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

L-1670 Rev 0 11© OmniGuide, Inc.
5.0 WARNINGS
General Warnings
No modication of this equipment by the user is allowed. Modication will void the warranty.
BEACON laser system is designed to be used only with OmniGuide bers. Do not
use bers which are not approved for BEACON laser system.
Do not use laser accessories which are not approved for the BEACON laser system. Examine
accessories for any sign of damage before use. Do not use damaged accessories.
If this equipment is modied, appropriate inspection and testing must be
conducted to ensure continued safe use of the equipment
To avoid risk of electric shock, this equipment must only be connected to supply mains with protective earth
BEACON Laser System weights more than 150 lbs and may cause injury if proper care is not
used when moving it. The system should always be moved slowly and carefully
Warnings for Laser Surgical Procedures
The BEACON Advanced Energy Laser System is a FDA Class 4 Laser device that produces invisible beams of high-
energy infrared radiation at 10.6 microns wavelength (Class 4). Articulating arm has also an output of the laser beam
at the visible wavelength of 635 nm (Class 2M). Improper use of the Laser could result in serious personal injury.
Proper electrical and Laser safety training and strict observation of all safety precautions as specied in the Laser
Instructions for Use or Operations Manual 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 hazards associated with it. Consult medical literature regarding
techniques, complications, and hazards prior to performing these procedures.
All personnel in the immediate area of laser use must wear eye protection specically rated for CO2
Lasers (OD 4+). Failure to do so may result in serious and permanent damage to the eyes.
Laser beam coming out of the articulating arm is a non-divergent that should not be activated
without an accessory attached to the articulating arm. Laser beam should not be aimed at the
walls, oors or other object as it will create burn marks -even from a distance.
Before instruments and accessories from different manufacturers are employed in a procedure, the user must
verify compatibility with the OmniGuide System. If in doubt, contact OmniGuide for assistance.
The laser should be activated only when the laser treatment site is clearly observable and the ber tip is directed at it.
A re extinguisher must be available in the operating room when the laser is being
utilized. Saline solution or water should also be readily available.
Flammable prep solutions (e.g. alcohol-based prep solutions) must not be used during Laser procedures.
Follow established protocols for laser surgery to minimize the risk of airway res.
A smoke evacuation system must be utilized to remove surgical plume.
Do not submerge any portion of The BEACON Advanced Energy Laser System in uid.

L-1670 Rev 0 12© OmniGuide, Inc.
Warnings Specic to the Fiber
With most ber assemblies, pressurized gas exits the ber tip during the laser procedure and may cause venous gas
embolism. To reduce the risk of embolism, do not bring the tip into contact with blood vessels or vascular tissue. The
gas pressure delivered to the system should not exceed the pressures listed on the insert provided with each ber. For
airway cases, the ber should not be used below the carina. See ber IFU for additional ber-specic warnings.
The pressurized gas exiting the ber’s tip during the laser procedure may cause temporary ination
and separation of sub-mucosal aps or mild emphysema under supercial layers of tissue.
Only use medical-grade Helium gas.
Do not retract, probe, or manipulate tissue with the distal-end tip of the OmniGuide ber.
Do not use excessive force while handling the OmniGuide ber inside an endoscopic handpiece. The
use of excessive force could potentially lead to ber breakage or distal-end tip detachment.
The use of high laser power along with extensive bending of the ber may result in gas temperatures
exceeding 60oC, which can cause thermal damage to healthy tissue. Always use the minimum laser
power possible for a given procedure and minimize the amount of bending of the ber.
For sterile procedures, the use of the OmniGuide Gas Filter Unit (cat# ACC-GFU-100) is required.
There is a possibility that the OmniGuide ber will fail to transmit light during the course of a
surgical procedure. Therefore, it is recommended that you have at least two ber assemblies
available prior to starting a surgical procedure using the OmniGuide Laser System.
Warnings Specic to Compressed Gas
(Disclaimer: The supply of the gas per OmniGuide specications, the gas delivery system, and the gas supply operation
and maintenance procedures, including the observation of compressed gas safety precautions, are the responsibility
of the healthcare-providing facility. Refer to general safety regulations for handling of compressed gases.)
Only personnel trained in compressed gas safety procedures should be allowed
to connect the compressed gas tanks to the system.
Using pressurized gas during some endoscopic procedures (e.g. gastrointestinal, gynecological, etc.) could lead to over-
insufations and the danger of tissue perforation. An approved system for pressure monitoring and gas evacuation,
chosen by a physician, is required to prevent over-insufations and ensure patient safety. Use of insufators or other
approved gas evacuation devices that are equipped with a sensor for internal pressure and a pressure relief valve
are recommended. Refer to the manufacturer’s instructions for equipment set up and detailed instructions.
For sterile cases where Gas Filter Unit is used, never exceed the maximum gas pressure rated for the Gas Filter Unit.
Always monitor the vital signs of the patient for symptoms of gas embolism.
Always monitor patient’s blood oxygen level.
Before the start of a medical procedure using the OmniGuide Adapter and ber, verify that the gas delivered to the system is
of the proper type and pressure for the ber being used. This information can be found on the insert provided with each ber.

L-1670 Rev 0 13© OmniGuide, Inc.
Sterility Warnings
The OmniGuide ber is supplied sterile for one-time use. The method of sterilization is
radiation. Consult relevant OmniGuide ber IfU for handling instructions
Do not use the ber product if the package is damaged, opened, or if sterility is compromised.
Wear sterile gloves and observe proper surgical aseptic technique while handling the sterile ber.
Do not use an OmniGuide Adapter in a sterile procedure without the Gas Filter Unit (cat# ACC-GFU-100).
Use sterile drape to cover articulating arm during sterile procedures.
Accessories (micromanipulators and handpieces) must be cleaned and/or sterilized before
the procedure using methods described in the IfUs provided for accessories.
6.0 CAUTIONS
Cautions for Laser Surgical Procedures
Physicians performing Laser procedures should be trained and compliant with their relevant health care facility requirements in:
• Laser safety (ANSI-Z136.1)
• Clinical use of CO2Lasers
• The use of the OmniGuide System
Build-up of tissue or tissue debris on the distal-end tip of the OmniGuide bers 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 ber IFUs
for specic instructions on how to clean ber tips during surgical procedures. Replace the ber if performance does not improve.
The OmniGuide ber is a single use device. Reuse of ber voids all warranties of sterility and is prohibited.
Do not bend the OmniGuide ber to a radius less than the minimum radius and maximum angle specied for the ber (typically
3cm, 30 degree). Bending the ber below this limit may cause ber failure. Refer to ber IFUs for more instructions on ber usage.
To assure the proper functioning of the device, The BEACON Advanced Energy Laser System
must be serviced be performed by an OmniGuide authorized representative.
After a surgical procedure, visibly inspect the integrity of the OmniGuide Fiber. In
particular, verify that no portion of the ber is missing or detached.
Excessive bending of OmniGuide ber will lower its output power. Please consult ber IFUs for the
minimum allowable bending radius and angle of the ber. Do not kink or pinch the Fiber.
The OmniGuide System is not currently compatible with optical scanners.
Reected Energy Protection
Do not aim laser beam at the reective surfaces such as mirrors, polished metal, glass or polished
ceramics to avoid uncontrolled beam reection or scattering. All instruments used with the Laser
system should have brushed, burnished, or blackened non-reective surfaces.
Clinician and patient must use appropriate eye and skin protection. All personnel in the immediate area of laser use must wear eye
protection specically rated for CO2 Lasers (OD 4+). Failure to do so may result in serious and permanent damage to the eyes.

L-1670 Rev 0 14© OmniGuide, Inc.
Fire Protection
Drape the surgical eld with materials designed for use with lasers. The surgical drape must be ame retardant.
Keep combustible materials away from the area of laser use.
Take appropriate measures to prevent the possibility of a re associated with anesthesia such as use of a laser safe tracheotomy
tube at the 10.6 micron wavelength and maintaining oxygen levels at 30% or less of the anesthetic mixture while ring.
Eye Protection
Everyone in the immediate area of laser use must wear eye protection specically rated for CO2
Lasers (OD 4+). Failure to do so may result in serious and permanent damage to the eyes.
Use special precautions when working around eyes.
Do not look directly at the laser beam, aiming beam or aim laser at the eye even when wearing eye protection.
Tissue Protection
Start with low 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 tissue layer.
The clinician’s skin should be protected from exposure and the patient’s skin
should be protected from overexposure to Laser radiation.
The CO2laser is approved for soft tissue only and can cause thermal damage to bones
and teeth. Protect them from exposure to laser radiation as necessary.
Smoke Control
Smoke from the procedure could contain biologically hazardous materials and has to
be evacuated. Run smoke evacuator for 30 seconds after lasing stops.
The clinician should wear an appropriate mask/respirator specied by the safety procedures at your facility.
Refer also to the laser labeling for additional precautions.
Gas Management System
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 15© OmniGuide, Inc.
7.0 PRODUCT DESCRIPTION
In this section, the specications and characteristics of The BEACON Advanced Energy Laser 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.
The BEACON Advanced Energy Laser System
The Laser is FDA Class IV sealed, RF excited CO2Laser capable of producing CW or pulsed laser
radiation at 10.6 μm wavelength. Laser radiation can be directed either through OmniGuide
exible ber or through an articulated arm. Preferred laser modality can be selected from the
user screen. The laser is operated via a foot pedal to allow laser radiation only when required.
The back and front of the Laser are shown in Figure 7-1 and Figure 7-2 respectively.
The laser is designed to be operated in a general hospital environment and hospital OR rooms
with environmental characteristics indicated in the laser specication, refer to section 7.20.
Figure 7-1: Front of the Laser

L-1670 Rev 0 16© OmniGuide, Inc.
Figure 7-2. Back of the Laser: cover closed (left), back cover open (right).
Delivery System
The Delivery System consists of a ber adaptor and articulating arm. Either Fiber modality or
Articulating Arm modality has to be selected by the user as the rst step in operating the laser.
7.1.1 OmniGuide Fiber Adapter
To produce sufcient output power at the distal end of an OmniGuide ber, the laser beam
generated in the laser is delivered precisely to the input end of the ber by means of ber
adapter with a standard ST socket for ber connection. The adapter has a quick-disconnect gas
port for the helium gas supply and incorporates an RFID antenna as shown in Figure 7.3.

L-1670 Rev 0 17© OmniGuide, Inc.
7.1.1.1 RFID System
All Omniguide ber are equipped with passive RFID tags that allow authentication and
identication of bers to the laser system. An RFID antenna is built into the ber adapter
(Figure 7-3) enabling the laser system to recognize specic Omniguide ber when it is
plugged in and to offer laser settings compatible with that specic ber. The ber type
is displayed on the screen. The RFID system has the following characteristics:
Operating Frequency: 13.56MHz
Bandwidth: 870kHz
Transceiver output power: 100mW
Read range: < 5cm
RF communication data rates: 26.48 kbs (ISO 15693)
RF communications equipment (antenna on the ber adapter) should be used no closer
than 30 cm (12 inches) to any part of the medical equipment (other than BEACON
laser system), including cables as specied by the manufacturer of that equipment.
Otherwise, degradation of the performance of the other equipment could result.
7.1.2 Articulating Arm
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 OmniGuide website for the list of compatible accessories. The operator connects
the micromanipulator or handpiece to the end-joint of the articulated arm prior to patient treatment,
by threading it on, and disconnects it after treatment for cleaning and disinfection. Gas ports on
the micromanupulator or handpieces can be connected with airline attached to the articulating
arm. Please, refer to the IFUs of the specic accessory for installation and maintenance.
The OmniGuide Fiber
The exible OmniGuide ber is a single use, sterile, disposable device which is supplied separately
from the laser system. The OmniGuide ber guides CO2Laser light with a wavelength of 10.6 microns
and delivers energy from the laser to the surgical site, enabling minimally invasive procedures. A
close up of the ber connector at the proximal end, that is connected to the laser, is shown in gure
5-4. Fiber with RFID tag is required to operate The BEACON Advanced Energy Laser System.

L-1670 Rev 0 18© OmniGuide, Inc.
Figure 7-3: The proximal end ST connector on the OmniGuide ber. Note the
key that goes into the ST socket groove of the ber adaptor.
Description of AA accessories
The following accessories can be used with the BEACON laser system
through the attachment to the articulating arm:
Micromanipulators:
1. AccuBeam EasySpot (OmniGuide Cat.#420031)
2. AccuBeam MicroSpot (OmniGuide Cat.#420060)
Handpieces:
3. Incisional Hand Piece 75 mm (OmniGuide Cat.#420035)
4. Incisional Hand Piece 100 mm (OmniGuide Cat.#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 by TTI Medical, San Ramon, CA and covered by the
following 510(k)s: K864378 (Micromanipulators) and K945648 (Handpieces). Contact
OmniGuide directly for more detailed information on the accessories.
Touch Screen/Display Panel
The BEACON Advanced Energy Laser System has a touch screen panel mounted on the swivel joints.
Position of the touch screen can be adjusted by the user. The high-resolution touch screen features a smart
user interface that allows the operator to access and monitor the laser system operation functions.

L-1670 Rev 0 19© OmniGuide, Inc.
Foot Pedal Connection
The footswitch is connected to the laser by a cord 30 ft (10m) long. The footswitch cord should
be plugged directly into the food pedal connector receptacle on the bottom of the right side
of the laser box (Figure 7-4). Open the protective cover, and align red dot indicators and the
foot pedal connector and on the laser body before plugging the footswitch in. To remove the
footswitch, rmly hold the footswitch connector at the connection point and pull outwards.
Figure 7-4. Foot pedal (left), and foot pedal and interlock connections (right)
High Pressure Gas Input
The gas ow controller of the laser should be supplied with medical grade helium at a pressure
ranging from 110 to 125 PSI. The laser is equipped with automatically triggering valves that read
pressure and react prior to the mass ow controller. The Laser Gas Outlet pressure is controlled
from the touch-screen interface. Helium gas is used only to operate exible OmniGuide ber. The
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 connectors. For country specic connectors, please, contact OmniGuide service.
When a ber is used, the gas outlet on the top of the laser should be connected with the
outlet on the ber adaptor with supplied gas hose. An OmniGuide sterile gas lter unit should
be installed on the ber adaptor and connected to the gas outlet for sterile cases.
Laser has the ability to display the amount of gas available in the gas tanks on the laser touch screen.
Removable Back Panel
The removable back panel of the laser provides access to the gas management system. The back panel
must be closed during the normal operation of the laser. It can be removed only to install or to replace
gas cylinders. To remove the back panel, press down the latch on the top of the panel and open the
panel using cable storage hook as a handle. Removing the back panel will enable system interlock.
After closing the panel, make sure that the latch is locked. Otherwise
system interlock will prevent laser system from operation.

L-1670 Rev 0 20© OmniGuide, Inc.
Gas Management System
The gas management system is fully integrated into The BEACON Advanced Energy Laser System (see
Figure 7-2) and provides a convenient way to operate the laser. The gas management system consists of two
gas tanks, hosed connectors for two gas tanks, pressure regulator, gas valves, pressure transducers to sense
the amount of gas left in each of the gas tanks, electrical connections and gas supply quick-disconnect gas
supply port. Most of the gas management system is not visible from the outside and must not be adjusted or
accessed by the user. 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 specied by OmniGuide can be
used with The BEACON Advanced Energy Laser System: lled with compressed helium 99.9+% purity, E size.
The user connects the gas port on the laser adaptor laser to the gas supply port located on the top of
the laser by a hose supplied with the system (P/N 3-0162-012-00-01). The gas management system is
designed to be always operated with two gas cylinders in place. Two cylinders act as a single reservoir
of the gas: gas will be drawn from both cylinders and cylinders will be emptied at the same time.
Prior to starting the surgical procedure make sure that the gas tank valves are
open and there is enough gas for the surgery. System is designed to operate with
both gas cylinders in place. Do not operate the system with one cylinder.
Prior to replacing the compressed tanks make sure that valves on both gas tanks are closed.
Caution. Refer to OmniGuide ber IFUs for instructions on choosing appropriate gas pressure settings.
Door Interlock
The door interlock connection allows the use of the door interlock safety feature, as may be required at your
health care facility. If the door to the room where the laser is being used is opened, this feature will automatically
disable operation of the laser. If door interlock operation is not required, a door interlock plug (supplied with
the system), can be plugged into the door interlock connection at the back of the laser to defeat the interlock
and allow operation of the laser. The door interlock feature is implemented through the laser software.
Locking Wheels
The laser system is equipped with wheels. All four wheels can swivel for maneuverability.
All wheels have a locking mechanism which prevent the wheels from swiveling or moving.
To lock or unlock the wheels, use your foot to press on the locking lever.
Do not attempt to move the laser with wheels locked. That may result in tipping.
Emergency Switch
Emergency switch (red button) is located on the front panel. Pressing emergency
switch will disable the laser tube and will stop laser radiation.
Main Power Switch and Power Cable
The mains power switch (circuit breaker) and the mains power cable provide power to the laser
system. The switch is located on the bottom of the laser system, on the left side (see Figure 7-5).
The mains power switch must be in the ON position for the laser system to operate. Power on/
off button located on the front panel of the laser can be then used to turn laser system on.