EUROSPINE
EUROSPINE HRC Cervical Cage Product Line Instructions for Use
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N8-HRCC-I-T
EUROSPINE
3, Av des DAHLIAS, 94240 L’HAY-LES-ROSES, FRANCE
INSTRUCTIONS FOR USE NOTICE D’INSTRUCTIONS GEBRAUCHSANWEISUNG ISTRUZIONI PER L’USO NOTICIA DE INSTRUCCIONES INSTRUÇÕES DE UTILIZAÇÃO ΦΥΛΛΟ ΟΔΗΓΙΩΝ ΧΡΗΣΗΣ ИНСТРУКЦИЯ ПО ПРИМЕНЕНИЮ
---------For the instruments of interbody HRC Cervical cage Product Line Pour les INSTRUMENTS de la gamme de cage cervicale intersomatique HRC Für die INSTRUMENTE zwischen den Halswirbeln einzusetzenden HRC-Cages Per gli STRUMENTI della gamma di gabbia cervicale intersomatica HRC Para los INSTRUMENTOS de la gama de jaula cervical intersomática HRC Para os INSTRUMENTOS da gama de gaiola cervical intersomática HRC Για τα χειρουργικά εργαλεία θωρακικής μεσοσωματική αυχενικής κοιλότητα HRC για την θεραπεία των παθολογιών της σπονδυλικής στήλης. Для приспособлений из линейки продукции межтелового цервикального кейджа HRC --------The instrument identification is specified on the label of packaging and on the instrument. L’identification de l’instrument est spécifiée sur l’étiquette apposée sur le conditionnement. Die Identifizierung des Instruments wird auf dem Etikett der Verpackung spezifiziert. L’identificazione dello strumento è specificata sull’etichetta apposta sulla confezione. La identificación del instrumento queda especificada sobre la pieza así como sobre la etiqueta puesta sobre el embalaje.
A identificação do implante é especificada na etiqueta aposta na embalagem Η ταυτότητα του εργαλείου αναγράφεται στο σώμα αυτού, όπως και στη συσκευασία του. Идентификатор приспособления указан на этикетке упаковки и на приборе. ----------
en STORAGE AND HANDLING CONDITIONS: (To conform to the norm ISO 8828) • The instruments must be transported in such a way to prevent any damage. • In general, the instruments are delivered in containers. During the sterilisation by autoclave the instruments must be in their specific places. • When they are delivered without containers, the packaging of the instruments must remain intact until the moment of the sterilization. The absence of damage to the packaging must be controlled : in case of a damage to the packaging, the instrument must be considered as damaged and must be returned to the manufacturer or distributor. • Any instrument suspected to be contaminated must be decontaminated or returned to the manufacturer or distributor. • Never use a contaminated instrument (for instance; fallen down during the procedure). • For the containers in consignment, check before any use, the cleaning, the implant and instrument decontamination.
• In case of a bad state or of damage to the instruments or to the container, return them to the manufacturer or distributor without using them. Despite the care taken whilst manufacturing these instruments, traces of corrosion may appear, to avoid this: 1-Do not scratch the instrument. 2-Respect the specification of the detergents used. 3-Dry each instrument completely. CLEANING AND STERILIZATION WARNINGS:
• Do not use steel wool or abrasive cleaners. • Avoid products containing iodine or a high concentration of chlorine. • Only Eurospine instruments of similar metal composition can be deposited together in an ultrasonic cleaner. • Do not stack instruments or place heavy instruments over fragile instrument•Their bactericide, virucide, fongicide and sporicide properties have to be conform to norms, relative to 1 /20 Revision le 26/06/2020
N8-HRCC-I-T
antiseptics and to disinfectants (norm NF T 72-150 to NF T 72231). • Only instruments manufactured by Eurospine can be included in Eurospine trays and containers. • Eurospine contaminated or used instruments cannot be loaded into a box for machine cleaning. • Dirty Eurospine instruments should be treated separately from trays and boxes. Eurospine boxes are an organizing tool for the steam sterilization procedure. • The instruments must be thoroughly cleaned. • Eurospine instruments must undergo final sterilization before use. • The sterilization parameters are only valid for properly cleaned devices. • It is recommended to use cleaning agents with pH between 7 and 9.5. Cleaning products with pH greater than or equal to 11 can only be used in consideration of material compatibility data in accordance with its instructions for use. • Surgical patients as at risk for Creutzfeldt-Jakob disease and related infections should be treated with single-use instruments. After surgery, dispose of instruments used or suspected to have been used in patients with Creutzfeldt-Jakob Disease and / or follow current national guidelines. •Steam sterilization is the recommended sterilization method for Eurospine instruments. •The use of hard water should be avoided. Softened tap water can be used for the initial rinse. The final rinse should be performed with purified water to remove mineral deposits on the instruments.
CLEANING INSTRUCTIONS Point of use care • Throughout the surgical procedure, wipe the blood and / or debris off the devices to prevent them from drying on the surfaces with a disposable lint-free wipe. - Rinse cannulated instruments with sterile water or purified water to prevent drying of dirt and / or debris inside. • Contaminated devices should be separated from noncontaminated devices to prevent contamination of personnel or the environment. •The devices must be covered by a cloth moistened with sterile or purified water to prevent the drying of blood and / or debris. • Immersion in proteolytic enzyme solutions or other precleaning solutions facilitates cleaning, especially for complex instruments with areas that are difficult to access (eg, tubular and cannulated designs, etc.) • These enzymatic solutions as well as enzymatic foam sprays dissolve the proteinaceous material and prevent blood and protein-based materials from drying on the instruments. For best results, instruments should be cleaned within 30 minutes after use or after removal from the solution to minimize the risk of drying before cleaning. CLEANING - METHOD WITH AUTOMATIC / MECHANICAL WASHER Disassemble the instruments in accordance with the disassembly instructions provided by EUROSPINE if applicable. - Rinse soiled instruments with cold softened tap water for a minimum of 5 minutes. - Remove the most important stains with a soft brush or a soft, lint-free cloth. - Manually clean the instruments for a minimum of 5 minutes in a freshly prepared solution of enzymatic cleaner or detergent using a soft brush to remove soil and debris. - Rinse instruments with purified water for a minimum of 3 minutes. Use a syringe, pipette or water jet and a soft brush to rinse the lights and cannulations. If applicable, actuate joints, handles and other moving parts for thorough rinsing in purified water. - Prepare a fresh solution of enzymatic cleaner or detergent. Follow the manufacturer's instructions for the enzymatic cleaner or detergent for the correct parameters for dilution, temperature, water quality and duration of exposure. - Clean Eurospine instruments with ultrasound for a minimum of 15 minutes, using a minimum frequency of 40 KHz.
- Rinse instruments with purified water for at least 3 minutes. Use a syringe, pipette or water jet to flush out lights and cannulations. Use purified water for the final rinse. - Visually inspect the device. Repeat steps 2-7 until all visible soil is removed from the device. Mechanical Washing Procedure: (Pre-wash steps 1-7 must have been performed before this step.) Cycle
Minimum Time (min)
Pre-wash Wash Rinse
5 15 5
Thermal 10 disinfection Dry 40 * See additional information
Minimum Température /purified water (<40°C) 55°C purified water (<40°C) 93°C 110°C
Type of détergent / Detergent * / / /
Drying: If the mechanical washer does not have a drying cycle, or if the device is not treated in a mechanical washer: • Thoroughly dry the inside and outside of each device to prevent corrosion and malfunction. • Use a clean, soft, lint-free, disposable cloth to prevent surface damage. Pay particular attention to threads and areas where liquids may accumulate. • Dry the hollow parts (lights, cannulations) with a jet of medical grade compressed air. Inspection: • Check that the surfaces of the instruments are intact, that their adjustement is correct and that they function normally. Do not use heavily damaged instruments, instruments whose engravings are no longer readable, corroded instruments. • Instruments must be reassembled before sterilization unless otherwise specified, or if the box is not configured for the assembled device: • More detailed instructions on disassembling instruments are sent with each instrument delivery. • Store cleaned and dried devices in the appropriate locations of the Eurospine box. • As a sterile barrier system, use a suitable sterilization field or a reusable rigid container for sterilization, in accordance with ISO 11607. • Protect sharp or sharp instruments from contact with other objects that could damage the surface. Packaging: • To store cleaned and dried implants in the appropriate locations of the Eurospine box or in standard medical grade steam sterilization pouches which can be used to package individual implants. The packaging must be prepared following the AAMI double packaging method or an equivalent method. • As a sterile barrier system, use a suitable sterilization field or a reusable rigid container for sterilization, in accordance with ISO 11607. STERILIZATION
Cycle type
Minimum stérilization/ Exposure time (min)
Prevacuum
18
Minimum stérilization/ Exposure Temperature (°C) 134
Dry time
20 min
Recommendations for sterilization • The packaging of sterilization has to be adapted and validated for the usage and to the mode of sterilization. • Cleaning and sterilization processes have to be appropriate and validated. • Agents of disinfecting have to be used accordingly to prescriptions of manufacturer and to be compatible with materials of the present device (to see hereafter). • Their bactericide, virucide, fongicide and sporicide properties have to be conform to norms, relative to antiseptics and to disinfectants (norm NF T 72-150 to NF T 72-231). • The autoclave manufacturer’s operating and recomended guidlines for maximum sterilization load should be followed 2 /20 Revision le 26/06/2020
N8-HRCC-I-T INSTRUMENT HOLDER PREHENSEUR GREIFER 4 STRUMENTO PORTA IMPIANTO 4 PRENSOR APREENSOR Συλλήπτης ДЕРЖАТЕЛЬ ANTI-RETURN GRIPPER PRÉHENSEUR ANTI-RETOUR ANTI-RETURN GRIPPER PINZA DI NON RITORNO PINZA ANTIRRETORNO GARRA ANTI-RETORNO ΑΝΤΙΟΛΙΣΘΗΤΙΚΉ ΛΑΒΉ НЕВОЗВРАТНЫЙ ЗАХВАТ ROTATOR OF REVISION ROTATEUR DE REVISION ROTATOR DER REVISION ROTATORE DI REVISIONE ROTADOR ROTATOR DE REVISÃO ðåñéóôñïöÝá áíáèåþñçóçò ПЕРЕСМОТРЕННЫЙ РОТАТОР ANTI-RETURN ROTATOR OF REVISION ROTATEUR DE REVISION ANTI-RETOUR ANTI-RETURN REVISION ROTATOR ROTATORE DI REVISIONE ANTIRITORNO ROTADOR DE REVISIÓN ANTI-RETORNO ROTATOR DE REVISÃO ANTI-RETORNO ΡΟΤΑΤΡΟΣ ΑΝΑΤΡΟΠΗΣ ΕΠΙΣΤΡΟΦΗΣ Антивозвратный ротатор ROTATOR S ROTATEUR S ROTATOR S ROTATOR S ROTADOR S ROTADOR S ÐåñôñÝöùí S Вращатель S GUARD 1 GARDE 1 SICHERHEITSSCHUTZ 1 PROTECIONE 1 GUARDIA 1 GUARDA 1 Πρoστασία 1 ПРЕДОХРАНИТЕЛЬ 1 GUARD 1, LARGE GARDE 1, LARGE SICHERHEITSSCHUTZ 1,BREIT PROTECIONE 1,AMPIA GUARDIA 1,AMPLIA GUARDA 1, AMPLA Πρoστασία 1, ευρύ ПРЕДОХРАНИТЕЛЬ 1, БОЛЬШОЙ GUARD 2 GARDE 2 SICHERHEITSSCHUTZ 2 PROTECIONE 2 GUARDIA 2 GUARDA 2 Πρoστασία 2 ПРЕДОХРАНИТЕЛЬ 2 GUARD 3 GARDE 3 SICHERHEITSSCHUTZ 3 PROTECIONE 3 GUARDIA 3 GUARDA 3 Πρoστασία 3 ПРЕДОХРАНИТЕЛЬ 3 GUARD 4 GARDE 4 SICHERHEITSSCHUTZ 4 PROTECIONE 4 GUARDIA 4 GUARDA 4 Πρoστασία 4 ПРЕДОХРАНИТЕЛЬ 4 GUARD 4, LARGE GARDE 4, LARGE SICHERHEITSSCHUTZ 4,BREIT PROTECIONE 4,AMPIA GUARDIA 4,AMPLIA GUARDA 4, AMPLA Πρoστασία 4, ευρύ ПРЕДОХРАНИТЕЛЬ 4, БОЛЬШОЙ HRC cervical rod to untighten the holder HRC cervicale tige de desserrage pour préhenseur HRC cervical rstab zum losen des halters HRC cervical barra pallentare il dispresa HRC cervical barra para inapretar prensor Vara cervical HRC para destravar o suporte HRC τραχήλου της μήτρας για να σφίξετε τη θήκη HRC цервикальный стержень для ослабления держателя Filling Base Etau Füllbasis Torno Tornillo Torno Μέγγενη Наполнительная основа
Reference
ATTENTION
Material INSTRUMENT
HRCCIP
HRCCIP-AR
HRCCIR
See Figure 1
HRCCIR-AR
HRCCIRS*
*To use only for cervical cage Sd and Ld
G1
To use with cage Sd size 5, 6, 7, 8 et 9
G1L*
To use with cage Ld size 5, 6, 7, 8 et 9, *Optional
G2*
G3*
*Optional
*Optional
G4
To use only with cage Sd size 4
G4L*
To use only with cage Ld size 4, *Optional
HRCCITS
For all Holders
Stainless Steels/ Acier Inoxydable
Plastic Material (ex acetal, PPSU...) / Matériaux plastiques (ex acetal, PPSU..)
Mono bloc TRIAL CAGE 4S FANTOME mono bloc TAILLE 4S Mono bloc PHANTOM GRÖSSE 4S Blococo mono SPETTRO TAGLIA 4S El monobloc FANTOMA TAMAÑO 4S Mono bloc FANTASMA TAMANHO 4S Mono bloc Φάσμα μεγέθους 4S Моноблок ПРОБНЫЙ КЕЙДЖ 4S Mono bloc TRIAL CAGE 4L, LARGE FANTOME mono bloc TAILLE 4L, LARGE Mono bloc PHANTOM GRÖSSE 4L, BREIT Blococo mono SPETTRO TAGLIA 4L, AMPIA El monobloc FANTOMA TAMAÑO 4L, AMPLIA Mono bloc FANTASMA TAMANHO 4L, AMPLA Mono bloc Φάσμα μεγέθους 4L, ευρύ Моноблок ПРОБНЫЙ КЕЙДЖ 4L, БОЛЬШОЙ Mono bloc TRIAL CAGE 5S FANTOME mono bloc TAILLE 5S Mono bloc PHANTOM GRÖSSE 5S Blococo mono SPETTRO TAGLIA 5S El monobloc FANTOMA TAMAÑO 5S Mono bloc FANTASMA TAMANHO 5S Mono bloc Φάσμα μεγέθους 5S Моноблок ПРОБНЫЙ КЕЙДЖ 5S Mono bloc TRIAL CAGE 5L, LARGE FANTOME mono bloc TAILLE 5L, LARGE Mono bloc PHANTOM GRÖSSE 5L, BREIT Blococo mono SPETTRO TAGLIA 5L, AMPIA El monobloc FANTOMA TAMAÑO 5L, AMPLIA Mono bloc FANTASMA TAMANHO 5L, AMPLA Mono bloc Φάσμα μεγέθους 5L, ευρύ Моноблок ПРОБНЫЙ КЕЙДЖ 5L, БОЛЬШОЙ Mono bloc TRIAL CAGE 6S FANTOME mono bloc TAILLE 6S Mono bloc PHANTOM GRÖSSE 6S Blococo mono SPETTRO TAGLIA 6S El monobloc FANTOMA TAMAÑO 6S Mono bloc FANTASMA TAMANHO 6S Mono bloc Φάσμα μεγέθους 6S Моноблок ПРОБНЫЙ КЕЙДЖ 6S Mono bloc TRIAL CAGE 6L, LARGE FANTOME mono bloc TAILLE 6L, LARGE Mono bloc PHANTOM GRÖSSE 6L, BREIT Blococo mono SPETTRO TAGLIA 6L, AMPIA El monobloc FANTOMA TAMAÑO 6L, AMPLIA Mono bloc FANTASMA TAMANHO 6L, AMPLA Mono bloc Φάσμα μεγέθους 6L, ευρύ Моноблок ПРОБНЫЙ КЕЙДЖ 6L, БОЛЬШОЙ Mono bloc TRIAL CAGE 7S FANTOME mono bloc TAILLE 7S Mono bloc PHANTOM GRÖSSE 7S Blococo mono SPETTRO TAGLIA 7S El monobloc FANTOMA TAMAÑO 7S Mono bloc FANTASMA TAMANHO 7S Mono bloc Φάσμα μεγέθους 7S Моноблок ПРОБНЫЙ КЕЙДЖ 7S Mono bloc TRIAL CAGE 7L, LARGE FANTOME mono bloc TAILLE 7L, LARGE Mono bloc PHANTOM GRÖSSE 7L, BREIT Blococo mono SPETTRO TAGLIA 7L, AMPIA El monobloc FANTOMA TAMAÑO 7L, AMPLIA Mono bloc FANTASMA TAMANHO 7L, AMPLA Mono bloc Φάσμα μεγέθους 7L, ευρύ Моноблок ПРОБНЫЙ КЕЙДЖ 7L, БОЛЬШОЙ Mono blocT RIAL CAGE 8S FANTOME mono bloc TAILLE 8S Mono bloc PHANTOM GRÖSSE 8S Blococo mono SPETTRO TAGLIA 8S El monobloc FANTOMA TAMAÑO 8S Mono bloc FANTASMA TAMANHO 8S Mono bloc Φάσμα μεγέθους 8S Моноблок ИСПЫТУЕМОГО КЕЙДЖА 8S Mono bloc TRIAL CAGE 8L, LARGE FANTOME mono bloc TAILLE 8L, LARGE Mono bloc PHANTOM GRÖSSE 8L, BREIT Blococo mono SPETTRO TAGLIA 8L, AMPIA El monobloc FANTOMA TAMAÑO 8L, AMPLIA Mono bloc FANTASMA TAMANHO 8L, AMPLA Mono bloc Φάσμα μεγέθους 8L, ευρύ Моноблок ПРОБНЫЙ КЕЙДЖ 8L, БОЛЬШОЙ Mono bloc TRIAL CAGE 9S FANTOME mono bloc TAILLE 9S Mono bloc PHANTOM GRÖSSE 9S Blococo mono SPETTRO TAGLIA 9S El monobloc FANTOMA TAMAÑO 9S Mono bloc FANTASMA TAMANHO 9S Mono bloc Φάσμα μεγέθους 9S Моноблок ПРОБНЫЙ КЕЙДЖ 9S Mono bloc TRIAL CAGE 9L, LARGE FANTOME mono bloc TAILLE 9L, LARGE Mono bloc PHANTOM GRÖSSE 9L, BREIT Blococo mono SPETTRO TAGLIA 9L, AMPIA El monobloc FANTOMA TAMAÑO 9L, AMPLIA Mono bloc FANTASMA TAMANHO 9L, AMPLA Mono bloc Φάσμα μεγέθους 9L, ευρύ Моноблок ПРОБНЫЙ КЕЙДЖ 9L, БОЛЬШОЙ
*OPTIONAL SOC
/
Reference
ATTENTI ON
HRCCIFS4
For cages size 4Sd
HRCCIFL4*
For cages size 4 Large *Optiona l
HRCCIFS5
For cages size 5Sd
HRCCIFL5*
For cages size 5 Large *Optiona l
HRCCIFS6
For cages size 6Sd
HRCCIFL6*
For cages size 6 Large *Optiona l
HRCCIFS7
For cages size 7Sd
HRCCIFL7*
For cages size 7 Large *Optiona l
HRCCIFS8
For cages size 8Sd
HRCCIFL8*
For cages size 8Large *Optiona l
HRCCIFS9
For cages size 9Sd
HRCCIFL9*
For cages size 9 Large *Optiona l
20 /20 Revision le 26/06/2020
Material
Stainless Steels/ Acier Inoxydable