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Astar PhysioGo.Lite Laser User Manual

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Summary of Contents for Astar PhysioGo.Lite Laser

  • Page 1 PhysioGo.Lite Laser – User manual...

  • Page 3: Table Of Contents

    1. Basic information Contents INTRODUCTION ................................... 5 ....................................5 ANUFACTURER .................................. 5 ISK MANAGEMENT PROCESS INTENDED USE ..................................... 6 ....................................7 NTENDED USERS ....................................7 SER TRAINING WARRANTY AND MANUFACTURER'S RESPONSIBILITY ........................8 OPERATIONAL SAFETY ................................. 9 ..............................9 AINS SUPPLY AND OPERATION MODE ...........................
  • Page 4 Figure 7.2 Screenshot sample view for laser therapy – cluster applicator ....................... 41 Figure 7.3 Information screen sample view ..............................42 Figure 10.1. The unit error signaling and information visible after closing of the error message ..............54 User Manual – PhysioGo.Lite Laser page 4 / 66...

  • Page 5: Introduction

    Read this manual carefully before starting the unit operation! Follow the recommendations presented in this manual! The laser therapy unit PhysioGo.Lite Laser should be installed by the seller. The recipient has the right to insist on the product operation training.

  • Page 6: Intended Use

    450 mW for wave length 808 nm and 100 mW for 660 nm, the PhysioGo.Lite Laser unit is classified as a small power output laser device. In physiotherapy such lasers are designated as ”cold”, ”soft” or biostimulating.

  • Page 7: Intended Users

    User training The PhysioGo.Lite Laser 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 producer 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 producer as a reparable. User Manual – PhysioGo.Lite Laser page 8 / 66...

  • Page 9: Operational Safety

    LED indicator located on the housing of the switched-mode power supply type GSM60B24-P1J by Mean Well. Recommendations related to isolation the device from the supply mains: Do not position the PhysioGo.Lite Laser so that it is difficult to operate the disconnection of the device • from the supply mains.

  • Page 10: Warnings And Safety Notes

    WARNINGS and safety notes The PhysioGo.Lite Laser unit has been designed and manufactured in such a way that its use does not jeopardize the health and safety of patients, users and third parties, as well as the unit should provide a therapeutic benefits to patients if it is operated in appropriate conditions and in accordance with its intended purpose.
  • Page 11 If the user is not going to apply the remote interlock connector and the emergency laser stop, the DOOR • plug, available as a standard accessory, performs their function. It is recommended to turn PhysioGo.Lite Laser device off when it is not used, so as it is not operated by • unqualified or random persons.

  • Page 12: Explosion Proof Environment

    Operation, storage and transport conditions are presented in chapter 4.2. • Explosion proof environment PhysioGo.Lite Laser is not adopted to operation in rooms, where combustible gases or their vapors occur. It is recommended to avoid anesthetics or oxygen derivate gases, such as nitrous oxide (N O) and oxygen. Some materials (e.g.

  • Page 13: Electromagnetic Environment

    Operator's finger – much lower comfort of operation compared to the pen Technical supervision The User of PhysioGo.Lite Laser unit must perform technical inspection of the unit at year's intervals. The inspection must be performed by a unit authorized by manufacturer. The inspection is performed at the user's expense.

  • Page 14: Eye Protection

    4. Operational safety Eye protection Astar recommends the following types of protective goggles: models with AST, TP2, ML3 and DI4 filters – manufactured by NoIR, optical density and spectral ranges are • shown in the tables below: Table 4-2. Parameters of AST filter...
  • Page 15 4. Operational safety model with 31-21128 filter – manufactured by Honeywell (formerly Sperian), optical density and spectral • ranges are shown in the table below: Table 4-6. Parameters of 31-21128 filter Spectral range [nm] Optical density Symbol 630-730 DIR L4 770-1070 DIR L4 models with P1L22 and P1H03 filters –...

  • Page 16: Laser Labels

    The above-mentioned models provide an adequate level of safety for the patient and the user during laser therapy treatment with the use of applicators handled by any PhysioGo.Lite Laser unit model. It is admissible to wear other types of protective goggles under condition that appropriate level of safety is guaranteed by their manufacturer (they must meet requirements of EN207/EN 208 standard, feature CE marking and declaration of conformity).

  • Page 17: Applied Parts

    4. Operational safety Figure 4.5. Labels of scanning and cluster applicators Applied parts The PhysioGo.Lite Laser unit has one type of applied part of BF type. It includes: • point laser applicators, • scanning applicator, cluster applicator, • • laser applicators sockets, laser applicators plugs with cables.

  • Page 18: Unit Description

    5. Unit description General characteristics Laser therapy PhysioGo.Lite Laser unit is a highly specialized medical device based on modern microprocessor platform. The unit has a plastic console casing. It is equipped with a color touch LCD display with a diagonal of 12.7 cm (5’’).

  • Page 19: Front Panel

    5. Unit description Front panel Arrangement of front panel components is shown in figure 5.3. Figure 5.3 Arrangement of front panel components Table 5-1. Description of front panel components Symbol Description Function The unit is equipped with a touch-sensitive display. The screen clearly Liquid crystal display displays all information related to the device operation.

  • Page 20: Operation Status And Battery Level Indicators

    The unit is turned on. Steady No light Mains cable light Battery is fully charged. connected ON („1”) No light Steady light Unit is running on battery supply. Mains cable disconnected User Manual – PhysioGo.Lite Laser page 20 / 66...

  • Page 21: Battery Installation

    If the problem repeats, contact your authorized service. Battery installation PhysioGo.Lite Laser can be optionally fitted with a battery. Users can install the battery by themselves. WARNING: Before performing the below actions, turn the device power off and disconnect the SMPS from the mains.

  • Page 22: Name Plate

    This is an optional module with an emergency stop pushbutton (mushroom head), manufactured according to the IEC/EN 60947-5-1 standard, used for immediate interruption of laser emission in case of danger. The User Manual – PhysioGo.Lite Laser page 22 / 66...
  • Page 23 5. Unit description module is fitted with a socket to connect the remote interlock connector, which significantly facilitates the safety system organization (see: 5.6.1). The base of the module is fitted with magnets, which allow their easy placement on the dedicated trolley with metal shelves (e.g. Versa or Versa X). Figure 5.6 The view of the emergency laser stop In case of danger and when the emergency stop is used, before continuing the normal use, the following procedures have to be performed —...

  • Page 24: Laser Applicators

    They pass through a clear polycarbonate plate, which is also the laser aperture. Laser beams are divergent. All devices and applicator parameters are described in detail in chapters 8 and 11. User Manual – PhysioGo.Lite Laser page 24 / 66...
  • Page 25 5. Unit description Figure 5.8 Point laser applicators and optical fibers Figure 5.9 Laser scanning applicator – panel description Table 5-7. Laser scanning applicator – panel description Symbol Description Radiation wavelength 660 nm selection indicator Radiation wavelength 808 nm selection indicator Field shape selection indicator Output radiation indicator Figure 5.10 Scanning and cluster laser applicators...
  • Page 26 Table 5-8. Laser cluster applicator - panel description Symbol Description Radiation wavelength 660 nm selection indicator Radiation wavelength 808 nm selection indicator Output radiation indicator Emission start/stop button Single-diode mode indicator Multi-diode mode indicator User Manual – PhysioGo.Lite Laser page 26 / 66...

  • Page 27: Device Installation And Start-Up

    6. Device installation and start-up 6. Device installation and start-up Unit installation The first installation should be performed by a qualified manufacturer's or distributor's representative! After removing the unit from the carton, check if the complete unit has been delivered. In case of any inconsistencies contact the distributor or manufacturer.
  • Page 28 6. Device installation and start-up Method of mounting the holders is presented in the following figures. Figure 6.1 Method of mounting the point applicator holder User Manual – PhysioGo.Lite Laser page 28 / 66...

  • Page 29: Connection Of Laser Applicators

    6. Device installation and start-up Figure 6.2 Method of mounting the cluster applicator holder 6.1.2 Connection of laser applicators Laser applicators should be connected to laser therapy sockets according to figure 6.3. Meaning of laser applicator symbols is shown in the table below. All connectors are protected against pulling out. When plugging a connector in, twist the thread to secure it.

  • Page 30: Laser Scanner Stand

    It is recommended to loosen or turn (depend on need) handwheel locking the arm of the stand or handwheel locking the laser scanner to adjust the right scanner position. Both handwheels are presented in figure 6.5. User Manual – PhysioGo.Lite Laser page 30 / 66...
  • Page 31 6. Device installation and start-up Figure 6.5 Handwheels – scanner and arm of the stand To protect the stand from unintentional change of its position it is recommended to lock wheel brakes – • brake should be pressed to the floor. To release the brake, lift it up (wheel with brake is shown in the figure 6.6.

  • Page 32: Integrated Emergency Laser Stop And Remote Interlock Connector (Door) Installation

    Do not touch the screen during the system start-up. 6.2.1 Laser therapy access code The code which allows for laser applicator operation has the shape of: Entering an incorrect code prevents the device operation. User Manual – PhysioGo.Lite Laser page 32 / 66...

  • Page 33: Setup Mode

    6. Device installation and start-up Setup mode 6.3.1 Basic information Keyboard components designed for the unit operation are called ”keys”. The area on the screen, where after its pressing a specific unit reaction is followed, is called ”button”. The area on the screen that has the possibility to select or deselect any item, is called ”selection field”. To enter Setup mode, press To leave Setup mode, press To go back one level, press...

  • Page 34: Functional Settings

    Dermatology • Angiology The classification of preset treatment programs into the above-mentioned categories do not limit their applications in other fields, according to the knowledge and experience of doctors and physiotherapists. User Manual – PhysioGo.Lite Laser page 34 / 66...

  • Page 35: Control Functions

    6. Device installation and start-up 6.3.4.3 The battery save mode When the mode is activated, the device switches automatically into the standby mode after two hours of inactivity, which prolongs the battery life. The laser scanner switches off after 30 minutes of inactivity. 6.3.5 Control functions 6.3.5.1 Miscellaneous...

  • Page 36: Information

    Provides information about the number of treatment procedures performed. Statistics can be deleted. If you want to delete statistics, press Delete programs counters button. 6.3.6.6 Accessories statistics There appears the information on connected accessories. User Manual – PhysioGo.Lite Laser page 36 / 66...

  • Page 37: Transport Position - The Stand With Scanning Applicator

    6. Device installation and start-up Transport position – the stand with scanning applicator Step Description Click the UNIT ON / OFF (STANDBY) button on the front panel A message will appear on the display: Press to shut down the system correctly. Disconnect the mains cable from the power supply.

  • Page 38: Unit Operation

    – see 6.3.5.3. Therapeutic dose is described as energy density and is expressed in J/cm . Dose of radiation must be • adapted to the goals of therapy. User Manual – PhysioGo.Lite Laser page 38 / 66...

  • Page 39: Screen Configuration

    7. Unit operation • Technical parameters of the equipment, that is the wave length and surface of an applicator, have direct impact on the dose of radiation. • Methods of application (point applicator – contact; cluster applicator – contact, contactless), scanning applicator (contactless) is adapted depending on the size of application area and the goal of therapy.

  • Page 40: General Configuration

    The table below explains the meaning of the symbols presented in tab: Symbol Description Selected laser point probes Selected scanning laser applicator Selected cluster laser applicator Ongoing treatment Treatment interrupted Pause Error (yellow symbol) User Manual – PhysioGo.Lite Laser page 40 / 66...

  • Page 41: Display Description

    7. Unit operation Display description An example of the appearance of a treatment screen is presented below. Figure 7.2 Screenshot sample view for laser therapy – cluster applicator Symbol Description Applicator identifier / program name Output energy and power emitted by laser applicator Presentation of the treatment elapsing time Information field –...
  • Page 42 Select the option Preset programs from Program modes menu or the medical field. Confirm by pressing the selected field once again. Select the program from the list. Prepare the patient for the treatment according to indications in point 7.1 User Manual – PhysioGo.Lite Laser page 42 / 66...

  • Page 43: Voll And Nogier Programs

    7. Unit operation Step Description Press the key scanning applicator cluster applicator point applicator Set the shape and size of the Set the treatment area. Set the treatment area. treatment area as well as Press the key Press the key default scanner distance.

  • Page 44: Manual Mode Operation

    To resume the treatment procedure, it is recommended to follow the instructions shown on the display. User programs The User has the possibility to save in to the device memory own sets of treatment parameters in the form of programs. User Manual – PhysioGo.Lite Laser page 44 / 66...
  • Page 45 7. Unit operation Saving of user program: Step Description Prepare the unit to work in manual mode (steps 1 – 5 see section 7.7). Set the program parameters. Press the button from main menu. Select the item number under which the program will be saved. Confirm your choice by clicking the field once again.

  • Page 46: Safe Shutdown Procedure

    If you want to charge the battery, leave the device connected to the mains. If you do not use the device for a long time, remove the mains cable plug from the mains socket. User Manual – PhysioGo.Lite Laser page 46 / 66...

  • Page 47: Definitions And Parameters

    8. Definitions and parameters 8. Definitions and parameters Due to the wide impact range, lasers may be applied to treat disorders on many fields, among others in: • sports medicine, orthopedics, • • rheumatology, neurology, • • dermatology. • laryngology, stomatology, •...

  • Page 48: Point Laser Applicators (Laser Probes)

    For standard fiber applicators the treatment time is extended up to 25%, for applicators dedicated to laser acupuncture up to 67%. User Manual – PhysioGo.Lite Laser page 48 / 66...

  • Page 49: Scanning Applicator

    8. Definitions and parameters Scanning applicator Characteristic of treatment parameters: Symbol Description Available parameters Laser diode with the 808 nm wavelength Laser diode with the 660 nm wavelength Type of radiation source Laser diode with the 660 nm wavelength and laser diode with the 808 nm wavelength Energy dose 0,5 J/cm...

  • Page 50: Cluster Applicator

    1 Hz – 5000 Hz – pulse mode • Duty factor during • 10 – 90% regulation step 10% pulse operation Treatment time 1 second – 100 minutes, variable step Delivered energy Maximum 3000 J User Manual – PhysioGo.Lite Laser page 50 / 66...

  • Page 51: Indications And Contraindications

    9. Indications and contraindications 9. Indications and contraindications Indications difficult healing wounds and ulcerations bursitis, tendovaginitis, fasciitis • • • post-surgical wounds, post-amputation • subcutaneous hemorrhages (ecchymosis), wounds contusions • skin necrosis • difficult, prolonged union of fractured bones • skin damages muscles, ligaments, cartilage, synovium, ulcerations of shanks, trophic ulcerations...

  • Page 52: Maintenance, Cleaning, Disinfection

    The manufacturer does not recommend to use any product designated for cleaning screens, because there is no guarantee that the chemicals will not lead to faster wear out of touchscreen layers. User Manual – PhysioGo.Lite Laser page 52 / 66...

  • Page 53: Cleaning And Disinfection Of The Scanning And Cluster Applicator

    10. Maintenance, cleaning, disinfection Cleaning and disinfection of the scanning and cluster applicator NOTE: Before attempting to perform following operations isolate the unit and SMPS from the mains supply! Cleaning of the scanning or cluster laser applicator and their cables shall be performed with lightly humid sponge or soft cloth with delicate soap solution or mild detergent.

  • Page 54: Special Messages

    Warnings Self-test procedure Each time the PhysioGo.Lite Laser unit is started, a special self-test procedure is performed during which all modules and functional blocks of the device are tested. If any errors or damage are detected, the relevant information will be presented on the display screen. The module where the irregularity has been detected is blocked and the associated function is not available.

  • Page 55: Troubleshooting

    10. Maintenance, cleaning, disinfection Troubleshooting Table 10-3. Symptoms Undertaking action Check fuse. If it is blown, replace it in accordance with indications in point The unit does not respond 10.8. to mains supply Try to connect different mains cable. If the problem persists, contact your authorized service. Turn off and on the device.

  • Page 56: Fuse Replacement

    Connect the power supply cord to the device socket. Then connect the mains cable to the mains socket. Switch the power switch on and start the device. Check the device operation. User Manual – PhysioGo.Lite Laser page 56 / 66...

  • Page 57: Specification And Accessories

    11. Specification and accessories Specification and accessories Technical data Classifications: Medical device class: IIb, rule 9 (according to MDD 93/42/EEC and REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017) Electrical safety class: Application part type: Laser device class: Degree of protection provided by enclosures: IP20...
  • Page 58 Operation conditions: Temperature range: +15÷+30°C Relative humidity: 30÷75% Pressure range: 700÷1060 hPa (70 – 106 kPa) Transport conditions: Temperature range: -10÷+45°C Relative humidity: 20÷95% Pressure range: 700÷1060 hPa (70 – 106 kPa) User Manual – PhysioGo.Lite Laser page 58 / 66...

  • Page 59: Emc Parameters

    RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the PhysioGo.Lite Laser unit is used exceeds the applicable RF compliance level above, the unit should be observed to verify normal operation.
  • Page 60 Voltage interruptions 250 cycles for 50 Hz Complies IEC 61000-4-11 300 cycles for 60 Hz Immunity test Compliance level Proximity fields from RF wireless communications equipment according to 8.10 IEC Complies 60601-1-2:2014 User Manual – PhysioGo.Lite Laser page 60 / 66...

  • Page 61: Standard Accessories

    11. Specification and accessories Standard accessories Name Quantity PhysioGo.Lite Laser controller A-UL-AST-PLL Switch mode power supply – type HPU63B-108 by Sinpro or GSM60B24-P1J by Mean Well Mains cable Integrated remote interlock connector/ emergency A-AL-AST-DOOR-PL laser stop connector Spare fuse – time lag T3,15L250V...

  • Page 62: Appendix A. Symbol Description

    Degree of protection provided by enclosures (IP code), based on IEC 60529 Fuse, symbol IEC 60417-5016 Unit version Serial number, symbol ISO 7000-2498 Batch code, symbol ISO 7000-2492 Catalogue number, symbol ISO 7000-2493 Medical device, symbol 5.7.7. of ISO 15223-1 standard User Manual – PhysioGo.Lite Laser page 62 / 66...
  • Page 63 Appendix A Symbol Definition Unique Device Identifier, symbol 5.7.10. of ISO 15223-1 standard Disposal of used devices together with other waste is prohibited, complied with the requirements of WEEE General symbol for recovery/recyclable, symbol ISO 7000-1135 Operator's manual; operating instructions, symbol ISO7000-1641 Switch mode power supply socket, direct current, symbol IEC 60417-5031 Switched-mode power supply identification Follow operating instructions, symbol ISO 7010-M002...

  • Page 64: Switched-Mode Power Supply - Casing

    Marking of compliance with the requirements of legal regulations in force in the European Union. UL+CUL conformity mark (USA, Canada). The alphanumeric string represents the approved UL report number. HPU63B-108 Federal Communications Commission EMC compliance mark (USA) (Sinpro) User Manual – PhysioGo.Lite Laser page 64 / 66...
  • Page 65 Appendix A Symbol Description SMPS type GSM60B24-P1J The Eurasian Conformity mark – conformity with all technical regulations of the (Mean Well) Eurasian Customs Union. GSM60B24-P1J Caution, symbol ISO 7000-0434A (Mean Well) GSM60B24-P1J Dangerous voltage, symbol IEC 60417-5036 (Mean Well) For indoor use only, symbol IEC 60417-5957 Class II equipment, symbol IEC 60417-5172 Compliance with the RoHS directive SJ/T 11364-2014 (China).

  • Page 66: Appendix B. Disassembly Of Laser Scanner From The Stand

    13. Appendix B. Disassembly of laser scanner from the stand To disassembly laser scanner from the stand: Disconnect the plug of interconnecting cable. • • Hold one hand the stand and release the scanner from the mounting socket. User Manual – PhysioGo.Lite Laser page 66 / 66...

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