Medtronic AA07-R Instructions for Use

Instructions for Use
175040EN D

The Electric Stealth-Midas™ MR8™ System

Customer service

Contact your Medtronic Neurosurgery sales representative or call:

Medtronic Neurosurgery Service Group
[phone] or [phone]
[e-mail]

Outside the U.S.A., contact your Medtronic regional distributor or Medtronic Neurosurgery sales representative.

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The following are trademarks or registered trademarks of Medtronic, Inc. in the United States and other countries: Midas Rex®, Stealth-Midas™ MR8™, StealthStation™ S8,
IPC™, ClearView™, Legend™, and Synergy™. 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.

Contents

Glossary ..........................................................................................................................................................................................1

Indications for use ...................................................................................................................................................................... 1

Device description ..................................................................................................................................................................... 1

Contraindications ....................................................................................................................................................................... 1

Special notices ............................................................................................................................................................................. 1

Warnings ........................................................................................................................................................................................ 1

System ................................................................................................................................................................................... 1

System cables .....................................................................................................................................................................2

Tool and disposable components ............................................................................................................................... 3

Cautions ......................................................................................................................................................................................... 3

Electric Stealth-Midas MR8 motor ........................................................................................................................................ 4

Components........................................................................................................................................................................4

Connection to IPC .............................................................................................................................................................4

Multifunction foot control unit ....................................................................................................................................5

Technical specications ..................................................................................................................................................5

Guidance and manufacturer’s declaration - electrical safety EMC (electromagnetic compatibility) ..........6

Functional standards for electrical systems ............................................................................................................. 6

Part-1: Electromagnetic immunity .............................................................................................................................. 6

Part-1: Electromagnetic emissions .............................................................................................................................. 6

Recommended separation distances between portable and mobile RF communications equipment

and the MR8 system ......................................................................................................................................................... 7

Part-2: Guidance and manufacturer’s declaration – electromagnetic immunities ...................................7

MR8 dissecting tools and attachments .............................................................................................................................. 8

Straight attachment assembly .....................................................................................................................................8

Straight attachment disassembly ................................................................................................................................ 8

Angled attachment assembly ....................................................................................................................................... 9

Angled attachment disassembly ................................................................................................................................. 9

ClearView tool assembly ................................................................................................................................................. 10

ClearView tool disassembly ........................................................................................................................................... 10

Navigable dissecting tools and attachments .......................................................................................................... 11

Sterile sphere assembly ..................................................................................................................................................11

Navigation ............................................................................................................................................................................11

Troubleshooting .........................................................................................................................................................................11

System accessories: disposable components ..................................................................................................................12

Cleaning brushes ............................................................................................................................................................... 12

System accessories: non-disposable components ......................................................................................................... 12

Instrument tray...................................................................................................................................................................12

Rigid sterilization container (sterilization case) ...................................................................................................... 12

Electric Stealth-Midas MR8 system reprocessing instructions ...................................................................................13

Warnings and cautions .................................................................................................................................................... 13

Limitations on reprocessing .......................................................................................................................................... 13

Point of use .......................................................................................................................................................................... 13

Containment and transportation ................................................................................................................................ 13

Preparation for cleaning: automated ......................................................................................................................... 13

Cleaning: automated .......................................................................................................................................................14

Cleaning: manual...............................................................................................................................................................15

Disinfection .........................................................................................................................................................................16

Drying .................................................................................................................................................................................... 16

Maintenance, inspection, and testing .......................................................................................................................16

Packaging ............................................................................................................................................................................. 17

Sterilization .......................................................................................................................................................................... 19

Storage .................................................................................................................................................................................. 19

Use .......................................................................................................................................................................................... 19

Return policy for devices exposed to TSE (transmissible spongiform encephalopathies) .............................. 20

Planned maintenance ............................................................................................................................................................... 20

Storage ........................................................................................................................................................................................... 20

Disposal ..........................................................................................................................................................................................20

Limited warranty* ......................................................................................................................................................................20

Symbols .........................................................................................................................................................................................21

Glossary

Dissecting tool Disposable cutting tool that connects to Stealth-Midas MR8 motor
MR8 Midas Rex, 8th Generation
IPC Integrated Power Console, used to power the Electric Stealth-Midas MR8 motor
DK Double locking
FCU Foot Control Unit
FWD Forward - Rotation is clockwise
REV Reverse - Rotation is counter-clockwise

Electric Stealth-Midas™ MR8™ System

Indications for use

The Stealth-Midas MR8 System is indicated for the drilling, burring, and removal of hard tissue and bone in spinal and cranial surgical procedures. Computer-assisted
surgery and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is

indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone,

or vertebra, can be identied relative to a CT- or MR-based model, uoroscopic images, or digitized landmarks of the anatomy.

Device description

The Stealth-Midas MR8 is a powered drill that will remove hard tissue, bone, and biomaterials during surgical procedures. The permanently attached tracker will allow

for intraoperative navigation of spinal and cranial procedures using the StealthStation S8.

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

Contraindications

None.

Special notices

The words warning, caution, and note have special meanings in this manual, and should be carefully reviewed:

Warning: A warning indicates that the personal safety of the patient or physician may be involved. Disregarding this information could result in injury to the patient or physician.
Caution: A caution indicates that there is a risk of damaging equipment.

Note: A note is intended to provide additional information, which may be useful, but is not essential to complete the procedure.

Warnings

System

W1 The Stealth-Midas MR8 and its associated applications should be used only as an adjunct for surgical guidance. It is not a replacement for the surgeon’s

knowledge, expertise, or judgment.

W2 Operate the Stealth-Midas MR8 system only after appropriate anatomical landmarks have been identied and the intended surgical site has been conrmed.

Refer to the StealthStation S8 software IFU for instructions to complete these guidelines.
W3 Operate the Stealth-Midas MR8 system only after fully engaging the Secondary Lock.
W4 The tracker is permanently axed to the Stealth-Midas MR8 motor and should not be removed at any time.
W5 Do not apply force when verifying dissecting tools.
W6 The Stealth-Midas MR8 operator must be familiar with this Instructions for Use, Midas Rex MR8 Electric High Speed Drill System Instructions for Use, IPC User’s

Guide, ClearView Insert, StealthStation S8 Pocket Guide, and StealthStation S8 System Manual for their precautions, procedures, and safety issues.
W7 The Stealth-Midas MR8 System and its associated equipment should be used only by qualied medical professionals who are thoroughly trained and

experienced in performing surgery with Medtronic computer-assisted surgery systems.
W8 Always inspect the components before and after use for any damage. If damage is observed, do not use damaged component until it is repaired by Medtronic

or replaced.
W9 Use adequate irrigation during dissection to prevent thermal necrosis.
W10 Do not use an overheated device, as it may cause thermal injury to the patient or operator.
W11 Heavy side loads and/or long operating periods may cause the device to overheat. If overheating occurs:

W11a Never place an overheated motor on the patient or draping during the surgery.

W11b Discontinue use and rest the motor by using intermittently or wrap the motor/attachment interface with a moist sterile towel.

W11c If the motor is passed o, the receiver should grasp the motor by the proximal end close to the motor cable.
W12 Do not use excessive force to pry or push bone with the attachment or dissecting tool during surgery.
W13 Use only dissecting tools specically designed for use with this drill system. Match the nomenclature and color code on the MR8 dissecting tool packaging to

the same nomenclature and color band on the MR8 attachment.

Conrm that the dissecting tool packaging label has the Stealth-Midas MR8 logo ( ) if navigation is required.
W14 Do not use the Stealth-Midas MR8 system without proper cleaning and sterilization.
W15 Sterilize and dry reusable device before storing. Decrease likelihood of cross-contamination with timely sterilization. After each procedure, properly clean and

sterilize all reusable system components.
W16 All service must be performed by Medtronic qualied personnel only.
W17 Employ visualization, including use of imaging techniques (for example, uoroscopy, image guided surgery) when using rotating powered accessories

Discontinue powered application in the event of lack of visualization of surgical site.
W18 Do not attempt to remove a dissecting tool or attachment while the motor is running or when the motor or attachment is in an overheated state to prevent

laceration of user and/or cross contamination through compromised glove.
W19 Do not immerse the system components, except recommended by the cleaning instructions in this Instructions for Use.
W20 The Stealth-Midas MR8 motors will not run if the attachment is not in the fully locked position.
W21 Do not modify any components of the system. Performance could be diminished.

1

Electric Stealth-Midas™ MR8™ System

W22 Do not use a Stealth-Midas MR8 system if the motor continues to run after releasing the foot control unit.
W23 Do not place motor, attachment, or dissecting tool on the patient or in an unsecured location during surgery.
W24 Do not use an attachment and dissecting tool combination that results in tool ail or excessive vibration.
W25 Do not attempt to run the MR8 motors immediately after autoclaving. Allow an adequate cooling period after steam sterilization.
W26 Verify functionality prior to reuse.

W26a Conduct a visual inspection of the cables for cracks, tears, or corrosion.
W26b Check attachments for proper appearance. Install attachment and dissecting tool, then briey run motor.
W26c Check motor for overheating.
W26d Check attachment for overheating.
W26e Check dissecting tool for ail.
W26f Check for bent or missing pins in cable connectors.

W27 Do not place the electric Stealth-Midas MR8 motor in the proximity of a magnetic eld, such as magnetic drape or magnetic resonance imaging (MRI) equipment

to avoid inadvertent motor activation.

W28 The Stealth-Midas MR8 system complies with IEC/EN60601-1-2, ed. 3.0 and ed. 4.0 safety standard for electromagnetic compatibility (EMC), 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.

W29 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 system’s Instructions for Use.
W30 Portable and mobile radio frequency (RF) communications equipment can aect medical electrical equipment.
W31 Use of accessories other than those specied and sold by Medtronic may result in increased emissions and decreased immunity of this unit.
W32 Do not use any parts other than Medtronic system components, as damage or substandard performance could result.
W33 When using MR8 variable exposure attachments, surgeons should become familiar with the performance of dissecting tools before use and should explore the

eect of various levels of tool exposure on tool stability. If the tool exhibits excessive chatter, vibration, or movement, decrease the tool exposure.
W34 Motors and attachments may fail due to extended use resulting in component(s) detaching and falling from the motor or attachment, causing patient injury.
W35 Electrical contacts must be dry prior to use.
W36 Do not sterilize and supply for surgical use any device that is not visibly clean and free of particulates. If particulates are present, repeat reprocessing, starting

with the Preparation for Cleaning step.
W37 When using MR8 non-DK variable exposure attachments, ensure that the attachment is still in the locked position after each adjustment of the tool exposure.

Attempting to increase the tool exposure too far may result in the attachment accidentally being unlocked.
W38 Excessive side loading could cause non-DK angled attachments to unlock accidentally from motor.
W39 When not operating the motor, eliminate accidental foot control activation.
W40 Do not use the MR8 system in the presence of ammable anesthetics to avoid potential ignition or explosion of gases.
W41 Do not operate the MR8 system without eye protection.
W42 Remove navigation spheres from tracker and discard prior to cleaning and sterilization.
W43 Do not load more than one MR8 motor inside the instrument tray per sterilization cycle.
W44 Do not wrap the rigid sterilization container.
W45 Use the MR8 instrument tray and the rigid sterilization container for sterilizing the re-usable MR8 devices only.
W46 Do not use the instrument tray and sterilization container for cleaning or disinfection of the re-usable devices.
W47 Do not use alkaline cleaning for the instrument tray or the rigid sterilization container.
W48 Use the instrument tray and the rigid sterilization container for sterilization only. The MR8 system devices must be cleaned separate from the trays.
W49 Devices cannot be sterilized to an adequate Sterility Assurance Level (SAL) without prior cleaning and decontamination.
W50 The MR8 system operator should take appropriate measures in ensuring that sensitive anatomy is protected during drilling and use of the MR8 system.

System cables

W51 Do not use cables or power cables with cracks, tears, or corrosion.

Tool and disposable components

W52 Tool utes are sharp and may perforate surgical gloves. Tool stems may be grasped with a hemostat to aid in installation and removal. Use methods at the

operative site to control bleeding that do not compromise patient safety during surgery.
W53 Keep the cutting area of the tool away from ngers and loose clothing to prevent laceration of user and cross-contamination through compromised glove.
W54 A tool’s size and geometry may create excessive vibration at certain speeds. Increase or decrease speed of the motor to prevent vibration. Change to a new

tool to prevent unintended tissue removal from patient.
W55 Excessive noise from the tool when drilling close to the cochlea or ossicular chain may cause patient hearing damage.
W56 Dissecting tools are for single-use only. Do not attempt to sterilize them. The dissecting tools are packed sterile and not intended for repeat use. To prevent

contamination, use only once.
W57 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 removed from the patient. Unremoved tool fragments may cause tissue damage to the patient.
W58 Do not sterilize disposable devices. They are sterilized at the factory and are not intended for repeat use. To prevent contamination, use only once.
W59 Do not use an accessory if its packaging is opened or damaged. Sterility may be compromised if packaging is opened or damaged.
W60 Do not use dull tools. Use of dull tools can reduce cutting eectiveness and can cause the motor temperature to increase.
W61 Fluted tools are designed to be used in forward mode. Diamond tools may be used in forward or reverse modes.
W62 Exposure of tool packaging to ambient light for extended periods of time may cause damage to packaging.
W63 The MR8 system operator should take appropriate measures in ensuring that sensitive anatomy is protected during drilling and use of the MR8 system.
2

Electric Stealth-Midas™ MR8™ System

Cautions

C1 When using a non-DK angled attachment, hold the motor assembly by the attachment so that the attachment does not inadvertently loosen from the motor.
C2 Remove devices from instrument case before placing into washer-disinfector and allow devices to drain. Orient devices in the washer-disinfector by following

manufacturer recommendations.
C3 Do not use low-temperature hydrogen peroxide gas plasma sterilization due to the lumen internal diameter and length restrictions.
C4 Do not use low-temperature liquid peracetic acid sterilization due to immersion procedure.
C5 Remove and discard accessories following local regulations for disposal of contaminated materials.
C6 Do not soak or submerge MR8 system devices.
C7 Do not use ultrasonic cleaners for MR8 system devices.
C8 Do not use chlorine-based or corrosive cleaning agents such as bleach, lye, acetone, sodium hypochlorite or bleach, sodium hydroxide, formic acid, or

solutions containing glutaraldehyde.
C9 Use only nylon cleaning brushes. Non-nylon cleaning brushes leave residue that may prevent the tool from being secured properly in the motor.
C10 Do not expose these devices to sterilization temperatures greater than 137°C (279°F). Exposure to temperatures greater than 137°C (279°F) may impact the

performance of the device and also the ecacy of the sterilization cycle.
C11 Because of the variability in cleaning eciencies and sterilizer operating parameters, all given parameters (temperature, time, et cetera) should be validated by

persons who have training and expertise in sterilization processes. Deviation from the recommended sterilization processes is at the risk of the user facility.
C12 Remove devices from instrument case before placing into washer disinfector and allow devices to drain. Orient devices in the washer-disinfector by following

manufacturer recommendations.
C13 Devices should be cleaned within 30 minutes (30:00) of use to limit xation of contaminants.
C14 Do not remove tracker from the motor.

3

Electric Stealth-Midas™ MR8™ System

132

Mode

Mode

Electric Stealth-Midas MR8 motor

Components

The Electric Stealth-Midas MR8 motor (Figure 1) is a high speed, high torque,
navigable electric motor used to dissect bone and biomaterial at selectable
speeds from 200 to 75,000 rpm.

The following instructions for the Electric Stealth-Midas MR8 are in addition to the
general assembly instructions found in the IPC instructions for use. Complete IPC
setup, then continue to the instruction below.

IPC set up

The following instructions for the electric MR8 motors are in addition to the
general assembly instructions found in the Integrated Power Console User’s
Guide. To obtain a copy of the IPC User’s Guide, please contact Medtronic or
your local distributor.

Use an IPC device that has software version V2.7.3.0 or later, or update the
IPC device to the latest software by contacting your Medtronic Neurosurgery
Group sales representative. If outside the USA, contact your Medtronic regional
distributor or Medtronic Neurosurgery Group sales representative.

Connection to IPC

Locate the Electric Stealth-Midas MR8 connection port on the IPC connector
panel (Figure 2) and insert the connector.

Note: Refer to IPC User’s Guide for setup and more detailed instructions on

operation of IPC and touchscreen.

IPC touchscreen controls

To set or adjust the Stealth-Midas MR8 motor controls, on the IPC touchscreen
(Figure 3), in the control box, do the following:

Speed

• To adjust speed in Forward (FWD) or Reverse (REV) mode, in the Speed
control box, press the plus button to increase speed or the minus button to
decrease speed.

Irrigation

• To adjust the irrigation ow rate, in the Pump control box, press the plus button
to increase ow rate or the minus button to decrease ow rate. If intermittent
ow is available, pressing the plus or minus button progresses the system
through intermittent and continuous ow. The system displays Intermittent
when in intermittent ow mode.
Note: To adjust ow rate, you can use the touchscreen or the IntelliFlow
irrigation remote control.

• Default, 0cc per minute in Forward or Reverse mode

• For additional instructions see the IPC User’s Guide.

Acceleration and deceleration

• To adjust acceleration and deceleration, on the Defaults menu (Figure 3), press
the corresponding plus or minus button. Acceleration is the rate at which the
motor speeds up to reach the target speed. Deceleration is the rate at which
the motor slows down to reach the target speed or stop.
Note: While in the default menu, the motor will not be active to demonstrate the
selected acceleration and deceleration. To determine the desired values, adjust the
acceleration and deceleration during motor operation and note the preferred values.

• To enable adjustment of acceleration or deceleration during motor operation
and to display the acceleration and deceleration adjustment options on the
motor operational screen; On the Defaults menu, select Show On Screen
and then press [OK]. To hide the acceleration and deceleration during motor
operation, on the Defaults menu, deselect Show On Screen.

1

Electric Stealth-Midas MR8

1

5

1. IPC connection

2. Cable

2

1. Electric Stealth-Midas MR8 motor

2. Intelliow irrigation remote control

3. Foot control unit

3

4

IPC Connector Panel

Stealth-Midas MR8 touchscreen

3

3. Tracker

4. Secondary lock

2

5. Collet

Rotation (FWD and REV)

• To change rotation mode, in the Mode control box, select FWD (forward) or
REV (reverse).
Important: System conguration may be dierent from the default. If the REV
(reverse) button appears raised (Figure 4-1) and does not have a selectable radio
button, you cannot select the Reverse mode. If the REV button appears concave
(Figure 4-2) and has a selectable radio button, you can select the Reverse mode
via the touchscreen or the multifunction foot control unit.

• Conrm rotational direction on the IPC display prior to running a nger/foot
control system check.

4

4-1

REV button raised

IPC touchscreen

FWD

REV

4-2

IPC touchscreen

REV button concave

FWD

REV

Electric Stealth-Midas™ MR8™ System

2

Multifunction foot control unit

Note: Conduct a system check by pressing the foot control unit to briey run the motor and conrm proper function prior to any procedure.

Important: By default, press each button on the foot control unit for at least 100 mS for the selection to become active. Use the IPC touchscreen settings screen to

change the default value.

5

Multifunction foot control unit and y-splitter

1

1

3

5

4

To use the multifunction foot control unit (Figure 5) to control the motor, do the following:

• To select Forward or Reverse mode, press the mode button (Figure 5, Number 1).

• To start or adjust the speed of a motor in variable mode, press the foot control unit (Figure 5, Number 5).

• To toggle between the start/stop mode and variable speed mode, press the control button (Figure 5, Number 3).

Note: Functionality of the control button may be changed in the motor Defaults menu to pause irrigation. Refer to Change System Settings in the Pre-Operating
Instructions section of the IPC User’s Guide.

• To change the motor, press the motor button (Figure 5, Number 2).

Cleaning the multifunction foot control unit
For cleaning instructions refer to the section, Clean the multifunction foot control unit, in the Cleaning and sterilization section of the IPC User’s Guide.

5

4

2

1. Mode button

6

3

7

8

2. Motor button

3. Control button

4. Slip-resistant food pad

5. Foot control unit

6. Y-splitter

7. Port 1

8. Port 2

Technical specications

Table 1: MR8 electric touch technical specications

Electric Stealth-Midas MR8 motor (EM800N)

Size Weight Speed Duty cycle for applied part

Length: 16.5 cm x Diameter: 1.65 cm 130 grams 75,000 rpm forward/

reverse

For use in operating room temperatures up to 40°C (104°F), the Electric
Stealth-Midas MR8 motor is rated for 3 minutes at 75,000 rpm followed by
25 minutes of rest.

For normal operating room temperatures (typically 20°C/68°F), the Electric
Stealth-Midas MR8 motor is rated for cutting indenitely at 75,000 rpm.

5