Medtronic AF02R Instructions for Use
MIDAS REX® MR7
Pneumatic High-Speed System
Instruction Manual
Rx Only
Symbols
Lubricant/Diuser
Attachment
STERILE
Control Unit
REGULATOR
Brush
|
EC REP
The following symbols may appear within this manual, on product labeling, or on the product itself:
Attention, see Instructions for Use. Tube Control
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
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
Instrument Case
Dissecting Tool
Refurbished
Air Pressure Relief
Attachment
Instrument Case
Lubricant/Diffuser
Dissecting Tool
Attachment
Control Unit
Refurbished
Use by date
Accessory
Accessory
Date of manufacture
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
Adapter
Regulator
Bone Mill
Motor
Brush
Adapter
municipal waste.
Tool Control
Authorized Representative in the
European Community
Consult Instructions for Use
Contents
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 .........................................................................................................8
Legend® Dissecting Tools ........................................................................................................9
General Guidelines For Attachment and Tool Applications ........................................... 10
Setting up the Operating Room ..................................................................................................... 13
Power Source Requirements ............................................................................................... 13
Pneumatic Connections....................................................................................................... 13
Setting up the MR7 System ............................................................................................................. 14
Installing the Oiler Cartridge .............................................................................................. 14
Connecting the Motor ......................................................................................................... 15
Installing an Attachment and Tool ................................................................................................ 16
Straight Attachments ............................................................................................................ 16
Specialized Attachments ...................................................................................................... 16
Activating the Motor ....................................................................................................................... 17
Disassembling the MR7 System ..................................................................................................... 18
Depressurize the System ...................................................................................................... 18
Disconnect Hoses ................................................................................................................. 18
Discard the Lubricant/Diuser Cartridge ......................................................................... 18
Remove the Attachment and Tool ...................................................................................... 18
Cleaning & Sterilizing the MR7 System ........................................................................................ 19
MR7 Motor ............................................................................................................................ 19
Legend Attachments / Tubes ............................................................................................... 20
i
MR7 Pneumatic Control Unit / Regulator Hose /
Triton Adapter / Instrument Case ...................................................................................... 22
Transmissible Spongiform Encephalopathies (TSE) Return Policy............................... 22
Troubleshooting ............................................................................................................................... 23
Refurbishing or Repairs .................................................................................................................. 26
Preventative Maintenance ............................................................................................................... 27
Limited Warranty ............................................................................................................................. 28
Appendix A—Specialized Attachments ........................................................................................ 29
Angled Attachments ............................................................................................................. 29
Angled Double Lock Attachments ..................................................................................... 30
Curved Bur Attachments ..................................................................................................... 32
Variable Exposure Attachments ......................................................................................... 33
Footed Attachments ............................................................................................................. 33
Rotating Footed Attachments ............................................................................................. 34
Contra-Angle Attachment (16-MF) ................................................................................... 35
Metal Cutting Attachments ................................................................................................. 36
Telescoping Attachments ..................................................................................................... 37
Perforator Driver Attachments ........................................................................................... 38
Jacobs® Chuck Attachments ................................................................................................ 39
Bone Mill Attachment .......................................................................................................... 40
ii
General Information
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 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.
The MR7 system consists of the following components:
• MR7 or MR7 Touch Motor
• MR7 Pneumatic Control Unit with Various Connectors
• MR7 Regulator Hose
• MR7 Lubricant/Diuser Cartridge
• MR7 Triton® Adapter (optional)
• Legend® Attachments*
• Legend® Dissecting Tools*
*The MR7 system uses the same attachments and dissecting tools as the Legend® Pneumatic High-Speed System.
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 sternotomy surgeries.
General Information
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, but is not essential to complete the
procedure.
1
General Information
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 modied Midas Rex MR7 System components. Inspect the Midas Rex MR7 System for
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.
• Install attachment and dissecting tool, then briey run motor.
• Do not operate the Midas Rex MR7 System without eye protection.
• 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.
* Check motor for overheating and leaking lubricant.
* Check attachment for overheating.
* Check dissecting tool for ail.
• 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 intermittently, or wrap the motor/attachment interface with a moist
sterile towel.
• If the motor is passed o, the receiver should grasp the motor by the proximal end close to the motor hose.
• To avoid injury to the patient or user, do not place the handpiece on the patient or in an unsecured location, when not
in use.
• Midas Rex MR7 motors should only be operated when the attachment is in the 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
6. Safety Slide (MR7 Touch Only)
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
In addition to the components listed in Figure 1, each MR7 motor has a lubricant/diuser housing at the end of the motor
hose, as seen in Figure 2.
Figure 2: Lubricant/Diuser Housing
3
System Components
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
N2 DISS to Male Schrader Adapter
(PC110)
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 (PC111)
The N2 DISS to male Schrader adapter (Figure 6a)
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
(PC120)
The N2 DISS to air DISS adapter (Figure 7) allows for
the regulator hose to be attached to an Air DISS inhouse gas connection.
N2 DISS to Female Schrader
Adapter (PC140)
The N2 DISS to female Schrader adapter (Figure
7a) allows for the Pneumatic Control Unit’s N2 DISS
pressure hose connection to be attached to a Male
Schrader in-house gas connection.
Figure 6. N2 DISS to Male Schrader Adapter
PC110
Figure 6a. N2 DISS to Male Schrader Adapter - UK
PC111
Figure 7. N2 DISS to Air DISS Adapter
PC120
Figure 7a. N2 DISS to Female Schrader Adapter
PC140
5
System Components
N2 DISS to Surgical Tool Air Male SIS
Adapter (PC150)
The N2 DISS to surgical tool air male SIS adapter (Figure 7b)
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 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.
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 connected between
the control unit and the gas source, rather than being
integrated into the control unit
Figure 7b. N2 DISS to Surgical Tool Air Male SIS Adapter
PC150
Figure 8. N2 DISS to W4 Adapter
Figure 9. Motor Wrench
Figure 10. Triton Adapter
6
System Components
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 AT10 (base)
TT12A (tube)
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
NOTE: Angled and straight attachments with the same length, marking, and color band share the same dissecting tool.
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 prex 14 (14MH30) may be used in either the 14-AM straight or 14-AM angled attachment.
The telescoping attachment requires the use of the AT10
attachment base, as well as a telescoping tube. Tubes are
available in straight, curved, or hooded form.
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.
7
System Components
Disposable Components
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/diuser cartridge (Figure 11) provides
lubrication to the motor and lters oil from exhausted air.
Telescoping Tubes
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 dicult.
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.
NOTE: Cleaning brushes will not pass through angled,
contra-angle, metal cutting, perforator, or Jacobs Chuck
attachments, because they are not cannulated.
Figure 11: Lubricant/Diuser Cartridge
Figure 12: Telescoping Tube
Figure 13: Cleaning Brushes
3.2mm
2.4mm
1.2mm
8
System Components
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 prexes to identify specic attachment types, as well as a variety of suxes to provide
additional information about the dissecting tool. Tools that use a design taken from the Mednext line are designated by an
additional “-MN” sux.
Associated
Attachment
Length
(x.x millimeters)
Tool
Head Diameter
Optional
Prex
Tool
Head Shape
Optional
Sufx
Tool Number Prexes (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 Sufxes (note that more than one of the suxes 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
9
System Components
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 dissecting tool combination that results in tool ail or excessive vibration.
• 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.
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 injury to the patient or operating room
sta.
Surgical
Application
Spine 8-B, 9-M, 14-AM,
Commonly
Used
Attachments
15-A
Telescoping Match Head
Footed, Straight Tapered
Commonly Used
Dissecting Tools
Match Head
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 eectively
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 eciency with approach angle. For
decortication, laminotomy, entry hole, nerve decompression,
osteophyte removal, etc.
Hole Maker/Saw
Matched sets of Hole Makers and Hole Saws are ecient and
eective for interbody fusion.
Cylinder
Eective bone sculpting and planing. For graft shaping,
debridement, corpectomy, decortication, interbody fusion,
fusion takedown, etc.
Acorn
Curved design varies dissection eciency with varied
approach angles. For entry hole, laminotomy, bone shaping,
debridement, corpectomy, decortication, fusion takedown, etc.
Elongated spherical design allows controlled, delicate
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,
entry hole, suture hole, midface advancement, etc.
Suggested
Motor(s)
MR7, MR7
Touch
MR7, MR7
Touch
10
Loading...