Manual para Midas Rex Mr7
Manual para Midas Rex Mr7
Manual para Midas Rex Mr7
Instruction Manual
Instrukcja obsáugi
Návod
Használati útmutató
Rx Only
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Symbols
The following symbols may appear within this manual, on product labeling, or on the product itself:
Quantity Lubricant/Diffuser
Lubricant/Diffuser
For single patient use only. Do not Dissecting Tool Dissecting Tool
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 Attachment
Attachment
Non-Sterile Control Unit Control Unit
STERILE
Sterilized by Gamma Irradiation Refurbished Refurbished
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MR7 Pneumatic Control Unit / Regulator Hose /
Triton Adapter / Instrument Case ...................................................................................... 21
Transmissible Spongiform Encephalopathies (TSE) Return Policy............................... 21
Troubleshooting ............................................................................................................................... 22
Refurbishing or Repairs .................................................................................................................. 25
Preventative Maintenance............................................................................................................... 26
Limited Warranty ............................................................................................................................. 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 Attachments ........................................................................................... 37
Jacobs® Chuck Attachments ................................................................................................ 38
Bone Mill Attachment.......................................................................................................... 39
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General Information
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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/Diffuser 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.
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.
NOTE: A note is intended to provide additional information, which may be useful, but is not essential to complete the
procedure.
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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 modified Midas Rex MR7 System components. Inspect the Midas Rex MR7 System for
damage prior to each use:
• 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.
• Heavy side loads and/or long operating periods may cause the device to overheat. If overheating occurs:
• 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.
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.
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.
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System Components
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System Components
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
1 3
2
4
5 6
1. Collet
2. Motor Case
3. Swivel
4. Hose
5. Finger Control Lever
6. Safety Slide (MR7 Touch Only)
In addition to the components listed in Figure 1, each MR7 motor has a lubricant/diffuser housing at the end of the motor
hose, as seen in Figure 2.
Figure 2: Lubricant/Diffuser Housing
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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 Figure 3: Pneumatic Control Unit
cause injury or damage equipment, and will void the
manufacturer’s warranty.
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.
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System Components
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N2 DISS to Male Schrader Adapter Figure 6: 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 for connection of the regulator
hose to a male Schrader in-house gas connection.
Motor Wrench
The motor wrench (Figure 9) is used to align arrows
on motor collet flats prior to installation of a Legend
attachment. 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
connected between the control unit and the gas source,
rather than being integrated into the control unit
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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 AT10 (base) The telescoping attachment requires the use of the AT10
TT12A (tube) attachment base, as well as a telescoping tube. Tubes are
available in straight, curved, or hooded form.
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 prefix 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.
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System Components
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Disposable Components
Figure 11: Lubricant/Diffuser Cartridge
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/diffuser cartridge (Figure 11) provides
lubrication to the motor and filters 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 difficult. Figure 12: Telescoping Tube
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.
3.2mm
2.4mm
1.2mm
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System Components
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Legend® Dissecting Tools
Legend dissecting tools are sterile cutting tools, intended for cutting bone and biomaterials.
Associated
Attachment Tool
Length Head Diameter
(x.x millimeters)
Optional
Pre¿x
Tool
Head Shape Optional
Suf¿x
Tool Number Suf¿xes (note that more than one of the suffixes 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
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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 dissecting tool combination that results in tool flail or excessive vibration.
Commonly
Surgical Commonly Used Suggested
Used
Application Dissecting Tools Motor(s)
Attachments
Spine 8-B, 9-M, 14-AM, Match Head MR7, MR7
15-A Elongated spherical design allows controlled, delicate Touch
dissection. For entry hole, nerve decompression, osteophyte
removal, sinus dissection, etc.
Ball
Helical cutting flutes dissect bone or cement effectively
from a wide variety of approach angles. For debridement,
decortication, sinus dissection, etc.
Oval
Helical cutting flutes and curved design blend acorn and ball
styles to vary dissection efficiency 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 efficient and
effective for interbody fusion.
Cylinder
Effective bone sculpting and planing. For graft shaping,
debridement, corpectomy, decortication, interbody fusion,
fusion takedown, etc.
Acorn
Curved design varies dissection efficiency with varied
approach angles. For entry hole, laminotomy, bone shaping,
debridement, corpectomy, decortication, fusion takedown, etc.
Telescoping Match Head MR7, MR7
Elongated spherical design allows controlled, delicate Touch
dissection. For entry hole, nerve decompression, osteophyte
removal, sinus dissection, etc.
Footed, Straight Tapered
Slender design for precise dissection with minimal bone loss.
For transection, osteotomy, graft harvesting, bone shaping,
entry hole, suture hole, midface advancement, etc.
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System Components
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Commonly
Surgical Commonly Used Suggested
Used
Application Dissecting Tools Motor(s)
Attachments
Neurosurgical– 7-6ST, 8-B, 9-M, Match Head MR7
Cranial 10-9ST, 14-AM, Elongated spherical design allows controlled, delicate
15-A dissection. For entry hole, nerve decompression, osteophyte
removal, sinus dissection, etc.
Ball
Helical cutting flutes dissect bone or cement effectively
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.
Acorn
Curved design varies dissection efficiency with varied
approach angles. For entry hole, laminotomy, bone shaping,
debridement, corpectomy, decortication, fusion takedown, etc.
Telescoping Match Head
Elongated spherical design allows controlled, delicate
dissection. For entry hole, nerve decompression, osteophyte
removal, sinus dissection, etc.
Footed Tapered
Slender design for precise dissection with minimal bone loss.
For transection, osteotomy, graft harvesting, bone shaping,
entry hole, suture hole, midface advancement, etc.
General 7-6ST, 8-B, 9-M, Match Head MR7, MR7
Surgery and 10-9ST, 14-AM Elongated spherical design allows controlled, delicate Touch
Plastic Surgery dissection. For entry hole, nerve decompression, osteophyte
(Craniofacial/ removal, sinus dissection, etc.
Maxillofacial/ Ball
Sternotomy) Helical cutting flutes dissect bone or cement effectively
from a wide variety of approach angles. For debridement,
decortication, sinus dissection, etc.
Tapered
Slender design for precise dissection with minimal bone loss.
For transection, osteotomy, graft harvesting, bone shaping,
entry hole, suture hole, midface advancement, etc.
Twist Drill
Helical design with stop produces a hole with a precise depth.
Ideal for plating.
Ear, Nose, and 7-6ST, 10-9ST Ball MR7
Throat (Otology, Helical cutting flutes dissect bone or cement effectively
Neurootology) from a wide variety of approach angles. For debridement,
decortication, sinus dissection, etc.
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System Components
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Commonly
Surgical Commonly Used Suggested
Used
Application Dissecting Tools Motor(s)
Attachments
Orthopaedics 8-B, 9-M, Ball MR7, MR7
14-AM, 21-TU, Helical cutting flutes dissect bone or cement effectively Touch
26-R, Footed, from a wide variety of approach angles. For debridement,
Telescoping decortication, sinus dissection, etc.
Tapered
Slender design for precise dissection with minimal bone loss.
For transection, osteotomy, graft harvesting, bone shaping,
entry hole, suture hole, midface advancement, etc.
Acorn
Curved design varies dissection efficiency with varied
approach angles. For entry hole, laminotomy, bone shaping,
debridement, corpectomy, decortication, fusion takedown, etc.
Cylinder
Effective bone sculpting and planing. For graft shaping,
debridement, corpectomy, decortication, interbody fusion,
fusion takedown, etc.
Footed Tapered
Slender design for precise dissection with minimal bone loss.
For transection, osteotomy, graft harvesting, bone shaping,
entry hole, suture hole, midface advancement, etc.
Biometals/ MC Metal Cutter MR7, MR7
Bioceramics/ Cutting flutes or diamond wheel design remove metals, Touch
Biomaterials ceramics and other biomaterials effectively from a variety
of approach angles. For cutting rods, pins, plates, implants,
screws, etc.
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Setting up the Operating Room
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Setting up the Operating Room
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.
Pneumatic Connections
CAUTION: If you are using the Midas Rex Safety Valve Regulator instead of the Legend Regulator, you must replace the
in-line oiler with the DISS/WF4 adapter before use.
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Setting up the MR7 System
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Setting up the MR7 System
Installing the Oiler Cartridge Figure 15: Aligning the Lubricant/Diffuser Cartridge with the
WARNING: Do not use the MR7 system with the Midas Housing
Rex in-line oiler. The MR7 motor is sufficiently lubricated
by the lubricant/diffuser on the motor hose, and will be
over-lubricated if the Midas Rex in-line oiler is used.
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 lubricant/diffuser cartridge perpendicular
to the housing (Figure 15), and press the cartridge’s
circular fitting onto the housing’s circular receptacle
(Figure 16), breaking the foil seal.
3. Rotate the cartridge down until it clicks into place.
4. Verify that the symbol on the cartridge is lined up
with the notch on the housing (Figure 17).
WARNINGS:
• Failure to properly secure the lubricant/diffuser Figure 16: Pressing the Cartridge onto the Housing
cartridge may cause injury to operator and/or
operating room staff.
CAUTIONS:
• Do not use an MR7 motor without a lubricant/
diffuser installed.
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Setting up the MR7 System
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Connecting the Motor Figure 18: Connecting the Motor Hose to the Motor Port
NOTES:
• If using the MR7 Touch motor, slide the control slide
on the pneumatic control unit to the position
(Figure 19). This will automatically depress and lock
the foot pedal. The control will not lock into the
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.
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Installing an Attachment and Tool
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Installing an Attachment and Tool
WARNING: Dissecting tool flutes are sharp and may Figure 21: Sliding the Attachment over the Motor Collet
perforate surgical gloves. Tools may be grasped with a
hemostat to aid in installation and removal.
Straight Attachments
Installation:
1. Slide the attachment over the motor collet, aligning
the triangular markers (Figure 21). You will feel and
hear the attachment click into place when it is fully
seated.
2. Insert the dissecting tool into the attachment with a
slight rotational motion (Figure 22). You will feel and
hear the tool click into place when it is fully seated in
the attachment.
Figure 22: Inserting the Dissecting Tool into the Attachment
3. Turn the attachment to the position on the motor
case (Figure 23). Gently pull on the shaft of the
dissecting tool to verify proper installation.
Removal:
Removal is the reverse of installation.
Specialized Attachments
See Appendix A—Specialized Attachments for installation
and removal instructions for other attachments.
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Activating the Motor
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Activating the Motor
NOTE: In order to activate the MR7 Touch motor, the safety slide on the finger control switch must be in the | position, and
the control slide on the foot control must be in the 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 foot control pedal (Figure 24), or by pressing on the finger control lever (MR7
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.
Figure 24: Foot Control Pedal
Control Slide
WARNINGS:
• Do not use excessive force to pry or push bone with the attachment or tool during dissection. This could cause the tool
to break and cause injury to the patient or operating room staff.
• MR7 motors should only be operated when the attachment is in the position.
NOTE: 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
re-adjust pressure as needed.
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Disassembling the MR7 System
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Disassembling the MR7 System
Disconnect Hoses
Release the motor hose from the control unit, by holding the hose firmly and pressing the motor port connection button.
Figure 26: Motor Port Connection and Pressure Relief Buttons
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Cleaning & Sterilizing the MR7 System
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Cleaning & Sterilizing the MR7 System
MR7 Motor
Warnings and Do not soak/submerge MR7 devices.
Precautions Do not use ultrasound to clean MR7 devices.
Do not use chlorine based or corrosive cleaning agents such as bleach, lye, acetone, sodium hypochlorite/bleach, sodium
hydroxide, formic acid, or solutions containing glutaraldehyde.
The use of a washer-disinfector for cleaning may cause a pre-mature degradation in performance.
Allow an adequate cooling period after steam sterilization.
Use ONLY nylon cleaning brushes. Non-nylon cleaning brushes leave residue that may prevent the tool from being secured
properly in the handpiece.
Limitations Verify functionality prior to re-use.
INSTRUCTIONS
Point of Use No particular requirements. Follow hospital procedures.
Containment and It is recommended that devices are reprocessed as soon as is practical following use.
Transportation
Preparation for No particular requirements. Follow hospital procedures.
Decontamination
Cleaning: Review the washer-disinfector warning above, before using this cleaning method. Remove devices from instrument trays
Automated before placing into washer baskets. Orient devices following recommendations of the washer/disinfector manufacturers. Verify
(Do NOT use ultrasonic that devices are visually clean after automated cleaning.
washer) Recommended Washer Cycle
Pre-Wash: Cold tap water, 2 min.
Wash: 66oC, 5 min. using a neutral enzymatic detergent, pH 6.0–8.0
Rinse: Hot tap water, 1 min.
Cleaning: Manual Wipe all external surfaces of the motor and hose, and wipe inner surface of oiler housing with a cloth dampened with a neutral
enzymatic detergent, pH 6.0–8.0.
Brush motor case and collet with a nylon brush dampened with a neutral enzymatic detergent. If using the MR7 Touch motor,
be sure to brush under the finger control lever.
Rinse motor thoroughly under running water, collet end pointed down. Dry collet and motor with lint free towel.
Verify that devices are visually clean after manual cleaning.
Disinfection No particular requirements. Follow hospital procedures.
Packaging For sterilization, place devices in instrument tray. Devices may be unwrapped, or wrapped with up to two layers of 1-ply
polypropylene wrap
Sterilization Steam Sterilization:
(Temperatures are Cycle: Gravity Pre-vac Pre-vac (FR/WHO) Pre-vac (UK)
minimum required,
Temperature: 132°C 132°C 134°C 134°C
times are minimum
required) Time: 25 min. 4 min. 18 min. 3 min.
Drying: 15 minutes 15 minutes 20 minutes 10 minutes
*Items contaminated with Transmissible Spongiform Encephalopathies (TSE) agents may be decontaminated using steam
autoclave at a temperature of 134–137°C for a single cycle of 18 minutes or repeated for a total of six 3-minute cycles as
referenced in NHS Estates HTM 2010 parts 4 & 6: Appendix 2, Items Contaminated With TSE Agents and WHO Infection Control
Guidelines for Transmissible Spongiform Encephalopathies. Medtronic recommends that all products used on a patient
suspected or confirmed with a TSE diagnosis be incinerated.
STERRAD Sterilization: Do not use low temperature hydrogen peroxide gas plasma sterilization due to lumen internal diameter
and length restrictions.
100% EtO Sterilization Parameters:
Preconditioning: 51–59°C, 70 ±5% relative humidity, 30 min.
Temperature: 51–59°C
Relative humidity: 70 ±5%
Ethylene oxide concentration: 725 ± 25mg/L
Gas exposure time (full-cycle): 4 hours
Aeration: 18 hours at 51–59°C
Steris: Do not use liquid peracetic acid sterilization due to immersion procedure.
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Cleaning & Sterilizing the MR7 System
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Maintenance, Inspect devices for any damage before and after each use. If damage is observed, do not use the device until it is repaired.
Inspection and Testing After cleaning and sterilization, verify functionality prior to re-use.
Storage Store with other sterile devices.
NOTE: The instructions provided above have been validated by the manufacturer as being CAPABLE of preparing the
product for re-use. It remains the responsibility of the processor to ensure that the reprocessing as actually performed,
using equipment, materials and personnel in the reprocessing facility, achieves the desired result. This normally requires
validation and routine monitoring of the process.
INSTRUCTIONS
Point of Use No particular requirements.
Containment and It is recommended that devices are reprocessed as soon as is practical following use.
Transportation
Preparation for No particular requirements. Follow hospital procedures.
Decontamination
Cleaning: Review the washer-disinfector warning above, before using this cleaning method. Manually rinse attachments/tubes under
Automated tap water, until no visible soil is noticed, before placing them into the automatic washer. Remove devices from instrument trays
(Do NOT use ultrasonic before placing into washer baskets. Orient devices following recommendations of the washer/disinfector manufacturers.
washer) Recommended Washer Cycle
Pre-Wash: Cold tap water, 2 min.
Wash: 66°C, 5 min. using a neutral enzymatic detergent, pH 6.0–8.0
Rinse: Hot tap water, 1 min.
Cleaning: Manual Wipe all attachments and telescoping tubes with a cloth, dampened with a surgical instrument cleaning solution.
Immerse the head of Contra-Angle attachments in surgical instrument cleaning solution and run the motor for 1 minute.
Other attachments and tubes may be mechanically agitated in cleaning solution, but not soaked or immersed.
A nylon brush dampened with a surgical instrument cleaning solution may be used to clean the external surfaces and internal
connecting surfaces of the attachments and tubes.
Straight attachments, footed attachments and telescoping straight tubes have special cleaning brushes sized to the
attachment’s or telescoping tube’s internal diameter. Push the brush wet with surgical instrument cleaning solution through
the attachment or telescoping tube from rear to front to loosen and remove debris trapped inside.
Move any moveable parts back and forth to allow solution to thoroughly clean attachment, e.g., sleeve on footed attachment,
perforator attachment.
Rinse thoroughly with tap water.
Thoroughly dry attachments. An air gun may be used to blow moisture out from rear to front of attachment.
Using an aerosol spray lubricant (such as Pana Spray), perform the following steps to lubricate attachments:
Holding the can approximately 10–15 cm (3–6 in.) away from the attachment, spray all components that move, rotate, or
slide with three quick squirts.
Articulate movable components to ensure proper lubrication.
Remove excess lubricant with a clean cloth.
Disinfection No particular requirements Follow hospital procedures.
Packaging For sterilization, place devices in instrument tray. Devices may be unwrapped, or wrapped with up to two layers of 1-ply
polypropylene wrap.
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Cleaning & Sterilizing the MR7 System
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Sterilization Steam Sterilization:
(Temperatures are Cycle: Gravity Pre-vac Pre-vac (FR/WHO)* Pre-vac (UK)*
minimum required,
Temperature: 132°C 132°C 134°C 134°C
times are minimum
required) Time: 25 min. 4 min. 18 min. 3 min.
Drying: 15 minutes 15 minutes 20 minutes 10 minutes
*Items contaminated with TSE agents may be decontaminated using steam autoclave at a temperature of 134–137°C for a
single cycle of 18 minutes or repeated for a total of six 3-minute cycles as referenced in NHS Estates HTM 2010 parts 4 & 6:
Appendix 2, Items Contaminated With TSE Agents and WHO Infection Control Guidelines for Transmissible Spongiform
Encephalopathies. Medtronic recommends that all products used on a patient suspected or confirmed with a TSE diagnosis
be incinerated.
STERRAD Sterilization: Do not use low temperature hydrogen peroxide gas plasma sterilization due to lumen internal diameter
and length restrictions.
100% EtO Sterilization Parameters:
Preconditioning: 51–59°C, 70 ±5% relative humidity, 30 min.
Temperature: 51–59°C
Relative Humidity: 70 ±5%
Ethylene oxide concentration: 725 ± 25mg/L
Gas exposure time (full-cycle): 4 hours
Aeration: 18 hours at 51–59°C
Steris: Do not use liquid peracetic acid sterilization due to immersion procedure.
Maintenance, Inspect devices for any damage before and after each use. If damage is observed, do not use the device until it is repaired.
Inspection and Testing Verify functionality prior to re-use.
Storage Store with other sterile devices.
NOTE: The instructions provided above have been validated by the manufacturer as being CAPABLE of preparing the
product for re-use. It remains the responsibility of the processor to ensure that the reprocessing as actually performed,
using equipment, materials and personnel in the reprocessing facility, achieves the desired result. This normally requires
validation and routine monitoring of the process.
20
Cleaning & Sterilizing the MR7 System
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MR7 Pneumatic Control Unit / Regulator Hose / Triton Adapter /
Instrument Case
Warnings and Do not soak/submerge MR7 devices.
Precautions Do not use ultrasound to clean MR7 devices.
Do not use chlorine based or corrosive cleaning agents such as bleach, lye, acetone, sodium hypochlorite/bleach, sodium
hydroxide, formic acid, or solutions containing glutaraldehyde.
Do not sterilize the MR7 pneumatic control unit, regulator hose, or Triton adapter.
Limitations Verify functionality prior to re-use.
INSTRUCTIONS
Point of Use No particular requirements. Follow hospital procedures.
Containment and It is recommended that devices are reprocessed as soon as is practical following use.
Transportation
Preparation for No particular requirements. Follow hospital procedures.
Decontamination
Cleaning: Not validated.
Automated
(Do NOT use ultrasonic
washer)
Cleaning: Manual Wipe the pneumatic control unit, regulator hose, Triton adapter, and instrument case with a cloth dampened with surgical
instrument cleaning solution after each use.
Disinfection No particular requirements. Follow hospital procedures.
Packaging No particular requirements. Follow hospital procedures.
Sterilization Do not sterilize pneumatic control unit, regulator hose, or Triton adapter.
Maintenance, Inspect devices for any damage before and after each use. If damage is observed, do not use the device until it is repaired.
Inspection and Testing Verify functionality prior to re-use.
Storage Do not store with sterile devices.
NOTE: The instructions provided above have been validated by the manufacturer as being CAPABLE of preparing the
product for re-use. It remains the responsibility of the processor to ensure that the reprocessing as actually performed,
using equipment, materials and personnel in the reprocessing facility, achieves the desired result. This normally requires
validation and routine monitoring of the process.
21
Troubleshooting
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Troubleshooting
NOTE: All Legend and MR7 devices returned for servicing or refurbishing should be properly cleaned and sterilized prior to
shipping.
22
Troubleshooting
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Motor is Too Hot to Touch/Hold:
Possible Cause Solution
Inadequate cool down period following sterilization. Motor must be allowed to cool down following steam
sterilization.
Inadequate lubrication. Check for proper installation of the lubricant/diffuser
cartridge.
Attachment transferring heat to the motor. Switch attachments to determine whether the heat is
being generated by the motor or the attachment. Return
the failing component to MPSS for refurbishing.
Heavy side loading during dissection. Discontinue use and rest the motor by using it
intermittently or wrap the motor with a moist sterile
towel. If overheating continues, return the motor to
MPSS for refurbishing.
Inadequate irrigation. Ensure adequate irrigation to surgical site during bone
dissection.
23
Troubleshooting
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Dissecting Tool Flails:
Possible Cause Solution
A non-Legend dissecting tool is being used. Replace with a Legend dissecting tool.
Worn attachment or tube bearings. Try another attachment or tube to isolate the location
of the problem. If the attachment is failing, return it to
MPSS. If the tube is failing, dispose of it and use a new
tube.
Attachment/tube and tool are not compatible. Match color code on the dissecting tool packaging to the
color code on the attachment/tube.
Motor is damaged. Return motor to MPSS to be refurbished.
Dissecting tool’s size and geometry may contribute to flailing Adjust the speed by changing the pressure setting or
at certain speeds. foot/finger control. Do not use if flailing persists. Change
dissecting tools.
Dissecting Tool Will not Seat Properly in the Motor or Attachment Collet:
Possible Cause Solution
Debris in collet of attachment or motor. Clean the attachment or motor thoroughly according
to the instructions in this manual. If cleaning does not
correct the problem, return the attachment or motor to
MPSS to be refurbished.
A non-Legend dissecting tool is being used. Replace with a Legend dissecting tool.
24
Refurbishing or Repairs
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Refurbishing or Repairs
When the MR7 System requires servicing or refurbishing, contact Medtronic Powered Surgical Solutions Repair Services for
a return authorization and instructions for returning the equipment. Medtronic Powered Surgical Solutions provides quality
assured service by factory-trained personnel who will utilize genuine Midas Rex Legend parts as required. All items being
returned for servicing or refurbishing should be properly cleaned and sterilized prior to shipping.
Contact:
Medtronic Powered Surgical Solutions Repair Services:
(800) 335-9557 or (817) 788-6440
mmrcustomerservice@medtronic.com
Peak performance, reliability and maximum service life from your MR7 System may be assured by using only those Midas
Rex Legend products for your MR7 System that are manufactured by and sold through Medtronic Powered Surgical
Solutions, Fort Worth, Texas. While Medtronic Powered Surgical Solutions guarantees complete compatibility among its
products within a specific product line, the dissecting tools are designed for single-use only, and Medtronic disclaims any
responsibility when reprocessed dissecting tools are used. If you would like more information about the patient and product
risks associated with reprocessed tools, please contact the number or e-mail address listed above.
Due to safety and environmental concerns, Medtronic Powered Surgical Solutions requests the return of pneumatic high
speed motors for proper disposal at the end of the product life cycles.
25
Preventative Maintenance
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Preventative Maintenance
The Midas Rex MR7 System Preventive Maintenance Manual has been developed to assist you in getting the greatest
ownership value from your MR7 System, while helping to maximize its performance, safety and reliability. The scheduled
preventive maintenance/service program is in addition to the required routine cleaning after each use. Please refer to the
preventive maintenance manual for the specific steps necessary to maintain the MR7 System.
26
Limited Warranty
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Limited Warranty
A. This Limited Warranty provides the following assurance to the purchaser of a Medtronic Midas Rex® MR7 Pneumatic
High Speed System. This Limited Warranty is extended only to the buyer purchasing the MR7 System directly from
Medtronic or from its affiliate or its authorized distributor or representative. The Midas Rex® MR7 Pneumatic High
Speed System includes the motor, foot control, instrumentation cases and trays (hereafter referred to as System
Components), straight and angled motor attachments (hereinafter referred to as “Attachments”), telescoping tubes
(hereinafter referred to as Semi-reusable Components) and dissecting tools and other accessories not listed above
and jointly referred to as MR7 Pneumatic High Speed System, unless specifically noted.
(1) Should a System Component fail to function to Medtronic’s published specifications during the term of
this Limited Warranty (one year from the date of sale of a new System Component or 90 days from the
date of sale of a refurbished or used System Component), Medtronic will either repair or replace the Motor
Component or any portion thereof.
(2) Should an Attachment fail to function to Medtronic’s published specifications during the term of this
Limited Warranty (90 days from the date of sale of a new Attachment), Medtronic will either repair or
replace the Attachment or any portion thereof.
(3) Should a Semi-reusable Component fail to function to Medtronic’s published specifications during
the term of this Limited Warranty (30 days from the date of sale of a new Semi-reusable Component),
Medtronic will replace the Semi-reusable Component or any portion thereof.
(4) Should a Single Use Component fail to function to Medtronic’s published specifications prior to its “use
by” date Medtronic will replace the Single Use Component.
B. To qualify for this Limited Warranty, these conditions must be met:
(1) The Product must be used on or before its “Use By” or “Use Before” date, if applicable.
(2) The Product must be used in accordance with its labeling and may not be altered or subjected to misuse,
abuse, accident or improper handling.
(3) Medtronic must be notified in writing within thirty (30) days following discovery of a defect.
(4) The Product must be returned to Medtronic within thirty (30) days of Medtronic receiving notice as
provided for in (3) above.
(5) Upon examination of the Product by Medtronic, Medtronic shall have determined that: (i) the Product was
not repaired or altered by anyone other than Medtronic or its authorized representative, (ii) the Product
was not operated under conditions other than normal use, and (iii) the prescribed periodic maintenance
and services, if applicable, have been performed on the Product
C. This Limited Warranty is limited to its express terms. THIS LIMITED WARRANTY IS IN LIEU OF ALL OTHER
WARRANTIES, EXPRESSED OR IMPLIED WHETHER STATUTORY OR OTHERWISE, INCLUDING ANY IMPLIED WARRANTY
OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. In no event shall Medtronic be liable for any
consequential, incidental, prospective or other similar damage resulting from a defect, failure, or malfunction of the
MR7 System, whether a claim for such damage is based upon the warranty, contract, negligence or otherwise.
D. The exclusions and limitations set out above are not intended to, and should not be construed so as to, contravene
mandatory provisions of applicable law. Users may benefit from statutory warranty rights under legislation
governing the sale of consumer goods. If any part or term of this Limited Warranty is held by any court of
competent jurisdiction to be illegal, unenforceable, or in conflict with applicable law, the validity of the remaining
portion of the Limited Warranty shall not be affected, and all rights and obligations shall be construed and enforced
as if this Limited Warranty did not contain the particular part or term held to be invalid.
27
Appendix A—Specialized Attachments
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Appendix A—Specialized Attachments
Angled Attachments Figure 27: Sliding the Attachment over the Motor Collet
Installation:
1. Slide the attachment over the motor collet, aligning
the triangular markers (Figure 27). You will feel and
hear the attachment click into place when it is fully
seated.
2. Turn the attachment to the position on the motor
case (Figure 28).
3. With the “tool lock” in the position, insert the
dissecting tool into the attachment with a slight Figure 28: Attachment in the Locked Position
rotational motion (Figure 29). You will feel and hear
the tool click into place when it is fully seated.
4. Turn the tool lock to the position (Figure 30). Gently
pull on the shaft of the dissecting tool to verify
proper installation.
NOTE: A dissecting tool may be installed in the
attachment before the angled attachment is placed on
the motor.
Removal: Figure 29: Inserting the Dissecting Tool into the Attachment
Removal is the reverse of installation.
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Appendix A—Specialized Attachments
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Angled Double Lock Attachments Figure 31: Installing the attachment.
Installation:
1. Slide the attachment over the motor collet, aligning
the triangular markers.
2. Pull the attachment towards the motor and turn the
attachment to the position.
3. With the “tool lock” in the position, insert the
dissecting tool into the attachment with a slight
rotational motion. You will feel the tool click into
place when it is fully seated.
4. Turn the tool lock to the position. Gently pull on
the shaft of the dissecting tool to verify proper
installation.
5. On Variable Exposure Attachments, use the TUBE
adjustment ring to adjust the exposure of the
dissecting tool. With the tool pointing away from
you, turn the ring to the right to increase the length
Figure 32: Inserting the Dissecting Tool into the Attachment
of the tube, thereby decreasing the exposure of the
tool. Turn the ring to the left to decrease the length
of the tube, thereby increasing the exposure of the
tool.
Removal:
1. To remove the attachment, hold the motor in the
palm of your hand, and push the sleeve on the
attachment distally while turning the attachment to
the position.
2. Release the sleeve and remove the attachment.
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Appendix A—Specialized Attachments
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Curved Bur Attachments Cooling the Bur
1. Prior to initial use, soak the cooling sleeve by dipping
WARNINGS: it into a cup of saline or DI water, as shown below.
Wetting of the cooling sleeve prior to cutting
• Use adequate irrigation and keep the cooling sleeve
soaked during dissection. Inadequate irrigation may
cause thermal necrosis.
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Appendix A—Specialized Attachments
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Variable Exposure Attachments
Figure 34: Adjusting Tool Exposure
CAUTION: The Legend Variable Exposure attachments
can be distinguished from standard attachments by
the dual color bands on the attachment. Match the
color band on the attachment to the color code on the
dissecting tool packaging.
WARNINGS:
• Surgeons should familiarize themselves with the
performance of dissecting tools before use, and
should explore the effect of various levels of tool
exposure on dissection stability. If the tool exhibits
excessive chatter, vibration, or movement, decrease
the tool exposure.
Installation:
1. Refer to the appropriate section of this manual on
installing fixed or angled attachments.
2. After installation, use the TUBE adjustment ring to
adjust the exposure of the dissecting tool (Figure 34).
With the tool pointing away from you, turn the
ring to the right to increase the length of the tube,
thereby decreasing the exposure of the tool. Turn the
ring to the left to decrease the length of the tube,
thereby increasing the exposure of the tool.
WARNING: Do not use the Variable Exposure
Attachment if the TUBE adjustment ring spins freely
or fails to click into place with each adjustment, as the
exposure may change without warning.
Removal:
1. Removal is the reverse of installation.
2. When cleaning, clean the attachment completely,
first without adjusting the tube length, then with the
tube fully extended, and with the tube fully retracted.
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Appendix A—Specialized Attachments
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Footed Attachments Figure 35: Inserting the Tool into the Collet
Installation:
1. Insert the dissecting tool into the motor collet with a
slight rotational motion (Figure 35). You will feel and
hear the tool click into place when it is fully seated.
2. Slide the footed attachment over the dissecting
tool, onto the motor, aligning the triangular markers
(Figure 36).
3. Pull the footed attachment towards the motor and
turn the attachment to the position (Figure 37). Figure 36: Sliding the Attachment onto the Motor
Removal:
1. To remove the Legend footed attachment, hold
the motor in the palm of your hand, and push the
sleeve on the attachment distally while turning the
attachment to the position (Figure 38).
WARNING: Remove Legend Footed Attachments
cautiously and slowly per instructions to avoid injury to
the operator.
2. Release the sleeve and remove the attachment.
3. Pull the dissecting tool out of the motor collet and Figure 37: Attachment in the Locked Position
discard the tool.
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Appendix A—Specialized Attachments
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Rotating Footed Attachments Figure 39: Inserting the Tool into the Collet
Installation:
1. Insert the dissecting tool into the motor collet with a
slight rotational motion (Figure 39). You will feel and
hear the tool click into place when it is fully seated.
2. Slide the attachment over the dissecting tool and
Figure 40: Sliding the Attachment onto the Motor
onto the motor, aligning the triangular markers
(Figure 40). You will feel and hear the attachment
click into place when it is fully seated.
3. Turn the attachment to the position (Figure 41).
NOTE: The footed end of the attachment now has 360˚
of unrestricted rotation.
Removal:
Removal is the reverse of installation.
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Appendix A—Specialized Attachments
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Contra-Angle Attachment (16-MF) Figure 42: Sliding the Attachment over the Motor Collet
Installation:
1. Decrease the pressure at the compressed gas source
to 80 psi (5.5 bar).
2. Adjust the pressure as needed by lowering it at the
gas source, then push down the pressure relief on
the pneumatic control unit to exhaust the excess
pressure in the hoses.
3. Slide the attachment over the motor collet, aligning
the triangular markers (Figure 42). You will feel and
hear the attachment click into place when it is fully Figure 43: Attachment in the Locked Position
seated.
4. Turn the attachment to the position (Figure 43).
5. Turn the attachment head lever to the open position
(Figure 44).
6. Insert the dissecting tool and return the lever to the
closed position. Gently pull on the dissecting tool
shaft to verify proper installation.
Removal:
1. Removal is the reverse of installation.
2. Discard the dissecting tool after removing it from the
attachment.
NOTE: A dissecting tool may be installed and locked in
the attachment before the Contra-Angle attachment is
installed on the motor.
Figure 44: Opening the Attachment Head Lever
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Appendix A—Specialized Attachments
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Metal Cutting Attachments
Figure 45: Sliding the Attachment over the Motor Collet
WARNING: For metal transection, observe the following
safety guidelines:
Installation:
1. Slide the attachment over the motor collet aligning
the triangular markers (Figure 45). You will feel and Figure 46: Inserting the Tool into the Attachment
hear the attachment click into place when it is fully
seated.
2. Turn the attachment to the position.
3. Turn the tool lock towards the icon, and insert
the dissecting tool into the attachment with a slight
rotational motion (Figure 46). You will feel and hear
the tool click into place when it is fully seated.
4. Turn the tool lock to the position (Figure 47). Gently
pull on the shaft of the dissecting tool to verify
proper installation.
NOTE: A dissecting tool may be installed and locked in
the attachment before the metal cutting attachment is
installed on the motor.
Removal:
Removal is the reverse of installation.
WARNING: Do not use metal cutting dissecting tools on Figure 47: Turning the Tool Lock to the Locked Position
bone.
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Appendix A—Specialized Attachments
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Telescoping Attachments Figure 48: Sliding the Attachment over the Motor Collet
Installation:
1. Slide the attachment over the motor collet aligning
the triangular markers (Figure 48). You will feel and
hear the attachment click into place when it is fully
seated.
NOTE: A dissecting tool may be installed and locked in
the attachment before the telescoping attachment is
installed on the motor.
2. Turn the attachment to the position.
3. Turn the TUBE locking ring towards the icon.
4. Insert the base of the telescoping tube into the Figure 49: Inserting the Telescoping Tube
attachment (Figure 49).
5. To lock the tube in place, turn the TUBE locking ring
towards the icon. Do not over tighten.
6. To insert the tool, make sure that the TOOL locking
ring is in the position, and insert the dissecting
tool into the top of the tube (Figure 50). You will
feel and hear the tool click into place when it is fully
seated.
7. Turn the TOOL locking ring to the position. Gently
pull on the shaft of the dissecting tool to verify
proper installation.
8. If the tube position needs to be changed, turn the
TUBE locking ring towards the icon, re-position the Figure 50: Inserting the Dissecting Tool
tube, then turn the TUBE locking ring towards the
icon.
Removal:
1. To remove the attachment, unlock both locking rings,
and pull the telescoping tube and tool out of the
attachment.
2. Turn the attachment to the position and remove it
from the motor.
NOTE: Telescoping tubes are disposable following
multiple uses, and should be discarded when heat or
excessive vibration is noticed, or when insertion of the
tool becomes difficult.
Figure 51: Locking Rings
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Appendix A—Specialized Attachments
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Perforator Driver Attachments Figure 52: Sliding the Attachment over the Motor Collet
Installation:
1. Slide the attachment over the motor collet aligning
the triangular markers (Figure 52). You will feel and
hear the attachment click into place when it is fully
seated.
2. Turn the attachment to the position (Figure 53).
3. To install a cranial perforator device with a Hudson
shank, pull back on the collar of the attachment
(Figure 54).
4. Insert the device and release the collar.
NOTE: A cranial perforator device may be installed in
the attachment before the attachment is installed on the
Figure 53: Attachment in the Locked Position
motor.
Removal:
1. To remove the cranial perforator device, pull back on
the collar of the attachment.
2. To remove the attachment, turn it to the position
and slide it off of the motor.
WARNING: Consult the cranial perforator device labeling
for the recommended speed specifications.
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Appendix A—Specialized Attachments
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Jacobs® Chuck Attachments Figure 55: Sliding the Attachment over the Motor Collet
Installation:
1. Slide the attachment over the motor collet aligning
the triangular markers (Figure 55). You will feel and
hear the attachment click into place when it is fully
seated.
2. Turn the attachment to the position (Figure 56).
3. To install a drill bit, turn the Jacobs key to open the
collar.
4. Insert the drill bit and tighten the collar.
NOTE: A drill bit may be installed in the attachment
before the Jacobs Chuck attachment is installed on the
motor.
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Appendix A—Specialized Attachments
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Bone Mill Attachment Figure 57: Bone Mill Attachment
WARNINGS: 5
• Do not operate the Bone Mill attachment without
the bowl, and cap secured in place.
4
Using the Bone Mill Attachment Figure 59: Inserting the Motor
1. Place the bowl onto Bone Mill base and secure the
latches.
2. Lay harvested bone specimens into the bowl.
CAUTIONS:
• The addition of any liquid to the milling process
should be administered in small volumes to prevent
leakage.
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Appendix A—Specialized Attachments
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NOTE: If bone does not process, deactivate the motor,
rotate the motor to the position, and remove the cap.
Reinsert the cap in the HIGH position and activate the
motor. If bone spins without milling or jams, divide bone
chunks into two batches and process separately.
7. Process the bone for 5–15 seconds and visually check
to gauge quality of milling before continuing.
8. Continue to process bone in 5–15 second batches
until the majority of particles reach desired size.
9. To remove bone particles stop operation of the
motor and rotate it to the position. Remove the
cap by rotating it clockwise. Use the spatula inside
the bowl and cap to remove bone particles.
NOTES:
• Milling time is dependent on the density of the
patient’s bone, the ratio of cancellous and cortical
bone, the size of the individual particles and the
batch amount of the bone to be processed. Always
check bone after 10–15 seconds to gauge quality of
milling.
After Use
1. Rotate the motor to the position.
2. Unlatch the Bone Mill disposables from the base.
3. Discard the bowl, cap, and spatula per hospital
procedure.
4. Clean the Bone Mill base according to the directions
below.
5. Clean the motor according to its instruction manual.
Bone Mill bowl, cap, and spatula are single use
devices. Opened but unused Bone Mill disposables
may not be re-sterilized under any sterilization
method.
Preventative Maintenance
The Bone Mill Attachment should be returned for factory
maintenance annually (approximately 100 procedures).
If the Bone Mill Attachment does not function according
to these instructions, call your Medtronic Regional
Distributor or Medtronic Neurologic Sales Representative.
If necessary, return the Bone Mill Attachment base to
your Distributor or Sales Representative to be repaired.
40
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