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OmniGuide BEACON 420060AA Instructions For Use Manual

Advanced energy laser system
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To be used with: OmniGuide Catalog Numbers: 420060AA, 420030-AA
Caution: U.S federal law restricts this device to sale by or on the order of a licensed healthcare professional.
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.
BEACON™ Advanced Energy Laser System
Instructions for Use
OmniGuide, Inc.
4 Maguire Rd. Lexington, MA 02421
1-888-666-4484 or 1-617-551-8444 US
www.omni-guide.com

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Summary of Contents for OmniGuide BEACON 420060AA

  • Page 1 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 2: Table Of Contents

    Gas Management System ..................................14 7.0 PRODUCT DESCRIPTION ..........................15 The BEACON Advanced Energy Laser System ............................15 Delivery System ......................................16 The OmniGuide fiber ....................................17 Description of AA accessories .................................. 18 Touch Screen/Display Panel ..................................18 foot Pedal Connection .................................... 19 High Pressure Gas Input ...................................
  • Page 3 Disposal Instruction ..................................43 14.0 MAINTENANCE ............................43 Overview ........................................43 Notification ....................................... 43 Alignment: ........................................ 43 Calibration ........................................ 43 Gas Management ..................................... 43 functionality ......................................44 Parts .......................................... 44 OmniGuide Service ....................................44 L-1670 Rev 0 © OmniGuide, Inc.
  • Page 4 System does not start ....................................44 Password does not work ................................... 44 No effect on tissue ....................................44 Low power or no power is observed out of the OmniGuide fiber: ......................45 System too hot ......................................45 16.0 WARRANTY ..............................45 Point of Sale Warranty ....................................

  • Page 5: Preface

    System. BEACON is a surgical laser that delivers CO energy via two modes of operation. The first is through OmniGuide’s patented, polymer-based flexible fiber, which is utilized within a specialty-specific hand piece by the surgeon. The second modality is free-beam energy delivered via an articulating arm mounted on the laser system.

  • Page 6: Notice Concerning Warranty

    Operating or handling of this medical laser, inconsistent with this manual, may void the warranty. 4.0 WARNING, CAUTION AND SYMBOLS Contraindications Do not use OmniGuide Laser System if the medical history of the patient is not compatible with laser treatment. Adverse Effects Potential complications could include: •...

  • Page 7: Symbols Used In This Manual

    Applied part type B connection Ground Emergency STOP button symbol Tipping hazard symbol Laser interlock symbol food pedal connection symbol Read the manual before use Do not dispose as general waste L-1670 Rev 0 © OmniGuide, Inc.

  • Page 8: Warning Signs And Laser Labels

    Warning Signs and Laser Labels Figure 4-1. Location of the labels L-1670 Rev 0 © OmniGuide, Inc.
  • Page 9 IEC STD 60601-2-22 Certified to: Certified to: OMNIGUIDE INC. certifies that this product complies with 21 CFR 1040.10 and 1040.11 OMNIGUIDE INC. certifies that this product complies with 21 CFR 1040.10 and 1040.11 CSA STD C22.2 # 60601-1 CSA STD C22.2 # 60601-1 except for deviations pursuant to Laser Notice No.
  • Page 10 Laser emission and applied part connection label (articulating arm) Do not block air intake label Maximum gas pressure rating label for the gas management system label fuses voltage and current rating label Figure 4-3. Laser labels L-1670 Rev 0 © OmniGuide, Inc.

  • Page 11: Warnings

    General Warnings No modification of this equipment by the user is allowed. Modification will void the warranty. BEACON laser system is designed to be used only with OmniGuide fibers. Do not use fibers which are not approved for BEACON laser system.

  • Page 12: Warnings Specific To The Fiber

    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 13: Sterility Warnings

    • 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. Refer to OmniGuide fiber IFUs for specific instructions on how to clean fiber tips during surgical procedures.

  • Page 14: Fire Protection

    Gas system is designed to be operated with two gas cylinders always in place. Do not operate the system with just one gas cylinder. This could result in the helium gas leaking into environment. L-1670 Rev 0 © OmniGuide, Inc.

  • Page 15: Product Description

    The Laser is fDA Class IV sealed, Rf excited CO Laser capable of producing CW or pulsed laser radiation at 10.6 μm wavelength. Laser radiation can be directed either through OmniGuide flexible fiber or through an articulated arm. Preferred laser modality can be selected from the user screen.

  • Page 16: Delivery System

    Articulating Arm modality has to be selected by the user as the first step in operating the laser. 7.1.1 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.

  • Page 17: The Omniguide Fiber

    Please, refer to the IFUs of the specific accessory for installation and maintenance. The OmniGuide Fiber The flexible OmniGuide fiber is a single use, sterile, disposable device which is supplied separately from the laser system. The OmniGuide fiber guides CO Laser light with a wavelength of 10.6 microns...

  • Page 18: Description Of Aa Accessories

    Figure 7-3: The proximal end ST connector on the OmniGuide fiber. Note the key that goes into the ST socket groove of the fiber adaptor. Description of AA accessories The following accessories can be used with the BEACON laser system...

  • Page 19: Foot Pedal Connection

    When a fiber is used, the gas outlet on the top of the laser should be connected with the outlet on the fiber adaptor with supplied gas hose. An OmniGuide sterile gas filter unit should be installed on the fiber adaptor and connected to the gas outlet for sterile cases.

  • Page 20: Gas Management System

    Storage for compressed gas tanks is located under removable back panel of the laser. Gas tanks can be accessed and replaced by the user. Only gas cylinder types specified by OmniGuide can be used with The BEACON Advanced Energy Laser System: filled with compressed helium 99.9+% purity, E size.

  • Page 21: Power On/Off Push Button

    On position before laser system starts. To turn laser system off always push power on/ off button first, before unplugging the laser power cord or switching off the main power switch. L-1670 Rev 0 © OmniGuide, Inc.

  • Page 22: Laser Modality Indicators

    USB connection Laser is equipped with USB port located on the front panel of the laser system. The USB port is used by OmniGuide personnel only, for diagnostics and software updates. Handle There is a handle on the front panel of the laser system to help you easily roll the system.

  • Page 23: Air Outlet

    Spot size: fIBER: fiber outputs a diverging laser beam. Exact laser spot size depends on fiber used and distance from the tissue. Please, refer to OmniGuide Fiber instructions for use (IFU). Beam divergence of the of the laser beam coming out of the fiber is ≤ 250 mRad depending on the fiber type.
  • Page 24 Electrical: Class I Sterility: Dual laser system is not intended to be sterilized OmniGuide fibers are supplied sterile for a single use Accessories (micromanipulators and handpieces) are reusable and must be cleaned/sterilized before the procedure Applied parts: Fiber and laser accessories are classified as applied part, type B...
  • Page 25 Exact laser spot size depends on fiber used and distance from the tissue. Please, refer to OmniGuide Fiber instructions for use (IFU). Beam divergence of the of the laser beam coming out of the fiber is ≤...

  • Page 26: Safety

    Laser beams are also powerful enough to burn skin, clothing or paint and can damage the light-sensitive elements in video cameras, photo multipliers and photo diodes. L-1670 Rev 0 © OmniGuide, Inc.

  • Page 27: Electrical Safety

    Laser radiation may ignite endogenous gases. OmniGuide provides the following recommendations to promote the safe use of The BEACON Advanced Energy Laser System. Operators are advised to adhere to these recommendations and employ sound Laser safety practices at all times.

  • Page 28: Transportation And Storage

    The BEACON Advanced Energy Laser System is not designed for mobile use. If it becomes necessary to relocate the laser, contact OMNIGUIDE Customer Support or your distributor for details. failure to do so may result in personal injuries or damage to the system and may void any warranty.

  • Page 29: Unpacking And Inspection

    Laser. If you need to ship the Laser back to OmniGuide, you MUST ship it in the OmniGuide shipping container and packing material. If the Laser is not packed properly and damage occurs during shipment, the customer will incur all charges for the repair of damaged or missing parts.

  • Page 30: Facilities Requirement

    Never operate the Laser without the air filter, do not use any other filter than the one provided by OmniGuide. Operating with dust, water or dirt in the environment around the laser or without the filter could result in damage to the laser. For filter replacement please contact OmniGuide service.

  • Page 31: Compressed Gas Requirement

    120 V 15A 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 32: System Operation

    12.1.13 If required attach a sterile gas filter unit in line between the helium supply hose and fiber port. 12.1.14 Attach a valid OmniGuide fiber to the fiber port and wait for the fiber tag to be recognized 12.1.15 Insert the fiber into the appropriate hand piece or scope and ensure the fiber is properly seated in accordance with the fiber IFU.

  • Page 33: Arm Usage Mode

    “Arm” icon in the upper left and choosing “change mode. Post Procedure Breakdown 12.1.31 Press the power button on the front of the laser to turn it off 12.1.32 When the unit has powered down it can be unplugged from the wall. L-1670 Rev 0 © OmniGuide, Inc.

  • Page 34: Graphical User Interface

    12.1.33 OmniGuide fibers are single use disposable as are sterile gas filter units. 12.1.34 OmniGuide handpieces can be cleaned sterilized and re- used in accordance with their corresponding IFUs 12.1.35 After use, the laser unit should be wiped with IPA wipes or equivalent as recommended by the hospital infection control procedures.
  • Page 35 12.1.38 Home Screen: occurs after the password is input or whenever the “Home” button is pressed Figure 12-2 – Home Screen, Select Mode 12.1.39 Selecting Arm Accessories: Occurs after choosing “Arm” mode from the home screen Figure 12-3 L-1670 Rev 0 © OmniGuide, Inc.
  • Page 36 12.1.40 Arm Delivery Mode: Main Screen (Occurs after selecting Arm accessories) Figure 10-4: Main Screen, Arm Mode 12.1.41 Fiber Delivery Mode: Occurs after selecting Fiber Mode from the Home Screen Figure 12-5: Select Mode L-1670 Rev 0 © OmniGuide, Inc.
  • Page 37 12.1.42 Fiber Delivery Mode: Main Screen Figure 12-6 12.1.43 Helium Supply Details: Occurs when touching the Helium Supply icon. Figure 12-7 L-1670 Rev 0 © OmniGuide, Inc.
  • Page 38 12.1.44 Pulse Duration (Single Pulse): Occurs whenever the user touches the single pulse icon. Figure 12-8 12.1.45 Pulse Duration (Repeat Pulse): Occurs whenever the user touches the repeat pulse icon. Figure 12-9 L-1670 Rev 0 © OmniGuide, Inc.
  • Page 39 12.1.46 Switching Modes: Occurs when touching the Delivery Mode icon and takes the user to the Home Screen. Figure 12-10 12.1.47 Laser Log: Occurs when the user touches the Laser Log icon Figure 12-11 L-1670 Rev 0 © OmniGuide, Inc.
  • Page 40 12.1.48 Settings Main Screen: Occurs when the user touches the settings button Figure 12-12 12.1.49 Load User Settings: Occurs when the user touches the Load User Settings Icon Figure 12-13 L-1670 Rev 0 © OmniGuide, Inc.
  • Page 41 12.1.50 Main System Settings: Occurs when the user touches the system settings icon Figure 12-14 12.1.51 Language Settings: Occurs when the user touches the Language button Figure 12-15 L-1670 Rev 0 © OmniGuide, Inc.

  • Page 42: Cleaning, Sterilization And Disposal

    12.1.52 Passcode Change: Occurs when the user touches the Passcode Button. Allows the user to change the Main Password at Startup. User will be asked to confirm passcode. Figure 12-16 12.1.53 Note: Rep and Service settings are only available to OmniGuide trained personnel. 13.0 CLEANING, STERILIZATION AND DISPOSAL Cleaning Instructions The adapter, display screen, and articulating arm can be cleaned by wiping its exterior with a cloth moistened with 70% IPA or equivalent recommended by the hospital infection control procedures.

  • Page 43: Fiber Disposal Instruction

    A maintenance required notification will appear when the laser has passed its next maintenance date. This date is set in the service mode for the laser which is only accessible by OmniGuide trained technicians. This is a notification only and will not render the unit unusable. However, usage of the laser system without proper maintenance by an OmniGuide trained technician is highly discouraged and the user does so at their own discretion assuming full risk and liability.

  • Page 44: Functionality

    Password does not work Retype the pin code (password). If you cannot get into the main menu, restart the system and retry. If you have no success entering the main menu contact OmniGuide service for assistance (1-888-666-4484). No effect on tissue 1.

  • Page 45: Low Power Or No Power Is Observed Out Of The Omniguide Fiber

    If the problem persists, contact OmniGuide for assistance. Call OmniGuide Service at 888-666-4484 ext. 3. 16.0 WARRANTY Point of Sale Warranty for point of sale warranty on new and refurbished units please refer to OmniGuide’s terms and conditions. Parts and Service Warranty OmniGuide warrants that Parts installed and services performed by OmniGuide or OmniGuide-...

  • Page 46: Warranty Exclusions

    If there is a need to send the system to the manufacturer the laser and the accessories must be properly packed and labelled in their original shipping box as shown in figure 17-1. Figure 17-1. OmniGuide laser in the shipping crate L-1670 Rev 0...

  • Page 47: Shipping Instructions

    Shipping instructions Before shipping the system back to OmniGuide please first contact OmniGuide or your distributor so that you will receive authorization to ship. 18.0 WARNINGS AND ALARMS Laser System Warnings Error Condition Displayed text FIBER Maximum fiber usage reached.

  • Page 48: Laser System Alarms

    SySTEM Maintenance required. Current date later than the prescribed W-25 Maintenance Required next maintenance due date Call OmniGuide Service at 888-666-4484 ext 3. Refer to Instructions for Use for Micro- Micro-Manipulator selected in Refer to Instructions for Use for W-26...
  • Page 49 Gas Underflow error Critical Underflow deviation while in READY state. If problem persists, replace with a new OmniGuide fiber or call OmniGuide Service at 888-666-4484 ext 3. flow controller error. Please re-start the laser system. MfC Communication No communication with MfC when...
  • Page 50 Ambient temperature too high to operate the laser. Ambient Temperature LC asserts Temperature fault bit and Temperature A-36 If the problem persists, call OmniGuide Too High reading is above the max operational temperature. Service at 888-666-4484 ext 3. Ambient temperature too low to operate the laser.

  • Page 51: Guidance And Manufacturer's Declaration

    Error Condition Displayed text HARDWARE Power Supply Relay System error. Call OmniGuide Service A-60 Relay contacts are shorted Contacts failure at 888-666-4484 ext 3. Shutter does not move from Open/ System error. Call OmniGuide Service A-61 Shutter Failure (1) Close position when commanded at 888-666-4484 ext 3.

  • Page 52: Electromagnetic Immunity Ii

    80 MHz to 6000 MHz conforms to IEC 60601 IEC 61000-4-3 ed3.0 (with A1:2007+A2:2010) Conducted, Radio-frequency, / 6V / 6V Electromagnetic Immunity Test 150 kHz to 80 MHz conforms to IEC 60601 IEC 61000-4-6 ed2.0 (with A1:2004+A2:2006) L-1670 Rev 0 © OmniGuide, Inc.

  • Page 53: References

    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-1670 Rev 0 © OmniGuide, Inc.

  • Page 54: Product Information

    21.0 PRODUCT INfORMATION Product Inquiries for USA OmniGuide, Inc. 4 Maguire Rd. Lexington, MA 02421 Phone: (617) 551-8444 or (888) OMNI-GUIDE Fax: (617) 551-8445 Email: service@omni-guide.com URL: www.omni-guide.com L-1670 Rev 0 © OmniGuide, Inc.
  • Page 55 L-1670 Rev 0 © OmniGuide, Inc.

This manual is also suitable for:

Beacon 420030-aa

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