Asclepion QuadroStar 532/980 User manual

1520 99 002 – 04 04
QuadroStar
USER'S MANUAL

Copyright
1520 99 002 – 04 04
Knowledge of this manual is required for the operation of the instrument. Would you
therefore please make yourself familiar with the contents of this manual and pay special
attention to hints concerning the safe operation of the instrument.
The specifications are subject to change; the manual is not covered by an update service.
© Unless expressly authorized, forwarding and duplication of this document, and the
utilization and communication of its contents are not permitted. Violations will entail
an obligation to pay compensation.
All rights reserved in the event of granting of patents or registration of a utility
model.

Contents
1520 99 002 – 04 04 1
Contents
1INTENDED USE........................................................................................................3
2TECHNICAL DATA...................................................................................................5
2.1 General specifications.................................................................................................5
2.2 Laser specifications.....................................................................................................5
2.3 Device models..............................................................................................................7
Control ................................................................................................................................................... 7
3SAFETY NOTES.......................................................................................................8
4START-UP ..............................................................................................................11
4.1 Scope of delivery........................................................................................................11
4.1.1 Basic device......................................................................................................................... 11
4.1.2 Accessories.......................................................................................................................... 11
4.1.3 Optional accessories............................................................................................................11
4.2 Installation..................................................................................................................12
4.2.1 Installation note.................................................................................................................... 13
4.2.2 Connection of door interlock and warning lamp................................................................... 13
4.2.3 Connection to power outlet .................................................................................................. 14
4.2.4 Footswitch and applicator .................................................................................................... 14
4.2.5 Service and I²C connector ................................................................................................... 15
4.3 Preparations for use ..................................................................................................15
4.4 Switching on...............................................................................................................16
5OPERATION...........................................................................................................17
5.1 Adjustment of treatment parameters........................................................................17
5.2 Adjustment of spot size.............................................................................................22
5.3 Adjustment of aiming beam intensity.......................................................................22
5.4 Special functions (TOOLS)........................................................................................22
5.4.1 Laser calibration................................................................................................................... 24
5.4.2 Calibration of the touchscreen............................................................................................. 24

Contents
1520 99 002 – 04 04 2
5.5 Activation of Ready mode and treatment.................................................................25
5.5.1 Releasing the treatment beam............................................................................................. 26
5.5.2 Switching the device off ....................................................................................................... 27
6CLEANING, DISINFECTION AND STERILIZATION..............................................29
6.1 Advice for cleaning, disinfection and sterilization of accessories.........................29
6.2 General advice for cleaning, disinfection and sterilization.....................................29
6.3 Special advice for handling, cleaning, disinfection and sterilization.....................31
7ACCESSORIES ......................................................................................................35
8ERROR MESSAGES..............................................................................................37
9FAULT REMOVAL..................................................................................................38
9.1 General information...................................................................................................38
9.2 Error messages and fault removal............................................................................38
9.3 Possible malfunctions...............................................................................................40
10 SERVICE.................................................................................................................41
11 REGULAR SAFETY TESTS AND CALIBRATION.................................................42
12 WARNINGS.............................................................................................................44
13 LABELING..............................................................................................................46
14 DISPOSAL..............................................................................................................49

Intended Use
1520 99 002 – 04 04 3
1 Intended Use
The QuadroStar is optionally supplied with one or two laser modules, with only one laser
being actively operated each. The laser modules used are either frequency-doubled disc
lasers (LBO laser) or diode lasers. The diode laser is available with three different
wavelengths. The availability of different wavelengths and the possibility to combine two
laser modules result in a wealth of applications.
The LBO laser emits light at a wavelength of 532 nm, which is absorbed very well by
hemoglobin. Thus, this laser is ideally suitable for dermatology, especially for the
treatment of superficial vascular lesions, but also for the gentle vaporization of benign
pigmented lesions and other skin irregularities.
The diode laser emits light in the near infrared at optionally 808, 938 or 978 nm. These
wavelengths are absorbed by hemoglobin, melanin and water. However, because of the
comparatively low absorption, they penetrate deeper into tissue. In dermatology, the diode
laser can also be used for the treatment of vessels.
There are many applications of the diode laser in minor surgery. Tissue can be
coagulated or vaporized depending on the energy or power density applied. Using the
fiber-contact technique, tissue can also be cut. Besides, the diode laser is well suitable for
the endovascular coagulation of dilated veins (varicose veins).
In dentistry, the diode laser is used for soft-tissue surgery by analogy to the described
surgical applications or for tooth bleaching.
In providing this new, powerful medical device, Asclepion Laser Technologies GmbH
rested on its many years of experience in the development and production of medical
lasers and particularly its competence in the field of solid-state lasers and diode lasers.
The QuadroStar is a reliable, compact laser device that is extremely easy to use. The
device fully complies with the requirements of the Medical Device Directive. It is largely
maintenance-free and excels by a long service life.
The device is designed for use in both clinics and private practices. Because of its
compact design and light weight, it can easily be transported.
The QuadroStar complies with the generally accepted rules of technology and the relevant
safety regulations.

Intended Use
1520 99 002 – 04 04 4
It must expressly be pointed out here, that only those persons are allowed
to use the device who attended an introductory course on the use of the
device as confirmed by their signature in the medical device logbook. In
addition, the user must have read this user's manual and the application
manual.
As part of the installation procedure, the installing technician employed with
or trained by Asclepion Laser Technologies GmbH will give an initial
introduction into the operation of the device.
Active medical devices may be used only by persons who can ensure
proper handling because of their qualification and practical experience.
Specialist training courses are offered, for instance, also by Asclepion Laser
Technologies GmbH.
Non-observance of the instructions given may result in risks to the health
of patients and operators as well as damage to the device!
The manufacturer will not assume any liability for such damage.
Medical Device Directive / Medical Product Act
The QuadroStar complies with the EC Medical Device Directive 93/42/EEC and
its national equivalent in form of the German Medical Product Act (MPA).
Device Type acc. to MPA: II b
UMDNS-No.: 16-948

Technical Data
1520 99 002 – 04 04 5
2 Technical Data
2.1 General specifications
Beam guidance: Flexible optical fiber
Display: LCD display
Operator guidance: Touchscreen
Cooling: Internal air cooling, power-regulated
Door interlock connector: Potential-free contact 5 VDC / max. 20 mA (TTL)
Laser warning lamp: Potential-free relay contact
Max. 24 V / 0.5 A (normally open contact)
Operating conditions: Temperature: +15 °C ... +30 °C
Rel. humidity: ≤85 %
Atmospheric pressure: 700 ... 1060 hPa
Transport and storage conditions:Temperature: -5°C … +55°C
Rel. humidity: 10 % … 95 % (no condensation)
Dimensions (W x D x H): 41 x 39 x 21 cm
Weight: Approx. 20 kg
Power requirements: 115 / 230 VAC
50/60 Hz
Max. 600 VA
Classification acc. to MPA II b
Protection Class: I
Accessories See Section 7, page 35.
2.2 Laser specifications
Laser type: Diode-pumped, frequency-doubled
solid-state laser (LBO)
Wavelength: 532 nm
Laser Class: 4 (requires laser-protective eyewear D 532 L4)
Laser power: 0.5 … 5 watts, distal
Operating modes: cw, single pulse, burst and repeat pulse mode
Pulse duration: 5 ms ... 2.5 s, adjustable

Technical Data
1520 99 002 – 04 04 6
Pulse repetition rate: 1 ... 120 Hz
Number of pulses in burst mode: 2 ... 50, infinite
Tolerance of output power: Max.±20 %
Spot size: Handpiece 0.5; 1.0 and 1.5 mm
Energy density: 0.5 … approx. 6,300 J/cm²,
adjustable depending on handpiece used
Beam divergence (half angle): Max. 125 mrad (7.2°)
Laser type: Diode laser
Wavelength: 808 nm
938 nm
978 nm
Laser Class: 4 (requires laser-protective eyewear D 808-978 L3)
Laser power: 1 … 25 watts, distal
Operating mode: cw, single pulse, burst and repeat pulse mode
Pulse duration: 5 ms … 2.5 s, adjustable
Pulse repetition rate: 1 … 120 Hz
Tolerance of output power: Max.±20 %
Spot size: Handpiece 0.6; 1.0 and 1.5 mm
Bare fiber 0.2; 0.3 and 0.6 mm
Energy density: 0.5 J/cm² … approx. 22,000 J/cm²,
adjustable depending on handpiece
Beam divergence (half angle): Max. 390 mrad (21°) with handpiece
Max. 370 mrad (22°) with bare fiber
Number of pulses in burst mode: 2 … 50, infinite
Laser type Laser diode, aiming laser
Wavelength 635 nm
Laser Class I
Laser power <1 mW, adjustable in steps
Operating mode cw or blinking (approx. 1 Hz)

Technical Data
1520 99 002 – 04 04 7
2.3 Device models
Model Model Number built-in laser modules
QuadroStar 532/980 1520 LBO 532 and Diode 978
QuadroStar 532 1521 LBO 532
QuadroStar 532/940 1522 LBO 532 and Diode 938
QuadroStar 532/810 1523 LBO 532 nm and Diode 808
QuadroStar 980 1524 Diode 978
QuadroStar 940 1525 Diode 938
QuadroStar 810 1526 Diode 808
The basic unit is identical for all device models, the models only differ in the number and
the type of built-in laser modules. On devices containing two built-in lasers, these cannot
be operated simultaneously.
The models can be identified by the Model Number specified on the type label on the rear
panel of the device.
Control
The output parameters and the safety equipment of the device are monitored and
controlled by a computer system.
A calibration port automatically compensates both the aging of laser modules and the
reduction in the transmission of the beam delivery system.
Operating mode
The device operates in both continuous (cw) and in pulsed mode (single pulse, pulse
repetition, burst). It is designed for temporary use (less than 30 min continuous duty).
Operation
Operation is via a touchscreen with plain-text user guidance. The following operating
parameters are adjustable: Wavelength or laser module, power or energy density, pulse
duration and pulse pause or pulse rate.
In addition to the parameters selected, the following parameters and device states are
displayed: Applied total energy, laser standby and, if necessary, plain-text error
messages.
The system automatically detects the connected fiber type. When using a handpiece, the
spot size is selectable via the touchscreen.
The laser is released by means of a footswitch.

Safety Notes
1520 99 002 – 04 04 8
3 Safety Notes
In this manual, the following symbols are used to refer you to dangers or notes on
operation of the device:
Risk of accidents or physical injury.
Risk of technical damage.
The QuadroStar complies with the requirements of the German Medical Product Act
(MPA) and thus those of the EC Medical Device Directive (93/42/EEC). Observe the
German Medical Devices Operator Ordinance (MPBetreibV) or the relevant national
legislation and regulations regarding the operation of laser devices.
The QuadroStar is a Class IIb device as per the above directive.
The MPA and the Medical Devices Operator Ordinance (MPBetreibV) bind the
owner/operator, the authorized persons and users of Class IIb devices to take a number
of safety precautions. In particular, such devices should be operated only in accordance
with the generally accepted rules of technology and the relevant regulations on labor
safety and the prevention of accidents.
In handling medical laser devices, observe the currently binding version of the relevant
regulations on the prevention of accidents by laser radiation of the German Professional
Associations. A copy of these regulations is provided with this manual. Furthermore, you
are bound to keep a medical device logbook, which is also enclosed with this manual. Our
service technician will assist you in filling it in as part of the startup procedure.
Please note that this device must be checked annually for technical safety.
The results of these safety checks must be recorded in the medical device
logbook.
Do not install the QuadroStar in explosion-risk areas.
Only persons employed with or authorized by Asclepion Laser
Technologies GmbH are allowed to service, repair or modify the device.

Safety Notes
1520 99 002 – 04 04 9
The Regulations for the Prevention of Accidents by Laser Radiation of the German
Professional Associations (or any equivalent national regulations) lay down general rules
for the protection against hazardous laser exposure. In the context of medical application,
they aim to protect operating personnel during laser operation. The laser devices are
classified in different classes depending on the potential risks involved. The QuadroStar is
classified in Class 4.
This classification means that improper use of the device constitutes
risks to the eyes by direct and scattered laser radiation. Besides, the
laser radiation may cause fire and explosion hazards.
To avert these risks, the above regulations bind the owner/operator of the device, inter
alia, to meet the following requirements:
•Duty of notification: Prior to initial start-up, the intended use of the laser must be
notified to the competent Professional Association and the labor-safety authority
•A Laser Safety Officer must be appointed in writing.
The duties of the laser safety officer should include at least the following:
- Supervision of the operation of the laser device
- Assistance to the owner/operator to ensure safe operation and implement
the necessary safety precautions
- Co-operation with labor-safety specialists in fulfilling their tasks, including
the information about important issues of laser radiation protection.
•Laser zone: While the laser is in operation, the area in which the maximum permissible
radiation level may be exceeded, the so-called "laser zone", must be delimited and
marked by a laser warning sign. Warning lamps at the entrances must indicate the
operation of the laser.
•The NOHD (Nominal Ocular Hazard Distance) of the laser device is so high that the
entire room where the laser is operated is to be considered as laser zone.
•Personal eye protection: All persons present in the laser zone must wear laser
protective eyewear. The laser protective eyewear must provide a protection level of at
least D L4 for 532 nm and D L3 for 808 ... 978 nm (acc. to DIN EN 207 in the currently
valid form).
•Dangerous reflections: The laser beam may be reflected by many metal surfaces and
not only by those normally considered. Therefore, always take care to remove all metal
objects, such as watches, earrings, etc. from the operational range of the laser.

Safety Notes
1520 99 002 – 04 04 10
•Risk of fire: Many non-metal materials may catch fire under normal operating
conditions if exposed to laser radiation (e.g. plastic, paper, wood, cotton, etc.).
Therefore, remove combustible objects from the operational range of the laser.
Besides, the laser device must never be used in the presence of flammable anesthetics
or disinfectants. Residues of these substances must have been fully evaporated before
using the laser device.
The Regulations for the Prevention of Accidents by Laser Radiation lay down binding
protection standards. Examples are given to illustrate how to achieve these standards.
The examples given cannot be regarded as final and complete because of the dramatic
on-going technical progress especially in laser technology. Therefore, other equivalent
precautions may also be suited and desired in the interest of the physician and the
patient.
Safety features of the device
In the development of the QuadroStar, numerous precautions have been taken to ensure
a high degree of active safety in combination with high operating convenience.
•Immediately after the device is switched on, the integral PC control performs a self-test
of the device.
•Following this test, a number of safety-relevant components are tested automatically.
•If the device passed the test successfully, it will switch to the "Non-ready" mode
("Standby"). If the test was not successful, an error message will be displayed.
•While the laser is in operation, the PC control system is continuously checked for
proper function.
•High priority has been given to preventing any risk to the physician and the patient
caused by an individual component failure.
•The device carries various safety labels. These labels must always be clearly readable
and replaced instantly when damaged.

Start-up
1520 99 002 – 04 04 11
4 Start-up
Initial installation of a new QuadroStar must always be performed by an authorized
representative of Asclepion Laser Technologies GmbH, who will explain the responsible
operator how to operate the device based on the instructions given in this manual.
4.1 Scope of delivery
Verify that all components required for safe operation of the laser device are present:
4.1.1 Basic device
•Basic laser device
•Power cable
•Footswitch
•Remote door interlock connector
•Two keys
•User's Manual
•Laser protective eyewear for physician (one each per laser module)
•Eye protection for the patient
4.1.2 Accessories
•Optical fiber with handpiece and three spacers for every laser module
4.1.3 Optional accessories
•Bare fiber Diode 810 ... 980 - 200 µm core diameter
•Bare fiber Diode 810 ... 980 - 300 µm core diameter
•Bare fiber Diode 810 ... 980 - 400 µm core diameter
•Bare fiber Diode 810 … 980 - 600 µm core diameter
•Bleaching handpiece
•Transport case

Start-up
1520 99 002 – 04 04 12
4.2 Installation
Figure 1: Front view
Figure 2: Connectors on rear panel of device
Handpiece receptacles
Calibration port
Fiber output with
SMA connector
Laser warning lamp
Laser STOP button
Key switch
Control knob
Display with
touchscreen
Fiber-coding connectors
Power input connector
Power switch
Footswitch
I
2
C Connector for door
interlock and
laser warning lamp
Service port
Equipotential
terminal
Line fuses

Start-up
1520 99 002 – 04 04 13
4.2.1 Installation note
Considering the cable connections and the optimum ventilation required for an efficient
cooling of the device, keep a minimum distance of 20 cm between side and rear panels of
the QuadroStar and the wall.
4.2.2 Connection of door interlock and warning lamp
In addition to the prescribed warning signs, every entrance to the laser
area (usually the laser treatment room) must be equipped with warning
lamps that are lighting (or flashing) as long as the laser emits radiation.
On the rear panel of the device, a connector is provided for the connection of a door interlock and
a warning lamp (see illustration below).
Door interlock 5 VDC / 20 mA
Relay contact for laser warning lamp (max. 24 V / 0.5 A)
Figure 3: Connectors for door interlock and laser warning lamp
By connecting the two "door interlock 5 VDC / 20 mA" terminals to an external contact,
such as a door interlock, you can prevent laser radiation from being emitted when the
door of the laser room is opened.
This safety device serves to automatically shut off the surgical beam when the door is
being opened thus precluding any risk to the person entering.
The laser can only be operated, when this contact is closed. Therefore, the door interlock
connector is factory-fitted with a provided shorting bridge. To connect a door interlock
circuit, remove this bridge and connect your door interlock circuit to the same terminals. If
you do not use a door interlock circuit, make sure the shorting bridge is connected to the
respective terminals.

Start-up
1520 99 002 – 04 04 14
The same connector provides connection to a potential-free normally open contact. This
contact allows a circuit for a low-voltage warning lamp to be switched (max. 24V / 0.5 A).
The contact closes when the laser is switched to READY mode.
If you intend to install a door interlock or the external laser warning lamp
later, make sure to switch off the device before and disconnect the power
cable from the power outlet.
The prescribed laser warning lamp may, of course, also be installed completely separately
from the laser device and turned on and off via a normal light switch.
4.2.3 Connection to power outlet
Absolutely make sure that the power cable is disconnected from the power
outlet when the device is installed!
When choosing the power outlet, consider all technical data of the local
mains and the device (refer to Section 2.1,page 5). First, verify that the
available line power agrees with the specified power requirements.
Please observe the requirements of DIN VDE 0100 or any national
equivalent in the currently valid form.
The device is provided with a power cable. Before connecting the device to the power
outlet, make sure the power switch is set to '0' (device being dead). First, plug the power
cable into the power input connector on the rear panel of the device before connecting the
other end of the cable to the power outlet.
If required, an earth wire can be connected between the equipotential terminal on the
device and the earth-potential terminal of the electrical supply system.
Operation of the laser requires that the device be connected to a single-phase power
outlet protected by a fuse rated for at least 600 VA (Type C, slow-blow).
4.2.4 Footswitch and applicator
Now, connect the footswitch to the footswitch connector provided at the rear panel of the
device (refer to Figure 2, page 12). Make sure to insert the plug as far as it will go. Then,
lock it by turning the cap nut clockwise.
Afterwards, plug the applicator (bare fiber or fiber with handpiece) as far as it will go into
the SMA connector on the front panel of the device (refer to Figure 1, page 12) and

Start-up
1520 99 002 – 04 04 15
tighten the cap. Then, plug the fiber-coding plug into the corresponding connector below
the fiber connector and lock it by turning the cap nut clockwise until it snaps in.
Make sure to use the correct fiber connector each for the selected laser module.
Consider that the transmission fiber may be damaged or show premature
aging, if the fiber connector has not been screwed down correctly.
4.2.5 Service and I²C connector
These connectors located at the rear panel of the device are provided only for service
purposes and should be used solely by service technicians employed with or authorized
by Asclepion Laser Technologies GmbH.
Never connect any devices to the Service port and the I²C connector on the
rear panel of the device.
4.3 Preparations for use
After installation and any relocation of the device from a cold to a warm
environment with a temperature difference of more than 5°C, allow for the
following periods of adjustment to the room temperature with the device
unpacked before using the device (laser operation):
Min. 2 hours for temperature differences of up to 10°C,
Min. 4 hours for temperature differences of up to 15°C,
Min. 8 hours for temperature differences exceeding 20°C.
Afterwards, switch the device on without an applicator connected and let
the device warm up for at least 30 minutes.
Take care that the installation and operating environment of the device
meets the following conditions:
Temperature: 15 to 30°C
Relative humidity: max. 85%.
Non-observance may result in the destruction of the device.

Start-up
1520 99 002 – 04 04 16
Besides, verify that the following requirements have been met:
1. The line voltage specified on the label at the rear panel agrees with the line voltage
available at the place of installation.
2. The power plug has been plugged into an appropriate power outlet.
3. The potential equalizing cable has been connected (if required).
4. The SMA connector of the applicator (bare fiber or fiber with handpiece) has been
firmly connected to the SMA connector of the fiber output on the front panel of the
device. The fiber-coding plug has been plugged into the corresponding connector.
5. The footswitch plug has been properly connected to the footswitch connector on the
rear panel of the device and screwed down.
6. Warning lamps have been mounted at the laser room entrance and switched on (if
necessary).
4.4 Switching on
Make sure that all safety precautions have been taken.
Then, follow this procedure:
•Switch the power switch on the rear panel of the device (see Figure 2, page 12) to
I (ON).
•Verify that the Laser STOP button is deactivated (not pressed).
•Afterwards, insert the safety key in the key switch (see Figure 1, page 12) and turn
it clockwise as far as it will go.
While the device automatically tests essential and safety-relevant modules, the starting screen
appears on the display.
After a few seconds, one of the following menus will appear on the screen:
The menu for the selection of the laser wavelength (or the laser) appears (Figure 4, page 17) if
your device is equipped with two laser modules. Otherwise, the basic menu in "Standby" mode
appears (Figure 6, page 19).

Operation
1520 99 002 – 04 04 17
5 Operation
The use of controls or adjustments or performance of procedures other
than those specified in this manual may result in hazardous laser radiation
exposure.
5.1 Adjustment of treatment parameters
The treatment parameters are to be adjusted via the touchscreen and the control knob at
the right of the front panel (see Figure 1, page 12). Adjustment is very straightforward and
self-explanatory.
Select the function by pressing the corresponding function key on the touchscreen:
•Simple ON/OFF function keys appear highlighted when activated.
•Function keys with several options are marked by a red frame after they were activated
by tapping on them. To select the desired parameter, turn the control knob. To confirm
and store the selected parameter, briefly depress the control knob or alternatively tap
the activated function key on the touchscreen once more.
Keys of adjustable parameters are always highlighted in color. Keys that are not
highlighted are deactivated. They only serve for information.
After the switch-on routine has been passed, always the following menu will appear on the
display (only on devices with several laser modules):
Figure 4: Menu for selection of laser module
Successful key pressure is confirmed by a short beep signal.

Operation
1520 99 002 – 04 04 18
By tapping on the desired wavelength, the corresponding laser module is activated.
Afterwards, the system prompts you to use the laser protective eyewear, laser applicator
and fiber connector appropriate for the selected laser wavelength. Please confirm having
done so by pressing the "Confirm" key (Figure 5, page 18).
The activated fiber connector is signaled by the laser warning LED directly above the SMA
fiber connector (Figure 1).
Figure 5: System prompt to use correct protective eyewear, applicator and fiber connector
On devices with only one laser module, the menus of Figure 4, page 17, and Figure 5,
page 18 are inapplicable.
The device is in "Standby" mode then with the screen showing all adjustable parameters
of the activated laser module (Figure 6, page 19).