25 Laser Holmiun Lisa Sphinx
25 Laser Holmiun Lisa Sphinx
25 Laser Holmiun Lisa Sphinx
laser products
User Manual
Holmium laser
Sphinx
Manufacturer:
LISA laser products OHG,
Max-Planck-Str. 1
37191 Katlenburg-Lindau
Germany
Fon: +49-(0)5556-9938-0
Fax: +49-(0)5556-9938-10
Email: info@lisalaser.de
web: www.lisalaser.de
LISA laser products OHG, Max-Planck-Straße 1, 37191 Katlenburg, Germany, Fon +49 (0)5556-9938-0, Fax +49 (0)5556-9938-10
GA035006112SphinxE11V02.doc
gültig ab / effective from: 25.10.2010
Sphinx
Contents
0 About this manual..........................................................................................................................................0-1
0.1 Safety instructions and symbols used in this manual ............................................................................0-1
0.2 General safety instruction ......................................................................................................................0-2
1 Delivery..........................................................................................................................................................1-1
1.1 Regular scope of delivery.......................................................................................................................1-1
2 Product description........................................................................................................................................2-1
2.1 Identification of the model ......................................................................................................................2-2
2.2 General description ................................................................................................................................2-2
2.3 Intended use...........................................................................................................................................2-2
2.4 Contraindications ...................................................................................................................................2-2
2.5 Side effects.............................................................................................................................................2-3
2.6 Authorized Users....................................................................................................................................2-3
2.7 Classification ..........................................................................................................................................2-3
2.8 Overview ................................................................................................................................................2-4
2.8.1 Front view........................................................................................................................................2-4
2.8.2 Rear view ........................................................................................................................................2-5
2.9 Basic physico-technical principles .........................................................................................................2-6
2.10 Basic physico-medical principles........................................................................................................2-6
2.10.1 Tissue interaction............................................................................................................................2-6
2.10.2 Irrigation liquid.................................................................................................................................2-6
2.11 Fibre selection ....................................................................................................................................2-7
3 Installation of the laser device .......................................................................................................................3-1
3.1 General remarks ....................................................................................................................................3-2
3.1.1 Unpacking .......................................................................................................................................3-2
3.1.2 Before first use................................................................................................................................3-2
3.2 Electrical installation...............................................................................................................................3-2
3.2.1 Power requirements........................................................................................................................3-2
3.3 Connecting a door interlock ...................................................................................................................3-3
3.4 Medical devices book.............................................................................................................................3-4
3.5 Environmental conditions .......................................................................................................................3-4
3.5.1 Transportation and storage of the laser device ..............................................................................3-4
3.5.2 Operation conditions .......................................................................................................................3-4
3.6 Cooling ...................................................................................................................................................3-4
3.7 Electromagnetic compatibility (EMC) .....................................................................................................3-5
3.7.1 Guidance and manufacturer’s declaration - electromagnetic emissions ........................................3-5
3.7.2 Guidance and manufacturer’s declaration - electromagnetic immunity..........................................3-6
3.7.3 Guidance and manufacturer’s declaration - electromagnetic immunity for equipment and systems
that are not life-supporting.............................................................................................................................3-7
3.7.4 Recommended separation distances between portable and mobile RF communications equipment
and devices that are not life-supporting ........................................................................................................3-8
3.7.5 List of cables and their length .........................................................................................................3-8
4 Laser safety ...................................................................................................................................................4-1
4.1 General information................................................................................................................................4-2
4.2 Laser safety officer.................................................................................................................................4-3
4.3 Laser area ..............................................................................................................................................4-3
4.4 NOHD, Nominal Ocular Hazardous Distance ........................................................................................4-3
4.5 Required eye protection .........................................................................................................................4-4
4.5.1 Eye protection markings for USA (ANSI Z136.1)............................................................................4-4
4.5.2 Eye protection markings for European Union (EN 207) .................................................................4-4
Risk of injury! This instruction concerns the safety of patients, operators and other
persons. Disregarding this instruction may result in an injury to the patient or operator.
DANGER
In this manual the following symbol is used to warn of the risk of injury from laser
radiation. This instruction concerns the safety of patients, operators and other persons
who are in the room where the laser is operated.
DANGER
Danger of operational fault! Failure to follow this instruction can lead to damage to the
laser system, the applicator or the laser fibre.
WARNING
The Sphinx laser system is intended solely for medical professionals trained in the use of
the laser system.
WARNING
Observe the specific national laws and regulations on operation and safety of laser
equipment.
DANGER
Inspect laser system for damage on housing or cables. Do not use defective laser device.
DANGER
The device must stand in upright position during operation, storage and transport.
Do not turn the laser device upside down.
WARNING Do not lay the laser device down on one of the sides.
Never open the protective covers of the laser, as opening the protective covers will give
access to high voltage/current components and laser radiation.
DANGER Only LISA laser products approved service technicians should open the laser device.
The storage or transport ambient temperature should be between -15 °C to 70 °C, the
relative humidity 10% to 90% (none condensing) and the air pressure 700 hPa to
1060 hPa.
The operational ambient temperature should be between 15 °C to 28 °C, the relative
WARNING humidity 10% to 90% (none condensing) and the air pressure 700 hPa to 1060 hPa.
Severe jolts or vibration can cause severe damage to the system!
Installation and Service of the device should only be performed by trained experts and
based on this manual
WARNING
For the disposal of the instrument no special procedure has to be followed. Be aware of
NOTICE local regulations. Please contact your local representative for questions. LISA laser offers
to re-cycle the device at its end-of-life
1 Delivery
The regular scope of delivery of the Sphinx includes at least the following items:
1 User manual
2 Product description
This section provides important information about the device. The section contains a general description
of the Sphinx laser, its intended use and authorized users, the contraindications and side effects. You will
learn how to identify your specific model and get information about the device classification.
The basic physico-technical and physico-medical aspects of laser tissue interaction are explained.
You will find information about the laser fibres that are approved for the Sphinx in the section 2.11 ”Fibre
selection” and the fibre manual.
Content
Sphinx 30 Sphinx 45
Sphinx 60 Sphinx 80 Sphinx 100
litho litho
Wavelength 2120 ± 3 nm
Energy 0.5 – 4.0 J 0.5 – 4.0 J 0.5 – 4.5 J 0.5 – 4.5 J 0.5 – 4.5 J
Repetition rate single pulse; single pulse; single pulse; single pulse; single pulse;
4 – 20 Hz 4 – 30 Hz 4 – 30 Hz 4 – 30 Hz 4 – 30 Hz
2.4 Contraindications
Contraindications, related directly to the Sphinx are not known. The contraindications of surgical or
endoscopic laser procedures meet the common ones for classical surgeries like:
General inability to receive surgical or endoscopic procedures, pregnancy, sepsis, anticoagulation or
bleeding disorders are contraindications to use the laser device.
The medical professional should decide on the laser usage depending on the patient’s situation.
2.7 Classification
The Sphinx laser systems belong to the following classifications/nomenclatures:
Medical product class according to MDD 93/42/EEC (Medical Device Directive) Class IIb
Medical Device Class according to Title 21 of CFR, Parts 862-892 Class II
Medical product nomenclature according to UMDNS 17-769
Laser class according to IEC 60825 Class 4
Laser classification US FDA CDRH (21CFR1040.10) (working laser) Class IV
Laser class according to IEC 60825 (pilot laser) Class 2
Laser classification US FDA CDRH (21CFR1040.10) (pilot laser) Class II
Protection class according to IEC 60601 Class I
Protection group according to EN 60529 IP22
The Sphinx laser system complies with the ”Essential Requirements of the European Medical Devices
Directive 93/42/EEC”.
Observe the applicable guidelines of your employer’s liability insurance association and equal ranking
organizations. The responsibilities, relevant safety measures and personal protective gear are described
in these regulations.
Observe the specific national laws and regulations on operation and safety of medical devices
and laser equipment.
The documents referred to and this manual must be read carefully before operating the laser
system.
The installation of a laser system must be according to the instructions given in this manual.
2.8 Overview
Fibre holder
(extended)
Fibre connection
(beam outlet)
Operating panel
Laser Stop
Fixing brake
Receptable for
Footswitch
Connection for
door interlock
Key switch
Computer
interface
Power cord
Any medically approved water-based irrigation liquid may be used. It does not matter whether the
aqueous medium is a Glycine or Sodium Chloride solution. Both media will provide very similar
absorption and cooling characteristics. In contrast with HF surgery, the conductivity of the irrigation liquid
has no effect upon the operation of the laser.
When used with the laser the irrigation liquid assumes the following functions:
1. efficient removal of the heat generated by the laser.
2. the irrigation fluid limits the effective zone to the vapour bubble, which builds up in front of the
fibre tip during the laser pulse.
Refer to the particular user manual of the laser fibres for more information about the safe
use of the fibres.
WARNUNG
Only use laser fibres, which are suitable for the respective laser system.
Observe the minimum bending radius of the laser fibre.
Content
Installation, Operation and Service of the device should only be performed by trained
experts and based on this manual.
WARNING
3.1.1 Unpacking
The devices are usually shipped in a wooden transport crate. To avoid damages to the system, the
unpacking should be done only by a LISA laser products service representative. Before operation remove
all packaging material and transport cushions from the system.
The keys and the door interlock dummy connector are packed separately.
For the specific scope of delivery refer to the shipping documents.
Inspect laser system for damage on housing or cables. Do not use the device if it appears
to be damaged.
WARNING
Sphinx 30 litho
Plug type Schuko plug Type CEE7/7, 250V, 16 A, IP44 (acc. DIN 49441)
Plug type CEE-plug (1P+N+PE, 6h), 400V, 32A, blue (acc. IEC 60309-2)
Tab. 4: Power requirements of the Sphinx 45 - Sphinx 100 (three phase models)
Plug type CEE-plug (3P+N+PE, 6h), 400V, 16A, red (acc. IEC 60309-2)
The laser system has an internal monitoring of the line voltage. If the line voltage is out of the acceptable
range an acoustic warning signal sounds. In this case check the electrical house installation.
The connection of the Sphinx laser should be done with the plug type that is given in the related
datasheet. In case you need another plug/receptacle combination please contact your LISA laser
products representative.
If no door-interlock switch is used, the dummy connector supplied with the laser should be plugged into
the free socket. The dummy connector is fitted with an electrical bridge between pin 1 and pin 3.
When the door-interlock switch circuit is broken the laser is immediately de-activated. After the door-
interlock switch has been closed again the laser can only be operated again after pressing the ‘ready’
button.
3.6 Cooling
The Sphinx laser device is equipped with an integrated active cooling system. While the laser is being
operated this active cooling system draws off the resultant dissipation power into the room air. Because of
the efficiency of the laser device, the dissipation power is almost identical with the consumption power.
In rooms, which are not air-conditioned, one should take account of a corresponding warming of the room
air. The laser may be operated at an ambient temperature of up to about 28 °C. The device switches off
automatically if the internal temperature of the laser becomes too high.
The ventilation grilles on the side frames of the laser device must not be covered during
operation of the laser device.
During operation the device must not be placed with one of its longer sides directly
WARNING against a wall!
The air flow from the laser device has to be directed away from the patient!
WARNING
The essential performance of the laser device is to deliver laser radiation with the pre-set parameters on
activation of the footswitch.
The function of the Sphinx may be affected by mobile or cordless phones and other RF–
communications equipment.
WARNING Do not use mobile or cordless phones and other RF–communications equipment during
operation of the Sphinx.
The Sphinx is intended for use in combination with the original accessories/cables and in
the electromagnetic environment specified below. The use of others than those specified
may result in increased emissions or decreased immunity of the device.
WARNING
The Sphinx should not be used adjacent to or stacked with other equipment. If it is
necessary to use the laser device adjacent to or stacked with other equipment the Sphinx
should be observed to verify normal operation.
WARNING
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies
NOTE 2 These guidelines may no apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
buildings, objects and people.
a
The field strength of fixed transmitters, such as base stations for radio (cellular/cordless) telephones, land mobile radios, amateur
radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the EMC
environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in
the location in which the product is used exceeds the applicable compliance level above, the product should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be required, such as reorienting or relocating
the product.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
4 Laser safety
This section provides important information and guidelines about the laser safety. Regulations regarding
laser safety for the safe installation and operation of a medical laser are described. You will get guidelines
for the protective measures and the marking for the operation room. The Nominal Ocular Hazardous
Distance (NOHD) is calculated and you will get information about the required laser safety eyewear.
Content
Only use the laser for the purpose, for which it was designed!
Never point the laser beam at a person!
Irradiation of persons can cause injuries to the skin and eyes.
DANGER
All persons in the laser area must wear appropriate laser safety eyewear.
Lock device by removing key of key switch to prevent unauthorized use of laser device
DANGER
The use of a damaged laser fibre may cause accidental laser exposure and injury to the
personnel or patient.
DANGER Before use, always make sure that the laser fibre is undamaged.
Smoke generated by laser tissue interaction may contain viable tissue particles or toxic
substances!
DANGER Use an appropriate smoke evacuation.
The NOHD is calculated according to the European standard DIN EN 60825-1 „Safety of laser devices“.
Wavelength λ = 2,1 µm
Numerical aperture of fibre NA = 0,22
φ = 25,4° = 0,443 rad
Fibre diameter a = 200 µm
Pulse energy EPuls = 5,4 J
Average power Pmean = 119 W
Pulse length (minimum) tmin = 150 µs
Pulse frequency (maximum) f = 22 Hz
Pulse peak power Pp = EPuls / tmin = 5,4 J / 150 µs = 3,6*104 W
The calculation of the NOHD follows either the calculation of single pulses or the calculation of a
cumulated series of pulses what ever leads to a higher restriction.
The calculation of the NOHD of the Sphinx Holmium laser follows the assessment of the average power.
For safety reasons we recommend to use only safety eyewear that is supplied by LISA laser products or
your LISA representative. Please contact us for further information.
Fig. 3: Warning Sign (hazard symbol) for entrance doors of laser area
Aperture label
A in Fig. 9
Fig. 5: Aperture label
4.7.3 Laser-Stop
The Laser Stop-Button is marked with the following sign (original black on yellow) (Fig. 6):
Label Laser-Stop
B in Fig. 10
Fig. 6: Label Laser-Stop
Content
5.2 Nameplate
The name plate (Fig. 7) of Sphinx laser is attached to the back of the device (position G in Fig. 10). It
comprises all the necessary data for the identification of your laser system.
The following symbols are used:
IP 22
Pay attention to user date of Applied part type Protective class CE-Mark Serial Number
manual manufacture BF
Nameplate Sphinx 30 (green aiming beam) Nameplate Sphinx 30 (red aiming beam)
DANGER
HIGH VOLTAGE
D
C
Content
Irradiation of the eyes by direct or indirect laser radiation can lead to injuries and
irreversible damage to the eyes. Do not look into the laser beam. All persons present in
the laser area must wear appropriate laser safety goggles.
DANGER
There is a danger of injury from uncontrolled emission of laser radiation. Only use the
laser system and the laser radiation for intended purposes.
DANGER Only with a laser fibre connected, the “Ready state” can be activated.
Inspect laser system for damage on housing or cables. Do not use defective laser device.
DANGER
Check the fibre connector on heating during operation of laser device. If temperature of
the fibre connector rises above approximately 50 °C switch off laser device, to prevent
damage to the fibre or connector.
WARNING
The housing and the operator panel has room temperature normally. Shut down device
immediately if the outer device parts heat up. Call service engineer.
WARNING
Shut down device immediately if smoke of cable fire is recognised and call service
engineer.
DANGER
If you hear unusual loud operating noise shut down device immediately and call service
engineer.
WARNING
The fibre connector might contain allergic substances. Wear protective gloves or avoid
direct prolonged contact to your skin.
DANGER
6.3.1 Prearrangement
If laser has been stored at an ambient temperature outside the “Operational ambient temperature” range
the laser needs to adjust its temperature.
For large temperature difference it should be kept in the operation room for at least 3 hours to let adjust
the temperature.
Before switch on of the laser check if:
The necessary safety precautions have been taken. (Section 4).
1. The laser system is connected to a suitable power supply (Section 3.2.1).
2. The door-interlock or the dummy connector is connected and the entrance doors are closed. (Section
Connecting a door interlock3.3)
4. The necessary laser fibres and laser applicators are to hand. Concerning the use of laser fibres and
laser applicators please consult the manual for the accessory in question.
5. All persons present in the laser area are wearing appropriate laser safety glasses. Take care that the
laser safety glasses are suitable for the emitted wavelength and do not show signs of damage
(Section 4.5).
2. The microprocessor control carries out various checks on the device during the first 70 seconds after
switching-on (start-up). At first the laser warning lamp stays permanently on and the colour monitor
screen is dark. After approx. 40 seconds the manufacturer’s logo appears on the screen, the laser
warning lamp blinks and during the course of a test routine the laser emits an audible internal laser
pulse. The start display (XXX) appears on the monitor displaying the brand name of the model. After
approx. 50 seconds the warning lamp goes out and the selection menu appears (see section on
“Operation of the display control”).
Fig. 11: Start display after switching-on the laser system (example Sphinx 30 litho)
3. Possible fault messages during the Start-up routine appear on the screen in clear text (see section on
“Fault messages”).
4. The desired mode is selected either directly or as a pre-setting (memo) (see section on “Operation of
the display control”).
6. Pressing the release button opens the fibre port. Attach the laser fibre as instructed in this manual
(see section on “Connecting the laser fibre”) and the laser fibre’s manual. The fibre port will close
automatically after about 10 seconds.
7. Take care when attaching the laser fibre that dust, dirt or liquids never penetrate into the beam outlet
on the laser device!
Dust, dirt or liquid penetrating into the beam outlet can severely damage the fibre
coupling blast shield and the focussing cell. Please observe the instructions in the section
on “Care and maintenance” relating to the checking and replacement of the fibre coupling
blast shield.
WARNING
8. By pressing the release button a second time the laser is switched from “Stand By” to “Ready”. The
“Ready” mode is indicated by the illumination of the laser warning lamp and the pilot laser being
switched on. Should the pilot laser not be visible at the distal end of the fibre then the setting for the
brightness of the pilot laser should be adjusted (see section on “Altering the pulse duration and the
brightness of the pilot laser”).
9. The laser emission is activated by pressing on the foot switch. Note that the foot switch has a clearly
tangible pressure point. The first laser pulse will not be emitted until a few tenths of a second after the
action point has been passed.
10.Before the laser is used on a patient, always make sure that the laser device and used accessories
are in a proper state (Section 6.4 ”Orderly state of the laser system").
2. the maximum adjustable power corresponds with the value on the name plate,
4. the displayed parameters are plausible and the graphical and numerical readout correspond
5. a fibre that is in a orderly state emits power during operation of the laser.
At this stage by using the -button or the -button either the “Power” or “Burst” (or optionally
“Dose”) mode is selected or pre-set parameters are called up from the “Memo” mode . Your selection
appears in highlighted and you can then call it up with the -button.
The operation of the “Power”, “Burst” and “Dose (optionally)” modes is characterized by the following
features:
“Power” Control of the radiation emitted by the laser device according to the formula: power
= energy x frequency, i.e. the energy and frequency of the emitted radiation can be
varied. The laser emits laser pulses as long as the foot switch is depressed.
“Burst” Control of the radiation emitted by the laser device according to the parameters
energy and number of pulses. A burst of pulses is emitted at set pulse energy and
repetition rate. Once a pre-set number of pulses is reached, the laser device stops.
“Dose” Control of the radiation emitted by the laser device according to the formula: Partial
dose x positions = dose, i.e. a selected dose is divided up into a certain number of
partial doses. Once this dose is reached, the laser device stops.
Start-up
Selection menu
Depending upon the parent menu, the menu’s “More parameters” are easily variable. Using the “Return”
function from one menu “More parameters” can be exclusively returned to the previously selected mode.
Altering the parameters such as (laser pulse) energy, frequency and power is carried out exclusively by
means of the four function buttons on the operating console. What the function buttons do depends upon
the display shown (menu). In the right display border each menu has a toolbar, determining the meaning
of the function buttons specific to that menu.
The possible meanings of the function buttons are:
Increase the selected parameter highlighted and marked by the hand symbol.
Decrease the selected parameter highlighted and marked by the hand symbol.
Change the selected parameter which has a black font, a highlighted background and the hand
symbol to the next parameter or change to the next item on the menu. In all menus the menu
items are arranged below the bar graph displays. As soon as a menu item is selected its font
colour changes from grey to back and its background is highlighted.
Entry confirmation, change to the selected menu.
The eye indicates the parameters monitored during variation of the parameters
(see also section on “Variation of parameters in the power mode”).
The padlock symbol marks the parameter, which was last set and is to be maintained within
the technically possible limits during parameter variation (see also section on “Variation of
parameters in the power mode”).
1 2
7 8 9 10 11
# Meaning
1 Menu bar, describes the function of the menu, in this case: “Power” mode
2 Σ E indicates how much energy has been emitted since the last summation-reset
3
By pressing the button the hand symbol is changed to the next adjustable parameter or the next
item on the menu.
4
By pressing the button the parameter indicated by the hand symbol and the red spot is
increased. In this case the frequency was increased
5
By pressing the button the parameter indicated by the hand symbol and the red spot is
decreased. In this case the frequency was decreased.
6 In this mode the fourth button from the top has no function
7 The other modes can be selected with the menu item “Menu list”.
8 Behind the menu item “More parameters” are hidden setting of the pulse duration and the intensity of
the pilot laser.
9 “Energy” parameter is selected and can be adjusted. The hand symbol indicates the parameter,
which can be altered with the arrow keys.
10 “Frequency” parameter is not ready to be adjusted. The eye, indicates the parameter is being
monitored
11 “Power” parameter is not ready to be adjusted, it is locked. This parameter was the last to be set and
will be adhered to during parameter variations.
Sphinx lasers manufactured after 2010-09 on will not have the possibility to adjust the power.
This number can be reset to zero by using the button to change to the menu item “Menu list” and
A dirty or damaged blast shield or a dirty or damaged fibre connector absorbs laser
power. The absorbed laser power leads to heating of the dirty or damaged place and
can lead to further damage through overheating.
WARNING
In the power mode the laser device’s computer control system permits the variation of parameters within
the limits set by the design of the laser device. For example, at the maximum frequency setting the
maximum pulse energy is no longer available.
The maximum average power is achieved at a specific repetition rate. At higher and lower frequencies the
maximum average attainable power decreases.
The setting range of each parameter is shown at the side of the setting bar.
If the parameter identified with is varied by the user, the computer control system automatically
calculates the parameter marked with the symbol. During this the parameter marked with is
kept constant.
The choice of the correct parameters for different medical applications is imparted in the laser training
sessions, which are offered by the manufacturer. Section “Clinical applications” provides guidelines.
(script then changes from grey to black) and activated with the button.
Thereupon the following menu appears:
In order to adjust the pulse duration setting the button must be pressed until the pulse duration is
selected and marked by the symbol and the highlighted background. Afterwards, the desired
... until the symbol are placed on the pilot laser. Then press and until the
desired brightness is set.
In this menu using the button again it is possible to change between the variable parameters (pulse
# Meaning
1 Number of pulses to be applied
Variation of the adjustable parameters in the burst mode is carried out according to the same method as
in the power mode.
You can stop the laser emission during the burst sequence at any time by realising the footswitch. When
you activate the footswitch again a new burst sequence starts.
By pressing the and buttons the desired “No. ..NORMAL”, which is to be loaded, is selected
To do so the menu item “Menu list” is selected in the respective operational menu using the button
and from it “Memo” is selected using the and buttons. Thereupon an image appears similar to
the one above, in which the menu item “Save” is selected with the button and loaded with the
button.
The remark for the setting to be saved is written in the free field, the relevant letters being selected with
the and buttons and activated with the button. The last character can be removed by
The completed remark will be saved, together with the setting data by selecting “Save memo” with the
button and press the button. After selecting “Yes” with button and pressing the
button the actual laser setting is stored and the previous settings of this single dataset are overwritten.
The device then returns immediately to the saved operational mode.
1 2
# Meaning
1 Energy emitted in this application
2 Dose to be applied
In addition to the “Σ E:”, already mentioned in relation to the power mode, the dose to be applied
appears in brackets in the header.
During the selection of the parameters the value directly behind “ Σ E:” is zero, that is to say, that up to
this point no energy has been emitted. During the application the energy emitted up until that point is
shown in joules in this position.
Variation of the adjustable parameters in the dose mode is carried out according to the same method as
in the power mode.
In the dose mode the frequency is set in the “More parameters” menu below the dose mode.
The laser can in the dose mode – without affecting the energy summation – be stopped at any time for as
long as you like and then be reactivated.
Every time a partial dose is reached a gong is heard, which tells the operator that a partial dose has been
emitted. This gives the operator the opportunity to deactivate the foot switch and to place the laser
applicator in a different spot, in order to give the next partial dose in a new position.
Before using the laser fibres, carefully read the safety instructions in the additional fibre
manual, to avoid any danger for your patients, personnel or yourself and to protect the
device from damages.
DANGER
Check the laser fibre before every use for functionality and if the fibre is correctly cleaned
/ sterilized.
It is not allowed to use damaged lasers fibres. There is the danger that the laser fibre
DANGER breaks at the damaged position during the laser process.
Only use laser fibres, which are suitable for the respective laser system.
Note possible restrictions concerning the maximum permissible power.
WARNING The use of not qualified laser fibres or the use of too high laser power can lead to
damages of the laser fibre or the laser system. Using laser fibres that are not approved by
LISA laser products will result in a loss of the manufacture’s warranty for the system.
Unscrew the protecting cap of the fibre connector only for checking the fibre and
connecting the laser fibre to the laser system.
During storing and preparation of the laser fibre the protecting cap must be screwed on
WARNING the fibre connector.
It is not allowed to use laser fibres with a damaged buffer. There is the danger that the
laser fibre breaks at the damaged position during the laser process.
A break of the laser fibre can lead to injuries of the patient or user.
DANGER
When coiling up / storing the laser fibres the minimum bending radius should not fall
below 10-15 cm.
WARNING
During the laser process the laser fibre must not be kinked or strongly bended!
Observe the minimum bending radius (note the table of laser fibres), since otherwise the
danger exists, that the fibres break during the laser process at the kinked or bended
DANGER position!
A break of the laser fibre can lead to injuries of the patient or user.
Never use a haemostat or similar instruments to clamp the fibre.
When using laser fibres with soiled or damaged fibre connectors the laser power is
absorbed in the soiled or damaged area. This leads to overheating and may cause
severe damages of the focussing optics of the laser system.
WARNING Do not use damaged laser fibres any longer!
The use of damaged fibres can lead to injuries because the laser radiation can be emitted
at the damaged point and not at the distal end of the fibre. And may lead to injuries of the
patient or user.
DANGER
Please note, that the fibre coupler of the laser system may be damaged, if the fibre
connector will be handled with violence.
WARNING
Do not replace the laser fibres in the ‘ready’ operational state (laser warning lamp is
switched on)!
WARNING
1. Check the laser fibre for functionality and if the fibre is correctly cleaned / sterilized.
2. Press the release (READY) button to open the fibre port. Note that the fibre port will close
automatically after about 10 seconds. Take care that no dirt or liquids penetrate into the beam outlet
3. Remove protection cap of the fibre.
4. Place the fibre into the SMA-receptacle, screw it in and tighten it finger-tight.
5. Press the release button a second time in order to activate the laser (Ready-mode). The “Ready”
mode is indicated by the illumination of the laser warning lamp and the pilot laser being switched on.
In case the aiming beam is not visible at the distal end of the fibre first check and adjust the
brightness of the aiming beam. If the aiming beam is still not visible inspect the fibre again for
damages.
6. The laser emission is activated by pressing on the foot switch. Note that the foot switch has a clearly
tangible pressure point. The first laser pulse will not be emitted until a few tenths of a second after the
action point has been passed
7. Before the laser is used on a patient, always make sure that the laser device and used accessories
are in a proper state (Section 6.4 ”Orderly state of the laser system").
Surface cleaning using a damp cloth with a mild non-caustic cleaning solution, an alcohol
solution or a disinfectant may be undertaken. Do not use any alcoholic solution (e.g.
ethanol, iso-propanol) or acetone to clean the display or operating consol, respectively.
WARNING
1. Switch off the laser device and pull out the mains connector.
2. Disconnect the fibre, the foot switch cable and the interlock
4. Disinfect and clean the surfaces of the laser device except the display and the operating consol
with a non-caustic cleaning solution, an alcohol solution or a disinfectant. Take care that no
moisture can penetrate into the device neither through the cooling grilles nor the fibre port.
5. To clean the display and the operating consol use non-caustic cleaning solutions. Do not use any
alcoholic solution (e.g. ethanol, iso-propanol) or acetone. Be aware many disinfectant contain
alcohol.
Disinfect the foot switch and its cable with common disinfectant and clean it with a damp cloth containing
non-caustic mild cleaning solutions. The footswitch is water resistant and can be rinsed with water. No
moisture should penetrate the foot switch connector.
7 Clinical applications
The following text is based upon the experiences of users of Sphinx Holmium lasers and international
publications concerning the medical use of Holmium lasers. This literature is available to interested
parties on request. Please make yourself aware of the content of this section before you use the laser
clinically. Start your experience of lasers with low power settings.
Note the relevant safety regulations (see section on “Laser safety”) and follow the instructions of your
establishment’s laser safety officer.
Content
Whenever a Sphinx laser system is used there is a potential risk of thermal damage. Start
with low power settings.
The laser should only be activated if the fibre tip and the tissue at which the laser is
DANGER directed are within sight.
Irradiation of flammable materials, liquids or gases can cause them to ignite. Please
prevent the ignition of any material.
The laser system must not be used in an explosive atmosphere.
DANGER
Take into consideration that some anaesthetic gases and gases produced by the human
body (e.g. methane) are flammable and explosive.
For all endoscopic applications with the Sphinx laser there is a risk of perforation.
Therefore the laser may only be switched on if the distal tip of the fibre and its effect to
tissue is under visual control of the surgeon controlling the foot switch. Start with low
DANGER power settings.
The potential complications, which may result from endoscopic or open laser procedure,
are the same as those normally encountered in conventional endoscopic surgery and
may include but are not limited to: pain, perforation, entrapment, evulsion, haemorrhage,
DANGER infections, sepsis, tissue trauma, bleeding and oedema.
Firing the laser while the fibre tip is inside the applicator may lead to injuries of the patient
and damages of the applicator. Always make sure that the fibre tip extents out of the
DANGER applicator at least one millimetre.
Because the laser fibre erodes during the use of the laser, the length of the protruded
laser fibre tip should be inspected continuously during the application. In all cases the
laser fibre tip has to protrude from the surgical instrument at least one millimetre.
WARNING
7.2 Preparation
Follow the safety instructions and warnings in this and in referred manuals.
Prepare the laser system and the accessories according to the instructions mentioned in section 6
“Operation of the laser device”.
Evaluate the risk of the laser surgery and its potential side effects and contraindications (see section 2.4
and 2.5).
Before you start with the procedure make sure that the selected fibres are compatible to instruments
used. Good fibre guidance inside the instrument is very important for the treatment control. Make sure
that the inner diameter of your instrument and the outer diameter of the fibre match closely. Make sure
that the fibres can easily be introduced into the instrument and check that the laser fibre can be fixed
properly. During operation the distal end of the fibre should always be inside the field of vision of the
optic.
The cladding of the laser fibre acts as mechanical reinforcement. To protect the fibre tip against kinking
and breaking the “naked” length of the fibre at its distal end should be only 3 – 5 mm. When the fibre is
inserted into the instrument the cladding at the distal end should protrude from the instrument to avoid
direct contact between the “naked” fibre and the guidance tube. To get more information about the
handling of the laser fibres refer to the particular fibre manual.
7.4 Applications
The table shows an overview about the parameter settings for the different applications. A detailed
description of the procedures is available on request.
Orthopädie / Orthopedics
Meniscectomy / 1.2 J 15 Hz 450 µs
Meniskektomie
Smoothing of cartilage lesions / 0.8 J 10 Hz 650 µs
Knorplelglättung
Lateral release / 1.5 J 10 Hz 650 µs
Lateral Rlease
Capsular shrinkage / 1.0 J 10 Hz 650 µs
Kapselschrumpfung
Synovectomy / 1.2 J 15 Hz 650 µs
Synovektomie
HNO / ENT
Reduction of turbinates / 0.8 J 8 Hz 650 µs
Nasenmuschelreduktion
Reduction of nasal septum (cartilage / bone) / 0.8 J 8 Hz 150 µs
Nasenseptumreduktion (Knorpel / Knochen)
Shrinkage of polyps / 0.8 J 8 Hz 650 µs
Nasenpolypen
The values could be used as the basic parameters which can be stored to the laser program
memory. Modify the settings due to your experiences.
The mentioned settings should be regarded as a guideline and should be individually modified depending
on the conditions.
Laser settings depend on fiber tip condition. A blurred aiming beam indicates bad cutting characteristics.
7.4.1 Arthroscopy
The Holmium-YAG laser can be used in arthroscopy for the following clinical applications:
(Partial-)resection of the meniscus
Smoothing of cartilage lesions
Treatment of synovia
Lateral release
Particularly advantageous in arthroscopy is the combination of the specific ablation from tissue, the
haemostatic effect and the slim laser applicator.
LISA laser products OHG supplies all the laser accessories for arthroscopic applications.
Danger !
With all arthroscopic applications using the Holmium laser there is a danger of thermal damage. Start with
low power settings. Therefore the laser may only be switched on if the effect of the laser – that is the
distal fibre end – can be observed. Start with low power settings.
7.4.2 Urology
The Holmium-YAG laser is used in urology in the following clinical applications:
Removal of urethral strictures
Removal of ureter strictures
Resection of the prostate
Bladder neck incisions
In-situ ablation of bladder tumours
Lithotripsy of bladder stones
Lithotripsy of urethral calculi and of kidney stones
The haemostatic effect of the Holmium laser is particularly advantageous in the ablation of soft tissue.
For urological applications LISA laser products OHG supplies the necessary laser fibres as standard
accessories. The endoscopic urological instruments, which are required in addition, must have a working
channel to take the laser fibre and be approved by the manufacturer for laser use. Please allow us to
advise you.
Danger !
With all applications of the Holmium laser in the urogenital tract there is a danger of perforation. Therefore
the laser may only be switched on if the effect of the laser – that is the distal fibre end – can be observed.
Start with low power settings.
Do not activate the laser when the distal fibre end is inside the instrument.
WARNING
While attempting to push the distal fibre end into the flexed ureterorenoscope, internal
damage can be caused to the ureterorenoscope.
WARNING
The patient can suffer injuries if the laser is activated when the distal laser fibre end is
inside the instrument.
DANGER
7.4.3 ENT
The Holmium laser is used for the following clinical applications in ENT:
Reduction of turbinates (mucosa)
Ablation of bones and cartilage (turbinates and septum)
Shrinkage of nasal polyps
Shrinkage of benign tumours of the larynx
Because of the combination of the following features the Holmium-YAG laser is particularly advantageous
for working in ENT:
• directional, ablation effect on mucous membrane, cartilage and bones
• excellent haemostasis
• necrosis confined to narrow area
• slender laser applicators
• flexible fibre guide
• little post-operative pain
• very good healing of the wound
• preservation of the mucosa.
LISA laser products OHG supplies the laser accessories for use in ENT.
During all applications of the Holmium laser in ENT there exists the danger of thermal
damage. Start with low power settings. Space out your work in order to allow the area
directly around the place where treatment is being given to reach a thermal balance.
DANGER The laser may then only be activated if the effect of the laser – that is the distal fibre
end and the irradiated tissue – can be observed.
Content
Content
Installation, maintenance and service of the device should only be performed by trained
experts and based on this manual.
WARNING
For regular maintenance procedures, like inspection and cleaning of the laser and the
accessories, checking the proper state of the device and connection and disconnection of
the laser fibres you should follow the instruction given in this and in the related manuals.
WARNING
Never open the protective covers of the laser, as opening the protective covers will give
access to high voltage/current components and laser radiation.
DANGER Only LISA laser products approved service technicians should open the laser device.
Pay attention on stable stand of the laser device. Use the fixing brake to prevent the
system from unwanted movements.
WARNING
The Sphinx is not fully protected against incoming moisture. There is the danger of an
electrical shock. Please switch off the laser system and disconnect the power supply.
Warning
Surface cleaning using a damp cloth with a mild non-caustic cleaning solution, an alcohol solution or a
disinfectant may be undertaken). Take care that no moisture can penetrate into the device by neither by the grid
on the sides nor the fibre port.
4. Replace the two bolts in the console cover and tighten them lightly.
When using a damaged or dirty fibre coupler protection shield laser power is absorbed by
the dirt or the broken parts. This may lead to an over heating of the connector or the
coupler and may destroy them.
Warning Do not operate the laser without or with a damaged laser coupler protection shield.
11 Technical Data
Technical Detail Ausführung / Data
1 Gerät / Device
2 Abmessungen (H x B x T) / ca. / approx. 1040 x 450 x 1070 mm
Dimensions (H x W x D)
3 Gewicht / Weight ca. / approx. 160 kg
4 Schutzart / Degree of protection IP 22
(nach / acc. IEC 60529)
5 Medizinprodukteklasse / IIb
Medical device class
(nach / acc. MDD Anhang / Annex IX)
6 UMDNS Klassifizierung / Classification 17 - 769
Netzanschluß / Mains supply
7 Elektrischer Anschluss / Sphinx 30 230 V, 50/60 Hz, 16A (1~, N, PE)
Electrical requirements
230 V, 50/60 Hz, 20A (1~, N, PE)
Sphinx 45 or
400 V, 50/60 Hz, 16A (3~, N, PE)
230 V, 50/60 Hz, 16A (1~, N, PE)
Sphinx 60 or
400 V, 50/60 Hz, 16A (3~, N, PE)
230 V, 50/60 Hz, 16A (1~, N, PE)
Sphinx 80 or
400 V, 50/60 Hz, 16A (3~, N, PE)
230 V, 50/60 Hz, 16A (1~, N, PE)
Sphinx 100 or
400 V, 50/60 Hz, 16A (3~, N, PE)
8 Netzstecker / Mains plug Schuko-Stecker / plug Typ / type CEE
Sphinx 30 7/7 (nach / acc. DIN 49441)
250V, 16A, grau / grey
Sphinx 45
CEE-Stecker / plug (1P+N+PE, 6h)
(nach / acc. IEC 60309-2)
Sphinx 60 230V, 32A, blau / blue
or
Sphinx 80 CEE-Stecker / plug (3P+N+PE, 6h)
(nach / acc. IEC 60309-2)
400V, 16A, rot / red
Sphinx 100
Sphinx 45 max. 45 W
Sphinx 60 max. 60 W
Sphinx 80 max. 80 W
14 Annex
Document Attached
Declaration of Conformity
EC-Certificate Annex II
Decontamination Certificate