A-Star PhysioMG User manual

PhysioMG –
User Manual

1. Basic information and contents
Page 3 / 58 Issue date 02.09.2019, release 10.0
Contents
1. INTRODUCTION .......................................................................................................................................................5
1.1 MANUFACTURER ............................................................................................................................................................. 5
1.2 RISK MANAGEMENT PROCESS .............................................................................................................................................. 5
2. INTENDED USE .........................................................................................................................................................6
2.1 INTENDED USERS .............................................................................................................................................................. 6
2.2 USER TRAINING ............................................................................................................................................................... 7
3. WARRANTY AND MANUFACTURER'S RESPONSIBILITY..............................................................................................8
4. OPERATIONAL SAFETY .............................................................................................................................................9
4.1 MAINS SUPPLY AND OPERATION MODE.................................................................................................................................. 9
4.2 STORAGE,OPERATION AND TRANSPORT CONDITIONS ................................................................................................................ 9
4.3 WARNINGS AND SAFETY NOTES ........................................................................................................................................ 9
4.4 APPLIED PARTS AND WORKING TEMPERATURE ....................................................................................................................... 12
4.5 EXPLOSION PROOF ENVIRONMENT...................................................................................................................................... 12
4.6 ELECTROMAGNETIC ENVIRONMENT .................................................................................................................................... 12
4.7 OPERATION OF TOUCH-SENSITIVE DISPLAYS .......................................................................................................................... 13
4.8 TECHNICAL SUPERVISION.................................................................................................................................................. 13
4.9 DISPOSAL ..................................................................................................................................................................... 14
5. UNIT DESCRIPTION ................................................................................................................................................15
5.1 GENERAL CHARACTERISTICS .............................................................................................................................................. 15
5.2 KEYBOARD.................................................................................................................................................................... 16
5.3 MAGNETIC FIELD APPLICATORS .......................................................................................................................................... 17
5.4 NAME PLATES ............................................................................................................................................................... 19
6. DEVICE INSTALLATION AND START-UP ...................................................................................................................20
6.1 INSTALLATION ............................................................................................................................................................... 20
6.1.1 Connection of magnetic field applicators....................................................................................................... 20
6.1.2 First operation................................................................................................................................................ 22
6.2 SETUP MODE................................................................................................................................................................. 22
6.2.1 Basic information ........................................................................................................................................... 22
6.2.2 Language ....................................................................................................................................................... 22
6.2.3 Global settings ............................................................................................................................................... 23
6.2.4 Functional settings......................................................................................................................................... 23
6.2.5 Service ............................................................................................................................................................ 24
6.2.6 Statistics......................................................................................................................................................... 25
6.3 TRANSPORT POSITION ..................................................................................................................................................... 25
6.3.1 Couch ............................................................................................................................................................. 25
6.3.2 The stand with CP applicator ......................................................................................................................... 25
6.3.3 Trolley for applicators .................................................................................................................................... 25
7. UNIT OPERATION...................................................................................................................................................27
7.1 PATIENT PREPARATION AND TREATMENT PERFORMANCE ......................................................................................................... 27
7.1.1 General information....................................................................................................................................... 27
7.1.2 Magnetotherapy ............................................................................................................................................ 27
7.2 SCREEN CONFIGURATION ................................................................................................................................................. 28
7.3 GENERAL CONFIGURATION ............................................................................................................................................... 29
7.3.1 Treatment channel configuration – for two-channel models......................................................................... 29
7.3.2 Channel selection tabs ................................................................................................................................... 29
7.4 DISPLAY DESCRIPTION ..................................................................................................................................................... 30
7.5 DUAL MODE ................................................................................................................................................................. 31
7.6 APPLICATION OF MAGNETIC FIELD ...................................................................................................................................... 32
7.7 OPERATION WITH PRESET TREATMENT PROGRAMS ................................................................................................................. 33
7.8 FAVORITE PROGRAMS ..................................................................................................................................................... 35
7.9 MANUAL MODE OPERATION ............................................................................................................................................. 35
7.10 USER PROGRAMS ...................................................................................................................................................... 35
7.11 USER SEQUENCES...................................................................................................................................................... 37
7.12 SAFE SHUTDOWN PROCEDURE...................................................................................................................................... 39
8. DEFINITIONS AND PARAMETERS ............................................................................................................................40
8.1 GENERAL INFORMATION .................................................................................................................................................. 40
8.2 TREATMENT PARAMETERS ................................................................................................................................................ 40
8.2.1 The mode of magnetic field generation ......................................................................................................... 42
8.2.2 Spectrum........................................................................................................................................................ 43

1. Basic information and contents
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8.3 LIMITATION OF INDUCTION WITH FREQUENCY INCREASE .......................................................................................................... 44
9. INDICATIONS AND CONTRAINDICATIONS...............................................................................................................46
9.1 INDICATIONS ................................................................................................................................................................. 46
9.2 CONTRAINDICATIONS ...................................................................................................................................................... 46
9.3 POSSIBLE SIDE EFFECTS .................................................................................................................................................... 47
10. MAINTENANCE, CLEANING, DISINFECTION.............................................................................................................48
10.1 CLEANING OF TOUCHSCREEN ....................................................................................................................................... 48
10.2 CLEANING OF THE UNIT AND APPLICATORS CASINGS........................................................................................................... 48
10.3 DISINFECTION .......................................................................................................................................................... 48
10.4 SPECIAL MESSAGES.................................................................................................................................................... 49
10.5 SELF-TEST PROCEDURE............................................................................................................................................... 49
10.6 TROUBLESHOOTING ................................................................................................................................................... 50
10.7 FUSE REPLACEMENT .................................................................................................................................................. 50
11. SPECIFICATION AND ACCESSORIES .........................................................................................................................52
11.1 TECHNICAL DATA ...................................................................................................................................................... 52
11.2 EMC PARAMETERS ................................................................................................................................................... 54
11.3 STANDARD ACCESSORIES............................................................................................................................................. 56
11.4 OPTIONAL ACCESSORIES ............................................................................................................................................. 56
12. APPENDIX A. SYMBOL DESCRIPTION ......................................................................................................................57
List of illustrations and tables
Figure 4.1. A label informing about the temperatures of the solenoid applicators ................................................................. 12
Figure 5.1 General view of the PhysioMG 827 ......................................................................................................................... 15
Figure 5.2. General view of PhysioMG 825 and 815 units........................................................................................................ 15
Figure 5.3 Arrangement of keyboard components on the example of PhysioMG 827 ............................................................ 16
Figure 5.4 CS35, CS60 and CS75 solenoid applicators .............................................................................................................. 17
Figure 5.5 View of the controller and solenoid applicator with a couch .................................................................................. 17
Figure 5.6. CS35 applicator on the trolley ................................................................................................................................ 18
Figure 5.7. CP applicators on a stand ....................................................................................................................................... 18
Figure 5.8. CPEP applicators..................................................................................................................................................... 19
Figure 6.1 View of the PhysioMG 827 sockets label................................................................................................................. 20
Figure 6.2 View of the PhysioMG 825 sockets label................................................................................................................. 21
Figure 6.3 View of the PhysioMG 815 sockets label................................................................................................................. 21
Figure 6.4. Incorrectly connected applicator............................................................................................................................ 22
Figure 6.5 Screen view – date and time edition ....................................................................................................................... 23
Figure 6.6. Transport position of the trolley ............................................................................................................................ 26
Figure 7.1 Field description ...................................................................................................................................................... 28
Figure 7.2 Location of channel selection tabs .......................................................................................................................... 29
Figure 7.3. An example of the appearance of a treatment screen for magnetotherapy treatment – a single applicator ....... 30
Figure 7.4. An example of the appearance of a treatment screen for magnetotherapy treatment – dual mode ................... 31
Figure 7.5. View of the parameters edit screens in dual mode................................................................................................ 31
Figure 7.6 Examples of magnetic field application ................................................................................................................... 32
Figure 7.7 Samples view of the information screen ................................................................................................................. 33
Figure 8.1. Manual frequency setting....................................................................................................................................... 42
Figure 8.2. Manual time setting ............................................................................................................................................... 42
Figure 8.3. Single-half wave...................................................................................................................................................... 42
Figure 8.4. Double-half wave.................................................................................................................................................... 43
Figure 8.5. Frequency spectrum............................................................................................................................................... 43
Figure 8.6. Decrease in induction value with frequency increase ............................................................................................ 45
Table 1. Available models of the PhysioMG unit........................................................................................................................ 6
Table 2. Recommendations for the operation of touch screens .............................................................................................. 13
Table 3. Permissible configurations of applicators in the sockets of various models of PhysioMG ......................................... 21
Table 4. Signaling special messages ......................................................................................................................................... 49
Table 5. The "hardware" error coding system.......................................................................................................................... 49

1. Basic information and contents
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1. Introduction
Read this Guide carefully before starting the unit operation! Follow the recommendations
presented in this Guide! This user guide refers to model 815, 825 and 827 of the unit.
Model of the unit can be found on the name plate.
The Physio MG unit should be installed and started off 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 guide, 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.
WARNING: No modification of this equipment is allowed!
1.1 Manufacturer
ASTAR Sp. z o.o.
UL. ŚWIT 33
43-382 BIELSKO-BIAŁA, POLAND
www.astar.eu
1.2 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
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2. Intended use
The PhysioMG unit is an active, non-invasive therapeutic device, intended for carrying out treatment
procedures using low frequency magnetic field generated by dedicated applicators.
The magnetic field can be used to treat conditions in the following areas:
•orthopedics,
•sports medicine,
•aesthetic medicine,
•rheumatology,
•neurology,
•urology,
•dermatology,
•angiology,
•gynecology,
•stomatology.
A list of indications and contraindications is given in Chapter 9.
When characterizing the biological effects of low frequency magnetic field, first of all it is necessary to
mention:
•modification of cellular signal transmission,
•effects on the structure of biological membranes and the processes of ions' transportation,
•effects on the processes of nucleic acid replication and transcription as well as protein synthesis,
•effects on cell proliferation processes,
•effects on oxygen free radicals and cell apoptosis processes,
•regenerative effects,
•osteogenetic effects,
•anti-inflammatory effects,
•analgesic effects.
The unit possesses the base of preset treatment procedures along with therapeutic encyclopedia, which
significantly increases comfort of operation. There is also a possibility to create own user-defined programs and
sequences.
Complete medical product features:
•PhysioMG controller,
•LE_CS type couch,
•ST_CS type trolley for applicators,
•stand for type CP applicator,
•solenoid applicators,
•plate applicators.
Available functionality depends on the model of the unit – for details, see Table 1.
Table 1. Available models of the PhysioMG unit
Model LCD touch
screen
Number of
treatment
channels
Applicable applicators
Channel 1 Channel 2
815 5’’ 1 CP, CS35, CS60 -
825 5’’ 2 CS35, CS60, CP, CPEP CS35, CS60, CP, CPEP
827 7’’ 2 CS35, CS60, CS75, CP,
CPEP
CS35, CS60, CS75, CP,
CPEP

2. Intended use
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2.1 Intended users
The patient should not be the operator.
Users (operators) of PhysioMG device can be:
•specialists in the field of the low frequency magnetic field 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 electrotherapy, low frequency
magnetic field therapy and 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 multifunctional devices for therapy, resulting
from education, experience and training.
Physical and cognitive requirements of the operator:
•eyesight enabling to recognize elements of LCD and keyboard,
•hearing enabling to hear the patient's voice,
•reading comprehension that allows to read the instructions of use and information on the LCD 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).
2.2 User training
The PhysioMG user has to be properly trained in the device safe and effective use, before starting the
operation. Training in the rules of operation can be carried out by representatives of the manufacturer or
seller, based on this user manual. Recommended training positions:
•information about the intended use of the device,
•occupational safety information,
•information on the construction and method of the output signals 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.

4.Operational safety
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3. Warranty and manufacturer's responsibility
The manufacturer warrants the controller, applicators, couch and trolley 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. Warranty includes all material and workmanship
faults.
The manufacturer undertakes to observe the warranty agreement, if the following conditions are met:
•all repairs, changes, extensions and calibrations of equipment are performed by manufacturer or
authorized service personnel,
•the mains supply system in the treatment room meets requirements of standards in force,
•the unit is operated by qualified personnel, in compliance with instructions presented in this manual,
•the unit is operated in compliance with its intended use.
The warranty does not cover consumables, i.e. connecting cables, mains cables, holders and fuses, straps and
covers, 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 equipment enclosures,
•adjustment and/or unauthorized calibration,
•use of non-original accessories.
The warranty does not cover any damage due to a failure to adhere to the recommendations stated in
Chapters 4.3 and 10 hereof.
The manufacturer is not liable in case of transmission of infection by equipment components.
The expected "life time" of the device is 10 years.
After elapse of 10 years from date of introduction of device and accessories in the market the manufacturer is
not liable for device and accessories' faults or its consequences. After elapse of the expected life time of the
device the user bears the complete responsibility for the occurrence of medical incidents.
The manufacturer bears no responsibility for results of faulty installation, wrong diagnosis, wrong use of the
device and equipment, failure to observe user's manual and performance of repairs by unauthorized persons.
Inside the device there are no user serviceable components, except for fuses.
No parts can be serviced or maintained when the device is in use with a patient.
On demand, the manufacturer makes available technical diagrams, parts lists, descriptions, instructions
for calibration or other helpful information to appropriately qualified user's technical staff to repair these parts
of unit, which are described by the producer as a reparable.

4. Operational safety
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4. Operational safety
4.1 Mains supply and operation mode
The PhysioMG unit is designed for supply from AC mains with rating 230V ±10%, 50/60Hz. It is a medical
device under safety class I, 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.
The unit is connected to the mains by means of a detachable mains cable. The unit must not be placed in a
way that makes it difficult to disconnect it. The power supply cord is equipped with a mains plug that isolates
the device from the supply mains on all poles simultaneously.
Recommendations related to isolation the device from the supply mains:
•Do not position the device 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:
•removing the mains cable plug from the mains power socket,
•removing the mains cable plug from the socket on the unit,
•switching the mains switch to the "0" position.
4.2 Storage, operation and transport conditions
The unit must be stored in closed rooms, where the atmosphere is free from vapors and caustic substances
and:
•the temperature is maintained between +5°C and +45°C,
•relative humidity does not exceed 75%,
•atmospheric pressure value is between 700 and 1060 hPa (70-106 kPa).
The unit is intended for operation under the following conditions:
•ambient temperature between +15°C and +30°C,
•relative humidity between 30% to 75%,
•atmospheric pressure between 700 to 1060 hPa (70-106 kPa).
If further transport of the device is required, use the delivery packaging. Transport shall be performed with
covered transport means.
Recommended transport conditions:
•ambient temperature between -10°C and +45°C,
•humidity between 20 and 95%,
•atmospheric pressure between 700 and 1060 hPa (70-106 kPa).
4.3 WARNINGS and safety notes
The PhysioMG unit has been designed and manufactured in such a way that its use does not cause a hazard
to the health and safety of patients, operators and third parties, as well as the unit provides therapeutic
benefits to patients if it is operated in appropriate conditions and in accordance with its intended purpose.

4.Operational safety
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General information:
•The unit may be operated by qualified personnel in compliance with instructions presented further
in this manual.
•To avoid the risk of electric shock, the equipment must only be connected to mains supply with
protective earth (mains socket with grounding pin).
•No modification of this equipment is allowed!
•The treatment station (bed, couch, chair) shall be located away from other electric devices and water
supply / sewerage installation / central heating system, so that it is impossible for the patient to touch
any of them during treatment procedure.
•Do not position the device so that it is difficult to operate the disconnection of the device from the
supply mains.
•Do not remove warning signs and labels put by the manufacturer on the unit casing and casings of
accessories.
•The unit and magnetic field applicators shall be protected against high temperatures and atmospheric
conditions (e.g. direct sunlight).
•Damaged cables and/or applicators shall be replaced immediately. Pay special attention to the casing
cracks, threadbare insulation and partially torn interconnecting cables.
•Prevent any fluid from penetrating inside the unit and applicators. In case of any fluid getting inside the
unit, switch the unit immediately off, isolate from the mains and contact service to inspect the unit.
•By any means do not cover the vents. Do not insert any objects into the ventilation holes.
•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.
•The couch is designed for stationary work. It is recommended to prepare the couch location so that the
patient can easily access it from at least one side.
•The couch was designed for patients weighing up to 135 kg.
•Changing the position of the couch should not be performed during the therapy.
•Moving the couch with the patient lying on it is prohibited.
•Only one solenoid applicator may be placed on the couch.
•The position of the CP type applicator mounted on a stand or solenoid one mounted on the couch can
only be changed by the personnel operating the unit.
•It is necessary to be careful during carrying the solenoid applicators due to their weight.
•CPEP applicators are not identical to CPE applicators in previous magnetotherapy devices (PhysioGo,
Etius). They cannot be used interchangeably.
•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 lead, 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 the manufacturer. 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 PhysioMG adjacent to or stacked with other equipment should be avoided because it could
result in improper operation. If such use is necessary, the unit and the other equipment should be
observed to verify that they are operating normally.
•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 PhysioMG, including cables
specified by the manufacturer. Otherwise, degradation of the performance of this equipment could
result.