Laser - Lisa - Sphinx JR - Manual Usuario - Ing

LISA
laser products
User Manual
Holmium laser
Sphinx jr.
LISA laser products OHG, Max-Planck-Straße 1, 37191 Katlenburg, Germany, Fon +49 (0)5556-9938-0, Fax +49 (0)5556-9938-10
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
CAUTION: US federal law restricts this device to sale by or on the order of a physician!
Dokument / Filename: GA035010011SphinxJrE01V01.doc gültig ab / effective: 02.04.2012

Vorlage / Template: DVLISAMehrseitigesDokument02.dot
Sphinx jr.
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
1.2 Software version ....................................................................................................................................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 ............................................................................................................................................2-2
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 Fibre selection........................................................................................................................................2-6
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.............................................................................................................................3-3
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 according to EN 207:2002-12 .................................................................4-4
4.5.3 Eye protection markings according to EN 207:2010-04 .................................................................4-4
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Sphinx jr.
4.6 Marking of entrance doors to laser areas ..............................................................................................4-5

4.7 Laser safety labels .................................................................................................................................4-6
4.7.1 Explanatory label ............................................................................................................................4-6
4.7.2 Aperture label..................................................................................................................................4-6
4.7.3 Laser-Stop ......................................................................................................................................4-7
5 Labelling of the device ..................................................................................................................................5-1
5.1 Used symbols.........................................................................................................................................5-2
5.2 Nameplate..............................................................................................................................................5-2
5.3 Danger Label Electric Energy ................................................................................................................5-2
5.4 Position of warning signs and labels......................................................................................................5-3
6 Operation of the laser device ........................................................................................................................6-1
6.1 General safety information.....................................................................................................................6-2
6.2 Starting-up..............................................................................................................................................6-3
6.2.1 Prearrangement ..............................................................................................................................6-3
6.2.2 Switching-on routine: ......................................................................................................................6-3
6.2.3 Connecting the footswitch...............................................................................................................6-4
6.2.4 Connecting the door interlock .........................................................................................................6-4
6.2.5 Connecting a potential equalisation lead........................................................................................6-4
6.3 Proper condition of the laser system......................................................................................................6-5
6.4 Operating and display components .......................................................................................................6-5
6.4.1 Operating console...........................................................................................................................6-5
6.5 Operating the display control .................................................................................................................6-6
6.5.1 Pulse effect .....................................................................................................................................6-8
6.5.2 Menu structure of the display control..............................................................................................6-9
6.6 Pulsed Mode ..........................................................................................................................................6-9
6.7 Burst mode...........................................................................................................................................6-10
6.8 Double footswitch.................................................................................................................................6-10
6.9 Operational states of the system .........................................................................................................6-11
6.9.1 Set laser device in ready mode ....................................................................................................6-11
6.10 Setting the brightness of the pilot laser / aiming beam ....................................................................6-13
6.10.1 Set laser device to “Stand by” mode ............................................................................................6-14
6.11 The Memo menu ..............................................................................................................................6-14
6.11.1 Loading of pre-selected settings...................................................................................................6-14
6.11.2 Memo – Saving settings ...............................................................................................................6-15
6.12 Usage statistic and counter reset .....................................................................................................6-15
6.13 Connecting a laser fibre to the laser.................................................................................................6-16
6.13.1 Safety information.........................................................................................................................6-16
6.13.2 Checking the laser fibre ................................................................................................................6-17
6.13.3 Attaching the laser fibre to the fibre port.......................................................................................6-17
6.14 Disconnecting the fibre from the laser..............................................................................................6-18
6.15 Switching-off routine.........................................................................................................................6-18
6.16 Cleaning the laser system ................................................................................................................6-19
7 Clinical applications and Tissue interaction ..................................................................................................7-1
7.1 Safety instructions..................................................................................................................................7-2
7.2 Preparation.............................................................................................................................................7-3
7.3 Step-by-step procedure .........................................................................................................................7-3
7.4 Applications............................................................................................................................................7-4
7.4.1 Arthroscopy.....................................................................................................................................7-5
7.4.2 Urology............................................................................................................................................7-5
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Sphinx jr.
7.4.3 ENT.................................................................................................................................................7-6
7.5 Laser tissue interaction ..........................................................................................................................7-7
7.5.1 Basic physico-technical principles ..................................................................................................7-7
7.5.2 Basic physico-medical principles ....................................................................................................7-7
7.5.3 Tissue interaction............................................................................................................................7-7
7.5.4 Irrigation liquid.................................................................................................................................7-8
8 Error messages and malfunctions.................................................................................................................8-1
8.1 Error messages......................................................................................................................................8-2
8.2 Technical customer support...................................................................................................................8-2
9 Care and Maintenance..................................................................................................................................9-1
9.1 Safety information ..................................................................................................................................9-2
9.2 Regular safety check .............................................................................................................................9-2
9.3 Cleaning of the device ...........................................................................................................................9-2
9.4 Re-processing the accessories..............................................................................................................9-2
9.5 Check and exchange of fibre coupler protection shield .........................................................................9-3
9.6 Calibration of the laser output ................................................................................................................9-4
9.6.1 Test of accuracy..............................................................................................................................9-4
9.6.2 Use of the power meter ..................................................................................................................9-4
9.7 Exchange or refilling of cooling liquid ....................................................................................................9-4
9.8 Disposal of laser device and accessories..............................................................................................9-4
10 Accessories for Sphinx jr. Holmium-YAG lasers .....................................................................................10-1
10.1 Laser fibres.......................................................................................................................................10-1
10.2 Laser safety eyewear .......................................................................................................................10-1
11 Technical Data.........................................................................................................................................11-1
12 Decontamination of Returned Equipment ...............................................................................................12-1
13 Index and List of Figures .........................................................................................................................13-1
14 Annex.......................................................................................................................................................14-1
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Sphinx jr. About this manual
0 About this manual

This manual provides important information concerning the safe handling of the medical Holmium-YAG
laser system Sphinx jr.
This manual describes the models:
Sphinx jr.
You will find the name of the specific model and the power range (max. power) on the name plate
(Fig. 8). In addition the name of the laser model and the software version appears on the start display
(Fig. 12) after switch on.
Information and remarks referring only to a designated model, option or version is emphasised specially.
Before using the laser device for the first time read and comprehend this manual, referred
documents and manuals of the accessories (e.g. fibres and applicators) carefully and follow the
instructions! Please keep it for future reference.
Observe the applicable guidelines of your employer’s liability insurance association and equal ranking
organizations and your national guidelines and regulations on the safe use of medical laser devices. The
responsibilities, relevant safety measures and personal protective equipment are described in these
regulations.
Observe the specific 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 the laser system has to be done according to the instructions given in this
manual.
Subject to technical modifications and amendments! Due to enhancements images and technical
data may vary slightly.
In numbers the following separators are used in this manual: “.”=thousands separator;
“,”=digital separator
0.1 Safety instructions and symbols used in this manual

The safety instructions in this manual are intended to prevent possible injuries, material damage and
operational faults.
In this manual a distinction is made between the safety instructions used to warn of possible injury
(DANGER) and instructions warning against operational faults (WARNING):
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
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Sphinx jr. About this manual
0.2 General safety instruction

This Section includes a summary of the basic DANGER and WARNING instructions. Please refer also to
the specific safety instructions in the other sections and the related manuals.
The Sphinx jr. 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
devices.
DANGER
The device must stand in upright position during operation and storage.
Do not turn the laser device upside down.
WARNING During operation and storage do not lay the laser device down on one of the sides.
Pay attention on stable stand of the laser device.

Use break, to prevent unintended rolling of laser device.
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.
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
The laser device must not be disposed as domestic waste. It contains

valuable and hazardous material which should be re-cycled or disposed
NOTICE according to local regulations. Please contact your local representative for
questions. LISA laser offers to re-cycle the device at its end-of-life. Please
contact your local representative for questions.

Sphinx jr. Delivery
1 Delivery
1.1 Regular scope of delivery

The Holmium Sphinx jr. laser device is supplied without medical accessories. Laser fibres, applicators
and other accessories must be ordered separately from the device manufacturer or his representative.
The regular scope of delivery of the Sphinx jr. includes at least the following items:
Sphinx jr. laser system qty. items included

Sphinx jr. Holmium-YAG 1 Sphinx jr. Holmium-YAG medical laser
medical laser
1 Door-interlock dummy connector (REF 101 600 166)
1 User manual
2 Keys (REF 101 610 002)
Single-pedal footswitch “Kix” (REF 101 630 147)

1 alternatively:
Double-pedal footswitch “Kix DUO” (REF 101 630 144)
For the exact scope of delivery refer to the shipment note.
1.2 Software version

This manual refers to the laser software version 01Vxx (see Fig. 12).

Sphinx jr.
Sphinx jr. Product description
2 Product description
This section provides important information about the device. The section contains a general description
of the Sphinx jr. 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.
You will find information about laser fibres which are approved for the Sphinx jr. in section 2.9 ”Fibre
selection” and in the fibre manual.
Content
2.1 Identification of the model

2.2 General description
2.3 Intended use of the surgical pulsed Holmium laser Sphinx jr.
2.4 Contraindications
2.5 Side effects
2.6 Authorized Users
2.7 Classification
2.8 Overview
2.8.1 Front view
2.8.2 Rear view
2.11 Fibre selection

2.1 Identification of the model

You can find the name of the model, the power range (max. power) and the character of the emitted laser
radiation on the name plate (Fig. 8).
Tab. 1 gives a short overview of the technical specifications. For detailed technical data refer to
section 11 “Technical Data”.
Sphinx jr.
Wavelength 2.123 ± 3 nm
Power (mean) max. 30 W
Pulse energy 0,5 – 3,5 J adjustable
Pulse peak power 6 – 18 kW adjustable
Pulse duration 100 - 700 µs
Repetition rate Single pulse;

1 – 20 Hz
Tab. 1: Specifications Sphinx jr.
2.2 General description

The Sphinx jr. Holmium laser device is a surgical laser system. The laser radiation is solely delivered in
pulses. The Sphinx jr. laser has the wavelength 2.123 nm (±3 nm) (equal to 2,1 micron). This wavelength
is invisible infrared.
The laser radiation is focused by a fibre coupler into a flexible silica laser fibre. The laser radiation is
delivered by this silica fibre to the surgical site. The distal end of the fibre is attached to an appropriate
applicator which serves as the surgeon’s working instrument. Various laser fibres and applicators
designed for specific purposes are available for clinical use.
The laser system is operated from an operating panel with a display and control elements. The laser is
activated by a footswitch. Setting of operating parameters and activating the laser device is described in
the section 6 “Operation of the laser device”.
2.3 Intended use

The Sphinx jr. is a surgical laser used for the transient emission of laser energy for the vaporisation and
coagulation of soft tissue and the ablation of hard tissue and for laser lithotripsy. Direct application of the
Sphinx jr. laser on the central nervous system and on the cardiovascular system is not intended.
The laser radiation is transmitted through a laser fibre. The distal end of the fibre is enclosed in an
appropriate applicator.
Please refer to the applications in section 7 “Clinical applications”.
2.4 Contraindications
Contraindications, related directly to the Sphinx jr. 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.
2.5 Side effects

The potential complications, which may result from a surgical laser procedure, are the same as those
normally encountered in conventional surgery and may include but are not limited to pain, perforation,
entrapment, evulsion, haemorrhage, infections, sepsis, tissue trauma, bleeding and oedema.

2.6 Authorized Users

The Sphinx jr. laser is designed for professional users. It may only be used by qualified persons who have
been trained by the manufacturer or by an authorised representative of the manufacturer in the correct
and safe operation of the laser on basis of the manual. Only those people may receive a training who
have an appropriate medical knowledge or professional clinical experience.
Re-processing of laser fibres, applicators and accessories should be performed by trained professionals
only.
Maintenance and service of the device should only be performed by trained and authorised experts
approved by LISA laser products and based on this and related manuals.
2.7 Classification
The Sphinx jr. 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 3R
Laser classification US FDA CDRH (21CFR1040.10) (pilot laser) Class III
Protection class according to IEC 60601 Class I
Protection group according to EN 60529 IP20
The Sphinx jr. laser system complies with the ”Essential Requirements” of the European Medical Devices
Directive 93/42/EEC.

2.8 Overview
2.8.1 Front view

The beam outlet, all the important operating and display components, the laser stop button, the key
switch and the receptacle for the footswitch, are located on the front of the device (Fig. 1).
Fibre holder
Fibre connection
(beam outlet)
Operating panel
Light stripes
(illumination:
green or red)
Laser Stop
Key switch
Receptable for
footswitch
Fixing brake
Fig. 1: Front view

2.8.2 Rear view

At the rear side of the device you will find a door for the footswitch storage hood, the door interlock
connection, the power cord, the connection for the power equalization lead, the name plate and the fixing
break.
Connection for
door interlock
Power cord
Door of storage
hood
Name plate
Connection for
power equalization
lead
Fixing break
Fig. 2: Rear view (Sphinx jr. with closed back door)

The footswitch can be stored behind a door in the storage hood. The footswitch is fixed by magnets. The
footswitch Kix or Kix DUO should be positioned as shown in the picture (Fig. 3). In this orientation the
protection bar of the footswitch closes when the door is closed.
Storage hood
for footswitch
.
Fig. 3: Rear view (Sphinx jr. with open back door)
2.9 Fibre selection

A range of laser fibres is available for the Sphinx jr. These fibres differ in core diameter and in the outer
(cladding) diameter, in mechanical flexibility and in direction of radiation.
Select the fibre according to the application, the compatibility with the used instrument/applicator and the
mechanical properties required for the treatment.
In general small core diameter fibres are more flexible than fibres with larger core diameter but also less
mechanically stable. The smaller the core diameter of a fibre is the higher is the intensity of the laser
beam at the distal tip of the fibre.
For more information about the laser fibres please refer to the information in the manual of the fibres.
Refer to the particular user manual of the laser fibres for more information about the safe
use of the fibres.
WARNING
Only use laser fibres, which are suitable for the respective laser system.
Observe the minimum bending radius of the laser fibre.
Observe restrictions concerning the maximum permissible laser power.
WARNING

Sphinx jr. Installation of the laser device
3 Installation of the laser device

This section gives important information about the safe installation of the device.
You will get information about the specific regulations for operators of medical devices, about the
requirements regarding the electrical installation, the environmental conditions. You will get notes
regarding the EMI conditions.
Content
3.1 General remarks

3.1.1 Unpacking
3.1.2 Before first use
3.2 Electrical installation
3.2.1 Power requirements
3.3 Connecting a door interlock
3.4 Medical devices book
3.5 Environmental conditions
3.5.1 Transportation and storage of the laser device
3.5.2 Operation conditions
3.6 Cooling
3.7 Electromagnetic compatibility (EMC)
3.7.1 Guidance and manufacturer’s declaration - electromagnetic emissions
3.7.2 Guidance and manufacturer’s declaration - electromagnetic immunity
3.7.3 Guidance and manufacturer’s declaration - electromagnetic immunity for equipment and systems
that are not life-supporting
3.7.4 Recommended separation distances between portable and mobile RF communications
equipment and devices that are not life-supporting
3.7.5 List of cables and their length

3.1 General remarks

The laser system and the relevant local regulations impose specific requirements upon the installation
site. These requirements concern the safety precautions, electrical supply and heat management.
The installation of the laser system has to be carried out by an expert authorized by LISA laser products.
This person will also carry out a functional test after the laser system has been installed at the designated
site.
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
3.1.2 Before first use

Prior to the first use of the laser, the system needs to be safety tested at the site of operation. The test
should follow the manufacture’s instruction and needs to be performed by qualified and authorized
service personnel. The results of the test shall be reported.
3.2 Electrical installation

The Sphinx jr. laser is intended to be used in a medical location. The electrical installation should follow
the specific requirement for these locations and should be in accordance with the IEC 60364-7-710 and
referenced standards. Please contact LISA laser products or your LISA representative for any questions.
During operation an unusual shut-down of the Sphinx jr. does not endanger the patient. Surgeries with
the Sphinx jr. can be interrupted, repeated or continued with alternative devices without any problems.
3.2.1 Power requirements

The requirements regarding the mains connection for the types of laser device described here might be a
little different, depending upon the power class of the device. Please note the maximum current
consumption from the name plate. The manufacturer recommends, if possible, a wall socket with its own
fuse. Apart from the laser device, no additional electrical loads should be connected to this fuse.
The following table describes the power requirements of the diverse Sphinx jr. models. The exact
requirements for the laser system in question are given on the name plate (Fig. 8).

Tab. 2: Power requirements of the Sphinx jr. 30
Sphinx jr.
Supply 200-240 V, 50/60 Hz, 12 A, 1~/N/PE,

and
110V-127 V, 50/60 Hz, 20 A ,1~/N/PE,
Plug type “Schuko” plug Type CEE7/7, 250 V, 16 A, IP44 (acc. DIN 49441)
or
Hopsital Grade Plug NEMA 5-20P
or
BS 1363, 250 V, 13 A
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 jr. 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.
3.3 Connecting a door interlock

A door interlock may be plugged into the socket on the back side of laser system (Fig. 2) and locked. The
installation of the door-interlock must be done in collaboration between one of the manufacturer’s service
technicians and your house technician.
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 the laser can be operated again after setting the system to ‘ready’ mode.
3.4 Medical devices book

Due to regulation in some countries the operator of the medical device is obliged to keep records of the
device history in a medical devices book. The medical device book has to be shown on request to the
competent authorities.
The following records are kept:
1. Training of the personnel responsible for the laser system
2. Training of the users
3. Technical safety inspections
4. Maintenance measures and
5. Functional errors.
The medical devices book has to be kept without gaps until the system is finally taken out of service and
stored for a further period beyond that time. The duration of this period is subject to national regulation.
Please make sure that you follow the applicable regulation in your country.

3.5 Environmental conditions
Storage, transport or operation of the system at temperatures below 0 °C may cause

damages to the laser, if the anti-freeze is not appropriate
WARNING Severe jolts or vibration can cause severe damage to the system!
3.5.1 Transportation and storage of the laser device

During transportation of the Sphinx jr., take care that the device is not subjected to severe jolts or
vibrations.
The ambient 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.
At delivery the laser system is freeze protected down to -15 °C. If there is danger that the ambient
temperature may drop to below 0 °C, the anti-freeze of the cooling liquid must be checked by an
authorized expert.
3.5.2 Operation conditions

The Sphinx jr. is designed for continuous operation (definition acc. IEC 60601-1) at an operational
ambient temperature between 15 °C to 28 °C, relative humidity 10 % to 90 % (none condensing) and air
pressure 700 hPa to 1060 hPa.
If laser has been stored at a temperature outside this operational ambient temperature range the laser
needs to adjust its temperature. For large temperature difference it should be kept in the operation room
at the operational temperature for at least 3 hours to achieve a temperature adjustment.
During operation of the Sphinx jr., take care that the device is not subjected to severe jolts or vibrations.
The laser device should be placed in a position that the air flow from the internal cooling ventilators is
directed away from the patient.
3.6 Cooling
The Sphinx jr. laser device is equipped with an integrated cooling system. While the laser is operated the
cooling system discharges the waste heat into the ambient air. The maximum heat load is in the range of
the totally consumed electrical power.
In rooms, which are not air-conditioned, take into account that the ambient temperature rises. 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.
Do not cover the ventilation in- and outlets at the front, back and at the bottom of the
device during operation of the laser.
WARNING
The air flow from the laser device has to be directed away from the patient!
WARNING

3.7 Electromagnetic compatibility (EMC)

Medical Electrical Equipment like the Sphinx jr. needs special precautions regarding EMC and needs to
be installed and put into service according to the EMC information provided in the accompanying
documents.
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 jr. 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 jr.
The Sphinx jr. 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 jr. 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 jr. should be observed to verify normal operation.
WARNING
3.7.1 Guidance and manufacturer’s declaration - electromagnetic emissions

The Sphinx jr. is intended for use in the environment specified below. The customer or user of the Sphinx jr. should assure that the
product is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions CISPR 11 Group 1 The Sphinx jr. uses RF energy for its internal function.
Therefore, the RF emission is very low and is not likely to
cause any interference in nearby electronic equipment.
RF emissions CISPR 11 Class A The Sphinx jr. is suitable for use in all establishments other
Harmonic emissions IEC 61000-3-2 Class A than domestic establishments and those directly connected to
the public low-voltage power supply network that supplies
Voltage fluctuations/ flicker emissions Complies buildings used for domestic purposes.
IEC 61000-3-3

3.7.2 Guidance and manufacturer’s declaration - electromagnetic immunity

Immunity test IEC 60601 – test level Compliance level Electromagnetic environment -
guidance
Electrostatic discharge (ESD) ± 6 kV contact ± 6 kV contact Floors should be wood, concrete or
IEC 61000-4-2 ceramic tile. If the floors are covered
± 8 kV air ± 8 kV air
with synthetic material, the relative
humidity should be at least 30%.
Electrical fast transient/burst ± 2kV for power supply ± 2kV for power supply Mains/line power quality should be
IEC 61000-4-4 lines lines that of a typical commercial or
hospital environment.
± 1 kV for input/output ± 1 kV for input/output lines
lines
Surge IEC 61000-4-5 ± 1 kV differential mode ± 1 kV differential mode Mains/line power quality should be
that of a typical commercial or
± 2 kV common mode ± 2 kV common mode
Voltage dips, short < 5% UT Essential performance of Mains/line power quality should be
interruptions and voltage (> 95% dip in UT) for the laser device remain that of a typical commercial or
variations on power supply ½ cycle hospital environment. If the user of
input lines IEC 61000-4-11 the Sphinx jr. requires continued
operation during power mains/line
40% UT Essential performance of interruptions it is recommended that
(60% dip in UT) for the laser device remain the Sphinx jr. should be powered
5 cycles from an uninterruptible power supply
or battery.
70% UT Laser device remains in

(30% dip in UT) for stable condition
25 cycles
< 5% UT Laser device remains in

(> 95% dip in UT) for 5 s stable condition
Power frequency (50/60 Hz) 3 A/m 3 A/m Power frequency magnetic fields
magnetic field IEC 61000-4-8 should be at levels characteristic of
a typical location in a commercial or
NOTE: UT is the a. c. mains voltage prior to application of the test level.

3.7.3 Guidance and manufacturer’s declaration - electromagnetic immunity for

equipment and systems that are not life-supporting
Immunity test IEC 60601 – test level Compliance level Electromagnetic environment -
guidance
Portable and mobile RF communications
equipment should be used no closer to
any part of the Sphinx jr., including
cables, than the recommended
separation distance calculated from
equation applicable to the frequency of
the transmitter.
Conducted RF 3 Vrms complies Recommended separation distance
IEC 61000-4-6 150 kHz to 80 MHz
V1=3 Vrms
d = 1,2 P
Radiated RF 3 V/m complies Recommended separation distance
IEC 6100-4-3 80 MHz to 2,5 GHz E1=3 V/m
d = 1,2 P 80 MHz to 800 MHz
d = 2,3 P 800 MHz to 2,5 GHz
where P is the maximum power output

rating of the transmitter in watts [W]
(according to the transmitter
manufacturer) and d is the recommended
separation distance in meters [m]
Field strengths from fixed RF
transmitters, as determined by an
a
electromagnetic site survey , should be
less than the compliance level in each
b
frequency range .
Interference may occur in the vicinity of
devices with the following symbol:
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.

3.7.4 Recommended separation distances between portable and mobile RF

communications equipment and devices that are not life-supporting
The Sphinx jr. is intended for use in an electromagnetic environment in which radiated disturbances are controlled.
The user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment and the Sphinx jr. as recommended below.
Rated nominal output power of Separation distance as a function of transmitter frequency [m]
the transmitter [W] 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
d = 1,2 P d = 1,2 P d = 2,3 P

0,01 0,12 0,12 0,23
0,1 0,38 0,38 0,73
1 1,2 1,2 2,3
10 3,8 3,8 7,3
100 12 12 23
For transmitters rated at a nominal output power not listed in the table above, the recommended separation distance (d) in meters
[m] can be determined using the applicable equation (observe frequency). P = nominal power of the transmitter in Watt [W].
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.
3.7.5 List of cables and their length

Cable part no. Length
Power supply cable n/a 5,0 m
Potential equalisation lead 101 630 123 5,0 m
Footswitch Kix. 101 630 147 2,9 m
Footswitch Kix DUO 101 630 144 2,9 m

Sphinx jr. Laser safety
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
4.1 General information

4.2 Laser safety officer
4.3 Laser area
4.4 NOHD, Nominal Ocular Hazardous Distance
4.5 Required eye protection
4.5.1 Eye protection markings for USA (ANSI Z136.1)
4.5.2 Eye protection markings for European Union (EN 207)
4.6 Marking of entrance doors to laser areas
4.7 Laser safety labels
4.7.1 Explanatory label
4.7.2 Aperture label
4.7.3 Laser-Stop

4.1 General information

The Sphinx jr. Holmium laser uses as its working beam a pulsed Ho-YAG laser with an emission
wavelength of 2,1 µm. The laser device is a class 4 laser device in accordance with IEC 60825.
Accidental irradiation of persons can cause injuries to the skin and the eyes.
A laser with an emission wavelength of 635 nm (red) or an emission wavelength of 532 nm (green) (see
labelling of the device) and an output of max. 5,0 mW is used as aiming beam (pilot laser). This laser is
class 3R. Thus, one must refrain from irradiating persons when they are not undergoing treatment.
Observe the applicable national guidelines of your employer’s liability insurance association and equal
ranking organizations and your national guidelines / regulations on the safe use of medical laser devices.
The responsibilities, relevant safety measures and personal protective gear are described in these
regulations.
Follow the instructions in this manual and those in the laser accessory manual.
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.
Use of controls or adjustments or performance of procedures other than those specified

herein may result in hazardous radiation exposure and may lead to injuries of skin and
eyes.
DANGER
Irradiation of flammable materials, gases or liquids can cause them to ignite.

Do not use the laser in an explosive atmosphere!
DANGER
Lock device by removing key of key switch to prevent unauthorized use of laser device
DANGER
The “ready-mode” can only be activated if a fibre is connected.

The laser should only be used if the desired target is clearly visible.
DANGER
Use only laser fibres, dedicated for Sphinx jr. laser system.
Be aware the fibre restrictions due to maximum laser power.
Use of not dedicated fibre or too much laser power might result in damage to fibre or
DANGER
laser.
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.

4.2 Laser safety officer

According laser safety regulations in most countries the operator of a laser, usually the hospital
administration, has to appoint in writing a proficient person as the laser safety officer of the organization.
The laser safety officer is regarded as proficient if, during his professional training or experience he has
acquired sufficient knowledge about the use of the laser, which is to be brought into use, and is
thoroughly informed about the effect of laser radiation, about safety measures and safety regulations, so
that he is able to assess the necessary safety precautions and check their effectiveness.
Make sure that you fulfil your national regulation on the safety of medical laser devices before operating
the system.
4.3 Laser area

The laser area is considered to be that area, in which the amount of radiation can exceed the current
maximum permitted exposure limit of the cornea of the eye (MPE), including the possibility of a random
unintended deviation of the laser beam. Usually the laser area is identical to the room, in which the laser
is installed.
4.4 NOHD, Nominal Ocular Hazardous Distance

As laser radiation is more or less divergent the energy density decreases with increasing distance from
the laser source. The NOHD marks the distance were the energy density of the laser radiation is equal to
the MPE (Maximum Permissible Exposure Limit).
The NOHD is calculated according to the European standard 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 EPulse = 4,2 J
Average power Pavr = 36 W
Pulse length (minimum) tmin = 100 µs
Pulse frequency (maximum) f = 22 Hz
Pulse peak power Pp = EPuls / tmin = 4,2 J / 100 µs = 4,2*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 jr. Holmium laser follows the assessment of the average
power.
Average energy of irradiation

According to Cap.13.3b of DIN EN 60825-1 the mean value of the radiation of a series of pulses is (MPE
limit):
E series = 5600 ⋅ t −0, 75Wm −2 = 5600 ⋅ (10 s ) −0,75 Wm −2 = 995,83Wm −2
The actual power (Pmean) of a series of pulses is:

Pmean = PP ⋅ t min ⋅ f = 4,2 ⋅10 4 W ⋅100μs ⋅ 22 Hz = 92W
The NOHD (rNOHD) is than calculated as:

4 ⋅ 2,5 ⋅ Pmean 4 ⋅ 2,5 ⋅ 92W
−a − 200 ⋅ 10 −6 m
π ⋅ E series π ⋅ 995,83Wm −2
rNOHD = = = 1,23m
φ 0,443rad
The NOHD for the Sphinx jr. Holmium laser is: 1,3 m.

4.5 Required eye protection

All personnel who are within the NOHD are considered to be within the laser area and shall wear suitable
eye protection supplied with a minimum protection class/optical density at 2,1 µm.
Referenced Standard Protection Class / Wavelength
Optical Density (OD)
EN 207:2002-12 L2 2.123 nm
EN 207:2010-04 LB2 2.123 nm
ANSI Z136.1 OD3 2.123 nm
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.
4.5.1 Eye protection markings for USA (ANSI Z136.1)

The protection levels are expressed in optical densities (OD) for the different wavelengths. The ANSI
optical density is based on the full protection provided by the filter before radiation breakthrough (and
therefore, eye-injury) occurs, e.g. OD.
4.5.2 Eye protection markings according to EN 207:2002-12

This standard requires that the filter must withstand an impact of 10 seconds duration from a laser with no
loss of protection. Filters which meet these requirements are marked with the appropriate protection level,
“L_” e.g. DIR >1400-2200 L2 XXX DIN CE.
DIR Laser type. D = continuous wave / I = Pulsed / R = Giant Pulsed (Q-switched) /
M = Mode-locked pulsed
>1400-2200 Wavelength rage against which the filter provides protection.
L2 Scale number (protection level).
L1 = maximum spectral transmittance of 10-1, L2 = 10-2, etc. up to L10 = 10-10
XXX Manufacturer’s designation
DIN CE Signifies conformity to EN 207
4.5.3 Eye protection markings according to EN 207:2010-04

This standard requires that the filter must withstand an impact of 5 seconds duration from a laser with no
loss of protection. Filters which meet these requirements are marked with the appropriate protection level,
“LB_” e.g. DIR >1400-2200 LB4 XXX DIN CE.
DIR Laser type. D = continuous wave / I = Pulsed / R = Giant Pulsed (Q-switched) /
M = Mode-locked pulsed
>1400-2200 Wavelength range against which the filter provides protection.
LB2 Scale number (protection level).
LB1 = maximum spectral transmittance of 10-1, LB2 = 10-2, etc. up to LB10 = 10-10
XXX Manufacturer’s designation
DIN CE Signifies conformity to EN 207

4.6 Marking of entrance doors to laser areas

All entrance doors to the laser area (e.g. the operating theatre), in which the laser system is set up and
operated, have to be marked on the outside with the following laser hazard symbol in accordance with
IEC 60825 (or the relevant local regulation) (Fig. 4) (original black on yellow).
If a laser is used the operating theatre becomes the laser area.
A laser warning light at all entrance doors to the laser area (operating room) is mandatory. This light
always has to be illuminated when the laser is in operation.
030 703 040
LISA laser products

www.lisalaser.com
Fon: +49 5556 9938-0
Fig. 4: Warning Sign (hazard symbol) for entrance doors of laser area

4.7 Laser safety labels

This section describes the type and the location of the danger and regulatory compliance labels of the
Sphinx jr. laser. From the labelling of the system the user gets important information regarding the device
and the safety of laser devices. The labelling follows the IEC 60825-1:2007 standard.
4.7.1 Explanatory label

The following signs are attached to the back of the laser, (original black on yellow). They show the laser
class and output (Fig. 5).
Explanatory label
F in Fig. 11
Fig. 5: Explanatory label laser radiation output
4.7.2 Aperture label

The beam outlet is marked with the following signs (original black on yellow) (Fig. 6):
030 703 011
Aperture label Aperture label

A in Fig. 10 B in Fig. 10
Fig. 6: Aperture label

4.7.3 Laser-Stop
The Laser Stop-Button is marked with the following sign (original black on yellow) (Fig. 7):
Label Laser-Stop
C in Fig. 10
Fig. 7: Label Laser-Stop

Sphinx jr.
Sphinx jr. Labelling of the device
5 Labelling of the device

This section describes the type and the location of the danger and regulatory compliance labels of the
Sphinx jr. laser. From the labelling of the system the user gets important information regarding the device
and the safety of laser devices. The labelling has to follow the applicable standards and regulations.
The position of the labels is given in Fig. 10 and Fig. 11.
Content
5.1 Used symbols

5.2 Nameplate
5.3 Position of warning signs and labels

5.1 Used symbols

The following symbols are used:
REF SN
Reference Serial Number Laser output Applied part Pay attention to Key-switch OFF ON
no. type BF user manual (OFF / ON)
x °C
x °C
YYYY
Receptacle Operating CE-Mark Protective Do not dispose in Date of Potential Manufacturer
for footswitch temperature class domestic waste manufacture equation
5.2 Nameplate
The name plate (Fig. 8) of Sphinx jr. laser is attached to the back of the device (position G in Fig. 11). It
comprises all the necessary data for the identification of your laser system.
Fig. 8: Nameplate Sphinx jr. (H in Fig. 11)
5.3 Danger Label Electric Energy

Parts of the device where danger from High Voltage electric energy may occur are labelled with the
following sign (used inside device only):
DANGER
HIGH VOLTAGE
Fig. 9: Danger Label Electricity

5.4 Position of warning signs and labels

A
Fig. 10: Labels at the front of the device
Fig. 11: Labels at the back of the device

Sphinx jr.
Sphinx jr. Operation of the laser device
6 Operation of the laser device

This section describes the operation of the laser device. You will get information about the different
operating elements. The different operational modes are described.
You will learn how to set the laser parameters and how to check the orderly state of the device and the
laser fibres. The procedures are described step-by-step.
You will get important safety information.
Content
6 Operation of the laser device

6.1 General safety information
6.2 Starting-up
6.2.1 Prearrangement
6.2.2 Switching-on routine:
6.2.3 Connecting the footswitch
6.2.4 Connecting the door interlock
6.2.5 Connecting a potential equalisation lead
6.3 Proper condition of the laser system
6.4 Operating and display components
6.4.1 Operating console
6.5 Operating the display control
6.5.1 Hammer effect
6.5.2 Menu structure of the display control
6.6 Pulsed Mode
6.7 Burst mode
6.8 Double footswitch
6.9 Operational states of the system
6.9.1 Set laser device in ready mode
6.9.2 Set laser device in “Stand by” mode
6.10 The Memo menu
6.10.1 Loading of pre-selected settings
6.10.2 Memo – Saving settings
6.11 Setting the brightness of the pilot laser / aiming beam
6.12 Usage statistic and counter reset
6.13 Connecting a laser fibre to the laser
6.13.1 Safety information
6.13.2 Checking the laser fibre
6.13.3 Attaching the laser fibre to the fibre port
6.14 Disconnecting the fibre from the laser
6.15 Switching-off routine
6.16 Cleaning the laser system

6.1 General safety information
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 The “Ready state” can be activated only when a laser fibre is connected.
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
During normal operation the housing and the operator panel have room temperature.
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

6.2 Starting-up
6.2.1 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 measures 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 interlock 3.3)
3. The footswitch is attached (Section 6.2.3)
4. The necessary laser fibres and laser applicators are available. Concerning the use of laser fibres
and laser applicators please consult the relevant manuals.
5. All persons 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 4.3).
6.2.2 Switching-on routine:

1. Switch the laser device on using the key switch on the front of the device (1/4 turn to the right).
The cooling water pump and the passive cooling system will immediately start to work.
The status symbol is illuminated green when the laser device is connected to the power line. The
microprocessor control carries out various checks on the device during the first 60 seconds after
switching-on (start-up). At first the light stripes (Fig. 1) are illuminated in green and the colour touch
screen is dark. After completion of the start-up a short tune is played. After approx. 40 seconds the Start
display (Fig. 12) appears on the screen and during the course of a test routine the laser emits an audible
internal laser pulse. The start display appears on the monitor displaying the brand name of the model and
the symbol of the manufacturer. After approx. 60 s the selection menu appears (see section on
“Operation of the display control”).
Software version
Fig. 12: Start up display after switching-on the laser system
The software version of the laser system is written in the start display at the right bottom (01vXX: Version
01, revision state XX)
2. Possible fault messages during the Start-up routine appear on the screen in clear text (see
section on “Fault messages”).
3. The desired mode is selected either directly or as a pre-setting (memo) (see section on
“Operation of the display control”).
4. Turn the fibre holder upright.

6.2.3 Connecting the footswitch

The connector at the free end of the footswitch cable is plugged into the socket at the front side of the
system (Fig. 1) and locked. The connector will fit in only one orientation. For safety and ease of control
the footswitch and the distal end of the laser fibre always should be as close as possible to each other
and under control of the same person. For the Sphinx jr. two footswitch variants are available: The single-
pedal footswitch Kix and the double-pedal footswitch Kix DUO.
Fig. 13: Single footswitch “Kix“ Fig. 14: Double footswitch “Kix DUO“
If no footswitch is connected the following screen (Fig. 15) appears. Please attach the single footswitch
Kix or the double footswitch Kix DUO. If a footswitch is connected a status symbol appears on the
console. In case you insert the single footswitch Kix this symbol appears. If you insert a double
footswitch both symbols for the left and the right footswitch appear on the console. When the
footswitch is connected the screen should look like shown in Fig. 16.
Fig. 15: Screen „No footswitch connected“
6.2.4 Connecting the door interlock

A door interlock may be plugged into the socket on the rear side of the laser system (Fig. 2) and locked. If
no door interlock switch is used, the dummy connector supplied with the laser on delivery must be
plugged into the free socket. When the doorinterlock switch circuit is broken – or pin 1 and pin 3 are not
bridged – the laser is immediately de-activated. After the door-interlock switch has been closed again the
laser operates again after pressing the ‘ready’ button. The installation of the door-interlock must be done
in collaboration between one of the manufacturer’s service technicians and your house technician (Fig.
2).
If the interlock circuit is not closed or if the dummy connector is not inserted a status symbol appears
red on the console. In addition a message appears on the screen. Otherwise the symbol is green.
6.2.5 Connecting a potential equalisation lead

The purpose of additional potential equalisation is to equalise potentials between different metal parts that
can be touched simultaneously; or to reduce differences of potentials which can occur during operation

between medical electrical devices and conductive parts of other objects. Connect the appropriate
potential equalisation lead to the connector at the back side of the laser device (Fig. 2).
6.3 Proper condition of the laser system

The laser system is in normal state if:
1. after switch on first the start display and then the parameter menu appears,
2. the maximum adjustable power corresponds with the value on the name plate,
3. the readings on the display are clearly legible
4. the displayed parameters are plausible and the graphical and numerical readout correspond
5. a fibre that is in proper condition emits power during operation of the laser.
6.4 Operating and display components

The operating and display components are arranged in two groups on the front side of the laser.
The operating console contains the most important operating and indicating components (Fig. 16).
The receptacle for the footswitch, the key switch and the emergency (laser stop) button are located at the
front of the device (Fig. 1).
The power line cable (Fig. 2) and the storage for the footswitch (Fig. 3) is located at the back side of the
device.
6.4.1 Operating console

All communication between operator and laser device passes through the operating console. The beam
outlet is integrated into the operating console on its left side. A fibre holder is located at the left side of the
operating console.
The output components of the laser device are the coloured display, the laser warning lamp, a cycle-
segment display and a loudspeaker.
The input elements are the capacitive touch screen and the ready slider. Devices up to serial number
(SN) 006 have an additional adjusting wheel.
Segment display
Laser warning (adjusting wheel
lamp SN < 007)
Beam outlet
Coloured touch
screen
Status symbols
(see Tab. 3 )
ready slider
Fig. 16: Operating console
The symbols (Tab. 3) on the left side of the console give important information about the status of the
laser device.

Tab. 3: Status symbols used on the operational console
red: interlock is open green: fibre connected billing system green: device is
switched on
green: Interlock is
closed yellow: device is in
power down mode
red:error occurs green single footswitch green: right footswitch green: laser is active
or left footswitch pedal pedal is connected
is connected yellow: limit of pump
yellow: footswitch is energy is reached
yellow: footswitch is pressed
pressed
6.5 Operating the display control

Use the touch screen to set and change the laser parameters.
The touch screen is divided into four parts:
1. Status line with laser device name, the power setting, the system message and the energy
counter
2. the laser mode and the laser parameters of the single footswitch or the left footswitch pedal of the
double footswitch Kix DUO are shown on the left side in yellow-brown colour
3. the laser mode and the laser parameters of the right footswitch pedal of a the double footswitch
Kix DUO on the right side in green-blue colour. If a single footswitch is connected to the laser
device this part is invisible
4. the bottom line with the menu of the memory, the setting of the aiming beam, the usage statistics
and the general parameter menu.
1.
2. 3.
4.
On the right side of the status line the summarisation symbol Σ and the unit J indicate how much energy
has been emitted since the last summation-reset.
Touch the mode area “pulsed mode” to select the “pulsed mode” or the “burst mode”. The selected mode
is highlighted and its parameters will appear.
By touching a parameter at the screen with a finger, this parameter can be set. Since the finger touches
the parameter slider on the screen the slider is highlighted and the value can be adjusted. Slide the
indicator to the left to decrease the parameter or to the right to increase it.

name of the power system energy

laser device setting message counter
parameters parameters
of the left of the right
footswitch footswitch
pedal pedal
(appears
mode only for
selection double
footswitch)
laser
parameter
entering memo setting of usage Setting of

menu aiming statistics general
beam parameters
(e.g. language)
Fig. 17: Set up of the touch screen
Tab. 4: Laser parameters and their symbol:
Symbol Parameter Explanation

Pulsed mode In pulsed mode the laser emits laser pulses
continuously.
Burst mode In burst mode the laser emits a fixed series of

laser pulses.
Energy in Joule [J] Energy of a single laser pulse
Frequency in Pulses per seconds

Hertz [Hz]
Pulse effect The parameter influences the pulse peak power

and the pulse duration. Adjustment of laser pulse
for hard and soft stones or tissue
Number of pulses Number of pulses to be applied and emitted after
in burst mode pressing the footswitch.

6.5.1 Pulse effect

A special feature of Sphinx jr. lasers is the adjustability of the pulse effect. By the effect the pulse duration
and the pulse peak power is set. The range of the pulse effect is 10 to 100.
In the diagrams in Fig. 18 and Fig. 19 the pulse shape is displayed. At the x-axis of the diagram is the
time and at the y-axis the power. For both diagrams the scale is similar. The laser pulse shape is different
depending on the preset effect. At the pulse effect setting “100” the pulse duration is short (e.g. ~160 µs)
and the peak power is high (here e.g. ~18 kW). At the pulse effect setting “10” the pulse duration is much
longer (here: ~400 µs) and the pulse peak power is lower (e.g. ~7 kW)
Fig. 18: Diagram of a short laser pulse with a high Fig. 19: Diagram of a long laser pulse with a
peak power at pulse effect “100” moderate peak power at pulse effect “10”
When the laser pulse duration is altered the set pulse energy remains constant. The result is an
increased peak power for short laser pulses and a lower peak power for long pulses.
This special technical feature is particularly useful, for example, in lithotripsy and during the removal and
cutting of soft tissue.
For the same amount of pulse energy a short laser pulse is more effective for removing hard tissue than a
longer laser pulse of similar energy, because of its higher peak pulse output. On the other hand, the
coagulating effect of the long laser pulse is better than the coagulating effect of the short laser pulse.
The laser-tissue interaction can be summarized as follows:
Tab. 5: Usage of the pulse effect
Pulse Pulse duration Pulse peak Removal of hard tissue, Removal of soft tissue,
effect power lithotripsy coagulation
100 Short laser pulse High peak + -
10 Long laser pulse Low peak - +
In order to change the effect, tip your finger on the hammer symbol and the parameter slider will appear.
Touch the slider and move it to the desired value.

6.5.2 Menu structure of the display control
Start-up
Footswitch
attached?
Pulsed mode Burst mode Memo Pilot Statistics/ Menu

Menu Laser counter
More parameters More parameters Memo Power Usage General

entry setting data setting
reset selection
6.6 Pulsed Mode

In pulsed mode the energy, the frequency and the pulse effect of the emitted radiation can be varied. The
laser emits pulses as long as the footswitch is pressed. When the “pulsed” mode is selected the following
menu appears:
mode selection:
here: the highlighted frame option “burst mode” (not
indicate the selected mode selected)
“pulsed mode”
Status line
(grey in “Stand-
Parameter by”)
slider to
indicate value
set
parameter
value
bar to indicate the

adjustable range of the Triangle to close parameter
parameter “energy” in menu
correlation to the
“frequency”
Fig. 20: The parameter menu in “pulsed mode”
In the pulsed mode the power (P) is calculated (Pavarage = Energy x Frequency) and displayed in the top line.
Here power (P) means the average power of the laser device, which can be adjusted over a range of
some 10 watts. This average power is different from the pulse peak power of a single pulse, which is in
the range of several kilowatts.

6.7 Burst mode

The burst mode was specially designed for the application of the laser device in lithotripsy.
During this application a single pulse or a pre-set series of pulses is emitted. You can set the number of
pulses and the repetition rate. The laser emission stops automatically when the specified number of
pulses is reached or when you release the footswitch.
The following parameters can be set in the burst mode menu:
1. Energy of the individual laser pulse
2. Pulse effect
3. Number of pulses
The repetition rate (frequency) is always the highest rate which is possible at the selected energy.
Variation of the adjustable parameters in the burst mode is carried out according to the same method as
in the pulsed 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.
Mode selection
option “pulsed mode” (not here: the highlighted frame
selected) indicates the selected mode
”burst mode”
Slider to indicate
set value
Triangle to close
parameter menu
The highlighted number of Number pulses which

pulses is selected, here: can be set 1 to 5
“1 pulse”
Fig. 21: The parameter menu in “burst mode
6.8 Double footswitch

The double footswitch Kix DUO allows the surgeon to switch between two settings without touching the
(non-sterile) screen. Therefore, the surgeon does not depend on the circulating nurse to adjust the laser
parameters.
If the double footswitch Kix DUO (Fig. 22) is connected to the laser device the laser mode parameters of
the left and of the right pedal are displayed on the screen (Fig. 23). The laser parameters of the left pedal
have a yellow-brown background and the parameters of the right pedal have green-blue background.
Left pedal
marked
yellow-brown
Right pedal
marked
green-blue
Fig. 22: Double footswitch „Kix DUO”
The yellow-brown
colour indicates the
laser parameters of the
left pedal of the Kix
DUO
The green-blue
colour indicates the
laser parameters of
the right footswitch
Fig. 23: Yellow-brown and green-blue background indicate the parameters of the left and the right pedal
of a double footswitch.
At the same time only one set of parameters (related to the left or the right pedal) is active. The surgeon
selects the pedal by pressing it for approximately 1 s. A sound tunes and the yellow frame indicates the
selected footswitch pedal (Fig. 24). To activate the laser with the selected laser parameters press the
same footswitch pedal a second time. Before you can activate the laser the laser must be switched from
the stand by to the ready mode.
The yellow frame indicates The yellow frame indicates

the selected footswitch pedal: the selected footswitch pedal:
here left pedal here right pedal
Fig. 24: Yellow frame marks the selected foot pedal of a double footswitch
6.9 Operational states of the system

During operation two different operational states are possible:
1. Stand-by: The system is fully operational but is not yet ready to emit laser radiation. The laser
warning lamp (Fig. 26) and the pilot laser are not yet switched on. This state is reached after the
start-up and whenever the release is set back. The light stripes are illuminated green.
2. Ready: By activating the ‘ready’ slider once (Fig. 25) the system is switched from the Stand-by state
to the Ready state. The system is now ready to emit laser radiation. The laser warning lamp is lit and
the pilot laser is switched on. The light stripes are illuminated red. By pressing the footswitch laser
radiation is emitted. Pressing the ‘ready’ slider again switches the system back into Stand-by state.
6.9.1 Set laser device in ready mode

1. To set the laser into ready-mode a fibre must be connected. 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 30 seconds.

2. By sliding the thumb or finger over the ready slider (from left to right) the laser is switched from
“Stand-by” to “Ready”
.
Fig. 25: Sliding the finger over the ready slider sets the laser device into “Ready” Mode
The “Ready” mode is indicated by the illumination of the laser warning lamp, the red ready slider, the red
status bar in the screen and the light stripes are shining red (Fig. 26).
In addition, the pilot laser is switched on. At the beginning the pilot laser is blinking several seconds until
the laser device is ready. A delay for at least 2 s is mandatory due to regulations in the laser safety
standard (IEC 60825-1).
If the pilot laser is not visible at the distal end of the fibre adjust the setting for the brightness of the pilot
laser (see section 6.10) and check the fibre (see section 0).
Red status line
Red ready slider
Red laser warning lamp
Red light stripes
Fig. 26: Indications for the “Ready” mode
Fig. 27: Red status line indicate that the laser device is in “Ready” mode
The laser emission is activated by pressing the footswitch. Emission of the first laser pulse will follow after
a short delay of a few tenths of a second after pressing the foot pedal.

During the laser emission the laser pulse characteristics are displayed with a diagram called oszillograph.
The shape of the laser pulse is shown. The pulse characteristics can be varied by the pulse effect. A
pulse effect “100” leads to short pulse duration and a high peak power and a lower pulse effect leads to
longer pulse duration and a medium pulse peak power (Fig. 28).
Fig. 28: Pulse characteristic of a short pulse with a high peak power (left) and a long pulse with medium
pulse peak power (right).
Before the laser is used on a patient, always make sure that the laser device and used accessories are in
a proper state (Section 6.3 ”Proper condition of the laser system").
6.10 Setting the brightness of the pilot laser / aiming beam

The pilot laser power (brightness) is set in the pilot laser menu.
The laser beam power can be varied between off and 100%. At 100 % the power of the emitted light
might be up to 5 mW. Do not look into the aiming beam!
For the Sphinx jr. a red or a green pilot laser is available. Please check the name plate for detailed
information on your system.
Fig. 29: Pilot laser menu

6.10.1 Set laser device to “Stand by” mode

By touching the ready slider the laser is switched from the “Ready” mode into the “Stand by” mode like
shown in Fig. 30.
Fig. 30: Switching to „Stand By“ mode
6.11 The Memo menu

The setting of laser parameters can be saved within the memo menu. In addition you can load laser
settings within this menu.
By touching the screen at “Memo” the memo menu appears.
After selection of the “Memo” menu the following screen image appears.
Memory number
Laser parameters
left pedal
Memory name
Laser parameters
Laser parameters right pedal
Free memo
position
Fig. 31: Memo menu
Laser parameter
Yellow / orange colour: Pulsed mode:
Laser parameter for the left Energy: 1,6 J,
footswitch pedal: Frequency: 12 Hz and
effect 25
Green / blue colour: Burst mode:
Laser parameter for the right Energy: 1,2 J,
footswitch pedal: 5 pulses
effect 57
6.11.1 Loading of pre-selected settings

By pressing the memory name „e.g. urether stone” is selected and the following figure (Fig. 32) will
appear. Please confirm the selection by pressing the “load” button or the memory name and the laser
parameters will be loaded.

Fig. 32: Loading of the laser parameter settings
6.11.2 Memo – Saving settings

The laser parameter settings can be saved by pressing a free memory position which has a black
background (Fig. 31). In case no free memory position is shown on the page please scroll the pages until
a free memory position is available.
In the following sample the memory position number 7 has been selected
and the name “test” has been written as the memory name. To delete a single letter within the name
press the back arrow . The laser settings are saved with the name “TEST” by pressing the
button “save”.
Fig. 33: the memo menu (left) with empty memory positions and the save menu (right)
6.12 Usage statistic and counter reset

The usage data can be checked within the statistics menu. The following table explains the recorded
usage data:
Tab. 6: Recorded usage data
Start Date and time in Greenwich mean time of the first laser activation
Duration Time between the first and the last laser activation
Laser active Time, in which the laser was emitting radiation
Pulse count Summed number of emitted pulses
Energy Summed energy in J (displayed in the top right corner of the status line)
The usage data is recorded for the whole laser system. The device does not separate the usage data of
each pedal of a double footswitch.

Fig. 34: Usage statistic
By pressing the “Restart” button you reset all data to zero.
6.13 Connecting a laser fibre to the laser
6.13.1 Safety information
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
and sterilized.
It is not allowed to use damaged laser 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.
The values shown for power and energy presuppose perfect focussing in the fibre, a perfect fibre coupling
blast shield and the laser fibre being in perfect condition. If the laser fibres are not in a perfect condition
the transmission can drop considerably. The calibration of the indicated value with the emission from the
fibre is explained in the section on “Calibration of the energy and power display”.
A dirty or damaged fibre coupler protection 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 pulsed 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.
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.
6.13.2 Checking the laser fibre

Before connecting the fibre check the following:
1. The free-standing fibre tip in the fibre connector (ca. 0.5 mm in diameter, depending on fibre type)
must be smoothly reflective and free from damage and dirt. The hollow space within the fibre
connector surrounding the fibre tip must be free of any sign of blackening or burning. If necessary
use a magnifying glass (e.g. FibreScope 50 (REF 101 503 415)) for checking.
2. The fibres must be undamaged and without a kink throughout the entire length.
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
6.13.3 Attaching the laser fibre to the fibre port
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 try to 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. Remove the protection cap of the fibre.

3. Hold the connector close to the beam outlet. The fibre port will open automatically and the fibre
connector is illuminated. Alternatively touch the Ready slider to open the fibre port manually. Note
that the fibre port will close automatically after about several seconds. Take care that no dirt or
liquids penetrate into the beam outlet.
4. Place the fibre into the SMA-receptacle, screw it in and tighten it finger-tight.
Fig. 35: Connecting the fibre
Fig. 36: Illuminated fibre coupler
When the fibre is connected the fibre status symbol will appear and the green lights next to the fibre
port will appear continuously. The aiming beam (pilot laser) is switched on automatically (blinking at low
frequency) when the fibre is connected.
To switch the laser into the Ready mode please read section 6.9.1 “Set laser device in ready mode”.
The “Ready” mode is indicated by the illumination of the laser warning lamp, the red light stripes and the
pilot laser (aiming beam) being switched on continuously. 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.
1. The laser emission is activated by pressing on the footswitch. Emission of the first laser pulse will
follow after a short delay of a few tenths of a second after pressing the foot pedal.
2. Before the laser is used on a patient, always make sure that the laser device and used
accessories are in a proper state (Section 6.3 ”Proper condition of the laser system").
6.14 Disconnecting the fibre from the laser

1. Unscrew the connected fibre connector from the SMA-receptacle (turn to the left) and carefully
take it out.
2. Check the proper state of the fibre.
3. Screw protective cap onto the fibre connector.
6.15 Switching-off routine

1. Switch off the laser device with the key switch. The fibre port is closed automatically. All settings
are retained for the next time it is used.
2. Take off laser safety goggles.
3. Pull out the mains plug and wind the mains cable back into the cable drum.

6.16 Cleaning the laser system

The laser device is not protected against incoming moisture. There is the danger of an
electrical shock. Switch off the laser and disconnect the laser from the mains supply
before cleaning the device.
WARNING
1. Switch off the laser device and pull out the mains connector.
2. Disconnect the fibre, the foot switch cable and the interlock
3. Wear protection gloves for disinfection and cleaning
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 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.
6. 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.
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

Sphinx jr. Clinical applications
7 Clinical applications and Tissue interaction

The following text is based upon the experiences of users of Sphinx jr. 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
7.1 Safety instructions

7.2 Preparation
7.3 Step-by-step procedure
7.4 Applications
7.4.1 Arthroscopy
7.4.2 Urology
7.4.3 ENT
7.5 Laser tissue interaction
7.5.1 Basic physico-technical principles
7.5.2 Basic physico-medical principles
7.5.3 Tissue interaction
7.5.4 Irrigation liquid

7.1 Safety instructions

If you use a broken fibre, an incorrect inserted fibre or a non fixed fibre in the applicator,
the fibre might slid out of the applicator or irradiation occurs in the instrument. This might
result in injuries of the patient or yourself or could damage the applicator or fibre.
DANGER
Whenever a Sphinx jr. 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.
The “ready-mode” can only be activated if a fibre is connected.

The laser should only be used if the desired target is clearly visible.
DANGER
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 jr. 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 footswitch. 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
Before you start the procedure and before induction of the anaesthesia follow the described preparation
procedure.
1. Make sure that all persons involved in the operation of the laser have read and understood the
safety instructions and warnings in this and in referred manuals.
2. Evaluate the risk of the laser surgery and its potential side effects and contraindications (see
section 2.4 and 2.5)
3. Prepare the laser system and the accessories according to the instructions mentioned in section
6 “Operation of the laser device”.
4. Before induction of the anaesthesia make sure that the laser system is fully functioning (see
section 6.3), and that all necessary instruments, fibres and accessories are available.
5. 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 fibres can
easily be introduced into the instrument and check that the laser fibre can be fixed properly.
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.
7.3 Step-by-step procedure

1. Switch-on the laser according to the procedure described in section 6.2.
2. Remove the sterilized fibre from the pouch or box using aseptic technique. Before the laser
application starts, the sterile operation nurse (scrub nurse) hands over the fibre end with the fibre
connector to the circulating nurse, who operates the laser system. Inspect the fibre for damages
as described in section 6.13
3. The circulating nurse removes the protective cap of the fibre connector, opens the beam outlet of
the laser system, and inserts the connector in straight line and screws in the fibre connector
carefully into the fibre coupler. The expansion nut of the fibre connector is fixed tightly, until you
feel a resistance (section 6.13).
4. Set the aiming beam to a high intensity. Check if the aiming beam is transmitted from the distal
end of the fibre and if the beam is clearly visible on a white target. If the aiming beam is weak or
poorly visible or the appearing somewhere on the entire length of the fibre, do not use; discard
the fibre or return it to the supplier.
5. Introduce the fibre into the applicator, handpiece or endoscope. Make sure that the fibre fits to the
chosen instrument and that the inner diameter of your instrument and the outer diameter of the
fibre match closely to have good fibre guidance.
6. Position the aiming beam to the target tissue. Make sure the fibre tip extents out of the
instrument.
7. Set the laser parameters as instructed in sections 6.6 (Pulsed Mode) and 6.7 (Burst mode). The
laser is activated by pressing the footswitch. Make sure that the targeted tissue and the distal tip
of the fibre are always visible when firing the laser.
8. You should always take into account a minimum consumption of the fibre during an operation.
The surgeon recognises this erosion of the fibre tip during the laser application as an increasing
scattering of the aiming beam at the distal fibre tip. The burn-up of the fibre tip reduces the beam
quality and cutting efficiency of the working laser beam. The laser fibre tip should be inspected
continuously during the operation. In all cases the laser fibre tip has to protrude from the surgical
instrument at least half a millimetre.
9. After the procedure disconnect the fibre from the laser and immediately screw on the protection
cap (section 6.14). For re-processing, follow the instructions in the particular fibre manual.
10. Switch off and clean the laser as described in section 9.3.

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.
Application / Anwendung Pulse energy / Frequency / Pulse effect /

Pulsenergie Frequenz Pulseffekt
Urology / Urologie
Ureter Strictures / 1.2 J 12 Hz 10
Strikturen der Harnleiter
Urethra Strictures / 1.5 J 15 Hz 10
Strikturen der Harnröhre
Bladder tumor ablation / 1.0 J 10 Hz 10
Blasentumor-Abtragung
Open penis tumor resection / 0.8 J 20 Hz 10
Penistumor-Resektion
Fragmentation of Bladder Stones / 1.5 J 10 Hz 10-100
Lithotripsie von Blasensteinen
Fragmentation of Ureter Calculi / 1.2 J 10 Hz 10-100
Lithotripsie von Harnleitersteinen
Fragmentation of Kidney Stones / 1.0 J 10 Hz 10-100
Lithotripsie Nierenkelch-Steinen
Fragmentation of stones in the renal pelvis/ 1.0 J 10 Hz 10-100
Lithotripsie Nierenbecken-Steinen
Fragmentation of stones (dusting) 0.5-0.8 J 20 Hz 100
Lithotripsie („Dusting“)
Orthopädie / Orthopedics
Meniscectomy / 1.2 J 15 Hz 50
Meniskektomie
Smoothing of cartilage lesions / 0.8 J 10 Hz 50
Knorplelglättung
Lateral release / 1.5 J 10 Hz 10
Lateral Rlease
Capsular shrinkage / 1.0 J 10 Hz 10
Kapselschrumpfung
Synovectomy / 1.2 J 15 Hz 10
Synovektomie
HNO / ENT
Reduction of turbinates / 0.8 J 8 Hz 10-30
Nasenmuschelreduktion
Reduction of nasal septum (cartilage / bone) / 0.8 J 8 Hz 50 -100
Nasenseptumreduktion (Knorpel / Knochen)
Shrinkage of polyps / 0.8 J 8 Hz 10
Nasenpolypen

Application / Anwendung Pulse energy / Frequency / Pulse effect /

Pulsenergie Frequenz Pulseffekt
Wirbelsäule / Spine
Foraminoplasty (soft tissue) / 1.5 J 12 Hz 30
Foraminioplastie (Weichgewebe)
Foraminoplasty / (bone) 2.5 J 12 Hz 50-80
Foraminioplastie (Knochen)
PLDD / 0.6 J 10 Hz 10
PLDD total max. 1200 J
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.
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
DANGER 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
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.
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.
DANGER

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.

7.5 Laser tissue interaction
7.5.1 Basic physico-technical principles

The Sphinx jr. Holmium Laser is a so-called Holmium-YAG laser.
As a result of optical excitation by the light from the flash lamp the Holmium laser crystal spontaneously
emit light with a wavelength of 2,1 µm. Photons, which emerge by chance from the laser crystal onto the
optical axis and are reflected back into the crystal, experience optical amplification when there is sufficient
optical excitation of the laser crystal by the flash lamp, i.e. the intensity of the light beam increases within
the laser rod like an avalanche. The emission of the laser radiation is therefore stimulated by
spontaneously emitted light. The acronym LASER was formed from this relationship:
LASER = Light Amplification by Stimulated Emission of Radiation
A part of the light beam emerges through the output mirror as a working beam and is focussed from a
focussing optic into a laser fibre made from quartz glass. This fibre, provided with a suitably shaped
handpiece serves the operator as working instrument.
7.5.2 Basic physico-medical principles

This section will deal with the underlying principles of laser-tissue interaction. More detailed information
about special medical applications will follow lower down in the section on “Clinical applications”.
The Holmium laser emits invisible pulsed laser radiation of the 2,1 µm wavelength. Aqueous tissue
absorbs radiation of this wavelength particularly well, i.e. laser radiation affecting the tissue is absorbed in
a particularly short path distance and converted into heat. At 2,1 µm wavelength this so-called absorption
length amounts to approximately. 0,3 mm.
For the efficient removal of tissue it is necessary that the absorption process (duration of one laser pulse)
dissipates as quickly as the removal of the heat created within the tissue by thermal conduction and
convection. The output capability of the laser device in question is based upon the relatively short pulse
duration of less than 170 µs (see “Technical data” section).
With significantly longer pulse duration heat would dissipate into the surrounding area during the laser
pulse and would then no longer be available for tissue removal.
7.5.3 Tissue interaction

The tissue-removing effect of the Holmium laser is based upon direct heating of aqueous tissue during
the absorption of a laser pulse. The effective zone within the tissue is limited by the absorption length.
The absorption length describes the path length, upon which a weak laser beam, which causes no
change in the tissue, is attenuated to 1/e = 37% of its initial intensity. After a further 0.3 mm the intensity
then amounts to only 37% x 0.37% = 14%; etc.
In practical use a greater intensity is chosen, because a tissue change or tissue removal is the purpose of
using the laser. Removal is attributed to the direct heating of the tissue to above boiling point. The
resultant vaporization leads to the removal of the vaporized tissue.
The effect of the laser is at its maximum directly in front of the fibre tip. Because of the divergence of the
laser beam, the diameter of the laser beam increases continuously with the distance from the fibre tip. At
the same time the intensity and, consequently, the effect of the laser beam decreases.
The extent of what is removed depends upon the amount of pulse energy used and the area irradiated
with one pulse. As a rule of thumb one can say: The closer the fibre tip is brought to the tissue surface the
narrower though deeper is the removal. The greater the pulse energy used, the deeper is the effect.
The damage zone is not limited to the visible removal of tissue, since the individual laser pulse penetrates
beyond the excision further into the tissue. In addition, there is heating of the tissue through thermal
conduction, because heat flows out into the surrounding area through heat conduction from the area, in
which the laser pulse was absorbed.
Depending upon the treatment technique, the actual damage zone can become larger than 2 mm. As a
rule of thumb one can say: The greater the set frequency or the longer the applicator is held in one place,
the wider is the thermal damage zone. The greater the pulse energy used and the lower the frequency,
the narrower is the thermal damage zone.

7.5.4 Irrigation liquid

The Holmium laser is extremely suitable for applications using aqueous irrigation liquids. Such
circumstances occur, for example, in arthroscopy and transurethral urology. The use of the Holmium laser
on tissue in the air can easily lead to overheating and carbonization of the tissue and the throwing out of
tissue particles.
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.

Sphinx jr. Error messages and malfunctions
8 Error messages and malfunctions

This section provides information how to deal with malfunctions of the laser. The different error and
warning messages are explained and you will get recommendation how to solve the error.
You will find the address of our customer service.
Content
8.1 Error messages

8.2 Technical customer support

Sphinx jr. Error messages and malfunctions
8.1 Error messages

During operation the system continuously monitors its function and safety. Every irregularity detected by
the laser is displayed in clear text on the screen with a three-digit number, together with information on
how to deal with it (Fig. 37). Errors clear themselves once the cause is removed. Afterwards the laser
must be released with the ‘Press to close’ button. You will find a detailed list of messages and errors in
the service manual.
If it is not possible to correct an error, inform an authorised service technician. You will find the telephone
number of your service technician in the section 8.2. Please mention the error code together with the F-
Code and details when reporting a malfunction.
The messages look like this:
Fig. 37: Error message (left) and message when the error is not persisting (right)
8.2 Technical customer support

For technical service and support please contact the technical service department of LISA laser products
or your local representative.
Service
Max-Planck-Str. 1
Germany
Fon: +49-(0)5556-9938-0
Fax: +49-(0)5556-9938-10
Email: service@lisalaser.com

Sphinx jr. Care and Maintenance
9 Care and Maintenance

This section will be devoted solely to measures, which appertain to the maintenance of the laser system’s
functional capability. This section is not a repair or service manual!
You will get information about cleaning and maintenance of the Sphinx jr..
Content
9.1 Safety information

9.2 Regular safety check
9.3 Cleaning of the device
9.4 Re-processing the accessories
9.5 Check and exchange of fibre coupler protection shield
9.6 Calibration of the laser output
9.6.1 Test of accuracy
9.6.2 Use of the power meter
9.7 Exchange or refilling of cooling liquid

9.1 Safety information
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
9.2 Regular safety check

Every 12 months the laser system should undergo a technical safety inspection and maintenance by a
service technician authorized by the manufacturer to ensure proper and safe laser performance. This
inspection will include a test for accuracy and calibration of the laser output. The inspection shall follow a
procedure as described in IEC 62353.
The detailed instruction for the safety check and the test report form is available in the relevant service
manual.
9.3 Cleaning of the device

The laser device is not protected against incoming moisture. There is the danger of an
electrical shock. Switch off the laser and disconnect the laser from the mains supply
before cleaning the device.
WARNING
Surface cleaning using a damp cloth with a mild non-caustic cleaning solution, an alcohol
solution or a disinfectant may be undertaken.
WARNING
1. Switch off the laser device and disconnect the device from the mains supply.
2. Disconnect the fibre, the footswitch cable and the interlock
3. Wear protection gloves for disinfection and cleaning
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. Clean the footswitch with a damp cloth containing non-caustic mild cleaning solutions and
disinfect the footswitch and its cable with common disinfectant. The footswitch is water resistant
and can be rinsed with water. No moisture should penetrate the footswitch connector.
9.4 Re-processing the accessories

To re-process accessories like fibres, handpieces and applicators please refer to the particular user
manuals for detailed descriptions. You can order these manuals from LISA laser products or your LISA
representative.

9.5 Check and exchange of fibre coupler protection shield
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.
The fibre connector and its coupler is protected against dirt and damage by the fibre coupler protection
shield (REF 101 660 045). This protection or blast shield is located within the fibre coupler behind the
beam lock (Fig. 16). It should be subjected to a visual inspection on a regular basis by an authorised
service engineer (e.g. once per year or when the first fibre is connected). Have a broken or dirty fibre
coupler protection shield exchanged by a service technician. Please contact LISA laser products or its
representative for help.
To change the protection window open the cap [1] close to the fibre coupler (Fig. 38). Use long-nosed
pliers to pull out the protection shield [2] (Fig. 40).
1
Fig. 38: Cap above the fibre coupler protection
Fig. 39: Remove cap
shield
Fig. 40: Removal of fibre coupler protection Fig. 41: Inspect the fibre coupler protection shield
shield and insert a clean one if necessary
Lift the fibre coupler’s protection shield up to the light or place it against a clean, bright background (e.g.
clean, white paper). A clean protection shield is colourless and transparent. A significantly dirty fibre
coupler protection shield decreases the laser by about 50%. That means that half of the power emitted by
the laser is absorbed in the protection shield and converted there into heat. You can continue to use a
fibre coupler shield with only a few dots on as this means only a slight loss in power. But remember to
check the shield frequently. A dirty fibre coupler’s protection shield must be replaced immediately.
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.

9.6 Calibration of the laser output

The displayed values for energy and power shown on the screen display are based on values, taken
directly from the laser resonator. The values are reduced by a fixed factor, which takes into account for
the transmission loss of an optimum transmission system (fibre). Below will be described how the power
reading on the screen display can be calibrated. In normal use this calibration is unnecessary. Calibration
procedures should be performed annually by a properly trained and authorized service representative.
9.6.1 Test of accuracy

With the external laser power meter it is possible to determine the power emitted from the fibre tip by a
given fibre. The calibration factor for the power reading on the screen display is determined as follows:
Calibration factor = Reading of the external laser power meter / Power reading on laser display
If the power deviation between the reading on the power meter and the set value (reading on the display)
is greater than 20% then call your authorized LISA service centre in order to arrange a calibration of the
laser system.
The power emitted from the transmission system is corrected for each setting in accordance with the
following formula:
Power = Calibration factor * Power reading on laser display
The transmission properties of a fibre are highly dependent upon the condition of both ends of the fibre.
The unavoidable burning off of the distal fibre end can reduce the transmission to 50%. Evaluation and, if
necessary, the shortening of the distal fibre end are explained in the relevant accessories’ manual.
9.6.2 Use of the power meter

The external power meter (REF 101 503 140) can be ordered from LISA laser products.
The pilot laser should be set to maximum brightness and an orderly fibre attached to the laser. Before
activating the laser all persons present in the laser area must wear appropriate safety goggles. The laser
is activated by a footswitch, whilst the laser fibres pointed downwards. In doing this care is taken that
persons are not endangered and that the laser beam does not cause unnecessary or dangerous heating
of material.
With your free hand press the reset-knob on the power meter for 2 seconds, after which the black
absorbent surface is brought into the laser beam. The red spot of the pilot laser should cover about 2/3 of
the absorbent surface. If the measuring system gives out a series of three signal tones, the measurement
is complete and the footswitch is released. The power meter displays the measurement obtained in watts
for several seconds. Then, after a more rapid tone sequence, it returns to its rest position.
9.7 Exchange or refilling of cooling liquid

While the laser is being operated the cooling system draws off the resultant dissipation power into the
room air. The cooling system needs sufficient amount of cooling liquid. Before putting the laser in
operation cooling liquid supplied by the laser manufacturer must be filled up. This is checked by the
instrument automatically and is displayed as a message code at the operation panel, if the level is low.
Both the draining as well as the filling of the laser system with cooling liquid may only be undertaken by
an expert authorized by the system manufacturer. Please contact LISA laser products or its
representative. Operating the laser system without cooling water may lead to severe damage to the
laser..
9.8 Disposal of laser device and accessories

Please disinfect the surface of the laser device and its accessories before disposal. The laser device
must not be disposed as domestic waste. It contains valuable and hazardous material which should be
re-cycled or disposed according to local regulations. LISA laser products or its representative offers to re-
cycle the device at its end-of-life. Please contact your local representative for questions.

Sphinx jr. Accessories for Sphinx jr. Holmium-YAG lasers
10 Accessories for Sphinx jr. Holmium-YAG lasers

Please note that the safety and performance of the laser system is only guaranteed with accessories
approved by LISA laser products. Please contact LISA laser products or your LISA laser products
representative if the accessory part is not mentioned in the following list.
Only laser fibres that are supplied by the LISA laser products may be connected to the laser system. So-
called SMA compatible products supplied by other manufacturers may cause costly damage to laser
optics in the fibre coupler.
Use the accessories only for their intended application and make sure that they are approved for the use
with the Sphinx jr.
10.1 Laser fibres

Name Description Part No.
FlexiFib Reusable laser fibre, 101 503 189
273 µm core diameter
FlexiFib-SU Single use laser fibre, sterile, 101 503 387
PercuFib Reusable laser fibre, 101 503 128
PercuFib-SU Single use laser fibre, sterile, 101 503 384
RigiFib Reusable laser fibre, 101 503 213
RigiFib-SU Single use laser fibre, sterile, 101 503 289
RigiFib 800 Reusable laser fibre, 101 503 287
RigiFib-SU 800 Single use laser fibre, sterile, 101 503 385
RigiFib 1000 Reusable laser fibre, 101 503 284
SideFib Side firing laser fibre, single use, sterile, 101 503 138
10.2 Laser safety eyewear

Name Description Part No.
Laser safety glasses (with ear
101 503 399
pieces, small)
Laser safety glasses (with ear
fits over spectacles 101 503 400
pieces or head strap, large))
Steel goggles steel , non transparent, for patient 101 503 184

Sphinx jr.
Sphinx jr. Technical Data
11 Technical Data
Technisches Detail / Technical Detail Ausführung / Data
1 Gerät / Device Sphinx jr.
2 Abmessungen (H x B x T) / ca. / approx. 1000 x 450 x 740 mm
Dimensions (H x W x D)
3 Gewicht / Weight ca. / approx. 95 kg
4 Schutzart / Degree of protection IP 20
(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 / 200V – 240V, 50/60Hz, max. 12A (1~, N, PE)
Electrical requirements oder / or
100V – 127V, 50/60Hz, max. 20A (1~, N, PE)
automatische Umschaltung /
automatic change-over
8 Netzstecker / Mains plug Schuko-Stecker / plug Typ / type CEE 7/7 (nach /
acc. DIN 49441)
250V, 16A, grau / grey
oder / or
Hospital Grade Plug NEMA 5-20P
oder / or
BS 1363, 250V, 13A, weiß / white
9 Zuleitung / Power supply cord ca. / approx. 5,0 m
10 Leistungsaufnahme / max. 2,3 kVA
Power consumption
11 Schutzklasse / I / class I equipment
Protection against electrical shock
(nach / acc. IEC 61140)
12 Erdableitstrom N.C. / max. 0,3 mA @ 253 V (60 Hz)
Earth leakage current N.C.
Arbeitslaser / Working laser
13 Typ / Type YAG:Cr,Tm,Ho Festkörperlaser /
solid state laser
14 Laserklasse / Laser class 4
(nach /acc. IEC 60825-1: 2007)
15 Emissionswellenlänge / Wavelength 2123 nm +/- 3 nm
16 Mittlere Leistung / Avarage power max. 30 W
17 Pulsespitzenleistung / Pulse peak power max. 18 kW
18 Pulsenergie / Pulse energy 0,5 – 3,5 J
19 Pulswiederholrate / Pulse repetition rate 1 – 20 Hz, Einzelpuls / single pulse, Pulsfolge /
burst
20 Pulsdauer / Pulse duration 100 µs - 650 µs, Änderbar / alterable

Sphinx jr. Technical Data
Zielstrahl / Aiming beam

1 Typ / Type Diodenlaser / diode laser
2 Laserklasse / Laser class 3R
(nach / acc. IEC 60825-1: 2007)
3 Emissionswellenlänge / Wavelength 635 nm, auf Wunsch / optional 532nm
4 Leistung / Power max. 5 mW
Anwendungsteil / Applied part
5 Typ / Type (nach / acc. IEC 60601-1) BF
6 Strahlführung / Beam delivery Quarz – Quarz Multimode Faser /
silica – silica multimode fibre
(nur Lisa-Fasern verwendbar / LISA fibres only)
7 Faserkupplung / Fibre connector LISA-FSMA
8 Bedieneinheit / User panel Farb- / colour LCD Display, touchsensitiv
Anschlüsse / Connectors
9 Interlock Neutrik-Stecker / connector Serie / type XLR, 4-
polig / pin an der Geräterückseite / at the backside
of the device
10 Fußschalter / Footswitch Neutrik-Stecker / connector Serie / type XLR, 7-
polig / pin an der Gerätevorderseite / at the
frontside of the device
2,9 m Zuleitung / cable length
Kühlsystem / Cooling system Luft-Kühlflüssigkeit / Air-Fluid
11 Kühlflüssigkeit / Cooling fluid Entionisiertes Wasser (85 Vol.%)
+ Monoethylenglykol (15 Vol.%) /
deionised water (85 v/v %)
+ monoethyleneglycol (15 v/v %)
Umgebungsbedingungen /
Environmental conditions
Betrieb / Operation
12 Umgebungstemperatur / +15 °C - +28 °C / +59 °F - +82 °F
Air temperature
13 Rel. Luftfeuchte / Rel. air humidity 10 – 90 %, nicht kondensierend /
non-condensing
Lagerung / Storage / Transport
14 Umgebungstemperatur / -15 °C - +70 °C / +5 °F - +158 °F
Air temperature
15 Beschleunigung / Acceleration max. 25 g
16 Transportlage / transport position Aufrecht / upright, Seitenlage / lateral
Hersteller / Manufacturer
17 LISA laser products OHG Tel. +49 (0) 5556-9938-0
Max-Planck-Str.1 Fax. +49 (0) 5556-9938-10
D-37191 Katlenburg-Lindau e-mail info@lisalaser.de
Deutschland / Germany web www.lisalaser.de

Sphinx jr. Decontamination of Returned Equipment
12 Decontamination of Returned Equipment

To comply with the postal and transportation laws, equipment shipped to LISA laser products for repair or
return must be properly decontaminated with a chemical germicide that is commercially available and
cleared for use as a "Hospital Disinfectant." To ensure that all equipment has been properly
decontaminated, a signed Decontamination Certificate must be enclosed in the package.
If equipment is received without a Decontamination Certificate, LISA laser products will assume that the
product is contaminated and will assess the customer with cleaning costs.
Any inquiries should be directed to the technical service department of Lisa laser products or the local
representative.
Service
Max-Planck-Str. 1
Germany
Fon: +49-(0)5556-9938-0
Fax: +49-(0)5556-9938-10
Email: info@lisalaser.de

Sphinx jr.
Sphinx jr. Index and List of Figures
13 Index and List of Figures

Absorption length 7-7 Loading of pre-selected settings 6-14
Accessories 10-1 Mains connection 3-2
Arthroscopy 7-5 Marking of entrance doors 4-5
Authorised users of the laser device 0-2 Medical devices book 3-3
Authorized Users 2-3 Memo 6-14
Average power 6-9 Memo Save settings 6-15
Burst mode 6-10 Name plate 5-2
Care and maintenance 9-1 NOHD 4-3
Checking the laser fibre 6-17 Operation of the laser device 3-4
Classifications 2-3 Operational ambient temperature 0-2, 3-4
Clinical applications 7-1 Operational fault 0-1
Cooling 3-4 Operational states 6-12
Cooling liquid 9-4 Orderly state of the laser device 6-5
Core 2-6 Pilot laser brightness 6-12
Door interlock 3-3, 6-4 Pilot laser power 6-13
ENT 7-6 Pressure 0-2
Fibre coupler's protection shield 9-3 Re-processing of accessories 9-2
Fibre selection 2-6 Risk of injury 0-1
Footswitch 6-3, 6-13, 6-18 Safety instructions 0-1
Glycine 7-8 Sodium Chloride solution 7-8
Holmium-YAG laser 7-7 Storage ambient temperature 0-2
Humidity 0-2 Switch-on routine 6-3
Installation 3-2 Symbols 0-1
Intended purpose 2-2 Technical safety control 9-2
Intended use 2-2 Temperature 0-2
Laser area 4-3, 4-5 Tissue interaction 7-7
Laser pulse duration 6-8 Transportation and storage 3-4
Laser radiation 0-1 Urology 7-5
Laser safety 4-2 Wash liquid 7-8
Laser safety eye wear 4-4
Laser safety officer 4-3
Laser warning light 4-5

Sphinx jr.
Figures
Fig. 1: Front view ....................................................................................................................................... 2-4
Fig. 2: Rear view (Sphinx jr. with closed back door) ................................................................................. 2-5
Fig. 3: Rear view (Sphinx jr. with open back door).................................................................................... 2-6
Fig. 4: Warning Sign (hazard symbol) for entrance doors of laser area ................................................... 4-5
Fig. 5: Explanatory label laser radiation output ......................................................................................... 4-6
Fig. 6: Aperture label ................................................................................................................................. 4-6
Fig. 7: Label Laser-Stop ............................................................................................................................ 4-7
Fig. 8: Nameplate Sphinx jr. (H in Fig. 11) ............................................................................................... 5-2
Fig. 9: Danger Label Electricity ................................................................................................................. 5-2
Fig. 10: Labels at the front of the device ................................................................................................... 5-3
Fig. 11: Labels at the back of the device................................................................................................... 5-3
Fig. 12: Start up display after switching-on the laser system .................................................................... 6-3
Fig. 13: Single footswitch “Kix“ .................................................................................................................. 6-4
Fig. 14: Double footswitch “Kix DUO“........................................................................................................ 6-4
Fig. 15: Screen „No footswitch is connected“............................................................................................ 6-4
Fig. 16: Operating Console........................................................................................................................ 6-5
Fig. 17: Set up of the touch screen ........................................................................................................... 6-7
Fig. 18: Diagram of a short laser pulse with a high peak power at pulse effect “100” .............................. 6-8
Fig. 19: Diagram of a wide laser pulse with a moderate peak power at pulse effect “10” ........................ 6-8
Fig. 20: The parameter menu in “pulsed mode” ........................................................................................ 6-9
Fig. 21: The parameter menu in “burst mode.......................................................................................... 6-10
Fig. 22: Double footswitch „Kix DUO”...................................................................................................... 6-11
Fig. 23: Yellow-brown and green-blue background indicate the parameters of the left and the right pedal
of a double footswitch. .................................................................................................................... 6-11
Fig. 24: Yellow frame marks the selected foot pedal of a double footswitch .......................................... 6-11
Fig. 25: Sliding the finger over the ready slider sets the laser device into “Ready” Mode ...................... 6-12
Fig. 26: Indications for the “Ready” mode ............................................................................................... 6-12
Fig. 27: Red status line indicate that the laser device is in “Ready” mode ............................................. 6-12
Fig. 28: Pulse characteristic of a short pulse with a high peak power (left) and a long pulse with medium
pulse peak power (right). ................................................................................................................ 6-13
Fig. 29: Pilot laser menu.......................................................................................................................... 6-13
Fig. 30: Switching to „Stand By“ mode .................................................................................................... 6-14
Fig. 31: Memo menu................................................................................................................................ 6-14
Fig. 32: Loading of the laser parameter settings..................................................................................... 6-15
Fig. 33: the memo menu (left) with empty memory positions and the save menu (right) ....................... 6-15
Fig. 34: Usage statistic ............................................................................................................................ 6-16
Fig. 35: Connecting the fibre ................................................................................................................... 6-18
Fig. 36: Illuminated fibre coupler ............................................................................................................. 6-18
Fig. 37: Error message (left) and message when the error is not persisting (right) .................................. 8-2
Fig. 38: Cap above the fibre coupler protection shield.............................................................................. 9-3
Fig. 39: Remove cap ................................................................................................................................. 9-3
Fig. 40: Removal of fibre coupler protection shield ................................................................................... 9-3
Fig. 41: Inspect the fibre coupler protection shield and insert a clean one if necessary........................... 9-3
Sphinx jr. Annex
14 Annex
Document Attached
Declaration of Conformity
ISO 13485 Certificate
EC-Certificate Annex II
Material Safety Data Sheet
Decontamination Certificate
Test Report: End-of-Production Test
Test Report: Functional check
User Manual of reusable laser fibres:

Version: GA035002
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Dokument / Filename: GA035010011SphinxJrE01V01.doc gültig ab / effective: 02.04.2012

GA035010011SphinxJrE01V01.doc Seite / Page i

4.6 Marking of entrance doors to laser areas ..............................................................................................4-5

GA035010011SphinxJrE01V01.doc Seite / Page ii

GA035010011SphinxJrE01V01.doc Seite / Page iii

0 About this manual

0.1 Safety instructions and symbols used in this manual

GA035010011SphinxJrE01V01.doc Seite / Page 0-1

0.2 General safety instruction

Pay attention on stable stand of the laser device.

The laser device must not be disposed as domestic waste. It contains

GA035010011SphinxJrE01V01.doc Seite / Page 0-2

1.1 Regular scope of delivery

Sphinx jr. laser system qty. items included

2 Keys (REF 101 610 002)

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

1.2 Software version

GA035010011SphinxJrE01V01.doc Seite / Page 1-1

2.1 Identification of the model

GA035010011SphinxJrE01V01.doc Seite / Page 2-1

2.1 Identification of the model

Power (mean) max. 30 W

Pulse energy 0,5 – 3,5 J adjustable

Pulse peak power 6 – 18 kW adjustable

Pulse duration 100 - 700 µs

Repetition rate Single pulse;

Tab. 1: Specifications Sphinx jr.

2.2 General description

2.3 Intended use

2.5 Side effects

GA035010011SphinxJrE01V01.doc Seite / Page 2-2

2.6 Authorized Users

GA035010011SphinxJrE01V01.doc Seite / Page 2-3

2.8.1 Front view

Fig. 1: Front view

GA035010011SphinxJrE01V01.doc Seite / Page 2-4

2.8.2 Rear view

Fig. 2: Rear view (Sphinx jr. with closed back door)

GA035010011SphinxJrE01V01.doc Seite / Page 2-5

2.9 Fibre selection

GA035010011SphinxJrE01V01.doc Seite / Page 2-6

3 Installation of the laser device

3.1 General remarks

GA035010011SphinxJrE01V01.doc Seite / Page 3-1

3.1 General remarks

3.1.2 Before first use

3.2 Electrical installation

3.2.1 Power requirements

GA035010011SphinxJrE01V01.doc Seite / Page 3-2

Tab. 2: Power requirements of the Sphinx jr. 30

Supply 200-240 V, 50/60 Hz, 12 A, 1~/N/PE,

3.3 Connecting a door interlock

3.4 Medical devices book

GA035010011SphinxJrE01V01.doc Seite / Page 3-3

3.5 Environmental conditions

Storage, transport or operation of the system at temperatures below 0 °C may cause

3.5.1 Transportation and storage of the laser device

3.5.2 Operation conditions

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3.7 Electromagnetic compatibility (EMC)

3.7.1 Guidance and manufacturer’s declaration - electromagnetic emissions

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