Medtronic CA850S Instructions for Use

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Instructions for Use 175039EN B

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

MR8 Pneumatic and MR8 Pneumatic Touch Motors

Customer service

Contact your Medtronic Neurosurgery sales representative or call:

Medtronic Neurosurgery Service Group (800) 335-9557 or (817) 788-6440

RS.DFWrepairs@medtronic.com

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

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The following are trademarks or registered trademarks of Medtronic, Inc. in the United States and other countries: Midas Rex™ , MR8™, Legend™, and Triton™. All other trademarks, service marks, registered trademarks or registered service marks are the property of their respective owners in the United States and other countries.

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

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

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

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

MR8 pneumatic motors ......................................................................................................................................................................................................1

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

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

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

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

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

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

System hoses ..........................................................................................................................................................................................................................2

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

Pneumatic control unit .......................................................................................................................................................................................................3

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

MR8 pneumatic high-speed system components................................................................................................................................................................4

Regulator ..................................................................................................................................................................................................................................5

Regulator hose .......................................................................................................................................................................................................................5

MR8 pneumatic touch motors .........................................................................................................................................................................................5

MR8 pneumatic connections and adapters ............................................................................................................................................................................6

Operating room set up ...................................................................................................................................................................................................................7

System set up .....................................................................................................................................................................................................................................8

Install the oiler cartridge ...................................................................................................................................................................................................8

Connect the motor ...............................................................................................................................................................................................................9

Activate the motor ................................................................................................................................................................................................................9

Assembly ..................................................................................................................................................................................................................................10

Tool nomenclature ................................................................................................................................................................................................................10

MR8 attachments..............................................................................................................................................................................................................................13

Straight attachments ...........................................................................................................................................................................................................14

Angled attachments ............................................................................................................................................................................................................15

Variable exposure straight and angled attachments ...............................................................................................................................................16

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

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

Rotating footed attachments ...........................................................................................................................................................................................19

Metal cutting attachments ................................................................................................................................................................................................20

Telescoping attachments and tubes ..............................................................................................................................................................................21

Perforator driver attachments ..........................................................................................................................................................................................22

Jacobs chuck attachments.................................................................................................................................................................................................23

J-latch attachments ..............................................................................................................................................................................................................24

Disassembling the MR8 pneumatic system ............................................................................................................................................................................24

Depressurize the system.....................................................................................................................................................................................................24

Disconnect hoses ..................................................................................................................................................................................................................24

Discard the lubricant/diuser cartridge .......................................................................................................................................................................24

System accessories: disposable components ........................................................................................................................................................................25

Cleaning brushes...................................................................................................................................................................................................................25

System accessories: non-disposable components ..............................................................................................................................................................25

Instrument tray ......................................................................................................................................................................................................................25

Rigid sterilization container (sterilization case)..........................................................................................................................................................25

MR8 system reprocessing instructions .....................................................................................................................................................................................26

Warnings and cautions........................................................................................................................................................................................................26

Limitations on reprocessing ..............................................................................................................................................................................................26

Point of use ..............................................................................................................................................................................................................................26

Containment and transportation ....................................................................................................................................................................................26

Preparation for cleaning: automated .............................................................................................................................................................................26

Cleaning: automated ...........................................................................................................................................................................................................27

Cleaning: manual ..................................................................................................................................................................................................................28

Disinfection .............................................................................................................................................................................................................................29

Drying ........................................................................................................................................................................................................................................29

Maintenance, inspection, and testing ...........................................................................................................................................................................29

Packaging .................................................................................................................................................................................................................................30

Sterilization ..............................................................................................................................................................................................................................32

Storage ......................................................................................................................................................................................................................................32

Use ..............................................................................................................................................................................................................................................32

Return policy for devices exposed to TSE (transmissible spongiform encephalopathies) ....................................................................................32

Planned maintenance .....................................................................................................................................................................................................................33

For scheduled maintenance intervals 1, 2, 3, 5, 6, 7, 9, 10, and 11 ......................................................................................................................33

For scheduled maintenance intervals 4, 12 ................................................................................................................................................................34

For scheduled maintenance interval 8 ..........................................................................................................................................................................34

Disposal ................................................................................................................................................................................................................................................35

Troubleshooting ...............................................................................................................................................................................................................................35

MR8 motor ...............................................................................................................................................................................................................................35

MR8 attachments or telescoping tubes ........................................................................................................................................................................35

MR8 dissecting tools ............................................................................................................................................................................................................36

Medtronic Midas Rex MR8 pneumatic high speed systems limited warranty* .........................................................................................................36

Symbols ................................................................................................................................................................................................................................................37

The Midas Rex MR8 pneumatic high-speed drill system

Glossary

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

DK Double locking PCU Pneumatic Control Unit MR8 Midas Rex, 8th Generation

General information

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

Indications for use

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

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

• Lumbar Microdiscectomy • Transforaminal Lumbar Interbody Fusion (TLIF)

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

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

MR8 system description

MR8 pneumatic motors

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

MR8 attachments

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

MR8 surgical dissecting tools

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

Contraindications

None.

Special notices

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

Warning: A warning indicates that the personal safety of the patient or physician may be involved. Disregarding this information could result in injury to the patient or user. Caution: A caution indicates that there is a risk of damaging equipment. Note: A note is intended to provide additional information, which may be useful, but is not essential to complete the procedure.

Warnings

System

W1 The MR8 system operator must be familiar with this Instructions for Use, its precautions, procedures and safety issues. W2 The MR8 system and its associated equipment should be used only by qualied medical professionals who are thoroughly trained and experienced in

performing surgery with Medtronic surgery systems.

W3 Always inspect the components before and after use for any damage. If damage is observed, do not use damaged component until it is repaired by Medtronic

or replaced. W4 Use adequate irrigation during dissection to prevent thermal necrosis. W5 Do not use an overheated device, as it may cause thermal injury to the patient or operator. W6 Heavy side loads and/or long operating periods may cause the device to overheat.

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

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

W6c If the motor is passed o, the receiver should grasp the motor by the proximal end close to the motor hose. W7 Do not use excessive force to pry or push bone with the attachment or dissecting tool during surgery. W8 Use only dissecting tools specically designed for use with this drill system. Match the nomenclature and color code on the MR8 dissecting tool packaging to

the same nomenclature and color band on the MR8 attachment. W9 Do not use the MR8 system without proper cleaning and sterilization. W10 Sterilize and dry the reusable device before storing. Decrease the likelihood of cross-contamination with timely sterilization. After each procedure, properly

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

The Midas Rex MR8 pneumatic high-speed drill system

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

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

W13 Do not attempt to remove a dissecting tool or attachment while the motor is running, or when the motor or attachment is in an overheated state to prevent

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

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

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

W21c Check motor for overheating.

W21d Check attachment for overheating.

W21e Check dissecting tool for ail.

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

motor activation. W23 Do not use metal-cutting attachment or tools to cut/resect bone. W24 For metal transection, observe the following safety guidelines:

W24a Wear eye protection.

W24b Irrigate well to cool the cutting surfaces.

W24c Protect the wound site from metal debris.

W24d Use a clamp or grasping device to control loose fragments during transection of any metal component. W25 Do not use any parts other than Medtronic system components, as damage or substandard performance could result. W26 When using MR8 variable exposure attachments, surgeons should become familiar with the performance of dissecting tools before use and should explore the

eect of various levels of tool exposure on tool stability. If the tool exhibits excessive chatter, vibration, or movement, decrease the tool exposure. W27 Motors and attachments may fail due to extended use resulting in component(s) detaching and falling from the motor or attachment and may cause patient injury. W28 When using the MR8 non-DK variable exposure attachments, ensure that the attachment is still in the locked position after each adjustment of the tool

exposure. Attempting to increase the tool exposure too far may result in the attachment accidentally being unlocked. W29 Remove MR8 footed attachments cautiously and slowly, as per instructions to avoid injury to the operator. W30 Excessive side loading could cause non-DK angled attachments to unlock accidentally from motor. W31 Place MR8 pneumatic nger controlled motor in Safe mode (“0”) while not in use. W32 When not operating the motor, eliminate accidental foot control activation. W33 Do not use the MR8 system in the presence of ammable anesthetics to avoid potential ignition or explosion of gases.

W34 Do not operate the MR8 system without eye protection. W35 Failure to properly secure the lubricant/diuser or oil cartridge may cause injury to operator and/or operating room sta. W36 Do not use the pneumatic control unit to operate systems other than the Midas Rex devices. W37 You must ensure the adapter is fully threaded onto the regulator hose and that the adapter is fully threaded/connected to the corresponding wall outlet before

operating the pneumatic system. W38 Do not attempt to use a motor that is leaking lubricant. MR8 motors which fail due to extended use and/or lubricant seal failure may allow foreign matter to

migrate or emit from the tool collet end of the motor. Non-sterile uid may leak into the surgical site. As a result, measures may be required to protect the

patient from infection, per the physician’s discretion. W39 Do not load more than one MR8 motor inside the instrument tray per sterilization cycle. W40 Do not wrap the rigid sterilization container. W41 The MR8 system operator should take appropriate measures in ensuring that sensitive anatomy is protected during drilling and use of the MR8 system.

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

System hoses

W48 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.

Tools and disposable components

W49 Tool utes are sharp and may perforate surgical gloves. Tool stems may be grasped with a hemostat to aid in installation and removal. Use methods at the

operative site to control bleeding that do not compromise patient safety during surgery. W50 Keep the cutting area of the tool away from ngers and loose clothing to prevent laceration of the user and cross-contamination through a compromised glove. W51 A tool’s size and geometry may create excessive vibration at certain speeds. Increase or decrease the speed of the motor to prevent vibration. Change to a new

tool to prevent unintended tissue damage. W52 Excessive noise from the tool when drilling close to the cochlea or ossicular chain may cause patient hearing damage.

The Midas Rex MR8 pneumatic high-speed drill system

W53 Consult the cranial perforator manufacturer device labeling for the recommended speed specications. W54 Tools with “L” identication are longer tools intended for light bone dissection. The increased tool head/stem conguration may aect dissection stability. W55 Dissecting tools are for single-use only. Do not attempt to sterilize them. The dissecting tools are packed sterile and not intended for repeat use. To prevent

contamination, use only once.

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

the tool are removed from the patient. Unremoved tool fragments may cause tissue damage to the patient. W57 Do not sterilize disposable devices. They are sterilized at the factory and are not intended for repeat use. To prevent contamination, use only once. W58 Do not use an accessory if its packaging is damaged or opened outside the sterile eld. Sterility may be compromised if packaging is opened or damaged. W59 Do not use dull tools. Use of dull tools can reduce cutting eectiveness and can cause the motor temperature to increase. W60 Fluted tools are designed to be used in forward mode. Diamond tools may be used in forward or reverse modes. W61 Exposure of tool packaging to ambient light for extended periods of time may cause damage to packaging.

Pneumatic control unit

W62 Do not carry pneumatic control unit by the N2 DISS pressure hose. W63 Do not disassemble equipment before gas pressure is released from the pneumatic control unit and associated hoses.

Cautions

C1 When using a non-DK angled attachment, hold the motor assembly by the attachment so that the attachment does not inadvertently loosen from the motor. C2 Do not use a twist drill dissecting tool at an operating pressure over 80 psi (5.5 bar). C3 Use of a washer-disinfector for cleaning may cause a pre-mature degradation in performance. C4 Remove devices from instrument tray before placing into washer-disinfector and allow devices to drain. Orient devices in the washer-disinfector by following

manufacturer recommendations. C5 Do not use low-temperature hydrogen peroxide gas plasma sterilization due to the lumen internal diameter and length restrictions. C6 Do not use low-temperature liquid peracetic acid sterilization due to immersion procedure. C7 Remove and discard accessories following local regulations for disposal of contaminated materials. C8 Do not use an MR8 motor without a lubricant/diuser or oiler cartridge installed. C9 Do not use chlorine-based or corrosive cleaning agents such as bleach, lye, acetone, sodium hypochlorite or bleach, sodium hydroxide, formic acid, or solutions

containing glutaraldehyde. C10 Do not use a lubricant/diuser or oiler cartridge for more than one hour of drill time. C11 Do not reuse or attempt to rell a lubricant/diuser or oiler cartridge. It is a single-use product. C12 Do not use a lubricant/diuser or oiler cartridge if it appears to be damaged or if the inner foil seal is punctured. C13 Devices should be cleaned within 30 minutes (30:00) of use to limit xation of contaminants. C14 Do not use ultrasonic cleaner. Review the washer-disinfector cautions before using this cleaning method. C15 Do not expose these devices to sterilization temperatures greater than 137°C (279°F). Exposure to temperatures greater than 137°C (279°F) may impact the

performance of the device and also the ecacy of the sterilization cycle. C16 Because of the variability in cleaning eciencies and sterilizer operating parameters, all given parameters (temperature, time, etcetera) should be validated by

persons who have training and expertise in sterilization processes. Deviation from the recommended sterilization processes is at the risk of the user facility.

The Midas Rex MR8 pneumatic high-speed drill system

MR8 pneumatic high-speed system components

The MR8 pneumatic drill system is made of various system elements that work together as a system in order to resect, drill, or saw soft and hard tissue, bone, and biomaterials, and metals during various surgical procedures. The MR8 pneumatically powered, high-speed drill system consists of a choice of various pneumatic motors (pneumatic exhaust hose and the motor) equipped with a foot or nger controller, PCU, surgical dissecting tools, attachments to drive various surgical tools, and system accessories.

MR8 pneumatic motors

The MR8 system consists of pneumatic motors (Figures 1 - 2) which are high-speed, high-torque motors used to dissect bone and biomaterials. The MR8 system operates in a range from 80 to 120 psi. These motors are equipped with a foot or nger controller and various types of interchangeable attachments and dissecting tools. Each pneumatic motor has an integral exhaust hose. The exhaust hose connects the pneumatic motor to the pneumatic foot control and exhausts gas from the motor through a lubricant diuser. Each MR8 motor has a lubricant/diuser and oiler cartridge housing at the end of the exhaust hose. A regulator hose connects the foot controller to the gas supply source.

The MR8 pneumatic motors provide the power to operate disposable surgical dissecting tools, intended for use in various surgical procedures. These motors are designed to interface with a series of attachments and surgical dissecting tools utilizing a standard quick-connect and quick-disconnect locking and unlocking mechanism.

The MR8 pneumatic motors can be controlled either by using the foot pedal or through the nger control mechanism. The nger-controlled pneumatic motors operate in the same manner as the foot-controlled pneumatic motors. Pressing the nger control increases the speed and letting go of the nger control reduces the speed to a stop.

The MR8 pneumatic motors are reusable devices which are supplied non-sterile and require cleaning and sterilization prior to each surgical use. Each MR8 motor has a lubricant/diuser housing at the end of the motor hose.

1. Collet

2. Motor case

3. Swivel

MR8 pneumatic motor MR8 pneumatic touch motor

4. Hose

5. Lubricant/diuser housing

1. Telescoping nger rest

2. Motor safe mode switch

3. Swivel

4. Hose

5. Collet

6. Motor case

7. Lubricant/diuser housing

The Midas Rex MR8 pneumatic high-speed drill system

Pneumatic control unit

The pneumatic control unit (Figure 3) provides variable speed motor control through a foot pedal. It also allows the user to switch between nger and foot control of the motor (if applicable).

Regulator

The regulator (Figure 4) controls the delivery pressure of compressed gas to the pneumatic control unit. The pressure gauges monitor cylinder pressure (right gauge) and delivery pressure (left gauge).

Note: Outlet pressure gauge accurate to +/- 12 psi.

Regulator hose

Connects from the gas source to the pneumatic control unit to deliver compressed gas.

MR8 pneumatic control unit MR8 regulator

MR8 pneumatic motor

Technical specications

Table 1. MR8 pneumatic motor technical specications

MR8 pneumatic motor (PM800)

Size Weight

Length: 9.49 cm (3.74 in) x Diameter: 2.08 cm (0.82 in) 123.34 grams

MR8 pneumatic touch motor

Notes:

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

• The MR8 pneumatic control unit is provided with a supply pressure gauge. The control unit has a handle for ease of re-positioning unit while on the oor or for carrying the unit. A hole is provided in the base of the control unit to hang on a wall hook. Port cover is attached to prevent debris ingress when a port is not in use.

The MR8 pneumatic touch motor functions exactly as the pneumatic motor that is controlled using the PCU but oers the operator an option to control the motor with a nger control mechanism. The MR8 pneumatic touch motor also oers the user an option to control the motor with the foot via a PCU.

Technical specications

Table 2. MR8 pneumatic touch motor technical specications

MR8 pneumatic touch motor (PM810)

Size Weight

Length: 11.07 cm (4.36 in) x Diameter: 2.08 cm (0.82 in) 147.24 grams

The Midas Rex MR8 pneumatic high-speed drill system

MR8 pneumatic connections and adapters

Warning: The adapter must be fully threaded onto the regulator hose and that the adapter is fully threaded or 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 5) allows for the regulator hose to connect to AUS-SIS wall ttings 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

The N2 DISS to male Schrader adapter (Figure 6) allows for the regulator hose to be attached to a female Schrader in-house gas connection.

N2 DISS to male Schrader adapter (UK)

The N2 DISS to male Schrader adapter (Figure 7) allows for the pneumatic control unit’s N2 DISS pressure hose connection to be attached to a female Schrader (UK) in-house gas connection.

N2 DISS to air DISS adapter

The N2 DISS to air DISS adapter (Figure 8) allows for the regulator hose to be attached to an Air DISS in- house gas connection.

N2 DISS to female Schrader adapter

The N2 DISS to female Schrader adapter (Figure 9) allows for the pneumatic control unit’s N2 DISS pressure hose connection to be attached to a male Schrader inhouse gas connection.

N2 DISS to surgical tool air male SIS adapter

The N2 DISS to surgical tool air male SIS adapter (Figure 10) allows for the pneumatic control unit’s N2 DISS pressure hose connection to be attached to an AUS-SIS surgical tool air in-house gas connection.

N2 DISS to WF4 adapter

The N2 DISS to WF4 adapter (Figure 11) allows for the regulator hose to be attached to a Midas Rex safety valve regulator.

N2 DISS to surgical tool air

male SIS adapter gas source

N2 DISS to female

Schrader adapter

N2 DISS to male

Schrader adapter

N2 DISS to surgical tool air

male SIS adapter

N2 DISS to male

Schrader adapter (UK)

N2 DISS to WF4 adapter

N2 DISS to air DISS adapter

The Midas Rex MR8 pneumatic high-speed drill system

Pneumatic adapter diagram

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. 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. Regulator

Operating (dynamic) pressure may be checked diagnostically at the MR8 pneumatic control unit 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 MR8 pneumatic control unit reads within a range of 80 – 120 psi (5.5 –8.3 bar), as required.

To ensure optimal motor performance, set nominal operating pressure to 100 psi (6.9 bar). If the surgeon requests additional power during a procedure, compressed gas source may be turned up to an operating pressure of 120 psi (8.3 bar). To decrease pressure, turn down the in-house compressed gas source or loosen the pressure handle on the regulator. Push down on the pressure relief at the pneumatic control unit to exhaust excess pressure.

Operating room set up

Power source requirements.

Table 3. MR8 pneumatic motors required operating pressure

Required operating (dynamic) pressure Nominal operating (dynamic) pressure Approximate ow rate required Gas type

80-120 psi 100 psi 12 cubic feet/minute Nitrogen or dry-ltered

5.5-8.3 bar 6.9 bar 340 liters/minute

Caution: Do not run the motor at an operating pressure above or below the required operating pressure range. Operating pressure below 80 psi (5.5 bar) may not provide proper lubrication to the motor. Operating pressure above 120 psi (8.3 bar) may damage or reduce the life of the motor.

compressed air

The Midas Rex MR8 pneumatic high-speed drill system

System set up

Warnings:

• Failure to properly secure the lubricant diuser or oiler cartridge may cause injury to operator or operating room sta.

• Do not attempt to remove the lubricant diuser or oiler cartridge while the system is pressurized.

Cautions:

• Do not use the MR8 pneumatic motor without a lubricant diuser or oiler cartridge installed.

• Do not use a lubricant diuser or oiler cartridge for more than one hour of drill time.

• Do not reuse a lubricant diuser or oiler cartridge. It is a single-use product.

• Do not attempt to rell a used lubricant diuser or oiler cartridge.

• Do not use a lubricant diuser or oiler cartridge if it appears to be damaged or if the inner foil seal is punctured.

Note: Each MR8 motor has a lubricant diuser and oiler cartridge housing at the end of the exhaust hose.

Install the oiler cartridge within the non-sterile eld

1. Set the non-running (static) pressure to 80 – 120 psi (5.5 – 8.3 bar) at the gas source. Operating (dynamic) pressure may be adjusted later.

2. Hold the oiler cartridge perpendicular to the housing (Figure 13-1) and press the cartridge’s circular tting onto the housing’s circular receptacle (Figure 13-2), 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 13-3).

13-1

Installation of the oiler cartridge Installation of the oiler cartridge Installation of the oiler cartridge

14-1

Connecting the motor Finger/foot control slide

13-2

14-2

13-3

14-3

Aligning the collet at

The Midas Rex MR8 pneumatic high-speed drill system

Connect the motor

Connect the motor hose to the motor port on the top of the pneumatic control unit, by swinging the port cover to the side and pressing the end of the hose into the port (Figure 14-1).

Warnings:

• 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.

• To avoid injury to the patient or user, do not use the pneumatic control unit to operate systems other than the MR8, Legend, and Triton systems.

• Prior to installation of a MR8 attachment and dissecting tool, ensure that the arrows on the motor collet ats are aligned (Figure 14-3). If the arrows are not

aligned, use the motor wrench to turn the collet at closest to the motor case until its arrow is aligned with the arrow on the other collet at.

• To avoid injury when using the MR8 touch motor, ensure the motor safe mode switch is in the “O” position before installing the attachment and tool.

Notes:

• If using the MR8 touch motor, slide the control slide on the pneumatic control unit to the “On” position (Figure 14-2). This will automatically depress and lock the

foot pedal. The control will not lock into the “On” position unless the motor hose is connected into the motor port. When the motor hose is removed from the motor port, the foot pedal will return to normal position.

Activate the motor

Notes:

• To decrease pressure, turn down the in-house compressed gas source or loosen the pressure handle on the regulator. Push down on the pressure relief at the

pneumatic control unit to exhaust excess pressure in the hoses. Then readjust pressure as needed.

• In order to activate the MR8 pneumatic touch motor, the motor safe mode switch on the nger control switch must be in the “On” position and the control slide

on the foot control must be in the “O” position. The control slide will not lock in the position unless a motor is connected to the motor port.

1. Activate the motor by pressing on the PCU pedal (Figure 15) or by pressing on the nger control lever (MR8 pneumatic touch motor only).

2. Adjust operating pressure as needed at the compressed gas source until supply pressure gauge on pneumatic control unit reads within a range of 80–120 psi (5.5–8.3 bar) as required. Operating pressure (with motor running) will decrease slightly from the non-running (static) pressure setting when the motor is activated.

PCU pedal

1. Foot control pedal

2. Air pressure gauge

3. Control slide

The Midas Rex MR8 pneumatic high-speed drill system

MR8 surgical dissecting tools

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

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

Assembly

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

Tool nomenclature

Part numbers for MR8 surgical dissecting tools follow a nomenclature, which is described in the diagram below (Figure 17). Standard tool part numbers consist of the associated attachment length, the tool family identier, and the tool head diameter. Part numbers may also include a variety of prexes to identify specic attachment types, as well as a variety of suxes to provide additional information about the dissecting tool.

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

MR8 -

MR8 surgical dissecting tool nomenclature

9 M H 3 0

MR8 surgical dissecting tools

1234

1. Optional prex

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

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

Tool number prexes Tool number suxes

Note: A single part number will use only

one prex.

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

Tool family identier (form/function)

Footed attachments

Telescoping tube

Acorn

Ball

Cylinder

Hole maker

Hole saw

Metal cutter

Match head

Oval

Reverse taper

Tapered or side cutter

Twist drill

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

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

6. Optional sux

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

Ball

Barrel

Carbide

Cornerstone

Diamond

Diamond coarse

Diamond ne

Diamond extra coarse

Diamond extra ne

DXF

Fine

Match ute (on telescoping tools)

Spiral utes

3-Flute or symmeTRI

Extra

Extra ne

Tool length modiers

L Long

5 6

The Midas Rex MR8 pneumatic high-speed drill system

Surgical application Commonly used attachments Commonly used dissecting tools

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

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

Ball

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

Oval

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

Hole maker and hole saw

Matched sets of hole makers and hole saws are ecient and eective for interbody fusion.

Cylinder

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

Acorn

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

MR8 telescoping Match head

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

Spine MR8 footed, MR8 straight Tapered

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

Reverse tapered

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

The Midas Rex MR8 pneumatic high-speed drill system

Surgical application Commonly used attachments Commonly used dissecting tools

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

and MR8 15

MR8 footed Tapered

Match head

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

Ball

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

Twist drill

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

Acorn

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

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

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

Ear, nose, and throat (otology, neurootology)

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

Match head

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

Ball

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

Tapered

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

Twist drill

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

MR8 7, MR8 10 Ball

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

The Midas Rex MR8 pneumatic high-speed drill system

Surgical application Commonly used attachments Commonly used dissecting tools

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

MR8 footed, and MR8 telescoping

Biometals/bioceramics/

MR8 MC9, MR8 MC14 Metal cutter

biomaterials

Ball

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

Tapered

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

Acorn

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

Cylinder

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

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

MR8 attachments

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

The attachments provide support and stability to the rotating surgical tools during use in various surgical procedures. The attachments are reusable devices, supplied nonsterile, and require cleaning and sterilization prior to each surgical use. Attachments feature a tool lock mechanism that secures and aligns the tool to the attachment. Arrow icons (Figure 18-1) are etched onto attachments and motors to guide the user to lock (Figure 18-2) or unlock (Figure 18-3) the attachment from the motor.

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

18-1

Attachment arrow icons

18-2

Attachment

lock

18-3

Attachment

unlock

The Midas Rex MR8 pneumatic high-speed drill system

Straight attachments

Warnings:

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

• Use only dissecting tools specically designed for use with this drill system. Match the nomenclature and color code on the MR8 dissecting tool packaging to the same nomenclature and color band on the MR8 attachment.

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

Assembly:

1. Slide a straight attachment over the motor collet aligning the triangular arrows on the attachment and the motor case (Figure 19-1). An audible click, heard and perceptible by touch, conrms that the attachment is fully seated.

2. Insert the tool into the attachment with a slight rotational motion (Figure 19-2). An audible click, heard and perceptible by touch, conrms that the tool is fully seated.

3. Rotate the attachment in the direction indicated by arrow on the attachment until the attachment alignment mark is directly in line with the locked symbol (Figure 19-3). Note: When a click is heard the attachment is fully seated and the collet brake fully released.

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

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

Disassembly

1. Hold the motor in palm of hand. Rotate the attachment to the unlocked position. In this position, the arrows in the attachment and motor will line up as in Figure 19-2.

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

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

19-1

19-2

19-3

Straight attachment assembly

Straight attachment assembly/disassembly

Straight attachment assembly

The Midas Rex MR8 pneumatic high-speed drill system

Angled attachments

Warnings:

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

• Use only dissecting tools specically designed for use with this drill system. Match the nomenclature and color code on the MR8 dissecting tool packaging to the

same nomenclature and color band on the MR8 attachment.

Notes:

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

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

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

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

Assembly

1. With the tool lock in the unlocked position, insert a tool into the angled attachment with a slight rotational motion (Figure 20-1). An audible click, heard and

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

2. Rotate the tool lock/unlock sleeve in the direction indicated by arrow until the tool lock alignment mark is directly in line with the locked symbol (Figure 20-2).

3. Gently pull on the tool to ensure that it is locked into the motor. Note: Tool should rotate freely. If not, unlock the attachment, re-seat the tool, and re-lock the attachment.

4. Slide the angled attachment over the motor collet aligning the triangular arrows on the attachment and the motor case. An audible click, heard and perceptible by touch, conrms that the attachment is fully seated.

5. Rotate the attachment in the direction indicated by the arrow until attachment alignment mark is directly in line with the locked symbol. Note: When a click is heard the attachment is fully seated and the collet brake fully released.

6. Verify that both the attachment to motor alignment mark and the tool lock alignment mark are directly in line with the locked symbols (Figure 20-3).

Disassembly

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

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

20-1

20-2

1. Tool lock/unlock sleeve

20-3

Angled attachment assembly

The Midas Rex MR8 pneumatic high-speed drill system

Variable exposure straight and angled attachments

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

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

Notes:

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

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

• Dissecting tool size and geometry may contribute to excessive vibration at certain speeds. Increase or decrease speed by adjusting the foot or nger control, or by changing the console speed setting. If necessary, use a dierent dissecting tool.

• Do not use the variable exposure attachment if the tube adjustment dial spins freely or fails to click into place with each adjustment, as the exposure may change without warning.

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

• Make sure that the tool and attachment are still locked after making any adjustments to the tool exposure on variable exposure attachments. If the attachment is unlocked, the system will not function. If the tool is unlocked, it can cause reduced speed and overheating.

Assembly:

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

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

(Figure 21).With the tool pointing away from you, turn the ring to the right to increase the

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

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

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

Variable exposure attachment assembly

The Midas Rex MR8 pneumatic high-speed drill system

Angled double lock (DK) attachment

Notes:

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

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

Assembly:

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

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

3. Rotate the tool lock in direction indicated by arrow until the tool lock alignment mark is directly in line with the locked symbol (Figure 22-2). Note: Pull on the tool to ensure that it is secured in the attachment.

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

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

22-1

Angled double lock (DK) attachment assembly Angled double lock (DK) attachment assembly

22-2

Disassembly:

1. To remove the attachment, hold the motor in the palm of your hand, and push the attachment distally while turning the attachment to the unlocked position (Figure 22-3).

2. Release and remove the attachment.

22-3

Angled double lock (DK) attachment disassembly

The Midas Rex MR8 pneumatic high-speed drill system

Fixed footed attachments

Warning: Use only dissecting tools specically designed for use with this drill system. Match the nomenclature and color code on the MR8 dissecting tool packaging

to the same nomenclature and color band on the MR8 attachment.

Notes:

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

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

Assembly

1. Insert a dissecting tool into the motor collet with a slight rotational motion (Figure 23-1). An audible click, heard and perceptible by touch, conrms that the tool is fully seated.

2. Slide the xed footed attachment over the dissecting tool onto the motor aligning triangular arrows on the attachment and the motor case (Figure 23-2).

3. Pull the xed footed attachment towards the motor and rotate the attachment to the locked position on the motor case (Figure 23-3).

4. Check to ensure a gap exists between the tip of the tool and the foot of the attachment as shown in Figure 23-4. This will prevent damage to the attachment and/ or injury to patient.

23-1

23-3

Disassembly

1. To remove the xed footed attachment, hold the motor in the palm of your hand. Push the xed footed attachment distally while rotating the attachment to the unlocked position on the motor case and then release the sleeve (Figure 23-5).

2. To avoid injury from the dissecting tool, use thumb and index nger to cautiously and slowly lift the attachment o of the motor and away from the dissecting tool (Figure 23-6).

3. Pull the dissecting tool out of the motor collet and discard the tool (Figure 23-7).

23-5

Fixed footed attachment assembly Fixed footed attachment assembly

Fixed footed attachment assembly

Fixed footed attachment disassembly Fixed footed attachment disassembly

23-6

23-2

23-4

23-7

Fixed footed attachment disassembly

The Midas Rex MR8 pneumatic high-speed drill system

Rotating footed attachments

Notes:

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

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

• Ensure proper installation of tool in footed attachment. Failure to follow instructions may result in the tool tip contacting the foot of the attachment causing

damage to the attachment and/or harm to patient.

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

Assembly:

1. Insert a dissecting tool into the motor collet with a slight rotational motion (Figure 24-1). An audible click, heard and perceptible by touch, conrms that the tool is fully seated.

2. Slide the rotating footed attachment over the dissecting tool onto the motor aligning triangular arrows on the attachment and the motor case (Figure 24-2).

3. Pull the rotating footed attachment towards the motor and rotate the attachment to the locked position on the motor case (Figure 24-3).

4. Check to ensure a gap exists between the tip of the tool and the foot of the attachment as shown in Figure 24-4. This will prevent damage to the attachment and/ or injury to patient.

Disassembly:

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

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

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

24-1

24-3

Rotating footed attachment assembly Rotating footed attachment assembly

Rotating footed attachment assembly Tool gap

24-2

24-4

The Midas Rex MR8 pneumatic high-speed drill system

Metal cutting attachments

Warnings:

• Do not use metal cutting dissecting tools on bone.

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

any metal component.

Notes:

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

• A dissecting tool may be installed and locked in the attachment before the metal cutting attachment is installed on the motor.

• The Legend system metal cutter dissecting tool can be used with the MR8-ASMC9 attachment. Match the color code on the metal cutter Legend dissecting tool packaging to the same color band on the MR8 attachment.

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

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

Assembly:

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

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

3. To insert the tool, make sure that the tool locking ring is in the unlocked position, and insert the dissecting tool into the top of the tube (Figure 25).

4. Rotate the dissecting tool until it drops into position and is fully seated (Figure 25).

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

Disassembly:

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

2. Discard the tool.

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

Metal cutting attachment

The Midas Rex MR8 pneumatic high-speed drill system

Telescoping attachments and tubes

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

Warnings: Use only dissecting tools specically designed for use with this drill system. Match the nomenclature and color code on the MR8 dissecting tool packaging to the same nomenclature and color band on the MR8 attachment.

Notes:

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

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

telescoping Legend dissecting tool packaging to the same color band on the MR8 telescoping tube.

Assembly

1. Slide the attachment over the motor collet aligning the triangular markers. A tactile click conrms the attachment is fully seated. Note: A dissecting tool and telescoping tube may be installed and locked in the attachment before the telescoping attachment is installed on the motor.

2. Rotate the attachment to the locked position.

3. Rotate the tube locking ring toward the unlocked icon (Figure 26-1).

4. Insert the base of the telescoping tube into the attachment (Figure 26-2).

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

6. To insert the tool, make sure that the tool locking ring is in the unlocked position, and insert the dissecting tool into the top of the tube (Figure 26-3). A tactile click conrms that the tool is fully seated.

7. Rotate the tool locking ring to the locked position. Gently pull on the shaft of the dissecting tool to verify proper installation (Figure 26-4).

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

Disassembly

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

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

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

26-1

Telescoping attachments and tubes assembly Telescoping attachments and tubes assembly

26-3

26-4

Telescoping attachments and tubes assembly

26-2

Telescoping attachments and tubes assembly

The Midas Rex MR8 pneumatic high-speed drill system

Perforator driver attachment

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

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

Assembly

1. Slide the perforator driver over the motor collet, aligning the triangular markers (Figure 27-1). A tactile click conrms the attachment is fully seated.

2. Rotate the attachment to the locked position (Figure 27-2).

3. To install a cranial perforator device with a Hudson shank, pull back on the collar of the attachment (Figure 27-3).

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

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

Disassembly

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

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

Table 4. Maximum output speed

Gas pressure (dynamic) MR8-AD03

80 psi 850 rpm

100 psi 1050 rpm

120 psi 1140 rpm

27-1

Perforator driver assembly Perforator driver assembly Perforator driver assembly

27-2

27-3

The Midas Rex MR8 pneumatic high-speed drill system

Jacobs chuck attachment

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

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

Assembly

1. Slide the attachment over the motor collet aligning the triangular markers (Figure 28-1). A tactile click conrms that the attachment is fully seated.

2. Rotate the attachment to the locked position (Figure 28-2).

3. To install a drill bit, rotate the Jacobs chuck key counterclockwise to open the jaw as shown in Figure 28-3.

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

Disassembly

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

the attachment o of the motor.

28-1

Jacobs chuck

attachment assembly

28-2

Jacobs chuck

attachment assembly

28-3

Jacobs chuck attachment assembly

The Midas Rex MR8 pneumatic high-speed drill system

J-latch attachment

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

Assembly:

1. Assemble and secure the attachment onto the motor using the Straight attachments Assembly instructions (Figure 29-1).

2. Insert the tool into the attachment with a slight rotational motion. An audible click, perceptible by touch, conrms that the tool is fully seated (Figure 29-2).

3. Turn the tool lock sleeve in the direction shown on the attachment to lock the tool (Figure 29-3). Gently pull on the tool to ensure that it is locked into the motor.

Disassembly:

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

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

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

4. Lift the attachment o of the motor.

29-1

J-latch attachment assembly J-latch attachment assembly

29-2

29-3

J-latch attachment assembly

Disassembling the MR8 pneumatic system

Depressurize the system

Warning: Do not disassemble equipment before the gas is released from control unit.

1. Turn o the compressed gas at the source.

2. Press the pressure relief button on the pneumatic control unit, to release remaining gas.

Disconnect hoses

Release the motor hose from the control unit, by holding the hose rmly and pressing the motor port connection button (Figure 30).

Motor port connection and pressure relief buttons

1. Motor port connection button 2. Pressure relief button

Discard the lubricant/diuser cartridge

Caution: Do not re-use a lubricant/diuser cartridge. It is a single-use product.

Remove the lubricant/diuser cartridge from the housing and discard it.

The Midas Rex MR8 pneumatic high-speed drill system

System accessories: disposable components

Cleaning brushes

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

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

Table 5. Disposable cleaning brush dimensions

Internal bore diameter Brush length

1.2 mm 20 cm (8 in)

2.4 mm 41 cm (16 in)

3.2 mm 41 cm (16 in)

System accessories: non-disposable components

Instrument tray

The CA850 instrument tray holds MR8 attachments and/or other MR8 system equipment (Figures 31 and 32) to be sterilized and is placed inside a rigid sterilization container or wrapped for steam sterilization.

Note: The instrument tray can also hold one of the following motors: MR8 pneumatic motor (PM800) and the MR8 pneumatic touch motor (PM810).

Instrument tray closed

3/4 DIN CA850

3/4 DIN CA850 instrument tray

upper level with attachments

Rigid sterilization container (sterilization case)

The rigid sterilization container is a sterilization containment device designed to hold MR8 system equipment for sterilization, storage, transportation, and aseptic

presentation of its contents (Figure 33). This container 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 MR8 attachments and/or other MR8 system equipment to be sterilized and is placed inside the rigid sterilization container as shown in Figure 34. A lter system is incorporated in the sterilization container to provide for air evacuation and sterilant penetration during the sterilization cycle and to act as a barrier to microorganisms during storage, handling, and transport.

3/4 DIN rigid sterilization container Tray inside of the container

The Midas Rex MR8 pneumatic high-speed drill system

MR8 system reprocessing instructions

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

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

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

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

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

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

1910.1030, occupational exposure to blood-borne pathogens.

Warnings and cautions

Limitations on reprocessing

Point of use Reprocessing begins at the point of use.

Containment and transportation

Preparation for cleaning: automated

• Do not soak/submerge devices.

• Do not use ultrasonic cleaners to clean devices.

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

• Allow an adequate cooling period after steam sterilization.

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

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

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

Caution: Devices should be cleaned within 30 minutes (30:00) of use to limit xation of contaminants. Do not place soiled instruments into the instrument case. Transport used devices in a separate container. If the device cannot be reprocessed immediately, keep the device moist during transport. It is recommended that devices are reprocessed as soon as is practical following use. To prolong the life of the device, reprocess immediately after use.

MR8 pneumatic motor and MR8 pneumatic touch motor:

• Ensure that the attachment, tube, dissecting tool, and lubricant/diuser have been removed from the motor prior to cleaning.

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

• Use a nylon brush to aid in cleaning.

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

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

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

• For nger control lever, it shall be placed in the washer with the telescoping nger rest in the fully extended position.

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

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

MR8 attachments and tubes:

• Ensure that the attachment, tube, dissecting tool, and lubricant/diuser have been removed from the motor prior to cleaning.

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

• Use a nylon brush to aid in cleaning.

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

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

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

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

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

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

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

The Midas Rex MR8 pneumatic high-speed drill system

Cleaning: automated Warnings:

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

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

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

Cautions:

• Do not use ultrasonic cleaner.

Table 6: Neutral Wash Cycle Parameters

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

Phase Recirculation/soak

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

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

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

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

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

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

If visible soil remains, repeat cleaning.

Table 7: Alkaline Wash Cycle Parameters

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

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

Phase Recirculation/soak

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

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

Rinse 1 minute (01:00) Hot tap water

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

Puried water rinse 1 minute, 30 seconds

If visible soil remains, repeat cleaning.

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

(minutes)

(01:30)

Water temperature Cleaner type

10 - 16°C (50 - 61°F)

43 - 55°C (109 - 131°F)

Water temperature Cleaner type

10 - 16°C (50 - 61°F)

43 - 60°C (109 - 140°F)

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

Not applicable

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

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

Not applicable

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

Not applicable

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

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

2. Actuate movable components to ensure proper lubrication.

3. Remove excess lubricant with a clean cloth.

The Midas Rex MR8 pneumatic high-speed drill system

Cleaning: manual MR8 pneumatic and MR8 pneumatic touch motors:

• Ensure that the attachment, tube, dissecting tool, and lubricant/diuser have been removed from the motor prior to cleaning.

• If cleaning the MR8 pneumatic touch motor, make sure to brush under the nger lever.

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

• Use a nylon brush to aid in cleaning.

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

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

• Wipe all external surfaces of the motor, hose, and oiler housing, and wipe the inner surface of 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. For the Pneumatic Touch motor, be sure to brush under the nger control lever.

• For nger control lever, actuate all moving parts (telescoping nger rest and motor safe mode switch) through their full range of motion while rinsing under warm running tap water (23 - 43°C / 73 - 109°F).

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

MR8 attachments and tubes:

• Ensure that the attachment, tube, dissecting tool, and lubricant/diuser have been removed from the motor prior to cleaning.

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

• Use a nylon brush to aid in cleaning.

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

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

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

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

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

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

• For angled type attachments, perforator driver attachment, or Jacobs chuck attachment, only place one half (e.g., tube/tool side) of the attachment into the cleaner at a time (Figures 35-1 – 35-3). Do not immerse the entire attachment. Gently agitate the attachment in the cleaner and actuate any moveable parts. Then, place the other half (e.g., base side) of the attachment into the cleaner and repeat (Figures 35-1 – 35-3).

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

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

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

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

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

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

35-1

Angled attachment cleaning example Perforator attachment cleaning example

35-2

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

35-3

Jacobs chuck attachment cleaning example

The Midas Rex MR8 pneumatic high-speed drill system

1. Tube/tool side 2. Base side

Pneumatic control unit

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 foot pedal with the damp cloth until visually clean.

3. Dry the unit with a clean, non-abrasive cloth.

Instrument tray and rigid sterilization container

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

remove any visible soil.

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

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

cavities, to ensure all visible soil is removed.

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

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

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

soak for a minimum of 10 minutes.

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

clean areas to remove all visible soil.

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

5. Following the warm tap water rinse, thoroughly rinse the rigid sterilization container and instrument tray in room temperature 25°C (77°F) puried water (deionized, reverse osmosis, or equivalent) water for a minimum of 30 seconds.

Note: After cleaning, visually examine all parts of the rigid sterilization container and instrument tray for cleanliness. If visible soil remains, repeat cleaning.

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

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

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

2. Actuate movable components to ensure proper lubrication.

3. Remove excess lubricant with a clean cloth.

Disinfection No particular requirements.

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

Maintenance, inspection, and testing

cleaning sections on specic drying instructions.

Do not reprocess for surgical use a device that has obvious damage or corrosion. Return to Medtronic for service. Visually inspect the reprocessed devices following cleaning. Inspection should be performed with adequate lighting. Magnication is not

required. A device that shows or exhibits the properties listed below is at the end of its useful life. Attachments and telescoping tubes may be disposed of at the end of their useful life according to local and national regulations. Due to safety and environmental concerns, Medtronic requests the return of pneumatic high-speed motors for proper disposal at the end of the product’s useful life.

• Obvious damage or corrosion

• Pitting, cracks, fractures, or bending

• Illegible laser etchings, engravings, and other markings

• Discoloration, corrosion, stains or rust.

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

The Midas Rex MR8 pneumatic high-speed drill system

Packaging Warnings:

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

• Do not wrap the rigid sterilization container.

• Use the instrument tray and the rigid sterilization container for sterilization only, not for cleaning or disinfection.

There are two options available for packaging:

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

2. Devices can also be sterilized by placing them inside the 3/4 DIN CA850 instrument tray and then placing the 3/4 DIN CA850 instrument tray inside the 3/4 DIN rigid sterilization container.

Instrument tray:

1. Inspect the following components before each sterilization cycle. Make sure the instrument tray does not have cracks or tears, and that the silicone brackets (Figure 36) are not damaged.

Silicone brackets

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

3. Variable exposure attachments (AVAXX, AVAXXDK, AVSXX) must be placed in the instrument tray with their tube in the fully extended position (Figure 37).

4. Place the motor inside the instrument tray as shown in Figure 38.

5. Close the instrument tray with the lid.

3/4 DIN CA850 instrument tray with variable

exposure attachments

1. Variable exposure attachment in the fully extended position

Placement of the motor in the

3/4 DIN CA850 instrument tray

The Midas Rex MR8 pneumatic high-speed drill system

Option 1: Wrap the instrument tray for sterilization:

• The user facility is responsible for using only accessories (such as sterilization wraps, chemical indicators, and biological indicators) that are

cleared and labeled for the validated sterilization parameters specied in this Instructions for Use by the Food and Drug Administration for medical facilities in the U.S.A. and its territories, or conform to EN ISO 11607 for medical facilities outside of the U.S.A. and its territories.

• The 3/4 DIN CA850 instrument tray should be wrapped with two layers of 1-ply polypropylene wrap using a sequential envelope

technique. For use in the USA, an FDA-cleared wrap should be used.

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

1. Use one lter (Case Medical SCF01) for the rigid sterilization container’s lid and use two lters (Case Medical SCF01) for the 3/4 DIN size rigid sterilization container’s base. a. Place the lter over the perforations in the lid and place a lter retention plate over the lter. b. Secure the lter retention plate by pushing downwards at the center and rotating the handles until you hear them click (Figure 39).

2. Place a rack around the lter plates (Figure 40).

3. Place the instrument tray with the lid on into the rigid sterilization container (Figure 41). Note: Use only the 3/4 DIN CA850 instrument tray with the 3/4 DIN rigid sterilization container.

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

section of the latch in toward the rigid sterilization container (Figure 42). You will feel a solid click.

b. Place the appropriate metal ID tags in the label holders located on either side of the rigid sterilization container latches (Figure 43).

Note: Use only the approved tamper-evident seals (Case Medical SCS01B). Using a nonapproved tamper-evident seal could damage the locking clip.

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

Rigid sterilization container lter placement 3/4 DIN sterilization container with rack

Instrument tray inside the rigid sterilization container 3/4 DIN closed container

Tamper-evident seal on the 3/4 DIN container

The Midas Rex MR8 pneumatic high-speed drill system

Sterilization Warnings:

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

• Do not sterilize and supply for surgical use any device that is not visibly clean and free of particulates. If particulates are present, repeat reprocessing, starting with the Preparation for Cleaning step.

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

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

Cautions:

• Do not expose these devices to sterilization temperatures greater than 137°C (279°F). Exposure to temperatures greater than 137°C (279°F) may impact the performance of the device and also the ecacy of the sterilization cycle.

• Because of the variability in cleaning eciencies and sterilizer operating parameters, all given parameters (temperature, time, etcetera) should be validated by persons who have training and expertise in sterilization processes. Deviation from the recommended sterilization processes is at the risk of the user facility.

Notes:

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

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

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

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

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

Cycle Temperature Exposure time Minimum dry time*

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

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

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

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

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

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

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

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

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

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

2. Unlatch the container.

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

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

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

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

The Midas Rex MR8 pneumatic high-speed drill system

Planned maintenance

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

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

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

Table 8: scheduled maintenance intervals

Maintenance level Number of tools used per motor

per year

A 150–200 12–16* 19–23 3 months

B 100–149 8–11 15–18 4 months

C 50–99 4–7 12–15 5 months

D <50 <4 <11 6 months

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

Notes:

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

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

• The MR8 system has a limited warranty for a period of 1 year from the date of purchase for motors, hoses, pneumatic control unit, regulator hose, regulator, adapters, and instrument trays and rigid sterilization containers. The attachments and telescoping tubes have a limited warranty for a period of 90 days from the date of purchase. After the warranty period, any costs incurred for repair/refurbishing become the responsibility of the customer. This limited warranty does not include the cost associated with any of the factory level service requirements identied in the Preventive Maintenance Schedule. Extended Maintenance Agreements are available.

Number of uses per month per motor

Number of uses per month per attachment**

Time interval

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

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

Motor

1. Visually inspect the exhaust (green) hose and ensure that it does not have any nicks, cracks, holes, tears, or other visible signs of wear.

2. Wipe the external surface of the exhaust (green) hose with a cloth. Perform the heat and seal check below (Step 5) and then inspect the hose. If an oily lm remains on the hose, do not use and return the motor to Medtronic for service.

3. Visually inspect the air tting and ensure that it does not exhibit any signs of damage.

4. Visually inspect the serial number and ensure that it remains legible.

5. Heat and seal check: a. Attach and lock a straight or footed attachment onto the motor. Check to ensure that there is a tactile feel and an audible click when the attachment is

locked on the motor. b. Connect the motor to a pneumatic control unit attached to a compressed gas source. c. Run the motor for 5 minutes (05:00) at the maximum pressure setting available between 80psi – 120psi. d. Feel the motor case and the attachment base and ensure they are not uncomfortably hot to the touch. e. Remove the attachment and visually inspect the tool collet area, and the nger control valve area (if applicable) for any signs of oil.

6. MR8 touch only: Run the motor for a short duration and then release the nger control lever. If the motor continues to run after the nger control lever is released, do not use and return the motor to Medtronic for service.

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

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

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

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

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

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

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

7. Heat Check: Caution: Feel the motor case, the attachment base, knuckle (angled area for angled attachment only), and the attachment tip (straight and angled attachments only) periodically and cautiously to ensure they are not uncomfortably hot to the touch. a. Attach and lock the attachment onto the motor. Ensure that there is a tactile click when the attachment is locked onto the motor.

Note: Ensure that the secondary lock is engaged on the angled attachments. b. Connect the motor to a pneumatic control unit attached to a compressed gas source. c. Run the motor and attachment at the maximum pressure setting available between 80psi – 120psi for 3 minutes (03:00). d. Allow the motor to cool and then repeat steps 1 to 7 for each attachment in the system.

8. Exceptions: a. Run J-latch attachment at 80psi for 3 minutes (03:00). b. Perforators and Jacobs chuck at the maximum pressure setting available between 80psi – 120psi for 5 minutes (05:00)

The Midas Rex MR8 pneumatic high-speed drill system

Pneumatic control unit, regulator, and regulator hose

1. Visually inspect the air ttings and regulator hose for any signs of blockage, damage, or wear.

2. Static gage check: Note: This is a static functional test only. The pressure gages should be placed on your facility’s routine calibration schedule and be assessed for accuracy during its regular calibration date. a. Connect the pneumatic control unit/regulator to a compressed gas source. b. Pressurize the pneumatic control unit/regulator. c. Conrm that the gage is functional.

3. Pneumatic control unit: a. Pressure relief button check:

i. Connect the pneumatic control unit to a compressed gas source. ii. Pressurize the pneumatic control unit. iii. Turn o the compressed gas source. iv. Press the pressure relief button. v. Conrm that the compressed gas has been released and the gage on the pneumatic control unit drops to zero.

b. Finger/foot control switch functionality check:

i. Connect a motor to the pneumatic control unit. ii. Place the switch in “On” the position. iii. Conrm the foot pedal is depressed. iv. Remove the motor from the pneumatic control unit. v. Place the switch in the “On” position.

vi. Conrm the foot pedal is released. c. Visually inspect the motor port cover for any signs of wear or damage. d. Visually inspect the foot control pedal for any build-up of debris or indication of damage. Ensure the pedal moves freely. e. Pedal check:

i. Attach the motor to the pneumatic control unit.

ii. Connect the pneumatic control unit to a compressed gas source.

iii. Depress the foot pedal and run the motor for a short duration.

iv. Release the foot pedal and observe the motor.

v. If the motor continues to run after the foot pedal control lever is released, do not use and return the foot control to Medtronic for service.

vi. Visually inspect the motor port cover for damage.

For scheduled maintenance intervals 4, 12

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

At these maintenance intervals, it is important that the units be returned to Medtronic for factory level inspection and service. Note: The costs associated with any of the factory level service requirements are not included in the limited warranty. Extended maintenance agreements are available.

Pneumatic control unit, regulator, and regulator hose

1. Visually inspect the air ttings and regulator hose for any signs of blockage, damage, or wear.

2. Static gage check: Note: This is a static functional test only. The pressure gages should be placed on your facilities routine calibration schedule and be assessed for accuracy during its regular calibration date. a. Connect the pneumatic control unit/regulator to a compressed gas source. b. Pressurize the pneumatic control unit/regulator. c. Conrm that the gage is functional.

3. Pneumatic control unit: a. Pressure relief button check:

b. Finger/foot control switch functionality check:

i. Attach the motor to the pneumatic control unit.

ii. Connect the pneumatic control unit to a compressed gas source.

iii. Depress the foot pedal and run the motor for a short duration.

iv. Release the foot pedal and observe the motor.

v. If the motor continues to run after the foot pedal control lever is released, do not use and return the foot control to Medtronic for service.

vi. Visually inspect the motor port cover for damage.

For scheduled maintenance interval 8

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

At this maintenance interval, it is important that the units be returned to Medtronic for factory level inspection and service. Note: The costs associated with any of the factory level service requirements are not included in the limited warranty. Extended maintenance agreements are available.

The Midas Rex MR8 pneumatic high-speed drill system

Storage

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

Disposal

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

Troubleshooting

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

Problem Possible cause Recommendations

MR8 motor

Motor not running or low on power

Motor continues to run Pneumatic control unit is not functioning properly Depressurize the system and return the pneumatic control unit to Medtronic

System makes an abnormal noise

Motor is too hot to touch/hold

Attachment does not seat properly on motor

Hoses not properly connected Make sure all connections are secure. Ensure supply pressure is within 80-120 psi. Operating pressure inadequate Check gas supply pressure guage. Increase pressure according to

Attachment not properly installed and locked onto the motor Remove and re-install attachment and tool to ensure proper installation

Foot pedal on pneumatic control unit not functioning properly Check for obstructions under the foot pedal. If foot pedal continues to fail,

Motor stalls Manually spin the dissecting tool, then activate the motor. If the motor

Finger control is not functioning properly Return motor to Medtronic for service. Pneumatic control unit is locked in the nger control position Move the nger control lever to the foot control position. Inadequate lubrication Check for proper installation of the lubricant/diuser cartridge. If the problem

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

Worn bearings Switch attachments to determine whether the bearings are failing in the motor

Attachment not properly installed and locked onto the motor Remove and reinstall attachment and tool to ensure proper installation

Safety relief valve has been activated by high air pressure Ensure that air operating/dynamic air pressure is no higher than 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/diuser cartridge. Attachment transferring heat to the motor Switch attachments to determine whether the heat is being generated by the

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

Inadequate irrigation Ensure adequate irrigation to surgical site during bone dissection. Damaged tactile ring on motor collet Contact Medtronic Customer Service to return the motor for service.

compressed gas requirements, if necessary.

and locking of attachment onto motor.

return the pneumatic control unit to Medtronic for service.

continues to stall, return it to Medtronic for service.

for service.

persists, replace the cartridge. If replacing the cartridge doesn’t x the problem, return the motor to Medtronic for service.

Depressurize the system and return the motor to Medtronic for service.

or in the attachment. Return the failing component to Medtronic for service.

and locking of the attachment onto the motor.

motor or the attachment. Return the failing component to Medtronic for service.

motor with a moist sterile towel. If overheating continues, return the motor to Medtronic for service.

MR8 attachments or telescoping tubes

Attachment will not properly seat on the motor

Tool is dicult to remove from the attachment

16-MF Contra-Angle attachment is overheating

Perforator is running too slow Pressure set incorrectly Check the pressure setting at the foot control. Footed attachment will

not lock

Motor collet ats are not aligned Use the Medtronic motor wrench to rotate the at closest to the motor

Aging of attachment Return to Medtronic for service or purchase new equipment. Improper cleaning Use of reprocessed tools Use of an unauthorized refurbisher The Contra-Angle attachment operates by a set of internal

gears to engage the drive shaft. It is normal for some heat to be generated approximately 2 cm from the distal end of the attachment and at the right of the angle head.

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

case until its marker is aligned with the marker on the at farthest away from the motor case.

Verify pressure setting of 80 psi (5.5 bar).

If heat continues or is excessive, return the equipment to Medtronic for service or purchase new euipment.

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

The Midas Rex MR8 pneumatic high-speed drill system

Problem Possible cause Recommendations

MR8 dissecting tools

Dissecting tool fails A non-MR8 dissecting tool is being used Replace with an MR8 dissecting tool.

Dissecting tool vibrates excessively

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

Smoke is generated by the attachment or motor

Worn attachment or tube bearings Try another attachment or tube to isolate the location of the problem.

Attachment/tube and tool are not compatible Match color code on the dissecting tool packaging to the color code on

Motor is damaged Return motor to Medtronic for service.

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

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

Debris in collet of attachment or motor Clean the attachment or motor thoroughly according to the instructions

A non-MR8 dissecting tool is being used Replace with an MR8 dissecting tool.

Attachment is not in the locked position Make sure the attachment is in the locked position.

If the attachment is failing, return it to Medtronic. If the tube is failing, dispose of it and use a new tube.

the attachment/tube.

Adjust the speed by changing the pressure setting or foot/nger control. Do not use if failing persists. Change dissecting tools.

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

in this manual. If cleaning does not correct the problem, return the attachment or motor to Medtronic for service.

Medtronic Midas Rex MR8 pneumatic high speed systems limited warranty*

(U.S. customers only)

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

extended only to the buyer purchasing the MR8 system directly from Medtronic or from its aliate or its authorized distributor or representative. The Midas Rex MR8 pneumatic high speed system (hereinafter all items listed below are collectively referred to as product) includes, as may be applicable, the motor, foot control, instrument trays and rigid sterilization containers (hereafter referred to as system components), straight and angled motor attachments (hereinafter referred to as “attachments”), telescoping tubes (hereinafter referred to as semi-reusable components), and dissecting tools and other accessories not listed above and jointly referred to as other components, unless specically noted. a. Should a system component fail to function to Medtronic’s published specications during the term of this limited warranty (one year from the date of sale

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

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

attachment), Medtronic will either repair or replace the attachment or any portion thereof. c. Should a semi-reusable component fail to function to Medtronic’s published specications during the term of this limited warranty (30 days from the date of

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

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

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

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

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

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

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

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

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

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

*This limited warranty is provided by Medtronic Neurosurgery Group, 4620 North Beach Street, Fort Worth, Texas 76137-4116. It applies only in the United States. Areas outside the United States should contact their local Medtronic representative for terms of the warranty. After the warranty period, any costs incurred for repair/refurbishing become the responsibility of the customer. This limited warranty does not include the cost associated with any of the factory level service requirements identied in the preventive maintenance schedule. Extended maintenance agreements are available.

EC REP

STERILE R

DEHP

REGULATOR

Symbols

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

The Midas Rex MR8 pneumatic high-speed drill system

Compliant with European Council Directive MDD 93/42/EEC

Authorized Representative in the European Community

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

Consult Instructions for Use

Follow Instructions for Use

Caution

Do not oil.

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

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

Non-Sterile

Serial Number

Catalog Number

Lot Number

Package Contents

Quantity

Use With

Finger-Operated Control

Foot-Operated Control

Accessory

Adapter

Attachment

Brush

!USA

PHT

Lubricant/Diuser

USA Only

Do not use if package is open or damaged

Package Quantity

Double-Locking

Diameter

Unlock

Lock

Contains DEHP (di-2-ethyl hexyl phthalate)

Tool control

Air Pressure Relief

Regulator

Lubricant/Diuser

+ XX °C + XX °F

Sterilized using Irradiation

+ XX °C + XX °F

Temperature Limitation

Tube Control

Manufacturer

Date of Manufacture

Use By Date

Dissecting Tool

Refurbished

Dissecting Tool

Control Unit

Instrument Tray

Motor

Refurbished

Multi-Use Disposable Attachment

Part Number

175039EN B

EC REP

2019-02

May be covered by U.S. Patents:

Medtronic.com/patents

Made in USA. Printed in USA.

Medtronic Powered Surgical Solutions

4620 North Beach Street

Fort Worth, Texas 76137 USA

+1 800 433 7080

Medtronic B.V.

Earl Bakkenstraat 10

6422 PJ Heerlen The Netherlands +31 45 566 8000

Medtronic Australian Sponsor:

Medtronic Australasia Pty Ltd

2 Alma Road

Macquarie Park, NSW 2113 Australia

Medtronic of Canada Ltd

99 Hereford Street

Brampton, Ontario L6Y 0R3

Canada

+1 905 460 3800

Europe/Middle East/Africa

Medtronic International Trading Sàrl

Route du Molliau 31

Case Postale 84

CH- 1131 Tolochenaz

Switzerland

+41 21 802 7000

medtronic.com

manuals.medtronic.com

Medtronic CA850S Instructions for Use

Specifications and Main Features

Frequently Asked Questions

User Manual

Customer service

Contents

Glossary

General information

Indications for use

MR8 system description

MR8 pneumatic motors

MR8 attachments

MR8 surgical dissecting tools

Contraindications

Special notices

System hoses

Tools and disposable components

Pneumatic control unit

Cautions

MR8 pneumatic high-speed system components

MR8 pneumatic motors

Pneumatic control unit

Regulator

Regulator hose

MR8 pneumatic motor

MR8 pneumatic touch motor

MR8 pneumatic connections and adapters

Operating room set up

System set up

Connect the motor

Activate the motor

MR8 surgical dissecting tools

Assembly

Tool nomenclature

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

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

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

MR8 attachments

Straight attachments

Angled attachments

Variable exposure straight and angled attachments

Angled double lock (DK) attachment

Fixed footed attachments

Rotating footed attachments

Metal cutting attachments

Telescoping attachments and tubes

Perforator driver attachment

Jacobs chuck attachment

J-latch attachment

Disassembling the MR8 pneumatic system

Depressurize the system

Disconnect hoses

System accessories: disposable components

Cleaning brushes

System accessories: non-disposable components

Instrument tray

Rigid sterilization container (sterilization case)

MR8 system reprocessing instructions

Warnings and cautions

Limitations on reprocessing

Point of use Reprocessing begins at the point of use.

Containment and transportation

Preparation for cleaning: automated

Cleaning: automated Warnings:

Cleaning: manual MR8 pneumatic and MR8 pneumatic touch motors:

Disinfection No particular requirements.

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

Maintenance, inspection, and testing

Packaging Warnings:

Sterilization Warnings:

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

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

Planned maintenance

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

Pneumatic control unit, regulator, and regulator hose

For scheduled maintenance intervals 4, 12

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

Pneumatic control unit, regulator, and regulator hose

For scheduled maintenance interval 8

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