LED Surgical Headlamp Operation and Service Manual Rev A

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

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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

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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. • 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 LED Surgical Headlight System must be used with the recommended Integra battery or with recommended Integra power cords with plugs inserted into properly grounded AC power outlets. • The LED Surgical Headlight System should never be used in ocular surgery or in a surgical procedure requiring direct illumination of the eye.

• 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. • 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 hour 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.

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.

• 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.

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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

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Headband

Suspension Linkage

Controller

90520 LED Headlight w/Batteries and AC/DC Power Supply Duct System Headlight Module

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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

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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

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• 20’ DC Power Extension Cord

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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:

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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

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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. 6

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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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Battery power

AC/DC power #90500 LED Headlight

#90500 LED Headlight

#90522 Battery

#90531 20’ DC power cord

#407421 AC/DC Power Supply Connector

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#90521 Holster

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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: • 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

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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

Electromagnetic Compatibility (EMC) User Information

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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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

REF #

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.

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

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

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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

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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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