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

4. Operational safety
page 11 / 60 Issue date 19.06.2023, rev. 2.0
The unit is connected to the mains by means of a detachable mains cable. 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 Tecaris so that it is difficult to operate the disconnection of the device from the supply
mains.
•To isolate the device from the supply mains, hold the mains socket-outlet with one hand, grasp the mains
plug with second hand and disconnect it from the mains socket-outlet.
Disconnection from the mains takes place after:
•switching the mains switch to the "0" position,
•removing the mains cable plug from the mains power socket,
•removing the mains cable plug from the socket on the unit.
Do not use adapters, splitters or extension cords to supply the unit.
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 to +45°C,
•relative humidity does not exceed 75%,
•atmospheric pressure value is between 700 hPa and 1060 hPa (70 – 106 kPa).
The unit is intended for operation under the following conditions:
•ambient temperature between +15°C to +30°C,
•relative humidity between 30% to 75%,
•atmospheric pressure between 700 hPa and 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 to +45°C,
•humidity between 20% to 95%,
•atmospheric pressure between 700 hPa and 1060 hPa (70 – 106 kPa).
4.3 WARNINGS and safety notes
The Tecaris 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 therapeutic benefits to
patients if it is operated in appropriate conditions and in accordance with its intended purpose.
General information:
•The device may be operated by qualified personnel in compliance with instructions presented in this
Instruction – see 2.1.
•To avoid the risk of electric shock, the equipment must only be connected to mains supply with protective
earth pin.
•No modification of this equipment is allowed!
•If possible, it is recommended that the treatment station (bed, couch, chair) should be made of
non-conductive materials.
•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.
•An unused electrode should be placed in the device holder. Do not place the electrodes on any conductive
object (e.g. metal table, metal couch).
•Do not close the electrical circuit by the direct contact of the active and passive electrode.

4. Operational safety
Instructions for use - Tecaris page 12 / 60
•Do not position the Tecaris 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 and detachable parts
casings.
•The unit, applicators and electrodes shall be protected against high temperatures and atmospheric
conditions (e.g. direct sunlight).
•Detachable parts of the unit should be regularly inspected. Damaged cables, electrodes and/or
applicators shall be replaced immediately. Pay special attention to the casing cracks, threadbare
insulation and partially torn interconnecting cables.
•Prevent any fluid or cream from penetrating inside the unit and applicator. In case of any substance
getting inside the unit or the applicator, switch the unit immediately off, isolate from the mains and
contact service for inspection.
•By any means do not cover the vents. Do not insert any objects into the ventilation holes.
•The unit may be only used with detachable parts, spare parts, disposable items which have been
determined to be safe and appropriate inspection bodies have not issued contraindications against their
use.
•It is permissible to use another compatible neutral electrode cable, but its length must not exceed 3m.
•Electrodes are sensitive to mechanical damages that is why they should be used with caution. Throwing,
banging against hard surfaces and similar actions that may lead to damage of the surface shall be avoided.
•It is forbidden to use capacitive electrodes with damaged coating e.g. visible defects, scratches or chips.
•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.
Occupational Health and Safety, operator’s safety:
•It is recommended to carry out radio frequency current therapy procedures in separate rooms. This
recommendation also applies to all types of diathermy devices. If necessary, consider shielding of room.
•The operator should avoid wrapping applicator cables around the hands or putting them behind the neck.
These cables should also have as little contact with the patient as possible.
•Jewelry should be taken off from the hand area before starting the treatment.
•The treatment should be conducted with gloves on (CE marked nitrile gloves are recommended).
•Stop treatment before mounting, dismounting, or replacing an electrode.
•Never disconnect the applicator while it is operating.
•The operator should not touch the passive electrode during the procedure.
Thermal protection:
•The device has a thermal sensor controlling the temperature of the generator. Occasionally, generation
may stop when operating at maximum parameters for a long period of time in a room where the
temperature significantly exceeds the value recommended in section 4.2. The treatment is stopped then,
the code will display on the screen to report the overheating and the device will be blocked. This safety
function protects the device from premature wear and damage.
•In order to avoid blockage due to overheating, the device is equipped with additional forced cooling
mode. It activates, if the temperature of the generator approaches the limit value. The sequence of
operation of this mode allows you to finish the treatment after which a screen similar to the
acclimatization screen is activated.

4. Operational safety
page 13 / 60 Issue date 19.06.2023, rev. 2.0
Figure 4.2 Forced cooling mode screen
The process of the forced cooling lasts 15 minutes maximally. If in this period of time the cooling systems is
not able to decrease the temperature to the required level, the error code will display on the screen to report
the overheating and the device will be blocked.
Therapeutic:
•The device is intended for adult conscious patients.
•Before performing the treatment, make sure there are no contraindications to its implementation.
•It is impermissible for the patient to carry out the treatment on their own.
•High frequency current therapy is not recommended for patients with implanted and external electronic
devices (e.g. cardiac pacemakers, insulin pump, hearing aid). A possible hazard exists due to
concentration or re-direction of high frequency currents.
•Bystanders with implanted and external electronic devices (e.g. cardiac pacemakers, insulin pumps,
hearing aids) should not be present in rooms where high frequency current therapy is performed.
•Patients with metal, cement or plastic implants should consult with their treating physician.
•The Tecaris device and other equipment should not be used simultaneously. First and foremost, the
Tecaris device should not be used on patients connected to diagnostic or physiological monitoring
equipment.
•It is recommended to remove the removable dentures prior to procedure performed in the facial area.
•Treatments that increase tissue temperature are not recommended for acute inflammation.
•Treatment parameters and treatment site should be consistent with the medical indications. The applied
output power should be appropriate to the indication.
•Special care should be taken when treating patients with low blood pressure. Treatment may cause a
drop in blood pressure which is associated with dizziness.
•Caution should also be exercised in patients who have fluctuations and spikes in blood pressure or
hypertension.
•Sitting or reclining position should be applied to patients with respiratory disorders or breathing
difficulties.
•Avoid placing electrodes that form the circuit on the chest and upper back or crossing over the heart.
•The entire surface of the return plate should adhere well to the patient's body. If a cylindrical electrode
is used, the patient should hold it firmly in their hand. Do not start the procedure until the electrode is
properly positioned.
•During treatment with 300 kHz, a slight neuromuscular stimulation can occur, if contact between the
active electrode and the patient's body is lost.
•It is strongly forbidden to treat pregnant women or women with the likelihood of pregnancy.
•Patients should be informed about the possible side effects.
•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 keep the records of treatment, including the parameters of the therapy, the area of
treatment, treatment technique, dose and symptoms after therapy.
Not following the instructions below may result in patient burns:
•Take special care with patients with disturbed superficial sensation (esp. with impaired temperature
sensation) or increased threshold for pain.

4. Operational safety
Instructions for use - Tecaris page 14 / 60
•Use of an inappropriate cream, not intended for TECAR / RF therapy. It is recommended to apply RF
therapy cream manufactured by FIAB. Using the improper cream can also lead to electrode damage.
•If the coating of the capacitive electrode is damaged, replace the electrode with a new one.
•Skin-to-skin contact (for example between the arm and body of the patient) should be avoided. For
example, a rolled-up towel can be used to separate body parts.
•Do not operate the unit without the neutral electrode properly attached.
•The patient should not feel heat under the passive electrode. Such sensation indicates a poor contact.
•The size of the active electrode should be adjusted to the treated body area to avoid touching the skin
with the edge of the electrode. The applicator should be handled parallel to the skin. Improper contact
of the electrode with the skin may also cause discomfort or pain.
•While performing a treatment, pay attention to the patient's level of heat sensation in order to adjust
the settings and intensity of the treatment to the current sensation. Stop the treatment immediately if
the patient feels too intense heat.
•It is prohibited to leave the patients unattended during treatments.
•Do not perform treatments on patients under the influence of alcohol.
•Do not perform treatments on patients under the influence of intoxicants.
•Immediately disconnect the patient in the case of appearing warning on error messages on the display.
Failure of the device could result in an unintended increase of output power.
4.4 Explosion proof environment
The device is not adopted to operation in rooms, where combustible gases or their vapors occur. It is
recommended to avoid anesthetic or oxygen derivate gases, such as nitrous oxide (N2O) and oxygen. Some
materials, e.g. cotton, after oxygen saturation can be burned at high temperatures generated during normal use
of the device. 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 ignition of endogenous gases.
The unit must be separated from the mains before approaching the disinfection room, where it is installed.
4.5 Electromagnetic environment
•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 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 Tecaris unit. Manufacturer does not claim
compatibility of the Tecaris unit with high frequency surgical equipment.
•If the device is subjected to electromagnetic interference with an intensity that exceeds the compliance
levels declared in section 11.2, the display may be affected, generation may be interrupted or the device
may restart.
•WARNING: Use of the Tecaris adjacent to or stacked with other equipment should be avoided because it
could result in improper operation.
•WARNING: Electromagnetic field generated by the Tecaris cables during treatment may adversely influence
the operation of other electronic equipment. The hazard for patients with pacemakers and other active
implants is the possibility of interfering with the operation of these devices or the possibility of their damage
during therapy.
•It is recommended to use original detachable parts, spare parts and equipment of Astar.
•WARNING: Use of detachable parts, 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.
•WARNING: 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 Tecaris, including
cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could
result.

4. Operational safety
page 15 / 60 Issue date 19.06.2023, rev. 2.0
The Tecaris 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.
4.6 Applied part
The device has BF type applied part with a single function. It includes active and passive (neutral) electrode,
applicator and cables along with plugs. The appropriate symbol of the BF type applied part is placed on the socket
label.
4.6.1 Applied parts not intended to supply heat to a patient
Resistive electrodes and IASTM applicator are not intended to supply heat to the patient. The increase in their
temperature results only from the increase in the patient's body temperature at the treatment site.
The passive (neutral) electrode is not intended to supply heat to the patient. The increase of its temperature
results only from the increase in the patient's body temperature at the treatment site.
4.6.1 Applied parts intended to supply heat to a patient
Electrodes intended for capacitive mode are covered with a special material with dissipative properties, which
heats up during treatment. 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 current intensity should be adjusted to achieve the desired level of
heat sensation by the patient (see 7.1.2), which at the same time will be tolerated by the skin. For a strong
overheating effect, the temperature of the capacitive electrode could achieve 55°C.
4.7 Essential performance
With regard to the Tecaris device, essential performance means the generation of a radio frequency current (300,
500, 750 or 1000 kHz) to raise the temperature locally in the treatment site. The electric current is delivered to
the patient by direct contact of electrodes (active and neutral) and a coupling medium, such as RF therapy cream.
The active power in resistive mode should not exceed 100 W, the apparent power in capacitive mode should not
exceed 300 VA.
4.7.1 Tests of essential performance and basic safety
Calibrating or servicing the device shall be carried out by the manufacturer or an authorized service personnel
in accordance with separate guidelines. If the warnings given in this Instruction are followed, there is no risk for
persons performing the above-mentioned activities.
The user must perform technical inspection of the unit at year's intervals. The inspection must be performed by
a service authorized by the manufacturer. The inspection is performed at the user's expense.
Recommendations for test:
Test item Method of
checking Acceptance criteria
Required
measuring
equipment
Safety test:
•patient leakage current
measurement,
•touch current measurement,
•insulation resistance if
necessary
The manufacturer
allows the methods
compliant with the
requirements of the
standards:
•IEC 60601-1
•
IEC 62353
The measurement results are within the
limits specified by the applied standard
Safety tester
meeting the:
•IEC 60601-1
•IEC 62353
requirements

4. Operational safety
Instructions for use - Tecaris page 16 / 60
Test item Method of
checking Acceptance criteria
Required
measuring
equipment
Control of correctness of the
performed self-test
Visual inspection No errors No requirements
Evaluation of keyboard function
and operation
Manual and visual
inspection
The keys respond properly to pressure
No requirements
The knob turns without excessive
resistance
The unit responds to the knob turning
The knob is illuminated
Evaluation of touchscreen
function and operation
Manual and visual
inspection
The touch panel responds correctly to
pressing
No requirements
Inspection of the controller
condition for casing defects and
damage of sockets
Visual inspection
No deformation or cracks of the casing
No requirements
Undamaged sockets
No loosened sockets
Inspection of resistive electrodes
condition for defects and damage Visual inspection
Surface without damage and sharp edges
No requirements
No visible damage to the silicone
insulating cap
No visible damage to the electrode cover
When the electrode is mounted in the
applicator, the metal shaft is not visible
Inspection of capacitive
electrodes condition for defects
and damage
Visual inspection
No damaged coating e.g. visible defects,
scratches or chip
No requirements
Surface without damage and sharp edges
No visible damage to the silicone
insulating cap
No visible damage to the electrode cover
When the electrode is mounted in the
applicator, the metal shaft is not visible
Inspection of the applicator
condition for defects and damage Visual inspection
No deformation or cracks of the casing
No requirements
When the electrode is mounted in the
applicator, the metal shaft is not visible
No damage to electrode socket,
electrode is securely mounted in the in
socket (“click”), electrode and applicator
are well fitted
No damage to red locking button
No tear and bending of cable insulation
The cable bend is not loose
Undamaged connector
Inspection of the passive
electrode condition for defects
and damage
Visual inspection
No visible damage such as permanent
crease or deformation, broken coat on
edges, damaged cable attachment
No requirements
Inspection of the passive
electrode cable condition for
defects and damage
Visual inspection
No tear and bending of cable insulation
No requirements
Undamaged connector
Undamaged clamp of neutral electrode
Inspection of optional detachable
parts for defects and damage Visual inspection
Surface of IASTM applicator without
damage, sharp edges, corrosion
No requirements
No tear and bending of IASTM applicator
cable insulation
Undamaged connector of IASTM
applicator
Undamaged plug and socket of IASTM
applicator cable
Active power output
measurement in the resistive
mode
Voltage
measurement at
100Ω standard
resistor or direct
measurement using
TC-TST-10 tester
Active power consistent with the rated
value (tolerance ±20%)
Standard resistor
100Ω and
oscilloscope or TC-
TST-10 tester

4. Operational safety
page 17 / 60 Issue date 19.06.2023, rev. 2.0
Test item Method of
checking Acceptance criteria
Required
measuring
equipment
Apparent power output
measurement in capacitive mode
Voltage
measurement at
standard load
100Ω+330pF or
direct
measurement using
TC-TST-10
Apparent power consistent with the
rated value (tolerance ±20%)
Standard load
100Ω+330pF
and oscilloscope or
TC-TST-10 tester
Open circuit detection
Visual inspection
Lack of contact message
No requirements
The inspection must also include verification of the quality of applied detachable parts and treatment materials.
No action is required to maintain basic safety and essential performance with respect to electromagnetic
interference during device “life time”.
Positive result of the technical inspection confirms that basic safety and essential performance is maintained.
4.8 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.
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
Instructions for use - Tecaris page 18 / 60
5. Unit description
5.1 General characteristics
The radio frequency current physiotherapy unit Tecaris is a highly specialized medical device based on modern
microprocessor platform.
The electronic system includes:
•microcontroller module,
•user interface, which consists of LCD touch screen, illuminated knob for parameter selection and
START/STOP and CHANGE/STANDBY keys,
•power circuits supplying the appropriate voltage,
•RF current generator,
•auxiliary circuits, e.g. fan control system, temperature, output signal and voltage measurement systems.
Microprocessor advanced electronic system:
•monitor all operating parameters and controls them in real time.
•controls the generator,
•cooperates with LCD touchscreen, screen is backlit and clearly illustrates and indicates different functions.
Tecaris has a plastic enclosure. The unit is equipped with a color touch LCD display with a diagonal of 17.8 cm
(7’’). The mains switch, fuse socket and mains socket are located on the left side panel. The detachable parts
connection sockets are located on the rear side.
General view of the unit is presented in Figure 5.1, view of the left side panel in Figure 5.2.
Figure 5.1 General view

5. Unit description
page 19 / 60 Issue date 19.06.2023, rev. 2.0
Figure 5.2 Left side panel view
5.2 Front panel
5.2.1 START/STOP key
Pressing the START/STOP key results in generation after ending of parameters edition. Pressing START/STOP key
while performing a treatment result is treatment interruption and automatically the unit enters the main menu.
5.2.2 CHANGE/STANDBY key
Pressing the START/STOP key results in changing the edited parameter in manual or treatment mode.
Pressing and holding the CHANGE/STANDBY for 3 seconds key turns off the display and automatically the unit
enters the standby mode. The knob backlight blinks in the standby mode.
5.2.3 Knob
Using the knob, you can:
•change the value of edited parameter,
•select an item in the menu.
The knob is backlighted while operation.
The operation of the knob depends on the parameter being edited.
5.3 Rear and side panels, service sockets
On the unit rear panel output sockets are located. On the left side panel there are located:
•unit mains switch,
•fuse socket,
•mains socket.
On the right-side panel there are:
•memory card slot,
•service socket.
The memory card slot and service socket are intended only for service purposes performed by the authorized
service of the manufacturer. It is forbidden for the operator to connect any cables or memory cards to these
sockets.

5. Unit description
Instructions for use - Tecaris page 20 / 60
These sockets, when used for service purposes, are used only to connect:
•service socket (3.5 JACK) - a PC computer via a cable with an integrated FTDI communication module, with
interface in USB-A and UART standard, with constant operating voltage Vin / Vout 3.3 V,
•memory card slot – SD memory card, constant voltage Vin / Vout 3.3 V
The technical staff is not allowed to connect to service sockets cables with different specifications, adapters,
readers, emulators and other devices.
Near the service sockets, there is a sign of the obligation to read the instructions for use of the device.
5.4 Name plate
The name plate is located on the bottom of unit casing. Among others there are following data on the name plate
(see Appendix A):
•device name and version,
•UDI-DI code,
•serial number and date of production – UDI-PI code,
•nominal voltage and operating frequencies,
•types of applied fuses,
•IP protection class,
•manufacturer's data.
Figure 5.3 Name plate of Tecaris device