UltraScan Encore Operator Manual Rev C

This manual is copyrighted with all rights reserved. Under copyright laws, this manual may not be copied in whole or in part or reproduced in any other media without the express written permission of Lumenis, Inc. Permitted copies must carry the same proprietary and copyright notices as were affixed to the original. Under the law, copying includes translation into another language. Please note that while every effort has been made to ensure that the data given in this document is accurate, the information, figures, illustrations, tables, specifications, and schematics contained herein are subject to change without notice. Lumenis, the Lumenis Logo, and UltraPulse are registered trademarks of Lumenis, Inc. Coherent and the Coherent Logo are registered trademarks of Coherent, Inc. UltraScan, TrueSpot, Encore, CO2 Lite, and CoolScan are trademarks of Lumenis, Inc. Kodak is a registered trademark of Eastman Kodak Company. Puritan is a registered trademark of Hardwood Products Company LP. Enzol and Cidezyme are registered trademarks of Johnson & Johnson. Miltex is a registered trademark of Miltex Instrument Company, Inc.

Regulatory European Representative: Lumenis (Germany) GmbH Heinrich-Hertz-Strasse 3 D-63303 Dreieich Germany Manufactured by Lumenis Ltd. P.O.B. 240 Yokneam 20692 Israel © The Lumenis Group of Companies December 2006 0633-227-01 Revision C

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OPERATION 5 Preoperative Instructions 6 Inspect the UltraScan Encore components 6 Assemble the UltraScan Encore handpiece 8 Attach the UltraScan Encore to the laser articulated arm 9 Connect the communication cable 10 Prepare smoke evacuation 11 If desired, position a sterile draping sleeve 12 Turn on the UltraScan Encore 13 Perform the laser beam alignment check 14 CoolScan™ mode 15 Intraoperative Instructions 17 System beeps 17 Turn on the pattern generator 17 Select the pattern number (pattern shape) 18 Select the pattern size 19 Select the pattern density 20 Pattern density versus pattern size 21 Average Pattern Fluence 21 UltraScan Encore pattern chart 22 Select single pattern or repeat pattern 24 Single pattern mode (default setting) 24 Repeat pattern mode 25 Preview the pattern 26 Select the energy or fluence 28 Energy level and fluence 29 Select the repetition rate or average power 30 CO2 Lite™ mode 31 Target and deliver the treatment beam 33 Postoperative Instructions 34

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MAINTENANCE 35 Troubleshooting Guide 35 Common problems and suggested solutions 35 Perform the Laser Beam Alignment Check 40 Inspect and Clean the UltraScan Encore 42 Clean the external surface of the delivery system 42 Inspect the UltraScan Encore optics 42 Clean the UltraScan Encore optics 43 Inspect the UltraScan Encore handpiece tip, handpiece tip inner tube, and spatula tip 44 Clean the UltraScan Encore handpiece tip, inner tube, and spatula tip 44 Sterilize the UltraScan Encore handpiece tip, handpiece tip inner tube, and spatula tips 45 Specifications 46 Warranty Information 47 Decontamination of Returned Equipment 47

SAFETY AND REGULATORY 49 Laser Safety Eyewear 50 Additional Ocular Protection 53 Additional Safety Considerations 54 Fire hazards 55 Nontarget tissues may be protected in a variety of ways 55 Regulatory Compliance 56 Location of regulatory and other system labels 56

INDICATIONS FOR USE 57 DECONTAMINATION CERTIFICATE 59

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peration The UltraScan Encore computerized pattern generator (CPG) combines unsurpassed uniformity and speed for accurate, repeatable skin resurfacing. The treatment beam is collimated, so the spot size and fluence remain constant at virtually any distance from the target tissue. The UltraScan Encore generates precise, repeatable patterns allowing treatment of large areas quickly, with uniform fluence. Lumenis lasers and delivery systems are precision medical instruments. They have undergone extensive testing and with proper handling are useful and reliable clinical instruments. If you have questions regarding your laser or delivery system, contact your local Lumenis representative. WARNING Lasers generate a highly concentrated beam of light which may cause injury if improperly used. To protect the patient and operating personnel, the entire laser and the appropriate delivery system operator manuals, including all Safety and Regulatory sections, should be carefully read and comprehended before operation.

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Preoperative Instructions The UltraScan Encore is shipped clean and nonsterile from the factory. Before using the device in a sterile procedure, sterilize the handpiece tip, handpiece tip inner tube, and spatula tip. Cleaning and sterilization instructions are detailed in the Maintenance section of this manual. Most nursing staff prefer to inspect the delivery system components and to perform a laser beam alignment check daily, usually prior to scheduled cases and before patients are premedicated. Doing so ensures adequate time to troubleshoot a problem or seek professional service with the least disruption to patient care. You may perform these routine surgical tasks outside of the sterile field; however, if so, ensure enough time for sterilization before scheduled cases.

Inspect the UltraScan Encore components When unpacking the delivery system, and before each use, inspect for dirt, debris, or damage. If assembled, disassemble the UltraScan by unscrewing the handpiece tip inner tube to separate the handpiece body from the handpiece tip (see the handpiece illustration on the following page). Inspect the inside of the handpiece tip to ensure that it is clean of any residual laser plume contamination or dirt. The input and output optics in the handpiece body should appear translucent, smooth, bright, and free of any cracks, spots, debris, or obvious damage. If cleaning is required, follow the instructions provided in the Maintenance section of this manual. If the device appears damaged, contact your local Lumenis service representative.

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Communication cable clips Communication cable

UltraScan Encore handpiece

Standard spatula tip

Inspect the UltraScan Encore components

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Assemble the UltraScan Encore handpiece The handpiece tip inner tube screws the handpiece tip onto to the handpiece body. Ensure that the handpiece tip inner tube, handpiece tip, and handpiece body are secure and locked into place prior to use.

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Handpiece tip

Handpiece tip inner tube

UltraScan Encore assembly/disassembly

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Handpiece body

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Attach the UltraScan Encore to the laser articulated arm Before attaching the UltraScan Encore to the laser, verify that the laser keyswitch is in the off position. Attach the UltraScan Encore to the laser articulated arm by screwing the handpiece body onto the threaded end of the articulated arm. Ensure that the UltraScan Encore is secure and will not loosen during use.

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Laser articulated arm

Attach the UltraScan Encore to the laser articulated arm

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Connect the communication cable The UltraScan Encore is controlled by laser system software. The UltraScan Encore communication cable provides constant communication between the laser and the UltraScan Encore handpiece. Treatment parameters are selected with the laser control screen and monitored by the laser system software via the communication cable. 1. Insert the communication cable plug into the receptacle on the rear of the laser. 2. Insert the opposite end of the communication cable into the communication receptacle on the UltraScan Encore handpiece. 3. Secure the communication cable along the length of the articulated arm with the communication cable clips, as shown in your UltraPulse Encore Operator’s Manual.

Communication cable

➟ Connect the communication cable to the UltraScan Encore handpiece U ltra S can ™ E ncore ™ 0633-227-01, Revision C

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Prepare smoke evacuation If smoke evacuation is desired, attach 22 millimeter (7/8 inch) inner diameter evacuation tubing to the smoke evacuation port. WARNING Smoke evacuation of approximately 15 lps (32 cfm), or more, is highly recommended with the use of this product. If smoke evacuation is not used, laser plume debris may accumulate on the output lens, causing lens damage, decreased energy transmission, or unintended, adverse tissue effect.

➟ Attach smoke evacuation tubing

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If desired, position a sterile draping sleeve If desired, position a sterile draping sleeve over the delivery system, as shown.

Position a sterile draping sleeve

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Turn on the UltraScan Encore 1. Turn on the laser with the laser keyswitch. Wait a few minutes while the laser performs a self-test. If the UltraScan Encore is properly connected to the laser, the CPG controls will display on the laser control screen. The UltraScan Encore controls will remain dimmed and unavailable until you press the CPG on selector. 2. The red aiming beam should exit from the UltraScan Encore handpiece. If necessary, adjust the aiming beam intensity with the touchscreen controls, as shown in your UltraPulse Encore Operator’s Manual. 1

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UltraScan Encore controls

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Perform the laser beam alignment check Perform the beam alignment check as described in the Maintenance section of this manual or in the Quick Reference Guide included with this manual. Most nursing staff prefer to perform a laser beam alignment check daily, usually prior to scheduled cases and before patients are premedicated. Doing so ensures adequate time to troubleshoot a problem or seek professional service with the least disruption to patient care. WARNING Beam alignment checks are extremely important for the safe operation of your laser equipment. Do not use the laser or delivery system if aiming and treatment beams are not coincident; call your local Lumenis service representative. Misalignment of aiming and treatment beams may result in laser exposure to nontarget tissues and possible injury.

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CoolScan™ mode CoolScan mode offers non-linear delivery of the treatment beam. When scanning a pattern in CoolScan mode, the laser delivers the treatment beam to spots in the pattern non-contiguously. CoolScan mode is controlled from the Options screen. To turn CoolScan mode on or off, first push the Options tab at the top of the display screen. The Options screen appears on the display.

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Options screen selection tab

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 Then, push the on button to activate CoolScan mode, or push the off button to deactivate it. When CoolScan mode is deactivated, the treatment beam is delivered in a linear, row by row sequence to spots within the pattern.

Cool Scan™

CoolScan mode off

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CoolScan mode on/off controls

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Intraoperative Instructions As directed in your laser operator manual or Quick Reference Guide, prepare the treatment room and verify that the laser is turned on and in standby mode.

System beeps The laser will emit a single beep with every control screen selection, and a long, low beep when a minimum or maximum setting is reached or when an error has occurred.

Turn on the pattern generator Press the CPG on selector on the control screen to activate the UltraScan Encore controls. The UltraScan Encore controls will change color to indicate that they are enabled.

CPG on

CPG off

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Pattern generator on/off control

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Select the pattern number (pattern shape) Select the desired pattern with the pattern number selectors. An outline of the selected pattern shape will appear in the pattern display. The number of available patterns will depend upon your laser model.

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Pattern shape controls

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Select the pattern size Select the desired pattern size with the size selectors. The pattern size number will appear in the pattern size display. Depending upon your laser model, some pattern sizes may not be available at lower pattern density settings. If you attempt to select a pattern size that is incompatible with the existing density setting, the system will emit a long, low beep, indicating that the selection is not available.

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Pattern size controls

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Select the pattern density Pattern density refers to the overlap of individual treatment spots in a pattern. The following illustration provides an example of several pattern density settings and the relative position of treatment spots:

Density 1 (–10%)

Density 2 (0%)

Density 4 (20%)

Density 8 (50%)

Pattern density settings and resultant spot overlap

Select the desired pattern density with the density selectors. A density number will appear in the pattern density display.

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Pattern density controls

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