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Summary of Contents for Astar Lumina
- Page 1 Lumina - User Manual...
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Page 3: Table Of Contents
1. Basic information and tables Contents INTRODUCTION ............................... 5 ................................5 ANUFACTURER .............................. 5 ISK MANAGEMENT PROCESS INTENDED USE ................................. 6 ................................6 NTENDED USERS ................................7 SER TRAINING WARRANTY AND MANUFACTURER'S RESPONSIBILITY....................8 OPERATIONAL SAFETY ............................. 9 ..........................9 AINS SUPPLY AND OPERATION MODE ........................ - Page 4 Figure 4.1. Classification label sample ............................12 Figure 4.2. Warning label sample ............................. 13 Figure 5.1. General view of the Lumina lamp – stand construction ..................15 Figure 5.2. General view of the Lumina lamp – table construction ..................15 Figure 5.3.
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Page 5: Introduction
Follow the recommendations presented in this Guide! This manual applies to 5.0 version and higher. Device version is located on the nameplate. Light therapy Lumina lamp should be installed by the seller. The recipient has the right to insist on the product operation training. -
Page 6: Intended Use
Lumina – phototherapy lamp is an active, non-invasive therapeutic device. Lumina is intended to perform heating operations using thermal energy emitted by the bulb, which are aimed at heating the skin and subcutaneous tissue covered by these operations. The required radiation characteristics are achieved by application of a suitable type of filter. -
Page 7: User Training
2.2 User training The Lumina lamp user has to be properly trained in the device safe and effective use, before starting the operation. Training in the rules of operation can be carried out by representatives of the manufacturer or seller, based on this user manual. -
Page 8: Warranty And Manufacturer's Responsibility
On demand, the manufacturer makes available technical diagrams, parts lists, descriptions, instructions for calibration or other helpful information to appropriately qualified user's technical staff to repair these parts of unit, which are described by the manufacturer as a reparable. User Guide - Lumina Page 8 of 42... -
Page 9: Operational Safety
4.1 Mains supply and operation mode The Lumina lamp is designed for supply from AC mains with rating 230 V 10%, 50/60 Hz. It is a medical device under safety class I, type B. The unit may be used only in rooms, where the electric system is executed in compliance with standards in force. - Page 10 Portable RF 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 Lumina, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
- Page 11 4. Operational safety Occupational Health and Safety: • The operator must wear protective goggles during treatment. • Patients should wear protective goggles when the light therapy is performed in the area around the face and chest. • Do not look directly at the source of radiation without wearing protective goggles. •...
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Page 12: Explosion Proof Environment
Due to the intended use, the device can be used in hospitals, clinics, rehabilitation centers and other health care facilities under the supervision of qualified personnel. Simultaneous operation of the Lumina lamp with devices generating strong electromagnetic field, such as short wave, microwave diathermies, high frequency surgical equipment, MRI systems, may disturb unit operation. For this reason, it is recommended to maintain appropriate distance between these devices or to switch off the generator of strong fields during therapy with the unit. -
Page 13: Technical Supervision
Figure 4.2. Warning label sample 4.7 Technical supervision The user of Lumina lamp must perform annual technical inspection of the unit. The inspection must be performed by a unit authorized by the manufacturer. The inspection is performed at the user's expense. - Page 14 (WEEE) – see the table with symbol description used for marking the product in Appendix A. Used infrared light bulb should be disposed of according to the rules for the used light sources. Bulbs used in Lumina lamp do not contain electronic components. User Guide - Lumina Page 14 of 42...
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Page 15: Device Construction
General view of the lamp is presented in Figure 5.1. and Figure 5.2. Figure 5.1. General view of the Lumina lamp – stand construction Figure 5.2. General view of the Lumina lamp – table construction Page 15 of 42 Issue date 02.09.2019... - Page 16 The mains switch, fuse socket and mains socket are located on the rear side of casing. Details are shown in the Figure 5.4. Figure 5.4. View of the rear side of the lamp tube Symbol Description Mains rocker Mains and fuse socket User Guide - Lumina Page 16 of 42...
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Page 17: Lamp Controller
5. Device construction 5.2 Lamp controller The controller works as a module built into the lamp tube. The electronic controller system consists of: • microcontroller module, • user interface consisting of a two-digit seven-segment display, keys and LED diodes, • power circuits providing adequate supply voltages, •... -
Page 18: Parameter Change Key
The name plate is located on the lamp tube. Among others there are following data on the name plate (see Appendix A): • device version, • serial number, • voltage and power frequency, maximum power, • type of applied fuses, • manufacturer's data. User Guide - Lumina Page 18 of 42... -
Page 19: Device Installation And Start-Up
This is aimed at adaptation of the lamp to conditions in operation room. The Lumina lamp shall be placed near mains socket with power input 230 V and 50/60 Hz. Due to manufacturing under safety class I the unit can be connected only to a socket with protective earth pin. - Page 20 6. Device installation and start-up Figure 6.1. Assembly of a stand to the base Figure 6.2. Assembly of a lamp tube to the stand Figure 6.3. Attachment of mains cable clips User Guide - Lumina Page 20 of 42...
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Page 21: Assembling - Lamp On A Table Stand
6. Device installation and start-up 6.3 Assembling – lamp on a table stand • Stand table base set on the flat surface. • Take out of the packaging the lamp tube along with the U-shaped holder. Loosen the knobs that attach the U-shaped holder to the lamp tube. -
Page 22: Filter And Bulb Assembly
The bulb and filter installation is shown in the Figure 6.6., part c and d. The method of disassembly of the bulb and filter is shown in the Figure 6.6., parts a and b. User Guide - Lumina Page 22 of 42... -
Page 23: First Operation
6. Device installation and start-up Figure 6.6. Assembly / disassembly of the bulb and filter 6.5 First operation Connect the mains cable to the socket located on the lamp tube, then to the mains power supply. Then turn on the lamp with the use of mains switch. After switching the mains supply on, the unit starts its operation from self-test on the internal functional blocks. -
Page 24: Device Operation
After the treatment it is necessary to check carefully the skin of the patient. In palpation assessment the skin should be slightly or moderately warm with noticeable heat erythema with speckled pattern in the User Guide - Lumina Page 24 of 42... -
Page 25: Setting The Lamp On A Stand
7. Device operation area of radiation. Intensity of radiation may differ due to intensity of the treatment and content of pigment in the skin. • The risk of occurrence of burns is decreased by: cautious and careful application of treatments (including the assessment of an ability to differentiate by the patient the intensity of temperature), the adequate communication to the patient of the information concerning the character of heat stimulus, checking the degree of the skin’s overheating during the treatment. -
Page 26: Setting The Lamp On A Table Stand
Set, by controlling the handles located on the front of the lamp tube, the appropriate lamp angle of operation. Tighten the knob screws placed on the U-shaped holder, left and right. User Guide - Lumina Page 26 of 42... -
Page 27: Lamp Configuration Change
7. Device operation 7.4 Lamp configuration change Note: Ask another person for help if you have any difficulties with assembling the lamp tube. If the lamp is assembled on a stand and you want to work on the table base: Step Description Unplug the mains cable from the lamp... - Page 28 Base with mounted wheels set on the floor. If the base is not assembled, see section 6.2. Disconnect the mains cable from the controller. Holding the lamp tube, unscrew the fixing screw and remove the washer. User Guide - Lumina Page 28 of 42...
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Page 29: Treatment Time Setting
7. Device operation Step Description Move the U-shaped holder position so that the control panel is up. Place the washer in the U-shaped holder opening, then place the screw through the washer and U-shaped holder. NOTE: The washer should be placed between the U-shaped holder and the stand arm (on the top of the U-shaped holder) providing adequate insulation between the lamp tube and the stand arm. -
Page 30: Start And End Of The Treatment
Press START / STOP key to turn off the buzzer. The fan is switched on synchronously with the bulb. At the end of the treatment procedure, the fan is still working for some time while cooling the lamp tube. User Guide - Lumina Page 30 of 42... -
Page 31: Definitions And Parameters
8. Definitions and parameters 8. Definitions and parameters 8.1 Treatment parameters Characteristic of treatment parameters: Symbol Description Available parameters Range: 1 – 30 minutes Treatment time Regulation: 1 minute Default value: 15 minutes Range: 10 – 99 % Regulation: 10 % Default value: 99 % Maximum radiation power at settings 99: 375W Bulb light... -
Page 32: Indications And Contraindications
9.2.2 Irradiation limitations • irradiation of patients with disturbed superficial sensation should be avoided • avoid simultaneous exposure to infrared radiation, visible (red) radiation and ultraviolet User Guide - Lumina Page 32 of 42... -
Page 33: Possible Side Effects
9. Indications and contraindications 9.3 Possible side effects Pay special attention to the correct methodology of the procedure. In case of non-observance, tissue overheating may occur in the area of the treatment. In this situation, appropriate help should be given immediately. -
Page 34: Maintenance, Cleaning, Disinfection
Put the filter into the front of the lamp (Figure 10.1 Connect the mains cable – firstly to the socket placed in the rear panel of the lamp tube and then to the mains. User Guide - Lumina Page 34 of 42... -
Page 35: Fuse Replacement
10. Maintenance, cleaning, disinfection Figure 10.1. Filter and bulb replacement 10.2 Fuse replacement NOTE: Before proceeding to the further described operations disconnect the unit from the mains! In case of blown fuses, they must be replaced. Their parameters are given in section „Specification and accessories”... -
Page 36: Cleaning And Disinfection - Lamp
Eyewear cleaning agents from Chemax, Uvex, Carl Zeiss, Bausch & Lomb, and Alpro can be used. Items that come into contact with the patient's body, such as goggles, should be disinfected after each treatment. User Guide - Lumina Page 36 of 42... -
Page 37: Troubleshooting
10. Maintenance, cleaning, disinfection 10.5 Troubleshooting Problem Undertaking action Check whether the device is connected to the mains. Check, if the mains cable is working properly. If you have the After switching on the power supply, opportunity, try to connect another cable of the same type. none of the controller indicators is lit. -
Page 38: Specification And Accessories
Application type: Classification in compliance with IEC 60601-2-57: Exempt Group Degree of protection provided by enclosures: IP20 Operation mode: The Lumina lamp is intended for continuous operation. Treatment parameters: Described in section 8.1 Accuracy of operation parameters: 10% Treatment time: 20%... -
Page 39: Emc Parameters
RF transmitters, an electromagnetic site survey should be considered If the measured field strength in the location in which the Lumina lamp is used exceeds the applicable RF compliance level above, the unit should be observed to verify normal operation. -
Page 40: Standard Accessories
Bulb manufactured by Helios infrared lamp emitter R-125 E27, 230V 375W Front safety mesh without glass filter A-AO-AST-NET_NF_V5.0 Other Name Safety goggles for the patient Safety goggles for the therapist Allen key (size 4) User Guide - Lumina Page 40 of 42... -
Page 41: Appendix A. Symbol Description
Appendix A 12. Appendix A. Symbol description Symbol Explanation Caution, see the ASSOCIATED DOCUMENTS, symbol ISO 7000-0434A B type equipment, symbol IEC 60417-5840 Date of production: year, symbol ISO 7000-2497 IP20 Degree of protection provided by enclosures (IP code), symbol IEC 60529 Fuse, symbol IEC 60417-5016 Device version Serial number, symbol ISO 7000-2498... - Page 42 Weight Packaging size The marking of conformity with legal regulations for medical devices applicable in the European Union along with the number of the Notified Body taking part in the conformity assessment. User Guide - Lumina Page 42 of 42...
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