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OmniGuide FELS-25A User Manual
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OmniGuide FELS-25A User Manual

Beampath with intelliguide fiber enabled co2 laser
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FELS-25A,
®
BeamPath with IntelliGuide
Fiber
™
Enabled CO
Laser
2
Users Manual
To be used with: OmniGuide Catalogue Number: FELS-25A,
FELS-25A-E, FELS-25A-S2, FELS-25A-S3, FELS-25A-S4.
  '-
/
0483
9 '$ /
A.R.C. LASER GmbH
* &! - 57976
Bessemerster. 14
. 61===1;;;199=9 !$ 61;6<1::61=999 
D-90411 Nurnberg, Germany
Tel. 49 911 21779-0
URL:
http://www.omni-guide.com
L-1633 Rev. 3
© OmniGuide, Inc.
Page 1

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Summary of Contents for OmniGuide FELS-25A

  • Page 1 ® BeamPath with IntelliGuide Fiber ™ Enabled CO Laser Users Manual To be used with: OmniGuide Catalogue Number: FELS-25A, FELS-25A-E, FELS-25A-S2, FELS-25A-S3, FELS-25A-S4.   '- 0483 9 '$ / A.R.C. LASER GmbH * &! - 57976 Bessemerster. 14 .
  • Page 2 This article is covered by the following patents: U.S. Patent No. 7349589, 7167622, 7331954, 7991258. OmniGuide, Inc. (OG) is not responsible for injury or damage resulting from improper use of the system. If there is any doubt concerning the use of the system or the User’s Manual, contact OG immediately for assistance.
  • Page 3 ;/7/ "& &+ /////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// 7: ;/8/ &$ &+ //////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// 7; ;/9/ !"  &! & $% ( & &! 1 $ ///////////////////////////////////////////////////////////////////////////////// 7<      ...................16    ....................17 L-1633 Rev. 3 © OmniGuide, Inc. Page 3...
  • Page 4 +%& !% !& %&$&//////////////////////////////////////////////////////////////////////////////////////////////////////////////////// 98 Password does not work/////////////////////////////////////////////////////////////////////////////////////////////////////////////// 98 13.2. 68/8/ ! & ! &%%' //////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// 99 68/9/ !) "!)$ !$ ! "!)$ % !%$( !'& ! &   ' $. ///////////////////////////////////////////////// 99 L-1633 Rev. 3 © OmniGuide, Inc. Page 4...
  • Page 5 #'$% !$  ////////////////////////////////////////////////////////////////////////////////////////////////////////////// :7 6>/7/ '$!" '&!$, "$% &&( //////////////////////////////////////////////////////////////////////////////////////////// :7 +"%! '&*  &%$&(......................42 75/6/ % !$ %  *"   %'& &!   & &  '&'$$0% %$&! /////////////////////////// :8 L-1633 Rev. 3 © OmniGuide, Inc. Page 5...
  • Page 6 PREFACE This manual is designed to help the user understand and operate the FELS-25A Fiber Enabled CO Laser systems. The family of the FELS-25A systems consists of the following versions: • FELS-25A, which accepts 110V, 50/60 Hz Electrical input •...
  • Page 7 Operating or handling of this medical Laser, inconsistent with this manual, may void the warranty. WARNING, CAUTION AND SYMBOLS 2.1. Contraindications Do not use OmniGuide Laser System if the medical history of the patient is not compatible with Laser treatment. 2.2. Adverse Effects Potential complications could include: •The general complications related to surgical procedures, such as local and systemic infections...
  • Page 8 ________________________________________________________ This symbol is intended to alert the operator that there are specific warnings or precautions associated with the medical device, which are not otherwise found on the label. _________________________________________________________ L-1633 Rev. 3 © OmniGuide, Inc. Page 8...
  • Page 9 Note: Emergency Switch Shield may or may not be present on laser Figure 2-1. Location of the warning signs showing the front and right side of the Laser (top) and the back side (bottom) L-1633 Rev. 3 © OmniGuide, Inc. Page 9...
  • Page 10 1. Warning Aperture 2. Laser Stop 3. Laser Warning 4. Laser Danger L-1633 Rev. 3 © OmniGuide, Inc. Page 10...
  • Page 11 5. Laser Compliance 6. ETL 7. Modification Label 8. Product Identification L-1633 Rev. 3 © OmniGuide, Inc. Page 11...
  • Page 12 For sterile procedures, the use of the OmniGuide Gas Filter Unit (cat# ACC-GFU-100) is required. There is a possibility that the OmniGuide fiber will fail to transmit light during the course of a surgical procedure. Therefore, it is recommended that you have at least two fiber assemblies available prior to starting a surgical procedure using the OmniGuide Laser System.
  • Page 13 Always monitor patient’s blood oxygen level. Before the start of a medical procedure using the OmniGuide Adapter and fiber, verify that the gas delivered to the system is of the proper type and pressure for the fiber being used. This information can be found on the insert provided with each fiber.
  • Page 14 The use of the OmniGuide System Build up of tissue or tissue debris on the distal-end tip of the OmniGuide fibers or handpiece can result in overheating of the device. If build-up/contamination occurs during use, clean the tip by dipping into saline solution.

  • Page 15: Product Description

    Refer also to the Cautions section of your Laser Manual and to Laser Labeling for additional precautions. PRODUCT DESCRIPTION In this section the specifications and characteristics of the FELS-25A system will be discussed. Characteristics to be discussed include mechanical, thermal, electric and the laser system user interfaces. Also discussed are environmental requirements and limitations.
  • Page 16 %;9:F (GFBGF AAD "@F7D>A5= AAF )763> A@@75F;A@ A@@75FAD !;9: *757BF35>7 )D7EEGD7 &3@397?7@F )D;@F7D (GFBGF 3E "@BGF 3F3 @AF ;@ GE7 G6;A "@BGF A@@75F;A@ @AF ;@ GE7 Figure 5-1. Back of the Laser L-1633 Rev. 3 © OmniGuide, Inc. Page 16...
  • Page 17 110 to 125 PSI. The Laser Gas Outlet pressure is controlled from the touch-screen interface. ____________________________________________________________ Set the outlet pressure as directed by the instructions for use (IFU) for the specific fiber being used. ____________________________________________________________ L-1633 Rev. 3 © OmniGuide, Inc. Page 17...
  • Page 18 5.1.8. OmniGuide Fiber Adapter To produce sufficient output power at the distal end of an OmniGuide fiber, the laser beam generated in the laser is delivered precisely to the input end of the fiber by means of fiber adapter with a standard ST socket for fiber connection. The adapter has a quick-disconnect gas port for the helium gas supply and incorporates an RFID antenna as shown in figure 5.3.
  • Page 19 ;47D 3E )ADF Figure 5-3. Close up of socket of the fiber adapter, where the OmniGuide fiber is connected. Note the groove in the fiber connection socket. It should be aligned with the arrow/key on the connector of the fiber for the fiber to properly connect.
  • Page 20 5.3. OmniGuide Cart and Gas Management System The specially designed laser system cart (see Figure 5-5 ) provides a convenient way to hold the laser, compressed gas tanks and gas management system (see Error! Reference source not found.). The gas...
  • Page 21 Prior to starting the surgical procedure make sure that the gas tank valves are open. ____________________________________________________________ ____________________________________________________________ Prior to replacing the compressed tank make sure that the gas tank valve is closed. ____________________________________________________________ L-1633 Rev. 3 © OmniGuide, Inc. Page 21...
  • Page 22 ____________________________________________________________ Refer to OmniGuide fiber IFUs for instructions on choosing appropriate gas pressure settings. ______________________________________________________ 5.4. Operating Specifications for Laser Laser wave length 10 6000 nm Output Power Maximum 30 Watt at Laser output Power Stability ± 20 % Spot size Dependent on fiber used and distance from tissue.
  • Page 23 Figure 5-7 Dimensions of the FEL-25A Laser L-1633 Rev. 3 © OmniGuide, Inc. Page 23...
  • Page 24 Figure 5-8 Dimensions for the Fiber Enabled Laser on OG designed Cart L-1633 Rev. 3 © OmniGuide, Inc. Page 24...
  • Page 25 Laser light, because of its special properties, poses safety hazards not associated with light from other sources. The light from the FELS-25A is invisible to the naked eye. The safe use of Laser requires that all operators be properly trained and the proper use of PPE be used in the operation of this device.
  • Page 26 Eye, skin and fire safety is a great concern when using a high-power, class IV Laser such as the FELS-25A. There is potential for secondary beams present at various angles near the incident radiation site. While weaker than the main beam, such beams may still be sufficiently intense to cause eye damage and skin burns.

  • Page 27: Transportation And Storage

    (red colored rear input). 6.4. Compliance to Standards Relevant to CE-Mark The FELS-25A Laser does meet all the applicable standards of the CE-Mark. Please see section 17 for more details.

  • Page 28: Unpacking And Inspection

    Report exactly the items missing and verify whether the Laser can be installed or the items missing will not allow you to install and operate the Laser. If you need to ship the Laser back to OmniGuide, you MUST ship it in the OmniGuide shipping container and packing material.
  • Page 29 FACILITIES REQUIREMENT The dimensions of the Laser are given in Figure 5-7 and the dimensions of the entire FELS-25A system with a cart with gas handling capability are given in Figure 5-8. If the cart is not available with the Laser the following information is important for safe use.
  • Page 30 9.3. Compressed Gas Requirement The OmniGuide Laser system is designed to be used with medical-grade Helium gas, delivered to the fiber at a pressure that depends on the type of fiber and the application. Please see fiber IFU for details.

  • Page 31: System Operation

    This allows the internal parameters to be checked and verify the system is running according to specifications. This routine takes about 2 minutes, and when complete the display will change to the pin code screen (see Error! Reference source not found.). L-1633 Rev. 3 © OmniGuide, Inc. Page 31...
  • Page 32 Once the Laser initializes, it will prompt the user to enter the password as shown in Figure 10-2. Once the correct password is entered the Laser will go to the home screen as shown in Figure 10-3. Figure 10-2 Password Screen L-1633 Rev. 3 © OmniGuide, Inc. Page 32...
  • Page 33 Since the user did not press the superpulse button, the Laser is at CW. The user also has the choice save the existing setting under a specific surgeon preset by pressing the icon. L-1633 Rev. 3 © OmniGuide, Inc. Page 33...
  • Page 34 If the Laser is in Ready mode and the foot pedal is pressed, the Laser will only fire for the amount of time displayed in the On field. The Laser will fire one shot for each foot pedal press. L-1633 Rev. 3 © OmniGuide, Inc. Page 34...
  • Page 35 The foot pedal is currently pressed and the Laser is firing. Gas flow is set to the displayed value. The status will change back to “Laser in Ready” once the foot pedal is not longer pressed. L-1633 Rev. 3 © OmniGuide, Inc. Page 35...
  • Page 36     EGD97A@E ,A 366 EGD97A@ +7>75F +GD97A@ ,A 76;F EGD97A@ +5DA>> 6AI@ 8AD ?AD7 EGD97A@E Figure 10-5 Surgeon Presets L-1633 Rev. 3 © OmniGuide, Inc. Page 36...
  • Page 37 +5DA>> 6AI@ 8AD ?AD7 EGD97A@E Figure 10-6 Edit or Delete Surgeons +:;8F =7K $7K4A3D6 +7>75F ;7>6 FA 47 76;F76 F;F>7 8;DEF 3@6 >3EF @3?7 35=EB357 +3H7 AD 3@57> F:7 5:3@97E Figure 10-7 Surgeon Presets L-1633 Rev. 3 © OmniGuide, Inc. Page 37...
  • Page 38 Total time firing: This shows the number of seconds the Laser was actually fired. • Total output energy: This is obtained by multiplying the power out with the total time firing to give us the total output energy. L-1633 Rev. 3 © OmniGuide, Inc. Page 38...
  • Page 39 The system settings button allows you to alter Laser settings such as language, screen brightness, and system time as shown in Figure 10-9. +AG@6 ,;?7AGF 3F7 ,;?7 D;9:F@7EE %3E7D ;@8A +F3DFGB )3EEIAD6 DDAD %A9 6H3@576 &A67 Figure 10-9 System Settings L-1633 Rev. 3 © OmniGuide, Inc. Page 39...
  • Page 40 _____________________________________________________________ If uncertain about any portion of this IFU, contact OmniGuide for assistance. 10.4.1. Preoperative System Preparation Visually inspect the fiber adapter and verify that there is no discernible damage, that all parts are clean and there are no loose parts or loose connections.
  • Page 41 During the procedure, be sure to observe sterile technique. The Laser and OmniGuide Adapter are not sterile. The Adapter does not need to be sterilized, but the adapter can only be used in sterile procedures when it is accompanied by the OmniGuide Gas Filter Unit (P/N ACC-GFU-100).

  • Page 42: Maintenance

    12.1. Overview: It is strongly recommended the FELS-25A undergoes a yearly Preventive Maintenance (PM) performed by an OmniGuide trained professional. While the laser itself is a standard CO2 laser system, the fiber coupling, fiber mechanics, and any changes in its behavior can be easily overlooked by personnel who are not familiar with the OmniGuide Beampath technology.

  • Page 43: Troubleshooting

    It is also to be inspected for any leaks or damaged connections. 12.5. Parts: The FELS-25A laser, cart, and accessories are to be inspected for any loose, damaged, or missing parts. The following parts are to be replaced annually 12.5.1.
  • Page 44 OmniGuide warrants that the parts are free from defects in materials and workmanship. For specific warranty terms and conditions for your FELS-25A Laser system refer to your sales contract. The FELS- 25A is warranted for parts for a period of 12 months. Warranty begins from date of shipment. Any specific terms with your distributor are part of the purchase agreement between you and your distributor.

  • Page 45: Packing Procedure

    14.2. Responsibility of the buyer Damage to the FELS-25A caused by failure of buyer’s utilities or buyer’s failure of setup or maintaining the equipment is solely the responsibility of the buyer. Damage caused by the distributor or damage caused by the buyer are specifically excluded from the warranty.
  • Page 46 *7EA@3FAD F7?B7D3FGD7 ;E ?73EGD76 3@6 ;8 8AG@6 FA %3E7D ,7?B7D3FGD7 DDAD 47 AGFE;67 A8 F:7 EB75;8;53F;A@   ,7EF GDD7@F 776435= 8DA? %3E7D :736 *7B>357 F:7 5GDD7@F E7@EADE >AI A@FDA> A?? DDAD -@34>7 FA 5A??G@;53F7 I;F: & H;3 *+ L-1633 Rev. 3 © OmniGuide, Inc. Page 46...

  • Page 47: Guidance And Manufacturer's Declaration

    ,:7 %3E7D ;E EG;F34>7 8AD GE7 ;@ 3>> "+)* 7EF34>;E:?7@FE AF:7D F:3@ 6A?7EF;5 3@6 F:AE7 6;D75F>K 5A@@75F76 FA F:7 >AI HA>F397 BAI7D EGBB>K @7FIAD= F:3F EGBB>;7E 4G;>6;@9E GE76 8AD 6A?7EF;5 BGDBAE7E !3D?A@;5E 7?;EE;A@E %++  "    L-1633 Rev. 3 © OmniGuide, Inc. Page 47...
  • Page 48 D75A??7@676 F:3F F:7 %3E7D 47 BAI7D76 ;@BGF >;@7E 8AD  5K5>7 8DA? 3@ G@;@F7DDGBF;4>7 BAI7D EGBB>K AD 3 "   43FF7DK 6;B ;@ - 8AD  5K5>7 6;B ;@ - 8AD  E75 L-1633 Rev. 3 © OmniGuide, Inc. Page 48...
  • Page 49 5A@8AD?E FA "  E:AG>6 47 >7EE F:3@ F:7 5A?B>;3@57 >7H7> ;@ 735:  &!L "   8D7CG7@5K D3@97 "@F7D87D7@57 ?3K A55GD ;@ F:7 H;5;@;FK A8 7CG;B?7@F ?3D=76 I;F: F:7 8A>>AI;@9 EK?4A> L-1633 Rev. 3 © OmniGuide, Inc. Page 49...
  • Page 50 FA    0     0     0                       L-1633 Rev. 3 © OmniGuide, Inc. Page 50...
  • Page 51 • Laser Surgery and Medicine, Principles and Practice, Carmen A. Puliafito, John Wiley & Sons, ISBN 0471120707 • Medical Laser Endoscopy, Dennis M. Jensen, Kluwer Academic Publisher, ISBN 07920305795 • Medical Lasers and Their Safe Use, D.H. Sliney & S.L. Trokel, Springer-Verlag, ISBN 3540978569 L-1633 Rev. 3 © OmniGuide, Inc. Page 51...

  • Page 52: Product Information

    Phone: (617) 551-8444 or (888) OMNI-GUIDE Fax: (617) 551-8445 Email: service@omni-guide.com URL: www.omni-guide.com 19.2. European Authorized Representative A.R.C. LASER GmbH Bessemerstr. 14 D-90411 Nuremberg Phone: +49 911 21779-0 Fax: +49 911 21779-99 URL: http://www.arcLaser.de/ Email: info@arcLaser.de L-1633 Rev. 3 © OmniGuide, Inc. Page 52...
  • Page 53 03+  BE; O  BE; 03+  BE; O  BE; .7D;8K D79G>3FAD AGFBGF "@F7>>; G;67 A@>K 4 "@F7>>; G;67 D79G>3FAD AGFBGF 0'%+(+%#4+/. '#352'& #33 #+, #,5' 3557BF34>7 D3@97 03+ BE; O  BE; L-1633 Rev. 3 © OmniGuide, Inc. Page 53...
  • Page 54 ! 50'2 5,3' M / "@F7>>; G;67 A@>K %3E7D D7CG;D76 D753>;4D3F;A@ 5 %3E7D %;9:F ,7EF E3H7 @7I HA>F397 #3'2 +)*4 '34 /,4#)' 2+)+.#, #,5' +.#, #6'& #,5' *75AD6 7DDADE 8DA? >A9 L-1633 Rev. 3 © OmniGuide, Inc. Page 54...
  • Page 55 ______W Percentage lost through 125μm Stainless Steel Ferrule ≤ 70% ______% Power out of 285μm Zirconia Ferrule at 4W CW. ______W Percentage lost through 285μm Zirconia Ferrule ≤ 20% ______% *73>;9@76 >3E7D L-1633 Rev. 3 © OmniGuide, Inc. Page 55...
  • Page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ev. 3 © OmniGuide, Inc. Page 56...