OmniGuide FELS-25A User manual
L-1633 Rev. 3 © OmniGuide, Inc. Page 1
To be used with: OmniGuide Catalogue Number: FELS-25A,
FELS-25A-E, FELS-25A-S2, FELS-25A-S3, FELS-25A-S4.
FELS-25A,
BeamPath with IntelliGuide™Fiber
Enabled CO2Laser
Users Manual
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URL: http://www.omni-guide.com
0483
A.R.C. LASER GmbH
Bessemerster. 14
D-90411 Nurnberg, Germany
Tel. 49 911 21779-0
L-1633 Rev. 3 © OmniGuide, Inc. Page 2
Caution: Federal law restricts this device to sale by or on the order of a physician or dentist.
•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-1633 Rev. 3 © OmniGuide, Inc. Page 3
Table of Contents
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L-1633 Rev. 3 © OmniGuide, Inc. Page 6
PREFACE
This manual is designed to help the user understand and operate the FELS-25A Fiber Enabled CO2Laser
systems. The family of the FELS-25A systems consists of the following versions:
•FELS-25A, which accepts 110V, 50/60 Hz Electrical input
•FELS-25A-E, which accepts 220V, 50/60 Hz Electrical input.
FELS-25A will refer to all the units (unless the specific units are called out). This manual contains
information on the performance and operation of the Laser as well as installation and control methods.
The FELS-25A uses a C-LAS medical CO2Laser manufactured by A.R.C. Laser GmbH (Bessemerstr. 14
D-90411 Nürenberg, Germany, tel. 0049-911-217790) for OmniGuide, Inc. The CO2 Laser is fitted with an
adapter that enables the Laser to deliver energy through a flexible optical fiber. The adapter and optical
fiber are manufactured by OmniGuide, Inc. The Laser has an integrated gas control system on a cart
designed by OmniGuide that holds the Laser, compressed gas tanks and gas tank regulator. The Laser
system is intended to be used in medicine for medical use only. Other non-medical uses may cause severe
damage to the system. It is recommended that any user of the system read this manual prior to operating
the Laser.
---------------------------------------------------------------------------------
Caution – Use of controls or adjustments or performance of procedures other than
those specified in this manual may result in hazardous radiation exposure.
---------------------------------------------------------------------------------
1.1.Regulatory Status of Product
The FELS-25A system includes all safety features required by the United States Food and Drug
Administration (FDA) and Center of Devices and Radiological Health (CDHR). All required interlocks,
warning labels and indicators are in full compliance with 21 CFR 1040 and it has been 510k cleared for
the following Indications for Use: The OmniGuide BeamPath FELS 25A, CO2Laser 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
•Otorhinolaryngology
•Pediatric Surgery
•Plastic & Reconstructive Surgery
•Podiatry
•Urology
Note: For fiber and handpiece Indications for Use, see applicable Instructions for Use.
L-1633 Rev. 3 © OmniGuide, Inc. Page 7
The Laser has been tested to the European Standards and Regulations, carrying the CE Mark affixed 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
1.2.Notice Concerning Warranty
Operating or handling of this medical Laser, inconsistent with this manual, may void the warranty.
WARNING, CAUTION AND SYMBOLS
2.1.Contraindications
Do not use OmniGuide Laser System if the medical history of the patient is not compatible with Laser
treatment.
2.2.Adverse Effects
Potential complications could include:
•The general complications related to surgical procedures, such as local and systemic infections
•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 physician or dentist adequately trained to, and familiar with such
surgical techniques and clinical use of CO2lasers.
•Usage of gas can increase the chance of embolism, see OmniGuide fiber IFUs for additional
information
2.3.Definition 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.
2.4.Definition 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.
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 sufficient magnitude to constitute a risk of
electric shock.
________________________________________________________
L-1633 Rev. 3 © OmniGuide, Inc. Page 8
________________________________________________________
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.
________________________________________________________
This symbol is intended to alert the operator that there are specific warnings or
precautions associated with the medical device, which are not otherwise found on
the label.
_________________________________________________________
L-1633 Rev. 3 © OmniGuide, Inc. Page 9
2.5.Location of Warning Labels
Figure 2-1. Location of the warning signs showing the front and right side of the Laser (top) and the
back side (bottom)
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Emer
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Switch Shield
L-1633 Rev. 3 © OmniGuide, Inc. Page 10
1.Warning Aperture
2.Laser Stop
3.Laser Warning
4.Laser Danger
L-1633 Rev. 3 © OmniGuide, Inc. Page 11
5.Laser Compliance
6.ETL
7.Modification Label
8.Product Identification
L-1633 Rev. 3 © OmniGuide, Inc. Page 12
WARNINGS
3.1.Warnings for Laser Surgical Procedures
The FELS-25A is a Class IV Laser device that produces invisible beams of high-energy infrared radiation.
Improper use could result in serious personal injury. Proper electrical and Laser safety training and strict
observation of all safety precautions as specified in the Laser Instructions for Use or Operations Manual
are required to operate the device and/or provide its maintenance.
Before endoscopic 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.
Laser surgical procedures should be performed only by individuals adequately trained and familiar with
such surgical techniques. 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 specifically rated for CO2
Lasers. Failure to do so may result in serious and permanent damage to the eyes.
The Laser should be activated only when the Laser treatment site is clearly observable and the fiber tip is
directed at it.
A fire 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 fires.
A smoke evacuation system must be utilized to remove surgical plume.
With most fiber assemblies, pressurized gas exits the fiber 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 fiber. For airway cases, the fiber should not be used below the carina. See fiber
IFU for additional fiber-specific warnings.
The pressurized gas exiting the fiber’s tip during the Laser procedure may cause temporary inflation and
separation of sub-mucosal flaps or mild emphysema under superficial layers of tissue.
Only use medical-grade Helium gas.
Do not retract, probe, or manipulate tissue with the distal-end tip of the OmniGuide fiber.
Do not use excessive force while handling the OmniGuide fiber inside an endoscopic handpiece. The use
of excessive force could potentially lead to fiber breakage or distal-end tip detachment.
The use of high Laser power along with extensive bending of the fiber 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 fiber.
Do not submerge any portion of the FELS-25A Laser/Adapter in fluid.
For sterile procedures, the use of the OmniGuide Gas Filter Unit (cat# ACC-GFU-100) is required.
There is a possibility that the OmniGuide fiber will fail to transmit light during the course of a surgical
procedure. Therefore, it is recommended that you have at least two fiber assemblies available prior to
starting a surgical procedure using the OmniGuide Laser System.
L-1633 Rev. 3 © OmniGuide, Inc. Page 13
The distal-end of the OmniGuide fiber should not touch tissue.
3.2.Warnings specific to compressed Gas
(Disclaimer: The supply of the gas per OmniGuide specifications, 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.)
If gas is being supplied to the Adapter via a compressed gas tank, review the proper procedures for
handling of compressed gases before connecting the Adapter to the gas tank. Only personnel trained in
compressed gas safety procedures should be allowed to connect the adapter to a compressed gas tank.
Using pressurized gas during some endoscopic procedures (e.g. gastrointestinal, gynecological, etc.)
could lead to over-insufflations and the danger of tissue perforation. An approved system for pressure
monitoring and gas evacuation, chosen by a physician, is required to prevent over-insufflations and
ensure patient safety. Use of insufflators 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 fiber, verify that the gas
delivered to the system is of the proper type and pressure for the fiber being used. This information can
be found on the insert provided with each fiber.
3.3.Sterility Warnings
The OmniGuide fiber is supplied sterile. The method of sterilization is radiation.
Do not use the product if the package is damaged, opened, or if sterility is compromised.
The product is sold sterile for single use. Reuse poses risk of infection.
Wear sterile gloves and observe proper surgical aseptic technique while handling the sterile fiber.
Do not use an OmniGuide Adapter in a sterile procedure without the Gas Filter Unit (cat# ACC-GFU-
100).
CAUTIONS
4.1.Cautions for Laser Surgical Procedures
Physicians performing Laser procedures should be trained and compliant with their relevant health care
facility requirements in:
oLaser safety
oClinical use of CO2Lasers
L-1633 Rev. 3 © OmniGuide, Inc. Page 14
oThe use of the OmniGuide System
Build up of tissue or tissue debris on the distal-end tip of the OmniGuide fibers or handpiece can result in
overheating of the device. If build-up/contamination occurs during use, clean the tip by dipping into
saline solution. Refer to OmniGuide fiber IFUs for specific instructions on how to clean fiber tips during
surgical procedures. Replace 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 radius less than the minimum radius and maximum angle
specified for the fiber (typically 3cm, 30 degree). Bending the fiber below this limit may cause fiber
failure. Refer to fiber IFUs for more instructions on fiber usage.
To assure the proper functioning of the device, FELS-25A 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 fiber is missing or detached.
Excessive bending of OmniGuide fiber will lower its output power. Please consult fiber IFUs for the
minimum allowable bending radius and angle of the fiber. Do not kink or pinch the Fiber.
The OmniGuide System is not compatible with optical accessories such as scanners.
4.2.Reflected energy protection
Avoid reflective metals near the laser beam.
Clinician and patient must use appropriate eye and skin protection.
4.3.Fire Protection
Drape the surgical field with materials designed for use with Lasers. The surgical drape must be flame
retardant.
Keep combustible materials away from the area of Laser use.
Take appropriate measures to prevent the possibility of a fire 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 firing.
4.4.Eye protection
Everyone in the Laser area must wear eye protection appropriate for CO2 Lasers.
Use special precautions when working around eyes.
Do not look directly at the Laser beam, even when wearing eye protection.
4.5.Tissue protection
Start with low power and increase power gradually to achieve desired effect.
Use the shortest exposure time for the desired result.
L-1633 Rev. 3 © OmniGuide, Inc. Page 15
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.
4.6.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 a mask.
Refer also to the Cautions section of your Laser Manual and to Laser Labeling for additional precautions.
PRODUCT DESCRIPTION
In this section the specifications and characteristics of the FELS-25A system will be discussed. Characteristics
to be discussed include mechanical, thermal, electric and the laser system user interfaces. Also discussed are
environmental requirements and limitations.
5.1.Fiber Enabled Laser
The Laser is a class IV sealed, RF excited CO2Laser capable of producing CW or pulsed laser radiation at
10.6 µm wavelength. 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 5-1 and Figure 5-2 respectively.
L-1633 Rev. 3 © OmniGuide, Inc. Page 16
Figure 5-1. Back of the Laser
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L-1633 Rev. 3 © OmniGuide, Inc. Page 17
Figure 5-2. Front of the Laser
5.1.1.Foot Pedal Connection
The footswitch should be plugged directly into the food pedal connector receptacle at
the rear of the box. There is a small red dot on the plug and a red dot on the receptacle,
the plug will only insert when these red dots are lined up. To remove the footswitch,
firmly hold the footswitch connector at the connection point and pull outwards. The
footswitch is shielded with a protection cover. After finishing surgery it should be put
beside the unit.
5.1.2.Warning Light Output
A door warning light may be connected to this port.
5.1.3.USB and RJ45 connections
The laser has USB/RJ45 port for service use only.
5.1.4.High Pressure Gas Input
The back side of the laser, at the Laser Gas Inlet port, should be supplied with medical
grade helium at a pressure ranging from 110 to 125 PSI. The Laser Gas Outlet pressure
is controlled from the touch-screen interface.
____________________________________________________________
Set the outlet pressure as directed by the instructions for use (IFU) for the specific fiber being used.
____________________________________________________________
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L-1633 Rev. 3 © OmniGuide, Inc. Page 18
5.1.5.Gas Management Data Connection
If helium gas supplied from helium gas tanks on the laser system cart, the system has
the ability to display the amount of gas available in the gas tanks on the laser touch
screen. The gas management data connectors on the back of the laser and on the gas
management system have to be connected by a gas management data cable supplied
with the system (P/N 1-0142-014-00-01).
5.1.6.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, P/N 1-0205-007-01-03), 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.
5.1.7.RFID Antenna
RFID antenna is built into the fiber adapter and is a component of the system RFID
functionality that allows the laser system to recognize specific Omniguide fiber and
adjust accordingly the default settings and settings limits for the power and gas
pressure. The specific fiber type is indicated on the laser touch screen.
5.1.8.OmniGuide Fiber Adapter
To produce sufficient output power at the distal end of an OmniGuide fiber, the laser
beam generated in the laser is delivered precisely to the input end of the fiber by means
of fiber adapter with a standard ST socket for fiber connection. The adapter has a
quick-disconnect gas port for the helium gas supply and incorporates an RFID antenna
as shown in figure 5.3.
L-1633 Rev. 3 © OmniGuide, Inc. Page 19
Figure 5-3. Close up of socket of the fiber adapter, where the OmniGuide fiber is
connected. Note the groove in the fiber connection socket. It should be aligned with the
arrow/key on the connector of the fiber for the fiber to properly connect.
5.2.The OmniGuide fiber
The flexible OmniGuide fiber guides CO2 Laser light with a wavelength of 10.6 microns and delivers
energy from the laser to the surgical site, enabling minimally invasive procedures. A typical close up of
the fiber connector at the proximal end, that is connected to the laser, is shown in
Figure 5-4 .
Figure 5-4. The proximal end ST connector on the OmniGuide fiber. Note the key that
goes into the ST socket groove of the fiber adaptor.
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L-1633 Rev. 3 © OmniGuide, Inc. Page 20
5.3.OmniGuide Cart and Gas Management System
The specially designed laser system cart (see Figure 5-5 ) provides a convenient way to hold the laser,
compressed gas tanks and gas management system (see Error! Reference source not found.). The gas
management system consists of two gas tank hosed connectors for two gas tanks, pressure regulator, gas
tank selection valve, pressure transducers to sense the amount of gas left in each of the gas tanks, gas
management data electrical connection and gas supply quick-disconnect gas supply port. The pressure
regulator is not visible from the outside and must not be adjusted or accessed by the user. The user
connects the Gas Input on the rear of the laser to the gas supply port of the Gas Management System by a
hose supplied with the system (P/N 3-0162-013-00-00).
Figure 5-5 Complete Cart, Laser System
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