Stealth-Midas MR8 System Instructions for Use Rev F April 2022

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 Pneumatic Stealth-Midas™ MR8™ system description ... 1 Pneumatic motors... 1 Attachments... 1 Surgical dissecting tools... 1 System accessories... 1 Indications for use... 1 Target patient population... 1 Intended use...1 Clinical benefits...1 Contraindications... 1 Special notices... 1 Warnings... 2 Precautions... 3 Training requirements...3 Residual risks... 3 Possible adverse events... 3 Material composition... 3 Pneumatic Stealth-Midas™ MR8™ motor... 4 Components... 4 Operating room set up... 4 Power source requirements... 4 Adapters... 5 Pneumatic connections... 6 Pneumatic Stealth-Midas™ MR8™ system... 7 Setting up the system... 7 Connecting the motor... 7 Activating the motor... 7 MR8™ dissecting tools and attachments... 8 Straight attachment assembly... 8 Straight attachment disassembly... 8 Angled attachment assembly... 9 Angled attachment disassembly... 9 Variable exposure straight and angled attachments... 10 Navigable dissecting tools and attachments... 10 Sterile sphere assembly... 10 Navigation... 10 Troubleshooting... 11

Disassembling the system... 12 Depressurize the system... 12 Disconnect hoses... 12 Discard the lubricant/diffuser cartridge... 12 Remove the attachment and tools... 12 System set-up check ...12 System accessories: disposable devices... 12 Cleaning brushes... 12 System accessories: non-disposable devices... 12 Motor wrench... 12 Instrument tray... 12 Rigid sterilization container (sterilization case)... 13 Sterility...13 Pneumatic Stealth-Midas™ MR8™ system reprocessing instructions... 13 Warnings and cautions... 13 Limitations on reprocessing... 13 Point of use... 13 Containment and transportation... 13 Preparation for cleaning: automated... 14 Cleaning: Automated... 15 After cleaning: Automated ...15 Cleaning: Manual... 16 After cleaning: Manual ...17 Disinfection... 17 Drying... 17 Maintenance, inspection, and testing... 17 Packaging... 18 Sterilization... 20 Storage... 20 Use... 20 Return policy for devices exposed to TSE (transmissible spongiform encephalopathies)... 21 Planned maintenance... 21 Storage... 21 Disposal... 21 Limited warranty... 21 Symbols ... 22

Pneumatic Stealth-Midas™ MR8™ System

Glossary Dissecting tool

Disposable cutting tool that connects to Stealth-Midas™ MR8™ motor

DK

Double Locking

PCU

Pneumatic Control Unit

MR8

Midas Rex™ System, 8th generation

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 use of the using Pneumatic Stealth-Midas™ MR8™ System. The Pneumatic Stealth-Midas™ 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 system by being trained in Medtronic Midas Rex Hands-On Workshops or by one of the local authorized representatives.

Pneumatic Stealth-Midas™ MR8™ system description The Stealth-Midas™ MR8™ System includes a powered drill to operate disposable surgical dissecting tools that will remove hard tissue, bone, and biomaterials during surgical procedures. The permanently attached tracker will allow for intraoperative navigation of spinal and cranial procedures using the Medtronic Stealth Systems.

Pneumatic motors Pneumatic 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.

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) and variable exposure (straight and angled).

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.

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, and tool rack. All of these are considered medical devices except for the tool rack.

Indications for use The Pneumatic Stealth-Midas™ MR8™ System is indicated for the drilling, burring, and removal of hard tissue and bone in spinal and cranial surgical procedures. Computer-assisted surgery and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitized landmarks of the anatomy.

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

Intended use The Pneumatic Stealth-Midas™ MR8™ System is intended to be used to perform the task of removing soft and hard tissue and bone through intraoperative navigation in spinal and cranial procedures with the StealthStation™ S8 System.

Clinical benefits Clinical benefits of the Pneumatic Stealth-Midas™ MR8™ System include real-time visualization of the instrument tip relative to patient anatomy with clinically acceptable accuracy, sufficient power to cut bone and biomaterials, ergonomic grip that allows precise control, sensory feedback while cutting, optimized visibility and maneuverability in the surgical site, the ability to adjust/configure the system efficiently, and a portfolio of attachments and tools that meet different surgical needs.

Contraindications None.

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.

1

Pneumatic Stealth-Midas™ MR8™ System

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 W45 W46 2

The Stealth-Midas™ MR8™ System and its associated applications should be used only as an adjunct for surgical guidance. It is not a replacement for the surgeon’s knowledge, expertise, or judgment. Operate the Stealth-Midas™ MR8™ System only after appropriate anatomical landmarks have been identified and the intended surgical site has been confirmed. Refer to the Medtronic Stealth Systems manuals for instructions to complete these guidelines. Operate the Stealth-Midas™ MR8™ System only after fully engaging the Secondary Lock. Do not apply force when verifying dissecting tools. The user must be familiar with this Stealth-Midas™ MR8™ SystemIFU, the Midas Rex™ MR8™ Pneumatic High-Speed Drill System IFU, Midas Rex™ MR8™ ClearView™ IFU, and Medtronic Stealth Systems manuals for 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 MR8™ dissecting tool packaging to the same nomenclature and color band on the MR8™ attachment. Confirm that the dissecting tool packaging label has the Stealth-Midas™ MR8™ logo ( Stealth-MidasTM MR8TM ) if navigation is required. Do not use the reusable devices without proper cleaning and sterilization. Sterilize and dry reusable device before storing. All service must be performed by Medtronic qualified personnel only. Discontinue 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 user and/or cross contamination through 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 a system if the motor continues to run after releasing the FCU. 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 the motor in the proximity of a magnetic field, such as magnetic drape or magnetic resonance imaging (MRI) equipment to avoid inadvertent motor activation. When using variable exposure attachments, surgeons should become familiar with the performance of dissecting tools before use and should explore 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, causing patient injury. 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. When using 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. Excessive side loading could cause non-DK angled attachments to unlock accidentally from motor. Failure to properly secure the lubricant/diffuser or oil cartridge may cause injury to patient, user, and/or operating room staff. Do not use a motor that is leaking lubricant. 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 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. The system user should that ensure sensitive anatomy is protected during drilling and use of the system. Failure to do so could cause injury to the patient. Do not use any parts other than Medtronic device unless as noted, as damage or substandard performance could result. Do not pinch, kink, obstruct, cut, tear, or step on the motor/exhaust hose. This may cause the hose to burst, potentially injuring the patient or user. 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 user and cross-contamination through 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. Excessive noise from the tool when drilling close to the cochlea or ossicular chain may cause patient hearing damage. 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. Excessive pressure applied to tool may cause tool fracture. Should a tool fracture in use, exercise extreme care to ensure all fragments of the tool are removed from the patient. Unremoved tool fragments may cause tissue damage to the patient. Do not use a dissecting tool if its packaging is opened or damaged. Sterility is compromised if packaging is opened or damaged.

Pneumatic Stealth-Midas™ MR8™ System W47 Do not use dull tools. Use of dull tools can reduce cutting effectiveness and can cause the motor temperature to increase. Use of a dull tool may lead to heat at the cutting site. W48 Exposure of tool packaging to ambient light for extended periods of time may cause damage to packaging. W49 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. W50 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 P19 P20 P21 P22 P23 P24 P25 P26 P27

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. Remove and discard tools and accessories following local regulations for disposal of contaminated materials. 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. Do not soak or submerge system devices. Do not use ultrasonic cleaners for system devices. Do not use a pneumatic motor without a lubricant/diffuser or oiler cartridge installed. Use only nylon cleaning brushes. Non-nylon cleaning brushes leave residue that may prevent the tool from being secured properly in the motor. The use of a washer-disinfector for cleaning may cause a degradation in performance. 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. 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. Remove navigation spheres from tracker prior to cleaning and sterilization. Use the instrument tray and the rigid sterilization container for sterilizing the reusable devices only. Do not use the instrument tray and sterilization container for cleaning or disinfection of the reusable devices. Because of the variability in cleaning efficiencies and sterilizer operating parameters, all given parameters (temperature, time, et cetera) should be validated by persons who have training and expertise in sterilization processes. Deviation from the recommended sterilization processes is at the risk of the user facility. Do not use a lubricant/diffuser or oiler cartridge for more than one hour of drill time. Do not reuse or attempt to refill a lubricant/diffuser or oiler cartridge. It is a single-use product. Do not use a lubricant/diffuser or oiler cartridge if it appears to be damaged or if the inner foil seal is punctured. It is recommended that devices should be cleaned as soon as possible, preferably within 30 minutes following use to limit fixation of contaminants. The tracker is permanently affixed to the motor and should not be removed at any time. Do not remove tracker from the motor. Do not use the PCU to operate systems other than the Midas Rex™ devices. Do not carry PCU by the N2 DISS pressure hose. Do not disassemble equipment before gas pressure is released from PCU and associated hoses. Ensure the adapter is fully threaded onto the regulator hose and fully threaded/connected to the corresponding wall outlet before operating the pneumatic system.

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 Pneumatic Stealth-Midas™ MR8™ System are: General Surgical Complications, Thermal Injury, Tissue or Bone Damage, Blood Loss, Nervous System Injury, Cerebrospinal Fluid Leakage, Infection, Hearing Damage, and Death.

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.

3

Pneumatic Stealth-Midas™ MR8™ System

Pneumatic Stealth-Midas™ MR8™ motor Components The Pneumatic Stealth-Midas™ MR8™ motor is a high-speed, high-torque motor used to dissect bone and biomaterials (Figure 1). Pneumatic Stealth-Midas™ MR8™ motor

1

1. Collet 2. Pneumatic motor 3. Tracker 4. Hose 5. Foot switch connection

Technical specifications and performance characteristics Table 1. MR8™ pneumatic motor technical specifications and performance characteristics MR8™ pneumatic motor (PM800N) Size

Weight

Length: 4.29 in (10.89 cm) x Diameter: 2.08 cm (0.82 in)

158.75 grams

Operating room set up Power source requirements Precaution: Do not run the motor at an operating pressure above or below the required operating pressure range. Operating pressure below 552 kPa (80 psi) may not provide proper lubrication to the motor. Operating pressure above 827 kPa (120 psi) may damage or reduce the life of the motor. Table 2: Power source requirements Required Operating (Dynamic) Pressure

4

Nominal Operating (Dynamic) Pressure

Approximate Flow Rate Required

80 psi to 120 psi

100 psi

12 cubic feet/minute

552 kPa to 827 kPa

690 kPa

340 liters/minute

Gas Type Nitrogen or Dry-Filtered Compressed Air

Pneumatic Stealth-Midas™ MR8™ System

Adapters Precaution: Ensure the adapter is fully threaded onto the regulator hose and fully threaded/connected to the corresponding wall outlet before operating the pneumatic system. N2 DISS to surgical tool air male SIS adapter gas source (Australia/New Zealand only) The N2 DISS to surgical tool air male SIS adapter gas source (Figure 2-1) allows for the regulator hose to connect to AUS-SIS wall fittings for surgical tool air. The functioning of the N2 DISS to surgical tool air male SIS adapter gas source is intended for use in Australia and New Zealand only. N2 DISS to male Schrader adapter Allows for the PCU’s N2 DISS pressure hose connection to be attached to a Female Schrader in-house gas connection (Figure 2-2). An N2 DISS to Female Schrader Adapter is also available for connection of the PCU’s N2 DISS pressure hose to a Male Schrader in-house gas connection. N2 DISS to male Schrader adapter (UK) The N2 DISS to male Schrader adapter (Figure 2-3) allows for the PCU’s N2 DISS pressure hose connection to be attached to a female Schrader (UK) in-house gas connection. N2 DISS to air DISS adapter Allows for the PCU’s N2 DISS pressure hose connection to be attached to an Air DISS in-house gas connection (Figure 2-4). N2 DISS to female Schrader adapter The N2 DISS to female Schrader adapter (Figure 2-5) allows for the PCU’s N2 DISS pressure hose connection to be attached to a male Schrader in-house gas connection. N2 DISS to surgical tool air male SIS adapter The N2 DISS to surgical tool air male SIS adapter (Figure 2-6) allows for the PCU’s N2 DISS pressure hose connection to be attached to an AUS-SIS surgical tool air inhouse gas connection. N2 DISS to WF4 adapter Allows for the PCU’s N2 DISS pressure hose connection to be attached to a regulator previously used for Midas Rex Classic or Midas Rex III Motors (Figure 2-7). The in-line oiler must be removed from the regulator. Triton pneumatic adapter The Triton adapter (Figure 2-8) allows the Triton handpiece to be driven by the MR8 PCU. It functions much the same way as the Triton port on the Legend PCU, except that it is connected between the control unit and the gas source, rather than being integrated into the control unit. 2-1 N2 DISS to surgical tool air male SIS adapter gas source

2-2

2-5

2-6

N2 DISS to female Schrader adapter

N2 DISS to male Schrader adapter

N2 DISS to surgical tool air male SIS adapter

2-3

N2 DISS to male Schrader adapter (UK)

2-4

N2 DISS to air DISS adapter

2-7

N2 DISS to WF4 adapter

2-8

Triton pneumatic adapter

5

Pneumatic Stealth-Midas™ MR8™ System

Pneumatic connections Precaution: If you are using the Midas Rex™ safety valve regulator instead of the Legend™ regulator, you must replace the in‑line oiler with the DISS/WF4 adapter before use. Warning: The adapter must be fully threaded onto the regulator hose and connected to the corresponding wall outlet before operating the pneumatic system. Regulator The regulator (Figure 3) controls the delivery pressure of compressed gas to the PCU. The pressure gauges monitor cylinder pressure (right gauge) and delivery pressure (left gauge). Note: Outlet pressure gauge accurate to ± 12 psi. 3

Pneumatic adapter diagram

4 5 3

6

2

7

1

8

9

10 1. Regulator hose (N2 DISS)

6. N2 DISS to male Schrader adapter gas source

2. N2 DISS to male Schrader adapter - UK gas source

7. Gas source (N2 DISS)

3. N2 DISS to female Schrader adapter gas source

8. Midas Rex™ safety valve regulator

4. N2 DISS to surgical tool air male SIS adapter gas source (Australia/New Zealand only)

9. DISS/WF4 adapter

5. N2 DISS to air DISS adapter gas source

10. Legend™ regulator

Operating (dynamic) pressure may be checked diagnostically at the PCU while the motor is running. Operating pressure will decrease slightly from the non-running (static) pressure setting when the motor is activated. Adjust operating pressure as needed at the compressed gas source until supply pressure gauge on PCU reads within a range of 552 kPa to 827 kPa (80 psi to 120 psi), as required. To ensure optimal motor performance, set nominal operating pressure to 690 kPa (100 psi). If the surgeon requests additional power during a procedure, compressed gas source may be turned up to an operating pressure of 827 kPa (120 psi). To decrease pressure, turn down the in-house compressed gas source or turn the pressure handle on the regulator counter-clockwise. Push down on the pressure relief at the PCU to exhaust excess pressure.

6

Pneumatic Stealth-Midas™ MR8™ System

Pneumatic Stealth-Midas™ MR8™ system Setting up the system

4 Aligning the lubricant/diffuser cartridge with the housing

5

Pressing the cartridge onto the housing

6

Correctly installed lubricant/diffuser cartridge

7

Connecting the motor hose to the motor port

8

Aligning the collet arrows

9

Foot control unit

Installing the oiler cartridge in the non-sterile field 1. Set the non-running (static) pressure to 552 kPa to 827 kPa (80 psi to 120 psi) at the gas source. Operating (dynamic) pressure may be adjusted later. 2.

Hold the lubricant/diffuser cartridge perpendicular to the housing (Figure 4), and press the cartridge’s circular fitting onto the housing’s circular receptacle (Figure 5), breaking the foil seal.

3.

Rotate the cartridge down until it clicks into place and is secured onto the oiler stem end of the motor hose.

4.

Verify that the lock symbol on the cartridge is lined up with the notch on the housing (Figure 6).

Warnings: • Failure to properly secure the lubricant/diffuser or oiler cartridge may cause injury to patient, user, and/or operating room staff. • Do not remove the lubricant/diffuser or oiler cartridge while the system is pressurized. Precautions: • Do not use the motor without a lubricant/diffuser or oiler cartridge installed. • Do not use a lubricant/diffuser or oiler cartridge for more than one hour of drill time. • Do not re-use or attempt to refill a lubricant/diffuser or oiler cartridge. It is a single-use product. • Do not use a lubricant/diffuser or oiler cartridge if it appears to be damaged, or if the inner foil seal is punctured.

Connecting the motor Connect the motor hose to the motor port on top of the PCU, by swinging the port cover to the side and pressing the end of the hose into the port (Figure 7). Warning: Do not pinch, kink, obstruct, cut, tear, or step on the motor/exhaust hose. This may cause the hose to burst, potentially injuring the patient or user. Note: The motor’s exhaust hose may have an oily film on the external surface from the pressure and/or temperature differentials following sterilization. Wipe the exhaust hose with a sterile cloth prior to use. If motor continues to have oil on the exhaust hose, return the motor to Medtronic for refurbishing. Prior to installation of an MR8 attachment and dissecting tool, ensure the motor collet arrows are aligned (Figure 8). If the arrows are not aligned, use the motor wrench to turn the collet flat closest to the motor case until the arrows are aligned.

1. Foot control pedal 2. Motor port 3. Air pressure gauge 4. Control slide

Activating the motor 1. 2.

Activate the motor by pressing on the foot control pedal (Figure 9). Adjust operating pressure as needed at the compressed gas source until supply pressure gauge on PCU reads within a range of 552 kPa to 827 kPa (80 psi to 120 psi) as required. Operating pressure (with motor running) will decrease slightly from the non-running (static) pressure setting when the motor is activated. Note: To decrease pressure, turn down the in-house compressed gas source or turn the pressure handle on the regulator counter-clockwise. Push down on the pressure relief at the PCU to exhaust pressure in the hoses. Then readjust pressure as needed.

7

Pneumatic Stealth-Midas™ MR8™ System

MR8™ dissecting tools and attachments Straight attachment assembly Warning: Match the nomenclature and color code on the tool packaging to the same nomenclature and color code on the attachment. Confirm that the dissecting tool packaging label has the Stealth-Midas™ MR8™ logo ( Stealth-MidasTM MR8TM ) if navigation is required. Notes: • Prior to installation of an attachment and dissecting tool, ensure the motor collet arrows are aligned. If the arrows are not aligned, use the motor wrench to turn the collet flat closest to the motor case until the arrows are aligned. • The motors will not operate if the attachment is not in the fully locked position. 1. 2.

10

Slide a straight attachment over the motor collet aligning triangular arrows on the attachment and the motor case (Figure 10). An audible click, heard and perceptible by touch, confirms that the attachment is fully seated. Insert the tool into the attachment with a slight rotational motion (Figure 11). An audible click, heard and perceptible to the touch, confirms that the tool is fully seated. Straight attachment assembly

Insert tool

11

3. To lock the attachment, 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 12). Note: You will hear an audible click as the attachment is rotated to the locked position. 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.

5. To rotate the secondary lock to the locked position, rotate the secondary lock collar marked with “NAV” in the direction of the arrow to achieve a snug connection between attachment and motor (Figure 13). Apply enough rotational torque so that a solid connection is attained. The secondary lock should become fully engaged after ¼ turn. Once fully engaged, the arrow head on the “NAV” locking ring will be in proximity to the lock symbol on the motor. Note: This secondary lock is required to eliminate motion between the attachment and the motor, which could impact navigation accuracy. 12

Attachment in the locked position

13

Locking the secondary lock

Straight attachment disassembly 1. 2. 3. 4. 14

8

Hold the motor in the palm of your hand and unlock the secondary lock by rotating it by a ¼ turn in order to bring the arrow on the “NAV” locking ring in proximity to the unlock symbok on the motor (Figure 14). Rotate the attachment to the unlocked position. The arrows in the attachment and motor will line up by the unlock symbol (Figure 15). Remove the dissecting tool from the attachment and discard the tool. Use thumb and index finger to pull the attachment off the motor. Straight attachment disassembly: Unlock the secondary lock

15

Rotate the attachment to the unlocked position

Pneumatic Stealth-Midas™ MR8™ System

Angled attachment assembly 1. 2.

With the attachment tool lock in the unlocked position, insert a dissecting tool into the angled attachment with a slight rotational motion (Figure 16). An audible click, heard and perceptible by touch, confirms that the tool is fully seated. Lock the tool by rotating 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 17).

16

Angled attachment assembly: Insert tool

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. Slide the angled attachment over the motor collet aligning the triangular arrows on the attachment and the motor. The angled attachment will be to the left of the motor with the motor tracker facing up (Figure 18). An audible click, heard and perceptible by touch, confirms that the attachment is fully seated. Rotate the attachment in the direction indicated by the arrow until the attachment alignment mark is directly in line with the locked symbol. You will hear an audible click as the attachment is rotated to the locked position.

4.

5.

17

Angled attachment assembly: Rotate tool lock

18

Angled attachment assembly: Motor tracker facing up

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 19). 7. To rotate the secondary lock to the locked position, rotate the secondary lock collar marked with “NAV” in the direction of the arrow to achieve a snug connection between attachment and motor (Figure 20). Apply enough rotational torque so that a solid connection is attained. The secondary lock should become fully engaged after ¼ turn. Once fully engaged, the arrow head on the “NAV” locking ring will be in proximity to the lock symbol on the motor. Notes: • This secondary lock is required to eliminate motion between the attachment and the motor, which could impact navigation accuracy. • Navigation is enabled for angled attachments in the down orientation. • Angled attachment assembly instructions are applicable to double locking attachments. 19

Angled attachment assembly: Tool/attachment lock to motor

Angled attachment disassembly 1. 2. 3.

4.

5.

Rotate the attachment tool lock to the unlocked position to remove the tool from the angled attachment. Remove the dissecting tool from the attachment and discard the tool. Hold the motor in the palm of your hand and unlock the secondary lock by rotating it by a ¼ turn in order to bring the arrow on the “NAV” locking ring in proximity to the unlock symbok on the motor. Rotate the attachment to the unlocked position. The arrows in the attachment and motor will line up by the unlock symbol (Figure 21). Note: If using a DK attachment, push the attachment distally before rotating. Use thumb and index finger to remove the angled attachment from the motor.

20

Secondary lock tightens attachment to motor

21

Unlocked position of the angled attachment

9

Pneumatic Stealth-Midas™ MR8™ 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 effect of various levels of tool exposure on dissection stability. If the tool exhibits excessive chatter, vibration, or movement, decrease the tool exposure. Notes: • For fixed and variable straight attachments, the tool is locked in the motor collet. On fixed and variable angled attachments, the tool is locked in the attachment collet. • There is a rotatable dial on the variable exposure attachment, not included on the fixed attachment. • Dissecting tool size and geometry may contribute to excessive vibration at certain speeds. Increase or decrease speed by adjusting the foot or finger lever, or by changing the IPC™ system speed setting. If necessary, use a different 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 attachment assembly instructions and the variable exposure angled attachments using the Angled attachment assembly instructions. 2. After assembly, use the tube adjustment ring to adjust the exposure of the dissecting tool (Figure 22).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 attachment disassembly instructions and the variable exposure angled attachments using the Angled attachment disassembly instructions.

Navigable dissecting tools and attachments

22

Variable exposure attachment assembly

23

Midas tool sample label with Stealth-Midas™ MR8™ logo

24

Sterile sphere assembly

Note: Refer to the Midas Rex™ MR8™ Pneumatic High-Speed drill system Instructions for IFU on tool nomenclature and attachment details. Dissecting tools Use only dissecting tools specifically designed for use with this drill system. Confirm that the dissecting tool packaging label has the Stealth-Midas™ MR8™ logo ( Stealth-MidasTM MR8TM ) if navigation is required (Figure 23). Attachments The Stealth-Midas™ MR8™ system is compatible with MR8™ attachment types that correspond to a navigable tool: straight, angled, variable, or doublelocking. Note: The location of the tool head (tip) relative to the tracker does not change when the tool exposure changes.

Sterile sphere assembly Open sterile spheres package (P/N 8801085). One pack is a set of five. Place single-use sterile spheres on each of the tracker’s four posts (Figure 24). Press on each sterile sphere onto the stem until they “snap” into place. Ensure the sterile spheres are firmly seated on the posts, clean and dry before navigating.

Navigation Once the sterile spheres are assembled the product can be optically tracked by the StealthStation™ S8 system. Refer to the StealthStation™ S8 Spine and Cranial Software Pocket Guides for further instructions on selection of instrument tool cards, verification, and navigation of the Stealth-Midas™ MR8™ devices.

10

Pneumatic Stealth-Midas™ MR8™ System

Troubleshooting Issue Motor not running or low on power

Possible Cause Hoses not properly connected.

Action Make sure all connections are secure. Check gas supply pressure gauge.

Operating pressure inadequate.

Increase pressure according to compressed gas requirements, if necessary.

Attachment not properly installed and locked onto the motor.

Remove and re-install attachment and tool to ensure proper installation and locking of attachment onto motor.

Foot control unit on PCU not functioning properly.

Check for obstructions under the foot control unit. If foot control unit continues to fail, return the PCU to Medtronic.

Motor stalls.

Manually spin the dissecting tool, then activate the motor. If the motor continues to stall, return it to Medtronic.

Motor continues to run

PCU is not functioning properly.

Depressurize the system and return the PCU to Medtronic.

System makes an abnormal noise

Inadequate lubrication.

Check for proper installation of the lubricant/diffuser cartridge. If the problem persists, replace the cartridge. If replacing the cartridge does not fix the problem, return the motor to Medtronic.

Motor’s exhaust hose is damaged, or internal pressure hose is detached.

Depressurize the system and return the motor to Medtronic.

Worn bearings.

Switch attachments to determine whether the bearings are failing in the motor or in the attachment. Return the failing component to Medtronic.

Attachment not properly installed and locked onto the motor.

Remove and reinstall attachment and tool to ensure proper installation and locking of the attachment onto the motor.

Motor is too hot to touch/hold

Safety relief valve has been activated by high air pressure.

Ensure that air operating/dynamic air pressure is no higher than 827 kPa (120 psi).

Inadequate cool down period following sterilization.

Motor must be allowed to cool down following steam sterilization.

Inadequate lubrication.

Check for proper installation of the lubricant/diffuser cartridge.

Attachment transferring heat to the motor.

Switch attachments to determine whether the heat is being generated by the motor or the attachment.

Heavy side loading during dissection.

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

Attachment will not properly seat in the motor

Motor collet arrows are not aligned.

Use the motor wrench to rotate the flat closest to the motor case until the arrows are aligned.

Tool is difficult to remove from attachment

Aging of attachment.

Return to Medtronic or purchase new attachment.

Improper cleaning. Use of reprocessed tools. Use of an unauthorized refurbisher. Dissecting tool fails

A non-Stealth-Midas™ MR8™ dissecting tool is being used.

Replace with a Stealth-Midas™ MR8™ dissecting tool.

Worn attachment bearings.

Try another attachment to isolate the location of the problem. If the attachment is failing, return it to Medtronic for service.

Attachment and tool are not compatible.

Match color code on the dissecting tool packaging to the color code of the attachment

Motor is damaged.

Return motor to Medtronic.

Dissecting tool’s size and geometry may contribute to failing at certain speeds.

Adjust the speed by changing the pressure setting or foot control. If failing persists, change dissecting tool.

Dissecting tool vibrates excessively

Dissecting tool’s size and geometry may create excessive vibration at certain speeds.

Adjust the speed by changing the pressure setting or foot control. Change dissecting tools.

Dissecting tool will not seat properly in the motor or attachment collet

Debris in collet of attachment or motor.

Clean the attachment or motor thoroughly according to the instructions in this manual. If cleaning does not correct the problem, return the attachment or motor to Medtronic.

A non-Stealth-Midas™ MR8™ dissecting tool is being used.

Replace with a Stealth-Midas™ MR8™ dissecting tool.

Attachment is not in the locked position.

Make sure the attachment is in the locked position.

Smoke is generated by the attachment or motor System does not navigate *For navigation troubleshooting, consult the StealthStation S8 Pocket Guide and StealthStation S8 System Manual

Non-navigated dissecting tool selected on packaging

Ensure tool has the Stealth-Midas™ MR8™ logo.

Angled attachment not in fully locked position

Confirm that the attachment to motor lock and secondary lock are both secure.

Incorrect Angled Attachment orientation

Confirm angled attachment tool faces away from tracker.

11

Pneumatic Stealth-Midas™ MR8™ System

Disassembling the system

25

Motor port connection and pressure relief buttons

Depressurize the system 1. Turn off the compressed gas at the source. 2. Press the pressure relief button on the PCU, to release remaining gas (Figure 24). Warning: Do not disassemble equipment before the gas is released from the control unit.

1

2

1.

Motor port connection button

2.

Pressure relief button

Disconnect hoses Release the motor hose from the control unit, by holding the hose firmly and pressing the motor port connection button (Figure 25).

Discard the lubricant/diffuser cartridge Remove the lubricant/diffuser cartridge from the housing and discard it. Precaution: Do not re-use a lubricant/diffuser cartridge. It is a single-use product.

Remove the attachment and tools 1. 2.

Follow the applicable instructions in the Dissecting Tools and Attachments section of this manual to remove the attachment and tool from the motor. Discard used dissecting tools in an appropriate container.

System set-up check During set-up of system, verify functionality system prior to use: • Conduct a visual inspection of the hoses for cracks, tears, or corrosion. • Check attachments for proper appearance. • Install the attachment and dissecting tool, then briefl y run the motor. • Check motor and attachment for overheating. • Check dissecting tool for flail.

System accessories: disposable devices

Table 3: Disposable cleaning brush dimensions Internal bore diameter

Brush length

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

1.2 mm

20 cm (8 in)

The disposable cleaning brushes are sized for MR8 attachments; however, they will not pass through the angled attachments, because they are not cannulated.

2.4 mm

41 cm (16 in)

3.2 mm

41 cm (16 in)

Cleaning brushes

System accessories: non-disposable devices Motor wrench The motor wrench is an accessory designed specifically for aligning the arrows on the Stealth-Midas™ MR8™ motor collet prior to installing a Stealth-Midas™ MR8™ attachment when needed.

Instrument tray The 3/4 DIN CA875 instrument tray holds the Stealth-Midas™ MR8™ motor and attachments (Figures 26-27) to be sterilized and is placed inside the rigid sterilization container or wrapped for steam sterilization. 26

12

3/4 DIN CA875 instrument tray closed

27

3/4 DIN CA875 instrument tray upper level with attachments

Pneumatic Stealth-Midas™ MR8™ System

Rigid sterilization container (sterilization case)

28

3/4 DIN rigid sterilization container

The rigid sterilization container is a sterilization containment device designed to hold the Stealth-Midas™ MR8™ system devices for sterilization, storage, transportation, and aseptic presentation of its contents (Figure 28). This case is available in a 3/4 DIN size. 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 Stealth-Midas™ MR8™ attachments and/or other system accessories to be sterilized and is placed inside the rigid sterilization container. A filter system is incorporated 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.

Sterility The REUSABLE Pneumatic Stealth-Midas™ MR8™ system is provided NON-STERILE. Devices must be cleaned and sterilized prior to the first use and any reuse. The Stealth-Midas™ MR8™ surgical dissecting tools are provided STERILE and SINGLE USE only.

Pneumatic Stealth-Midas™ MR8™ system reprocessing instructions Cleaning is the removal of organic soil. Effective 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 precautions

• • • • • •

Limitations on reprocessing

Dispose of attachments in accordance with hospital, administrative, or government policies. Due to safety and environmental concerns, Medtronic requests the return of pneumatic 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. Note: See the “Maintenance, inspection, and testing” section in this document to determine if the device is at its end of useful life.

Point of use

Reprocessing begins at the point of use. Do not allow blood, debris, or bodily fluids to dry on the device. Remove excess soil using running, cold tap water 10–22°C (50–72°F). Tap water is defined as potable water with hardness value between 0.7 mmol/L to 2.0 mmol/L.

Containment and transportation

Precaution: It is recommended that devices should be cleaned as soon as possible, preferably within 30 minutes following use to limit fixation of contaminants. 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.

Do not remove tracker from the motor. Do not disassemble the pneumatic system before the gas is released from the PCU. Remove navigation spheres from tracker and discard before cleaning and sterilization. Do not soak or submerge pneumatic system devices. Do not use ultrasonic cleaners for pneumatic system devices. 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. • Use only nylon cleaning brushes. Non-nylon cleaning brushes leave residue that may prevent the tool from being secured properly in the motor. • The use of a washer-disinfector for cleaning may cause a degradation in performance..

13

Pneumatic Stealth-Midas™ MR8™ System Preparation for cleaning: Automated

Stealth-Midas™ MR8™ motor: • Do not remove tracker from the motor. Tracker is permanently affixed. • Remove devices from instrument tray before placing into washer-disinfector and allow devices to drain. • Ensure that the attachment, tube, dissecting tool, and lubricant/diffuser have been removed from the motor prior to cleaning. • Remove navigation spheres from the tracker and discard. • With collet end and oiler housing pointed down, manually rinse the motor 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. • Remove devices from instrument trays before placing into washer. • Orient devices following recommendations of the washer/disinfector manufacturer. • Clean per recommended washer cycle per Table 4 or Table 5. • After cleaning, visually examine all parts of the device for cleanliness. If visible soil remains, repeat cleaning. Stealth-Midas MR8™ attachments: • Do not remove tracker from the motor. Tracker is permanently affixed • Ensure that the attachment, tube, dissecting tool, and lubricant/diffuser have been removed from the motor prior to cleaning. • Rinse attachments 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 3) 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 4 or Table 5. • After cleaning, visually examine all parts of the device for cleanliness. If visible soil remains, repeat cleaning. Stealth-Midas MR8™ accessories (motor wrench, tool rack) • Manually rinse accessories under cold running tap water (10–22°C / 50–72°F) to remove any visible soil. • Use a nylon brush to aid in cleaning. Stealth-Midas MR8™ instrument tray: • To clean the instrument tray after use, thoroughly rinse the instrument tray under running cold tap water (10–22°C / 50–72°F) to remove any visible soil. • Use a soft-bristled brush or clean cloth to aid soil removal around brackets and handles. • Gently flush the gasket region of the instrument tray if soil is visible. • 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 3 or Table 4. • After cleaning, visually examine the instrument tray for cleanliness. If visible soil remains, repeat cleaning. Rigid MR8™ Sterilization container: • To clean the sterilization container after use, discard the single use filters and thoroughly rinse the sterilization container under running cold tap water (10–22°C / 50–72°F) to remove any visible soil. • Use a soft-bristled brush or clean cloth to aid soil removal around brackets, filter retention plates, and handles. • Gently flush 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, filter retention plates, instrument brackets, and cavities to ensure all visible soil is removed. • Remove the filter 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 3 or Table 4. • After cleaning, visually examine the sterilization container for cleanliness. If visible soil remains, repeat cleaning.

14

Pneumatic Stealth-Midas™ MR8™ System Cleaning: Automated

Warnings: • Use the instrument tray and the rigid sterilization container for sterilizing the reusable devices only. • Do not use the instrument tray and sterilization container for cleaning or disinfection of the reusable devices. • Do not use alkaline cleaning for the instrument tray or the rigid sterilization container. Precautions: • Do not use ultrasonic cleaner. Table 4: Neutral Wash Cycle Parameters MR8™ motors, attachments, and instrument tray – neutral Phase

Recirculation/soak (minutes)

Water temperature

Detergent type

Pre-wash

2 minutes (02:00)

Cold tap water 10–16°C (50–61°F)

Not applicable

Enzyme wash

2 minutes (02:00)

Hot tap water 43–55°C (109–131°F)

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

Wash 1

2 minutes (02:00)

66°C (151°F) (setpoint)

Neutral pH detergent like Steris Prolystica 2x concentrate neutral detergent, 1.0 mL/L (1/8 oz/ gallon)

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

Purified water rinse

10 seconds (00:10)

66°C (151°F) (setpoint)

Not applicable

If visible soil remains, repeat cleaning. Table 5: Alkaline Wash Cycle Parameters MR8™ motors, attachments – 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 (minutes)

Water temperature

Detergent type

Pre-wash

2 minutes (02:00)

Cold tap water 10–16°C (50–61°F)

Not applicable

Wash

5 minutes (05:00)

43°C (109°F) (set point)

Alkaline detergent* like Dr. Weigert neodisher® MediClean forte, 2 mL/L (1/4 oz/gal)

Rinse

1 minute (01:00)

Hot tap water 43–60°C (109–140°F)

Not applicable

Thermal rinse

1 minute (01:00)

90°C (194°F) (setpoint)

Not applicable

Purified water rinse

1 minute, 30 seconds (01:30)

66°C (151°F) (setpoint)

Not applicable

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 verified alkaline detergent compatibility for working solutions up to 10.5 pH. After Cleaning: Automated

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.

15

Pneumatic Stealth-Midas™ MR8™ System Cleaning: Manual

Stealth-Midas™ MR8™ pneumatic motor: • Do not remove tracker from the motor. Tracker is permanently affixed • Ensure that the attachment, tube, dissecting tool, and lubricant/diffuser have been removed from the motor prior to cleaning. • Remove navigation spheres from the tracker and discard. • With collet end and oiler housing pointed down, manually rinse the motor 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 running cold tap water. • Prepare with tap water, a neutral enzymatic cleaner (such as 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, hose, and oiler housing with a cloth dampened with the prepared cleaner. • Brush motor case, collet, and oiler housing 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 oiler housing pointed down. • Following the warm tap water rinse, the device should be thoroughly rinsed in room temperature 25°C (77°F) purified water (deionized, reverse osmosis, or equivalent) for a minimum of 30 seconds with collet end and oiler housing 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. Stealth-Midas™ MR8™ pneumatic attachments: • Do not remove tracker from the motor. Tracker is permanently affixed • Ensure that the attachment, tube, dissecting tool, and lubricant/diffuser have been removed from the motor prior to cleaning. • Thoroughly rinse the attachments under running cold 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 running cold tap water. • Prepare with tap water, a neutral enzymatic cleaner (such as 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 attachments 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 base. • Straight attachments have special cleaning brushes sized to the attachment’s internal diameter (refer to Table 2). Push the brush wet with the prepared cleaner through the attachment from rear to front to loosen and remove debris trapped inside. • Other attachments may be mechanically agitated in the prepared cleaner solution but not soaked. • For angled attachments, only place one half (e.g., tube side) of the attachment into the cleaner 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 (Figure 29). • Ensure that the tube on the angled attachment be cleaned with the appropriate sized brush (refer to Table 2). • Actuate any moveable parts through their full range of motion to allow cleaner to thoroughly clean 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. • Following the warm tap water rinse, the device should be thoroughly rinsed in room temperature 25°C (77°F) purified water (deionized, reverse osmosis, or equivalent) for a minimum of 30 seconds. • 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. 29

Angled attachment cleaning example

1 1. Tube/tool side

2 2. Base side

PCU, regulator, and regulator hose 1. Dampen a cloth with a neutral enzymatic detergent, pH 6.0–8.0, or a phenol based disinfectant, mixed according to manufacturer’s instructions. 2. Wipe the surface with the damp cloth until visually clean. 3. Dry the unit with a clean, non-abrasive cloth.

16