A-Star PhysioGo.Lite Electro User manual

PhysioGo.Lite Electro
– User manual

1. Basic information and contents
page 3 / 96 Issue date 18.05.2021, rev. 1.0
Contents
1. INTRODUCTION .......................................................................................................................................................6
MANUFACTURER ............................................................................................................................................................. 6
RISK MANAGEMENT PROCESS .............................................................................................................................................. 6
2. INTENDED USE .........................................................................................................................................................7
INTENDED USERS .............................................................................................................................................................. 8
USER TRAINING ............................................................................................................................................................... 8
3. WARRANTY AND MANUFACTURER'S RESPONSIBILITY..............................................................................................9
4. OPERATIONAL SAFETY ...........................................................................................................................................10
MAINS SUPPLY AND OPERATION MODE................................................................................................................................ 10
STORAGE,OPERATION AND TRANSPORT CONDITIONS .............................................................................................................. 10
WARNINGS AND SAFETY NOTES ...................................................................................................................................... 11
EXPLOSION PROOF ENVIRONMENT...................................................................................................................................... 13
ELECTROMAGNETIC ENVIRONMENT .................................................................................................................................... 13
OPERATION OF TOUCH-SENSITIVE DISPLAYS .......................................................................................................................... 13
APPLIED PARTS .............................................................................................................................................................. 13
ESSENTIAL PERFORMANCE ................................................................................................................................................ 14
4.8.1 Test 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 ................................................................................................................................................................. 19
CURRENT AND VOLTAGE STABILIZATION –CC AND CV MODE ................................................................................................... 20
PROTECTION ................................................................................................................................................................. 21
5.6.1 Detection of a high resistance in the patient circuit....................................................................................... 21
5.6.2 Electrodes condition control........................................................................................................................... 22
5.6.3 Current accuracy control in CC mode ............................................................................................................. 22
5.6.4 Overcurrent in CV mode................................................................................................................................. 22
5.6.5 Information on the features of generated signal ........................................................................................... 22
6. DEVICE INSTALLATION AND START-UP ...................................................................................................................24
UNIT INSTALLATION ........................................................................................................................................................ 24
6.1.1 Connection of patient’s cables and application of electrodes........................................................................ 24
FIRST OPERATION ........................................................................................................................................................... 25
SETUP MODE................................................................................................................................................................. 25
6.3.1 Basic information ........................................................................................................................................... 25
6.3.2 Language ....................................................................................................................................................... 26
6.3.3 Global settings ............................................................................................................................................... 26
6.3.4 Functional settings......................................................................................................................................... 26
6.3.5 Control functions............................................................................................................................................ 27
6.3.6 Information .................................................................................................................................................... 28
TRANSPORT POSITION –TROLLEY FOR THE UNIT ..................................................................................................................... 29
7. UNIT OPERATION...................................................................................................................................................30
PATIENT PREPARATION AND TREATMENT PERFORMANCE ......................................................................................................... 30
7.1.1 General information....................................................................................................................................... 30
7.1.2 Electrotherapy................................................................................................................................................ 30
SCREEN CONFIGURATION ................................................................................................................................................. 31
GENERAL CONFIGURATION ............................................................................................................................................... 32
7.3.1 Treatment channel configuration .................................................................................................................. 32
7.3.2 Channel selection tabs ................................................................................................................................... 32
7.3.3 Current selection screens ............................................................................................................................... 33
7.3.4 Limitations ..................................................................................................................................................... 34
DISPLAY DESCRIPTION ..................................................................................................................................................... 34
OPERATION WITH PRESET TREATMENT PROGRAMS AND SEQUENCES ........................................................................................... 35
FAVORITE PROGRAMS ..................................................................................................................................................... 37

1. Basic information and contents
User Manual – PhysioGo.Lite Electro page 4 / 96
MANUAL MODE OPERATION ............................................................................................................................................. 38
USER PROGRAMS ........................................................................................................................................................... 38
USER SEQUENCES ........................................................................................................................................................... 39
I/T CURVE ............................................................................................................................................................... 42
SAFE SHUTDOWN PROCEDURE...................................................................................................................................... 43
8. DEFINITIONS AND PARAMETERS............................................................................................................................44
TERMINOLOGY .............................................................................................................................................................. 44
OUTPUT SIGNAL MODULATIONS......................................................................................................................................... 44
TREATMENT TIMER ......................................................................................................................................................... 45
TENS PULSE CURRENT .................................................................................................................................................... 45
INTERFERENTIAL CURRENTS............................................................................................................................................... 47
KOTZ’CURRENT (RUSSIAN STIMULATION) ............................................................................................................................ 48
MEDIUM FREQUENCY CURRENTS........................................................................................................................................ 50
SP-TENS PULSE CURRENT ............................................................................................................................................... 52
DIADYNAMIC CURRENTS................................................................................................................................................... 53
GALVANIC CURRENT .................................................................................................................................................. 54
ULTRA REIZ CURRENT (TRÄBERT’S CURRENT)................................................................................................................... 55
UNIPOLAR AND BIPOLAR SINE SURGE ............................................................................................................................. 56
LEDUC’S CURRENT..................................................................................................................................................... 58
RECTANGULAR PULSE CURRENTS................................................................................................................................... 59
TRIANGULAR PULSE CURRENTS ..................................................................................................................................... 61
NEOFARADIC PULSE CURRENTS ..................................................................................................................................... 63
MICROCURRENTS...................................................................................................................................................... 64
IG PULSES ............................................................................................................................................................... 65
EMS ..................................................................................................................................................................... 66
H-WAVES................................................................................................................................................................ 68
EXPONENTIAL PULSES................................................................................................................................................. 69
HUFSCHMIDT STIMULATION......................................................................................................................................... 71
TONOLYSIS .............................................................................................................................................................. 72
9. INDICATIONS AND CONTRAINDICATIONS...............................................................................................................75
INDICATIONS ................................................................................................................................................................. 75
9.1.1 TENS and SP-TENS current ............................................................................................................................. 75
9.1.2 Interferential and AMF currents..................................................................................................................... 75
9.1.3 Kotz’ current – Russian stimulation................................................................................................................ 76
9.1.4 Medium frequency currents ........................................................................................................................... 76
9.1.5 Diadynamic currents ...................................................................................................................................... 76
9.1.6 Galvanic current............................................................................................................................................. 76
9.1.7 Ultra Reiz current ........................................................................................................................................... 77
9.1.8 Sine Surge....................................................................................................................................................... 77
9.1.9 Leduc’s current............................................................................................................................................... 77
9.1.10 Rectangular impulses..................................................................................................................................... 77
9.1.11 Triangular impulses........................................................................................................................................ 78
9.1.12 Neofaradic currents ....................................................................................................................................... 78
9.1.13 Microcurrents................................................................................................................................................. 78
9.1.14 IG pulses......................................................................................................................................................... 78
9.1.15 EMS ................................................................................................................................................................ 79
9.1.16 H-waves ......................................................................................................................................................... 79
9.1.17 Exponential currents ...................................................................................................................................... 79
9.1.18 Hufschmidt stimulation and tonolysis............................................................................................................ 79
CONTRAINDICATIONS FOR ELECTROTHERAPY ......................................................................................................................... 80
10. MAINTENANCE, CLEANING, DISINFECTION............................................................................................................. 81
CLEANING OF THE UNIT AND SWITCH MODE POWER SUPPLY CASING ...................................................................................... 81
CLEANING OF TOUCHSCREEN ....................................................................................................................................... 81
CLEANING AND DISINFECTION OF THE ELECTROTHERAPY ACCESSORIES .................................................................................... 82
CABLE CONDITION CONTROL ........................................................................................................................................ 82
VERIFICATION OF ELECTRODES CONDITION ...................................................................................................................... 83
SPECIAL MESSAGES .................................................................................................................................................... 84
SELF-TEST PROCEDURE ............................................................................................................................................... 84
TROUBLESHOOTING ................................................................................................................................................... 85
FUSE REPLACEMENT .................................................................................................................................................. 86
11. SPECIFICATION AND ACCESSORIES .........................................................................................................................87

page 5 / 96 Issue date 18.05.2021, rev. 1.0
TECHNICAL DATA ...................................................................................................................................................... 87
EMC PARAMETERS ................................................................................................................................................... 89
STANDARD ACCESSORIES............................................................................................................................................. 91
OPTIONAL ACCESSORIES ............................................................................................................................................. 91
12. APPENDIX A. SYMBOL DESCRIPTION, I(T) CURVE DIAGRAM ...................................................................................92
CONTROLLER,ACCESSORIES,PACKAGING ........................................................................................................................ 92
SWITCHED-MODE POWER SUPPLIES –CASING .................................................................................................................. 94
Table of figures
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. Rough diagram of the output circuit of the unit working in CV mode (one channel)............................................. 20
Figure 5.6. Presentation of information about the high resistance in the patient circuit ........................................................ 21
Figure 5.7. Signalization of worn electrodes ............................................................................................................................ 22
Figure 6.1 Electrotherapy sockets label.................................................................................................................................... 24
Figure 6.2. Connection of electrodes ....................................................................................................................................... 24
Figure 6.3. Supply part label..................................................................................................................................................... 25
Figure 7.1 Field description ...................................................................................................................................................... 31
Figure 7.2 Screenshot sample view for dual circuit electrotherapy A+B.................................................................................. 34
Figure 7.3 Screenshot sample view for single circuit electrotherapy A and B.......................................................................... 35
Figure 7.4 Screenshot sample view for electrotherapy sequences .......................................................................................... 35
Figure 7.5 Information screen sample view ............................................................................................................................. 36
Figure 8.1. Manual time setting ............................................................................................................................................... 45
Figure 10.1. The unit error signaling and information visible after closing of the error message............................................ 84
List of tables
Table 4.1. Recommendations for the operation of touch screens ........................................................................................... 13
Table 4.2. Essential performance and basic safety testing recommendations......................................................................... 14
Table 5.1 Description of front panel components.................................................................................................................... 17
Table 5.2. Non-battery unit ...................................................................................................................................................... 18
Table 5.3. Unit equipped with battery ..................................................................................................................................... 18
Table 5.4. Additional information about battery indicator ...................................................................................................... 18
Table 5.5. The battery installation method .............................................................................................................................. 19
Table 5.6. Currents classification.............................................................................................................................................. 23
Table 8.1. Permitted amplitude values in relation to pulse duration....................................................................................... 61
Table 8.2. Available frequency values in relation to pulse duration ........................................................................................ 70
Table 10.1. Signaling special messages .................................................................................................................................... 84
Table 10.2. The "hardware" error coding system..................................................................................................................... 85
Table 10.3................................................................................................................................................................................. 85

1. Basic information and contents
User Manual – PhysioGo.Lite Electro page 6 / 96
1. Introduction
Read this manual carefully before starting the unit operation! Follow the recommendations
presented in this manual!
The electrotherapy unit PhysioGo.Lite Electro 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
page 7 / 96 Issue date 18.05.2021, rev. 1.0
2. Intended use
Electrotherapy unit PhysioGo.Lite Electro is an active, non-invasive therapeutic device, intended for carrying our
treatment procedures using:
•bipolar (bidirectional) and unipolar (unidirectional) low frequency currents,
•bipolar (bidirectional) and unipolar (unidirectional) medium frequency currents.
The unit is equipped with two fully independent treatment channels. The list of available therapies in particular
channels is shown in the table below.
Channel Therapy
1
Single circuit electrotherapy – A
Dual circuit electrotherapy – A+B
2 Single circuit electrotherapy – B
Detailed information about available configurations is presented further in this manual.
The unit possesses the base of preset treatment procedures along with therapeutic encyclopedia, which
significantly increases comfort of operation.
There is also a possibility to create own user-defined:
•programs,
•sequences.
The unit may perform treatments by:
•TENS, BURST and formed in packages to spastic paralysis SP-TENS currents,
•interferential currents – dynamic and isoplanar,
•one-channel sine wave current (AMF),
•Kotz’ – Russian stimulation,
•diadynamic according to Bernard – MF, DF, CP, CP-ISO, LP, RS, MM currents (in continuous and interrupted
mode),
•ionophoresis and galvanization of constant current (in the continuous and interrupted mode),
•Träbert (Ultra Reiz), Leduc’ and neofaradic (in continuous and interrupted mode),
•medium frequency current,
•unipolar and bipolar sine surge currents,
•triangular or rectangular pulses (in continuous and interrupted mode),
•microcurrents,
•IG pulses,
•EMS currents,
•H-waves,
•exponential pulses,
•tonolysis and Hufschmidt stimulation – to spastic paralysis,
•qualitative and quantitative electrodiagnostic of the nervous-muscle system.
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.

2.Intended use
User Manual – PhysioGo.Lite Electro page 8 / 96
Intended users
The patient should not be the operator.
Users (operators) of PhysioGo.Lite Electro can be:
•specialists in the field of the electrotherapy,
•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 electrotherapy,
•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 electrotherapy, 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 accessories),
•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 Electro 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
page 9 / 96 Issue date 18.05.2021, rev. 1.0
3. Warranty and manufacturer's responsibility
The manufacturer warrants the controller to be free of faults for the period of time and conditions stated in
Warranty Certificate. 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 electrodes, viscose covers, connection cables, mains cables,
patient’s cables 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
User Manual – PhysioGo.Lite Electro page 10 / 96
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 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 are placed on the identification label
on the bottom of the device.
The power supply is connected to the mains using the detachable power cord. 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.
Recommendations related to isolation the device from the supply mains:
•do not position the PhysioGo.Lite Electro 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.
Disconnection from the mains takes place after:
•switching the mains switch to the "0" position,
•removing the mains cable plug from the mains power socket,
•removing the SMPS output cord plug from the socket on the unit.
Selected devices are equipped with rechargeable battery which allows for operation without, or in conditions
of reduced quality of power supply.
Storage, operation and transport conditions
The PhysioGo.Lite Electro 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).