Frontal Sinus 2mm Mini
Trephine Drill
Foret 2 mm pour minitrépanation pour
sinus frontal
Mini trapano da 2 mm per seno frontale
Mini-Trephinbohrer (2 mm) für
Frontalsinus
Mini fresa de 2 mm para trepanación del
seno frontal
Product Information and Instructions
FR Informations et instructions concernant le produit IT Informazioni
sul prodotto ed istruzioni per l’uso DE Produktinformationen und
Gebrauchsanweisung ES Instrucciones e información sobre el
producto
EN Symbols FR Symboles IT Simboli DE Symbole ES Simbolos
EN For use up to “NNNN” RPM. FR “NNNN”
<NNNN
min
EN 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 without notice
and without incorporating those changes to products already sold. Released documents are
available to view or print at manuals.medtronic.com. FR Les informations contenues dans ce
document sont exactes au moment de la publication. Medtronic se réserve le droit d’apporter
des modications au produit décrit dans ce document, sans préavis et sans aucune obligation
d’intégrer ces modications dans les produits déjà vendus. Les documents publiés sont disponibles
pour consultation ou impression sur le site manuals.medtronic.com. IT Le informazioni contenute
nel presente documento sono accurate al momento della pubblicazione. Medtronic si riserva
il diritto di apportare modiche al prodotto descritto nel presente manuale senza preavviso e
senza applicare tali modiche a eventuali prodotti già venduti. I documenti pubblicati possono
essere visualizzati/stampati tramite su manuals.medtronic.com. DE Die in dieser Publikation
enthaltenen Informationen waren zum Zeitpunkt der Veröentlichung exakt. Medtronic behält
sich das Recht vor, das in dieser Gebrauchsanweisung beschriebene Produkt ohne Ankündigung
und ohne Integration dieser Änderungen in bereits verkaufte Produkte zu ändern. Sämtliche
derzeit freigegebene Publikationen stehen unter manuals.medtronic.com zum Einsehen und
Ausdrucken bereit. ES La información contenida en este documento era exacta en el momento
de su publicación. Medtronic se reserva el derecho de realizar cambios en el producto descrito
en este manual sin previo aviso, y no tiene la obligación de incorporar dichos cambios en los
productos ya adquiridos. Los documentos publicados pueden visualizarse o imprimirse en
manuals.medtronic.com.
rpm au maximum IT Da usare no a “NNNN”
giri al minuto D E Bis zu einer Drehzahl von
“NNNN” pro Minute ES Para utilizar hasta un
máximo de “NNNN” rpm
EN The following is a trademark or registered trademark of Medtronic, Inc. in the United States
and other countries: XPS®. 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.
FR Le nom suivant est un nom commercial ou une marque déposée de Medtronic, Inc aux ÉtatsUnis comme dans les autres pays: XPS®. Tous les autres noms commerciaux, marques de service,
marques déposées ou marques de service enregistrées appartiennent à leurs propriétaires
respectifs aux États-Unis comme dans les autres pays. IT Il seguente marchio è un marchio
commerciale o un marchio registrato di Medtronic, Inc. negli Stati Uniti e in altri paesi: XPS®. Tutti
gli altri marchi commerciali, marchi di servizio, marchi registrati o marchi di servizio registrati
appartengono ai rispettivi proprietari negli Stati Uniti e in altri paesi. DE Der folgende Name
ist in den USA und anderen Ländern eine Marke oder eingetragene Marke von Medtronic, Inc.:
XPS®. Alle anderen Marken, Dienstleistungsmarken, eingetragenen Marken oder eingetragenen
Dienstleistungsmarken sind das Eigentum ihrer jeweiligen Inhaber in den USA und anderen
Ländern. ES La siguiente es una marca comercial o marca registrada de Medtronic, Inc. en EE.UU.
y otros países: XPS®. Todas las demás marcas comerciales, marcas de servicio y marcas registradas
son propiedad de sus respectivos propietarios en EE.UU. y otros países.
En
En
Device description
e Frontal Sinus 2mm Mini Trephine Drill is an interchangeable drill bit intended for use with
the Xomed XPS System and Drill Guide with Skin Protector. e 2mm reusable drill is packaged
singly and provided sterile for rst time convenience.
Indications for use
e Frontal Sinus Mini Trephine Drill is indicated for use in incising or removing bone and
tissues in ear, nose, and throat, including sinus and rhinology surgery.
Contraindications
None are known.
Warnings
• Excessive noise from the drill or eccentricity of the drill may cause hearing damage when
drilling close to the cochlea or ossicular chain.
• e use of a drill may cause an inordinate amount of heat buildup resulting in thermal injury
to tissue. is heat buildup may be accentuated by eccentricity of the drill.
• Do not operate drill continuously. Use irrigation. Drill is intended for use with the 1892001
Drill Guide.
• Excessive force may lead to drill bending, breakage or excess vibration. If the drill fractures
during use, the resultant rough surfaces may cause lacerations of the body tissue. A drill
which fractures inside a patient may also cause tissue injury and necessitate emergency
procedures for extraction.
• Eccentricity of the drill can cause drill vibration and may result in excess tissue and bone
destruction.
• Always keep the cutting tip of the drill away from ngers and loose clothing.
• Bending or prying may cause the drill to break causing harm to patient or sta.
Precautions
• Always ensure that the drill is securely engaged into the drill handpiece prior to operating
the system.
• Always examine operation of each drill in a handpiece before use.
• Conrm depth of penetration prior to use. CT Scan is an important reference for use to
avoid posterior sinus penetration.
Instructions for use
• Refer to the XPS System User’s Guide for detailed set up instructions of the system.
• Apply irrigation to both Drill Guide and drill. Operate drill in forward briey, remove and
irrigate again for reduced risk of thermal injury.
Reprocessing Instructions for Reusable Instruments
When applying dry times to Medtronic instrument trays and their accessories, dry times
outside the standard healthcare prevacuum parameters may be required. The current
recommended dry times may range from a standard 15 minutes to an extended time of 40
minutes. This is especially important for polymer-based (plastic) instrument trays. The user
should have adequate means to verify drying time, such as visual inspection.
Reprocessing Instructions
Reuse
The Mini Trephine 2mm Drill is provided sterile for rst time convenience. Maintaining a
quantity of sterile provided drills is recommended. All drills must be cleaned and sterilized
using the following process before each reuse. The Mini Trephine 2mm Drill has been tested
for reuse use up to ve (5) times without noticeable performance degradation.
Warnings and
Precautions
Limitations
Point of Use
Containment and
Transportation
Preparation for
Decontamination
• Before use, carefully inspect the device for any irregularities or
eccentricities.
• Damaged or worn product should be replaced.
• Do not cold soak in glutaraldehyde, chlorine, or ammonium solutions,
or dry sterilize, as damage to the instrument nish may occur.
• Discard any device that shows signs of damage or wear.
• After cleaning and sterilization, verify functionality prior to re-use.
• This product must be cleaned and sterilized before any reuse.
• Rinse instrument immediately after use in distilled or demineralized
water. Keep instrument moist (for example, cover with a wet drape
or saturate with tap water - do not use saline) after use and prior
to decontamination, cleaning and sterilization to ensure adequate
cleaning.
• Instruments with cleaning ports and/or suction tubes shall be ushed
with neutral pH enzymatic detergent, followed by a tap water rinse.
It is recommended that devices are reprocessed as soon as is practical
following use.
• Promptly and thoroughly rinse with deionized water after each use.
• Fully disassemble modular designed instruments for eective
cleaning.
• Place instruments so they do not touch each other.
Note: Flushing in running water is essential between decontamination
and cleaning to prevent any risk of reaction between the two solutions.
3Frontal Sinus 2mm Mini Trephine Drill
En
Cleaning:
Automated
Cleaning: Manual
Disinfection Note: Do not cold soak in glutaraldehyde, chlorine, or ammonium
Packaging
Sterilization
(Temperatures
are minimum
required; times
are minimum
required)
Maintenance,
Inspection and
Testing
Storage Store instruments in a clean, dry area.
Additional
Information
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 is performed using validated equipment to achieve the desired
result. This normally requires validation and routine monitoring of the process.
Some devices have specic assembly instructions. In this case, refer to the assembly insert
provided with the device for additional instructions.
All validations performed per current AAMI TIR12, “Designing, testing, and labeling reusable
medical devices for reprocessing in health care facilities: A guide for medical device
manufacturers.”
.Medtronic recommends incineration of devices that have directly or indirectly contacted
patients suspected or conrmed with prions or a Transmissible Spongiform Encephalopathy
(TSE) such as Creutzfeldt‐Jacob disease (CJD).
Customer service information
For further information regarding the use of this product or to report any problems, please
contact Medtronic Xomed using the appropriate information provided on the blue and white
contact information card packaged with each device; or contact your local distributor.
• All instruments shall be thoroughly rinsed with tap water prior to
placement in the automatic washer.
• Remove instruments and equipment from any sterilization trays
before placing into washer baskets. Orient devices following
recommendations of washer/disinfector manufacturers.
• Use mildly alkaline or neutral pH detergent (pH 7.0 - 8.5)
recommended by washer/disinfector or detergent manufacturers.
• These products have been validated for eective cleaning using an
automatic washer/disinfector cycle consisting of the following:
Phase Recirculation
Time
Pre-wash 1 3 minutes cold tap water not applicable
Enzyme
5 minutes hot tap water neutral pH enzymatic detergent
Wash
Wash 1 5 minutes 66°C set point neutral pH detergent
Rinse 1 3 minutes hot tap water not applicable
Thoroughly examine instruments for any residual soil.
• Soak in lukewarm (less than 43°C), mild (pH 7.0 - 8.5), enzymatic
detergent and deionized water for a minimum of 2 minutes.
• Use a soft instrument brush to scrub instruments while submerged
in cleaning solution to remove organic matter. Rinse with deionized
water, then clean ultrasonically in a lukewarm (less than 43°C), mild
(pH 7.0 - 8.5), detergent and deionized water for 10 minutes.
• To prevent stains, use distilled or demineralized water as a nal rinse
prior to sterilization.
solutions, or dry heat sterilize, as damage to the instrument nish may
occur.
• A standard sterilization wrap may be used. In the US, an FDA
approved surgical wrap is required.
• In sets: Instruments may be loaded into dedicated Medtronic Xomed
instrument trays. Ensure that cutting edges are protected. Wrap trays
using appropriate method.
• Check the cleanliness and operation of the instrument. Clean again
if debris is present and remove from use any damaged instrument.
Close instruments with catches and racks on the rst notch. If
applicable, arrange the instruments in the dedicated instrument tray.
Follow the appropriate cycle listed in the table below.
• All steam cycles have been validated in the wrapped conguration
and can be sterilized wrapped or unwrapped. These devices have only
been validated for steam sterilization methods.
Instruments Only Instruments Only or Instruments in
Cycle Gravity Gravity Pre-vac Pre-vac (FR/WHO) Pre-vac (UK)
Temperature 121°C 132°C 132°C 134°C 134°C
Time 30 minutes 10 minutes 4 minutes 18 minutes 3 minutes
Drying 15 – 40 minutes, or until visibly dry
• Inspect components for any damage before and after each use. If
damage is observed do not use the instrument until it is repaired or
replaced.
• After cleaning and sterilization, verify functionality prior to re-use.
None
Water
Temperature
Detergent Type
Medtronic Xomed Instrument Trays
4 Frontal Sinus 2mm Mini Trephine Drill
Fr
Limited warranty
A. is LIMITED WARRANTY provides assurance for the customer who purchases a Medtronic
Xomed Product (hereinaer the “Product”) that should the Product fail to function to Medtronic
Xomed’s published specications during the term of this LIMITED WARRANTY (one year
from the date of shipment for new Product, 90 days from date of shipment for refurbished or
used Product), Medtronic Xomed will either replace, repair, or issue a credit (adjusted to reect
the age of the Product) for the Product or any portion thereof. is LIMITED WARRANTY is
extended only to the buyer purchasing the Product directly from Medtronic Xomed or from its
aliate or its authorized distributor or representative.
B. To qualify for this LIMITED WARRANTY, the following conditions must be met:
1. e Product must be used on or before its “Use By” or “Use Before” date, if applicable.
2. e 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 Xomed must be notied in writing within thirty (30) days following discovery of
a defect.
4. e Product must be returned to Medtronic Xomed within thirty (30) days of Medtronic
Xomed receiving notice as provided for in (3) above.
5. Upon examination of the Product by Medtronic Xomed, Medtronic Xomed shall have
determined that: (i) the Product was not repaired or altered by anyone other than Medtronic
Xomed or its authorized representative, (ii) the Product was not operated under conditions
other than normal use, and (iii) the prescribed periodic maintenance and services have been
performed on the Product.
C. is 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 Xomed be liable
for any consequential, incidental, prospective or other similar damage resulting from a defect,
failure, or malfunction of the Product, whether a claim for such damage is based upon the
warranty, contract, negligence or otherwise.
D. e 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.
Fr
Description du dispositif
La mèche Mini Trephine de 2mm pour le sinus frontal est une mèche interchangeable dessinée à
être utilisée avec le système XPS de Xomed et le porte-mèche avec protecteur de peau.
Indications d’utilisation
La mini-mèche Trephine pour sinus frontal est indiquée pour l’incision ou l’ablation d’os et de
tissus dans les oreilles, le nez, la gorge, et lors des interventions chirurgicales sino-rhynologiques.
Contre-indications
Aucune contre-indication connue.
Avertissements
• Une mèche trop bruyante ou trop excentrée pendant le mèche près du limaçon de l’oreille ou
de la chaîne ossiculaire peut entraîner des dommages auditifs.
• Le mèche peut causer un échauement accumulatif excessif et provoquer une brûlure des
tissus. L’excentricité de la mèche peut accentuer l’échauement accumulatif.
• Ne forer pas en continu. Appliquer de l’irrigation. La mèche est dessinée à être utilisée avec
le porte-mèche 1892001.
• Une pression trop forte peut courber la mèche, la casser ou provoquer des vibrations
excessives. Si la mèche se casse pendant la procédure, les surfaces ébréchées peuvent lacérer
les tissus. Une mèche qui se casse dans le corps du patient peut aussi endommager les tissus
et nécessiter une procédure d’urgence pour son extraction.
• L’excentricité de la mèche peut la faire vibrer et entraîner une destruction tissulaire et
osseuse.
• Tenez toujours l’extrémité tranchante de la lame ou de la mèche loin des doigts et des
vêtements.
• La torsion ou le forçage peut casser la lame ou la mèche et blesser le patient ou le personnel.
Précautions d’utilisation
• Toujours vérier que la mèche est bien enclenchée dans la pièce à main avant d’actionner le
système de fraisag.
• Vériez toujours le fonctionnement de chaque fraise dans la pièce à main avant de l’utiliser.
• Conrmer la profondeur de pénétration avant l’usage. Une tomodensitométrie est une
référence importante pour éviter la pénétration du sinus postérieur.
Mode d’emploi
• Se référer au manuel de l’utilisateur du Système XPS pour des instructions détaillées sur
l’installation du système.
• Irriguer la mèche et le porte-mèche. Faire fonctionner brièvement le moteur en marche
avant, l’enlever, et irriguer à nouveau pour réduire le risque d’une lésion thermique.
5Frontal Sinus 2mm Mini Trephine Drill
Loading...