Sunrise Medical 303 Declaration of Conformity, Déclaration deConformité, Konformitätserklärung

Page 8

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Declaration of Conformity

 

 

Declaración de Conformidad

 

 

Déclaration deConformité

Manufacturer:

 

 

Fabricante:

 

 

Fabricant:

 

Sunrise Medical

 

 

 

Sunrise Medical

 

 

 

Sunrise Medical

 

Respiratory Products Division

 

 

 

Respiratory Products Division

 

 

 

Respiratory Products Division

Address:

 

 

Dirección:

 

 

Adresse:

 

100 DeVilbiss Drive

 

 

 

100 DeVilbiss Drive

 

 

 

100 DeVilbiss Drive

 

Somerset, PA 15501 USA

 

 

 

Somerset, PA 15501 USA

 

 

 

Somerset, PA 15501 USA

Product Designation: Oxygen

 

 

Designación del producto:

 

 

Nature du produit:

 

Concentrators

 

 

 

Concentradors de Oxígeno

 

 

 

Concentrateurs d’oxygène

Catalog Number:

 

 

Número de Catálogo:

 

 

Numéro de Catalogue:

 

303IS, 505KS, 505NS

 

 

 

303IS, 505KS, 505NS

 

 

 

303IS, 505KS, 505NS

 

We herewith declare that the

 

 

 

Por medio de la presente

 

 

 

Par la présente, nous déclarons

 

above-mentioned product com-

 

 

 

declaramos que los productos

 

 

 

que le produit cité ci-dessus est

 

plies with the requirements of

 

 

 

arriba mencionados cumplen

 

 

 

conforme à la directive de

 

EC directive 93/42/EEC and the

 

 

 

con los requerimientos de la

 

 

 

Communauté Européenne

 

following (see Specifications

 

 

 

directiva EC de 93/42/EEC y

 

 

 

93/42/EEC et aux normes suiv-

 

Matrix for specific compliance

 

 

 

con lo siguiente (vea en la Tabla

 

 

 

antes (voir le Tableau des Spécifica-

 

by model):

 

 

 

de Especificationes el cumplim-

 

 

 

tions pour des informations sur les

Quality System Standards

 

 

 

iento específico por modelo):

 

 

 

réglementations applicables aux

 

 

Normas aplicadas del sistema

 

 

 

différents modèles):

 

Applied:

 

 

 

 

 

 

ISO9001/EN46001

 

 

 

de calidad:

 

 

Normes de qualité appliquées:

Notified body RWTÜV

 

 

 

IS09001/EN46001

 

 

 

ISO9001/EN46001

 

 

Corporación RWTÜV notificada

 

 

 

 

 

 

 

 

MDD Annex II Applied

 

 

 

 

Notification de l'organisme

 

 

Anexo II MDD aplicodo

 

 

 

RWTÜV

Safety Standards Applied:

 

 

 

 

 

 

 

Normas de seguridad aplicadas:

 

 

Annexe II de MDD appliquée

 

IEC 601-1+A1+A2

 

 

 

 

 

DIN VDE 0750 TEIL 1/12.91

 

 

 

IEC 601-1+A1+A2

 

 

Normes de sécurité appliquées:

 

ISO8359: 1996

 

 

 

DIN VDE 0750 TEIL 1/12.91

 

 

 

IEC 601-1+A1+A2

EMC Compliance To:

 

 

 

ISO8359: 1996

 

 

 

DIN VDE 0750 TEIL 1/12.91

 

 

Acatamiento de EMC a:

 

 

 

ISO8359 : 1996

 

IEC801-2 through 5

 

 

 

 

 

 

CISPR 11/EN55011

 

 

 

IEC 801-2 through 5

 

 

Respect EMC de:

 

IEC 601-1-2

 

 

 

CISPR 11/EN55011

 

 

 

IEC 801-2 through 5

Place: Somerset, PA

 

 

 

IEC 601-1-2

 

 

 

CISPR 11/EN55011

 

 

Lugar: Somerset, PA

 

 

 

IEC 601-1-2

Signature:

 

 

 

 

 

 

 

Firma:

 

 

Lieu: Somerset, PA

 

 

 

 

 

 

 

 

 

 

Name: Carolyn D.Troast

 

 

 

 

 

 

 

 

 

 

Signature:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Title: Director of quality and regu-

 

 

Nombre: Carolyn D.Troast

 

 

 

 

 

 

 

 

 

latory affairs

 

 

Título: Director de calidad y asuntos

 

 

Nom: Carolyn D.Troast

European Contact:

 

 

 

reglamentarios

 

 

Titre: Directeur de la qualité et des

 

Sunrise Medical Ltd.

 

 

Contacto en Europa:

 

 

 

affaires législatives

 

Sunrise Business Park

 

 

 

Sunrise Medical Ltd.

 

 

Personne-ressource en Europe:

 

High Street

 

 

 

 

 

 

 

 

 

Sunrise Business Park

 

 

 

Sunrise Medical Ltd.

 

Wollaston,West Midlands

 

 

 

 

 

 

 

 

 

 

High Street

 

 

 

Sunrise Business Park

 

DY8 4PS

 

 

 

 

 

 

 

 

 

 

Wollaston,West Midlands

 

 

 

High Street

 

ENGLAND

 

 

 

 

 

 

 

 

 

 

DY8 4PS

 

 

 

Wollaston,West Midlands

44-138-444-6688

 

 

 

 

 

 

 

 

 

 

 

ENGLAND

 

 

 

DY8 4PS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

0044

 

 

 

44-138-444-6688

 

 

 

 

ENGLAND

 

 

 

 

 

 

 

 

 

 

 

0044

 

 

 

44-138-444-6688

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

0044

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Konformitätserklärung

Hersteller:

Sunrise Medical

Respiratory Products Division

Adresse:

100 DeVilbiss Drive

Somerset, PA 15501 USA

Produktbezeichnung:

Sauerstoffkonzentratoren

Katalognummer:

303IS, 505KS, 505NS

Hiermit erklären wir, daß das oben genannte Produkt den Bestimmungen der EG-Richtlinie 93/42/EWG und den folgenden Richtlinien entspricht (spezifis- che Konformitätsangaben nach der Modellnummer siehe Spezifikationenmatrix):

Qualitätssystem Gültige Standards:

ISO9001/EN46001

Benaunte Stelle: RWTÜV

MDD Anhang II angewandt

Gültige Sicherheitsstandards:

IEC 601-1+A1+A2

DIN VDE 0750 TEIL 1/12.91 ISO8359: 1996

EMC-Erfüllung:

IEC801-2 bis 5

CISPR 11/EN55011

IEC 601-1-2

Ort: Somerset, PA

Unterschrift:

Name: Carolyn D.Troast

Titel: Leitung Qualitätssicherung

und Vorschriftenerfüllung

Kontakt in Europa:

Sunrise Medical Ltd. Sunrise Business Park High Street Wollaston,West Midlands DY8 4PS

ENGLAND

44-138-444-6688

0044

Dichiarazione di Conformità

Produttore:

Sunrise Medical

Respiratory Products Division

Indirizzo:

100 DeVilbiss Drive Somerset, PA 15501 USA

Designazione del prodotto:

Concentratori di ossigeno

Numero di catalogo:

303IS, 505KS, 505NS

Si dichiara che il prodotto men- zionato Ë conforme ai requisiti stabiliti dalla Direttiva europea CEE93/42 e seguenti (Vedere la tabella delle specifiche Matrix per la conformità per modello):

Standard dei sistemi di qualità applicati:

ISO9001/EN46001

Organismo notificato RWTUV

Applicato allegato II MDD

Standard di sicurezza applicati:

IEC 601-1+A1+A2

DIN VDE 0750 TEIL 1/12.91 ISO8359: 1996

Conformità EMC a:

IEC801- da 2 a 5

CISPR 11/EN55011

IEC 601-1-2

Ubicazione: Somerset, PA

Firma:

Nome: Carolyn D.Troast

Titolo:

Director of quality and regula- tory affairs

Contatto in Europa:

Sunrise Medical Ltd Sunrise Businnes Park High Street Wollaston,West Midlands DY8 4PS

ENGLAND

44-138-444-6688

0044

SP-505 Rev. B

8

Image 8
Contents Guide d’instructions Concentrateur ’oxygène DeVilbiss Table of Contents IndiceTable DES Matières InhaltsverzeichnisSpecifications 501DZOxygen Percentage Sound LevelEspecificaciones Caractéristiques Pour les appareils équipés d’unClasse et type d’équipement Organisme d’approbationTechnische Daten Empfohlener MaximaldurchflußBetriebshöhe Ausrüstungsklasse und TypSpecifiche Declaration of Conformity Déclaration deConformitéKonformitätserklärung Dichiarazione di ConformitàGEFAHR-RAUCHEN Verboten Lesen Sie bitte die gesamteWhy Your Physician Prescribed Supplemental Oxygen How Your DeVilbiss Oxygen Concentrator WorksPor qué su médico le pre- scribió un suplemento de oxígeno Cómo funciona su Concentradors de Oxígeno DeVilbissImportant Parts of Your Concentrator Partes IMPOR- Tantes DE SU ConcentradorPièces Importantes DE Votre Appareil Concentrateur Wichtige Teile Ihres O2 KonzentratorsAccessories AccessoiresAccessori Back ViewSetting UP Your Oxygen CONCEN- Trator Installation DE Votre Appareil Concentrateur D’OXYGÈNEInstallazione DEL Concentratore Before Operating Your Oxygen ConcentratorOxygen Tubing Connection With Humidification Connexion du tube d’oxy- gène à l’humidificateurCollegamento della tubazione di ossigeno con umidificazione Conexión tubo de oxígeno con humidificaciónOperating Your Devilbiss Oxygen Concentrator Devilbiss Oxygen Concentrators with OSD onlyUSO DE SU Concentrador Devilbiss CONCEN- Tradors DE Oxígeno OSD SOLA- MenteÜberprüfen Sie den Reserve Oxygen System Caring for Your Devilbiss Oxygen ConcentratorSistema DE Oxígeno DE Reserva Cuidado DE SU Devilbiss Concentradors DE OxígenoAir Filter and Oxygen Outlet Connector Cannula, Mask, and TubingExterior Cabinet Cánula, Mascarilla y TubosSymptom Possible Cause Remedy Minor TroubleshootingMinor Troubleshooting Chart Síntoma Causa posible Solución Detección Y Solución DE Problemas MenoresTabla DE Detección Y Solución DE Problemas Menores Symptômes Cause Possible Solution Voyants indicateurs visuels Cause Possible SolutionDépannage Mineur Tableau DE Dépannage MineurFehlersuche BEI Kleineren Problemen Diagramm ZUR Fehlersuche BEI Kleineren ProblemenSymptom Mögliche Ursache Abhilfe Zuständigen DeVilbiss Fachhändler verständigenIndividuazione DI Problemi Minori Tabella DI Individuazione DI Problemi MinoriSintomo Possibile causa Rimedio Fornitore della Sunrise MedicalDonnées sur le prestataire de Service Physician InformationOxygen use per day DeVilbiss Oxygen Concentrator Serial Number Check onePage Sunrise Medical SP-505 Rev. B

303, 501, 505 specifications

Sunrise Medical is a renowned name in the realm of mobility solutions, dedicated to enhancing the lives of individuals through innovative assistive technology. Among its prominent offerings are the Sunrise Medical 505, 501, and 303 models, each designed with a unique set of features, technologies, and characteristics tailored for different user needs.

The Sunrise Medical 505 is a lightweight and compact wheelchair designed for those who prioritize mobility and ease of use. One of its main features is the foldable frame, which allows for convenient transportation and storage. The 505 is equipped with a range of customization options, enabling users to select the seat width, depth, and backrest height that best suits their physique. This wheelchair is engineered with advanced maneuverability, thanks to its dual-axle design, which supports a smooth ride over various terrains. The 505's durable materials ensure longevity and resilience against daily wear and tear, while its intuitive joystick control allows users to navigate with precision and ease.

The Sunrise Medical 501 model stands out for its versatility and comfort. Designed with an emphasis on enhanced seating solutions, the 501 offers superior cushioning and support through its contoured seat and backrest. It features adjustable armrests and footrests, allowing users to modify the chair according to their comfort levels. Additionally, this model incorporates advanced technologies such as balancing systems that enhance stability and safety during movement. The 501 is particularly popular among users who require prolonged sitting periods, as it provides the necessary support to prevent pressure sores and ensure overall well-being.

On the other hand, the Sunrise Medical 303 embodies a blend of durability and advanced engineering. This model is often described as heavy-duty due to its reinforced structure that can withstand higher weight capacities while still maintaining stability. The 303 features an ergonomic design that prioritizes user comfort and ease of accessibility. Its innovative wheel design reduces rolling resistance, making it easier to navigate various surfaces. Furthermore, the 303 is equipped with puncture-proof tires, adding an extra layer of protection against flat tires and ensuring that users can depend on their mobility device for everyday use.

In summary, Sunrise Medical’s 505, 501, and 303 models represent a commitment to innovation and quality in wheelchair design. Each model offers distinct features and technologies tailored to meet the diverse needs of users, enhancing mobility, comfort, and independence in their daily lives. By prioritizing user-centered design, Sunrise Medical continues to make significant strides in the field of assistive technology, facilitating improved quality of life for individuals worldwide.