Ec300 PDF
Ec300 PDF
Ec300 PDF
MODEL: EC300
User’s Guide
The following are trademarks or registered trademarks of Medtronic, Inc. in the United States and other countries: CD HORIZON®,
Endo-Scrub®, Hydrodebrider®, Indigo™, Intelliflow®, IPC®, Legend®, Legend EHS®, Legend EHS Stylus©, Magnum®, Midas Rex®,
Mednext®, NIM®, NIM-ECLIPSE®, POWEREASE®, Skeeter®, SOLERA®, StraightShot®, Stylus Touch®, Triton®, TSRH® 3Dx™ , Visao® and
XPS®. 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.
GLOSSARY
The following words and acronyms may be used in this guide.
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, burts 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.
The system can be used to clear the end of a rigid rod endocscope in order to maintain good visualization of endoscopic procedures without
having to remove the scope from the surgical site.
This device is intended for use by physicians trained in the procedures described.
CONTRAINDICATIONS
The IPC system is contraindicated for arthroscopic microdiscectomy in individuals with the following:
• Severe/progressive neurological deficits
• Cauda equine syndrome
• Active infection.
Arthroscopic microdiscectomy is not indicated for individuals with sequestered disc fragments, discogenic pain, internal disc destruction, or
lumbago.
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 flammable anesthetics. Avoid potential ignition or explosion of gases.
W3 When not operating handpiece, eliminate accidental foot control activation. Control energy to and through the handpiece to prevent unintended tissue, bone,
or nerve resection.
W4 Disconnect power to the IPC system before cleaning the unit to avoid electrical macro shock.
W5 Do not attach unapproved components to the IPC system to avoid electrical macro shock.
W6 To avoid the risk of electrical shock, achieve electrical grounding reliability with proper connections. Connect the IPC system to hospital grade receptacles
only.
W7 This medical device complies with EN60601-1-2 safety standard for electromagnetic compatibility, requirements and test. However, if this equipment is
operated in the presence of high levels of electromagnetic interference (EMI) or highly sensitive equipment, interference may be encountered and the user
should take whatever steps are necessary to eliminate or reduce the source of the interference. Diminished performance may lengthen operating time for
anesthetized patient.
W8 Medical Electrical Equipment needs special Precautions regarding EMC and needs to be installed and put into service according to the EMC information
provided in this Guide.
W9 Portable and mobile RF communications equipment can affect Medical Electrical Equipment.
W10 Do not operate the IPC POWEREASE system in the presence of Magnetic Resonance Imaging devices.
W11 Use of accessories and cables other than those specified and sold by Medtronic may result in increased emissions and decreased immunity of this unit.
W12 The IPC system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the IPC system should be observed to
verify normal operation in the configuration in which it will be used.
W13 Do not attempt to run the IPC POWEREASE system handpiece immediately after autoclaving. Allow an adequate “cool down” period (Typically 1 hour).
W14 Consult the Legend Bone Mill product insert before use with the Integrated Power Console system.
W15 For metal transection, observe the following safety precautions:
W15a Eye wear protection is essential.
W15b Irrigate well to cool the cutting surfaces.
W15c Protect the wound site from metal debris.
W15d Use a clamp or grasping device to control loose fragments during transection of any metal component.
W16 Do not operate the IPC POWEREASE system without eye protection.
1-1
Component Warnings
W19 Do not use any parts other than Medtronic system components as damage or substandard performance could result.
W20 Always inspect the components before and after use for any damage. If damage is observed, do not use damaged part until it is repaired or replaced. Damaged
parts may deposit metal shavings on surgical site.
W21 When precise location of blade tip is required, engage the rotation lock on the handpiece, then calibrate and verify the blade tip on Image Guided Surgery
(IGS) system. Always lock M4 handpiece when driving non-rotatable blades to maintain their IGS calibration.
W22 Employ visualization, including use of imaging techniques (e.g., fluoroscopy, image guided surgery) when using rotating powered accessories. Discontinue
powered application in the event of lack of visualization of surgical site.
W23 Midas Rex Variable Exposure attachments. Surgeons should familiarize themselves with the performance of dissecting tools before use, and should explore the
effect of various levels of tool exposure on dissection stability. If the tool exhibits excessive chatter, vibration, or movement, decrease the tool exposure.
W24 Motors and attachments may fail due to extended use and allow a component to detach and fall from the motor or attachment, causing patient injury.
W25 Electrical contacts must be dry prior to use.
W26 Heavy side loads and/or long operating periods may cause the device to overheat.
W27 Do not use an overheated device, as it may cause thermal injury to the patient or operator.
W28 Use adequate irrigation. The use of a tool without irrigation may cause an inordinate amount of heat buildup resulting in a thermal injury to tissue. Depending
on the amount of irrigation used, the drill bits and saw blades can achieve temperatures in excess of 50°C.
W29 Do not attempt to change a dissecting tool, saw blade, or attachment while the motor is running, or when the motor or attachment is in an overheated
state.
W30 Do not immerse the system components, except as noted.
W31 Do not place motor, attachment and tool on the patient or in an unsecured location during surgery.
W32 A system that is not functioning properly should not be used until all necessary repairs have been made and the unit is tested to ensure that it is functioning in
accordance with Medtronic specifications.
W33 Match the nomenclature and color code on the tool packaging to the same nomenclature and color code on the Attachment.
W34 Make sure that the attachment is still in the locked position after each adjustment of the tool exposure, as attempting to increase the tool exposure too far,
may result in the attachment accidentally being unlocked.
W35 Midas Rex Legend EHS Motor and Midas Rex Legend EHS Stylus Motor should only be operated when the attachment is in the locked position.
W36 Smoke and/or excessive heat may be generated if attachment is not in the fully locked position. This may result in thermal injury to the surgeon or staff.
W37 The Indigo and Legend EHS motors will not run properly unless the attachment is in the locked position.
W38 DO NOT change accessory with handpiece running to prevent laceration of user and cross-contamination through compromised glove.
W39 Remove Legend Footed Attachments cautiously and slowly as per instructions to avoid injury to the operator.
W40 DO NOT modify accessories used with the handpiece. Performance could be diminished with modified accessories.
W41 The safe use of the Endo-Scrub 2 System in procedures where surgical lasers are also employed has not been clinically demonstrated.
W42 In order to ensure compliance with requirements of IEC 60601-1, use a Medtronic approved power cable.
W43 To avoid the risk of electric shock, this equipment must only be connected to a supply main with protective earth.
W44 Keep NIM Muting Probe cable away from IPC system cables.
W45 Verify reusable device was sterilized prior to use. If not sterilized, do not use.
Disposable Warnings
W46 Tools are available for resection of soft tissue and bone for surgical procedures. Use of tools depends on the intended application and patient needs. Sharp-
cutting powered tools induce bleeding and removal of significant tissue and bone.
W47 Use methods at the operative site to control bleeding that do not compromise patient safety during at-risk surgery.
W48 Always keep the cutting area of the tool/saw blade away from fingers and loose clothing. Prevent laceration of user and cross-contamination through
compromised glove.
W49 Operate the tool only after the appropriate anatomical landmarks and the intended surgical site have been confirmed.
W50 Use care in application of the moving cutting end to only appropriate anatomical landmarks and the intended surgical site when using powered accessories.
W51 Insertion of metal objects in accessory tip may cause the accessory to break leaving fragments in the wound. The fragments may be difficult to remove,
causing irritation, inflammation and foreign-body response at surgical site.
W52 Bending or prying may break the accessory, causing harm to patient or staff.
W53 Do not use excessive force to pry or push bone with the attachment, tool or blade during dissection.
W54 A tool’s size and geometry may create excessive vibration at certain speeds. Increase or decrease speed on console. Change to a new tool to prevent
unintended tissue removal from patient.
W55 Test for wobble at desired speed prior to use. Discontinue use of accessory if tip begins to wobble and replace accessory to prevent unintended tissue removal
from patient.
W56 Eccentricity of the tool can cause tool vibration and may result in excess tissue and bone destruction and hearing damage.
W57 Excessive noise from the tool when drilling close to the cochlea or ossicular chain may cause hearing damage.
W58 CONSULT the cranial perforator device labeling for the recommended speed specifications.
W59 Tools with “L” identification are longer tools intended for light bone dissection. The increased tool head/stem configuration may affect dissection stability.
W60 Tool flutes and blade teeth are sharp and may perforate surgical gloves. Tools/blades may be grasped with a hemostat to aid in installation and removal.
W61 DO NOT attempt to resharpen used tools. Worn tools should be replaced with new ones frequently to ensure effective cutting and control.
W62 Carefully inspect tool both prior to and following each use for signs of excessive wear, fragmentation, eccentricities or other defects. Replace any suspicious
tools with a new one prior to use.
W63 Excessive pressure applied to bur may cause bur fracture. Should a tool fracture in use, extreme care must be exercised to ensure that all fragments of the tool
are retrieved and removed from the patient. Unremoved tool fragments may cause tissue damage to the patient.
W64 Do not use metal-cutting tools on bone.
W65 Use only rotary tools specifically designed for use with this drill system.
W66 When using non-rotatable tools, ensure rotation lock is engaged to prevent inadvertent rotation.
W67 The use of powered reciprocating instruments may result in vibration / related injury.
W68 Powered blades should be operated in the oscillate mode only. Operating in the forward mode may cause damage to the blade.
W69 Do not attempt to sterilize disposable devices. The disposables are packed sterile and are not intended for repeat use. To prevent contamination, use only
once.
1-2
PRECAUTIONS
P1 PRIME/FLUSH Priming is a feature designed to purge air out of the tubing set(s) during setup. The first time a Prime or Flush button is pressed it will turn on
pump 1 and/or 2 long enough to purge air out of the tubing set(s). Turning power Off and On resets the PRIME feature. Once pressed all Prime buttons will
change to Flush buttons.
P2 To prevent damage to curved tools, disconnect suction tube prior to changing tool during procedure.
P3 When using an angled attachment, hold the handpiece assembly by the attachment so that the attachment does not inadvertently loosen from the
handpiece.
P4 For Legend tools only:
If a tool package is opened, but the tool is not used or contaminated, the tool can be re-sterilized. Remove tool from original packaging and place into an
approved autoclave package. Steam sterilize as follows:
High-Vacuum Steam 132°C for 5 minutes
Gravity Displacement 132°C for 15 minutes
The re-sterilized tool must be used promptly following re-sterilization. If rust or corrosion is encountered after re-sterilization, do not use the re-sterilized
tool.
P5 DO NOT run the 16-MF attachment with operating speed above 62,000 rpm. This may cause over heating and damage to internal gears of attachment.
P6 DO NOT use twist drill or Contra-Angle tool at an operating speed over 62,000 rpm.
P7 Do not attempt to disconnect the cable from the Midas Rex Legend EHS Stylus Motor.
P8 Do not kink cables. Inspect cables and pins for cracks, tears or corrosion.
P9 Do not use anti-fog on scope or sheath, as weeping or leaking may result.
P10 Disconnect cable from Midas Rex Legend EHS motor prior to sterilization.
P11 The use of a washer-disinfector for cleaning may cause a pre-mature degradation in performance.
P12 Remove devices from instrument case before placing into washer disinfector and allow devices to drain.
P13 Orient devices in the washer-disinfector by following manufacturer recommendations.
P14 DO NOT use low-temperature hydrogen peroxide gas plasma sterilization due to the lumen internal diameter and length restrictions.
P15 DO NOT use low-temperature liquid peracetic acid sterilization due to immersion procedure.
P16 DO NOT steam or EO sterilize the Legend Attachment Cleaning Nozzle.
P17 Remove and discard accessories following local regulations for proper disposal of contaminated materials.
P18 Disposable devices are for single-use only.
P19 Clean the motor and cable while still connected together. This will help to reduce ingress of debris.
P20 Use ONLY recommended cleaning agents.
P21 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.
P22 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.
P23 When using a Y-Splitter, only one Multifunction Foot Pedal shall be active at a time.
P24 Only one Y-Splitter shall be used at a time.
P25 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.
1-3
Physical Dimensions
Size 277 mm Width x 353 mm Height x 267 mm Depth
Weight 7.3 kg
Operational Environment
Temperature +10 °C to +33 °C
Humidity 30 % to 75 % RH
Barometric Pressure 700 - 1060 hPa
Transport and Storage Environment
Temperature -40 °C to +70 °C
Humidity 10 % to 95 % RH
Barometric Pressure 500 to 1060 hPa
Display / Touchscreen
Type High contrast, digital, graphic color, visible in complete darkness
Resolution Display 21 cm diagonal, resolution 480 X 640 pixels
Audio Output
Baseline Audio Sound Level 60 dBA minimum SPL (1 m)
Electrical
Input Voltage 100 V-240 V ± 10%
Frequency 50/60 Hz
Power Consumption 500 VA
Auxiliary AC output 200 VA Max.
Internal Fuse 5 x 20 mm T. L. 5 A, 250 V
Medtronic Xomed P/N 11270066
Duty Cycle for Applied Part Maximum On Time 120 Seconds
Minimum Off Time 180 Seconds
Power Cord Product Numbers
North America: United Kingdom, Continental Europe:
USA, Barbados, Belize, Bolivia, Canada, Ireland, Hong Kong, Malaysia, Singapore Austria, Belgium, Finland, France, Germany,
Colombia, Ecuador, Venezuela P/N EA606 or 1895821 Greece, Korea, Luxembourg, Netherlands,
Standard P/N EA600 or 1895820 Norway, Portugal, Spain, Sweden
6 meter P/N EA650 or 189721 P/N EA602 or 1895822
China India, South Africa Switzerland
P/N EA604 P/N EA607 P/N EA601
Argentina Israel Denmark
P/N EA608 P/N EA609 P/N EA610
Australia, New Zealand Japan Italy, Chile
P/N EA605 P/N EA603 or 1895823 P/N EA611
1-4
System Figures
Figure 1-1. IPC Console Front Figure 1-2. IPC Console Back
1
2
5
4
6 7 8
1-5
Figure 1-3. IPC Console Connector Panel Figure 1-4. Multifunction Foot Pedal & Y-Splitter
2
1 6
3
7 8
1 2 3 4 5 6 7 8 5
2
4
1
1 Legend EHS motor 4 Stimulus input from patient
interface (NIM or NIM-ECLIPSE)
3
2 Legend EHS Stylus motor 5 Stimulus output to stim bur
guard or POWEREASE 5
3 Spine shaver handpiece, 6 Skeeter handpiece 4
StraightShot M5 microdebrider,
StraightShot M4 microdebrider, 7 Endo-Scrub 2 finger switch,
1 Mode button 5 Foot pedal
StraightShot Magnum II Endo-Scrub 2 foot pedal,
microdebrider, StraightShot Intelliflow irrigation remote 2 Handpiece button 6 Y-Splitter
III microdebrider, Stylus Touch control
3 Control button 7 Port 1
motor, Visao drill, Indigo drill, 8 Multifunction foot pedal
Midas Rex microsaws, Triton drill 4 Slip-resistant foot pad 8 Port 2
1 Handpiece Name
Speed Mode Pump 1 Prime 1
60000
RPM
+ FWD
None Endo-Scrub® 2
2
REV
Acceleration 3
2
100
% +
Pump 2 Control
Finger Foot Both
0 +
cc/min
Prime
Pump 2 Prime
(Handpiece Name) 8
3
None
7 None Endo-Scrub® 2
4
M4
M4
Irrigation
Irrigation
4 EndoScrub 2
Pumps Flow
3 + 6
5 ?
On Setting Prime
Help
1 Displays active handpiece 5 Opens Help screen 1 Close Pumps screen 3 Pump 1 panel available
2 Accessory control panel 6 Irrigation accessory panel accessories
3 Foot pedal variable control 7 Inactive handpiece 2 Prime/Flush pump 4 Pump 2 panel available
accessories
4 Opens Pumps screen 8 Set active handpiece settings as
default settings
1-6
Figure 1-7. Operating Room Setup Figure 1-8. IPC System Configuration
3
2 5
4
1 6 1 2
10
9
7
8
9
5
Figure 1-9. IntelliFlow Remote Control
6
8
1
1-7
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.
1-8
1-9
1-10
Y-Splitter
Y-Splitter (Figure 1-4) allows using a maximum of two multifunction foot pedals connected to a single IPC (see P23 & P24). In this configuration,
the Y-Splitter shall be connected to the IPC, and the Multifunction Foot Pedal(s) shall be connected to the Y-Splitter. When connecting a single foot
pedal to the Y-Splitter, you may connect to either Port 1 or 2.
IntelliFlow Irrigation Remote Control
Use the IntelliFlow irrigation remote control (Figure 1-9) to start/stop and change irrigation flow while in the sterile field.
If you are using handpiece irrigation:
• To pause irrigation flow, press the Pause/On-Off button.
• To adjust flow rate, press the Fine Adjustment or Coarse Adjustment Increase/Decrease button.
If you are using the Suction Irrigator:
• To pause or turn on/off the Suction Irrigator, press the Pause/On-Off button.
• To adjust flow rate, press the Fine Adjustment Increase/Decrease button.
• To select the stainless steel tubing size (French size), press the Stainless Steel Tubing Size button.
1-11
Recommended separation distances between portable and mobile RF communications equipment and the IPC
The IPC is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the IPC can help
prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the IPC
as recommended below, according to the maximum output power of the communications equipment.
Rated maximum power Separation distance according to frequency of transmitter meters
of transmitter
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
W
d = 1.2√P d = 1.2√P d = 2.3√P
0.01 0.12 0.12 0.23
0.10 0.38 0.38 0.73
1.00 1.20 1.20 2.30
10.00 3.80 3.80 7.30
100.00 12.00 12.00 23.0
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated 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 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and
people.
1-12
Interference may occur in the vicinity of equipment marked with the following
symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
NOTE 3 When operating the IPC with Stylus Touch, the compliance level is 3 V/m except from 88 MHz to 91 MHz where it is 1 V/m. The formula for separation
distance for the IPC with Stylus Touch will be d = 3.5 √P in that frequency range.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the IPC is used exceeds the applicable RF compliance
level above, the IPC should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-
orienting or relocating the IPC .
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
1-13
1-14
BEFORE USE
Clean and sterilize the device, prior to first use. Refer to the Reprocessing Instructions contained in this manual for additional information.
TRITON AO/SYNTHES CHUCK AND TRINKLE CHUCK ASSEMBLY Figure 2-3. AO/Synthes Chuck and Trinkle
1. To install a drill bit, pull back on the attachment collar (Figure 2-3). Chuck Assembly
2. Insert the drill bit and release the attachment collar.
2-1
TRITON HUDSON AND ZIMMER CHUCK ASSEMBLY Figure 2-5. Hudson and Zimmer Chuck
To install an instrument, pull back on the attachment collar, then insert the male end of the instrument Assembly
into the chuck (Figure 2-5).
2-2
M
L
Figure 2-7. Triton Handpiece Safe and Run positions
M
L
L
L
SAFE: Turn trigger control to either side to lock RUN: Trigger control in the vertical position will
handpiece in SAFE mode. allow activation of the handpiece.
1 2
TRITON
FWD Speed
100
%
+
REV Speed
100
%
+
2-3
Reverse mode (regardless of what position the Mode select switch is in).
NOTE: The trigger control must be pressed to activate the handpiece, even
when you are stepping on the foot pedal. ON
3. Remove your foot from the pedal to return the handpiece to the mode
OFF
currently defined by the Mode select switch on the handpiece.
2-4
SUCTION IRRIGATOR
The following instructions for the Suction Irrigator are in addition to “Set up the IPC” general assembly instructions. Complete IPC setup, then
continue to the instructions below.
Figure 3-1. Suction Irrigator Figure 3-2. Suction Irrigator Adapter Kit
(1)
(3)
(2)
(4)
(5)
3-1
Figure 3-3. IPC General System Default Menu Figure 3-4.Handpiece Connection Screen
Suction Irrigator
Size Flow
8 IIIIIIIII
Fr + On +
3-2
ENDO-SCRUB 2
The following instructions for the Endo-Scrub 2 are in addition to “Set up the IPC” general assembly instructions. Complete IPC setup, then continue
to the instructions below. Refer to the Endo-Scrub 2 System Instructions for Use, Endo-Scrub Sheaths Instructions for Use and Endo-Scrub 2 Finger
Switch Instructions for Use for additional information.
The IPC System incorporates Endo-Scrub 2 functionality by using irrigation pump number one (1) and controlling operation with the touch screen
and an external foot pedal or finger switch.
DO NOT use the Endo-Scrub 2 for infusion, for disinfection or sterilization of an endoscope, or for suction removal of blood and debris.
Use the Endo-Scrub 2 sheath only with an endoscope listed on the sheath product label, as malfunction or poor performance could result.
Figure 4-1. Endo-Scrub 2 Finger Switch Figure 4-2. Endo-Scrub 2 Foot Pedal
(5)
(1)
(2)
(3)
(4)
ENDO-SCRUB 2 ASSEMBLY
1. Wet the endoscope.
2. Slowly, slide the approved endoscope into the Endo-Scrub 2 sheath (Figure 4-3).
3. Connect the irrigation tubing and a light source (Figure 4-4).
ENDO-SCRUB 2 ACTIVATION
Note: The procedure below also applies if using the multifunction foot pedal.
1. To activate the Endo-Scrub wash cycle, press and release the finger switch.
2. To initiate a continuous flow of irrigant, press and hold the finger switch.
CONNECT ENDO-SCRUB 2 TO IPC CONSOLE
1. Locate the Endo-Scrub 2 connector cover on the back of the IPC console (Figure 1-2). Figure 4-5. IPC Endo-Scrub 2 Connection Port
2. Insert a small screwdriver in the notch on the cable connector cover and pull.
3. Connect the control switch cable to the cable connector.
4. Connect the Endo-Scrub 2 finger switch (Figure 4-1) or the foot pedal (Figure 4-2) to the
console (Figure 4-5).
(1)
4-1
Figure 4-7. IPC General System Default Menu Figure 4-8.Handpiece Connection Screen
4-2
5 4
Figure 5-2. Spine Shaver (SC1) Assembly Figure 5-3. Spine Shaver (SC1) Assembly Figure 5-4. Spine Shaver (SC1) Assembly
5-1
Figure 5-5. Spine Shaver (SC1) Suction Irrigation Assembly Figure 5-6. Spine Shaver (SC1) Suction Irrigation Assembly
1 2
Forward Mode: Default, 12000 rpm; variable adjustment from 50 to 12000 rpm. SC1 Handpiece
Oscillate Mode: Default, 3400 cpm; variable adjustment from 50 to 5000 rpm. Speed Mode
• To adjust the irrigation flow rate, in the Pump control box, press the plus button to increase OSC
flow rate or the minus button to decrease flow rate. If intermittent flow is available, pressing 3400 +
CPM FWD
the plus or minus button progresses the system through intermittent and continuous flow. The
Blade Position
system displays Intermittent when in intermittent flow mode.
Forward Mode: Default, 30 cc per minute. 180°
• In oscillating mode only, you can use the Blade Position control box to do any of the
following:
To rotate the inner blade 180 0, press the delta button. 180º
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 finger wheel (Figure 5-1).
5-2
2 3 4
SPINE SHAVER (SC1) MULTIFUNCTION FOOT PEDAL Figure 5-10. Multifunction Foot Pedal & Y-Splitter
CONTROLS
Important: 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 2
change the default value. 1 6
Use the multifunction foot pedal (Figure 5-10) 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 3
pedal. 7 8
5
2
• To rotate the inner blade (1800) press the control button. 4
• To change the handpiece, press the handpiece button. 1
3
5
4
5-3
Figure 6-1. StraightShot M5 Handpiece Figure 6-2. StraightShot Magnum II and III Handpiece
1 2 3 2
5 4
Figure 6-3. Blade or Bur Assembly Figure 6-4. Blade or Bur Assembly Figure 6-5. Blade or Bur Assembly
6-1
Figure 6-6. Suction and Irrigation Assembly Figure 6-7. Suction and Irrigation Assembly
6-2
1 2
6-3
6-4
MULTIFUNCTION FOOT PEDAL CONTROLS Figure 6-14. Multifunction Foot Pedal & Y-Splitter
Important: 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.
2
To use the multifunction foot pedal (Figure 6-14) to control the handpiece do the 6
1
following:
3
5
4
6-5
6-6
Figure 7-1. Legend EHS Motor Figure 7-2. Legend EHS Stylus Motor
3
1 2
1 2
1 Rotating collet
2 Stationary collet
3 4-pin cable connection
3
Figure 7-3. Legend EHS Motor Cable Connection Figure 7-4. Disconnect Legend EHS Cable from Motor
2 1
7-1
Figure 7-6. Legend EHS Stylus Touchscreen Figure 7-7. Legend EHS or Legend EHS Stylus Mode Figure 7-8. Stylus Default Setting Menu
Mode Mode
FWD FWD
REV REV
7-2
LEGEND EHS AND LEGEND EHS STYLUS CLEANING AND STERILIZATION INSTRUCTIONS
Refer to documents M000030A234 and M000030A235 in the Cleaning and Sterilization section.
7-3
STYLUS TOUCH
The Stylus Touch (Figure 8-1) 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 finger lever that emulates the functions of the multifunction
foot pedal.
The following instructions for the Stylus Touch are in addition to “Set up the IPC” general assembly instructions. Complete IPC setup, then continue
to the instructions below.
1 2 3 4
6 5
CONNECT STYLUS TOUCH TO IPC CONSOLE Figure 8-3. Stylus Touch Connection Ports
Locate the Stylus Touch connection port on the connector panel (Figure 8-3)
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
1 2
and Prime Pumps” for more information.
Control operation of the Stylus Touch with the IPC touchscreen and the 1 Stylus Touch connection port
multifunction foot pedal. 2 Multifunction foot pedal connection port
8-1
Figure 8-4. Stylus Touch Touchscreen Figure 8-5. Stylus Touch Default Setting Menu Figure 8-6. Stylus Touch Safe Mode
Speed
SAFE +
RPM
Mode Mode
FWD FWD
REV REV
8-2
8-3
9 MH30
1 2 3 4 5 6
9-1
2. Insert the tool into the attachment with a slight rotational motion (Figure 9-6). An audible click, heard and perceptible by touch, confirms
that the tool is fully seated.
Figure 9-6. Straight Attachment Assembly
3. Rotate the attachment in the direction indicated by arrow until the attachment alignment mark is directly in line with the locked symbol
(Figure 9-7).You will hear two clicks as the attachment is rotated.
Figure 9-7. Straight Attachment Assembly
4. Gently pull on the tool to ensure that it is locked into the handpiece.
Note: Tool should rotate freely. If not, unlock the attachment, re-seat the tool, and re-lock the attachment.
9-2
3. Gently pull on the tool to ensure that it is locked into the handpiece.
Note: Tool should rotate freely. If not, unlock the attachment, re-seat the tool, and re-lock the attachment.
4. Slide the angled attachment over the motor collet aligning triangular arrows on the attachment and the motor case. An audible click, heard
and perceptible by touch, confirms that the tool is fully seated.
5. Rotate the attachment in the direction indicated by the arrow until attachment alignment mark is directly in line with the locked symbol.
You will hear two clicks as the attachment is rotated.
6. Verify that both the attachment to motor alignment mark and the tool lock alignment mark are directly in line with the locked symbol
(Figure 9-10).
Figure 9-10. Angled Attachment Assembly
2. Slide the footed attachment over the dissecting tool onto the motor aligning triangular arrows on the attachment and the motor case
(Figure 9-12).
Figure 9-12. Footed Attachment Assembly
3. Pull the footed attachment towards the motor and rotate the attachment to the locked position on the motor case (Figure 9-13).
Figure 9-13. Footed Attachment Assembly
9-3
2. To avoid injury from the dissecting tool, use thumb and index finger to cautiously and slowly lift the attachment off of the motor and away
from the dissecting tool (Figure 9-15).
Figure 9-15. Footed Attachment Disassembly
3. Pull the dissecting tool out of the motor collet and discard the tool (Figure 9-16).
Figure 9-16. Footed Attachment Disassembly
9-4
Figure 9-18. Contra-Angle Attachment Assembly Figure 9-19. Contra-Angle Attachment Assembly
9-5
4. Be sure that the TOOL Locking Ring is in the unlocked position. Insert the dissecting tool into the telescoping tube (Figure 9-23). Tactile
feedback is felt when the dissecting tool is fully seated.
Figure 9-23. Telescoping Straight Attachment Assembly
5. Turn the TOOL Locking Ring to the locked position (Figure 9-24).
9-6
Maximum Speed
Console Setting AD01 Output Speed (MAX) AD03 Output Speed (MAX)
60000 rpm 645 rpm 830 rpm
70000 rpm 745 rpm 965 rpm
72000 rpm 770 rpm 995 rpm
74000 rpm 790 rpm 1020 rpm
75000 rpm 805 rpm 1035 rpm
9-7
A
A
B
9-8
9-9
LEGEND EHS, LEGEND EHS STYLUS AND STYLUS TOUCH CLEANING AND STERILIZATION
INSTRUCTIONS
Refer to documents M000030A234, 68E4132 and M000030A235 in the Cleaning and Sterilization section.
Variable Exposure Attachment Cleaning
When cleaning, clean the attachment completely. First without adjusting the tube length, then with the tube fully extended, and finally with the
tube fully retracted.
9-10
The Skeeter does not use irrigation. By default, the system sets both pumps to None. (1) (2)
Control the operation of the Skeeter with the IPC touchscreen and the multifunction foot 1 Skeeter connection port
pedal. 2 Multifunction Foot Pedal connection port
Skeeter
SKEETER TOUCHSCREEN CONTROLS Speed Mode
To set or adjust Skeeter controls, on the IPC touchscreen, in the Skeeter control box (Figure
10-3), do the following: 16000 + RPM
FWD
• To change rotation mode, in the Mode control box, select FWD (forward) or REV REV
(reverse).
• To adjust speed, in the Speed control box, press the plus button to increase speed or
the minus button to decrease speed. +
Default, 16000 rpm; variable adjustment from 1000 to 16000 rpm.
following:
3
10-1
10-2
Visao Reusable Bur Guards with and without Visao Single Use Bur Guard with irrigation. Visao Single Use STIM Bur Guard with and without
irrigation. irrigation. The STIM Bur Guard also provides nerve
stimulation to standard burs in static and dynamic
modes when used with both the Medtronic Nerve
Integrity Monitor (NIM) and the IPC System.
11-1
11-2
Figure 11-6. IPC Visao Connection Port Figure 11-7. Visao Touchscreen
Visao
Speed Mode
80000
RPM
+ FWD
1 2 3 4 REV
VISAO MULTIFUNCTION FOOT PEDAL CONTROLS Figure 11-8. Multifunction Foot Pedal & Y-Splitter
Important: 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.
2
To use the multifunction foot pedal (Figure 11-8) to control the handpiece do 6
1
the following:
• To select Forward or Reverse mode, press the mode button.
• To start or adjust the speed of a handpiece in variable mode, press the foot 3
pedal. 7 8
5
2
• To toggle between the start/stop mode and variable speed mode, press the 4
control button. 1
Note: Functionality of the control button may be changed in the handpiece
Defaults menu to pause irrigation. Refer to Change System Settings in the 3
Pre-Operating Instructions section. 5
• To change the handpiece, press the handpiece button. 4
11-3
Indigo™
High-Speed Otologic Drill
2 3 4 5
6 Incorrect Alignment
Indigo™
High-Speed Otologic Drill
Important: The Indigo High-speed Otologic drill is designed to work only with Medtronic Xomed burs and Indigo attachments. The use of other
burs and attachments may result in sub-standard performance and will void the manufacturer’s warranty. Do not use with Midas Rex attachments
or burs.
1. Verify the alignment marks on the motor collet are in alignment (Figure 12-1).
Note: If the marks are misaligned, turn the collet until the marks are aligned.
2. Slide the attachment over the motor collet (Figure 12-2) so that the alignment mark on the attachment aligns with the alignment mark
(unlocked symbol) on the motor collet.
3. Insert the bur with a slight twisting motion until you feel it seat into position.
4. Turn the attachment so the alignment mark aligns with the locked symbol on the motor collet. You will hear two clicks while rotating the
attachment.
5. To ensure a secure fit, gently pull the tool.
Important: The Indigo motor will not run correctly unless the attachment is in the locked position.
Warning: Smoke may be generated if attachment is not in the locked position (W36).
Indigo™
High-Speed Otologic Drill
Indigo™
High-Speed Otologic Drill
12-1
Indigo™
High-Speed Otologic Drill
Indigo™
High-Speed Otologic Drill
12-2
1 2
• To change rotation mode, in the Mode control box, select FWD (forward) or REV (reverse).
Important: System configuration may be different from the default. If the REV (reverse)
Indigo
Speed Mode
button appears raised and does not have a selectable radio button (Figure 12-7), you
cannot select the Reverse mode. If the REV button appears concave (Figure 12-7) and has 60000 + FWD
a selectable radio button, you can select the Reverse mode via the touchscreen or the RPM REV
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. +
Pump 2
Default, 52000 rpm; variable adjustment from 200 to 60000 rpm in increments of 200, 500
30 +
and then 1000 until 60000. cc/min
Prime
Note: The speed you set remains constant when you switch between modes.
Warning: A tool’s size and geometry may create excessive vibration at certain speeds.
Increase or decrease speed on console. Change to a new tool to prevent unintended tissue Figure 12-7. Indigo Mode
removal from patient (W54).
Mode Mode
• To adjust the irrigation flow rate, in the Pump control box, press the plus button to increase FWD FWD
flow rate or the minus button to decrease flow rate. If intermittent flow is available, pressing
the plus or minus button progresses the system through intermittent and continous flow REV REV
of irrigation at 5, 10, 15 and 20 cc per minute. The system displays Intermittent when in
intermittent mode.
Default, 30cc per minute.
Note: To adjust flow rate, you can use the touchscreen or the IntelliFlow Irrigation remote control.
12-3
12-4
Figure 13-1. Foot-Controlled Microsaw Handpieces Figure 13-2. Finger-Controlled Microsaw (Microsaw Touch) Handpieces
7
1
6
1
2 5
2
5
3 4
2 Sagittal saw blade release button 5 Color band 1 Reciprocating saw collet 5 Color band
3 Oscillating saw head 2 Sagittal saw blade release button 6 Finger lever safe mode switch
3 Oscillating saw head 7 Finger lever
4 Oscillating saw collet
* Blade depth markings are approximate and should be used for reference only.
1 2
13-1
Figure 13-4. Sagittal Saw Assembly Figure 13-5. Blade Installation Angles
Figure 13-6. Oscillating Saw Assembly Figure 13-7. Oscillating Pin Alignment
3
2
13-2
1 2
13-3
Figure 13-11. Microsaws Touchscreen Figure 13-12. Finger-Controlled Microsaw Safe Mode
Speed
SAFE +
RPM
MICROSAW MULTIFUNCTION FOOT PEDAL CONTROLS Figure 13-13. Multifunction Foot Pedal & Y-Splitter
Important: By default, press each button on the foot pedal for at least 100 mS for
the selection to become active. Use the IPC Settings screen to change the default
value.
2
To use the multifunction foot pedal (Figure 13-13) to control the handpiece, do the 1 6
following:
• To start or adjust the speed of a handpiece in variable mode, press the pedal.
• To toggle between the start/stop mode and variable-speed mode, press the 3
7 8
control button. 5
2
Note: Functionality of the control button may be changed in the handpiece 4
1
Defaults menu to pause irrigation. Refer to Change System Settings in the Pre-
Operating Instructions section.
3
• To change the active handpiece, press the handpiece button.
Note: You can switch between finger-controlled handpieces by pressing the 5
finger lever on the handpiece. 4
13-4
Duty Cycle
≤ 20°C Ambient (one cut period = 20 seconds on / 20 seconds off )
Reciprocating: ≤ 15 cut periods1
Sagittal: ≤ 6 cut periods2
Oscillating: ≤ 4 cut periods3
Time for cool down after maximum number of cut periods listed above: 25 minutes.
15 periods with Light Force (0.8 Lbf ), 5 periods with Medium Force (2.1 Lbf ), 5 periods with Heavy Force (3.9 Lbf )
22 periods with Light Force (0.8 Lbf ), 2 periods with Medium Force (1.5 Lbf ), 2 periods with Heavy Force (3.0 Lbf )
31 period with Light Force (0.7 Lbf ), 2 periods with Medium Force (1.5 Lbf ), 1 period with Heavy Force (2.6 Lbf )
41 period with Light Force (0.8 Lbf ), 2 periods with Medium Force (2.1 Lbf ), 2 periods with Heavy Force (3.9 Lbf )
52 periods with Light Force (0.8 Lbf ), 2 periods with Medium Force (1.5 Lbf ), 2 periods with Heavy Force (3.0 Lbf )
61 period with Light Force (0.7 Lbf ), 1 period with Medium Force (1.5 Lbf ), 1 period with Heavy Force (2.6 Lbf )
13-5
(1)
DEVICE DESCRIPTION (8)
The IPC POWEREASE System is specifically designed for drilling, tapping, and driving screws
during spine surgery. (2)
The IPC POWEREASE system consists of a POWEREASE Driver (Figure 14-1) that is powered by the
IPC, along with the following POWEREASE driver compatible working end instruments: (3)
(7) (7)
(4)
• Taps
(5)
• Drill Bits
• Drivers
• Rod Cutter
• Post Cutter
• Set Screw Break-off Instrument (SSBO) (6)
The POWEREASE System and accessories are compatible with the following implant systems:
• CD HORIZON SOLERA Spinal System
• TSRH 3Dx Spinal System 1 Quick disconnect unlocked 5 Finger sensor trigger
2 Quick disconnect locked 6 NIM-ECLIPSE cable
3 Mechanized working collar connector
ASSEMBLE THE IPC locking pins (2)
4 Variable speed trigger
7 Mode select switch
8 Flat side indicators
Important: The manual start/stop button on the IPC console (Figure 1-2) does not function with
the POWEREASE driver.
Note: The POWEREASE driver does not use the IPC pump system. The pumps are available for use Figure 14-2. IPC POWEREASE Connection Ports
with other accessories requiring irrigation or cooling.
1. Verify the wheels are locked on the IPC cart.
2. Inspect all components for damage and determine if the system is ready for use.
3. Mount the IPC and irrigation/collant bags on the I.V. pole.
Important: Mount the irrigant and coolant bags above the IPC to ensure adequate flow.
4. Plug the IPC into the power source. Position the IPC so that it does not obstruct the power (1) (2) (3)
source for the purpose of disconnecting the Main voltage by the power cord. 1 POWEREASE connection 3 Stimulus output to
2 Stimulus input from NIM- POWEREASE
5. Locate the POWEREASE connection port on the IPC connector panel (Figure 14-2) and ECLIPSE
insert the connector from the POWEREASE driver.
6. If using the NIM-ECLIPSE with the IPC POWEREASE, assemble the IPC POWEREASE and the
NIM-ECLIPSE system.
7. Turn on the IPC and do the following:
• Verify the system passes the self-test.
• Verify the POWEREASE screen appears on the IPC monitor.
8. Confirm the IPC POWEREASE System Operation.
14-1
CLASSIC WORKING END ASSEMBLY AND OPERATION Figure 14-5. Classic Working End
NOTE: Please see the POWEREASE System Working Ends User’s Manual and IFU for a listing of
compatible working ends and further details regarding their proper use. Contact Customer
Service or your sales representative for the most up-to-date version of the package insert or
manual.
1. On the POWEREASE driver, pull back on and hold the quick disconnect to unlock the (1) (2) (3) (4)
collet (Figure 14-1, 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 14-5, 1) into the collet until fully seated.
Fully seated is on or near the drive shaft shoulder (Figure 14-6).
Note: If using a two sided shaft, align the flat sides on the drive shaft with the marks on 1 Four sided drive shaft 3 Drive shaft shoulder
the collet (Figure 14-1, 8). 2 Flat Side 4 Shaft
3. Release the quick disconnect to place the working end in the locked position (Figure
14-1, 2). Figure 14-6. Classic Working End Seating
4. To set the mode on the POWEREASE driver, rotate the mode select switch (Figure 14-3)
to Forward (F), Reverse (R), or Oscillate .
• 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.
5. To adjust the speed of the driver, increase pressure to increase speed or decrease pressure to decrease speed.
NOTE: The IPC touchscreen displays the maximum speed for the selected mode.
6. Reverse procedure to remove the classic working end accessory.
14-3
14-4
INTEGRATED POWER
C O N S O L E
POWEREASE®
IPC
BUR
2
EHS
NIM
7 3
6 12 9
10
NIM-ECLIPSE® System
68L2120 A
11 4
NIM-ECLIPSE® System
68L2125 A
NIM-ECLIPSE
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 Preamplifier Interface Cable 11 Controller
6 Preamplifier Module 12 Notebook Power Supply
14-5
A-1
A-2
Motor with attachment rotates, but an abnormal Bearings are worn. Change the attachment to isolate the location of the
noise is heard. problem.
Poor electrical connection. Check all connections from electrical source to
console.
Ensure motor and foot control cables are properly
connected.
Internal failure of motor, console, or cable. Change motor, console, or cable to isolate the failing
component.
Attachment not properly installed. Remove and reinstall the attachment and dissecting
tool.
Legend EHS, Legend EHS Stylus and Stylus Touch Attachments and Telescoping Tubes
Issue Possible Cause Action
Attachment or Telescoping Tube has Heat from worn attachment/tube DO NOT use. Try another attachment/tube.
uncomfortable temperature to touch/hold. bearings.
Telescoping Tubes are multi-use disposable. If problem
is resolved with a new Telescoping Tube, discard the
over-heated tube.
Attachment/tube unclean due to improper Check that appropriate cleaning procedures are being
cleaning procedures. followed.
Heavy side loading during dissection. Discontinue use and rest the attachment by using
intermittently, try another identical attachment or
wrap the attachment interface with a moist sterile
towel.
Attachment/telescoping tube is bent, loose, Attachment mishandled, failed due to extended DO NOT use. Dispose of telescoping tube. Telescoping
damaged or missing a component. use or excessive force applied during use. Tubes are multi-use disposable. Contact Customer
Service.
Color band on Attachment/Telescoping Tube fades Incorrect cleaning or sterilization method. Use nomenclature markings on the attachment to
or discolors. match with a corresponding dissecting tool or Contact
Customer Service.
Use of chlorine based or corrosive agents.
Aging. Telescoping Tubes are multi-use disposable.
Attachment has excess lubrication. Over lubrication during cleaning process. Visually inspect and wipe excess lubrication.
Footed attachment has a component missing from Attachment damaged by dissecting tool drilling DO NOT use. Contact Customer Service.
leg/foot area or foot is bent. out part or all of leg/foot area.
Bend caused by incorrect use.
16-MF contra-angle attachment is overheating. The contra-angle attachment operates by a set of If heat continues or is excessive, Contact Customer
internal gears to engage the drive shaft. It is normal Service.
for some heat to be generated approximately 2 cm
from the distal end of the attachment and at the
right of the angle head.
A-3
A-4
ERROR CODES
Code # Title Cause Description
1 MCB does not report that it booted within 5 seconds of AI telling it to start and System Error. Power off. Wait 10 seconds. Power on. If error persists, call
subsequent reattempts fail. Customer Service.
2 NOT USED. NOT USED. NOT USED
3 UI-MCB Com Failure - Max resends exceeded. System Error. Power off. Wait 10 seconds. Power on. If error persists, call
Customer Service.
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 stalled. Check tubing connection.
10 Pump 2 stalled (no transitions on opto sensor). Pump #2 stalled. Check tubing connection.
11 Unrecognized/damaged handpiece plugged in on port 1 (first 12 pin). Handpiece. Unplug handpiece and plug back in. If error persists, replace
handpiece.
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 stalled. Check accessory.
16 MCB motor overcurrent detected. Motor overcurrent. Unplug handpiece and plug back in. If error persists, replace
handpiece.
17 Unrecognized/damaged multifunction foot pedal plugged in. Foot Pedal When using foot pedal only, unplug foot pedal and plug
Connection error. back in. If error persists, replace foot pedal or switch to
manual control.
19 UI self test failure - culture (language) registry entry. Self Test Failed. Power off. Wait 10 seconds. Power on. If error persists, call
Customer Service.
20 UI self test failure - sector configuration registry entry.
21 UI self test failure - corrupt usage data file or unable to create usage data file.
22 NOT USED. NOT USED. NOT USED.
A-5
23 MCB non-specific self test failure. Self Test Failed. Power off. Wait 10 seconds. Power on. If error persists, call
Customer Service.
24 MCB self test failure - port 1.
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.
A-6
POST-OPERATIVE INSTRUCTIONS
Disconnect Accessory Cable from Console
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 (1). Remove these types of cable connectors straight
from the connector panel.
Warning: After disconnecting insulated connectors (see W79) 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.
B-1
Limitations Verify functionality prior to re-use, by connecting the handpiece to the IPC and pressing the trigger. Verify that the drive shaft rotates.
Point of Use Disconnect device from the IPC. Remove and discard disposables.
Containment and It is recommended that devices are reprocessed as soon as is practical following use.
Transportation
Preparation for Disconnect device from the IPC. Remove and discard disposables.
Decontamination
Recommended Washer Cycle Phase Recirculation Time Water Temperature Detergent Type and Concentration
Packaging For sterilization, place devices in instrument tray. Devices may be unwrapped, or wrapped with up to two layers of 1-ply polypropylene wrap
STERRAD Do not use low temperature hydrogen peroxide gas plasma sterilization due to lumen internal diameter and length restrictions.
Maintenance, Inspection • Inspect devices for any damage before and after each use. If damage is observed, do not use the device until it is repaired.
and Testing • Verify functionality prior to re-use.
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 0C (set point) Neutral enzymatic detergent, pH 6.0-8.0
Final Rinse 1 minute Hot tap water Not applicable
Cleaning: Manual • Wipe all external surfaces of the motor and cable 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 collet and motor with towel.
• Verify that devices are visually clean after manual cleaning.
• Rinse thoroughly with tap water.
Disinfection Follow hospital procedures.
Packaging For sterilization, place devices in instrument tray. Devices may be unwrapped, or wrapped with up to two layers of 1-ply polypropylene wrap.
Sterilization Steam Sterilization
(Temperatures are
minimum required, Cycle Gravity Pre-Vac Pre-Vac
times are minimum Temperature 132 0C 132 0C 134 0C
required)
Time 25 minutes 4 minutes 3 minutes
Drying 15 minutes 15 minutes 10 minutes
STERRAD Do not use low temperature hydrogen peroxide gas plasma sterilization due to lumen internal diameter and length restrictions.
STERIS Do not use liquid peracetic acid sterilization due to immersion procedure.
100% EtO Sterilization Parameters
Preconditioning 51-59 °C, 70 ±5 % relative humidity, 30 min.
Sterilization Temperature 51-59 °C
Relative Humidity 70 +/- 5 %
Ethylene oxide concentration 725 +/- 25 mg/L
Gas exposure time (full-cycle) 4 hours
Aeration 51-59 °C, 18 hours
Maintenance, • Inspect devices for any damage before and after each use. If damage is observed, do not use the device until it is repaired.
Inspection and • Verify functionality prior to re-use.
Testing
Storage Store with other sterile devices.
Additional 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 contacted patients suspected or confirmed with Transmissible Spongiform Encephalopathy (TSE)/ CJD diagnosis.
Point of Use This product is provided non-sterile and must be cleaned and sterilized before the first use and any reuse.
Containment and It is recommended that devices are reprocessed as soon as is practical following use.
Transportation
Preparation for Follow hospital procedures.
Decontamination
Cleaning: Review the washer-disinfector warning above, before using this cleaning method. Remove devices from instrument trays before placing into washer baskets.
Automated (Do Orient devices following recommendations of the washer/disinfector manufacturers. Verify that devices are visually clean after automated cleaning.
NOT use ultrasonic Recommended Washer Cycle Phase Recirculation Time Water Temperature Detergent Type and Concentration
washer)
Pre-Wash 2 minutes Cold tap water Not applicable
Wash 5 minutes 66 0C (set point) Neutral enzymatic detergent, pH 6.0-8.0
Rinse 1 minute Hot tap water Not applicable
Cleaning: Manual • 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.
Packaging For sterilization, place devices in instrument tray. Devices may be unwrapped, or wrapped with up to two layers of 1-ply polypropylene wrap.
Maintenance, • Inspect devices for any damage before and after each use. If damage is observed, do not use the device until it is repaired.
Inspection and • After cleaning and sterilization, verify functionality prior to re-use.
Testing
Storage Store with other sterile devices.
Additional 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 contacted patients suspected or confirmed with Transmissible Spongiform Encephalopathy (TSE)/ CJD diagnosis.
Cleaning: Manual • Soak in lukewarm (less than 43 °C), mild (pH 7.0 - 8.5), enzymatic detergent and deionized water for a minimum of 2 minutes.
• Then clean ultrasonically in lukewarm solution of mild detergent (less than 43 °C; pH 7.0 - 8.5) and deionized water for at least 10 minutes.
• Rinse thoroughly with deionized water and wipe dry.
• Following cleaning, apply a light coating of silicone spray or Pana Spray in the following manner: grasp the PTFE bearing and rotate the bur to assure application of the spray inside
the bearing.
Note: When using an ultrasonic cleaner or a spray washing machine, follow the manufacturer’s recommendations, particularly with regard to articulated instruments and positioning of
instruments.
Disinfection Do not cold soak in gluteraldehyde.
Packaging • A standard sterilization wrap may be used. In the US, an FDA approved surgical wrap is required. Ensure that the pack is large enough to contain the instrument without stressing the
seals.
• In sets: Instruments may be loaded into dedicated Medtronic Xomed instrument trays. Ensure that cutting edges are protected. Wrap trays using appropriate method.
Sterilization • 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
(Temperatures are assembly to maintain the sterility of the instrument(s).
minimum required; • All steam cycles have been validated in the wrapped configuration and can be sterilized wrapped or unwrapped.
times are minimum
required) Cycle Gravity Gravity Pre-Vac Pre-Vac (FR/WHO) Pre-vac (UK)
Temperature 121 °C 132 °C 132 °C 134 °C 134 °C
Time 30 minutes 10 minutes 4 minutes 18 minutes 3 minutes
Drying 15 minutes, or until visibly dry
STERRAD Not validated.
100 % EtO Sterilization Parameters
Conditioning in Chamber Sterilization
Temperature 54 +/- 2 °C Temperature 54 +/- 2 °C
Relative Humidity 60 +/- 5 % Relative Humidity 60 +/- 5 %
Vacuum Set Point 1.3 psia Ethylene Oxide Concentration 600 +/- 25 mg/L
Preconditioning Time 30 minutes Gas Exposure Time (full cycle) 120 minutes
Aeration 8 hours heated aeration at 48-52 °C or 24 hours aeration at ambient temperature
Maintenance, Discard any burs that shows signs of damage or wear.
Inspection and
Testing
Storage Store burs in a clean, dry area.
Additional 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
performed using validated equipment to achieve the desired result. This normally requires validation and routine monitoring of the process.
Some devices have specific assembly instructions. In this case, refer to the assembly insert provided with the device for additional instructions.
All validations performed per current AAMI TIR12, “Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers.”
Medtronic recommends incineration of devices that have directly contacted patients suspected or confirmed with Transmissible Spongiform Encephalopathy (TSE)/ CJD diagnosis.
Vacuum Set Point 1.3 psia Ethylene Oxide Concentration 600 +/- 25 mg/L
Preconditioning Time 30 minutes Gas Exposure Time (full cycle) 120 minutes
Maintenance, • Inspect components for any damage before and after each use. If damage is observed do not use the instrument until it is repaired.
Inspection and • After cleaning and sterilization, verify functionality prior to re-use.
Testing
Storage It is extremely important that the handpiece be rapidly and completely dried before storage to prevent corrosion and residue deposits in the bearing and motor.
Additional 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 contacted patients suspected or confirmed with Transmissible Spongiform Encephalopathy (TSE)/ CJD diagnosis.
Visao medtronic.com.
68E3281 F
Point of Use • This product is provided non-sterile and must be cleaned and sterilized before the first use and any reuse.
• To remove occasional residual buildup on handpiece cable connector, use a soft brush and isopropyl alcohol.
Containment and It is recommended that instruments are reprocessed as soon as is practical following use.
Transportation
Preparation for Remove the bur from the handpiece, otherwise disassembly is not required.
Decontamination
Cleaning: • Remove instruments and equipment from any sterilization trays before placing into washer baskets. Orient devices following recommendations of washer/
Automated disinfector manufacturers.
• Use alkaline or neutral pH detergent recommended by washer/disinfector or detergent manufacturers.
• These products have been validated for effective cleaning using an automatic washer/disinfector cycle consisting of a minimum 44 minutes total time,
including a pre-wash, main wash & rinse, and thermal rinse. The thermal rinse shall be at least 10 minutes long at a minimum temperature of 60°C.
Cleaning: Manual • After surgery, clean the irrigation sleeves and bur guards with an enzymatic detergent solution. Wipe the handpiece and cable with disinfectant applied to a
clean, non-abrasive cloth.
• A chuck brush cleaner (REF 3112500) or an appropriately sized small (plastic bristle) bore brush may be inserted into the distal end of the Visao handpiece,
irrigation sleeves and bur guards to assist in removing fluids, tissue, or bone fragments, making sure to clean all passages. Use an enzymatic detergent
solution to loosen and remove collected tissues from the unit.
• Rinse out the distal end of the handpiece. Shake excess water from the handpiece.
• Ensure all water is drained from the cooling housing. If saline was used for cooling during surgery, use distilled water to rinse the housing prior to
draining.
• Using distilled water, rinse saline from the irrigation nozzles. Drain the nozzle of all water.
• Sterilize the handpiece immediately after cleaning.
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
instrument without stressing the seals.
• In sets: Instruments may be loaded into dedicated instrument trays or general purpose sterilization trays. Wrap trays using appropriate method.
Sterilization The sterilization parameters given below should be used for devices that are fully disassembled when disassembly is possible. Use basic aseptic technique during
(Temperatures post-sterilization assembly to maintain the sterility of the instrument(s). All steam sterilization cycles have been validated in the wrapped configuration and
are minimum instruments can be sterilized wrapped or unwrapped.
required, times Steam Sterilization
are minimum
Cycle Gravity Pre-Vac Pre-Vac (FR/WHO) Pre-vac (UK)
required)
Temperature 121 0C 132 0C 134 0C 134 0C
Time 40 minutes 4 minutes 18 minutes 3 minutes
Drying 8 minutes, or until visibly dry
STERRAD 100S Compatible (Handpiece Only)
100% EtO Sterilization Parameters
Preconditioning
Sterilization Temperature 54-55 0C
Relative Humidity 60 +/- 5 %
Ethylene oxide concentration 600 +/- 25 mg/L
Gas exposure time (full-cycle) 120 minutes
Aeration 48-52 0C, 8 hours
Maintenance, • Inspect components for any damage before and after each use. If damage is observed do not use the instrument until it is repaired.
Inspection and • After cleaning and sterilization, verify functionality prior to re-use.
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 bearing
and motor.
Additional Increase temperatures higher than those stated when necessary to satisfy governmental or health care facility requirements so long as the temperature does not
Information exceed 149 °C. Heating above 149 °C may damage the handpiece and will void the warranty.
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 contacted patients suspected or confirmed with Transmissible Spongiform Encephalopathy (TSE)/ CJD diagnosis.
Point of Use This product is provided non-sterile and must be cleaned and sterilized before the first use and any reuse.
Containment and It is recommended that devices are reprocessed as soon as is practical following use.
Transportation
Preparation for Follow hospital procedures.
Decontamination
Cleaning: Use a cleaning agent that is suitable for use on aluminum surfaces. A neutral enzymatic to mild alkaline agent (pH 6.0 to 10.5) is preferred. If a washer-disinfector
Detergent is used, see the instructions supplied with the washer-disinfector machine to select the recommended cleaning agent.
Cleaning: • Remove devices from instrument trays before placing into washer baskets.
Automated (Do • Prior to cleaning, cover the drill cable connector end with Handpiece Cleaning Cap, catalog number 3318520.
NOT use ultrasonic • Orient devices following recommendations of the washer/disinfector manufacturers.
• After completion of the cleaning steps, remove Handpiece Cleaning Cap or other protective components prior to sterilization.
washer)
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 0C (set point) Neutral enzymatic to mild alkaline
detergent, pH 6.0-10.5
Rinse 1 minute Hot tap water Not applicable
Cleaning: Manual • Prior to cleaning, cover the drill cable connector end with Handpiece Cleaning Cap, catalog number 3318520.
• Wipe all external surface of the motor and cable with a cloth dampened with the detergent prepared with lukewarm tap water.
• Brush motor case and collet with a nylon brush dampened with a neutral enzymatic detergent.
• Rinse motor thoroughly under running water, collet end pointed down.
• Dry collet and motor with lint free towel
• After completion of the cleaning steps, remove Handpiece Cleaning Cap or other protective components prior to sterilization.
• Verify that devices are visually clean after manual cleaning
Packaging Place devices in instrument tray, and double wrap instrument case with 1-ply polypropylene wrap. In the US, an FDA approved surgical wrap must be used.
Maintenance, • Inspect components for any damage before and after each use. If damage is observed do not use the instrument until it is repaired.
Inspection and • After cleaning and sterilization, verify functionality prior to re-use.
Testing
Storage Store with other sterile devices.
Additional 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 contacted patients suspected or confirmed with Transmissible Spongiform Encephalopathy (TSE)/ CJD diagnosis.
Cleaning: Automated • All attachments must be thoroughly rinsed manually with tap water, ensuring all hard to reach areas are rinsed, prior to transfer to automatic washer for processing.
(Do NOT use ultrasonic • Remove devices from instrument trays before placing into washer baskets.
washer) • Orient devices following recommendations of the washer/disinfector manufacturers.
Recommended Washer Cycle Phase Recirculation Time Water Temperature Detergent Type and Concentration
Pre-Wash 2 minutes Cold tap water Not applicable
Wash 5 minutes 660C (set point) Neutral enzymatic to mild alkaline detergent,
pH 6.0-10.5
Rinse 1 minute Hot tap water Not applicable
Cleaning: Manual • Use the detergent, prepared with lukewarm tap water for the cleaning process.
• Thoroughly wipe the straight and angled attachments with a cloth dampened with the detergent.
• Wipe entire attachment until all gross soil has been removed.
• Using a brush wetted with the detergent, brush the attachments to clean the external surfaces and internal connecting surfaces.
• For the angled attachment: Wet an appropriately sized cleaning brush (Ø 2.4mm) with the detergent. Insert the brush into the bore at the front of the attachment. Brush
the bore to loosen debris trapped inside. Rinse the bore to remove debris.
• For the straight attachment: Wet an appropriately sized cleaning brush (Ø 2.4mm) with the detergent. Push the brush through the straight attachment from the rear to
front to loosen and remove debris trapped inside. Rinse bore to remove debris.
• Place one half of the straight or angled attachment into the detergent. Do not immerse the entire attachment. Gently agitate the attachments in the detergent and
actuate any moveable parts.
• Place the other half of the attachment into the detergent and repeat. Do not immerse the entire attachment.
• Rinse the attachment thoroughly with tap water. Flush both ends to remove detergent.
Drying and • Thoroughly dry the attachments. An air gun may be used on the straight attachment to blow moisture out from the rear to front.
Lubrication • Using an aerosol spray lubricant (such as Pana Spray), perform the following steps to lubricate attachments:
• Holding the can approximately 10-15 cm (3-6 inches) away from the attachment, spray all components that move, rotate, or slide with three quick squirts.
• Articulate movable components to ensure proper lubrication.
• Remove excess lubricant with a clean cloth.
Disinfection Follow hospital procedures.
Packaging Place devices in instrument tray, and double wrap instrument case with 1-ply polypropylene wrap. In the US, an FDA approved surgical wrap must be used.
Sterilization Steam Sterilization
(Temperatures are
minimum required, Cycle Gravity Pre-Vac Pre-Vac (FR/WHO) Pre-vac (UK)
times are minimum Temperature 132 0C 132 0C 134 0C 134 0C
required)
Time 25 minutes 4 minutes 18 minutes 3 minutes
Drying 20 minutes
STERRAD Not validated
100% EtO Sterilization Parameters
Preconditioning 55 0C, 70 % relative humidity, 30 minutes
Sterilization Temperature 55 0C
Relative Humidity 70 %
Ethylene oxide concentration 725 mg/L
Gas exposure time (full-cycle) 240 minutes
Aeration 53-57 0C, 18 hours
Maintenance, • Inspect components for any damage before and after each use. If damage is observed do not use the instrument until it is repaired.
Inspection and Testing • After cleaning and sterilization, verify functionality prior to re-use.
Storage Store with other sterile devices.
Additional Information None
Note: The instructions provided above have been validated by the manufacturer as being CAPABLE of preparing the product for re-use. It remains the responsibility of the processor to ensure that the reprocessing is
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 contacted patients suspected or confirmed with Transmissible Spongiform Encephalopathy (TSE)/ CJD diagnosis.
Containment and It is recommended that devices are reprocessed as soon as is practical following use.
Transportation
Cleaning: Automated • Prior to placing the saws in the automated washer, manually rinse the saw body with the distal end pointed down under tap water, until no visible soil is noticed.
(Do NOT use ultrasonic • Move any movable parts back and forth to allow water to reach hard-to-rinse areas.
washer) • Transfer the devices into the washer for processing, making sure that the oscillating saw collet is open. Place the devices in the washer to facilitate drainage.
• Verify that devices are visually clean after automated cleaning.
Recommended Washer Cycle Phase Recirculation Time Water Temperature Detergent Type and Concentration
Cleaning: Manual • Rinse the device thoroughly under running water, with the collet end pointed down.
• Wipe the saw body and cable with a cloth dampened with a neutral enzymatic detergent, pH 6.0-8.0 (henceforth referred to as “cleaning solution”).
• With the blade collet end pointed down, brush saw body, blade-release button, and extended lever tip (if applicable) with a nylon brush that has been dipped in cleaning
solution.
• Sagittal Only:
1. Dip the distal end of the saw in cleaning solution and agitate for 10-15 seconds.
2. Press and hold the blade-release button, then repeat step 1.
3. With the blade-release button pressed, flush approximately 15 mL of cleaning solution from a syringe into the blade opening.
4. Flush all ports with 15 mL of cleaning solution.
5. Repeat steps 1-4 using water instead of cleaning solution.
• Reciprocating Only:
1. With the distal end facing up, squeeze 30 mL of cleaning solution from a syringe into the distal end of the device so that the solution thoroughly reaches the inside of the
collet.
2. While the device is in the vertical position, rotate the collet knob back and forth three times.
3. Dump the solution from the device.
4. Repeat steps 1-3 a second time with cleaning solution.
5. Repeat steps 1-3 a third time with water.
• Rinse the device under running water, ensuring that water enters all ports/openings. Move any moveable parts to allow the solution to reach all areas. Rinse until there is no
visible evidence of soil or debris.
Drying and Lubrication • Dry the entire device with a lint-free towel.
• Reciprocating and Oscillating Only: If desired, complete the following steps using Pana Spray to lubricate the saw collet:
1. Holding the can approximately 10-15 cm (4-6 inches) away from the saw collet, spray into the hole of the shaft (reciprocating saw) or onto the proximal/bottom portion of the
collet near the locked/unlocked indicators (oscillating saw) with three quick squirts.
2. Articulate the collet to ensure proper lubrication.
3. Remove excess lubricant with a clean cloth.
Packaging For sterilization, place devices in instrument tray. Devices may be unwrapped, or wrapped with up to two layers of 1-ply polypropylene wrap.
STERRAD Do not use low temperature hydrogen peroxide gas plasma sterilization due to lumen internal diameter and length restrictions.
STERIS Do not use liquid peracetic acid sterilization due to immersion procedure.
Maintenance, • Inspect components for any damage before and after each use. If damage is observed, do not use the instrument until it is repaired.
Inspection and Testing • After cleaning and sterilization, verify functionality prior to reuse.
Containment and It is recommended that devices are reprocessed as soon as is practical following use.
Transportation
Preparation for Disconnect handpiece from console.
Decontamination
Cleaning: Manual • 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 flush 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.
Cleaning: The POWEREASE must undergo the manual cleaning process prior to processing in a washer/disinfector.
Automated (Do 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.
NOT use ultrasonic 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.
washer)
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 flush 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 0C (set point) Neutral enzymatic detergent, pH 6.0-8.0
Rinse 1 minute Hot tap water Not applicable
Packaging Steam sterilization may be performed wrapped or unwrapped. If wrapped, in the US, an FDA approved surgical wrap must be used.
Maintenance, • Inspect devices for any damage before and after each use. If damage is observed, do not use the device until it is repaired.
Inspection and • After cleaning and sterilization, verify functionality prior to re-use.
Testing
Storage Store with other sterile devices.
Additional 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 contacted patients suspected or confirmed with Transmissible Spongiform Encephalopathy (TSE)/ CJD diagnosis.
EMC Compliance Do Not Oil Do Not Immerse Caution: Federal law (USA) restricts this device to
Mark sale by or on the order of a physician.
Fuse
IPX1 Protected Against
Vertical Water Drops
Oscillate
EC REP Authorized Representative in the European
Community
Use By Date
IPX7 Protected Against The
Effects Of Temporary
F Forward Precaution: Pinch Hazard. Keep Fingers Clear Of
Rollers
Immersion In Water
DEHP
AC Power Start/Stop Foot Pedal Protective Earth
Connector
Non-Sterile Stim Bur Connector Right Foot Control RoHS - Environmental friendly use period - China
STERILE BUR Unit Button / (SJ/T11364-2006)
Control Button
Non-Sterile
Quantity NIM Console Connector Top Foot Control Do Not Dispose Of This Product In The Unsorted
NIM Unit Button / Municipal Waste Stream. Dispose Of This Product
Handpiece Button According to Local Regulations. See
Recycling.Medtronic.com for Instructions On
Proper Disposal Of This Product.
Not Greater Than Electrical High Speed Locked If the single use symbol is on the device label
>120 VAC
120vac EHS Handpiece Connector 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
Caution World Wide Standard Unlocked device and/or create a risk of contamination of the
Fr for Medical Tubing device, which could result in patient injury, illness,
Diameter or death.
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.
medtronic.com
manuals.medtronic.com