Integra Duo Instructions For Use Manual

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Page 1

Integra® Duo

LED Surgical Headlight System

Instructions for Use

Page 2

Page 3

Table of Contents

Indications & Contraindications

Overview

Baery Information

Device Speciﬁcations

Table of Symbols

Integra Duo Kit Options

Maintenance & Cleaning

EMC User Information

Warnings & Cautions

Preparing the System

Troubleshooting

Integra Duo Ordering Information

Replacement Parts

Repair & Return

Product Information Disclosure

Page 4

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

Indications for Use

The Integra® Duo LED Surgical Headlight System is designed to provide 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.

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Table of Symbols

500hPa

Restriction of Hazardous Substances (China) 5-Year Safe Use Period

Product complies with the requirements of directive 93/42/EEC

Listed by ETL

For Baery Purposes- No Naked Flames

Class II Equipment, used on power adapter

Recycle

Eligible for Call2Recycle Program Recycle (Taiwan)

Non-Sterile

Waste Electrical and Electronic Equipment

Manufacturer Date of Manufacture

(YYYY-MM-DD)

1060hPa

Storage Atmospheric Pressure Limitations

95%

Storage Humidity Limitations (Non-Condensing)

(120

(-4

Storage Temperature Limitations

MR Unsafe

Serial Number

Catalog Number

Consult Instructions for Use www.integralife.com

Caution

Keep Dry

Authorized Representative in the European Community

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

Degrees of protection provided by

enclosures (IP Code) for power adapter

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General Warnings

• The user should carefully study the Instructions for Use (IFU) before using the Integra

Duo LED Surgical Headlight System in the clinical environment. Instructions should be

followed, with special aention given to warnings, controls, and user speciﬁcations.

The IFU should be made available to appropriate personnel.

• This IFU contains information about the proper procedures for preparing this product

for its use and care.

• Before every procedure, carefully inspect the Integra Duo LED Surgical Headlight

System to ensure it has been properly maintained, cleaned, and is fully functional.

DO NOT use if inspection reveals any damage or loose connectors.

• Follow the instructions of other manufacturers’ equipment when used in conjunction

with 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.

• Electric shock hazard. If unit is not functioning properly, DO NOT OPEN. Please refer

to the Repair and Return section of this manual.

• The Integra Duo LED Surgical Headlight System must be used only with the

recommended Integra baery or with the AC power adapter supplied by Integra.

Using a diﬀerent AC power adapter may not provide protection against electric shock.

• The Integra Duo LED Surgical Headlight System should never be used in ocular

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

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General Warnings (Continued)

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

• Only use enough light to ensure good visualization and avoid prolonged close

stationary illumination of tissue to reduce the risk of thermal injury.

• 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.

• Keep cooling vents free of obstructions.

• To ensure patient / operator safety and optimal product performance, use only

recommended accessories and supplies with the system according to the instructions

for use. Use of accessories and cables other than those speciﬁed or provided by the

manufacturer of this equipment could result in increased electromagnetic 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 equipment.

• Portable RF communications equipment (including peripherals such as antenna cables

and external antennas) should be used no closer than 30 cm (12 inches) to any part of

the Integra Duo LED Surgical Headlight System, including cables speciﬁed by Integra.

Otherwise, degradation of the performance of this equipment could result.

• Care should be taken if the equipment is used adjacent to or stacked with other

equipment; if adjacent or stacked use is inevitable, the equipment should be observed

to verify normal operation in the conﬁguration in which it will be used.

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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.

Baery Warnings

• Defective baeries can damage the Integra Duo LED Surgical Headlight System.

If the baery shows any signs of damage, leakage, or cracking, it must be replaced

immediately, and only with an Integra baery recommended for or supplied with the

system.

• Improper disposal of baeries may create an explosion or contamination hazard.

Never dispose of baeries in refuse containers. Do not dispose of the baery in ﬁre.

Always recycle baeries according to local regulations.

• Improper handling of the baery can lead to heat generation, smoke, bursting, or ﬁre.

• Do not remove the label from the baery.

• Do not immerse the baery in water or other liquids.

• Do not disassemble or modify the baery.

• Do not directly connect or short-circuit the positive (+) and negative baery terminals.

• To avoid short circuits, keep baery terminals away from metal objects.

• Do not expose the baery to temperatures higher than 49°C/120°F.

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Baery Charger Warnings

• Do not expose the charger or power supply to water or liquids. The case is not sealed.

• Do not open the charger or power supply case. No user serviceable parts are inside.

• Do not cover the fan exhaust or obstruct the airﬂow; this will cause overheating.

• Use only the Integra supplied power supply, charger, baeries and power cords.

• Store the charger in a cool spot, away from external heat sources.

Caution

• 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.

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Overview

The Integra Duo LED Surgical Headlight System is a self-contained headlight system that

can be operated using either baery or direct power supply. Using a baery pack gives the

surgeon complete mobility allowing unrestricted movement in and around the operating

suite. The direct power supply option is intended to be a back-up to the baery system but

could also be used as a primary power source for unlimited operating time.

The Integra Duo LED Surgical Headlight System provides supplemental illumination during a

surgical procedure. 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. The air is drawn through a duct system and is gently

exhausted behind the surgeon and outside the surgical ﬁeld. The major components of the

headlight itself are shown in Figure 1 and described on the adjacent page.

Headlight

Headlight Cable

Comfort Code

Alphanumeric Sizing

System

Rear Knob

Figure 1

Top Knob

Duct System

Luminaire

Iris Wheel

Occipital Basket

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Luminaire

Headlight Cable

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.

The cable connects the headlight to the baery holster.

Duct System

Headband

Padding

Suspension Linkage

Intensity Knob

Comfort Code™ Alphanumeric Sizing System

Serves as a conduit for airﬂow from the luminaire to the cooling fan.

Oﬀers versatile size adjustment using two knobs (top and rear), lateral strap, and a pivoting occipital basket. Headband also incorporates a replaceable pad set for comfort.

Five (5) pads provide a so and responsive interaction between the headband and the user. Replacement of padding every six (6) months is recommended.

These two links connect the luminaire to the headband and provide range of motion while positioning.

Located on the holster and regulates power to the LED from either baery or direct power supply. This rotary switch allows for adjustment of light intensity.

An alphanumeric sizing system is located on the rear strap and leers located on the top strap. Once the correct ﬁt is determined, this combination will allow for quick setup of the headlight.

Suspension Linkage

Baery Holster

Intensity Knob

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Integra Duo 2-Bay Kit

The standard model includes all of the components

for both portable baery operation and direct

power operation.

Integra Duo 4-Bay Kit

LED Headlight

with Cable

The deluxe model includes all of the components

for both portable baery operation and direct

power operation. With two additional bays, it

oﬀers twice the charging capability of the standard

model.

LED Headlight

with Cable

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LED Headlight & Case

Baery Holster

2 Baeries

90600

Direct Power Supply:

AC Power Adapter & Power Cord

90690

LED Headlight & Case

90600

90621

2-Bay Charger: Baery Charger Base,

Charger Power Supply & Charger Cord

Baery Holster

90621

90622

90624

2 Baeries

90622

Direct Power Supply:

AC Power Adapter & Power Cord

90690

4-Bay Charger: Baery Charger Base,

Charger Power Supply & Charger Cord

90664

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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.

Adjust the top knob until the brow pad is

positioned comfortably against your forehead.

Aer adjusting the top knob, tighten the rear

knob slowly until headlight feels snug.

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.

Page 15

Achieve optimal ﬁt by rotating the dials

until your Comfort Code size is set on

the headlight.

Properly ﬁing 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

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

Write down your Comfort Code size

(number on rear strap & leer on top strap)

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Preparing the System:

Aaching the Baery Holster & Power

Plug the gray headlight cable into the keyed

connection point on the underside of the

baery holster. Align the indications on

the headlight cable and baery holster

connections; push the connector to snap it

into place.

Clip the baery holster to a comfortable location.

Baery Power Option: Insert and fully seat

the baery into the baery holster. For proper

baery orientation, align the baery so that the

5-pin connector in the holster mates with the 5

slots on the baery.

Direct Power Supply Option: Plug the black

AC power adapter into the baery holster

adjacent to the intensity knob. Align the

indications on the direct power cable and

baery holster connections; push the

connector to snap it into place.

To power on the LED Surgical Headlight, turn

the intensity knob, located on the underside

of the baery holster, clockwise. Turn the

headlight oﬀ by rotating the intensity knob

counter-clockwise.

Page 17

Disconnection requires a 1/4 turn

counter-clockwise.

The Integra Duo logo on the baery will

be visible through the opening of the

baery 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.

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Page 19

Baery Charge Status

The baery utilizes a 5-bar

LCD “fuel gauge”, located

on the top surface of the

baery, to indicate its

charge status.

Bars Charge

Low Baery Notiﬁcations

An audible notiﬁcation in

the form of a three-tone

cycle will sound when the

baery has ﬁeen minutes

of life remaining at the

current intensity seing.

The notiﬁcation will repeat

more frequently as the

baery approaches the

fully discharged state.

Approx. Minutes Remaining

5 81-100%

4 61% - 80%

3 41% - 60%

2 21% - 40%

1 1% - 20%

0 0%

Audible Notiﬁcation Cycles

15 1

12 1

9 2

6 3

3 Continuous

The baery life of the

headlight is dependent

on the intensity seing.

A headlight on maximum

intensity with a fully

charged baery will

operate for approximately

4 hours.

Conserving Baery Life

Lowering the headlight intensity seing will extend the life of the baery.

Raising the intensity seing will reduce the baery life.

Page 20

Recharging the Baery

1. Place the baery charger on a ﬂat, level surface away from sources of heat and moisture.

2. Connect the baery charger base, power supply, and supplied charger cord. Plug the

charger cord into any standard outlet.

3. Place the baery into one of the charger’s baery bays, ensuring that the 5-pin

connector is fully seated.

1. The baery will automatically begin charging. The indicating light on the charger

will provide charging status information.

Indicating Light Status

Green Flashing Baery Charging

Green Solid Baery Fully Charged

Red Solid Error, Replace Baery

• A completely discharged baery should become fully charged in approximately

three (3) hours.

• Charge the baeries completely before ﬁrst use.

• A baery may become fully discharged if le unused for a long period.

• If the LED Surgical Headlight System will not be used for several months or longer,

remove the baery from the baery holster prior to storing the system.

• The charger has holes allowing you to mount the unit to the wall if desired.

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-Bay Charger

-Bay Charger

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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 & Headlight (Hard Surfaces)

Luminaire Lens 70% Isopropyl alcohol Gently wipe lens surface.

Padding 70% Isopropyl alcohol Wipe down the padding, while

70% Isopropyl alcohol or lukewarm water and mild detergent

Wipe the surfaces of the headlight and cables. Excess solution entering the headlight assembly could damage internal components.

not saturating the cloth.

Cleaning Caution

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

solution.

• Do not sterilize the LED Surgical Headlight System.

Page 23

Troubleshooting

Trouble Area Possible Cause Corrective Action

Headlight will not switch on.

Brightness of spot decreases during use and/or the luminaire becomes hot to the touch.

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

Fully charged baery operates headlight for less than 2 hours.

Cooling fan is making a whirring, clicking sound or is not spinning.

Cord connections and/or baery may not be completely seated.

Temperature of LED may have increased due to blockage of airﬂow.

Detach and ﬁrmly seat cord and/or baery to assure complete connection.

Turn oﬀ the headlight; check and remove any obstructions from the luminaire, intensity knob, and fan vents.1 Return to Integra for service if issue is not resolved.

Lens may be dirty. Clean lens with 70% Isopropyl

alcohol.

Baery may be losing

Replace baery.

charge capacity.

Fan may have been

Return to Integra for service. damaged aer dropping headlight or as a result of electrostatic discharge.

The 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 seing. If the temperature of the LED continues to rise, the intensity of the headlight will default to a seing less than the low seing of the headlight. This serves to communicate the overheating condition while maintaining some level of illumination until an alternate light source can be employed.

Page 24

Device Speciﬁcations

Portable LED Headlight: Integra 90600

Classiﬁcation

Type

Waage

Lamp Life

Color Temperature

Spot Size Range Power Input

Risk Group 1

Baery: Integra 90622

Type

Capacity

Voltage

Electrical Safety

2-Bay Baery Charger: Integra 90624

Input

Output

Electrical Safety

FDA Class II, Exempt: CA, EU, AU: Class 1

LED

9.3 Was 48,000 Hours Average 5900°K 42mm to 125mm at 16 in (~40cm) working distance

9-15 VDC IEC 62471 For Blue Light

Lithium Ion, 4-cell pack

48.2 Wh

7.2 VDC @ 6700mAh IEC 62133 Ed. 2

100 – 240 VAC, 50-60 Hz, 1.7A

12 – 19 VDC, 3.0A IEC 60950-1

4-Bay Baery Charger: Integra 90664

Input

Output

Electrical Safety

100-240 VAC, 50/60Hz, 2.1A

19 VDC, 7.8A IEC 60950-1

Direct Power Kit: Integra 90690

Input

Output

AC Power Leakage

Electrical Safety

100-240Vac, 50Hz/60Hz

9Vdc, 3A <90 uA @ 264 VAC, 60 Hz IEC 60601-1 Ed. 3.1

Power Cords

Type

Appliance End

Outlet End

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

IEC 60320 C17 Country speciﬁc for US, UK, AU, EU

Page 25

Device Speciﬁcations

IO Cables Description

Description Length

Power cable: Shielded 18AWG AC power cable 12 

AC Power adapter cable: 2-conductor 20 AWG DC power cable 8  Headlight cable: Shielded 6-conductor 22/26AWG 5 

All cables are non-patient contacting.

Environment

Operating Temperature Below 5000’ (1,524m)

Operating Temperature Above 5000’ (1,524m)

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 adapter

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

6˚C to 40�C (43˚F to 104�F)

6�C to 32�C (43�F to 90�F)

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

• IEC 60601-1-6/ IEC 62366

• IEC 62471

• The Headlight and medical power supply are used in the patient environment. The baery charger is not used in the patient environment.

Page 26

Electromagnetic Compatibility (EMC) User Information

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.

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 A

Radiated and

Conducted

Emissions

Harmonics IEC 61000-3-2 Class A

Voltage ﬂuctuations/

ﬂicker emissions IEC

61000-3-3

Note: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas

and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class

B is normally required), this equipment might not oﬀer adequate protection to radio-frequency

communication services. The user might need to take mitigation measures, such as relocating or

reorienting the equipment.

Complies

The Integra LED Surgical Headlight System

is suitable for use in industrial areas and

hospitals (CISPR 11 class A).

Page 27

Electromagnetic Compatibility (EMC) User Information

Table 2:

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.

Immunity Test IEC 60601-1-2 Test

Level

Electrostatic Discharge (ESD) IEC 61000-4-2

Electrical Fast Transient/burst IEC 61000-4-4

Surge IEC 61000-4-5

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

Power Frequency 50/60 Hz Magnetic Field IEC 61000-4-8

± 8 kV contact ± 15 kV air

± 2 kV mains 100 kHz repetition frequency

±1 kV Diﬀerential ± 2 kV Common

Voltage Dips 100% drop, 0.5 periods, 0⁰, 45⁰, 90⁰, 135⁰, 180⁰, 225⁰, 270⁰, 315⁰ 100% dip, 1 period 30% dip, 25/30 periods Voltage Interruptions (all input current) 100% drop, 5 seconds

30 A/m, 50 or 60 Hz 30 A/m, 50 or 60 Hz

Compliance Level

± 8 kV contact ± 8 kV air*

± 2 kV mains 100 kHz repetition frequency

±1 kV Diﬀerential ± 2 kV Common

* Floors should be wood, concrete, or ceramic tile and the relative humidity should be > 30% to

prevent electrostatic discharges >8 kV. If ﬂoors are synthetic, ESD charges greater than 8 kV may be

present which can lead to damage to the headlight and loss of light output.

Page 28

Electromagnetic Compatibility (EMC) User Information (Continued)

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 IEC 60601-1-2 Test Level Compliance Level

Conducted RF IEC 61000-4-6

Radiated RF IEC 610000-4-3

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.

3V with 6V ISM, Amateur 80% AM at 1 kHz or risk frequency 150 kHz – 80 MHz

3 V/m, 80% AM AT 1 kHz or risk frequency 80 MHz – 2700 MHz

V1 = 3 Vrms

E1 = 3 Vrms

Page 29

Integra Duo Ordering Information

REF # Description Headlight Baery Kit AC Power Kit

90620US Duo Headlight

System w/ 2-Bay Kit - US

90620UK Duo Headlight

System w/ 2-Bay Kit - UK

90620EU Duo Headlight

System w/ 2-Bay Kit - EU

90620AU Duo Headlight

System w/ 2-Bay Kit - AU

90640US Duo Headlight

System w/ 4-Bay Kit - US

90640UK Duo Headlight

System w/ 4-Bay Kit - UK

90600 - Duo Headlight Only w/ Carrying Case

90630US -Duo 2-Bay Kit (Charger, 2 Baeries, Holster) - US

90630UK -Duo 2-Bay Kit (Charger, 2 Baeries, Holster) – UK

90630EU -Duo 2-Bay Kit (Charger, 2 Baeries, Holster) - EU

90630AU -Duo 2-Bay Kit (Charger, 2 Baeries, Holster) - AU

90634US -Duo 4-Bay Kit (Charger, 2 Baeries, Holster) - US

90634UK -Duo 4-Bay Kit (Charger, 2 Baeries, Holster) – UK

90660US - Duo Direct Power Kit (Supply & AC Cable) - US

90660US - Duo Direct Power Kit (Supply & AC Cable) - UK

90660US - Duo Direct Power Kit (Supply & AC Cable) - EU

90660US - Duo Direct Power Kit (Supply & AC Cable) - AU

90660US - Duo Direct Power Kit (Supply & AC Cable) - US

90660US - Duo Direct Power Kit (Supply & AC Cable) - UK

90640EU Duo Headlight

System w/ 4-Bay Kit - EU

90640AU Duo Headlight

System w/ 4-Bay Kit - AU

90600 - Duo Headlight Only w/ Carrying Case

90634EU -Duo 4-Bay Kit (Charger, 2 Baeries, Holster) - EU

90634AU -Duo 4-Bay Kit (Charger, 2 Baeries, Holster) - AU

90660US - Duo Direct Power Kit (Supply & AC Cable) - EU

90660US - Duo Direct Power Kit (Supply & AC Cable) - AU

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 – UK

90624US Duo 2-Bay Charger w/ Power Supply &

Cord – US

90624UK Duo 2-Bay Charger w/ Power Supply &

Cord – UK

90624EU Duo 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

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 Baery Holster (Qty 1) Baery holster only

90622 Duo Lithium Ion Baeries (Qty 2) (2) Baeries

90642 Duo Replacement Padding Set (1) Set of headlight padding

2-bay charger w/ power supply and charger cord

4-bay charger w/ power supply and charger cord

90620CS Duo Carrying Case Case only

90670 Duo Refresh Kit (padding, 2 baeries, holster) Holster, (2) baeries, and pad set

Page 31

Repair & 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 their local Integra representative or call Integra

Service & Repair at:

Location Number

US (toll-free) +1 888-772-7378

Outside USA +1 781-565-1401

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 baeries, 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:

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 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 wrien 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.

Page 32

PRODUCT INFORMATION DISCLOSURE

INTEGRA LIFESCIENCES CORPORATION (“INTEGRA”) HAS EXERCISED REASONABLE

CARE IN THE SELECTION OF MATERIALS AND THE MANUFACTURE OF THESE

PRODUCTS. INTEGRA WARRANTS THAT THESE PRODUCTS SHALL CONFORM TO

THE PRODUCT LIMITED WARRANTY AS PROVIDED IN THE PRODUCT LABELING OR

APPLICABLE PRODUCT 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 ANY

PERSON TO ASSUME ANY OTHER OR ADDITIONAL LIABILITY OR RESPONSIBILITY IN

CONNECTION WITH THESE PRODUCTS.

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Integra LifeSciences Services (France) Immeuble Séquoïa 2 97 allée Alexandre Borodine Parc Technologique de la Porte des Alpes 69800 Saint Priest, France Tel: +33 (0) 4 37 47 59 50 Fax: +33 (0) 4 37 47 59 25

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

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