RevoLixDUO en

Instructions for use
RevoLix DUO
Dual mode surgical laser
RevoLix DUO 120/20

RevoLix DUO 150/20
RevoLix DUO
Federal law restricts this device to sale by or on the order of a physician.
Filename: GA035008100RevoLixDUO_en
Edition: 035 008 100
Effective from: 2019-03-21

RevoLix DUO
Content
1 About these instructions for use ................................................................................................. 7

Signal words in these instructions for use ..................................................................................... 7
Safety and protective measures .................................................................................................... 8
2 Delivery ........................................................................................................................................... 9
Scope of delivery ........................................................................................................................... 9
3 Product description ..................................................................................................................... 10

Identification of the model ............................................................................................................ 10
General description...................................................................................................................... 10
Expected service life .................................................................................................................... 11
Intended use ................................................................................................................................ 11
Contraindications ......................................................................................................................... 11
Side effects .................................................................................................................................. 11
Authorized users .......................................................................................................................... 11
Classification ................................................................................................................................ 12
Applied part .................................................................................................................................. 12
Operating and display elements .................................................................................................. 12
Front view .................................................................................................................................... 12
Rear view ..................................................................................................................................... 13
Footswitch .................................................................................................................................... 14
Operating panel ........................................................................................................................... 14
Display elements ......................................................................................................................... 15
Status display .............................................................................................................................. 16
Visual and audible signals ........................................................................................................... 16
Emergency Laser Stop ................................................................................................................ 17
Key switch .................................................................................................................................... 17
Aiming laser ................................................................................................................................. 17
Laser fibre .................................................................................................................................... 17
Fibre holder .................................................................................................................................. 18
Foot brake .................................................................................................................................... 19
Fume extraction systems ............................................................................................................. 19
4 Installation of the laser device ................................................................................................... 20

Unpacking .................................................................................................................................... 20
Checking the module latches ...................................................................................................... 20
Mains supply ................................................................................................................................ 21
Door interlock switch.................................................................................................................... 21
Potential equalization................................................................................................................... 22
Operating conditions .................................................................................................................... 22
Cooling ......................................................................................................................................... 22
Electromagnetic compatibility (EMC) ........................................................................................... 23
EMC – Operating environment .................................................................................................... 23
Electromagnetic emissions and immunity ................................................................................... 24
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RevoLix DUO
Electrosurgical disturbances ........................................................................................................ 25

Transport and storage ................................................................................................................. 25
Function test before the first commissioning ............................................................................... 25
5 Laser safety .................................................................................................................................. 26

General information ..................................................................................................................... 26
Safety distance (NOHD, Nominal Ocular Hazard Distance) ....................................................... 26
Laser safety eyewear................................................................................................................... 28
Laser safety eyewear protection markings according to EN 207 ................................................ 28
Laser area .................................................................................................................................... 28
6 Labelling of the device ................................................................................................................ 30

Symbols used .............................................................................................................................. 30
Nameplate - laser device ............................................................................................................. 30
Nameplate - footswitch ................................................................................................................ 31
Laser safety labels ....................................................................................................................... 31
Warning signs for the laser beam outlet ...................................................................................... 31
Labelling of laser stop .................................................................................................................. 31
Explanatory label ......................................................................................................................... 32
Position of warning signs and labels ........................................................................................... 32
7 Operation of the laser device ..................................................................................................... 33

Operational states of the system ................................................................................................. 33
Application mode ......................................................................................................................... 33
Operating modes in application mode STONE ........................................................................... 34
Operating modes in application mode TISSUE ........................................................................... 34
CONTINUOUS............................................................................................................................. 34
PULSED ...................................................................................................................................... 34
SINGLE ........................................................................................................................................ 35
Selection of an application mode................................................................................................. 35
Selection of operating modes ...................................................................................................... 35
Selection of operating mode when using a single-pedal footswitch Kix ..................................... 35
Selection of operating mode when using a double-pedal footswitch Kix DUO ........................... 36
Setting laser parameters ............................................................................................................. 37
Adjusting the brightness of the aiming beam .............................................................................. 38
Resetting the time and energy display ........................................................................................ 38
Laser parameters......................................................................................................................... 38
Laser parameters - Application mode STONE – Operating mode PULSED .............................. 38
Laser parameters - Application mode TISSUE – Operating mode CONTINUOUS (CW) ........... 38
Laser parameters – Application mode TISSUE – Operating mode PULSED ............................. 39
Laser parameters – Application mode TISSUE – Operating mode SINGLE .............................. 39
Setting of parameters if a double-pedal footswitch Kix DUO is connected ................................ 39
Start-up procedure ....................................................................................................................... 39
Prearrangement ........................................................................................................................... 39
Connecting a door interlock ......................................................................................................... 40
Connecting the footswitch ........................................................................................................... 40
Switch-on routine of the laser device ........................................................................................... 40
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RevoLix DUO
Checking the laser fibre ............................................................................................................... 40

Connecting the laser fibre ............................................................................................................ 41
Emission of laser radiation .......................................................................................................... 41
Special features when using the double-pedal footswitch Kix DUO ........................................... 42
Remove or replace the laser fibre ............................................................................................... 43
Switch-off routine ......................................................................................................................... 43
Cleaning and disinfection ............................................................................................................ 43
Preparation of laser fibres, applicators and handpieces ............................................................. 44
8 Clinical applications .................................................................................................................... 45

Safety during use ......................................................................................................................... 45
Laser tissue interactions .............................................................................................................. 47
Basic physico-technical principles ............................................................................................... 47
Basic physico-medical principles ................................................................................................. 47
Tissue interaction ......................................................................................................................... 48
Laser surgery in a gaseous medium ........................................................................................... 49
Laser surgery in aqueous medium .............................................................................................. 50
Different application methods ...................................................................................................... 50
Preparation .................................................................................................................................. 50
Handpieces and endoscopes ...................................................................................................... 50
Step by step ................................................................................................................................. 51
Urology ........................................................................................................................................ 52
Urology – Thulium CW-Laser ...................................................................................................... 52
VapoResection of the Prostate (ThuVARP) ................................................................................ 53
VapoEnucleation of the Prostate (ThuVEP) ................................................................................ 54
Blunt Enucleation of the Prostate (ThuLEP) ................................................................................ 54
Vaporization of the prostate with SideFib-SU (side emitting laser fibre) ..................................... 55
Vaporization of the prostate with frontal emitting laser fibres ...................................................... 56
Opening of urethral strictures ...................................................................................................... 56
Opening of ureteral strictures ...................................................................................................... 56
Bladder neck incisions ................................................................................................................. 57
Vaporization of urothelial carcinoma of the upper urinary tract UTUC ........................................ 57
En bloc resection of bladder tumors ............................................................................................ 57
Partial nephrectomy ..................................................................................................................... 58
Condyloma and penile tumor excision ......................................................................................... 59
Urology – Holmium pulsed laser .................................................................................................. 59
Gynaecology ................................................................................................................................ 59
Incisions and excisions on the external female genitalia............................................................. 60
Conization .................................................................................................................................... 60
Hysteroscopy ............................................................................................................................... 60
Laparoscopic procedure .............................................................................................................. 60
Condyloma excision..................................................................................................................... 60
Ear, nose and throat surgery ....................................................................................................... 60
Turbinate reduction (Removal/shrinkage of the mucous membrane) ......................................... 61
Tonsillectomy ............................................................................................................................... 61
Oropharynx/Larynx tumor surgery ............................................................................................... 61
Treatment of nasal polyps ........................................................................................................... 61
Pneumology ................................................................................................................................. 61
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Treatment of bronchial and tracheal obstructions ....................................................................... 62

Orthopedics ................................................................................................................................. 62
Spinal surgery .............................................................................................................................. 62
PLDD ........................................................................................................................................... 62
Reference values of laser parameters for different applications ................................................. 63
Application mode TISSUE ........................................................................................................... 63
Application mode STONE ............................................................................................................ 66
9 Accessories .................................................................................................................................. 68
Laser fibres .................................................................................................................................. 68
Laser safety eyewear................................................................................................................... 69
Additional accessories ................................................................................................................. 69
10 Care and maintenance ................................................................................................................ 70

Visual and functional check ......................................................................................................... 70
Check and exchange of fibre coupler protection shield............................................................... 71
Cooling liquid ............................................................................................................................... 72
Calibration and checking the laser power.................................................................................... 72
Recurrent safety check ................................................................................................................ 72
Disposal of the device and the accessories ................................................................................ 73
11 Error diagnosis ............................................................................................................................ 74

Error messages ........................................................................................................................... 74
Customer service ......................................................................................................................... 74
Returned equipment .................................................................................................................... 75
12 Technical Data ............................................................................................................................. 76
13 Index.............................................................................................................................................. 78
14 List of Figures .............................................................................................................................. 80
15 List of Tables ................................................................................................................................ 82
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RevoLix DUO
1 About these instructions for use

These instructions for use provide important information concerning the safe handling of the laser devices
(see list on the cover page) of the company LISA Laser Products GmbH, Germany (LISA Laser
Products).
Information and instructions that only refer to a designated model are specially marked.
The instructions for use, the documents mentioned in this manual as well as the instructions for
use of the laser accessories (including fibres and handpieces) must be carefully read and noticed
before the first use of the laser device!
Please keep the instructions for use for future reference.
Before using, also familiarize yourself with national regulations and guidelines for the safe use of medical
laser devices and pay close attention to them. The responsibilities, conditions of use and occupational
safety measures are described in these regulations and instructions.
Subject to technical modifications and amendments! Due to enhancements images and technical
data may vary slightly.
These Instruction for use corresponds to software version MBL SCP 18Vxx.
Signal words in these instructions for use

The safety instructions and warnings in this instruction for use warn of possible risks of injury to patients,
users or third parties as well as property damage.
The signal words described below can be found in safety-related information that warns the user of
hazards and how to prevent these hazards. Warnings are usually given in the instructions for use when
describing tasks where hazards can occur. Read the warnings carefully and follow the measures to
prevent the danger.
A collection of general safety instructions can be found in the following chapter.
Indicates a highly hazardous situation which if not avoided will result in death or
serious injury.
Indicates a hazardous situation which if not avoided could result in death or

serious injury
Indicates a fairly hazardous situation which if not avoided could result in minor or
moderate injury.
Indicates imminent material damage
Provides recommendations, information and advice for efficient use.
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RevoLix DUO
Safety and protective measures

The following section contains important safety instructions and information. Failure to follow the
instructions may result in patient, user, or third party injury or or could cause damage to the laser device.
Please refer also to the specific safety instructions in the other sections and the related instructions for
use.
Laser radiation
The working laser emits Class 4 invisible laser radiation. Direct, reflective or
scattered laser radiation can cause severe eye injury and skin burns.
x Never look directly into the laser beam.
x Do not aim the laser beam at reflective surfaces or instruments.
x Never point the laser beam at other people.
x Wear suitable safety goggles.
Flammable materials and gases

Flammable materials and gases (including endogenous gases) may ignite due to
laser radiation and cause severe burns or poisoning and chemical burns.
x Do not use the laser radiation in an explosive atmosphere (oxygen-
enriched air).
x Do not aim the laser radiation at flammable gases, liquids or other
substances.
x Do not aim the laser radiation at flammable material and tissue.
x Use suitable non-flammable tubes and drapes for laser surgery etc.
x When using flammable disinfectants, ensure adequate drying.
Providing a wrong application mode due to a malfunction of the laser

device.
The delivery of laser radiation in the wrong mode of application can cause
unexpected tissue interaction and result in serious injury and severe thermal
tissue damage.
x Check the selection of the application mode (TISSUE / STONE) before
starting the laser application.
x Only trigger the emission if the effect of the laser radiation - the distal end
of the fiber and the tissue - can be observed.
A modification of the constructional or functional characteristics of the

RevoLix DUO laser device is not permitted.
The laser device must not be disposed of with household waste.
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RevoLix DUO
2 Delivery
Scope of delivery
The regular scope of delivery of the RevoLix DUO includes the following items:
Tab. 1: Regular scope of delivery
Quantity Included items
1 RevoLix DUO laser device
1 Door interlock dummy connector (REF 101 630 041)
1 Instructions for use
2 Keys (REF 101 660 006)
Single-pedal footswitch “Kix” (REF 101 630 147)

1 alternatively:
Double-pedal footswitch “Kix DUO” (REF 101 630 144)
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RevoLix DUO
3 Product description
This chapter includes a description of the intended use, contraindications and side effects, user
requirements, and important control elements and features.
Identification of the model

The model name, the power range (maximum power) and the wavelength of the emitted radiation are
shown on the nameplate (Fig. 15).
After switching on the laser device, the model name is also indicated on the startup screen (Fig. ).
An overview of the different models is given in the table below. For detailed technical data refer to
section 11.
Tab. 2: Specifications of different models of the RevoLix DUO laser devices
Model RevoLix DUO 120/20 RevoLix DUO 150/20
Thulium continuous wave laser
Wavelength 2013 ±10 nm 2013 ±10 nm
Power 5 - 120 W 5 - 150 W
Pulse duration 50 - 1000 ms 50 - 1000 ms

0.5 - 10 Hz, 0.5 - 10 Hz,
Repetition rate
Single pulse Single pulse
Holmium pulsed laser
Wavelength 2123 ±10 nm 2123 ±10 nm
Power 2.5 - 20 W 2.5 - 20 W
Pulse energy 0.5 – 2.6 J 0.5 – 2.6 J
Repetition rate 0.5 - 15 Hz 0.5 - 15 Hz
General description
The RevoLix DUO laser device integrates a combination of two laser sources:
First, the RevoLix DUO laser device consists of a Thulium continuous wave laser with the wavelength of
2 μm (2.013 nm ±10 nm). It emits the laser radiation continuously (continuous wave – CW).
Continuous wave emission can also be emitted intermittently (pulsed mode). In this case the maximum
power of the pulses is not higher than the continuous wave power.
On the other hand, the RevoLix DUO laser device consists of a pulsed Holmium:YAG laser. This pulsed
laser has high pulse peak powers at the wavelength of 2.1 μm (2123 nm ± 10 nm).
The wavelengths of both lasers are in the invisible infrared range.
The laser radiation is delivered by means of a fibre made of silica. The distal end of the fibre is guided by
a suitable applicator. For clinical applications, various applicators are available that are tailored to a
specific application.
The laser device is operated via the operating panel provided with a display. The laser emission is
activated by a footswitch.
The RevoLix DUO laser devices comply with the "Essential requirements of the European Medical
Devices Directive 93/42/EEC".
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RevoLix DUO
Expected service life

The RevoLix DUO laser device is designed for an expected service life of 10 years when used as
intended and subjected to regular maintenance and testing in accordance with the instructions in this
manual.
Intended use
The RevoLix DUO is a surgical laser used for invasive and surgically invasive incision, excision,
resection, ablation, vaporization and coagulation of soft tissue as well as for invasive and surgically
invasive destruction of stones in the genitourinary tract (bladder, ureter, kidney) and for the ablation and
removal of hard tissue such as cartilage or bone.
Direct application of the RevoLix DUO on the central nervous system and on the cardiovascular system
is not intended. The RevoLix DUO laser is also not indented for ophtalmological applications.
Contraindications
Contraindications, related directly to the RevoLix DUO laser device are not known. The contraindications
of surgical and endoscopic laser procedures generally correspond to those of conventional endoscopic or
surgical procedures in the respective field of application. Contraindications include general intolerance to
surgical or endoscopic procedures, untreated infections, pregnancy or sepsis.
The medical professional should decide depending on the patient’s condition whether intervention with
the RevoLix DUO laser device can take place.
Treatments of patients with coagulation disorders or under anti-coagulation therapy are subject to special
risks. The performance of such treatment must be assessed on a case-by-case basis by the attending
physician and taking into account current scientific evidence. The final decision on the procedure is up to
the attending physician.
You may also find information about this in the following overview article:
x Yana Barbalat, Marissa C. Velez, Christopher I. Sayegh and Doreen E. Chung; „Evidence of the
efficacy and safety of the Thulium laser in the treatment of men with benign prostatic obstruction“;
Ther Adv Urol 2016, Vol. 8(3) 181–191
x Feng Sun, Bangmin Han, Di Cui, Fujun Zhao, Xiaowen Sun, Jian Zhuo, Yifeng Jing, Haitao Liu,
Shujie Xia, Yong Yang, Guangheng Luo, Fengfu Guo; „Longterm results of Thulium laser
resection of the prostate: a prospective study at multiple centers“; World J Urol (2015) 33:503–
508
Please check further details within the chapter 8 “Clinical applications”.
Side effects
The side effects of surgical and endoscopic laser procedures generally correspond to those of
conventional endoscopic or surgical procedures in the respective field of application. The main
complications are pain, infection, fever, bleeding, perforation, trauma and edema. The laser radiation can
cause thermal tissue damage.
Authorized users
The RevoLix DUO laser device should only be used by persons with appropriate medical qualification
who have been trained by LISA Laser Products in accordance with the instructions for use.
Only persons may be admitted who, due to their knowledge and practical experience, are suitable for
handling the laser device. Trained persons must be entered by name into the medical product book
belonging to the laser device.
The re-processing of the laser fibres and other accessories may only be carried out by trained
professionals.
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RevoLix DUO
Classification
The RevoLix DUO laser systems belong to the following classifications / nomenclatures:
Tab. 3: Classifications
Medical product class according to MDD 93/42/EEC (Medical Device Directive) IIb
Medical product nomenclature according to UMDNS 17-447
Medical product nomenclature according to GMDN 36170
Laser class according to IEC 60825 (working laser) 4
Laser class according to IEC 60825 (aiming laser) 3R
Laser classification US FDA CDRH (21 CFR 1040.10) (working laser) IV
Laser classification US FDA CDRH (21 CFR 1040.10) (aiming laser) IIIA
Protection class according to IEC 61140 I
Degrees of protection according to EN 60529 IP20
Applied part BF
Applied part
The applied part of the laser device is the distal tip of the laser fibre, including the length of the laser fibre
that is inserted into the instrument.
With thelaser fibre connected, the laser device has a class BF application part.
Operating and display elements

The operating and display elements are arranged in three areas. They are attached to the front of the
device (Fig. 1, Fig. 2), to the back of the device (Fig. 3) and to the operating panel (Fig. 6).
Front view
The beam outlet, the connection for the footswitch, the laser-stop, the access for the fibre coupler
protection shield, the foot brake, the fibre holder and the front hatch for the instructions for use are at the
front side of the device. Beside the laser stop is the cut-out which is for opening the hatch.
Operating panel
Fibre holder
Recess for
opening the hatch
Fibre port
Laser stop
Front hatch
Connection for
footswitch
Fig. 1: Front view
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RevoLix DUO
Behind the front door are the storages for footswitch and instruction manuals.
Storage compartment for the

instructions for use
Footswitch
Foot brake
Fig. 2: Front view with open hatch
Rear view
At the rear side of the device you will find the key switch the door interlock connection, the power cord
and the service hatch. To open the service hatch you need a special tool or key
Service hatch Key switch
Connection for
door interlock
Winding for power
cord
Lock for service hatch
Power
cord
Connection for
potential equalization
Fig. 3: Rear view
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RevoLix DUO
Footswitch
The footswitch is the control switch for the laser emission. In the READY operating state, laser radiation is
emitted by pressing the footswitch pedal.
There are two types of footswitches available: the Kix single-pedal footswitch and the Kix DUO double-
pedal footswitch. The double-pedal footswitch provides extended functionality.
Connection
cable
Bar
Foot pedal Left foot pedal Right foot pedal
Fig. 4: Single-pedal footswitch Kix Fig. 5: Double-pedal footswitch Kix DUO
Operating panel
All communication between the operator and the laser device is via the operating panel.
The operating panel includes a two-color (blue/white) display [6], laser ready and laser warning lamp [2]
and a speaker. The input elements are three buttons - two select buttons [1] and [5], the ready button
"READY" [3] - and the adjusting wheel [4]. The control console can be swiveled through 180°.
2
3
1
4
6
5
Fig. 6: Operating panel
[1] Select button for the operating mode [4] Adjusting wheel
[2] Laser warning lamp for laser standby and [5] Select button for the laser parameters
laser emission display
[3] Ready button [6] Display
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RevoLix DUO
Display elements
The display shows all laser parameters in detail. Different elements are displayed depending on the
selected application mode, set operating mode and connected footswitch.
Laser parameters
Brightness of
aiming beam
Operating
mode Total duration of
laser emission
Total amount
Status display of emitted
laser energy
Fig. 7: Menu with single-pedal footswitch Kix
When the Kix DUO double-pedal footswitch is connected, two separate setting areas appear in the menu.
Laser parameter for Laser parameter for

left pedal right pedal
Indicator of the
Operating
selected pedal
mode
Status display
Fig. 8: Menu with double-pedal footswitch Kix DUO
Tab. 4: Name and meaning of the display elements
TISSUE Application mode (Thulium CW laser)

STONE Application mode (Holmium pulsed laser)
CONTINUOUS (CW) Laser radiation is emitted continuously (continuous wave).
PULSED Laser radiation is emitted in adjustable pulses.
SINGLE A single laser pulse is emitted.
SELECT Submenu for selecting the application mode
SYSTEM Status of the system.
Energy Set laser output energy [J]
Power Set laser output power [W].
Duration Set pulse duration [ms].
Repetition Set pulse repetition rate [Hz].
Counter Total number of emitted pulses [n].
Time Total duration of laser emission [hh:mm:ss].
Energy Total amount of emitted laser energy [kJ].
AimBeam Brightness of aiming beam [%].
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RevoLix DUO
Status display
As part of the parameter menu in the lower left corner the status display shows detailed information about
the operating status of the system.
PR Footswitch not pressed

PR If single-pedal footswitch is
connected: Pedal is pressed. WAIT Laser in STANDBY
PL Left pedal of the double-pedal WAIT Delay before release
footswitch is pressed RDY Laser device in
PR Right pedal of the double-pedal READY
footswitch is pressed
1 Footswitch not connected

1 Single-pedal footswitch
connected FI Fibre not connected
2 Double-pedal footswitch FI Fibre connected
connected
Fig. 9: Status display (Section from the display)
Visual and audible signals

The selected operating state is accompanied by specific audible and visual signals emitted by the laser
device.
The laser warning lamp in the operating panel (Fig. 6 [2]) is the visual signal for laser readiness and laser
emission. Depending on the operating state of the laser device, the laser warning light provides flashing
signals in the colors red and yellow (see Tab. 5).
In addition to the laser warning lamp, audible signals are emitted to indicate operating conditions. Thus, in
addition to the visual signal for laser emission display, a permanent or periodic beep - depending on the
type of emitted laser radiation - can be heard. Switching from the STANDBY mode to READY is also
accompanied by a short confirmation tone.
Tab. 5: Visual and audible signals
Operating condition visual / audible signal
During system test the laser warning lamp lights up briefly indicating the
START-UP internal functional test. At the same time, the start-up melody of the laser
device sounds.
If the ready button on the operating panel is pressed, the laser device
switches from the STANDBY operating mode to READY. This will be
Change between
followed by a brief audible message and the laser warning lamp will flash
STANDBY - READY
red four times at a frequency of 2 Hz. After this sequence, the visual signal
of the laser warning lamp changes to a steady red glow.
During the emission of pulsed laser radiation, a periodic signal tone can be
EMISSION (STONE:
heard. The laser warning lamp alternately lights red and yellow - according
PULSED)
to the selected pulse repetition rate (up to a maximum of 10 Hz).
During the emission of CW laser radiation, a permanent audible signal is

EMISSION (TISSUE:
heard. At the same time the laser warning lamp illuminates alternately red
CW)
and yellow at a constant frequency of 2 Hz.
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RevoLix DUO
Tab. 5: Visual and audible signals
Operating condition visual / audible signal
During the emission of pulsed laser radiation, a periodic audible signal can
EMISSION (TISSUE:
be heard. The laser warning lamp alternately lights red and yellow -
PULSED)
according to the selected pulse repetition rate (up to a maximum of 10 Hz).
During the emission of a single laser pulse, an audible signal is heard and
EMISSION (TISSUE:
the laser warning lamp changes from red to yellow for the duration of the
EINZEL)
laser pulse.
Change between the If a change is made between the pedals of the Kix DUO double-pedal
pedals of the Kix DUO footswitch, an audible signal sounds when the pedal is pressed.
Emergency Laser Stop

The laser device is equipped with an emergency laser stop button (laser stop). The laser stop is located
on the front of the laser device (Fig. 1). By pressing the laser stop, the emission of laser radiation is
interrupted immediately.
If there is no longer a hazardous situation, the laser stop can be unlocked by turning to the left. Then
follow the steps indicated in the display.
Make sure that the laser stop is easily accessible at all times during operation of the laser device.
Key switch
The key switch (Fig. 3) is used to switch the laser device on and off. In the OFF position, the key can be
removed and thus the laser device is secured against unauthorized use.
Aiming laser
The laser device is equipped with an aiming laser. The aiming beam of the aiming laser is only visible in
READY and EMISSION mode and marks the working laser range of action.
The laser device may be ordered with either a red or a green aiming beam. The aiming beam is
adjustable in its brightness (0 – 100 %).
Visible laser radiation

When looking directly into the target beam, eye damage can occur.
x Do not point the aiming beam at people.
x Avoid direct irradiation of the eyes.
Laser fibre
The laser delivery system is a laser fibre made of silica. The laser fibre is connected to the laser device
via the fibre port (Fig. 1).
Different laser fibres are available for the RevoLix DUO laser device (Chapter 9 „Accessories“). The laser
fibres differ in core and outer diameter, mechanical flexibility and the direction of emission.
The choice of laser fibre for a medical application will depend on both the compatibility of the laser fibre
with the instrument / applicator used, as well as the desired mechanical properties (e.g., flexibility)
needed for a particular treatment.
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RevoLix DUO
Use of incompatible laser fibres

Incompatible or unsuitable laser fibres can be damaged during use. The breakage
may cause unintended emission of laser radiation and may result in heat, tissue
damage and burns.
x Only use laser fibres that are suitable for the RevoLix DUO laser device
and are expressly approved by LISA Laser Products for use with this
laser device.
x Consider possible performance limitations of the laser fibres.
x Consider the prescribed minimum bending radius for the laser fibre.
Fibre holder
Release the locking of the fibre holder [1.] and pull the fibre holder to the desired length [2.]. Then fix the
fibre holder again [3.]. Pass the laser fibre through the fibre holder.
Fibre
holder
Locking 2.
1. 3.
Fig. 10: Fibre holder
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RevoLix DUO
Foot brake
The swiveling front wheels are locked by the foot brake. Moving the laser device is thus prevented.
To activate the foot brake, press the pedal on the front of the laser device down. To release the brake,
pull the pedal back up.
Foot brake released Foot brake locked
Fig. 11: Foot brake
Fume extraction systems

In open laser surgery potentially infectious material or cell debris can be released via the laser fume. The
laser fume should be extracted as close as possible to the source (recommendation for the filter
specification according to DIN EN 60601-2-22 Bbl 1:2007 – ULPA filter with retention efficiency of at least
99.999% with particle sizes of at least 0.1 μm).
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RevoLix DUO
4 Installation of the laser device

The laser device may only be installed by a trained and authorized specialist.
The installation of the RevoLix DUO laser device includes specific requirements on safety precautions,
electrical supply and environmental conditions. Before commissioning please also inform yourself about
further regulations for the operation of laser devices and active medical devices.
The commissioning of the laser device is subject to notification to the respective professional association
and the authority responsible for occupational safety. The relevant national regulations and occupational
safety measures regarding the safe use of medical devices and laser devices must be observed.
Information on laser safety and necessary safety measures can be found in chap. 5 „Laser safety".
Unpacking
The laser devices are usually delivered unpacked. Remove any protective films, edge protectors and
transport cushions before commissioning.
The keys and the door interlock dummy connector are supplied separately to the laser device.
If the laser device is shipped in a solid wooden transport box, you should only unpack the laser device
with an authorized LISA Laser Products representative to avoid possible damage.
Checking the module latches

The RevoLix DUO laser devices are modular and consist of four interconnected modules. The modules
are the Laser module (LM) , the Power module (PM), the Chiller module (CM) and the Equipment module
(EM) (Fig. 12). For transportation or service work, the modules can be separated by module latches
(quick-release fasteners).
The module latches are accessible after opening the front door and the service door. When assembled,
the moduel latches must always be properly locked.
Laser module (LM)

Power module (PM)
Equipment module (EM)
Chiller module (CM)
Fig. 12: Schematic diagram showing the modules of the RevoLix DUO laser device
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RevoLix DUO
Mains supply
All RevoLix DUO laser devices require a single-phase mains supply. The supply may be from a TN-S or
IT system. To prevent the supply from overload, there should be no other consumers than the laser
device.
Exact requirements for the laser device are given on the nameplate.
Danger due to electric current

To avoid the risk of electric shock, this device may only be connected to a supply
mains with protective earth.
The laser device is equipped with an internal monitoring of the supply voltage. If the supply voltage is
outside the permitted range, a warning tone sequence will sound and a message will appear in the
display. Then check the connection requirements again and have your house installation checked.
If you have any questions about the installation please contact the customer service of LISA Laser
Products.
Tab. 6: Requirements for the mains supply
Model RevoLix DUO 120/20 RevoLix DUO 150/20
208 - 240 V, 50/60 Hz, 16 A

Mains supply
1~/N/PE
Power consumption max. 3.6 kVA
"Schuko" plug type CEE7/7, 250 V, 16 A, IP44 (DIN 49441)

Mains plug
The power plug serves as a mains isolation device

Place the laser device in such a way that access to the mains plug of the mains
cable is ensured at all times so that the laser device can be completely
disconnected from the supply mains.
The laser device is equipped with a non-detachable power cord, which can not be individually replaced by
maintenance personnel. In case of a power cord defect, please contact LISA Laser Products customer
service.
Door interlock switch

To connect a door interlock switch, a connection is provided on the back of the laser device (Fig. 3). If the
door interlock switch is opened, the laser emission is deactivated immediately. After closing the door
interlock, the laser device can only be operated after being released again by pressing the ready button
(Fig. 6).
If no door interlock switch is used, the dummy connector supplied with the laser should be plugged into
the free connection. The dummy connector is fitted with an electrical bridge between pin 1 and pin 3.
Detailed information on connecting the door interlock switch is available from LISA Laser Products
Customer Service.
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RevoLix DUO
Potential equalization
The use of additional potential equalization may be necessary to equalize different electrical potentials
with simultaneous contact; or to minimize potential differences that may occur during operation between
the medical electrical devices and the conductive parts of other devices. Connect the appropriate
potential equalization lead into the potential equalization connection on the back of the laser device (Fig.
3).
In this context, also consider the requirements of IEC 60601-1 for medical electrical systems.
Operating conditions
The ambient temperature during operation of the laser should be between 15 °C to 28 °C, the relative
humidity 10% to 90% (non-condensing) and the atmospheric pressure 700 hPa to 1060 hPa.
The laser device can be operated permanently up to an ambient temperature of 28 °C. The laser source
shuts off automatically if the coolant temperature is too high.
If the laser device has been stored or transported at an ambient temperature outside its operating
temperature (15 °C to 28 °C), the temperature of the laser device must first adjust to the temperature of
the operating locationFor large temperature differences this can take up to 3 hours.
During operation, make sure that the laser device is not subjected to severe jolts or vibrations.
Cooling
The RevoLix DUO laser device is equipped with integrated active cooling system.
During operation, the cooling system removes the excess heat to the ambient air. The warm outgoing air
exits from the ventilation openings on the left side of the laser device. In non-air-conditioned rooms a
corresponding increase in room temperature is to be expected.
An additional cooling water or gas supply is not required.
Outgoing
air
Fig. 13: Ventilation outlets
If there is insufficient air circulation, the laser device may become very hot.
x The ventilation openings on the sides of the laser device must not be
covered during operation.
x Keep a sufficient distance between the sides of the laser device and
walls.
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RevoLix DUO
Electromagnetic compatibility (EMC)

Medical Electrical Equipment like the RevoLix DUO laser device needs special precautions regarding
EMC and needs to be installed and put into service according to the EMC information provided in the
accompanying documents.
EMC – Operating environment

The RevoLix DUO laser device may only be used in professional health care facilities, including clinics,
independent surgery centers, operating theaters and endoscopy rooms.
The RevoLix DUO laser device may also be operated in rooms where HF surgical devices are used.
Use of the RevoLix DUO laser device adjacent to or stacked with other
equipment should be avoided because it could result in improper operation. If
such use is necessary, RevoLix DUO laser device and the other equipment
should be observed to verify that they are operating normally.
The RevoLix DUO laser device is not intended for use in home health care and should not be connected
to a public mains network that also supplies buildings used for residential purposes. The RevoLix DUO
Laser Device Characteristics (CISPR 11, Class A), as determined by emissions, may not provide
adequate protection for radio communications in residential areas.
The RevoLix DUO laser device is intended for use only with original accessories and cables as specified
in Tab. 7.
Tab. 7: Cable lengths of accessories
Accessories REF Cable length
Potential equalization lead 101 630 123 5.0 m
Footswitch Kix 101 630 147 2.9 m
Footswitch Kix DUO 101 630 144 2.9 m
The use of accessories other than those approved or provided by LISA Laser
Products could result in increased electromagnetic emissions or decreased
electromagnetic immunity of the laser device and result in improper operation.
Portable RF communications equipment (radios) (including peripherals such as

antenna cables and external antennas) should be used no closer than 30 cm (or
12 inches) to any part of the RevoLix DUO laser device, including specified
cables. Otherwise, degradation of the performance of this equipment could result.
Page 23
RevoLix DUO
Electromagnetic emissions and immunity

The RevoLix DUO laser device complies with the requirements of IEC 60601-1-2:2014 (Electromagnetic
disturbances- Requirements and Tests). In the following, the test methods, classifications and test levels
complied with as well as the compliance with the basic EMC standards are listed in detail.
Tab. 8: Conformity of electromagnetic immunity

Basic standard / test
Test requirements Port Test level
method
Immunity to electrostatic discharge IEC 61000-4-2:2008 Enclosure Contact discharge

(ESD) port ± 8 kV
Air discharge
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV
SIP/SOP Contact discharge
± 8 kV
Air discharge
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV
Immunity to high frequency IEC 61000-4-3:2006 Enclosure 80 MHz bis 2.7 GHz, 3V/m
electromagnetic fields + AMD1:2007 port 80 % AM bei 1 kHz
+ AMD2:2010
Immunity to near fields of wireless IEC 61000-4-3:2006 Enclosure 385 MHz - 27 V/m, PM 18 Hz
RF communication devices + AMD1:2007 port 450 MHz - 28 V/m, FM ± 5 kHz
+ AMD2:2010
710 – 780 MHz - 9 V/m, PM 217 Hz
810 – 930 MHz - 28 V/m, PM 18 Hz
1720 – 2450 MHz - 28 V/m, PM 217 Hz
5240 – 5785 MHz - 9 V/m, PM 217 Hz
Immunity to fast transient electrical IEC 61000-4-4:2012 Power ± 2 kV, 100 kHz Repetition frequency
disturbances / burst supply cord
± 1 kV, 100 kHz Repetition frequency
SIP/SOP
Immunity against surge voltages IEC 61000-4-5:2005 Power Line against line
supply cord ± 0.5 kV, ± 1 kV
Line against ground
± 0.5 kV, ± 1 kV, ± 2 kV
Immunity to conducted disturbances IEC 61000-4-6:2013 Power 0.15 MHz to 80 MHz - 3 V
induced by high-frequency fields supply cord ISM frequency bands - 6 V
80 % AM at 1 kHz
SIP/SOP 0.15 MHz to 80 MHz - 3 V
ISM frequency bands - 6 V
80 % AM at 1 kHz
Immunity to magnetic fields with IEC 61000-4-8:2009 Enclosure 30 A/m, 50 Hz/60 Hz
energy-related frequencies port
Immunity to voltage dips, short-time IEC 61000-4-11:2004 Power 0 % UT; 1/2 period at 0, 45, 90, 135, 180,
interruptions and voltage fluctuations supply cord 225, 270 and 315 degrees
0 % UT; 1 period bei 0 Grad
70 % UT; 25 periods bei 0 Grad
0 % UT; 250 periods
UT is the AC mains voltage before applying the test
levels.
Page 24
RevoLix DUO
Tab. 9: Conformity of electromagnetic emission

Test requirements Accordance
method
Conducted and radiated emissions CISPR 11:2009 Class A

+ AMD1:2010 Group 1
Distortions by harmonics IEC 61000-3-2:2005 Matches

+ AMD1:2008
+ AMD2:2009
Limitation of voltage changes, IEC 61000-3-3:2013 Matches
voltage fluctuations and flicker
Electrosurgical disturbances
The use of the recommended tests in accordance with IEC 60601-2-2, Annex BB.4, has proven that the
function of the RevoLix DUO laser device is not impaired by electrosurgical devices and the
RevoLix DUO laser device can be operated in rooms where HF surgical devices are also used.
Tab. 10: Electrosurgical disturbances

Test requirements Port Test level
method
Interference from electrosurgical IEC 60601-2-2:2009 Enclosure Generation of strong E-fields and H-
equipment Annex BB.4 SIP/SOP fields by monopolar cutting and
coagulation with an electrosurgical unit.
Power
supply cord
Transport and storage

When transporting and storing the laser, the temperature should be between -15 °C to +70 °C, the
relative humidity 10 % to 90 % (non-condensing) and the air pressure 700 hPa to 1060 hPa.
If there is a risk of the ambient temperature dropping below +3 °C, then it must be checked whether the
cooling system of the laser device is equipped with sufficient frost protection. Upon delivery, the laser
device is protected against frost down to -15 °C. If the temperature drops below 0 °C, the coolant
antifreeze must be checked by a service technician. If this is not the case or not sure, the coolant must be
drained from the unit by a service technician. Before putting the laser device into operation, the coolant
must be refilled. Operating the laser device without coolant will damage the laser device.
Function test before the first commissioning

Before the first commissioning by the operator, a functional test according to the manufacturer's
instructions must be made and recorded at the place of operation. For this purpose, a form is available
from LISA Laser Products.
Page 25
RevoLix DUO
5 Laser safety
The RevoLix DUO laser device emits Class 4 laser radiation. Irradiation of persons can cause skin and
eye injuries. Familiarize yourself with the safety measures for laser safety.
Laser radiation
General information
Depending on the selected laser source, the RevoLix DUO laser device can emit continuous laser
radiation (CW) of wavelength 2013 nm or pulsed laser radiation of wavelength 2123 nm. The aiming laser
is a semiconductor laser with 635 nm emission wavelength (red color) or 532 nm emission wavelength
(green color). This aiming laser corresponds to laser class 3R.
Please inform yourself about national health and safety regulations and accident prevention regulations
that may impose additional requirements and specifications on laser protection measures and the
designation of a laser safety officer when operating medical laser devices.
Safety distance (NOHD, Nominal Ocular Hazard Distance)

As the laser radiation from the fibre is divergent the laser power density decreases with increasing
distance from the laser source. The safety distance (Nominal Ocular Hazard Distance (NOHD)) indicates
the distance at which the laser power density of the laser radiation is equal to the Maximum Permissible
Exposure limit. The maximum permissible exposure (MPE) for the cornea of the eye is the relevant limit
value underlying the calculation of the NOHD.
The NOHD is calculated according to the standard IEC 60825-1 „Safety of laser devices“:
Tab. 11: Calculation of the NOHD for continuous wave laser radiation of the RevoLix DUO 150/20 laser devices
Wavelength λ = 2.01 μm
Numerical aperture of fibre NA = 0.22
) = 2 * arcsin (NA)
Opening angle
) = 25.4° = 0.444 rad
Fibre core diameter a = 272 μm
Average power P0 = 150 W + 20 % = 180 W
Time basis t = 10 s (for wavelength > 1400 nm)
MPE (maximum permissible exposure) 1000 W m-2
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RevoLix DUO
4P଴
ට െܽ
πEMZB
NOHDCW ൌ
ߔ
The NOHD is accordingly calculated:
Ͷ ‫ ڄ‬180
ට െ 272 ‫ ڄ‬10-6 m
ߨ ‫ ڄ‬1000 Wm-2
NOHDCW ൌ ൌ 1.08 m
0.444 rad
The NOHD (the safety distance) for the continuous wave laser radiation of the RevoLix DUO
laser device is 1.08 m.
Tab. 12: Calculation of the NOHD for pulsed laser radiation of the RevoLix DUO 150/20 laser devices
Wavelength λ = 2.1 μm
Numerical aperture of fibre NA = 0.22
) = 2 * arcsin (NA)
Opening angle
) = 25.4° = 0.444 rad
Fibre core diameter a = 272 μm
Maximal energy E0 = 2.6 J + 20 % = 3.1 J
MPE (maximum permissible exposure) 359 Jm-2
4E଴
ට െܽ
πEMZB
NOHDPULSE ൌ
ߔ
The NOHD is therefore calculated as:
Ͷ ‫ ڄ‬3.1 J
ට െ 272 ‫ ڄ‬10-6 m
ߨ ‫ ڄ‬359 Jm-2
NOHDPULSE ൌ ൌ 0.24 m
0.444 rad
The NOHD (the safety distance) for the pulsed laser radiation of the RevoLix DUO 150/20 laser
devices is 0.24 m.
Page 27
RevoLix DUO
Laser safety eyewear

If the laser device is ready, all persons present in the laser area must wear suitable laser safety eyewear.
The laser safety eyewear must have at least the protection level LB3 at DI for the wavelengths of the
laser device. The laser safety eyewear should be specified and tested according to EN 207 and must
have a CE mark.
Tab. 13: Safety eyewear – Minimum protection level for the RevoLix DUO laser devices
Protection Class / Laser type

Referenced Standard Wavelength
Optical Density (OD)
EN 207:2010-04 LB3 2013 nm ± 10 nm

DI
ANSI Z136.1 OD3 2123 nm ± 10 nm
For safety reasons we recommend to use only laser safety eyewear that is supplied by LISA Laser
Products. Using other laser safety eyewear is not recommended as they may not provide the required
protection.
Laser safety eyewear protection markings according to EN 207

Laser safety eyewear which meets the requirements according to the standard EN 207:2010-04 are
marked with the appropriate protection level.
Tab. 14: Marking example of laser safety eyewear
Element Description
DI Laser type D = continuous wave / I = Pulsed
>1400-2200 Wavelength range against which the filter provides protection.
Protection level (LB1 – LB8)

LB3
LB3 = maximum spectral transmittance of 10-3
XXX Manufacturer’s designation
DIN CE Signifies conformity to EN 207
Laser area
The laser range is the range in which the irradiance can exceed the applicable maximum permissible
exposure (MPE) for the cornea of the eye, including the possibility of random deflection of the laser beam.
In general, the laser area is equal to the laser operating area. Laser areas of class 4 laser devices must
be delimited during operation and clearly marked. This can be done by warning and information signs
(laser warning symbol W004 - ISO 7010).
In addition, a laser warning lamp must indicate the operating status of the laser device at all access points
of the laser area. This laser warning lamp must always be switched on when the laser device is ready to
emit radiation.
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RevoLix DUO
Fig. 14: Warning Sign (hazard symbol) for the identifcation of entrance doors of laser areas
Page 29
RevoLix DUO
6 Labelling of the device

The labeling of the RevoLix DUO laser device is described below. The labelling of the system provides
the user with important information. The positions of the individual labels can be found in the figures in
section 6.4.4.
Symbols used
The following symbols are on the outside of the laser device:
Tab. 15: Symbols on the outside of the laser device
Follow instructions for use Application part BF Interlock Footswitch OFF ON
Nameplate - laser device

The nameplate is attached to the back of the device (Fig. 23). It contains all important data for the
identification of the laser device and the specifications of the mains supply.
Fig. 15: Nameplate laser device (Example - RevoLix DUO 150/20)
The following symbols are used on the nameplate:
Tab. 16: Nameplate symbols
YYYY-MM
Date of manufacture
Manufacturer Serial number Laser output Operating temperature
(YYYY-MM)
IP20
Do not dispose in domestic
Mass of the device Protection CE-mark
waste
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RevoLix DUO
Nameplate - footswitch
The nameplate of the footswitch is located on the rear side of the footswitch. It contains the information
necessary to identify the footswitch.
Fig. 16: Nameplate footswitch (Example – Kix)
The following symbols are used:
Tab. 17: Symbols on the nameplate of the footswitch
REF SN YYYY-MM
Degree of Do not dispose in Date of

Order number Serial number CE-mark Manufacturer
protection domestic waste manufacture
Laser safety labels
Warning signs for the laser beam outlet

The laser beam is emitted from the distal tip of the connected laser fibre. The fibre port is marked as
follows:
Fig. 17: Laser warning label Fig. 18: Aperture label
Labelling of laser stop

The laser stop is labeled as follows:
Fig. 19: Laser stop
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RevoLix DUO
Explanatory label
The following labels describe the laser radiation and the laser class:
Fig. 20: Laser radiation characteristics (Example RevoLix DUO 150/20 with green aiming beam)
Fig. 21: Laser class
Position of warning signs and labels
Warning beam
aperture
Labelling
laser stop
Nameplate
Labelling
laser radiation
Fig. 22: Position of warning signs and labels front side Fig. 23: Position of warning signs and labels back side
Page 32
RevoLix DUO
7 Operation of the laser device

This chapter describes the operation of the RevoLix DUO laser device. You receive information about the
different application modes, operating modes and operating states; it explains how to use the laser device
and how to set the laser parameters.
Use of controls or adjustments in ways other than those described in this manual
may result in hazardous radiation exposure and skin and eye injury.
Operational states of the system

During operation three different operational states are possible:
1. STANDBY:
The system is fully operational but is not ready to emit laser radiation. The laser warning lamp (Fig.
6 [2]) and the aiming beam are off. The STANDBY state is active after the START-UP.
2. READY:
Press the ready button (Fig. 6 [3]) once to switch the device from STANDBY to READY. The device
is now ready to emit laser radiation. The laser warning lamp lights up and the aiming beam is visible.
Pressing the ready button again switches the device back to the STANBY operating state.
It is not possible to change from STANDBY to READY if the footswitch is pressed at the same time.
3. EMISSION:
Pressing the footswitch activates the laser emission. The laser beam emission is indicated by a
blinking laser warning lamp accompanied by a beep.
Application mode
The RevoLix DUO laser device provides continuous wave laser radiation and pulsed laser radiation with
its two laser sources. The laser sources can be selected via the application mode:
Tab. 18: Application modes
Application mode Laser source Laser radiation

TISSUE Thulium CW laser CW
STONE Holmium pulsed laser PULSED
It can be chosen between operating modes within the respective application mode. The various setting
options are shown in the menu structure
Selection menu
Application mode
Application mode Application mode

TISSUE STONE
Operating modes Operating modes Operating modes Mode change Operating modes Mode change
selection selection selection selection
PULSED SELECTION PULSED SELECTION
DURATION SINGLE
Selection menu
Application mode
Fig. 24: Menu structure
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RevoLix DUO
The active application mode is displayed in the upper left corner of the display.
Fig. 25: Application mode TISSUE Fig. 26: Application mode STONE
Emission of laser radiation in the wrong application mode

The emission of laser radiation in the wrong application mode can cause
unexpected tissue interaction and result in serious injury and severe thermal
tissue damage.
x Check the selection of the application mode (TISSUE / STONE) before
starting the laser application.
x Only activate the emission if the effect of the laser radiation - the distal
end of the fiber and the tissue - can be observed.
Operating modes in application mode STONE

In the application mode STONE, only pulsed laser radiation can be emitted:
x PULSED
Operating modes in application mode TISSUE

In operating mode TISSUE the RevoLix DUO laser device can emit laser radiation in three different
operating modes:
x CONTINUOUS (CW)
x PULSED
x SINGLE
CONTINUOUS
In CONTINUOUS (CW) mode, laser radiation is emitted continuously at the set laser power.
This mode is used for resections, tissue retrieval and vaporization of soft tissue.
PULSED
In the operating mode PULSED, the laser radiation is emitted with the set laser power as well as the set
pulse duration and repetition rate.
The operating mode PULSED is especially selected by surgeons for incision of soft tissue with sensitive
and delicate tissue in the surrounding of the surgeon’s site. Damage to the surrounding tissue is
minimized.
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RevoLix DUO
SINGLE
In SINGLE mode, a single laser pulse with the set laser power and pulse duration is emitted. After this
pulse no further pulses are emitted unless the footswitch is release and pressed again.
The operating mode SINGLE is especially selected by surgeons for incision of soft tissue with sensitive
and delicate tissue in the surrounding of the surgeon’s site. Damage to the surrounded tissue is
minimized.
Selection of an application mode
A change of the application mode is initiated by selecting the menu item SELECTION with the selection
button [1]. Now follow the on-screen instructions and press the select button [5].
Fig. 27: Example – Operating mode CONTINUOUS (CW) Fig. 28: Example – Operating mode PULSED
In the displayed selection menu you can switch between the application modes TISSUE and STONE by
pressing the selection button [1]. The selected application mode is marked by a white background.
Confirm your selection by pressing the right selection key [5]. The laser device changes to the selected
application mode.
Fig. 29: Example – Operating mode CONTINUOUS (CW)
Selection of operating modes
Selection of operating mode when using a single-pedal footswitch Kix

When connecting a single-pedal footswitch, you can switch between the CONTINUOUS, PULSED and
SINGLE modes by pressing the select button [1]. The selected mode is highlighted by a white
background.
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RevoLix DUO
Fig. 30: Selection of the operating mode
Fig. 31: Example – Operating mode CONTINUOUS Fig. 32: Example – Operating mode PULSED
Selection of operating mode when using a double-pedal footswitch Kix DUO

The Kix DUO double-pedal footswitch allows the surgeon in application mode TISSUE to switch between
two different laser settings. When the Kix DUO double-pedal footswitch is connected to the laser device,
the laser parameters for the left and right pedals are displayed separately (Fig. 35 und Fig. 36).
Left footpedal
Right footpedal
Fig. 33: Double-pedal footswitch Kix DUO
The left pedal is permanently assigned to the CONTINUOUS (CW) mode and can not be changed. The
right pedal mode can be assigned without restrictions to CW, PULSED or SINGLE.
Operating mode Operating mode

left footpedal right footpedal
Fig. 34: Operating modes with double-pedal footswitch
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RevoLix DUO
The desired operating mode is selected with the select button [1]. The active modes are highlighted by a
white background.
Fig. 35: Example - CONTINUOUS (CW) mode for left foot Fig. 36: Example - CONTINUOUS (CW) mode for left foot
pedal, CONTINUOUS (CW) for right foot pedal pedal, PULSED for right foot pedal
Enhanced functionality with the KixDUO dual-pedal footswitch is not available in application mode
STONE.
Setting laser parameters

Laser parameters can only be changed in the STANDBY and READY operating states.
The individual laser parameters are selected by pressing the select button [5]. The active adjustable laser
parameter is highlighted with a white background. The adjustment of the laser parameter then takes place
via the adjusting wheel [4].
Fig. 37: Select button for the laser parameters Fig. 38: Adjusting wheel for the laser parameters
The set laser parameters are displayed numerically and as a graphic value. The graphic display (bar)
represents the set laser parameter in relation to the maximum adjustable value.
Graphical Numerical Graphical Numerical
value value value value
Fig. 39: Numerical / graphical display of laser parameters
Page 37
RevoLix DUO
Adjusting the brightness of the aiming beam

The brightness of the aiming beam can be adjusted between 0 and 100% by selecting "AimBeam". By
turning the adjusting wheel [4] clockwise, the brightness increases up to a value of 100%, turning the dial
counterclockwise decreases the brightness. Set the brightness in the READY operating state, as the
aiming beam then is visible.
After start-up of the laser device, the aiming beam is automatically set to 30% brightness if the brightness
value was set to less than 30% at the last use. Higher brightness settings of the aiming beam are stored
and available at restart.
Resetting the time and energy display

The total time of laser emission (time) and the total amount of emitted energy (energy) are displayed
automatically.
During operation of the laser device, these two values can be marked with the select button [5] and reset
to zero by turning the adjusting wheel [4]. Each time the laser device is restarted; these two values are
also reset to zero.
Laser parameters
The adjustable laser parameters of the working laser depend on the device model:
Tab. 19: Adjustment ranges and step widths of the available models of the RevoLix DUO laser device
RevoLix DUO 120/20 RevoLix DUO 150/20
Holmium pulsed laser (Application mode: STONE)
Energie [J] 0.5 – 2.6

Frequency (pulse repetition rate) [Hz] 5 – 15
Pulsdauer [μs] 200 – 600 (depending on the operating point)
Thulium CW-Laser (Application mode: TISSUE)
Power [W] 5 – 120 5 – 150

Frequency (pulse repetition rate) [Hz] 0.5 – 10
Pulse duration [ms] 50 – 1000
Laser parameters - Application mode STONE – Operating mode PULSED

In application mode STONE and operating mode PULSED, the laser energy and frequency (repetition
rate) can be adjusted. The selection of the laser parameters is made via the select button [5], the
parameters can be changed via the adjusting wheel [4].
The setting of the desired laser power is made by turning the adjusting wheel. It is possible to set all
values between the minimum and the maximum laser output power, depending on the respective step
width. Turning the adjusting wheel (Fig. 38) clockwise increases the laser power. Turning the adjusting
wheel counterclockwise decreases the laser power.
Laser parameters - Application mode TISSUE – Operating mode CONTINUOUS

(CW)
In application mode TISSUE and operating mode CONTINUOUS (CW), the laser power can be adjusted.
The power setting can be selected using the select button [5], the power can be changed via the adjusting
wheel [4].
The setting of the desired laser power is made by turning the adjusting wheel. It is possible to set all
values between the minimum and the maximum laser output power, depending on the respective step
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RevoLix DUO
width. Turning the adjusting wheel (Fig. 38) clockwise increases the laser power. Turning the adjusting
wheel counterclockwise decreases the laser power.
Laser parameters – Application mode TISSUE – Operating mode PULSED

In application mode TISSUE and the operating mode PULSED, the laser power, the pulse duration and
the frequency (pulse repetition rate) can be set. The selection of the laser parameters is made via the
select button [5]; the values are changed, as in CONTINUOUS (CW) mode, by means of the adjusting
wheel [4].
The laser power can accept all values, depending on the respective step width, between the minimum
and the maximum laser output power.
The laser parameters pulse duration and frequency are also adjustable depending on the step width, but
are interdependent. The pulse-pause ratio is approximately constant in all settings - the pause between
two laser pulses corresponds at least to the set pulse duration. When increasing the pulse duration, the
frequency is calculated and tracked. The pulse duration limits the maximum possible pulse repetition rate
(frequency). If the pulse duration is shortened, the frequency will not be tracked automatically and must
be set via the adjusting wheel.
Laser parameters – Application mode TISSUE – Operating mode SINGLE

In application mode TISSUE and operating mode SINGLE, the laser power and the pulse duration of the
laser pulse can be set. The selection of the laser parameters is made via the select button [5]; the values
are changed via the adjusting wheel [4].
Setting of parameters if a double-pedal footswitch Kix DUO is connected

The settings of the laser parameters are made separately for the two foot pedals. The left foot pedal is
permanently assigned the CONTINUOUS (CW) mode and can not be changed. Accordingly only the
setting of the laser power is available here.
Note: The right foot pedal power setting can not exceed the left foot pedal power setting.
Enhanced functionality with the Kix DUO dual-pedal footswitch is not available in STONE application
mode.
Start-up procedure
Prearrangement
The laser device must be set up at a proper spatial distance from the surgical field. Make sure that the
ventilation outlets are not obstructed and the outgoing air is not directed at the patient.
The footswitch of the device must always be directly accessible and easy to operate for the operating
person. The connecting cable between the foot switch and the laser device must be laid in such a way
that there is no danger of stumbling and no obstruction occurs. The laser stop shall be immediately
reachable at all times.
When the laser device is not moved, use the parking brake to prevent unwanted movement.
Before switching on the device, make sure that
x the necessary laser safety measures have been implemented (Chap. 5).
x the laser device is connected to a suitable and sufficient mains supply.
x the door interlock is connected or bridged by means of the corresponding door interlock dummy
plug and the entrance doors to the laser area are closed.
x laser fibres and laser applicators are at hand.
x all persons in the laser area wear suitable laser safety goggles. Make sure that the laser safety
goggles are suitable for the emitted wavelength and are not damaged (chapter 5.3).
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RevoLix DUO
Do not operate the RevoLix DUO laser device if you notice obvious damage to the laser device
Connecting a door interlock

Insert the door interlock connector to the connection at the back of the laser device (Fig. 3). If you do not
use a door interlock switch, you must insert the supplied door interlock dummy plug into the connection
for the door interlock.
Connecting the footswitch

Carefully remove the footswitch from its holder. Please note that the bar opens automatically as soon as
the foot switch is removed from its holder.
Connect the footswitch to the laser device. The connection is located under the laser stop on the front of
the device (Fig. 1).
Please pay attention to a stable and non-slip stand of the footswitch.
Switch-on routine of the laser device

Switch on the laser device by the key switch (¼ turn to the right). The switch-on takes place with a short
delay.
The start-up screen appears on the display. The start-up screen shows the software version of the
RevoLix DUO laser device. After a short time the automatic system test takes place. After the system
test is completed, the mode and laser parameter display appears.
Now select the desired application mode, operating mode and the laser parameters (Chap. 7.2 ff).
Model designation
Software version
Fig. 40: Startup screen
Checking the laser fibre

The following section describes important checks that you must perform before using the laser fibre. .
Detailed test descriptions can also be found in the respective user manuals for the laser fibres.
x Check the marking of the laser fibre for readability. Do not use the laser fibre if the information is
unreadable or missing.
x Make sure that the selected laser fibre is suitable and approved for the laser device. Pay
particular attention to performance limitations.
x For single-use laser fibres, inspect the packaging for any damage that may affect sterility. If the
package is damaged or sterility is in doubt, do not use the product.
x For single use laser fibres, ensure that the expiration date is not exceeded.
x Examine the laser fibre for kinks, breaks and other damage. The laser fibre must not be damaged
over its entire length.
x The mechanical stability of the distal end of the laser fibre is verified by a lateral load - as if you
make a point with a ballpoint pen.
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x Check the laser fibre connector and the end of the laser fibre in the laser fibre connector. The
laser fibre connector must be free from damage and dirt.
x The front surface of the laser fibre in the laser fibre connector must be planar, optically glossy
and free from damage.
x Check the light transmission of the laser fibre from the distal tip to the laser fibre connector. Align
the distal end of the laser fibre with a bright light source and observe the laser fibre end in the
laser fibre connector. There must be a clear and bright point of light from the laser fibre end in the
connector.
Absorption of laser radiation in defective fibre connector

A defective or dirty fibre connector may heat up. Touching the hot fibre connector
may result in burns. Likewise, damage may occur to the coupling optics of the
laser device.
x Check the laser fibre as instructed above prior to use.
x Do not use a laser fibre with dirty or damaged fibre connector.
Connecting the laser fibre

Remove the protective cap of the laser fibre connector - the free-standing fibre end in the laser fibre
connector is very sensitive and must not be damaged or soiled.
Press down the shutter of the fibre port and insert the laser fibre connector into the fibre coupling. Then
tighten the fibre connector.
Adjust the fibre holder to the desired height and guide the laser fibre through the fibre holder.
Fig. 41: Connecting the laser fibre
Emission of laser radiation

Set the desired application mode, operating mode and laser parameters as described. For the aiming
beam you should initially choose a brightness of 100%. Set the laser device from STANDBY to READY
by pressing the ready button [3].
Fig. 42: Change to the READY operating state Fig. 43: Active laser warning lamp
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RevoLix DUO
The change of the operating status is confirmed with a short audible signal, the laser warning lamp lights
up permanently red. The aiming beam is also activated and becomes visible. The laser device is now
ready to emit laser radiation.
Laser radiation
Align the distal end of the laser fibre with a white surface. Do not look directly into the aiming beam.
Check that the radiation from the aiming beam exits the fibre only from the distal tip of the fibre and not
elsewhere. A functioning laser fibre projects a circular image of the aiming beam onto the white surface.
Do not use the laser fibre if the aiming beam is weak, barely visible, and visible along the laser fibre or
along the stripped fibre end.
Make sure you have selected the correct laser parameters again.
Insert the distal end of the fibre into the handpiece/endoscope. To start the laser emission, press the foot
pedal. Please note that the operation of the footswitch should only be performed by the person
performing the laser intervention. The alternating red and yellow lights of the laser warning lamp and the
audible beep indicate the emission of laser radiation.
In the CONTINUOUS (CW) and PULSED modes, laser radiation is emitted while the foot pedal is
pressed.
In SINGLE mode, only a single laser pulse is delivered at the preset values. To deliver another laser
pulse, you must press the foot pedal again.
Return to STANDBY if the laser device is not used for some time and at the end of the case by again
pressing the ready button [3].
Special features when using the double-pedal footswitch Kix DUO

With the Kix DUO double-pedal footswitch, you can have in application mode TISSUE two different
operating modes and laser parameters permanently available: one setting on the left foot pedal and other
on the right foot pedal.
Both laser parameter sets are displayed simultaneously. The active laser parameters are marked by a
white frame. At the same time the corresponding foot pedal is activated.
Marking frame
Fig. 44: Left laser parameters and left foot pedal active Fig. 45: Right laser parameters and right foot pedal active
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To change to the second settings, the corresponding foot pedal must be pressed briefly until the
characteristic change sound is heard.
To switch between configurations, you must press the new foot pedal briefly (1 s). Switching to the new
foot pedal and the associated laser parameter is confirmed by a change sound from the laser device. At
the same time, the now active laser parameters in the display are marked by a white frame. If the laser
device is in the READY operating state and you press the foot pedal a second time, the laser emission is
started.
If both pedals are pressed at the same time, no laser radiation is emitted.
You can change between the laser parameters in the STANDBY and READY operating states.
For the aiming beam only a common brightness adjustment can be made.
Remove or replace the laser fibre

Put the laser device in STANDBY mode. Unscrew the laser fibre connector and pull the connector fibre
out of the port. Put the protective cap back onto the fibre connector.
The reusable laser fibres can be re-processed. Laser fibres for single use must be disposed of. Detailed
information can be found in the instructions for use of the laser fibres.
Switch-off routine
Set the laser to STANDBY and remove the laser fibre from the laser device as described. Slide the fibre
holder down again.
Switch off the laser device at the key switch (Fig. 3). Then unplug the mains connector from the mains
socket. Secure the power cord at the back of the laser device.
To prevent unauthorized use of the laser device, remove the key from the key switch.
Cleaning and disinfection

Turn off the device and unplug the mains connector. Always carry out the cleaning work with the parking
brake activated in order to prevent the device from rolling away.
The laser device and its operating panel can be cleaned with a soft damp cloth and soapy water or an
alcoholic solution. The disinfection can be done with a commercial disinfectant.
Make sure that no liquid penetrates through the fibre port or the ventilation openings into the laser device.
Always clean and disinfect the wheels of the laser device.
Clean the footswitch and its cable with a commercial disinfectant and a damp cloth. The footswitch is
waterproof and can be rinsed under running water.
Do not use aggressive cleaners or abrasives.
Hazard of Infection
The laser device and its accessories may be contaminated with biological
materials after use. In case of improper cleaning / disinfection, these materials
can enter the environment and represent a potential source of infection.
x Clean and disinfect the laser device, footswitch and other accessories
carefully after each use.
x Clean and disinfect the laser device before relocating to eliminate cross-
contamination.
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Hazard due to electric current

The laser device is not protected against the ingress of liquid. There is a risk of
electric shock.
x Before cleaning and disinfecting you must switch off the laser device and
disconnect it from the power supply
Preparation of laser fibres, applicators and handpieces

For reprocessing the reusable laser fibres, applicators and handpieces, it is essential to follow the
detailed instructions in the separate instructions for use. If these are not available, request the instructions
for use from LISA Laser Products.
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8 Clinical applications
The clinical applications are based on the experience of users and the international literature on the use
of the RevoLix DUO laser device. This literature is available to interested parties upon request.
Familiarize yourself with the contents of this chapter before using the laser device clinically.
The indicated treatment parameters should be considered as a guideline only. The effect of the settings
can not be determined beforehand for each individual case. The settings must be checked individually
and adjusted if necessary. Start with low power settings and increase power and pulse duration if
necessary.
Please note the current relevant literature for the respective application. The specified supplementary
literature should serve as an introduction.
Safety during use
Laser Fume
Hazard of infection / poisoning by viable tissue particles or toxic components in
the laser fume or the laser fume plume.
x Use appropriate smoke evacuation for the particular application.
Laser radiation
Uncontrolled delivery of laser radiation risks causing tissue damage and severe
thermal damage.
x Check the settings (laser parameters and operating mode) of the laser
device before starting the laser application.
x Always start with low power settings. If necessary, increase the laser
power gradually to the required level.
of the fibre and the tissue - can be observed.
Unexpected effect of the laser radiation

Unexpected effect of the laser radiation due to mix up of the foot pedals of the
Kix DUO double pedal foot switch.
x Check the selection of the laser parameters and their assignment to the
footswitches before starting the laser application.
of the fibre and the tissue - is visible.
Perforations caused by laser radiation

In all endoscopic and laparoscopic applications there is a risk of perforation.
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Improper handling of laser fibres

Mechanical damage or excessive bending of the laser fibre as a result of
improper handling. At the damaged or excessively curved location of the laser
fibre, laser radiation may cause heat to develop, causing tissue damage and
burns.
x Do not bend the laser fibre too much. Consider the prescribed minimum
bending radius.
x Fix the laser fibre securely on / in the handpiece / endoscope.
x Do not use laser fibres that are kinked or otherwise damaged.
Detachment of damaged laser fibre components

Fragments can detach from damaged laser fibres. Unretrieved device fragments
(UDF) can cause injuries or diseases in the human body.
x The outer plastic sheath of the laser fibre (jacket) serves at the distal end
as a mechanical reinforcement and as a kink protection. To prevent the
fibre tip from breaking off, the stripped fibre length must not exceed
2 - 5 mm.
x Direct contact of the stripped glass fibre with the metal fibre guide may
cause the fibre to break.
x Use only compatible handpieces / endoscopes in combination with the
laser fibre. Consider the requirements of the laser fibre on the bending
radius and the necessary working channel.
x Use only instruments / endoscopes that do not have sharp corners and
edges. Check the handpiece / endoscope before use.
x Only use laser fibres that are compatible with the RevoLix DUO laser
device and are expressly approved by LISA Laser Products for use with
this laser device.
x Consider the prescribed minimum bending radius for the laser fibre.
Improper handling
In an attempt to advance the distal tip of the fibre within a deflected endoscope, it
can cause extensive damage that is not immediately recognized.
x Do not insert the laser fibre into a deflected endoscope.
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Laser tissue interactions
Basic physico-technical principles

The laser tissue interaction is based on the strong absorption of the 2 μm laser radiation by water
molecules, which make up the main component of the tissue. Color and blood circulation are negligible
for the effect of the RevoLix DUO laser device on tissue. The penetration depth of the 2 μm laser
radiation of the RevoLix DUO laser device into the tissue is approx. 0.5 mm beyond the visible cut
surface.
Fig. 46: Absorption spectrum of water with laser wavelengths
Basic physico-medical principles

The laser beam emerging from the laser fibre diverges in the form of a cone with an aperture angle of
approximately 25° (divergence of the laser radiation from the laser fibre) , that is, the beam diameter
increases continuously with increasing distance of the laser fibre tip to the tissue. This reduces the
intensity and consequently the effect of the laser radiation on the tissue. The effect (the intensity) of the
laser radiation is thus largest directly at the beam exit from the laser fibre.
Intensity is defined as power per area.
The tissue effect of the 2 μm laser depends on the intensity of the laser radiation on the tissue.
The intensity
x increases with increasing laser power
x and decreases with increasing distance of the laser fibre tip to the tissue.
The tissue effect is also influenced by the surrounding medium (whether gaseous (open surgery) or
aqueous (endourology)).
A gaseous medium (air, CO2) dissipates less heat from the OP situs, causing overheating of the tissue
and undesirable carbonisation. Any resulting smoke must be extracted by suitable means (smoke
evacuation).
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An aqueous medium (rinsing liquid) has two advantages over the air:
x An aqueous medium ensures a much better cooling of the tissue: carbonization is largely avoided
and visual tissue identification is facilitated.
x In addition, in an aqueous medium, any tissue that is farther than 5 mm from the fibre tip is
protected from laser action by the strong absorption of 2 μm of laser radiation in the aqueous
medium. This is a safety issue.
For low intensity (low power setting and/or greater distance of the laser fibre from the tissue)
x the effect of the laser on the tissue is mainly coagulating.
x the density of the absorbed laser power is lower (ablation threshold I s in Fig. 47) than is required
for the vaporization of the water in the tissue. The tissue effect is purely coagulating.
x the distance of the laser fibre tip from the tissue does not cause vaporization even during
prolonged irradiation because the absorbed laser power dissipates into the surrounding medium
(tissue, surrounding gas or aqueous medium) (no heat accumulation, no build-up of temperature).
x in other words: the cooling effect by heat dissipation into the surrounding tissue prevents the
required temperature build-up for the evaporation of the tissue (below ablation threshold Is in Fig.
47).
With increasing intensity (higher laser power and/or shorter distance of the laser fibre tip to the tissue
(smaller spot diameter)) the temperature of the tissue increases.
At some point (Is in Fig. 41), heat accumulation in the irradiated tissue has increased the temperature to
the evaporation point of the water in the tissue.
Fig. 47: Tissue effect as a function of absorbed power density
The rate of ablation (ablation rate in Fig. 47) can be controlled to some extent by varying the power
density (sector II in Fig. 47).
Further increase of the power density (sector III in Fig. 47) does not lead to a further increase of the
ablation rate, because the tissue is protected by the evaporating ablation products from the laser
radiation.
Carbonization of the tissue occurs mainly when using the laser in open surgery.
Tissue interaction
An aqueous medium (irrigation liquid) absorbs the 2 μm laser beam. At sufficiently high power, a steam
bubble forms at the fibre tip, which is almost stationary at a small distance (distance of the fibre tip to a
tissue surface) and provides the optical contact for the laser beam to the tissue. The steam bubble paves
the way of the laser radiation to the tissue where it can develop its effect.
When the distance between the fibre tip and the tissue is increased to about 1 to 4 mm, the steam bubble
collapses and the laser beam loses contact with the tissue surface. The laser radiation is completely
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absorbed by the aqueous medium before the tissue surface is reached (the aqueous irrigation fluid
shields the tissue from the laser radiation). The tissue is not vaporized. This shielding by the irrigation
fluid can be understood as a safety feature of the 2 micron laser radiation in endourology.
The damage zone is not limited to the visible cut into the tissue, since the laser energy penetrates beyond
the visible cut even further into the tissue (optical penetration depth is greater than cutting depth). In
addition, heating of the surrounding tissue occurs because heat flows out of the laser energy absorbing
volume via heat conduction.
The optical penetration of the laser power is limited to a depth of less than 0.5 mm underneath the visible
cut (penetration depth). Thermal damage to deeper lying tissue can only occur by heat conduction.
The damage zone depends on the treatment technique. At a power density that allows cutting of the
tissue, the damage zone is less than 1 mm. As a rule of thumb, the longer the fibre is held in place, the
greater the thermal damage zone.
With the Thulium CW laser, the coagulation and ablation properties are mild due to the CW laser radiation
compared to the pulsed laser radiation of the holmium pulse laser. The tissue is coagulated or incised
without causing trauma to the surrounding tissue. The vision is not affected by blisters and no tissue
pieces - including living cells - contaminate lenses or goggles.
The CW laser radiation of the Thulium CW laser is ideal for the treatment of soft tissue.
The pulsed laser radiation of the holmium pulsed laser is ideal for the removal and fragmentation of
stones and hard tissue. The very high pulse peak power generated by the holmium laser vaporizes the
water embedded in the tissue and, via this effect, ruptures or shatters the tissue types, i.e. both soft and
hard tissue.
As the laser pulse radiates into the aqueous fluid, a vapor bubble forms at the end of the laser fiber. The
bladder in combination with the effects of the laser beam removes and smashes stones and hard tissue
very effectively.
The disadvantage of the pulsed high-power radiation may be cracks and trauma in the surrounding
tissue; In addition, blistering, which obstructs the view. When the holmium laser is used in open surgery,
spills of tissue may contaminate the endoscope lenses. For soft tissue applications, therefore, the CW
laser radiation of the Thulium CW laser should be used.
For the efficient removal of tissue, it is necessary that the absorption process (duration of a laser pulse)
runs just as fast as the removal of the heat generated within the tissue by heat conduction and heat
transport. The performance of the Holmium pulse laser of the RevoLix DUO laser device is due to the
relatively short pulse duration (between 200 μs - 600 μs).
The following variable treatment parameters are available to the user:
Tab. 20: Treatment parameters
Parameter Variation Effect
x Density of absorbed power,

Power setting High or low power
x Ablation rate
Contact or non-contact x Density of absorbed power,

Beam diameter at tissue
mode x Ablation rate
Laser fibre, x Fibre flexibility,

Different core- and jacket diameter.
optical core x Beam intensity
Open surgery (gaseous medium) or x Cooling

Medium
surgery in aqueous medium x Shielding
Laser surgery in a gaseous medium

The cooling of the tissue is low if the laser is used in a gaseous medium. Vaporization occurs as soon as
the absorbed power density has reached the ablation threshold. Carbonization is almost inevitable,
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especially for larger cuts in gaseous medium. In carbon dioxide atmosphere, less carbonization takes
place because the required oxygen is missing.
For the use of the RevoLix DUO laser device in a gaseous medium, it is recommended to drip water or
saline solution on application sites along the laser fibre. This prevents carbonization and makes it
possible to visually differentiate the tissue.
Laser fumes must be removed by smoke evacuation.
Thermal tissue damage

For applications in gaseous media, there is a greater range of the laser beam.
The lower tissue cooling can lead to a stronger carbonization of the tissue and
unwanted thermal damage.
Laser surgery in aqueous medium

An aqueous medium cools the application site intensively. Carbonization is very limited because the
temperature increase is limited by the evaporation enthalpy of the aqueous medium (at about 100 °C) and
the tissue.
For the following reasons, aqueous media allow higher power settings compared to gaseous media:
1. Compared to open surgery, the cooling is stronger; more laser power is needed to achieve the
desired effect.
2. Compared with open surgery, less carbonization occurs.
The irrigation fluid used can be any conventional irrigation solutions such as distilled water, 0.9 % NaCl
solution, Purisol (mannitol / sorbitol) solution, Ringer's solution and 1.5 % glycine solution. When using
the irrigation fluids, always pay attention to the manufacturer's user information. Glycine solution reacts
with the laser radiation at the tip of the fibre and can reduce the lifetime of laterally emitting (so-called
sidefire) laser fibres.
Different application methods

The choice of the distance between the distal end of the laser fibre and the tissue to be treated depends
on the particular intended application. Different approaches have developed, which differ in the distance
of the distal laser fibre tip to the tissue.
1. Near-contact method: This method is used in the vaporization of tissue with simultaneous
coagulation (hemostasis). The fibre end is held close to the tissue to remove it. Immediate bleaching
of the tissue indicates its coagulation.
2. Contact method: When cutting tissue (incisions), the laser fibre must be in light contact with the
tissue surface as you pull the fibre end over the tissue surface. This is advantageous because in this
way the fibre end can not get caught in the tissue.
Preparation
Handpieces and endoscopes

Before the operation, make sure that the available laser fibres are compatible with the handpieces or
endoscopes to be used. Make sure that the laser fibre can be inserted into the endoscope or handpiece
without any effort and pulled out again. Also check if the laser fibre can be securely fixed.
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For controlled use, it is imperative that the laser fibre in the instrument is accurately guided up to its distal
end. Chose that fibre guide tubes whose inner diameter is closest to the outer diameter of the laser fibre.
The outer diameter of the laser fibres is indicated on the label of the laser fibre and on the packaging.
While the outermost plastic sheath of a laser fibre (jacket) serves as a mechanical protection, the
underlying coating of the silica serves as mechanical stabilization of the fibre and improves the breaking
strength of the fibre.
To prevent the fibre tip from breaking off, the stripped fibre tip should not be more than 5 mm. A direct
contact of the stripped laser fibre with the metal fibre guide may result in breakage of the laser fibre.
For endoscopic instruments, the distal tip of the fibre must be placed in the field of view of the user.
Please note the instructions and information in the separate operating instructions for the laser fibres.
Use of incompatible instruments

Mechanical damage or excessive bending of the laser fibre as a result of
combination with incompatible handpieces / endoscopes. At the damaged or
excessively bent location of the laser fibre, laser radiation may cause heat to
develop, causing tissue damage as well as burns and property damage to the
handpiece / endoscope used.
x Use only compatible handpieces / endoscopes in combination with the
laser fibre. Consider the requirements of the laser fibre on the bending
radius and the necessary working channel.
x Use only handpieces / endoscopes without rough edges. Check the
handpiece / endoscope prior to use.
x Do not go below the minimum bending radius of the laser fibre.
x Use only laser fibre fixations which prevent mechanical damage to the
laser fibre.
x Insert the laser fibre carefully into the handpiece / endoscope.
Insufficient fixation of the laser fibre

In case of insufficient fixation, the laser fibre may slip back into the handpiece /
endoscope. Laser radiation which is released inside the handpiece / endoscope
may heat the handpiece / endoscope and cause tissue damage and burns.
x Fix the laser fibre securely on / in the handpiece / endoscope.
x Use only fixings suitable for the outer diameter of the laser fibre. Consider
the technical data of the laser fibre (outer diameter) and the intended
fixation.
Step by step
1. Commission the laser device as described in Chapter 7 „Operation of the laser device".
2. Remove the laser fibre from the packaging following sterile procedures and inspect the laser fibre for
damage as described in chapter 7.12 „Checking the laser fibre“. Damaged laser fibres must not be
used.
3. Before the laser is used, the sterile surgical nurse transfers the fibre end with the fibre connector to
the non-sterile OR nurse who operates the laser device. The non-sterile OR nurse removes the
protective cap from the laser fibre connector and connects the laser fibre to the laser device (Chapter
7.13).
4. Switch the laser device to the READY operating state. This turns on the red or green aiming beam.
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5. Set the aiming beam to high brightness. Check that the red or green target beam exits only at the
distal tip of the fibre and is easy to recognize. Do not use the laser fibre if the aiming beam is only
faintly visible or escaping in the area of the fibre jacket.
6. Insert the laser fibre into the instrument to be used. Make sure that they are compatible with each
other. Bring the instrument to the desired position.
7. Make sure that the fibre tip protrudes from the instrument.
8. Position the instrument together with the laser fibre so that the aiming beam is directed at the tissue
to be treated.
9. Set the laser parameters. The emission of laser radiation of the working laser is triggered by pressing
the footswitch. Only trigger the emission of laser radiation if the distal end of the fibre and the target
tissue are clearly visible.
10. During laser use, there may occur a slight burnback of the fibre tip depending on parameter setting
and application. During the laser application, the surgeon perceives the burnback as increasing
scattering of the aiming beam at the distal tip of the fibre. The so called fibre burnback reduces the
beam quality and thus affects the cutting performance.
11. During surgery, the distal end of the laser fibre must be constantly monitored. Make sure that the fibre
end always protrudes at least one millimeter from the instrument to avoid damage to the instrument.
12. Remove the fibre from the laser immediately when the operation is completed. For reusable laser
fibres, screw the protective cap onto the fibre connector immediately. For reprocessing the reusable
laser fibre follow the instructions in the corresponding instructions for use. Laser fibres for single use
must be disposed of.
13. To switch off and clean the laser device, please follow the instructions in chapter 7.16 „Switch-off
routineSwitch-off routine" and 7.17 „Cleaning and disinfection“
Urology
Urology – Thulium CW-Laser

The applications described below - section 8.5.2 to section 8.5.14 - are performed with the Thulium CW
laser. CW laser radiation is particularly suitable for soft tissue applications.
The RevoLix DUO laser device is used in the application mode TISSUE (Thulium CW laser) in urology for
the following clinical applications:
x VapoResection of the Prostate (ThuVARP)
x VapoEnucleation of the Prostate (ThuVEP)
x Blunt Enucleation of the Prostate (ThuLEP)
x Vaporization of the prostate with SideFib-SU sidefiring laser fibre (ThuVAP)
x Vaporization of the prostate with RigiFib 800 or RigiFib 1000 (ThuVAP)
x Opening of urethral strictures
x Elimination of ureteral strictures
x Bladder neck incisions
x Resection of bladder tumors
x Ablation of tumors in the ureter
x Ablation of tumors in the kidney
x Condyloma and penile tumor excision
Particularly beneficial in soft tissue ablation is the excellent hemostatic effect of the RevoLix DUO laser
device.
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For urological applications, LISA Laser Products supplies the necessary laser fibres, laser resectoscopes
and rigid ureterorenoscopes as standard accessories. In addition, necessary urological-endoscopic
instruments must have a working channel for receiving the laser fibre and, if necessary, be approved by
the instrument manufacturer for laser use. Please get advice from LISA Laser Products.
VapoResection of the Prostate (ThuVARP)

The vaporesection of the prostate is performed with frontal emitting laser fibres (RigiFib, RigiFib 800).
The instrument used for the application is a laser resectoscope (RexScope). The laser fibre is guided via
a guide tube up to the distal end of the instrument.
Use the contact procedure for resection and start with a low power setting. Adjust the power setting
according to your observations and experiences.
In the EAU guideline "Laser and Technology" 2011 the counter-indication for patients under the influence
of coagulation drugs is formulated differently compared to the general warning in Chap. 3.4. According to
studies, the Tm:Yag CW treatment is at least as well applicable to these patients as the Ho:YAG
treatment. Both methods suggest sufficient coagulation properties:
x “The available clinical and preclinical experimental data suggests that Tm:YAG” (like the
RevoLix DUO laser device in Thulium mode (comment by the author)) “can be used in patients
on anticoagulative medication, similar to Ho:YAG, which has lower coagulative properties due to
the pulsed energy application mode.”
In addition, the EAU guideline "Laser and Technology" 2011 recommends the following:
x ThuVARP is an alternative to TURP for small- and medium-sized prostates
x ThuVARP and ThuVEP are suitable for patients at risk of bleeding or taking anticoagulant
medication.
x ThuVEP is an alternative to TURP, to HoLEP and OP for large size prostates.
In the S2e guideline "Therapie des Benignen Prostatasyndroms (BPS)“ of the Academy of German
Urologists 2014 the contraindication is considered as follows:
x „Performing anticoagulation seems possible."
Furthermore, the S2e guideline recommends:
x The Thulium:YAG vaporesection leads to a significant improvement in the micturition parameters
and symptoms in small and medium-sized prostate volumes, which is comparable with the
TUR-P.
x The Thulium:YAG vaporesection has a strong influence on the BOO, which potentially also
applies to the vapoenucleation.
x The Thulium:YAG vapoenucleation leads to a significant improvement of the micturition
parameters as well as the symptoms. The results are comparable to those of the TUR-P in the
short and medium term. The results are comparable to those of HoLEP.
x The Thulium:YAG vapoenucleation can be performed volumetrically independent and also in
patients with chronic relapsing urinary retention.
A detailed description of the surgical technique of the prostate resection can be found in the following
listed literature:
x Bach T., Herrmann T.R., Ganzer R., Burchardt M., Gross A.J.; “RevoLix vaporesection of the
prostate: Initial results after 54 patients with an one-year follow-up”; World J. Urol., 2007, Vol. 25
(3), 257-262
x Xia S.J., Zhuo J., Sun X.W., Han B.M., Shao Y., Zhang Y.N.; “Thulium Lasers versus Standard
Transurethral Resection of the Prostate: A Randomized Prospective Trial”; European Urology,
European Urology, 2008, Vol. 53.2, 382-390
x A video is available from LISA Laser Products, which demonstrates the surgical technique of
simultaneous vaporization and resection of prostate which was introduced by N. Schmeller,
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Salzburg, Austria. Presented by Götschl R., Schmeller N.; “The Thulium resection of the
prostate”; at AUA, 2005 San Antonio, Texas, USA
x Bach T., Xia S.J., Yang Y., Mattioli S., Watson G.M.; Gross A.J., Herrmann T.R.W.;
“Thulium:YAG 2 μm cw laser prostatectomy: where do we stand?”; World J. Urol., 2010, 28(2),
163-168.
x Cui D., Sun F., Zhuo J., Sun X., Han B., Zhao F., Jing Y., Lu J., Xia S.; “A randomized trial
comparing Thulium laser resection to standard transurethral resection of the prostate for
symptomatic benign prostatic hyperplasia: four-year follow-up results”; World J Urol, 2014,
32(3):683-9.
x Yan H., Ou TW., Chen L., Wang Q., Lan F., Shen P., Li J., Xu J.: “Thulium laser vaporesection
versus standard transurethral resection of the prostate: a randomized trial with transpulmonary
thermodilution hemodynamic monitoring.”; Int J Urol. 2013, 20(5):507-12.
VapoEnucleation of the Prostate (ThuVEP)

Use the contact procedure for resection and start with a low power setting. Adjust the power setting
A possible treatment technique is the enucleation technique where the lobes are cut to a few parts. The
implementation essentially corresponds to HoLEP (see Peter J. Gilling, "Surgical Atlas, Holmium Laser
Enucleation of the Prostate (HoLEP)" 2008.
The findings and assessments from the EAU Guideline 2011 and the S2e guideline 2014 include the
consideration of the ThuVEP (described in previous section 8.5.2 about ThuVARP).
Various methods of vapoenucleation are used. A detailed description of the surgical technique can be
found in the following international literature:
x Bach T., Xia S.J., Yang Y., Mattioli S., Watson G.M.; Gross A.J., Herrmann T.R.W.;
“Thulium:YAG 2 μm cw laser prostatectomy: where do we stand?”; World J. Urol., 2010, 28(2),
163-168.
x Bach T., Wendt-Nordahl G., Michel S., Herrmann T.R.W. Gross A.J.; „Feasibility and efficacy of
Thulium:YAG laser enucleation (VapoEnucleation) of the prostate”; World J. Urol. 2009(27); 541-
545
x Herrmann T.R.W., Bach T., Imkamp I., Georgiou A., Burchardt M., Oelke M., Gross A.J.;
“Thulium laser enucleation of the prostate (ThuLEP): transurethral anatomical prostatectomy with
laser support. Introduction of a novel technique for the treatment of benign prostatic obstruction”;
World J. Urol. 2010, (28) 45-51
x Bach T., Netsch C., Haecker A., Michel S., Herrmann T.R.W., Gross A.J.; „ Thulium:YAG laser
enucleation (VapoEnucleation) of the prostate: safety and durability during intermediate-term
follow-up”; World J. Urol. 2010, (28) 39-43
x Hauser S., Rogenhofer S., Ellinger J., Strunk T., Müller S.C., Fechner G.; “Thulium Laser
(RevoLix) Vapoenucleation of the Postate Is a Safe Procedure in Patients with an Increased Risk
of Hemorrhage”; Urologia Internationalis 2012; 88(4):390-4. 2012
x Bach T., Netsch C., Pohlmann L., Herrmann T. R, Gross A. J.; „Thulium:YAG Vapoenucleation in
Large Volume Prostates.”; Journal of Urology, Vol. 186, 2323-2327, December 2011. 2011
Blunt Enucleation of the Prostate (ThuLEP)

The blunt enucleation of the prostate is performed with frontal emitting laser fibres (RigiFib, RigiFib 800).
The actual enucleation is purely by mechanical force by pushing the adenoma out of the prostatic
capsule.
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Use the contact procedure for the first incisions and hemostasis. Start with a low power setting. Adjust the
power setting according to your observations and experiences.
A video tutorial on the blunt enucleation of the prostate using the RevoLix DUO laser device in Thulium
mode from and with Prof. Herrmann is available on request from LISA Laser Products.
Supplementary literature:
x Herrmann TR, Bach T, Imkamp F, Georgiou A, Burchardt M, Oelke M, Gross AJ; „Thulium laser
enucleation of the prostate (ThuLEP): transurethral anatomical prostatectomy with laser support.
Introduction of a novel technique for the treatment of benign prostatic obstruction. World J Urol.
2010;28(1):45-51. doi: 10.1007/s00345-009-0503-0.
x Kyriazis I, Świniarski PP, Jutzi S, Wolters M, Netsch C, Burchardt M, Liatsikos E, Xia S, Bach T,
Gross AJ, Herrmann TR. „Transurethral anatomical enucleation of the prostate with Tm:YAG
support (ThuLEP): review of the literature on a novel surgical approach in the management of
benign prostatic enlargement“; World J Urol. 2015 Apr; 33(4):525-30. doi: 10.1007/s00345-015-
1529-0. 2015. Review
Vaporization of the prostate with SideFib-SU (side emitting laser fibre)

The vaporization of the prostate is performed with a side emitting laser fibre ("Sidefire" fibre), which emits
the laser radiation laterally to the fibre direction (about 70°).
The instrument used is a special laser cystoscope for the "Sidefire" laser fibre. The laser fibre is guided
via a guide tube up to the distal end of the instrument. A fixation in the instrument does not take place,
since the steering of the laser beam during the application takes place primarily by rotation and
translation of the laser fibre.
The laser light emerges laterally from the laser fibre at a 70° angle. Note that the
exit window protrudes from the distal end of the instrument and that the laser
beam is not radiating towards the optics.
First insert the sheaths by the help of an obturator. Then switch the obturator against the laser
cystoscope. Then insert the laser fibre into the instrument, place the laser device in READY and direct the
aiming beam towards the tissue to be vaporized. Control the laser fibre with the aid of the SideFib-SU
laser fibre. Use a low power setting at the beginning. Activate emission with the footswitch. Use the non-
contact method for vaporization of the prostate.
If the laser radiation hits water, a steam bubble forms at the fibre tip. Vaporization begins when the steam
bubble bridges the gap between the laser fibre and the tissue. The optimal distance between laser fibre
and tissue is about 1 mm. If the separation between fibre tip and tissue gets too large then the steam
bubble becomes unstable and the tissue vaporization rate decreases drastically.
The laser radiation is directed by gently rotating the laser fibre back and forth in slow fan movements over
the tissue surface ("sweeping technique").
Find out about this surgical procedure using the latest literature or contact LISA Laser Products.
Tissue adhesion is possible at the exit point of the laser radiation, which must be removed regularly.
These tissue adhesions lead to accelerated erosion of the laser fibre. The adherence of tissue can be
controlled if an optimal distance (about 1 mm) to the tissue surface is always maintained. If the
vaporization effect does not come back after cleaning the laser fibre, then the laser fibre should be
replaced.
Change the power setting according to your observations and experiences.
An illustration of the surgical technique is available on video material available on request from LISA
Laser Products.
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Vaporization of the prostate with frontal emitting laser fibres

The vaporization of the prostate is performed with a frontal emitting laser fibre (RigiFib 800,
RigiFib 1000) with a large optical core diameter. These laser fibres have the advantage over the laterally
emitting laser fibres that they can be reprocessed.
The instrument used for the application is a special laser resectoscope. The laser fibre is guided via a
guide tube up to the distal end of the instrument.
First insert the sheaths by the help of an obturator before using the laser element with the laser fibre. Put
the laser device in READY. Then direct the aiming beam towards the tissue to be vaporized. The
instrument is only moved as far as necessary for the overview of the surgical field. Use a low power
setting at the beginning. Activate the emission of laser radiation with the footswitch. When the laser
radiation hits water, a steam bubble is created in front of the fibre tip. Vaporization begins when the steam
bubble bridges the gap between the laser fibre and the tissue. The optimal distance between laser fibre
and tissue is about 1 mm. If the laser radiation does not strike the tissue surface directly, the steam
bubble becomes unstable and the vaporization rate decreases drastically.
The laser radiation is directed by gently rotating the laser fibre back and forth in slow fan movements over
the tissue surface ("sweeping technique").
Find out about this surgical procedure using the latest literature or contact LISA Laser Products.
Tissue adhesion is possible at the exit point of the laser radiation, which must be removed regularly.
These tissue adhesions lead to accelerated erosion of the laser fibre. The adherence of tissue can be
controlled if an optimal distance (about 1 mm) to the tissue surface is always maintained.
Change the power setting according to your observations and experiences.
A detailed description of the surgical technique is available on video material available on request from
LISA Laser Products.
Opening of urethral strictures

The opening of urethral strictures is performed with frontal radiating laser fibres (PercuFib, RigiFib).
The instrument used for the application is a special laser resectoscope (RexScope). The laser fibre is
guided via a guide tube up to the distal end of the instrument.
At the beginning, use a low power setting and work on contact-type incisions. Change the power setting
x Chiang P.K., Lin Y.Y., Tsai W.K., Lin W.C., Hsu J.M., “Endoureterotomy for ureteral stricture
using a Thulium laser: Preliminary experience”, Urological Science 22 (2011), 103-105
Opening of ureteral strictures

The opening of ureteral strictures is performed with frontal emitting laser fibres (PercuFib).
The instrument used for this purpose is a rigid (or flexible) ureterorenoscope. The laser fibre is guided
through the working channel of the ureterorenoscope up to the distal end of the instrument.
Use a low power setting at the beginning. Work on incisions in the contact procedure. Change the power
setting according to your experience.
x Guo F.F.; Lu H.; Wang G.J.; Tan S.F.; He X.F.; Wang J.M.; Liu H.J.; Zhu W.B.; “Transurethral 2μ
laser in the treatment of urethral stricture” World J Urol (2010) 28:173–175
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Bladder neck incisions

Bladder neck incision is made with frontal emitting laser fibres (PercuFib, RigiFib).
The instrument used for the application is a special laser resectoscope (RexScope). The laser fibre is
guided via a guide tube up to the distal end of the instrument.
Use a low power setting at the beginning. Work on incisions in the contact procedure. The surgical
procedure is identical to the "Turner-Warwick" procedure. Change the power setting according to your
observations and experiences.
A detailed description of the surgical technique is in the literature. Video material is available on request
x Bach T., Herrmann T.R., Cellarius C., Gross A.J.; “Bladder neck incision using a 70 W 2 micron
continuous wave laser (RevoLix)”; World J. Urol., 2007, Vol. 25 (3), 263-267
x Sharifiaghdas F., Parizi M.K., Ahadi B., “Efficacy of Transurethral Bladder Neck Incision with 2-
Micron Continuous Wave Laser (RevoLix) for the Management of Bladder Outlet Stricture in
Women”; Female Urology, 2013, Vol. 10 (1), 790-794
Vaporization of urothelial carcinoma of the upper urinary tract UTUC

The vaporization of urothelial carcinoma of the upper urinary tract is performed with frontal emitting laser
fibres (PercuFib).
The instrument used for this purpose is a rigid (or flexible) ureterorenoscope. The laser fibre is guided
through the working channel up to the distal end of the instrument.
Use a low power setting at the beginning. Work on ablation in close-contact procedure. Change the
Keep in mind that the laser radiation also leads to heating of the fluid in the kidneys and urinary tract.
Work in intervals.
A detailed description of the surgical technique is in the literature.
x Defidio L, De Dominicis M, Di Gianfrancesco L, Fuchs G, Patel A., “First collaborative experience
with Thulium laser ablation of localized upper urinary tract urothelial tumors using retrograde
intra-renal surgery”; Arch Ital Urol Androl. 2011;83(3):147-53
x Defidio L, Di Pinto A. “Retrograde laser-ablation with flexible ureterorenoscope of an upper
urinary tract tumor in an orthotopic urinary diversion”; Arch Ital Urol Androl. 2007;79(1):36-8
En bloc resection of bladder tumors

Ablation of bladder tumors is performed with frontal emitting laser fibres (PercuFib, RigiFib).
Use a low power setting at the beginning. Work on resection in contact procedure. Change the power
setting according to your observations and experiences.
A detailed description of the surgical technique is in the literature.
A video tutorial on the ablation of bladder tumors using the RevoLix DUO laser device in Thulium mode
from and with Prof. Herrmann is available on request from LISA Laser Products.
x Gao Xu, Ren Shancheng, Xu Chuanliang, Sun Yinghao; „Thulium laser resection via a flexible
cystoscope for recurrent non-muscle-invasive bladder cancer: initial clinical experience”; British
Journal of Urology International (BJUI); 2008, 102(9), 1115-1118
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x Wolters M., Kramer M.W., Jutzi S., Stöhrer M., Becker J., Nagele U., Bach T., Gross A.J., Kuczyk
M.A., Herrmann T.R.W.; “Thulium:YAG laser en bloc mucosectomy for accurate staging of
primary bladder cancer”; 2012, Video 2012-45, European Urology Supplements Vol. 11 (1)
x Kramer M.W., Bach T., Wolters M., Imkamp F., Gross A.J., Kuczyk M.A., Merseburger A.S.,
Herrmann T.R.W.; “Current evidence for transurethral laser therapy of non-muscle invasive
bladder cancer”; World J Urol.; 2011;29(4):433-442
x Wolters M., Kramer M.W., Becker J.U., Christgen M., Nagele U., Imkamp F., Burchardt M.,
Merseburger A. S., Kuczyk M.A., Bach T., Gross A.J., Herrmann T.R.W.; “Tm:YAG laser en bloc
mucosectomy for accurate staging of primary bladder cancer: early experience”, World J Urol.;
2011;29(4):429-432.
x Struck JP, Karl A, Schwentner C, Herrmann TRW, Kramer MW; „En bloc resection and
vaporization techniques for the treatment of bladder cancer”, Der Urologe Ausgabe A; 2018
Partial nephrectomy
Partial nephrectomy is performed with frontal emitting laser fibres (PercuFib, RigiFib).
The instrument used for the application is a special laser handpiece (SurgiLas). The laser fibre is guided
via a guide tube up to the distal end of the instrument.
Use a low power setting at the beginning. Use the contact procedure for resection. Use a irrigation and to
remove blood from the surgical site and reduce smoke. Change the power setting according to your
observations and experiences.
Strong bleeding
In a partial nephrectomy, blood vessels with a diameter greater than 1.5 mm can
not be cut with sufficient hemostasis, which can lead to heavy bleeding.
x Prepare the temporary clamping of the renal artery to perform temporary
ischemia in case of bleeding.
x Note that the ischemia time must not exceed 30 minutes.
x Then use the conventional methods of hemostasis.
x Note the current literature on the use of Thulium laser for partial
nephrectomy.
A detailed description of the surgical technique is in the literature. Video material is available on request
x Loertzer H., Strauß A., Ringert R.H., Schneider P.; ”Laser-supported partial laparoscopic
nephrectomy for renal cell carcinoma without ischaemia time”, BMC Urology 2013 13:31
x Thomas A. Z., Smyth L., Hennessey D., O’Kelly F., Moran D., Lynch T. H.; ”Zero Ischemia
Laparoscopic Partial Thulium Laser Nephrectomy”; Journal of Endourology, 2013, 27(11), 1366-
1370
x Loertzer H., Schneider P., Thelen P., Ringert R.H., Strauß A.; „Laser now also to be used in
organ-preserving kidney surgery?”; Der Urologe 2012 51(6), 837-842, in German
x Mattioli S., Muñoz R., Recasens R., Berbega C., Teichmann H.; “What does RevoLix® laser
contribute to partial nephrectomy?”; Archivos Españoles de Urología, 200861 (9): 1126-1129
[Spanish]
x de Boorder T. Kruger A.B., Klaessens J., Grimbergen M., Verdaasdonk R.; “Comparing different
treatment modalities for partial nephrectomies without ischemic period: laser, Hydro-Jet and RF”;
Photonic Therapeutics and Diagnostics IV; 2008, (Vol. 6842, p. 68420W). International Society
for Optics and Photonics.
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x Gruschwitz T.; Stein R.; Schubert J.; Wunderlich H.; “Laser - supported partial nephrectomy for
renal cell carcinoma”; Urology 71 (2), Feb. 2008, 334-336
Condyloma and penile tumor excision

Condyloma and penile tumor excision are performed with frontal emitting laser fibres (PercuFib, RigiFib).
The instrument used for the application is a special laser handpiece (SurgiLas). The laser fibre is guided
via a guide tube up to the distal end of the instrument.
Use a low power setting at the beginning. Work on the excision of tumors in the near-contact procedure.
Wipe off the carbonized and coagulated tissue to evaluate the result. Change the power setting according
to your observations.
x Blokker R.S., Lock T.M.T.W., de Boorder T.; “Comparing Thulium Laser and Nd:YAG Laser in the
Treatment of Genital and Urethral Condylomata Acuminata in Male Patients”; Lasers in Surg.
Med. 2013 (45), 582-588
Urology – Holmium pulsed laser

The applications described below are performed with the holmium pulsed laser .. The pulsed laser
radiation is particularly suitable for applications in hard tissue.
The RevoLix DUO laser device is used in the application mode STONE (holmium pulsed laser) in urology
in the following clinical applications:
x Lithotripsy of bladder stones
x Lithotripsy of ureteral stones and kidney stones
For urological applications, LISA Laser Products supplies the necessary laser fibers as accessories. In
addition, the necessary urological-endoscopic instruments must have a working channel for receiving the
laser fiber and be released by the instrument manufacturer for laser use. Please get advice from LISA
Laser Products.
Please note the current literature on the respective applications. The listed literature should serve as an
introduction here:
x Guidelines on Urolithiasis; Eds.: Türk C, Knoll T, Petrik A, Sarica K, Skolarikos A, Straub M, Seitz
C; European Association of Urology, Eur Urol 40(2015):362-371
x 2007 Guideline for the Management of Ureteral Calculi; Eds.: Preminger G. M., et al., EAU/AUA
Nephrolithiasis Guideline Panel; The journal of urology 178.6 (2007): 2418-2434
x AUA guideline on management of staghorn calculi: diagnosis and treatment recommendations."
Preminger G. M., et al., The Journal of urology 173.6 (2005): 1991-2000.
x S2k-Leitlinie zur Diagnostik, Therapie und Metaphylaxe der Urolithiasis (AWMF 043/025); Eds.:
Knoll T., Bach T., Humke U., Neisius A., Stein R., Schönthaler M., Wendt-Nordahl G., Der
Urologe. Ausg. A. 55.7 (2016): 904.
Gynaecology
The RevoLix DUO laser device is used in the application mode TISSUE (Thulium CW laser) in
gynecology in the following clinical applications:
x Incisions and excisions on the external female genitalia
x Conization
x Hysteroscopy
x Laparoscopic procedure
x Condyloma excision
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Particularly beneficial in soft tissue ablation is the hemostatic effect of the laser described herein.
For gynecological applications, LISA Laser Products supplies the necessary laser fibres as standard
accessories. The additional endoscopic instruments required must have a working channel for receiving
the laser fibre and be approved by the instrument manufacturer for laser use. Please let us advise you.
Incisions and excisions on the external female genitalia

Use a low power setting at the beginning. Work on ablation in the near contact procedure and incision in
the contact procedure. Wipe off the carbonized and coagulated tissue to evaluate the result. Change the
Conization
The same work recommendations apply as in Chapter 8.6.1 "Incisions and excisions on the external
female genitalia".
Hysteroscopy
Use a low power setting at the beginning. Use the contact procedure for resection. Change the power
setting according to your observations and experiences.
Laparoscopic procedure
the contact procedure. Change the power setting according to your observations and experiences.
Add dropwise aqueous solution at the interface to reduce smoke formation and carbonisation. Rinse
blood out of the interface with aqueous solution.
Risk of gas insufflation with the risk of gas embolism

In all laparoscopic procedures there is a risk of gas embolism due to gas
insufflation.
x Use CO2 gas if possible
x Work with the lowest possible gas pressure.
Condyloma excision
The same work recommendations apply as in the chapter 8.5.13 „Condyloma and penile tumor excision“.
x Blokker R.S., Lock T.M.T.W., de Boorder T.; “Comparing Thulium Laser and Nd:YAG Laser in the
Treatment of Genital and Urethral Condylomata Acuminata in Male Patients”; Lasers in Surg.
Med. 2013 (45), 582-588
Ear, nose and throat surgery

The RevoLix DUO laser device is used in the application mode TISSUE (Thulium CW laser) in ENT
surgery in the following clinical applications:
x Turbinate reduction (Removal/shrinkage of the mucous membrane)
x Tonsillectomy
x Oropharynx/laryngeal tumor surgery
x Treatment of nasal polyps
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Particularly beneficial in soft tissue ablation is the hemostatic effect of the laser described herein.
LISA Laser Products supplies the necessary laser fibres as standard accessories. The additional
necessary (endoscopic) instruments must have a working channel for receiving the laser fibre and be
released by the instrument manufacturer for laser use. Please let us advise you.
Turbinate reduction (Removal/shrinkage of the mucous membrane)

the contact procedure. Change the power setting according to your observations.
Add dropwise aqueous solution at the interface to reduce smoke formation and carbonisation. Rinse
blood out of the interface with aqueous solution.
Tonsillectomy
The same work recommendations apply as in the chapter 8.7.1 „Turbinate reduction (Removal/shrinkage
of the mucous membrane)“.
Oropharynx/Larynx tumor surgery

The same work recommendations apply as in the chapter 8.7.1 „Turbinate reduction (Removal/shrinkage
of the mucous membrane)“.
Treatment of nasal polyps

Use a low power setting at the beginning. Work for the Vaporizationin non contact procedure.
Activate the emission of laser radiation as you slowly move the fibre end back and forth a few millimeters
above the surface of the tissue. Observe the vaporization and coagulation effect.
Change the power settings and the distance of the laser fibre to the tissue according to the desired effect.
This is advantageous because in this way the fibre end can not get caught in the tissue. It is possible to
undercut or ablate the tissue.
Pneumology
The RevoLix DUO laser device is used in the application mode TISSUE (Thulium CW laser) in
pneumology in the following application:
x Treatment of bronchial and tracheal obstructions
LISA Laser Products supplies the necessary laser fibres as standard accessories. The additional
necessary (endoscopic) instruments must have a working channel for receiving the laser fibre and be
released by the instrument manufacturer for laser use. Please let us advise you.
Possible serious injury from inflamed tissue or deflagration

In all pneumological applications of the laser device there is a risk of tube fires
and deflagration.
In all pneumological applications of the laser device there is a risk that the treated
tissue ignites.
x Make sure that the laser beam does not hit the tube either directly or in a
reflected way. Use only tubes and instruments that are laser safe.
x Keep the O2 concentration as low as possible during ventilation.
x For non-contact vaporization, use gas-purged laser fibres that are flushed
with CO2 or N2
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Intraoperative tubular fires in the context of laser surgery are rare, but represent a
high-grade and life-threatening threat to anesthetized patients.
If a laser beam hits directly on the oxygen-rich gas mixture with which a patient is
ventilated intraoperatively, deflagration and an extensive jet of flame occur with
the consequence of corresponding mucous membrane burns. The pressure wave
also allows dust particles and other products of burning to reach the distal lung
areas and cause pathological reactions there.
Laser tubes also do not represent absolute safety for the patient in this context.
Although they reduce the risk of tube burn, they do not exclude it.
Treatment of bronchial and tracheal obstructions

Use a low power setting at the beginning. Work for non-contact vaporisation. Work in PULSED mode or
activate emission in CONTINUOUS for a short time only, while holding the fibre end a few millimeters
above the surface of the fabric. Observe the vaporization and coagulation effect. Change the power
settings and the distance of the fibre to the fabric according to the desired effect. Change the power
setting according to your observation and experience.
Orthopedics
The RevoLix DUO laser device can be used in application mode STONE (Holmium pulsed Laser) in
orthopedics for the following clinical applications:
x (partial) resection of the meniscus
x Smoothing of cartilage lesions
x Synovia treatment
x Lateral Release
Particularly advantageous in arthroscopy is the combination of the directed, erosive effect of tissue, the
haemostatic effect and the slim laser applicator.
For arthroscopic applications, LISA Laser Products supplies all accessories. Please get advice from LISA
Laser Products.
Spinal surgery
The tissue effect of the holmium pulsed laser is particularly advantageous in spine surgery.
For the applications, LISA Laser Products supplies the necessary laser fibers as standard accessories.
The additional endoscopic instruments required must have a working channel for receiving the laser fiber
and be approved by the instrument manufacturer for laser use. Please let us advise you.
PLDD
Use a low power setting at the beginning. Work for the vaporisation in the near contact procedure
Change the power settings and the distance of the laser fiber to the tissue according to the desired effect.
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Reference values of laser parameters for different applications

The laser parameters mentioned in the tables serve as orientation and are based on experience. These reference values should be adapted individually to your
conditions. Start the application with lower laser powers. Evaluate the setting based on the laser effects on the target tissue
Please observe the safety and warning instructions in the relevant chapters.
Application mode TISSUE

Tab. 21: Applications and settings for application mode TISSUE
Application
Power
Frequency (pulse
repetition rate)
Operating mode
Laser fibre
Accessories or
endoscope
Distance to the
tissue
Urology
RigiFib, RigiFib 800
VapoResection of the prostate 50 – 150 W - CONTINUOUS Laser resectoscope Contact
or equivalent SU fibres
RigiFib
Enucleation of the prostate 50 – 90 W - CONTINUOUS Laser resectoscope Contact
SideFib-SU, RigiFib 800,

Laser resectoscope or
Vaporization of the prostate 70 – 150 W - CONTINUOUS RigiFib 1000 Near - Contact
Laser cystoscope
PercuFib
Eliminating ureteral strictures 5 – 15 W - CONTINUOUS Ureterorenoscope Contact
or equivalent SU fibre
PercuFib, RigiFib Laser resectoscope
Urethral strictures 10 – 15 W - CONTINUOUS Contact
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Application
Power
Frequency (pulse
repetition rate)
Operating mode
Laser fibre
Accessories or
endoscope
Distance to the
tissue
RigiFib Laser resectoscope

Bladder neck incisions 15 – 30 W - CONTINUOUS Contact
RigiFib, PercuFib Laser resectoscope Near - Contact
Ablation of bladder tumors 5 – 20 W - CONTINUOUS
or equivalent SU fibres Contact
RigiFib, PercuFib, FlexiFib Laser handpiece
Partial nephrectomy 15 – 30 W - CONTINUOUS Contact
or equivalent SU fibres SurgiLas
RigiFib, PercuFib Laser handpiece
5 – 15 W - CONTINUOUS Near - Contact
or equivalent SU fibres SurgiLas, Fume suction
Condylomas
2 - 5 Hz RigiFib, PercuFib Laser handpiece
5 – 15 W PULSED Near - Contact
50 - 200 ms or equivalent SU fibres SurgiLas, Fume suction
Gynaecology
Surgical procedure on the outer PercuFib, RigiFib Laser handpiece
10 – 25 W - CONTINUOUS Contact
genital area or equivalent SU fibres SurgiLas
PercuFib, RigiFib Laser handpiece
Conization 20 – 30 W - CONTINUOUS Contact
PercuFib, RigiFib
Hysteroscopy 10 – 20 W - CONTINUOUS Hysteroscope Contact
PercuFib, RigiFib
Laparoscopic procedures 5 – 15 W - CONTINUOUS Laser handpiece Near - Contact
PercuFib, RigiFib Laser handpiece
Condylomas
2 - 5 Hz PercuFib, RigiFib Laser handpiece
50 - 200 ms or equivalent SU fibres SurgiLas
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Application
Power
Frequency (pulse
repetition rate)
Operating mode
Laser fibre
Accessories or
endoscope
Distance to the
tissue
ENT
PercuFib Laser handpiece
Turbinate reduction
5 – 15 W PULSED Contact
Tonsillectomy PercuFib Laser handpiece
Oropharynx/Larynx tumor surgery PercuFib Laser handpiece
RigiFib, PercuFib Laser handpiece
Treatment of nasal polyps or equivalent SU fibres SurgiLas
Pneumology
ColFib-SU, RigiFib, PercuFib Laser handpiece
Treatment of bronchial and 5 – 15 W - CONTINUOUS Near - Contact
tracheal obstructions
2 - 5 Hz ColFib-SU, RigiFib, PercuFib or Laser handpiece
200 - 500 ms equivalent SU fibres SurgiLas
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Application mode STONE

Tab. 22: Applications and settings for application mode STONE
Application
Pulse energy
Frequency (Pulse
repetition rate)
Laser fibre
Equipment or
endoscope
Urology
PercuFib, RigiFib
Lithotripsy of bladder stones 1.5 J 10 Hz Cystoscope or comparable endoscope
LithoFib, FlexiFib, PercuFib
Lithotripsy of ureteral stones 1.2 J 10 Hz Rigid URS, flexible URS
LithoFib, FlexiFib, PercuFib, RigiFib
Lithotripsy of calyx stones 1.0 J 10 Hz Flexible URS, nephroscope
Lithotripsy of renal pelvis stones 1.0 J 10 Hz Rigid URS, flexible URS, nephroscope
Lithotripsy („Dusting“) 0.5 - 0.8 J 15 Hz Rigid URS, flexible URS, nephroscope
Orthopedics
RigiFib
Meniscectomy 1.2 J 15 Hz Laser handpiece SurgiLas
RigiFib
Cartilage smoothing 0.8 J 10 Hz Laser handpiece SurgiLas
Seite 66
RevoLix DUO
Application
Pulse energy
Frequency (Pulse
repetition rate)
Laser fibre
Equipment or
endoscope
RigiFib
Lateral Release 1.5 J 10 Hz Laser handpiece SurgiLas
RigiFib
Capsular shrinkage 10 J 10 Hz Laser handpiece SurgiLas
RigiFib
Synovectomy 1.2 J 15 Hz Laser handpiece SurgiLas
Spinal column
PercuFib
Foraminoplasty (soft tissue) 1.5 J 10 Hz
PercuFib
Foraminoplasty (bone) 2.0-2.5 J 8 Hz
0.6 J PercuFib
PLDD 10 Hz
total max. 1200 J or equivalent SU fibre
Seite 67
RevoLix DUO
9 Accessories
The products listed below are standard accessories for use with the RevoLix DUO laser device. In
addition, any accessories used must be expressly identified as suitable for use with the RevoLix DUO
laser device. Please contact LISA Laser Products if you would like to use unlisted accessories with the
RevoLix DUO laser device.
Please contact LISA Laser Products for further available accessories.
Laser fibres
Note that only laser fibres supplied by LISA Laser Products may be connected to the laser device.
Products of other manufacturers and suppliers can lead to impairments of product safety and damage to
the coupling optics or instruments used.
Tab. 23: Laser fibres
Product name Description Order number
Reusable laser fibre,

FlexiFib 101 503 189
272 μm core diameter
Reusable laser fibre, Length 5 m

FlexiFib 5m 101 503 118
Single use laser fibre, sterile,

FlexiFib-SU 101 503 387

PercuFib 101 503 128

PercuFib-SU 101 503 384

RigiFib 101 503 213

RigiFib-SU 101 503 289

RigiFib 800 101 503 287

RigiFib-SU 800 101 503 385

RigiFib 1000 101 503 284

RigiFib-SU 1000 101 503 386
Gas-purged laser fibre for single use,

ColFib-SU 101 503 392
Side-emitting laser fibre for single use, 550 μm core

SideFib-SU 101 503 138
diameter
Seite 68
RevoLix DUO
Laser safety eyewear

Tab. 24: Laser safety eyewear
Laser protective eyewear, Lightweight plastic goggles,

101 503 141
goggle fits over glasses
Laser protective eyewear,

Glasses with earpieces 101 503 399
glasses
Laser protective eyewear, Glass goggles,

101 503 400
goggle fits over glasses
Additional accessories
Tab. 25: Additional accessories
One-pedal foot switch,

Kix Plug 7 pin with blue mark 101 630 147
for all RevoLix DUO SN 200 or higher
Double pedal foot switch,
Kix DUO Plug 7 pin with blue mark 101 630 144
for all RevoLix DUO SN 200 or higher
Interlock connector Door interlock dummy connector 101 630 041
Key Key for switching on the laser devices 101 660 006
Fibre coupler protective

Protective shield for fibre connection 101 630 012
shield
Potential connection cable Length 5 m 101 630 123
Seite 69
RevoLix DUO
10 Care and maintenance

Wait and check the laser device regularly. The work described below is a preventive measure to ensure
the continuous readiness of the RevoLix DUO laser device.
All maintenance should only be performed by knowledgeable and trained staff.
Laser radiation and electric current

Do not carry out any work on the laser device other than described in this
maintenance manual. Opening housing parts can provide access to voltage or
current-carrying parts as well as invisible laser radiation.
Infection risk
materials after use and present a potential source of infection.
x Clean and disinfect the laser device and its accessories before
performing any maintenance.
Visual and functional check

The following checks should be performed at regular intervals to ensure safe operation of the laser
device:
Tab. 26: Maintenance / inspection schedule
Recommended
Check
frequency
Housing parts
Housing parts, handles and doors have no sharp corners and edges or other visible damage. Monthly
The modular quick fasteners are closed and hold the modules firmly together.
Fibre holder
Monthly
The fibre holder can be pulled out easily and securely fixed by the clamping.
Power and footswitch cables
The cables and their strain reliefs have no damage. The transition points between the cable Before every use
and connector/device should be checked very thoroughly.
Parking brake and wheels
Monthly
All wheels are smooth. After pressing the parking brake, the device can no longer be moved.
Fibre coupler protective shield Upon need
The fibre coupler shield has no damage. The optical window is clean and also free from
(see chap. 10.2)
damage.
Laser stop
The laser stop is pressed in the READY operating state. The laser device responds with an Monthly
error message.
Door interlock
An error message is displayed if the door interlock switch is interrupted or the interlock dummy Monthly
plug is removed from the laser device.
Laser fibre detection
An error message is displayed if the laser device is switched from STANDBY to READY Monthly
without the laser cable connected or if the laser fibre connector is disconnected in the READY
operating state.
Display
The display in the operating panel is clearly legible and has no errors. The displayed values in Monthly
the display are plausible. The graphical and numerical display of the set values are the same.
Seite 70
RevoLix DUO
Recommended
Check
frequency
Laser power Annually or as required
See chapter 10.4. (see chapter 10.4)
Aiming beam Before any treatment or
The quality of the aiming beam at the distal tip of the laser fibre is uniform and circular. There when changing the laser
are no dark shadows, stray light or smudges visible. A slight inhomogeneous intensity
distribution is possible. fibre
Special accessories
Other accessories used in the operation of the laser device - such as smoke evacuators - Upon need
should also be checked for damage and proper functioning.
Laser protective eyewear
Monthly
The laser goggles have no scratches, cracks or damaged racks. The marking is readable.
Check and exchange of fibre coupler protection shield

The coupling optics are protected against damage and dirt by a fibre coupler protection shield (REF 101
630 012). This protective shield must be checked regularly for damage and dirt. A check is required if a
laser fibre with burnt fibre connectors has been removed from the laser device and in case of an error
message 012 "fibre connector hot". A soiled fibre coupler protection shield significantly weakens the laser
power. This means that a large part of the emitted laser power is absorbed in the protective shield and
converted into heat there. This can lead to damage of the fibre coupler or the laser fibre.
To remove the fibre coupler protective shield, the cover [1.] on the top of the laser device is raised or
pushed to the side. Now pull the locking slide [2.] out to the front. You can now pull up the fibre coupler
protection shield [3.] with the aid of pliers or tweezers on the wire bracket.
2. 1. 3.
Fig. 48: Removal of fibre coupler protection shield
To test the fibre coupler shield, hold it against the light or place it on a clean, bright surface. The optical
window must be colorless transparent and free from damage and dirt. If the optical window is damaged or
soiled, the fibre optic protection shield must be replaced.
Optical window
Fig. 49: Fibre coupler protection shield
Seite 71
RevoLix DUO
A soiled or damaged fibre coupler shield can absorb and thereby overheat laser
radiation. This can lead to a malfunction of the laser device and cause serious
damage to the coupling optics.
x Check the fibre coupler shield regularly.
x Do not operate the laser device with a dirty or damaged fibre coupler
shield.
x Never operate the laser device without a fibre optic protection shield.
Cooling liquid
The level of coolant in the laser device is automatically detected. If too little cooling liquid is present, a
corresponding message appears in the display. The laser device must not be operated without coolant. If
necessary, have the coolant filled by LISA Laser Products Customer Service.
Calibration and checking the laser power

The laser device is equipped with a control that keeps the emitted laser power constant in the laser head
and monitors it. This ensures a match of the emitted laser power with the set laser power.
The accuracy and compliance of displayed and emitted laser radiation is part of the safety check (SC),
which must be carried out at least once a year.
If you suspect that the emitted laser power is no longer the set value, then you can check this by
measuring the laser power with an external laser power meter at the distal tip of the laser fibre.
If the difference between displayed and measured power is greater than 20%, customer service should
be contacted by LISA Laser Products to recalibrate the laser device.
Please note that the measured laser power may depend on the characteristics and condition of the laser
fibre used for the measurement. By wear, damage or contamination of the laser fibre, the transmission of
radiation can be significantly reduced.
An external power meter - Power Meter PED (REF 101 503 140) - can be obtained from LISA Laser
Products.
Recurrent safety check

Every 12 months, according to a recurrent safety check (SC) should be carried out.
The exact scope of the safety inspection can be found in the test specificati
ons available on request from LISA Laser Products.
Have the recurrent safety check only made by LISA Laser Products or by a
trained and authorized LISA Laser Products Customer Service.The recurrent
safety test should be carried out by LISA Laser Products or by a trained and
authorized LISA Laser Products Customer Service
Seite 72
RevoLix DUO
Disposal of the device and the accessories

The laser device must not be disposed of with household waste. The device contains substances which
must be recycled or disposed of in accordance with statutory regulations. Clean and disinfect the laser
device and its accessories before disposal.
LISA Laser Products also offers the return of the device after decommissioning.
Hazard of Infection
materials after use. Improper disposal may cause these materials to enter the
environment and constitute a potential source of infection.
x Clean and disinfect the laser device and its accessories before disposing.
Seite 73
RevoLix DUO
11 Error diagnosis
This chapter provides information on how to deal with possible malfunctions of the RevoLix DUO laser
device. In this chapter you will also find the address of the customer service.
Error messages
During the system test and the entire operation, device checks are carried out permanently, which trigger
warnings or error messages in the event of an error. Each irregularity detected by the system processor is
displayed in clear text along with a three-digit number on the display and an instruction is given.
Please record any malfunctions in the medical device book and also inform LISA Laser Products
Customer Service. The contact details can be found in chapter
The error messages appear on the display as follows:
Message 012 (Interlock open),

F-Code F03, F21 Message Systemtest
Fig. 50: Error message during operation Fig. 51: Message during START-UP
Errors reset automatically after the error is no longer present. Subsequently, the laser device must be
released again with the ready button (READY).
If an error persists, contact LISA Laser Products. For an error message, please indicate the error
message number and the displayed text as well as the F-code (Fnn) specified in the footer.
Customer service
For technical problems with the RevoLix DUO laser devices, please contact our technical customer
service:
LISA Laser Products GmbH

Albert-Einstein-Str. 4
37191 Katlenburg-Lindau
Germany

+49 5556 9938-77
+49 5556 9938-10
| service@lisalaser.de
ß www.lisalaser.de
Seite 74
RevoLix DUO
Returned equipment
Equipment and its accessories that are returned to LISA Laser Products for maintenance or repair must
be thoroughly cleaned of any potential pathogens using suitable cleaning and disinfecting agents. If you
have any questions, please contact LISA Laser Products or your local representative.
Hazard of Infection
materials after use and present a potential source of infection.
x Clean and disinfect equipment and accessories before shipping.
Page 75
RevoLix DUO
12 Technical Data
Tab. 27: Technical Data
Technical Detail Data

Device RevoLix DUO 120/20 RevoLix DUO 150/20
Dimensions (H x W x D) approx. 1025 x 420 x 1007 mm
Weight approx. 185 kg
Noise emission approx. 67 dBA
Degree of protection (acc. IEC 60529) IP 20
Mains supply
Electrical requirements 208 - 240 V AC,
50/60 Hz,
(1~, N, PE),
max. 16 A
Mains plug Safety plug,
type CEE 7/7 (DIN 49441)
250V, 16A, grey
Power supply cord ca. 5.9 m
Power consumption max. 3.6 kVA
Main voltage limits min. 187 V
max. 264 V
Protection class (nach IEC 61140) I
Earth leakage current N.C. max. 0.5 mA @ 264 V AC (60 Hz)
Working Laser I
(Application mode TISSUE)
Type Tm:YAG DPSS laser
Laser class (acc. IEC 60825-1: 2007) 4
Emission wavelength 2013 nm ±10 nm
Power 5 - 120 W ±20 % 5 - 150 W ±20 %
Pulse duration cw / 50 - 1000 ms
Pulse repetition rate 0.5 - 10 Hz
Working Laser I
(Application mode STONE)
Type Ho:YAG laser
Laser class (acc. IEC 60825-1: 2007) 4
Emission wavelength 2123 nm ±10 nm
Power 2.5 – 20 W ±20 %
Pulse energy 0.5 – 2.6 J
Pulse repetition rate 0.5 - 15 Hz
Pulse duration 200 – 600 μs depending on the operating point
Seite 76
RevoLix DUO
Technical Detail Data

Device RevoLix DUO 120/20 RevoLix DUO 150/20
Aiming laser
Type Diode laser
Laser class (acc. IEC 60825-1: 2007) 3R
Emission wavelength 635 nm (red) or 532 nm (green)
Power max. 1 mW, adjustable
Applied part
Type (acc. IEC 60601-1) BF
Beamline Quarz – Quarz Multimode – Fibre /
(only LISA-fibres usable)
Fibre coupling FSMA LISA
Operating unit
Display LCD Display, White/blue
Controls 3 keys, 1 Setting wheel
Connections
Interlock Neutrik socket type XLR, 4-pin
Footswitch Neutrik socket type XLR, 7-pin
Cooling system Internal compressor, closed circuit
Refrigerant R 134 A
Coolant Deionized water (85 % by volume)
+ Monoethylene glycol (15 % by volume)
Environmental conditions
Operation
Ambient temperature +59° F - +82.4° F
Relative humidity 10 - 90 %, not condensating
Heat input 1.5 kW to 2.7 kW depending on the laser power setting
Storage / Transport
Ambient temperature -5° F - +158° F
Acceleration max. 25 g
Transport position upright
Page 77
RevoLix DUO
13 Index
Absorption ........................................................ 47 Condyloma excision .....................................60
Accessories ...................................................... 68 Conisation ....................................................60
Aiming beam .................................................... 17 Hysteroscopy................................................60
Aiming laser ...............................................17, 26 Incisions and excisions on the external
female genitalia .........................................60
Air flow........................................................22, 39
Laparoscopic procedures .............................60
Air inlet .......................................................22, 39
Installation ........................................................20
Air outlet .....................................................22, 39
Intensity ............................................................47
Application mode.............................................. 33
Irrigation fluid ...................................................50
Selection ....................................................... 35
Kix .............................................................. 14, 31
STONE ......................................................... 34
Kix DUO ............................................... 14, 15, 31
TISSUE ......................................................... 34
Laser area ........................................................28
Authorized users .............................................. 11
Laser area identification ...................................28
Beam exit ......................................................... 31
Laser delivery system ......................................17
Care and maintenance ..................................... 70
Laser emission indicator ..................................14
Checking the laser fibre ................................... 40
Laser fume .......................................................19
Classifications .................................................. 12
Laser Moduls ...................................................20
Cleaning ........................................................... 43
Laser parameter
Coagulative ...................................................... 48
Aiming beam brightness ...............................38
Contraindication ............................................... 11
Energy ..........................................................38
Cooling ............................................................. 22
Setting ..........................................................37
Cutting performance, reduced ......................... 52
STONE – pulsed ..........................................38
damage zone ................................................... 49
Time..............................................................38
Divergence ....................................................... 47
TISSUE - CONTINUOUS (CW) ...................38
Door interlock ................................................... 21
TISSUE - PULSED .......................................39
Ear, nose and throat-surgery ........................... 60
TISSUE - SINGLE ........................................39
Nasal polyps ................................................. 61
Laser ready indicator .......................................14
Oropharynx/Larynx tumor surgery ................ 61
Laser safety .....................................................26
Tonsillectomy................................................ 61
Laser Stop ........................................................31
Turbinate reduction....................................... 61
Laser warning lamp.............................. 14, 28, 33
EMC ................................................................. 23
Mains supply ....................................................21
Enucleation ...................................................... 54
Maximum permissible exposures ....................26
Exhaust ......................................................22, 39
Module latches .................................................20
Explanatory label .............................................. 32
Modules ...........................................................20
Fibre coupler protection shield ......................... 71
MPE .................................................................26
Fibre port .......................................................... 17
Nameplate .................................................. 30, 31
Fibre selection .................................................. 17
NOHD...............................................................26
Foot switch ....................................................... 40
Operating mode
Footswitch ..................................................31, 33
Selection .......................................................35
Gynecology ...................................................... 59
Page 78
RevoLix DUO
Operating panel ..........................................10, 14 Smoke evacuation ...........................................19

Operational ambient temperature .................... 22 Software version ................................................ 7
Operational mode Spinal surgery
CONTINUOUS (CW) .................................... 34 PLDD ............................................................62
PULSED ....................................................... 34 Spinal surgery ..................................................62
SINGLE ........................................................ 35 Switch-off routine .............................................43
Operational state Switch-on routine .............................................40
READY ......................................................... 33 Symbols ...........................................................30
Operational state Temperature .............................................. 22, 25
STANDBY ..................................................... 33 Tissue interaction .............................................48
Operational state Transporting and storing ..................................25
EMISSION .................................................... 33 Treatment parameters .....................................49
Operational states ............................................ 33 Urology
Orthopedics ...................................................... 62 Ablation of bladder tumors ...........................57
Outgoing air ................................................22, 39 Bladder neck incision ...................................57
Penetration depth ............................................. 47 Blunt enucleation of the prostate ..................54
Pneumology ..................................................... 61 Condyloma and penile tumor excision .........59
Treatment of bronchial and tracheal Holmium pulsed laser ...................................59
obstructions ............................................... 62
Opening of urethral strictures .......................56
Prostate ..........................................53, 54, 55, 56
Partial nephrectomy .....................................58
Re-processing of accessories .......................... 44
Thulium CW laser .........................................52
Resection ......................................................... 53
VapoEnucleation of the prostate ..................54
Safety check ..................................................... 72
VapoResection of the prostate .....................53
SC .................................................................... 72
Vaporization of the prostate ................... 55, 56
Scattering of the aiming beam ......................... 52
Vaporization of urothelial carcinoma ............57
Scope of delivery................................................ 9
Vaporization .....................................................48
Side effects ...................................................... 11
Ventilation outlet ........................................ 22, 39
Signal words ....................................................... 7
Page 79
RevoLix DUO
14 List of Figures
Fig. 1: Front view ......................................................................................................................................... 12
Fig. 2: Front view with open hatch .............................................................................................................. 13
Fig. 3: Rear view ......................................................................................................................................... 13
Fig. 4: Single-pedal footswitch Kix .............................................................................................................. 14
Fig. 5: Double-pedal footswitch Kix DUO.................................................................................................... 14
Fig. 6: Operating panel................................................................................................................................ 14
Fig. 7: Menu with single-pedal footswitch Kix ............................................................................................. 15
Fig. 8: Menu with double-pedal footswitch Kix DUO ................................................................................... 15
Fig. 9: Status display (Section from the display) ......................................................................................... 16
Fig. 10: Fibre holder .................................................................................................................................... 18
Fig. 11: Foot brake ...................................................................................................................................... 19
Fig. 12: Schematic diagram showing the modules of the RevoLix DUO laser device ................................ 20
Fig. 13: Ventilation outlets ........................................................................................................................... 22
Fig. 14: Warning Sign (hazard symbol) for the identifcation of entrance doors of laser areas ................... 29
Fig. 15: Nameplate laser device (Example - RevoLix DUO 150/20) .......................................................... 30
Fig. 16: Nameplate footswitch (Example – Kix) .......................................................................................... 31
Fig. 17: Laser warning label ........................................................................................................................ 31
Fig. 18: Aperture label ................................................................................................................................. 31
Fig. 19: Laser stop ...................................................................................................................................... 31
Fig. 20: Laser radiation characteristics (Example RevoLix DUO 150/20 with green aiming beam) ........... 32
Fig. 21: Laser class ..................................................................................................................................... 32
Fig. 22: Position of warning signs and labels front side .............................................................................. 32
Fig. 23: Position of warning signs and labels back side ............................................................................. 32
Fig. 24: Menu structure ............................................................................................................................... 33
Fig. 25: Application mode TISSUE ............................................................................................................. 34
Fig. 26: Application mode STONE .............................................................................................................. 34
Fig. 27: Example – Operating mode CONTINUOUS (CW) ........................................................................ 35
Fig. 28: Example – Operating mode PULSED ............................................................................................ 35
Fig. 29: Example – Operating mode CONTINUOUS (CW) ........................................................................ 35
Fig. 30: Selection of the operating mode .................................................................................................... 36
Fig. 31: Example – Operating mode CONTINUOUS .................................................................................. 36
Fig. 32: Example – Operating mode PULSED ............................................................................................ 36
Fig. 33: Double-pedal footswitch Kix DUO.................................................................................................. 36
Fig. 34: Operating modes with double-pedal footswitch ............................................................................. 36
Fig. 35: Example - CONTINUOUS (CW) mode for left foot pedal, CONTINUOUS (CW) for right
foot pedal ..................................................................................................................................... 37
Fig. 36: Example - CONTINUOUS (CW) mode for left foot pedal, PULSED for right foot pedal ............... 37
Fig. 37: Select button for the laser parameters ........................................................................................... 37
Page 80
RevoLix DUO
Fig. 38: Adjusting wheel for the laser parameters ...................................................................................... 37

Fig. 39: Numerical / graphical display of laser parameters ......................................................................... 37
Fig. 40: Startup screen ................................................................................................................................ 40
Fig. 41: Connecting the laser fibre .............................................................................................................. 41
Fig. 42: Change to the READY operating state .......................................................................................... 41
Fig. 43: Active laser warning lamp .............................................................................................................. 41
Fig. 44: Left laser parameters and left foot pedal active ............................................................................. 42
Fig. 45: Right laser parameters and right foot pedal active ........................................................................ 42
Fig. 46: Absorption spectrum of water with laser wavelengths ................................................................... 47
Fig. 47: Tissue effect as a function of absorbed power density .................................................................. 48
Fig. 48: Removal of fibre coupler protection shield ..................................................................................... 71
Fig. 49: Fibre coupler protection shield ....................................................................................................... 71
Fig. 50: Error message during operation .................................................................................................... 74
Fig. 51: Message during START-UP .......................................................................................................... 74
Page 81
RevoLix DUO
15 List of Tables
Tab. 1: Regular scope of delivery ................................................................................................................. 9
Tab. 2: Specifications of different models of the RevoLix DUO laser devices........................................... 10
Tab. 3: Classifications ................................................................................................................................. 12
Tab. 4: Name and meaning of the display elements .................................................................................. 15
Tab. 5: Visual and audible signals .............................................................................................................. 16
Tab. 6: Requirements for the mains supply ................................................................................................ 21
Tab. 7: Cable lengths of accessories .......................................................................................................... 23
Tab. 8: Conformity of electromagnetic immunity ........................................................................................ 24
Tab. 9: Conformity of electromagnetic emission ......................................................................................... 25
Tab. 10: Electrosurgical disturbances ......................................................................................................... 25
Tab. 11: Calculation of the NOHD for continuous wave laser radiation of the RevoLix DUO
150/20 laser devices .................................................................................................................... 26
Tab. 12: Calculation of the NOHD for pulsed laser radiation of the RevoLix DUO 150/20 laser
devices ......................................................................................................................................... 27
Tab. 13: Safety eyewear – Minimum protection level for the RevoLix DUO laser devices ........................ 28
Tab. 14: Marking example of laser safety eyewear .................................................................................... 28
Tab. 15: Symbols on the outside of the laser device .................................................................................. 30
Tab. 16: Nameplate symbols ...................................................................................................................... 30
Tab. 17: Symbols on the nameplate of the footswitch ................................................................................ 31
Tab. 18: Application modes ........................................................................................................................ 33
Tab. 19: Adjustment ranges and step widths of the available models of the RevoLix DUO laser
device .......................................................................................................................................... 38
Tab. 20: Treatment parameters .................................................................................................................. 49
Tab. 21: Applications and settings for application mode TISSUE .............................................................. 63
Tab. 22: Applications and settings for application mode STONE ............................................................... 66
Tab. 23: Laser fibres ................................................................................................................................... 68
Tab. 24: Laser safety eyewear .................................................................................................................... 69
Tab. 25: Additional accessories .................................................................................................................. 69
Tab. 26: Maintenance / inspection schedule............................................................................................... 70
Tab. 27: Technical Data .............................................................................................................................. 76
Page 82
LISA Laser Products GmbH
Albert-Einstein-Str. 4
37191 Katlenburg-Lindau
Germany
+49 5556 9938-0

+49 5556 9938-10
| info@lisalaser.de
ß www.lisalaser.de

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Instructions for use

RevoLix DUO 120/20

Federal law restricts this device to sale by or on the order of a physician.

Edition: 035 008 100

Effective from: 2019-03-21

1 About these instructions for use ................................................................................................. 7

3 Product description ..................................................................................................................... 10

4 Installation of the laser device ................................................................................................... 20

Electrosurgical disturbances ........................................................................................................ 25

5 Laser safety .................................................................................................................................. 26

6 Labelling of the device ................................................................................................................ 30

7 Operation of the laser device ..................................................................................................... 33

Checking the laser fibre ............................................................................................................... 40

8 Clinical applications .................................................................................................................... 45

Treatment of bronchial and tracheal obstructions ....................................................................... 62

10 Care and maintenance ................................................................................................................ 70

11 Error diagnosis ............................................................................................................................ 74

12 Technical Data ............................................................................................................................. 76

14 List of Figures .............................................................................................................................. 80

15 List of Tables ................................................................................................................................ 82

1 About these instructions for use

Signal words in these instructions for use

Indicates a hazardous situation which if not avoided could result in death or

Indicates imminent material damage

Provides recommendations, information and advice for efficient use.

Safety and protective measures

Flammable materials and gases

Providing a wrong application mode due to a malfunction of the laser

A modification of the constructional or functional characteristics of the

The laser device must not be disposed of with household waste.

Tab. 1: Regular scope of delivery

Quantity Included items

1 RevoLix DUO laser device

1 Door interlock dummy connector (REF 101 630 041)

1 Instructions for use

2 Keys (REF 101 660 006)

Single-pedal footswitch “Kix” (REF 101 630 147)

Identification of the model

Tab. 2: Specifications of different models of the RevoLix DUO laser devices

Model RevoLix DUO 120/20 RevoLix DUO 150/20

Thulium continuous wave laser

Wavelength 2013 ±10 nm 2013 ±10 nm

Power 5 - 120 W 5 - 150 W

Pulse duration 50 - 1000 ms 50 - 1000 ms

Wavelength 2123 ±10 nm 2123 ±10 nm

Power 2.5 - 20 W 2.5 - 20 W

Pulse energy 0.5 – 2.6 J 0.5 – 2.6 J

Repetition rate 0.5 - 15 Hz 0.5 - 15 Hz

Expected service life

Operating and display elements

Fig. 1: Front view

Storage compartment for the

Fig. 2: Front view with open hatch

Service hatch Key switch

Fig. 3: Rear view

Foot pedal Left foot pedal Right foot pedal

Fig. 4: Single-pedal footswitch Kix Fig. 5: Double-pedal footswitch Kix DUO

Fig. 6: Operating panel