Integra Operation and Service Manual
1 Integra
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 2
Integra CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN Indications for use The Integra is designed to provide illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures. This device is intended to be used by professional users. Contraindications The Integra 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. 3
Table of Symbols Do not dispose No naked flames Meets requirements of the Medical Device Directive Recycle symbol Listed by ETL UN approved container Eligible for Call2Recycle Program Recycling symbol (Taiwan) REF 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 In this manual, this symbol and Caution indicate conditions or practices that could damage the equipment or other property Caution: Federal (USA) law restricts this device to sale by or on the order of a physician Temperature limitations EU Authorized Representative Humidity limitations Manufacturer Atmospheric pressure 4
Integra General Warnings The user should carefully study the Operation and Service Manual before using the 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. This Manual contains information about the proper procedures for preparing this product for its use and care. Before every procedure, carefully inspect the LED Surgical 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. 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 must be used with the recommended Integra battery or with recommended Integra power cords with plugs inserted into properly grounded AC power outlets. The should never be used in ocular surgery or in a surgical procedure requiring direct illumination of the eye. 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. When the is not in use, turn off the power. Explosion Hazard. Do not use the LED Surgical Headlight System in an oxygen rich environment or in the presence of flammable anesthetics, liquids, vapors, gases, or dusts. 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. 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 (4) 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 will be unused for several months or longer, remove the battery from the battery holster prior to storing the system. The produces high intensity light. Use care not to point the Headlight directly at the eye while in use. 5
Battery Warnings 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. 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. Improper handling of the battery can lead to heat generation, smoke, bursting, or fire. Do not remove the label from the battery. Do not immerse the battery in water or other liquids. Do not disassemble, modify, or solder the battery. 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. 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 manufacturer s recommended power supply, charger, batteries and power cords. Store the charger in a cool spot, away from external heat sources. If replacement is necessary, replace only with approved power cord. Caution During recharging, the charger may become warm. No modification of this equipment is allowed. This device should be used in environments that meet the operating environmental conditions in the specification section of this manual. You must charge the batteries for four (4) 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 will be unused for several months or longer, remove the battery from the battery holster prior to storing the system. 6
Integra Overview 1 The Integra 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 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. 1 Headband Suspension Linkage Controller Headlight Module Duct System Headlight Cable Headlight Module Controller Duct System 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. 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. Serves as a conduit for airflow from the headlight module to the cooling fan. Headband Suspension Linkage Headlight Cable Offers versatile size adjustment using two knobs (top and back) and incorporates a replaceable pad set. Connects the headlight module to the headband and allows for positioning of the headlight module Connects the Battery or Direct DC Power Supply to the Controller. 7
90520 LED Headlight w/batteries and AC/DC Power Supply 2 The deluxe model includes components for both the portable battery operation as well as AC/DC Power operation. LED Headlight with Cable 2 Batteries Battery Holster Battery Charger Base 60W Power Supply AC Mains Power Cords 30W Power Supply 20 DC Power Extension Cord 2 90520D LED Headlight with AC/DC Power Only 3 The AC/DC Power Only model comes equipped with these components: LED Headlight with Cable AC Mains Power Cord 30W Power Supply 20 DC Power Extension Cord 3 8
Integra Preparing to Use the System- With Battery Option 4 1. Clip the Battery Holster in a comfortable location. 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: 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 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. 9
Preparing to Use the System- With Battery Option 5 6 7 8 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. 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. 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. 5 6 7 8 Battery power #90500 LED Headlight AC/DC power #90500 LED Headlight #90522 Battery #90531 20 DC Power Cord #407421 AC/DC Power Supply Connector #90521 Holster 10
Integra Battery Charge Status and Low Battery Notification 9 1. The Battery utilizes a 5-bar LCD fuel gauge to indicate its charge 9 status (Figure 9): 5 bars displayed 81% - 100% charged 4 bars 61% - 80% 3 bars 41% - 60% 2 bars 21% - 40% 1 bar 1% - 20% No bars 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 1 audible notification cycle 12 minutes 1 cycle 9 minutes 2 cycles 6 minutes 3 cycles 3 minutes 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. 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 11
Recharging the Battery 10 1. Place the Battery Charger on a flat, level surface away from 10 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. 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. 12
Integra Maintenance and Cleaning Maintenance The Integra 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. Caution Do not immerse any component of the in cleaning solution. Caution Do not sterilize the. 13
Troubleshooting Trouble Area Possible Cause Corrective Action Headlight will not switch on Brightness of spot decreases during use Brightness of spot is diminished and / or the spot appears fuzzy Fully charged battery operates headlight for less than 2 hours Cooling fan is making a whirring or clicking sound Power cord connections may not be effective Temperature of LED may have increased due to blockage of airflow Lens may be contaminated Battery may be losing charge capacity Fan may have been damaged after dropping headlight Detach and firmly seat to assure complete connection Turn off the headlight, check and remove any obstructions from the headlight module and controller fan vents. a Clean lens with 70% Isopropyl Alcohol Replace battery Return to Integra for service a 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. 14
Integra Electromagnetic Compatibility Portable LED Headlight Type Wattage Lamp Life Color Temperature Spot Size Range Power Input 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 Input Output Direct Power Kit Classifications Power Input Power Output AC Power Leakage Electromagnetic Compatibility Power Cords Type Appliance End Outlet End Environment LED 13 Watts >25,000 hours 5,250 K 25mm to 125mm at 16 in (~40cm) working distance 9-15 VDC US/FDA, Canada, Australia, EU: Class II, Double Insulated 100-240 VAC, 47-63 Hz, 1.5 A 24 VDC, 2.7 A US/FDA, Canada, Australia, EU: Class II, Double Insulated 100-240 VAC, 47-63 Hz, 1.0 A 15 VDC, 2.0 A <100μA @ 264VAC, 60Hz EN55022/55024/61000 Class II, 2.5-3.0A, Double Insulated, Detachable IEC 60320 C17 Country specific for US, UK, AU, EU 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 Mode of Operation Continuous Ingress Protection IP20 Pressure Operating 700-1060hPa / Storage 500-1060hPa 15
Electromagnetic Compatibility (EMC) User Information Table 201 Guidance and Manufacturer s Declaration Emissions All Equipment and Systems The Integra 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 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 Harmonics IEC 61000-3-2 Voltage fluctuations/flicker emissions IEC 61000-3-3 Class B Radiated and Conducted Emissions Class A Complies The Integra 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. Table 202 Guidance and Manufacturer s Declaration Immunity All Equipment and Systems The Integra 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 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 ± 6 kv contact ± 8 kv air ± 2 kv mains ± 1 kv I/O ±1 kv Differential ± 2 kv Common >95% Dip for 0.5 Cycle 60% Dip for 5 Cycles 30% Dip for 25 Cycles >95% Dip for 5 sec Compliance Level ± 6 kv contact ± 8 kv air ± 2 kv mains Not applicable ±1 kv Differential ± 2 kv Common >95% Dip for 0.5 Cycle 60% Dip for 5 Cycles 30% Dip for 25 Cycles >95% Dip for 5 sec Electromagnetic Environment -- Guidance Floors should be wood, concrete, or ceramic tile. If floors are synthetic, the relative humidity should be at least 30% Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. 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. 3 A/m 3 A/m Power frequency magnetic fields should be that of a typical commercial or hospital environment. 16
Integra Electromagnetic Compatibility (continued) Table 204 Guidance and Manufacturer s Declaration Electromagnetic Immunity The Integra 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 Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 3 Vrms from 150 khz to 80 Mhz 3 Vrms from 80 MHz to 2.5GHz Compliance Level V1 = 3 Vrms E1 = 3V/m 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 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 survey a, should be less than the compliance level in each frequency range b. 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 17
Integra Surgical Headlight Systems Ordering Information REF # Description Headlight Battery Kit AC/DC Power Kit 90520 Integra with Batteries and AC/DC Power 90520US 90520EU 90520UK 90520AU LED Headlight w/batteries & AC/DC Power Supply - US LED Headlight w/batteries & AC/DC Power Supply - EU LED Headlight w/batteries & AC/DC Power Supply - UK LED Headlight w/batteries & AC/DC Power Supply - AU 90520D Integra with AC/DC Power Only 90520DUS 90520DEU 90520DUK 90520DAU LED Headlight with AC/DC Power Supply Only - US LED Headlight with AC/DC Power Supply Only - EU LED Headlight with AC/DC Power Supply Only - UK LED Headlight with AC/DC Power Supply Only - AU 90500 90530US 90550US 90500 90530EU 90550EU 90500 90530UK 90550UK 90500 90530AU 90550AU 90500 N/A 90550US 90500 N/A 90550EU 90500 N/A 90550UK 90500 N/A 90550AU 18
Integra Replacement Parts & Accessories Ordering Information 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 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 19
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 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. 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. 20
Integra Manufactured by: Integra Burlington MA, Inc 22 Terry Avenue Burlington, MA 01803 Authorized EU Representative: Integra LifeSciences Services France Immeuble Séquloa 2, 97 allée Alexandre Borodine Parc Technologique de la Porte des Alpes 69800 Saint Priest - France +33 (0) 437 47 59 1 For more information or to place an order, please contact: Integra n 311 Enterprise Drive, Plainsboro, NJ 08536 800-997-4868 USA n 609-936-5400 outside USA n 888-980-7742 fax integralife.com 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