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Related Manuals for Asclepion QuadroStar 532/980
Summary of Contents for Asclepion QuadroStar 532/980
- Page 1 QuadroStar USER'S MANUAL 1520 99 002 – 04 04...
- Page 2 Copyright 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. ©...
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Page 3: Table Of Contents
Contents Contents INTENDED USE......................3 TECHNICAL DATA ....................5 General specifications ....................5 Laser specifications.....................5 Device models ......................7 Control ..............................7 SAFETY NOTES ....................... 8 START-UP ......................11 Scope of delivery......................11 4.1.1 Basic device......................... 11 4.1.2 Accessories.......................... 11 4.1.3 Optional accessories......................11 Installation ........................12 4.2.1 Installation note ........................ - Page 4 Contents Activation of Ready mode and treatment ..............25 5.5.1 Releasing the treatment beam..................... 26 5.5.2 Switching the device off ....................... 27 CLEANING, DISINFECTION AND STERILIZATION ..........29 Advice for cleaning, disinfection and sterilization of accessories......29 General advice for cleaning, disinfection and sterilization........29 Special advice for handling, cleaning, disinfection and sterilization.....31 ACCESSORIES ......................
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Page 5: Intended Use
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. - Page 6 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.
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Page 7: Technical Data
Technical Data 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. - Page 8 Technical Data Pulse repetition rate: 1 ... 120 Hz Number of pulses in burst mode: 2 ... 50, infinite Max. ± 20 % Tolerance of output power: 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.
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Page 9: Device Models
Technical Data 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... -
Page 10: Safety Notes
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. 1520 99 002 – 04 04... - Page 11 Safety Notes 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.
- Page 12 Safety Notes • 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.
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Page 13: Start-Up
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... -
Page 14: Installation
Start-up 4.2 Installation Handpiece receptacles Control knob Display with Laser warning lamp touchscreen Fiber output with SMA connector Key switch Laser STOP button Calibration port Fiber-coding connectors Figure 1: Front view Power switch Power input connector Service port Footswitch Line fuses Equipotential Connector for door terminal... -
Page 15: Installation Note
Start-up 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. -
Page 16: Connection To Power Outlet
Start-up 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. -
Page 17: 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. -
Page 18: Switching On
Start-up 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. -
Page 19: Operation
Operation 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). - Page 20 Operation 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).
- Page 21 Operation Figure 6: "Standby" menu: Repeat pulse mode with handpiece The treatment parameters adjustable do not only depend on the laser module used, but also on the operating mode selected and the applicator used. The following parameters are selectable (From top left to bottom right of the touchscreen): Parameter Symbol Display...
- Page 22 Operation Available only in single pulse, repeat Energy density Fluence in J/cm² pulse and burst mode and when using an applicator with handpiece Spot diameter in Available only when using a fiber Spot size applicator with handpiece Available only in cw mode or when Laser power Power in watts using a bare fiber...
- Page 23 Operation • Single pulse operating mode (SINGLE) In this operating mode, the device emits a single laser pulse of the selected power and pulse duration, when the operator presses the footswitch. At the end of the pulse, the laser is automatically switched off, even when the operator keeps the footswitch depressed.
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Page 24: Adjustment Of Spot Size
Operation • Laser power This parameter indicates the laser power in watts emitted to the patient's skin. • Aiming beam laser (PILOT) On activation of this key, you can adjust both the intensity (only in "Standby“ mode) and the operating mode (continuous or blinking) of the aiming beam laser. 5.2 Adjustment of spot size Beside the used laser module, above all the beam diameter of the therapy laser depends on the applicator used. - Page 25 Operation Figure 7: Tools menu You can see, which of the laser modules is activated, by the red background color of the respective wavelength key. The corresponding displays of the total emission time, the applied total energy and the key for power calibration are arranged directly under the wavelength field.
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Page 26: Laser Calibration
The periodic laser calibration does not take the place of the prescribed annual test of the laser power by service technician employed with or authorized and trained by Asclepion Laser Technologies GmbH (Section 11, page 42). Periodic laser calibration must always be performed with the handpiece applicator. -
Page 27: Activation Of Ready Mode And Treatment
Operation 5.5 Activation of Ready mode and treatment Prior to pushing the READY key, the attending physician should verify that all persons present in the laser room wear laser protective eyewear appropriate for the selected laser module as specified in Section 2, page 5. For the patient to be treated, the patient eyewear is provided. -
Page 28: Releasing The Treatment Beam
Operation Figure 8: "Ready" menu in Burst operating mode with handpiece When you change any parameter in "Ready" mode, the device will automatically switch to "Standby" again, which means that you have to press the "Standby/Ready“ key once more to return to the "Ready" mode. Note that in READY mode a laser pulse will be fired when you inadvertently depress the footswitch! The QuadroStar is equipped with an easy to operate "Laser STOP"... -
Page 29: Switching The Device Off
Operation On depression of the footswitch, Class 4 laser radiation will be emitted from the end of the fiber or the handpiece. Make sure to comply with all relevant regulations for the protection against unintentional laser radiation effects. In particular, the attending physician is not allowed to release the laser unless the aiming beam spot was found to be perfect and the fiber end or the handpiece was directed directly onto the skin area to be treated. - Page 30 Operation Never leave the device unattended, while it is switched on. Switch the power switch to "0" to completely disconnect the device from line power supply. After you have switched off the device, make sure you have removed the key from the key switch. Keep the key in a safe place to prevent unauthorized use of the device.
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Page 31: Cleaning, Disinfection And Sterilization
Cleaning, Disinfection and Sterilization Cleaning, Disinfection and Sterilization 6.1 Advice for cleaning, disinfection and sterilization of accessories Multiple use accessories Handpieces and transfer fibers are designed for multiple use. The spacers can be sterilized. Parts that do not get into touch with patients, if used as intended, can be disinfected by wiping them with a disinfectant. - Page 32 Cleaning, Disinfection and Sterilization INSTRUCTIONS: Remove dirt from surfaces using a disposable / paper towel. Workplace: No special requirements. Storage and It is advisable to recondition accessory items as soon as transport: possible after their use. No special requirements. Preparations for Disassemble accessory units by following the instructions for cleaning: use/cleaning provided.
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Page 33: Special Advice For Handling, Cleaning, Disinfection And Sterilization
Cleaning, Disinfection and Sterilization Vacuum autoclave, at least five minutes at 134°C. Sterilization: 150°C must not be exceeded. No special requirements. Storage: The manufacturer has validated that the instructions given above are SUITABLE for the preparation of the accessory parts for their reuse. The reconditioner is responsible that the actually performed reconditioning procedure yields the desired results with the equipment and material used and the personnel working in the reconditioning facility. - Page 34 Cleaning, Disinfection and Sterilization For the reconditioning of handpieces and spacers, observe the general advice given in Section 6.1, page 29. Clean handpiece lenses before use. The spacer is to be inserted in the handpiece by pressing it in. To remove it from the handpiece, you need simply withdraw it.
- Page 35 Cleaning, Disinfection and Sterilization • Screw the SMA plug into its counterpart of the fiber coupling as far as it will go. Avoid torsional stress to the fiber. In extreme cases, failure to screw down the fiber properly may result in damage to the coupling optics in the fiber connector.
- Page 36 Cleaning, Disinfection and Sterilization Users are allowed to clean the external surfaces of the device only. You may clean all accessible components of the device with a soft, slightly moistened cloth. Take care that the cloth is neither wet nor even dripping wet. To remove sticking dirt, you can use a mild detergent or disinfectant.
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Page 37: Accessories
Please note that the Medical Product Law binds you to use only such accessories on the device that have been tested and approved and that are intended for this laser by Asclepion Laser Technologies GmbH. On request, Asclepion Laser Technologies GmbH will readily send you an updated list of such accessories. strongly... - Page 38 Accessories Designation Part No. Bare fiber, Diode 810 ... 980 – 600 µm 2884 00 000 Bleaching handpiece 4203 00 000 Physician's laser protective eyewear, 1227 00 000 LBO 532 Physician's laser protective eyewear, 1228 00 000 Diode 810 - 980 Eye protection for patient, 532 - 980 1229 00 000 1520 99 002 –...
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Page 39: Error Messages
Error Messages Error Messages If the device does not respond to turning the key switch to ON, make sure the following requirements are met: 1. The Emergency Stop button has been unlocked (by turning the red knob anticlockwise until the lock is released and the button jumps out; refer to Figure 1, page 12). -
Page 40: Fault Removal
Improper use or maintenance of the laser system may void the warranty granted by Asclepion Laser Technologies GmbH. Before starting any repair or if you have questions that have not been answered by this manual, contact your service representative (see Section 10, page 41). - Page 41 Internal fault in data storage Switch the device off and then try to switch it on again. Code xxx If the error persists, contact Asclepion Laser Technologies GmbH or a service representative expressly authorized by Asclepion Laser Technologies GmbH. Fiber coding plug not plugged or defective Unknown Plug the fiber-coding plug in again or replace the applicator.
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Page 42: Possible Malfunctions
(Disconnect power plug before! See Figure 2, page 12). Check line fuses of domestic power supply system. If the error persists, contact Asclepion Laser Technologies GmbH or a service representative expressly authorized by Asclepion Laser Technologies GmbH. The aiming beam... -
Page 43: Service
If you need assistance by customer service, please get in touch with us via the address or phone number given below. When contacting your service representative of Asclepion Laser Technologies GmbH, always keep the model and the serial number of the device at hand. -
Page 44: Regular Safety Tests And Calibration
Only persons employed with or authorized by Asclepion Laser Technologies GmbH are allowed to service, repair or modify the device. The power delivered by the therapy lasers must be checked at least once a year by a service technician employed with or trained and authorized by Asclepion Laser Technologies GmbH. - Page 45 Regular Safety Tests and Calibration CALIBRATION OF THE LASER Perform the laser calibration according to Section 5.4.1, page 24 Frequency: Monthly To be checked by: Operator of the device CHECKING THE FIBER HANDPIECE Check if the fiber handpiece is in perfect state. Frequency: Before every use To be checked by:...
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Page 46: Warnings
Warnings 12 Warnings Do not start up the device unless you have read this User's Manual. Always keep the User's Manual in a handy location. Before starting up the laser device, switch off cellular phones and similar equipment. Only specialists appropriately qualified and authorized are allowed to open the laser device. - Page 47 Warnings The use of controls or adjustments of the equipment for operation, maintenance, testing and calibration or the performance of procedures other than those specified in this manual may result in hazardous laser radiation exposure. Never connect any devices to the Service and I²C connectors on the rear panel of the laser device.
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Page 48: Labeling
Labeling 13 Labeling Various warning and information labels are affixed to the front and the rear panel of the laser device. Laser exit aperture (Figure 11) Fiber applicator (Figure 12) Laser STOP button (Figure 13) Figure 9: Labels on front panel Laser warning sign (Figure 14) Laser warning sign... - Page 49 Labeling Figure 11: Laser exit aperture Figure 12: Optical fiber applicator STOP Figure 13: Laser STOP button Figure 14: Laser warning sign EN 60825-1 1520 99 002 – 04 04...
- Page 50 Labeling Figure 15: Laser warning sign 21 CFR Serial number Type BF device 6,3 A Date of manufacture Figure 17. Line fuse Figure 16. Type label door interlock footswitch Figure 18. Potential equalization Figure 19: Interface connectors 1520 99 002 – 04 04...
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Page 51: Disposal
Disposal 14 Disposal The device must be disposed of in compliance with the regulations on electronic waste. Please consult our Technical Service if you have any questions regarding disposal. 1520 99 002 – 04 04...
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