Medtronic MIDAS REX MR7 Instruction Manual
MIDAS REX® MR7
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Pneumatic High-Speed System
Pneumatyczny system wysokoobrotowy
Pneumatický vysokorychlostní systém
Nagy sebességĦ pneumatikus rendszer
Instruction Manual
Instrukcja obsáugi
Návod
Használati útmutató
Rx Only
Symbols
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The following symbols may appear within this manual, on product labeling, or on the product itself:
Attention, see Instructions for Use. Tube Control
STERILE
United States federal law restricts this
device to sale by or on the order of a
physician.
Reference Number Use with
Lot Number Multi-Use Disposable
Serial Number
Quantity
Instrument Case
Air Pressure Relief
Attachment
Instrument Case
Lubricant/Diffuser
Lubricant/Diuser
For single patient use only. Do not
re-use, re-process, or re-sterilize this
product. Re-use, re-processing or
re-sterilization 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.
Approximately equal to
Non-Sterile
Sterilized by Gamma Irradiation
Dissecting Tool
Attachment
Control Unit
Refurbished
Dissecting Tool
Attachment
Control Unit
Refurbished
+
Use by date
Accessory
Accessory
Date of manufacture
REGULATOR
Temperature Limitations
Unlock
Lock
|
On
Off USA Only
Finger-Operated Control Manufacturer
Foot-Operated Control Do not dispose to unsorted
Compliant with European Council
Directive MDD 93/42/EEC.
Bone Mill
MOTOR
Brush
Adapter
Regulator
Bone Mill
Motor
Brush
Adapter
municipal waste.
Tool Control
EC REP
Authorized Representative in the
European Community
Consult Instructions for Use
Contents
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General Information ...........................................................................................................................1
Indications for Use ..............................................................................................................................1
Contraindications ....................................................................................................................1
Special Notices .........................................................................................................................1
General Safety Precautions .....................................................................................................2
No Latex Policy ........................................................................................................................2
System Components ...........................................................................................................................3
Non-Disposable Components ...............................................................................................3
Disposable Components .........................................................................................................7
Legend® Dissecting Tools ........................................................................................................8
General Guidelines F
or Attachment and Tool Applications .............................................. 9
Setting up the Operating Room ..................................................................................................... 12
Power Source Requirements ............................................................................................... 12
Pneumatic Connections....................................................................................................... 12
Setting up the MR7 System ............................................................................................................. 13
Installing the Oiler Cartridge .............................................................................................. 13
Connecting the Motor ......................................................................................................... 14
Installing an Attachment and Tool ................................................................................................ 15
Straight At
tachments ............................................................................................................ 15
Specialized Attachments ...................................................................................................... 15
Activating the Motor ....................................................................................................................... 16
Disassembling the MR7 System ..................................................................................................... 17
Depressurize the System ...................................................................................................... 17
Disconnect Hoses ................................................................................................................. 17
Discard the Lubricant/Di user Cartridge ......................................................................... 17
Remove the Attachment and Tool ...................................................................................... 17
Cleaning & Sterilizing the MR7 System ........................................................................................ 18
MR7 Motor ............................................................................................................................ 18
Legend At
tachments / Tubes ............................................................................................... 19
i
MR7 Pneumatic Control Unit / Regulator Hose /
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Triton Adapter / Instrument Case ...................................................................................... 21
Transmissible Spongiform Encephalopathies (TSE) Return Policy............................... 21
Troubl eshooting ............................................................................................................................... 22
Refurbishing or Repairs .................................................................................................................. 25
Preventative Maintenance ............................................................................................................... 26
Limited Warran
ty ............................................................................................................................. 27
Appendix A—Specialized Attachments ........................................................................................ 28
Angled Attachments ............................................................................................................. 28
Angled Double Lock Attachments ..................................................................................... 29
Curved Bur Attachments ..................................................................................................... 30
Variable Exposure Attachments ......................................................................................... 31
Footed Attachments ............................................................................................................. 32
Rotating Footed Attachments ............................................................................................. 33
Contra-Angle Attachment (16-MF) ................................................................................... 34
Metal Cutting Attachments ................................................................................................. 35
Telescoping Attachments ..................................................................................................... 36
Perforator Driver At
tachments ........................................................................................... 37
Jacobs® Chuck Attachments ................................................................................................ 38
Bone Mill Attachment .......................................................................................................... 39
ii
General Information
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Read and understand this manual before use of the MR7 System.
The Midas Rex® MR7 system is designed for use by medical professionals familiar with powered surgical instrumentation.
The surgeon is responsible f
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.
The MR7 system consists of the following components:
• MR7 or MR7 T
• MR7 Pneumatic Control Unit with Various Connectors
• MR7 Regulator Hose
• MR7 Lubricant/Di user Cartridge
• MR7 Triton® Adapter (optional)
• Legend® Attachments*
• Legend® Dissecting Tools*
*The MR7 syst
ouch Motor
em uses the same attachments and dissecting tools as the Legend® Pneumatic High-Speed System.
or learning the proper techniques in the use of this system, as inappropriate use may potentially
General Information
Indications for Use
The Medtronic Midas Rex MR7 System is a pneumatically operated surgical instrument system. The pneumatic motors
provide power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery,
including craniotomy and spinal surgery; as well as Ear, Nose and Throat (ENT), orthopedic and general surgical applications
including maxillofacial, craniofacial and sternotom
y surgeries.
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 physician.
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
procedure.
, but is not essential to complete the
1
General Information
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General Safety Precautions
WARNINGS:
• Do not use the Midas Rex MR7 System before proper cleaning and sterilization.
• Do not operate the Midas Rex MR7 System in the presence of Magnetic Resonance Imaging devices.
• Do not use damaged, faulty, or modi ed Midas Rex MR7 S
damage prior to each use:
• Check the motor’s exhaust hose for cracks or tears.
• Visually inspect attachments and tools. Do not use bent or damaged tools.
• I
nstall attachment and dissecting tool, then brie y run motor.
* Check motor for overheating and leaking lubricant.
* Check attachment for overheating.
* Check dissecting tool for ail.
• Do not operate the Midas Rex MR7 S
• Motors and attachments which fail due to extended use may allow a component to detach and fall from the motor or
attachment, and may cause patient injury.
• Heavy side loads and/or long operating periods may cause the device to overheat. If overheating occurs:
• Never place an overheated motor on the patient or draping during surgery.
• Discontinue use and rest the motor by using intermitt
sterile towel.
• If the motor is passed o , the receiver should grasp the motor by the proximal end close to the motor hose.
• T
o avoid injury to the patient or user, do not place the handpiece on the patient or in an unsecured location, when not
in use.
ystem without eye protection.
ystem components. Inspect the Midas Rex MR7 System for
ently, or wrap the motor/attachment interface with a moist
• Midas Rex MR7 motors should only be operated when the attachment is in the
If a dissecting tool package is opened, but the tool is not used or contaminated, the tool can be re-sterilized by steam
sterilization. Remove tool from all original packaging and place into an approved autoclave package. Steam sterilize as
follows:
High Vacuum Steam: 270° F (132° C) for 5 minutes
Gravity Displacement: 270° F (132° C) for 15 minutes
The re-sterilized tool must be used promptly following re-sterilization. If rust or corrosion is encountered after
re-sterilization, do not use the re-sterilized tool
.
position.
No Latex Policy
Legend and MR7 products, packaging materials, labels, package inserts, and similar items manufactured by and/or for
Medtronic Powered Surgical Solutions (MPSS) do not contain latex.
2
System Components
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Non-Disposable Components
MR7 Motor
The MR7 motor is a high-speed, high-torque motor used to dissect bone and biomaterials.
Figure 1: Motor Components
System Components
1
5
1. Collet
2. Motor Case
3. Swivel
4. Hose
5. Finger Control Lever
3
2
4
6
6. Safety Slide (MR7 Touch Only)
In addition to the components listed in Figure 1, each MR7 motor has a lubricant/di user housing at the end of the motor
hose, as seen in F
igure 2.
Figure 2: Lubricant/Di user Housing
3
System Components
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WARNING: Use only Medtronic Midas Rex Legend or MR7
devices with an MR7 motor. Use of other devices may
cause injury or damage equipment, and will void the
manufacturer’s warranty.
Pneumatic Control Unit
The pneumatic control unit (Figure 3) provides variable
speed motor control controls 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.
Figure 3: Pneumatic Control Unit
Instrument Case
The instrument case (Figure 5) is used to organize
equipment.
Regulator Hose
Connects from the gas source to the pneumatic control
unit to deliver compressed gas.
Figure 4: Regulator
Figure 5: Instrument Case
4
System Components
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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. A N2 DISS to female Schrader
adapter is also available f
hose to a male Schrader in-house gas connection.
or connection of the regulator
N2 DISS to Air DISS Adapter
The N2 DISS to air DISS adapter (Figure 7) allows for the
regulator hose to be attached to an Air DISS in-house gas
connection.
N2 DISS to WF4 Adapter
The N2 DISS to WF4 adapter (Figure 8) allows for the
regulator hose to be attached to a Midas Rex safety valve
regulator previously used for Midas Rex Classic or Midas
Rex III motors. The in-line oiler must be removed from the
safety valve regulator.
Motor Wrench
The motor wrench (Figure 9) is used to align arrows
on motor collet ats prior to installation of a Legend
attachment.
Figure 6: N2 DISS to Male Schrader Adapter
Figure 7: N2 DISS to Air DISS Adapter
Figure 8: N2 DISS to WF4
Adapter
Triton Adapter
The Triton adapter (Figure 10) allows the Triton handpiece
to be driven by the MR7 pneumatic control unit. It
functions much the same way as the Triton port on
the Legend pneumatic control unit, except that it is
connec
rather than being integrated into the control unit
ted between the control unit and the gas source,
Figure 9: Motor Wrench
Figure 10: Triton Adapter
5
System Components
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Legend Attachments
Legend motor attachments are available in various designs to facilitate a variety of surgical procedures. Attachments vary in
length, diameter, and overall design. They are marked and color-coded to correspond with their associated dissecting tools.
A few of the Legend attachments available are listed in the table below.
Attachment Example Other Details/Options
Standard Straight Attachments AS09
Standard Angled Attachments AA14
Straight Variable Exposure Attachments AVS07
Angled Variable Exposure Attachments AVA07
Fixed Footed Attachments AF01
Rotating Footed Attachments AF01R
Telescoping Attachments A
Contra-Angle Attachment AC16
Metal Cutting Attachment ASMC
Perforator Attachment AD01 Available in 800 RPM or 1000 RPM form.
5/32” Jacobs Chuck Attachment AD02
Bone Mill Attachment BM100
T10 (base)
TT12A (tube)
The telescoping attachment requires the use of the AT10
attachment base, as well as a telescoping tube. Tubes are
available in straight, cur
ved, or hooded form.
NOTE: Angled and straight attachments with the same length, mark
Curved and straight telescoping tubes with the same length, marking, and color band also share the same dissecting tool.
Example: The 14-AM straight and 14-AM angled attachments are 14 cm long, marked 14-AM and have a green color band.
All dissecting tools with the pre x 14 (14MH30) may be used in either the 14-AM straight or 14-AM angled attachment.
Be sure to match the color code and nomenclature on the Legend Dissecting Tool packaging with the color band and
nomenclature on the Legend Attachment.
ing, and color band share the same dissecting tool.
6
Disposable Components
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WARNING: Use only Medtronic Midas Rex Legend or
MR7 devices with an MR7 motor. Use of other devices
may cause injury or damage equipment, and will void
the manufacturer’s warranty.
Lubricant/Diffuser Cartridge
The lubricant/di user cartridge (Figure 11) provides
lubrication to the motor and lters oil from exhausted air.
Telescoping T ubes
Telescoping tubes (Figure 12) 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.
Cleaning Brushes
Cleaning brushes (Figure 13) are used to clean debris
from lumen of attachments and telescoping tubes. Sized
for an internal bore diameter of 3.2 mm, 2.4 mm or 1.2
mm in Legend Attachments and Telescoping Tubes.
System Components
Figure 11: Lubricant/Di user Cartridge
Figure 12: Telescoping Tube
NOTE: Cleaning brushes will not pass thr
contra-angle, metal cutting, perforator, or Jacobs Chuck
attachments, because they are not cannulated.
ough angled,
Figure 13: Cleaning Brushes
3.2mm
2.4mm
1.2mm
7
System Components
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Legend® Dissecting Tools
Legend dissecting tools are sterile cutting tools, intended for cutting bone and biomaterials.
Dissecting Tool Nomenclature
Part numbers for Legend dissecting tools follow a standard naming convention, which is described in the diagram below.
A basic part number consists of the associated attachment length, the tool head shape, 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 dissec
additional “-MN” su x.
ting tool. Tools that use a design taken from the Mednext line are designated by an
Associated
Attachment
Length
Tool
Head Diameter
(x.x millimeters)
Optional
Pre¿ x
Tool
Head Shape
Optional
Suf¿ x
Tool Number Pre¿ xes (not all inclusive)
F... For use with footed attachments
MC For use with metal cutting attachments
T For use with telescoping attachments
Tool Head Shapes (not all inclusive)
AC Acorn MH Match Head
BA Ball OV Oval
CY Cylinder RT Reverse Taper
HM Hole Maker TA Tapered
HS Hole Saw TD Twist Drill
Tool Number Suf¿ xes (note that more than one of the su xes listed may be combined in a single part number)
L Long S Spiral
D Diamond SH Short
X Extra DC Diamond Coarse
F Fine DX Diamond Extra Coarse
C Carbide MN Mednext Tool Design
8
System Components
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WARNINGS:
• Dissecting tools are for single-use only. Do not attempt to sterilize them. The dissecting tools are packed sterile and are
not intended for repeat use. To prevent contamination, use only once.
• Do not use an attachment and dissec
• Do not attempt to remove a tool while the motor is running.
• Do not attempt to remove a tool from an overheated motor or attachment.
• Do
not use the device if the package is opened or damaged.
ting tool combination that results in tool ail or excessive vibration.
General Guidelines For Attachment and Tool Applications
These are general guidelines for dissecting tool applications and are not an all-inclusive listing.
WARNING: Be sure to match the color code and nomenclature on the Legend Dissecting Tool packaging with the color
band and nomenclature on the Legend Attachment. Failure to do so could result in injur
sta .
Surgical
Application
Spine 8-B, 9-M, 14-AM,
Commonly
Used
Attachments
Match Head
15-A
Telescoping Match Head
Footed, Straight Tap er ed
Elongated spherical design allows controlled, delicate
dissection. For entry hole, nerve decompression, osteophyte
removal, sinus dissection, etc.
Ball
Helical cutting utes dissect bone or cement e ec
from a wide variety of approach angles. For debridement,
decortication, sinus dissection, etc.
Oval
Helical cutting utes and curved design blend acorn and ball
styles to vary dissection e ciency with appr
decortication, laminotomy, entry hole, nerve decompression,
osteophyte removal, etc.
Hole Maker/Saw
Matched sets of Hole Makers and Hole Saws are e cient and
e ective for interbody fusion.
Cylinder
E ec
tive bone sculpting and planing. For graft shaping,
debridement, corpectomy, decortication, interbody fusion,
fusion takedown, etc.
Acorn
Curved design varies dissection e ciency with varied
approach angles. F
debridement, corpectomy, decortication, fusion takedown, etc.
Elongated spherical design allows controlled, delicate
dissection. For entr
removal, sinus dissection, etc.
Slender design for precise dissection with minimal bone loss.
For transection, osteotomy, graft harvesting, bone shaping,
entr
y hole, suture hole, midface advancement, etc.
Commonly Used
Dissecting Tools
or entry hole, laminotomy, bone shaping,
y hole, nerve decompression, osteophyte
y to the patient or operating room
Suggested
Motor(s)
MR7, MR7
Touch
tively
oach angle. For
MR7, MR7
Touch
9
System Components
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Surgical
Application
Neurosurgical–
Cranial
General
Surgery and
Plastic Surgery
(Craniofacial/
Maxillofacial/
Sternotomy)
Ear, Nose, and
Throat (Otology,
Neurootology)
Commonly
Used
Attachments
7-6ST, 8-B, 9-M,
10-9ST, 14-AM,
15-A
Telescoping Match Head
Footed Ta pe re d
7-6ST, 8-B, 9-M,
10-9ST, 14-AM
7-6ST, 10-9ST Ball
Match Head
Elongated spherical design allows controlled, delicate
dissection. For entry hole, nerve decompression, osteophyte
removal, sinus dissection, etc.
Ball
Helical cutting ute
from a wide variety of approach angles. For debridement,
decortication, sinus dissection, etc.
Twist Drill
Helical design with stop produces a hole with a precise depth.
Ideal for plating.
A
corn
Curved design varies dissection e ciency with varied
approach angles. For entry hole, laminotomy, bone shaping,
debridement, corpectomy, decortication, fusion takedown, etc.
Elongated spherical design allo
dissection. For entry hole, nerve decompression, osteophyte
removal, sinus dissection, etc.
Slender design for precise dissection with minimal bone loss.
For transection, osteotomy, graft harvesting, bone shaping,
entr
y hole, suture hole, midface advancement, etc.
Match Head
Elongated spherical design allo
dissection. For entry hole, nerve decompression, osteophyte
removal, sinus dissection, etc.
Ball
Helical cutting utes dissect bone or cement e ectively
from a wide variety of approach angles. F
decortication, sinus dissection, etc.
Tap er ed
Slender design for precise dissection with minimal bone loss.
For transection, osteotomy, graft harvesting, bone shaping,
entry hole, suture hole, midface advancement, et
Twist Drill
Helical design with stop produces a hole with a precise depth.
Ideal for plating.
Helical cutting utes dissect bone or cement e ec
from a wide variety of approach angles. For debridement,
decortication, sinus dissection, etc.
Commonly Used
Dissecting Tools
s dissect bone or cement e ectively
ws controlled, delicate
ws controlled, delicate
or debridement,
c.
tively
Suggested
Motor(s)
MR7
MR7, MR7
Touch
MR7
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