A-Star PhysioGo.Lite Sono User manual

PhysioGo.Lite Sono –
User manual

1. Basic information and contents
page 3 / 64 Issue date 07.05.2021, release 1.0
Contents
1. INTRODUCTION .......................................................................................................................................................5
MANUFACTURER ............................................................................................................................................................. 5
RISK MANAGEMENT PROCESS .............................................................................................................................................. 5
2. INTENDED USE .........................................................................................................................................................6
INTENDED USERS .............................................................................................................................................................. 7
USER TRAINING ............................................................................................................................................................... 7
3. WARRANTY AND MANUFACTURER'S RESPONSIBILITY..............................................................................................8
4. OPERATIONAL SAFETY .............................................................................................................................................9
MAINS SUPPLY AND OPERATION MODE.................................................................................................................................. 9
STORAGE,OPERATION AND TRANSPORT CONDITIONS .............................................................................................................. 10
WARNINGS AND SAFETY NOTES ...................................................................................................................................... 10
EXPLOSION PROOF ENVIRONMENT...................................................................................................................................... 12
ELECTROMAGNETIC ENVIRONMENT .................................................................................................................................... 13
OPERATION OF TOUCH-SENSITIVE DISPLAYS .......................................................................................................................... 13
APPLIED PARTS .............................................................................................................................................................. 13
ESSENTIAL PERFORMANCE ................................................................................................................................................ 14
4.8.1 Tests of essential performance and basic safety............................................................................................ 14
DISPOSAL ..................................................................................................................................................................... 15
5. UNIT DESCRIPTION ................................................................................................................................................16
GENERAL CHARACTERISTICS .............................................................................................................................................. 16
FRONT PANEL ................................................................................................................................................................ 17
5.2.1 Operation status and battery level indicators................................................................................................ 18
BATTERY INSTALLATION ................................................................................................................................................... 19
NAME PLATE AND LABEL WITH PARAMETERS ......................................................................................................................... 20
ULTRASOUND HEADS ...................................................................................................................................................... 20
5.5.1 Main features of SnG head ............................................................................................................................ 21
5.5.2 Signaling the lack of contact of the ultrasound heads ................................................................................... 22
5.5.3 Temperature control of ultrasound heads ..................................................................................................... 22
6. DEVICE INSTALLATION AND START-UP ...................................................................................................................23
UNIT INSTALLATION ........................................................................................................................................................ 23
6.1.1 Assembling of the holders.............................................................................................................................. 23
6.1.2 Connection of ultrasound heads .................................................................................................................... 25
6.1.3 Connection in combined therapy ................................................................................................................... 26
FIRST OPERATION ........................................................................................................................................................... 26
SETUP MODE................................................................................................................................................................. 27
6.3.1 Basic information ........................................................................................................................................... 27
6.3.2 Language ....................................................................................................................................................... 27
6.3.3 Global settings ............................................................................................................................................... 27
6.3.4 Functional settings......................................................................................................................................... 28
6.3.5 Control functions............................................................................................................................................ 30
6.3.6 Information .................................................................................................................................................... 30
TRANSPORT POSITION –TROLLEY FOR THE UNIT AND ACCESSORIES ............................................................................................. 31
7. UNIT OPERATION...................................................................................................................................................32
PATIENT PREPARATION AND TREATMENT PERFORMANCE ......................................................................................................... 32
7.1.1 General information....................................................................................................................................... 32
7.1.2 Ultrasound therapy ........................................................................................................................................ 32
7.1.3 Combined therapy.......................................................................................................................................... 33
7.1.4 Method of treatment performance................................................................................................................ 34
SCREEN CONFIGURATION ................................................................................................................................................. 36
GENERAL CONFIGURATION ............................................................................................................................................... 37
DISPLAY DESCRIPTION ..................................................................................................................................................... 38
OPERATION WITH PRESET TREATMENT PROGRAMS ................................................................................................................. 38
FAVORITE PROGRAMS ..................................................................................................................................................... 40
MANUAL MODE OPERATION ............................................................................................................................................. 41
USER PROGRAMS ........................................................................................................................................................... 41
COMBINED THERAPY TREATMENT....................................................................................................................................... 42

1. Basic information and contents
User Manual – PhysioGo.Lite Sono page 4 / 64
SAFE SHUTDOWN PROCEDURE...................................................................................................................................... 43
8. DEFINITIONS AND PARAMETERS............................................................................................................................ 44
STANDARD ULTRASOUND HEADS (GU-5, GU-1)................................................................................................................... 45
SNG–SINGLE-TRANSDUCER MODE .................................................................................................................................... 46
SNG–DUAL-TRANSDUCER MODE ...................................................................................................................................... 47
SNG–FOURFOLD-TRANSDUCER MODE ............................................................................................................................... 48
CHARACTERISTICS OF PULSE PARAMETERS ............................................................................................................................ 49
9. INDICATIONS AND CONTRAINDICATIONS...............................................................................................................50
INDICATIONS ................................................................................................................................................................. 50
9.1.1 Standard and SnG heads therapy................................................................................................................... 50
9.1.2 LIPUS therapy................................................................................................................................................. 50
CONTRAINDICATIONS ...................................................................................................................................................... 50
10. MAINTENANCE, CLEANING, DISINFECTION............................................................................................................. 52
CLEANING OF THE UNIT,SWITCH MODE POWER SUPPLY AND MAINS FILTER CASING ................................................................... 52
CLEANING OF TOUCHSCREEN ....................................................................................................................................... 52
CLEANING AND DISINFECTION OF THE ULTRASOUND HEADS ................................................................................................. 53
SPECIAL MESSAGES .................................................................................................................................................... 53
SELF-TEST PROCEDURE ............................................................................................................................................... 53
TROUBLESHOOTING ................................................................................................................................................... 54
FUSE REPLACEMENT .................................................................................................................................................. 55
11. SPECIFICATION AND ACCESSORIES .........................................................................................................................56
TECHNICAL DATA ...................................................................................................................................................... 56
EMC PARAMETERS ................................................................................................................................................... 58
STANDARD ACCESSORIES............................................................................................................................................. 59
OPTIONAL ACCESSORIES ............................................................................................................................................. 59
12. APPENDIX A. SYMBOL DESCRIPTION ...................................................................................................................... 60
CONTROLLER,HEADS,MAINS FILTER,PACKAGING ............................................................................................................. 60
SWITCHED-MODE POWER SUPPLIES –CASING .................................................................................................................. 63
Figure list
Figure 4.1. The method of correct connection of the SMPS, mains filter and controller........................................................... 9
Figure 5.1 General view............................................................................................................................................................ 16
Figure 5.2 Unit rear panel view ................................................................................................................................................ 16
Figure 5.3 Arrangement of front panel components ............................................................................................................... 17
Figure 5.4 The battery installation method.............................................................................................................................. 19
Figure 5.5. Label with parameters............................................................................................................................................ 20
Figure 5.6 SnG ultrasound head, a cross-section through applicator (marked two transducers) ............................................ 21
Figure 5.7 Way of inserting the hook-and-loop belt through the head handles ...................................................................... 21
Figure 6.1 Method of mounting the standard ultrasound head holder ................................................................................... 24
Figure 6.2 Method of mounting the SnG head holder ............................................................................................................. 25
Figure 6.3 Ultrasond heads sockets.......................................................................................................................................... 26
Figure 6.4 Combined therapy socket........................................................................................................................................ 26
Figure 7.1 Field description ...................................................................................................................................................... 36
Figure 7.2 Screenshot sample view for SnG head .................................................................................................................... 38
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

1. Basic information and contents
page 5 / 64 Issue date 07.05.2021, release 1.0
1. 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.
The unit may only be operated by qualified personnel or under supervision of such personnel!
WARNING: The device is intended for adult patients only. It is not intended for use in a home healthcare
environment.
Description of symbols used in this manual:
Read appropriate passage of this user manual, warnings or important information. Failure
to observe warnings can lead to injuries.
Important notices and information.
Following texts marked with this symbol facilitates device operation.
NOTE:
The outlook of screens shown in this manual may slightly differ from their actual outlook during device operation.
These differences may concern size and type of fonts and size of symbols. There are no differences in the content
of shown information.
NOTE:
This manual contains information for use and technical description.
WARNING: No modification of this equipment is allowed!
Manufacturer
ASTAR Sp. z o.o.
ul. Świt 33
43-382 Bielsko-Biała, Poland
www.astar.eu
Risk management process
The manufacturer conducts continuous risk management process referring to the device construction, its
intended use, method of operation and maintenance. Residual risks are presented in this User Manual in form
of information about precautions, contraindications and warnings.

2.Intended use
User Manual – PhysioGo.Lite Sono page 6 / 64
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
MHz, with a total area of the head front of 5 cm2, for classic ultrasound therapy and LIPUS therapy,
as well as combined therapy,
•GU-1 standard ultrasound head, which generates an ultrasound wave with a frequency of 1 MHz or 3
MHz, with a total area of the head front of 1 cm2, for classic ultrasound therapy and LIPUS therapy,
as well as combined therapy,
•SnG hands-free ultrasound head, which generates an ultrasound wave with a frequency of 1 MHz or 3
MHz, with a total area of the head front of 17.3 cm2, for stationary ultrasound therapy and LIPUS
therapy, as well as combined therapy.
Standard heads are operated by the operator during treatment.
The hands-free head simulates the movements of the therapist due to the switching sequence of the ultrasonic
transducers and the modulation of the ultrasonic wave. Details – see chapter 5.5.1.
The unit enables the simultaneous connection of two ultrasound heads. The device has one therapeutic channel
for ultrasound therapy. Further information on supported types of ultrasound heads are given in sections 5.5
and 8. The unit possesses the base of preset treatment procedures along with therapeutic encyclopedia, which
significantly increases comfort of operation. There is a possibility to create own user-defined programs – for all
applicators.
Detailed information about indications and contraindications are presented in chapter 9.
Due to the optional availability of a battery, the unit is perfectly suited for use:
•in sports medicine in case of training camps,
•wherever there are problems with power supply quality.
Impact of ultrasounds application on tissues includes:
•increase in cell membranes permeability
•improvement of tissue respiration and stimulation of cellular metabolism
•changes in tissue colloid structure and their hydration
•changes in tissue ion systems
•change of tissue reading in alkaline direction
The therapeutic application includes:
•analgesic effect:
-cervical arthritic spondylosis pains
-rachialgias, chest and loins section
-sciatic neuralgia pains
-painful shoulder syndrome
-tennis elbow
-phantom limb pains
•reduction of muscle tone
•degenerative joint diseases
•neuralgias
•lockjaw
•scars
•shin ulceration
•medicine application (phonophoresis)

2. Intended use
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Intended users
The patient should not be the operator.
Users (operators) of PhysioGo.Lite Sono can be:
•specialists in the field of the ultrasound therapy,
•physiotherapists specializing in the therapy of the musculoskeletal system,
•sports medicine specialists,
•aesthetic medicine specialists,
•trained personnel performing treatments under the supervision of the above-mentioned specialists.
The user should have:
•knowledge about the indications and contraindications for the use of ultrasound therapy,
•knowledge of the terminology and technical terms used in the manual (e.g. knowledge of units of physical
quantities),
•practical skills in performing therapeutic treatments using devices for ultrasound therapy, resulting from
education, experience and training.
Physical and cognitive requirements of the operator:
•eyesight enabling to recognize elements of screen and keyboard,
•hearing enabling to hear the patient's voice,
•reading comprehension that allows to read the instructions of use and information on the screen of the
device,
•two functional upper limbs that allow to perform treatments and other activities related to the operation
of the device (e.g. cleaning of applicators),
•age in the range of admissible value of professional activity (depending on the regulations of the country
where the device is used).
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.
Recommended training positions:
•information about the intended use of the device,
•occupational safety information,
•information on the construction and method of the output signal generation,
•information on available settings and operation modes,
•instructions for use,
•indications and contraindications for the therapy,
•information on recommended maintenance, cleaning and disinfection,
•handling in the event of a technical malfunction.
Due to requirements of local law and regulations in different countries, additional training activities may be
required. The user should inform the seller about such requirements in order to receive complete information.

3. Warranty and manufacturer's responsibility
User Manual – PhysioGo.Lite Sono page 8 / 64
3. Warranty and manufacturer's responsibility
The manufacturer warrants the controller and ultrasound heads to be free of faults for the period of time and
conditions stated in Warranty Certificates. The manufacturer also provides post-warranty service for a period of
10 years from launching the unit onto the market. The warranty includes all material and workmanship faults.
The manufacturer undertakes to observe the warranty agreement, if the following conditions are met:
•all repairs, changes, extensions and calibrations of equipment are performed by manufacturer or authorized
service personnel,
•the mains supply system in the treatment room meets requirements of standards in force,
•the unit is operated by qualified personnel, in compliance with instructions presented in this manual,
•the unit is operated in compliance with its intended use.
The warranty does not include consumables, such as connection cables, mains cables, holders and fuses, as well
as faults or damage caused by:
•improper placement, installation or configuration of the device,
•misuse or failure to observe the instructions presented in this user manual,
•inaccurate or inadequate maintenance carried out by the operator,
•improper environmental conditions specified for the product,
•unauthorized opening of the outer casing,
•adjustment and/or unauthorized tuning,
•use of non-original accessories.
The warranty does not cover any damage due to a failure to adhere to the recommendations stated in chapters
4.3 and 10 hereof.
The manufacturer is not liable in case of transmission of infection by equipment components.
The expected "life time" of the device is 10 years.
After elapse of 10 years from date of introduction of device and accessories in the market the manufacturer is
not liable for device and accessories' faults or its consequences. After elapse of the expected life time of the
device the user bears the complete responsibility for the occurrence of medical incidents.
The manufacturer bears no responsibility for results of faulty installation, wrong diagnosis, wrong use of the
device and equipment, failure to observe user's manual and performance of repairs by unauthorized persons.
Inside the device there are no user serviceable components, except for fuses and battery.
No parts can be serviced or maintained when the device is in use with a patient.
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.

4. Operational safety
page 9 / 64 Issue date 07.05.2021, release 1.0
4. Operational safety
Mains supply and operation mode
The unit is designed for supply from AC mains with rating 100-240 V and frequency 50/60 Hz. It is
a medical device under safety class II, type BF. The unit may be used only in rooms, where the electric system
is executed in compliance with standards in force. The unit is intended for continuous operation. It is not
necessary to switch it off from the mains between particular treatment procedures.
An external switched-mode power supply (SMPS) treated as part of the device is the source of supply for the
device. Two models are allowed to be used with the device:
•type HPU63B-108 by Sinpro, constant output voltage 24V, rated current 2.62A,
•type GSM60B24-P1J by Mean Well, constant output voltage 24V, rated current 2.5A.
The types of switched-mode power supply approved for use with the device is placed on the identification label.
The SMPS may be connected to the mains only by a special, detachable mains power supply cord integrated
with the PLMF2A anti-interference filter. This filter is used to reduce electromagnetic disturbance that is
generated during ultrasound therapy treatments.
The power supply cord is equipped with a mains plug that isolates the device from the supply mains on all poles
simultaneously.
The socket in the device where the plug of the switched-mode power supply is connected is marked with
and safety sign ISO 7010 - M002.
Connecting to the mains and the proper operation of the switched-mode power supply is signaled:
•by the green LED indicator located on the housing of the switched-mode power supply type HPU63B-108
by Sinpro,
•by the blue LED indicator located on the housing of the switched-mode power supply type GSM60B24-P1J
by Mean Well.
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
from the supply mains.
•To isolate the device from the supply mains, hold the mains socket-outlet with one hand, grasp the mains
plug with second hand and disconnect it from the mains socket-outlet.

4. Operational safety
User Manual – PhysioGo.Lite Sono page 10 / 64
Disconnection from the mains takes place after:
•switching the power switch to the "0" position,
•removing the SMPS output cord plug from the socket on the unit,
•removing the mains cable plug from the mains socket.
Selected models are equipped with rechargeable battery which allows for operation without, or in conditions
of reduced quality of mains supply.
Storage, operation and transport conditions
The PhysioGo.Lite Sono unit must be stored in closed rooms, where the atmosphere is free from vapors and
caustic substances and:
•the temperature is maintained between + 5°C and +45°C,
•relative humidity does not exceed 75%,
•atmospheric pressure value is between 700 and 1060 hPa (70-106 kPa).
The unit is intended for operation under the following conditions:
•ambient temperature between +15°C and +30°C,
•relative humidity between 30% to 75%,
•atmospheric pressure between 700 to 1060 hPa (70-106 kPa).
If further transport of the device is required, use the delivery packaging. Transport shall be performed with
covered transport means.
Recommended transport conditions:
•ambient temperature between -10°C to +45°C,
•humidity between 20 and 95%,
•atmospheric pressure between 700 and 1060 hPa (70-106 kPa).
The above conditions refer also to the battery mode.
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.
General:
•PhysioGo.Lite Sono unit may be operated by qualified personnel in compliance with instructions (see 2.1).
•To avoid the risk of electric shock, the equipment must only be connected to mains supply with protective
earth (mains socket with grounding pin).
•In order to ensure conformity with the requirements relating to electromagnetic disturbance, the device
should be connected to grounded mains supply (mains socket with grounding pin). This solution is a
functional earthing.
•The SMPS may be connected to the mains only by a special, detachable mains power supply cord
integrated with the PLMF2A anti-interference filter.
•No modification of this equipment is allowed!
•The treatment station (bed, couch, chair) shall be located away from other electric devices and water
supply / sewerage installation / central heating system, so that it is impossible for the patient to touch
any of them during treatment procedure.
•Do not position PhysioGo.Lite Sono so that it is difficult to operate the disconnection of the device from
the supply mains.
•Do not remove warning signs and labels put by the manufacturer on the unit casing and casings of
accessories.
•The unit and ultrasound heads shall be protected against high temperatures and atmospheric conditions
(e.g. direct sunlight).
•Damaged cables and/or heads shall be replaced immediately. Pay special attention to the casing cracks,
threadbare insulation and partially torn interconnecting cables.