OmniGuide BEACON 420060AA User manual

BEACON™ Advanced Energy Laser System
Instructions for Use
To be used with: OmniGuide Catalog Numbers: 420060AA, 420030-AA
OmniGuide, Inc.
4 Maguire Rd. Lexington, MA 02421
1-888-666-4484 or 1-617-551-8444 US
www.omni-guide.com
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.

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
Denition of Warning ............................................................................................................................................................................... 6
Denition 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 Specic to the Fiber ................................................................................................................................................................. 12
Warnings Specic to Compressed Gas .................................................................................................................................................... 12
Sterility Warnings...................................................................................................................................................................................... 13
6.0 CAUTIONS ..................................................................................................................................................... 13
Cautions for Laser Surgical Procedures.................................................................................................................................................... 13
Reected 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

L-1670 Rev 0 3© OmniGuide, Inc.
Power On/Off Push Button....................................................................................................................................................................... 21
Laser Modality indicators ......................................................................................................................................................................... 22
USB connection........................................................................................................................................................................................ 22
Handle...................................................................................................................................................................................................... 22
Air Outlet.................................................................................................................................................................................................. 23
Scanner Connection ................................................................................................................................................................................. 23
Operating Specications for Laser ........................................................................................................................................................... 23
8.0 SAFETY........................................................................................................................................................... 26
Laser Safety Requirements ....................................................................................................................................................................... 26
Optical Safety........................................................................................................................................................................................... 26
Electrical Safety ........................................................................................................................................................................................ 27
Compliance to Standards Relevant to CE-Mark....................................................................................................................................... 27
9.0 TRANSPORTATION AND STORAGE ............................................................................................................. 28
10. UNPACKING AND INSPECTION ................................................................................................................... 29
List of Items in the 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
Use Preparation........................................................................................................................................................................................ 32
Surgical Preparation ................................................................................................................................................................................. 32
Fiber Mode Usage.................................................................................................................................................................................... 32
Arm Usage Mode ..................................................................................................................................................................................... 33
Post Procedure Breakdown ...................................................................................................................................................................... 33
Graphical User Interface........................................................................................................................................................................... 34
13.0 CLEANING, STERILIZATION AND DISPOSAL ............................................................................................. 42
Cleaning Instructions................................................................................................................................................................................ 42
Sterilization Guidelines............................................................................................................................................................................. 42
Fiber Disposal Instruction......................................................................................................................................................................... 43
14.0 MAINTENANCE ........................................................................................................................................... 43
Overview .................................................................................................................................................................................................. 43
Notication............................................................................................................................................................................................... 43
Alignment:................................................................................................................................................................................................ 43
Calibration................................................................................................................................................................................................ 43
Gas Management..................................................................................................................................................................................... 43
Functionality............................................................................................................................................................................................. 44
Parts.......................................................................................................................................................................................................... 44
OmniGuide Service .................................................................................................................................................................................. 44

L-1670 Rev 0 4© OmniGuide, Inc.
15.0 TROUBLESHOOTING .................................................................................................................................. 44
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.............................................................................................................................................................................. 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 Warnings............................................................................................................................................................................. 47
Laser System Alarms ................................................................................................................................................................................ 48
19.0 GUIDANCE AND MANUFACTURER’S DECLARATION ............................................................................... 51
Electromagnetic Emission ........................................................................................................................................................................ 51
Electromagnetic Immunity ....................................................................................................................................................................... 52
Electromagnetic Immunity II..................................................................................................................................................................... 52
20. REFERENCES ................................................................................................................................................. 53
21.0 PRODUCT INFORMATION .......................................................................................................................... 54
Product Inquiries for USA......................................................................................................................................................................... 54

L-1670 Rev 0 5© OmniGuide, Inc.
1.0 PREFACE
This manual is designed to help the user understand and operate The BEACON Advanced Energy Laser
System. BEACON is a surgical laser that delivers CO2 energy via two modes of operation. The rst is
through OmniGuide’s patented, polymer-based exible ber, which is utilized within a specialty-specic
hand piece by the surgeon. The second modality is free-beam energy delivered via an articulating
arm mounted on the laser system. This manual will outline operational features of both functions.
The system consists of the following versions:
Cat.# 420060-AA
BEACON Advanced Energy Laser System with 30W maximum power output , 120/230V, 50/60 Hz Electrical input
Cat.# 420030-AA
BEACON Advanced Energy Laser System with 60W maximum power output, 120/230V, 50/60 Hz Electrical input
The BEACON Advanced Energy Laser System will refer to all the units (unless the
specic units are called out). This manual contains information 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: [phone] or 1-617-551-8444 US
URL: http://www.omni-guide.com
Caution – Use of controls or adjustments or performance of procedures other than
those specied in this manual may result in hazardous radiation exposure.
3.0 REGULATORY STATUS OF PRODUCT
The BEACON Advanced Energy Laser System includes all safety features required
by the United States Food and Drug Administration (FDA) and Center of Devices
and Radiological Health (CDRH). All required interlocks, warning labels
and indicators are in full compliance with 21 CFR 1040 and it has been 510(k) cleared for the following
Indications for Use: The BEACON Advanced Energy Laser System is indicated for the incision,
excision, ablation, vaporization and coagulation of body soft tissues in the following specialties:
• Dermatology
• General Surgery
• Gynecology
• Head & Neck Surgery
• Neurosurgery
• Oral Surgery
• Orthopedic Surgery in Soft Tissue
• Otolaryngology (ENT)
• Plastic & Reconstructive Surgery
• Podiatry
• Urology

L-1670 Rev 0 6© OmniGuide, Inc.
The BEACON Advanced Energy Laser System device can be used only by trained medical
professionals on general population of the patients. Applicability of the BEACON Advanced
Energy Laser System to treatment of the patient is determined by a qualied physician
based on the patient’s medical history within cleared indications for use.
Note: For ber and laser accessories Indications for Use, see applicable ber or laser accessories Instructions
for Use. The Laser has been tested to the European Standards and Regulations, carrying the CE Mark afxed to
the product. Information about the Management System can be obtained from the manufacturer.
Note: This product is not intended for neurosurgical/neurotology use in CE Mark recognized European
Countries. Accessories used with articulating arm (e.g. micromanipulators and handpieces) comply
with their respective regulatory requirements such as 510(k) and CE marking.
Note: This product is not intended for direct contact with the patient. Only bers or laser accessories attached
to the laser may contact the patient. Fiber and laser accessories are classied as applied part, type B.
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:
• The general complications related to surgical procedures, such as local and systemic infections
• Thermal tissue damage
• Perforation of tissue or tissue adherence related to misuse of the device.
• Laser surgical procedures should be performed only by a licensed healthcare
practitioner adequately trained to, and familiar with such surgical techniques
and clinical use of CO2lasers, and hazards associated with it.
• Usage of gas can increase the chance of gas embolism, see
OmniGuide ber IFUs for additional information
Denition of Warning
Warning is the term used to alert the user to possible injury, death, or other
serious adverse reactions associated with the use or misuse of the device. Warning
statements are placed at the appropriate sections of this User Manual.
Denition of Caution
Caution is the term used to alert the user of the possibility of a problem with the device associated
with its use or misuse. Such problems include device malfunctions or device failure and may result
in minor or moderate injury to the user and/or patient, damage to the device, or damage to
other property. Caution statements appear at the appropriate sections of this User Manual.

L-1670 Rev 0 7© OmniGuide, Inc.
Symbols Used in this Manual
This symbol is intended to alert the operator to the presence
of dangerous voltages associated with the laser that may be of
sufcient magnitude to constitute a risk of electric shock.
This symbol is intended to alert the operator that there are
specic warnings or precautions 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 radiation.
This symbol is to alert the operator to the danger of exposure
to laser radiation being emitted from the aperture.
Fiber port symbol
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 8© OmniGuide, Inc.
Warning Signs and Laser Labels
Figure 4-1. Location of the labels

L-1670 Rev 0 9© OmniGuide, Inc.
1-0009-084-00-00 Rev 0
OMNIGUIDE INC. certies that this product complies with 21 CFR 1040.10 and 1040.11
except for deviations pursuant to Laser Notice No. 50, dated June 17, 2017.
OmniGuide, Inc.
4 Maguire Road
Lexington, MA 02421
Email: [email protected]
Phone: [phone]
MADE IN THE USA
!
Conforms to:
AAMI STD ES60601-1
IEC STD 60601-1-6
IEC STD 62304
IEC STD 60825-1
IEC STD 60601-2-22
Certied to:
CSA STD C22.2 # 60601-1
VISIBLE AND INVISIBLE
LASER RADIATION.
AVOID EYE OR SKIN EXPOSURE TO DIRECT
OR SCATTERED RADIATION.
CO2LASER: CLASS 4 IEC 60825-1:2014
AIMING LASER: CLASS 2M IEC 60825-1:2014
P0= 30W
λ= 10600nm
Pulse Duration: 50ms - 1sec
CO2
Laser:
Aiming Laser P0< 1mW
λ= 635nm
CO2Laser: 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. certies that this product complies with 21 CFR 1040.10 and 1040.11
except for deviations pursuant to Laser Notice No. 50, dated June 17, 2017.
OmniGuide, Inc.
4 Maguire Road
Lexington, MA 02421
Email: [email protected]
Phone: [phone]
MADE IN THE USA
!
Conforms to:
AAMI STD ES60601-1
IEC STD 60601-1-6
IEC STD 62304
IEC STD 60825-1
IEC STD 60601-2-22
Certied to:
CSA STD C22.2 # 60601-1
VISIBLE AND INVISIBLE
LASER RADIATION.
AVOID EYE OR SKIN EXPOSURE TO DIRECT
OR SCATTERED RADIATION.
CO2LASER: CLASS 4 IEC 60825-1:2014
AIMING LASER: CLASS 2M IEC 60825-1:2014
P0= 60W
λ= 10600nm
Pulse Duration: 50ms - 1sec
CO2
Laser:
Aiming Laser P0< 1mW
λ= 635nm
CO2Laser: 10600nm / 60W
Aiming Laser: 635nm
Voltage: 110-240 VAC
VA: 1500
Hz: 50/60
Weight: 70kg
M
Figure 4-2. Main Labels for the 30W and 60W laser units

L-1670 Rev 0 10© OmniGuide, Inc.
Interlock and foot pedal label
Ground label
Tipping Hazard label
Emergency STOP button label
Laser emission and applied part
connection label (ber adapter)
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