Integra Integra Duo Instructions For Use Manual Download Page 1 | Manualshive

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Instructions for Use

Integra

®

Duo

LED Surgical Headlight System

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Summary of Contents for Integra Duo

Page 1: ...Instructions for Use Integra Duo LED Surgical Headlight System ...

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Page 3: ...formation 04 Indications Contraindications 12 Integra Duo Kit Options 31 Repair Return 26 EMC User Information 22 Maintenance Cleaning 05 Table of Symbols 14 Preparing the System 32 Product Information Disclosure 29 Integra Duo Ordering Information 23 Troubleshooting 06 Warnings Cautions 3 ...

Page 4: ...ide supplemental illumination aiding visualization during surgical diagnostic or therapeutic procedures 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 4 ...

Page 5: ...te of Manufacture YYYY MM DD Non Sterile MR Unsafe Keep Dry Caution Degreesofprotectionprovidedby enclosures IPCode forpower adapter Authorized Representative in the EuropeanCommunity Caution Federal USA law restrictsthisdevicetosalebyoron theorderofaphysician Storage Temperature Limitations Storage Humidity Limitations Non Condensing Storage Atmospheric Pressure Limitations Waste Electrical and E...

Page 6: ...this product To reduce the risk of fire and electric shock do not expose electrical equipment to moisture 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 Elect...

Page 7: ...magnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation The Integra Duo LED Surgical Headlight System complies with applicable domestic and international standards for electromagnetic interference and should not present problems to other equipment or be affected by other devices As a precaution avoid using the device in close proximity to other e...

Page 8: ...al of batteries may create an explosion or contamination hazard Never dispose of batteries in refuse containers Do not dispose of the battery in fire Always recycle batteries according to local regulations Improper handling of the battery can lead to heat generation smoke bursting or fire Do not remove the label from the battery Do not immerse the battery in water or other liquids Do not disassemb...

Page 9: ...t 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 During recharging the charger may become warm This device should be used in environments that meet the operating environmental conditions in the Device Specifications section of this manual Battery Charger Warnings C...

Page 10: ...the battery system but could also be used as a primary power source for unlimited operating time TheIntegraDuoLEDSurgicalHeadlightSystemprovidessupplementalilluminationduringa surgicalprocedure Itdoesnothaveanyessentialperformancethatisnotcoveredbybasicsafety The Integra Duo LED Surgical Headlight System utilizes an LED light source with an active cooling system A thermostatically controlled cooli...

Page 11: ...ads provide a soft and responsive interaction between the headband and the user Replacement of padding every six 6 months is recommended Suspension Linkage These two links connect the luminaire to the headband and provide range of motion while positioning Intensity Knob Located on the holster and regulates power to the LED from either battery or direct power supply This rotary switch allows for ad...

Page 12: ... of the components for both portable battery operation and direct power operation Integra Duo 4 Bay Kit The deluxe model includes all of the components for both portable battery operation and direct power operation With two additional bays it offers twice the charging capability of the standard model 12 ...

Page 13: ...upply AC Power Adapter Power Cord 90690 Direct Power Supply AC Power Adapter Power Cord 90690 2 Bay Charger Battery Charger Base Charger Power Supply Charger Cord 90624 4 Bay Charger Battery Charger Base Charger Power Supply Charger Cord 90664 LED Headlight Case 90600 LED Headlight Case 90600 13 ...

Page 14: ...on the occipital basket ensuring the pad sits low on the back of your head Adjust the top knob until the brow pad is positioned comfortably against your forehead Confirm that the headlight is securely adjusted to your head tight enough for your preference and loose enough to stay comfortable for the duration of your case If not tighten or loosen the knobs as needed After adjusting the top knob tig...

Page 15: ...e 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 back of your head Tightening the back knob allows the pivoting straps to self adjust and conform to the shape of your head Tighten Loosen OR 15 ...

Page 16: ...ation align the battery so that the 5 pin connector in the holster mates with the 5 slots on the battery To power on the LED Surgical Headlight turn the intensity knob located on the underside of the battery holster clockwise Turn the headlight off by rotating the intensity knob counter clockwise DirectPowerSupplyOption Plug the black AC power adapter into the battery holster adjacent to the inten...

Page 17: ...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 located on the luminaire 17 ...

Page 18: ...18 ...

Page 19: ...mately 4 hours An audible notification in the form of a three tone cycle will sound when the battery has fifteen minutes of life remaining at the current intensity setting The notification will repeat more frequently as the battery approaches the fully discharged state Lowering the headlight intensity setting will extend the life of the battery Raising the intensity setting will reduce the battery...

Page 20: ...charger will provide charging status information IndicatingLight Status Green Flashing Battery Charging Green Solid Battery Fully Charged Red Solid Error Replace Battery A completely discharged battery should become fully charged in approximately three 3 hours Charge the batteries completely before first use A battery may become fully discharged if left unused for a long period If the LED Surgical...

Page 21: ...2 Bay Charger 4 Bay Charger 21 ...

Page 22: ...esurfacesofthe headlightandcables Excess solutionenteringtheheadlight assemblycoulddamage internalcomponents Luminaire Lens 70 Isopropylalcohol Gentlywipelenssurface Padding 70 Isopropylalcohol Wipe down the padding while not saturating the cloth Cleaning Guide CAUTION Unplug the unit prior to cleaning Maintenance The Integra Duo LED Surgical Headlight System requires no routine maintenance For se...

Page 23: ...attery may not be completely seated Detach and firmly seat cord and or battery to assure complete connection Brightness of spot decreases during use and or the luminaire becomes hot to the touch Temperature of LED may have increased due to blockage of airflow Turn off the headlight check and remove any obstructions from the luminaire intensity knob and fan vents 1 Return to Integra for service if ...

Page 24: ... 2 Wh Voltage 7 2 VDC 6700mAh Electrical Safety IEC 62133 Ed 2 2 BayBatteryCharger Integra90624 Input 100 240 VAC 50 60 Hz 1 7A Output 12 19 VDC 3 0A Electrical Safety IEC 60950 1 4 BayBatteryCharger Integra90664 Input 100 240 VAC 50 60Hz 2 1A Output 19 VDC 7 8A Electrical Safety IEC 60950 1 DirectPowerKit Integra90690 Input 100 240Vac 50Hz 60Hz Output 9Vdc 3A AC Power Leakage 90 uA 264 VAC 60 Hz ...

Page 25: ...w 5000 1 524m 6 C to 40 C 43 F to 104 F Operating Temperature Above 5000 1 524m 6 C to 32 C 43 F to 90 F Maximum Operating Altitude 3000m Operating Humidity 30 to 75 Relative Humidity non condensing Storage Transport Humidity 0 to 95 Relative Humidity non condensing Storage Transport Temperature 20 C to 49 C 4 F to 120 F Mode of Operation Continuous Ingress Protection IP20 device IP22 power adapte...

Page 26: ...he 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 EmissionsTest Compliance Electromagnetic Enforcement Guidance RF Emissions CISPR 11 Group 1 The Integra LED Surgical Headlight System uses RF energy only for its internal function Therefore RF emissions are very low and are no...

Page 27: ...ctrostatic Discharge ESD IEC 61000 4 2 8 kV contact 15 kV air 8 kV contact 8 kV air Electrical Fast Transient burst IEC 61000 4 4 2 kV mains 100 kHz repetition frequency 2 kV mains 100 kHz repetition frequency Surge IEC 61000 4 5 1 kV Differential 2 kV Common 1 kV Differential 2 kV Common For Direct Power AC Operation Voltage dips short interruptions and voltage variations on power supply input li...

Page 28: ... NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people NOTE 3 Table 9 testing included Table3 Guidance Manufacturer sDeclaration Electromagnetic Immunity The Integra LED Surgical Headlight System is intended for use in the electro...

Page 29: ...00 Duo Headlight Only w Carrying Case 90630AU Duo 2 Bay Kit Charger 2 Batteries Holster AU 90660US Duo Direct Power Kit Supply AC Cable AU 90640US Duo Headlight System w 4 Bay Kit US 90600 Duo Headlight Only w Carrying Case 90634US Duo 4 Bay Kit Charger 2 Batteries Holster US 90660US Duo Direct Power Kit Supply AC Cable US 90640UK Duo Headlight System w 4 Bay Kit UK 90600 Duo Headlight Only w Carr...

Page 30: ...o 2 Bay Charger w Power Supply Cord EU 90624AU Duo 2 Bay Charger w Power Supply Cord AU 90664US Duo 4 Bay Charger w Power Supply Cord US 4 bay charger w power supply and charger cord 90664UK Duo 4 Bay Charger w Power Supply Cord UK 90664EU Duo 4 Bay Charger w Power Supply Cord EU 90664AU Duo 4 Bay Charger w Power Supply Cord AU 90621 Duo Battery Holster Qty 1 Battery holster only 90622 Duo Lithium...

Page 31: ...egra s option either to repair or replace any component which fails during the warranty period due to any defect in workmanship or material if 1 Customer promptly reports such defect to Integra in writing 2 If requested by Integra customer returns equipment to Integra with shipping charges paid by Integra 3 Upon inspection Integra finds the equipment to be defective This warranty is contingent upo...

Page 32: ...CT CATALOG THIS WARRANTY IS EXCLUSIVE AND INTEGRA 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 INTEGRA NEITHER ASSUMES NOR AUTHORIZES...

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Page 36: ... rights reserved Printed in the USA OTLH 1100 17 01 Rev A 11 18 1107980 1 EN U S Patent www integralife com patentmarking Integra York PA Inc 589 Davies Drive York PA 17402 USA toll free phone 800 654 2873 fax 888 980 7742 integralife com custsvcnj integralife com Integra LifeSciences Services France Immeuble Séquoïa 2 97 allée Alexandre Borodine Parc Technologique de la Porte des Alpes 69800 Sain...

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