Integra Miltex | Medical Instruments | Medical Device Company

Integra
™
LED Surgical Headlight System
Integra
™
LED Surgical Headlight System
0123
Viviane Montarnal
Assistant General Counsel/Directrice juridique
Europe
+33 (0) 437 47 59 59 +33 (0) 682 382 986 cell
[email protected]
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+33 (0) 437 47 59 99 fax
Integra n Immeuble Séquloa 2, 97 allée Alexandre Borodine
Parc Technologique de la Porte des Alpes
69800 Saint Priest, France
For more information or to place an order, please contact:
Integra 311 Enterprise Drive, Plainsboro, NJ 08536
800-997-4868 USA 609-936-5400 outside USA 888-980-7742 fax
integralife.com
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The Integra logo is a trademark of Integra LifeSciences Corporation.
©2011 Integra LifeSciences Corporation. All rights reserved. Printed in the USA. P/N 7216678 Rev. A
Operation and Service Manual
Table of contents
Indications For Use........................................................................................................................................................................................... 03
Contraindications............................................................................................................................................................................................. 03
Table of Symbols............................................................................................................................................................................................... 04
General Warnings.............................................................................................................................................................................................. 05
Battery Warnings.............................................................................................................................................................................................. 06
Battery Charger Warnings............................................................................................................................................................................... 07
Overview............................................................................................................................................................................................................ 07
Preparing to Use the System........................................................................................................................................................................... 09
Operating the System...................................................................................................................................................................................... 09
Battery Charge Status and Low Battery Notification................................................................................................................................. 11
Recharging the Battery.................................................................................................................................................................................... 12
Maintenance and Cleaning.............................................................................................................................................................................. 13
Troubleshooting................................................................................................................................................................................................ 14
Specifications.................................................................................................................................................................................................... 15
Electromagnetic Compatibility (EMC)........................................................................................................................................................... 16
Integra Surgical Headlight Systems Ordering Information........................................................................................................................ 18
Replacement Parts & Accessories Ordering Information........................................................................................................................... 19
Repair and Return.............................................................................................................................................................................................. 20
Limited Warranty.............................................................................................................................................................................................. 20
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CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN
Table of Symbols
Do not dispose
No naked flames
Indications for use
The Integra™ LED Surgical Headlight System is designed to provide illumination to aid visualization during minor surgical,
diagnostic, or therapeutic procedures.
Meets requirements of the Medical
0123
Device Directive
Contraindictions
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.
REF
Listed by ETL
Meets requirements of the Federal
Communications Commission
Eligible for Call2Recycle Program
UN approved container
Part Number
Serial Number
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
3
Recycle symbol
Recycling symbol (Taiwan)
Restriction of Hazardous Substances
(China) 5 Year safe use period
Refer to Manual
In this manual, this symbol and “Caution”
indicate conditions or practices that
could damage the equipment or other
property
4
General Warnings
Battery Warnings
•The user should carefully study the Operation and Service 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.
•Only use enough light to ensure good visualization, and avoid prolonged close stationary illumination of tissue to reduce the risk of thermal injury to tissue.
•This Manual contains information about the proper procedures for preparing this product for its use and care.
•Explosion Hazard. Do not use the LED Surgical Headlight System in the presence of flammable anesthetics, liquids, vapors, gases, or dusts.
•Before every procedure, carefully inspect the LED Surgical Headlight System to ensure it has been properly maintained and cleaned, and that it is fully functional. DO NOT use if inspection reveals any damage such as case damage or loose connectors.
•Follow the instructions of other manufacturer’s 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 LED Surgical Headlight System.
•When the LED Surgical Headlight System is not in use, turn off the power.
•Keep cooling vent and fans free of obstructions.
•To ensure patient and operator safety and optimal product performance, use only accessories and supplies recommended for or supplied with the system, and use them according to the directions for use.
•The 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.
•Do not directly connect or short-circuit the positive (+) and negative (-) battery terminals.
•SAFETY PRECAUTIONS MUST ALWAYS BE EXERCISED WHEN USING ELECTRICAL EQUIPMENT TO PREVENT •To avoid short circuits, keep battery terminals away from OPERATOR/PATIENT SHOCK, FIRE HAZARD OR EQUIPMENT metal objects.
DAMAGE.
•Do not expose the battery to temperatures higher than •Electric shock hazard. If unit is not functioning properly,
49C/120F.
DO NOT OPEN. Please refer to the Repair and Return section of this Manual.
•You must charge the batteries for four hour or until completely charged, before using the battery power option.
•The LED Surgical Headlight System must be used with the recommended Integra battery or with recommended Integra •A dead battery may result if the batteries are left uncharged power cords with plugs inserted into properly grounded AC or unused for a long period of time.
power outlets.
•If the LED Surgical Headlight System will be unused for •The LED Surgical Headlight System should never be used several months or longer, remove the battery from the in ocular surgery or in a surgical procedure requiring direct battery holster prior to storing the system.
illumination of the eye.
Battery Charger Warnings
•Defective batteries can damage the Surgical Headlight 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.
•Do not expose the charger or power supply to water or liquids. The case is not sealed.
•Improper disposal 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.
•Do not cover the fan exhaust or obstruct the airflow, this will cause overheating.
•Improper handling of the battery can lead to heat generation, smoke, bursting, or fire.
•Do not open the charger or power supply case. No user serviceable parts are inside.
•Use only the manufacturer’s recommended power supply, charger, batteries and power cords.
•Store the charger in a cool spot, away from external heat sources.
•Do not remove the label from the battery.
•Do not immerse the battery in water or other liquids.
•Do not disassemble, modify, or solder the battery.
•Do not directly connect or short-circuit the positive (+) and negative (-) battery terminals.
Caution
•During recharging, the charger may become warm.
•To avoid short circuits, keep battery terminals away from metal objects.
•Do not expose the battery to temperatures higher than 49C/120F.
•You must charge the batteries for four hours or until completely charged, before using the battery power option.
•A dead battery may result if the batteries are left uncharged or unused for a long period of time.
•If the LED Surgical Headlight System will be unused for several months or longer, remove the battery from the battery holster prior to storing the system.
•The LED Surgical Headlight System produces high intensity light. Use care not to point the Headlight directly at the eye while in use.
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90520D LED Headlight with AC/DC Power Only
Overview
1
The Integra LED Surgical Headlight System is a self-contained headlight system that can be operated using either battery
or 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.
2
The AC/DC Power Only model comes
equipped with these components:
2
• LED Headlight with Cable
• AC Mains Power Cord
The Integra LED Surgical Headlight System utilizes an LED light source with an active cooling system. A thermostaticallycontrolled 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.
• 30W Power Supply
• 20’ DC Power Extension Cord
1
Headband
Suspension
Linkage
Controller
90520 LED Headlight w/Batteries and AC/DC Power Supply
Duct System
Headlight
Module
3
Headlight
Cable
The deluxe model includes all the components for both portable battery operation as well as AC/DC Power operation.
• LED Headlight with Cable
• 2 Batteries
• Battery Holster
• Battery Charger Base
Headlight Module
7
Contains 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.
Controller
Regulates 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.
Headband
Offers versatile size adjustment using two knobs (top and back) and incorporates a replaceable
pad set.
Suspension Linkage
Connects 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.
• 60W Power Supply
• AC Mains Power Cords
• 30W Power Supply
3
• 20’ DC Power
Extension Cord
8
Preparing to Use the System- With Battery Option
4
1.Clip the Battery Holster in a comfortable location.
Preparing to Use the System- With Battery Option
4
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:
5
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.
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2. Adjust the headband for optimal comfort by rotating the adjustment knobs on the top and back of the headband.
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• High Switch setting is approximately 2 hours plus low battery notification cycle
• Medium Switch setting is approximately 2 1/2 hours plus low battery notification cycle
5
3.Connect the Headlight’s power cable to the power source. For the Portable Battery Option, this is the battery holster (Figure 7). For the Direct Power Option, this is the 20’ DC Power Extension cord from the Direct Power Supply (Figure 8). The connectors are not keyed and will accept either orientation.
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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.
• Low Switch setting is approximately 3 hours plus low battery notification cycle
With AC/DC Power Option
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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8
Battery power
AC/DC power
#90500
LED
Headlight
#90500
LED
Headlight
#90522
Battery
#90531
20’ DC
power cord
#407421
AC/DC
Power
Supply
Connector
9
#90521 Holster
10
Battery Charge Status and Low Battery Notification
9
1. The Battery utilizes a 5-bar LCD “fuel gauge” to indicate its charge status (Figure 9):
5 bars displayed
4 bars
3 bars
2 bars
1 bar
No bars
Recharging the Battery
9
81% - 100% charged
61% - 80%
41% - 60%
21% - 40%
1% - 20%
Fully discharged
2. An audible notification in the form of a three-tone cycle will sound when the battery has fifteen minutes of charge remaining. The notification will repeat more frequently as the battery approaches the fully-discharged state.
15 minutes remaining
12 minutes
9 minutes
6 minutes
3 minutes
1 audible notification cycle
1 cycle
2 cycles
3 cycles
Notification cycle repeats until battery is fully discharged
3. Lowering the Headlight intensity setting will extend the duration of the charge. If the intensity setting is lowered after the low battery notification sounds, the system will be reset and will reflect the longer remaining battery charge.
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1.Place the Battery Charger on a flat, level surface away from sources of heat and moisture.
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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. Place the battery into the Charger’s battery bay, ensuring that the 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
Green solid
Red solid
Battery charging
Battery fully charged
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.
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:
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• High Switch setting is approximately 2 hours plus low battery notification cycle
• Medium Switch setting is approximately 2 1/2 hours plus low battery notification cycle
• Low Switch setting is approximately 3 hours plus low battery notification cycle
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Maintence and Cleaning
Troubleshooting
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.
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.
Cleaning
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.
Fan may have been damaged after
dropping headlight.
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.
Return to Integra for service.
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 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
a
Caution
Do not immerse any component of the LED SurgicalHeadlight System in cleaning solution.
Caution
Do not sterilize the LED Surgical Headlight System.
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Electromagnetic Compatibility
Portable LED Headlight
Table 201
Guidance and Manufacturer’s Declaration – Emissions All Equipment and Systems
Type
LED
Wattage
13 Watts
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.
Lamp Life
> 25,000 hours
Emissions Test
Compliance
Electromagnetic Enforcement -- Guidance
Color Temperature
5,250 K
RF Emissions CISPR 11
Group 1
Spot Size Range
25mm to 125mm at 16 in (~40mm) working distance
Power Input
9-15 VDC
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 The Integra LED Surgical Headlight System is suitable for use in all
Conducted Emissions establishments including domestic and those directly connected to the
public low voltage power supply network that supplies buildings used
Class A
for domestic purposes.
Complies
Battery Power Kit
Type
Lithium Ion, 4 cell pack
Harmonics IEC 61000-3-2
Classifications
US/FDA, Canada, Australia, EU: Class I
Capacity
37 Wh
Voltage fluctuations/flicker
emissions IEC 61000-3-3
Voltage
14.4 VDC @ 2.6 Ah
Electrical Safety
IEC 60601-1
Table 202
Guidance and Manufacturer’s Declaration – Immunity All Equipment and Systems
Battery Charger, Single Bay
Classification
US/FDA, Canada, Australia, EU: Class II, Double Insulated
Input
100-240 VAC, 47-63 Hz, 1.5 A
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.
Output
24 VDC, 2.7 A
Immunity Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment -Guidance
Classifications
US/FDA, Canada, Australia, EU: Class II, Double Insulated
Electrostatic Discharge
(ESD) IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Power Input
100-240 VAC, 47-63 Hz, 1.0 A
Floors should be wood, concrete, or
ceramic tile. If floors are synthetic, the
relative humidity should be at least 30%
Power Output
15 VDC, 2.0 A
AC Power Leakage
<100μA @ 264VAC, 60Hz
± 2 kV mains
± 1 kV I/O
± 2 kV mains
Not applicable
Electromagnetic Compatibility
EN55022/55024/61000
Electrical Fast
Transient/burst IEC
61000-4-4
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
Cycle
60% Dip for 5 Cycles
30% Dip for 25 Cycles
>95% Dip for 5 sec
>95% Dip for 0.5
Cycle
60% Dip for 5 Cycles
30% 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 Frequency
50/60 Hz Magnetic Field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields should
be that of a typical commercial or
hospital environment.
Direct Power Kit
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
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Electromagnetic Compatibility (EMC) User Information
Operating Temperature
6 C to 40 C (43 F to 104 F). Above 5,000 ft (1,524 m) elevation, the
maximum 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
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Electromagnetic Compatibility (continued)
Integra Surgical Headlight Systems Ordering Information
Table 204
Guidance and 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 insure that it is used in such an environment.
Immunity Test
IEC 60601
Test Level
Compliance
Level
Conducted RF
IEC 61000-4-6
3 Vrms from
V1 = 3 Vrms
150 kHz to 80 Mhz
Electromagnetic Environment — Guidance
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,
2.33, and 5/8 meters).
Recommended separation distance:
80 MHz to 800 MHz
800 MHz to 2.5 GHz
where is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer and 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.
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
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.
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.
a
b
17
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1]V/m
18
Replacement Parts & Accessories Ordering Information
Repair and Return
Returning Device for Repair
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
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 Customer Service at +1-914-592-9050, or US and Canada Toll Free: 1-(800) 431-1123
Limited Warranty
19
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
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
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
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, 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 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 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.
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