A-Star PhysioGo.Lite Laser User manual

PhysioGo.Lite Laser –
User manual

1. Basic information
page 3 / 66 Issue date 09.11.2022, release 10.1
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 ................................................................................................................................... 9
WARNINGS AND SAFETY NOTES ........................................................................................................................................................... 10
EXPLOSION PROOF ENVIRONMENT.......................................................................................................................................................... 12
ELECTROMAGNETIC ENVIRONMENT ........................................................................................................................................................ 13
OPERATION OF TOUCH-SENSITIVE DISPLAYS.............................................................................................................................................. 13
TECHNICAL SUPERVISION ...................................................................................................................................................................... 13
EYE PROTECTION................................................................................................................................................................................. 14
LASER LABELS ..................................................................................................................................................................................... 16
APPLIED PARTS ............................................................................................................................................................................. 17
DISPOSAL .................................................................................................................................................................................... 17
5. UNIT DESCRIPTION .................................................................................................................................................................... 18
GENERAL CHARACTERISTICS .................................................................................................................................................................. 18
FRONT PANEL..................................................................................................................................................................................... 19
5.2.1 Operation status and battery level indicators..................................................................................................................... 20
BATTERY INSTALLATION ........................................................................................................................................................................ 21
NAME PLATE ...................................................................................................................................................................................... 22
LASER RADIATION MEASUREMENT .......................................................................................................................................................... 22
PROTECTION ...................................................................................................................................................................................... 22
5.6.1 Remote interlock connector................................................................................................................................................ 22
5.6.2 Emergency laser stop.......................................................................................................................................................... 22
LASER APPLICATORS............................................................................................................................................................................. 24
6. DEVICE INSTALLATION AND START-UP ....................................................................................................................................... 27
UNIT INSTALLATION............................................................................................................................................................................. 27
6.1.1 Assembling of the holders................................................................................................................................................... 27
6.1.2 Connection of laser applicators .......................................................................................................................................... 29
6.1.3 Laser scanner stand ............................................................................................................................................................ 30
6.1.4 Integrated emergency laser stop and remote interlock connector (DOOR) installation...................................................... 32
FIRST OPERATION................................................................................................................................................................................ 32
6.2.1 Laser therapy access code .................................................................................................................................................. 32
SETUP MODE...................................................................................................................................................................................... 33
6.3.1 Basic information ............................................................................................................................................................... 33
6.3.2 Language............................................................................................................................................................................ 33
6.3.3 Global settings.................................................................................................................................................................... 33
6.3.4 Functional settings ............................................................................................................................................................. 34
6.3.5 Control functions ................................................................................................................................................................ 35
6.3.6 Information ........................................................................................................................................................................ 36
TRANSPORT POSITION –THE STAND WITH SCANNING APPLICATOR ................................................................................................................ 37
TRANSPORT POSITION –TROLLEY FOR THE UNIT AND ACCESSORIES................................................................................................................ 37
7. UNIT OPERATION....................................................................................................................................................................... 38
PATIENT PREPARATION AND TREATMENT PERFORMANCE ............................................................................................................................ 38
7.1.1 General information ........................................................................................................................................................... 38
7.1.2 Laser therapy...................................................................................................................................................................... 38
SCREEN CONFIGURATION ...................................................................................................................................................................... 39
GENERAL CONFIGURATION.................................................................................................................................................................... 40
DISPLAY DESCRIPTION .......................................................................................................................................................................... 41
OPERATION WITH PRESET TREATMENT PROGRAMS .................................................................................................................................... 41
7.5.1 Voll and Nogier programs................................................................................................................................................... 43
FAVORITE PROGRAMS .......................................................................................................................................................................... 43
MANUAL MODE OPERATION ................................................................................................................................................................. 44
USER PROGRAMS ................................................................................................................................................................................ 44
SAFE SHUTDOWN PROCEDURE ............................................................................................................................................................... 46
8. DEFINITIONS AND PARAMETERS ................................................................................................................................................ 47
POINT LASER APPLICATORS (LASER PROBES).............................................................................................................................................. 48

1. Basic information
User Manual – PhysioGo.Lite Laser page 4 / 66
SCANNING APPLICATOR ........................................................................................................................................................................ 49
8.2.1 Limitation of the laser scanner power ................................................................................................................................ 49
CLUSTER APPLICATOR .......................................................................................................................................................................... 50
9. INDICATIONS AND CONTRAINDICATIONS ................................................................................................................................... 51
INDICATIONS...................................................................................................................................................................................... 51
CONTRAINDICATIONS........................................................................................................................................................................... 51
10. MAINTENANCE, CLEANING, DISINFECTION ................................................................................................................................. 52
CLEANING OF THE UNIT AND SWITCH MODE POWER SUPPLY CASING ........................................................................................................ 52
CLEANING OF TOUCHSCREEN ........................................................................................................................................................... 52
CLEANING AND DISINFECTION OF THE SCANNING AND CLUSTER APPLICATOR ............................................................................................. 53
CLEANING AND DISINFECTION OF THE POINT LASER APPLICATORS ............................................................................................................ 53
10.4.1 Disinfection and sterilization of the optical fiber applicators.............................................................................................. 53
SPECIAL MESSAGES ........................................................................................................................................................................ 54
SELF-TEST PROCEDURE ................................................................................................................................................................... 54
TROUBLESHOOTING....................................................................................................................................................................... 55
FUSE REPLACEMENT ...................................................................................................................................................................... 56
11. SPECIFICATION AND ACCESSORIES ............................................................................................................................................. 57
TECHNICAL DATA .......................................................................................................................................................................... 57
EMC PARAMETERS........................................................................................................................................................................ 59
STANDARD ACCESSORIES ................................................................................................................................................................ 61
OPTIONAL ACCESSORIES ................................................................................................................................................................. 61
12. APPENDIX A. SYMBOL DESCRIPTION .......................................................................................................................................... 62
CONTROLLER,ACCESSORIES,PACKAGING ........................................................................................................................................... 62
SWITCHED-MODE POWER SUPPLY –CASING ....................................................................................................................................... 64
13. APPENDIX B. DISASSEMBLY OF LASER SCANNER FROM THE STAND ............................................................................................ 66
Figure list
Figure 4.1 The symbols of the emergency laser stop and remote interlock connector ................................................................................... 11
Figure 4.2 Labels for marking the room, where laser therapy treatment procedures are performed ............................................................. 16
Figure 4.3 Laser label of the unit...................................................................................................................................................................... 16
Figure 4.4 Labels of point applicator................................................................................................................................................................ 16
Figure 4.5. Labels of scanning and cluster applicators ..................................................................................................................................... 17
Figure 5.1 General view ................................................................................................................................................................................... 18
Figure 5.2 Unit rear panel view........................................................................................................................................................................ 18
Figure 5.3 Arrangement of front panel components ....................................................................................................................................... 19
Figure 5.4 The battery installation method...................................................................................................................................................... 21
Figure 5.5. Therapy selection mode screen ..................................................................................................................................................... 22
Figure 5.6 The view of the emergency laser stop............................................................................................................................................. 23
Figure 5.7 Emergency laser stop label sample ................................................................................................................................................. 23
Figure 5.8 Point laser applicators and optical fibers ........................................................................................................................................ 25
Figure 5.9 Laser scanning applicator – panel description................................................................................................................................. 25
Figure 5.10 Scanning and cluster laser applicators .......................................................................................................................................... 25
Figure 5.11. Laser cluster applicator - panel description.................................................................................................................................. 26
Figure 6.1 Method of mounting the point applicator holder ........................................................................................................................... 28
Figure 6.2 Method of mounting the cluster applicator holder......................................................................................................................... 29
Figure 6.3 Laser therapy sockets...................................................................................................................................................................... 30
Figure 6.4 Sticking the magnetic tape to the power supply ............................................................................................................................. 30
Figure 6.5 Handwheels – scanner and arm of the stand .................................................................................................................................. 31
Figure 6.6 Wheel with brake ............................................................................................................................................................................ 31
Figure 6.7. The view of the device on a stand .................................................................................................................................................. 31
Figure 6.8 Remote interlock connector socket ................................................................................................................................................ 32
Figure 6.9 Screen view – date and time edition ............................................................................................................................................... 33
Figure 7.1 Field description.............................................................................................................................................................................. 39
Figure 7.2 Screenshot sample view for laser therapy – cluster applicator ....................................................................................................... 41
Figure 7.3 Information screen sample view ..................................................................................................................................................... 42
Figure 10.1. The unit error signaling and information visible after closing of the error message .................................................................... 54

1. Basic information
page 5 / 66 Issue date 09.11.2022, release 10.1
1. Introduction
Read this manual carefully before starting the unit operation! Follow the recommendations
presented in this manual!
The laser therapy unit PhysioGo.Lite Laser should be installed by the seller. The recipient has the right to insist
on the product operation training.
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 Laser page 6 / 66
2. Intended use
Laser therapy unit PhysioGo.Lite Laser is an active, non-invasive therapeutic device, intended for carrying out
treatment procedures using laser radiation within the visible (for wavelength 660 nm) and invisible range (for
wavelength 808 nm).
As regards to laser radiation, the unit may be operated with point, cluster and scanning laser applicators. Due to
the available maximum radiation power output at the level of 450 mW for wave length 808 nm and 100 mW for
660 nm, the PhysioGo.Lite Laser unit is classified as a small power output laser device. In physiotherapy such
lasers are designated as ”cold”, ”soft” or biostimulating.
The unit is a laser therapy device class 3B.
The device has one therapeutic channel for laser therapy. The list of available applicators in particular channels
is presented in the Table 2-1. Further information on supported types of laser applicator are given in sections 5.7
and 8.
Table 2-1
Socket Socket labelling Laser applicator type
1 /
Cluster laser applicator (cluster applicator) or scanning laser applicator
(laser scanner)
2 Point laser applicator (laser probe)
3 Point laser applicator (laser probe)
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
laser applicators. Laser therapy treatments can be performed in continuous or pulse mode.
Detailed information about indications and contraindications are presented in chapter 9.
Impact of low energy laser radiation on tissue includes:
•improvement of micro-circulation,
•stimulation of angiogenesis,
•increase in amplitude of activity potentials with nerve fibers,
•increase in enzyme activity,
•changes in potential of cell membranes,
•changes in secretion of neurotransmitters, hormones and kinins.
At the level of cells follows:
•acceleration of electrolyte exchange between cell and environment,
•increase in biological activity,
•anti-mutagen impact,
•changes in liquid crystal structure of biological membranes
•increase in synthesis of collagen, proteins, RNA and ATP.
Due to the wide range of impact laser may be applied to treat disorders on many fields, among others in:
•sports medicine,
•orthopedics,
•rheumatology,
•neurology,
•dermatology
•laryngology,
•stomatology,
•esthetic medicine.

2. Intended use
page 7 / 66 Issue date 09.11.2022, release 10.1
An important factor of bio-stimulating laser activity is the missing heat effect, which allows application for acute
conditions.
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.
Intended users
The patient should not be the operator.
Users (operators) of PhysioGo.Lite Laser can be:
•specialists in the field of the laser 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 laser 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 laser 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 Laser user has to be properly trained in the device safe and effective use, before starting the
operation. Training in the rules of operation can be carried out by representatives of the manufacturer or seller,
based on this user manual.
Recommended training positions:
•information about the intended use of the device,
•occupational safety information,
•information on the construction and method of the shockwave 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 Laser page 8 / 66
3. Warranty and manufacturer's responsibility
The manufacturer warrants the controller and laser applicators 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,
•firmware updates are performed by the manufacturer, an authorized service personnel or distributor,
•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, gas springs, laser
applicator lenses, optical fiber applicators, 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 chapter
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.
The firmware that is part of the device is not intended to be installed, configured or updated by the user. See
section 6.3.6.1 for details.
On demand, the producer makes available technical diagrams, parts lists, descriptions, instructions for calibration
or other helpful information to appropriately qualified user's technical staff to repair these parts of unit, which
are described by the producer as a reparable.

4. Operational safety
page 9 / 66 Issue date 09.11.2022, release 10.1
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 Laser 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 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.
There is an option to equip the device with a battery which allows for operation without, or in conditions of
reduced quality of power supply.
Storage, operation and transport conditions
The PhysioGo.Lite Laser 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.

4. Operational safety
User Manual – PhysioGo.Lite Laser page 10 / 66
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 Laser unit has been designed and manufactured in such a way that its use does not
jeopardize the health and safety of patients, users and third parties, as well as the unit should provide a
therapeutic benefits to patients if it is operated in appropriate conditions and in accordance with its intended
purpose.
General:
•PhysioGo.Lite Laser unit may be operated by qualified personnel (see 2.1), in compliance with
instructions presented further in this manual.
•No modification of this equipment is allowed!
•Using the methods of control, adjustment or performance of procedures other than those specified
herein may result in exposure to hazardous laser radiation.
•The treatment station (bed, couch) 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 the PhysioGo.Lite Laser 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 laser
applicators.
•The unit and laser applicators shall be protected against high temperatures and atmospheric conditions
(e.g. direct sunlight).
•Damaged cables shall be replaced immediately. Pay special attention to the casing cracks, threadbare
isolation and partially torn interconnecting cables.
•Prevent any fluid from penetrating inside the unit. In case of any fluid getting inside the unit, switch the
unit immediately off, isolate from the mains and contact the authorized service to inspect the unit.
•By any means do not cover the vents. Do not insert any objects into the vents.
•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.
•Laser applicators may only be connected to the sockets when power supply is switched off. Connecting
of probes with the power on may cause irreversible damage of the laser diode which is beyond the scope
of warranty repairs!
•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.
Electromagnetic compatibility:
•It is recommended to use original accessories, spare parts and equipment of Astar. 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.
•Use of the PhysioGo.Lite Laser 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 Laser and the other
equipment should be observed to verify that they are operating normally.