Integra · • The LED Surgical Headlight System should never be used in ocular surgery or in a surgical procedure requiring direct illumination of the eye

OperatiOn and Service ManualIntegra® LED Surgical Headlight System

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Integra®

LED Surgical Headlight System

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Table of contents

Indications For Use .......................................................................................................................................................................................... 03 Contraindications ............................................................................................................................................................................................ 03 Table of Symbols............................................................................................................................................................................................... 04 General Warnings ............................................................................................................................................................................................. 05Battery Warnings ............................................................................................................................................................................................. 06Battery Charger Warnings .............................................................................................................................................................................. 07Overview ........................................................................................................................................................................................................... 07Preparing to Use the System .......................................................................................................................................................................... 09Operating the System ..................................................................................................................................................................................... 09Battery Charge Status and Low Battery Notification ................................................................................................................................ 11Recharging the Battery ................................................................................................................................................................................... 12Maintenance and Cleaning ............................................................................................................................................................................. 13Troubleshooting ............................................................................................................................................................................................... 14 Specifications ................................................................................................................................................................................................... 15Electromagnetic Compatibility (EMC) .......................................................................................................................................................... 16Integra® Surgical Headlight Systems Ordering Information ...................................................................................................................... 18Replacement Parts & Accessories Ordering Information .......................................................................................................................... 19 Repair and Return ............................................................................................................................................................................................. 20Limited Warranty ............................................................................................................................................................................................. 20

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Integra®


Indications for use

Contraindications

CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN

The Integra® LED Surgical Headlight System is designed to provide illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures.

The Integra® LED Surgical Headlight System is contraindicated for use in neonate transillumination, ophthalmic procedures, or with photosensitive patients or patients who have received photosensitizing agents (hematoporphyrin derivatives) within three months.

This device is intended to be used by professional users.

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No naked flames

Meets requirements of the Medical Device Directive

Listed by ETL UN approved container

Eligible for Call2Recycle Program Recycling symbol (Taiwan)

Part Number

Restriction of Hazardous Substances (China) 5 Year safe use period

Serial Number Refer to Manual

In this manual, this symbol and “Warning” indicate conditions or practices that could lead to illness or injury

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician

In this manual, this symbol and “Caution” indicate conditions or practices that could damage the equipment or other property

Do not dispose

Recycle symbol

Table of Symbols

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REF

EU Authorized Representative

Manufacturer

Temperature limitations

Humidity limitations

Atmospheric pressure

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Integra®


General Warnings

•TheusershouldcarefullystudytheOperationandService Manual before using the LED Surgical Headlight System in the clinical environment. Instructions should be followed, with special attention given to warnings, controls, and user specifications. The Manual should be available to appropriate personnel.

•ThisManualcontainsinformationabouttheproper procedures for preparing this product for its use and care.

•Beforeeveryprocedure,carefullyinspecttheLEDSurgical Headlight System to ensure it has been properly maintained, cleaned, and is fully functional. DO NOT use if an inspection reveals any damage such as case damage or loose connectors.

•Followtheinstructionsofothermanufacturer’sequipment when used in conjunction with this product.

•Toreducetheriskoffireandelectricshock,donotexpose electrical equipment to moisture. When cleaning, do not immerse any electrical device in liquid.

•DonotuseorstoreliquidsonorabovetheLEDSurgical Headlight System.

•SAFETYPRECAUTIONSMUSTALWAYSBEEXERCISED WHEN USING ELECTRICAL EQUIPMENT TO PREVENT OPERATOR/PATIENT SHOCK, FIRE HAZARD OR EQUIPMENT DAMAGE.

•Electricshockhazard.Ifunitisnotfunctioningproperly, DO NOT OPEN. Please refer to the Repair and Return section of this Manual.

•TheLEDSurgicalHeadlightSystemmustbeusedwiththe recommended Integra battery or with recommended Integra power cords with plugs inserted into properly grounded AC power outlets.

•TheLEDSurgicalHeadlightSystemshouldneverbeused in ocular surgery or in a surgical procedure requiring direct illumination of the eye.

•TheLEDSurgicalHeadlightSystemproduceshighintensity light. Use care not to point the Headlight directly at the eye while in use.

•Onlyuseenoughlighttoensuregoodvisualization,and avoid prolonged close stationary illumination of tissue to reduce the risk of thermal injury to tissue.

•WhentheLEDSurgicalHeadlightSystemisnotinuse,turn off the power.

•ExplosionHazard.DonotusetheLEDSurgicalHeadlight System in an oxygen rich environment or in the presence of flammable anesthetics, liquids, vapors, gases, or dusts.

•Keepcoolingventandfansfreeofobstructions.

•Toensurepatientandoperatorsafetyandoptimal product performance, use only accessories and supplies recommended for or supplied with the system, and use them according to the directions for use.

•TheHeadlightSystemcomplieswithapplicabledomestic and international standards for electromagnetic interference. As a precaution, avoid using the device in close proximity to other equipment.

•Donotdirectlyconnectorshort-circuitthepositive(+)and negative (-) battery terminals.

•Toavoidshortcircuits,keepbatteryterminalsawayfrom metal objects.

•Donotexposethebatterytotemperatureshigherthan 49C/120F.

•Youmustchargethebatteriesforfour(4)hoursoruntil completely charged before using the battery power option.

•Adeadbatterymayresultifthebatteriesareleftuncharged or unused for a long period of time.

•IftheLEDSurgicalHeadlightSystemwillbeunusedfor several months or longer, remove the battery from the battery holster prior to storing the system.

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Battery Warnings Battery Charger Warnings

Caution

•DefectivebatteriescandamagetheSurgicalHeadlight System. If the battery shows any signs of damage, leakage, or cracking, it must be replaced immediately and only with an Integra® battery recommended for or supplied with the system.

•Improperdisposalofbatteriesmaycreateanexplosionor contamination hazard. Never dispose of batteries in refuse containers. Do not dispose of the battery in fire. Always recycle batteries according to local regulations.

•Improperhandlingofthebatterycanleadtoheat generation, smoke, bursting, or fire.

•Donotremovethelabelfromthebattery.

•Donotimmersethebatteryinwaterorotherliquids.

•Donotdisassemble,modify,orsolderthebattery.

•Donotdirectlyconnectorshort-circuitthepositive(+)and negative (-) battery terminals.

•Toavoidshortcircuits,keepbatteryterminalsawayfrom metal objects.

•Donotexposethebatterytotemperatureshigherthan 49C/120F.

•Youmustchargethebatteriesforfour(4)hoursoruntil completely charged, before using the battery power option.

•Adeadbatterymayresultifthebatteriesareleftuncharged or unused for a long period of time.

•IftheLEDSurgicalHeadlightSystemwillbeunusedfor several months or longer, remove the battery from the battery holster prior to storing the system.

•Donotexposethechargerorpowersupplytowateror liquids. The case is not sealed.

•Donotopenthechargerorpowersupplycase.Nouser serviceable parts are inside.

•Donotcoverthefanexhaustorobstructtheairflow,thiswill cause overheating.

•Useonlythemanufacturer’srecommendedpowersupply, charger, batteries and power cords.

•Storethechargerinacoolspot,awayfromexternalheat sources. If replacement is necessary, replace only with approved power cord.

•Duringrecharging,thechargermaybecomewarm.

•Nomodificationofthisequipmentisallowed.

•Thisdeviceshouldbeusedinenvironmentsthatmeetthe operating environmental conditions in the specification section of this manual.

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Integra®


Overview

The Integra® LED Surgical Headlight System is a self-contained headlight system that can be operated using either a battery or a direct power supply. Using a battery pack gives the surgeon complete mobility, allowing unrestricted movement in and around the operating suite. The direct power supply option can be used as a primary power source for unlimited operating time, or as a back-up to the battery system.

The Integra® LED Surgical Headlight System utilizes an LED light source with an active cooling system. A thermostatically-controlled cooling fan draws air at a very low flow rate through ports on the side and back of the headlight module, quietly cooling the LED. The air is drawn through a system of ducts and is gently exhausted behind the surgeon. The major components of the Headlight itself are shown in Figure 1 and described below.

Headlight Modulecontains the led light source, a thermostat for monitoring led temperature, an iris for controlling spot size, and optical elements to project a homogeneous spot of light to the surgical field.

Controllerregulates power to the led from either Battery or direct dc power Supply, adjusts the cooling fan according to led temperature and houses a four position rotary switch to control led intensity.

Duct System Serves as a conduit for airflow from the headlight module to the cooling fan.

HeadbandOffers versatile size adjustment using two knobs (top and back) and incorporates a replaceable pad set.

Suspension Linkageconnects the headlight module to the headband and allows for positioning of the headlight module

Headlight Cable connects the Battery or direct dc power Supply to the controller.

Suspension Linkage

Headlight Module

Headband

Controller

Duct SystemHeadlight Cable

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1

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90520D LED Headlight with AC/DC Power Only

90520 LED Headlight w/Batteries and AC/DC Power Supply

The AC/DC Power Only model comes equipped with these components:

• LEDHeadlightwithCable

• ACMainsPowerCord

• 30WPowerSupply

• 20’DCPowerExtensionCord

The deluxe model includes components for both the portable battery operation as well as AC/DC Power operation.

• LEDHeadlightwithCable

• 2Batteries

• BatteryHolster

• BatteryChargerBase

• 60WPowerSupply

• ACMainsPowerCords

• 30WPowerSupply • 20’DCPower Extension Cord

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2

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Integra®


Preparing to Use the System- With Battery Option

With AC/DC Power Option

1. Clip the Battery Holster in a comfortable location.

2. Insert and fully seat the Battery into the Battery Holster. For proper battery orientation, align the battery so that the 5-pin connector in the holster mates with the 5 slots on the battery. The battery label will be visible through the opening in the outside surface of the holster, as shown in Figure 4.

3. Approximate battery continuous run time is dependent on switch setting, level of charge and calibration state of battery. On a fully charged battery, approximate run times are:

• HighSwitchsettingisapproximately2hourspluslowbattery notification cycle

• MediumSwitchsettingisapproximately21/2hourspluslowbattery notification cycle

• LowSwitchsettingisapproximately3hourspluslowbattery notification cycle

1. Connect the AC/DC Power Supply to the supplied AC Mains power cord. Plug the AC Mains power cord into any standard 100 VAC to 240 VAC 47-63 Hz outlet.

2. Connect the output cord of the AC/DC Power Supply to the Extension DC Power Cord. Align the connectors and push firmly until they are firmly seated. The connector pins are not keyed and will accept either orientation.

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Preparing to Use the System- With Battery Option

1. Place the LED Headlight on the head, with the light module located between the eyes (Figure 5). Optimal coaxial (shadow-free) positioning is achieved when a line drawn between the pupils bisects the headlight module lens.

2. Adjust the headband for optimal comfort by rotating the adjustment knobs on the top and back of the headband.

3.ConnecttheHeadlight’spowercabletothepowersource.Forthe Portable Battery Option, this is the battery holster (Figure 7). For the DirectPowerOption,thisisthe20’DCPowerExtensioncordfrom the Direct Power Supply (Figure 8). The connectors are not keyed and will accept either orientation.

4. To illuminate the LED headlight, turn the rotary switch located on the back of the headlight to the desired intensity (Figure 6). The available settings are Low, Medium, and High.

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#90500 LED Headlight

#90500 LED Headlight

Battery power AC/DC power

#90522Battery

#90531 20’ DC Power Cord

#407421AC/DCPowerSupply

Connector

#90521 Holster

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Integra®


1. The Battery utilizes a 5-bar LCD “fuel gauge” to indicate its charge status (Figure 9):

5 bars displayed 81% - 100% charged4 bars 61% - 80%3 bars 41% - 60%2 bars 21% - 40%1 bar 1% - 20%No bars Fully discharged

2.Anaudiblenotificationintheformofathree-tonecyclewillsoundwhenthebatteryhasfifteenminutesofcharge remaining. The notification will repeat more frequently as the battery approaches the fully-discharged state.

15 minutes remaining 1 audible notification cycle12 minutes 1 cycle 9 minutes 2 cycles6 minutes 3 cycles3 minutes Notification cycle repeats until battery is fully discharged

3.LoweringtheHeadlightintensitysettingwillextendthedurationofthecharge.Iftheintensitysettingisloweredafter the low battery notification sounds, the system will be reset and will reflect the longer remaining battery charge.

4. Approximate battery continuous run time is dependent on switch setting, level of charge and calibration state of battery. On a fully charged battery, approximate run times are:

•HighSwitchsettingisapproximately2hourspluslowbatterynotificationcycle

•MediumSwitchsettingisapproximately21/2hourspluslowbatterynotificationcycle

•LowSwitchsettingisapproximately3hourspluslowbatterynotificationcycle

Battery Charge Status and Low Battery Notification

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1. Place the Battery Charger on a flat, level surface away from sources of heat and moisture.

2. Connect the Battery Charger base to the 60W power supply. Insert the supplied AC Mains cord into the power supply. Plug the AC Mains cord into any standard 100 VAC to 240 VAC 47-63 Hz outlet.

3.PlacethebatteryintotheCharger’sbatterybay,ensuringthatthe 5-pin connector is fully seated (Figure 10).

4. The Battery Charger will automatically begin charging. The LEDs in the charger status window will provide charging status information:

Green flashing Battery charging Green solid Battery fully charged Red solid Error — replace battery

5. A completely discharged battery should become fully charged in approximately two and one-half (2.5) hours.

6. Each fully charged battery is designed to operate for approximately 2 hours plus low battery warning cycle on the high switch setting.

Recharging the Battery

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Integra®


Maintenance

The Integra® LED Surgical Headlight System requires no routine maintenance. For servicing and/or repair, refer to the Repair and Return section of this manual.

Cleaning

1. Unplug the unit prior to cleaning.

2. Wipe the surfaces of the Headlight and cables with a cloth slightly dampened with a mild detergent, 70% isopropyl alcohol, mild soap and water or solution of 10% bleach and water. Use only 70% isopropyl alcohol to clean the Headlight lens. Excess solution entering the headlight assembly could damage internal components. Use caution to ensure cloth is not saturated with solution.

3. Do not operate the system until the Headlight is thoroughly dry.

Maintenance and Cleaning

Caution

Caution

Do not immerse any component of the LED Surgical Headlight System in cleaning solution.

Do not sterilize the LED Surgical Headlight System.

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Troubleshooting

Trouble Area Possible Cause Corrective Action

Headlight will not switch on Power cord connections may not be effective

Detach and firmly seat to assure complete connection

Brightness of spot decreases during use Temperature of LED may have increased due to blockage of airflow

Turn off the headlight, check and remove any obstructions from the headlight module and controller fan vents.a

Brightness of spot is diminished and / or the spot appears fuzzy

Lens may be contaminated Clean lens with 70% Isopropyl Alcohol

Fully charged battery operates headlight for less than 2 hours

Battery may be losing charge capacity Replace battery

Cooling fan is making a whirring or clicking sound

Fanmayhavebeendamagedafterdropping headlight

Return to Integra for service

aThe operating temperature of the LED is continuously monitored and the fan speed is adjusted to maintain proper LED operating temperatures. In the event of a malfunction in the cooling system or blockage of airflow, the power in the LED will be reduced to the low setting. If the temperature of the LED continues to rise, the intensity of the headlight will default to a setting less than the low setting of the headlight. This serves to communicate the overheating condition while maintaining some level of illumination until an alternate light source can be employed.

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Integra®


Portable LED Headlight

Type LED

Wattage 13 Watts

Lamp Life >25,000 hours

Color Temperature 5,250 K

Spot Size Range 25mm to 125mm at 16 in (~40cm) working distance

Power Input 9-15 VDC

Battery Power Kit

Type Lithium Ion, 4 cell pack

Capacity 37-45 Wh

Voltage 14.4 VDC @ 2.6-3.1 Ah

Electrical Safety IEC 60601-1

Battery Charger, Single Bay

Classifications US/FDA, Canada, Australia, EU: Class II, Double Insulated

Input 100-240 VAC, 47-63 Hz, 1.5 A

Output 24 VDC, 2.7 A

Direct Power Kit

Classifications US/FDA, Canada, Australia, EU: Class II, Double Insulated

Power Input 100-240 VAC, 47-63 Hz, 1.0 A

Power Output 15 VDC, 2.0 A

AC Power Leakage <100μA @ 264VAC, 60Hz

Electromagnetic Compatibility EN55022/55024/61000

Power Cords

Type Class II, 2.5-3.0A, Double Insulated, Detachable

Appliance End IEC 60320 C17

Outlet End Country specific for US, UK, AU, EU

Environment

Operating Temperature 6Cto40C(43Fto104F).Above5,000ft(1,524m)elevation,themaximum operating temperature is 32 C (90 F).

Operating Humidity 10% to 95% Relative Humidity, non-condensing

Storage/Transport Temperature -20 C to 49 C (-4 F to 120 F)

Storage/Transport Humidity 30% to 80% Relative Humidity, non-condensing

Mode of Operation Continuous

Ingress Protection IP20

Pressure Operating 700-1060hPa / Storage 500-1060hPa

Electromagnetic Compatibility

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Electromagnetic Compatibility (EMC) User Information

Table 201Guidance and Manufacturer’s Declaration – Emissions 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 insure that it is used in such an environment.

Emissions Test 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 not likely to cause any interference in nearby electronic equipment.

RF Emissions CISPR 11 Class B Radiated and Conducted Emissions

The Integra® LED Surgical Headlight System is suitable for use in all establishments including domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.

Harmonics IEC 61000-3-2 Class A

Voltage fluctuations/flicker emissions IEC 61000-3-3

Complies

Table 202Guidance and Manufacturer’s Declaration – Immunity All Equipment and Systems


Immunity Test IEC 60601Test Level

ComplianceLevel

Electromagnetic Environment -- Guidance

Electrostatic Discharge(ESD) IEC 61000-4-2

± 6 kV contact± 8 kV air

± 6 kV contact± 8 kV air

Floors should be wood, concrete, or ceramic tile. If floors are synthetic, the relative humidity should be at least 30%

Electrical FastTransient/burst IEC 61000-4-4

± 2 kV mains± 1 kV I/O

± 2 kV mainsNot applicable

Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC 61000-4-5 ±1 kV Differential± 2 kV Common

±1 kV Differential± 2 kV Common

Mains power quality should be that of a typical commercial or hospital environment.

For Direct Power (AC) Operation: Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

>95% Dip for 0.5 Cycle60% Dip for 5 Cycles30% Dip for 25 Cycles>95% Dip for 5 sec

>95% Dip for 0.5 Cycle60% Dip for 5 Cycles30% Dip for 25 Cycles>95% Dip for 5 sec

Mains power quality should be that of a typical commercial or hospital environment. If the user requires continued operation during power mains interruptions, it is recommended that the unit be powered from an uninterruptable power supply or battery accessory.

Power Frequency50/60 Hz Magnetic FieldIEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be that of a typical commercial or hospital environment.

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Integra®


Electromagnetic Compatibility (continued)

Table 204Guidance and Manufacturer’s Declaration – Electromagnetic Immunity


Immunity Test IEC 60601Test Level

ComplianceLevel

Electromagnetic Environment — Guidance

Conducted RFIEC 61000-4-6

3 Vrms from 150 kHz to 80 Mhz

V1 = 3 Vrms Portable and mobile RF communications equipment should be no closer to any part of the LED Surgical Headlamp System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter (distances 1.17 and 2.33).

Recommended separation distance: d = [3.5/V1]√P d = [3.5/E1]√P 80 MHz to 800 MHz d = [3.5/E1]√P 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).Field strengths from fixed RF transmitters, as determined by an electromagnetic surveya, should be less than the compliance level in each frequency rangeb.

Radiated RF IEC61000-4-3

3 Vrms from 80MHz to 2.5GHz

E1 = 3V/m

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.a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the system under test is used exceeds the applicable RF compliance level above, the system under test should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the system under test.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1]V/m

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Integra® Surgical Headlight Systems Ordering Information

REF # Description Headlight Battery Kit AC/DC Power Kit

90520 Integra® LED Surgical Headlight System with Batteries and AC/DC Power

90520US LED Headlight w/Batteries & AC/DC Power Supply - US

90500 90530US 90550US

90520EU LED Headlight w/Batteries & AC/DC Power Supply - EU

90500 90530EU 90550EU

90520UK LED Headlight w/Batteries & AC/DC Power Supply - UK

90500 90530UK 90550UK

90520AU LED Headlight w/Batteries & AC/DC Power Supply - AU

90500 90530AU 90550AU

90520D Integra® LED Surgical Headlight System with AC/DC Power Only

90520DUS LED Headlight with AC/DC Power Supply Only - US

90500 N/A 90550US

90520DEU LED Headlight with AC/DC Power Supply Only - EU

90500 N/A 90550EU

90520DUK LED Headlight with AC/DC Power Supply Only - UK

90500 N/A 90550UK

90520DAU LED Headlight with AC/DC Power Supply Only - AU

90500 N/A 90550AU

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Integra®


Replacement Parts & Accessories Ordering Information

90500 led Headlight Only

90542 led Headband replacement pads (10/Box)

90521 Battery Holster

90522 lithium ion Batteries-QtY. 2

90531 20’ dc power cord

407421 ac/dc 30W power Supply

90523 Battery charger, Single Bay

407481 Battery charger 60W power Supply

90590US ac Mains power cord - uS

90590EU ac Mains power cord - eu

90590UK ac Mains power cord - uK

90590AU ac Mains power cord - au

90530US Battery Kit - uS contains 90521 Holster, 90523 charger, 407481 60W charger power Supply, 90522 Batteries (QtY.2), 90590uS power cord

90530EU Battery Kit - eu contains 90521 Holster, 90523 charger, 407481 60W charger power Supply, 90522 Batteries (QtY. 2), 90590eu power cord

90530UK Battery Kit - uK contains 90521 Holster, 90523 charger, 407481 60W charger power Supply, 90522 Batteries (QtY. 2),, 90590uK power cord

90530AU Battery Kit - au contains 90521 Holster, 90523 charger, 407481 60W charger power Supply, 90522 Batteries (QtY. 2),, 90590au power cord

90550US ac/dc power Kit - uS contains 407421 ac/dc 30W power Supply, 90531 20’ dc power cord, 90590uS power cord

90550EU ac/dc power Kit - eu contains 407421 ac/dc 30W power Supply, 90531 20’ dc power cord, 90590eu power cord

90550UK ac/dc power Kit - uK contains 407421 ac/dc 30W power Supply, 90531 20’ dc power cord, 90590uK power cord

90550AU ac/dc power Kit - au contains 407421 ac/dc 30W power Supply, 90531 20’ dc power cord, 90590au power cord

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Repair and Return

Returning Device for Repair

This device must be clean and decontaminated prior to return to Integra. Integra reserves the right to return any unrepaired equipment that is contaminated with blood or other organic material.

Warranty Service and Repair

To obtain service under warranty or return product for repair, the customer should contact its local Integra representative or call Integra Customer Service at +1-914-592-9050, or US and Canada Toll Free: 1-(800) 431-1123

Limited Warranty

Integra warrants that the LED Surgical Headlight System shall be free from defects in material and workmanship under normal use and service for a period of three (3) years from the date of shipment, except the batteries, which are warrantedforone(1)yearfromthedateofshipment.Integra’ssoleandexclusiveliabilityunderthewarrantyshallbe,atIntegra’soption,eithertorepairorreplaceanycomponentwhichfailsduringthewarrantyperiodduetoanydefectinworkmanship or material, F.O.B. factory 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 Integra3. Upon inspection, Integra finds the equipment to be defective.

This warranty is contingent upon normal and proper use of the LED Surgical Headlight System. It does not cover equipment that has been modified with non-Integra parts without the written approval of Integra, subjected to unusual physical or electrical stress, or damaged during shipment. This warranty is non-transferable unless authorized in writing by Integra.

Integra reserves the right to make design changes on its products without liability to incorporate said change in Integra products previously designed or sold.

Upon receipt of the product, it should be carefully inspected. If any defect is discovered, notification must be given immediately to the manufacturer or authorized distributor.

Integra and the Integra logo are trademarks of Integra LifeSciences Corporation in the United States and/or other countries. ©2012 Integra LifeSciences Corporation. All rights reserved. Printed in the USA. P/N 60903358 Rev. A

For more information or to place an order, please contact:Integra n 311 Enterprise Drive, Plainsboro, NJ 08536800-997-4868 USA n 609-936-5400 outside USA n 888-980-7742 faxintegralife.com

Authorized EU Representative:Integra LifeSciences Services FranceImmeuble Séquloa 2, 97 allée Alexandre BorodineParc Technologique de la Porte des Alpes69800 Saint Priest - France+33 (0) 437 47 59 1

Integra®


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Manufactured by:Integra Burlington MA, Inc22 Terry AvenueBurlington, MA 01803

Documents

Integra · • The LED Surgical Headlight System should never be used in ocular surgery or in a surgical procedure requiring direct illumination of the eye