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Summary of Contents for EnCor Ultra

Page 1: ...WDEOH IRU XVH LQ WKH SUHVHQFH RI DPPDEOH DQHVWKHWLF 8 After use this product may be a potential biohazard Handle and dispose of in accordance with acceptable medical practice and applicable local stat...

Page 2: ...ver on the stand and adjusting the tray up or down as illustrated in Figure 9 Figure 8 Locking the system casters Figure 9 Adjusting the tray height 2 Connect the ENCOR Breast Biopsy Driver to the rec...

Page 3: ...YHU Disposal of Equipment After following the cleaning recommendations above there are no biohazard risks involved with the disposal of the ENCOR ULTRA Breast Biopsy System or any of the reusable acce...

Page 4: ...GLFDO HTXLSPHQW KDV SDVVHG DOO UHTXLUHG WHVWLQJ IRU HOHFWULF VKRFN UH DQG PHFKDQLFDO KD DUGV LQ DFFRUGDQFH ZLWK 8 1 60601 1 CAN CSA C22 2 No 601 1 ODVVL FDWLRQ Class I Type BF equipment Table 3 Nomina...

Page 5: ...0DQXIDFWXUHU V HFODUDWLRQ PPXQLW ME Equipment and ME Systems 7DEOH XLGDQFH DQG 0DQXIDFWXUHU V HFODUDWLRQ PPXQLW The ENCOR ULTRA UHDVW LRSV 6 VWHP LV LQWHQGHG IRU XVH LQ WKH HOHFWURPDJQHWLF HQYLURQPHQ...

Page 6: ...ts resulting from misuse of this product are not covered by this limited warranty 72 7 7 17 2 33 7 6 0 7 352 8 7 55 17 6 1 8 2 27 5 55 17 6 7 5 35 66 25 03 1 8 1 87 NOT LIMITED TO ANY IMPLIED WARRANTY...

Page 7: ...s utilisation ce produit peut pr senter un risque biologique Manipuler et liminer le produit conform ment aux pratiques m dicales acceptables et aux lois et r glementations locales r gionales et nati...

Page 8: ...KDQW OH OHYLHU GH YHUURXLOODJH sur le support et en ajustant le plateau vers le haut ou vers le bas comme illustr la Figure 9 Figure 8 Blocage des roulettes du syst me Figure 9 R glage de la hauteur d...

Page 9: ...du mat riel Apr s avoir suivi les recommandations de nettoyage ci dessus il n existe aucun risque biologique mettre au rebut le syst me de biopsie mammaire ENCOR ULTRA ou tout autre accessoire UpXWLO...

Page 10: ...HQWDWLRQ DPRYLEOH Conformit lectrique Ce mat riel m dical a pass avec succ s tous les tests requis concernant les risques d lectrocution et d incendie et les dangers m caniques conform ment aux normes...

Page 11: ...niveau de test Conseils et d claration du fabricant Immunit quipements et syst mes lectrom dicaux Tableau 7 Conseils et d claration du fabricant Immunit Le syst me de biopsie mammaire ENCOR ULTRA HVW...

Page 12: ...875 6 5 17 6 48 6 62 17 3 7 6 28 03 7 6 2035 6 6 16 6 0 7 5 7287 5 17 03 7 48 7e 0 5 1 28 e48 7 21 81 62 1 63e 48 5 3 5 3 5 9 6 8 5 1 6 85 7 1 8 81 6 75 7 18 5 63216 6 200 6 1 5 76 28 62 5 6 5e68 7 17...

Page 13: ...GXNW HLQH ELRORJLVFKH HIDKUHQTXHOOH GDUVWHOOHQ Die Handhabung und Entsorgung m ssen nach anerkannten medizinischen Verfahren und JHPl JHOWHQGHQ UWOLFKHQ VWDDWOLFKHQ XQG XQGHVJHVHW HQ XQG 9RUVFKULIWHQ...

Page 14: ...ch unten Bewegen der Ablage gem Abbildung 9 angepasst werden Abbildung 8 Arretieren der Feststellbremsen Abbildung 9 Anpassen der Ablageh he 2 Den ENCOR Brustbiopsieantrieb an den rechteckigen Anschlu...

Page 15: ...GHU DUDQWLH LH RPSRQHQWHQ GHV ENCOR ULTRA UXVWELRSVLHV VWHPV QLFKW DXWRNODYLHUHQ 1LFKW EHU HUKLW HQ Entsorgung Bei Befolgen der obenstehenden Reinigungsempfehlungen sind mit der Entsorgung des ENCOR...

Page 16: ...60 Hz dreiadrig geerdet mit entfernbarem Netzkabel 220 240 VAC 600 VA 50 60 Hz dreiadrig geerdet mit entfernbarem Netzkabel Einhaltung elektrischer Normen 0HGL LQLVFKH XVU VWXQJ LP LQEOLFN DXI 6WURPVF...

Page 17: ...pannung vor Anwendung der Pr fpegel UNOlUXQJ GHV HUVWHOOHUV XQG 5LFKWOLQLHQ XP HWULHE 6W UIHVWLJNHLW 0 HUlWH XQG 0 6 VWHPH 7DEHOOH UNOlUXQJ GHV HUVWHOOHUV XQG 5LFKWOLQLHQ XP HWULHE 6W UIHVWLJNHLW Das...

Page 18: ...Defekte infolge einer unsachgem en Verwendung dieses Produkts werden durch diese eingeschr nkte HZlKUOHLVWXQJ QLFKW DEJHGHFNW 62 7 0 5 0 1 5 7 1 1 6 7 8 b66 56 7 7 6 1 6 5b1 7 352 8 7 5 17 6b07 1 5 1...

Page 19: ...LVFKLR ELRORJLFR Maneggiare e smaltire secondo le pratiche mediche comunemente accettate e le leggi e le normative locali regionali e nazionali applicabili 9 Non utilizzare in presenza di infezione Pr...

Page 20: ...ggio situata sul supporto e regolando il vassoio verso l alto o il basso secondo quanto illustrato nella Figura 9 Figura 8 Bloccaggio delle rotelle del sistema LJXUD 5HJROD LRQH GHOO DOWH D GHO YDVVRL...

Page 21: ...RUH DL 6PDOWLPHQWR GHOO DSSDUHFFKLDWXUD Dopo aver seguito le precedenti raccomandazioni sulla pulizia non vi sono rischi biologici coinvolti nello smaltimento del sistema per biopsia della mammella EN...

Page 22: ...pericolo di elettrocuzione di incendio e meccanico in conformit agli standard UL 60601 1 IEC EN 60601 1 CAN CSA C22 2 N 601 1 ODVVL FD LRQH Classe I apparecchiatura di tipo BF Tabella 3 Valori nominal...

Page 23: ...applicazione del livello di test XLGD H GLFKLDUD LRQH GHO SURGXWWRUH PPXQLWj Apparecchiature e sistemi EM 7DEHOOD XLGD H GLFKLDUD LRQH GHO SURGXWWRUH PPXQLWj Il sistema per biopsia della mammella ENCO...

Page 24: ...agato La presente garanzia limitata non copre il normale consumo o logoramento del prodotto derivante dall uso n i difetti derivanti dal cattivo utilizzo del presente prodotto 1 0 685 216 17 7 9 17 48...

Page 25: ...R SDUD VHU HPSOHDGR HQ SUHVHQFLD GH DQHVWpVLFRV LQ DPDEOHV 8 Despu s de su uso este producto puede suponer un peligro biol gico potencial 0DQLS OHOR GHVpFKHOR FRQIRUPH D OD SUiFWLFD PpGLFD DFHSWDGD D...

Page 26: ...el soporte y ajustando la bandeja hacia arriba o hacia abajo como se ilustra en la Figura 9 Figura 8 Bloqueo de las ruedas del sistema Figura 9 Ajuste de la altura de la bandeja 2 Conecte el conducto...

Page 27: ...quipo Si se siguen las recomendaciones anteriores de limpieza no existen riesgos de bioseguridad al eliminar el sistema de biopsia mamaria ENCOR ULTRA o alguno de los accesorios reutilizables al QDO G...

Page 28: ...ado a tierra con cable de alimentaci n extra ble 220 240 VCA 600 VA 50 60 Hz 3 hilos conectado a tierra con cable de alimentaci n extra ble Conformidad el ctrica Este equipo m dico ha pasado todas las...

Page 29: ...riente alterna antes de aplicar el nivel de ensayo XtD HFODUDFLyQ GHO DEULFDQWH QPXQLGDG Equipos ME y Sistemas ME 7DEOD XtD HFODUDFLyQ GHO DEULFDQWH QPXQLGDG Se prev que el Sistema de biopsia mamaria...

Page 30: ...Bard Peripheral Vascular o al reembolso del precio neto pagado El desgaste producido por el uso normal o los defectos derivados del uso indebido de este producto no est n cubiertos por esta garant a...

Page 31: ...3 JHFODVVL FHHUG KXOSPLGGHO HW V VWHHP LV QLHW JHVFKLNW YRRU JHEUXLN LQ aanwezigheid van ontvlambare anesthetica 8 Na gebruik kan dit product een mogelijk biologisch gevaar vormen Deze producten moet...

Page 32: ...tioneel De trayhoogte kan worden aangepast door de vergrendelingshendel op de standaard te ontgrendelen en de tray omhoog of omlaag te verplaatsen zoals getoond in Afbeelding 9 Afbeelding 8 Zwenkwiele...

Page 33: ...apparatuur Wanneer bovenstaande reinigingsaanbevelingen zijn opgevolgd bestaat er geen biologisch gevaar bij het afvoeren van het ENCOR ULTRA borstbiopsiesysteem of een van de herbruikbare accessoires...

Page 34: ...VAC 600 VA 50 60 Hz 3 draads geaard met afneembaar netsnoer Elektrische conformiteit Deze medische apparatuur heeft alle vereiste tests met betrekking tot elektrische schokken brandgevaar en mechanisc...

Page 35: ...spanning v r toepassing van het testniveau Richtlijnen en verklaring van de Fabrikant Immuniteit ME apparatuur en ME systemen Tabel 7 Richtlijnen en verklaring van de Fabrikant Immuniteit Het ENCOR UL...

Page 36: ...t voor slijtage door normaal gebruik of defecten als gevolg van onjuist gebruik van dit product 9225 29 5 77 72 67 1 9 59 1 7 3 5 7 352 8 7 5 17 1 5 5 17 6 3 7 2 03 7 521 5 0 5 1 7 3 5 7 727 5 03 5 5...

Page 37: ...H HOLPLQH GH DFRUGR FRP DV SUiWLFDV PpGLFDV DSURYDGDV H FRP D OHJLVODomR H UHJXODPHQWRV ORFDLV HVWDWDLV H IHGHUDLV DSOLFiYHLV 9 N o utilize na presen a de infe o Precau es 1 Este dispositivo deve apen...

Page 38: ...ja pode ser ajustada libertando a alavanca de bloqueio no suporte e ajustando a bandeja para cima ou para baixo conforme ilustrado na Figura 9 LJXUD ORTXHDU RV URGt LRV GR VLVWHPD Figura 9 Ajustar a a...

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