Asclepion QuadroStar 532/980 User manual

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QuadroStar
USER'S MANUAL

Copyright
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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
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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
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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
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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
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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
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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
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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
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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
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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.