ELITE 300 Xenon Illuminator Operator Manual Rev M May 2014

TABLE OF CONTENTS

1.

INTRODUCTION

2.

WARNINGS

3.

SPECIFICATIONS

4.

OPERATING ELEMENTS, SYMBOLS AND FUNCTIONS 4.1 FRONT PANEL 4.2 REAR PANEL

5.

INSTALLATION 5.1 SETTING UP LIGHT SOURCE 5.2 CONNECTING LIGHT CABLE

6.

OPERATION 6.1 POWERING UP LIGHT SOURCE 6.2 LIGHT BRIGHTNESS DISPLAY AND CONTROL 6.3 LAMP LIFE HOURS DISPLAY

7.

CLEANING

8.

DISINFECTION 8.1 DISINFECTING CONTROL UNIT

9.

MAINTENANCE, SERVICING & REPAIR, WARRANTY 9.1 LAMP REPLACEMENT 9.2 WARRANTY

10.

END OF PRODUCT LIFE

11.

TROUBLESHOOTING

12.

CHART OF MEDICAL DEVICE SYMBOLS

13.

CHART OF ELECTRICAL SYMBOLS USED

LIT037 CUDA® SURGICAL ELITE 300 (English)

Rev. M Date of Revision:05/14/14 Page 2 of 60

1. INTRODUCTION Congratulations on the purchase of your new Elite 300 Xenon Illuminator! This user-friendly Xenon Illuminator is a high efficiency light source utilizing state-of-the-art illumination technology. It offers a variety of features such as: •

5600º K daylight brightness for perfect color definition

•

Quiet operation

•

Compact and light weight

•

Turret which adapts to various types of light guides

•

Mechanical iris

•

Easy lamp replacement

•

Lamp life display indication

This Operator Manual will help you to install the device and optimally integrate it with other components of your system. It will also instruct you how to operate the Xenon Illuminator and how to keep it clean. It will give you maintenance and service guidelines as well as recommendations for best performance results. INTENDED USE The intended use of this device is to provide light for fiberoptic cables and instruments – providing light for instrumentation via fiberoptic cables for use in surgical fields.

LIT037 CUDA® SURGICAL ELITE 300 (English)

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2. WARNINGS/ CAUTION Caution

Federal law restricts this device to sale by or on the order of a licensed practioner.

Caution To prevent fire or electric shock, do not open or expose the light source unit to rain or moisture. Refer all servicing to qualified personnel only. Caution Not suitable for use in presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide. Caution To prevent any potential electro-magnetic interference, do not use any kind of cellular phone near the light source. Caution This product should be used only with type BF endoscopic instruments which have been certified according to IEC 60601-1 for medical equipment and IEC 60601-2-18 for endoscopic equipment.

This symbol indicates type BF equipment. Caution User must not alter this device in any fashion. Doing so voids all warranties and statements of suitability for any purpose. Caution All devices connecting to the Illuminator must be classified as medical equipment. Additional information processing equipment connected to the Illuminator, a Medical System and the operator must determine that all equipment complies with the appropriate end-product standards (such as IEC 60950 or IEC 60065 and the Standard for Medical System, IEC 60601-1-1). Caution Always set the intensity control to the minimum level and insert the fiberoptic cable into the unit before turning on the power. When light is not required at the surgical site the intensity control should be should be set to the fully dimmed position. If it becomes necessary to remove the fiber optic cable without turning the unit off turn the intensity control to the fully dimmed position. Caution The fiber optic cable must be a NON-CONDUCTIVE CABLE. It should not have conductive shielding or any other conductive connection between the patient and equipment. Such connection will impair safety of the equipment. It must be rinsed free of soaking/disinfectant solution and dried before plugging into the light source receptacle. Ensure the optical surface is clean before engaging into the light source. Caution When using high intensity lightsources at full output, the recommended distance from the headlight module to the patient is not less than 12 inches (30.5 cm). If using less than 12 inches from the patient, the light intensity must be turned down. Caution User is responsible for determining if interruption of light output will create an unacceptable risk. If this determination is made arrangements should be taken to reduce the risk.

LIT037 CUDA® SURGICAL ELITE 300 (English)

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3. SPECIFICATIONS Item

Specification

Lamp type Power

Cermax type 300 watt Xenon 300 Watt

Color temperature

5600º K

Lamp life

650 hours (typical)

Lamp replacement

Cartridge replacement from the side of the unit

Light guide adapter

Turret type to fit your choice of four: Storz, ACMI, Pentax, Wolf, Olympus Mechanical iris control from the front panel

Brightness control Input voltage Power consumption Regulatory Approvals

100-120 V AC, 50/60 Hz 220-240 V AC, 50 Hz 450 watt max

Equipment Class

UL60601, EN 60601-1, EN 60601-1-2, CAN/CSA, C22.2, No 601.1-M90 BF-type

Mode of Operation

Continuous operation

Water Resistant

Not Protected Equipment, IPX0

Operating Environment Temperature Relative Humidity Air Pressure

+10° to +40° C (50° to 104° F) 30 to 85% 700 to 1060 hPa

Storage Environment Temperature Relative Humidity Air Pressure

-20° to +60° C (-4° to 140° F) 0 to 95% 700 to 1060 hPa

Dimensions

355 (14)W x 130 (5)H x 250 (10)D mm

Weight

13.2 lbs./6.0 kg

LIT037 CUDA® SURGICAL ELITE 300 (English)

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4. OPERATING ELEMENTS, SYMBOLS AND FUNCTIONS 4.1 FRONT PANEL

1

1

1

Figure 1. Light Source Front Panel No

Name

Function

1

Turret

Accepts light source end fitting of light guide cable

2

Intensity Control

Mechanically controls the light output

3

Power switch

Turns the light source on and off; illuminates green when turned on.

LIT037 CUDA® SURGICAL ELITE 300 (English)

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4.2

REAR PANEL

Figure 2. Light Source Rear Panel No.

Name

Function

1

Fuses

Over current protection. Type, AGC 5A

2

Hour Meter

Allows tracking of total running time on unit and provides a control on individual lamp hours

3

AC main inlet

Accepts AC Power cord

4

Product label

Product Label containing: Model Number, Serial Number, Electrical Ratings, Manufacturer Name, Regulatory Marks and FDA “Rx Only” Symbol

5

Venting grids

Allows adequate ventilation and cooling of the light source

6

Fan

Fan 12V DC, airflow for cooling of unit

7

Hour meter reset

Resets hour meter to zero hours

button 8

Connector

For potential equalization

LIT037 CUDA® SURGICAL ELITE 300 (English)

Rev. M Date of Revision:05/14/14 Page 7 of 60

5. INSTALLATION

1 2 4 3

5.1 SETTING UP THE LIGHT SOURCE Place the light source on a stable surface (cart, counter, stand, etc.). NOTE

Avoid places where the light source may be splashed with liquid. Absolutely DO NOT use in any environment with explosive or flammable gases. DO NOT block the venting grids of the light source or impede exhaust air flow. Users must ensure that ventilation air temperatures are below the maximum rating for the light source and are not influenced by warm exhaust from other sources.

Make sure the power switch is in OFF position. Connect AC power cord to the power inlet located on the rear panel of the light source. Make sure power cord is completely seated into the power inlet. Use only cords provided with the light source. CAUTION Plug the AC power cord into a wall outlet using the three (3) prong plug supplied with the unit. To prevent electric shock, connect power cords of peripheral equipment through medical isolation transformers. CAUTION NOTE

When using medical isolation transformer, be sure to check the transformer power ratings. Make sure that the power cord is connected to the main power with three prong plug (USA use UL2601-1 rated isolation transformers and/or power strips only).

When used in clinical or residential areas near radio or TV units, this equipment may be subjected to radio interference.To avoid CAUTION adverse electromagnetic effects, DO NOT operate this equipment near RF energy equipment. 5.2 CONNECTING THE LIGHT CABLE Connect the light cable to endoscope and then plug the light cable endfitting into the appropriate port of the turret on the front panel.

LIT037 CUDA® SURGICAL ELITE 300 (English)

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6. OPERATION 6.1 POWERING UP THE LIGHT SOURCE To operate the light source: Attach the instrument or headlamp to the light source. Turn on the power switch. The fan will start. The indicator on power switch will light. 6.2 LIGHT BRIGHTNESS DISPLAY AND CONTROL The light brightness adjustment enables the user to obtain a brighter or darker illumination of the object of observation. Adjust the light intensity by turning the intensity control knob. 6.3 LAMP LIFE HOURS DISPLAY The hour meter shows the total elapsed running time of the unit. Record the hours when replacing the lamp.

7. CLEANING NOTE

Always disconnect the power cord before cleaning.

The light source can be cleaned with any cleaning agents, which are used for external cleaning of electric equipment, according to instructions given by the manufacturer of the cleaning solution. Do not allow excessive moisture or liquids to come in direct contact with the light source. Do not use cleaning agents that are not permitted for use with plastics, i.e., ammonia, acetone, salty acids (HCl), etc. Do not allow cleaning agents or liquids to enter the control unit outlets or vents at side, back or bottom of the unit.

8. DISINFECTION 8.1

DISINFECTING THE LIGHT SOURCE

NOTE

Always disconnect the power cord before cleaning.

Use any disinfectant agents which are commonly applied while disinfecting surfaces of electric medical equipment. Such disinfectant agents usually arrive in the form of sprays or damp cloths. Follow the instructions given by the manufacturer of the disinfectant solution.

LIT037 CUDA® SURGICAL ELITE 300 (English)

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9. MAINTENANCE, SERVICING AND REPAIR, WARRANTY Performance of preventive maintenance is not essential. Regular maintenance can, however, contribute to identifying potential problems before they become serious; thus, enhancing the instrument’s reliability and extending its useful operating life. Maintenance services can be obtained from your local representative or from the manufacturer. Defective items of equipment are to be serviced and repaired exclusively by persons authorized by the manufacturer. All repair work shall employ original manufacturer’s parts only. 9.1 LAMP REPLACEMENT WARNING CERMAX lamps are at high internal pressure when cold and at operating temperature; therefore, CERMAX lamps may unexpectedly rupture resulting in discharge of hot fragments of quartz and/or glass and metal. Only handle lamps with protective covers in place. Do not handle lamps without their protective covers unless government approved safety glasses, facemasks (with neck protector, chest protector and gauntlets) are worn. Always disconnect power cord and turn main switch off before lamp replacement. CAUTION Take utmost care not to hit gas-seal edge of lamp; it may cause gas leaks or lamp failure. CAUTION

Do not touch the lamp and patient simultaneously when changing the lamp. CAUTION Open lamp compartment door and pull out lamp cartridge. Replace lamp cartridge with new unit and log the serial number and hours on the hour meter. Close the lamp compartment door. Re-connect the power cord and turn the light source on according to 6.1. Reset hour meter to zero by depressing hour meter reset button on rear panel.

LIT037 CUDA® SURGICAL ELITE 300 (English)

Rev. M Date of Revision:05/14/14 Page 10 of 60

9.2 LIMITED WARRANTY Your fiberoptic product(s) carry a 3-year warranty from the date of shipment on workmanship and all defects of material, excluding replaceable sweatbands, headband, fiberoptic cable and lamps. Should your product prove to have such defects within three years of the shipment, ST TECHNOLOGIES will repair or replace the product or component part without charge. Should your fiberoptic product(s) need servicing under this warranty, please contact ST TECHNOLOGIES for return authorization documentation. You should carefully pack unit in a sturdy carton and ship it to the factory. Please include a note describing the defects, your name, telephone number and a return address. Warranty does not cover equipment subject to misuse, accidental damage, normal wear and tear or if transferred to a new owner without authorization from ST TECHNOLOGIES. This warranty gives you specific legal rights and you may also have other rights that vary from state to state. POST WARRANTY REPAIRS: You may return your product(s) for repair, shipping prepaid to the factory. Your product will be inspected and an estimate of repair charges will be submitted to you for approval.

10.

•

In the U.S call:

877 814 2237 (toll free)

•

From Jacksonville, FL call:

904 208 2291

END OF PRODUCT LIFE In accordance with the European Waste from Electrical and Electronic Equipment (WEEE) directive, we encourage our customers to recycle this product whenever possible. Disposal of this unit must be performed in accordance with the applicable local environmental regulations. In the US a list of recyclers in your area can be found at: http:/www.eiae.org/. Please contact customer service to issue a return authorization to return product to manufacturer at the end of product life.

LIT037 CUDA® SURGICAL ELITE 300 (English)

Rev. M Date of Revision:05/14/14 Page 11 of 60

11. TROUBLESHOOTING Problem The power indicator (refer to 4.1) is not lit. The power indicator is lit, but Xenon lamp will not ignite.

Solution A. Check that the AC power cord is properly connected. B. Check the fuses. If necessary, replace. A. Check lamp connection. B. Check that the lamp door cover is secured. C. Check hourmeter if lamp hours exceeds the rated lamp life. D. Replace the lamp (refer to 9.1).

12. CHART OF MEDICAL DEVICE SYMBOLS USED Manufacturer Date of manufacture (YYYYMM or YYYY) “Authorized Representative” in the European Community Caution, consult accompanying documents Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner Consult Instructions for Use CE mark

13. CHART OF ELECTRICAL SYMBOLS USED AC Current Equipotentiality Power on

Power off Type BF

Product labeling Product label containing model number, serial number, electrical ratings, manufacturer name, Regulatory marks, and FDA “Rx Only” symbol.

LIT037 CUDA® SURGICAL ELITE 300 (English)

Rev. M Date of Revision:05/14/14 Page 12 of 60

ELITE 300 Illuminateur au xénon Manuel de l’opérateur

ST Technologies 6018 Bowdendale Avenue Jacksonville, FL 32216 USA Customer Service: 904 208 2291 Toll Free 877 814 2237 EC|REP

RMS UK, Ltd. 28 Trinity Road Nailsea, Somerset BS48 4NU United Kingdom TEL: 01275 858891

LIT037 CUDA® SURGICAL ELITE 300 (French)

Rev. M Date de révision:05/14/14 Page 13 of 60

TABLE DES MATIÈRES

1.

INTRODUCTION

2.

AVERTISSEMENTS

3.

CARACTÉRISTIQUES TECHNIQUES

4.

ÉLÉMENTS FONCTIONNELS, SYMBOLES ET FONCTIONS 4.1 PANNEAU AVANT 4.2 PANNEAU ARRIÈRE

5.

INSTALLATION 5.1 MONTAGE DE LA SOURCE LUMINEUSE 5.2 BRANCHEMENT DU CÂBLE DE TRANSFERT DE LA LUMIÈRE

6.

FONCTIONNEMENT 6.1 MISE EN MARCHE DE LA SOURCE LUMINEUSE 6.2 COMMANDE DE L’INTENSITÉ LUMINEUSE 6.3 AFFICHAGE DES HEURES DE SERVICE DE LA LAMPE

7.

NETTOYAGE

8.

DÉSINFECTION 8.1 DÉSINFECTION DE L’UNITÉ DE COMMANDE

9.

ENTRETIEN, MAINTENANCE ET RÉPARATIONS, GARANTIE 9.1 REMPLACEMENT DE LA LAMPE 9.2 GARANTIE

10.

FIN DE VIE DU PRODUIT

11.

DÉPANNAGE

12.

TABLEAU DES SYMBOLES DE DISPOSITIFS MEDICAUX UTILISES

13.

SYMBOLES ELECTRIQUES

LIT037 CUDA® SURGICAL ELITE 300 (French)

Rev. M Date de révision:05/14/14 Page 14 of 60

ELITE 300 Xenon Lichtgenerator Bedienungsanleitung ST Technologies 6018 Bowdendale Avenue Jacksonville, FL 32216 USA Customer Service: 904 208 2291 Toll Free 877 814 2237 EC|REP

RMS UK, Ltd. 28 Trinity Road Nailsea, Somerset BS48 4NU United Kingdom TEL: 01275 858891

LIT037 CUDA® SURGICAL ELITE 300 (German)

Rev. M Datum Auflage:05/14/14 Page 25 of 60

INHALTSVERZEICHNIS

1.

EINFÜHRUNG

2.

SICHERHEITSHINWEISE

3.

TECHNISCHE DATEN

4.

BETRIEBSTEILE, SYMBOLE UND FUNKTIONEN 4.1 FRONTKONSOLE 4.2 RÜCKSEITE

5.

INSTALLIERUNG 5.1 VORBEREITUNG DER LICHTQUELLE ZUM ANSCHLUSS 5.2 ANSCHLUSS DES LICHTKABELS

6.

BETRIEB 6.1 EINSCHALTEN DER LICHTQUELLE 6.2 LICHTSTÄRKE-ANZEIGE UND -REGELUNG 6.3 LAMPEN-BETRIEBSSTUNDENANZEIGE

7.

REINIGUNG

8.

DESINFEKTION 8.1 DESINFEKTION DES GERÄTS

9.

WARTUNG, INSPEKTION UND REPARATUR UND GARANTIE 9.1 ERSETZEN VON LAMPEN 9.2 BESCHRÄNKTE GARANTIE

10. ENDE DER BETRIEBSZEIT 11. FEHLERSUCHE UND –BEHEBUNG 12. TABELLE MIT SYMBOLEN, DIE AUF MEDIZINISCHEN GERÄTEN VERWENDET WERDEN 13. ELEKTRISCHE SYMBOLE

LIT037 CUDA® SURGICAL ELITE 300 (German)

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ELITE 300 Illuminatore Xenon Manuale d’uso ST Technologies 6018 Bowdendale Avenue Jacksonville, FL 32216 USA Customer Service: 904 208 2291 Toll Free 877 814 2237 EC|REP

RMS UK, Ltd. 28 Trinity Road Nailsea, Somerset BS48 4NU United Kingdom TEL: 01275 858891

LIT037 CUDA® SURGICAL ELITE 300 (Italian)

Rev. M Data di Revisione: 05/14/14 Page 37 of 60

INDICE

1.

INTRODUZIONE

2.

AVVERTENZE

3.

SPECIFICHE TECNICHE

4.

ELEMENTI OPERATIVI, SIMBOLI E FUNZIONI 4.1 PANNELLO ANTERIORE 4.2 PANNELLO POSTERIORE

5.

INSTALLAZIONE 5.1 INSTALLAZIONE DELLA SORGENTE LUMINOSA 5.2 COLLEGAMENTO DEL CAVO A FIBRE OTTICHE

6.

FUNZIONAMENTO 6.1 ACCENSIONE DELLA SORGENTE LUMINOSA 6.2 CONTROLLO DELLA LUMINOSITA’ 6.3 INDICATORE DELLA VITA DELLA LAMPADA

7.

PULIZIA

8.

DISINFEZIONE 8.1 DISINFEZIONE DELL’UNITA’ DI CONTROLLO

9.

MANUTENZIONE, ASSISTENZA TECNICA E RIPARAZIONI, GARANZIA 9.1 SOSTITUZIONE DELLA LAMPADA 9.2 GARANZIA

10. FINE DELLA VITA DEL PRODOTTO 11. SOLUZIONE DEI PROBLEMI 12. TABELLA DEI SIMBOLI USATI SUI DISPOSITIVI MEDICI 13. SIMBOLI ELETTRICI

LIT037 CUDA® SURGICAL ELITE 300 (Italian)

Rev. M Data di Revisione: 05/14/14 Page 38 of 60

ELITE 300 Fuente de Luz de Xenon Manual de uso ST Technologies 6018 Bowdendale Avenue Jacksonville, FL 32216 USA Customer Service: 904 208 2291 Toll Free 877 814 2237 EC|REP

RMS UK, Ltd. 28 Trinity Road Nailsea, Somerset BS48 4NU United Kingdom TEL: 01275 858891

LIT037 CUDA® SURGICAL ELITE 300 (Spanish)

Rev. M Fecha de revision:05/14/14 Page 49 of 60

ÍNDICE

1.

INTRODUCCIÓN

2.

ADVERTENCIAS

3.

ESPECIFICACIONES

4.

ELEMENTOS DE FUNCIONAMIENT0, SIMBOLOS Y FUNCIONES 4.1 PANEL FRONTAL 4.2 PANEL POSTERIOR

5.

INSTALACIÓN 5.1 PUESTA EN MARCHA DE LA FUENTE DE LUZ 5.2 CONEXIÓN DEL CABLE DE FIBRA OPTICA

6.

FUNCIONAMIENTO 6.1 ENCENDIDO DE LA FUENTE DE LUZ 6.2 CONTROL DE ILUMINACIÓN 6.3 INDICADOR DE LAS HORAS DE UTILIZACIÓN DE LA BOMBILLA

7.

LIMPIEZA

8.

DESINFECCIÓN 8.1 DESINFECCIÓN DE LA UNIDAD DE CONTROL

9.

MANTENIMIENTO, SERVICIO Y REPARACIÓN 9.3 SUSTITUCIÓN DE LA BOMBILLA 9.4 GARANTÍA LIMITADA

10. FINAL DE LA VIDA PRODUCTIVA 11. RESOLUCIÓN DE PROBLEMAS 12. TABLA DE SÍMBOLOS USADOS EN DISPOSITIVOS MÉDICOS 13. SÍMBOLOS ELÉCTRICOS

LIT037 CUDA® SURGICAL ELITE 300 (Spanish)

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