DNV GL BUSINESS ASSURANCE - ?· DNV GL – BUSINESS ASSURANCE CERTIFICADO DE CONFORMIDADE Certificate…

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<p>DNV GL BUSINESS ASSURANCE </p> <p>CERTIFICADO DE CONFORMIDADE Certificate of Conformity / Certificado de Conformidad </p> <p> Certificado n: 6269-2015-PC-BRA-INMETRO Vlido at: 08/04/2020 Certificate #/Certificado n Validity Term/Fecha de Vencimiento </p> <p>DNV GL Business Assurance Det Norske Veritas Certificadora Ltda. - Av. Alfredo Egydio de Souza Aranha, 100 - Bloco D - 3 Andar 04726-908 - So Paulo, SP, Brasil Rev 0 - 1/5 Tel: + 55 11 3305 33 05 - www.dnvgl.com </p> <p>Produto: Product/Producto </p> <p>Sistema para Cirurgia do Segmento Anterior </p> <p>Tipo / Modelo: Type Model/Tipo Modelo </p> <p>Pulsar 2 </p> <p>Fornecedor Solicitante: Applicant Supplier/Fornecedor Solicitante </p> <p>MEDIPHACOS INDUSTRIAS MEDICAS S/A AV. DEPUTADO CRISTOVAM CHIARADIA, 777 BURITIS BELO HORIZONT MG BRASIL CEP: 30.575-815 </p> <p>Fabricante : Manufacturer/Fabricante </p> <p>OPTIKON 2000 S.P.A VIA DEL CASALE DI SETTEBAGNI, 13 00138 ROMA - ITLIA </p> <p>Normas Tcnicas: Standards/Normas </p> <p>ABNT NBR IEC 60601-1:2010 ABNT NBR IEC 60601-1-2:2010 IEC 60601-2-2:2009 </p> <p>Laboratrio de Ensaio: Testing Laboratory/Laboratorio de Ensayo </p> <p>CMC Centro Misure Compatibilit S.r.l. </p> <p>N do Relatrio de Ensaios e Emisso: Test Report Number and Issue/N del informe de Ensayo y emisin </p> <p>S14207901 Emisso: 02 de Maro de 2015 S14207801 Emisso: 02 de Maro de 2015 S14207501 Emisso: 11 de Dezembro de 2014 </p> <p>Modelo de Certificao: Certification Model/Modelo de Certificacin: </p> <p>Certificado emitido com base no Modelo com Avaliao do SGQ do processo produtivo do produto e a realizao de ensaios (de tipo e de rotina) no produto conforme clusula 5.2 dos Requisitos de Avaliao da Conformidade, anexo Portaria n 350 do INMETRO, publicada em 2010. </p> <p>Portaria: Governmental Regulation/Regulacin Oficial </p> <p>Portaria INMETRO n 350 de 06 de setembro de 2010. </p> <p>Data de Emisso: Date of issue/Fecha de Otorgamiento </p> <p>02 de Setembro de 2015 </p> <p>Adriano Marcon Duarte Gerente Regional </p> <p>Regional Manager </p> <p>Revisor Tcnico do processo </p> <p>Ivan Medeji Auditor Auditor </p> <p> Nota: A falta de cumprimento das condies estabelecidas no contrato pode tornar este certificado invlido. O documento assinado digitalmente e distribudo eletronicamente o original do certificado e vlido. Ref:. www.dnvba.com/br/Certificacao/Pages/assinatura-digital.aspx </p> <p>DNV GL BUSINESS ASSURANCE </p> <p>CERTIFICADO DE CONFORMIDADE Certificate of Conformity / Certificado de Conformidad </p> <p> Certificado n: 6269-2015-PC-BRA-INMETRO Vlido at: 08/04/2020 Certificate #/Certificado n Validity Term/Fecha de Vencimiento </p> <p>DNV GL Business Assurance Det Norske Veritas Certificadora Ltda. - Av. Alfredo Egydio de Souza Aranha, 100 - Bloco D - 3 Andar 04726-908 - So Paulo, SP, Brasil Rev 0 - 2/5 Tel: + 55 11 3305 33 05 - www.dnvgl.com </p> <p>Descrio do Equipamento: Equipment Description/ Descripcin del equipo: </p> <p> PULSAR 2 um aparelho usado em procedimentos cirrgicos no segmento anterior do olho humano. Caractersticas Eltricas: electrical characteristics/caractersticas electricas: </p> <p>Tenso de Alimentao: 100/120V~ 220/240V Potncia Eltrica nominal: 75VA Frequncia de rede: 50/60Hz Classificao: Classe I </p> <p>Grau de proteo contra penetrao: Equipamento: IPX0 Pedal: IPX8 Modo de Operao: Contnuo Equipamento de Categoria AP/APG: No </p> <p>Manual: Manual/Manual: </p> <p>Manual do Usurio Pulsar 2 Cod. 111004EN 2015-02-18 Rev. L </p> <p>Software Embarcado &amp; Acompanhado: Embedded &amp; Accompanied Software/Software Integradas &amp; Acompaado </p> <p> Internal Firmware Version 4.0.8 Acessrios e partes ensaiados em conjunto com o produto: Accessories and parts tested together with the product/ Accesorios y partes ensayados junto con el producto: </p> <p> Vit Module Double Linear Footswitch Phaco Handpiece SLIM 4 20G Phaco Tip, 15o Silicone Sleeve 20G Phaco Tip Wrench Cassette with Colletcion Thank Test Chamber Diathermy Bipolar Cable Diathermy Forceps Vitrectomy Probe 20G 23G Endoill Probe </p> <p>DNV GL BUSINESS ASSURANCE </p> <p>CERTIFICADO DE CONFORMIDADE Certificate of Conformity / Certificado de Conformidad </p> <p> Certificado n: 6269-2015-PC-BRA-INMETRO Vlido at: 08/04/2020 Certificate #/Certificado n Validity Term/Fecha de Vencimiento </p> <p>DNV GL Business Assurance Det Norske Veritas Certificadora Ltda. - Av. Alfredo Egydio de Souza Aranha, 100 - Bloco D - 3 Andar 04726-908 - So Paulo, SP, Brasil Rev 0 - 3/5 Tel: + 55 11 3305 33 05 - www.dnvgl.com </p> <p>Acessrios Accessories / Accesorios </p> <p> Acessrios e partes </p> <p>Ref Descrio Ref Descrio Ref Descrio 5,5 eclipse video overlay system 123010 23G high speed posterior vitrectomy probe 116001 teste chamber 112101 double linear footswitch 123011 23G serrated jaw microforceps 116002 drainage bag 112102 single linear footswitch 123012 23G end grip microforceps 116003 sterelization tray 25x15x3,8cm 112103 dual linear footswitch 123013 25G end gripping microforceps 116005 adpter for single use handpiece 112201 remote control for pulsar 123014 25G serrated jaw microforceps 116006 Capsulorhexis forceps 113101 Phaco Handpiece Slim 4 124001 20G scleral infusion cannula angled 3mm 117001 I/A tubing set with ACS3 for pulsar 113102 Phaco Handpiece 124002 20G scleral infusion cannula angled 4mm 117002 ACS3 device for pulsar 113201 19G Standard phaco tip 5 124003 20G scleral infusion cannula angled 6mm 117004 I/A tubing set for Pulsar autoclavable 113202 19G Standard phaco tip 15 124006 19/20 scleral plug with holder (4 pcs) 121010 VIT MODULE FOR PULSAR 2 113203 19G Standard phaco tip 30 124008 23G Trans scleral angled pic 122006 remote control 113204 19G Standard phaco tip45 124009 23G Trans scleral angled pic, long 123001 20G high speed posterior vitrectomy probe 113205 20G standard phaco tip 15 124010 23G Trans scleral angled pic, pointed 123002 anterior vitrectomy probe with silicone seleeve 113206 20G standard phaco tip 30 124011 23G Trans scleral round incision sclerotome 123005 20G microscissors 45 113207 20G standard phaco tip 45 124012 23G Trans scleral infusion cannula 4mm 123006 High speed vitrectomy probe for coaxial illumination 113208 22G Carbon coat + diaphragm phaco tip 5 124013 reusable infusion tube for 23G vitrectomy kit 123007 microscissors 45 for coaxial illumination 113209 22G Carbon coat + diaphragm phaco tip 30 124014 23G angled pic for scleral guides 123008 serrated jaw microforceps for coaxial illumination 113210 22G Carbon coat + diaphragm phaco tip 45 124015 25G angled pic for scleral guides 123009 end gripping microforceps for coaxial illmination </p> <p>113211 22G Carbon coat + diaphragm phaco tip progressive 125101 air injection tube 114216 20G I/A cannula with silicone sleeve straight </p> <p>113212 19G Kawano double claw phaco tip 15 125201 syringes holder for silicone oil injection 114217 20G I/A cannula with silicone sleeve angled 113213 19G Kawano double claw phaco tip 30 125202 tube for silicone oil injection control 114218 21G I/A cannula with silicone sleeve straight 113214 19G Kawano double claw phaco tip 45 128101 20G endoillumination probe 192521 20G scleral infusion cannula /silicone tube/stopcock 113217 pars plana phaco tip 128102 20G illumination for vitrectomy probe/microscissor 192525 19G viscous fluid removal kit single use 113218 19G Pezzola diaphragm phaco tip 128103 20G illuminator for microforceps 192526 5000cst silicone oil injection kit 10ml 113219 20G Carbon coat+diaphragm tip 5 128104 20G illumination probe for pics 192527 1000cst silicone oil injection kit 10ml 113220 20G Carbon coat+diaphragm tip 15 128201 20G tapered spatula for illumination probe 192620 endodiathermy probe 20G single use 113221 20G Carbon coat+diaphragm tip 30 128202 20G bent pic for illumination probe 192623 endodiathermy probe 23G single use 113222 20G Carbon coat+diaphragm angled 128203 20G hooked pic for illumination probe 192625 endodiathermy probe 25G single use 113228 19G biconical phaco tip 15 128204 20G peeling spatula for illumination probe 192801 20g endoillumination probe 113229 20G Bordim high followability phaco tip 128904 Three way adapter (halogen ligth source) 192802 20g wide angle endoillumination probe </p> <p>113230 biconical 20G phaco tip 15 128905 two way adapter (xenon light source) 192803 20g wide angle endoillumination probe multi port for adapter </p> <p>113232 19G Bordim high followability phaco tip 129003 fundus lens for vitrectomy 192804 18G trocar w/endoillumination irrigation multi port for adapter </p> <p>113233 biconical 21G phaco tip 15 129004 periphery lens for vitrectomy 192805 18G trocar w/endoillumination irrigation multi port for adapter </p> <p>113234 20G standard phaco tip 5 129005 bincocave lens for fluid/gas exchange 192806 20g endoillumination probe multi port for adapter 113235 Standard phaco tip 21G 5 129006 charles handpiece 192807 23G standard illumination probe M/port </p> <p>113236 Standard phaco tip 21G 15 129007 tube for endodiathermy probe 192808 25G endoillumination probe multi port adapter single use </p> <p>113237 Standard phaco tip 21G 30 129008 Aspiration handpiece 192809 23G wide angle illumination probe M/port 113301 silicone sleeve for 19G U/S tip size 3.2mm 129009 20G cannula for retinal manipulation 113309 Silicone Sleeve (Green) 1.7-2.1mm 113303 PTFE sleeve for 19G U/S tips incision size 3.2mm 129010 tube for handpiece 114219 21G I/A cannula with silicone sleeve angled </p> <p>113304 PTFE sleeve for 20G U/S tips incision size 2.8mm 129011 23G aspiration cannula 113238 Biconical Phaco Tip (1,8 mm) </p> <p>113306 PTFE sleeve for 19G progressive U/S tips 129014 23G vitrectomy kit trocar 192203 25G trocar kit Single use 113307 silicone sleeve for 21G U/S tip size 2.3mm 129016 forceps for 23G scleral guides plus 115301 diathermy forceps 113308 silicone sleeve for 20G U/S tip size 2.8mm 129017 Pressure plate for conjunctiva 115302 diatermy pencil eraser 113401 phaco tip wrench 129018 sterelization tray 6,5x15,5x2cm 115303 endodiathermy probe 20G 113402 phaco tip wrench 129019 Luer adapter for single use cannula 115305 endodiathermy probe with reflux, 19G 114101 I/A handpiece long barrel 181003 I.V pole extension including blocking screw 192512 air injection tube single use 114102 I/A handpiece short barrel 181004 equipped motorized cart 192513 air injection tube with filter single use 114201 19G I/A cannula with silicone sleeve straight 191001 minimal IOP forced irrgation kit single use 192514 2-way stopcock single use 114203 19G I/A cannula with silicone sleeve angled 191004 kiss kawano irrigation surge suppressor 192516 adapter for simultaneous connection air/minimal IOP 114205 I/A cannula with metal sleeve 191311 Phaco Handpiece single use 5 114401 Seleeve for anterior vitreous cutter 114207 I/A cannula with metal sleeve 191313 Phaco Handpiece single use 30 115101 diathermy bipolar cable 114211 12 o'clock I/A cannula with metal sleeve 191314 Phaco Handpiece single use 45 115103 diathermy handle for subretinal drainage 114212 12 o'clock I/A cannula with metal sleeve 191315 Phaco Handpiece single use diaphrag 115210 3 mm diathermy electrode for subretinal drainage 114216 20G I/A cannula with silicone sleeve straight 191316 Phaco Handpiece single use progressive tip 192302 25G high speed vitrectomy probe single use 114217 20G I/A cannula with silicone sleeve angled 191602 screen &amp; mayo drape single use 192303 23G high speed posterior vitrectomy probe 114218 21G I/A cannula with silicone sleeve straight 191701 I/A tubing set W/O ACS3for pulsar 192403 infusion tube with 3-way stopcock for 23G scleral guide 114219 21G I/A cannula with silicone sleeve angled 191702 I/A tubing set W ACS3for pulsar 192511 air injection filter single use 114301 irigation probe for bimanual technique 191703 Cassete I/A tubing set for Pulsar 114302 Aspiration probe for bimanual technique 191704 Cassete with collection bag for Pulsar 114303 Irrigating nucleos manipulator 192201 25G trocar kit single use 114304 Irrigating chopper 192301 20g vitrectomy probe </p> <p>DNV GL BUSINESS ASSURANCE </p> <p>CERTIFICADO DE CONFORMIDADE Certificate of Conformity / Certificado de Conformidad </p> <p> Certificado n: 6269-2015-PC-BRA-INMETRO Vlido at: 08/04/2020 Certificate #/Certificado n Validity Term/Fecha de Vencimiento </p> <p>DNV GL Business Assurance Det Norske Veritas Certificadora Ltda. - Av. Alfredo Egydio de Souza Aranha, 100 - Bloco D - 3 Andar 04726-908 - So Paulo, SP, Brasil Rev 0 - 4/5 Tel: + 55 11 3305 33 05 - www.dnvgl.com </p> <p>Data Auditoria de Certificao Inicial: Date Initial Certification Audit/Fecha inicial de Auditora de Certificacin: </p> <p> 07 de Julho de 2014 Data do aceite da proposta: Date of acceptance of the proposal / Fecha de aceptacin de la propuesta: 08 de Junho de 2014 Observaes: Observations/Observaciones </p> <p> 1. A validade deste Certificado de Conformidade est atrelada realizao das avaliaes de manuteno e </p> <p>tratamento de possveis no conformidades de acordo com as orientaes da DNV GL previstas no RAC da Portaria INMETRO 350 de 06 de setembro de 2010. Para verificao da condio atualizada de regularidade deste Certificado de Conformidade deve ser consultado o banco de dados de produtos e servios certificados do Inmetro. The validity of this Certificate is linked to carrying out assessments maintenance and treatment of possible non-compliance in accordance with the orientations of DNV GL specified in the RAC of Portaria INMETRO 350 of 06 September 2010. To check the updated condition of regularity of this certificate must be obtained from the INMETRO product and service certificate database. La validez de este certificado est vinculada a la realizacin de evaluaciones de mantenimiento y tratamiento de la posible no conformidades de acuerdo con las orientaciones de DNV GL previstos en RAC de la Portaria INMETRO 350 de 06 de septiembre de 2010. Para comprobar el estado actualizado de la regularidad del Certificado debe ser obtenido de la base de datos de productos y servicios INMETRO Certificados. </p> <p> 2. Este Certificado de Conformidade vlido para os produtos de modelo e tipo idntico ao prottipo ensaiado. </p> <p>Qualquer modificao de projeto ou utilizao de componentes e materiais diferentes daqueles descritos na documentao deste processo, sem autorizao prvia da DNV GL, invalidar o certificado. This Certificate is valid for the product model and type identical to the prototype tested. Any design change or use of components and different materials from those described in the documentation of this process, without prior approval of DNV GL, invalidate the certificate./ Este Certificado es vlido para el modelo de producto y tipo idntico al prototipo ensayado. Cualquier cambio de diseo o el uso de los componentes y materiales diferentes de los descritos en la documentacin de este proceso, sin la aprobacin previa de la DNV GL, invalidan el certificado. </p> <p> 3. Devem ser submetidos aos ensaios de rotina 100% das unidades fabricadas de acordo com o Anexo A do RAC da </p> <p>Portaria INMETRO 350 de 06 de setembro de 2010. Shall be subjected to routine tests 100% of the units manufactured in accordance with Annex A of RAC of regulation Portaria INMETRO 350 of September 6, 2010. / Deben ser sometidos a pruebas de rutina 100% de las unidades fabricadas de acuerdo con el anexo A del RAC de la regulacin Portaria INMETRO 350 de 6 de septiembre del 2010. </p> <p> 4. O processo de manuteno da certificao consta da avaliao anual dos requisitos estabelecidos no anexo A, B e </p> <p>C do RAC da Portaria INMETRO 350 de 06 de Setembro de 2010. A qualquer momento, o Inmetro ou a Anvisa pode solicitar a realizao de ensaios de tipo para verificao da manuteno da conformidade de produtos certificados. The certification maintenance process given in the annual assessment of the requirements of Annex A, B and C of RAC from Portaria of INMETRO 350 of September 06, 2010. At any time, Inmetro or Anvisa may request the performing of type tests to check the maintenance of compliance of certified products. / El proceso de mantenimiento de la certificacin dada en la evaluacin anual de los requisitos del anexo A, B y C del RAC de la Portaria INMETRO 350 de 06 de septiembre de 2010. En cualquier momento, INMETRO o Anvisa podr solicitar la realizacin de los ensayos de tipo para comprobar el mantenimiento de la conformidad de los productos certificados </p> <p>DNV GL BUSINESS ASSURANCE </p> <p>CERTIFICADO DE CONFORMIDADE Certificate of Conformity / Certificado de Conformidad </p> <p> Certificado n: 6269-2015-PC-BRA-INMETRO Vlido at: 08/04/2020 Certificate #/Certificado n Validity Term/Fecha de Vencimiento </p> <p>DNV GL Business Assurance Det Norske Veritas Certificadora Ltda. - Av. Alfredo Egydio de Souza Aranha, 100 - Bloco D - 3 Andar 04726-908 - So Paulo, SP, Brasil Rev 0 - 5/5 Tel: + 55 11 3305 33 05 - www.dnvgl.com </p> <p>5. responsabilidade do fornecedor solicitante comunicar a DNV GL qualquer alterao no produto com a conformidade avaliada, bem como submeter anlise e aprovao da DNV GL de qualquer modificao efetuada antes da comercializao do produto modificado. It is the responsibility of the applicant supplier communicate DNV GL any change in the product with the assessed conformity and submit to examination and approval of DNV GL of any modifications made before the commercialization of modified product. / Es responsabilidad del proveedor solicitante comunicar DNV GL cualquier cambio en el producto con la conformidad evaluados y someterse a examen y aprobacin de DNV GL de cualquier modificacin que se realice antes de la venta del producto modificado. </p> <p> 6. O fornecedor solicitante ou o fabricante devem aplicar o Selo de Identificao da Conformidade em todos os </p> <p>equipamentos certificados, conforme critrios estabelecidos no RAC da Portaria INMETRO 350 de 06 de setembro de 2010. The applicant supplier or manufacturer must apply the Conformity Identification Mark in all certified equipment, according to criteria established in the RAC of Portaria INMETRO 350 of September 6, 2010 / El proveedor solicitante o fabricante debe aplicar la Marca de identificacin de Conformidad en todos los equipos certifiados, de acuerdo con los criterios establecidos en el RAC de la Portaria INMETRO 350 de 06 de septiembre 2010 </p> <p> 7. Quando houver a interrupo da fabricao, importao ou comercializao do produto o fornecedor solicitante </p> <p>deve comunicar imediatamente tal fato a DNV GL e ao Inmetro. When stopping the manufacture, importation or sale of the product the applicant supplier must immediately communicate this to the DNV GLand Inmetro. / Cuando se interrumpe la fabricacin, importacin o venta del producto el proveedor solicitante debe comunicar inmediatamente este hecho a DNV GL y INMETRO. </p> <p> Projeto DNV GL n: DNV GL Project n/Proyecto DNV GL n: </p> <p> PRJC-254515-2010-PRC-BRA Histrico: History/historia: </p> <p>Reviso Revision/Revisin </p> <p>Descrio Description/ descripcin </p> <p>Data Date/Fecha </p> <p>0 Certificao inicial Efetivao Initial Certification Effective / Initial Certification - Efectivo 08/04/2015 </p> <p>1 Alterao da Razo social do Solicitante. Alterao do Layout do Certificado 02/09/2015 </p>