Instructions for Use
175042EN E
Midas Rex™ Legend™
Depth Stop Attachment and Tools
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Customer service
For further information regarding the use of this product or to report any problems, please contact Medtronic
Customer Service, or contact your local distributor:
Medtronic Powered Surgical Solutions
4620 North Beach Street
Fort Worth, Texas 76137 USA
US Help Line (800-335-9557)
RS.DFWrepairs@medtronic.com
International Service: International Customers should contact their local Medtronic representative.
The information contained in this document is accurate at time of publication. Medtronic reserves the right to make
changes to the product described in this manual. Refer to manuals.medtronic.com for the current version.
The following are trademarks or registered trademarksof Medtronic, Inc. in the United States and other countr ies: IPC™, Legend™, Midas
Rex™, MR7™, Visualase™, and Stealth Autoguide™. All other trademarks, service marks, registered trademarks or registered service marks are
the property of their respective owners in the United States and other countries.
EN
EN
NOTE: Attach these instructions to your IPC/Legend/MR7/Stealth Autoguide/Visualase Instruction
Manual or User’s Guide. Refer to your instruction manual or user’s guide for additional indications,
contraindications, safety precautions, and more detailed instructions for use. This attachment is
designed for use with the Legend depth stop dissecting tools, the Stealth Autoguide, and the Legend
electric and pneumatic motors. Refer to the dissecting tool’s labeling for information on specic
operating requirements and limitations, and to the Stealth Autoguide manual for interface details.
Indications for use
The Midas Rex™ Legend™ depth stop attachment and tools are indicated for the incision, cutting,
removing, and drilling of soft and hard tissue during cranial surgical procedures with the intent to create
a hole through the cranium to allow surgeons access to desired surgical locations and/or to facilitate
insertion, placement of other surgical devices during such procedures.
Device description
The Midas Rex™ Legend™ depth stop attachment and tools are intended to create a cranial access hole
of a known diameter and depth.
Contraindications
None.
Warnings
W1 The attachment shall only be used after the proper cleaning and sterilization protocol has been
followed.
W2 Failure to fully lock the attachment and dissecting tools may lead to product detachment and/
or patient injury.
W3 Drilling with trajectories above the angle limits provided in Table 2 may lead to damage of sub-
cranial tissue and patient injury.
W4 Verify the drill depth setting on the attachment prior to drilling. Contacting the brain or other
tissue with a rotating dissecting tool may lead to patient or user injury.
W5 Applying high lateral forces while drilling may result in loss of accuracy and/or injury to the patient.
W6 Dissecting tools are single use only. Reprocessing and re-using a dissecting tool may cause
injury to the patient.
W7 Perform proper ushing and irrigation during drilling to prevent entrance of debris into the
brain and potentially cause injury.
W8 Inspect the attachment before and after each use for damage, wear, or illegible markings.
W9 Using an attachment and/or dissecting tool that appears unstable may cause loss of accuracy
and/or patient injury.
W10 Using interface products others than those approved for use in this IFU may lead to serious
patient injury.
W11 Selec ting the wrong dissec ting tool may cause instrumentation incompatibility and/or loss of accuracy.
W12 Contact between a rotating dissecting tool and the drill guide or other equipment may damage
the dissecting tool and may cause dissecting tool instability or loss of accuracy.
W13 Excessive drilling forces may cause dissecting tool instability or loss of accuracy.
W14 The dissecting tool performance may be compromised when operated outside of the recommended
speed or pressure setting and may cause patient injury.
Installation
Note: If any damage, wear, rust, or corrosion is observed with the product or if action is required beyond
cleaning, do not use the product and return to Medtronic for service.
1. Slide attachment over the motor collet, aligning the
triangular arrows on the attachment and the motor
case. An audible click, heard and perceptible by touch,
conrms that the attachment is fully seated (Figure 1).
1
1
EN
2. Insert the tool into the attachment with a slight
2
rotational motion (Figure 2). An audible click, heard
and perceptible by touch, conrms that the tool is
fully seated.
3. Rotate the attachment in the direction indicated
3
by arrow on the attachment until the attachment
alignment mark is directly in line with the locked
symbol (Figure 3). You will hear two clicks as the
attachment is rotated.
4. Gently pull on the tool to ensure that it is locked into the assembly. Free run the drill assembly
prior to use to check for proper function and dissecting tool stability.
Drilling
The Legend depth stop attachment and dissecting tools are intended to be used with the Stealth
Autoguide drill guides to create cranial access holes. Refer to Table 1 for procedure, dissecting tool, and
drill guide compatibility.
Table 1: Drill guide compatibility
Procedure Attachment Dissecting tool Hole diameter
Biopsy
Biopsy DS1TD75 7.5mm 28322
ASDS01
sEEG bolt placement DS1TD24 2.4mm 28326
Visualase bone anchor placement DS1TD32L 3.2mm 28324
DS1TD32 3.2mm 28326
Stealth Autoguide drill
guide number
After following installation steps 1 through 4, prepare for drilling with the following steps:
1. To adjust the drill depth setting, rotate collar on
4
the attachment so that the arrow aligns with the
desired drill depth (Figure 4).
Note: The numbers correspond to the drill depth
Collar
in millimeters.
2. Insert the drill assembly into corresponding drill
5a
5b
guide per Table 1 for the given procedure (Figure 5a).
3. Power the drill assembly per the following:
(1) For electric motors: set the Integrated Power
Console (IPC) speed between 60,000 RPM to
75,000 RPM
(2) For pneumatic motors: set the pneumatic foot
(PCU) control pressure between 80 psi to 120 psi
4. Provide a slight forward drilling force until the
shoulder of the attachment comes in contact with
the top of the drill guide (Figure 5b). Use irrigation
Drill
guide
Shoulder
while drilling.
5. Stop Legend motor before removing drill
assembly from drill guide.
6. Verify that the hole has been fully created. If not,
readjust the depth setting and repeat steps 2-5.
2
Drill angle limitations
Warnings: Refer to warning W3.
Dissecting tool Drill angle limit
DS1TD24
EN
Table 2: Drill angle limits
DS1TD32
DS1TD32L
DS1TD75
30°
10°
Removal
1. Hold the motor in palm of hand. Rotate the attachment to the unlocked position. In this position,
the arrows on the attachment and motor will line up.
2. Remove the dissecting tool from the attachment and discard the tool per local regulations.
3. Use thumb and index nger to lift the attachment o of the motor.
Cleaning and sterilization
Devices should be cleaned and then sterilized per the instructions below:
Medtronic recommends incineration of devices that have directly contacted patients suspected or conrmed
with a Transmissible Spongiform Encephalopathy (TSE)/ Creutzfeldt-Jakob disease (CJD) diagnosis.
Reprocessing instructions
Warnings Do not soak/submerge devices.
Do not use ultrasound to clean devices.
Do not use chlorine based or corrosive cleaning agents such as bleach, lye,
acetone, sodium hypochlorite/bleach, sodium hydroxide, formic acid, or
solutions containing glutaraldehyde.
The use of a washer-disinfector for cleaning may cause a 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 dissecting tool from being secured properly in the handpiece.
Limitations on
reprocessing
Point of use Reprocessing begins at the point of use. Reprocess the device within 30
Containment and
transportation
The product is provided non-sterile and must be cleaned and sterilized before
rst use and any reuse.
minutes of use. Do not allow blood, debris, or bodily uids to dry on the device.
Remove excess soil using running, cold tap water 10 - 22°C (50 - 72°F). Tap
water is dened as potable water with a hardness value of <150 mg/L.
It is recommended that devices are reprocessed as soon as is practical
following use.
3
EN
Reprocessing instructions
Preparation for
decontamination
Preclean
instructions
prior to use in
an automated
washer
Detach the attachment from the motor. Remove and discard the tool. Do not
soak devices.
Review the washer-disinfector warning above, before using this cleaning method.
Manually rinse attachment/tubes under tap water, until no visible soil is noticed.
Actuate moving parts through their full range of motion while under running
tap water.
While rinsing under running tap water, an appropriately sized nylon brush may
be used internally or externally to aid in cleaning attachments.
Remove devices from instrument trays before placing into washer baskets.
Attachment must be placed in the washer with the tube in the fully extended
position.
Orient devices following recommendations of the washer/disinfector manufacturers.
Clean per one of the recommended washer cycles below.
After cleaning per the recommended washer cycle below, visually examine the
attachment for cleanliness.
Cleaning: Automated
Caution: Do not use ultrasonic cleaner. Review the washer-disinfector warning above, before using
this cleaning method.
Automated wash cycle using a neutral enzymatic detergent (pH 6.0-8.0)
Phase Recirculation time Water temperature Detergent type
Pre-wash 2 minutes (02:00) Cold tap water Not applicable
Wash 5 minutes (05:00) 66°C (151°F) (set point)
Rinse 1 minute (01:00) Hot tap water Not applicable
Neutral enzymatic
detergent, pH 6.0-8.0
Automated wash cycle using an alkaline detergent (pH 8.0 -10.5)
Phase Recirculation time Water temperature Detergent type
Pre-wash 2 minutes (02:00) Cold tap water Not applicable
Wash 5 minutes (05:00)
Rinse 1 minute (01:00) Hot tap water Not applicable
Thermal rinse 1 minute (01:00)
Puried water rinse
4
1 minute 30 seconds
(01:30)
43°C (109°F)
(set point)
90°C (194°F)
(set point)
66°C (151°F)
(set point)
Alkaline detergent with
pH 8.0 - 10.5
Not applicable
Not applicable
Reprocessing instructions
Cleaning: Manual 1. Thoroughly rinse the attachment under cold running tap water
(10–22°C/50–72°F) to remove any visible soil. Actuate all moveable parts
through their full range of motion while rinsing. Use a nylon brush to aid in
cleaning. Give particular attention to crevices and other areas that present a
challenge to cleaning.
2. Using tap water, prepare a neutral enzymatic cleaner like Steris Prolystica 2x
concentrate enzymatic cleaner following the manufacturer’s recommendation
of 1.0mL/L(1/8oz/gallon) at a temperature of 23°C(73°F) or use an equivalent
neutral pH cleaner following that manufacturer’s recommendations.
3. Wipe the attachment with a cloth dampened with the prepared cleaner.
4. Use a nylon brush dampened with the prepared cleaner to clean the external
surfaces of the attachment. Actuate all moveable parts through their full
range of motion to allow the cleaner to thoroughly clean the attachment.
5. Use a 3.2mm diameter nylon brush dampened with the prepared cleaner
to clean the inner diameter of the attachment. Push the brush through the
attachment from rear to front to loosen and remove debris trapped inside.
6. Thoroughly rinse the attachment under warm running tap water
(23–43°C/73–109°F). Actuate all moveable parts through the full range of
motion while rinsing. Flush both ends to remove cleaner.
7. Following the warm tap water rinse, thoroughly rinse the attachment with
room temperature (25°C/77°F) puried water (deionized, reverse osmoses,
or equivalent) for a minimum of 30 seconds.
8. Verify that the attachment is visually clean after manual cleaning. If visible
soil remains, repeat cleaning.
Drying and
lubrication
Note: Medtronic no longer recommends using the Legend attachment cleaning
nozzle (PA120), as this may cause some attachments to overheat.
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 the attachment.
1. Holding the can approximately 10-15cm (3-6 in.) away from the attachment,
spray all components that move, rotate, or slide with three quick squirts.
2. Articulate movable components to ensure proper lubrication.
3. Remove excess lubricant with a clean cloth.
Packaging Place the attachment in the Stealth Autoguide instrument tray. Follow the
sterilization instructions for Stealth Autoguide found in the Stealth AutoguideIFU.
Sterilization Place the attachment in the Stealth Autoguide instrument tray.
Follow the sterilization instructions for Stealth Autoguide system found in the
Stealth Autoguide IFU.
Maintenance,
inspection, and
testing
Inspect devices for any damage before and after each use. If damage is observed,
do not use the device until it is repaired.
Verify functionality prior to re-use.
Storage Store with other sterile devices.
EN
5
EN
Return policy for devices exposed to Transmissible Spongiform Encephalopathies (TSE)
Reusable devices that have been used on patients with suspected Creutzfeldt-Jakob Disease (CJD) or
other Transmissible Spongiform Encephalopathies (TSE) should be quarantined and not reused until
a diagnosis is conrmed or excluded. Medtronic Powered Surgical Solutions (MPSS) will not authorize
or accept the return of MPSS products that directly contacted a patient or are contaminated with a
patient’s body uids that is suspected or conrmed with TSE or CJD diagnosis. Furthermore, MPSS
recommends that all MPSS product used on a patient conrmed with or suspected of a TSE/CJD
diagnosis be incinerated. If TSE/CJD is excluded as a diagnosis, the quarantined reusuable equipment
may be returned for use after appropriate cleaning, decontamination and sterilization. Hospital
personnel should contact their infection control personnel for current procedures and policy for
reusable equipment processing. Contact your Sales Representative for temporary equipment while
original equipment is quarantined or for replacement of product incinerated under this policy. Contact
MPSS Regulatory Aairs Department for additional information regarding TSE/CJD contamination.
Limited warranty* (U.S. customers only)
A. This Limited Warranty provides the following assurance for the customer who purchases a Legend
Depth Stop Attachment. This Limited Warranty is extended only to the buyer purchasing the
Legend Depth Stop Attachment directly from Medtronic or from its aliate or its authorized
distributor or representative.
1. Should the Attachment fail to function to Medtronic’s published specications due to defect in
materials or workmanship during the term of this Limited Warranty (ninety [90] days from the
date of shipment of the Attachment to customer), Medtronic will either repair or replace the
Attachment or any portion there of at no charge.
B. To qualify for this Limited Warranty, the following conditions must be met:
1. The product must be used on or before its “Use By” or “Use Before” date, if applicable.
2. The Attachment 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 notied in writing within thirty (30) days following discovery of a defect.
4. The Attachment must be returned to Medtronic within thirty (30) days of Medtronic receiving
notice as provided for in (3) above.
5. Upon examination of the Attachment by Medtronic, Medtronic shall have determined that: (a)
the Attachment was not repaired or altered by anyone other than Medtronic or its authorized
representative, (b) the Attachment was not operated under conditions other than normal use,
and (c) the prescribed periodic maintenance and services, if applicable, have been performed
on the Attachment.
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 IPC
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 benet 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 conict with applicable law, the validity of the remaining portion of the Limited Warranty shall
not be aected, and all rights and obligations shall be construed and enforced as if this Limited
Warranty did not contain the particular part or term held to be invalid.
*This Limited Warranty is provided by Medtronic Powered Surgical Solutions, 4620 North Beach Street,
Fort Worth, Texas 76137-4116. It applies only in the United States. Areas outside the United States
should contact their local Medtronic representative for terms of the warranty.
6
Symbols
EC REP
Compliant with European Council
Directive MDD 93/42/EEC
Authorized Representative in the
European Community
Caution: Federal law (USA) restricts this
device to sale by or on the order of a
physician.
Consult Instructions for Use
Manufacturer
Use By Date
Catalog Number
Use With
Attachment
Lot Number
Diameter
Dissecting Tool
Single Use
Locked
Do not use if package is damaged
Package Quantity
Non-sterile
Sterilized using Irradiation
Serial Number
175042EN E
EC REP
2019-11
May be covered by U.S. Patents:
Medtronic.com/patents
©2019 Medtronic, Inc.
Made in USA. Printed in USA.
Medtronic Powered Surgical Solutions
4620 North Beach Street
Fort Worth, Texas 76137 USA
+1 800 643 2773
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
+31 45 566 8000
Medtronic Australian Sponsor:
Medtronic Australasia Pty Ltd
2 Alma Road
Macquarie Park, NSW 2113 Australia
medtronic.com
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