LED ROVER Instructions for Use Rev P Nov 2015

TABLE OF CONTENTS

1.

INTRODUCTION

2.

INTENDED USE/INDICATIONS FOR USE

3.

WARNINGS/LABELING

4.

SPECIFICATIONS

5.

OPERATION

6.

BATTERY INFORMATION

7.

CLEANING/STERILIZATION

8.

WARRANTY

9.

CHART OF MEDICAL DEVICE STMBOLS

LIT102 CUDA® Surgical (English)

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1.

INTRODUCTION

The LED Rover is a Light Emitting Diode (LED) and battery unit to couple onto the light post of commercially available endoscopes having an ACMI or Wolf light post. The LED Rover is made to take the place of conventional light cable and remote light source. It couples to the endoscope in the same fashion as a conventional light cable by press fitting onto the endoscope’s light post. The LED Rover is powered by two lithium 3V, CR123 batteries (or interchangeable equivalents). The batteries power an LED via a current converter that supplies a constant current to the LED. The light is directed into the light post of the scope. The light is then carried by fiber optics internal to the scope to illuminate the target.

2.

INTENDED USE / INDICATIONS FOR USE The LED Rover is used to illuminate the site of surgery during minimally invasive surgical procedures in arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery) and in Endoscopy (general, gastroenterological and ENT surgery). The light is transmitted from the light source through a scope.

3.

WARNINGS / LABELING 3.1 WARNINGS Caution Battery powered equipment is considered unsuitable for use in the presence of flammable anesthetics. Caution Federal law restricts this device to sale by or on the order of a licensed practioner. Caution The LED Rover is provided non-sterile. If used for sterile procedures, the unit must be sterilized or draped with commercially available surgical drapes. Caution The LED Rover will become warm to the touch but even prolonged contact during use will not cause injury.

LIT102 CUDA® Surgical (English)

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Caution Avoid looking directly at the LED inside the port or pointing it directly at anyone’s eyes. The LED is painfully bright, can momentarily blind a person and will cause lingering ghost images. Caution Handle damaged or leaking batteries with care. Should you come in contact with the electrolyte, wash the exposed area with soap and water. Should the eye come in contact with the electrolyte, flush the eye with water for 15 minutes and seek medical attention. Do not incinerate discarded batteries. Follow local EPA requirements for proper disposal. Caution Always follow the instructions for use provided with the rechargeable batteries and charger system which are provisioned for use with your ROVER system.

3.2 LABELING The LED Rover will be wrapped in bubble wrap and placed in the white box labeled as shown below.

The device has no known contraindications.

LIT102 CUDA® Surgical (English)

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4. SPECIFICATIONS Item Lamp Type Color temperature Lamp life Battery Current converter output Discharge time Model Dimensions Weight Electrical Protection Medical Classification

Specification LED 6500° K (nominal) 50,000 hrs. (nominal) Lithium CR123, 3Volts (2X) or Lithium Ion RCR123A 3V (2X) 611 milliamps (nominal) 110 minutes (typical, actual endurance may vary) LED Rover 5.1 inches long X 1.25 inches diameter at LED housing 3.7 oz. Class I, Type BF FDA Class II Europe Class I

5. OPERATION The LED Rover is operated by a pushbutton switch inside a protective silicone rubber boot at the back end of the handle. It features a momentary ON function with partial depression of the switch, and clicks to stay ON with full depression. Depress the switch fully again to turn it off.

6. BATTERY INFORMATION 6.1 DISPOSABLE BATTERY MODEL BATTERY REPLACEMENT Unscrew the headpiece that houses the LED. (Do not remove the switch; the batteries cannot fit through the switch end.) Remove the old batteries and insert the new ones. Observe correct polarity. The positive (+) end of both batteries must point toward the headpiece. The positive end of the battery has a protruding nipple, the negative (-) end is flat. NOTE: Because discharge characteristics may vary between designations or between used and unused batteries, always replace batteries in pairs with pairs of identical new batteries. Replace disposable 3 volt Lithium CR123 primary batteries only with similar size and voltage batteries. Storage: Store in a dry area at 40º F – 85º F.

LIT102 CUDA® Surgical (English)

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6.2 RECHARGEABLE BATTERY MODEL The rechargeable model lightsource differs from the standard only by the use of rechargeable batteries. The batteries supplied may be of various voltages which work in the ROVER system. All batteries will be RCR123R-type cells. Always use batteries of the same chemistries and voltages together in the ROVER system. Battery life in the ROVER system will vary depending upon the battery voltages used. Always replace batteries in pairs which have each been fully charged. Always replace batteries in pairs when discarding units that are spent beyond their useful life. Follow all local and government policies for battery disposal. Consult the instructions for use with your rechargeable battery system for proper operation and warning statements. Never use chargers that are not designed to work with the battery chemistry and voltages of cells supplied with your ROVER system. Battery recharge times will vary based upon the battery voltages used and the charger system supplied.

7.

CLEANING / STERILIZATION 7.1 CLEANING The LED Rover is a high quality optical device. Care for it appropriately. A soft brush with mild detergent may be used to clean the device. The lens of the LED inside the optic port may be wiped with a swab. Avoid harsh or abrasive material that could scratch or in any way damage the optical surface. 7.2

STERILIZATION The LED Rover is provided non-sterile. The device should be cleaned and disinfected or sterilized prior to use, according to your institution’s requirements. Caution Do not reprocess the LED Rover using steam sterilization or autoclave. Use of these processes will result in damage to the instrument, and void its warranty. Process per your institution’s validated procedures and process parameters.

LIT102 CUDA® Surgical (English)

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Compatible Sterilization Method: STERRAD™ in STERRAD sterilizer. Double wrap with sterilization wrap. The full cycle of the Sterrad sterilizer comprises two identical exposure phases (6 minute injection, 2 minute diffusion and 2 minute plasma) preceded by a 10-minute pre-exposure plasma phase. Follow the instructions provided with the STERRAD Sterilization System for sterilization processing via this equipment and method. NOTE: The LED Rover has a black anodized exterior finish which is affected by Sterrad sterilization. The black anodized finish gradually bleaches; however, this is irrelevant to the functionality of the unit. 7.3

HIGH LEVEL DISINFECTION (IMMERSION) The LED Rover may be immersed in high level disinfectant solution no deeper than six (6) inches (15cm) for as long as one (1) hour. Process according to the disinfectant manufacturer's instructions or your institution's established protocol. We make no claims other than the Rover's immersibility as stated.

8.

LIMITED WARRANTY Your fiberoptic products(s) carry a 1-year warranty from the date of shipment on workmanship and all defects of material except batteries. Should your product prove to have such defects within one year from the date of 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 product 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, and normal wear and tear. This warranty gives you specific legal rights and you may also have other rights that vary from state to state.



In the U.S call:

877 814 2237



Customer Service

904 208 2291

LIT102 CUDA® Surgical (English)

(toll free)

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9. CHART OF MEDICAL DEVICE SYMBOLS USED Manufacturer Date of manufacture (YYYYMM or YYYY) “Authorized Representative” in the European Community

Caution, consult accompanying documents Consult Instructions for Use CE mark

LIT102 CUDA® Surgical (English)

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LED ROVER Manuel d’instructions

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

LIT102 CUDA® Surgical (French)

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SOMMAIRE

1.

INTRODUCTION

2.

UTILISATION/INSTRUCTIONS D’UTILISATION

3.

MISES EN GARDE / ÉTIQUETTAGE

4.

SPECIFICATIONS

5.

FONCTIONNEMENT

6.

INFORMATION SUR LES PILES

7.

NETTOYAGE/STÉRILISATION

8.

GARANTIE

9.

TABLEAU DES SYMBOLES DE DISPOSITIFS MEDICAUX UTILISES

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INDICE

1.

INTRODUZIONE

2.

DESTINAZIONE D’USO/INDICAZIONI PER L’USO

3.

AVVERTENZE/ETICHETTATURA

4.

SPECIFICHE TECNICHE

5.

FUNZIONAMENTO

6.

INFORMAZIONI SULLA BATTERIA

7.

PULIZIA/STERILIZZAZIONE

8.

GARANZIA

9.

TABELLA DEI SIMBOLI USATI SUI DISPOSITIVI MEDICI

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LED ROVER Instrucciones de utilización

ST Technologies 6018 Bowdendale Avenue Jacksonville, FL 32216 EE.UU. Customer Service: 904 208 2291 Toll Free 877 814 2237

REP|CE

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

LIT102 CUDA® Surgical (Spanish)

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ÍNDICE

1.

INTRODUCCIÓN

2.

UTILIZACIÓN PREVISTA/INDICACIONES DE UTILIZACIÓN

3.

ADVERTENCIAS/ETIQUETAS

4.

ESPECIFICACIONES

5.

FUNCIONAMIENTO

6.

INFORMACIÓN DE LAS PILAS

7.

LIMPIEZA/ESTERILIZACIÓN

8.

GARANTÍA

9.

TABLA DE SÍMBOLOS USADOS EN DISPOSITIVOS MÉDICOS

LIT102 CUDA® Surgical (Spanish)

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