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OmniGuide BEACON 420030-AA, Instructions For Use Manual

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OmniGuide BEACON 420030-AA Instructions For Use Manual Download Page 2

L-1670 Rev 0

2

© OmniGuide, Inc.

TABLE Of CONTENTS

1.0 PREfACE ........................................................................................................................................................ 5
2.0 MANUfACTURING INfORMATION .............................................................................................................. 5
3.0 REGULATORY STATUS Of PRODUCT ........................................................................................................... 5

Notice Concerning Warranty .................................................................................................................................................................... 6

4.0 WARNING, CAUTION AND SYMBOLS .......................................................................................................... 6

Contraindications ..................................................................................................................................................................................... 6
Adverse Effects ......................................................................................................................................................................................... 6

Definition of Warning

 ............................................................................................................................................................................... 6

Definition of Caution

 ................................................................................................................................................................................ 6

Symbols Used in this Manual ................................................................................................................................................................... 7
Warning Signs and Laser Labels ............................................................................................................................................................... 8

5.0 WARNINGS .................................................................................................................................................... 11

General Warnings ..................................................................................................................................................................................... 11
Warnings for Laser Surgical Procedures ................................................................................................................................................... 11

Warnings Specific to the Fiber

 ................................................................................................................................................................. 12

Warnings Specific to Compressed Gas

 .................................................................................................................................................... 12

Sterility Warnings ...................................................................................................................................................................................... 13

6.0 CAUTIONS ..................................................................................................................................................... 13

Cautions for Laser Surgical Procedures .................................................................................................................................................... 13

Reflected Energy Protection

 ..................................................................................................................................................................... 13

fire Protection .......................................................................................................................................................................................... 14
Eye Protection .......................................................................................................................................................................................... 14
Tissue Protection ...................................................................................................................................................................................... 14
Smoke Control.......................................................................................................................................................................................... 14
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 ........................................................................................................................................................................... 19
Removable Back Panel ............................................................................................................................................................................. 19
Gas Management System ........................................................................................................................................................................ 20
Door Interlock........................................................................................................................................................................................... 20
Locking Wheels ........................................................................................................................................................................................ 20
Emergency Switch .................................................................................................................................................................................... 20
Main Power Switch and Power Cable ....................................................................................................................................................... 20

Summary of Contents for BEACON 420030-AA

Page 1: ...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 79...

Page 2: ...to the Fiber 12 Warnings Specific to Compressed Gas 12 Sterility Warnings 13 6 0 CAUTIONS 13 Cautions for Laser Surgical Procedures 13 Reflected Energy Protection 13 Fire Protection 14 Eye Protection...

Page 3: ...Box 29 Safety Issues in Laser Setup 29 11 0 FACILITIES REQUIREMENT 30 Electrical Power Connection 30 Compressed Gas Requirement 31 Door Interlock 31 Foot Pedal Connector 31 12 0 SYSTEM OPERATION 32 Us...

Page 4: ...rranty 45 Parts and Service Warranty 45 Services Remedy 45 Warranty Exclusions 46 17 0 PACKING PROCEDURE 46 Packing of the system 46 Shipping instructions 47 18 0 WARNINGS AND ALARMS 47 Laser System W...

Page 5: ...ormation on the pe formance and operation of the Laser as well as installation and control methods 2 0 MANUFACTURING INFORMATION Manufactured for OmniGuide Inc 4 Maguire Rd Lexington MA 02421 Tel 1 88...

Page 6: ...consistent 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...

Page 7: ...s associated with the medical device which are not otherwise found on the label This symbol is intended to alert the operator to the danger of exposure to hazardous visible and invisible laser radiati...

Page 8: ...L 1670 Rev 0 8 OmniGuide Inc Warning Signs and Laser Labels Figure 4 1 Location of the labels...

Page 9: ...aser 10600nm 30W Aiming Laser 635nm Voltage 110 240 VAC VA 1500 Hz 50 60 Weight 66kg M 1 0009 084 00 01 Rev 0 OMNIGUIDE INC certifies that this product complies with 21 CFR 1040 10 and 1040 11 except...

Page 10: ...OP button label Laser emission and applied part connection label fiber adapter Laser emission and applied part connection label articulating arm Do not block air intake label Maximum gas pressure rati...

Page 11: ...are required to operate the device and or provide its maintenance Laser surgical procedures should be performed only by individuals adequately trained and familiar with such surgical techniques and ha...

Page 12: ...cedure Therefore it is recommended that you have at least two fiber assemblies available prior to starting a surgical procedure using the OmniGuide Laser System Warnings Specific to Compressed Gas Dis...

Page 13: ...eplace the fiber if performance does not improve The OmniGuide fiber is a single use device Reuse of fiber voids all warranties of sterility and is prohibited Do not bend the OmniGuide fiber to a radi...

Page 14: ...ow power and increase power gradually to achieve desired effect Use the shortest exposure time for the desired result Exposure of charred tissue to the laser radiation can heat and injure underlying t...

Page 15: ...Laser capable of producing CW or pulsed laser radiation at 10 6 m wavelength Laser radiation can be directed either through OmniGuide flexible fiber or through an articulated arm Preferred laser modal...

Page 16: ...ed 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 i...

Page 17: ...The BEACON Advanced Energy Laser System is also equipped with articulating arm which can be connected with OmniGuide approved accessories such as micromanipulators and handpieces Please refer to Omni...

Page 18: ...420036 5 Incisional Hand Piece 125 mm OmniGuide Cat 420037 6 Incisional Hand Piece 200 mm OmniGuide Cat 420038 7 Incisional Hand Piece 250 450 mm OmniGuide Cat 420039 All accessories are manufactured...

Page 19: ...he Beacon laser has storage for two E size compressed Helium cylinders located under the back cover of the laser Gas tanks can be connected with the gas management system using gas hoses with CGA 930...

Page 20: ...ystem with one cylinder Prior to replacing the compressed tanks make sure that valves on both gas tanks are closed Caution Refer to OmniGuide fiber IFUs for instructions on choosing appropriate gas pr...

Page 21: ...e will be supplied for power connections outside of the United States Using main switch for shutting down the laser system may result in corruption of system software Figure 7 5 Location of the main p...

Page 22: ...r blinking light on the laser modality indicator shows which laser modality is engaged So ght laser is firing USB connection Laser is equipped with USB port located on the front panel of the laser sys...

Page 23: ...is kept pressed 10 Single pulse with pulse duration of 50 msec 1000 msec single pulse of laser emission per each foot pedal activation 11 Repeat pulse with individual pulse duration of 50 msec 1000 m...

Page 24: ...icromanipulators 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 60 W Unit Laser wave le...

Page 25: ...zone NHZ 93 Meters Nominal ocular hazard distance NOHD 93 m Maximum Permissible Exposure MPE 0 1 W cm2 Aiming beam characteristics Wavelength 635 nm Power 1 mW Class 2M Connectors Cords FIBER custom S...

Page 26: ...tors be properly trained and the proper use of PPE be used in the operation of this device Laser energy exposure near the aperture may cause burns Direct eye contact with the output beam from the Lase...

Page 27: ...emits 10 6 m Never look directly into the Laser output port when the power is on Post warning signs to alert personal of the use of a Laser When operating the Laser limit access to the area to indivi...

Page 28: ...BEACON Advanced Energy Laser System system Before moving the laser it is recommended to disconnect the footswitch from the laser and attach it to the back panel A handle located on the front panel al...

Page 29: ...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: ...rly Post appropriate warning signs in prominent locations at all entrances to the laser room When the laser system is in operation limit entry to the room and limit access to the laser to the personal...

Page 31: ...tlet on the top of the laser has a 1 8 quick disconnect port The gas hose supplied with the system connects the gas outlet at the front of the laser to the fiber adapter A Gas Filter Unit P N ACC GFU...

Page 32: ...not power on confirm that the mains power switch next to the power cord is on and that the Emergency Machine Off switch is pulled out Fiber Mode Usage 12 1 10 Enter the password and review any notifi...

Page 33: ...rd and review any notifications from system start up 12 1 23 Select the arm icon 12 1 24 Determine what accessories will be used with the articulating arm 12 1 24 1 Consult section 5 4 of the current...

Page 34: ...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 12 1 36 Co...

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...

Page 36: ...de Inc 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...

Page 37: ...L 1670 Rev 0 37 OmniGuide Inc 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...

Page 38: ...niGuide Inc 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...

Page 39: ...9 OmniGuide Inc 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...

Page 40: ...v 0 40 OmniGuide Inc 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 Figu...

Page 41: ...Rev 0 41 OmniGuide Inc 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...

Page 42: ...arm hand pieces are to be treated as biohazardous and to be cleaned in accordance with that specific accessories IFUs Used fibers are biohazardous material and must be disposed in a manner consistent...

Page 43: ...hnician is highly discouraged and the user does so at their own discretion assuming full risk and liability Alignment The OmniGuide optical adapter and articulating arm are to have its alignment confi...

Page 44: ...wer cord is fully securely plugged into an individual outlet 2 Check if electrical power cord is fully plugged into the Laser 3 Check if mains switch at the laser base is in ON position 4 Check if eme...

Page 45: ...ppears replace the OmniGuide Fiber and repeat this test If the problem persists contact OmniGuide for assistance System too hot 1 Is the laser system wrapped too tightly in sterile wrap or the air inl...

Page 46: ...applicable product specifications and written instructions 16 1 4 Abuse negligence accident loss or damage to a Product in transit 16 1 5 Improper site preparation unauthorized maintenance or modific...

Page 47: ...er above the maximum allowed in the fiber tag data for the current gas setting Action Required Laser is at maximum power setting for current gas flow Please increase gas flow in order to increase powe...

Page 48: ...RFID presence lost by laser controller when in Ready mode Fiber disconnected Please reconnect OmniGuide Fiber A 02 RFID Communication Failure No communication with RFID sensor when Fiber modality sel...

Page 49: ...sserts fault bit Foot pedal failure Foot pedal error Please reconnect or replace the foot pedal If the problem persists call OmniGuide Service at 888 666 4484 ext 3 system A 25 System Watchdog Timeout...

Page 50: ...ror Call OmniGuide Service at 888 666 4484 ext 3 A 44 Power Supply Failure During operation the HW Control status relay contacts indicate that the laser power supply has been disabled RC1 0 or RC2 0 L...

Page 51: ...s and Tests Electromagnetic Emission GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMISSION The Laser is intended for use in a typical commercial or hospital environment The customer or the...

Page 52: ...s short interruptions and voltage variations on power supply input lines IEC 61000 4 11 ed2 0 2004 03 0 UT 100 dip in UT for 0 5 cycle 0 UT 100 dip in UT for 1 cycle 70 UT 30 dip in UT for 25 cycles 1...

Page 53: ...he Perioperative Challenge Kay A Ball Mosby Publishing ISBN 081510524X Lasers and Optical Fibers in Medicine Abraham Kazir Academic Press ISBN 0124019404 Laser Surgery and Medicine Principles and Prac...

Page 54: ...OmniGuide Inc 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 ww...

Page 55: ...L 1670 Rev 0 55 OmniGuide Inc...

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