Related Manuals for Fotona QX MAX
Summary of Contents for Fotona QX MAX
- Page 1 Fotona d.o.o. Stegne 7 SI-1000 Ljubljana Slovenia, EU Phone: + 386 1 500 91 00 Fax: + 386 1 500 92 00 www.fotona.com OPERATOR MANUAL Fotona QX MAX 82277 CE ENG 24...
- Page 2 Copyright © Fotona d.o.o. All rights reserved. The contents of this publication may not be reproduced in any form without the explicit permission of Fotona d.o.o. Page 2/61 82277 OM QX MAX CE ENG 24 Date of issue/Latest revision: 7. July 2021...
- Page 3 Foreword Dear customer, Thank you for purchasing a Fotona laser system and placing your trust in our brand. We are certain that your Fotona system will be an asset to your practice and will provide you with significant advantages in many different areas of your daily work.
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Page 4: Table Of Contents
4.5.3.7. Selecting the MELODY of the audio signal during treatment .............. 32 4.5.3.8. Checking the total-pulses counter ...................... 32 4.6. I ......................32 NTRA OPERATIVE NSTRUCTIONS 4.6.1. System READY and STANDBY Modes ..................32 Page 4/61 82277 OM QX MAX CE ENG 24... - Page 5 10. ENERGY METERS CALIBRATION PROCEDURE ................59 10.1. E KTP N :YAG L ........59 NERGY ETER ALIBRATION ROCEDURE FOR THE ASER 10.2. E :YAG L ..........60 NERGY ETER ALIBRATION ROCEDURE FOR THE ASER 82277 OM QX MAX CE ENG 24 Page 5/61...
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Page 6: Introduction And System Characteristics
Portable radiofrequency communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the QX MAX system, including cables specified by the manufacturer. Otherwise, degradation of the performance of the equipment could result. -
Page 7: System Characteristics
R650 Dermatological handpiece, provides 650 nm wavelength with 2, 3 Circle; 2, 3 and 4 mm and 4 mm spot sizes. Recommended for the removal of green colored tattoos. 82277 OM QX MAX CE ENG 24 Page 7/61... -
Page 8: Indications For Use
Do NOT attempt any laser treatments if the patient has a history of hyper- sensitive or abnormally sensitive skin. RMS-236 *The intended use of QX MAX in South Korea is incision, ablation and vaporization of the soft tissue in general dermatology. 2.2. Indications, Contra-indications, Side-effects... -
Page 9: Safety And Regulatory Compliance
RMS-41, 91, 92, 93, 104, 105, 107, 108, 109, 232, 249, 250 WARNING! Never allow the laser beam to be directed at anything other than the target area. RMS-42 82277 OM QX MAX CE ENG 24 Page 9/61... - Page 10 1 mW, and therefore additional ocular protection for this laser is not needed. WARNING! Ensure that all entrances to the laser treatment room are equipped with proper laser safety warning signs. RMS-58 Page 10/61 82277 OM QX MAX CE ENG 24...
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Page 11: Nominal Ocular Hazard Distance (Nohd)
3.1.1. Nominal Ocular Hazard Distance (NOHD) The following table specifies the divergences and the minimum distances at which laser light emitted from Fotona laser systems are not considered harmful (NOHD – Nominal Ocular Hazard Distance). Divergence Handpiece NOHD (m) (mrad) 0.65... -
Page 12: Explosion And Fire Hazards
Stop the treatment if a significant reduction in application efficiency is observed when using the R585 or R650 handpieces. Check whether all optical surfaces on the handpiece are undamaged. Contact your local Fotona representative and/or technical service when in doubt. RMS-136 3.4. Protecting Non-Target Tissues... -
Page 13: Electro-Magnetic Compliance Statement
Electromagnetic Environment - Guidance RF emissions Group 1 The Fotona QX MAX laser system delivers energy to the patient in laser light form. The CISPR 11 electromagnetic energy is generated only for the internal functioning of the device. Nearby electronic equipment may be affected. -
Page 14: Electromagnetic Immunity
0.5 cycle for 0.5 cycle variations on power If the operator of the Fotona QX MAX laser at 0°, 45°, 90°, 135°, at 0°, 45°, 90°, 135°, supply input lines system requires continuous operation during 180°, 225°, 270°... - Page 15 Specified in Table 3.3 of this document IEC 61000-4-3 The Fotona QX MAX laser system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. For transmitters rated at maximum output power not listed in Table 6, the recommended...
- Page 16 LTE Band 7 NOTE: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the Fotona QX MAX laser system may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.
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Page 17: Safety Features
RMS-48 WARNING! With regard to electromagnetic interference requirements, the QX MAX device can be used in either home care or professional healthcare facilities. However, it must not be used in certain specific locations where the level of... -
Page 18: Laser Emission Indicator
Class I limits. The protective housing can only be opened using special tools and should only be attempted by qualified service personnel, authorized by Fotona. 3.6.6. Location of Controls All the controls of the laser system are located on the front panel of the device for easy and safe access during operation. -
Page 19: Manual Reset
82277 OM QX MAX CE ENG 24 Page 19/61... -
Page 20: The Laser System In Operation
ATTACH DOORSWITCH" will appear on the system display after switching on the system. To set up the doorswitch interlock, please consult your local Fotona representative or technical service for assistance. The doorswitch interlock port, designated as "DOORSWITCH", is located at the rear of the device. -
Page 21: Laser Beam Delivery System
The articulated arm must be attached and aligned onsite during installation of the laser system. Only skilled and trained personnel, authorized by Fotona, may perform the attachment and alignment procedure. WARNING! Do not switch on the laser system without having a handpiece attached to the articulated arm. -
Page 22: Switching The System On And Off
Switch on the main switch located at the rear of the device. The system performs a power-on self-test of the built-in microprocessor. The message “System Test 1 2…Pass” appears on the display. The “Fotona Laser Systems Fotona QX MAX” message appears on the display after completing the power-on self-test. -
Page 23: Selecting The Treatment Settings
Switch on the main switch. When the “Fotona Laser Systems Fotona QX MAX” message appears on the display, turn the key in the keylock switch to the horizontal ON position. 4.5. Selecting the Treatment Settings 4.5.1. Selecting the Laser Treatment Source... - Page 24 READY using the selected handpiece. Refer to the section “Changing the Beam Converters”. Figure 3: QX MAX display appearance as the R585 handpiece is selected. Note the “remaining use” percentage is at 100% (top right-hand corner of the display).
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Page 25: Selecting The Handpiece Treatment Parameters
Figure 4: This figure illustrates a typical KTP spot size selection of a 4 mm spot size. Figure 5: This figure illustrates a typical Nd:YAG spot size selection of a 5 mm spot size. 82277 OM QX MAX CE ENG 24 Page 25/61... -
Page 26: Low Fluence Regime With R28 Handpiece
KTP laser, this is not an acceptable selection. 4.5.2.2. Low fluence regime with R28 handpiece The QX MAX laser system provides two possibilities for selecting low-fluence treatments with the R28 handpiece: 1. By selecting the lowest possible fluence on the control panel at the selected spot size. -
Page 27: R28 Spacer With Glass Contact Window
The user should use the HP R28 d with this spacer according to Application manual. WARNING! When using the Fotona QX MAX R28 spacer with glass contact window, white plastic side shield must ALWAYS BE ATTACHED as it protects the operator from laser beams, reflected from the glass window. -
Page 28: Selecting The Spot Size On The R585 And R650 Handpieces
The R650 handpiece allows 2, 3 and 4 mm spot sizes to be selected for the 650 nm wavelength. Individual spot sizes are selected by attaching the corresponding spacers marked 2, 3 or 4 mm, which are included with both handpieces. Page 28/61 82277 OM QX MAX CE ENG 24... -
Page 29: Selecting And Confirming The Spot Size On The Control Panel
After the calibration procedure has been successfully completed, the red LED diode in the READY key will be lit. The laser treatment can now be started. NOTE While changing the spot size, fluence may change automatically. 82277 OM QX MAX CE ENG 24 Page 29/61... -
Page 30: Selecting The Laser Treatment Parameters
The session counter shows the number of pulses performed with a selected wavelength since the last reset of the session counter. Note that when the laser system is switched off, all session counters are automatically reset back to zero. Page 30/61 82277 OM QX MAX CE ENG 24... -
Page 31: Resetting The "Remaining Use" Percentage Counter
Press the (-) key to return to the previous menu to reset the conversion parameter. Press the SET key to return to the laser-treatment parameter selection menu or press the MENU key if other settings under the MENU section require reviewing. 82277 OM QX MAX CE ENG 24 Page 31/61... -
Page 32: Selecting The Melody Of The Audio Signal During Treatment
If you wish to terminate the warming procedure press the Standby key; after termination it will be possible to work at lower energy settings. Page 32/61 82277 OM QX MAX CE ENG 24... -
Page 33: Starting The Treatment
Failure to comply with this warning can result in improper beam delivery, which may result in higher or lower treatment parameters. RMS-122 82277 OM QX MAX CE ENG 24 Page 33/61... -
Page 34: During The Treatment
Carefully screw the two handpiece parts together, being careful not to touch any optical surfaces. Reset the remaining use percentage on the laser system. Set the conversion parameter (see chapter “4.5.3.6 Setting the conversion parameter”) Page 34/61 82277 OM QX MAX CE ENG 24... -
Page 35: Moving The System
The key in the keylock switch is in the vertical OFF position. Indicates that the system is about to perform the RUNNING SELF TEST Power-On Self-Test of the system integrated circuitry, PLEASE WAIT during the start-up procedure. 82277 OM QX MAX CE ENG 24 Page 35/61... - Page 36 It is probable USE LOWER SETTINGS that, after working with lower energy parameters for a time, the laser will be warm enough so that higher energy settings can be used. Page 36/61 82277 OM QX MAX CE ENG 24...
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Page 37: Maintenance
5. MAINTENANCE 5.1. General Fotona laser systems have been designed to provide years of trouble-free operation. The built-in computer processor performs self-diagnostics and initiates corrective actions when necessary, as well as automatic calibrations to ensure a properly functioning system. If a non-correctable error is detected, the laser system will disable and a message will be displayed on the screen. -
Page 38: Operator Maintenance
A dirty and blocked air filter may reduce the cooling capacity of the system, which may lead to overheating of the laser. The air filter should be cleaned at least twice a year. Page 38/61 82277 OM QX MAX CE ENG 24... -
Page 39: Electrical Power Supply
The deionizing cartridge and the cooling liquid should be replaced only by qualified service personnel, authorized by Fotona. Contact Fotona or your local Fotona representative to obtain a list of qualified and Fotona- authorized service personnel. 5.4.2. Regular Inspection of Laser Safety Related Features 5.4.2.1. -
Page 40: Leakage Currents And Grounding Impedance Of The Laser System Measurements
NOTE The energy meters should only be calibrated by qualified service personnel, authorized by Fotona. Contact Fotona or your local Fotona representative to obtain a list of qualified and Fotona-authorized service personnel. Please refer to chapter 10 for more detailed information. -
Page 41: Cleaning The Handpiece During The Treatment
Flush and rinse in running water for at least 1 minute. Single use plastic tube Beam ring Tube ring Figure 15: Spacer tube detached from the handpiece and disassembled 82277 OM QX MAX CE ENG 24 Page 41/61... -
Page 42: Replacing The Protective Window
possibility for an approved program for thermal disinfection (A0 value ≥ 3000 or – in the case of older devices – at least 5 min at 90°C/194°F; in case of Page 42/61 82277 OM QX MAX CE ENG 24... - Page 43 WD G 7836 CD, Miele & Cie. GmbH & Co., Gütersloh, (thermal disinfection) and the precleaning and cleaning detergent Neodisher medizym (Dr. Weigert GmbH & Co. KG, Hamburg) according to the specified procedure. 82277 OM QX MAX CE ENG 24 Page 43/61...
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Page 44: Manual Cleaning And Disinfection
VAH/DGHM or FDA approval or CE marking) and compatible with the used cleaning detergent. The used detergents must be compatible with the spacer/beam ring/tube ring materials (see section 5.5.4 Material resistance). Fotona recommends the use of Cidezyme detergent (Johnson & Johnson). Avoid using combined cleaning/disinfection detergents. -
Page 45: Post Cleaning And Disinfection Check
RMS-185 NOTE Only the handpiece spacer is intended for sterilization. The handpiece body together with its optical components is NOT intended for sterilization. If sterilized, irreparable damage will occur. 82277 OM QX MAX CE ENG 24 Page 45/61... - Page 46 WARNING! The immediate-use steam sterilization procedure should not be used. When sterilizing multiple items in one autoclave cycle, ensure that the sterilizer’s maximum load is not exceeded. RMS-270, 271 Page 46/61 82277 OM QX MAX CE ENG 24...
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Page 47: Material Resistance
20 times. The end of life for these parts should be determined based on wear and damage. The user is responsible for each further use as well 82277 OM QX MAX CE ENG 24 Page 47/61... -
Page 48: Specifications
Fotona will not be held liable for damages incurred due to the use of dirty or damaged handpieces. The processing is the sole responsibility of the operator. 6. SPECIFICATIONS 6.1. LASER... -
Page 49: General
- Frequency - Pulse repetition rate - Laser type - System state (STANDBY or READY) - Laser status: EMISSION when in READY state - Laser pulse count - Menu – with Pilot, Melody and Error history 82277 OM QX MAX CE ENG 24 Page 49/61... - Page 50 - atmospheric pressure range of 700 hPa to 1060 Storage and transport: - ambient temperature range 0 C to +50 C (without cooling water) - relative humidity range of 10% to 90% (incl. condensation) Page 50/61 82277 OM QX MAX CE ENG 24...
- Page 51 Footswitch cable length: 3 m (Optional wireless footswitch) Power cord length: Beam delivery system: 7-mirror articulated arm permanently attached to the system with R28, FS20, FS20A, FS50, R585 or R650 handpieces 82277 OM QX MAX CE ENG 24 Page 51/61...
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Page 52: Labelling
7. LABELLING In accordance with the IEC 60825-1:2014 standard, Fotona laser systems have warning labels on specific locations to indicate conditions under which the operator could be subjected to laser radiation. For the label locations, refer to the figures below. - Page 53 Fotona QX MAX - Back View 82277 OM QX MAX CE ENG 24 Page 53/61...
- Page 54 Fotona QX MAX - Side View Page 54/61 82277 OM QX MAX CE ENG 24...
- Page 55 R650 R585 82277 OM QX MAX CE ENG 24 Page 55/61...
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Page 56: Explanation Of Labels
WEEE should be collected separately by the relevant local authorities. Contact your local Fotona representative in order to collect and return a disused Fotona laser system. With this you will contribute to the reuse, recycling and/or other forms of WEEE recovery. - Page 57 State in which he or she practices to use or order the use of the device. 82277 OM QX MAX CE ENG 24 Page 57/61...
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Page 58: Storage And Shipment
9.1. Warranty Shipments, Returns and Adjustments Any warranty claim must be made promptly and must be received by Fotona within the applicable warranty period. In the event that the device must be returned for repair and/or adjustment, authorization from Fotona must be obtained. -
Page 59: Decontamination Of Returned Equipment
9.2. Decontamination of Returned Equipment Equipment sent back to Fotona or authorized service facilities for repair, must be properly decontaminated in order to comply with transportation laws. The decontamination must be performed according to the chapter Cleaning and Disinfection in this Operator Manual. -
Page 60: Energy Meter Calibration Procedure For The Nd:yag Laser
0.4 J/cm (energy readings should fall within the 160 mJ to 240 mJ range) and 1.9 J/cm (energy readings should fall within the 760 mJ to 1140 mJ range). Page 60/61 82277 OM QX MAX CE ENG 24... -
Page 61: Decontamination Certificate
Operator Manual. The undersigned also agrees to reimburse Fotona for any costs incurred in cleaning the enclosed equipment, in the event said item(s) are received by Fotona in a contaminated condition.
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