A-Star Tecaris User manual

Tecaris
Instructions for use

1. Basic information
page 3 / 60 Issue date 19.06.2023, rev. 2.0
Contents
1. BASIC INFORMATION...............................................................................................................................................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 ...........................................................................................................................................10
4.1 MAINS SUPPLY AND OPERATION MODE................................................................................................................................ 10
4.2 STORAGE,OPERATION AND TRANSPORT CONDITIONS .............................................................................................................. 11
4.3 WARNINGS AND SAFETY NOTES ...................................................................................................................................... 11
4.4 EXPLOSION PROOF ENVIRONMENT ..................................................................................................................................... 14
4.5 ELECTROMAGNETIC ENVIRONMENT .................................................................................................................................... 14
4.6 APPLIED PART................................................................................................................................................................ 15
4.6.1 Applied parts not intended to supply heat to a patient ................................................................................. 15
4.6.1 Applied parts intended to supply heat to a patient........................................................................................ 15
4.7 ESSENTIAL PERFORMANCE ................................................................................................................................................ 15
4.7.1 Tests of essential performance and basic safety............................................................................................ 15
4.8 DISPOSAL ..................................................................................................................................................................... 17
5. UNIT DESCRIPTION ................................................................................................................................................18
5.1 GENERAL CHARACTERISTICS .............................................................................................................................................. 18
5.2 FRONT PANEL ................................................................................................................................................................ 19
5.2.1 START/STOP key............................................................................................................................................. 19
5.2.2 CHANGE/STANDBY key .................................................................................................................................. 19
5.2.3 Knob ............................................................................................................................................................... 19
5.3 REAR AND SIDE PANELS,SERVICE SOCKETS ............................................................................................................................ 19
5.4 NAME PLATE ................................................................................................................................................................. 20
5.4.1 UDI code......................................................................................................................................................... 21
5.5 ELECTRODES,APPLICATORS AND CABLES .............................................................................................................................. 21
5.5.1 Active electrodes and applicator.................................................................................................................... 22
5.5.2 Neutral electrode ........................................................................................................................................... 23
5.6 TROLLEY TRANSPORT POSITION .......................................................................................................................................... 23
5.7 PROTECTION ................................................................................................................................................................. 23
5.7.1 Control of the connected active electrode...................................................................................................... 23
5.7.2 Control of electrodes contact quality ............................................................................................................. 23
6. DEVICE INSTALLATION AND START-UP ...................................................................................................................24
6.1 INSTALLATION ............................................................................................................................................................... 24
6.1.1 Mounting of applicator holder....................................................................................................................... 25
6.1.2 Connection of an active electrode applicator................................................................................................. 26
6.1.3 Connection of an active electrodes ................................................................................................................ 26
6.1.4 Connection of neutral (passive) electrode...................................................................................................... 27
6.1.5 Connection of IASTM applicator - optional .................................................................................................... 28
6.1.6 First operation................................................................................................................................................ 29
6.2 SETUP MODE................................................................................................................................................................. 29
6.2.1 Basic information ........................................................................................................................................... 29
6.2.2 Language ....................................................................................................................................................... 29
6.2.3 Global settings ............................................................................................................................................... 29
6.2.4 Control functions............................................................................................................................................ 30
6.2.5 Information .................................................................................................................................................... 31
7. UNIT OPERATION...................................................................................................................................................32
7.1 PATIENT PREPARATION AND TREATMENT PERFORMANCE ......................................................................................................... 32
7.1.1 General information....................................................................................................................................... 32
7.1.2 Resistive-capacitive radio frequency current therapy .................................................................................... 32
7.2 SCREEN CONFIGURATION ................................................................................................................................................. 34
7.3 DISPLAY DESCRIPTION ..................................................................................................................................................... 35
7.4 MANUAL MODE OF OPERATION ......................................................................................................................................... 36

1. Basic information
Instructions for use - Tecaris page 4 / 60
7.4.1 Treatment time modification ......................................................................................................................... 36
7.4.2 Operation mode change ................................................................................................................................ 37
7.5 SAFE SHUTDOWN PROCEDURE ........................................................................................................................................... 37
8. DEFINITIONS AND PARAMETERS............................................................................................................................38
8.1 RF CURRENT THERAPY CHARACTERISTICS AND ITS IMPACT ON THE BODY ...................................................................................... 38
8.2 OPERATION MODES ........................................................................................................................................................ 39
8.3 TREATMENT PARAMETERS ................................................................................................................................................ 40
8.3.1 Maximum output voltages and currents........................................................................................................ 41
8.3.2 Load resistance range .................................................................................................................................... 41
8.3.3 Output signal modulation .............................................................................................................................. 41
8.3.4 Output characteristics.................................................................................................................................... 42
9. INDICATIONS AND CONTRAINDICATIONS...............................................................................................................48
9.1 INDICATIONS ................................................................................................................................................................. 48
9.2 CONTRAINDICATIONS ...................................................................................................................................................... 48
9.2.1 Application restrictions .................................................................................................................................. 49
9.3 POSSIBLE SIDE EFFECTS .................................................................................................................................................... 49
10. MAINTENANCE, CLEANING, DISINFECTION............................................................................................................. 50
10.1 CLEANING OF THE UNIT CASING .................................................................................................................................... 50
10.2 CLEANING OF TOUCHSCREEN ....................................................................................................................................... 50
10.3 CLEANING AND DISINFECTION OF DETACHABLE PARTS ........................................................................................................ 51
10.4 SPECIAL MESSAGES .................................................................................................................................................... 51
10.5 TROUBLESHOOTING ................................................................................................................................................... 52
10.6 FUSE REPLACEMENT .................................................................................................................................................. 53
11. SPECIFICATION AND PARTS OF THE UNIT ...............................................................................................................54
11.1 TECHNICAL DATA ...................................................................................................................................................... 54
11.2 EMC PARAMETERS ................................................................................................................................................... 55
11.3 STANDARD PARTS OF THE UNIT..................................................................................................................................... 56
11.4 OPTIONAL PARTS OF THE UNIT...................................................................................................................................... 57
12. APPENDIX A. SYMBOL DESCRIPTION ......................................................................................................................58
12.1 CONTROLLER,PARTS OF THE UNIT,PACKAGING ................................................................................................................ 58
Figure list
Figure 4.1. Voltage selector .................................................................................................................................. 10
Figure 4.2 Forced cooling mode screen ................................................................................................................ 13
Figure 5.1 General view ........................................................................................................................................ 18
Figure 5.2 Left side panel view.............................................................................................................................. 19
Figure 5.3 Name plate of Tecaris device ............................................................................................................... 20
Figure 5.4. UDI code – examples........................................................................................................................... 21
Figure 6.1 Acclimatization screen ......................................................................................................................... 24
Figure 6.2. Holder mounting ................................................................................................................................. 25
Figure 6.3. Correct position of the detachable parts ............................................................................................ 25
Figure 6.4. Active electrode applicator socket...................................................................................................... 26
Figure 6.5. Connection of an active electrode to the applicator .......................................................................... 26
Figure 6.6 Connection of convex resistive electrode to the applicator ................................................................ 27
Figure 6.7. Connection of neutral (passive) electrode .......................................................................................... 27
Figure 6.8. Neutral (passive) electrode socket...................................................................................................... 27
Figure 6.9. Connection of IASTM applicator ......................................................................................................... 28
Figure 6.10. IASTM socket..................................................................................................................................... 28
Figure 6.11. Screen view – date and time edition................................................................................................ 30
Figure 7.1. Example of passive electrode placement under the patient's abdomen (calf treatment) ................. 33
Figure 7.2 Description of the screen – manual mode ........................................................................................... 34
Figure 7.3. Description of the treatment screen................................................................................................... 35
Figure 7.4. Example of the treatment screen ....................................................................................................... 36
Figure 7.5. Selection of the "Treatment time" field.............................................................................................. 36
Figure 7.6. Selection of the "Operation mode" field............................................................................................. 37
Figure 8.1. Modulation 25%.................................................................................................................................. 41
Figure 10.1. The unit error signaling and information visible after closing of the error message........................ 51

1. Basic information
page 5 / 60 Issue date 19.06.2023, rev. 2.0
1. Basic information
Read this Instructions for use carefully before starting the unit operation! Follow the
recommendations presented in this Instructions for use!
The resistive-capacitive radio frequency current physiotherapy unit Tecaris 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 Instructions for use:
Read appropriate passage of this Instructions for use, 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 Instruction 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 Instruction contains Information for use and technical description. This Instructions for use is provided in
the paper form. It is possible to receive a copy of the instructions in the form of a file. To do this, please submit
the form available at https://astar.eu/instructions/
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 Instructions for use
in form of information about precautions, contraindications and warnings.

2. Intended use
Instructions for use - Tecaris page 6 / 60
2. Intended use
The resistive-capacitive radio frequency current physiotherapy unit Tecaris is an active, non-invasive therapeutic
device.
The device is a generator of RF sinusoidal alternating current (300, 500, 750 or 1000 kHz) to locally increase the
temperature in the treatment area. The electric current is delivered to the patient through direct contact method
with non-injured skin, using active and neutral electrodes and a coupling medium, such as RF therapy cream.
Parts of the body intended for treatments with Tecaris are back, upper limb (shoulder, arm, forearm, hand),
lower limb (hip, thigh, shank, foot), neck and face for interaction with body tissues such as muscle, skeletal,
nervous, circulatory and lymphatic system and/or skin.
The device can operate in monopolar mode – resistive (RES) or capacitive (CAP). It is also possible to operate
with an optional applicator for a combination of radio frequency current and Instrument Assisted Soft Tissue
Mobilization (IASTM).
During radio frequency current therapy, the current circuit is an active electrode and a passive electrode, also
called neutral electrode or return plate.
In the resistive mode relationship known as Joule's law is applied. The current, understood as the movement of
electric charges, flows through the parts of the body located between the electrodes, resulting in the release of
heat in the tissues. The increase in temperature occurs primarily in the deeper areas of the body. The higher the
resistance of the tissues, the more heat is released. The thermal effect is strongest for tissues with a high density
and low water content (e.g. bones, tendons).
In capacitive mode, a local temperature rise occurs as a result of the combined thermal effect of the current
resulting from Joule's law and heating of dissipative material covering the active electrode. Therapeutic effect is
then most effective in superficial tissues (epidermis, dermis, subcutaneous tissues and superficial muscular
tissues).
The passive electrode is not intended to provide heat, it only closes the circuit.
The therapy can be used to treat diseases in the following areas:
•orthopedics,
•rehabilitation,
•sports medicine,
•aesthetic medicine.
Its specific medical purposes are:
•treatment or alleviation of disease,
•treatment or alleviation of an injury or disability.
The list of indications and contraindications is given in chapter 9.
The information on the available detachable parts is presented in chapters 5.5 and 6.1.
2.1 Intended users
The patient should not be the operator.
This device should not be operated by persons with implanted or external electronic devices (e.g. pacemakers,
insulin pumps, hearing aids).
Users (operators) of Tecaris can be:
specialists in the field of the therapy of the musculoskeletal system,
physiotherapists specializing in the therapy of the musculoskeletal system,
sports medicine specialists,

2. Intended use
page 7 / 60 Issue date 19.06.2023, rev. 2.0
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 RF current therapy, medium-wave
and long-wave diathermy within the range commonly referred to as TECAR therapy,
•knowledge of the terminology and technical terms used in the Instructions (e.g. knowledge of units of
physical quantities),
•practical skills in performing therapeutic treatments using devices in which the physical agent is generated
by radiofrequency (high frequency) electrical current.
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 the electrodes),
•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 Tecaris user must 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 Instruction for use.
Recommended training positions:
•information about the intended use of the device,
•occupational safety information,
•information on the construction and method of the RF current,
•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
Instructions for use - Tecaris page 8 / 60
3. Warranty and manufacturer's responsibility
The manufacturer warrants the controller and applicators (angular and straight) to be free of faults for the period
of time and conditions stated in Warranty certificate. The manufacturer also provides post-warranty service for
a period of 10 years from launching the unit onto the market. 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 Instruction,
•the unit is operated in compliance with its tended use.
The warranty does not cover consumables, i.e.:
•mains cable,
•fuses,
•handles,
•resistive electrodes,
•capacitive electrodes,
•neutral electrode,
•neutral electrode cable,
•Velcro belts,
•IASTM applicators.
The warranty also does not cover faults or damage caused by:
•improper placement, installation, or configuration of the device (including changing the supply voltage
and/or fuses without clear need),
•misuse or failure to observe the instructions presented in this Instructions for use,
•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 parts of the unit.
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 electrodes and applicators
The expected "life time" of the device is 10 years.
After elapse of 10 years from date of introduction of device and detachable parts in the market the manufacturer
is not liable for their 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 parts of the unit, failure to observe Instructions for use and performance of repairs by unauthorized
persons.

3. Warranty and manufacturer's responsibility
page 9 / 60 Issue date 19.06.2023, rev. 2.0
A list of items which may be user replaceable:
•fuses,
•electrodes,
•applicators,
•neutral electrode cable.
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 6.2.5.1 for details.
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
Instructions for use - Tecaris page 10 / 60
4. Operational safety
4.1 Mains supply and operation mode
Depending on the mains voltage in a given country, the device can be supplied from an AC mains with a rated
voltage of 230V ± 10% and a frequency of 50/60Hz or 120V ± 6% and frequency 50/60Hz. The choice is made
with the voltage selector.
Tecaris 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.
Do not change the setting of the voltage selector, if it is not strongly recommended – this may cause damage
to the device that is not subject to warranty. It is recommended that the change should be performed only by
qualified technical personnel (e.g. an electrician).
To change the voltage selector setting:
Step Description
1.
Make sure that the unit is unplugged from the mains. Switch the mains switch to the "0" position.
2. Carefully turn the unit upside down.
3.
Switch the power supply voltage to the correct value (until you hear a click of the voltage selector)
using a screwdriver.
4.
Change fuses according to chapter 10.6.
5.
Reconnect the mains cable – first to the socket on the side of the controller, then to the mains. Switch
the mains switch to the "I" position.
6.
Check the device operation.
Figure 4.1. Voltage selector