Medtronic 3747105 Instructions for Use
XPS® Bone Bridge™ Drill Bit
Mèche XPS® Bone Bridge™
XPS® Bone Bridge™ punta da trapano
XPS® Bone Bridge™ Bohraufsatz
Fresa para el sistema XPS® Bone Bridge™
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
Rx Only
EN The following are trademarks or registered trademarks of Medtronic, Inc. in the United
States and other countries: Bone Bridge™ and 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 Les noms suivants sont des noms commerciaux
ou des marques déposées de Medtronic, Inc aux États-Unis comme dans les autres pays:
Bone Bridge™ et 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 I seguenti marchi sono marchi commerciali
o marchi registrati di Medtronic, Inc. negli Stati Uniti e in altri paesi: Bone Bridge™ e 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 Die
folgenden Namen sind in den USA und anderen Ländern Marken oder eingetragene Marken
von Medtronic, Inc.: Bone Bridge™ und XPS®. Alle anderen Marken, Dienstleistungsmarken,
eingetragenen Marken oder eingetragenen Dienstleistungsmarken sind das Eigentum
ihrer jeweiligen Inhaber in den USA und anderen Ländern. ES Las siguientes son marcas
comerciales o marcas registradas de Medtronic, Inc. en EE.UU. y otros países: Bone Bridge™
y 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 XPS Bone Bridge Drill Bit is an interchangeable drill bit intended for use with the Medtronic
Xomed XPS System and with Bone Bridge Drill Guide. e reusable drill is packaged singly and
provided sterile for rst time convenience.
Indications for use
e XPS Bone Bridge Drill Bit is indicated for use in incising or removing bone and tissues in
creating a bone tunnel xation point for suture in a browli surgery.
Contraindications
ere are no known contraindications.
Warnings
• Do not operate drill continuously. Use irrigation. Drill is intended for use with the 3747101
Bone Bridge Drill Guide.
• 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.
• 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
• Conrm depth of penetration prior to use. CT Scan is an important reference for use to avoid
penetration.
• 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.
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 (Per ISO17664)
Cleaning and Sterilization instructions are subject to change without notice. Up to date
instructions are available online at manuals.medtronic.com.
68E3979 B
Reuse
The XPS Bone Bridge Drill Bit 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.
Warnings and Precautions • Before use, carefully inspect the device for any irregularities
Limitations • Discard any device that shows signs of damage or wear.
Point of Use • This product must be cleaned and sterilized before any
XPS® Bone Bridge™ Drill Bit
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.
• After cleaning and sterilization, verify functionality prior
to re-use.
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.
3
En
Containment and
Transportation
Preparation for
decontamination
Cleaning: Automated • All instruments shall be thoroughly rinsed with tap water
Phase Recirculation Time Water temperature Detergent type
Pre-wash 1 3 minutes cold tap water not applicable
Enzyme Wash 5 minutes hot tap water neutral pH enzymatic detergent
Wash 1 5 minutes 66oC set point neutral pH detergent
Rinse 1 3 minutes hot tap water not applicable
Thoroughly examine instruments for any residual soil.
Cleaning: Manual • Soak in lukewarm (less than 43°C), mild (pH 7.0 - 8.5),
Disinfection Note: Do not cold soak in glutaraldehyde, chlorine, or
Packaging • A standard sterilization wrap may be used. In the US, an
Sterilization
(Temperatures are
minimum required; times
are minimum required)
Instruments Only Instruments Only or Instruments in Medtronic
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
Maintenance, Inspection
and Testing
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.
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:
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.
ammonium solutions, or dry heat sterilize, as damage to the
instrument nish may occur.
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.
Xomed Instrument Trays
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.
4
XPS® Bone Bridge™ Drill Bit
Fr
Storage Store instruments in a clean, dry area.
Additional Information None
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 contacted patients
suspected or conrmed with Transmissible Spongiform Encephalopathy (TSE)/ CJD diagnosis.
NHS Estates HTM 2010 Parts 4 & 6: Appendix 2, Items contaminated with TSE Agents and
WHO Infection Control Guidelines for Transmissible Spongiform Encephalopathies refers to a
TSE decontamination cycle using a 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.
Note: In France, soaking the device in one mole of Soda (NaOH) per liter of solution is the
recommendation of French Instruction DGS/RI3/2011/449 in order to prevent CreutzfeldJakob Disease transmission.
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.
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 XPS Bone Bridge est une mèche interchangeable dessinée à être utilisée avec le système
XPS de Medtronic Xomed et le guide-mèche Bone Bridge. Chaque emballage contient une mèche
réutilisable qui a été stérilisée dans le but de faciliter le premier usage.
Indications d’utilisation
La mèche XPS Bone Bridge est indiquée pour inciser ou réséquer os et tissus en créant un tunnel
osseux, point de xation des sutures lors de liing du front.
Contre-indications
Aucune contre-indication connue.
XPS® Bone Bridge™ Drill Bit
5
Fr
Avertissements
• Ne forer pas en continu. Appliquer de l’irrigation. La mèche est dessinée à être utilisée avec le
mèche Bone Bridge 3747101.
• 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.
• 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 courboure ou le forçage peuvent casser la lame ou la mèche et blesser le patient ou le
personnel.
Précautions d’utilisation
• Conrmer la profondeur de pénétration avant l’usage. Une tomodensitométrie est une
référence importante pour éviter la pénétration du sinus postérieur.
• 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.
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.
Instructions de retraitement pour les instruments réutilisables
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.
Instructions pour le retraitement (conformément à la norme ISO17664)
Toutes les instructions de nettoyage et stérilisation peuvent changer sans préavis. Les
dernières instructions sont disponibles en ligne sur le site manuals.medtronic.com.
68E3979 B
Réutilisation
La mèche XPS Bone Bridge est livrée stérile dans le but de faciliter son premier usage. Une
réserve de plusieurs mèches stériles est recommandée. Toutes les mèches doivent être
nettoyées et stérilisées avant chaque réutilisation comme indiqué ci-après.
Avertissements et
précautions
Limitations • Éliminer tout instrument montrant des signes d’usure ou
Utilisation initiale • Ce produit doit être nettoyé et stérilisé avant d’être réutilisé.
Conditionnement et
transport
• Avant toute utilisation, inspecter soigneusement le
dispositif à la recherche d’irrégularités ou d’excentricités.
• Un produit usé ou endommagé doit être remplacé.
• Il n’est pas recommandé de faire tremper les instruments
dans une solution froide de glutaraldéhyde, de chlore
ou d’ammonium, ni de les stériliser à sec sous peine de
compromettre le ni des surfaces externes.
de détérioration.
• Après le nettoyage et la stérilisation, vérier le bon
fonctionnement des instruments avant de les réutiliser.
• Rincer l’instrument immédiatement après utilisation avec
de l’eau distillée ou déminéralisée. Maintenir l’instrument
humide (par exemple, en le recouvrant d’un champ
humide ou imbibé d’eau du robinet, mais sans utiliser de
solution saline) après utilisation et avant décontamination,
nettoyage et stérilisation an d’assurer un nettoyage
approprié.
• Les instruments dotés de ports de nettoyage et/ou
de tubulures d’aspiration doivent être rincés avec un
détergent enzymatique à pH neutre puis sous l’eau
courante.
Il est recommandé de procéder au retraitement des
instruments le plus tôt possible après leur utilisation.
6
XPS® Bone Bridge™ Drill Bit
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