User’s Guide
REF
Integrated Power Console (IPC™) System
1898001
Symbols
EUR · USA · JPN · AUS
IPX1
EC REP
IPX7
ACC
IPX8
DEHP
STERILE
NIM
Accessory
REF
LOT
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
Table of Contents
Symbols .......................................................................................................................................................... 2
IPC™ 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 ............................................................................................... 15
Limited warranty ........................................................................................................................................................................................................... 17
For items contaminated with TSE agents ............................................................................................................................................................ 17
Endo-Scrub™ 2 .............................................................................................................................................. 18
StraightShot™ M5, StraightShot™ M4, StraightShot™ Magnum™ II, and StraightShot™ III .................... 21
Skeeter™ Ultra-Lite Oto-Tool ....................................................................................................................... 26
Indigo™ High-Speed Otologic Drill ............................................................................................................. 28
Visao™ High-Speed Drill ............................................................................................................................... 32
Troubleshooting ........................................................................................................................................... 35
Error codes .................................................................................................................................................... 37
Cleaning and sterilization ............................................................................................................................ 39
Reprocessing Instructions - Endo-Scrub™ 2 Finger Switch ........................................................................................................................... 40
Reprocessing Instructions - StraightShot™ M5, StraightShot™ M4, StraightShot™ Magnum™ II, StraightShot™ III .................. 41
Reprocessing Instructions - Skeeter™ Oto-Flex Burs ........................................................................................................................................ 43
Reprocessing Instructions - Skeeter™ Handpiece ............................................................................................................................................. 44
Reprocessing Instructions - Indigo™ High-Speed Otologic Drill ................................................................................................................. 45
Reprocessing Instructions - Indigo™ High-Speed Otologic Drill Attachments ...................................................................................... 46
Reprocessing Instructions - Visao™ Handpiece .................................................................................................................................................. 47
Reprocessing Instructions - Frontal Sinus 2mm Mini Trephine Drill ........................................................................................................... 48
Reprocessing Instructions - Medtronic Burs ....................................................................................................................................................... 49
Customer service .......................................................................................................................................... 50
Integrated Power Console (IPC™) System
IPC™ SYSTEM
IPC™ System
Glossary
The following words and acronyms may be used in this guide.
FCU Foot Control Unit
FWD Forward - Rotation is clockwise
I.V. Intravenous
IPC™ Integrated Power Console
NIM™ Nerve Integrity Monitor - One or all of the Nerve Integrity Monitor units: NIM-Response™ 2.0, NIM-Neuro™ 2.0, NIM-
Response™ 3.0 and NIM-Neuro™ 3.0
NIM-Eclipse™ Nerve Integrity Monitor for spinal surgeries
OSC Oscillate
REV Reverse - Rotation is counter-clockwise
XPS Xomed Power System
Tool Surgical cutting device
Motor Handpiece/drill
Accessory Any compatible product that can be used with the IPC™
Attachment Any compatible product that can be secured to a handpiece
Indications for use
The IPC™ System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone in Head & Neck/ENT
(Otologic, Neurologic, Neurotologic, Sinus, Rhinologic, Nasopharyngeal/Laryngeal), Oral/Maxillofacial and Plastic/Reconstructive/Aesthetic
surgical procedures.
Device description
The IPC™ System is a powered microdebrider, drill and saw system that will remove soft tissue, hard tissue and bone during surgical procedures.
The system consists of a power control console, foot pedal, connection cables and assorted handpieces to drive various burs, blades, drills, rasps,
cannulae and saws. It includes integrated irrigation pumps for irrigation of blades, burs and for motor coolant.
In addition to the handpieces and pumps there is a connection for continuous stimulation of the Visao™ straight burs that enables nerve
integrity monitoring during surgical procedures. The Nerve Integrity Monitor (NIM™) is a separate device that stimulates and monitors the nerve.
This system has connections that allow the NIM™ to be connected with the Visao™ handpiece and stimulating bur guard, enabling the NIM™ to
stimulate and monitor the nerve at the surgical site.
This device is intended for use by physicians trained in the procedures described.
Contraindications
None.
Additional IPC™ congurations
Additional IPC™ congurations are available. Refer to the following User’s Guides for related information.
• IPC™ POWEREASE™ System Model: 2340000 (IPC™ User’s Guide)
• Neurosurgical IPC™ System Model: EC300 (IPC™ User’s Guide CFN 175027)
Consult the appropriate User’s Guide for indications, contraindications, warnings, and component information specic to each system.
Warnings
System warnings
W1 It is important that the IPC™ system operator be familiar with the system User’s Guide, its precautions, procedures and safety issues.
W2 Do not use the IPC™ system in the presence of ammable anesthetics. Avoid potential ignition or explosion of gases.
W3 To avoid the risk of electric shock, this equipment must only be connected to a supply main with protective earth.
W4 To avoid the risk of electrical shock, achieve electrical grounding reliability with proper connections. Connect the IPC™ system to hospital
grade receptacles only.
W5 Do not attach any system component or accessory other than Medtronic approved components to the IPC™ system as this may result in
electrical shock, component damage, substandard performance, increased emissions, or decreased immunity.
1-4
Integrated Power Console (IPC™) System
IPC™ SYSTEM
W6 Disconnect power to the IPC™ system before cleaning the unit to avoid electrical shock.
W7 This medical device complies with EN60601-1-2 safety standard for electromagnetic compatibility, requirements and test. However, if this
equipment is operated in the presence of high levels of electromagnetic interference (EMI) or highly sensitive equipment, interference may
be encountered and the user should take whatever steps are necessary to eliminate or reduce the source of the interference. Diminished
performance may lengthen operating time for the anesthetized patient.
W8 Do not operate the IPC™ system in the presence of Magnetic Resonance Imaging devices.
W9 Medical Electrical Equipment needs special Precautions regarding EMC and needs to be installed and put into service according to the EMC
information provided in this User’s Guide.
W10 The IPC™ system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the IPC™ system
should be observed to verify normal operation in the 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.
Component Warnings
W16 Always inspect the components before and after use for any damage or malfunction. If damage or malfunction is observed, do not use
damaged part until it is repaired or replaced. Use of damaged or malfunctioning parts can increase risk of injury.
W17 Motors and attachments may fail due to extended use and allow a component to detach and fall from the motor or attachment, causing
patient injury.
W18 Do not use an overheated device as it may cause thermal injury. Smoke and/or excessive heat may be caused by:
• Applying excessive force while cutting (e.g. side loading)
• Long operating periods (exceeding handpiece duty cycle)
• Attachment not fully locked in handpiece
• Inadequate or loss of irrigation
• Component failure or wear
W19 The handpieces will not run properly unless the attachment is in the locked or secured position.
W20 Do not change accessory with handpiece running to prevent laceration of user and cross-contamination through compromised glove.
W21 Do not place motor, attachment and tool on the patient or in an unsecured location during surgery.
W22 Do not activate foot pedal without conrming the safe position and handling of the handpiece. Accidental handpiece activation could
result in unintended tissue, bone, or nerve resection.
W23 Verify reusable device was cleaned and sterilized prior to use. If not sterilized, do not use.
W24 For warnings & precautions related to reprocessing, refer to Cleaning and sterilization instructions.
W25 This system requires insulated connectors for the StraightShot™ M4 Microdebrider, StraightShot™ Magnum™ II Microdebrider,
StraightShot™ III Microdebrider, Midas Rex™ Spine Shaver (SC1), Visao™, or Skeeter™ handpieces and the multifunction foot pedal.
W26 When using StraightShot™ microdebrider handpieces with non-rotatable tools, ensure rotation lock is engaged to prevent inadvertent
rotation. When using with optical Image Guided Surgery (IGS), engage the rotation lock prior to calibration and verication of the tip.
Disposable Warnings
W27 Tools are available for resection of soft tissue and bone for surgical procedures. Use of tools depends on the intended application and
patient needs. Sharp cutting powered tools induce bleeding and removal of signicant tissue and bone.
W28 Do not use accessory if package is opened or damaged. Broken seal oers no protection against cross-contamination.
W29 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.
W30 Use methods at the operative site to control bleeding that do not compromise patient safety during at-risk surgery.
W31 Always keep the cutting area of the tool away from ngers and loose clothing to prevent laceration of user and cross-contamination
through compromised glove.
W32 Excessive noise from the tool when drilling close to the cochlea or ossicular chain may cause hearing damage.
W33 Improper use of high speed burs can result in damage to the eye and/or orbit, vascular damage, nerve damage, and/or cerebral damage.
Use appropriate caution when operating this device in the vicinity of critical anatomy.
W34 Excessive pressure applied to tool may cause tool fracture. Should a tool fracture in use, extreme care must be exercised to ensure that all
fragments of the tool are retrieved and removed from the patient. Unremoved tool fragments may cause tissue damage to the patient.
W35 Do not use excessive force to pry or push bone with the attachment, tool or blade during dissection.
W36 Do not apply excessive side loading. Excessive side loading could cause angled attachments to unlock accidentally from motor.
Integrated Power Console (IPC™) System
1-5
IPC™ SYSTEM
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 use the burs above the speed indicated on the bur label.
W45 If an airway blade becomes clogged during use, 1-5 cc of irrigant could be aspirated by the patient before detection by the user.
W46 Do not attempt to sterilize disposable devices. The disposables are packed sterile and are intended for single use. Devices lose sterility
upon removal from packaging.
Precautions
P1 Do not kink cables. Inspect cables and pins for cracks, tears or corrosion.
P2 When using a Y-Splitter, only one multifunction foot pedal shall be active at a time.
P3 Do not connect multiple Y-Splitters.
P4 StraightShot™ handpieces are intended to operate at speeds greater than 6,000 rpm only when used with the high speed bur line.
P5 Do not use anti-fog on scope or sheath, as weeping or leaking may result.
P6 Do not use excessive force to insert the endoscope into the Endo-Scrub™ 2 sheath. this will damage the endoscope as well as the Endo-
Scrub™ 2 sheath.
P7 If the endoscope tip can be seen extending beyond the tip of the Endo-Scrub™ 2 sheath, then the sheath has been damaged. Damaged
product must be immediately discarded.
P8 Remove and discard accessories following local regulations for proper disposal of contaminated materials.
P9 When using an angled attachment, hold the handpiece assembly by the attachment so that the attachment does not inadvertently loosen
from the handpiece.
P10 Always examine operation of each tool in a handpiece before use.
P11 Powered burs and drills should be operated in the Forward mode only.
P12 To prevent damage to tools, disconnect suction tube prior to changing tool during procedure.
P13 Ensure the blade or bur is fully engaged in the microdebrider. For blades, verify the tip is fully engaged with the outer cannula prior to use.
P14 T&A blades: Gently remove the inner tube from the outer tube. The inner tube may elongate upon removal from the outer tube. If this
occurs, the inner tube may not lock properly into the handpiece or the blade may not work properly.
P15 T&A blades: Rotate the inner tube when removing and inserting it in the outer tubes to prevent damage to the internal seal. If the seal is
damaged, the blade will leak at the handpiece.
System requirements and 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
1-6
Integrated Power Console (IPC™) System
2005, 2012
2005, 2012
2006, 2014
1996, 1999
2007, 2014
2005, 2014
Physical Dimensions
Size 277 mm Width x 353 mm Height x 267 mm Depth
Weight 7.3 kg
Operational Environment
Temperature +10 °C to +33 °C
Humidity 30 % to 75 % RH
Barometric Pressure 700 - 1060 hPa
Transport and Storage Environment
Temperature -40 °C to +70 °C
Humidity 10 % to 95 % RH
Barometric Pressure 500 to 1060 hPa
Display / Touchscreen
Type High contrast, digital, graphic color, visible in complete darkness
Resolution Display 21 cm diagonal, resolution 480 X 640 pixels
Audio Output
Baseline Audio Sound Level 60 dBA minimum SPL (1 m)
Electrical
Input Voltage 100 V-240 V ± 10%
Frequency 50/60 Hz
Power Consumption 500 VA
Auxiliary AC output 200 VA Max.
Internal Fuse 5 x 20 mm T. L. 5 A, 250 V
Medtronic Xomed P/N 11270066
Duty Cycle for Applied Part Maximum On Time 120 Seconds
Minimum O Time 180 Seconds
IPC™ SYSTEM
System power cords
Region Part Number Region Part Number Region Part Number
USA, Barbados, Belize,
Bolivia, Canada,
Colombia, Ecuador,
Venezuela
Standard
EA600 or 1895820
6 meter
EA650 or 1897821
United Kingdom,
Ireland, Hong Kong,
Malaysia, Singapore
EA606 Austria, Belgium, Finland,
France, Germany, Greece,
Korea, Luxembourg,
Netherlands, Norway,
Portugal, Spain, Sweden
EA602 or 1895822
China EA604 India, South Africa EA607 Switzerland EA601
Argentina EA608 Israel EA609 Denmark EA610
Australia, New Zealand EA605 Japan EA603 or 1895823 Italy, Chile EA611
System sounds
The following tones can sound while using the IPC™ Console.
IPC™ Tone Cause(s)
1 Tone • 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
1-7
IPC™ 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 StraightShot™ M5 microdebrider,
StraightShot™ M4 microdebrider,
StraightShot™ Magnum™ II
microdebrider, StraightShot™ III
microdebrider, Visao™ drill, Indigo™
drill
1-8
Figure 1-3. IPC™ Console Connector Panel
3567 8
4
(NIM™ or NIM-Eclipse™)
POWEREASE™
6 Skeeter™ handpiece
7 Endo-Scrub™ 2 nger switch, Endo-
Scrub™ 2 foot pedal, IntelliFlow™
irrigation remote control
8 Multifunction foot pedal
Figure 1-4. Multifunction Foot Pedal & Y-Splitter
1
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
IPC™ SYSTEM
Figure 1-5. IPC™ Touchscreen
1
Speed
2
3
4
5
1 Displays active handpiece 5 Opens Help screen
2 Accessory control panel 6 Irrigation accessory panel
3 Foot pedal variable control 7 Inactive handpiece
4 Opens Pumps screen 8 Set active handpiece settings as default
Acceleration
Pump 2
Pumps
?
?
Help
Handpiece Name
+
60000
100
+
+
%
+
+
0
cc/min
EndoScrub 2
Flow
+
RPM
Prime
(Handpiece Name)
Setting
Finger
3
Control
+
+
Mode
FWD
REV
Foot
Both
PrimeOn
Figure 1-6. IPC™ Pumps Screen
Prime
Pump 1
None
None
3
Pump 2
8
None
7
6
4
1 Close Pumps screen 3 Pump 1 panel available accessories
2 Prime/Flush pump 4 Pump 2 panel available accessories
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
1-9
IPC™ 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.
1-10
Integrated Power Console (IPC™) System
IPC™ SYSTEM
Pre-and Post-operating instructions
The following are general IPC™ pre- and post-operating instructions. Refer to other sections of this IFU for operating instructions 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
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
1. Verify Operation Room set up (Figure 1-7). The surgeon may have preferences to the location and visibility.
2. Verify the wheels are locked on the IPC™ cart.
3. Inspect all components for damage and determine if the system is ready for use.
4. Mount the IPC™ and irrigation/coolant bags on the I.V. pole (Figure 1-8).
Notes:
• Mount irrigant and coolant bags above the IPC™ to ensure adequate ow.
• It is recommended to use an irrigation pole with minimum base diameter of 53 cm and to mount all items as low as possible to increase
stability during use.
• For transport or uneven oor conditions greater than 10 degrees, maximum height to mount the console is 38 cm if irrigation and coolant
bags are at fully extended pole height.
5. Plug the IPC™ into the power source. Position the IPC™ so that it does not obstruct the power source for the purpose of disconnecting the
Main voltage by the power cord.
6. Locate the correct foot pedal or accessory connection port on the connector panel (Figure 1-3), align the mark on the connector to the mark
on the console, and then insert the connector.
7. Connect suction, cooling and/or irrigation tubing.
8. Turn on the IPC™ and verify the system passes the self-test and the accessory screen appears on the IPC™ monitor.
Note: If the IPC™ does not detect a handpiece or foot pedal the Connect Handpiece/Connect Foot Switch screen appears. Do the following:
• Verify the cable is connected to the correct connection port.
• Press [OK] in the Connect Handpiece/Connect Foot Switch message window to continue use of the IPC™ without the handpiece or foot
pedal.
Calibrate touchscreen
Note: This step is optional.
1. Turn on the IPC™ console.
2. When the system starts, on the Splash screen, press [Settings].
3. On the Settings screen, press Touch Screen Calibration and follow the screen prompts.
Integrated Power Console (IPC™) System
1-11
IPC™ SYSTEM
Change system settings
Note: During surgery, system settings can be overwritten.
1. Turn on the IPC™ console.
2. While the system starts, on the Splash screen, press [Settings].
3. To change the language, press the appropriate language.
4. To change the default settings, press [Default].
• On the Default screen, press the Forward or Backward arrow to change the accessory.
• Make changes to the default settings.
• To 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
Visao™ 80000 X O 30
Indigo™ 52000 X O 30
StraightShot™ M5 5000 O X 05
StraightShot™ M4 5000 O X 05
StraightShot™ III, Magnum™ II 5000 O X 30
Skeeter™ 16000 X O v 0
Endo-Scrub™ 2 3
Suction Irrigator 8 50 %
Set up and prime pumps
• The IPC™ turns on pump 1 and/or 2 long enough to purge air out of the tubing set(s) the rst time the prime button is pressed.
• The IPC™ resets the prime feature when you turn IPC™ power O and On.
• After you prime the pump, the prime button and functionality become ush functionality.
1. Connect tubing from an IPC™ cartridge to irrigation or coolant port on an accessory.
2. On the irrigation tubing, turn the clamp to OPEN.
3. If an accessory uses the clear drip chamber (Visao™), ll the clear drip chamber with coolant. To ll, squeeze and release the chamber until
full.
4. On the IPC™ touchscreen (Figure 1-5), press the pumps button.
Note: The IPC™ pumps screen is also available from the Connect Handpiece/Connect Foot Switch screen which the system displays during
IPC™ preparation for use if a handpiece or foot switch is not detected by the system.
5. On the IPC™ pumps screen (Figure 1-6), select the accessory for each pump.
6. For each pump, press the prime button and verify the following:
• Pump(s) run until air is completely purged from tubing.
• Small amount of lubricant ows at the tip of the irrigation device.
• Pump(s) turns o.
7. Press the close button.
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Integrated Power Console (IPC™) System
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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
Visao™ X X O O
Indigo™ O X O O O O
StraightShot™ M5 O X* X O
StraightShot™ M4 O X* X O
StraightShot™ III, Magum II O X* X O
Skeeter™ O O O O
Endo-Scrub™ 2 X O X O
Suction Irrigator O O O O
* When the IPC™ detects both the StraightShot™ M4 or StraightShot™ M5 and the Legend EHS Stylus Touch handpiece, by default, the system sets
pump 2 as a “shared” irrigation pump. You must manually connect the irrigation tubing to the active handpiece.
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.
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Disassemble the IPC™
1. Remove irrigation tubing or cartridge from IPC™ pump.
Note: Before removing the tubing from the pump, adjust the clamp on the intravenous tubing to the CLOSED position to prevent excessive
drainage of irrigant from the intravenous bag.
2. Disconnect components and cables. To disconnect non-silicone multi-pin cables from the console, push the cable toward the console and
then pull out by the lock ring.
Note: Silicone insulated multi-pin and single pin cable connectors do not have a lock ring. Remove these types of cable connectors straight
from the connector panel.
3. After disconnecting insulated connectors from the console, connectors that have debris under the insulator must be cleaned according to
Cleaning and Sterilization instructions. If debris is still present after cleaning and sterilization, return for warranty servicing.
4. See Cleaning and sterilization section of this User’s Guide for instructions.
IPC™ components
Auxiliary power to console
• The auxiliary power outlet is available for use with the Hydrodebrider™ and Bone Mill consoles only.
• The auxiliary power outlet is for use at grid voltage ≤120 VAC only.
Multifunction foot pedal
You can use the multifunction foot pedal (Figure 1-4) to start/stop the handpiece, control handpiece speed, handpiece selection and mode of
operation. Refer to the Multifunction foot pedal controls topic for each handpiece for 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.
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IPC™ SYSTEM
IntelliFlow™ irrigation remote control
Use the IntelliFlow™ irrigation remote control (Figure 1-9) to start/stop and change irrigation ow while in the sterile eld.
If you are using handpiece irrigation:
• To pause irrigation ow, press the Pause/On-O button.
• To adjust ow rate, press the Fine Adjustment or Coarse Adjustment Increase/Decrease button.
If you are using the Suction Irrigator:
• To pause or turn on/o the Suction Irrigator, press the Pause/On-O button.
• To adjust ow rate, press the Fine Adjustment Increase/Decrease button.
• To select the stainless steel tubing size (French size), press the Stainless Steel Tubing Size button.
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Integrated Power Console (IPC™) System
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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 Elec tromagnetic environment - guidance
Electrostatic
discharge (ESD) IEC
61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic eld
IEC 61000-4-8
NOTES:
1. UT is the mains voltage prior to application of the test level.
2. When the console is powered and connected to the footswtich, application of -15KV air discharge onto the footswitch buttons may cause the console to freeze. Power cycle the
console to re-establish normal operation.
Group 1 The IPC™ System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause
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.
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IPC™ SYSTEM
Guidance and manufacturer’s declaration – electromagnetic immunities - part II
The IPC™ System is intended for use in the electromagnetic environment 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
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Integrated Power Console (IPC™) System
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