HOFFMA N PERMAN ENT VEN TILATION (TY MPANOST OMY) TUBES
TUBES DE VENT ILATION PERM ANENTE HOFFMAN (POUR PARACEN TESE DU TYMPAN)
TUBI DI VENTI LAZIONE PER MANENT I (PER TIMPANOSTOM IA)
HOFFMAN PERMANENTVENTILATIONSTUBEN (PARAZENTESETUBEN)
TUBOS DE VENT ILACIÓN PERMANEN TE (TIMPANOSTOMIA) HOFFM AN
Product Information & Instructions
Informations e t instructions concerna nt le produit / Infor mazioni sul prodotto e d istruzion i per l’uso /
Produktinformation und G ebrauchsanweisung / I nstrucciones e infor mación sobre el producto
Rx Only
2
English
13MM
2.45 MM
4.0 MM
2.00 DIA MM
.75 MM
.75 MM
DEVICE DE SCRIPTION A ND INTEN DED USE
e Medtronic Xomed Homan H /A Coated Per manent Ventilation Tube with Li ner is intended to provide long-term vent ilation or
drai nage of the midd le ear when ins erted under t he tympanic membra ne.
IN DICATIO NS
e surgeon must use medical judgment and consider the patient’s medical history prior to a decision to surgically insert a Homan
ventil ation tube. Pat hologic condit ions for which Hom an ventilation tube s are indicate d include but are not limited to:
Long-ter m or persistent eus tachian tube dysf unction (obstr uction) requir ing a permanent tympanic stoma for normal middle ea r •
funct ion.
Repeated fai lure or rejection of standard my ringotomy-place d tympanostomy tubes.•
CONTRAINDICATIONS
e Medtronic Xomed Homan Pe rmanent Ventilat ion Tubes are contrai ndicated for us e in:
Patients with e ustachian tube dysfunction who respond to conventional t herapy (medications, conventiona l tympanos tomy tubes, •
adenoidectomy, etc.).
Patients who may be refractory to conventional therapy but are anticipated to have a temporary or short-term eustachia n tube •
obstr uction only.
Patients with a ctive infec tions of the midd le ear or exter nal ear canal.•
Extensive ad hesions or granu lomatous dise ase of the middle ear.•
POSSI BLE ADVERSE E FFECTS
e middle ear may d evelop subsequent s econdary infect ions from either water or airborne pathogens. (Care should b e taken to •
avoid water enterin g the ear.)
Persistent perfor ation of the ty mpanum aer t ube removal.•
Granu lomatosis reaction of the tymp anum necessitating tube removal .•
OPERAT IVE PROCEDU RE
(As recommended by Ron ald A. Homan, M.D.)
Proper su rgical proc edures and technique s are the respon sibility of t he medical profe ssional. e fol lowing procedu re is furni shed for
infor mational pur poses only. Each physicia n must evaluat e the appropriaten ess of this proc edure based on his/her ow n medical t raining
and experience and t he needs of the pat ient.
Under appropriate anesthesia, elevate a tympanomeatal ap. e ap should be approximately 25 mm in length posteroinferiorly where 1.
the tube is to be placed. Inspect the middle ear. Excessive mucosal thickening, adhesions and inammation are contraindicated to the
implantation of the Homan vent tube.
Clear the mucosa from the medial surface of the bony annulus at the proposed point of insertion. Create a groove in the bony annulus 2.
using a surgical drill with a 2.0 mm diamond bur. e groove should be just deep enough to accommodate the full diameter of the tube
(approximately 1 mm deep). Angle the groove medially so that the tube will lie deeper medially with its lateral tip angled toward the
center of the ear canal. is allows for better alignment of the liner during insertion and removal.
Drill a well perpendicular to the groove to accommodate the outer titanium ring. is ring adds further stabilization for the titanium 3.
tube when osteointegrated. Use the titanium tube as a guide to determine the location of this perpendicular well. is well should be
drilled with a 0.75 mm or 1.0 mm diamond bur. See Figure 1 for pictorial view of titanium outer tube.
Figure 1.
Place the Homan vent tube with the hydroxylapatite coating on the outer surface of the tube in direct contact with the bone.4.
e uoroplastic liner has been manufactured longer than the length of the titanium tube. is allows for the liner to be trimmed to an 5.
appropriate length for each patient. e liner should be le as long as possible so that it extends into the middle ear past the medial edge
of the titanium tube, but not touching the middle ear mucosa.
Place the liner into the titanium tube. e at edge on the outer lip of the tube is designed to avoid traumatizing the canal skin during 6.
removal and replacement. is at edge should be oriented toward the canal skin. See Figure 2 for view of FLPL Liner.
Replace the tympanomeatal ap over the titanium tube and pack the external canal with absorbable gel foam. 7.
POSTOPE RATIVE CA RE
Remove the gel foam aer seven to ten postoperative days and begin the patient on a topical drop for cleansing.1.
Care should be exercised when inserting or removing the uoroplastic liner so as not to dislodge the titanium tube, especially in the 2.
early postoperative weeks.
e uoroplastic liner does not need routine replacement unless it becomes obstructed. Replacement liners are available by order.3.
Once the ear is healed, no routine care should be necessary. e patient should take precautions to keep water out of the ear. e ear 4.
should be examined regularly, the interval determined by the rate of accumulation of ceruminous debris or as deemed necessary by the
physician.
IMPORTANT NOTE
MAGNET IC RESONANCE I MAGING MRI
e Homa n Permanent Ventilation Tube is manufactured only from nonmag netic tita nium alloy. Wh ile there are no k nown reports
of MRI-re lated adverse eects to p atient due to any Medt ronic Xomed venti lation tubes , caution is advi sed when admi nistering M RI
procedu res. Image ar tifact ca n occur due to the materi al composition of the implanted d evice. Because of the potential for such art ifact,
alter native imaging technique s, such as CT sca nning, shou ld be considered .
STERILITY
e Medtronic Xomed Homan Pe rmanent Ventiliation tube is bei ng delivered as a st erile product a nd is intended for si ngle use only.
3
Français
THIS PRODUCT I S NOT TO BE RESTERIL IZED. Medtronic Xomed does not tak e responsibil ity for products t hat have been reste rilized
by the hospital .
LIMI TED WARRAN TY
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.
CUSTOM ER SERVICE IN FORMATION
For further information regarding the use of this product or to report any problems, please contact Medtronic using the appropriate
information provided on the blue and white contact information card packaged with each device; or contact your local distributor.
DESCR IPTION DU PRODUIT ET U TILISATION PR EVUE
Le tube Homa n de ventilation perma nente revêtu d’hydroxylapatite ave c garniture est un pro duit Medtronic Xom ed spécialement conçu
pour le drain age ou la ventilat ion de longue durée de l’oreil le moyenne lorsqu’ il est inséré sous la membrane du t ympan.
IN DICATIO NS
Le chi rurgien doit faire appel à ses connai ssances méd icales et tenir compte d es antécédents du patient av ant de décider d ’insérer u n tube
de venti lation Homan. Les ét ats pathologiques pou r lesquels ces t ubes sont indiqué s comprennent, ent re autres :
le dysfonctionnement (obstruct ion) persistant ou prolongé de la trompe d’Eustache requérant un stomate du tympan permanent •
pour un fonction nement normal de l ’oreille moyenne .
l’é chec ou le rejet répétés de tubes de pa racentèse du ty mpan stand ard placés par my ringotomie.•
CONTR E-INDICATIONS•
Les tubes de vent ilation perm anente Homan de Medtron ic Xomed sont contre-i ndiqués dans les cas suivants :•
chez les patients présenta nt un dysfonctionnement de la trompe d’Eu stache et réag issant à la thérapie cla ssique (médicaments, •
tubes de paracentèse du tympan sta ndard, adénoïdectom ie, etc.) ;
chez les patients qui peuvent être réfractaires à la thérapie classique mais dont l’obstruction de la trompe d’Eustache est •
diag nostiquée comme étant s eulement tempora ire ou de courte durée ;
chez les patients sourant d ’infect ions évolutives de l ’oreil le moyenne ou du conduit aud itif exter ne ;•
en cas d ’adhérences imp ortantes ou de g ranulomatose de l’oreil le moyenne.•
EFFET S INDESIR ABLES POSS IBLES
L’oreil le moyenne peut subir d ’autres infections seconda ires provenant d ’agents pat hogènes dans l ’air ou d ans l’eau. (Il convient •
d’é viter toute pénét ration d’eau da ns l’oreille.)
Perforat ion persista nte du tympan aprè s le retrait du tube.•
Réact ion granulomateuse du t ympan requérant le retrait du tube.•
PROCEDU RE DE MISE EN PLACE
(Recommandée par Rona ld A. Homan, d octeur en médecine)
Il incombe au médecin d’employer de bonnes techniques et procédures chirurgicales. La méthode suivante est fournie uniquement à titre
indic atif. Chaque mé decin doit éva luer sa perti nence en fonction de s on expérience e t de sa formation mé dicale, ai nsi que des besoi ns du
patient .
Sous anesthésie appropriée, soulevez un lambeau tympanoméatique. Il doit mesurer environ 25 mm de long postéro-inférieurement à 1.
l’emplacement prévu pour le tube. Examinez l’oreille moyenne. Tout épaississement excessif des muqueuses, toute adhérence et toute
inammation représentent autant de contre-indications pour l’implantation du tube de ventilation Homan.
Dégagez la muqueuse de la surface médiale de l’anneau tympanal au point prévu pour l’insertion. Pratiquez une fente dans l’anneau 2.
à l’aide d’un foret chirurgical à pointe diamant de 2 mm. Cette fente doit être juste assez profonde (environ 1 mm) pour accueillir le
4
Loading...