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.
Contents
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
MR8 pneumatic motors ......................................................................................................................................................................................................4
Pneumatic control unit .......................................................................................................................................................................................................5
Regulator ..................................................................................................................................................................................................................................5
Regulator hose .......................................................................................................................................................................................................................5
MR8 pneumatic motors ......................................................................................................................................................................................................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
MR8 surgical dissecting tools .......................................................................................................................................................................................................10
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/diuser 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
Storage .................................................................................................................................................................................................................................................35
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 qualied 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 specically 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 qualied personnel only.
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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 briey 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
eect 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/diuser 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.
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The Midas Rex MR8 pneumatic high-speed drill system
W53 Consult the cranial perforator manufacturer device labeling for the recommended speed specications.
W54 Tools with “L” identication are longer tools intended for light bone dissection. The increased tool head/stem conguration may aect 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 eectiveness 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/diuser 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/diuser or oiler cartridge for more than one hour of drill time.
C11 Do not reuse or attempt to rell a lubricant/diuser or oiler cartridge. It is a single-use product.
C12 Do not use a lubricant/diuser 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 ecacy of the sterilization cycle.
C16 Because of the variability in cleaning eciencies 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.
3
The Midas Rex MR8 pneumatic high-speed drill system
3
1
2
3
4
5
6
7
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 diuser. Each MR8 motor has a lubricant/diuser 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/diuser housing at the end of the motor hose.
1
2
1
1. Collet
2. Motor case
3. Swivel
MR8 pneumatic motor MR8 pneumatic touch motor
4
5
4. Hose
5. Lubricant/diuser housing
2
1. Telescoping nger rest
2. Motor safe mode switch
3. Swivel
4. Hose
5. Collet
6. Motor case
7. Lubricant/diuser housing
4
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.
3
MR8 pneumatic control unit MR8 regulator
4
MR8 pneumatic motor
Technical specications
Table 1. MR8 pneumatic motor technical specications
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 briey run the motor and conrm 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 oers the operator an option to control the motor
with a nger control mechanism. The MR8 pneumatic touch motor also oers the user an option to control the motor with the foot via a PCU.
Technical specications
Table 2. MR8 pneumatic touch motor technical specications
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
5
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.
5
N2 DISS to surgical tool air
male SIS adapter gas source
9
N2 DISS to female
Schrader adapter
6
10
N2 DISS to male
Schrader adapter
N2 DISS to surgical tool air
male SIS adapter
7
11
N2 DISS to male
Schrader adapter (UK)
N2 DISS to WF4 adapter
8
N2 DISS to air DISS adapter
6
The Midas Rex MR8 pneumatic high-speed drill system
4
12
Pneumatic adapter diagram
5
3
6
2
7
1
8
9
10
1. Regulator hose (N2 DISS) 6. N2 DISS to male Schrader adapter gas source
2. N2 DISS to male Schrader adapter - UK gas source 7. Gas source (N2 DISS)
3. N2 DISS to female Schrader adapter gas source 8. 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
7
The Midas Rex MR8 pneumatic high-speed drill system
System set up
Warnings:
• Failure to properly secure the lubricant diuser or oiler cartridge may cause injury to operator or operating room sta.
• Do not attempt to remove the lubricant diuser or oiler cartridge while the system is pressurized.
Cautions:
• Do not use the MR8 pneumatic motor without a lubricant diuser or oiler cartridge installed.
• Do not use a lubricant diuser or oiler cartridge for more than one hour of drill time.
• Do not reuse a lubricant diuser or oiler cartridge. It is a single-use product.
• Do not attempt to rell a used lubricant diuser or oiler cartridge.
• Do not use a lubricant diuser or oiler cartridge if it appears to be damaged or if the inner foil seal is punctured.
Note: Each MR8 motor has a lubricant diuser 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
8
Aligning the collet at
The Midas Rex MR8 pneumatic high-speed drill system
3
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.
15
PCU pedal
1. Foot control
pedal
2. Air pressure
gauge
3. Control slide
1
2
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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 dierent 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
identier, and the tool head diameter. Part numbers may also include a variety of prexes to identify specic
attachment types, as well as a variety of suxes 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.
17
MR8 -
MR8 surgical dissecting tool nomenclature
9 M H 3 0
16
MR8 surgical dissecting tools
1234
1. Optional prex
2. Attachment length, x centimeters
(Ex. 9 = 9 cm)
3. Tool family identier, xx form/function
(Ex. MH = Match head)
Tool number prexes Tool number suxes
Note: A single part number will use only
one prex.
Prex Tool attachments Sux Tool head cutting modiers
F
T
Tool family identier (form/function)
AC
BA
CY
HM
HS
MC
MH
OV
RT
TA
TD
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 sux
Note: More than one sux may be
combined in a single part number.
Ball
B
Barrel
BR
Carbide
C
Cornerstone
CS
Diamond
D
Diamond coarse
DC
Diamond ne
DF
Diamond extra coarse
DX
Diamond extra ne
DXF
Fine
F
Match ute (on telescoping tools)
M
Spiral utes
S
3-Flute or symmeTRI
T
Extra
X
Extra ne
XF
Tool length modiers
L Long
5 6
10