6 Do not use excessive force to insert the endoscope into the Endo-Scrub™ 2 sheath. this will damage the endoscope as well as the Endo-

Scrub™ 2 sheath. P7 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. P8 Remove and discard accessories following local regulations for proper disposal of contaminated materials. P9 When using an angled attachment, hold the handpiece assembly by the attachment so that the attachment does not inadvertently loosen

from the handpiece. P10 Always examine operation of each tool in a handpiece before use. P11 Powered burs and drills should be operated in the Forward mode only. P12 To prevent damage to tools, disconnect suction tube prior to changing tool during procedure. P13 Ensure the blade or bur is fully engaged in the microdebrider. For blades, verify the tip is fully engaged with the outer cannula prior to use. P14 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. P15 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.

System requirements and specications

Console Specications

Functional Standards for Electrical Systems

ANSI/AAMI ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential

performance

IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential

performance

EN 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential

performance

IEC 60601-1-4 Medical electrical equipment - Part 1: General Requirements for Safety, Part 4: Programmable

Electrical Medical Systems

IEC 60601-1-2 Medical electrical equipment - Part 1-2: General Requirements for Safety - Collateral Standard:

Electromagnetic Compatibility - Requirements and Tests

CAN/CSA C22.2 #60601-1 Medical Electrical Equipment - Part 1: General Requirements for basic safety and essential

performance

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Integrated Power Console (IPC™) System

2005, 2012

2006, 2014

1996, 1999

2007, 2014

2005, 2014

Physical Dimensions

Size 277 mm Width x 353 mm Height x 267 mm Depth

Weight 7.3 kg

Operational Environment

Temperature +10 °C to +33 °C

Humidity 30 % to 75 % RH

Barometric Pressure 700 - 1060 hPa

Transport and Storage Environment

Temperature -40 °C to +70 °C

Humidity 10 % to 95 % RH

Barometric Pressure 500 to 1060 hPa

Display / Touchscreen

Type High contrast, digital, graphic color, visible in complete darkness

Resolution Display 21 cm diagonal, resolution 480 X 640 pixels

Audio Output

Baseline Audio Sound Level 60 dBA minimum SPL (1 m)

Electrical

Input Voltage 100 V-240 V ± 10%

Frequency 50/60 Hz

Power Consumption 500 VA

Auxiliary AC output 200 VA Max.

Internal Fuse 5 x 20 mm T. L. 5 A, 250 V

Medtronic Xomed P/N 11270066

Duty Cycle for Applied Part Maximum On Time 120 Seconds

Minimum O Time 180 Seconds

IPC™ SYSTEM

System power cords

Region Part Number Region Part Number Region Part Number

USA, Barbados, Belize, Bolivia, Canada, Colombia, Ecuador, Venezuela

Standard EA600 or 1895820 6 meter EA650 or 1897821

United Kingdom, Ireland, Hong Kong,

Malaysia, Singapore

EA606 Austria, Belgium, Finland,

France, Germany, Greece, Korea, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden

EA602 or 1895822

China EA604 India, South Africa EA607 Switzerland EA601 Argentina EA608 Israel EA609 Denmark EA610 Australia, New Zealand EA605 Japan EA603 or 1895823 Italy, Chile EA611

System sounds

The following tones can sound while using the IPC™ Console.

IPC™ Tone Cause(s)

1 Tone

2 Tones Change from Oscillate to Forward. 3 Tones

Long Tone Change from handpiece to drill.

• Conrmation of change button pressed.

• Change from Forward to Oscillate.

• Change of active handpiece.

• Audible Alarm. Error detected. See screen for error message.

• Active handpiece is in Reverse and foot pedal pressed.

• First time accessory changes from Forward to Reverse.

Integrated Power Console (IPC™) System

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IPC™ SYSTEM

System gures

Figure 1-1. IPC™ Console Front

1 Pump 1: Coolant, lens cleaning or irrigation

2 Touchscreen

3 Power on/o

4 Pump 2: Irrigation or lens cleaning

5 Console connector panel for peripheral devices

Figure 1-2. IPC™ Console Back

67 8

1 Pole clamp

2 Compact ash card port (Medtronic Use)

3 Manual start/stop

4 Auxiliary power outlet

5 Endo-Scrub™ 2 connector

6 Fuse access

7 Equipotential Ground Connector.

Apply potential equalization conductor.

8 Hospital grade power cord connector

1 Not applicable 4 Stimulus input from patient interface

2 Not applicable 5 Stimulus output to stim bur guard or

3 StraightShot™ M5 microdebrider,

StraightShot™ M4 microdebrider, StraightShot™ Magnum™ II microdebrider, StraightShot™ III microdebrider, Visao™ drill, Indigo™ drill

1-8

Figure 1-3. IPC™ Console Connector Panel

3567 8

(NIM™ or NIM-Eclipse™)

POWEREASE™

6 Skeeter™ handpiece

7 Endo-Scrub™ 2 nger switch, Endo-

Scrub™ 2 foot pedal, IntelliFlow™ irrigation remote control

8 Multifunction foot pedal

Figure 1-4. Multifunction Foot Pedal & Y-Splitter

1 Mode button 5 Foot pedal

2 Handpiece button 6

3 Control button 7 Port 1

4 Slip-resistant foot pad 8 Port 2

Y-Splitter

Integrated Power Console (IPC™) System

IPC™ SYSTEM

Figure 1-5. IPC™ Touchscreen

Speed

1 Displays active handpiece 5 Opens Help screen

2 Accessory control panel 6 Irrigation accessory panel

3 Foot pedal variable control 7 Inactive handpiece

4 Opens Pumps screen 8 Set active handpiece settings as default

Acceleration

Pump 2

Pumps

Help

Handpiece Name

60000

100

cc/min

EndoScrub 2

Flow

RPM

Prime

(Handpiece Name)

Setting

Finger

Control

Mode

FWD

REV

Foot

Both

PrimeOn

Figure 1-6. IPC™ Pumps Screen

Prime

Pump 1

None

Pump 2

None

1 Close Pumps screen 3 Pump 1 panel available accessories

2 Prime/Flush pump 4 Pump 2 panel available accessories

None

M4 Irrigation

Irrigation

Prime

Endo-Scrub® 2

Prime

Endo-Scrub® 2

Figure 1-7. Operating Room Setup

1 Mode anesthesia equipment 6 Microscope

2 IPC™ system 7 Surgeon

3 Nursing supplies/Surgical

instruments

4 Scrub nurse 9 Anesthesiologist

5 NIM™ Monitor 10 Patient

Integrated Power Console (IPC™) System

8 Electro-Surgical unit

1-9

IPC™ SYSTEM

Figure 1-8. IPC™ System Conguration

Figure 1-9. IntelliFlow™ Remote Control

1 Irrigation and coolant bags 7 Irrigation pole base diameter

2 Irrigation pole 8 Irrigation pole basket

3 IPC™ console 9 Power cord

4 Console connector panel 10 Pump 2

5 Accessory cables 11 Pump 1

6 Console height

1 Pause/On-O

2 Increase/Decrease Fine Adjustment

3 Increase/Decrease Coarse Adjustment OR

Select stainless steel tubing size (French size) for suction irrigator.

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Integrated Power Console (IPC™) System

IPC™ SYSTEM

Pre-and Post-operating instructions

The following are general IPC™ pre- and post-operating instructions. Refer to other sections of this IFU for operating instructions specic to individual handpieces or accessories.

When the system arrives

• Verify the contents of the box match the packing slip. If incomplete or damaged, notify Medtronic Customer Service.

• If container is damaged, or cushioning material shows stress, notify carrier and Medtronic Customer Service. Keep shipping materials for carrier inspection.

• Save the cartons and packing material. If the instrument is to be shipped the shipping package will provide proper protection.

Set up the IPC™

Refer the related topics for detailed instruction.

1. Install pump cartridges or irrigation tubing.

2. Prepare IPC™ for use.

3. Calibrate touchscreen, if necessary.

4. Change system settings, if necessary.

5. Set up and prime pumps.

6. Conrm system operation.

7. Press the manual start/stop button on the back of the console (Figure 1-2) and verify you can start/stop the handpiece, irrigation and/or coolant ow.

Install the pump cartridges or irrigation tubing

1. Locate the correct pump and lift up the lock (Figure 1-10). Pump 1: Coolant, lens cleaning or irrigation Pump 2: Irrigation Note: The number on the pump must match the number on the cartridge (either 1/1 or 2/2). If the cartridge does not have a pump designator number, use the Pump Setup Screen to install the pump cartridge.

2. Insert the pump cartridge.

3. Snap the pump lock shut.

Note: Ensure the pump cartridge does not crimp the tubing.

Figure 1-10. Install Pump Cartridge

Prepare IPC™ for use

1. Verify Operation Room set up (Figure 1-7). The surgeon may have preferences to the location and visibility.

2. Verify the wheels are locked on the IPC™ cart.

3. Inspect all components for damage and determine if the system is ready for use.

4. Mount the IPC™ and irrigation/coolant bags on the I.V. pole (Figure 1-8). Notes:

• Mount irrigant and coolant bags above the IPC™ to ensure adequate ow.

• It is recommended to use an irrigation pole with minimum base diameter of 53 cm and to mount all items as low as possible to increase

stability during use.

• For transport or uneven oor conditions greater than 10 degrees, maximum height to mount the console is 38 cm if irrigation and coolant

bags are at fully extended pole height.

5. Plug the IPC™ into the power source. Position the IPC™ so that it does not obstruct the power source for the purpose of disconnecting the Main voltage by the power cord.

6. Locate the correct foot pedal or accessory connection port on the connector panel (Figure 1-3), align the mark on the connector to the mark on the console, and then insert the connector.

7. Connect suction, cooling and/or irrigation tubing.

8. Turn on the IPC™ and verify the system passes the self-test and the accessory screen appears on the IPC™ monitor. Note: If the IPC™ does not detect a handpiece or foot pedal the Connect Handpiece/Connect Foot Switch screen appears. Do the following:

• Verify the cable is connected to the correct connection port.

• Press [OK] in the Connect Handpiece/Connect Foot Switch message window to continue use of the IPC™ without the handpiece or foot

pedal.

Calibrate touchscreen

Note: This step is optional.

1. Turn on the IPC™ console.

2. When the system starts, on the Splash screen, press [Settings].

3. On the Settings screen, press Touch Screen Calibration and follow the screen prompts.

Integrated Power Console (IPC™) System

1-11

IPC™ SYSTEM

Change system settings

Note: During surgery, system settings can be overwritten.

1. Turn on the IPC™ console.

2. While the system starts, on the Splash screen, press [Settings].

3. To change the language, press the appropriate language.

4. To change the default settings, press [Default].

• On the Default screen, press the Forward or Backward arrow to change the accessory.

• Make changes to the default settings.

• To conrm system settings and return to the Splash screen, press [OK].

5. For accessories with audible tones, press the REV Audible Tones button to control the following:

• The system delivers one set of reverse beeps when the Reverse mode is activated.

• The system delivers one set of reverse beeps the rst time the drill is used in Reverse mode after the Reverse mode has been activated.

6. To conrm system settings and continue to the IPC™ touchscreen, press [OK].

7. To restore settings to factory default, press [Restore].

Handpiece default settings

The system conguration is dependent on the handpiece(s) connected to the console. The following table denes the default congurations, default settings (X) and default options (O).

Note: During use, update the default settings for the active handpiece by pressing the Set active handpiece settings as default settings button (Figure 1-5).

Table 1. IPC™ Touchscreen Default Congurations

Speed Mode or Mode Select Switch

Handpiece rpm cpm % Forward Oscillate Reverse Acceleration Deceleration Size Flow Irrigation Control

Visao™ 80000 X O 30

Indigo™ 52000 X O 30

StraightShot™ M5 5000 O X 05

StraightShot™ M4 5000 O X 05

StraightShot™ III, Magnum™ II 5000 O X 30

Skeeter™ 16000 X O v 0

Endo-Scrub™ 2 3

Suction Irrigator 8 50 %

Set up and prime pumps

• The IPC™ turns on pump 1 and/or 2 long enough to purge air out of the tubing set(s) the rst time the prime button is pressed.

• The IPC™ resets the prime feature when you turn IPC™ power O and On.

• After you prime the pump, the prime button and functionality become ush functionality.

1. Connect tubing from an IPC™ cartridge to irrigation or coolant port on an accessory.

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

3. If an accessory uses the clear drip chamber (Visao™), ll the clear drip chamber with coolant. To ll, squeeze and release the chamber until full.

4. On the IPC™ touchscreen (Figure 1-5), press the pumps button. Note: The IPC™ pumps screen is also available from the Connect Handpiece/Connect Foot Switch screen which the system displays during IPC™ preparation for use if a handpiece or foot switch is not detected by the system.

5. On the IPC™ pumps screen (Figure 1-6), select the accessory for each pump.

6. For each pump, press the prime button and verify the following:

• Pump(s) run until air is completely purged from tubing.

• Small amount of lubricant ows at the tip of the irrigation device.

• Pump(s) turns o.

7. Press the close button.

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Integrated Power Console (IPC™) System

IPC™ SYSTEM

Pump default congurations

The pump conguration is dependent on the handpiece(s) connected to the console. The following table denes the pump default settings (X) and default options (O).

Table 2. IPC™ Pumps Screen Default Congurations

Pump 1 Pump 2 Endo-Scrub™ 2 Suction Irrigator

Handpiece Cooling Irrigation Irrigation Pump 1 Pump 2 Pump 1 Pump 2

Visao™ X X O O

Indigo™ O X O O O O

StraightShot™ M5 O X* X O

StraightShot™ M4 O X* X O

StraightShot™ III, Magum II O X* X O

Skeeter™ O O O O

Endo-Scrub™ 2 X O X O

Suction Irrigator O O O O

* When the IPC™ detects both the StraightShot™ M4 or StraightShot™ M5 and the Legend EHS Stylus Touch handpiece, by default, the system sets pump 2 as a “shared” irrigation pump. You must manually connect the irrigation tubing to the active handpiece.

Conrm system operation

1. Conrm the irrigation pedal starts handpiece and irrigation ow. Verify the speed changes from white to yellow in the Speed box on the touchscreen.

2. Conrm the foot pedal buttons operate. Refer to Multifunction foot pedal for details.

3. On the touchscreen, verify you can do all of the following:

• Adjust Speed: In the Speed box, press the plus and minus buttons.

• Change Modes: In a Mode box, press any mode button.

• Adjust Flow Rate: In the Irrigation box, press the plus and minus buttons.

Disassemble the IPC™

1. Remove irrigation tubing or cartridge from IPC™ pump. Note: Before removing the tubing from the pump, adjust the clamp on the intravenous tubing to the CLOSED position to prevent excessive

drainage of irrigant from the intravenous bag.

2. Disconnect components and cables. To disconnect non-silicone multi-pin cables from the console, push the cable toward the console and then pull out by the lock ring.

Note: Silicone insulated multi-pin and single pin cable connectors do not have a lock ring. Remove these types of cable connectors straight from the connector panel.

3. After disconnecting insulated connectors from the console, connectors that have debris under the insulator must be cleaned according to Cleaning and Sterilization instructions. If debris is still present after cleaning and sterilization, return for warranty servicing.

4. See Cleaning and sterilization section of this User’s Guide for instructions.

IPC™ components

Auxiliary power to console

• The auxiliary power outlet is available for use with the Hydrodebrider™ and Bone Mill consoles only.

• The auxiliary power outlet is for use at grid voltage ≤120 VAC only.

Multifunction foot pedal

You can use the multifunction foot pedal (Figure 1-4) to start/stop the handpiece, control handpiece speed, handpiece selection and mode of operation. Refer to the Multifunction foot pedal controls topic for each handpiece for specic use and control.

Y-Splitter

Y-Splitter (Figure 1-4) allows using a maximum of two multifunction foot pedals connected to a single IPC™. In this conguration, the Y-Splitter shall be connected to the IPC™, and the multifunction foot pedal(s) shall be connected to the Y-Splitter. When connecting a single foot pedal to the Y-Splitter, you may connect to either Port 1 or 2.

Integrated Power Console (IPC™) System

1-13

IPC™ SYSTEM

IntelliFlow™ irrigation remote control

Use the IntelliFlow™ irrigation remote control (Figure 1-9) to start/stop and change irrigation ow while in the sterile eld. If you are using handpiece irrigation:

• To pause irrigation ow, press the Pause/On-O button.

• To adjust ow rate, press the Fine Adjustment or Coarse Adjustment Increase/Decrease button.

If you are using the Suction Irrigator:

• To pause or turn on/o the Suction Irrigator, press the Pause/On-O button.

• To adjust ow rate, press the Fine Adjustment Increase/Decrease button.

• To select the stainless steel tubing size (French size), press the Stainless Steel Tubing Size button.

1-14

Integrated Power Console (IPC™) System

IPC™ SYSTEM

Electromagnetic compatability

Environment of Intended Use: Professional healthcare facility environment

Guidance and manufacturer’s declaration – electromagnetic emissions

The IPC™ System is intended for use in the electromagnetic environment specied below. The customer or the user of the IPC™ System should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions

CISPR 11

RF emissions

CISPR 11

Harmonic emissions

IEC 61000-3-2

Voltage

uctuations/icker

emissions

IEC 6100-3-3

The IPC™ System is intended for use in the electromagnetic environment specied below. The customer or the user of the IPC™ System should assure that it is used in such an environment.

Immunity test IEC 60601-1-2 test level Compliance level Elec tromagnetic environment - guidance

Electrostatic discharge (ESD) IEC 61000-4-2

Electrical fast transient/burst IEC 61000-4-4

Surge IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Power frequency (50/60 Hz) magnetic eld

IEC 61000-4-8

NOTES:

1. UT is the mains voltage prior to application of the test level.

2. When the console is powered and connected to the footswtich, application of -15KV air discharge onto the footswitch buttons may cause the console to freeze. Power cycle the console to re-establish normal operation.

Group 1 The IPC™ System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause

any interference in nearby electronic equipment.

Class A The IPC™ Systems suitable for use in all establishments, ther than domestic and those directly connected to the public low-

voltage power supply network that supplies buildings used for domestic purposes.

Class A

Complies

Guidance and manufacturer’s declaration – electromagnetic immunities - part I

± 8 kV contact ± 15 kV air

± 2 kV for power supply lines ± 1 kV for input/output lines

± 1 kV line to line ± 2 kV line to earth

(100% dip in UT)

0% U

for 0.5 cycle at 0°, 45°, 90°, 135°, 180°, 225°, 270°, and 315°

0% UT (100% dip in UT) for 1 cycle at 0°

40% UT (60% dip in UT) for 5 cycles

70% U

(30% dip in UT) for 0.5 sec

(100% dip in UT) for 5 sec

0% U

30 A/m 30 A/m Power frequency magnetic elds should be at levels characteristic of a typical location

± 8 kV contact ± 15 kV air

± 2 kV for power supply lines ± 1 kV for input/output lines

± 1 kV line to line ± 2 kV line to earth

0% UT (100% dip in UT) for 0.5 cycle at 0°, 45°, 90°, 135°, 180°, 225°, 270°, and 315°

0% UT (100% dip in UT) for 1 cycle at 0°

40% UT (60% dip in UT) for 5 cycles

70% U

(30% dip in UT) for 0.5 sec

(100% dip in UT) for 5 sec

0% U

The relative humidity should be at least 5% Note-1.

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the IPC™ System requires continued operation during power mains interruptions, it is recommended that the IPC™ System be powered from an uninterruptible power supply or a battery.

in a typical commercial or hospital environment.

Integrated Power Console (IPC™) System

1-15

IPC™ SYSTEM

Guidance and manufacturer’s declaration – electromagnetic immunities - part II

The IPC™ System is intended for use in the electromagnetic environment specied below. The customer or the user of the IPC™ System should assure that it is used in such an environment.

Immunity test IEC 60601-1-2 test

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from structures, objects and people.

level

3 Vrms 150 kHz to 80 MHz

6 Vrms 150 kHz to 80 MHz in ISM bands and amateur radio bands

3 V/m 80 MHz to 2.7 GHz

9–28 V/m Spot frequencies 385 MHz–5.785 GHz Pulse modulation

Compliance level Electromagnetic environment - guidance

3 Vrms 150 kHz to 80 MHz

6 Vrms 150 kHz to 80 MHz in ISM bands and amateur radio bands

3 V/m 80 MHz to 2.7 GHz

9–28 V/m Spot frequencies 385 MHz–5.785 GHz Pulse modulation

Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30cm (12 inches) to any part of the IPC™ System, including cables specied by the manufacturer. Othewise, degradation of the performance of this equipment may result.

Portable and mobile RF communications equipment should be used no closer to any part of the IPC™ System including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer, E is the immunity test levels in volt per meter (V/m), and d is the recommended separation distance in meters (m).

Interference may occur in the vicinity of equipment marked with the following symbol:

d = (6/E) √P

Recommended separation distances between

portable and mobile RF communications equipment and the IPC™ System

The IPC™ System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the IPC™ System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the IPC™ System as recommended below, according to the maximum output power of the communications equipment.

Rated

maximum

output

power of

transmitter

P(W)

0.01 0.03 0.03 0.07 0.03 0.03 0.03 0.07

0.1 0.07 0.07 0.21 0.07 0.07 0.07 0.21

1 0.22 0.22 0.67 0.22 0.22 0.22 0.67

10 0.7 0.7 2.12 0.7 0.7 0.7 2.12

100 2.2 2.2 6.7 2.2 2.2 2.2 6.7

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from structures, objects and people.

380 MHz–390MHz

d = 0.22√P

430 MHz–470MHz

d = 0.22√P

Separation distance according to frequency of transmitter m

704 MHz–787MHz

d = 0.67√P

800 MHz–960MHz

d = 0.22√P

1.7 GHz–1.99GHz d = 0.22√P

2.4 GHz–2.57GHz d = 0.22√P

5.1 GHz–5.8GHz d = 0.67√P

1-16

Integrated Power Console (IPC™) System

IPC™ SYSTEM

Limited warranty

A. This Limited Warranty provides the following assurance for the customer who purchases a Medtronic IPC™ System. This Limited Warranty is

extended only to the buyer purchasing the IPC™ System directly from Medtronic or from its aliate or its authorized distributor or representative. The IPC™ System includes the console, motor or handpiece, foot control, motor cables, instrumentation cases and trays (hereafter referred to as System Components), straight and angled motor attachments (hereinafter referred to as “Attachments”), bur guards and telescoping tubes (hereinafter referred to as Semi-reusable Components) and dissecting tools, irrigation and coolant tubing, and Intelliow remote control (hereinafter referred to as Single Use Components) and jointly referred to as the IPC™ System, unless specically noted. i. Should a System Component fail to function to Medtronic’s published specications during the term of this Limited Warranty (one [1] year

from the date of sale of a new System Component or ninety [90] days from the date of sale of a refurbished or used System Component), Medtronic will either repair or replace the Motor Component or any portion thereof.

ii. Should an Attachment fail to function to Medtronic’s published specications during the term of this Limited Warranty (ninety [90] days

from the date of sale of a new Attachment), Medtronic will either repair or replace the Attachment or any portion thereof.

iii. Should a Semi-reusable Component fail to function to Medtronic’s published specications during the term of this Limited Warranty (thirty

[30] days from the date of sale of a new Semi-reusable Component), Medtronic will replace the Semi-reusable Component or any portion thereof.

iv. Should a Single Use Component fail to function to Medtronic’s published specications prior to its “use by” date Medtronic will replace the

Single Use Component.

B. To qualify for this Limited Warranty, the following conditions must be met:

i. The Product must be used on or before its “Use By” or “Use Before” date, if applicable. ii. The Product must be used in accordance with its labeling and may not be altered or subjected to misuse, abuse, accident or improper

handling. iii. Medtronic must be notied in writing within thirty (30) days following discovery of a defect. iv. The Product must be returned to Medtronic within thirty (30) days of Medtronic receiving notice as provided for in (3) above. v. Upon examination of the Product by Medtronic, Medtronic shall have determined that: (i) the Product was not repaired or altered by any-

one other than Medtronic or its authorized representative, (ii) the Product was not operated under conditions other than normal use, and

(iii) the prescribed periodic maintenance and services, if applicable, have been performed on the Product.

C. This Limited Warranty is limited to its express terms. THIS LIMITED WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED

WHETHER STATUTORY OR OTHERWISE, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. In no event shall Medtronic be liable for any consequential, incidental, prospective or other similar damage resulting from a defect, failure, or malfunction of the IPC™ System, whether a claim for such damage is based upon the warranty, contract, negligence or otherwise.

D. The exclusions and limitations set out above are not intended to, and should not be construed so as to, contravene mandatory provisions of

applicable law. Users may benet from statutory warranty rights under legislation governing the sale of consumer goods. If any part or term of this Limited Warranty is held by any court of competent jurisdiction to be illegal, unenforceable, or in conict with applicable law, the validity of the remaining portion of the Limited Warranty shall not be aected, and all rights and obligations shall be construed and enforced as if this Limited Warranty did not contain the particular part or term held to be invalid.

For items contaminated with TSE agents

Medtronic recommends incineration of devices that have directly or indirectly contacted patients suspected or conrmed with prions or a Transmissible Spongiform Encephalopathy (TSE) such as Crutzfeldt-Jakob disease (CJD).

Integrated Power Console (IPC™) System

1-17

ENDOSCRUB™ 2

(5)

Endo-Scrub™ 2

Device description

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.

Indications for use

The device is indicated for use during routine diagnostic procedures and during endoscopic sinus surgery with standard mechanical instruments.

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 foot pedal or nger switch.

DO NOT use the Endo-Scrub™ 2 for infusion, for disinfection or sterilization of an endoscope, or for suction removal of blood and debris. Use the Endo-Scrub™ 2 sheath only with an endoscope listed on the sheath product label, as malfunction or poor performance could result.

Figure 2-1. Endo-Scrub™ 2 Finger Switch Figure 2-2. Endo-Scrub™ 2 Foot Pedal

(1)

(2)

1 Finger switch 4 Light connection

2 Endo-Scrub™ 2 sheath 5 Finger Switch cable

3 Irrigation connection

(3)

(4)

Endo-Scrub™ 2 assembly

1. Inspect the endoscope to ensure that it is in good condition. Imperfections will prevent complete retraction of irrigant. The scope lens should be free of ne pits, microcracks, or rough seals. The endoscope barrel should be free of mineral deposits or other encrustation.

2. Wet interior insertion port of the plastic sheath hub and outer surface of the endoscope shaft prior to assembly. Wetting both surfaces of each item allows for easier positioning.

3. Slowly, slide the approved endoscope into the Endo-Scrub™ 2 sheath (Figure 2-3). The endoscope tip MUST NOT extend past the sheath end as irrigation run-in will occur.

Note: Do not force the endoscope fully into the plastic hub. The sheath may be damaged beyond use if the endoscope is pushed fully into the plastic hub.

4. Connect the irrigation tubing and a light source (Figure 2-4).

Figure 2-3. Endo-Scrub™ 2 Assembly Figure 2-4. Endo-Scrub™ 2 Assembly

Endo-Scrub™ 2 nger switch assembly

If using the Endo-Scrub™ 2 nger switch, complete the following:

1. Slide the nger switch onto the Endo-Scrub™ 2 sheath (Figure 4-1). Align the cutout section of the ring with the luer connector of the tubing set. The nger switch is properly installed when the cutout section of the ring is rmly seated against the luer connector.

2. Activate the pump by pressing the actuator button located on the nger switch.

1-18

Integrated Power Console (IPC™) System

ENDOSCRUB™ 2

Endo-Scrub™ 2 activation

1. To activate the Endo-Scrub™ 2 wash cycle, press and release the nger switch or multifunction foot pedal.

2. To initiate a continuous ow of irrigant, press and hold the nger switch or multifunction foot pedal. Note: Do not use the Endo-Scrub™ 2 as a suction device. If blood or debris are suctioned into the sheath, it may be necessary to briskly ush

out the empty sheath by using a syringe lled with sterile normal saline solution.

Connect Endo-Scrub™ 2 to IPC™ console

1. Locate the Endo-Scrub™ 2 connector cover on the back of the IPC™ console (Figure 1-2).

2. Insert a small screwdriver in the notch on the cable connector cover and pull.

3. Connect the control switch cable to the cable connector.

4. Connect the Endo-Scrub™ 2 nger switch (Figure 2-1) or the multifunction foot pedal (Figure 2-2) to the console (Figure 2-5).

Endo-Scrub™ 2 touchscreen controls

To set or adjust Endo-Scrub™ 2 controls, on the IPC™ touchscreen, in the Flow section of the Endo-Scrub™ control box (Figure 2-6), do the following:

• To enable the Endo-Scrub™ 2 , press the On/O check-box.

• To adjust the ow rate, press the plus button to increase ow rate or the minus button to decrease ow rate.

• To prime the pump, press the prime button.

Figure 2-5. IPC™ Endo-Scrub™ 2 Connection Port Figure 2-6. IPC™ Endo-Scrub™ 2 Touchscreen

(1)

1 Finger switch or foot pedal connection port

Endo-Scrub™ 2 in standalone mode

The Endo-Scrub™ 2 can operate as a standalone device by changing the IPC™ system defaults.

1. On the Defaults menu (Figure 2-7), in the Stand Alone section, select Endo-Scrub™ and then press [OK].

2. On the Handpiece Connection screen (Figure 2-8), in the Endo-Scrub™ box, press [OK].

Figure 2-7. IPC™ General System Default

Figure 2-8. Handpiece Connection Screen

Integrated Power Console (IPC™) System

1-19

ENDOSCRUB™ 2

Endo-Scrub™ 2 cleaning and sterilization instructions

Refer to document 68E4005 in the Cleaning and Sterilization section.

Endo-Scrub™ 2 foot pedal cleaning

If debris is found under the foot pedal boot, return for warranty service. Do not immerse or sterilize the foot pedal unit. Do not use alcohol, other solvents or abrasive cleaners.

1. Wipe down the Endo-Scrub™ 2 foot pedal with a cloth dampened with a neutral enzymatic detergent, pH 6.0-8.0 or phenol based disinfectant.

2. Dry the unit with a clean, non-abrasive cloth.

1-20

Integrated Power Console (IPC™) System

STRAIGHTSHOT™ M5, STRAIGHTSHOT™ M4, STRAIGHTSHOT™ MAGNUM™ II, AND STRAIGHTSHOT™ III

12 3

StraightShot™ M5, StraightShot™ M4, StraightShot™ Magnum™ II, and StraightShot™ III

Device description

The StraightShot™ M5 Microdebrider handpiece is an accessory to the IPC™ system and uses a cannulated motor that provides a suction path through the motor. The handpiece can operate at speeds of 30,000 rpm forward and 7500 rpm oscillate. The higher forward operating speeding allows the handpiece to support high speed burs.

The StraightShot™ M4 Microdebrider, features a nger wheel that enables the user to rotate the cutting tip of specially designed straight and curved rotatable blades. It is also compatible with non-rotating blades and burs. It includes a locking mechanism to prevent inadvertent rotation of non-rotating blades. The lightweight design combines high power and precision performance and can operate in forward mode of 12000 rpm for bur operation and 5000 rpm in oscillate for blade operation. The StraightShot™ M4 also provides irrigation tubing management grooves to keep tubing out of the surgeon’s way during a procedure.

Note: The StraightShot™ III and the StraightShot™ Magnum™ II are not for sale in the United States. The IPC™ incorporates the microdebrider at pump 2. Control operation of the microdebrider with the IPC™ touchscreen and the multifunction

foot pedal. When the IPC™ detects both the StraightShot™ M4 or StraightShot™ M5 and the Legend EHS Stylus handpieces, the system defaults Pump 2 to

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

Figure 3-1. StraightShot™ M5 Handpiece Figure 3-2. StraightShot™ Magnum™ II and III Handpiece

1 Finger wheel 4 Finger wheel lock 1 Suction barb 2 Locking collar

2 Irrigation tubing groove 5 Locking collar

3 Suction barb

StraightShot™ M4 and StraightShot™ M5 blade or bur assembly

1. Insert the tool aligning the tabs with the notches (Figure 3-3). Orientate the irrigation barb to the left or right side.

Note: The StraightShot™ M4 and the StraightShot™ M5 use a four-tab alignment system.

• For rotating straight blades, orient the irrigation barb at the 3 o’clock position for right-handed surgeons and 9 o’clock for left-handed

surgeons.

• For rotating curved blades, orient the irrigation barb at 3 o’clock.

• For rotatable blades, adjust the nger wheel with small back-and-forth motions until the blade is engaged.

2. Press the locking collar (Figure 3-4).

3. Release the locking collar. Note: If the collar does not return to full out position adjust the nger wheel with small back-and-forth motions until collar pops out.

4. Pull on the blade or the bur to ensure engagement and visually check to make sure the distal tip of the inner blade is in contact with the distal tip of the outer cannula (Figure 3-5).

Figure 3-3. Blade or Bur Assembly Figure 3-4. Blade or Bur Assembly Figure 3-5. Blade or Bur Assembly

Integrated Power Console (IPC™) System

1-21

STRAIGHTSHOT™ M5, STRAIGHTSHOT™ M4, STRAIGHTSHOT™ MAGNUM™ II, AND STRAIGHTSHOT™ III

StraightShot™ M4 and StraightShot™ M5 suction and irrigation tube assembly

1. Attach a suction tube to the suction source and an irrigation tube on the irrigation barb (Figure 3-6).

2. Secure suction and irrigation in the irrigation groove on the handpiece (Figure 3-7).

Figure 3-6. Suction and Irrigation Assembly Figure 3-7. Suction and Irrigation Assembly

StraightShot™ Magnum™ II and StraightShot™ III blade and bur assembly

1. Press the collet and insert blade in collet (Figure 3-8).

2. Release the collet (Figure 3-8).

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

StraightShot™ Magnum™ II and StraightShot™ III suction and irrigation assembly

1. Attach a suction tube to the suction source and an irrigation tube on the irrigation barb (Figure 3-9).

2. Secure suction and irrigation tubing with tubing clips.

Figure 3-8. StraightShot™ II and III Blade and Bur Assembly Figure 3-9. StraightShot™ II and III Suction and Irrigation

Assembly

Connect StraightShot™ to IPC™ console

Locate the StraightShot™ connection port on the connector panel (Figure 3-10) and insert the connector. Note: To insert multi-pin connectors (indicated by a silver or red mark on the connector), align the mark on the connector to the mark on the console, then insert the connector.

Figure 3-10. IPC™ Connection Ports

1-22

1 Handpiece connection port

2 Multifunction foot pedal connection port

Integrated Power Console (IPC™) System

STRAIGHTSHOT™ M5, STRAIGHTSHOT™ M4, STRAIGHTSHOT™ MAGNUM™ II, AND STRAIGHTSHOT™ III

StraightShot™ touchscreen controls

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

M4 touchscreen. Note: When you stop the blade, one of the following occurs:

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

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

To set or adjust StraightShot™ controls, on the IPC™ touchscreen, in the StraightShot™ Handpiece control box (Figure 3-11, 3-12), do the following:

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

• To adjust speed for the StraightShot™ M4, StraightShot™ Magnum™ II, and StraightShot™ III, in the Speed control box, press the plus to increase speed or the minus button to decrease speed. Forward Mode: Default, 12000 rpm; variable adjustment from 50 to 12000 rpm. Oscillate Mode: Default, 5000 rpm; variable adjustment from 50 to 5000 rpm.

• To adjust speed for the StraightShot™ M5, in the Speed control box, press the plus to increase speed or the minus button to decrease speed. Forward Mode: Default, 12000 rpm; variable adjustment from 50 to 30000 rpm. Oscillate Mode: Default, 5000 rpm; variable adjustment from 50 to 7500 rpm.

• To adjust the irrigation ow rate, in the Pump control box, press the plus button to increase ow rate or the minus button to decrease ow rate. If intermittent ow is available, pressing the plus or minus button progresses the system through intermittent and continuous ow. The system displays Intermittent when in intermittent ow mode. Forward Mode: Default, 30 cc per minute.

Oscillate Mode: Default, 5 cc per minute.

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

• To rotate outer blade, use the nger wheel (Figure 3-1).

• In oscillating mode only, you can use the Blade Position control box to do any of the following: Note: The motion indicator indicates rotation direction of the blade.

To enable the multifunction foot pedal to change rotation displacement, press the delta button. To rotate inner blade in small increments, press the counter-clockwise buttons.

Figure 3-11. StraightShot™ M4 Touchscreen Figure 3-12. StraightShot™ M5 Touchscreen

Integrated Power Console (IPC™) System

1-23

STRAIGHTSHOT™ M5, STRAIGHTSHOT™ M4, STRAIGHTSHOT™ MAGNUM™ II, AND STRAIGHTSHOT™ III

Microdebrider blade control

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

• To rotate the outer blade (Figure 3-13), use the nger wheel (Figure 3-1).

• To rotate the inner blade, use the Blade Position control box on the IPC™ touchscreen. Refer to the related accessory Controls topic for further information.

Multifunction foot pedal controls

By default, press each button on the foot pedal for at least 100 ms for the selection to become active. Use the IPC™ touch screen Settings screen to change the default value.

To use the multifunction foot pedal (Figure 3-14) to control the handpiece do the following:

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

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

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

• To change the handpiece, press the handpiece button.

Figure 3-13. Blade Dissection Figure 3-14. Multifunction Foot Pedal & Y-Splitter

1 Suction ow in through inner blade irrigation ow between inner and outer blades 1 Mode button 5 Foot pedal

2 Outer blade 2 Handpiece button 6

3 Inner blade 3 Control button 7 Port 1

4 Outer sleeve 4 Slip-resistant food pad 8 Port 2

Y-Splitter

Cleaning and sterilization instructions

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

StraightShot™ M4 technical specications

StraightShot™ M4 1898200T

Size 14.3 cm Length x 1.8 cm Width (1898200T)

Weight 228 g 1898200T

Speed 50-5000 rpm oscillate

50-12000 rpm forward

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

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

1-24

Integrated Power Console (IPC™) System

STRAIGHTSHOT™ M5, STRAIGHTSHOT™ M4, STRAIGHTSHOT™ MAGNUM™ II, AND STRAIGHTSHOT™ III

StraightShot™ M5 technical specications

StraightShot™ M5 1899200

Size 12.5 cm Length x 2.0 cm Width (1899200)

Weight 203 g 1899200

Speed 50-7500 rpm oscillate

50-30000 rpm forward

Duty Cycle for Applied Part The StraightShot™ M5 handpiece under full load is rated for intermittent operation per the following:

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

StraightShot™ Magnum™ II and StraightShot™ III technical specications

StraightShot™ Magnum™ II 1897200 StraightShot™ III 1897201

Size 17 cm Length x 1.6 cm Width (1897200/1897201)

Weight 240 g 1897200, 1897201

254 g 1897200T

Speed 50-5000 rpm oscillate

50-12000 rpm forward

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

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

Integrated Power Console (IPC™) System

1-25

SKEETER™ ULTRALITE OTOTOOL

Skeeter™ Ultra-Lite Oto-Tool

Device description

The Skeeter™ handpiece and burs may be used with the IPC™ via direct connection with the Skeeter™ handpiece connector. The lightweight Skeeter™ Ultra-Lite Oto-Tool Handpiece weighs 57 grams. The drill shaft diameter is approximately 2mm and is angled approximately 15 degrees from the plane of the handpiece. The shaft angulation and small diameter maximize visualization of the surgical eld during drill use.

The Skeeter™ is used with the Oto-Flex bur. The Oto-Flex bur, designed for use with the Skeeter™, are composed of a exible stainless steel shaft with a bur and a PTFE bearing at one end, and the handpiece engagement at the other. The inside of the PTFE bearing is lightly coated with silicone spray to reduce operating friction.

Oto-Flex bur color coding

For identication of size, all Oto-Flex Burs are color coded. Diamond burs are further dierentiated from carbide burs by a white band on the shaft of each diamond bur. A color code chart is provided in the base of the Oto-Tool System sterilization case. The bur size identication color codes are as follows:

Color Bur Size Color Bur Size Color Bur Size

Violet 0.5 mm Blue 0.6 mm Orange 1.0 mm Red 2.3 mm Green 0.7 mm Gray 1.4 mm Black Specialty

Skeeter™ assembly

1. Press the bur release button (Figure 4-1).

2. Load the desired bur for the procedure into the handpiece by inserting the bur shaft through the distal end of the handpiece with a slight twisting motion while simultaneously pressing the bur release button.

3. The bur is locked into place when a “click” is noted. Locking of the bur should be checked prior to use by rmly pulling on the bur after the “click” is noted.

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

5. To remove the bur from the handpiece, press the bur release button on the handpiece and pull the bur out.

Yellow 0.8 mm Brown 1.8 mm

Connect Skeeter™ to IPC™ console

On the IPC™ Console, locate the Skeeter™ accessory connection port on the connector panel (Figure 4-2), align the mark on the connector to the mark on the console, then insert the connector.

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

Figure 4-1. Skeeter™ Handpiece Assembly Figure 4-2. IPC™ Connection Port

(1) (2)

1 Bur at distal end 4 Bur shaft 1 Skeeter™ handpiece connection port

2 Bur color code 5 Bur release button 2 Multifunction foot pedal connection port

3 PTFE bearing

1-26

Integrated Power Console (IPC™) System

SKEETER™ ULTRALITE OTOTOOL

Skeeter™ touchscreen controls

To set or adjust Skeeter™ controls, on the IPC™ touchscreen, in the Skeeter™ control box (Figure 4-3), do the following:

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

• To adjust speed, in the Speed control box, press the plus button to increase speed or the minus button to decrease speed. Default, 16000 rpm; variable adjustment from 1000 to 16000 rpm.

Skeeter™ multifunction foot pedal controls

By default, press each button on the foot pedal for at least 100 ms for the selection to become active. Use the IPC™ touch screen Settings screen to change the default value.

To use the multifunction foot pedal (Figure 4-4) to control the handpiece do the following:

• To select Forward or Reverse mode, press the mode button.

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

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

• To change the handpiece, press the handpiece button.

Figure 4-3. Skeeter™ Touchscreen Figure 4-4. Multifunction Foot pedal and Y-Splitter

Skeeter

Speed

16000

RPM

Mode

FWD

REV

1 Mode button 5 Foot pedal

2 Handpiece button 6

3 Control button 7 Port 1

4 Slip-resistant food pad 8 Port 2

Skeeter™ cleaning and sterilization instructions

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

Skeeter™ technical specications

Skeeter™ 3055601

Size 17 cm Length x 1.6 cm Diameter

Weight 57 g

Speed 1000-16000 rpm forward/reverse

Duty Cycle for Applied Part Continuous run

Storage Temperature -40 C to +70  C

Humidity 10 % to 100 % RH

Barometric Pressure 500 to 1060 hPa

Y-Splitter

Integrated Power Console (IPC™) System

1-27

INDIGO™ HIGHSPEED OTOLOGIC DRILL

1 Correct Alignment

Indigo™ High-Speed Otologic Drill

Device description

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

The Indigo™ drill is designed to work only with Medtronic burs and Indigo™ attachments. The use of other burs and attachments may result in sub-standard performance and will void the manufacturer’s warranty.

Indigo™ drill straight attachment assembly

1. Verify the alignment marks on the motor collet are in alignment (Figure 6-1). Note: If the marks are misaligned, turn the collet until the marks are aligned.

2. Slide the attachment over the motor collet (Figure 6-2) so that the alignment mark on the attachment aligns with the alignment mark (unlocked symbol) on the motor collet.

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

4. Turn the attachment so the alignment mark aligns with the locked symbol on the motor collet. You will hear two clicks while rotating the attachment.

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

Note: The Indigo™ motor will not run correctly unless the attachment is in the locked position.

Indigo™ drill angled attachment assembly

1. Verify the alignment marks on the motor collet are in alignment (Figure 6-1). Note: If the marks are misaligned, turn the collet until the marks are aligned.

2. Slide the attachment over the motor collet (Figure 6-3) so that the alignment mark on the attachment aligns with the alignment mark (unlocked symbol) on the motor collet.

3. Turn the attachment so the alignment mark aligns with the locked symbol on the motor collet. You will hear two clicks while rotating the attachment.

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

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

6. Turn the lock ring so the alignment mark aligns with the locked symbol on the attachment. You will hear two clicks while rotating the attachment.

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

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

Figure 6-1. Indigo™ Alignment

Indigo™

High-Speed Otologic Drill

6 Incorrect Alignment

Indigo™

High-Speed Otologic Drill

1 Correct Alignment 4 Indigo™ Motor

2 Stationary Collet 5 Cable

3 Rotating Collet 6 Incorrect Alignment

1-28

Integrated Power Console (IPC™) System

Figure 6-2. Indigo™ Straight Attachment Assembly Figure 6-3. Indigo™ Angled Attachment Assembly

Indigo™

High-Speed Otologic Drill

Indigo™

High-Speed Otologic Drill

1 Tool Lock Ring

High-Speed Otologic Drill

Indigo™ drill irrigation and tubing clip assembly

1. Snap or slide the irrigation clip on to the attachment (Figure 6-4). Note: The irrigation clip is designed with two nodules that t in the grooves on the attachment.

2. Bend the irrigation tube to a desirable angle and adjust the clip closer to or farther from the bur, as necessary.

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

INDIGO™ HIGHSPEED OTOLOGIC DRILL

Indigo™

High-Speed Otologic Drill

Figure 6-4. Irrigation and Tubing Clip Assembly

Connect Indigo™ drill to IPC™ console

Locate the Indigo™ drill connection port on the connector panel (Figure 6-5) and insert the connector. Note: To insert multi-pin connectors (indicated by a silver or red mark on the connector), align the mark on the connector to the mark on the console, then insert the connector.

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

Figure 6-5. IPC™ Connection Ports

Integrated Power Console (IPC™) System

1 Handpiece connection port 2 Multifunction foot pedal connection port

1-29

INDIGO™ HIGHSPEED OTOLOGIC DRILL

Mode

Indigo™ drill touchscreen controls

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

• To change rotation mode, in the Mode control box, select FWD (forward) or REV (reverse). Note: System conguration may be dierent from the default. If the REV (reverse) button appears raised and does not have a selectable radio

button (Figure 5-7), you cannot select the Reverse mode. If the REV button appears concave (Figure 6-7) and has a selectable radio button, you can select the Reverse mode via the touchscreen or the multifunction foot pedal.

• To adjust speed, in the Speed control box, press the plus button to increase speed or the minus button to decrease speed. Default, 52000 rpm; variable adjustment from 200 to 60000 rpm in increments of 200, 500 and then 1000 until 60000.

Note: The speed you set remains constant when you switch between modes.

• To adjust the irrigation ow rate, in the Pump control box, press the plus button to increase ow rate or the minus button to decrease ow rate. If intermittent ow is available, pressing the plus or minus button progresses the system through intermittent and continuous ow of irrigation at 5, 10, 15 and 20 cc per minute. The system displays Intermittent when in intermittent mode. Default, 30cc per minute.

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

Indigo™ drill multifunction foot pedal controls

By default, press each button on the foot pedal for at least 100 ms for the selection to become active. Use the IPC™ touchscreen Settings screen to change the default value.

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

• To select Forward or Reverse mode, press the mode button.

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

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

Note: Functionality of the control button may be changed in the handpiece Defaults menu to pause irrigation. Refer to Change System Settings in the Pre-Operating Instructions section.

• To change the handpiece, press the handpiece button.

Figure 6-6. Indigo™ Touchscreen Figure 6-8. Multifunction Foot pedal and Y-Splitter

Indigo

Speed

Pump 2

cc/min

60000

RPM

Prime

Figure 6-7. Indigo™ Mode

FWD

REV

FWD

REV

Mode

FWD

REV

1 Mode button 5 Foot pedal

2 Handpiece button 6 Y-Splitter

3 Control button 7 Port 1

4 Slip-resistant food pad 8 Port 2

1-30

Integrated Power Console (IPC™) System

INDIGO™ HIGHSPEED OTOLOGIC DRILL

Indigo™ drill cleaning and sterilization instructions

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

Indigo™ drill technical specications

Indigo™ Drill 1845000

Size 11.9 cm Length x 1.53 cm Diameter

Weight 102 g

Speed 60000 rpm forward/reverse

Duty Cycle for Applied Part For continuous use in operating room temperatures up to 40°C, the Indigo™ motor is rated for 3 minutes at

60000 rpm, followed by 25 minutes of rest. For normal operating room temperatures (typically 20°C), the Indigo™ motor is rated for continuous cutting

indenitely at 60000 rpm.

Integrated Power Console (IPC™) System

1-31

VISAO™ HIGHSPEED DRILL

Visao™ High-Speed Drill

Device description

The Visao™ Hi-Speed Drill is used with the IPC™, which incorporates the Visao™ coolant at pump 1 and irrigation at pump 2. The Visao™ coolant pump cartridge uses both a pump tube and a drip chamber return tube. The lightweight design is used in otologic bone drilling operations. It may be used with either standard burs or with Visao™ High Speed Curved Burs to meet the needs of the surgeon, eliminating the need for handpiece attachments.

Set up Visao™ pump

Fill the clear-drip chamber with coolant before you prime the coolant system. Refer to Set up and Prime Pumps for instruction. If irrigation will not be used, select None for pump 2. Refer to Set up and Prime Pumps for instruction.

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

Visao™ bur guard assembly

On the Visao™, a bur guard (Figure 5-2) is required for use with all burs. Slide bur guard over the front end of the Visao™ until fully seated (Figure 5-1).

Figure 5-1: Bur Guard Assembly

Figure 5-2. Visao™ Bur Guards

Visao™ reusable bur guards with and without irrigation. Visao™ single use bur guard with irrigation. Visao™ single use STIM bur guard with and without

irrigation. The STIM bur guard also provides nerve stimulation to standard burs in static and dynamic modes when used with both the Medtronic Nerve Integrity Monitor (NIM™) and the IPC™ System.

Visao™ straight bur assembly

On the Visao™, a bur guard (Figure 5-2) is required for use with all burs.

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

2. Insert the tool until fully seated.

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

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

Visao™ curved bur assembly

On the Visao™, a bur guard (Figure 5-2) is required for use with all burs.

1. Align the alignment point on the Visao™ locking collar with the unlock symbol (Figure 11-4).

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

3. Gently press on the tool until full seated.

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

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

1-32

Integrated Power Console (IPC™) System

VISAO™ HIGHSPEED DRILL

Figure 5-3. Visao™ Straight Tool Assembly Figure 5-4. Visao™ Curved Bur Assembly

Visao™ irrigant and cooling tube assembly

Do not confuse the coolant tube with irrigation tube.

1. Connect one coolant tube to each coolant port (Figure 5-5). The coolant can ow in the left or right port if you connect the return tubing to the opposite port.

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

3. Conrm the coolant pedal starts the handpiece and coolant ow. Note: The coolant pump runs for 1 minute after you release the pedal

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

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

Connect Visao™ to IPC™ console

Locate the Visao™ connection port on the connector panel (Figure 5-6) and insert the connector. Note: To insert multi-pin connectors (indicated by a silver or red mark on the connector), align the mark on the connector to the mark on the

console, then insert the connector.

Figure 5-5. Visao™ Irrigant and Cooling Assembly Figure 5-6. IPC™ Connection Ports

1 Coolant tubing 2 Irrigation tubing 1 Visao™ handpiece connection port 2 Multifunction foot pedal connection port

Visao™ touchscreen controls

To set or adjust Visao™ controls, on the IPC™ touchscreen, in the Visao™ control box (Figure 5-7), do the following:

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

• To adjust speed, in the Speed control box, press the plus button to increase speed or the minus button to decrease speed. Default, 80000 rpm; variable adjustment from 200 to 80000 rpm.

Integrated Power Console (IPC™) System

1-33

VISAO™ HIGHSPEED DRILL

Visao™ multifunction foot pedal controls

By default, press each button on the foot pedal for at least 100 ms for the selection to become active. Use the IPC™ touch screen Settings screen to change the default value.

• To use the multifunction foot pedal (Figure 5-8) to control the handpiece do the following:

• To select Forward or Reverse mode, press the mode button.

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

• To toggle between the start/stop mode and variable speed mode, press the control button. Note: Functionality of the control button may be changed in the handpiece Defaults menu to pause irrigation. Refer to Change System Settings in the Pre-Operating Instructions section.

• To change the handpiece, press the handpiece button.

Figure 5-7. Visao™ Touchscreen Figure 5-8. Multifunction Foot pedal and Y-Splitter

Visao

Speed

Pump 2

80000

cc/min

RPM

Prime

Mode

FWD

REV

1 Mode button 5 Foot pedal

2 Handpiece button 6

3 Control button 7 Port 1

4 Slip-resistant food pad 8 Port 2

Y-Splitter

Visao™ cleaning and sterilization instructions

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

Visao™ technical specications

Visao™ 3334800

Size 16.0 cm Length x 2.0 cm Diameter

Weight 148 g

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

Duty Cycle for Applied Part The Visao™ High-Speed Drill under full load is rated for intermittent operation per the following:

Maximum On Time: 60 seconds Maximum O Time: 30 seconds

Visao™ use with IPC™ and NIM™

To use the NIM™ with the IPC™ use the stim bur guard (Figure 5-2). The stim bur guard connects the IPC™ to the NIM™ via the stim bur stimulus output port (Figure 5-6). The stim bur guard carries stimulating current to the tool’s tip and provides nerve stimulation to standard burs in static and dynamic modes. Refer to the NIM™ User’s Manual and stim bur guard product information and instructions for further information.

1-34

Integrated Power Console (IPC™) System

TROUBLESHOOTING

Troubleshooting

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

General system troubleshooting

Issue Possible Cause Action

Pump(s) does not run. Failed internal components. Contact Customer Service Little or no irrigation ow. Tubing Set improperly seated in pump. Reposition tubing in pump, verify pump lid

is fully closed with the uid ow from left to right.

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 ow. Set tubing clamps in “open” position. Irrigation ow rate setting low. Adjust irrigation ow rate. Irrigator obstructed. Replace irrigator.

Pump stall error. Tubing set improperly placed in pump. Reposition tubing in pump, verify pump lid

is fully closed with the uid ow from left to

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

of pump (see section on “Irrigation/Coolant

Pumps”).

Handpiece connected but console reads “Connect Handpiece.”

Handpiece connected but console displays incorrect handpiece.

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

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

Console does not power down. Power switch failure. Unplug power cord, Contact Customer Service. Touchscreen does not respond. Screen gasket displaced or failed internal

Touchscreen does not work properly. Touchscreen not calibrated. Calibrate Touchscreen. Console displays wrong handpiece / motor type. Console misidentied the handpiece /

Moisture in cable conicts with handpiece recognition.

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

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

Failed internal components. Contact Customer Service. Failed internal components. Contact Customer Service.

components.

motor.

Run a dry cycle when sterilizing.

circuit breaker is closed, etc.).

fuses (P/N 11270066 Fuse Kit 1898125 ).

Contact Customer Service.

Disconnect and reconnect the motor cable.

Turn console o then on.

Integrated Power Console (IPC™) System

Moisture in cable conicts with handpiece recognition.

Change motor, motor cable, or console to

isolate the problem.

Run a dry cycle when sterilizing.

1-35

TROUBLESHOOTING

Issue Possible Cause Action

Foot control unit buttons or pedal does not respond.

Faulty Y-Splitter. Disconnect Y-Splitter and connect FCU to IPC™

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

wait for console conrmation beep. Top button does not respond. One (1) handpiece connected (top button has

no function with 1 handpiece connected). Connector not fully inserted. Disconnect and reconnect the FCU cable

connector.

Try dierent FCU or console to isolate the

problem. Internal component failure. Contact Customer Service.

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

rocker switch on rear of console. Failed handpiece motor or motor driver. Contact Customer Service. Cables are not property connected. Ensure handpiece cable is properly connected. Cables are damaged. Check cables for cracks, splits, or bent

connector pins.

Handpiece is too hot to touch/hold. Blade, bur, and/or attachment transferring

heat to handpiece.

Remove and reinstall or change blade, bur,

and/or attachment. Ensure the part is properly

seated before resuming use. Inadequate irrigation and/or coolant. Ensure adequate irrigation and/or coolant is

present.

XOMED Blades or Burs

Issue Possible Cause Action

Appears to be damaged or defective. Damaged or defective. Remove and replace. Tool vibrates excessively, abnormal noise

movement.

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

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

collar.

No suction. Blade opening is obstructed. 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.

Tubing obstructed. Remove and inspect suction tubing, and if

obstructed, remove obstruction, reconnect tubing.

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

back locking collet, and re-seating tool.

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

Tool wobbles in handpiece. Tool wobbles in handpiece. 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.

Tool vibrates excessively, abnormal noise movement.

Tool is not rmly seated. Microdebriders, pull back locking collet

and reseat the tool. If applicable for model, thumbwheel may be rotated slightly to check.

Visao, unlock collar, check/reseat notch, lock collar.

1-36

Integrated Power Console (IPC™) System

Error codes

Code # Title Cause Description

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

to start and subsequent reattempts fail. 2 NOT USED. NOT USED. NOT USED 3 UI-MCB Com Failure - Max resends exceeded. System Error. Power o. Wait 10 seconds. Power on. If 4 UI-MCB Com Failure - Get answer failed. 5 UI-MCB Com Failure - No status message received. 6 UI-MCB Com Failure - Serialization ID error. 7 UI-MCB Com Failure - Timeout exception. 8 UI-MCB Com Failure - Variable not recognized. 9 Pump 1 stalled (no transitions on opto sensor). Pump #1

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

11 Unrecognized/damaged handpiece plugged in on port 1 (rst 12

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

12 pin). 13 Unrecognized/damaged handpiece plugged in on port 3 (4 pin). 14 Unrecognized/damaged handpiece plugged in on port 4

(Skeeter™). 15 Handpiece stalled. Handpiece

16 MCB motor overcurrent detected. Motor

17 Unrecognized/damaged multifunction foot pedal plugged in. Foot Pedal

System Error. Power o. Wait 10 seconds. Power on. If

error persists, call Customer Service.

Check tubing connection.

stalled.

Check tubing connection.

stalled. Handpiece. Unplug handpiece and plug back in. If error

persists, replace handpiece.

Check accessory.

stalled.

Unplug handpiece and plug back in. If error

overcurrent.

persists, replace handpiece.

When using foot pedal only, unplug foot Connection error.

pedal and plug back in. If error persists,

replace foot pedal or switch to manual

control.

ERROR CODES

When using Y-Splitter, disconnect foot pedal

and Y-Splitter, then connect foot pedal

directly to IPC™. If after reconnecting foot

pedal, the error goes away, replace Y-Splitter

with another unit. If error persists, replace

foot pedal and reconnect both Y-Splitter

and foot pedal or switch to manual control.

18 Damaged handpiece or nger lever base out of position. Finger Control

Not applicable. error.

19 UI self test failure - culture (language) registry entry. Self Test Failed. Power o. Wait 10 seconds. Power on. If 20 UI self test failure - sector conguration registry entry.

error persists, call Customer Service.

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

data le.

22 NOT USED. NOT USED. NOT USED.

Integrated Power Console (IPC™) System

1-37

ERROR CODES

Code # Title Cause Description

23 MCB non-specic self test failure. Self Test Failed. Power o. Wait 10 seconds. Power on. If 24 MCB self test failure - port 1.

error persists, call Customer Service.

25 MCB self test failure - port 2. 26 MCB self test failure - port 3. 27 MCB self test failure - port 4. 28 MCB self test failure - bridge transitor 1 shorted. 29 MCB self test failure - bridge transitor 2 shorted. 30 MCB self test failure - bridge transitor 3 shorted. 31 MCB self test failure - bridge transitor 4 shorted. 32 MCB self test failure - bridge transitor 5 shorted. 33 MCB self test failure - bridge transitor 6 shorted. 34 MCB self test failure - A/D converter. 35 MCB self test failure - motor error. 36 MCB self test failure - 3.3 volt supply. 37 MCB self test failure - 12 volt supply. 38 MCB self test failure - 48 volt supply. 39 MCB self test failure - FCU port.

1-38

Integrated Power Console (IPC™) System

CLEANING AND STERILIZATION

Cleaning and sterilization

Reprocessing Instructions are subject to change. Refer to manuals.medtronic.com for current Reprocessing Instructions.

Clean the multifunction foot pedal

• If debris is present under the foot pedal’s boot, return for warranty service.

• Do not immerse or sterilize the foot pedal.

• Do not use alcohol, other solvents or abrasive cleaners.

1. On the slip resistant foot pad ONLY, spray a neutral enzymatic detergent, pH 6.0-8.0, or a phenol based disinfectant, mixed according to manufacturer’s instructions.

2. Leave the solution on the foot pad for approximately 10 minutes.

3. Dampen a cloth with a neutral enzymatic detergent, pH 6.0-8.0, or a phenol based disinfectant, mixed according to manufacturer’s instructions.

4. Wipe the foot pedal with the damp cloth until visually clean.

5. Dry the unit with a clean, non-abrasive cloth.

Clean the Y-Splitter

1. Do not immerse or sterilize the Y-Splitter.

2. Do not use alcohol, other solvents or abrasive cleaners.

3. Dampen a cloth with a neutral enzymatic detergent, pH 6.0 – 8.0, or a phenol based disinfectant, mixed according to manufacturer’s instructions.

4. Wipe the Y-Splitter with a damp cloth until visually clean.

5. Dry the unit with a clean, non abrasive cloth.

Integrated Power Console (IPC™) System

1-39

Reprocessing Instructions

Cleaning and Sterilization instructions are subject to change. Up to date instructions are

Endo-Scrub 2 Finger Switch

Warnings and Precautions

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

Point of Use

Containment and Transportation

Preparation for Decontamination

Cleaning: Automated (Do NOT use ultrasonic washer)

Cleaning: Manual

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

Packaging

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

Maintenance, Inspection and Testing

Storage Store in a clean, dry area.

Additional Information

Note: The instructions provided above have been validated by the manufacturer as being CAPABLE of preparing the product for re-use. It remains the responsibility of the processor to ensure that the reprocessing is actually performed using equipment, materials and personnel in the reprocessing facility to achieve the desired result. This normally requires validation and routine monitoring of the process.

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

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

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

• After use, remove the nger switch from the sheath and disconnect the plug from the pump.

• Thoroughly rinse with water following use.

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

Promptly and thoroughly rinse with deionized water after each use.

Not validated

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

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

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

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

• A standard, sterilization wrap may be used. In the US, an FDA approved surgical wrap must be used. Ensure that the pack is large enough to contain the instrument without stressing the seals.

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

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

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

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

Steam Sterilization

Cycle Gravity Pre-Vac Pre-vac (UK)

Temperature 132 C 132 C 134 C

Time 10 minutes 4 minutes 3 minutes

Drying 15-30 minutes, or until visibly dry.

STERRAD Not validated.

100% EtO Sterilization Parameters Not validated.

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

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

None

available online at manuals.medtronic.com.

68E4005 F

Reprocessing Instructions

Microdebriders

StraightShot M5, StraightShot M4, StraightShot Magnum II, StraightShot III or

Midas Rex Spine Shaver

Warnings and Precautions

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

Point of Use

Containment and Transportation

Preparation for Decontamination

Cleaning: Automated (Do NOT use ultrasonic washer)

Cleaning: Manual

• Disconnect the power before cleaning.

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

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

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

• For Microdebrider handpiece cleaning, cover handpiece cable connector end with one of the following handpiece cable caps:

• Handpiece Cleaning Cap, Universal - catalog number 3318520.

• Handpiece Cable Cap, Small - catalog number 3318510.

• Use 3318520 for StraightShot M4, Spine Shaver, StraightShot Magnum II, and StraightShot III.

• Using 3318520 is optional for StraightShot M5.

• Use Catalog number 3318510 for other Microdebriders.

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

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

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

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

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

• Remove instruments and equipment from any instrument trays.

• Use alkaline (pH ≤10.5) or neutral pH detergent.

• Do not immerse the handpiece.

Auto Wash Pre-Cleaning Instructions - Neutral Detergent

• Manually rinse the handpiece, cable, and tubing management clips with running tap water to remove all visible soil from the device. Using a soft bristled brush and a neutral detergent solution, gently and thoroughly clean the entire open lumen of the device. Actuate the collet while rinsing and turn the thumbwheel. Hold the handpiece with collet end down when rinsing and run stream of water through the suction port.

• Place devices in the washer with the collet facing downward to facilitate drainage.

Auto wash Cycle - Neutral Enzymatic Detergent

Phase Minimum Time Temperature Detergent

Pre-wash 1 02:00 Cold tap water Not applicable

Enzyme wash 05:00 < 50°C neutral pH enzymatic detergent,

Rinse 1 01:00 Hot tap water Not applicable

Thermal rinse 01:00 82°C minimum Not applicable

Visually examine for cleanliness.

Auto Wash Pre-Cleaning Instructions - Alkaline Detergent

• Manually rinse the handpiece, cable, and tubing management clips with running tap water to remove all visible soil from the device. Using a soft bristled brush and a neutral detergent solution, gently and thoroughly brush the entire open lumen of the device. Actuate the collet while rinsing and turn the thumbwheel. Hold the handpiece with collet end down when rinsing and run stream of water through the suction port.

• Place devices in the washer with the collet facing downward to facilitate drainage.

Auto wash Cycle - Alkaline Detergent

Phase Minimum Time Temperature Detergent

Pre-wash 1 02:00 Cold tap water Not applicable

Wash 1 05:00 66°C (set point) alkaline detergent

Rinse 1 01:00 Hot tap water Not applicable

Thermal rinse 01:00 82°C minimum Not applicable

Visually examine for cleanliness.

• Remove instruments and equipment from instrument tray.

• Do not immerse the handpiece.

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

• Manually rinse the handpiece, cable, and tubing management clips with running tap water to remove all visible soil from the device. Hold the handpiece with collet end down when rinsing and run stream of water through the suction port.

• Use an enzymatic detergent solution to loosen and remove collected tissues from the unit.

• Using an enzymatic detergent solution and a soft cloth dampened with the detergent, wipe the motor and cable. Gently clean the handpiece, cable, and tubing management clips with a soft bristle brush wetted with the enzymatic detergent. Using a soft bristled brush, gently and thoroughly clean the entire open lumen of the device. Actuate the collet while cleaning and turn the thumbwheel. Use the brush to thoroughly clean the tubing management clips.

• Manually rinse the handpiece, cable, and tubing management clips with running tap water to remove all visible soil from the device.

• Hold the handpiece with collet end down when rinsing the lumen thoroughly.* * Additional Cleaning Instructions for XPS Straightshot M5/M4/Spine Shaver Microdebrider:

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

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

• Shake excess water from the handpiece.

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

Reprocessing Instructions

Cleaning and Sterilization instructions are subject to change. Up to date instructions are available online at manuals.medtronic.com.

68E3282 G

manufacturer’s recommended concentration

pH ≤ 10.5

Drying and Lubrication

Disinfection Do not cold soak in gluteraldehyde.

Packaging

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

Maintenance, Inspection and Testing

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

Additional Information

* This 40 minutes and 121C gravity sterilization cycle is not considered by the United States Food and Drug Administration (USFDA) to be a standard sterilization cycle. Users should

only use sterilizers and accessories (such as sterilization wraps, sterilization pouches, chemical indicators, biological indicators, and sterilization containers) that have been cleared by the USFDA for the selected sterilization cycle specications (40 minutes and 121°C).

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

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

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

• Sterilize the handpiece immediately after cleaning.

• A standard, sterilization wrap may be used. In the US, an FDA approved surgical wrap must be used. Ensure that the pack is large enough to contain the instrument without stressing the seals.

• In sets: Instruments may be loaded into dedicated instrument trays. Wrap trays using appropriate method.

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

Steam Sterilization

Cycle Gravity* Gravity

Temperature 121C 132C

Time 40 minutes 15 minutes

Drying 25 minutes, or until visibly dry

100% EtO Sterilization Parameters (set points)

Preconditioning 54°C, 60% relative humidity, 60 minutes

Sterilization Temperature

Relative Humidity

Ethylene oxide concentration

Gas exposure time (full-cycle)

Aeration

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

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

bearing and motor.

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

Reprocessing Instructions for

Reusable Instruments

Skeeter Oto-Flex Burs

Warnings and Precautions Remove bur from handpiece before reprocessing of bur and/or handpiece.

Limitations Discard any burs that shows signs of damage or wear.

Point of Use Remove burs from the handpiece before cleaning and sterilizing.

Containment and Transportation

Preparation for Decontamination

Cleaning: Automated R emove burs from any instrument trays before placing into washer baskets.

Cleaning: Manual Soak in lukewarm (less than 43 °C), mild (pH 7.0 - 8.5), enzymatic detergent and deionized water for a minimum of 2 minutes.

Disinfection Do not cold soak in gluteraldehyde.

Packaging A standard sterilization wrap may be used. In the US, an FDA approved surgical wrap is required. Ensure that the pack is large enough to contain the instrument without stressing the

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

Maintenance, Inspection and Testing

Storage Store burs in a clean, dry area.

Additional Information

is performed using validated equipment to achieve the desired result. This normally requires validation and routine monitoring of the process. Some devices have specic assembly instructions. In this case, refer to the assembly insert provided with the device for additional instructions. All validations performed per current AAMI TIR12, “Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers.” Medtronic recommends incineration of devices that have directly or indirectly contacted patients suspected or conrmed with prions or a Transmissible Spongiform Encephalopathy (TSE) such as CreutzfeldtJakob disease (CJD).

Before sterilization, carefully inspect the bur tips. Burs exhibiting the following conditions should be replaced: nicks on cutting surfaces noticeable wear on PTFE bearings severe bends or crimps on bur shaft Cold soak in glutaraldehyde, chlorine, or ammonium solutions, or dry heat sterilization is not recommended as damage to the bur may occur. Store burs in a clean, dry area.

Promptly and thoroughly rinse instruments with deionized water after each use.

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

Promptly and thoroughly rinse instruments with deionized water after each use.

Orient burs following recommendations of washer/disinfector manufacturers. Use alkaline or neutral pH detergent recommended by washer/disinfector or detergent manufacturers. Following cleaning, apply a light coating of silicone spray or Pana Spray in the following manner: grasp the PTFE bearing and rotate the bur to assure application of the spray inside the

bearing.

Phase Recirculation Time Water Temperature Detergent Type

Pre-wash 1 3 minutes Cold tap water Not applicable

Enzyme Wash 5 minutes Hot tap water Neutral pH enzymatic detergent

Wash 1 5 minutes 66

Rinse 1 3 minutes Hot tap water Not applicable

Then clean ultrasonically in lukewarm solution of mild detergent (less than 43 °C; pH 7.0 - 8.5) and deionized water for at least 10 minutes. Rinse thoroughly with deionized water and wipe dry. Following cleaning, apply a light coating of silicone spray or Pana Spray in the following manner: grasp the PTFE bearing and rotate the bur to assure application of the spray inside the

bearing.

Note: When using an ultrasonic cleaner or a spray washing machine, follow the manufacturer’s recommendations, particularly with regard to articulated instruments and positioning of instruments.

seals. In sets: Instruments may be loaded into dedicated Medtronic Xomed instrument trays. Ensure that cutting edges are protected. Wrap trays using appropriate method.

All steam cycles have been validated in the wrapped conguration and can be sterilized wrapped or unwrapped.

Cycle Gravity Gravity Pr e-Vac Pre-Vac (FR/

Temperature 121 °C 132 °C 132 °C 134 °C 134 °C

Time 30 minutes 10 minutes 4 minutes 18 minutes 3 minutes

Drying 15 minutes, or until visibly dry

STERRAD Not validated.

100 % EtO Sterilization Parameters

Conditioning in Chamber Sterilization

Temperature 54 +/- 2 °C Temperature 54 +/- 2 °C

Relative Humidity 60 +/- 5 % Relative Humidity 60 +/- 5 %

Vacuum Set Point 1.3 psia Ethylene Oxide Concentration 600 +/- 25 mg/L

Preconditioning Time 30 minutes Gas Exposure Time (full cycle) 120 minutes

Aeration 8 hours heated aeration at 48-52 °C or 24 hours aeration at ambient temperature

Discard any burs that shows signs of damage or wear.

None

C set point Neutral pH detergent

WHO)

Reprocessing Instructions

Cleaning and Sterilization instructions are subject to change. Up to date instructions are available online at manuals.medtronic.com. 68E3968 G

Pre-vac (UK)

Reprocessing Instructions

Cleaning and Sterilization instructions are subject to change. Up to date instructions are

Skeeter Handpiece

Warnings and Precautions

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

Point of Use

Containment and Transportation

Preparation for Decontamination

Cleaning: Automated (Do NOT use ultrasonic washer)

Cleaning: Manual

Drying and Lubrication

Disinfection Do not cold soak in gluteraldehyde.

Packaging

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

Maintenance, Inspection and Testing

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

Additional Information

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

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

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

• Disconnect the power before cleaning.

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

• Do not use any cleaning instruments in the cannulated shaft of the handpiece.

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

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

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

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

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

Disassembly not required, other than removal of the bur.

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

• Orient devices following recommendations of washer/disinfector manufacturers.

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

• These products have been validated for eective cleaning using an automatic washer/disinfector cycle consisting of a minimum 44 minutes total time, including a pre-wash, main wash & rinse, and thermal rinse. The thermal rinse shall be at least 10 minutes long at a minimum temperature of 60 °C.

• Carefully clean with an enzymatic detergent. Do not fully immerse.

• The cannulated needle nose should be cleaned by immersing in the detergent solution up to the level of the Bur Release button. Do not use any cleaning instruments in the cannulated shaft of the handpiece.

• Rinse by immersing the distal end of the handpiece (up to the Bur Release button) in distilled water, using a gentle swirling motion to ush away residual cleaning solution.

• Avoid water accumulation in the motor housing by shaking excess water out with a downward motion.

• Silicone spray or Pana Spray should be sprayed into the cannulated shaft of the handpiece prior to sterilization. Apply silicone spray or Pana Spray until surplus lubricant is noted on the outside of the Bur Release Button. Wipe away excess lubricant from the handpiece. Following this procedure will ensure that the bur release mechanism is well lubricated for proper functioning.

• Sterilize the handpieces immediately after cleaning.

• A standard, sterilization wrap may be used. In the US, an FDA approved surgical wrap must be used. Ensure that the pack is large enough to contain the instrument without stressing the seals.

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

• All steam sterilization cycles have been validated in the wrapped conguration and instruments can be sterilized wrapped or unwrapped.

Steam Sterilization

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

Temperature 121 C 132 C 132 C 134 C 134 C

Time 30 minutes 10 minutes 4 minutes 18 minutes 3 minutes

Drying 15 minutes, or until visibly dry.

STERRAD 100S Compatible

100% EtO Sterilization Parameters

Conditioning in Chamber Sterilization

Temperature 54 +/- 2 °C Temperature 54 +/- 2 °C

Relative Humidity 60 +/- 5 % Relative Humidity 60 +/- 5 %

Vacuum Set Point 1.3 psia Ethylene Oxide Concentration 600 +/- 25 mg/L

Preconditioning Time 30 minutes Gas Exposure Time (full cycle) 120 minutes

Aeration 8 hours heated aeration at 48-52 °C or 24 hours aeration at ambient temperature

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

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

motor.

None

available online at manuals.medtronic.com.

68E3969 H

Reprocessing Instructions

Cleaning and Sterilization instructions are subject to change. Up to date instructions are available online at manuals.medtronic.com. 68E4187 E

Warnings and Precautions

Limitations

Point of Use

Containment and

Indigo High-Speed Otologic Drill

• Do not soak/submerge devices.

• Do not use ultrasound to clean devices.

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

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

• Allow an adequate cooling period after steam sterilization.

Verify functionality prior to re-use.

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

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

Transportation

Preparation for

Follow hospital procedures.

Decontamination

Cleaning: Detergent

Cleaning: Automated (Do NOT use ultrasonic washer)

Cleaning: Manual

Disinfection

Packaging

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

Maintenance, Inspection and

Use a cleaning agent that is suitable for use on aluminum surfaces. A neutral enzymatic to mild alkaline agent (pH 6.0 to 10.5) is preferred. If a washerdisinfector is used, see the instructions supplied with the washer-disinfector machine to select the recommended cleaning agent.

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

• Prior to cleaning, cover the drill cable connector end with Handpiece Cleaning Cap, catalog number 3318520.

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

• After completion of the cleaning steps, remove Handpiece Cleaning Cap or other protective components prior to sterilization.

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

Pre-Wash 2 minutes Cold tap water Not applicable

Wash 5 minutes 66 C (set point) Neutral enzymatic to mild alkaline

detergent, pH 6.0-10.5

Rinse 1 minute Hot tap water Not applicable

• Prior to cleaning, cover the drill cable connector end with Handpiece Cleaning Cap, catalog number 3318520.

• Wipe all external surface of the motor and cable with a cloth dampened with the detergent prepared with lukewarm tap water.

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

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

• Dry collet and motor with lint free towel

• After completion of the cleaning steps, remove Handpiece Cleaning Cap or other protective components prior to sterilization.

• Verify that devices are visually clean after manual cleaning

Follow hospital procedures.

Place devices in instrument tray, and double wrap instrument case with 1-ply polypropylene wrap. In the US, an FDA approved surgical wrap must be used.

Steam Sterilization

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

(UK)

Temperature 132 C 132 C 134 C 134 C

Time 25 minutes 4 minutes 18 minutes 3 minutes

Drying 20 minutes

STERRAD Not validated

100% EtO Sterilization Parameters

Preconditioning 55 C, 70 % relative humidity, 30 minutes

Sterilization Temperature 55 C

Relative Humidity 70 %

Ethylene oxide concentration 725 mg/L

Gas exposure time (full-cycle) 240 minutes

Aeration 53-57 C, 18 hours

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

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

Testing

Storage

Additional

Store with other sterile devices.

None

Information

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

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

Reprocessing Instructions

Indigo High-Speed Otologic Drill Attachments

Reprocessing Instructions

Cleaning and Sterilization instructions are subject to change. Up to date instructions are available online at manuals.medtronic.com. 68E4188 E

Warnings and Precautions

Limitations Verify functionality prior to re-use.

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

Containment and Transportation

Preparation for Decontamination

Cleaning: Detergent A neutral enzymatic to mild alkaline agent (pH 6.0 to 10.5) is preferred. If a washer-disinfector is used, see the instructions supplied with the washer-disinfector machine

Cleaning: Automated (Do NOT use ultrasonic washer)

Cleaning: Manual

Drying and Lubrication

Disinfection Follow hospital procedures.

Packaging Place devices in instrument tray, and double wrap instrument case with 1-ply polypropylene wrap. In the US, an FDA approved surgical wrap must be used.

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

Maintenance, Inspection and Testing

Storage Store with other sterile devices.

Additional Information None

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

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

• Do not soak/submerge devices.

• Do not use ultrasound to clean devices.

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

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

• Allow an adequate cooling period after steam sterilization.

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

Follow hospital procedures.

to select the recommended cleaning agent.

• All attachments must be thoroughly rinsed manually with tap water, ensuring all hard to reach areas are rinsed, prior to transfer to automatic washer for processing.

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

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

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

Pre-Wash 2 minutes Cold tap water Not applicable

Wash 5 minutes 66C (set point) Neutral enzymatic to mild alkaline

Rinse 1 minute Hot tap water Not applicable

• Use the detergent, prepared with lukewarm tap water for the cleaning process.

• Thoroughly wipe the straight and angled attachments with a cloth dampened with the detergent.

• Wipe entire attachment until all gross soil has been removed.

• Using a brush wetted with the detergent, brush the attachments to clean the external surfaces and internal connecting surfaces.

• For the angled attachment: Wet an appropriately sized cleaning brush (Ø 2.4mm) with the detergent. Insert the brush into the bore at the front of the attachment. Brush the bore to loosen debris trapped inside. Rinse the bore to remove debris.

• For the straight attachment: Wet an appropriately sized cleaning brush (Ø 2.4mm) with the detergent. Push the brush through the straight attachment from the rear to front to loosen and remove debris trapped inside. Rinse bore to remove debris.

• Place one half of the straight or angled attachment into the detergent. Do not immerse the entire attachment. Gently agitate the attachments in the detergent and actuate any moveable parts.

• Place the other half of the attachment into the detergent and repeat. Do not immerse the entire attachment.

• Rinse the attachment thoroughly with tap water. Flush both ends to remove detergent.

• Thoroughly dry the attachments. An air gun may be used on the straight attachment to blow moisture out from the rear to front.

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

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

• Articulate movable components to ensure proper lubrication.

• Remove excess lubricant with a clean cloth.

Steam Sterilization

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

Temperature 132 C 132 C 134 C 134 C

Time 25 minutes 4 minutes 18 minutes 3 minutes

Drying 20 minutes

STERRAD Not validated

100% EtO Sterilization Parameters

Preconditioning 55 C, 70 % relative humidity, 30 minutes

Sterilization Temperature 55 C

Relative Humidity 70 %

Ethylene oxide concentration 725 mg/L

Gas exposure time (full-cycle) 240 minutes

Aeration 53-57 C, 18 hours

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

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

detergent, pH 6.0-10.5

Reprocessing Instructions

Cleaning and Sterilization instructions are subject to change. Up to date instructions are available online at manuals.medtronic.com.

68E3281 G

Warnings and Precautions

Limitations

Point of Use

Containment and

Reprocessing Instructions

Visao

• Disconnect the power before cleaning.

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

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

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

• For Visao handpiece cleaning (and Xcalibur Hi-Speed with angled cable), cover handpiece cable connector end with Handpiece Cleaning Cap, Universal, catalog number 3318520.

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

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

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

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

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

Transportation

Preparation for

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

Decontamination

Cleaning: Automated

Cleaning: Manual

Disinfection

Packaging

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

Maintenance, Inspection and

• Remove instruments and equipment from any sterilization trays before placing into washer baskets. Orient devices following recommendations of washer/disinfector manufacturers.

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

• After surgery, clean the irrigation sleeves and bur guards with an enzymatic detergent solution. Wipe the handpiece and cable with disinfectant applied to a clean, non-abrasive cloth.

• A chuck brush cleaner (REF 3112500) or an appropriately sized small (plastic bristle) bore brush may be inserted into the distal end of the Visao handpiece, irrigation sleeves and bur guards to assist in removing uids, tissue, or bone fragments, making sure to clean all passages. Use an enzymatic detergent solution to loosen and remove collected tissues from the unit.

• Rinse out the distal end of the handpiece. Shake excess water from the handpiece.

• Ensure all water is drained from the cooling housing. If saline was used for cooling during surgery, use distilled water to rinse the housing prior to draining.

• Using distilled water, rinse saline from the irrigation nozzles. Drain the nozzle of all water.

• Sterilize the handpiece immediately after cleaning.

Do not cold soak in gluteraldehyde.

• A standard, sterilization wrap may be used. In the US, an FDA approved surgical wrap must be used. Ensure that the pack is large enough to contain the instrument without stressing the seals.

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

Steam Sterilization

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

Temperature 121 C 132 C 134 C 134 C

Time 40 minutes 4 minutes 18 minutes 3 minutes

Drying 8 minutes, or until visibly dry

STERRAD 100S Compatible (Handpiece Only)

100% EtO Sterilization Parameters

Preconditioning

Sterilization Temperature 54-55 C

Relative Humidity 60 +/- 5 %

Ethylene oxide concentration 600 +/- 25 mg/L

Gas exposure time (full-cycle) 120 minutes

Aeration 48-52 C, 8 hours

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

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

Testing

Storage

Additional Information

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

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

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

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

Reprocessing Instructions for

Reusable Instruments

Reprocessing Instructions (Per ISO17664)

Cleaning and Sterilization instructions are subject to change without notice. Up to date instructions are available online at manuals.medtronic.com. 68E3963 C

Frontal Sinus 2mm Mini Trephine Drill

When applying dry times to Medtronic instrument trays and their accessories, dry times outside the standard healthcare prevacuum parameters may be required. The current recommended dry times may range from a standard 15 minutes to an extended time of 40 minutes. This is especially important for polymer-based (plastic) instrument trays. The user should have adequate means to verify drying time, such as visual inspection.

Reuse

The Mini Trephine 2mm Drill is provided sterile for rst time convenience. Maintaining a quantity of sterile provided drills is recommended. All drills must be cleaned and sterilized using the following process before each reuse. The Mini Trephine 2mm Drill has been tested for reuse use up to ve (5) times without noticeable performance degradation.

Warnings and Precautions

Limitations

Point of Use

Containment and Transportation

Preparation for Decontaimination

Cleaning: Automated

Cleaning: Manual

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

Packaging

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

Maintenance, Inspection and Testing

• Before use, carefully inspect the device for any irregularities or eccentricities.

• Damaged or worn product should be replaced.

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

• Discard any device that shows signs of damage or wear.

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

• This product must be cleaned and sterilized before any reuse.

• Rinse instrument immediately after use in distilled or demineralized water. Keep instrument moist (for example, cover with a wet drape or saturate with tap water - do

not use saline) after use and prior to decontamination, cleaning and sterilization to ensure adequate cleaning.

• Instruments with cleaning ports and/or suction tubes shall be ushed with neutral pH enzymatic detergent, followed by a tap water rinse.

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

• Promptly and thoroughly rinse with deionized water after each use.

• Fully disassemble modular designed instruments for eective cleaning.

• Place instruments so they do not touch each other.

Note: Flushing in running water is essential between decontamination and cleaning to prevent any risk of reaction between the two solutions.

• All instruments shall be thoroughly rinsed with tap water prior to placement in the automatic washer.

• Remove instruments and equipment from any sterilization trays before placing into washer baskets. Orient devices following recommendations of washer/disinfector

manufacturers.

• Use mildly alkaline or neutral pH detergent (pH 7.0 - 8.5) recommended by washer/disinfector or detergent manufacturers.

• These products have been validated for eective cleaning using an automatic washer/disinfector cycle consisting of the following:

Phase Recirculation Time Water Temperature Detergent Type

Pre-wash 1 3 minutes cold tap water not applicable

Enzyme Wash 5 minutes hot tap water neutral pH enz ymatic detergent

Wash 1 5 minutes 66

Rinse 1 3 minutes hot tap water not applicable

Thoroughly examine instruments for any residual soil.

• Soak in lukewarm (less than 43°C), mild (pH 7.0 - 8.5), enzymatic detergent and deionized water for a minimum of 2 minutes.

• Use a soft instrument brush to scrub instruments while submerged in cleaning solution to remove organic matter. Rinse with deionized water, then clean ultrasonically

in a lukewarm (less than 43°C), mild (pH 7.0 - 8.5), detergent and deionized water for 10 minutes.

• To prevent stains, use distilled or demineralized water as a nal rinse prior to sterilization.

• A standard sterilization wrap may be used. In the US, an FDA approved surgical wrap is required.

• In sets: Instruments may be loaded into dedicated Medtronic Xomed instrument trays. Ensure that cutting edges are protected. Wrap trays using appropriate method.

• Check the cleanliness and operation of the instrument. Clean again if debris is present and remove from use any damaged instrument. Close instruments with catches

and racks on the rst notch. If applicable, arrange the instruments in the dedicated instrument tray. Follow the appropriate cycle listed in the table below.

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

sterilization methods.

Instruments Only Instruments Only or Instruments in Medtronic Xomed Instrument Trays

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

Temperature 121°C 132°C 132°C 134°C 134°C

Time 30 minutes 10 minutes 4 minutes 18 minutes 3 minutes

Drying 15 – 40 minutes, or until visibly dry

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

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

C set point neutral pH detergent

Storage Store instruments in a clean, dry area.

Additional Information None

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

the reprocessing is performed using validated equipment to achieve the desired result. This normally requires validation and routine monitoring of the process. Some devices have specic assembly instructions. In this case, refer to the assembly insert provided with the device for additional instructions. All validations performed per current AAMI TIR12, “Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers.” Medtronic recommends incineration of devices that have directly or indirectly contacted patients suspected or conrmed with prions or a Transmissible Spongiform Encephalopathy (TSE) such as CreutzfeldtJakob disease (CJD). Note: In France, soaking the device in one mole of Soda (NaOH) per liter of solution is the recommendation of French Instruction DGS/RI3/2011/449 in order to prevent Creutzfeld-Jakob Disease transmission.

Reprocessing Instructions for

Reusable Instruments

Medtronic Burs