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Integra Duo Instructions For Use Manual
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Integra Duo Instructions For Use Manual

Led surgical headlight system
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Integra
Duo
®
LED Surgical Headlight System
Instructions for Use

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Summary of Contents for Integra Integra Duo

  • Page 1 Integra ® LED Surgical Headlight System Instructions for Use...
  • Page 3 Table of Contents Indications & Table of Symbols Warnings & Cautions Contraindications Overview Integra Duo Kit Options Preparing the System Battery Information Maintenance & Cleaning Troubleshooting Device Specifications EMC User Information Integra Duo Ordering Information Replacement Parts Repair & Return...
  • Page 4 Contraindications The Integra Duo LED Surgical Headlight System is contraindicated for use in neonatal transillumination, ophthalmic procedures, photosensitive patients or patients who have received photosensitizing agents (hematoporphyrin derivatives) within three months.
  • Page 5 Table of Symbols Restriction of Hazardous Substances For Battery Purposes- No Naked (China) 5-Year Safe Use Period Flames Product complies with the Class II Equipment, used on power requirements of directive 93/42/EEC adapter Listed by ETL Recycle Eligible for Call2Recycle Program Recycle (Taiwan) Non-Sterile Waste Electrical and Electronic...
  • Page 6 When cleaning, do not immerse any electrical device in liquid. • Do not use or store liquids on or above the Integra Duo LED Surgical Headlight System. • Safety precautions must always be exercised when using electrical equipment to prevent operator/patient shock, fire hazard or equipment damage.
  • Page 7 • When the Integra Duo LED Surgical Headlight System is not in use, turn off the power. • Explosion hazard. Do not use the Integra Duo LED Surgical Headlight System in the presence of flammable anesthetics, liquids, vapors, gases, or dusts.
  • Page 8 General Warnings (Continued) • When the Integra Duo LED Surgical Headlight System employs the direct power option, the cord may present a tripping hazard. • No modification of this equipment is allowed. • This device is not indicated for use in the MR environment.
  • Page 9 • Do not cover the fan exhaust or obstruct the airflow; this will cause overheating. • Use only the Integra supplied power supply, charger, batteries and power cords. • Store the charger in a cool spot, away from external heat sources.
  • Page 10 It does not have any essential performance that is not covered by basic safety. The Integra Duo LED Surgical Headlight System utilizes an LED light source with an active cooling system. A thermostatically-controlled cooling fan draws air through ports on the luminaire, quietly cooling the LED.
  • Page 11 Luminaire Contains the LED light source, an iris wheel for controlling spot size, and optical elements to project a homogeneous spot of light to the surgical field. Headlight The cable connects the headlight to the battery holster. Cable Duct System Serves as a conduit for airflow from the luminaire to the cooling fan.
  • Page 12 Integra Duo 2-Bay Kit The standard model includes all of the components for both portable battery operation and direct power operation. LED Headlight with Cable Integra Duo 4-Bay Kit The deluxe model includes all of the components for both portable battery operation and direct power operation.
  • Page 13 Battery Holster 2 Batteries LED Headlight & Case 90621 90622 90600 Direct Power Supply: 2-Bay Charger: Battery Charger Base, AC Power Adapter & Power Cord Charger Power Supply & Charger Cord 90690 90624 Battery Holster 2 Batteries LED Headlight & Case 90621 90622 90600...
  • Page 14 Preparing the System: Donning the Integra Duo Headlight Loosen both knobs (top and rear) by turning counter-clockwise to a size large enough to allow the headlight to easily fit onto your head without disturbing loupes, caps, mask, etc. Carefully don the headlight. Position the occipital basket ensuring the pad sits low on the back of your head.
  • Page 15 Achieve optimal fit by rotating the dials until your Comfort Code size is set on the headlight. Properly fitting the occipital basket will help keep the headband straps from riding too high on your head, avoiding undue pressure on tender points of the cranium. Over-tightening the top knob may cause the occipital basket to pivot upward, becoming unseated from the...
  • Page 16 Preparing the System: Attaching the Battery Holster & Power Plug the gray headlight cable into the keyed connection point on the underside of the battery holster. Align the indications on the headlight cable and battery holster connections; push the connector to snap it into place.
  • Page 17 Disconnection requires a 1/4 turn counter-clockwise. The Integra Duo logo on the battery will be visible through the opening of the battery holster, as shown. Disconnection requires a 1/4 turn counter-clockwise. The illuminated spot size is controlled by rotating the iris adjustment wheel...
  • Page 19 Battery Charge Status The battery utilizes a 5-bar The battery life of the Bars Charge LCD “fuel gauge”, located headlight is dependent 81-100% on the top surface of the on the intensity setting. battery, to indicate its A headlight on maximum 61% - 80% charge status.
  • Page 20 Recharging the Battery Place the battery charger on a flat, level surface away from sources of heat and moisture. Connect the battery charger base, power supply, and supplied charger cord. Plug the charger cord into any standard outlet. Place the battery into one of the charger’s battery bays, ensuring that the 5-pin connector is fully seated.
  • Page 21 2-Bay Charger 4-Bay Charger...
  • Page 22 Maintenance The Integra Duo LED Surgical Headlight System requires no routine maintenance. For servicing and/or repair, refer to the Repair and Return section of this manual. Cleaning Guide CAUTION: Unplug the unit prior to cleaning. Component Cleaning Agent Cleaning Instructions Cables &...

  • Page 23: Troubleshooting

    Return touch. to Integra for service if issue is not resolved. Brightness of spot is Lens may be dirty. Clean lens with 70% Isopropyl diminished and/or the alcohol.
  • Page 24 Device Specifications Portable LED Headlight: Integra 90600 FDA Class II, Exempt: CA, EU, AU: Class 1 Classification Type Wattage 9.3 Watts 48,000 Hours Lamp Life Color Temperature Average 5900°K Spot Size Range 42mm to 125mm at 16 in (~40cm) working distance...
  • Page 25 Ingress Protection IP20 device; IP22 power adapter Pressure Operating 700-1060hPA / Storage 500-1060hPa Classifications and Standards: The Integra Duo LED Surgical Headlight System meets the electrical safety requirements for: • IEC 60601-1 3.1 edition and collateral standards • IEC 60601-1-2:Ed. 4 •...
  • Page 26 Table 1: Guidance & Manufacturer’s Declaration – Emissions All Equipment & Systems The Integra LED Surgical Headlight System is intended for use in the electromagnetic environment specified below. The user should ensure that it is used in such an environment.
  • Page 27 Guidance & Manufacturer’s Declaration – Immunity All Equipment and Systems The Integra LED Surgical Headlight System is intended for use in the electromagnetic environment specified below. The customer or user should ensure that it is used in such an environment.
  • Page 28 Table 3: Guidance & Manufacturer’s Declaration – Electromagnetic Immunity The Integra LED Surgical Headlight System is intended for use in the electromagnetic environment specified below. The customer or user should ensure that it is used in such an environment. Immunity Test...
  • Page 29 Integra Duo Ordering Information REF # Description Headlight Battery Kit AC Power Kit 90620US Duo Headlight 90600 - Duo 90630US -Duo 90660US - Duo System w/ 2-Bay Headlight Only 2-Bay Kit (Charger, 2 Direct Power Kit Kit - US w/ Carrying Case Batteries, (Supply &...
  • Page 30 Replacement Parts & Accessories Ordering Information REF # Description Contains 90690US Duo Direct Power AC Cable Only – US Power cord (12’) 90690UK Duo Direct Power AC Cable Only – UK 90690EU Duo Direct Power AC Cable Only – EU 90690AU Duo Direct Power AC Cable Only –...
  • Page 31 (3) years from the date of shipment, except the batteries, which are warranted for one (1) year from the date of shipment. Integra’s sole and exclusive liability under the warranty shall be, at Integra’s option, either to repair or replace any component which fails during the warranty period due to any defect in workmanship or material if: Customer promptly reports such defect to Integra in writing.
  • Page 32 DISCLAIMS ALL OTHER WARRANTIES, WHETHER EXPRESSED OR IMPLIED, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. INTEGRA SHALL NOT BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL LOSS, DAMAGE, OR EXPENSE, DIRECTLY OR INDIRECTLY ARISING FROM USE OF THESE PRODUCTS.
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  • Page 36 U.S. Patent www.integralife.com/patentmarking Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. Comfort Code is a trademark of Integra LifeSciences Corporation. ©2018 Integra LifeSciences Corporation. All rights reserved. Printed in the USA. OTLH-1100-17-01 Rev. A 11/18 1107980-1-EN...