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The Midas Rex Legend MR8 Electric High-Speed Drill System Instructions for Use

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Instructions for Use 175038EN D The Midas Rex™ MR8™ Electric High-Speed Drill System MR8™ Electric, MR8™ Electric Plus, and MR8™ Electric Touch Motors

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Instructions for Use 175038EN D

The Midas Rex™ MR8™ Electric High-Speed Drill System MR8™ Electric, MR8™ Electric Plus, and MR8™ Electric Touch Motors

Customer service For further information regarding the use of this product or to report any problems, contact your Medtronic Customer Service , or contact your local distributor. Medtronic Powered Surgical Solutions 4620 North Beach Street Fort Worth, Texas 76137 USA US Help Line (800) 335-9557 or (800) 874-5797 [email protected] International Service: International Customers should contact their local Medtronic representative. The information contained in this document is accurate at time of publication. Medtronic reserves the right to make changes to the product described in this manual. Refer to manuals.medtronic.com for the current version.

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Contents

Glossary...1 General information...1 Midas Rex™ MR8™ system description...1 Electric motors...1 Attachments...1 Surgical dissecting tools...1 System accessories...1 Indications for use...1 Clinical benefits...1 Target patient population...1 Intended use...1 Contraindications...1 Special notices...2 Warnings...2 Precautions...3 Training requirements...3 Residual risks...3 Possible adverse events...3 Material composition...3 Use...4 Connection to IPC™ system...4 IPC™ system pump detection...4 IPC™ system touchscreen controls...4 Speed...5 Irrigation...5 Acceleration and deceleration...5 Rotation (FWD and REV)...5 Safe mode (SAFE)...5 MR8™ electric motors...6 MR8™ electric and electric plus motors...7 Multifunction FCU...7 Technical specifications and performance characteristics...7 MR8™ electric touch motors...8 Finger lever controls...8 Technical specifications and performance characteristics...9 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 MR8™ surgical dissecting tools...11 Assembly...11 Tool nomenclature...11 General guidelines for attachments and tool applications...12 MR8™ attachments...14 Straight attachments...15 Angled attachments...16 Variable exposure straight and angled attachments...17 Angled double lock (DK) attachments...18 Fixed footed attachments...19 Rotating footed attachments...21 Metal cutting attachments...22 Telescoping attachments and tubes...23 Perforator driver attachments...24 Jacobs chuck attachments...25 J-latch attachments...26 Irrigation tubing set...26

System set-up check...27 System accessories: disposable devices...27 Cleaning brushes...27 System accessories: non-disposable devices ...27 Motor wrench...27 Instrument trays...27 Rigid sterilization containers (sterilization cases)...28 Sterility...28 MR8™ system reprocessing instructions...28 Warnings and cautions...28 Limitations on reprocessing...28 Point of use...28 Containment and transportation...28 Preparation for cleaning: Automated...29 Cleaning: Automated...29 After Cleaning: Automated...30 Cleaning: Manual...30 After Cleaning: Manual...32 Disinfection...32 Drying...32 Maintenance, inspection, and testing...32 Packaging...32 Sterilization...35 Storage...35 Use...35 Return policy for devices exposed to TSE (transmissible spongiform encephalopathies)...36 Planned maintenance...36 For scheduled maintenance intervals 1, 2, 3, 5, 6, 7, 9, 10, and 11...36 For scheduled maintenance intervals 4, 8, 12...37 Storage...37 Disposal...37 Troubleshooting...38 Motor...38 Attachments or telescoping tubes...38 Dissecting tools...39 Medtronic Midas Rex™ MR8™ Electric High-Speed System limited warranty*...40 Symbols...41

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

Glossary The following words and acronyms may be used in this guide. DK FCU FWD ISM IPC MR8™ REV RF Vrms

Double locking Foot Control Unit Forward - Rotation is clockwise Industrial, scientific, and medical Integrated Power Console Midas Rex™, 8th Generation Reverse - Rotation is counter-clockwise Radio Frequency Root mean square voltage

PHYSICIAN NOTE: The physician must convey the indications, contraindications, warnings, and precautions given in this document to the patient.

General information Read and understand this manual before using the Midas Rex™ MR8™ Electric High-Speed Drill System. The Midas Rex™ 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 system by being trained in Medtronic Midas Rex™ Hands-On Workshops or by one of the local authorized representatives.

Midas Rex™ MR8™ system description Electric motors Electric motors provide power to operate disposable surgical dissecting tools. These motors are designed to interface with a series of attachments and surgical dissecting tools using a standard quick-connect locking mechanism. Motors operate in the same manner whether controlled by a finger mechanism or FCU.

Attachments Attachments are designed to align the surgical tools with the motor to provide support and stability during various surgical procedures. Attachment options, of various lengths, 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 flexibility with the length and style of attachment for surgeries.

Surgical dissecting tools Surgical dissecting tools are designed and intended to resect, drill, or saw soft and hard tissue, bone, biomaterial, and metal 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.

System accessories System accessories enable the Midas Rex™ MR8™ system to carry out the system’s intended use. Accessories include the motor wrench, cleaning brushes, instrument trays, sterilization cases, irrigation tubing sets, electric control switch, electrical power cables, and tool rack. All of these are considered medical devices except for the tool rack and electric power cables.

Indications for use The Medtronic Midas Rex™ MR8™ Electric High-Speed Drill System is an electrically operated surgical instrument system. The electric motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries. Additionally, the Midas Rex™ MR8™ Electric HighSpeed 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 • Lumbar Stenosis Decompression • Posterior Lumbar Interbody Fusion (PLIF)

• Transforaminal Lumbar Interbody Fusion (TLIF) • Anterior Lumbar Interbody Fusion (ALIF) • Direct Lateral Interbody Fusion (DLIF)

Clinical benefits Clinical benefits of the MR8™ High-Speed Drill Systems include optimized visibility and maneuverability in the surgical site, sufficient power to cut bone and biomaterials, ergonomic grip that allows precise control, sensory feedback while cutting, the ability to adjust/configure the system efficiently, and a portfolio of attachments and tools that meet different surgical needs.

Target patient population Candidates for surgical applications stated in the Indications for use.

Intended use The Midas Rex™ MR8™ Electric High-Speed Drill System is intended to be used to perform the task of removing soft and hard tissue and bone as stated in the indications for use.

Contraindications None.

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

Special notices The words warning, precaution, 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 user may be involved. Disregarding this information could result in injury to the patient or user. Precaution: A precaution 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 W1 W2 W3 W4 W5 W6 W7 W8 W9 W10 W11 W12 W13 W14 W15 W16 W17 W18 W19 W20 W21 W22 W23 W24 W25 W26 W27

W28 W29 W30 W31 W32 W33 W34 W35 W36 W37 W38 W39 W40 W41 W42 W43 W44 2

The system user must be familiar with this Instructions for Use (IFU) and the Integrated Power Console (IPC™) System User’s Guide, their precautions, procedures, and safety issues. The system and its associated accessories should be used only by qualified medical professionals who are thoroughly trained and experienced in performing surgery with Medtronic powered surgery systems. Always inspect the device before and after use for any damage. If damage is observed, do not use damaged device. Use adequate irrigation during dissection to prevent thermal necrosis. Do not use an overheated device, as it may cause thermal injury to the patient or user. Heavy side loads and/or long operating periods may cause the device to overheat. Never place an overheated device on the patient or draping during the surgery. Do not use excessive force to pry or push bone with the attachment or dissecting tool during surgery. Use only dissecting tools specifically designed for use with this drill system. Match the nomenclature and color code on the dissecting tool packaging to the same nomenclature and color band on the attachment. Do not use the reusable devices without proper cleaning and sterilization. Sterilize and dry the reusable device before storing. All service must be performed by Medtronic qualified personnel only. Discontinue the use of device if visualization to the surgical site is lost. Do not attempt to remove a dissecting tool or attachment while the motor is running to prevent laceration of the user and/or cross contamination through a compromised glove. Do not immerse the device, except when recommended by the cleaning instructions in this IFU. The motors should only be operated when the attachment/tool is in the fully locked position. Do not use the system if the motor continues to run after releasing the foot pedal or finger lever. Do not place the device on the patient or in an unsecured location during surgery. Do not use an attachment and dissecting tool combination that results in tool flail or excessive vibration. Do not use the reusable device immediately after steam sterilization. Allow an adequate cooling period after steam sterilization. Do not place motor in the proximity of a magnetic field, such as magnetic drape or Magnetic Resonance Imaging (MRI) equipment, to avoid inadvertent motor activation. The system complies with IEC/EN 60601-1-2, ed. 3.0 and ed. 4.0 safety standard for electromagnetic compatibility (EMC), requirements and test. However, if the system 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. 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 IFU. Portable and mobile radio frequency (RF) communications equipment can affect medical electrical equipment. Use of accessories other than those specified and sold by Medtronic may result in increased emissions and decreased Electromagnetic (EM) immunity of this unit. Do not use metal-cutting attachment or metal-cutter tools to cut/resect bone. For metal transection, observe the following safety guidelines: W27a Wear eye protection. W27b Irrigate well to cool the cutting surfaces. W27c Protect the wound site from metal debris. When using variable exposure attachments, surgeons should become familiar with the performance of dissecting tools before use and should explore the effect of various levels of tool exposure on tool stability. If the tool exhibits excessive chatter, vibration, or movement, decrease the tool exposure. Failure to follow prescribed maintenance schedule on motors and attachments may result in device(s) detaching and falling from the motor or attachment which may cause patient injury. Electrical contacts must be dry prior to use. When using the 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. Remove footed attachments cautiously and slowly, as per instructions to avoid injury to the user. Excessive side loading could cause non-DK angled attachments to unlock accidentally from motor. Place touch motor in Safe mode (“0”) while not in use. 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. Do not load more than one motor inside the instrument tray per sterilization cycle. Do not wrap the rigid sterilization container. The system devices must be cleaned separate from the instrument trays and sterilization cases. Do not load system devices into instrument trays or sterilization cases until the devices are clean. Devices cannot be sterilized to an adequate Sterility Assurance Level (SAL) without prior cleaning. Do not use any parts other than Medtronic device unless as noted, as damage or substandard performance could result. Do not use cables or power cables with cracks, tears, or corrosion as use may cause injury to patient, user, or operating room staff. Tool flutes are sharp and may perforate surgical gloves. Keep the cutting area of the tool away from fingers and loose clothing to prevent laceration of the user and cross-contamination through a compromised glove. A tool’s size and geometry may create excessive vibration at certain speeds. Increase or decrease pressure supplied to the motor to prevent vibration. If vibration persists, change to a different tool size or geometry to prevent unintended tissue damage.

The Midas Rex™ MR8™ Electric High-Speed Drill System W45 Excessive noise from the tool when drilling close to the cochlea or ossicular chain may cause patient hearing damage. W46 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. W47 Excessive pressure applied to a tool may cause tool fracture. Should a tool fracture in use, exercise extreme care to ensure all the fragments of the tool are removed from the patient. Unremoved tool fragments may cause tissue damage to the patient. W48 Do not use a dissecting tool if its packaging is damaged or opened outside the sterile field. Sterility is compromised if packaging is opened or damaged. W49 Do not use dull tools. Use of dull tools can reduce cutting effectiveness and can cause the system temperature to increase. Use of a dull tool may lead to heat at the cutting site. W50 Exposure of tool packaging to ambient light for extended periods of time may cause damage to packaging. W51 The system user should ensure sensitive anatomy is protected during drilling and use of the system. Failure to do so could cause injury to the patient. W52 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. W53 After each procedure, properly clean and sterilize all reusable devices.

Precautions P1 P2 P3 P4 P5 P6 P7 P8 P9 P10 P11 P12 P13 P14 P15 P16 P17 P18

Do not use a twist drill dissecting tool at an operating speed over 62,000 rpm. Do not use low-temperature hydrogen peroxide gas plasma sterilization due to the lumen internal diameter and length restrictions. Do not use low-temperature liquid peracetic acid sterilization due to immersion procedure. 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. Remove and discard tools and accessories following local regulations for disposal of contaminated materials. Do not soak or submerge system devices. Do not use ultrasonic cleaners for system devices. Use only nylon cleaning brushes. Non-nylon cleaning brushes leave residue that may prevent the tool from being secured properly in the motor. 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 efficacy of the sterilization cycle. Because of the variability in cleaning efficiencies 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. Do not modify device; performance could be diminished. When not operating the motor, eliminate accidental foot control activation. Do not operate the system without eye protection. Use the instrument tray and the rigid sterilization container for sterilizing the re-usable devices only. Do not use the instrument tray and rigid sterilization container for cleaning or disinfection of the reusable devices. Tools with “L” identification are longer tools intended for light bone dissection. The increased tool head/stem configuration may affect dissection stability. It is recommended that devices should be cleaned as soon as possible, preferably within 30 minutes following use to limit fixation of contaminants. Use of a washer-disinfector for cleaning may cause a degradation in performance.

Training requirements This device is intended for use by physicians, or appropriate staff, trained in the procedures described in the indications for use.

Residual risks Residual risks related to the use of the Medtronic Midas Rex™ MR8™ electric high-speed drill System are: General Surgical Complications, Thermal Injury, Tissue or Bone Damage, Nervous System Injury, Cerebrospinal Fluid Leakage, Infection, Hearing Damage, and Electric Shock.

Possible adverse events In the event that a serious incident has occurred related to device use, immediately report the event to Medtronic and the competent authorities.

Material composition Material contained in product that can cause an allergic reaction: nickel. Patients can be exposed to the following material in the dissecting tool with carbide ( Tool CFN with “C” in suffix), which are carcinogenic, mutagenic, and toxic for reproduction (CMR): Material

CAS number

Cobalt

7440‐48‐4.

For additional material of concern information such as REACH, CA Prop 65, or other product stewardship programs, go to www.medtronic.com/productstewardship.

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

Use The following instructions for the electric motors are in addition to the general assembly instructions found in the Integrated Power Console (IPC™) System User’s Guide. To obtain a copy of the IPC™ System User’s Guide, please contact Medtronic or your local distributor. Use an IPC™ system that has software version V2.7.4.0 or later, or update the IPC™ system 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™ system Locate the motor and FCU ports on the IPC™ system connector panel (Figure 1) and insert the multi-pin connector into either of the two motor ports provided. Note: Prior to use, check for bent or missing pins in the cable connectors. 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. 1

IPC™ system connector panel for the MR8™ system

1. 2. 3.

Electric, electric plus, and electric touch motors Intelliflow irrigation remote control FCU

IPC™ system pump detection The IPC™ system incorporates the electric, electric plus, and electric touch motor irrigation tubing sets at Pump 1. If you do not use irrigation for the motors, manually change Pump 1 to None. Refer to the Integrated Power Console (IPC™) System User’s Guide, Set up and Prime Pumps for more information. When the IPC™ system detects the electric or electric plus motor, Pump 2 defaults to None. When the IPC™ system detects both the electric and the electric plus motor, the system defaults Pump 2 to the Shared configuration. Use the pumps screen to override the Shared default by selecting the electric motor for Pump 1. Refer to the Integrated Power Console (IPC™) System User’s Guide, Set up and Prime Pumps for more information. Control the operation of the electric, electric plus and electric touch motors with the IPC™ system touchscreen and the multifunction FCU.

IPC™ system touchscreen controls To set or adjust the electric (Figure 2-1), the electric plus (Figure 2-2), or electric touch (Figure 2-3) motor controls, on the IPC™ system touchscreen: 2-1

IPC™ system touchscreen MR8™ electric motor

2-2

IPC™ system touchscreen MR8™ electric plus motor

2-3

IPC™ system touchscreen MR8™ electric touch motor

In the touchscreen control box, adjust or set motor speed, irrigation flow rate, motor acceleration/deceleration, motor rotation, and SAFE mode option.

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

Speed • The electric, electric touch, and 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 FWD or REV mode (Figures 3-1 and 3-2), in the Speed control box, press the plus button to increase speed or the minus button to decrease speed.

3-1 IPC™ system touchscreen REV button raised

3-2 IPC™ system touchscreen REV button concave

Mode

Mode FWD

FWD

REV

Note: When the 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. 4

IPC™ system safe mode (SAFE) touchscreen - MR8™ electric touch motor

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

Speed

SAFE + RPM

Irrigation • To adjust the irrigation flow rate, in the irrigation control box, press the plus button to increase flow rate or the minus button to decrease flow rate. If intermittent flow is available, pressing the plus or minus button progresses the system through intermittent and continuous flow. The system displays Intermittent when in intermittent flow mode. Note: To adjust flow rate, you can use the touchscreen or the IntelliFlow irrigation remote control. • The default flow rate is 0cc per minute in the FWD or REV mode. • For additional instructions see the Integrated Power Console (IPC™) System 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 or REV Important: System configuration may be different from the default. If the REV button appears raised (Figure 3-1) and does not have a selectable radio button, you cannot select the REV mode. If the REV button appears concave (Figure 3-2) and has a selectable radio button, you can select the REV mode via the touchscreen or the multifunction FCU. • Confirm rotational direction on the IPC™ system display prior to running a finger/foot control system check.

Safe mode (SAFE) • The electric touch motor comes with a safe mode option. When the motor is in safe mode, it is inoperable until the safety is turned off. The Speed control box on the IPC touchscreen displays SAFE when the 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, slide the safe mode switch on the electric touch finger lever to off (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.

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

MR8™ electric motors The electric motor (Figure 6) is a smaller and more compact version of the electric plus motor (Figure 7). The electric touch motor (Figure 8) is a small compact motor that includes a rotating and removable finger lever. The 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 electric motors provide the power to operate disposable surgical dissecting tools, intended for use in various surgical procedures. The electric motors can be controlled either by using the FCU or through the finger lever. The finger-controlled electric motors operate in the same manner as the foot-controlled electric motors. Pressing the finger lever increases the speed and lifting off of the finger lever 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. 6

MR8™ electric motor

MR8™ electric plus motor

1. 2.

Motor collet - Stationary Motor collet - Rotating

12-pin cable connector Motor cable

1. 2.

Motor collet - Stationary Motor collet - Rotating

3. 4.

12-pin cable connector Motor cable

MR8™ electric touch motor

5 6

3. 4.

1. 2. 3. 4. 5. 6.

Telescoping finger rest Finger lever Motor safe mode switch Control lever ring Motor collet - Stationary Motor collet - Rotating

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

MR8™ electric and electric plus motors Multifunction FCU Note: Conduct a system check by pressing the foot pedal to briefly run the motor and confirm proper function prior to any procedure. If motor overheats, discontinue use of the motor. Important: By default, the FCU is activated by pressing the corresponding button for at least 100 milliseconds (mS). Use the IPC™ system touch screen settings screen to change the default value. To use the multifunction FCU (Figure 9) to control the motor, do the following: • To select FWD or REV mode, press the mode button (Figure 9, Number 1). • To change the motor, press the motor button (Figure 9, Number 2). • 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 start or adjust the speed of a motor in variable mode, press the foot pedal (Figure 9, Number 5). Cleaning the FCU For cleaning instructions refer to the section, Clean the FCU, in the Cleaning and sterilization section of the Integrated Power Console (IPC™) System User’s Guide. Multifunction FCUs

1. 2. 3. 4. 5.

1 3

3 5

Mode button Motor button Control button Slip-resistant food pad Foot pedal

5 4

Technical specifications and performance characteristics Table 1: MR8™ electric motor technical specifications and performance characteristics 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)

87 grams

FWD/REV, variable speed of 200–75,000 rpm

For operating room temperatures up to 40°C (104°F), the electric motor is rated for 3 minutes (03:00) of continuous cutting time at 75,000 rpm, followed by 25 minutes (25:00) of rest. For normal operating room temperatures (typically 20°C/68°F), the electric motor is rated for continuous cutting at 75,000 rpm.

Table 2: MR8™ electric plus motor technical specifications and performance characteristics 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

FWD/REV, variable speed of 200–75,000 rpm

For operating room temperatures up to 40°C (104°F), the electric plus motor is rated for 3 minutes (03:00) of continuous cutting time at 75,000 rpm, followed by 25 minutes (25:00) of rest. For normal operating room temperatures (typically 20°C/68°F), the 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 finger lever to briefly run the motor and confirm proper function prior to any procedure. If motor overheats, discontinue use of the motor. The electric touch motor functions exactly as the electric motors that are controlled using the electric FCU but offers the user an option to control the motor with a finger lever. The electric touch motor also offers the user an option to control the motor with the foot via an electric FCU. The IPC touchscreen control modes can engage/disengage the finger and foot controls on the electric touch motor (Figure 10). 10

IPC™ system touchscreen control modes for the MR8™ electric touch motor 1. 2.

Engage/disengage finger lever Engage/disengage foot control

1 2 Finger lever controls The electric touch motor includes a removable and rotating finger lever. Assembly 1. Slide the finger 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 finger lever assembly to the alignment slots. 3. Conduct a system check by pressing the finger lever to briefly run the motor and confirm proper function prior to any procedure. Note: If motor overheats, discontinue use of the motor. Rotation 1. Unlock the finger 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 finger lever by pressing forward (Figure 12). 2. Slide the finger lever completely off the motor. 11

MR8™ electric touch finger lever assembly

1. 2. 3. 4.

Finger lever Alignment arrow Motor alignment slots Unlock lever

Unlocking the finger lever

Finger lever alignment

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

Technical specifications and performance characteristics Table 3: MR8™ electric touch technical specifications and performance characteristics 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, without cable

FWD/REV, variable speed of 200–75,000 rpm

For operating room temperatures up to 40°C (104°F), the electric touch motor is rated for 3 minutes (03:00) of continuous cutting time at 75,000 rpm, followed by 25 minutes (25:00) of rest.

127 grams, assembled

For normal operating room temperatures (typically 20°C/68°F), the 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 2005, CORR. 1:2009, AMMEND. 1:2012

IEC 60601-1

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance 2005, CORR. 1:2006, CORR. 2:2007, AMMEND. 1:2012

EN 60601-1

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance 2006, AMMEND. 12:2014

IEC 60601-1-4

Medical electrical equipment - Part 1: General requirements for safety, Part 4: Programmable electrical medical systems 1996, AMMEND. 1:1999

IEC 60601-1-2

Medical electrical equipment - Part 1-2: General requirements for safety, collateral standard: electromagnetic compatibility - requirements and tests ED. 3.0:2007, ED. 4.0:2014

CAN/CSA C22.2#60601-1

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

Environment of intended use: • Professional healthcare facility environment

Part-1: Electromagnetic immunity The MR8™ system is intended for use in the electromagnetic environment specified 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

± 8 kV contact

The relative humidity should be at least 5%.

± 15 kV air

Note 1 and 3

Electrical fast transient/burst IEC 61000-4-4

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

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

Surge IEC 61000-4-5

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

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

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

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°

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.

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

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

Note 1 and 3

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment

Note: 1. UT is the mains voltage prior to application of the test level. 2. When the console is powered and connected to the FCU, application of -15KV air discharge onto the foot switch buttons may cause the console to freeze. Power cycle the console to reestablish normal operation. 3. All electric motors are compliant with IEC/EN 60601-1-2, ed. 3.0 and ed. 4.0 standards. Refer to the Integrated Power Console (IPC™) System User’s Guide to determine specific standard compliance for the IPC™ system. 9

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

Part-1: Electromagnetic emissions The MR8™ system is intended for use in the electromagnetic environment specified 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

Group 1

The MR8™ system uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emission CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Class A

The MR8™ system is suitable for use in all establishments, other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings for domestic purpose.

Voltage fluctuations/flicker emissions IEC 61000-3-3

Complies

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

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

0.01

0.03

0.07

0.03

0.07

0.1

0.07

0.21

0.07

0.21

0.22

0.67

0.22

0.67

0.7

2.12

0.7

2.12

100

2.2

6.7

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 affected by absorption and reflection from structures, objects and people.

Part-2: Guidance and manufacturer’s declaration – electromagnetic immunities The MR8™ system is intended for use in the electromagnetic environment specified 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

3 Vrms 150 kHz to 80 MHz

6 Vrms 150 kHz to 80 MHz in ISM bands

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 specified by the manufacturer. Otherwise, degradation of the performance of this equipment may result.

3 V/m 80 MHz to 2.7 GHz

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

Radiated RF IEC 61000-4-3

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: 6 d P E 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:

Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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

MR8™ surgical dissecting tools

The 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 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 different 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 fluted or diamond coated.

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

Tool nomenclature Part numbers for surgical dissecting tools follow a nomenclature, which is described in the diagram below (Figure 15). Standard tool part numbers consist of the MR8™ product family designator, associated attachment length, the tool family identifier, and the tool head diameter. Part numbers may also include a variety of prefixes to identify specific attachment types, as well as a variety of suffixes 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 and in sealed packaging. 15

MR8™ surgical dissecting tool nomenclature

MR8 -

9 MH30 1

Note: MR8 prefix in the dissecting tool CFN indicates MR8™ product family. 1. 2. 3.

Optional prefix Attachment length, x centimeters (Ex. 9 = 9 cm) Tool family identifier, xx form/function (Ex. MH = Match head)

Tool head diameter, x.x or xx.x millimeters (Ex. 30 = 3.0 mm) Optional depth x.x or xx.x millimeters (Ex. 19 = 1.9 mm) Optional suffix

5. 6.

Tool number prefixes (not all inclusive)

Tool number suffixes (not all inclusive)

Note: A single part number will use only one prefix.

Note: More than one suffix may be combined in a single part number.

Prefix

Tool attachments

Suffix

Tool head cutting modifiers

Footed attachments

Ball

Telescoping tube

Barrel

Carbide

Tool family identifier (form/function)

Cornerstone

Acorn

Diamond

Ball

Diamond coarse

Cylinder

Diamond fine

Hole maker

Diamond extra coarse

Hole saw

DXF

Diamond extra fine

Metal cutter

Fine

Match head

Match flute (on telescoping tools)

Oval

Spiral flutes

Reverse taper

3-Flute or symmeTRI

Tapered or side cutter

Extra

Twist drill

Extra fine

Wing flute

Tool length modifiers L

Long

Short 11

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

General guidelines for attachments and tool applications These are general guidelines for dissecting tool applications and are not an all-inclusive listing.

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 flutes dissect bone or cement effectively from a wide variety of approach angles. For debridement, decortication, sinus dissection, etcetera. Oval Helical cutting flutes and curved design blend acorn and ball styles to vary dissection efficiency 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 efficient and effective for interbody fusion. Cylinder Effective bone sculpting and planing. For graft shaping, debridement, corpectomy, decortication, interbody fusion, fusion takedown, etcetera. Acorn Curved design varies dissection efficiency with varied approach angles. For entry hole, laminotomy, bone shaping, debridement, corpectomy, decortication, fusion takedown, etcetera.

MR8 telescoping

Spine

MR8 footed, MR8 straight

Match head Elongated spherical design allows controlled, delicate dissection. For entry hole, nerve decompression, osteophyte removal, 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. Reverse tapered Semi-trapezoidal shape with helical cutting flutes and a smooth cutting tip designed for efficient 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 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)

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

Ear, nose, and throat (otology, neurotology)

MR8 7, MR8 10

Ball Helical cutting flutes dissect bone or cement effectively from a wide variety of approach angles. For debridement, decortication, sinus dissection, etcetera. 13

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 Ball Helical cutting flutes dissect bone or cement effectively 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 efficiency with varied approach angles. For entry hole, laminotomy, bone shaping, debridement, corpectomy, decortication, fusion takedown, etcetera. Cylinder Effective bone sculpting and planing. For graft shaping, debridement, corpectomy, decortication, interbody fusion, fusion takedown, etcetera.

Biometals/bioceramics/ MR8 MC9, MR8 MC14 biomaterials

Metal cutter Cutting flutes or diamond wheel design remove metals, ceramics and other biomaterials effectively 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 non‑sterile, 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. Attachments are available in various designs, lengths, and diameters to facilitate a variety of surgical procedures. The attachments family includes a variety of standard attachments, fixed and rotating footed (craniotomes), telescoping, and specialty attachments (metal cutters, Jacobs chuck, J-latch, and perforator attachments). Standard attachments consist of straight and angled configurations, which are offered either as fixed or variable exposure. The availability of the Medtronic attachments allows the surgeon flexibility 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

MR8™ attachment arrow icons

16-2

MR8™ attachment lock

16-3

MR8™ attachment unlock

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

Straight attachments Warnings: • The motors will not run at all, if not locked. • Use only dissecting tools specifically designed for use with this drill system. Match the nomenclature and color code on the dissecting tool packaging to the same nomenclature and color band on the attachment. Note: An attachment will not seat on the motor if the arrows on the collet flats on the motor 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, confirms 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, confirms 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, reseat the tool, and relock the attachment. Disassembly 1. Hold the motor in the palm of your hand. Rotate the attachment to the unlocked position. In this position, the arrows in the attachment and motor will line up (Figure 17-2). 2. Pull the dissecting tool from the attachment and discard the tool. 3. Use thumb and index finger to lift the attachment off of the motor. 17-1

17-2

17-3

MR8™ straight attachment assembly

MR8™ straight attachment assembly/disassembly

MR8™ straight attachment assembly

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

Angled attachments Warnings: • The motors will not run at all, if not locked. • Use only dissecting tools specifically designed for use with this drill system. Match the nomenclature and color code on the dissecting tool packaging to the same nomenclature and color band on the attachment. Notes: • An attachment will not seat on the motor if the arrows on the collet flats 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, confirms 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, reseat the tool, and relock 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, confirms that the attachment is fully seated. 5. Rotate the attachment in the direction indicated by the arrow until the 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 the attachment off of the motor. 18-1

MR8™ angled attachment assembly

18-2

MR8™ angled attachment assembly

1. Tool lock/unlock sleeve 18-3

MR8™ angled attachment assembly

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