HemoSphere Quick Guide Nov 2019

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English

HemoSphere Advanced Monitor Quick Start Guide Carefully read these instructions for use, which address the warnings, precautions, and residual risks for this medical device. This quick start guide provides brief installation instructions for the HemoSphere advanced monitor. Refer to the HemoSphere advanced monitor operator’s manual, included on the enclosed USB memory stick, or at the website eifu.edwards.com, for detailed monitoring instructions. The electronic version of the operator’s manual is in a portable document format (PDF). Adobe Acrobat Reader is needed for viewing the file (https://get.adobe.com/reader/).

Description The HemoSphere advanced monitor provides Edwards hemodynamic monitoring technologies through modular connections. Refer to the operator’s manual for currently available connections and associated monitored parameters. Edwards, Edwards Lifesciences, the stylized E logo, and HemoSphere are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

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The HemoSphere advanced monitoring platform allows you to see and interact with patient hemodynamic parameters. In conjunction with the compatible sensors and predictive decision support software, the modular HemoSphere platform facilitates proactive clinical decision-making and insight for individualized patient care. Device performance, including functional characteristics, has been verified in a comprehensive series of testing to support the safety and performance of the device for its intended use when used in accordance with the established Instructions For Use.

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Indications for Use See the HemoSphere advanced monitor operator’s manual for details on available modules/cables and their specific indications for use and intended use statements.

Intended Use The HemoSphere advanced monitor is intended to be used in combination with a compatible Edwards hemodynamic monitoring technology module and/or cable and accompanying Edwards accessories and/or disposables.

Warnings Compliance to IEC 60601-1 is only maintained when the HemoSphere advanced monitor is connected as described. Connecting external equipment or configuring the system in a way not described here and in the HemoSphere advanced monitor operator’s manual will not meet this standard. Failure to use the device as instructed may increase the risk of electrical shock to the patient/operator. Do not modify, service or alter the product in any way. Servicing, alteration or modification may affect patient/operator safety and/or product performance. Read the operator’s manual included on the enclosed USB stick or at eifu.edwards.com carefully before attempting to use the HemoSphere advanced monitor. This product contains metallic components. Do NOT use in a Magnetic Resonance (MR) environment.

Precautions Do not use if the packaging or contents are damaged. Damage may include cracks, scratches, dents or any signs that the monitor, modules, cables, cable housing or system accessories may have been compromised during shipping or unpacking. Users and/or patients should report any serious incidents to the manufacturer and the Competent Authority of the Member State in which the user and/or patient is established.

HemoSphere Advanced Monitor Setup Refer to the HemoSphere advanced monitor operator’s manual included on the enclosed USB memory stick or located on the Edwards website (eifu.edwards.com) for comprehensive monitoring procedures, cautions and warnings.

2. Open the battery door on the lower right panel of the HemoSphere advanced monitor ① and insert the battery. 3. Insert desired hemodynamic technology module ② and/or cable ③. Refer to module or cable instructions for proper insertion/ connection procedures. 4. Connect the power cord to the rear panel of the monitor ④ and plug into a hospital grade outlet. Note: After inserting the battery for the first time, the battery must be fully charged and conditioned. Refer to operator’s manual for additional information. 5. Press the power button on the front of the monitor ⑤. Note: Upon initial startup the display language can be selected which affects the time/date format and units of measurement. 6. Follow instructions contained in the HemoSphere advanced monitor operator’s manual for desired hemodynamic technology module or cable monitoring.

MRI Information MR Unsafe Do not use the HemoSphere advanced monitor in an MR environment. The monitor is MR unsafe since the device contains metallic components, which can experience RF-induced heating in the MRI environment.

Operating conditions Temperature: 10 to 32.5 °C Humidity range: 20 to 90% non-condensing Altitude (Atmospheric Pressure): 0 ft/0 m (1013 hPa) to 3048 m/10,000 ft (697 hPa) IP Rating: IPX1

1. Securely position the HemoSphere advanced monitor or mount on a compatible stand.

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Maintenance The HemoSphere advanced monitor is a multi-use device and can be surface cleaned using a cloth dampened with cleaning agents containing 70% isopropyl alcohol, 2% glutaraldehyde, 10% bleach solution, or quaternary ammonium solution. Do not use any other cleaning agents, spray, or pour cleaning solution directly on the monitor.

Storage Temperature: -18 to 45 °C Relative humidity: 90% non-condensing at 45 °C Altitude: 0 to 20,000 feet (6096 m) Note: For long term storage (>3 months), a maximum storage temperature of 35 °C is recommended. Battery capacity starts to degrade with extended exposure above 35 °C.

Technical Assistance For technical assistance, please call Edwards Technical Support at the following telephone numbers: Inside the U.S. and Canada (24 hours):... 800.822.9837 Outside the U.S. and Canada (24 hours):... 949.250.2222 In the UK: . . . 0870 606 2040 - Option 4 In Ireland:... 01 8211012 Option 4 Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. This product is manufactured and sold under one or more of the following US patent(s): US Patent No. 6,371,923; and corresponding foreign patents. Additional patents pending. Prices, specifications and model availability are subject to change without notice. Refer to the symbol legend at the end of this document.

Symbol Legend • Légende des symboles • Zeichenerklärung • Significado de los símbolos

Y X

Y X

English

Français

Deutsch

Español

Catalogue number

Numéro de catalogue

Katalog-Nr.

Número de catálogo

Follow Instructions for use on the website eifu.edwards.com

Respecter le mode d’emploi disponible sur le site Web eifu.edwards.com

Gebrauchsanweisung auf der Website beachten eifu.edwards.com

Siga las instrucciones de uso del sitio web eifu.edwards.com

Serial Number

Numéro de série

Seriennummer

Número de serie

Manufacturer

Fabricant

Hersteller

Fabricante

Date of Manufacture

Date de fabrication

Herstellungsdatum

Fecha de fabricación

Authorized Representative in the European Community

Représentant autorisé dans la Communauté européenne

Autorisierter Vertreter für die Europäische Gemeinschaft

Representante autorizado en la Comunidad Europea

MR Unsafe

Incompatibilité IRM

Nicht MR-sicher

No seguro para RM

Provides protection against vertically falling water to IPX1 standard

Assure une protection contre les chutes verticales de gouttes d’eau conformément à la norme IPX1.

Schutz gegen senkrecht fallendes Tropfwasser gemäß IPX1

Ofrece protección contra agua que caiga de forma vertical según el estándar IPX1.

Provides protection against water splashing in any direction to IPX4 standard

Assure une protection contre les projections d’eau multidirectionnelles conformément à la norme IPX4.

Schutz gegen Spritzwasser aus beliebiger Richtung gemäß IPX4

Ofrece protección contra salpicadura de agua en cualquier dirección según el estándar IPX4.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Avertissement : les lois fédérales des États-Unis limitent la vente de ce dispositif à un médecin ou sur prescription d’un médecin.

Vorsicht: US-Bundesgesetzen zufolge darf dieses Produkt ausschließlich durch einen Arzt oder auf Bestellung eines Arztes verkauft werden.

Aviso: la ley federal de los Estados Unidos restringe la venta de este dispositivo y la limita exclusivamente a médicos o por prescripción facultativa.

Connector has protection against electric shocks and is defibrillator proof (Type CF according to IEC 60601-1)

Protégé contre les chocs électriques et les défibrillateurs (type CF coformément à la norme IEC 60601-1)

Der Anschluss ist gegen elektrische Schläge geschützt und Defibrillatorsicher (Typ CF gemäß IEC 60601-1)

El conector está protegido contra descargas eléctricas y a prueba de desfibrilación (tipo CF de conformidad con IEC 60601-1)

Restriction of Hazardous Substances (RoHS) compliance - China only

Conformité RoHS (Restriction sur l’usage de certaines substances dangereuses) - Chine uniquement

Einhaltung der Richtlinien zur Vermeidung gefährlicher Substanzen (RoHS) – nur China

Conformidad con la restricción de ciertas sustancias peligrosas (RoHS): solo para China

Federal Communications Commission (FCC) compliance - USA only

Conformité FCC (Federal Communications Commission) États-Unis uniquement

Einhaltung der Anforderungen der Conformidad con la Comisión Federal Federal Communications Commission de Comunicaciones (FCC): solo para (FCC) – nur USA EE. UU.

Separate collection for electrical and electronic equipment in accordance with EC Directive 2012/19/EU

Tri sélectif des équipements électriques et électroniques conformément à la directive CE 2012/19/UE

Getrennte Sammlung von Elektround Elektronikgeräten gemäß EU-Richtlinie 2012/19/EU

Recogida por separado de equipos eléctricos y electrónicos según la directiva de la CE 2012/19/UE

Temperature Limitation

Limite de température

Temperaturbegrenzung

Limitación de temperatura

Humidity Limitation

Limite d’humidité

Luftfeuchtebergrenzung

Limitación de humedad

Keep away from sunlight

Protéger de la lumière du soleil

Von Sonnenlicht fernhalten

Mantener alejado de la luz directa del sol

Do not use if package is damaged

Ne pas utliser si l’emballage est endommagé

Nicht verwenden, wenn Packung beschädigt ist

No usar si el empaquetado está dañado

Conformité Européenne (CE Mark) of TÜV SÜD Product Service GmbH (notified body)

Conformité européenne (marquage CE) de TÜV SÜD Product Service GmbH (organisme notifié)

Conformité Européenne (CE-Kennzeichnung) der TÜV SÜD Product Service GmbH (Benannte Stelle)

Conformité Européenne (Marca CE) de TÜV SÜD Product Service GmbH (organismo notificado)

Quantity

Quantité

Menge

Cantidad

55

Edwards Lifesciences Services GmbH Edisonstrasse 6 85716 Unterschleissheim Germany Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614 USA Made in USA

11/19 © Copyright 2019, Edwards Lifesciences LLC All rights reserved. Edwards Lifesciences SA Route de l’Etraz 70 1260 Nyon, Switzerland

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Telephone FAX

949.250.2500 800.424.3278 949.250.2525

WEB IFU 10007045004 A DOC-0133147 A