Annex to Declaration of Conformity Medical Device Directive 93/42/EEC Product Group: Heart-Lung Machine
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1 Page 1 of 2 DMS-No./Version Valid from / Valid until See signature / Annex to Declaration of Conformity Medical Device Directive 93/42/EEC Product Group: Heart-Lung Machine M AQUET This annex is valid only in conjunction with the Declaration of Conformity, dated (DMS-No./Version / V4) of Manufacturer: Cardiopulmonary AG Address: Kehler Str Rastatt Germany Product name: ROTAFLOW Centrifugal Pump System Consisting of: - ROTAFLOW Console - ROTAFLOW Drive Unit ROTAFLOW Emergency Drive Product(s) covered: Class lib - according to Annex IX of Medical Device Directive 93/42/EEC: ROTAFLOW Console Chinese (220 V / 50 Hz) Czech (230 V / 50 Hz) Danish (230 V / 50 Hz) Dutch (230 V / 50 Hz) English (230 V / 50 Hz) English / Australia (240 V / 50 Hz) English / North America (110 V / 60 Hz) English /U K (240 V / 50 Hz) English/US (115 V / 60 Hz) Finnish (230 V / 50 Hz) French (230 V / 50 Hz) German (230 V / 50 Hz) Italian (230 V / 50 Hz) Japanese (100 V / Hz) Norwegian (230 V / 50 Hz) Portuguese (230 V / 50 Hz) Portuguese / Brazilian (220 V / 60 Hz) Spanish (230 V / 50 Hz) Spanish / Latin Amer. (115 V / 60 Hz) Swedish (230 V / 50 Hz) Turkish (230 V / 50 Hz) FB-0049-A1 Version 3
2 Page 2 of 2 Annex to Declaration of Conformity DMS-No./Version * Medical Device Directive 93/42/EEC getinge group sefslztu^ats-'o?^ I Product Group: Heart-Lung Machine ROTAFLOW ICU Console Chinese (220 V / 50 Hz) English (230 V /50 Hz) English / Australia (240 V / 50 Hz) English / North America (110 V / 60 Hz) English/UK (240 V /50 Hz) English/US (115 V / 60 Hz) French (230 V / 50 Hz) German (230 V / 50 Hz) Italian (230 V /50 Hz) Japanese (100 V /50-60 Hz) Portuguese (230 V / 50 Hz) Portuguese / Brazilian (220 V / 60 Hz) Spanish (230 V / 50 Hz) Spanish / Latin Amer. (115 V / 60 Hz) ROTAFLOW Drive Unit Class I - according to Annex IX of Medical Device Directive 93/42/EEC: ROTAFLOW Emergency Drive For and on behalf of Cardiopulmonary AG: Date Name Dr. Rudolf Kober (Vice President R&D Cardiovascular) Signature FB-0049-A1 Version 3
3 Strana 1 z 2 C. DMS/verzia Platí od/ Platí do Pozri dátum podpisu/ Príloha k vyhláseniu o zhode Smernica o zdravotníckych pomôckach 93/42/EHS Produktová skupina: Mimotelové obehy Výrobca: Cardiopulmonary AG Adresa: Kehler Str Rastatt Nemecko Názov produktu Systém s odstredivým čerpadlom ROTAFLOW ktorý tvoria: - konzola ROTAFLOW - hnacia jednotka ROTAFLOW - núdzová pohonná jednotka ROTFLOW Výrobok/výrobky, na ktoré sa vyhlásenie vzťahuje: Trieda Ilb - podľa prílohy IX smernice o zdravotníckych pomôckach 93/42/EHS: Kat. č. Objednacie č. Opis výrobku Konzola ROTAFLOW čínsky (220 V / 50 Hz) český (230 V / 50 Hz) dánsky (230 V / 50 Hz) holandský (230 V/50 Hz) anglický (230 V / 50 Hz) anglický / Austrália (240 V / 50 Hz) anglický/ Severná Amerika (110 V / 60 Hz) anglický /V. Británia (240 V/ 50 Hz) anglický /Spojené štáty (115 V/60 Hz) fínsky (230 V/50 Hz) francúzsky (230 V / 50 Hz) nemecký (230 V / 50 Hz) taliansky (230 V/50 Hz) japonský (100 V/ Hz) nórsky (230 V / 50 Hz) portugalský (230 V / 50 Hz) portugalský / brazílsky (220 V / 60 Hz) španielsky (230 V/50 Hz) španielsky / Latin Amer. (115 V / 60 Hz) švédsky (230 V/50 Hz) turecký (230 V / 50 Hz)
4 Strana 2 z 2 C. DMS/verzia Platí od/ Platí do Pozri dátum podpisu/ Príloha k vyhláseniu o zhode Smernica o zdravotníckych pomôckach 93/42/EHS Produktová skupina: Mimotelové obehy Kat. č. Objednacie č. Opis výrobku Konzola ROTAFLOW ICU čínsky (220 V / 50 Hz) anglický (230 V / 50 Hz) anglický / Austrália (240 V / 50 Hz) anglický/ Severná Amerika (110 V / 60 Hz) anglický /V. Británia (240 V/ 50 Hz) anglický /Spojené štáty (115 V/60 Hz) francúzsky (230 V / 50 Hz) nemecký (230 V / 50 Hz) taliansky (230 V/50 Hz) japonský (100 V/ Hz) nórsky (230 V / 50 Hz) portugalský (230 V / 50 Hz) portugalský / brazílsky (220 V / 60 Hz) španielsky (230 V/50 Hz) Hnacia jednotka ROTAFLOW Trieda I - podľa prílohy IX Smernice o zdravotníckych pomôckach 93/42/EHS Kat. č. Objednacie č. Opis výrobku Núdzová hnacia jednotka ROTAFLOW Za spoločnosť Cardiopulmonary AG: Dátum Meno Podpis: Dr. Rudolf Kober (viceprezident pre nečitateľný podpis výskum a vývoj, Cardiovascular) FB-0049 Verzia 4
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