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|    Laura Gentili
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More Less | | Wire transfer, Check | Sample translations submitted: 1| English to Italian: Sample text, English into Italian, Medical Devices | Source text - English
BIOLOX®forte Ceramic inserts
Directions for use
PLEASE NOTE: These instructions for use refer only to the use of BIOLOX®forte INSERTS, which are fitted directly into the metal back of acetabular cups (Ceralock®). The acetabular cup intended for an insert must be approved by its supplier for the BIOLOX®forte insert.
Please also pay special attention to the instructions for the corresponding metallic back into which the BIOLOX®forte insert is to be inserted.
Manufacturer of the ceramic BIOLOX®forte inserts:
CeramTec GmbH, Werk Plochingen, Medical Technology Business Area
Fabrikstraße 23-29, 73207 Plochingen, Phone +49/7153/611-828, Fax +49/7153/611496
Product designation:
BIOLOX®forte insert with Ceralock® * – fixation in metal acetabular cups
General notes
The implantation of hip joint cups may only be performed by trained and experienced operating surgeons who possess relevant knowledge and experience of the use of hip joint replacement. The notes and instructions on the surgery from the prosthesis supplier must be observed.
Responsibility for any negative effects or complications due to the directions for use not being observed, to the false handling of material or because of a wrong indication being diagnosed, is held by the operating surgeon. Prosthesis components which have previously been used may not be reused. CeramTec bears no liability if these points are not observed.
Because an exact fit is required between the insert and the acetabular cup, only factory new parts may be combined.
BIOLOX® forte inserts are only suited for use with BIOLOX®- forte or BIOLOX® delta – ball heads. Coupling with other ball heads with ceramic balls from other manufacturers is not allowed.
Indications and contraindications
For the use of BIOLOX®forte inserts, all indications, contraindications and recommendations are valid, as they are known in total hip joint replacement with other wear couples, and accepted as a generally recognized standard.
The inclination of the cup components should not deviate substantially from a value of 40-45°.
The anteversion of the cup components should not deviate substantially from a value of 10-20°.
Contraindication
For cup positions which are not recommended, BIOLOX®forte Inserts should not be used. For steep implants, that is, for an inclination angle of more than 50°, BIOLOX®forte cup inserts should not be used. (Exceptions could be made for specifically designed systems with elements preventing dislocation, such as asymmetric or tilted inserts.) For cups in retroversion, no ceramic inserts should be used. Otherwise this could lead to increased compressive load on the edge of the cup, and thus to grain break in the ceramic inserts, together with an increase in ceramic abrasion. Tissue reactions, loosening of the prosthesis and in extreme cases, a break in the ceramics can be a consequence of excessive ceramic abrasion.
During the implantation you should ensure there is sufficient joint tension, since dislocation can also lead to the above consequences.
CeramTec AG does not assume any liability if these points are not observed. Please read the instruction leaflet of the prosthesis system which is combined with this insert, for other risks and side-effects.
Characteristics and advantages of the BIOLOX®forte inserts
BIOLOX®forte is highly pure aluminum oxide ceramics in accordance with ISO 6474 and has the following characteristics: bio-inert, bio-compatible, bio-stable, mechanically stable, corrosion-resistant, excellent fatigue-resistant characteristics, high shock resistance and tensile strength, fracture toughness, extremely high hardness. Every BIOLOX®forte - or BIOLOX®delta – ball head which matches in diameter can be combined with the corresponding BIOLOX®forte insert.
Important information for the operating surgeon
1. Sterilization
If the implantation components are re-sterilized, a BIOLOX®forte insert may never be sterilized in the acetabular cup.
Sterilization with a steam autoclave is allowed, with the usual parameters.
After sterilization in the autoclave, the BIOLOX®forte insert must not be cooled down quickly, that is, not quenched, by immersing in water, for example. The BIOLOX®forte inserts must be cooled down slowly, by storing them on a sterile cloth for approx. 20 min.
The sterilization instructions of the prosthesis supplier must also be observed.
2. Avoiding damage
An insert which is damaged in any way must not be used, for example, an insert which has fallen on the floor may no longer be implanted.
Metal cups from which the insert has been removed again should be replaced with new metal cups. Used inserts should not be used again. Any unintended re-use should be avoided at all costs.
3. If the cup or insert is changed, the instructions of the prosthesis company should be observed.
4. Reliable connection of insert/acetabular cup
The insert/acetabular cup connection allows a reliable torsion-free fitting. BIOLOX®forte inserts must fit perfectly together with the metal cup of the acetabular cup. It is essential that the following is observed:
BIOLOX®forte inserts may only be used with the metal acetabular cups authorized by the prosthesis supplier.
5. Fitting the BIOLOX®forte inserts into the acetabular cup
Aim: A perfect fit of the BIOLOX®forte insert.
Before you place the BIOLOX®forte inserts into the cup, make sure that all foreign particles, such as tissue remains, bone or cement particles have been removed.
The ceramic insert should be placed and fitted in accordance with the instructions of the cup system manufacturer. To do this, the instruments of the cup system manufacturer should be used, if they are provided. Clinical experience has shown that an insert can also be placed properly by hand into the acetabular cup.
Before the final fitting of the insert with a plastic impactor, the correct fit of the insert should be tested with the finger.
6. Sterility
BIOLOX®-forte Inserts can be supplied in sterile or non-sterile form – in the latter case, only to the prosthesis company.
Sterile Supply: Sterile BIOLOX®forte inserts were sterilized with 25 kGy. Cup inserts supplied in sterile form should be kept sealed in their original packaging until they are used. Before use, the sterility expiry date on the label should be checked and the protective packaging should be inspected for damage, since this can have an influence on the sterility.
When removing from protective packaging, the rules for asepsis should be observed.
Ceramics sterilized by gamma rays may be changed in color. This has no influence on the strength or any other characteristic of the insert.
During re-sterilization, implants consisting of several components should be taken apart and sterilized separately.
7. Interaction with drugs
There is no knowledge of any interaction with drugs.
8. Warnings
In very isolated cases, the in vivo break of ceramic implant components can occur. To keep this risk as low as possible, all parts have been subjected to an individual part test before delivery.
Causes of failure can be the incorrect fixation of the ceramic components to the metallic cup inserts. The use of prosthesis components not authorized for use with BIOLOX®o products can also lead to the break of the ceramic insert.
Short, sharp strains, such as falls, accidents or excessive load – due to activities not recommended (e.g. certain types of sport), unrealistically high expectations of the possibilities of mobility caused by the prosthesis – can lead to a break, in some cases a long time after such an event.
The range of motion is restricted for unfavorable cup positions, such as in a steep implantation, so that for an inclination angle of more than 50°, no BIOLOX® cup insert should be used. (Exceptions could be made for specifically designed systems with elements preventing dislocation, such as asymmetric tilted inserts.) For cups in retroversion, no ceramic inserts should be used.
9. Patient behavior
It should be pointed out to the patient that the same demands cannot be made of artificial joints as of real ones. Every form of athletic or competitive sport, or sport with pushing or jerking movements in which the artificial joint is involved, is contraindicated. In these cases liability on the part of CeramTec AG is excluded. The patient must be informed about possible postoperative complications.
An increased risk exists in patients with unrealistic expectations of their ability to move, in those with increased body weight, those with weak bone structure, who are physically very active.
Revision: July 2003
| Translation - Italian
Inserti in ceramica BIOLOX®forte
Istruzioni per l'uso
ATTENZIONE: queste istruzioni per l'uso si riferiscono esclusivamente agli INSERTI BIOLOX®forte, che vengono inseriti direttamente nel dorso metallico delle coppe acetabolari (Ceralock®). La coppa acetabolare destinata all'inserto deve essere stata approvata dal fabbricante per l'uso con l'inserto BIOLOX®forte.
Prestare particolare attenzione alle istruzioni relative al dorso metallico nel quale va introdotto l'inserto BIOLOX®forte.
Produttore degli inserti in ceramica BIOLOX®forte:
CeramTec GmbH, Werk Plochingen, Area Commerciale Tecnologie Mediche
Fabrikstraße 23-29, 73207 Plochingen, Germania, Tel. +49/7153/611-828, Fax +49/7153/611496
Designazione del prodotto:
inserto BIOLOX®forte con Ceralock® * – per l'inserimento in coppe acetabolari metalliche
Informazioni generali
L'impianto di coppe nell'articolazione dell'anca deve essere eseguito esclusivamente da chirurghi esperti e opportunamente addestrati, in possesso delle competenze e dell'esperienza necessarie all'applicazione di artoprotesi dell'anca. Attenersi alle note e alle istruzioni relative all'intervento fornite dal fabbricante della protesi.
Il chirurgo che esegue l'intervento è responsabile di eventuali effetti collaterali o complicazioni dovuti alla mancata osservanza delle istruzioni per l'uso, al maneggiamento erroneo dei materiali o a diagnosi non corrette. I componenti della protesi usati in precedenza non possono essere riutilizzati. CeramTec non si assume alcuna responsabilità in caso di mancata ottemperanza di quanto sopra.
Dato che l'inserto deve combaciare perfettamente con la coppa acetabolare, è possibile combinare solo componenti nuovi provenienti dalla fabbrica.
Gli inserti BIOLOX®forte vanno utilizzati esclusivamente con teste di forma sferica BIOLOX®forte o BIOLOX®delta. È vietato l'accoppiamento con teste sferiche in ceramica realizzate da altre case produttrici.
Indicazioni e controindicazioni
Per l'utilizzo degli inserti BIOLOX®forte sono valide tutte le indicazioni, controindicazioni e raccomandazioni in quanto questi inserti sono comunemente utilizzati, insieme ad altri sistemi di accoppiamento, per l'artroprotesi totale dell'anca e accettati come standard generalmente riconosciuto.
L'inclinazione dei componenti della coppa non deve deviare significativamente da un valore di 40-45°.
L'anteversione dei componenti della coppa non deve deviare significativamente da un valore di 10-20°.
Controindicazioni
Non utilizzare gli inserti BIOLOX®forte per posizioni della coppa sconsigliate. Non utilizzare gli inserti BIOLOX®forte per impianti che presentano una forte inclinazione (con un angolo di inclinazione superiore a 50°). (Fanno eccezione i sistemi appositamente progettati con elementi antilussanti quali ad esempio gli inserti asimmetrici o inclinati.) Non utilizzare inserti in ceramica per coppe in retroversione. In caso contrario si potrebbe provocare un aumento del carico compressivo sul bordo della coppa con conseguente frammentazione della grana degli inserti in ceramica, oltre che un aumento dell'abrasione della ceramica. Un'eccessiva abrasione della ceramica può provocare reazioni dei tessuti, allentamenti della protesi e, in casi estremi, rotture del materiale.
Durante l'impianto, assicurarsi che la tensione dell'articolazione sia sufficiente, in quanto anche un'eventuale lussazione può provocare le conseguenze elencate in precedenza.
CeramTec AG non si assume alcuna responsabilità in caso di mancata ottemperanza di quanto sopra. Per informazioni su altri rischi ed effetti collaterali, leggere l'opuscolo informativo relativo al sistema dell'artoprotesi utilizzato con questo inserto.
Caratteristiche e vantaggi degli inserti BIOLOX®forte
Il BIOLOX®forte, costituito da ceramica (ossido di alluminio ad elevato grado di purezza) in conformità alla norma ISO 6474, presenta le seguenti caratteristiche: bionerte, biocompatibile, biostabile, meccanicamente stabile, resistente alla corrosione, estremamente resistente agli sforzi, resistente ai colpi e alla lacerazione, antifratture, elevato grado di compattezza. Ogni testa sferica BIOLOX®forte o BIOLOX®delta avente un diametro compatibile può essere combinata con il corrispondente inserto BIOLOX®forte.
Importanti informazioni per il chirurgo che esegue l'intervento
1. Sterilizzazione
In caso di risterilizzazione dei componenti dell'impianto, l'inserto BIOLOX®forte non deve mai essere sterilizzato nella coppa acetabolare.
È consentita la sterilizzazione a vapore mediante autoclave, con l'impiego di parametri standard.
Dopo la sterilizzazione nell'autoclave, l'inserto BIOLOX®forte non deve essere raffreddato rapidamente, per esempio mediante immersione nell'acqua. Gli inserti BIOLOX®forte vanno raffreddati lentamente; collocarli in un panno sterile per circa 20 min.
Attenersi inoltre alle istruzioni di sterilizzazione fornite dal fabbricante della protesi.
2. Prevenzione di eventuali danni
Gli inserti danneggiati in qualunque forma non devono essere utilizzati; per esempio, in caso di caduta sul pavimento, l'inserto non potrà più essere impiantato.
Le coppe metalliche da cui è stato rimosso l'inserto vanno sostituite con nuove coppe. Gli inserti usati non vanno riutilizzati. Evitare assolutamente la possibilità di un eventuale riutilizzo accidentale.
3. In caso di sostituzione della coppa o dell'inserto, attenersi alle istruzioni fornite dal fabbricante della protesi.
4. Abbinamento affidabile dell'inserto alla coppa acetabolare
L'abbinamento inserto/coppa acetabolare permette un accoppiamento affidabile privo di torsioni. Gli inserti BIOLOX®forte devono combaciare perfettamente con la coppa metallica della coppa acetabolare. È indispensabile attenersi a quanto segue:
gli inserti BIOLOX®forte possono essere utilizzati esclusivamente con coppe acetabolari metalliche approvate dal fornitore della protesi.
5. Inserimento degli inserti BIOLOX®forte nella coppa acetabolare
Scopo: combaciamento perfetto dell'inserto BIOLOX®forte.
Prima di introdurre gli inserti BIOLOX®forte nella coppa, verificare che siano stati rimossi tutti i corpi estranei (frammenti di tessuti, osso e particelle di cemento).
L'inserto di ceramica va inserito e fatto combaciare in conformità alle istruzioni del fabbricante del sistema di coppe. Per eseguire questa operazione, utilizzare gli strumenti forniti dal fabbricante del sistema di coppe (se esistono). L'esperienza clinica ha dimostrato che l'inserto può essere inserito correttamente nella coppa acetabolare anche a mano.
Prima dell'applicazione finale dell'inserto mediante collettore inerziale di plastica, verificare con il dito che l'inserto combaci correttamente.
6. Sterilità
Gli inserti BIOLOX®forte possono essere forniti in forma sterile o non sterile (nel secondo caso, esclusivamente al fabbricante di protesi).
Fornitura sterile: gli inserti BIOLOX®forte sterili sono stati sottoposti a sterilizzazione a 25 kGy. Gli inserti per coppe forniti in forma sterile vanno conservati sigillati nella confezione originale fino al momento del loro utilizzo. Prima dell'uso, controllare la data di scadenza della sterilizzazione riportata sull'etichetta e ispezionare l'involucro protettivo per accertare eventuali danni che possono compromettere la sterilità dell'inserto.
Durante la rimozione dell'involucro protettivo, osservare le norme per l'asepsi.
La sterilizzazione a raggi gamma della ceramica può provocare variazioni di colore. Tale fenomeno non ha alcun effetto sulla resistenza o su altre caratteristiche dell'inserto.
Durante la risterilizzazione, gli impianti costituiti da vari componenti devono essere smontati; i componenti vanno sterilizzati separatamente.
7. Interazione con farmaci
Non è nota alcuna interazione con farmaci.
8. Avvertenze
In rarissimi casi, può verificarsi la rottura in vivo dei componenti degli impianti in ceramica. Per ridurre al minimo tale rischio, tutte le parti vengono sottoposte a test separati prima della spedizione.
Una delle cause di difetti è l'applicazione non corretta dei componenti in ceramica agli inserti della coppa metallica. Anche l'uso di componenti non autorizzati per l'impiego con i prodotti BIOLOX® può provocare rotture dell'inserto in ceramica.
Sforzi rapidi e violenti come quelli dovuti a cadute, incidenti o carichi eccessivi provocati da attività sconsigliate (ad esempio alcuni tipi di sport) e che implicano aspettative eccessive nei confronti delle possibilità di mobilità garantite dalla protesi possono provocare rotture. In alcuni casi, tali rotture si possono verificare anche molto tempo dopo l'evento in questione.
La gamma di movimenti è limitata per posizioni sfavorevoli della coppa, per esempio nel caso di impianti inclinati; pertanto, in presenza di un angolo di inclinazione superiore a 50°, non utilizzare gli inserti per coppe BIOLOX®. (Fanno eccezione i sistemi appositamente progettati con elementi antilussanti quali ad esempio gli inserti asimmetrici o inclinati.) Non utilizzare inserti in ceramica per coppe in retroversione.
9. Comportamento del paziente
Spiegare al paziente che le articolazioni artificiali non sono in grado di sopportare gli stessi sforzi a cui vengono sottoposte quelle naturali. Sono controindicate tutte le forme di attività sportiva atletica o competitiva, nonché gli sport che prevedano spinte o movimenti rapidi che interessano l'arto artificiale. Nei casi di cui sopra, CeramTec AG declina ogni responsabilità. Al paziente devono essere illustrate le possibili complicazioni postoperatorie.
Esiste un aumento del rischio nel caso di pazienti con aspettative non realistiche circa la possibilità di movimento, nei pazienti in sovrappeso e in quelli con struttura ossea fragile.
Revisione: luglio 2003
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More Less | | All Terms, Medicine, Prepress & Printing | | OTHER | | Years of translation experience: 14. Registered at ProZ.com: Dec 1999. Became a member: Apr 2002. | | | N/A | | N/A | | Reproductive Technologies, Medicine and Health | | Adobe Acrobat, FrameMaker, Microsoft Excel, Microsoft Word, Powerpoint, SDL TRADOS, SDLX, Wordfast | | CV/Resume available upon request | | Laura Gentili endorses ProZ.com's Professional Guidelines. | | About me
- 14 years of experience as full-time professional translator specializing in medical, technical, and marketing translations from English into Italian.
- 10 years of experience as copy editor for leading Italian publishing houses.
Fields of expertise:
Assisted Reproduction Technologies
Biotechnology
Cardiology
Gynaecology
Laboratory medicine
Orthopaedics
Pharmacology
Urology
Material translated:
Clinical Trial Protocols
Guidelines
IFU's
Investigator's brochures
Manuals
Marketing Surveys
Medical Reports
Patient information leaflets
Product Brochures
MEDICAL:
Since 1999 I have been translating documentation for GE Healthcare (formerly GE Medical Systems) (approx. 800K words in total), dealing in particular with Nuclear Medicine systems and Clinical Information Systems (CIS).
I regularly translate clinical trial protocols, informed contents, and related documents.
Other subjects: assisted reproduction technology (ART), reproductive immunology, orthopedic devices, automated laboratory systems, cardiac monitors, surgical instruments and spinal devices, fluoroscopy equipment, ultrasound techniques for the detection of osteoporosis, surgical navigation system technologies for knee and spine, thermoregulation systems for surgery, debriding agents, urology devices.
TECHNICAL:
PRINTING:
Since 1995 I have been translating documentation related to printing, prepress workflows, printers, etc. Main customers: Creo, Scitex, Sharp.
LASER BASED ADVANCED MANUFACTURING SYSTEMS:
Laser based advanced manufacturing systems for semiconductor, electronics, and medical markets. Main customer: GSI Lumonics.
COMMUNICATION TEST AND MANAGEMENT SOLUTIONS:
Documentation and user manuals about instruments, systems, services for communication providers. Main customers: Acterna, Psion Teklogix, Fluke Networks.
INDUSTRIAL AND MEDICAL GASES:
Main customer: Air Liquide.
MARKETING:
CUSTOMER SURVEYS:
Customer surveys for the following end clients:
Intel, Philips, Bayer, Wyeth Consumer Healthcare, Citibank, etc.
CORPORATE COMMUNICATION:
Corporate magazines, Code of Ethics, etc.
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