Medtronic 62106 Instructions for Use
Durepair® Dura Regeneration Matrix
Instructio ns for Use
Cautio n: U. S. federa l law restr icts
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Package Contents
Use by
Caution
Reference Number
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Lot Number
Manufacturer
Storage temperatures
Do Not Reu se
this dev ice to sale by o r on the order
of a physician.
Sterilization: Ethylene-Oxide Gas
Consult I nstruc tions for U se.
Do Not Res terilize
Sterilize
Durepair® is a registered trademark of TEI Biosciences Inc.
Durepair® Dura Regeneration Matrix
Description
Durepa ir® Dura Reg eneration Ma trix is a collag en implant for t he repair of de fects in th e dura mater. Dure pair is suppli ed sterile, in a
double -peel pack age, and is inten ded for single (one-time) use-only. Du repair is avail able in a varie ty of sizes inte nded to be cut by
the surg eon to the desir ed shape.
Indications
Durepair is indicated as a dura substitute for the repair of the dura mater.
Safety
Durepa ir is manufac tured fro m bovine skin, on e of the pures t sources of col lagen that is com mercially ava ilable. The sou rce material is
solely d erived from c attle obt ained in compl iance with Unit ed States and Eu ropean regul atory requ irements.
Instructions for Use
• Inspec t packagin g and reject p roduct if pr eviously dam aged or opene d.
• If Temperat ure Indicato r Dot is presen t, DO NOT USE if Dot is b lack.
• Peel open t he outer pack age and asept ically delive r the inner, ster ile package to t he sterile e ld.
• Rinse su rgical glove s, if necessa ry, to remove any glo ve powder prio r to touching pr oduct.
• Remove pr oduct fro m package usin g sterile, atr aumatic forc eps or a gloved han d.
• Cut dry D urepair to the s ize and shape ne eded to cover the d ura defec t.
• Soak Dur epair in room te mperature s terile 0.9% sa line until hydr ated (typic ally less than on e minute). Hydrat ion is indicat ed
by a color ch ange from whi te (dry) to grey (wet). To fac ilitate wet ting, press ure can be appl ied with glove d ngers acr oss
surf ace of the device u ntil Durepa ir has a unifor m grey, wet appear ance.
• Keep Dure pair immers ed in sterile s aline until r eady for use.
• Durepa ir may be implant ed with eithe r side against t he brain to cover t he defect , and can be sutu red in place usin g 2 to 3
millime ter bites in the g raft and hos t tissue.
• Alterna tively, Durepa ir can be used a s an onlay graf t by trimming Du repair to a size p ermittin g a minimum of 1 cm ove rlap
with the r emaining dur a. Stay sutures m ay be used if des ired.
• For bes t results, th e graft shou ld be applied an d xed in place ca refully.
• Discar d any unused pie ces of Durepa ir.
Storage
Store at ro om temperatu re (2°-30° C; 35°-86° F ). Keep away from he at sources.
How Supplied
Durepa ir is supplied s terile, in a dou ble-peel p ackage, and is in tended for single-use (one-time) only. Durepair is ava ilable in
multip le sizes. So lon g as the packag e has not been dama ged or opene d, the contents a re guarantee d sterile and n onpyrogeni c. If
Temperatu re Indicator D ot is present , DO NOT USE if Dot is bl ack. Packag es for each of th e components s hould be inta ct upon rece ipt.
The encl osed produc t is designe d for single pat ient use only. Do no t re-use, re -process, o r re-steri lize this produ ct. Re-us e,
re-pr ocessing or re -sterili zation may comp romise the s tructura l integrit y of the device an d/or create a ris k of contaminat ion of
the devi ce, which could r esult in patie nt injury, illn ess, or death. D o not use if pack age has been pr eviously ope ned or damaged .
Medtro nic Neurosur gery is not re sponsible f or the perfo rmance of any pr oduct that ha s been reste rilized.
Patient Education
It is the phy sician’s respo nsibility to e ducate the pa tients and/or t heir repres entative(s) reg arding surgi cal procedu res involvin g
dura rep air. This should in clude a desc ription of ass ociated war nings, prec autions, com plications , and an explana tion of potent ial
alternative products and treatments.
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