LiMON Module PC5100 and PC5140 Instructions for Use R 07

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ИНСТРУКЦИИ ЗА УПОТРЕБА KASUTUSJUHISED 사용 지침 NAUDOJIMO INSTRUKCIJA NÁVOD NA POUŽITIE NAVODILA ZA UPORABO UPUTSTVA ZA UPOTREBU HƯỚNG DẪN SỬ DỤNG 使用说明书 使用說明書

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INSTRUCTIONS FOR USE... 5 GEBRAUCHSANWEISUNG... 6 INSTRUCTIONS D´UTILISATION... 7 INSTRUCCIONES DE USO... 8 ISTRUZIONI D’USO... 9 GEBRUIKSAANWIJZING... 10 INSTRUÇÕES DE UTILIZAÇÃO... 11 BRUGERMANUAL... 12 BRUKSANVISNING... 13 BRUKSANVISNING... 14 KÄYTTÖOHJEET... 15 HASZNÁLATI ÚTMUTATÓ... 16 NÁVOD K POUŽITÍ... 17 INSTRUKCJA OBSŁUGI... 18 РУКОВОДСТВО ПО ЭКСПЛУАТАЦИИ... 19 ΟΔΗΓΙΕΣ ΧΡΗΣΗΣ... 20 INSTRUCŢIUNI DE UTILIZARE... 21 UPUTE ZA UPOTREBU... 22 KULLANIM TALİMATLARI... 23 ИНСТРУКЦИИ ЗА УПОТРЕБА... 24 KASUTUSJUHISED... 25 사용 지침... 26 NAUDOJIMO INSTRUKCIJA... 27 NÁVOD NA POUŽITIE... 28 NAVODILA ZA UPORABO... 29 UPUTSTVA ZA UPOTREBU... 30 HƯỚNG DẪN SỬ DỤNG... 31 使用说明书... 32 使用說明書... 33 Symbols... 34 Subject to modification without further notice

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ENGLISH - INSTRUCTIONS FOR USE: LiMON module PC5100 / PC5140

INTENDED USE:

The PULSION LiMON module is intended for use with the PULSION monitors. The LiMON module sends and receives light waves in near-infrared and infrared regions via the LiMON sensors. This allows continuous monitoring of the functional oxygen saturation of arterial haemoglobin (SpO2)* as well as an intermittent determination of the concentration of indocyanine green, a dye approved as a diagnostic drug. Important: Only LiMON sensors approved by PULSION Medical Systems may be used for the measurement. *This parameter will not be available for the PulsioFlex Monitor from software version 5.0.

GENERAL WARNINGS AND PRECAUTIONS:

• Federal (USA) law restricts this device to sale by or on the order of a physician. This device is intended for use in hospitals and hospital-like health care facilities and by trained health care professionals. • For safety of operation and for accuracy of measurements, only sensors approved by PULSION Medical Systems may be used with the LiMON module. • The LiMON module is not intended to be placed on the patient’s skin. • Explosion hazard when used in the presence of flammable anaesthetics.

CLEANING PROCEDURE:

• The surface of the LiMON module is cleanable and disinfectable. • Clean with a lint-free cloth, moistenend with warm water (40 °C/104 °F maximum) and soap, a diluted non-caustic detergent, tenside, ammonia- or alcohol-based cleaning agent. • Appropriate agents are: water and soaps, dishwasher detergents (Edison Schnellreiniger, Alconox), dilution of ammonia < 3%, window cleaner (ammonia- and alcohol-based), ethanol 70%, isopropanol 70%, Cutasept, Hospisept, Kodan Tinktur forte, Sagrosept, Spitacid, Sterilium flüssig, dilution of formaldehyde (35 to 37%), Cidex, Gigasept, Kohrsolin. • Do not use strong solvents such as acetone or trichloroethylene. • The sensor receptacle is suitable for dry cleaning only!

DISPOSAL: The 2002/96/EEC Directive aims to increase the separate collection, reuse, recovery and recycling of waste from electrical and electronic equipment. This directive applies to all electrical and electronic appliances as well as to medical devices. The LiMON module is subject to this directive and is labelled with the symbol of the crossed-out wheeled bin.

IMPORTANT: The LiMON module must not be opened. Checks which require the LiMON module to be opened must be made by a PULSION technician or a person trained by PULSION.

Technical Data: Equipment Type (applied part)

Type BF, defibrillation-proof

Ingress Protection Classification

IP40

Operating Conditions Temperature Range

10 °C to 40 °C (50 °F to 104 °F)

Relative Humidity

30% - 75% (non-condensing)

Ambient Pressure

700 hPa to 1060 hPa

Transport and Storage Conditions Temperature Range

-20 °C to 60 °C (-4 °F to 140 °F)

Relative Humidity

20% - 90% (non-condensing)

Ambient Pressure

270 hPa to 1060 hPa

Please also refer to the instructions for use of the utilized devices and disposables!

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Gebrauchsanweisung beachten

Gerätetyp BF, geschützt gegen Defibrillatoren

Latex frei

CE Kennzeichnung

Entsorgung von Elektro-Altgeräten

Vereinigung für Wertstoffrecycling

Consult operating instructions

Equipment Type BF, protected against defibrillation

Latex free

CE mark

Electronic Waste disposal

German Recycling System Corporation

Codice lotto

Codice articolo

Italiano

Union allemande de recyclage

Élimination des déchets électroniques

Marque CE

Sans latex

Classe d'appareil BF, protégé des influences causées par les défibrillateurs

Lotnummer

Artikelnummer

Nederlands

Temperatura de almacenamiento

Temperatura di conservazione

Marchio CE

Privo di lattice

Sociedad alemana de sistemas de reciclaje

Duitse organisatie Ente tedesco per il van recyclingsyssistema di riciclaggio teem

Afvoer van elektronisch afval

CE-markering

Zonder latex

Apparecchio di Apparaatklasse BF, tipo BF protetto da beschermd tegen interferenze causate defibrillators da defibrillatore

Eliminación de dese- Smaltimento di rifiuti chos electrónicos elettronici

Distintivo CE

Sin látex

Clase de aparato BF, protegido contra desfibrilador

Raadpleeg de gebruiksaanwijzing

Opslagtemperatuur

Fecha de fabricación Data di fabbricazione Productiedatum

Número de lote

Referencia

Español

Consultez le manuel Consultar las instruc- Consultare le istrud’utilisation ciones de uso zioni d'uso

Température d’entreposage

Lagerungstemperatur

Numéro de lot

Storage temperature

Chargennummer

Lot number

N° d'article

Date de fabrication

Artikelnummer

Article number

Français

Date of manufacture Herstellungsdatum

Deutsch

English

Companhia alemã de sistema de reciclagem

Eliminação de resíduos electrónicos

Marca CE

Não contém látex

Equipamento tipo BF, protegido contra desfibrilação

Consulte as instruções de operação

Temperatura de armazenagem

Data de fabricação

N.º do lote

N.º do artigo

Português

HEAD OFFICE

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PULSION Medical Systems SE Hans-Riedl-Straße 17 85622 Feldkirchen GERMANY Tel.: +49 (0)89 45 99 14-0 Fax: +49 (0)89 45 99 14-18 Email: [email protected] Internet: www.PULSION.com

INTERNATIONAL

US

TR

CN

For local contact: Please visit our website www.maquet.com MAQUET Tibbi Sistemler San. Ve Tic. A.S. Buyukhanli Plaza Kucukbakkalkoy Mah. Defne Sok. No:3 Kat:8 Atasehir/İstanbul/Türkiye

生产企业：PULSION Medical Systems SE 注册地址 : Hans-Riedl-Strasse 17 85622 Feldkirchen, Germany 生产地址 : Hans-Riedl-Strasse 17 85622 Feldkirchen, Germany 电话：+49-(0)89-45 99 14-0 传真：+49-(0)89-45 99 14-18 售后服务：上海景年医疗器械有限公司 地址：上海市外高桥保税区美盛路56号4号楼105室 邮编：200336 电话：021-62090999 传真：021-62705386 医疗器械注册证书编号：国食药监械（进）字2014 第3211994 号 医疗器械产品标准编号：YZB/GER 1509-2014《心输出量测量仪》

For more information about PULSION products, contact your PULSION distribution partner, for online educational or scientific material and references, please visit our website www.PULSION.com or call or email to the indicated office.