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
®

 '- /
9'$/
* &! -57976
.6 === ;;; 99=9!$6 ;6< ::6 =999
URL: http://www.omni-guide.com
0483
A.R.C. LASER GmbH
Bessemerster. 14
D-90411 Nurnberg, Germany
Tel. [phone]

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
...................................................................................................................................5
6/6/'&!$+&&'%!$!'&//////////////////////////////////////////////////////////////////////////////////////////////////////////////;
6/7/!&! $  $$ &+///////////////////////////////////////////////////////////////////////////////////////////////////////////////<
-.........................................................................................6
7/6/! &$ &! %///////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////<
7/7/($%&%///////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////<
7/8/ &! !$  /////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////<
7/9/ &! !'&! //////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////<
7/:/!&! !$  %/////////////////////////////////////////////////////////////////////////////////////////////////////////////////>
.............................................................................................................................01
8/6/$  %!$%$'$$!'$%////////////////////////////////////////////////////////////////////////////////////////////67
8/7/$  %%"&!!"$%%%///////////////////////////////////////////////////////////////////////////////////////////////68
8/8/&$&+$  %/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////68
...............................................................................................................................02
9/6/'&! %!$%$'$$!'$%//////////////////////////////////////////////////////////////////////////////////////////////68
9/7/& $+"$!&&! /////////////////////////////////////////////////////////////////////////////////////////////////////////////69
9/8/$$!&&! //////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////69
9/9/+"$!&&! //////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////69
9/:/%%'"$!&&! //////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////69
9/;/!! &$!//////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////6:
..........................................................................................................04
:/6/$ %$///////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////6:
:/7/ '$////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////6>
:/8/ '$& %  &+%&/////////////////////////////////////////////////////////////////////////////////75
:/9/"$& "&! %!$%$/////////////////////////////////////////////////////////////////////////////////////////////////////77
....................................................................................................................................14
;/6/%$&+#'$ &%///////////////////////////////////////////////////////////////////////////////////////////////////////////////7:
;/7/"&&+///////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////7:
;/8/&$&+////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////7;
;/9/!" &!& $%( &&! $/////////////////////////////////////////////////////////////////////////////////7<
...........................................................................................16
.................................................................................................17

L-1633 Rev. 3 © OmniGuide, Inc. Page 4
=/6/%&!&% &!*//////////////////////////////////////////////////////////////////////////////////////////////////////////////////////7=
=/7/&+%%'% $&%%+ %$&'"/////////////////////////////////////////////////////////////////////////////////7=
 .......................................................................................................18
>/6/$!! #'$ &%//////////////////////////////////////////////////////////////////////////////////////////////////////////////////7>
>/7/&$!)$! &! /////////////////////////////////////////////////////////////////////////////////////////////////////////////85
>/8/!"$%%%#'$ &//////////////////////////////////////////////////////////////////////////////////////////////////////////85
>/9/!!$ &$!///////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////85
>/:/!!&! &!$///////////////////////////////////////////////////////////////////////////////////////////////////////////////////////86
............................................................................................................20
65/6/)&! %$+%&/////////////////////////////////////////////////////////////////////////////////////////////////////////////////86
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65/8/%$ &$////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////87
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65/:/+////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////96
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65/</!%& "$&(+%&'&!) /////////////////////////////////////////////////////////////////////////////////////////////////97
-...........................................................................31
66/6/   %&$'&! %/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////97
66/7/&$,&! ' %//////////////////////////////////////////////////////////////////////////////////////////////////////////////////97
66/8/$%"!% %&$'&! //////////////////////////////////////////////////////////////////////////////////////////////////////////////97
 #(##.......................................................................................................................31
67/6/($()///////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////97
67/7/  &/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////98
67/8/$&! ////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////98
67/9/%  &//////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////98
67/:/$&%//////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////98
67/;/*""!$&/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////98
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L-1633 Rev. 3 © OmniGuide, Inc. Page 5
68/:/+%&&!!!&//////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////99
&&#(,.............................................................................................................................33
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..........................................................................................................34
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.........................................................................................................................40
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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. [phone]) 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)
6
4
3 5 87
12
1
Note: Emer
g
enc
y
Switch Shield ma
y
or ma
y
not be
p
resent on laser
Emer
g
enc
y
Switch Shield

L-1633 Rev. 3 © OmniGuide, Inc. Page 10
1.Warning Aperture
2.Laser Stop
3.Laser Warning 4.Laser Danger