OPERATION AND SERVICE MANUAL

Integra Luxtec OPERATION AND SERVICE MANUAL EN Integra Luxtec For use with high power surgical light sources such as Integra Luxtec MLX 300W system. 1

Table of Contents Indications for Use...2 Contraindications...2 Symbols... 3 General Warnings...4 DLX UltraLite Pro Camera Control Unit (CCU) Assembly...4 DLX UltraLite Pro Camera Overview Inspection Before Use... 5 Installation of CCU to Floor stand (optional)... 5 Set-Up For Use...6 Connection Instructions... 6-7 White Balance...8 Troubleshooting...8 Cleaning...9 DLX UltraLite Pro Camera Specifications...9 Ordering Equipment... 10 Electromagnetic Compatibility (EMC) User Information...11-14 Repair and Return Instructions...15 Limited Warranty...15 Disposal of the Product, Packaging Material and Accessories...15

CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. Symbols Found on a medical grade light source, other illumination related equipment, fiber optic cables and corresponding packaging. Indications for use Caution IPXO Ordinary protection against ingress of fluids The surgical headlight camera is intended to provide remote viewing of the surgical procedure by health care professionals. The image may be recorded for documentation or training purposes. Humidity Limitation AWB White Balance Contraindications This device is not intended to provide images for diagnostic use. Temperature Limitation Y/C Video S-Video chromaticity & luminance Composite video User Groups Keep dry Waste Electrical and Electronic Equipment The DLX Camera System is intended for use in the operating room by medical professionals. The DLX Camera System is not used for any purpose that is related to the procedure and is not indicated for any medical condition. Rather, it can be used for educational purposes or for recording of the procedure. REF LOT Part Number Batch Code Atmospheric Pressure Limitation Common user groups include surgeons, surgeon s assistants and circulating nurses. Serial Number EC REP Authorized Representative in the European Community 003285NTSC / 003285PAL Model Differences Manufacturer PN Description 003285NTSC 003285PAL N0000091 Assembly, CCU NTSC X - Date of Manufacture N0000092 Assembly, CCU PAL - X 003285HLNTSC Headlight Camera System (NTSC) HL & CCD Only X - This device meets CE requirements 003285CCNTSC 003285HLPAL 003285CCPAL Fixed Focus Headlight Camera System (NTSC) CCU Only Headlight Camera System (PAL) HL & CCD Only Fixed Focus Headlight Camera System (PAL) CCU Only X - - X - X Certified by CSA Alternating Current 401272 Fixed Focus Headlight Camera Switch Box Common to both systems Double Insulated DLXPSK 30W Custom Power Supply Common to both systems 003285CASE Fixed Focus Headlight Camera System Hard Case Common to both systems 602596 Adapter BNC RCPT / RCA Plug Common to both systems Do Not Use if package is damaged 602598 25 BNC Plug Video Cable Common to both systems 600960 25 S-Video Cable Male/Male Common to both systems On/Off 003285BKT Fixed Focus Headlight Camera System Mounting Bracket Common to both systems Interference 2 3

Integra Luxtec General Warnings DLX UltraLite Pro Camera Overview The user should carefully study the Operation and Service Manual before using the equipment in a clinical environment. This Manual contains information about the proper procedures for preparing this product for its use and care. Instructions should be followed, with special attention given to warnings, controls and user specifications. The Manual should be available to the appropriate personnel. A warning statement in this manual identifies a condition or practice which, if not corrected or discontinued immediately, could lead to patient or user injury, illness or death. The user of this product should be thoroughly familiar and trained in the assembly, use and care of this product. Inspection Before Use The DLX UltraLite Pro Camera includes a camera head mounted on the headlight module, a headlight cable, a headband, video connecting cables and adapters, and a camera control unit (CCU). Check to make sure you have all cables, adapters and camera parts. Please verify that all components have been received undamaged. Follow the instructions and restrictions in the operating manuals of other manufacturer s equipment when they are used in conjunction with this product. Before every procedure, carefully inspect the Camera 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 cable cuts or loose connectors. To reduce the risk of fire and electric shock, do not expose electrical equipment to moisture. When cleaning, do not immerse camera head or any electrical device in liquid. Do not use or store liquids on or above the camera. All electrical equipment must be used with approved hospital grade power cords and power plugs inserted properly into grounded AC power outlets. Electric shock hazard. If unit is not functioning properly, DO NOT OPEN CAMERA CONTROL UNIT ASSEMBLY. Please refer to the Repair and Return Section of this Manual for instructions. Do not use in the presence of flammable anesthetics, liquids, vapors, gases or dusts. Use care not to point any light guide directly at the eye while operating this system. WARNING: No modification of this equipment is allowed, including personal adjustments to the camera angle. Do not position the equipment so that it is difficult to remove the power plug. To reduce the risk of tripping, please be cautious of the cables. Installation of CCU to Floor Stand (optional) DLX Pro Camera Control Unit Assembly 1. Using a 5/64 Allen or Phillips screwdriver, remove cable bracket on left side of the floor stand and keep the screws handy. See Figure 1. 2 1 3 4 5 2. Mount the bracket to the floor stand using the existing screws. See Figure 2. 3. Mount CCU to the bracket using a Phillips screwdriver. See Figure 3. 6 1. Power Switch/Power Indicator Turns the camera control unit (CCU) on and off, and illuminates when the power is turned on. 2. Camera Head Connector Connects the camera head to CCU. 3. AWB Switch Activates the white balance function. 4. S-Video Connector Connects CCU to S-VIDEO input of a monitor, recording device, printer, etc. 5. BNC Video Connector Connects to video input of a monitor, recording device, printer, etc. Can be used at the same time as the S-VIDEO connector. 6. DC Power 4 Figure 1 Figure 2 Figure 3 Connects to a DC power supply. 5

Set-up For Use Power must be off. Align the slot on the camera head connector with keyway shown on the front of the CCU. Push the camera head connector fully into the CCU. Plug the DC power cord from the power supply brick into the mating connector at the rear of the CCU. Connect the video cables from the back of the CCU to a monitor, printer, recording device, etc. (see connection instructions). Infrequently, you will need to use the RCA plug to connect to a monitor or recording device. In order to do this, connect the RCA plug adapter to the end of the BNC cable as shown below. Push on button to activate the camera (the button should illuminate). CAUTION: Carefully align the slot on the camera head connector with the keyway shown on the front of the CCU. See Figure 4. Step 2: Camera head connection to the CCU: CAUTION: Carefully align the slot on the camera head connector with the keyway shown on the front of the CCU. See Figure 4. Figure 4 Connection Instructions Step 1: Camera Control Unit connection to a Recording Device. The CCU has both S-video and BNC video connections. Connect the video cable(s) from the CCU to the VIDEO IN of the recording device. If both S-video and BNC video cables are used, make sure they do not connect to the VIDEO IN of the same recording device. CAUTION: DO NOT plug in the power supply to the wall outlet yet. DO NOT TURN THE POWER ON YET! Figure 4 Step 3: Power ON. 1. Connect power cord to rear of CCU. 2. Plug the CCU power supply to the wall outlet. (Do not turn on Camera yet). 3. Plug and turn on the monitor, recording device and/or printer. 4. Select Line A or Line B. 5. Put on the headlight with the camera. 6. Connect the headlight cable to a compatible light source. 7. Turn on the light source and the camera power. The camera power switch is located on the front panel of the CCU. 8. Look at the front of the monitor. A picture should be visible on the monitor. CAUTION: The camera head MUST be connected to the CCU PRIOR to turning on the CCU. Connecting the camera head to the CCU while the power is on will damage or destroy the video chip. If you still do not have a picture, make sure you have selected the same Line A or B that you have selected in the rear of the monitor. If you still do not have a picture, turn OFF the camera power and check all of your connections on the camera, recording device, printer, and monitor. Turn the camera power back on. If you still do not have a picture, please contact your local Integra sales representative. 6 7

White Balance White balance optimizes the color definition at different illumination levels. White Balance before each procedure is strongly recommended. 1. Fully open the iris of the headlight module. 2. Point the camera and headlight at a white object. Make sure the image fills the monitor entirely. 3. Press the AWB button on the rear of the CCU and hold for 5 seconds. The camera will white balance automatically. Cleaning The can be wiped down using 70% isopropyl alcohol. Be sure to unplug the power cord before cleaning. Allow 5 minutes for alcohol to evaporate before reconnecting to power. This equipment is not sold sterile and is not intended to be sterilized. DLX UltraLite Pro Camera Specifications Troubleshooting Weight Control Unit 550g (19.4oz) Problem Cause Action No image on monitor Camera not turned on Turn power on Camera head not connected to controller Connect camera head cable to front of CCU with power OFF CCU not plugged into AC outlet Plug CCU power cord into outlet Monitor not turned on Turn monitor on Monitor settings not correct Consult monitor manufacturer s guide Intermediate component (recording device/ Consult connection diagram in this manual printer) connection not correct Poor Image quality Components not connected properly Consult connection diagram in this manual Dirty camera lens / obstruction Refer to cleaning instructions Bad / damaged camera Contact your Integra distributor Video standard incompatibility (NTSC/PAL) Consult components manufacturers guides Image not centered on monitor Illumination spot not vertically centered on Contact your Integra distributor video image Colors not correct White balance is not correct Follow white balance instructions in this manual to reset Black and white image S-Video cable connection is loose Secure S-Video cable connections Dim image Insufficient light at surgical site Increase light output per light source user instructions If you are still having issues with your system after following the above troubleshooting tips, please contact your local Integra sales representative Dimensions Camera Head Dia: 0.43 (10.9mm), L: 1.88 (48.0mm) Control Unit W: 3.00 (76mm), H: 3.30 (84mm), D: 3.50 (89mm) Power Supply 100-240VAC ± 10% Power Consumption Effective pixel number Effective image area 20W (max) 12V (nominal) Horizontal: 752 pixels; Vertical: 582 pixels - PAL Horizontal: 768 pixels; Vertical: 494 pixels - NTSC Horizontal: 3.65mm; Vertical: 2.71mm (1/4 inch type) Certifications EMI/EMC: EN 60601-1-2:2007 and IEC 60601-1-2:2007 Third Edition INCLUDING CORRIGENDUM 1:2010 US SAF: AAMI ES60601-1 2005/(R) 2012 CAN SAF: CSA C22.2 60601-1: 2014 CE marked in accordance with Medical Devices Directive 93/42/EEC Recommended Conditions Operating: Temperature 5 to 40 C and 10 to 85% relative humidity, non-condensing Storage: Temperature 0 to 50 C and 10 to 85% relative humidity, non-condensing Transportation and Storage Environmental Conditions Temperature Operating: 5-40 C Storage: 0-50 C Relative Humidity Atmospheric Pressure: Expected Service life: Operating: 10-85% (Non-Condensing) Storage: 10-85% (Non-Condensing) Operating: 700 to 1060hPa Storage: 500 to 1060hPa 3 years All specifications are subject to change without notice Rated Mains Frequency: 50-60 Hz Rated Mains Power Consumption: 1.0A Rated Mains Voltage: 100-240 V ~ Water Ingress Rating: IPX0 8 9

Ordering Equipment To place an order, contact your local Integra distributor or call Integra customer service at 1-800-431-1123 (USA) or +1-914-789-7094 to identify your local distributor. Reference 003285BKT 003285CASE 003285CCNTSC 003285CCPAL 003285HLNTSC 003285HLPAL 003285NTSC 003285PAL DLXPSK Description Fixed Focus Headlight Camera System MTNG BKT Fixed Focus Headlight Camera System Hard Case Fixed Focus Headlight Camera System(NTSC) CCU ONLY Fixed Focus Headlight Camera System (PAL) CCU ONLY Headlight Camera System (NTSC) HL & CCD ONLY Headlight Camera System (PAL) HL & CCD ONLY Fixed Focus Headlight Camera System (NTSC (US)) Fixed Focus Headlight Camera System (PAL (OUS)) DLX Power Supply Electromagnetic Compatibility The information contained in this section (such as separation distances) is specifically written with regard to the. The numbers provided will not guarantee faultless operation but should provide reasonable assurance of such. This information may not be applicable to other medical electrical equipment; older equipment may be particularly susceptible to interference. General Notes: Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in this document and the remainder of the instructions to use this device. Portable and mobile RF communications equipment can affect medical electrical equipment. Cables and accessories not specified within the instructions for use are not authorized. Using other cables and/or accessories may adversely impact safety, performance and electromagnetic compatibility (increased emissions and decreased immunity). 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. Electromagnetic Emissions This equipment is intended for use in the electromagnetic environment specified below. The user of this equipment should assure that it is used in such an environment. Emissions Compliance according to Electromagnetic environment RF emissions (CISPR 11) Group 1 The equipment uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electrical equipment. CISPR Emissions Classification Class B The equipment is suitable for use in Harmonic emissions (IEC 61000-3-2) Class A all establishments including domestic establishments and those directly connected to Voltage fluctuations/flicker (IEC 61000-3-3) Complies the public low-voltage power supply network that supplies buildings used for domestic purposes. 10 11

Electromagnetic Immunity This equipment is intended for use in the electromagnetic environment specified below. The user of this equipment should assure that it is used in such an environment. This equipment is intended for use in the electromagnetic environment specified below. The customer or user of this equipment should assure that it is used in such an environment. Immunity against IEC 60601-1-2 test level Compliance level (of this device) electrostatic discharge, ESD (IEC 61000-4-2) electrical fast transient/bursts (IEC 61000-4-4) surges on AC mains lines (IEC 61000-4-5) contact discharge:± 6 kv air discharge: ± 8 kv power supply lines: ± 2 kv longer input/output lines: ± 1 kv common mode: ± 2 kv differential mode: ± 1 kv ± 6 kv ± 8 kv ± 2 kv ± 1 kv ± 2 kv ± 1 kv Electromagnetic environment Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be kept at levels to reduce electrostatic charge to suitable levels. 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. Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance Conducted RF rf coupled into lines (IEC 61000-4-6) radiated rf (IEC 61000-4-3) 150 khz to 80 MHz outside ISM bandsa 150 khz to 80 MHz in ISM bands a 3 Vrms Portable and mobile RF communications equipment, including cables, should be used no closer to any part of the DLX UltraLite Pro Camera Controller Unit than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter as below: Recommended separation distance d=1.2/v1] P 10 Vrms d=1.2/ P 80 MHz to 800 MHz power frequency magnetic field 50/60 Hz (IEC 61000-4-8) voltage dips and short interruptions on AC mains input lines (IEC 61000-4-11) 3 A/m 3 A/m Equipment which emits high levels of power line magnetic fields (in excess of 3A/m) should be kept at a distance to reduce the likelihood of interference dip >95%, 0.5 periods dip 60%, 5 periods dip 30%, 25 periods dip >95%, 5 seconds >95%, 0.5 per. 60%, 5 per. 30%, 25 per. >95%, 5 sec. Mains power quality should be that of a typical commercial or hospital environment. If user requires continued operation during power mains interruptions, insure that batteries are installed and charged. Insure that battery life exceeds longest anticipated power outages or provide an additional uninterrupted power source. 80 MHz - 2.5 GHz 10 V/m d=2.3/ 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 site survey a, should be less than the compliance level in each frequency range b. Interference may occur in the vicinity of equipment marked with the following symbol: a The ISM (industrial, scientific and medical) bands between 150 khz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. b 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 equipment is used exceeds the applicable RF compliance level above, the equipment should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the equipment. 12 13

Recommended separation distances between portable and mobile RF communications equipment and the DLX unit Rated maximum output power of transmitter W Separation distance according to frequency transmitters in meters 150 khz - 80 MHz d=1.2/v1] P 80 MHz - 800 MHz d=1.2/v1] P 800 MHz - 2.5 GHz d=2.3 P 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1: At 80 MHz and 800 MHz, the separation distance for 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. Repair And Return Information All repairs to the DLX Camera System must be performed by Integra. This device must be cleaned prior to return to Integra. Refer to cleaning instructions on page 9 of this manual. Integra reserves the right to return unrepaired any equipment that is not cleaned free of blood or other organic material. Warranty Service and Repair: To obtain service under warranty or return product for repair, the customer should contact your local Integra representative or call Integra Customer Service at 1-800-431-1123 or +1-914-789-7094. Limited Express Warranty Integra warrants that the new 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. Integra s sole and exclusive liability under the warranty shall be, at Integra s option, either to repair 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, and 3. Upon inspection, Integra finds the equipment to be defective. This warranty is contingent upon normal and proper use of the equipment. 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. EXCEPT FOR INTEGRA S APPLICABLE STANDARD WARRANTY, INTEGRA AND ITS SUBSIDIARIES ( INTEGRA ) EXCLUDE ALL 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, EXEMPLARY OR CONSEQUENTIAL LOSS, DAMAGE, OR EXPENSE, DIRECTLY OR INDIRECTLY ARISING FROM USE OF THIS PRODUCT. INTEGRA DOES NOT ASSUME NOR AUTHORIZE ANY PERSON TO ASSUME FOR IT ANY OTHER OR ADDITIONAL LIABILITY OR RESPONSIBILITY IN CONNECTION WITH THESE PRODUCTS. Disposal of the Product, Packing Material, and Accessories The DLX Camera System and Packaging contains recyclable metal, electronic and packaging materials and components. All electronic components should be treated as electronic waste materials and either recycled or disposed of under relevant regulations and laws valid in the country of use. Metal components can be recycled into general metal recycling or disposal. All packaging components can be recycled or disposed of under general practices. 14 15

Rx ONLY in USA Manufactured by: Integra York PA, Inc. 589 Davies Drive York, PA 17402 n USA Integra LifeSciences Services (France) SAS Immeuble Sequoia 2 97 allée Alexandre Borodine Parc Technologique de la Porte des Alpes 69800 Saint Priest France Telephone: 33 (0) 4 37 47 59 10 Fax: 33 (0) 4 37 47 59 29 For more information or to place an order, please contact: Integra n 311 Enterprise Drive, Plainsboro, NJ 08536 800-431-1123 USA n 914-789-7094 outside USA n 914-592-8056 fax integralife.com Integra, the Integra logo, Luxtec and UltraLite are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. Copyright 2016 Integra LifeSciences Corporation. All rights reserved. LAB-0000026-YK REV. AA 0572326-1