Browlift Bone Bridge™ Drill Guide
Guide de perçage Browlift Bone Bridge™
Guida per trapano Browlift Bone Bridge™
Bone Bridge™ Stirnlift-Bohrführung
Guía de perforación Browlift Bone Bridge™
Product Information and Instructions
FR Informations sur le produit et mode d’emploi 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 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.
EN
EN
Device description and intended use
The Medtronic Xomed Browlift Bone Bridge Drill Guide allows the surgeon to provide a brow xation point without the need of a
xation anchor or screw. The Browlift Bone Bridge Drill Guide may be used to create a bone tunnel with a skull penetration depth
of 3.56 mm, (+0.5 mm, - 0.31 mm). The drill guide facilitates creation of two bone tunnels which meet and allow passage of a
suture with the aid of the Medtronic Xomed Suture Passer. The suture can then be tied o to complete the xation of the brow
tissue.
The Browlift Bone Bridge Drill Guide must be cleaned and sterilized prior to rst use and before each reuse.
Indications
The Medtronic Xomed Browlift Bone Bridge Drill Guide is indicated for use as a drill guide to assist the surgeon in creating a bone
tunnel xation point for suture in a browlift surgery.
Contraindications
None known.
Possible adverse eects
Complicatons may include perforation of the skull in patients with a skull of less than 4.10 mm in the area being drilled.
Warnings
• Thickness of the skull will vary. The Bone Bridge Drill Guide is designed to create a bone tunnel which penetrates less than
4.10 mm. The surgeon should use tactile sensation during drilling to evaluate the depth of bone invasion by the drill. Prior
to drilling, surgeon should assess the need for a medical scan or other means of determining the thichness of the patient’s
skull in the area of drilling.
• Use only drills designed for the Browlift Bone Bridge Drill Guide; Universal Drill Bur, 3747103, and XPS Drill Bur, 3747105.
Failure to do so may result in excessive penetration by the drill bur.
• Movement of the Browlift Bone Bridge Drill Guide during drilling may aect the size and quality of the bone tunnel created.
Assure that the Drill Guide is rmly held in place during drilling.
• Damaged or worn Browlift Bone Bridge Drill Guide components may aect the depth of the drill progression. Damaged or
worn product should be replaced.
• Use extreme care during handling and cleaning of instruments with sharp points to prevent injury.
Operative procedure
Following complete mobilization of the brow:
1. Place the Drill Guide rmly against the skull. Orient the drill guides, preferably, such that the resulting bone tunnel will lie in
the transverse plane.
2. Lightly tap the Drill Guide handle such that the Drill Guide Pins will slightly demark the skull and provide a point of
reference.
3. While holding the Drill Guide rmly against the skull, insert either the Medtronic Xomed Universal Browlift Bone Bridge
Drill Bur* or the Medtronic Xomed XPS Browlift Bone Bridge Drill Bur* into the drill guide and proceed with drilling
one side of the bone tunnel. Drilling to the point at which the drill penetration stops against the Drill Guide will yield a
maximum depth of skull penetration of 4.1 mm. The surgeon should use tactile sensation during drilling to evaluate the
depth of bone invasion by the drill. Prior to drilling, surgeon should assess the need for a medical scan or other means of
determining the thickness of the patient’s skull in the area of drilling.
4. Carefully remove the drill from the drill guide and repeat step 3 in the opposite drill guide.
5. Remove the Drill Guide from the skull.
6. Thread the Medtronic Xomed Suture Passer through the bone tunnel until the wire loop end protrudes from the tunnel. A
suture may be fed through the wire loop and pulled back through the tunnel and tied.
* Note: The Universal Drill Bur is designed for use with any bone drill accepting 1/8” drill burs. The XPS Drill Bur is for use only
with the XPS Microresector System.
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.
68E3980 B
Warnings and Precautions • Before use, carefully inspect the device for any irregularities or eccentricities.
Limitations • Discard any device that shows signs of damage or wear.
• 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.
3Browlift Bone Bridge™ Drill Guide
EN
Point of Use • This product is provided non-sterile and must be cleaned and sterilized before the rst use and
Containment and
Transportation
Preparation for
decontamination
Cleaning: Automated • All instruments shall be thoroughly rinsed with tap water prior to placement in the automatic
Cleaning: Manual • Soak in lukewarm (less than 43°C), mild (pH 7.0 - 8.5), enzymatic detergent and deionized water
Disinfection Note: Do not cold soak in glutaraldehyde, chlorine, or ammonium solutions, or dry heat sterilize,
Packaging • A standard sterilization wrap may be used. In the US, an FDA approved surgical wrap is required.
Sterilization
(Temperatures are
minimum required; times
are minimum required)
Maintenance, Inspection
and Testing
Storage Store instruments in a clean, dry area.
Additional Information None
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.
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 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.
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.
as damage to the instrument nish may occur.
• 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 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
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.
Xomed Instrument Trays
4 Browlift Bone Bridge™ Drill Guide
FR
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 Creutzfeld-Jakob 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. This LIMITED WARRANTY provides assurance for the customer who purchases a Medtronic Xomed Product (hereinafter 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. This 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) 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 Xomed must be notied in writing within thirty (30) days following discovery of a defect.
(4) The 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. 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 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. 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.
FR
Description et indications d’utilisation
Le guide de perçage Browlift Bone Bridge de Medtronic Xomed permet au chirurgien d’obtenir un point de xation du sourcil sans
vis ni ancrage. Ce guide peut être utilisé pour créer un tunnel osseux d’une profondeur de 3,56 mm (+0,5 mm, - 0,31 mm). Il facilite
l’ouverture de deux tunnels osseux qui se rencontrent et permettent le passage d’un point de suture à l’aide du passeur de points
de suture de Medtronic Xomed. Ce point de suture peut ensuite être attaché pour terminer la xation du tissu sourcilier.
Le guide de perçage Browlift Bone Bridge doit être nettoyé et stérilisé avant la première utilisation et avant chaque emploi
ultérieur.
Indications
Le guide de perçage Browlift Bone Bridge de Medtronic Xomed est indiqué comme guide pour permettre au chirurgien de créer
un point de xation dans un tunnel osseux pour un point de suture lors d’une intervention chirurgicale de soulèvement de sourcil.
Contre-indications
Aucune connue.
Eets indésirables éventuels
Les complications peuvent comprendre une perforation de la calotte crânienne du patient si son épaisseur est inférieure à 4,1 mm
au niveau de la zone percée.
5Browlift Bone Bridge™ Drill Guide
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