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
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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.

4. Operational safety
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•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.
•By any means do not cover the vents. Do not insert any objects into the ventilation socks.
•The unit may be only used with accessories, spare parts, disposable items which have been determined
to be safe and appropriate inspection bodies have not issued contraindications against their use.
•Ultrasound heads are sensitive to mechanical damages that is why they should be used with caution.
Throwing, banging against hard surfaces and similar actions that may lead to damage of the head shall
be avoided. Careless use of the head may make its properties worse.
•Ultrasound heads are particularly sensitive to very low and very high temperatures. Special attention
should be paid, so not connect the device to the mains supply when it is too much cooled (e.g. winter
period, right after delivering by the forwarder).
•Ultrasound heads may only be connected to the sockets when the mains supply is switched off. Each head
contains memory with calibration data that are checked by microprocessor during self-test phase.
Plugging head to switched on unit will make the head be undetected, so its use will not be possible.
Sometimes it may also damage the ultrasound head.
•The ultrasound head has dedicated transport packaging. The front of the head is protected by rubber
cover, which secures it against mechanical damage during delivery. The cover must be removed before
use. It is not recommended to use it between treatments due to the possibility of damaging head parts.
•After switching the unit off, wait for 10 seconds before you switch it on again.
•Each serious incident concerned with the device should be reported to the manufacturer and competent
authority of the country, where the user or patient resides. Serious incident means any incident that
directly or indirectly led, might have led or might lead to any of the following:
the death of a patient, user or other person,
the temporary or permanent serious deterioration of a patient's, user's or other person's state of
health,
a serious public health threat.
Therapeutic:
•The device is intended for adult patients (patient has to be conscious). Minor patients – only on the
doctor's explicit recommendation, after considering contraindications.
•It is impermissible for the patient to carry out the treatment on their own.
•Patients with implanted electronic devices (e.g. cardiac pacemakers) or other metal implants should
consult a physician prior to treatment.
•If two heads are connected, the head which is not used should be placed in the holder. If any of the head
is not used for a longer period of time, it is recommended to disconnect this head.
•Before performing the treatment, make sure there are no contraindications to its implementation.
•Treatment parameters should be consistent with the indications of a physician and/or a physiotherapist.
•Do not perform ultrasound treatments on the cervical spine above the 3rd vertebra as the ultrasound
energy could affect the medulla oblongata.
•Before treatment it is necessary to interview the patient, including the occurrence of relative and
absolute contraindications to conduct therapy.
•Do not perform treatments on patients under the influence of alcohol.
•Do not perform treatments on patients under the influence of intoxicants.
•It is necessary to ensure the adequate interval between treatments for the patient, in order to avoid an
increase of the risk of complications.
•Take special care with patients with disturbed surface sensation.
•Sitting or reclining position should be applied to the patients with respiratory disorders or breathing
difficulties.
•Avoid applying ultrasound energy to internal organs of the abdominal cavity, thorax (i.e. heart area) and
gonads.
•Avoid application of ultrasounds in continuous mode directly over joints with cement or plastic
endoprostheses. Ultrasounds in LIPUS mode can be used with caution.
•Avoid application of ultrasounds in continuous mode (causing a thermal effect) in case of dermatological
diseases that are sensitive to heat, such as eczema, psoriasis. Ultrasound in the pulse mode can be used
to treat open wounds with precautions (head disinfection, sterile gel, correct treatment method). The
skin condition should be monitored and in case of its deterioration, the treatment should be stopped.

4. Operational safety
User Manual – PhysioGo.Lite Sono page 12 / 64
•Avoid application of ultrasounds in continuous mode (causing a thermal effect) over damaged nerves,
because they can cause unpleasant sensations (e.g. needles and pins) and do not accelerate their
regeneration.
•The patient should be in a position causing loosening of the part of the body subjected to therapy.
•The patient should immediately report an increase of pain or other unpleasant sensations.
•The choice of the ultrasound head should take into account the recommended technique of performing
a specific treatment. For details – see chapter 7.1.4.
•When performing treatments with standard heads, a dynamic or semi-stationary technique should be
applied. The stationary technique is only allowed for LIPUS therapy.
•Only a stationary (static) technique should be applied when performing treatments with hands-free SnG
heads.
•GU heads are not identical to GS heads used in previous ultrasound therapy devices such as Etius,
PhysioGo, Sonaris. They cannot be used interchangeably. SnG head is not supported by other devices.
•Avoid placing the hands-free head on superficial osteophymas, in order not to cause periosteal pain by a
thermal dose. It is also necessary to carefully attach the head with the original hook-and-loop belts
provided by the manufacturer, to limit its movement.
•Immediately stop the treatment in the case of appearing special messages on the display.
•Use a coupling gel for ultrasound devices. The gel should be a medical equipment, marked with the
conformity mark (the CE mark in EU). Avoid using a gel with undocumented origin.
•Where it is necessary to use other coupling medium (e.g. liquid paraffin), test the quality of contact
detection first (see 5.5.2).
•It is recommended to use distilled water when performing treatments in water, preferably after its
degasification. To degas water, boil it for 30 minutes, then close a container tightly and put it in the
refrigerator to cool. Heat water to the comfort temperature for the patient before use. The presence of
air bubbles during therapy may cause deterioration of operation parameters, especially at the stationary
positioning of the head.
•The surface of the front head of the ultrasound transducer can degrade and its parameters can
deteriorate if you use tap water with the addition of minerals, disinfectants or other chemical agents. In
the extreme case, the transducer may damage.
•The therapist should keep his or her hand outside of water during treatment.
•If you use a plastic container, the dose should be corrected, because the plastic absorbs reflected
ultrasound energy. If you use a metal container, the reflected energy returns to the treated body part
and there is no need to correct the dose.
•It is necessary to keep records of the treatment, including the parameters of the therapy, the area of
treatment, treatment technique, dose and symptoms after therapy.
•It is necessary to continuously update knowledge and follow literary activities in the scope of therapy.
Therapeutic – combined therapy:
•See warnings and information for electrotherapy and ultrasound therapy.
Battery use (optional):
•Rechargeable battery UR18650A 5S1P is designed for use only with Astar PhysioGo.Lite range of devices.
•In case of mechanical damage to the battery module, there is a risk of fire, explosion or burns, due to
used lithium-ion cells.
•Do not throw the battery or hit it. Do not heat it or incinerate.
•Do not short-circuit the contacts or disassemble the casing.
•Do not immerse in liquids.
•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 (N2O) and oxygen. Some
materials (e.g. cotton, wool) may after saturation with oxygen become combustible at high temperatures
generated with normal operation of equipment. It is recommended that solutions of adhesive and combustible
solvents be vaporized before equipment is operated. It is also recommended to pay attention to the danger of

4. Operational safety
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ignition of endogenous gases. The unit must be separated from the mains before approaching the disinfection
room, where it is installed.
Electromagnetic environment
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
produced during ultrasound therapy treatments.
•Due to the intended use the device can be used in hospitals, clinics, health centers, GP practices,
rehabilitation offices and other health care facilities, under the supervision of qualified personnel.
•Simultaneous operation of PhysioGo.Lite Sono unit with devices generating strong electromagnetic field,
such as short wave and 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 PhysioGo.Lite Sono unit.
Manufacturer doesn’t claim compatibility of the PhysioGo.Lite Sono unit with high frequency surgical
equipment.
•If the device is subjected to electromagnetic interference with an intensity that exceeds the compliance
levels declared in Section 11.2, the display may be affected, generation may be interrupted or the device
may restart.
•WARNING: Use of the PhysioGo.Lite Sono adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, the PhysioGo.Lite Sono and the other
equipment should be observed to verify that they are operating normally.
•It is recommended to use original accessories, spare parts and equipment of Astar.
•WARNING: Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation.
•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.
The PhysioGo.Lite Sono meets requirements of electromagnetic interference emission and immunity standards
and shall not pose a threat to correct operation of the other devices. Compliance levels for emissions and
immunity are given in the chapter 11.2.
Operation of touch-sensitive displays
Table 4-1.Recommendations for the operation of touch screens
Type of display Method of operation of the display
5” with a resistive touch panel
Recommended:
•Pen designed for resistive screens – preferably with a narrow plastic tip
Admissible:
•Operator's finger – much lower comfort of operation compared to the
pen
Applied parts
The PhysioGo.Lite Sono unit has an applied part of BF type. It includes:
•three types of ultrasound heads,
•ultrasound heads sockets,
•ultrasound heads plugs with cables.

4. Operational safety
User Manual – PhysioGo.Lite Sono page 14 / 64
The elements of the applied part are connected together. Physical contact of the ultrasound head with patient’s
body during normal use is essential for the device to perform its function.
The specification of the leads, along with the location of the output sockets and the characteristics of ultrasound
heads are described in detail in the chapters 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:
•continuous mode or
•pulse mode – with adjustable duty factor and frequency of packets,
with the use of ultrasonic transducers.
The device meets the requirements of IEC 60601-2-5 standard, where:
•the maximum effective intensity,
•the accuracy of output power, effective radiating area and effective intensity (power density),
•the acceptable level of unwanted ultrasound radiation,
•the temperature limits of ultrasonic transducers
are defined.
4.8.1 Tests of essential performance and basic safety
The user of unit must perform technical inspection of the unit at year's intervals. The inspection must be
performed by a service authorized by the manufacturer. The inspection is performed at the user's expense.
Recommendations for test:
Table 4-2. Recommendations for test of essential performance and basic safety
Test item Method of checking Acceptance criteria Required measuring
equipment
Safety test:
•patient leakage current
measurement,
•touch current measurement,
•insulation resistance if
necessary
The manufacturer
allows the methods
compliant with the
requirements of the
standards:
•IEC 60601-1
•IEC 62353
The measurement results are
within the limits specified by the
applied standard
Safety tester meeting
the:
•IEC 60601-1
•IEC 62353
requirements
Control of correctness of the
performed self-test
Visual inspection No errors No requirements
Evaluation of keyboard function
and operation
Manual and visual
inspection
The keys respond properly to
pressure
No requirements
Evaluation of touchscreen
function and operation
Manual and visual
inspection
The touch panel responds
correctly to pressing
No requirements
Inspection of the controller
condition for casing defects and
damage of sockets
Visual inspection
No deformation or cracks of the
casing
No requirements
Undamaged sockets
No loosened sockets
Inspection of the heads condition
for casing defects and damage of
interconnecting cables and
connectors
Visual inspection
No deformation or cracks of the
casing
No requirements
No tear and bending of cables
insulation
Undamaged connectors
Inspection of the SMPS condition
for casing defects and damage of
interconnecting cables and
connectors
Visual inspection
No deformation or cracks of the
casing
No requirements
No tear and bending of cable
insulation
Undamaged connector

4. Operational safety
page 15 / 64 Issue date 07.05.2021, release 1.0
Test item Method of checking Acceptance criteria Required measuring
equipment
Inspection of the mains filter
condition for casing defects and
damage of interconnecting cables
and connectors
Visual inspection
No deformation or cracks of the
casing
No requirements
No tear and bending of cable
insulation
Undamaged connector
Test of the power emitted by
ultrasound heads
The manufacturer
allows the methods
compliant with the
requirements of the IEC
60601-2-5 standard
The accuracy of the power
indication is within a tolerance of
± 20%
Radiation force balance
or ultrasonic power
meter
Detection of lack of contact of
the ultrasound head Visual inspection
Signaling by LED indicator /
indicators on the head
No requirements
Bars presenting the ultrasound
head contact quality are not
highlighted.
Message on the screen
The inspection must also include verification of the quality of applied accessories and treatment materials.
Positive result of the technical inspection confirms that basic safety and essential performance is maintained.
Disposal
In case, when the disposal of the unit will become necessary (e.g. after elapse of its service life), please contact
the manufacturer or manufacturer representative, which must react in an appropriate way i.e. collecting the unit
from the user. The user may also contact companies specialized in removal and/or disposal of electrical devices
or computer equipment. Under no circumstances should you place the unit along with other wastes. The name
plate includes an appropriate symbol (see Appendix at the end of the User Guide).
The unit is marked with an appropriate symbol complying with the directive on waste electrical and electronic
equipment (WEEE) – see table with description of the symbols used to label the product presented in Appendix
A.

5. Unit description
User Manual – PhysioGo.Lite Sono page 16 / 64
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’’).
On the rear side of the casing are located:
•power switch,
•fuse socket,
•mains socket,
•sockets for connection of ultrasound heads,
•combined therapy socket.
General view of the unit is presented in Figure 5.1, view of the rear panel in Figure 5.2.
Figure 5.1 General view
Figure 5.2 Unit rear panel view

5. Unit description
page 17 / 64 Issue date 07.05.2021, release 1.0
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
1. Liquid crystal display
The unit is equipped with a touch-sensitive display. The screen clearly
displays all information related to the device operation.
2.
Operation status and
battery level indicators
See 5.2.1.
3. Turn ON/OFF key
(STANDBY)
This key is marked with the symbol .
In order to activate the unit in the case of battery operation, please
hold on for at least 5 seconds. Extension of the holding time prevents
unintentional activation during transport.
4. Edit keys
These keys are marked with symbols .
Pressing any of them results in change of value of edited parameter or
setting in setup mode.
Keep holding the key down to change a parameter quicker.
5. START/STOP key
This key is marked with the symbol .
It is used with the sequence of starting emission. Its pressing, after
setting of treatment procedure parameters starts emission.
Pressing of this key once again stops the treatment procedure. The
emission of signal is stopped.

5. Unit description
User Manual – PhysioGo.Lite Sono page 18 / 64
5.2.1 Operation status and battery level indicators
Symbols and description of unit operation status signaled by LED indicators are summarized in the table below.
Table 5-2. Non-battery unit
Symbol Color Indicator status Mains switch Explanation
Operation
status
indicator
Green
No light OFF („0”)
The unit is turned off.
Turning ON:
•Turn the mains switch on
•Press the STANDBY key
Blinks ON („1”)
Unit is in standby mode. Turning
ON:
•Press the STANDBY key
Steady light ON („1”) The unit is ready for operation.
Battery
level
indicator
Yellow No light --- No battery.
Table 5-3. Unit equipped with battery
Symbol Color Indicator status Mains switch Explanation
Readiness Battery
Green
Yellow
No light No light OFF („0”)
The unit is turned off.
Turning ON:
•Turn the mains switch on
•Press the STANDBY key
Blinks
slowly No light
ON („1”)
Mains cable
connected
Unit is in standby mode. Battery is
fully charged.
Turning ON:
•Press the STANDBY key
Blinks
slowly Blinks slowly
ON („1”)
Mains cable
connected
Unit is in standby mode. Battery is
being charged.
Turning ON:
•Press the STANDBY key
Steady light Blinks slowly
ON („1”)
Mains cable
connected
The unit is turned on.
Battery is being charged.
Steady light No light
ON („1”)
Mains cable
connected
The unit is turned on.
Battery is fully charged.
No light Steady light
ON („1”)
Mains cable
disconnected
Unit is running on battery supply.

5. Unit description
page 19 / 64 Issue date 07.05.2021, release 1.0
Table 5-4. Additional information about battery indicator
Symbol Color Battery indicator status Explanation
Yellow
Blinks fast for 4 seconds Battery module has been disconnected.
3 pulses Battery low.
5 pulses
Battery error. Turn the unit off using STANDBY key and
switch the power switch off. Restart it after 10 seconds.
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.
The battery assembly method is illustrated in the following figures.
Figure 5.4 The battery installation method
Table 5-5. The battery installation method
Action no.: Description
1.
Turn the device over.
Unscrew four battery cover screws.
Remove the stabilizing cartridge. Keep it for further use.
2. Connect battery cable to the battery socket.
3. Place the battery in the enclosure.
4.
Reinstall battery cover by means of 4 screws.
Turn the device over
to its normal position. Connect power supply to the mains. Switch on
the unit and check If it starts correctly.
The above information is summarized on labels placed on the battery cover.

5. Unit description
User Manual – PhysioGo.Lite Sono page 20 / 64
Name plate and label with parameters
The name plate is located on the bottom of unit casing. Among others there are following data on the name plate
(see Appendix A):
•device version,
•serial number,
•nominal voltage and frequency of operation,
•type of applied fuses,
•manufacturer's data.
The label with ultrasonic wave parameters is located on the bottom of unit casing (see Appendix A):
•acoustic working frequencies (fawf),
•waveforms,
•values of pulses durations (pd), pulses repetition periods (prp), duty factors (DF).
Figure 5.5. Label with parameters
Ultrasound heads
The unit can operate with following types of ultrasound heads:
Head type Characteristics and intended use
GU-5
•standard head
•
basic type of head for carrying out the ultrasound therapy, phonophoresis,
LIPUS and combined therapy (with connection to an electrotherapy device)
•total area of the head front – 5 cm2
•effective radiating area – 3.4 cm2
•integrated temperature sensor
GU-1
•standard head
•head intended to small body parts
•total area of the head front – 1 cm2
•effective radiating area – 0.7 cm2
•integrated temperature sensor
SnG
•hands-free head
•
head for carrying out the ultrasound therapy, phonophoresis, LIPUS and
combined therapy (with connection to an electrotherapy device)
•2 ultrasonic transducers in one head - it can operate in single-transducer and
dual-transducer mode
•possibility to operate in single-section (A/B) or dual-section (A+B) mode
•total area of the head front in single-section mode – 17.3 cm2, in dual-section
mode – 34.6 cm2
•effective radiating area – 3 cm2
•integrated temperature sensor