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Astar PhysioGo.Lite Sono User Manual

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Summary of Contents for Astar PhysioGo.Lite Sono

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

  • Page 3: Table Of Contents

    1. Basic information and contents 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 7.3 Information screen sample view ..........................39 Figure 8.1. Manual time setting ............................... 47 Figure 10.1. The unit error signaling and information visible after closing of the error message ..........53 User Manual – PhysioGo.Lite Sono page 4 / 64...

  • Page 5: Introduction

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

  • Page 6: Intended Use

    2.Intended use 2. Intended use Ultrasound therapy unit PhysioGo.Lite Sono is an active, non-invasive medical device intended for carrying out treatments procedures using standard ultrasound therapy, low-intensity pulsed ultrasound (LIPUS) therapy and phonophoresis. As regards to ultrasounds, the unit may be operated with: GU-5 standard ultrasound head, which generates an ultrasound wave with a frequency of 1 MHz or 3 •...

  • Page 7: Intended Users

    User training The PhysioGo.Lite Sono 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 Sono page 8 / 64...

  • Page 9: Operational Safety

    Figure 4.1. The method of correct connection of the SMPS, mains filter and controller Recommendations related to isolation the device from the supply mains: Do not position the PhysioGo.Lite Sono so that it is difficult to operate the disconnection of the device •...

  • Page 10: Storage, Operation And Transport Conditions

    WARNINGS and safety notes The PhysioGo.Lite Sono unit has been designed and manufactured in such a way that its use does not cause a hazard to the health and safety of patients, operators and third parties, as well as the unit provides therapeutic benefits to patients if it is operated in appropriate conditions and in accordance with its intended purpose.
  • Page 11 4. Operational safety Prevent any fluid from penetrating inside the unit, SMPS or mains filter. In case of any fluid getting inside • the unit, SMPS or mains filter, switch the unit immediately off, isolate from the mains and contact service to inspect the unit.

  • Page 12: Explosion Proof Environment

    Operation, storage and transport conditions are presented in chapter 4.2. • Explosion proof environment PhysioGo.Lite Sono 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

    WARNING: 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 PhysioGo.Lite Sono, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

  • Page 14: Essential Performance

    5.1 and 5.5. The appropriate symbol of the BF type applied part is placed on the sockets label. Essential performance With regard to the PhysioGo.Lite Sono, essential performance is the generation of an ultrasonic wave with a frequency in the range of 500kHz – 5MHz in: •...

  • Page 15: Disposal

    4. Operational safety Required measuring Test item Method of checking Acceptance criteria equipment No deformation or cracks of the Inspection of the mains filter casing condition for casing defects and No tear and bending of cable Visual inspection No requirements damage of interconnecting cables insulation and connectors...

  • Page 16: Unit Description

    5. Unit description General characteristics Ultrasound therapy unit PhysioGo.Lite Sono 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 17: 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 18: Operation Status And Battery Level Indicators

    The unit is turned on. Steady light No light Mains cable Battery is fully charged. connected ON („1”) No light Steady light Unit is running on battery supply. Mains cable disconnected User Manual – PhysioGo.Lite Sono page 18 / 64...

  • Page 19: Battery Installation

    If the problem repeats, contact your authorized service. Battery installation PhysioGo.Lite Sono 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 20: Name Plate And Label With Parameters

    • total area of the head front in single-section mode – 17.3 cm , in dual-section mode – 34.6 cm • effective radiating area – 3 cm • integrated temperature sensor User Manual – PhysioGo.Lite Sono page 20 / 64...

  • Page 21: Main Features Of Sng Head

    5. Unit description The following data are located on the ultrasound head name plate (see Appendix A): acoustic working frequency, • • beam type, • beam non-uniformity ratio, nominal power, • • effective radiating area, manufacturer’s data • • serial number, reference number, production date, version, degree of protection provided by the enclosure, •...

  • Page 22: Signaling The Lack Of Contact Of The Ultrasound Heads

    This mechanism prevents the temperature from rising above the limit specified in IEC 60601-2-5. The moment when the temperature is measured is signaled by the LED indicator of the head turning off. User Manual – PhysioGo.Lite Sono page 22 / 64...

  • Page 23: 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 24 6. Device installation and start-up Method of mounting the holders is presented in the following figures. Figure 6.1 Method of mounting the standard ultrasound head holder User Manual – PhysioGo.Lite Sono page 24 / 64...

  • Page 25: Connection Of Ultrasound Heads

    6. Device installation and start-up Figure 6.2 Method of mounting the SnG head holder 6.1.2 Connection of ultrasound heads Ultrasound heads should be connected to sockets according to Figure 6.3. All connectors are protected against pulling out. When plugging a connector in, twist the thread to secure it. page 25 / 64 Issue date 07.05.2021, release 1.0...

  • Page 26: Connection In Combined Therapy

    In the case of battery operation, please hold on for at least 5 seconds the STANDBY key . Extension of the holding time prevents unintentional activation during transport. User Manual – PhysioGo.Lite Sono page 26 / 64...

  • Page 27: Setup Mode

    6. Device installation and start-up If after switching on mains supply the display is illegible and no light indicator is illuminated, check whether mains fuse or mains cable operate correctly. Care shall be given to apply fuses with rating given on the name plate.

  • Page 28: Functional Settings

    For medical fields, instead of the preset treatment programs the following options classified by medical nomenclature are available (according to chosen applicator): • Orthopedics • Sports medicine • Aesthetic medicine • Rheumatology Neurology • • Dermatology Angiology • User Manual – PhysioGo.Lite Sono page 28 / 64...
  • Page 29 6. Device installation and start-up 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. 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.

  • Page 30: Control Functions

    6.3.6 Information 6.3.6.1 Info Provides information about the serial number, version of the unit, software, interface and software build date. 6.3.6.2 Manufacturer Provides information about the manufacturer together with the contact details. User Manual – PhysioGo.Lite Sono page 30 / 64...

  • Page 31: Transport Position - Trolley For The Unit And Accessories

    6. Device installation and start-up 6.3.6.3 Distributor Provides information about the distributor in a given country together with the contact details. The „Change contact data” button can be use only by authorized unit, after entering the access code. The full data consists of: •...

  • Page 32: Unit Operation

    Proper pressure is necessary in order to ensure firm contact between the skin and the head which enables optimal transmission of ultrasound energy. It is necessary to use the coupling medium conducting the ultrasounds, preferably gel. • User Manual – PhysioGo.Lite Sono page 32 / 64...

  • Page 33: Combined Therapy

    7. Unit operation Coupling medium should be applied on the surface of skin, make continuous movements in the form of • overlapping or longitudinal circles, the head shall not be removed from skin, in case of pain or burning it is necessary to stop therapy and change parameters.

  • Page 34: Method Of Treatment Performance

    In single-transducer application, protection against tissue overheating is achieved by the ultrasonic wave modulation. LIPUS The head remains motionless during the treatment. User Manual – PhysioGo.Lite Sono page 34 / 64...
  • Page 35 7. Unit operation Examples of applications are presented below. Method Head Example Dynamic, semi- stationary LIPUS GU-5 Dynamic, semi- stationary LIPUS GU-1 page 35 / 64 Issue date 07.05.2021, release 1.0...

  • Page 36: Screen Configuration

    Edition field preset treatment program lists • • user-defined program lists settings • Note: If the edition / main menu field is greyed out, it means that it is inactive. User Manual – PhysioGo.Lite Sono page 36 / 64...

  • Page 37: General Configuration

    7. Unit operation General configuration Examples of accessory configurations are shown below: Channel Equipment Connected accessories: • standard ultrasound head (GU-1) standard ultrasound • head (GU-5) Connected accessories: standard ultrasound • head (GU-1) • SnG head Connected accessories: SnG head •...

  • Page 38: Display Description

    The simplest method of unit’s operation is to use its preset programs. The unit includes a database containing several dozens of most frequently met disorders together with suggested treatment types and parameters. In this mode, the operation is reduced to selection of disease entity from the list. User Manual – PhysioGo.Lite Sono page 38 / 64...
  • Page 39 7. Unit operation The values of the preset treatment programs parameters are based on the available literature data and they are determined as average values. Parameters should be treated exclusively as indications. Sole responsibility for application of preset treatment programs bears the user. Pressing the button after program selection results in appearing information which contains: •...

  • Page 40: Favorite Programs

    You can also remove the item from the favorite list, if you press the symbol User Manual – PhysioGo.Lite Sono page 40 / 64...

  • Page 41: Manual Mode Operation

    7. Unit operation To enter the favorite list, press the symbol If no item from the preset treatment program list is selected as a ”favorite”, the after entering the option, the list will be empty. NOTE: Favorite option is not available when you set the view of preset treatment programs by medical fields. See point 6.3.4.2.

  • Page 42: Combined Therapy Treatment

    Combined therapy treatment PhysioGo.Lite Sono device can cooperate with devices manufactured by Astar with electrotherapy function. This allows to perform a combined therapy, where the generator of current is the unit with this function, while PhysioGo.Lite Sono controls the operation of the ultrasound head.

  • Page 43: Safe Shutdown Procedure

    7. Unit operation Step Description Connect the ultrasound head / heads to the PhysioGo.Lite Sono. Connect accessories to the other device. Switch on both units. Set the appropriate electrotherapy parameters (according to the User Manual of the electrotherapy device) and ultrasound therapy (see section 7.7). Set the treatment time on PhysioGo.Lite Sono device longer than the time on electrotherapy device.

  • Page 44: Definitions And Parameters

    Because of the mechanical and thermal effects, the ultrasounds cause physicochemical changes in tissues, including: • acceleration of conventional reactions as well as oxidation and reduction in aqueous solutions, degradation of polymers, • • lysis and reactions in organic solvents. User Manual – PhysioGo.Lite Sono page 44 / 64...

  • Page 45: Standard Ultrasound Heads (Gu-5, Gu-1)

    8. Definitions and parameters The biological effect of ultrasounds is the resultant of thermal, mechanical and physicochemical effects and includes: • agitation of fibroblast activity, • stimulation of collagen synthesis, stimulation of synthesis of non-collagen proteins in fibroblasts (albumin and globulin), •...

  • Page 46: Single Transducer Mode

    Non-adjustable parameter, the result of power density and effective radiating area. Power Temporal maximum output power in pulse mode Effective 3 cm radiating area • YES – active LIPUS mode NO – disabled • User Manual – PhysioGo.Lite Sono page 46 / 64...

  • Page 47: Dual Transducer Mode

    8. Definitions and parameters Figure 8.1. Manual time setting SnG head – dual-transducer mode Parameters description: Symbol Description Available parameters Operating Non-adjustable parameter, two transducers active mode Available settings: Acoustic working • 1 MHz frequency 3 MHz • 1/3 MHz – switching frequency every 8 seconds •...
  • Page 48 1 s, Figure 8.1) Non-adjustable parameter, the result of power density and effective radiating area. Power Temporal maximum output power in pulse mode Effective 3 cm for every transducer radiating area User Manual – PhysioGo.Lite Sono page 48 / 64...

  • Page 49: Characteristics Of Pulse Parameters

    8. Definitions and parameters Characteristics of pulse parameters The pulse durations depending on the set frequency and duty factor are presented in Table 8-1. For the LIPUS mode, the parameter is non-adjustable – for the frequency of 1 kHz it is 1 ms. In pulse mode, the output power is equal to the product of the duty factor and the set power.

  • Page 50: Indications And Contraindications

    • • precautions should be taken for implants and endoprostheses (metal, plastic and cement) • skin conditions and wounds • peripheral nerves damage User Manual – PhysioGo.Lite Sono page 50 / 64...
  • Page 51 9. Indications and contraindications Therapy limitations: • ultrasound must not be applied above the third cervical vertebrae • avoid application in the area of heart, brain, eyes, facial sinuses, gonads, thyroid and lymph nodes (especially cervical), chest, over the parenchymal organs •...

  • 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 Sono page 52 / 64...

  • Page 53: Cleaning And Disinfection Of The Ultrasound Heads

    Warnings Self-test procedure Each time the PhysioGo.Lite Sono 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 54: Troubleshooting

    Switch on the unit. Enter the setup mode. Modify the US head sensitivity, Message – no ultrasound head following point 6.3.4.4. contact – appears frequently If the problem repeats, contact your service. User Manual – PhysioGo.Lite Sono page 54 / 64...

  • Page 55: Fuse Replacement

    10. Maintenance, cleaning, disinfection Symptoms Undertaking action Ultrasound head does not Switch on the unit. Enter the setup mode. Perform the US head calibration detect the lack of contact. procedure, according to point 6.3.5.3. If the problem repeats, contact your service. Unit equipped with battery Connect the mains supply.

  • Page 56: Specification And Accessories

    25x27x16,5cm Switched Mode Power Sup Sinpro, model HPU63B-108: Mains supply – input: 100-240 VAC; 1,62-0,72A; 47-63 Hz Output: 24VDC; 2,62A max Weight: 0,38 kg max Power supply dimensions (WxDxH) 13,2x5,6x3,7 cm User Manual – PhysioGo.Lite Sono page 56 / 64...
  • Page 57 11. Specification and accessories Switched Mode Power Supply Mean Well, model GSM60B24-P1J: Mains supply – input: 100-240 VAC; 1,4-0,7A; 50/60 Hz Output: 24VDC; 2,5A max Weight: 0,35 kg max Power supply dimensions (WxDxH) 12,5x5x3,15 cm Battery: Type: Li-Ion Voltage: 18 V Capacity: 2,1 Ah Charging time:...

  • Page 58: Emc Parameters

    RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the PhysioGo.Lite Sono unit is used exceeds the applicable RF compliance level above, the unit should be observed to verify normal operation.

  • Page 59: Standard Accessories

    Proximity fields from RF wireless communications equipment according to 8.10 IEC 60601- Complies 1-2:2014 Standard accessories Name Quantity PhysioGo.Lite Sono controller A-UL-AST-PLS Switch mode power supply – type HPU63B-108 by Sinpro or GSM60B24-P1J by Mean Well Mains cable with filter USG gel H-AS-CEM-ZEL500G Spare fuse –...

  • Page 60: 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 15223-1:2020 standard User Manual – PhysioGo.Lite Sono page 60 / 64...
  • Page 61 Appendix A Symbol Definition Unique Device Identifier, symbol 5.7.10. of ISO 15223-1:2020 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 supplies identification Follow operating instructions, symbol ISO 7010-M002...
  • Page 62 RBN / BNR (max) Beam non-uniformity ratio Rated output power Effective radiating area Head size / Total appl. area Total contact area (head front) IPX7 Degree of protection provided by enclosure User Manual – PhysioGo.Lite Sono page 62 / 64...

  • Page 63: Switched-Mode Power Supplies - Casing

    Appendix A Switched-mode power supplies – casing Symbol Description SMPS type TUV Rheinland conformity mark (the table lists the standards for which compliance has been demonstrated, the ID means the notified body’s report number). Marking of compliance with the requirements of legal regulations in force in the European Union.
  • Page 64 SMPS type Direct current (DC), symbol IEC 60417-5031 HPU63B-108 Alternating current (AC), symbol IEC 60417-5032 (Sinpro) GSM60B24-P1J IP22 Degree of protection provided by enclosures (IP code), based on IEC 60529 (Mean Well) User Manual – PhysioGo.Lite Sono page 64 / 64...

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