Medtronic 1922100 Instructions for Use
0123
Medtronic Xomed Inc,
6743 Southpoint Drive North
Jacksonville, FL 32216-0980 USA
904-296-9600
800-874-5797
Disposable XPS®
Irrigated Hydrobrader®
H® XPS® /
H® XPS®
/ XPS® H®
/ H®
XPS®
Bur
www.MedtronicENT.com
68E3427 C 05/07 ©Medtronic 2007
Product Information & Instructions
Informations et instructions concernant le produit /Informazioni sul prodotto ed
istruzioni per l’uso /Produktinformation und Gebrauchsanweisung /Instrucciones
e información sobre el producto
Rx Only
English
DEVICE DE SCRIPTION
e Disposable Hydrobrader® Bur is for use wit h the
StraightShot® or Magnum®
XPS® console. A connec tor is provided to attach the irr igation
tubing a nd provide irrigation to the sur face of the cutt ing tip.
Hooding is also provided on the xed outer cannula to help
reduce the amount of tissue splatter from the surgical site. e
cutting head contains a thin d iamond coating as an abrasive.
Tissue and irrigation are aspirated through t he slots in the
cutting head by attaching a vacuum source to the ha ndpiece.
Each Hydrobrader® bur package contains irrigation tubing and
is individually sterile pack aged. Hydrobrader® burs are ster ile,
disposable, and intended for single-use only.
INTE NDED USE / INDICATION S FOR USE
e Disposable Hydrobrader® bur is intended for general
dermabrasion, scar revision, acne scar revision, and tatto
removal.
CONTRAINDICATIONS
None known.
WARNINGS AND PRECAUTIONS
e StraightShot® or Mag num® handpieces with a •
Hydrobrader® is to be operate d ONLY by a healt h care
professional trained in the use of powered surgical
instruments and dermabrasion .
e dermabr asion surgica l technique may produce splatter •
and debris. Operati ng Room personnel should take
appropriate blood and body uid precautions.
Obstr uction of aspiration slots in cut ting head may result in •
excessive irrigation and debris splatter. Obstructions should
be cleared per the instructions for use.
For proper aspiration, the handpiece should not be operated •
above 4,00 0 RPM.
e cutting head of the Hydrobrader® bur ha s an abrasive •
surface. To prevent potentia l injury, exercise c aution in
keeping the abrasive surface away from hands, ngers, loose
clothing, or other surfaces.
Activate the handpiece ONLY at the operative site.•
Do not insert, or remove the Hydrobrader® bur with the •
handpiec e running. Warning: To prevent potential injury,
always turn the power control switch OFF or disconnec t the
handpiec e cord from the console when insert ing/removing
the Hydrobrader® bur or remov ing suction/irrigation tubing.
Agressive cleaning of the diamond coated surface may •
cause t he diamond fragments to break loose during use. It
is possible for such fragments to be le at the operative site.
e operative site should be irrigated to help ensure removal
of any diamond fragments.
e Hydrobrader® bur and Irr igation Tubing Set are •
provided sterile and are intended for sing le patient use.
handpieces in conjuction with an
INSTRUCTIONS FOR USE:
Hydrobrader® bur Installation
e Hydrobrader® bur, and Irrigation Tubing Set a re
provided sterile, disposable, and intended for single-use
only. Before using, inspect the Hydrobrader® bur. If the
Hydrobrader® bur appears to be damaged or defective, discard
it. Using t he thumb, depress the locking collar on the front of
the handpiece. Inser t the Hydrobrader® bur into the handpiece
with a slight rotating motion until it is fully seated. Rotate the
Hydrobrader® bur to atta in the desired position and release the
locki ng collar. Pull on the Hydrobrader® bur to ensure secure
engagement in the handpiece. If the Hydrobrader® bur is not
securely seated, pu ll back the locking colla r, reseat it a nd release
the locking collar.
Tub ing Att achme nt
Adjust the clamp on the irrigation tubing to the OFF position
and insert the I.V. spike into the bag of irrigation. If using t he
XPS® Irrigator, load the irrigation t ubing per the instructions
in the X PS® Irrigator User’s Guide. Attach the free end of t he
tubing to the irrigat ion connector on the Hydrobrader® bur
2
until the tubing is se cured. Attach standard suc tion tubing (not
provided) securely to the suction port on t he handpiece.
OPERATION
e roller clamp on the irr igation tubing s hould be in the OPEN
position when the surgeon i s ready to proceed w ith handpiece
operation. e i rrigation ows s imultaneou sly with the
activ ation of the handpiece when used w ith the XPS® I rrigator.
To c ha nge th e ow of i rrigation, adjust the heig ht of the irrigation
supply or cha nge the sett ing on the XPS® Irrigator. Ope rate
handpiec e only in forward or reverse direc tions as inst ructed
in the X PS® User’s Guide. For proper aspiration, the handpiece
should not b e operated above 4, 000 RPM.
Clearing Obstruction
Excessive irrigat ion uid at t he surgical site may indicate
obstr uction of the aspi ration slots in t he cutting head. Clear
any obst ructions by usi ng a bur brush or sma ll diameter
stylette.
LEAKING IRRIGATION
If the Hydrobrader® bur is being used with the XPS ® Irrigator,
check the XPS® Irrigator User’s Guide for proper operation
settings and installation of the irrigation tubing. Check the
attachment of the irr igation tubing to t he irrigation connector
on the Hydrobrader® bur. Check Hydrobrader® bur insertion
in the handpiece by pulling back the locking col lar, reseating
the Hydrobrader® bur and release locking collar. Verify suction
supply is work ing properly and inspect the suction tubing
connections on the handpiece and the suction cannister.
CONCLUSION
Upon conclusion of the handpiece operation, close OFF
the roller clamp on the irrigation tubing to stop the ow
of irrigation. Remove the Hydrobrader® bur by depressing
the locking colla r of the handpiece a nd pulling it out of the
handpiece. Discard t he Hydrobrader® bur a nd irrigation t ubing
per standard hospital policy and procedures.
STERILITY
e Dispos able XPS® Irr igated Hydrobrader® bur / Irrigation
Tubing Set are prov ided STERIL E and intended for single
patient use only.
DO NOT RE STERILI ZE OR REUSE THIS PRODUC T.
Medtronic Xomed assumes no l iability for products that have
been resteriliz ed by health ca re facilitie s.
CUSTOMER SERVICE INFORMATION
For fur ther informat ion regarding the use of this product or to
report a ny problems, please contact Medtron ic Xomed using
the appropriate informat ion provided on the blue a nd white
contact information card packaged with each device; or contac t
your local distributor.
LIMITED WARRANTY
A. is L IMITED WARRANTY provides assurance for the customer who purchases a Medtronic Xomed Product (hereina er
the “Product”) that should the Product fail to function to Medtron ic Xomed’s published speci cations during the term of this
LIMITED WARRAN TY (one year from the d ate of shipment for new Product, 90 days from date of shipment for ref urbished or
used Pro duct), Medtronic Xomed w ill either replace, repair, or issue a credit (adjusted to re ect the age of the Product) for the
Product or any portion t hereof. is LIMITED WARRA NTY is extended only to the buyer purchasing t he Product directly from
Medtronic Xomed or from its a liate or its authorized distributor or representative.
B. To qualif y for this LIM ITED WARRAN TY, the following condit ions 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 b e altered or subjected to misuse, abuse, accident or
improper handling.
(3) Medtronic Xomed mu st be noti ed in w riting wit hin thirty (30) days followi ng discovery of a defect.
(4) e P roduct must be returned to Medtron ic Xomed within thirty (30) days of Medtronic Xomed receiving notice as provided for
in (3) above.
(5) Upon exami nation of the Product by Medtronic Xomed, Medtronic Xomed shall have determined t hat: (i) the Product wa s not
repaired or altered by anyone other than Medtronic Xomed or its authorized representative, (ii) the Product wa s not operated under
conditions other tha n normal use, a nd (iii) the prescribed periodic maintenance and services have been performed on the Product.
C. is LIMITED WARR ANTY is li mited to its express terms. THIS LIMITED WARRANT Y IS IN LIEU OF ALL OTHER
WARRANTIES, EXPRESSE D OR IMPLIED WHETHER STATUTORY OR OT HERWISE, INCLUDING ANY IM PLIED
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PU RPOSE. In no event shall Medt ronic Xomed be
liable for a ny consequentia l, incidental, prospective or other similar damage resulting f rom a defect, fai lure, or malfunction of the
Product , whether a claim for such damage is based upon the warrant y, contract, neg ligence or other wise.
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 bene t from statutory warrant y rights under legislation governing the sale of consumer
goods. I f any part or term of this LIMITED WARRANTY is held by any court of competent ju risdiction to be illegal, unenforceable,
or in con ic t with applicable law, the valid ity of the remai ning portion of the LIMITED WARR ANTY sha ll not be a ected, and all
rights and obligations shall be construed and enforced as if this LIMITED WARR ANTY did not contain the particular part or term
held to be invalid.
GARANTIE LIMITÉE
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GAR ANZIA LIM ITATA
http://www.medtronicent-techcomms.com/warranties.html
GARANTIEERKLÄRUNG
http://www.medtronicent-techcomms.com/warranties.html
GARANTÍA LIMITADA
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