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ENT, Surgery, Aesthetics Application manual for the C-LAS laser wavelength 10,600 nm
ENT, Surgery, Aesthetics
Application manual for the C-LAS laser
wavelength 10,600 nm
WARNING
For your own safety follow all
guidelines for handling the equipment
and follow the safety instructions in
this manual.
© 2010 A .R.C . Laser GmbH all rights reserved. Names other here named carrier companies or products are trademarks theirs respective holder of rights.Every endeavour has been made at guarantee, that all performed informations are accurate in this manual. A .R.C . Laser assume yet no warranty for the trueness of the content in this handbook.July 2010
Bessemerstr. 1490411 Nürnbergphone:+49.911.21779-0 fax: [email protected]
CONTENT
1) Laser safety...................................................................4
Safety instructions........................................................5
2) Basics of laser application.................................................6
3) Application.....................................................................8
Indications / Contraindications........................................8
Technique....................................................................8
Alternative application in aesthetics and ENT...................9
Waveguide system......................................................10
Assembling................................................................11
Pre-treatment tests.....................................................12
Post treatment care.....................................................12
Methods in case of unwanted effects..............................12
Behavior in case of a system error.................................13
Treatment related issues..............................................13
Treatment parameters.................................................13
Delivery system .....................................................14
Applications............................................................16
Page 3 of 20
1) Laser safety
Laser radiation emitted by the C-LAS laser can cause severe damage to the
patient as well as to the user and third persons accompanying the laser use.
The C-LAS laser is classified in the laser class IV. This means that the radi-
ation can cause damage when it is directly applied to any tissue and also if
the radiation is scattered or reflected.
The C-LAS laser radiation is intense and efficient to evaporate and cut tissue.
The most serious injuries occur, when laser radiation is exposed to the eye.
Even low laser power is able to damage the cornea of the eye, which is not re-
versible. This may cause permanent loss of vision. The danger to the eye de-
pends on the wavelength of the radiation and on the dose (energy density per
time).
Laser radiation in the wavelength range between 400 and 1400 nm is the
most dangerous for the eye. It penetrates through the aqueous cornea, the
anterior chamber, the lens and the posterior chamber and reaches the retina
with only little or nearly no absorption.
Laser radiation in the wavelength range between 400 and 1400 nm is most
dangerous for the eye. The cornea as well as the anterior chamber, the lens
and the vitreous body of the eye contain mainly water. The other tissue com-
ponents (mainly collagen) play a minor role for the laser tissue interaction.
Between 400 and 1400 nm wavelength water has very low absorption. There-
fore the laser radiation is transmitted very well and nearly the full power
reaches the retina, where it is absorbed by the blood and the retinal pigment
ephithelium.
The C-LAS laser emits infrared laser radiation, therefore it is absolutely neces-
sary to wear eye safety goggles when using the C-LAS laser system. With its
intensity (e.g. focused beam), the C-LAS laser radiation can also do harm to
skin or other tissue. The radiation can radiation up inflammable material.
Page 4 of 20
Water absorption
Safety instructions
To avoid any injuries it is important to follow the laser safety
instructions:
1. Any user of the C-LAS laser system has to be trained by A.R.C. Laser au-
thorized personal or by someone trained by A.R.C. Laser authorized per-
sonal.
2. The room / the area, where the laser system is used has to be signed with
the laser warning symbols in a way that everyone can easily see that there
is a laser area, which should not be entered without the adequate protec-
tion while the laser is in use.
3. Do not use the system whenever you are not sure that every component
works in the dedicated way. Keep an eye on the fiber delivery: The spot
shown by the aiming beam should always be round and defined, no scat-
tering should occur. You may test this by using a radiation paper and hold-
ing a bare fiber end in a distance of about 5 cm (you have to put the laser
on Ready mode / laser safety goggles!)
4. Whenever the laser is on Ready mode (yellow
radiation on) every person within the area
where radiation from the laser can occur (laser
treatment area/ laser room) has to wear a
laser safety goggle which is suitable to protect
the eyes from C-LAS laser radiation.
5. The laser has to be used only for the defined application; never irradiate
any other material / tissue beside the intended use.
6. Special care should be taken to avoid irradiating reflecting materials. Re-
flected laser radiation can cause the same harm as direct application.
7. Switch off the Ready mode of the laser when the laser is not in use; e.g.
during operation breaks or at the end of the surgery.
Page 5 of 20
Ready-LEDs
2) Basics of laser application
The intended effect of the laser application is based on the interaction of the
radiation with the tissue components. The laser radiation is absorbed,
scattered or reflected by the tissue. Air has only little influence on the C-LAS
radiation and therefore the interaction between air and the C-LAS radiation
can be neglected. Reflection plays a major role with metal, glass and other re-
flecting surfaces.
When we apply the C-LAS radiation to tissue the reflection is not dominant.
Nevertheless it is not zero! When the radiation is scattered in the tissue, it
does not influence the absorption. Absorption is mainly responsible for the ef-
ficiency of the laser radiation. Absorption means that the C-LAS laser radiation
is converted mainly into heat, which causes the desired effects (coagulation/
vaporisation).
With low energy density (big laser spot or low power) the heat which is
achieved in the tissue can cause heating of the tissue. The smaller the spot
size is, or the higher the power is set, the warmer it gets. There is a limit,
when the tissue does no longer tolerate the heating, tissue proteins denatur-
ate, coagulation occurs. The next limit is achieved when tissue water (intra-
and extracellular water) suddenly evaporates (> 300°C). Tissue is fragmented
and destroyed. Cutting/ evaporation is achieved.
Temperature effect
Temperature Effect
> 40° C
45° – 65° C
> 65° C
> 100° C
> 150° C
> 300° C
some 1000° C
enzyme induction, membrane disaggregation, edema
tissue damage, reversible or irreversible, dependent on
the irradiation time
coagulation
dehydration
carbonisation
vaporization, ablation (removal of tissue)
ionisation, immediate burn (shock wave formation)
Tissue cutting always needs high energy densities (high power or small spot
size). At the cutting edges, respectively beside the evaporation zones the tis-
sue is always affected by the heat (coagulation). The positive effect and ad-
vantage of the laser use is that this can stop bleeding from cut vessels (hae-
mostasis). The negative effect is caused directly at the cutting edge where
more than 150°C occur. There is a development of carbonization, created by
burned carbon, which is toxic and prolongs the healing of the wound.
Page 6 of 20
To avoid extended collateral damage (carbonisation and coagulation) at the
cutting edges the application mode of the laser can be modified to a pulsed
mode, which causes less damage.
In continuous mode the laser permanently emits radiation. In pulse mode the
tissue can cool down between each laser pulse and therefore the side effects
of the heating can be reduced.
Page 7 of 20
3) Application
Indications / Contraindications
Surgery
indications contraindications
· vaporisation / ablation / cutting of soft tissue
· coagulation of blood· coagulation / denaturation of colla-
gen / tissue· excision of tissue (e. g. tumors)
· hard tissue treatment (bone, ...)
· application of the beam next to tem-
perature sensitive areas (e. g.
nerves in neurosurgery)
Technique
The C-LAS laser is available with two different de-
livery systems, the articulated arm and the flex-
ible waveguide. For the articulated arm two differ-
ent hand pieces are available, with 3 and 5 inch
focal distance.
The most common use in ENT is with a microma-
nipulator on the microscope. The micromanipulat-
or is mounted underneath the microscope and
guides the beam to the desired treatment area.
The micromanipulator is mounted via a footplate
which fits to the microscope.
Page 8 of 20
5 inch hand piece
A similar system is preferably
used in gynaecology, where the
C-LAS (only with articulated
arm) is connected to the colpo-
scope.
Alternative application in aesthetics and ENT
The C-LAS laser is available with two different delivery systems, the articu-
lated arm and the flexible waveguide.
Furthermore, there is a scanner available that can be combined with the
waveguide optics for ENT applications and is delivered with the articulated
arm for dermatology and aesthetics applications.
If the scanner is set out in front of the micromanipulator in the beam and dir-
ects the beam in accordance with its programming on the treatment area in
the desired form and sequence.
Page 9 of 20
Waveguide System
The waveguide is more flexible than the
articulated arm, but is limited in power.
In continuous emission mode, the wave-
guide should not be used with more than
18 Watt. In case of small bending radius
of the waveguide this should even be re-
duced to a lower value, as the transmis-
sion in the waveguide drops the smaller
the bending radius is. The lower the
transmission is, the higher the absorption
gets in the waveguide and this can cause
damage to the inner lumen of the wave-
guide transmitting the radiation. As a res-
ult of this, the absorption will rise immedi-
ately at the damaged area and this leads
to a destruction of the fiber delivery
IMPORTANT : The waveguide does not
transmit red aiming beam radiation. With
the UHP hand piece no aiming beam is
available.
To use the C-Las with waveguide, either
hand pieces or an adapter or scanner
hand piece are necessary to be connected
to the waveguide optic. Direct application is possible via a radiation and small
hand piece.
The Universal Hand Piece (UHP) system consists of a metall holding hand
piece (BG01268) and inserts (ME02264) to deliver the CO2 laser radiation.
All components are autoclavable, 134°C. It is only important to achieve a dry
inner lumen of the components before use.
Page 10 of 20
This means, that the user has to make sure that after the sterilization pro-
cess there is enough time for the parts to dry out or actively dry the material.
In case of water inside the insert, which may also result from water in the
UHP while positioning the insert, the CO2 laser radiation may be blocked. Be
careful handling the insert, the ceramic material is breaking easily.
Assembling:
To connect the inserts and the UHP the screw-tip of the UHP has to be opened
by one or two turns; do not remove the tip from the hand piece. The insert
can then be inserted. Do not press, but place the insert into the UHP up to the
end position where it stops. After assembling the UHP it can be connected to
the waveguide of the laser by the SMA connector.
An alternative to the UHP is the focusing
hand piece (BG01249), which can be dir-
ectly connected to the waveguide.
This hand piece acts in the same way as
the focusing hand pieces with the articu-
lated arm. It focuses the laser beam to a small spot size to cut. On the other
side, it is also possible to coagulate, when the hand piece distance to the
treatment area is enlarged and therefore the beam size is larger than in the
focal plane. This method is called defocusing; the result is a smaller power/
energy density and this leads to coagulation instead of cutting.
Note: This hand piece delivers an aiming beam!
Page 11 of 20
Pre-treatment tests
The C-LAS laser does an automatic internal testing on the power output be-
fore the device can be used. Keep an eye on the system components. Espe-
cially take a look on the waveguide (waveguide version) and hand pieces: the
spot shown by the aiming beam should always be round and defined, no scat-
tering should occur (waveguide version only with focusing hand piece). You
may test this, by using a radiation paper and watching the aiming beam pic-
ture. When doing this, be aware to wear safety googles.
Post treatment care
Postoperatively, no special care has to be taken regarding the laser treatment.
The advantage of the laser treatment is, that in case of surgery the haemo-
stasis effect of the laser treatment is very beneficial for the patient.
Conventional care, comparable to standard wound care which would be ap-
plied in case of scalpel use and cauterization is advised.
Attention:
Sutures, which are used to close wounds after surgery have to stay longer
than in case of conventional surgery without laser! The haemostasis effect of
the laser treatment sradiationly prolongs the wound healing and therefore su-
tures have to be removed 3 – 5 days later than normal.
Methods in case of unwanted effects
The application of laser radiation can cause vaporization of the tissue, which
results in tissue fragmentation (cutting): the depth of a cut might get too
deep, if the surgeon applies laser radiation at the same position for a too long
time. If this happens the wound has to be closed conventionally to the desired
amount (suture, etc.).
Second, the laser radiation causes haemostasis and the tissue gets coagu-
lated. The amount of irreversible damaged tissue depends on the time and
extend of the coagulation. Coagulated tissue is not harmful and does normally
not cause any problems.
In case of overheating of temperature sensitive areas (e.g. skin) intensive
cooling is advised.
In case of a big laser spot: When the surgeon has delivered too much energy
to the treatment area, the effect is comparable with a burn. Clinical proced-
ures should follow the guidelines for curing burns.
Page 12 of 20
Behavior in case of a system error
In case of any failure in the power generation of the laser, the power which is
delivered to the patient decreases. Overpower cannot occur, as the current for
the laser tube is limited. Less power than expected results in less effect.
When this occurs, the user can check for the beam delivery first and then for
the laser. Any damage to the delivery system results in a decrease of the
power. A broken waveguide can show a color change at the outside of the
waveguide as a result of the heat generated by absorption on the inside. A
disalignment in the articulated arm leads to an aiming beam delivery which is
non more centered at the end of the arm (note: already small changes not
clearly visible can lead to a decrease in power). The user should not continue
the use of the laser and contact his local A.R.C. Laser representative.
When he checks the laser a restart results in a new check of the system at the
beginning. When the laser measures to low or to high power, the system does
not start. Any error message displayed by the system can be checked in the
manual. In case of any insecurity or questions please contact your local A.R.C.
Laser representative.
Treatment related issues
Discomfort from the heating which is generated by the laser may occur. To
avoid this, the user should follow the application parameter guidelines and
avoid too long application times. If possible, cooling can reduce patients dis-
comfort after the treatment. All personal, including the patient have to wear
eye protection goggles, this may lead to de-
creased vision regarding contrast and color by
the personal and surgeon.
In case of any eye injury due to disregard of the
eye protection by safety goggles, a clinical cen-
ter specialized on eye care has to be consulted.
Page 13 of 20
Treatment parameters
Treatment parameters shown in this manual can only be an advice. The data
is based on average values generated by our multiple C-Las users.
Continuous mode causes more haemostasis and more extended collateral
damage (higher effective power, faster, more efficient cutting), pulsed mode
reduces collateral damage (less effective power, slower, less efficient cutting).
When using pulse mode, the effective power is half of the power in continuous
mode (50/50 ratio, on-off). The smaller the beam diameter is, the faster the
cutting and the deeper the cut will be.
Delivery system:
Waveguide optics (WG)
Hand piece [HP] / Micromanipulator
Power [W]
Frequency [Hz] Treatment
UHP 3 - 12 cw cut
UHP 4 - 15 500 cut
Focusing HP 2 - 10 cw In focus: cutdefocus: coagulation
Focusing HP 4 - 12 500In focus: cut
defocus: coagulation(better: cw mode!)
Adapter and Micromanipulator 2 - 8 cw In focus: cut
defocus: coagulation
Adapter and Micromanipulator 3 - 10 500
In focus: cutdefocus: coagulation(better: cw mode!)
Page 14 of 20
Articulated arm (AA)
Hand piece [HP] / Micromanipulator
Power [W]
Frequency [Hz]
Treatment
Fokussier-HS 2 - 30 cw In focus: cutdefocus: coagulation
Fokussier-HS 4 - 30 500 In focus: cutdefocus: coagulation(better: cw mode!)
Micromanipulator 2 - 15 cw In focus: cutdefocus: coagulation
Micromanipulator 3 - 20 500In focus: cut
defocus: coagulation(better: cw mode!)
Page 15 of 20
Applications
ENT: Cutting and removal/ Vaporization:
Laser settings for ENT
Delivery system + hand piece
Power [W]
Program-Nr.
Frequency [Hz]
Laser modeTreatment
WG + Scanner 5, P1 SCAN Cut with spot beam and max. 14 seconds
WG + Scanner 13, P10 SCAN Removal / vaporizing, dura-tion 2.2 seconds
WG + Scanner 13, P11 SCAN Removal / vaporizing, dura-tion 2.2 seconds
Stapedotomy: waveguides Optics + Scanner:
Laser settings for stapedotomy
Delivery system + hand piece
Power Program-Nr.
Frequency [Hz]
LasermodeTreatment
WG + Scanner 20, P2 SCAN Stapedotomy 0,3 mm ∅
WG + Scanner 20, P3 SCAN Stapedotomy 0,4 mm ∅
WG + Scanner 20, P4 SCAN Stapedotomy 0,5 mm ∅
WG + Scanner 20, P5 SCAN Stapedotomy 0,6 mm ∅
WG + Scanner 20, P6 SCAN Stapedotomy 0,7 mm ∅
WG + Scanner 20, P7 SCAN Stapedotomy 0,8 mm ∅
WG + Scanner 20, P8 SCAN Stapedotomy 0,9 mm ∅
WG + Scanner 20, P12 SCAN Stapes-supra struktur
Page 16 of 20
Gynecology: Articulated arm + colposcope:
Laser settings for gynaecology
Hand piece Power(Watt)
Frequency(Hz) Treatment
colposcope 8 - 30 CW In focus: cutdefocus: coagulation
Page 17 of 20
Aesthetic/ skin treatments: Articulated arm (AA) or waveguide (WG) +
scanner:
Laser settings for aesthetic/ skin treatments
Delivery system + hand piece
Power [W]
Program-Nr.
Frequency [Hz]
LasermodeTreatment
AA + Scanner 25, P1 SCAN Lesions removal,Fast removal
AA + Scanner 25, P2 SCAN Lesions removal,Fast removal
AA + Scanner 25, P3 SCAN Small Hypertrophic Grain re-moval
AA + Scanner 15, P4 SCANHypertrophic grain removal
with more Haemostasis/ heat
AA + Scanner 20, P5 SCAN Wrinkles of eyelids
AA + Scanner 25, P6 SCAN Skin Resurfacing Facial
AA + Scanner 20, P7 SCAN Grain removal , Facial
AA + Scanner 20, P8 SCAN Perioral wrinkle smoothing
AA + Scanner 25, P9 SCAN Fraxel weak
AA + Scanner 25, P10 SCAN Fraxel middle
AA + Scanner 25, P11 SCAN Fraxel stronge
Page 18 of 20
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