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
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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.

4. Operational safety
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•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 Laser,
including cables specified by the manufacturer. Otherwise, degradation of the performance of this
equipment could result.
Occupational safety and health for the laser operation:
•The device allows combining two functions in one security system: the remote interlock connector and
the emergency laser stop.
•The socket, where the remote interlock connector and the emergency laser stop should be connected, is
marked with symbols no. 101 and 112, according to D1 table of EN 60601-2-22 standard (based on IEC
60601-2-22).
Figure 4.1 The symbols of the emergency laser stop and remote interlock connector
•The manufacturer offers an optional external emergency laser stop with the possibility of connection the
remote interlock connector (e.g. in the form of a door opening sensor) to it. Details are given in section
5.6.
•An on-screen message confirms the activation of the remote interlock connector or the emergency laser
stop.
•The emergency laser stop has higher priority over the remote interlock connector.
•If the user is not going to apply the remote interlock connector and the emergency laser stop, the DOOR
plug, available as a standard accessory, performs their function.
•It is recommended to turn PhysioGo.Lite Laser device off when it is not used, so as it is not operated by
unqualified or random persons.
•Patient and operator must wear protective glasses during treatment. The suitable information is
presented in chapter 4.8. Third persons who are not wearing protective goggles should not be present in
the room.
•Do not look directly into the laser beam, also avoid looking on reflected rays.
•Avoid directing laser beam onto surfaces, which reflect light (details – see 5.7).
•Each treatment procedure must be started at the moment, when laser applicator is set in the right
direction.
•It is recommended, that walls of room, where the laser is operated, disperse to the greatest possible
extent laser radiation incident of them. The color of walls must be so matched that the incident laser
beam be visible.
It should be added that some surfaces, which disperse visible light, may reflect infrared radiation emitted
by laser.
•It is recommended to operate the unit, as far as possible, in a room dedicated exclusively to performance
of laser therapy treatment procedures. If fulfilling this recommendation is not possible, we suggest to
separate an area within the room used for different purposes in such a way that no emission of laser
radiation outside the delimited area is possible.
•It is recommended to mark the room, where the laser therapy treatment procedures are performed, with
warning labels and information delivered together with the unit.
•Point laser applicators may be operated according to contact on contact free method, laser scanner and
cluster applicator work contact free method only.
•The application methods depend on the area of application and the treatment purpose.
•Please take special care when handling laser applicator lens and optical fiber applicators, do not hit it
against hard surfaces, and avoid scratches. Mechanical damage of lens may cause reduction in power
output of laser radiation emitted by probe.
Increased temperatures:
•During operation of the cluster laser applicator, the head surface (polycarbonate panel) may be heated.
The direct contact of this surface with the patient's body is not intended. The contact may be incidental,

4. Operational safety
User Manual – PhysioGo.Lite Laser page 12 / 66
temporal, with the contact time less than a minute. Permissible temperature for such a situation and the
applicator's material is 60°C according to table 24 IEC 60601-1 (see also EN 60601-1).
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 be
consulted a physician prior to treatment.
•Prior to the treatment it is necessary to interview the patient, by taking into consideration relative and
absolute contraindications to use laser therapy. It is not recommended to carry out treatments in the
patients with neurological disorders, synkineses, trembling and convulsions.
•Treatment parameters should be consistent with the medical indications.
•Do not perform treatments on patients under the influence of alcohol.
•Do not perform treatments on patients under the influence of intoxicants.
•Sitting or reclining position should be applied to the patients with respiratory disorders or breathing
difficulties.
•The position of the patient should ensure good accessibility of the irradiated area and it should be
comfortable for the patient.
•It is necessary to avoid carrying out treatments in the area of abdomen in pregnant women or women
with the likelihood of pregnancy.
•It is necessary to keep the records of treatment, including the parameters of the therapy, the area of
treatment, treatment technique, dose and symptoms after therapy.
•It is necessary to ensure the adequate interval between treatments for the patient, in order to avoid an
increase of the risk of complications.
•It is necessary to continuously update knowledge and follow literary activities in the scope of therapy.
•Dose of radiation must be adapted to the goals of therapy. Therapeutic dose is described as energy
density and is expressed in J/cm2.
•Technical parameters of the equipment, that is the wave length and surface of an applicator, have direct
impact on the dose of radiation.
•It is necessary to follow the recommendations provided below when choosing energy density:
at the beginning of treatment series and in acute conditions it is necessary to use smaller doses up
to 4 J/cm2 – it is always necessary to observe the reaction of the patient’s organism,
in chronic conditions – higher doses, above 4 J/cm2.
•In therapy it is allowed to use the following application techniques:
single point or several points within a given area (e.g. painful points or acupuncture points, wound
along the edges or within a small distance from the wound, within a knuckle);
grid method and scanning (large surfaces).
•In each technique it is necessary to ensure that the radiation beam is at right angle on the tissue.
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 Laser 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
Warnings concerning electromagnetic compatibility are given in the chapter 4.3.
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 Laser 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 Laser unit.
The PhysioGo.Lite Laser 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
Technical supervision
The User of PhysioGo.Lite Laser unit must perform technical inspection of the unit at year's intervals. The
inspection must be performed by a unit authorized by manufacturer. The inspection is performed at the user's
expense.
The inspection should include:
•safety test,
•evaluation of keyboard function and operation,
•evaluation of touchscreen function and operation,
•control of correctness of the performed self-test,
•verification of the condition of laser applicators for casing defects and damage of interconnecting cables
and connectors,
•measurement of laser power level of all sources,
•examination of the mechanical structure of the stand in terms of stability, technical condition, quality of
connections and integrity, in particular checking:
the condition of the brakes in the stand wheels – whether they are broken or cracked,
whether the fastening screws are not loose,
condition of the gas spring (actuator).
The inspection must also include checking the quality of applied accessories and treatment materials.
Positive result of the technical inspection confirms that basic safety and essential performance is maintained.

4. Operational safety
User Manual – PhysioGo.Lite Laser page 14 / 66
Eye protection
Astar recommends the following types of protective goggles:
•models with AST, TP2, ML3 and DI4 filters – manufactured by NoIR, optical density and spectral ranges are
shown in the tables below:
Table 4-2. Parameters of AST filter
Spectral range [nm] Optical density Symbol
650-670 2+ DIR LB2
660 6+ DIR LB6
808-825 6+ DIR LB5
Table 4-3. Parameters of TP2 filter
Spectral range [nm] Optical density Symbol
650-<655 2+ DIR LB2
655-685 3+ DIR LB3
>685-690 2+ DIR LB2
770-<785 2+ DIR LB2
785-830 3+ DIR LB3
>830-845 2+ DIR LB2
Table 4-4. Parameters of ML3 filter
Spectral range [nm] Optical density Symbol
190-400 5+ 190 – 315 nm D LB7 + IR LB4
>315-395 D LB5 + IRM LB6
630-660 3+
630-660 + 800-915 DIR LB3
>660-670 + 780-920 DIR LB2
660-670 2+
800-915 3+
780-920 2+
Table 4-5. Parameters of DI4 filter
Spectral range [nm] Optical density Symbol
190-400 5+ 190 – 315 nm D L7 + R L4
>315-400 D L5 + R L6
625-850 4+ >830-850 DIR L3
625-830 DR L4
625-670 + >800-830 I L4
>670-800 I L5
660-835 5+
633 5+

4. Operational safety
page 15 / 66 Issue date 09.11.2022, release 10.1
•model with 31-21128 filter – manufactured by Honeywell (formerly Sperian), optical density and spectral
ranges are shown in the table below:
Table 4-6. Parameters of 31-21128 filter
Spectral range [nm] Optical density Symbol
630-730 4+ DIR L4
770-1070 4+ DIR L4
•models with P1L22 and P1H03 filters – manufactured by Laservision, optical density and spectral ranges
are shown in the tables below:
Table 4-7. Parameters of P1L22 filter
Spectral range [nm] Optical density Symbol
>315 - 375 8+ D LB6+ IR LB8 + M LB7Y
>375 - 378 6+ DIRM LB6
>378 - 382 4+ DIRM LB4
625 - <636 2+ DIRM LB2
636 - <640 4+ DIRM LB4
640 - 658 5+ DIRM LB5
>658 - 662 4+ DIRM LB4
>662 - 668 2+ DIRM LB2
797 - <804 2+ DIRM LB2
804 - <806 4+ DIRM LB4
806 - <809 5+ DIRM LB5
809 - 824 6+ D LB6 + I LB6Y + RM LB6
>824 - 827 5+ DIRM LB5
>827 - 829 4+ DIRM LB4
>829 - 836 2+ DIRM LB2
Table 4-8. Parameters of P1H03 filter
Spectral range [nm] Optical density Symbol
540 - <578 1+ DIRM LB1
578 - <595 2+ DIRM LB2
595 - <610 3+ DIRM LB3
610 - <630 5+ DIRM LB5
630 - <660 6+ DIRM LB6
660 - 775 7+ D LB6 + IR LB7 + M LB7Y
>775 - 790 6+ DIRM LB6
>790 - 800 5+ DIRM LB5
>800 - 820 4+ DIRM LB4
>820 - 835 3+ DIRM LB3
>835 - 850 2+ DIRM LB2
>850 - 870 1+ DIRM LB1

4. Operational safety
User Manual – PhysioGo.Lite Laser page 16 / 66
The above-mentioned models provide an adequate level of safety for the patient and the user during laser
therapy treatment with the use of applicators handled by any PhysioGo.Lite Laser unit model.
It is admissible to wear other types of protective goggles under condition that appropriate level of safety
is guaranteed by their manufacturer (they must meet requirements of EN207/EN 208 standard, feature CE
marking and declaration of conformity).
Laser labels
The unit is equipped with information labels on laser radiation and warnings against it. The user is obliged
to visibly mark with them the room, where the laser therapy treatment procedures are performed. A label must
be stuck in such a way that the longer ray, which connects the triangle with point in the center of the label, must
be on the right. The background of labels is yellow, framed and texts are in black.
Label patterns:
Figure 4.2 Labels for marking the room, where laser therapy treatment procedures are performed
Figure 4.3 Laser label of the unit
Figure 4.4 Labels of point applicator

4. Operational safety
page 17 / 66 Issue date 09.11.2022, release 10.1
Figure 4.5. Labels of scanning and cluster applicators
Applied parts
The PhysioGo.Lite Laser unit has one type of applied part of BF type. It includes:
•point laser applicators,
•scanning applicator,
•cluster applicator,
•laser applicators sockets,
•laser applicators plugs with cables.
Elements of applied part are connected.
Laser applicators generally do not require physical contact with patient’s body during normal use. So, they do
not come under the definition of the applied part, concerning the basic standard for the safety of medical
electrical equipment (in Poland PN-EN 60601-1, in Europe EN 60601-1, both based on IEC 60601-1), but they are
treated as applied parts (there are some indications to perform treatment with contact method, for point laser
applicators).
The specification of the leads, along with the location of the output sockets and the characteristics applicators
are described in detail in the chapters 5.1 and 5.7. The symbol of applied part type BF is presented on the label.
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 Laser page 18 / 66
5. Unit description
General characteristics
Laser therapy PhysioGo.Lite Laser unit 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,
•integrated remote interlock connector/ emergency laser stop socket,
•sockets for connection of accessories.
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 19 / 66 Issue date 09.11.2022, release 10.1
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 of laser radiation. Its
pressing, after setting of treatment procedure parameters, activates
status of unit readiness to emit laser radiation (laser probe, cluster
applicator) or starts emission (scanning applicator).
Pressing of this key once again stops the treatment procedure. The
emission of laser radiation is stopped.

5. Unit description
User Manual – PhysioGo.Lite Laser page 20 / 66
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
Orange No light --- No battery.
Table 5-3. Unit equipped with battery
Symbol Color Indicator status Mains switch Explanation
Readiness Battery
Green
Orange
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.