Integrated Power Console (IPC) System User's Guide PDF download

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Medtronic User’s Guide

Integrated Power Console (IPC™) System

CONSOLE

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Medtronic Setting

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Medtronic

IPC

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On/Off Button

Package Contents

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

IEC IREPI

Authorized Representative in the European Community

Conforms to ANSI/AAMI ES60601-1,

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Certified to CAN/CSA-C22.2 No.60601-1, IEC/EN 60601-1

lntertek 105345

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Fuse

IPX1

Protected Against Vertical Water Drops

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Oscillate

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Use By Date

IPX7

Protected Against The Effects Of Temporary Immersion In Water

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Forward

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Precaution: Pinch Hazard. Keep Fingers Clear Of Rollers

ACC CJ

Accessory

IPX8

Protected Against The Effects Of Temporary Immersion In Water

R

Reverse

V

Contains DEHP (di-2-ethyl hexyl phthalate)

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AC Power

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Foot Pedal Connector

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Protective Earth

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Output

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Fine Irrigant Adjustment

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Equipotential Ground Connector

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OFF >180s

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Consult Instructions for Use

Non-Sterile

BUR D

Stim Bur Connector

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NIM D

NIM Console Connector

DEHP

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Left Foot Control Unit Button / Mode Button

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Right Foot Control Unit Button / Control Button

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EHS D

Electrical High Speed Handpiece Connector

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World Wide Standard for Medical Tubing Diameter

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Date of Manufacture

Applied Part Duty Cycle

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Catalog Number

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Top Foot Control Unit Button / Handpiece Button Locked

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Serial Number

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Manufacturer

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Pump Head 1

Temperature Limitation

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Pump Head 2

Outer Limits = Transport

USA Only

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Ergonomically Engineered

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Speed Range

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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.

IAccessory I IAdapter I IAttachment I IBone Mill I Brush CJ

Control Unit I Dissecting Tool I Instrument Case I Lubricant/Diffuser I

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Multi-Use Disposable Attachment Regulator

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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™ configurations��4 Warnings��4 Precautions��6 System requirements and specifications��6 System sounds��7 System figures��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, NIMResponse™ 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™ configurations Additional IPC™ configurations 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 specific to each system.

Warnings System warnings W1 W2 W3 W4

It is important that the IPC™ system operator be familiar with the system User’s Guide, its precautions, procedures and safety issues. Do not use the IPC™ system in the presence of flammable anesthetics. Avoid potential ignition or explosion of gases. To avoid the risk of electric shock, this equipment must only be connected to a supply main with protective earth. 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. 1-4

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 configuration in which it will be used. W11 Portable and mobile RF communications equipment can affect 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 qualified personnel only. Repair and/or modification to the IPC™ system by anyone other than qualified service personnel may significantly compromise the unit’s ability to perform effectively and/or void the equipment warranty. 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 confirming 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 verification 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 significant tissue and bone. W28 Do not use accessory if package is opened or damaged. Broken seal offers no protection against cross-contamination. W29 Operate the tool only after the appropriate anatomical landmarks and the intended surgical site have been confirmed. 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 fingers 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

1-5

Ipc™ System

W37 Do not modify any system components or accessories. Use of modified 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 difficult to remove, causing irritation, inflammation and foreign-body response at surgical site. W39 Bending or prying may break the accessory, causing harm to patient or staff. 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 P2 P3 P4 P5 P6 P7 P8 P9 P10 P11 P12 P13 P14 P15

Do not kink cables. Inspect cables and pins for cracks, tears or corrosion. When using a Y-Splitter, only one multifunction foot pedal shall be active at a time. Do not connect multiple Y-Splitters. StraightShot™ handpieces are intended to operate at speeds greater than 6,000 rpm only when used with the high speed bur line. Do not use anti-fog on scope or sheath, as weeping or leaking may result. Do not use excessive force to insert the endoscope into the Endo-Scrub™ 2 sheath. this will damage the endoscope as well as the EndoScrub™ 2 sheath. If the endoscope tip can be seen extending beyond the tip of the Endo-Scrub™ 2 sheath, then the sheath has been damaged. Damaged product must be immediately discarded. Remove and discard accessories following local regulations for proper disposal of contaminated materials. When using an angled attachment, hold the handpiece assembly by the attachment so that the attachment does not inadvertently loosen from the handpiece. Always examine operation of each tool in a handpiece before use. Powered burs and drills should be operated in the Forward mode only. To prevent damage to tools, disconnect suction tube prior to changing tool during procedure. 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. 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. 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 specifications Console Specifications Functional Standards for Electrical Systems ANSI/AAMI ES60601-1

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

2005, 2012

IEC 60601-1

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

2005, 2012

EN 60601-1

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

2006, 2014

IEC 60601-1-4

Medical electrical equipment - Part 1: General Requirements for Safety, Part 4: Programmable Electrical Medical Systems

1996, 1999

IEC 60601-1-2

Medical electrical equipment - Part 1-2: General Requirements for Safety - Collateral Standard: 2007, 2014 Electromagnetic Compatibility - Requirements and Tests

CAN/CSA C22.2 #60601-1

Medical Electrical Equipment - Part 1: General Requirements for basic safety and essential performance

1-6

2005, 2014

Integrated Power Console (IPC™) System

Ipc™ System

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 Off Time 180 Seconds

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

• Confirmation of change button pressed. • Change from Forward to Oscillate. • Change of active handpiece.

2 Tones

Change from Oscillate to Forward.

3 Tones

• Audible Alarm. Error detected. See screen for error message. • Active handpiece is in Reverse and foot pedal pressed. • First time accessory changes from Forward to Reverse.

Long Tone

Change from handpiece to drill.

Integrated Power Console (IPC™) System

1-7

Ipc™ System

System figures Figure 1-1. IPC™ Console Front

Figure 1-2. IPC™ Console Back

1

...___

_____...

INTEGRATED POWER CONSOLE

...---

1

-------...

2

@ 2

Medtronic

•

3 3 4 5

® Medtronic

4

IPC

5

r

6

7

8

Pump 1: Coolant, lens cleaning or irrigation

1

Pole clamp

2

Touchscreen

2

Compact flash card port (Medtronic Use)

3

Power on/off

3

Manual start/stop

4

Pump 2: Irrigation or lens cleaning

4

Auxiliary power outlet

5

Console connector panel for peripheral devices

5

Endo-Scrub™ 2 connector

6

Fuse access

7

Equipotential Ground Connector.

1

Apply potential equalization conductor. 8

Hospital grade power cord connector

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

Figure 1-3. IPC™ Console Connector Panel

2

6

1

3

1

2

3

4

5

6

7

8

7

5 4

2

1

Not applicable

4

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

2

Not applicable

5

Stimulus output to stim bur guard or POWEREASE™

3

StraightShot™ M5 microdebrider, StraightShot™ M4 microdebrider, StraightShot™ Magnum™ II microdebrider, StraightShot™ III microdebrider, Visao™ drill, Indigo™ drill

6

Skeeter™ handpiece

7

Endo-Scrub™ 2 finger switch, EndoScrub™ 2 foot pedal, IntelliFlow™ irrigation remote control

1 2

Handpiece button

6

Y-Splitter

8

Multifunction foot pedal

3

Control button

7

Port 1

4

Slip-resistant foot pad

8

Port 2

1-8

8

3 5 4 Mode button

5

Foot pedal

Integrated Power Console (IPC™) System

Ipc™ System

Figure 1-6. IPC™ Pumps Screen

Figure 1-5. IPC™ Touchscreen

Handpiece Name

1

+ I- 60000 I+ RPM

Acceleration

2

I-

100 %

FWD

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REV

0

+

Pump 2

Control

Finger Foot

r.

I- 0 I+ + cc/min

None

Ii' I 6

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EndoScrub 2 Endo-Scrub

i

5

Flow

? Help

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1-

On ON

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33 1++

Setting Setting

2

(

(Handpiece Name)

Pumps

Endo-Scrub® 2

1

3

Pump 2

8 7

4

Prime

Both

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Prime

~

3

Pump 1

Mode

Speed

~

1•

Prime Prime

I

Prime

None None

4

Endo-Scrub® 2

M4 M4 Irrigation Irrigation

6

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

1

Close Pumps screen

3

Pump 1 panel available accessories

2

Prime/Flush pump

4

Pump 2 panel available accessories

Figure 1-7. Operating Room Setup

2 1

3

5

4 6

10 9 7

8 1

Mode anesthesia equipment

6

Microscope

2

IPC™ system

7

Surgeon

3

Nursing supplies/Surgical instruments

8

Electro-Surgical unit

4

Scrub nurse

9

Anesthesiologist

5

NIM™ Monitor

10

Patient

Integrated Power Console (IPC™) System

1-9

Ipc™ System

Figure 1-8. IPC™ System Configuration

Figure 1-9. IntelliFlow™ Remote Control

1 2

1

2

3 11

3 4

10

9

5

1

Pause/On-Off

2

Increase/Decrease Fine Adjustment

3

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

6 8

7

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

1-10

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 specific 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. Confirm 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 flow. Figure 1-10. Install Pump Cartridge

Install the pump cartridges or irrigation tubing

1. Locate the correct pump and lift up the lock (Figure 1-10). Pump 1: Coolant, lens cleaning or 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.

1

2

3

/

Prepare IPC™ for use 1. 2. 3. 4.

5. 6. 7. 8.

Verify Operation Room set up (Figure 1-7). The surgeon may have preferences to the location and visibility. Verify the wheels are locked on the IPC™ cart. Inspect all components for damage and determine if the system is ready for use. Mount the IPC™ and irrigation/coolant bags on the I.V. pole (Figure 1-8). Notes: • Mount irrigant and coolant bags above the IPC™ to ensure adequate flow. • 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 floor 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. Plug the IPC™ into the power source. Position the IPC™ so that it does not obstruct the power source for the purpose of disconnecting the Main voltage by the power cord. Locate the correct 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. Connect suction, cooling and/or irrigation tubing. 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 confirm system settings and return to the Splash screen, press [OK]. 5. For accessories with audible tones, press the REV Audible Tones button to control the following: • The system delivers one set of reverse beeps when the Reverse mode is activated. • The system delivers one set of reverse beeps the first time the drill is used in Reverse mode after the Reverse mode has been activated. 6. To confirm system settings and continue to the IPC™ touchscreen, press [OK]. 7. To restore settings to factory default, press [Restore].

Handpiece default settings

The system configuration is dependent on the handpiece(s) connected to the console. The following table defines the default configurations, default settings (X) and default options (O). Note: During use, update the default settings for the active handpiece by pressing the Set active handpiece settings as default settings button (Figure 1-5). Table 1. IPC™ Touchscreen Default Configurations Speed Handpiece

rpm

cpm

Mode or Mode Select Switch %

Forward

Oscillate

Reverse

X

Acceleration

Deceleration

Size

Flow

Irrigation

Visao™

80000

O

30

Indigo™

52000

X

StraightShot™ M5

5000

O

X

O

30 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

Set up and prime pumps • • • 1. 2. 3.

Control

50 %

a

The IPC™ turns on pump 1 and/or 2 long enough to purge air out of the tubing set(s) the first time the prime button is pressed. The IPC™ resets the prime feature when you turn IPC™ power Off and On. After you prime the pump, the prime button and functionality become flush functionality. Connect tubing from an IPC™ cartridge to irrigation or coolant port on an accessory. On the irrigation tubing, turn the clamp to OPEN. If an accessory uses the clear drip chamber (Visao™), fill the clear drip chamber with coolant. To fill, squeeze and release the chamber until full.

D

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 flows at the tip of the irrigation device. • Pump(s) turns off.

a

7. Press the close button.

1-12

Integrated Power Console (IPC™) System

Ipc™ System

Pump default configurations

The pump configuration is dependent on the handpiece(s) connected to the console. The following table defines the pump default settings (X) and default options (O). Table 2. IPC™ Pumps Screen Default Configurations Pump 1 Handpiece Visao™

Cooling

Irrigation

X

Pump 2

Endo-Scrub™ 2

Suction Irrigator

Irrigation

Pump 1

X

Pump 2 O

Indigo™

O

X

O

StraightShot™ M5

O

X*

X

O

StraightShot™ M4

O

X*

X

O

StraightShot™ III, Magum II

O

X*

X

O

Endo-Scrub™ 2

X

O

X

O

Suction Irrigator

O

Skeeter™

Pump 2 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.

Confirm system operation 1. Confirm the irrigation pedal starts handpiece and irrigation flow. Verify the speed changes from white to yellow in the Speed box on the touchscreen. 2. Confirm the 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 specific 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 configuration, 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 flow while in the sterile field. If you are using handpiece irrigation: • To pause irrigation flow, press the Pause/On-Off button. • To adjust flow rate, press the Fine Adjustment or Coarse Adjustment Increase/Decrease button. If you are using the Suction Irrigator: • To pause or turn on/off the Suction Irrigator, press the Pause/On-Off button. • To adjust flow rate, press the Fine Adjustment Increase/Decrease button. • To select the stainless steel tubing size (French size), press the Stainless Steel Tubing Size button.

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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 specified 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

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.

RF emissions CISPR 11

Class A

The IPC™ Systems suitable for use in all establishments, ther than domestic and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/flicker emissions IEC 6100-3-3

Complies

Guidance and manufacturer’s declaration – electromagnetic immunities - part I The IPC™ System is intended for use in the electromagnetic environment specified 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

Electromagnetic environment - guidance

Electrostatic discharge (ESD) IEC 61000-4-2

± 8 kV contact ± 15 kV air

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

Electrical fast transient/burst IEC 61000-4-4

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

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

Surge IEC 61000-4-5

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

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

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

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°

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.

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

70% UT (30% dip in UT ) for 0.5 sec

0% UT (100% dip in UT ) for 5 sec

30 A/m

Power frequency (50/60 Hz) magnetic field

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

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.

Integrated Power Console (IPC™) System

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Ipc™ System

Guidance and manufacturer’s declaration – electromagnetic immunities - part II The IPC™ System is intended for use in the electromagnetic environment specified below. The customer or the user of the IPC™ System should assure that it is used in such an environment. Immunity test Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

IEC 60601-1-2 test level

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

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 specified by the manufacturer. Othewise, degradation of the performance of this equipment may result.

3 V/m 80 MHz to 2.7 GHz

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

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

d = (6/E) √P 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:

((<•>))

a

NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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

Separation distance according to frequency of transmitter m 380 MHz–390 MHz d = 0.22√P

430 MHz–470 MHz d = 0.22√P

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

P(W) 0.01

0.03

0.07

0.03

0.07

0.1

0.07

0.21

0.07

0.21

1

0.22

0.67

0.22

0.67

10

0.7

2.12

0.7

2.12

100

2.2

6.7

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

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Integrated Power Console (IPC™) System

Limited warranty

Ipc™ System

A. This Limited Warranty provides the following assurance for the customer who purchases a Medtronic IPC™ System. This Limited Warranty is extended only to the buyer purchasing the IPC™ System directly from Medtronic or from its affiliate or its authorized distributor or representative. The IPC™ System includes the console, motor or handpiece, foot control, motor cables, instrumentation cases and trays (hereafter referred to as System Components), straight and angled motor attachments (hereinafter referred to as “Attachments”), bur guards and telescoping tubes (hereinafter referred to as Semi-reusable Components) and dissecting tools, irrigation and coolant tubing, and Intelliflow remote control (hereinafter referred to as Single Use Components) and jointly referred to as the IPC™ System, unless specifically noted. i. Should a System Component fail to function to Medtronic’s published specifications during the term of this Limited Warranty (one [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 specifications 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 specifications 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 specifications prior to its “use by” date Medtronic will replace the Single Use Component. B. To qualify for this Limited Warranty, the following conditions must be met: i. The Product must be used on or before its “Use By” or “Use Before” date, if applicable. ii. The Product must be used in accordance with its labeling and may not be altered or subjected to misuse, abuse, accident or improper handling. iii. Medtronic must be notified in writing within thirty (30) days following discovery of a defect. iv. The Product must be returned to Medtronic within thirty (30) days of Medtronic receiving notice as provided for in (3) above. v. Upon examination of the Product by Medtronic, Medtronic shall have determined that: (i) the Product was not repaired or altered by anyone other than Medtronic or its authorized representative, (ii) the Product was not operated under conditions other than normal use, and (iii) the prescribed periodic maintenance and services, if applicable, have been performed on the Product. C. This Limited Warranty is limited to its express terms. THIS LIMITED WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED WHETHER STATUTORY OR OTHERWISE, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. In no event shall Medtronic be liable for any consequential, incidental, prospective or other similar damage resulting from a defect, failure, or malfunction of the IPC™ System, whether a claim for such damage is based upon the warranty, contract, negligence or otherwise. D. The exclusions and limitations set out above are not intended to, and should not be construed so as to, contravene mandatory provisions of applicable law. Users may benefit from statutory warranty rights under legislation governing the sale of consumer goods. If any part or term of this Limited Warranty is held by any court of competent jurisdiction to be illegal, unenforceable, or in conflict with applicable law, the validity of the remaining portion of the Limited Warranty shall not be affected, and all rights and obligations shall be construed and enforced as if this Limited Warranty did not contain the particular part or term held to be invalid.

For items contaminated with TSE agents Medtronic recommends incineration of devices that have directly or indirectly contacted patients suspected or confirmed with prions or a Transmissible Spongiform Encephalopathy (TSE) such as Crutzfeldt-Jakob disease (CJD).

Integrated Power Console (IPC™) System

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Endo-scrub™ 2

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 finger 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 (5)

(1)

(2)

Figure 2-2. Endo-Scrub™ 2 Foot Pedal

(3) (4)

1

Finger switch

4

Light connection

2

Endo-Scrub™ 2 sheath

5

Finger Switch cable

3

Irrigation connection

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 fine 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 finger switch assembly If using the Endo-Scrub™ 2 finger switch, complete the following: 1. Slide the finger 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 finger switch is properly installed when the cutout section of the ring is firmly seated against the luer connector. 2. Activate the pump by pressing the actuator button located on the finger switch.

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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 finger switch or multifunction foot pedal. 2. To initiate a continuous flow of irrigant, press and hold the finger 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 flush out the empty sheath by using a syringe filled with sterile normal saline solution.

Connect Endo-Scrub™ 2 to IPC™ console 1. 2. 3. 4.

Locate the Endo-Scrub™ 2 connector cover on the back of the IPC™ console (Figure 1-2). Insert a small screwdriver in the notch on the cable connector cover and pull. Connect the control switch cable to the cable connector. Connect the Endo-Scrub™ 2 finger 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/Off check-box. • To adjust the flow rate, press the plus button to increase flow rate or the minus button to decrease flow 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 Menu Defaults

Figure 2-8. Handpiece Connection Screen

Connect Hand piece

Restore

General FCU Delay

,--

100 + Connect Footswitch Pump 1 REV Audible Tones

•

Pump 2

Stand Al one •

Press Ok to contirue wi!r):::(Jt Footsw itch

None

Endo-Scrub®

Purn11 s

Endo-Scrub®

S uction lrrigator

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.

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Integrated Power Console (IPC™) System

medtronic

15 cm ATT Legend Angled Attachment

Integrated Power Console (IPC) System User's Guide