Page 1
User’s Guide
REF
Integrated Power Console (IPC™) System
2340000
Page 2
Symbols
EUR · USA · JPN · AUS
IPX1
EC REP
IPX7
ACC
IPX8
DEHP
STERILE
NIM
Accessory
REF
LOT
SN
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,
Certied 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
ON
<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
Fr
Protected Against
Vertical Water Drops
Protected Against
The Eects Of
Temporary
Immersion In Water
Protected Against
The Eects 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
F
R
1
2
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/Diuser
Motor
Multi-Use Disposable Attachment
Regulator
USA Only Speed Range
<NNNN
min
For use up to
“NNNN” RPM
Page 3
Table of Contents
Symbols .......................................................................................................................................................... 2
IPC™ POWEREASE™ System ............................................................................................................................ 4
Glossary ............................................................................................................................................................................................................................... 4
Indications for use ...........................................................................................................................................................................................................4
Device description ........................................................................................................................................................................................................... 4
Contraindications ............................................................................................................................................................................................................4
Additional IPC™ congurations ..................................................................................................................................................................................4
Warnings .............................................................................................................................................................................................................................4
Precautions .........................................................................................................................................................................................................................6
System requirements and specications ................................................................................................................................................................6
System sounds ..................................................................................................................................................................................................................7
System gures ...................................................................................................................................................................................................................8
Pre-and Post-operating instructions ...................................................................................................................................................................... 11
IPC™ components ......................................................................................................................................................................................................... 13
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity ............................................................................................... 14
Limited warranty ........................................................................................................................................................................................................... 16
For items contaminated with TSE agents ............................................................................................................................................................ 16
POWEREASE™ Driver .................................................................................................................................... 17
Midas Rex™ Spine Shaver (SC1) ................................................................................................................... 22
Midas Rex™ Legend EHS™ Stylus Touch™ Drill ........................................................................................... 25
Troubleshooting ........................................................................................................................................... 28
Error codes .................................................................................................................................................... 30
Cleaning and sterilization ............................................................................................................................ 32
Reprocessing Instructions - POWEREASE™ Driver ............................................................................................................................................. 33
Reprocessing Instructions - Midas Rex™ Spine Shaver (SC1) ........................................................................................................................ 34
Reprocessing Instructions - Midas Rex™ Legend EHS™ Stylus Touch™ Drill ............................................................................................ 36
Customer service .......................................................................................................................................... 37
Integrated Power Console (IPC™) System
Page 4
IPC™ POWEREASE™ SYSTEM
IPC™ POWEREASE™ 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™ POWEREASE™ System is indicated for drilling, tapping and driving screws and working end attachments during spinal surgery,
including open and minimally invasive procedures. The IPC™ POWEREASE™ System is also used in the placement of screws, or cutting of screws,
posts, and rods.
The IPC™ is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical
(Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.
Device description
The IPC™ POWEREASE™ System consists of a driver specically designed for drilling, tapping and driving screws in the pedicle during spinal
surgery. The driver is driven by the IPC™ equipped with the appropriate software to operate the handpiece. The driver is used to drive working
end instruments capable of breaking setscrews, cutting posts, and cutting rods during spinal surgery.
The IPC™ POWEREASE™ System provides the power for tapping the pedicle and insertion of the pedicle screws is currently done manually using
an existing ratcheting handle which connects to the taps and drivers.
The POWEREASE™ Driver also has nerve stimulation capabilities when connected to the Medtronic NIM-Eclipse™ system. The NIM-Eclipse™ is
connected to the POWEREASE™ Driver via the NIM-Eclipse™ cable enabling the NIM-Eclipse™ to stimulate and monitor the nerve at the surgical
site.
The driver is equipped with a quick connect feature which allows for easy and secure attachment of working end instruments to perform the
various functions mentioned above.
Contraindications
The IPC™ POWEREASE™ system is contraindicated for arthroscopic microdiscectomy in individuals with the following:
• Severe/progressive neurological decits
• Cauda equine syndrome
• Active infection
Arthroscopic microdiscectomy is not indicated for individuals with sequestered disc fragments, discogenic pain, internal disc destruction, or
lumbago.
Additional IPC™ congurations
Additional IPC™ congurations are available. Refer to the following User’s Guides for related information.
• IPC™ System Model: 1898001 (IPC™ User’s Guide CFN 1898551)
• Neurosurgical IPC™ System Model: EC300 (IPC™ User’s Guide CFN 175027)
Consult the appropriate User’s Guide for indications, contraindications, warnings, and component information specic to each system.
1-4
Integrated Power Console (IPC™) System
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IPC™ POWEREASE™ 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™ POWEREASE™ 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.
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™ POWEREASE™ 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 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 conguration in which it will be used.
W11 Portable and mobile RF communications equipment can aect 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 qualied personnel only. Repair and/or modication to the IPC™ system by anyone other than
qualied service personnel may signicantly compromise the unit’s ability to perform eectively 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.
W16 Do not operate the IPC™ POWEREASE™ system without eye protection.
Component Warnings
W17 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.
W18 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.
W19 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
W20 The handpieces will not run properly unless the attachment is in the locked or secured position.
W21 Do not change accessory with handpiece running to prevent laceration of user and cross-contamination through compromised glove.
W22 Place Stylus Touch™ in safe mode while not in use.
W23 Do not place Stylus Touch™ handpiece in the proximity of magnetic eld, such as magnetic drape and MRI equipment, to avoid inadvertent
handpiece activation.
W24 Do not place motor, attachment and tool on the patient or in an unsecured location during surgery.
W25 Verify reusable device was cleaned and sterilized prior to use. If not sterilized, do not use.
W26 Do not attempt to run the IPC™ POWEREASE™ system handpiece immediately after autoclaving. Allow an adequate “cool down” period
(Typically 1 hour).
W27 For warnings & precautions related to reprocessing, refer to Cleaning and sterilization instructions.
W28 This system requires insulated connectors for the StraightShot™ M4 Microdebrider, StraightShot™ Magnum™ II Microdebrider,
StraightShot™ III Microdebrider, Midas Rex™ (SC1), Visao™, or Skeeter™ handpieces and the multifunction foot pedal.
Disposable Warnings
W29 Tools are available for resection of soft tissue and bone for surgical procedures. Use of tools depends on the intended application and
patient needs. Sharpcutting powered tools induce bleeding and removal of signicant tissue and bone.
W30 Do not use accessory if package is opened or damaged. Broken seal oers no protection against cross-contamination.
Integrated Power Console (IPC™) System
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IPC™ POWEREASE™ SYSTEM
W31 Operate the tool only after the appropriate anatomical landmarks and the intended surgical site have been conrmed. Ensure adequate
visualization when using powered accessories. Discontinue powered application in the event of lack of visualization of the surgical site.
W32 Use methods at the operative site to control bleeding that do not compromise patient safety during at-risk surgery.
W33 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.
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.
W37 Do not modify any system components or accessories. Use of modied 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
dicult to remove, causing irritation, inammation 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 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 Remove and discard accessories following local regulations for proper disposal of contaminated materials.
P5 When using an angled attachment, hold the handpiece assembly by the attachment so that the attachment does not inadvertently loosen
from the handpiece.
P6 Always examine operation of each tool in a handpiece before use.
P7 Powered burs and drills should be operated in the Forward mode only.
P8 To prevent damage to tools, disconnect suction tube prior to changing tool during procedure.
P9 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.
System requirements and specications
Console Specications
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
2005, 2012
2005, 2012
2006, 2014
1996, 1999
2007, 2014
2005, 2014
1-6
Integrated Power Console (IPC™) System
Page 7
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™ POWEREASE™ 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 • Conrmation 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
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IPC™ POWEREASE™ SYSTEM
12
System gures
Figure 1-1. IPC™ Console Front
1
2
3
4
5
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
1
2
3
4
5
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 Midas Rex™ Spine Shaver handpiece,
Stylus Touch™ motor
1-8
Figure 1-3. IPC™ Console Connector Panel
3567 8
4
(NIM™ or NIM-Eclipse™)
POWEREASE™
6 Not applicable
7 IntelliFlow™ irrigation remote control
8 Multifunction foot pedal
Figure 1-4. Multifunction Foot Pedal & Y-Splitter
1
5
4
2
3
1
5
1 Mode button 5 Foot pedal
2 Handpiece button 6 Y-Splitter
3 Control button 7 Port 1
4 Slip-resistant foot pad 8 Port 2
6
7
8
2
4
Integrated Power Console (IPC™) System
3
Page 9
Figure 1-5. IPC™ Touchscreen
IPC™ POWEREASE™ SYSTEM
Figure 1-6. IPC™ Pumps Screen
1
Speed
2
3
4
5
1 Displays active handpiece 5 Opens Help screen
2 Accessory control panel 6 Inactive handpiece
3 Foot pedal variable control 7 Set active handpiece settings as default
4 Opens Pumps screen
Acceleration
Pump 2
Pumps
?
?
Help
Handpiece Name
+
60000
100
+
+
%
+
+
0
cc/min
+
RPM
Prime
(Handpiece Name)
Control
Finger
Mode
FWD
REV
Foot
Both
Prime
Pump 1
None
None
3
7
6
4
1 Close Pumps screen 3 Pump 1 panel available accessories
2 Prime/Flush pump 4 Pump 2 panel available accessories
Pump 2
None
None
M4
M4
Irrigation
Irrigation
Prime
Endo-Scrub® 2
Endo-Scrub® 2
Prime
Endo-Scrub® 2
Endo-Scrub® 2
1
2
Figure 1-7. Operating Room Setup
3
2
1
10
4
9
7
8
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
5
6
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IPC™ POWEREASE™ SYSTEM
Figure 1-8. IPC™ System Conguration
1
Figure 1-9. IntelliFlow™ Remote Control
1
2
2
3
11
3
4
10
9
5
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 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
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IPC™ POWEREASE™ 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 specic 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. Conrm 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
Note: The POWEREASE™ driver does not use the IPC™ pump system. The pumps are available
for use with other accessories requiring irrigation or cooling.
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
1
2
3
Prepare IPC™ for use
Note: The manual start/stop button on the IPC™ console (Figure 1-2) does not function with the POWEREASE™ driver.
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.
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IPC™ POWEREASE™ SYSTEM
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.
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 conrm 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 conrm system settings and continue to the IPC™ touchscreen, press [OK].
7. To restore settings to factory default, press [Restore].
Handpiece default settings
The system conguration is dependent on the handpiece(s) connected to the console. The following table denes the default congurations,
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 Congurations
Speed Mode or Mode Select Switch
Handpiece rpm cpm % Forward Oscillate Reverse Acceleration Deceleration Size Flow Irrigation Control
Midas Rex™ Spine Shaver SC1 3400 O X 60
Stylus Touch™ 60000 X O 80 % 100 % 0 Finger
POWEREASE™ 120 X
120 X
250 X
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
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IPC™ POWEREASE™ SYSTEM
+
+
+
Pump default congurations
The pump conguration is dependent on the handpiece(s) connected to the console. The following table denes the pump default settings (X)
and default options (O).
Table 2. IPC™ Pumps Screen Default Congurations
Pump 1 Pump 2 Endo-Scrub 2 Suction Irrigator
Handpiece Cooling Irrigation Irrigation Pump 1 Pump 2 Pump 1 Pump 2
Midas Rex™ Spine Shaver SC1 O X O O
Stylus Touch™ X O O O O O
POWEREASE™ O O O O
* When the IPC™ detects both the Midas Rex™ Spine Shaver SC1 and the Stylus Touch™, by default, the system sets pump 2 as
a “shared” irrigation pump. You must manually connect the irrigation tubing to the active handpiece.
Conrm system operation
1. Conrm the irrigation pedal starts handpiece and irrigation ow. Verify the speed changes from white to yellow in the Speed box on the
touchscreen.
2. Conrm 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
Note: 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 specic 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 conguration, 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.
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.
Integrated Power Console (IPC™) System
1-13
Page 14
IPC™ POWEREASE™ 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 specied 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 specied 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
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
Class A The IPC™ Systems suitable for use in all establishments, ther than domestic and those directly connected to the public low-
Class A
Complies
any interference in nearby electronic equipment.
voltage power supply network that supplies buildings used for domestic purposes.
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
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% UT (30% dip in UT) for 0.5 sec
0% UT (100% dip in UT) for 5 sec
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% UT (30% dip in UT) for 0.5 sec
0% UT (100% dip in UT) for 5 sec
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.
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.
1-14
Integrated Power Console (IPC™) System
Page 15
IPC™ POWEREASE™ SYSTEM
Guidance and manufacturer’s declaration – electromagnetic immunities - part II
The IPC™ System is intended for use in the electromagnetic environment specied 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 aected by absorption and reection 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 specied 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 aected by absorption and reection from structures, objects and people.
380 MHz–390MHz
d = 0.22√P
430 MHz–470MHz
d = 0.22√P
Separation distance according to frequency of transmitter m
704 MHz–787MHz
d = 0.67√P
800 MHz–960MHz
d = 0.22√P
1.7 GHz–1.99GHz
d = 0.22√P
2.4 GHz–2.57GHz
d = 0.22√P
5.1 GHz–5.8GHz
d = 0.67√P
Integrated Power Console (IPC™) System
1-15
Page 16
IPC™ POWEREASE™ SYSTEM
Limited warranty
A. This Limited Warranty provides the following assurance for the customer who purchases a Medtronic IPC System. This Limited Warranty is ex-
tended only to the buyer purchasing the IPC System directly from Medtronic or from its aliate 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 Intelliow remote control (hereinafter referred to as Single Use Components) and jointly referred to as the IPC System, unless specically noted.
i. Should a System Component fail to function to Medtronic’s published specications 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 specications 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 specications 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 specications 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 notied 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 benet 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 conict with applicable law, the validity
of the remaining portion of the Limited Warranty shall not be aected, 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 conrmed with prions or a
Transmissible Spongiform Encephalopathy (TSE) such as Crutzfeld-Jakob disease (CJD).
1-16
Integrated Power Console (IPC™) System
Page 17
POWEREASE™ Driver
Device description
The IPC™ POWEREASE™ system is specically designed for drilling, tapping, and driving screws during spine surgery.
The IPC™ POWEREASE™ system consists of a POWEREASE™ Driver (Figure 2-1) that is powered by the IPC™, along with the following
POWEREASE™ driver compatible working end instruments:
• Taps
• Drill Bits
• Drivers
• Rod Cutter
• Post Cutter
• Set Screw Break-o Instrument (SSBO)
The POWEREASE™ system and accessories are compatible with the following implant systems:
• CD HORIZON SOLERA Spinal System
• TSRH 3Dx Spinal System
Figure 2-1. POWEREASE™ Driver
POWEREASE™ DRIVER
(1)
(2)
(3)
(8)
(7) (7)
(4)
(5)
(6)
Integrated Power Console (IPC™) System
1 Quick disconnect unlocked 5 Finger sensor trigger
2 Quick disconnect locked 6 NIM-Eclipse™ cable connector
3 Mechanized working collar locking pins (2) 7 Mode select switch
4 Variable speed trigger 8 Flat side indicators
1-17
Page 18
POWEREASE™ DRIVER
POWEREASE™ driver classic working end assembly
1. On the POWEREASE™ driver, pull back on and hold the quick disconnect to unlock the collet (Figure 2-1, 1).
Note: The quick disconnect must be held in the unlocked position when inserting or removing tools.
2. Insert the classic working end drive shaft (Figure 2-2, 1) into the collet until fully seated. Fully seated is on or near the drive shaft shoulder
(Figure 2-3).
Note: If using a two sided shaft, align the at sides on the drive shaft with the marks on the collet (Figure 2-1, 8).
3. Release the quick disconnect to place the working end in the locked position (Figure 2-1, 2).
POWEREASE™ driver mechanized working end assembly
1. On the POWEREASE™ driver, pull back on and hold the quick disconnect (Figure 2-1, 1) to unlock the collet.
Note: The quick disconnect must be held in the unlocked position when inserting or removing tools.
2. Align the slots on the working end collar with the mechanized working collar locking pins (Figure 2-4).
3. Release the quick disconnect to place the mechanized end in the locked position (Figure 2-1, 2).
Figure 2-2. Classic Working End
(1) (2) (3) (4)
1 Four sided drive shaft 3 Drive shaft shoulder
2 Flat side 4 Shaft
Figure 2-3. Classic Working End
Seating
Figure 2-4. Mechanical Working End
Seating
Connect POWEREASE™ driver to IPC™ console
Locate the POWEREASE™ driver connection port on the IPC™ connector panel (Figure 2-5) and insert the connector from the POWEREASE™
driver.
POWEREASE™ driver touchscreen controls
To adjust the maximum speed of the driver using the IPC™ POWEREASE™ touchscreen (Figure 2-6), in the relevant speed control box, press the
plus button to increase maximum speed or minus button to decrease maximum speed.
• Variable speed control:
FWD Speed: variable adjustment from 10 to 250 rpm in increments of 10 rpm.
REV Speed: variable adjustment from 10 to 250 rpm in increments of 10 rpm.
OSC Speed: variable adjustment from 10 to 200 rpm in increments of 10 rpm.
• IPC™ POWEREASE™ touchscreen color codes:
White: active speed at idle, nger o trigger.
Green: active speed at idle, nger on trigger.
Yellow: active speed in use.
Gray: inactive
• Trigger Status:
Ready For Use: Device is ready for use.
Locked: In the case of a trigger control anomaly, the trigger is locked until the anomaly has cleared and use of the POWEREASE™ may resume.
To disengage the lock, release and press the trigger. Contact Customer Service if the device does not return to Ready For Use.
1-18
Integrated Power Console (IPC™) System
Page 19
POWEREASE™ DRIVER
Figure 2-5. POWEREASE™ Driver Connection Ports
Figure 2-6. POWEREASE™ Touchscreen
(1) (2) (3)
1 POWEREASE™ connection port
2 Stimulus input from NIM-Eclipse™
3 Stimulus output to POWEREASE™
POWEREASE™ driver mode system operation
1. On the POWEREASE™ driver, rotate the mode select switch (Figure 2-7) to Forward (F), Reverse (R), or Oscillate .
Note: Use the mode select switch to change the handpiece from Forward, Reverse, or Oscillate when the handpiece is the active handpiece.
When the handpiece is the inactive handpiece, use the mode select switch to activate the handpiece.
For classic working end tools:
• Place mode select switch in Forward to drill, tap or insert screw.
• Place mode select switch in Reverse to back out drill, back out tap or back out screw.
• Place mode select switch in Oscillate to lock the tool in its current position. Refer to POWEREASE™ driver electronic ratcheting for
additional information.
For mechanized working end tools:
• Place the mode select switch in Forward to cut/shear implantable rods, cut vertical posts, break set screws.
• Place the mode select switch in Reverse to open the tool.
• Oscillate is intended as a rotational lock for classic working ends and has no function with mechanized working ends. However, if the
trigger is pulled, the tool shaft will oscillate 60 ° clockwise and counter-clockwise.
Figure 2-7. POWEREASE™
Mode Select Switch
2. On the IPC™ touchscreen, verify the following:
• The correct mode Speed box is active and the default speed appears in white.
• The Trigger Status is Ready For Use.
Note: If the trigger status is Locked, release and press the trigger to disengage the lock. Contact Customer Service if the trigger status does
not change to Ready For Use.
3. On the POWEREASE™ driver, touch the trigger (Figure 2-1) and verify the speed in the correct Speed box on the IPC™ touchscreen turns
green.
4. On the POWEREASE™ driver, press the trigger and verify the following:
• The speed increases as you increase pressure on the trigger.
• The speed in the correct Speed box on the IPC™ touchscreen turns yellow.
5. Remove nger from the POWEREASE™ driver trigger and verify the following:
• The driver rotation stops.
• The speed in the correct Speed box on the IPC™ touchscreen turns white.
6. Repeat steps 1 through 5 for each mode, Forward (F), Reverse (R), or Oscillate .
Integrated Power Console (IPC™) System
1-19
Page 20
POWEREASE™ DRIVER
POWEREASE™ driver electronic ratcheting
Ratcheting is intended to permit manual motion in one direction only.
• FWD Mode: With the trigger released, the handpiece functions as a ratchet allowing the handpiece to be turned in a clockwise direction
while ratcheting in a counter clockwise direction.
• REV Mode: With the trigger released, the handpiece functions as a ratchet allowing the handpiece to be turned in a counter clockwise
direction while ratcheting in a clockwise direction.
• OSC Mode: With trigger released, the handpiece locks the tool in its current position, and the surgeon can manually rotate the handpiece in a
clockwise or counter-clockwise direction.
POWEREASE™ ratchet test
1. Load a drill, tap or screwdriver in the collet. Refer to Classic Working End Assembly and Operation for details.
2. On the POWEREASE™ driver, set the mode select switch to Forward (F), (Figure 2-7).
3. Hold the POWEREASE™ driver shaft rmly and verify the following:
Note: Do not hold by the tool. Do not touch the trigger sensor.
• The driver ratchets when rotated counter clockwise.
• The driver does not ratchet when rotated clockwise.
4. Set the mode select switch to Reverse (R) and verify the following:
• The driver ratchets when rotated clockwise.
• The driver does not ratchet when rotated counter clockwise.
5. Set the mode select switch to Oscillate and verify the driver does not ratchet when rotated clockwise or counter clockwise.
POWEREASE™ Driver cleaning and sterilization instructions
Refer to document 68E4189 in the Cleaning and sterilization section.
POWEREASE™ Driver technical specications
POWEREASE™ Driver 2300000
Size
175 mm Width x 160 mm Height x 42 mm Length
Weight
Torque
Cable Length (Driver)
Cable Length (IPC™ to
Patient Interface Box)
Cable Length (Driver to
Duty Cycle for Applied Part
Essential Performance
900 g (1200 g including cable)
Speed
0 to 250 rpm (variable)
7 Nm
4.5 m
4.5 m
4.5 m
IPC™)
For continuous operating room temperatures up to 33 °C, the POWEREASE™ driver rates for continuous operation.
For normal operating room temperatures (below 25 °C), the POWEREASE™ driver rates for continuous operation.
• Handpiece motor comes to a complete stop from the run condition when the user releases the trigger switch
during expected normal use.
• Handpiece maintains modes (directio of rotation) of operation during expected normal use.
IPC™ POWEREASE™ system and the NIM-Eclipse™ system
Note: Do not use the IPC™ POWEREASE™ system and NIM-Eclipse™ System with multiple portable socket-outlets or extension cords.
The POWEREASE™ system is equipped with two cables that connect the IPC™ to the NIM-Eclipse™. Wires within the POWEREASE™ make contact
with the uncoated tool and carry stimulating current to the tool’s tip for nerve monitoring. Contact to your local NIM-Eclipse™ representative for
more information.
Note: Only taps, screws and drills are available for nerve stimulation. When the IPC™ POWEREASE™ driver is used in combination with the NIMEclipse™, the combination creates a medical electrical system. The system components are as follows:
• IPC™
• POWEREASE™ with accessories
• NIM-Eclipse™
• NIM™ cable set
1-20
Integrated Power Console (IPC™) System
Page 21
POWEREASE™ DRIVER
Assemble IPC™ POWEREASE™ and NIM-Eclipse™ systems
Refer to the NIM-Eclipse™ User’s Guide for set up and use of the NIM-Eclipse™ system, including the laptop computer.
Warnings:
• Only the POWEREASE™ handpiece with its accessories are intended to be used within the patient environment. The NIM-Eclipse™ cannot be
used in the patient vicinity (1.5 meter radius from patient).
• Do not touch the patient and the enclosure parts of the NIM-Eclipse™ simultaneously.
• Dispose of the single-use NIM™ cables after each procedure.
• Any peripheral devices connected to the system must meet IEC60602-1 requirements. Consult with your biomedical engineering
department to determine if the external devices meet this requirement.
1. Assemble the IPC™ and conrm IPC™ POWEREASE™ system operation.
2. Assemble the NIM-Eclipse™ according to the instructions in the NIM-Eclipse™ User’s Guide. Verify the laptop computer power cord is plugged
into the NIM-Eclipse™ 945ECLC Controller.
3. On the NIM-Eclipse™ stimulator extender, connect one end of the black NIM™ cable to the Stimulus Output connection port (Figure 2-8).
4. On the IPC™ connector panel, connect the other end of the black NIM™ cable to the Stimulus Input connection port (Figure 2-8).
Note: Route the wire so that it does not interfere with operating room personnel.
5. Connect one end of the blue NIM™ cable to the Stimulus Output IPC™ connector panel (Figure 2-8).
6. Connect the other end of the blue NIM™ cable to the NIM™ Stim Input on the POWEREASE™ driver.
Note: Route the wire so that it does not interfere with operating room personnel.
Figure 2-8. IPC™, POWEREASE™ driver, and NIM-Eclipse™ Connection
NIM-ECLIPSE® System
68L2120 A
INTEGRATED POWER
C O N S O L E
POWEREASE®
IPC
BUR
EHS
2
NIM
1
7
3
8
6
12
9
10
11
NIM-ECLIPSE® System
68L2125 A
4
5
1 Main POWEREASE™ cable 7 Mouse
2 NIM™ Cable 2 (blue) 8 Portable notebook computer
3 NIM™ Cable (black) 9 USB interface cable
4 Stimulator extender 10 Stimulator cable
5 Digital preamplier interface cable 11 Controller
6 Preamplier module 12 Notebook power supply
Integrated Power Console (IPC™) System
NIM-ECLIPSE
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Page 22
MIDAS REX™ SPINE SHAVER SC1
12 3
45
Midas Rex™ Spine Shaver (SC1)
The IPC™ incorporates the Midas Rex™ Spine Shaver (SC1) at pump 2. Control operation of the Spine Shaver (SC1) with the IPC™ touchscreen and
the multifunction foot pedal.
Figure 3-1. Spine Shaver (SC1) Handpiece
1 Finger Wheel 4 Finger Wheel Lock
2 Irrigation Tubing Groove 5 Locking Collar
3 Suction Barb
Spine Shaver (SC1) blade or bur assembly
1. Insert the tool aligning the tabs with the notches (Figure 3-2). Orientate the irrigation barb to the left or right side.
• 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.
2. Press the locking collar (Figure 3-3).
3. Release the locking collar.
Note: If 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 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 3-4).
Figure 3-2. Spine Shaver (SC1)
Assembly
Figure 3-3. Spine Shaver (SC1)
Assembly
Figure 3-4. Spine Shaver (SC1)
Assembly
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Integrated Power Console (IPC™) System
Page 23
MIDAS REX™ SPINE SHAVER SC1
+
+
180º
12
Spine Shaver (SC1) suction and irrigation tube assembly
1. Attach a suction tube to the suction source (Figure 3-5) and an irrigation tube on the irrigation barb (Figure 3-5).
2. Secure suction and irrigation in the irrigation groove on the spine shaver (Figure 3-6).
Figure 3-5. Spine Shaver (SC1) Suction Irrigation Assembly
Figure 3-6. Spine Shaver (SC1) Suction Irrigation Assembly
Connect Spine Shaver (SC1) to IPC™ console
Locate the Spine Shaver (SC1) connection port on the connector panel (Figure 3-7) 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.
Spine Shaver (SC1) touchscreen controls
To set or adjust Spine Shaver (SC1) controls, on the IPC™ touchscreen, in the control box (Figure 3-8), do the following:
• To change rotation mode, in the Mode control box select OSC (oscillating) or FWD (forward).
• To adjust speed, in the Speed control box, press the plus button to increase speed and the minus button to decrease speed.
Forward Mode: Default, 12000 rpm; variable adjustment from 50 to 12000 rpm.
Oscillate Mode: Default, 3400 cpm; variable adjustment from 50 to 5000 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, 30cc per minute.
Oscillate Mode: Default, 60cc per minute.
Note: To adjust ow rate, you can use the touchscreen or the IntelliFlow Irrigation remote control.
• In oscillating mode only, you can use the Blade Position control box to do any of the following:
To rotate the inner blade 180 press the delta button.
To rotate the inner blade in small increments, press the clockwise or counter-clockwise buttons.
Note: The motion indicator indicates rotation direction of the blade.
• To rotate the outer blade, use the nger wheel (Figure 3-1).
Figure 3-7. Spine Shaver (SC1) IPC Connection Ports
Figure 3-8. Spine Shaver (SC1) Touchscreen
SC1 Handpiece
Speed
+
3400
Blade Position
Pump 2
+
+
60
1 Spine Shaver (SC1) handpiece connection port
2 Multifunction footpedal connection port
Integrated Power Console (IPC™) System
cc/min
+
CPM
180°
Prime
Mode
OSC
FWD
1-23
Page 24
MIDAS REX™ SPINE SHAVER SC1
1
24
Spine Shaver (SC1) blade control
Periodically submerse blade tip in sterile water, with suction on, to keep blades clear during the procedure.
• To rotate the outer blade (Figure 3-9), use the nger wheel (Figure 3-1).
• To rotate the inner blade, use the Blade Position control box on the IPC™ touchscreen.
Spine Shaver (SC1) multifunction foot pedal controls
Note: 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.
Use the multifunction foot pedal (Figure 3-10) to control the following:
• To select forward or oscillating 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 (180) press the control button.
• To change the handpiece, press the handpiece button.
Figure 3-9. Blade Dissection
3
1 Suction ow in through inner blade
Irrigation ow between inner and outer blades
2 Outer blade
3 Inner blade
4 Outer sleeve
Figure 3-10. Multifunction Footpedal & Y-Splitter
1
5
4
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
2
3
1
5
6
7
4
Midas Rex™ Spine Shaver (SC1) cleaning and sterilization instructions
Refer to document 68E3282 in the Cleaning and sterilization section.
8
2
3
Midas Rex™ Spine Shaver (SC1) technical specications
Midas Rex™ Spine Shaver (SC1) ED100
Size 14.3 cm length x 1.8 cm width (ED100)
Weight 228g ED100
Speed 50-5000 rpm oscillate
50-12000 rpm forward
Duty Cycle for Applied Part Maximum on time = 60 seconds. Minimum o time = 30 seconds.
1-24
Integrated Power Console (IPC™) System
Page 25
MIDAS REX™ LEGEND EHS™ STYLUS TOUCH™ DRILL
12
Midas Rex™ Legend EHS™ Stylus Touch™ Drill
The Midas Rex™ Legend EHS™ Stylus Touch™ Drill (Figure 4-1) is a small, compact, high-speed, high-torque, reversible electric motor used to
dissect bone and biomaterials at variable speeds from 200 to 75000 rpm. The Stylus Touch™ motor includes a rotating nger lever that emulates
the functions of the multifunction foot pedal.
Consult the Legend EHS™ Handpieces User’s Guide M978448A001for compatible Stylus Touch™ attachments and tools.
Figure 4-1. Stylus Touch™ Motor
1
65
1 Telescoping nger rest 4 Control lever ring
2 Finger lever 5 Stationary collet
3 Finger lever safe mode switch 6 Rotating collet
2
3
4
Connect Stylus Touch™ to IPC™ console
Locate the Stylus Touch™ connection port on the connector panel (Figure 4-2) 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 the Stylus Touch™ at pump 1. If you do not use irrigation for the Stylus Touch™, manually change the Pump 1 to None.
Refer to “Set up and Prime Pumps” for more information.
Control operation of the Stylus Touch™ with the IPC™ touchscreen and the multifunction foot pedal.
Figure 4-2. Stylus Touch™ Connection Ports
1 Stylus Touch™ connection port
2 Multifunction foot pedal connection port
Integrated Power Console (IPC™) System
1-25
Page 26
MIDAS REX™ LEGEND EHS™ STYLUS TOUCH™ DRILL
+
+
Speed
Mode
Mode
Stylus Touch™ Touchscreen Controls
To set or adjust Stylus Touch™ controls, on the IPC™ touchscreen, in the control box (Figure 4-3), do the following:
• To change rotation mode, in the Mode control box, select FWD (forward) or REV (reverse).
Note: System conguration may be dierent from the default. If the REV (reverse) button appears raised (Figure 4-6) and does not have
a selectable radio button, you cannot select the Reverse mode. If the REV button appears concave (Figure 4-6) 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, 60000 rpm; variable adjustment from 200 to 75000 rpm.
Note: When the drill is in safe mode, the Speed control box displays SAFE (Figure 4-5). Refer to the Stylus Touch™ Safe Mode topic for
additional information.
• 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 mode.
Default, 0cc per minute.
Note: To adjust ow rate, you can use the touchscreen or the IntelliFlow Irrigation remote control.
• To adjust acceleration and deceleration, on the Defaults menu (Figure 4-4), press the corresponding plus or minus button. Acceleration is
the rate at which the motor speeds up to reach the target speed. Deceleration is the rate at which the motor slows down to reach the target
speed or stop.
Note: While in the default menu, the motor will not be active to demonstrate the selected acceleration and deceleration. In order to
determine the desired values, adjust the acceleration and deceleration during motor operation and note the preferred values.
• To enable the adjustment of acceleration or deceleration during drill operation and to display the acceleration and deceleration adjustment
options on the motor operational screen; On the Defaults menu, select Show On Screen and then press [OK]. To hide the acceleration and
deceleration during drill operation, on the Defaults menu, deselect Show On Screen.
Stylus Touch™ SAFE MODE
When the drill is in safe mode, it is inoperable until the safety is turned o. The Speed control box on the Stylus Touch™ touchscreen displays
SAFE when the drill is the active handpiece and in safe mode (Figure 4-5).
Switch the device to safe mode any time it is attached to the console, but not currently being used. To set the Stylus Touch™ to Safe Mode, on the
Stylus Touch™ drill, switch the Safe Mode nger lever (Figure 4-1) to on.
When more than one handpiece is attached to the console, use the safety switch of an inactive handpiece to activate that handpiece and make it
ready for use.
Figure 4-3. Stylus Touch™ Touchscreen Figure 4-4. Stylus Touch™ Default
Setting Menu
Figure 4-5. Stylus Touch™ Safe Mode
+
SAFE
Figure 4-6. Stylus Touch Rotation Mode
FWD
REV
+
RPM
FWD
REV
1-26
Integrated Power Console (IPC™) System
Page 27
MIDAS REX™ LEGEND EHS™ STYLUS TOUCH™ DRILL
Stylus Touch™ multifunction foot pedal controls
Note: 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 4-7) to control the drill do the following:
• To select Forward or Reverse mode, press the mode button.
• To start or adjust the speed of a drill 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 drill Defaults menu to pause irrigation. Refer to Change System Settings in
the Pre-Operating Instructions section.
• To change the drill, press the handpiece button.
Stylus Touch™ nger lever
The Stylus Touch™ motor includes a rotating nger lever that emulates the functions of the multifunction foot pedal.
1. Press the control lever ring forward (Figure 4-8).
2. Rotate the lever clockwise or counter clockwise until the lever locks in a new position.
Figure 4-7. Multifunction Foot Pedal & Y-Splitter
1
5
4
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
2
3
1
5
6
7
8
2
4
3
Figure 4-8. Stylus Touch™ Finger Lever Rotation
1
2
Midas Rex™ Legend EHS™ Stylus Touch™ Drill cleaning and sterilization instructions
Refer to documents 68E4132 in the Cleaning and sterilization section. Consult the Neurosurgical IPC™ System Model: EC300 User’s Guide for
compatible Stylus Touch™ attachments and tools cleaning and sterilization.
Midas Rex™ Legend EHS™ Stylus Touch™ Drill technical specications
Midas Rex™ Legend EHS™ Stylus Touch™ EM210
Size 15.26 cm Length x 1.65 cm Diameter
Weight 130 g
Speed 75000 rpm forward/reverse
Duty Cycle for
Applied Part
Integrated Power Console (IPC™) System
For use in operating room temperatures up to 40°C, the Midas Rex™ Legend EHS™ Stylus Touch™ drill is rated for 3
minutes at 60000 rpm followed by 25 minutes of rest.
For normal operating room temperatures (typically 20°C), the Midas Rex™ Legend EHS™ Stylus Touch™ drill is rated for
cutting indenitely at 60000 rpm.
1-27
Page 28
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 misidentied the handpiece /
Moisture in cable conicts 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.
1-28
Moisture in cable conicts with handpiece
recognition.
Change motor, motor cable, or console to
isolate the problem.
Run a dry cycle when sterilizing.
Integrated Power Console (IPC™) System
Page 29
TROUBLESHOOTING
Issue Possible Cause Action
Foot control unit buttons or pedal does not
respond.
Handpiece fails to rotate. Failed foot switch. Disconnect foot switch, use manual start/stop
Handpiece is too hot to touch/hold. Blade, bur, and/or attachment transferring
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 conrmation 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 dierent FCU or console to isolate the
problem.
Internal component failure. Contact Customer Service.
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.
Remove and reinstall or change blade, bur,
heat to handpiece.
Inadequate irrigation and/or coolant. Ensure adequate irrigation and/or coolant is
and/or attachment. Ensure the part is properly
seated before resuming use.
present.
Midas Rex™ Legend EHS™ Stylus Touch™ drill
Issue Possible Cause Action
Motor does not run. Finger switch not reaching maximum speed. Check that the control lever ring is properly
seated in one of the four possible positions.
Finger switch not responding. Safety switch
in safe mode.
Finger control damaged. Contact Customer Service.
Place switch in run mode.
Blades
Issue Possible Cause Action
Appears to be damaged or defective. Damaged or defective. Remove and replace.
Tool vibrates excessively, abnormal noise
movement.
No suction. Blade opening is obstructed. Use stylet to clear blade.
Tool is leaking irrigant. Tool not seated correctly in collet. Check for proper tool insertion by pulling
Tool wobbles in handpiece. Tool wobbles in handpiece. Reduce handpiece operating speeds.
Integrated Power Console (IPC™) System
Tool is not rmly seated. Microdebriders, pull back locking collet and
re-seat the tool.
Visao, unlock collar, check/re-seat notch, lock
collar.
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.
back locking collet, and re-seating tool.
Low or no suction. See Possible Cause, No ms.
Use tools that are rated for the console speed
selected.
1-29
Page 30
ERROR CODES
Issue Possible Cause Action
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.
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.
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.
1-30
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.
Integrated Power Console (IPC™) System
Page 31
ERROR CODES
Code # Title Cause Description
18 Damaged handpiece or nger lever base out of position. Finger Control
error.
Stylus Touch™ - A nger control error has
been detected. Check that the control lever
ring is properly seated in one of the four
possible positions. If error persists contact
Customer Service. Press OK to use alternate
control method.
POWEREASE™ - Please check mode select
switch to ensure a mode has been selected
by rotating mechanism until it rests in a
detent. If error persists, contact Customer
Service.
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 conguration 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.
23 MCB non-specic 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.
Integrated Power Console (IPC™) System
1-31
Page 32
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.
1-32
Integrated Power Console (IPC™) System
Page 33
Reprocessing Instructions
Reprocessing Instructions
Cleaning and Sterilization instructions are subject to
change. Up to date instructions are available online at
manuals.medtronic.com.
68E4189 D
Warnings and
Precautions
Limitations
Point of Use
Containment and
POWEREASE™ Driver
• 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.
No particular requirements.
It is recommended that devices are reprocessed as soon as is practical following use.
Transportation
Preparation for
Disconnect handpiece from console.
Decontamination
Cleaning: Manual
Cleaning:
Automated (Do
NOT use ultrasonic
washer)
Disinfection
Packaging
Sterilization
(Temperatures
are minimum
required, times
are minimum
required)
Maintenance,
Inspection and
• Rinse tap water through the open lumen of the handpiece, collet pointed down, until all evidence of soil and debris is removed. Actuate and rinse collet.
• Wipe external surface of the motor and cable with a cloth dampened with neutral enzymatic detergent, pH 6.0-8.0.
• Thoroughly clean the motor case, collet, and trigger area with a nylon brush dampened with neutral enzymatic detergent, pH 6.0-8.0. Actuate the collet
and trigger while brushing.
• Use a lumen brush to brush the entire length of the lumen.
• Rinse entire device, with collet pointed down, under running tap water.
• Immerse the collet portion of the device into neutral enzymatic detergent, pH 6.0-8.0 for a minimum of 2 minutes. Actuate and thoroughly brush the
collet while immersed. A syringe should be used to ush hard to reach areas.
• Rinse entire device, with collet pointed down, under running tap water. A syringe should be used to rinse hard to reach areas.
• Dry with lint free cloth.
• Verify that device is visually clean.
The POWEREASE must undergo the manual cleaning process prior to processing in a washer/disinfector.
1. Rinse tap water through the open lumen of the handpiece, collet pointed down until all evidence of soil and debris is removed. Actuate and rinse collet.
2. Wipe external surface of the motor and cable with a cloth dampened with neutral enzymatic detergent.
3. Brush motor case, collet, and trigger area with a nylon brush dampened with neutral enzymatic detergent. Actuate the collet and trigger while brushing.
4. Use a lumen brush to brush the entire length of the lumen.
5. Rinse entire device, with the collet pointed down, under running tap water.
6. Immerse the collet portion of the device into neutral enzymatic detergent for a minimum of 2 minutes. Actuate and brush the collet while immersed. A
syringe should be used to ush hard to reach areas.
7. Rinse entire device, with the collet pointed down, under running tap water. A syringe should be used to rinse hard to reach areas.
8. Place POWEREASE into a suitable washer/disinfector basket and process through a washer/disinfector cycle.
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 detergent, pH 6.0-8.0
Rinse 1 minute Hot tap water Not applicable
Follow hospital procedures.
Steam sterilization may be performed wrapped or unwrapped. If wrapped, 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 40 minutes
STERRAD Not validated
STERIS Not validated
100% EtO
Sterilization
Parameters
• Inspect devices for any damage before and after each use. If damage is observed, do not use the device until it is repaired.
• After cleaning and sterilization, verify functionality prior to re-use.
Not validated
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
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.
Medtronic recommends incineration of devices that have directly or indirectly contacted patients suspected or conrmed with prions or a Transmissible Spongiform Encephalopathy
(TSE) such as CreutzfeldtJacob disease (CJD).
Page 34
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 • 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: Automated
(Do NOT use ultrasonic
washer)
Cleaning: Manual • Remove instruments and equipment from instrument tray.
• 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.
• 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.
• 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
Page 35
Reprocessing Instructions
Microdebriders
StraightShot M5, StraightShot M4, StraightShot Magnum II, StraightShot III or
Midas Rex Spine Shaver
Drying and
Lubrication
Disinfection Do not cold soak in gluteraldehyde.
Packaging • 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
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 121C 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 specications (40 minutes and 121°C).
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.
Medtronic recommends incineration of devices that have directly or indirectly contacted patients suspected or conrmed with prions or a Transmissible Spongiform Encephalopathy
(TSE) such as CreutzfeldtJacob disease (CJD).
• 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.
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
conguration and instruments can be sterilized wrapped or unwrapped.
Steam Sterilization
Cycle Gravity* Gravity Pre -Vac Pre-Vac (FR/
WHO)
Temperature 121C 132C 132C 134C 134C
Time 40 minutes 15 minutes 4 minutes 18 minutes 3 minutes
Drying 25 minutes, or until visibly dry
100% EtO Sterilization Parameters (set points)
Preconditioning 54°C, 60% relative humidity, 60 minutes
Sterilization Temperature 54C
Relative Humidity 60%
Ethylene oxide concentration 725 mg/L
Gas exposure time (full-cycle) 120 minutes
Aeration 54C, 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.
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
Cleaning and Sterilization
instructions are subject to change.
Up to date instructions are available
online at manuals.medtronic.com.
68E3282 G
Pre-vac (UK)
Page 36
Reprocessing Instructions
Midas Rex™ Legend EHS™ Stylus Touch™
Reprocessing Instructions
Cleaning and Sterilization instructions are subject
to change. Up to date instructions are available
online at manuals.medtronic.com.
68E4132 E
Warnings and
Precautions
Limitations
Point of Use
Containment and
• 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 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:
Automated (Do
NOT use ultrasonic
washer)
Cleaning: Manual
Disinfection
Packaging
Sterilization
(Temperatures
are minimum
required, times
are minimum
required)
Maintenance,
Inspection and
Review the washer-disinfector warning above, before using this cleaning method. Remove devices from instrument trays before placing into washer baskets.
Orient devices following recommendations of the washer/disinfector manufacturers. Verify that devices are visually clean after automated cleaning.
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 detergent, pH 6.0-8.0
Rinse 1 minute Hot tap water Not applicable
• Wipe all external surfaces with a cloth dampened with a neutral enzymatic detergent, pH 6.0-8.0.
• 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 with towel.
• Verify that devices are visually clean after manual cleaning.
Follow hospital procedures.
For sterilization, place devices in instrument tray. Devices may be unwrapped, or wrapped with up to two layers of 1-ply polypropylene wrap.
Steam Sterilization
Cycle Pre-Vac Gravity Pre-Vac Pre-Va c Flash (Pre-Vac Unwrapped)
Temperature 132 C 132 C 134 C 134 C 132 C
Time 4 minutes 25 minutes 3 minutes 18 minutes 4 minutes
Drying 15 minutes 15 minutes 10 minutes 20 minutes Not applicable
STERRAD Not validated
100% EtO Sterilization Parameters
Preconditioning 55 ºC, 70 % relative humidity, Vacuum Set Point: 1.3 psia, Time: 30 minutes
Sterilization Temperature 55 ºC +/- 4º C
Relative Humidity 70 +/- 5 %
Ethylene oxide concentration 725 +/- 25 mg/L
Gas exposure time (full-cycle) 4 hours
Aeration 55 C +/-4 C, 12 hours
• Inspect devices for any damage before and after each use. If damage is observed, do not use the device 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
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.
Medtronic recommends incineration of devices that have directly or indirectly contacted patients suspected or conrmed with prions or a Transmissible Spongiform Encephalopathy
(TSE) such as CreutzfeldtJacob disease (CJD).
Page 37
Customer service
Medtronic Spinal and Biologics Business
Worldwide Headquarters
2600 Sofamor Danek Drive
Memphis, TN 38132
1800 Pyramid Place
Memphis, TN 38132
www.medtronic.com
US Help Line
901 396 3133
800 876 3133
Customer Service: 800 933 2635
International Service
International Customers should contact their local Medtronic oce.
The following are trademarks or registered trademarks of Medtronic, Inc. in the United States and other countries: Hydrodebrider™, Intelliow™, IPC™, Legend EHS™,
Midas Rex™, NIM™, NIM-Eclipse™, NIM-Neuro™, NIM-Response™, Stylus Touch™. All other trademarks, service marks, registered trademarks or registered service marks
are the property of their respective owners in the United States and other countries.
The information contained in this document is accurate at time of publication. Medtronic reserves the right to make changes to the product described in this manual.
Refer to manuals.medtronic.com for the current version.
Page 38
Medtronic Xomed
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M988683A001 A
2018-10
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