Instructions for Use
Instrucciones de uso
175042ML55 E
Midas Rex™ Legend™
Depth Stop Attachment and Tools
Herramientas y accesorio de
acoplamiento con tope de profundidad
Instructions for Use
175042ML55 E
Midas Rex™ Legend™
Depth Stop Attachment and Tools
EN To obtain a copy of this manual in your local language
contact your local Medtronic representative or go to
manuals.medtronic.com.
CS Máte -li zájem okopii této příručky ve svém jazyce,
kontaktujte místního zástupce společnosti Medtronic nebo
navštivte webové stránky manuals.medtronic.com.
DA Du kan få en kopi af denne vejledning på dit sprog ved at
kontakte den lokale Medtronic-repræsentant eller gå til
manuals medtronic.com.
DE Eine Kopie dieses Handbuchs in der jeweiligen Landessprache
kann vom örtlichen Medtronic-Vertreter angefordert oder
unter manuals.medtronic.com bezogen werden.
EL Για να λάβετε αντίγραφο του παρόντος εγχειριδίου
στην τοπική σας γλώσσα, επικοινωνήστε με τον τοπικό
αντιπρόσωπο της Medtronic ή επισκεφθείτε την ιστοσελίδα
manuals.medtronic.com.
ES Para obtener una copia de este manual en su idioma
local, póngase en contacto con su representante local de
Medtronic o visite manuals.medtronic.com.
FI Jos haluat tämän käyttöoppaan omalla kielelläsi, ota yhteyttä
paikalliseen Medtronicin edustajaan tai siirry osoitteeseen
manuals.medtronic.com.
FR Pour obtenir un exemplaire de ce manuel dans votre langue,
veuillez contacter votre représentant Medtronic local ou
visiter la page manuals.medtronic.com.
HR Da biste dobili kopiju ovog priručnika na svom jeziku,
obratite se lokalnom zastupniku tvrtke Medtronic ili posjetite
web-mjesto manuals.medtronic.com.
HU Ha szeretne egy saját nyelvű példányt a jelen kézikönyvből,
vegye fel a kapcsolatot a Medtronic helyi képviseletével,
vagy látogasson el a manuals.medtronic.com weboldalra.
IT Per ottenere una copia del presente manuale nella lingua
locale, contattare il rappresentante Medtronic di zona o
visitare la pagina manuals.medtronic.com.
KK
Осы нұсқаулықтың өзіңіздің жергілікті тіліңіздегі
көшірмесін алу үшін, жергілікті Medtronic өкіліне
хабарласыңыз немесе мына веб-сайтқа өтіңіз:
manuals.medtronic.com.
MK За да добиете копија од овој прирачник на вашиот локален
јазик, контактирајте со вашиот локален претставник на
Medtronic или појдете на manuals.medtronic.com.
NL Neem contact op met uw vertegenwoordiger van
Medtronic of ga naar manuals.medtronic.com voor een
exemplaar van deze handleiding in uw taal.
NO Du kan få et eksemplar av denne håndboken på ditt språk
ved å kontakte din lokale Medtronic-representant eller gå
til manuals.medtronic.com.
PL Aby uzyskać egzemplarz niniejszego podręcznika w
wybranym języku, należy się skontaktować z lokalnym
przedstawicielem rmy Medtronic lub odwiedzić stronę
manuals.medtronic.com.
PT-BR Para obter uma cópia deste manual em seu idioma
local, entre em contato com o representante local da
Medtronic ou acesse manuals.medtronic.com.
PT-PT Para obter uma cópia deste manual no seu idioma
local, contacte o seu representante local Medtronic
ou visite manuals.medtronic.com.
RO Pentru a obține o copie a acestui manual în limba locală,
contactați reprezentantul local Medtronic sau accesați
manuals.medtronic.com.
RU Для получения экземпляра этого руководства на вашем
языке обратитесь к местному представителю Medtronic
или посетите сайт manuals.medtronic.com.
SK Ak chcete získať kópiu tejto príručky vo svojom jazyku,
kontaktujte miestneho zástupcu spoločnosti Medtronic
alebo navštívte stránku manuals.medtronic.com.
SL Če želite izvod tega priročnika v svojem jeziku, se obrnite
na lokalnega predstavnika za Medtronic ali pa ga poiščite
na spletnem mestu manuals.medtronic.com.
SR Da biste dobili kopiju ovog priručnika za korisnike na svom
jeziku, kontaktirajte lokalno predstavništvo kompanije
Medtronic ili posetite lokaciju manuals.medtronic.com.
SV För att erhålla en kopia av denna handbok på ditt språk
kontaktar du din lokala representant för Medtronic eller går
till manuals.medtronic.com.
TR Bu k ılavuzun kendi dilinizde bir kopyasını almak için,
bölgenizdeki Medtronic temsilcinize başvurun veya
manuals.medtronic.com adresine gidin.
UK Щоб отримати копію цього посібника вашою місцевою
мовою, зв’яжіться зі своїм місцевим представником
Medtronic або відвідайте веб-сайт manuals.medtronic.com.
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 countries: 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 Selecting the wrong dissecting 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.
1
EN
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
2. Inser t the tool into the attachment with a slight rotational
motion (Figure 2). An audible click, heard and perceptible
by touch, conrms that the tool is fully seated.
2
3. Rotate the attachment in the direction indicated 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.
3
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.
2
Table 1: Drill guide compatibility
Procedure Attachment
Biopsy
Biopsy DS1TD75 7.5mm 28322
Dissecting
DS1TD32 3.2mm 28326
tool
Hole
diameter
Autoguide
drill guide
EN
Stealth
number
sEEG bolt
placement
Visualase
bone anchor
placement
After following installation steps 1 through 4, prepare for drilling
with the following steps:
1. To adjust the drill depth setting, rotate collar on the attachment
ASDS01
DS1TD24 2.4mm 28326
DS1TD32L 3.2mm 28324
so that the arrow aligns with the desired drill depth (Figure 4).
Note: The numbers correspond to the drill depth in millimeters.
4
Collar
2. Inser t the drill assembly into
corresponding drill 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
5a
Drill
guide
3
EN
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
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.
Drill angle limitations
Warnings: Refer to warning W3.
Table 2: Drill angle limits
Dissecting tool Drill angle limit
DS1TD24
5b
Shoulder
DS1TD32
DS1TD32L
DS1TD75
4
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.
Limitations on
reprocessing
Point of use Reprocessing begins at the point of use.
Containment
and
transportation
Preparation for
decontamination
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. Nonnylon cleaning brushes leave residue that
may prevent the dissecting tool from
being secured properly in the handpiece.
The product is provided non-sterile and
must be cleaned and sterilized before rst
use and any reuse.
Reprocess the device within 30 minutes of
use. Do not allow blood, debris, or bodily
fluids to dry on the device. Remove excess
soil using running, cold tap water 10 - 22°C
(50 - 72°F). Tap water is defined 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.
Detach the attachment from the motor.
Remove and discard the tool. Do not
soak devices.
EN
5
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