Medtronic CA800 Instructions for Use

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Instructions for Use 175038EN B

The Midas Rex™ MR8™ Electric High-Speed Drill System

MR8 Electric, MR8 Electric Plus, and MR8 Electric Touch Motors

Customer service

Contact your Medtronic Neurosurgery sales representative or call:

Medtronic Neurosurgery Service Group (800) 335-9557 or (817) 788-6440 RS.DFWrepairs@medtronic.com

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: IntelliFlow™, IPC™, Legend™, Midas Rex™, and MR8™. 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 ................................................................................................................................................................................................................................................1

General information ........................................................................................................................................................................................................................1

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

MR8 system description .................................................................................................................................................................................................................1

MR8 electric motors .............................................................................................................................................................................................................1

MR8 attachments ..................................................................................................................................................................................................................1

MR8 surgical dissecting tools ...........................................................................................................................................................................................1

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

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

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

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

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

Tools and disposable components .................................................................................................................................................................................2

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

IPC set up .............................................................................................................................................................................................................................................4

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

IPC pump detection .............................................................................................................................................................................................................4

IPC touchscreen controls ...............................................................................................................................................................................................................4

Speed .........................................................................................................................................................................................................................................4

Irrigation ...................................................................................................................................................................................................................................5

Acceleration and deceleration .........................................................................................................................................................................................5

Rotation (FWD and REV) .....................................................................................................................................................................................................5

Safe mode (SAFE) ..................................................................................................................................................................................................................5

MR8 electric and electric plus motors .......................................................................................................................................................................................7

Multifunction foot control unit ........................................................................................................................................................................................7

Technical specications ......................................................................................................................................................................................................7

MR8 electric touch motors ............................................................................................................................................................................................................8

Finger lever controls ............................................................................................................................................................................................................8

Guidance and manufacturer’s declaration - electrical safety EMC (electromagnetic compatibility) ................................................................9

Functional standards for electrical systems ................................................................................................................................................................9

Part-1: Electromagnetic immunity ..................................................................................................................................................................................9

Part-1: Electromagnetic emissions ..................................................................................................................................................................................10

Recommended separation distances between portable and mobile RF communications equipment and the MR8 system .....10

Part-2: Guidance and manufacturer’s declaration – electromagnetic immunities .......................................................................................10

Assembly ..................................................................................................................................................................................................................................11

Tool nomenclature ................................................................................................................................................................................................................11

MR8 attachments..............................................................................................................................................................................................................................14

Straight attachments ...........................................................................................................................................................................................................15

Angled attachments ............................................................................................................................................................................................................16

Variable exposure straight and angled attachments ...............................................................................................................................................17

Angled double lock (DK) attachments ..........................................................................................................................................................................17

Fixed footed attachments ..................................................................................................................................................................................................18

Rotating footed attachments ...........................................................................................................................................................................................20

Metal cutting attachments ................................................................................................................................................................................................21

Telescoping attachments and tubes ..............................................................................................................................................................................22

Perforator driver attachments ..........................................................................................................................................................................................23

Jacobs chuck attachments.................................................................................................................................................................................................24

J-latch attachments ..............................................................................................................................................................................................................25

Irrigation tubing set .............................................................................................................................................................................................................25

System accessories: disposable components ........................................................................................................................................................................26

Cleaning brushes...................................................................................................................................................................................................................26

System accessories: non-disposable components ..............................................................................................................................................................26

Instrument trays ....................................................................................................................................................................................................................26

Rigid sterilization containers (sterilization cases) ......................................................................................................................................................27

MR8 system reprocessing instructions .....................................................................................................................................................................................27

Warnings and cautions........................................................................................................................................................................................................27

Limitations on reprocessing ..............................................................................................................................................................................................27

Point of use ..............................................................................................................................................................................................................................27

Containment and transportation ....................................................................................................................................................................................27

Preparation for cleaning: automated .............................................................................................................................................................................28

Cleaning: automated ...........................................................................................................................................................................................................29

Cleaning: manual ..................................................................................................................................................................................................................30

Disinfection .............................................................................................................................................................................................................................31

Drying ........................................................................................................................................................................................................................................31

Maintenance, inspection, and testing ...........................................................................................................................................................................31

Packaging .................................................................................................................................................................................................................................32

Sterilization ..............................................................................................................................................................................................................................34

Storage ......................................................................................................................................................................................................................................34

Use ..............................................................................................................................................................................................................................................34

Return policy for devices exposed to TSE (transmissible spongiform encephalopathies) ....................................................................................35

Planned maintenance .....................................................................................................................................................................................................................35

For scheduled maintenance intervals 1, 2, 3, 5, 6, 7, 9, 10, and 11 ......................................................................................................................35

For scheduled maintenance intervals 4, 8, 12 ............................................................................................................................................................36

Disposal ................................................................................................................................................................................................................................................36

Troubleshooting ...............................................................................................................................................................................................................................36

MR8 motor ...............................................................................................................................................................................................................................36

MR8 attachments or telescoping tubes ........................................................................................................................................................................37

MR8 dissecting tools ............................................................................................................................................................................................................37

Medtronic Midas Rex MR8 electric high speed systems limited warranty* ................................................................................................................38

Symbols ................................................................................................................................................................................................................................................39

The Midas Rex MR8 electric high-speed drill system

Glossary

The following words and acronyms may be used in this guide.

DK Double locking FCU Foot Control Unit FWD Forward - Rotation is clockwise IPC Integrated Power Console MR8 Midas Rex, 8th Generation REV Reverse - Rotation is counter-clockwise

General information

Read and understand this manual before use of the MR8 system. The MR8 system is designed for use by medical professionals familiar with powered surgical instrumentation. The surgeon is responsible for learning the proper techniques in the use of this system, as inappropriate use may potentially be harmful. It is strongly recommended that the surgeon and dedicated operating room personnel are knowledgeable with the use of this equipment by being trained in Medtronic Midas Rex Hands-On Workshops or by one of the local authorized representatives.

Indications for use

The Medtronic MR8 drill system is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials in Neurosurgical (Cranial and Craniofacial including Craniotomy); Ear, Nose, and Throat (ENT), Maxillofacial, Orthopedic, Arthroscopic, Spinal, Sternotomy, and general surgical procedures.

Additionally, the MR8 drill system is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials during open and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures:

• Lumbar Microdiscectomy • Transforaminal Lumbar Interbody Fusion (TLIF)

• Lumbar Stenosis Decompression • Anterior Lumbar Interbody Fusion (ALIF)

• Posterior Lumbar Interbody Fusion (PLIF) • Direct Lateral Interbody Fusion (DLIF)

MR8 system description

MR8 electric motors

Electric motors provide power to operate interchangeable, disposable surgical dissecting tools. These motors are designed to interface with a series of attachments and surgical dissecting tools utilizing a standard quick-disconnect locking mechanism. Motors operate in the same manner whether controlled by a nger mechanism or FCU.

MR8 attachments

Attachments are designed to align the surgical tools with the motor to provide support and stability during various surgical procedures. Attachment options include regular (straight, and angled), variable exposure (straight and angled), footed (craniotomes), and telescoping attachments and tubes. There are a variety of specialty attachments, such as the perforator, Jacobs chuck, J-latch, and metal cutting that are also available. This allows exibility with the length and style of attachment for surgeries.

MR8 surgical dissecting tools

Surgical dissecting tools are designed and intended to resect, drill, or saw soft and hard tissue, bone, biomaterials, and metals during various surgical procedures. The surgical dissecting tools vary in length and the distal tips of the tools vary in shape and style. The tip designs include the following universal shapes: acorn, match head, ball or round, cylinder, oval, and tapered or side-cutting. Specialized tools such as metal cutters, twist drills, hole-makers, hole saws, and reverse tapered tools are also available.

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 user. 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 MR8 system operator must be familiar with this Instructions for Use, the IPC User’s Guide, their precautions, procedures, and safety issues. W2 The 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. W3 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. W4 Use adequate irrigation during dissection to prevent thermal necrosis. W5 Do not use an overheated device, as it may cause thermal injury to the patient or operator. W6 Heavy side loads and/or long operating periods may cause the device to overheat.

W6a Never place an overheated motor on the patient or draping during the surgery.

W6b Discontinue use and rest the motor by using it intermittently or wrap the motor/attachment interface with a moist sterile towel.

W6c If the motor is passed o, the receiver should grasp the motor by the proximal end close to the motor cable. W7 Do not use excessive force to pry or push bone with the attachment or dissecting tool during surgery. W8 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. W9 Do not use the MR8 system without proper cleaning and sterilization. W10 Sterilize and dry the reusable device before storing. Decrease the likelihood of cross-contamination with timely sterilization. After each procedure, properly

clean and sterilize all reusable system components. W11 All service must be performed by Medtronic qualied personnel only.

The Midas Rex MR8 electric high-speed drill system

W12 Employ visualization, including the use of imaging techniques (for example, uoroscopy, image guided surgery), when using rotating powered accessories.

Discontinue the powered application if visualization to the surgical site is lost.

W13 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 the user and/or cross contamination through a compromised glove. W14 Do not immerse the system components, except when recommended by the cleaning instructions in this Instructions for Use. W15 The MR8 motors will not run unless the attachment is in the locked position. W16 Do not modify any components of the system; performance could be diminished. W17 Do not use the MR8 system if the motor continues to run after releasing the foot pedal or nger lever. W18 Do not place the motor, attachment, or dissecting tool on the patient or in an unsecured location during surgery. W19 Do not use an attachment and dissecting tool combination that results in tool ail or excessive vibration. W20 Do not attempt to run the MR8 motors immediately after autoclaving. Allow an adequate cooling period after steam sterilization. W21 Verify functionality prior to reuse:

W21a Conduct a visual inspection of the cables for cracks, tears, or corrosion.

W21b Check attachments for proper appearance. Install the attachment and dissecting tool, then briey run the motor.

W21c Check motor for overheating.

W21d Check attachment for overheating.

W21e Check dissecting tool for ail.

W21f Check for bent or missing pins in the cable connectors. W22 Do not place MR8 motor in the proximity of a magnetic eld, such as magnetic drape or Magnetic Resonance Imaging (MRI) equipment, to avoid inadvertent

motor activation. W23 The 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. W24 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. W25 Portable and mobile radio frequency (RF) communications equipment can aect medical electrical equipment. W26 Use of accessories other than those specied and sold by Medtronic may result in increased emissions and decreased EM immunity of this unit. W27 Do not use metal-cutting attachment or tools to cut/resect bone. W28 For metal transection, observe the following safety guidelines:

W28a Wear eye protection.

W28b Irrigate well to cool the cutting surfaces.

W28c Protect the wound site from metal debris.

W28d Use a clamp or grasping device to control loose fragments during transection of any metal component. W29 Do not use any parts other than Medtronic system components, as damage or substandard performance could result. W30 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. W31 Motors and attachments may fail due to extended use resulting in component(s) detaching and falling from the motor or attachment and may cause patient injury. W32 Electrical contacts must be dry prior to use. W33 When using the 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. W34 Remove MR8 footed attachments cautiously and slowly, as per instructions to avoid injury to the operator. W35 Excessive side loading could cause non-DK angled attachments to unlock accidentally from motor. W36 Place MR8 touch motor in Safe mode (“0”) while not in use. W37 When not operating the motor, eliminate accidental foot control activation. W38 Do not use the MR8 system in the presence of ammable anesthetics to avoid potential ignition or explosion of gases.

W39 Do not operate the MR8 system without eye protection. W40 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.

W41 Do not load more than one MR8 motor inside the instrument tray per sterilization cycle. W42 Do not wrap the rigid sterilization container. W43 Use the MR8 instrument tray and the rigid sterilization container for sterilizing the re-usable MR8 devices only. W44 Do not use alkaline cleaning for the instrument tray or the rigid sterilization container. W45 Use the instrument tray and the rigid sterilization container for sterilization only. The MR8 system devices must be cleaned separate from the trays. W46 Do not use the instrument tray and rigid sterilization container for cleaning or disinfection of the re-usable devices. W47 Devices cannot be sterilized to an adequate Sterility Assurance Level (SAL) without prior cleaning and decontamination.

System cables

W48 Do not use cables or power cables with cracks, tears, or corrosion.

Tools and disposable components

W49 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. W50 Keep the cutting area of the tool away from ngers and loose clothing to prevent laceration of the user and cross-contamination through a compromised glove. W51 A tool’s size and geometry may create excessive vibration at certain speeds. Increase or decrease the speed of the motor to prevent vibration. Change to a new

tool to prevent unintended tissue damage. W52 Excessive noise from the tool when drilling close to the cochlea or ossicular chain may cause patient hearing damage. W53 Consult the cranial perforator manufacturer device labeling for the recommended speed specications. W54 Tools with “L” identication are longer tools intended for light bone dissection. The increased tool head/stem conguration may aect dissection stability. W55 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.

The Midas Rex MR8 electric high-speed drill system

W56 Excessive pressure applied to a tool may cause tool fracture. Should a tool fracture in use, extreme care must be exercised to ensure that all the fragments of

the tool are removed from the patient. Unremoved tool fragments may cause tissue damage to the patient. W57 Do not sterilize disposable devices. They are sterilized at the factory and are not intended for repeat use. To prevent contamination, use only once. W58 Do not use an accessory if its packaging is damaged or opened outside the sterile eld. Sterility may be compromised if packaging is opened or damaged. W59 Do not use dull tools. Use of dull tools can reduce cutting eectiveness and can cause the motor temperature to increase. W60 Fluted tools are designed to be used in forward mode. Diamond tools may be used in forward or reverse modes. W61 Exposure of tool packaging to ambient light for extended periods of time may cause damage to packaging. W62 The MR8 system operator should take appropriate measures in ensuring that sensitive anatomy is protected during drilling and use of the 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 Do not use a twist drill at an operating speed over 62,000 rpm. C3 Remove devices from instrument tray before placing into washer-disinfector and allow devices to drain. Orient devices in the washer-disinfector by following

manufacturer recommendations. C4 Do not use low-temperature hydrogen peroxide gas plasma sterilization due to the lumen internal diameter and length restrictions. C5 Do not use low-temperature liquid peracetic acid sterilization due to immersion procedure. C6 Remove and discard accessories following local regulations for disposal of contaminated materials. C7 Do not soak or submerge MR8 system devices. C8 Do not use ultrasonic cleaners for MR8 system devices. C9 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. C10 Use only nylon cleaning brushes. Non-nylon cleaning brushes leave residue that may prevent the tool from being secured properly in the motor. C11 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. C12 Because of the variability in cleaning eciencies and sterilizer operating parameters, all given parameters (temperature, time, etcetera) 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. C13 Devices should be cleaned within 30 minutes (30:00) of use to limit xation of contaminants.

The Midas Rex MR8 electric high-speed drill system

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 MR8 motors, and Foot Control Unit (FCU) ports on the IPC connector panel (Figure 1) and insert the multi-pin 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.

IPC console connector panel for the MR8 system

1. MR8 electric, MR8 electric plus, and MR8 electric touch motors

2. Intelliow irrigation remote control

3. Foot control unit

IPC pump detection

The IPC incorporates the MR8 electric, MR8 electric plus, and MR8 electric touch motor irrigation at Pump 1. If you do not use irrigation for the MR8 motors, manually change Pump 1 to None. Refer to the IPC User’s Guide, Set up and Prime Pumps for more information.

When the system detects the MR8 electric or MR8 electric plus motor, Pump 2 defaults to None. When the IPC detects both the MR8 electric or MR8 electric plus motor, the system defaults Pump 2 to the Shared conguration. Use the pumps screen to override

the Shared default by selecting the MR8 electric motor for Pump 1. Refer to the IPC User’s Guide, Set up and Prime Pumps for more information. Control the operation of the MR8 electric, MR8 electric plus and MR8 electric touch motors with the IPC touchscreen and the multifunction foot control unit.

IPC touchscreen controls

To set or adjust the MR8 electric (Figure 2-1), the MR8 electric plus (Figure 2-2), or MR8 electric touch (Figure 2-3) motor controls, on the IPC touchscreen, in the control box, do the following:

2-1

IPC MR8 electric touchscreen IPC MR8 electric plus touchscreen IPC MR8 electric touch touchscreen

2-2

2-3

Speed

• The MR8 electric, MR8 electric touch, and MR8 electric plus motors have a default speed of 75,000 rpm and a variable speed adjustment of 200 to 75,000 rpms.

• 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.

Note: When the MR8 electric touch motor is in safe mode, the Speed control box displays SAFE (Figure 4). Refer to the Safe mode (SAFE) topic for additional information.

The Midas Rex MR8 electric high-speed drill system

Mode

Irrigation

• To adjust the irrigation ow rate, in the irrigation 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.

• The default ow rate is 0cc per minute in the 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 2-1, 2-2, and 2-3), 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.

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 3-1) and does not have a selectable radio button, you cannot select the Reverse mode. If the REV button appears concave (Figure 3-2) 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.

3-1

IPC touchscreen

REV button raised

FWD

REV

3-2

IPC touchscreen

REV button concave

FWD

REV

Safe mode (SAFE)

• The MR8 electric touch motor comes with a safe mode option. When the motor is in safe mode, it is inoperable until the safety is turned o. The Speed control

box on the IPC touchscreen displays SAFE when the MR8 electric touch motor is the active motor and set to safe mode (Figure 4).

• Switch the device to safe mode any time it is attached to the console, but not currently being used. To set the motor to safe mode, on the MR8 electric touch

motor, switch the safe mode switch to o (Figure 5).

• When more than one motor is attached to the console, use the safety switch of an inactive motor to activate that motor and make it ready for use.

IPC MR8 electric touch motor

safe mode (SAFE) touchscreen

Speed

SAFE

RPM

Finger lever switched to safe mode on the MR8 electric touch motor

The Midas Rex MR8 electric high-speed drill system

MR8 electric motors

The MR8 electric motor (Figure 6) is a smaller and more compact version of the MR8 electric plus motor (Figure 7). The MR8 electric touch motor (Figure 8) is a small compact motor that includes a rotating and removable nger lever.

The MR8 electric motors are high-speed, high-torque, reversible electric motors used to dissect bone and biomaterial at selectable speeds from 200 to 75,000 rpm. These motors are designed to interface with a series of interchangeable attachments and dissecting tools utilizing a standard locking mechanism. The MR8 electric motors provide the power to operate disposable surgical dissecting tools, intended for use in various surgical procedures.

The MR8 electric motors can be controlled either by using the FCU or through the nger control mechanism. The nger-controlled electric motors operate in the same manner as the foot-controlled electric motors. Pressing the nger control increases the speed and lifting o of the nger control reduces the speed to a stop. The electric motors are reusable devices that are supplied non-sterile and require cleaning and sterilization prior to each surgical use.

Note: All motor cables are integrated and cannot be removed from the motor.

1 2

1. Stationary collet

2. Rotating collet

MR8 electric motor MR8 electric plus motor

1 2

3. 12-pin cable connector 1. Stationary collet

2. Rotating collet

3. 12-pin cable connector

MR8 electric touch motor

1. Telescoping nger rest

2. Finger lever

3. Motor safe mode switch

4. Control lever ring

5. Stationary collet

6. Rotating collet

The Midas Rex MR8 electric high-speed drill system

MR8 electric and electric plus motors

Multifunction foot control unit

Note: Conduct a system check by pressing the foot pedal to briey run the motor and conrm proper function prior to any procedure. Important: By default, the foot control unit is activated by pressing the corresponding button for at least 100 milliseconds (mS). Use the IPC touch screen settings

screen to change the default value.

To use the multifunction foot control unit (Figure 9) to control the motor, do the following:

• To select Forward or Reverse mode, press the mode button (Figure 9, Number 1).

• To start or adjust the speed of a motor in variable mode, press the foot pedal (Figure 9, Number 5).

• To toggle between the start/stop mode and variable speed mode, press the control button (Figure 9, 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 9, 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.

Multifunction foot control unit and y-splitter

Technical specications

MR8 electric motor (EM800)

Size Weight Speed Duty cycle for applied part

Length: 9.73 cm (3.83 in) x Diameter: 1.55 cm (0.61 in) Length of motor cable: 460 cm (181 in)

Table 1: MR8 electric motor technical specications

87 grams 75,000 rpm forward/reverse For operating room temperatures up to 40°C (104°F), the MR8

electric motor is rated for 3 minutes (03:00) of continuous cutting time at 75,000 rpm, all followed by 25 minutes (25:00) of rest.

For normal operating room temperatures (typically 20°C/68°F), the MR8 electric motor is rated for continuous cutting at 75,000 rpm.

1. Mode button

2. Motor button

3. Control button

4. Slip-resistant food pad

5. Foot pedal

6. Y-splitter

7. Port 1

8. Port 2

Table 2: MR8 electric plus motor technical specications

MR8 electric plus motor (EM850)

Size Weight Speed Duty cycle for applied part

Length: 9.73 cm (3.83 in) x Diameter: 2.10 cm (0.83 in) Length of motor cable: 460 cm (181 in)

171 grams 75,000 rpm forward/reverse For operating room temperatures up to 40°C (104°F), the MR8

electric plus motor is rated for 3 minutes (03:00) of continuous cutting time at 75,000 rpm, all followed by 25 minutes (25:00) of rest.

For normal operating room temperatures (typically 20°C/68°F), the MR8 electric plus motor is rated for continuous cutting at 75,000 rpm.

The Midas Rex MR8 electric high-speed drill system

MR8 electric touch motors

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

The MR8 electric touch motor functions exactly as the electric motors that are controlled using the electric FCU but oers the operator an option to control the motor with a nger control mechanism. The MR8 electric touch motor also oers the user an option to control the motor with the foot via an electric FCU.

The IPC touchscreen control modes can engage/disengage the nger and foot controls on the MR8 electric touch motor (Figure 10).

IPC touchscreen control modes for the MR8 electric touch motor

1. Engage/disengage nger control

2. Engage/disengage foot control

Finger lever controls

The MR8 electric touch motor includes a removable and rotating nger lever.

Assembly

1. Slide the nger lever onto the motor.

2. Align the arrow (Figure 11) with the alignment slots until the lever clicks into position.

Note: There is also an arrow on the unlock lever (Figure 11) that can be used to initially align the nger lever assembly to the alignment slots.

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

Rotation

1. Unlock the nger lever by pressing the unlock lever forward (Figure 12).

2. Rotate the lever clockwise or counter clockwise until the arrow aligns with the alignment slots and lever clicks into position (Figure 13).

Disassembly:

1. Unlock the nger lever by pressing forward (Figure 12).

2. Slide the nger lever completely o the motor.

MR8 electric touch nger lever assembly

1. Finger lever

2. Alignment arrow

3. Motor alignment slots

4. Unlock lever

Unlock the nger lever Finger lever alignment

The Midas Rex MR8 electric high-speed drill system

Technical specications

Table 3: MR8 electric touch technical specications

MR8 electric touch motor (EM810)

Size Weight Speed Duty cycle for applied part

Length: 10.38 cm (4.09 in) x Diameter: 1.59 cm (0.62 in)

• Length of motor cable: 460 cm (181 in)

90 grams 75,000 rpm forward/reverse For operating room temperatures up to 40°C (104°F), the

MR8 electric touch motor is rated for 3 minutes (03:00) of continuous cutting time at 75,000 rpm, all followed by 25 minutes (25:00) of rest.

For normal operating room temperatures (typically 20°C/68°F), the MR8 electric touch motor is rated for continuous cutting at 75,000 rpm.

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

Functional standards for electrical systems

ANSI/AAMI ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

EN 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC 60601-1-4 Medical electrical equipment - Part 1: General requirements for safety, Part 4: Programmable electrical medical systems

IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for safety, collateral standard: electromagnetic compatibility - requirements and tests

CAN/CSA C22.2#60601-1

Environment of intended use:

• Professional healthcare facility environment

2005, CORR. 1:2009, AMMEND. 1:2012

2005, CORR. 1:2006, CORR. 2:2007, AMMEND. 1:2012

2006, AMMEND. 12:2014

1996, AMMEND. 1:1999

ED. 3.0:2007, ED. 4.0:2014

Medical electrical equipment - Part 1: General requirements for safety ED. 3.0:2014

Part-1: Electromagnetic immunity

The MR8 system is intended for use in the electromagnetic environment specied below. The customer or the user of the MR8 system should assure that it is used in such an environment.

Immunity test Test level (IEC/EN 60601-1-2) Compliance level Electromagnetic environment – guidance

Electrostatic discharge (ESD) IEC 61000-4-2

Electrical fast transient/burst IEC 61000-4-4

Surge IEC 61000-4-5

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

Power frequency (50/60 Hz) magnetic eld IEC 61000-4-8

Note:

1. UT is the mains voltage prior to application of the test level.

2. When the console is powered and connected to the foot switch, application of -15KV air discharge onto the foot switch buttons may cause the console to freeze. Power cycle the console to re-establish normal operation.

3. All MR8 electric motors are compliant with IEC/EN60601-1-2, ed. 3.0 and ed. 4.0 standards. Refer to the IPC User’s Guide to determine specic standard compliance for the system.

± 8 kV contact

± 15 kV air

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

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

0 % U

(100 % dip in UT)

for 0.5 cycle at 0°, 45°, 90°, 135°, 180°, 225°, 270°, and 315°

0 % U

(100 % dip in UT)

for 1 cycle at 0°

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

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

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

30 A/m 30 A/m Power frequency magnetic elds should be at levels characteristic

± 8 kV contact

± 15 kV air

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

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

0 % UT (100 % dip in UT) for 0.5 cycle at 0°, 45°, 90°, 135°, 180°, 225°, 270°, and 315°

0 % UT (100 % dip in UT) for 1 cycle at 0°

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

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

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

The relative humidity should be at least 5%.

Note 1 and 3

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

Mains power quality should be that of a typical commercial or hospital environment. If the user of the MR8 system requires continued operation during power mains interruptions, it is recommended that the MR8 system be powered from a uninterruptible power supply or a battery.

Note 1 and 3

of a typical location in a typical commercial or hospital environment

The Midas Rex MR8 electric high-speed drill system

Part-1: Electromagnetic emissions

The MR8 system is intended for use in the electromagnetic environment specied below. The customer or the user of the MR8 system should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment – guidance

RF emission CISPR 11

Harmonic emissions IEC 61000-3-2

Voltage uctuations/icker emissions IEC 61000-3-3

Group 1 The MR8 system uses RF energy only for its internal

Class A The MR8 system is suitable for use in all

Class A

Complies

function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

establishments, other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings for domestic purpose.

Recommended separation distances between portable and mobile RF communications equipment and the MR8 system

The MR8 system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the MR8 system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the MR8 system as recommended below, according to the maximum output power of the communications equipment.

Rated maximum power of transmitter

0.01 0.03 0.03 0.07 0.03 0.03 0.03 0.07

0.1 0.07 0.07 0.21 0.07 0.07 0.07 0.21

1 0.22 0.22 0.67 0.22 0.22 0.22 0.67

10 0.7 0.7 2.12 0.7 0.7 0.7 2.12

100 2.2 2.2 6.7 2.2 2.2 2.2 6.7

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W ) according to the transmitter manufacturer.

Note: These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from structures, objects and people.

Separation distance (in meters) according to frequency of transmitter

380MHz-390MHz d = 0.22√P

430MHz-470MHz d = 0.22√P

704MHz-787MHz d = 0.67√P

800MHz-960MHz d = 0.22√P

1.7GHz-1.99GHz d = 0.22√P

2.4GHz-2.57GHz d = 0.22√P

5.1GHz-5.8GHz d = 0.67√P

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

The MR8 system is intended for use in the electromagnetic environment specied below. The customer or the user of the MR8 system should assure that it is used in such an environment.

Immunity test Test level (IEC/EN 60601-1-2) Compliance level Electromagnetic environment - guidance

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

Note: These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from structures, objects and people.

3 Vrms 150 kHz to 80 MHz

6 Vrms 150 kHz to 80 MHz in ISM bands

3 V/m 80 MHz to 2.7 GHz

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

3 Vrms 150 kHz to 80 MHz

6 Vrms 150 kHz to 80 MHz in ISM bands

3 V/m 80 MHz to 2.7 GHz

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

Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the MR8 system, including cables specied by the manufacturer. Otherwise, degradation of the performance of this equipment may result.

Portable and mobile RF communications equipment should be used no closer to any part of the MR8 system including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance:

d P

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer, E is the immunity test levels in volt per meter (V/m), and d is the recommended separation distance in meters (m).

Interference may occur in the vicinity of equipment marked with the following symbol:

The Midas Rex MR8 electric high-speed drill system

MR8 surgical dissecting tools

The MR8 surgical dissecting tools (Figure 14) are designed and intended to resect, drill, or saw soft and hard tissue, bone, biomaterials, and metals during various surgical procedures. Angled, metal cutting and telescoping attachments feature a tool lock mechanism that secures tool in the attachment. For other attachments, the tool is locked in the motor collet at the same time as the attachment is locked on the motor.

All MR8 surgical dissecting tools are similarly constructed in that they have a dissecting tip (head) of various shapes and are provided in various lengths and geometries for dierent surgical needs. The head designs of the surgical dissecting tools include the following universal shapes: match head, ball or round, oval, hole maker, hole saw, cylinder, acorn, tapered or side cutting, twist drill, metal cutter, and reverse tapered. Tool heads may be uted or diamond coated.

Assembly

Refer to the applicable attachment assembly instructions in this Instructions for Use for details on the assembly of an attachment to a motor.

Tool nomenclature

Part numbers for MR8 surgical dissecting tools follow a nomenclature, which is described in the diagram below (Figure 15). Standard tool part numbers consist of the associated attachment length, the tool family identier, and the tool head diameter. Part numbers may also include a variety of prexes to identify specic attachment types, as well as a variety of suxes to provide additional information about the dissecting tool.

Note: The surgical tools are designed and labeled for single-use only. The tools are supplied Gamma sterilized, in sealed packaging.

MR8 surgical dissecting tool nomenclature

MR8 surgical dissecting tools

MR8 -

1234

1. Optional prex

2. Attachment length, x centimeters (Ex. 9 = 9 cm)

3. Tool family identier, xx form/function (Ex. MH = Match head)

Tool number prexes Tool number suxes

Note: A single part number will use only

one prex.

Prex Tool attachments Sux Tool head cutting modiers

Tool family identier (form/function)

Footed attachments

Telescoping tube

Acorn

Ball

Cylinder

Hole maker

Hole saw

Metal cutter

Match head

Oval

Reverse taper

Tapered or side cutter

Twist drill

9 M H 3 0

5 6

4. Tool head diameter, x.x or xx.x millimeters (Ex. 30 = 3.0 mm)

5. Optional depth x.x or xx.x millimeters (Ex. 19 = 1.9 mm)

6. Optional sux

Note: More than one sux may be combined in a single part number.

Ball

Barrel

Carbide

Cornerstone

Diamond

Diamond coarse

Diamond ne

Diamond extra coarse

Diamond extra ne

DXF

Fine

Match ute (on telescoping tools)

Spiral utes

3-Flute or symmeTRI

Extra

Extra ne

Tool length modiers

L Long

The Midas Rex MR8 electric high-speed drill system

Surgical application Commonly used attachments Commonly used dissecting tools

Spine MR8 9, MR8 14, and MR8 15 Match head

Elongated spherical design allows controlled, delicate dissection. For entry hole, nerve decompression, osteophyte removal, sinus dissection, etcetera.

Ball

Helical cutting utes dissect bone or cement eectively from a wide variety of approach angles. For debridement, decortication, sinus dissection, etcetera.

Oval

Helical cutting utes and curved design blend acorn and ball styles to vary dissection eciency with approach angle. For decortication, laminotomy, entry hole, nerve decompression, osteophyte removal, etcetera.

Hole maker and hole saw

Matched sets of hole makers and hole saws are ecient and eective for interbody fusion.

Cylinder

Eective bone sculpting and planing. For graft shaping, debridement, corpectomy, decortication, interbody fusion, fusion takedown, etcetera.

Acorn

Curved design varies dissection eciency with varied approach angles. For entry hole, laminotomy, bone shaping, debridement, corpectomy, decortication, fusion takedown, etcetera.

MR8 telescoping Match head

Elongated spherical design allows controlled, delicate dissection. For entry hole, nerve decompression, osteophyte removal, sinus dissection, etcetera.

Spine MR8 footed, MR8 straight Tapered

Slender design for precise dissection with minimal bone loss. For transection, osteotomy, graft harvesting, bone shaping, entry hole, suture hole, midface advancement, etcetera.

Reverse tapered

Semi-trapezoidal shape with helical cutting utes and a smooth cutting tip designed for ecient bone sculpting and planing. For graft shaping, debridement, and decortication.

The Midas Rex MR8 electric high-speed drill system

Surgical application Commonly used attachments Commonly used dissecting tools

Neurosurgical–cranial MR8 7, MR8 9, MR8 10, MR8 14,

and MR8 15

MR8 footed Tapered

Match head

Elongated spherical design allows controlled, delicate dissection. For entry hole, nerve decompression, osteophyte removal, sinus dissection, etcetera.

Ball

Helical cutting utes dissect bone or cement eectively from a wide variety of approach angles. For debridement, decortication, sinus dissection, etcetera.

Twist drill

Helical design with stop produces a hole with a precise depth. Ideal for plating.

Acorn

Curved design varies dissection eciency with varied approach angles. For entry hole, laminotomy, bone shaping, debridement, corpectomy, decortication, fusion takedown, etcetera.

Slender design for precise dissection with minimal bone loss. For transection, osteotomy, graft harvesting, bone shaping, entry hole, suture hole, midface advancement, etcetera.

General surgery and plastic surgery (craniofacial/ maxillofacial/ sternotomy)

Ear, nose, and throat (otology, neurootology)

MR8 7, MR8 9, MR8 10, and MR8 14

Match head

Elongated spherical design allows controlled, delicate dissection. For entry hole, nerve decompression, osteophyte removal, sinus dissection, etcetera.

Ball

Helical cutting utes dissect bone or cement eectively from a wide variety of approach angles. For debridement, decortication, sinus dissection, etcetera.

Tapered

Slender design for precise dissection with minimal bone loss. For transection, osteotomy, graft harvesting, bone shaping, entry hole, suture hole, midface advancement, etcetera.

Twist drill

Helical design with stop produces a hole with a precise depth. Ideal for plating.

MR8 7, MR8 10 Ball

Helical cutting utes dissect bone or cement eectively from a wide variety of approach angles. For debridement, decortication, sinus dissection, etcetera.

The Midas Rex MR8 electric high-speed drill system

Surgical application Commonly used attachments Commonly used dissecting tools

Orthopaedics MR8 9, MR8 14, MR8 21, MR8 26,

MR8 footed, and MR8 telescoping

Biometals/bioceramics/

MR8 MC9, MR8 MC14 Metal cutter

biomaterials

Ball

Helical cutting utes dissect bone or cement eectively from a wide variety of approach angles. For debridement, decortication, sinus dissection, etcetera.

Tapered

Slender design for precise dissection with minimal bone loss. For transection, osteotomy, graft harvesting, bone shaping, entry hole, suture hole, midface advancement, etcetera.

Acorn

Curved design varies dissection eciency with varied approach angles. For entry hole, laminotomy, bone shaping, debridement, corpectomy, decortication, fusion takedown, etcetera.

Cylinder

Eective bone sculpting and planing. For graft shaping, debridement, corpectomy, decortication, interbody fusion, fusion takedown, etcetera.

Cutting utes or diamond wheel design remove metals, ceramics and other biomaterials eectively from a variety of approach angles. For cutting rods, pins, plates, implants, screws, etcetera.

MR8 attachments

Note: To assemble DK attachments, follow the instructions for the respective attachment. To disassemble DK attachments, push the attachment distally before rotating.

The attachments provide support and stability to the rotating surgical tools during use in various surgical procedures. The attachments are reusable devices, supplied nonsterile, and require cleaning and sterilization prior to each surgical use. Attachments feature a tool lock mechanism that secures and aligns the tool to the attachment. Arrow icons (Figure 16-1) are etched onto attachments and motors to guide the user to lock (Figure 16-2) or unlock (Figure 16-3) the attachment from the motor.

MR8 attachments are available in various designs, lengths, and diameters to facilitate a variety of surgical procedures. The attachments family includes a variety of MR8 standard attachments, xed and rotating footed (craniotomes), telescoping, and specialty attachments (metal cutters, Jacobs chuck, J-latch, and perforator attachments). MR8 standard attachments consist of straight and angled congurations, which are oered either as xed or variable exposure. The availability of the Medtronic attachments allows the surgeon exibility to choose the appropriate length and style for each type of surgical procedure, including minimal access surgeries. They are marked and color-coded to correspond with their associated dissecting tools. Angled and straight attachments with the same length, marking, and color band share the same dissecting tool. Telescoping tubes with the same length, marking, and color band also share the same dissecting tool.

16-1

Attachment arrow icons

16-2

Attachment

lock

16-3

Attachment

unlock

The Midas Rex MR8 electric high-speed drill system

Straight attachments

Warnings:

• The MR8 motors do not run at all, if not locked.

• 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.

Note: An attachment will not seat on the motor if the arrows on the collet ats are not in proper alignment. Assembly:

1. Slide a straight attachment over the motor collet aligning the triangular arrows on the attachment and the motor case (Figure 17-1). An audible click, heard and perceptible by touch, conrms that the attachment is fully seated.

2. Insert the tool into the attachment with a slight rotational motion (Figure 17-2). An audible click, heard and perceptible by touch, conrms that the tool is fully seated.

3. Rotate the attachment in the direction indicated by arrow on the attachment until the attachment alignment mark is directly in line with the locked symbol (Figure 17-3). Note: When a click is heard the attachment is fully seated and the collet brake fully released.

4. Gently pull on the tool to ensure that it is locked into the motor.

Note: Tool should rotate freely. If not, unlock the attachment, re-seat the tool, and re-lock the attachment.

Disassembly

1. Hold the motor in palm of hand. Rotate the attachment to the unlocked position. In this position, the arrows in the attachment and motor will line up as in Figure 17-2.

2. Pull the dissecting tool from the attachment and discard the tool.

3. Use thumb and index nger to lift the attachment o of the motor.

17-1

17-2

17-3

Straight attachment assembly

Straight attachment assembly/disassembly

Straight attachment assembly

The Midas Rex MR8 electric high-speed drill system

Angled attachments

Warnings:

• The MR8 motors do not run at all, if not locked.

Notes:

• An attachment will not seat on the motor if the arrows on the collet ats are not in proper alignment.

• To assemble DK attachments, follow the instructions for the respective attachment. To disassemble DK attachments, pull the attachment distally before rotating.

• A dissecting tool may be installed and locked in the attachment before the angled attachment is installed onto the motor.

• Angled and straight attachments with the same length, marking, and color band share the same dissecting tools.

Assembly

1. With the tool lock in the unlocked position, insert a tool into the angled attachment with a slight rotational motion (Figure 18-1). An audible click, heard and

perceptible by touch, conrms that the tool is fully seated.

2. Rotate the tool lock/unlock sleeve in the direction indicated by arrow until the tool lock alignment mark is directly in line with the locked symbol (Figure 18-2).

3. Gently pull on the tool to ensure that it is locked into the motor. 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 the triangular arrows on the attachment and the motor case. An audible click, heard and perceptible by touch, conrms that the attachment 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. Note: When a click is heard the attachment is fully seated and the collet brake fully released.

6. Verify that both the attachment to motor alignment mark and the tool lock alignment mark are directly in line with the locked symbols (Figure 18-3).

Disassembly

1. Rotate the tool lock to the unlocked position to remove the tool from the attachment.

2. Rotate the attachment to the unlocked position and lift attachment o of the motor.

18-1

18-2

1. Tool lock/unlock sleeve

18-3

Angled attachment assembly

The Midas Rex MR8 electric high-speed drill system

Variable exposure straight and angled attachments

The variable exposure attachments allow the user to vary the exposure of the tool by adjusting the attachment tube. Match the color band on the attachment to the color code on the dissecting tool packaging.

Warning: Surgeons should familiarize themselves with the performance of dissecting tools before use and should explore the eect of various levels of tool exposure on dissection stability. If the tool exhibits excessive chatter, vibration, or movement, decrease the tool exposure.

Notes:

• For xed and variable straight attachments, the tool is locked in the motor collet. On

xed and variable angled attachments, the tool is locked in the attachment collet.

• There is a rotatable dial on the MR8 variable exposure attachment, not included on the

xed attachment.

• Dissecting tool size and geometry may contribute to excessive vibration at certain

speeds. Increase or decrease speed by adjusting the foot or nger control, or by changing the console speed setting. If necessary, use a dierent dissecting tool.

• Do not use the variable exposure attachment if the tube adjustment dial spins freely

or fails to click into place with each adjustment, as the exposure may change without warning.

• Do not use the end of the tube as a depth gauge or depth stop.

• Make sure that the tool and attachment are still locked after making any adjustments

to the tool exposure on variable exposure attachments. If the attachment is unlocked, the system will not function. If the tool is unlocked, it can cause reduced speed and overheating.

Assembly:

1. Assemble the variable exposure straight attachment using the Straight attachments Assembly instructions and the variable exposure angled attachments using the Angled attachments Assembly instructions.

2. After assembly, use the tube adjustment ring to adjust the exposure of the dissecting tool

(Figure 19-1).With the tool pointing away from you, turn the ring to the right to increase

the length of the tube, thereby decreasing the exposure of the tool. Turn the ring to the left to decrease the length of the tube, thereby increasing the exposure of the tool.

Disassembly: Remove the variable exposure straight attachment using the Straight attachments

Disassembly instructions and the variable exposure angled attachments using the Angled attachments Disassembly instructions.

19-1

Variable exposure attachment assembly

Angled double lock (DK) attachments

Notes:

• Angled attachments with the same length, marking, and color band share the same dissecting tools.

• You can insert and lock a tool in the attachment before the angled attachment is installed on the motor.

Assembly:

1. Assemble the attachment onto the motor using the Angled attachments Assembly instructions.

2. Insert the tool into the attachment with a slight rotational motion. An audible click, perceptible by touch, conrms that the tool is fully seated (Figure 20-1).

3. Rotate the tool lock in direction indicated by arrow until the tool lock alignment mark is directly in line with the locked symbol (Figure 20-2). Note: Pull on the tool to ensure that it is secured in the attachment.

4. The tool should rotate freely. If not, unlock the attachment, re-seat the tool, and re-lock the attachment.

5. Verify that both the attachment to motor and the tool-lock alignment mark is directly in line with the corresponding locked symbol.

20-1

Angled double lock (DK) attachment assembly

The Midas Rex MR8 electric high-speed drill system

20-2

Disassembly:

1. To remove the attachment, hold the motor in the palm of your hand, and push the attachment distally while turning the attachment to the unlocked position (Figure 20-3).

2. Release and remove the attachment.

20-3

Angled double lock (DK) attachment assembly

Angled double lock (DK) attachment disassembly

Fixed footed attachments

Warning: 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.

Notes:

• Ensure proper installation of tool in footed attachment. Failure to follow instructions may result in the tool tip contacting the foot of the attachment causing damage to the attachment and/or harm to patient.

• To avoid injury from the dissecting tool, use thumb and index nger to cautiously and slowly lift the attachment o of the motor and away from the dissecting tool.

Assembly

1. Insert a dissecting tool into the motor collet with a slight rotational motion (Figure 21-1). An audible click, heard and perceptible by touch, conrms that the tool is fully seated.

2. Slide the xed footed attachment over the dissecting tool onto the motor aligning triangular arrows on the attachment and the motor case (Figure 21-2).

3. Pull the xed footed attachment towards the motor and rotate the attachment to the locked position on the motor case (Figure 21-3).

4. Check to ensure a gap exists between the tip of the tool and the foot of the attachment as shown in Figure 21-4. This will prevent damage to the attachment and/ or injury to patient.

21-1

Fixed footed attachment assembly

The Midas Rex MR8 electric high-speed drill system

21-2

21-3

Disassembly

1. To remove the xed footed attachment, hold the motor in the palm of your hand. Push the xed footed attachment distally while rotating the attachment to the unlocked position on the motor case and then release the sleeve (Figure 21-5).

2. To avoid injury from the dissecting tool, use thumb and index nger to cautiously and slowly lift the attachment o of the motor and away from the dissecting tool (Figure 21-6).

3. Pull the dissecting tool out of the motor collet and discard the tool (Figure 21-7).

Fixed footed attachment assembly Tool Gap

Fixed footed attachment assembly

21-4

21-5

21-6

21-7

Fixed footed attachment disassembly

The Midas Rex MR8 electric high-speed drill system

Rotating footed attachments

Notes:

• Rotating and xed footed attachments with the same length, marking and color band share the same dissecting tools.

• The footed end of the attachment has 360° of unrestricted rotation.

• To avoid injury from the dissecting tool, use thumb and index nger to cautiously and slowly lift the attachment o of the motor and away from the dissecting tool.

Assembly:

1. Insert a dissecting tool into the motor collet with a slight rotational motion (Figure 22-1). An audible click, heard and perceptible by touch, conrms that the tool is fully seated.

2. Slide the rotating footed attachment over the dissecting tool onto the motor aligning triangular arrows on the attachment and the motor case (Figure 22-2).

3. Pull the rotating footed attachment towards the motor and rotate the attachment to the locked position on the motor case (Figure 22-3).

4. Check to ensure a gap exists between the tip of the tool and the foot of the attachment as shown in Figure 22-4. This will prevent damage to the attachment and/ or injury to patient.

Disassembly:

1. Hold the motor in palm of hand. Rotate the attachment to the unlocked position. In this position, the arrows in the attachment and motor will line up.

2. Use thumb and index nger to lift the attachment o of the motor.

3. Remove the dissecting tool from the motor collet and discard the tool.

22-1

22-2

22-3

Rotating footed attachment assembly

22-4

The Midas Rex MR8 electric high-speed drill system

Metal cutting attachments

Warnings:

• Do not use metal cutting dissecting tools on bone.

• For metal transection, observe the following safety guidelines:

a. Wear eye protection. b. Irrigate well to cool the cutting surfaces. c. Protect the wound site from metal debris. d. Use a clamp or grasping device to control loose fragments during transection of

any metal component.

• 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.

Notes:

• The metal cutting attachments use the tungsten carbide or diamond wheel

dissecting tools.

• A dissecting tool may be installed and locked in the attachment before the metal

cutting attachment is installed on the motor.

• The Legend system metal cutter dissecting tool can be used with the MR8-ASMC9

attachment. Match the color code on the metal cutter Legend dissecting tool packaging to the same color band on the MR8 attachment.

All metal cutting dissecting tools have an “MC” attachment prex in their nomenclature (for example MR8-9MC30). Metal cutting dissecting tools should not be installed into other attachments.

The MR8 metal cutting attachments come in a double locking (DK) conguration.

Assembly:

1. Slide the metal cutting attachment over the motor collet aligning triangular marks on the attachment and the motor case. An audible click, heard and perceptible by touch, conrms that the attachment is fully seated.

2. Rotate the attachment to the locked position on the motor case.

3. To insert the tool, make sure that the tool locking ring is in the unlocked position, and insert the dissecting tool into the top of the tube (Figure 23).

4. Rotate the dissecting tool until it drops into position and is fully seated (Figure 23).

5. Rotate the tool locking ring to the locked position. Gently pull on the shaft of the dissecting tool to verify proper installation

Disassembly:

1. Rotate the tool locking ring to the unlocked position. Pull the dissecting tool from the attachment.

2. Discard the tool.

3. Push the attachment distally, then rotate the attachment to the unlocked position on the motor case and lift the attachment o the motor.

Metal cutting attachment

The Midas Rex MR8 electric high-speed drill system

Telescoping attachments and tubes

Telescoping attachments provide support to the rotating dissecting tool. Telescoping tubes are disposable following multiple uses and should be discarded when heat or excessive vibration is noticed or insertion of tools becomes dicult. Telescoping attachment MR8-AT10ADK is provided in a double locking (DK) conguration. The straight telescoping attachment (MR8-AT10) is available in both a DK and non-DK conguration.

Warnings: 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.

Notes:

• To assemble DK attachments, follow the instructions for the respective attachment. To disassemble DK attachments, push the attachment distally before rotating.

• The Legend system 12 cm, 14 cm, 15 cm, and 18 cm telescoping tubes and dissecting tools can be used with the MR8 system. Match the color code on the telescoping Legend dissecting tool packaging to the same color band on the MR8 telescoping tube.

Assembly

1. Slide the attachment over the motor collet aligning the triangular markers. A tactile click conrms the attachment is fully seated.

Note: A dissecting tool and telescoping tube may be installed and locked in the attachment before the telescoping attachment is installed on the motor.

2. Rotate the attachment to the locked position.

3. Rotate the tube locking ring toward the unlocked icon (Figure 24-1).

4. Insert the base of the telescoping tube into the attachment (Figure 24-2).

5. To lock the tube in place, rotate the tube locking ring towards the locked icon. Verify that the tube is secure by gently pulling on the tube. Do not over tighten the tube locking ring.

6. To insert the tool, make sure that the tool locking ring is in the unlocked position, and insert the dissecting tool into the top of the tube (Figure 24-3). A tactile click conrms that the tool is fully seated.

7. Rotate the tool locking ring to the locked position. Gently pull on the shaft of the dissecting tool to verify proper installation (Figure 24-4).

8. If the tube position needs to be changed, rotate the tube locking ring toward the unlocked icon and reposition the tube. Then, rotate the tube locking ring toward the locked icon.

Disassembly

1. To remove the attachment, rotate the tool locking ring and the tube locking ring to the unlocked position, and pull the telescoping tube and tool out of the attachment.

2. Rotate the attachment to the unlocked position and lift the attachment o the motor.

Note: Telescoping tubes should be discarded when heat or excessive vibration is noticed, or when insertion of the tool becomes dicult.

24-1

24-2

24-3

Telescoping attachments and tubes assembly

24-4

Telescoping attachments and tubes assembly

The Midas Rex MR8 electric high-speed drill system

Perforator driver attachments

The perforator attachment has a Hudson chuck to drive any device with a Hudson shank (for example: the cranial perforator device).

Warning: Consult the cranial perforator device labeling for the recommended speed specications. Note: A cranial perforator device may be installed in the attachment before the attachment is installed on the motor. Assembly

1. Slide the perforator driver over the motor collet, aligning the triangular markers (Figure 25-1). A tactile click conrms the attachment is fully seated.

2. Rotate the attachment to the locked position (Figure 25-2).

3. To install a cranial perforator device with a Hudson shank, pull back on the collar of the attachment (Figure 25-3).

4. Insert the device into the attachment with a slight rotational motion and release the collar.

5. The speeds achievable by the MR8-AD03 attachments are provided in Table 4.

Disassembly

1. Pull back proximally on the collar of the perforator attachment and then remove the cranial perforator device.

2. Rotate the perforator attachment to the unlocked position and lift the attachment o of the motor.

Table 4: Maximum output speed

Console setting MR8-AD03

60000 rpm 830 rpm

70000 rpm 965 rpm

72000 rpm 995 rpm

74000 rpm 1020 rpm

75000 rpm 1035 rpm

25-1

Perforator driver assembly Perforator driver assembly Perforator driver assembly

25-2

25-3

The Midas Rex MR8 electric high-speed drill system

Jacobs chuck attachments

The Jacobs chuck attachment is a non-cannulated, 5/32” chuck with key for drilling.

Note: A drill bit may be installed in the attachment before the Jacobs chuck attachment is installed on the motor. Assembly

1. Slide the attachment over the motor collet aligning the triangular markers (Figure 26-1). A tactile click conrms that the attachment is fully seated.

2. Rotate the attachment to the locked position (Figure 26-2).

3. To install a drill bit, rotate the Jacobs chuck key counterclockwise to open the jaw as shown in Figure 26-3.

4. Insert the drill bit and rotate the Jacobs key clockwise to tighten the jaws until the drill bit is secure.

Disassembly

To open the jaws, turn the Jacobs chuck key counterclockwise. Remove and discard the drill bit. Rotate the Jacobs chuck attachment to the unlocked position and lift

the attachment o of the motor.

26-1

Jacobs chuck

attachment assembly

26-2

Jacobs chuck

attachment assembly

26-3

Jacobs chuck attachment assembly

The Midas Rex MR8 electric high-speed drill system

J-latch attachments

This attachment is designed for use with industry standard J-latch dissecting tools. Refer to the dissecting tool’s labeling for information on specic operating requirements and limitations.

Assembly:

1. Assemble and secure the attachment onto the motor using the Straight attachments Assembly instructions (Figure 27-1).

2. Insert the tool into the attachment with a slight rotational motion. An audible click, perceptible by touch, conrms that the tool is fully seated (Figure 27-2).

3. Turn the tool lock sleeve in the direction shown on the attachment to lock the tool (Figure 27-3). Gently pull on the tool to ensure that it is locked into the motor.

Disassembly:

1. Turn the tool lock sleeve in the direction shown on the attachment to unlock the tool.

2. Remove the dissecting tool from the attachment and discard it.

3. Rotate the attachment on motor to the unlocked position.

4. Lift the attachment o of the motor.

27-1

27-2

27-3

J-latch attachment assembly

Irrigation tubing set

Refer to the IPC manual for instructions to attach the tubing set to the IPC. Note: Clip may not fasten to small bore attachment after having been used on large

bore attachment.

Assembly:

1. Adjust the location of plastic clip on the stainless-steel irrigation tube (Figure 28).

2. Bend the irrigation tube to the desired angle.

3. Snap the clip onto the distal end of attachment (near the tool).

Disassembly:

1. Remove irrigation tubing set from attachment by pulling on the clip to detach it.

2. Similarly detach all clips.

3. Discard the irrigation tubing set per local regulations.

Irrigation tubing set assembly

The Midas Rex MR8 electric high-speed drill system

System accessories: disposable components

Cleaning brushes

Clean debris from lumen of attachments and telescoping tubes with the appropriate cleaning brushes.

The disposable cleaning brushes are sized for MR8 attachments and telescoping tubes, but they will not pass through the angled, metal cutting, perforator, or Jacobs chuck attachments, because they are not cannulated.

Table 5: Disposable cleaning brush dimensions

Internal bore diameter Brush length

1.2 mm 20 cm (8 in)

2.4 mm 41 cm (16 in)

3.2 mm 41 cm (16 in)

System accessories: non-disposable components

Instrument trays

The instrument tray holds MR8 attachments, MR8 motors, and/or other MR8 system equipment to be sterilized and is placed inside a rigid sterilization container or wrapped for steam sterilization. This tray is available in a 1/2 DIN CA800 (Figures 29-1 - 29-2) and a 3/4 DIN CA850 (Figures 30-1 - 30-2) size.

29-1

29-2

Instrument tray closed

1/2 DIN CA800

1/2 DIN CA800 instrument tray upper

level with attachments

30-1

30-2

Instrument tray closed

3/4 DIN CA850

3/4 DIN CA850 instrument tray upper

level with attachments

The Midas Rex MR8 electric high-speed drill system

Rigid sterilization containers (sterilization cases)

The rigid sterilization containers are sterilization containment devices designed to hold the MR8 system equipment for sterilization, storage, transportation, and aseptic presentation of its contents. These containers are available in 1/2 DIN (Figure 31-1) and 3/4 DIN (Figure 31-2) sizes.

The system consists of a base with carrying handles and lid that is secured to the base by means of a latching mechanism. The instrument tray holds MR8 attachments, MR8 motors, and/or other MR8 system equipment to be sterilized and is placed inside the rigid sterilization container. A lter system is incorporated in the sterilization container to provide for air evacuation and sterilant penetration during the sterilization cycle and to act as a barrier to microorganisms during storage, handling, and transport.

31-1

1/2 DIN sterilization container 3/4 DIN sterilization container

31-2

MR8 system reprocessing instructions

Cleaning is the removal of organic soil. Eective cleaning:

• Minimizes the organic soil transfer from one patient to another.

• Prevents accumulation of residual soil throughout the device’s useful life.

• Allows for successful follow-up sterilization. Adequate reprocessing is contingent upon the thoroughness of cleaning.

Cleaning is the initial step. Sterilization occurs later in reprocessing and is intended to kill microorganisms to reduce the likelihood of transmission and possibilities of infection. To ensure acceptable reprocessing, there should be no delay between the cleaning, inspection, and sterilization.

Blood-borne pathogens - Universal precautions for handling this device after use should be observed by all hospital personnel according to OSHA standard 29 CFR 1910.1030, occupational exposure to blood-borne pathogens.

Warnings and cautions

Limitations on reprocessing

Point of use Reprocessing begins at the point of use.

Containment and transportation

• Do not soak/submerge devices.

• Do not use ultrasonic cleaners to clean devices.

• Do not use chlorine-based or corrosive cleaning agents such as bleach, lye, acetone, sodium hypochlorite/bleach, sodium hydroxide, formic acid, or solutions containing glutaraldehyde.

• Allow an adequate cooling period after steam sterilization.

Note: Attachments and telescoping tubes may be disposed of at the end of their useful life according to local and national regulations. Due to safety and environmental concerns, Medtronic requests the return of electric high speed motors for proper disposal at the end of the product useful life.

End of useful life is normally determined by wear and damage due to use. See the “Maintenance, inspection, and testing” section in this document to determine if the device is at its end of useful life.

Do not allow blood, debris, or bodily uids to dry on the device. Remove excess soil using cold running tap water 10 - 22°C (50 - 72°F). Tap water is dened as potable water with hardness value between 0.7 mmol/l to 2.0 mmol/l.

Caution: Devices should be cleaned within 30 minutes of use to limit xation of contaminants. Do not place soiled instruments into the instrument case. Transport used devices in a separate container. If the device cannot be reprocessed immediately, keep the device moist during transport. It is recommended that devices are reprocessed as soon as is practical following use. To prolong the life of the device, reprocess immediately after use.

The Midas Rex MR8 electric high-speed drill system

Preparation for cleaning: automated

MR8 electric, MR8 electric plus, and MR8 electric touch motors:

• Ensure that the attachment, tube, and dissecting tool have been removed from the motor prior to cleaning.

• If cleaning the MR8 electric touch motor, remove the nger control lever from the MR8 electric touch motor, if attached.

• With collet and cable connector ends pointed down, manually rinse the motor and cable under cold running tap water (10 - 22°C / 50 - 72°F) to remove any visible soil.

• Use a nylon brush to aid in cleaning.

• Give particular attention to crevices and other areas that present a challenge to cleaning.

• For nger control lever, actuate all moving parts (telescoping nger rest and motor safe mode switch) through their full range of motion while thoroughly rinsing under cold running water.

• Orient devices following recommendations of the washer/disinfector manufacturer.

• For nger control lever, place in the washer with the telescoping nger rest in the fully extended position.

• Clean per recommended washer cycle per Table 6 or Table 7.

• After cleaning, visually examine all parts of the device for cleanliness. If visible soil remains, repeat cleaning.

MR8 attachments and tubes:

• Ensure that the attachment, tube, and dissecting tool have been removed from the motor prior to cleaning.

• Manually rinse attachments/tubes under cold running tap water (10 - 22°C / 50 - 72°F) to remove any visible soil.

• Use a nylon brush to aid in cleaning

• Give particular attention to crevices and other areas that present a challenge to cleaning.

• Attachments with moving parts should be actuated through their full range of motion under cold running tap water.

• While rinsing under cold running tap water, use an appropriately sized (refer to Table 5) nylon lumen brush internally to aid in cleaning attachments.

• Variable exposure attachments (AVAXX, AVAXXDK, AVSXX) must be placed in the washer with their tube in the fully extended position.

• Orient devices following recommendations of the washer/disinfector manufacturer.

• Clean per recommended washer cycle per Table 6 or Table 7.

• After cleaning, visually examine all parts of the device for cleanliness. If visible soil remains, repeat cleaning.

Instrument tray:

• To clean the instrument tray after use, thoroughly rinse the instrument tray under cold running tap water to remove any visible soil.

• Use a soft-bristled brush or clean cloth to aid soil removal around brackets and handles.

• Give particular attention to crevices and other areas that present a challenge to cleaning.

• Carefully inspect trays, handles, instrument brackets, and cavities to ensure all visible soil is removed.

• Clean per recommended washer cycle per Table 6 or Table 7.

• After cleaning per the recommended washer cycle below, visually examine the instrument tray for cleanliness. If visible soil remains, repeat cleaning.

Rigid sterilization container:

• To clean the sterilization container after use, discard the single use lters and thoroughly rinse the sterilization container under cold running tap water to remove any visible soil.

• Use a soft-bristled brush or clean cloth to aid soil removal around brackets, lter retention plates, and handles.

• Gently ush the gasket region of the sterilization container if soil is visible.

• Give particular attention to crevices and other areas that present a challenge to cleaning.

• Carefully inspect containers, handles, gaskets, lter retention plates, instrument brackets, and cavities to ensure all visible soil is removed.

• Remove the lter retention plates from the lid and base by turning the lever on the retention plate clockwise. Do not remove the gasket for the cleaning procedure.

• Clean per recommended washer cycle per Table 6 or Table 7.

• After cleaning per the recommended washer cycle below, visually examine the sterilization container for cleanliness. If visible soil

remains, repeat cleaning.

Cleaning: automated Warnings:

• Use the instrument tray and the rigid sterilization container for sterilizing the re-usable devices only.

• Do not use the instrument tray and sterilization container for cleaning or disinfection of the re-usable devices.

• Do not use alkaline cleaning for the instrument tray or the rigid sterilization container.

Cautions:

• Do not use ultrasonic cleaner.

Table 6: Neutral Wash Cycle Parameters

MR8 motors, attachments and tubes, and instrument tray - neutral

Phase Recirculation/soak

Pre-wash 2 minutes (02:00) Cold tap water

Enzyme wash 2 minutes (02:00) Hot tap water

Wash 1 2 minutes (02:00) 66°C (151°F) (setpoint) Neutral pH detergent like Steris Prolystica 2x concentrate

Rinse 1 15 seconds (00:15) 43 - 60°C (109 - 140°F) Not applicable

Thermal rinse 1 minute (01:00) 90°C (194°F) (setpoint) Not applicable

Puried water rinse 10 seconds (00:10) 66°C (151°F) (setpoint) Not applicable

If visible soil remains, repeat cleaning.

Table 7: Alkaline Wash Cycle Parameters

MR8 motors, attachments and tubes – alkaline detergent (working solution pH ≤ 10.5)*

Note: Do not use alkaline cleaning for the instrument tray or the rigid sterilization container.

Phase Recirculation/soak

Pre-wash 2 minutes (02:00) Cold tap water

Wash 5 minutes (05:00) 43°C (109°F) (set point) Alkaline detergent like Dr. Weigert neodisher® MediClean forte,

Rinse 1 minute (01:00) Hot tap water

Thermal rinse 1 minute (01:00) 90°C (194°F) (setpoint) Not applicable

Puried water rinse 1 minute, 30 seconds

If visible soil remains, repeat cleaning.

*Alkaline detergent manufacturers provide alkaline detergents concentrated. The alkaline detergents must be diluted per the detergent manufacturer’s instructions for cleaning medical devices. Medtronic has veried alkaline detergent compatibility for working solutions up to 10.5 pH.

(minutes)

(01:30)

The Midas Rex MR8 electric high-speed drill system

Water temperature Detergent type

10 - 16°C (50 - 61°F)

43 - 55°C (109 - 131°F)

Water temperature Detergent type

10 - 16°C (50 - 61°F)

43 - 60°C (109 - 140°F)

66°C (151°F) (setpoint) Not applicable

Not applicable

Neutral pH enzymatic cleaner like Steris Prolystica® 2x concentrate enzymatic cleaner, 1.0mL/L (1/8 oz/gallon)

neutral detergent, 1.0mL/L (1/8 oz/ gallon)

Not applicable

2mL/L (1/4oz/gal)

Not applicable

After cleaning, lubricate attachments using an aerosol spray lubricant (such as Pana Spray) and perform the following steps to lubricate attachments:

1. Holding the can approximately 10-15 cm (3-6 in.) away from the attachment, spray all movable components with three quick squirts.

2. Actuate movable components to ensure proper lubrication.

3. Remove excess lubricant with a clean cloth.

The Midas Rex MR8 electric high-speed drill system

Cleaning: manual MR8 electric, MR8 electric plus, and MR8 electric touch motors:

• Ensure that the attachment, tube, and dissecting tool have been removed from the motor prior to cleaning.

• If cleaning the MR8 electric touch motor, remove the nger lever from the MR8 electric touch motor, if attached. Set aside for cleaning and follow the motor nger control lever instructions listed below.

• With the collet end and cable connector ends pointed down, thoroughly rinse the motor and cable under cold running tap water (10 - 22°C / 50 - 72°F) to remove any visible soil.

• Use a nylon brush to aid in cleaning.

• Give particular attention to crevices and other areas that present a challenge to cleaning.

• Prepare with tap water a neutral enzymatic cleaner, like Steris Prolystica 2x concentrate enzymatic cleaner, following the manufacturer’s recommendations of 1.0 mL/L (1/8 oz/gallon) at a temperature of 23°C (73°F) or use an equivalent neutral pH cleaner following that manufacturer’s recommendations.

• Wipe all external surfaces of the motor, cable, and cable connector with a cloth dampened with the prepared cleaner.

• Brush motor case, collet, and cable connector with a nylon brush dampened with the prepared cleaner.

• Rinse the device thoroughly under warm running tap water (23 - 43°C / 73 - 109°F), collet end and cable connector pointed down.

• Following the warm tap water rinse, the device should be thoroughly rinsed in room temperature 25°C (77°F) puried water (deionized, reverse osmosis, or equivalent) for a minimum of 30 seconds with collet end and cable connector pointed down.

• Dry the entire device with lint-free towel.

• Verify that devices are visually clean after manual cleaning. If visible soil remains, repeat cleaning.

MR8 electric touch motor nger control lever:

• Ensure that the attachment, tube, and dissecting tool have been removed from the motor prior to cleaning.

• Prepare with tap water a neutral enzymatic cleaner, like Steris Prolystica 2x concentrate enzymatic cleaner, following the manufacturer’s recommendations of 1.0mL/L (1/8 oz/gallon) at a temperature of 23°C (73°F) or use an equivalent neutral pH cleaner following that manufacturer’s recommendations.

• Brush all parts of the lever with a nylon brush dampened with the prepared cleaner.

• Actuate all moving parts (telescoping nger rest and motor safe mode switch) while rinsing under warm running tap water (23 - 43°C / 73 - 109°F).

• Rinse thoroughly under warm running tap water.

• Following the warm tap water rinse, the device should be thoroughly rinsed in room temperature (25°C / 77°F) puried water (deionized, reverse osmosis, or equivalent) for a minimum of 30 seconds with telescoping nger rest fully extended.

• Dry with a lint free towel.

• Verify that the device is visually clean after manual cleaning. If visible soil remains, repeat cleaning.

MR8 attachments and tubes:

• Ensure that the attachment, tube, and dissecting tool have been removed from the motor prior to cleaning.

• Thoroughly rinse the attachments/tubes under cold running tap water (10 - 22°C / 50 - 72°F) to remove any visible soil.

• Use a nylon brush to aid in cleaning.

• Give particular attention to crevices and other areas that present a challenge to cleaning.

• Actuate all moving parts through their full range of motion while rinsing under cold running tap water.

• Wipe all attachments and telescoping tubes with a cloth dampened with the prepared cleaner.

• Use a nylon brush dampened with the prepared cleaner to clean the external surfaces and internal connecting surfaces of the attachment/tube base. Note: While cleaning angled and curved telescoping tubes, it may be necessary to push the brush through both ends.

• Straight attachments, footed attachments, and telescoping straight tubes have special cleaning brushes sized to the attachment’s or telescoping tube’s internal diameter (refer to Table 5). Push the brush wet with the prepared cleaner through the attachment or telescoping tube from rear to front to loosen and remove debris trapped inside.

• Other attachments and tubes may be mechanically agitated in the prepared cleaner solution but not soaked.

• For angled type attachments, perforator driver attachment, or Jacobs chuck attachment, only place one half (e.g. tube/tool side) of the attachment into the cleaner at a time. Do not immerse the entire attachment. Gently agitate the attachment in the cleaner and actuate any moveable parts. Then place the other half (e.g. base side) of the attachment into the cleaner and repeat (Figures 32-1 – 32-3).

• Ensure that the tube lumen on the angled attachment, curved and angled telescoping tube, metal cutter attachment, or J-latch attachment is cleaned with the appropriate sized brush (refer to Table 5).

• Actuate any moveable parts through their full range of motion to allow cleaner to thoroughly clean attachment (for example, the dial on variable exposure attachment and the sleeve on perforator attachment).

• Under warm running tap water (23 - 43°C / 73 - 109°F), actuate any moveable parts through their full range of motion to allow water to thoroughly rinse the attachment.

• Rinse the attachment thoroughly with warm running tap water. Flush both ends to remove cleaner.

• Verify that devices are visually clean after manual cleaning. If visible soil remains, repeat cleaning.

• Thoroughly dry attachments. An air gun may be used to blow moisture out from rear to front of attachment.

The Midas Rex MR8 electric high-speed drill system

32-1

Angled attachment cleaning example Perforator attachment cleaning example

32-2

1. Tube/tool side 2. Base side 1. Tube/tool side 2. Base side

32-3

Jacobs chuck attachment cleaning example

1. Tube/tool side 2. Base side

Instrument tray and rigid sterilization container

1. Manually clean the rigid sterilization container and instrument tray only when a washer-disinfector is not available. a. Thoroughly rinse the rigid sterilization container and instrument tray under cold running tap water (10 - 22°C / 50 - 72°F) to

remove any visible soil.

b. Use a soft-bristled brush or clean cloth to aid soil removal around brackets, handles, and lter retention plates (only on the rigid

sterilization container). c. If soil is visible, gently ush the gasket region of the rigid sterilization container. d. Give particular attention to crevices and other areas that present a challenge to cleaning. e. Carefully inspect the rigid sterilization container and instrument tray, including the handles, gaskets, lter retention plates, and

cavities, to ensure all visible soil is removed.

2. Prepare neutral enzymatic cleaner Steris Prolystica 2x Concentrate. a. Prepare the enzymatic cleaner following the manufacturer’s recommendations of 1.0ml/L (1/8 oz/gallon) at a temperature of 23°C (73°F)

or use an equivalent neutral pH cleaner following that manufacturer’s recommendations.

b. Immerse the rigid sterilization container and instrument tray in the prepared enzymatic cleaner, actuate the tray and allow it to

soak for a minimum of 10 minutes.

3. Thoroughly clean the rigid sterilization container and instrument tray. a. Use a soft-bristled brush for the outer portion of the rigid sterilization container and instrument tray. b. Pay particular attention to crevices, lter retention plates (only on the rigid sterilization container), latches, and other hard-to-

clean areas to remove all visible soil.

4. After soaking, thoroughly rinse the rigid sterilization container and instrument tray under warm (23 - 43°C / 73 - 109°F) running tap water for a minimum of 1 minute to remove all residual cleaner. a. Rinse the rigid sterilization container and instrument tray. b. Use a syringe to aid in rinsing.

5. Following the warm tap water rinse, thoroughly rinse the rigid sterilization container and instrument tray in room temperature 25°C (77°F) puried water (deionized, reverse osmosis, or equivalent) water for a minimum of 30 seconds. Note: After cleaning, visually examine all parts of the rigid sterilization container and instrument tray for cleanliness. If visible soil remains, repeat cleaning.

6. Dry the instrument tray and rigid sterilization container with a clean, lint-free towel.

After cleaning, lubricate attachments using an aerosol spray lubricant (such as Pana Spray) and perform the following steps to lubricate attachments:

1. Holding the can approximately 10-15 cm (3-6 in.) away from the attachment, spray all movable components with three quick squirts.

2. Actuate movable components to ensure proper lubrication.

3. Remove excess lubricant with a clean cloth.

Disinfection No particular requirements.

Drying If necessary, dry the devices with a clean, lint-free towel. Refer to the motor, attachment/tube, instrument tray, and sterilization container

Maintenance, inspection, and testing

cleaning sections on specic drying instructions.

Do not reprocess for surgical use a device that has obvious damage or corrosion. Return to Medtronic for service. Visually inspect the reprocessed devices following cleaning. Inspection should be performed with adequate lighting. Magnication is not required. A device that shows or exhibits the properties listed below is at the end of its useful life. Attachments and telescoping tubes may be disposed of at the end of their useful life according to local and national regulations. Due to safety and environmental concerns, Medtronic requests the return of electric high-speed motors for proper disposal at the end of the product’s useful life.

• Obvious damage or corrosion

• Pitting, cracks, fractures, or bending

• Illegible laser etchings, engravings, and other markings

• Discoloration, corrosion, stains or rust.

• Mechanisms that are rough or stuck. These are indications of bad O-rings, or damaged internal components for example, variable exposure collars, tool lock collar, and sleeves.

The Midas Rex MR8 electric high-speed drill system

Packaging Warnings:

• Do not load more than one MR8 motor inside the instrument tray per sterilization cycle.

• Do not wrap the rigid sterilization container.

• Use the instrument tray and the rigid sterilization container for sterilization only. The MR8 system devices must be cleaned separate from the trays.

There are two options available for packaging:

1. Devices may be sterilized using a wrapped instrument tray. The instrument tray should be wrapped with two layers of 1-ply polypropylene wrap using a sequential envelope technique. For use in the USA, an FDA-cleared wrap should be used.

2. Devices can also be sterilized by placing them inside an instrument tray and then placing the instrument tray inside an appropriately sized rigid sterilization container.

Instrument tray:

1. Inspect the following components before each sterilization cycle. Make sure the instrument tray does not have cracks or tears and that the silicone brackets (Figure 33) are not damaged.

Silicone brackets

2. Arrange the cleaned devices in the instrument tray’s silicone brackets. The instrument tray includes printed outlines as a guide for the devices that t within the tray.

3. Variable exposure attachments (AVAXX, AVAXXDK, AVSXX) must be placed in the instrument tray with their tube in the fully extended position (Figure 34-1).

4. As applicable, ensure the nger lever is removed from the body of the motor. To remove, unlock the nger lever by pressing forward and then slide the nger lever completely o the motor.

5. Place the motor and nger lever (when applicable) inside the instrument tray as shown in Figure 34-2. If applicable, nger lever must be fully extended during the cleaning process to ensure proper sterilization.

6. Close the instrument tray with the lid.

34-1

1/2 DIN CA800 instrument tray with

variable exposure attachments

34-2

Placement of the motor in the 1/2 DIN

CA800 instrument tray lower level

1. Variable exposure attachment in the fully extended position

The Midas Rex MR8 electric high-speed drill system

Option 1: Wrap the instrument tray for sterilization:

• The user facility is responsible for using only accessories (such as sterilization wraps, chemical indicators, and biological indicators) that are cleared and labeled for the validated sterilization parameters specied in this Instructions for Use by the Food and Drug Administration for medical facilities in the U.S.A. and its territories, or conform to EN ISO 11607 for medical facilities outside of the U.S.A. and its territories.

• The instrument tray should be wrapped with two layers of 1-ply polypropylene wrap using a sequential envelope technique. For use in the USA, an FDA-cleared wrap should be used.

Option 2: Place the instrument tray into the rigid sterilization container:

1. Use one lter (Case Medical SCF01) for the rigid sterilization container’s lid and use one lter (Case Medical SCF01) for the 1/2 DIN size rigid sterilization container’s base. If using the 3/4 DIN size rigid sterilization container, use two lters (Case Medical SCF01) in the container’s base.

a. Place the lter over the perforations in the lid and place a lter retention plate over the lter. b. Secure the lter retention plate by pushing downwards at the center and rotating the handles until you hear them click (Figure 35).

2. Place a rack around the lter plates (Figure 36).

3. Place the instrument tray with the lid on into the rigid sterilization container (Figure 37). Note: Use only the 1/2 DIN CA800 instrument tray with the 1/2 DIN rigid sterilization container. Use only the 3/4 DIN CA850 instrument tray with the 3/4 DIN rigid sterilization container.

4. Close the rigid sterilization container and apply labels and seals. a. On both sides of the rigid sterilization container, position the top of the latch over the ridge in the lid and push the bottom

section of the latch in toward the rigid sterilization container (Figure 38-1). You will feel a solid click.

b. Place the appropriate metal ID tags in the label holders located on either side of the rigid sterilization container latches. Note: Use only the approved tamper-evident seals (Case Medical SCS01B). Using a nonapproved tamper-evident seal could damage

the locking clip.

5. Place the container at on the shelf of the sterilizer cart.

Rigid sterilization container lter placement 1/2 DIN sterilization container with rack

1/2 DIN CA800 tray inside of the rigid container 3/4 DIN CA850 tray inside of the rigid container

The Midas Rex MR8 electric high-speed drill system

38-1

Sterilization Warnings:

• Do not attempt to run the MR8 motors immediately after autoclaving. Allow an adequate cooling period after steam sterilization.

• 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.

• Use the instrument tray and the rigid sterilization container for sterilization only. The MR8 system devices must be cleaned separate from the trays.

• Devices cannot be sterilized to an adequate Sterility Assurance Level (SAL) without prior cleaning and decontamination.

Cautions:

• 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.

• Because of the variability in cleaning eciencies and sterilizer operating parameters, all given parameters (temperature, time, etcetera) 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.

Notes:

• The instructions provided have been validated by the manufacturer as being capable of preparing the product for reuse. It remains the responsibility of the processor to ensure that the reprocessing as actually performed, using equipment, materials, and personnel in the reprocessing facility, achieves the desired result. This normally requires validation and routine monitoring of the process.

• Load the parts into the sterilizer by following the sterilizer manufacturer’s recommended loading procedures and load congurations.

• These sterilization instructions have been validated to a sterility assurance level of 10-6.

• The recommended sterilization parameters are only valid with CE-marked equipment that is properly maintained and calibrated.

• Steam for sterilization should be generated from water that has been treated to remove total dissolved solids, ltered to remove contaminants and water droplets, and supplied via piping without deadlegs or other stagnant zones where contamination might collect. Steam saturation should be greater than 97%.

1/2 DIN closed container Tamper-evident seal on the 1/2 DIN container

38-2

Cycle Temperature Exposure time Minimum dry time*

In any geography - sterilization prevacuum (dynamic-air-removal) steam cycle parameters for medical facilities

Prevacuum 132°C (270°F) 4 minutes (04:00) 25 minutes (25:00)

Prevacuum 135°C (275°F) 3 minutes (03:00) 25 minutes (25:00)

Outside the U.S.A. - sterilization prevacuum (dynamic-air-removal) steam cycle parameters for medical facilities

Prevacuum 134°C (273°F) 18 minutes (18:00) 25 minutes (25:00)

*Minimum dry times were validated using sterilizers having vacuum drying capabilities. Drying cycles using ambient atmospheric pressures may require more time.

Storage Make sure that the container is dry before storage, and stored in cool, dry conditions at ambient room temperature. Store sterile devices

Use When you are ready to use the devices, follow these steps.

in such a way that the sterile package is not compromised.

1. Before you open the container, make sure that: a. You have selected the correct rigid sterilization container. b. The tamper-evident seals are intact.

2. Unlatch the container.

3. Use the ring on top of the lid to remove the lid. Using the ring avoids contaminating the container’s contents.

4. Remove the tray of devices and place it in the sterile eld.

The Midas Rex MR8 electric high-speed drill system

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

Reusable devices that have been used on patients with suspected Creutzfeldt-Jakob Disease (CJD) or other TSEs should be quarantined and not reused until a diagnosis is conrmed or excluded. The Neurosurgery Group will not authorize or accept the return of MPSS products that directly contacted a patient or are contaminated with a patient’s body uids that is suspected or conrmed with TSE or CJD diagnosis. Furthermore, MPSS recommends that all MPSS product used on a patient conrmed with or suspected of a TSE/CJD diagnosis be incinerated. If TSE/CJD is excluded as a diagnosis, the quarantined reusable equipment may be returned for use after appropriate cleaning, decontamination and sterilization. Hospital personnel should contact their infection control personnel for current procedures and policy for reusable equipment processing. Contact your sales representative for temporary equipment while original equipment is quarantined or for replacement of product incinerated under this policy.

Planned maintenance

Planned maintenance information is provided as a guide to assist the customer in getting the greatest ownership value from their MR8 system. This scheduled program helps to maintain the device’s performance, safety, and reliability. Maintenance for the MR8 system is in addition to the required routine cleaning after each use.

The frequency of maintenance depends on how often the system is used and the conditions which the system is subjected to, such as during cleaning and sterilization. The demands on MR8 systems can vary greatly from facility to facility. The time between scheduled maintenance is determined by tool usage per motor per year and per month per motor. Adhere to the scheduled maintenance intervals in Table 8.

Table 8: scheduled maintenance intervals

Maintenance level Number of tools used per motor

per year

A 150–200 12–16* 19–23 3 months

B 100–149 8–11 15–18 4 months

C 50–99 4–7 12–15 5 months

D <50 <4 <11 6 months

*A motor with more than 16 uses per month should be returned for Medtronic maintenance at a 6-month interval. **Usage per month for most attachments. Some attachments may require more frequent checks.

Number of uses per month per motor

Number of uses per month per attachment**

Time interval

Notes:

• If any damage, wear, rust or corrosion is observed with the product or if action is required beyond cleaning, do not use the product and return to Medtronic for service.

• The planned maintenance steps have been designed for a facility’s biomedical department or equivalent to perform.

• The console, motor, cables, tool rack, and rigid sterilization containers have a limited warranty period of 1 year from the date of purchase. The attachments and telescoping tubes have a limited warranty period of 90 days from the date of purchase. After the warranty period, any costs incurred for repairing or refurbishing the system becomes the responsibility of the customer. This limited warranty does not include the cost associated with any of the factory-level service requirements identied in the planned maintenance schedule. Extended maintenance agreements are available.

• Failure to follow recommended service and planned maintenance schedules for attachments or motors may prevent the tool from being secured properly. Identifying and following the scheduled maintenance intervals for the MR8 system will assist in reducing the potential for unanticipated down time as a result of wear.

For scheduled maintenance intervals 1, 2, 3, 5, 6, 7, 9, 10, and 11

Follow the detailed instructions for servicing the MR8 system in accordance with the 12 maintenance intervals.

Motor:

1. Visually inspect the motor cable to verify that it does not have any damage to the insulation or to the connector and that there is no debris evident. Do not use

the product if damage is found and return to Medtronic for service.

2. Turn the rotational collet of the motor as shown in Figure 39-1 using motor wrench provided by Medtronic to the position shown in Figure 39-2.

3. Plug in the foot control and the motor into the IPC.

4. If the display shows any errors, then the motor is not properly connected or the connectors of the motor are dirty, or the motor or console may need servicing.

5. Press the Reverse button on the foot control several times and verify that the console display toggles between << REVERSE and FORWARD >>. Leave the console in the << REVERSE mode. Press the foot pedal to start the motor in reverse and listen for 3 beeps when the motor starts in reverse.

6. Run motor for 5 minutes at 75,000 rpm. Verify that the motor case does not become uncomfortably hot to the touch.

7. Verify that when the foot pedal is released the motor stops and does not continue to run. If the motor continues to run when the foot pedal is released, do not use and return system to MPSS for service.

8. Using the motor wrench, turn the rotational collet such that it aligns with stationary collet as shown in Figure 39-3.

39-1

rotational collet

Turn the

39-2

Rotational collet turned and

ready for testing

1. Stationary collet

2. Rotational collet

39-3

Rotational collet aligned with

the stationary collet

The Midas Rex MR8 electric high-speed drill system

Attachments: straight, angled, footed, perforator, Jacobs chuck, metal cutting, J-latch, and telescoping Note: Telescoping tubes are multi-use disposables and do not receive scheduled maintenance. Discard if excessive heat or vibration is present.

1. Visually inspect the etching and color ring to ensure it remains legible and the color is distinguishable.

2. Visually inspect the attachment tube and base for any signs of debris or damage.

3. Visually and physically inspect (pull and twist by hand) the attachment for any loose or loosening components. If any components are loose, do not use.

4. Straight and angled: Visually inspect the attachment tip for any signs of wear. The tip should remain round with no evidence of deformation.

5. Footed: Visually inspect the foot of the attachment. The foot should not be bent and the proximal dimple should be smooth and showing no signs of damage.

6. Perforator and Jacobs chuck: Visually inspect the perforator and Jacobs chuck collet for any signs of wear or deformation. Rotate the collet of the attachment. It should rotate easily.

7. Heat Check: Caution: Feel the motor case, the attachment base, knuckle (angled area for angled attachment only), and the attachment tip (straight and angled attachments only) periodically and cautiously to ensure they are not uncomfortably hot to the touch.

a. Attach and lock the attachment onto the motor. Ensure that there is a tactile click when the attachment is locked onto the motor.

Note: Ensure that the secondary lock is engaged on the angled attachments.

b. Connect the motor to a console with the FCU attached. c. Turn the console on. d. Run the motor and attachment at 75,000 rpm for 3 minutes (03:00). e. Allow the motor to cool and then repeat steps 1 to 7 for each attachment in the system.

8. Exceptions: a. Run J-latch attachment at default speed for 3 minutes (03:00). b. Perforators and Jacobs chuck at default speed for 5 minutes (05:00)

For scheduled maintenance intervals 4, 8, 12

Motor and attachments: straight, footed, perforator, Jacobs chuck, telescoping, angled, and metal cutting

• At these maintenance intervals, it is important that the units be returned to Medtronic for factory level inspection and service.

Note: The costs associated with any of the factory level service requirements are not included in the limited warranty. Extended maintenance agreements are available.

Storage

Store devices in a clean, dry area with other sterile devices.

Disposal

Due to safety and environmental concerns, Medtronic requests the return of electric high speed motors for proper disposal at the end of the product life cycles.

Troubleshooting

If MR8 system components require servicing or refurbishing, return components to Medtronic for quality assured service by factory-trained personnel who will utilize genuine Medtronic MR8 system parts as required. All MR8 system components returned for servicing or refurbishing should be properly cleaned and sterilized prior to shipping.

Problem Possible cause Recommendations

MR8 motor

Motor is too hot to touch/ hold

Motor does not run Cables not properly connected Ensure motor and foot control cables are properly connected.

Atachment does not seat properly on motor

Inadequate cool down period following sterilization Motor must be allowed to cool down following steam sterilization.

Attachment transferring heat to the motor. Switch attachments to determine whether the heat is being generated by

Heavy side loading during dissection. Discontinue use and rest the motor by using it intermittently or wrap the

Speed setting is too low Ensure that a speed greater than 3,000 rpm is selected. Check the IPC for

Attachment not properly installed and locked onto the motor

Internal failure of motor and/or console. Change motor or console to isolate the problem.

Foot control not properly functioning Check for obstruction under the foot pedal.

Cables damaged Check cable for cracks, splits, or bent connector pins.

Damaged tactile ring on motor collet Contact Medtronic Customer Service to return the motor for service.

the motor or the attachment.

motor with a moist sterile towel.

error status.

Remove and reinstall the attachment and dissecting tool to ensure proper installation.

Problem Possible cause Recommendations

MR8 attachments or telescoping tubes

The Midas Rex MR8 electric high-speed drill system

Attachment or telescoping tube has uncomfortable temperature to touch or hold.

Color band on attachments or telescoping tubes fade or become discolored.

Attachment or telescoping tube displays rust.

Attachment or telescoping tube is bent, loose, damaged, or missing a component.

Attachment will not properly seat on motor.

Attachment has excess lubrication.

Diculty removing tool from attachment.

Footed attachment has a component missing from leg or foot area.

Perforator running too slow. Speed set incorrectly. Increase speed at IPC.

Footed attachment will not lock

Heat from worn attachment or tube bearings. Do not use. Try another attachment or tube. Contact Medtronic Customer

Attachment or tube is unclean due to improper cleaning procedures.

Heavy side loading during dissection. Discontinue use and rest the attachment by using intermittently, try another

Inadequate irrigation. Ensure adequate irrigation to surgical site.

Incorrect cleaning or sterilization method. Use nomenclature markings on the attachment to match with a

Use of chlorine based or corrosive cleaning agents.

Aging.

Incorrect cleaning or sterilization method. Do not use. Contact Medtronic Customer Service. Dispose of telescoping tube.

Use of chlorine-based or corrosive cleaning agents.

Aging.

Attachment mishandled, failed due to extended use or excessive force applied during use.

Motor collet ats are not in proper alignment. Using the Medtronic wrench, rotate the collet at closest to the motor case

Over lubrication during cleaning process. Visually inspect and wipe excess lubrication.

Aging of attachment. Improper cleaning. Use of reprocessed tools. Use of unauthorized re-furbisher.

Attachment tool lock left in locked position. Rotate the locking mechanism on tube side of attachment to the unlocked

Incorrect cleaning or sterilization of the motor collet. Check that appropriate cleaning procedures are being followed.

Attachment damaged by dissecting tool drilling out part or all of leg or foot area.

Attachment dropped or damaged during use.

Tool not seated properly Remove and reinstall the dissecting tool to ensure that it is properly seated.

Service. Telescoping tubes are multi-use disposable. If problem is resolved with a new telescoping tube, discard the overheated tube.

Check that appropriate cleaning procedures are being followed.

identical attachment or wrap the attachment interface with a moist sterile towel. If attachment continues to overheat, contact Medtronic Customer Service.

corresponding dissecting tool or contact Medtronic Customer Service. Telescoping tubes are multi-use disposable.

Telescoping tubes are multi-use disposable.

Do not use. Contact Medtronic Customer Service.

Dispose of telescoping tube.

Telescoping tubes are multi-use disposable.

until its arrow marker is aligned with the arrow marker on the other at.

Contact Medtronic Customer Service.

position.

Do not use. Contact Medtronic Customer Service.

An audible click, heard and perceptible by touch, conrms that the tool is fully seated.

MR8 dissecting tools

Dissecting tool ails. Device other than a MR8 dissecting tool used. Do not use. Replace with a MR8 dissecting tool.

Worn attachment or tube bearings. Do not use. Try another attachment or tube to isolate location of problem.

If ail is produced by a specic attachment, contact Medtronic Customer Service. Dispose of telescoping tube. Telescoping tubes are multi-use disposable.

Attachment or tube and tool combination improper. Do not use. Check for the correct nomenclature and color code on the

dissecting tool packaging to the same nomenclature and color band on the attachment or tube.

The Midas Rex MR8 electric high-speed drill system

Medtronic Midas Rex MR8 electric high speed systems limited warranty*

(U.S. customers only)

A. This limited warranty provides the following assurance to the purchaser of a Medtronic Midas Rex MR8 electric high speed system. This limited warranty is

extended only to the buyer purchasing the MR8 system directly from Medtronic or from its aliate or its authorized distributor or representative. The Midas Rex MR8 electric high speed system (hereinafter all items listed below are collectively referred to as product) includes, as may be applicable, the motor, foot control, instrument trays and rigid sterilization containers (hereafter referred to as system components), straight and angled motor attachments (hereinafter referred to as “attachments”), telescoping tubes (hereinafter referred to as semi-reusable components), and dissecting tools and other accessories not listed above and jointly referred to as other components, unless specically noted.

a. Should a system component fail to function to Medtronic’s published specications during the term of this limited warranty (one year from the date of sale

of a new system component or 90 days from the date of sale of a refurbished or used system component), Medtronic will either repair or replace the motor component or any portion thereof.

b. Should an attachment fail to function to Medtronic’s published specications during the term of this limited warranty (90 days from the date of sale of a new

attachment), Medtronic will either repair or replace the attachment or any portion thereof.

c. Should a semi-reusable component fail to function to Medtronic’s published specications during the term of this limited warranty (30 days from the date of

sale of a new semi-reusable component), Medtronic will replace the semi-reusable component or any portion thereof. d. Should a single use component fail to function to Medtronic’s published specications prior to its “use by” date Medtronic will replace the single use component. e. Should other components fail to function to Medtronic’s published specications during the term of this limited warranty (30 days from the date of sale of a

new other components), Medtronic will replace or repair the other components or any portion thereof.

B. To qualify for this limited warranty, the following conditions must be met:

a. The product must be used on or before its “use by” or “use before” date, if applicable. b. The product must be used in accordance with its labeling and may not be altered or subjected to misuse, abuse, accident or improper handling. c. Medtronic must be notied in writing within thirty (30) days following discovery of any defect or performance issue. d. The product must be returned to Medtronic within thirty (30) days of Medtronic receiving notice as provided for in (3) above. e. Upon examination of the product by Medtronic, Medtronic shall have determined that: (i) the product was not repaired or altered by anyone other than

Medtronic or its authorized representative, (ii) the product was not operated under conditions other than normal use, and (iii) the prescribed periodic

maintenance and services, if applicable, have been performed on the product

C. This limited warranty is limited to its express terms. This limited warranty is in lieu of all other warranties, expressed or implied whether statutory or otherwise,

including any implied warranty of merchantability or tness for a particular purpose. In no event shall Medtronic be liable for any consequential, incidental, prospective, or other similar damage resulting from a defect, failure, or malfunction of the product, whether a claim for such damage is based upon the warranty, contract, negligence, or otherwise.

D. The exclusions and limitations set out above are not intended to, and should not be construed so as to, contravene mandatory provisions of applicable law. Users

may benet from statutory warranty rights under legislation governing the sale of consumer goods. If any part or term of this limited warranty is held by any court of competent jurisdiction to be illegal, unenforceable, or in conict with applicable law, the validity of the remaining portion of the limited warranty shall not be aected, and all rights and obligations shall be construed and enforced as if this limited warranty did not contain the particular part or term held to be invalid.

*This limited warranty is provided by Medtronic Neurosurgery Group, 4620 North Beach Street, Fort Worth, Texas 76137-4116. It applies only in the United States. Areas outside the United States should contact their local Medtronic representative for terms of the warranty.

After the warranty period, any costs incurred for repair/refurbishing become the responsibility of the customer. This limited warranty does not include the cost associated with any of the factory level service requirements identied in the preventive maintenance schedule. Extended maintenance agreements are available.

EC REP

EUR · USA · JPN · AUS

105345

DEHP

Symbols

The following symbols can appear on this device and related packaging.

The Midas Rex MR8 electric high-speed drill system

12RZ

Compliant with European Council Directive MDD 93/42/EEC

Authorized Representative in the European Community

Compliance Mark EMC

Conforms to ANSI/AAMI ES60601-1, Certied to CAN/CSA-C22.2 No.606011, IEC/EN 60601-1

UL Mark

UL classied with respect to electric

shock, re, and mechanical hazards only in accordance with UL 606011 2FF7. UL classied for Canada with respect to electric shock, re, mechanical and other hazards only in accordance with CAN/CUSA C22.2 UL 601-1. Medical Equipment Certied for Canada 2FF7.

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

Consult Instructions for Use

Follow Instructions for Use

Caution

RF Transmitter (Interference May Occur)

Manufacturer

Date of Manufacture

Use By Date

Serial Number

Catalog Number

Lot Number

Package Contents

Quantity

Oscillate

Dissecting Tool

EHS

Refurbished

Output

Accessory

Adapter

Attachment

Brush

Dissecting Tool

Electrical High Speed Motor Connector

Instrument Tray

Motor

Refurbished

Multi-Use Disposable Attachment

Part Number

+ XX °C + XX °F

Do not oil.

Do Not Dispose Of This Product In The Unsorted Municipal Waste Stream. Dispose Of This Product According to Local Regulations. See Recycling.Medtronic.com for Instructions On Proper Disposal Of This Product.

If the single use symbol is on the device label then this device is designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death.

Non-Sterile

Sterilized using Irradiation

+ XX °C

Temperature Limitation

+ XX °F

Tube Control

Use With

AC Power

Start/Stop

Finger-Operated Control

Motor

Top Foot Control Unit Button / Motor Button

Foot Pedal Connector

Left Foot Control Unit Button / Mode Button

Right foot control unit button

!USA

PHT

USA Only

Do not use if package is open or damaged

Package Quantity

Double-Locking

Diameter

Unlock

Lock

Contains DEHP (di-2-ethyl hexyl phthalate)

Tool control

175038EN B

EC REP

2019-01

May be covered by U.S. Patents:

Medtronic.com/patents

Made in USA. Printed in USA.

Medtronic Powered Surgical Solutions

4620 North Beach Street

Fort Worth, Texas 76137 USA

+1 800 433 7080

Medtronic B.V.

Earl Bakkenstraat 10

6422 PJ Heerlen The Netherlands +31 45 566 8000

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Medtronic CA800 Instructions for Use

Specifications and Main Features

Frequently Asked Questions

User Manual

Customer service

Contents

Glossary

General information

Indications for use

MR8 system description

MR8 electric motors

MR8 attachments

MR8 surgical dissecting tools

Contraindications

Special notices

Warnings

System

System cables

Tools and disposable components

Cautions

IPC set up

Connection to IPC

IPC pump detection

IPC touchscreen controls

Speed

Irrigation

Acceleration and deceleration

Rotation (FWD and REV)

Safe mode (SAFE)

MR8 electric motors

MR8 electric and electric plus motors

Multifunction foot control unit

MR8 electric touch motors

Finger lever controls

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

Functional standards for electrical systems

Part-1: Electromagnetic immunity

Recommended separation distances between portable and mobile RF communications equipment and the MR8 system

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

MR8 surgical dissecting tools

Assembly

Tool nomenclature

MR8 surgical dissecting tool nomenclature

MR8 attachments

Straight attachments

Angled attachments

Variable exposure straight and angled attachments

Angled double lock (DK) attachments

Fixed footed attachments

Rotating footed attachments

Metal cutting attachments

Telescoping attachments and tubes

Perforator driver attachments

Jacobs chuck attachments

J-latch attachments

Irrigation tubing set

System accessories: disposable components

Cleaning brushes

System accessories: non-disposable components

Instrument trays

Rigid sterilization containers (sterilization cases)

MR8 system reprocessing instructions

Warnings and cautions

Limitations on reprocessing

Point of use Reprocessing begins at the point of use.

Containment and transportation

Preparation for cleaning: automated

Cleaning: automated Warnings:

Cleaning: manual MR8 electric, MR8 electric plus, and MR8 electric touch motors:

Disinfection No particular requirements.

Drying If necessary, dry the devices with a clean, lint-free towel. Refer to the motor, attachment/tube, instrument tray, and sterilization container

Maintenance, inspection, and testing

Packaging Warnings:

Sterilization Warnings:

Storage Make sure that the container is dry before storage, and stored in cool, dry conditions at ambient room temperature. Store sterile devices

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

Planned maintenance

For scheduled maintenance intervals 1, 2, 3, 5, 6, 7, 9, 10, and 11

For scheduled maintenance intervals 4, 8, 12

Motor and attachments: straight, footed, perforator, Jacobs chuck, telescoping, angled, and metal cutting