LED ROVER IV+ Instructions for Use Rev A June 2018

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 SYMBOLS

LIT 226 CUDA Surgical ®

(English)

Rev. A Date of Revision:06/21/18 Page 2 of 38

1.

INTRODUCTION

The LED Rover IV+ is a Light Emitting Diode (LED) and battery unit designed to couple onto the light post of commercially available endoscopes having an ACMI or Wolf light post. The LED Rover IV+ is made to take the place of conventional light cables and remote light sources. 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 IV+ is powered by a single "18650" size lithium-ion 3.7V rechargeable battery. The battery powers 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 internal fiber optics to the scope to illuminate the target.

2.

INTENDED USE / INDICATIONS FOR USE The LED Rover IV+ 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.

LIT 226 CUDA Surgical ®

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Rev. A Date of Revision:06/21/18 Page 3 of 38

3.

WARNINGS / LABELING

3.1 WARNINGS CAUTION Federal law restricts this device to sale by or on the order of a licensed practitioner. CAUTION Battery powered equipment is considered unsuitable for use in the presence of flammable anesthetics. CAUTION The LED Rover IV+ 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 IV+ will become warm to the touch; however, it has been shown that prolonged contact during use will not cause injury. 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/or can 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 Only operate the Rover IV+ with batteries approved by Sunoptic Technologies.

The device has no known contraindications.

LIT 226 CUDA Surgical ®

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Rev. A Date of Revision:06/21/18 Page 4 of 38

4. SPECIFICATIONS Item Lamp Type Color temperature Battery Current converter output Endurance time (Default Software) Model Dimensions Weight Electrical Protection Medical Classification Port Operating Environment Storage Environment

Specification LED 5000 K (nominal) Lithium Ion 18650 3.7V 800 milliamps (nominal) High 2.5 hours (typical, actual endurance may vary) Medium 4.5 hours (typical, actual endurance may vary) Low 15 hours (typical, actual endurance may vary) LED Rover IV+ Max Length: 4.9”, Max OD: 1.125” 0.32 lbs [145g] Class I, Type BF FDA Class II Europe Class I ACMI Temperature +0° to +30° C (32° to 86° F) Relative Humidity 0 to 85%rh, non condensing Air Pressure 700 to 1060 hPa Temperature -20° to +60° C (-4° to 140° F) Relative Humidity 30 to 95%rh, non condensing Air Pressure 700 to 1060 hPa

5. OPERATION The LED Rover IV+ 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 RECHARGEABLE BATTERY The rechargeable batteries provided are high capacity 18650 3.7 volt Lithium-ion battery. The battery charger provided is compatible only with the 3.7 volt high capacity rechargeable Lithium-ion batteries that are supplied. The 3.7 volt high capacity batteries provided are compatible only with chargers specifically designed for them. Do not put attempt to charge the batteries with another type of charger. A fully-discharged battery may require approximately eight hours to reach a full charge. The three indicator lights on the charging cradle will be blank when there is no battery in the cradle. The charger will flash one LED while determining what configuration of battery is in the charger and this LED will remain solid once the

LIT 226 CUDA Surgical ®

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configuration is determined. The second and third LEDs will flash while it is charging, and there will be three solid lights when the battery is fully charged. Batteries may be “topped off” to full charge even if they are not fully discharged. Batteries may be left in the charging cradle when charged. Avoid directly short circuiting a battery. The power converter operates on 100∼240 VAC, 50∼60Hz @ 0.25A. With fully charged batteries the light source is approximately 2.5 hours with the strongest brightness, followed by approximately ½ hour of usable light. Consult the charger's individual instructions for further operational details, additional warnings, and safety data. 6.2 BATTERY REPLACEMENT Unscrew the headpiece that houses the LED. (Do not remove the switch; the battery cannot fit through the switch end.) Remove the discharged battery and insert a fully charged battery. Observe correct polarity. The positive (+) end of the battery must point toward the headpiece. The positive end of the battery has a protruding nipple; the negative (-) end is flat.

7.

CLEANING / STERILIZATION 7.1 CLEANING The LED Rover IV+ 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 IV+ is provided non-sterile. The device should be cleaned and disinfected or sterilized prior to use, according to your institution’s requirements. 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 IV+ has a black anodized exterior finish which is affected by Sterrad sterilization. The black anodized finish gradually bleaches; however, this does not impact the functionality of the unit. CAUTION Do not reprocess the LED Rover IV+ 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.

LIT 226 CUDA Surgical ®

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Rev. A Date of Revision:06/21/18 Page 6 of 38

7.3

HIGH LEVEL DISINFECTION (IMMERSION) The LED Rover IV+ 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 IV+ immersibility as stated.

8.

LIMITED WARRANTY Your LED Rover IV+ carries 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, CUDA Surgical will repair or replace the product or component part without charge. Should your LED Rover IV+ need servicing ® under this warranty, please contact CUDA Surgical 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.

9.

•

In the U.S call:

877 814-2237 (toll free)

•

FAX number:

904 733-4832

•

Customer Service

904 208-2290

CHART OF MEDICAL DEVICE SYMBOLS USED Manufacturer Date of manufacture (YYYY-MM-DD) “Authorized Representative” in the European Community Caution, consult accompanying documents Consult Instructions for Use CE mark

LIT 226 CUDA Surgical ®

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TABLE DES MATIERES

1. INTRODUCTION 2. USAGE PREVU / INSTRUCTIONS POUR L'UTILISATION 3. AVERTISSEMENT / ETIQUETTAGE 4. SPECIFICATIONS 5. FONCTIONNEMENT 6. INFORMATION BATTERIE 7. NETTOYAGE / STERILISATION 8. GARANTIE LIMITEE 9. TABLEAU DES SYMBOLES DE L'APPAREIL MEDICAL

®

LIT 226 CUDA Surgical (French)

Rév. A Date de révision :06/21/18 Page 9 de 38

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 LIMITADA 9. TABLA DE SÍMBOLOS PARA DISPOSITIVOS MÉDICOS

LIT 226 CUDA Surgical ®

(Spanish)

Rev. A Fecha de revisión:06/21/18 Página 32 de 38