New Age TEKRA CT User manual

TEKRA CT
MANUAL
Instructions for use
New Age Italia srl
Via De Brozzi, 3 - 48022 Lugo (RA)
Tel.:[phone] - Telefax: +39-0545.369028
Web: www.newageitalia.it - E-mail: [e-mail]
This document is property of New Age Italia srl. All rights are reserved. Any copy or
reproduction of it through any means, including total or partial photocopy of the contents, is
prohibited without the written consent of New Age Italia srl.

Rev. 00 del 12/03/10
2/16

Rev. 00 del 12/03/10
3/16
INDEX
Cap.1 –PRESENTATION..................................................................... 5
1.1 –What is TEKRA CT?.................................................................. 5
1.2 Why use TEKRA CT? .................................................................. 5
1.3 –Who is TEKRA CT for? ............................................................. 5
1.4 –Indications.............................................................................. 5
1.5 –Contraindications.................................................................. 6
Cap.2 –OPERATION........................................................................... 7
2.1 –Connection and application of electrodes........................ 7
2.2 –Turning device on.................................................................. 8
2.3 –Selection of program type ................................................... 8
2.3.1 - - Manual mode..........................................................................8
2.3.2 - Reset program mode ................................................................8
2.3.3 - Personal program mode ...........................................................8
2.4 –Start of stimulation ................................................................. 8
2.5 –Setting time and intensity of emission ................................. 9
2.6 –Interrupt / end therapy ......................................................... 9
2.7 –Turning device off.................................................................. 9
2.8 –Configuration ......................................................................... 9
Cap.3 –PRESET PROGRAMS ............................................................. 9
Cap.4 –FREE PROGRAMS ............................................................... 11
4.1 –Setting a new program ....................................................... 11
4.2 ––Use and modification of a personal program ............... 11
Cap.5 –APPLICATIONS................................................................... 11
5.1 –Therapy sessions.................................................................. 11
5.2 –Adjusting emission power output ...................................... 11
5.3–Posture to be kept during the sessions............................... 12
Cap.6 ––POWER SUPPLY................................................................ 12
Cap.7 –SYMBOLS............................................................................ 12
DO NOT DISPOSE OF IN COMMON WASTE................................. 13
Cap.8 –MAINTENANCE .................................................................. 13
8.1 –Knob ..................................................................................... 13
8.2 –Device .................................................................................. 13
8.3 –Immediate maintenance: .................................................. 13

Rev. 00 del 12/03/10
4/16
Cap.9 –WARNINGS ........................................................................ 14
Cap.10 –TECHNICAL FEATURES ..................................................... 14
10.1 –Power supply...................................................................... 14
10.2 –Output features.................................................................. 15
10.3 –Other features .................................................................... 15
Cap.11 –BASIC SUPPLY AND ACCESSORIES................................. 15
11.1 –Basic supply ....................................................................... 15
11.1 –Accessories and consumption material ......................... 16
Cap.12 –BIBLIOGRAPHY ................................................................ 16
ATTENTION:
READ THIS INSTRUCTION MANUAL CAREFULLY
BEFORE USE.
IT IS RECOMMENDED TO SEEK THE ADVICE OF
MEDICAL PERSONNEL FOR THE THERAPEUTIC
INDICATIONS REQUIRED.

Rev. 00 del 12/06/09
5/16
Cap.1 –P R E S EN T A T I O N
TEKRA CT is included in a new line of electromedical devices for professional
physiotherapy. The main features of this innovative line of products are their small size,
facility for us and versatility.
1 . 1 –What is TEKRA CT?
The ongoing research in the field of medical devices has led to the creation of the new
system for deep diathermy, composed of the TEKRA XCRT generator with its
professional features. The innovative software generates electromagnetic fields for
therapeutic purposes to treat common pathologies (wounds, injuries, illnesses) by using
pre-set ready-to-use programs. Furthermore, there is free space in the memory to set-up
and record new protocols with custom-made parameters for the patient which can be
modified or cancelled later on. The possibility of setting-up new programs, the
technological innovation and the convenience of use make it an extremely progressive
product in the sector of electromedical devices.
1 . 2 Why use TEKRA CT?
With TEKRA CT you can apply electromagnetic fields with beneficial effects for the
reconstruction of bone tissue and, in general, for the regeneration of damaged tissues,
besides obtaining an analgetic, anti-inflammatory and regenerating effect. By
controlling the effects and progress of the therapy, new protocols can be implemented
with parameters which are more effective for the patient.
1 . 3 –Who is TEKRA CT for?
The medical field (especially physiotherapy) is the sector most suited for TEKRA CT to
fully express its potentialities.
–INDICATIONS AND CONTRAINDICATIONS
1 . 4 –Indications
The most common disorders treated with diathermy are those which attack the joints.
Electromagnetic fields are specially indicated for treatment of:
pseudarthrosis, arthrosis, arthritis;
inflammatory and degenerative arthropathy;
wound healing, bedsores;
oedemas, arteriopathy;
psoriasis.
circulatory deficit
muscular and tendinous injuries
torn muscles and tendons
bruised muscles
tendonitis

Rev. 00 del 12/06/09
6/16
We recommend consulting a doctor for the diagnosis and control of the therapy.
1 . 5 –Contraindi cations
Magnetic fields have some contraindications in common with other physical equipment
which acts by means of endogenous heat production:
presence of metallic fragments;
neoplasms (tumours);
tuberculosis;
acute inflammatory processes;
skin injuries;
sensitivity alteration.
pace-makers
pregnancy.

Rev. 00 del 12/06/09
7/16
Cap.2 –O P E RA T I O N
1 –Display TOUCH SCREEN
2 –KNOB + PUSH BUTTON
3 –Capacitive reference plate outlet
4 –Capacitive active electrode outlet
7 –STOP BUTTON
NOTE: check the contraindications and follow indications carefully before
applying diathermy.
2 . 1 –Connection and application of electrodes
Connect the electrode and plate wires to the outlet sockets of the device. Each
electrode or plate has its own specific connector. The connector is the bayonet type.
Therefore once the contact has been inserted, fasten it by turning the connector
clockwise.
7-Stop button
1-Display touch
screen
2- Knob + push button
3-Capacitive reference plate outlet
4- Capacitive active electrode
outlet

Rev. 00 del 12/03/10 8/16
2 . 2 –Turnin g device on
Press the rear switch to turn TEKRA CT on. An initial screen appears on the display
presenting the device including: the name of the appliance version, the START key
and the CONFIGURE key.
2 . 3 –Selection of p rogram type
TEKRA CT can operate in 3 different modes:
1- Manual mode
2- Reset program mode
3- Personal program mode
2.3.1 - - Manual mode
Press START on the initial screen to access the manual mode area. In this area, by
TURNING THE KNOB you can vary the value of the parameter selected, whereas
by PRESSING THE KNOB you pass from one parameter to the next. The
concerned parameters are: power output by the Capacitive stage, duration of the
Capacitive therapy.
2.3.2 - Reset program mode
Press START on the initial screen (touch screen) to access the work area. Then
press PROGRAMS (on touch screen)to enter the Menu for choosing specific
protocols where first of all the therapy to be used is selected, by turning the encoder
and then pressing ENTER (touch screen) or else PRESSING THE KNOB to
confirm the program selected.
2.3.3 - Personal program mode
The custom-made programs are at the bottom of the list of pre-set programs. Press
START on the initial screen (touch screen) to access the work area. Then press
PROGRAMS (on touch screen)to enter the Menu for choosing specific protocols.
At the bottom of the list first of all the therapy to be used is selected, by turning the
encoder and then pressing ENTER (touch screen) or else PRESSING THE KNOB
to confirm the program selected.
2 . 4 –Start of stimulation
Once a pre-set program has been selected or after having adjusted the parameters in
the manual mode area, START appears on the display. START to begin the
therapy.

Rev. 00 del 12/03/10 9/16
2 . 5 –Setting time and intensity of emission
The duration of the therapy and the intensity can be set at any time by rotating the
encoder. PRESS THE KNOB repeatedly to pass from the intensity parameter to the
time parameter and vice versa. The minimum increase in intensity is 1% and the
maximum intensity that can be set is 100%. Should the treated zone be in pain or too
hot, reduce the intensity or interrupt the therapy by pressing PAUSE (on the touch
screen) or STOP (on the keyboard).
2 . 6 –Interrupt / end therapy
Treatment emission is interrupted automatically when the Timer reaches 0 and an
acoustic signal is heard. If you wish to interrupt treatment before the end, press
PAUSE (on touch screen) or STOP (on the front panel). After the pause, to restart
treatment press START (on touch screen).
2 . 7 –Turnin g device off
In order to turn the device off, press the switch on the back of the device.
2 . 8 –Configuration
The TEKRA devices can be set-up according to personal requirements.
Press CONFIGURE (on touch screen) to access the setting area.
This section displays the following entries:
1) language: Italian, English, French, German, Spanish, Portuguese
2) brightness of display: from 0 to 10
3) volume of buzzer: from 0 to 10
4) timer of contact alarm: from 5 to 60 seconds
5) unblocking code: to enter before turning the device on the first time
Cap.3 –P R E S ET P R O G R AM S
TEKRA CT has 35 preset programs and 20 free protocols. Preset programs are listed
in the chart below:

Rev. 00 del 12/03/10 10/16
PROGRAM
TIME
POWER %
acne rosacea
20' CAP
60%
postherpetic neuralgia
30' CAP
60%
pyoderma, acne conglobata
30' CAP
50%
ulcer
30'CAP
40%
saphenous drainage
20' CAP
80%
Cellulitis
20' CAP
80%
Varicose veins
20' CAP
60%
Eczema
15' CAP
80%
Psoriasis
25' CAP
80%
Scars and keloids
20' CAP
60%
Dermatosis
20' CAP
60%
Scaly dermatitis
20' CAP
60%
Itching
20' CAP
60%
Keratinization disorders
20' CAP
60%
Stretch marks
20' CAP
80%
vertebral contusions
20' CAP
80%
cervicobrachial neuralgia
15' CAP
60%
sciatica-lumbosciatica
20' CAP
80%
neuralgia of trigeminal nerve
15' CAP
60%
intracostal neuralgia
15' CAP
60%
spasmodic ischemia
15' CAP
40%
fibromatosis
20' CAP
60%
fibrositis
15' CAP
60%
cervical fibrositis
20' CAP
80%
Rhinoplasty
15' CAP
60%
headaches
15' CAP
70%
Rhinitis
15' CAP
60%
Sinusitis
15' CAP
60%
tarsal sinus
20' CAP
80%
tendonitis
20' CAP
80%
rheumatic inflammation of hip
20' CAP
80%
Facial paralysis
15' CAP
60%
chronic prostatitus
20' CAP
60%
hamstring cramps
20' CAP
60%
Plantar Fascia
20' CAP
80%

Rev. 00 del 12/03/10 11/16
Cap.4 –F R E E P R O G R A MS
4 . 1 –Setting a new program
From the program section, press NEW (on touch screen) to enter the Free Program
menu. By rotating the encoder you can choose which of the 20 custom-made
programs available you wish to set. Press CHANGE (on touch screen) to enter the
section for setting the name. TURN THE KNOB to change the letter and PRESS
THE KNOB to move the letter selection cursor. Once you have chosen the name,
pass on to the parameter setting phase. Press PARAMETERS (on touch screen) to
move the cursor in the work phase setting section. In this zone, ROTATE THE
KNOB to set the parameter value and PRESS THE KNOB to pass from one
parameter to another. Up to 3 consecutive work phases can be set with TEKRA CT.
Different intensity and time values can be used in each of them. When the
parameters have been set, the name of the program can be modified once again.
Press NAME (on touch screen), save the program by pressing SAVE (on touch
screen) or else exit without saving by pressing EXIT (on touch screen).
4 . 2 ––Use and modification of a personal
program
To modify a personal program, just carry out the instructions carried in paragraph
4.1
Cap.5 –A P P LI C A T I O N S
5 . 1 –Therap y sessions
Apply the diathermy according to medical prescriptions. Applications are done
every day. Use the most suitable program for the patient until the ailment disappears
or considerably decreases.
5 . 2 –Adjusting emission power o utput
Intensity adjustment is a main component for the diathermy program to be
successful. It differs based on the type of program being used, the duration of the
application and the characteristics of the patient. The intensity can be changed
during the program to increase its affects. It can also be decreased in case of
overheating or if pain is felt. The treatment starts from a low power output which
gradually increases in intensity.

Rev. 00 del 12/03/10 12/16
NOTE: if the intensity set or its regulation cause excessive heating or pain in the
treated zone, the intensity of the stimulation must be reduced immediately or the
application must be stopped.
The device is capable of automatically limiting the risk of unpleasant burns caused
by the therapy. If the current supplied by the device exceeds 4.5A of absorption, the
intensity bar automatically blocks or is limited. This limiting action is highlighted by
a red bar.
5.3–Posture to be kept during the sessions
The ideal posture is to be relaxed, lying on ones back or facedown depending on the
zone of application. This position must be maintained during the entire session to
facilitate the effects produced by the electromagnetic field, especially the increased
the blood flow due to dilation of the blood vessels, During the treatment, the active
electrode must rest completely on the treated surface. It is therefore recommended to
maintain a position perpendicular to the tissue. The point effect consists in having
only a small part of the electrode touch the skin. In these conditions, there is a high
risk of burns. At most one joint at a time must be placed between the reference plate
and the electrode, or else the treatment session will not have success and the
satisfactory thermal effect will not be attained. Apply a good dosage of GEL
TEKRA between the electrode and the skin and between the plate and the skin. This
strongly limits the risk of burns due to the point effect.
Cap.6 ––P O W ER S U P P L Y
TEKRA CT must be powered by the electrical mains –Precautions for use
(1) Do not short-circuit the terminals.
(2) Do not set off sparks or flames.
Cap.7 –S Y M B OL S
BF DEVICE
ATTENTION, CONSULT THE ATTACHED DOCUMENTATION
THIS DEVICE IS MARKED CE IN COMPLIANCE WITH
476 DIRECTIVE EEC 93/42.

Rev. 00 del 12/03/10 13/16
DO NOT DISPOSE OF IN COMMON WASTE
TRANSMITTING DEVICE
Cap.8 –M A I NT E N A N C E
8 . 1 –Knob
The connection cable must be checked regularly to make sure it has no cracks which
can cause dispersion of the magnetic field. Clean the solenoids, pillow and rug
regularly with a moist cloth.
8 . 2 –Device
Use a cloth moistened in water and alcohol to clean the device. Do not use liquids
at all since there is not protection against their entrance (IP20).
8 . 3 –Immed iate maintenance:
Immediate maintenance at New Age Italia or by authorised personnel if:
the device has been subject to external mechanical stress (e.g.. serious drops);
the device has been overheated excessively (e.g. if left near intense heat sources;
you doubt that liquids may have penetrated inside;
the power supply, the cover or other parts are damaged, broken or missing;
it appears that the features of the device have been changed.
for safety purposes, do not operate with accessories (e.g. knobs and power
supply) other than those included in the basic supply.
The frequency of maintenance, functional checkups and inspection for
compliance with safety standards EN60601-1 for medical devices carried out with
secur-tester is yearly. The useful life span of the instrument is guaranteed by the
company only if maintenance is carried out regularly.
N. B.: have inspections carried out only by New Age Italia. The device can be sent
directly to company assistance workshops or delivered to the dealer where the
device was purchased.
Assistance centre:
New Age Italia srl - Via De Brozzi, 3 - 48022 Lugo (RA)
Tel.:[phone] - Telefax: +39-0545.369028
Web: www.newageitalia.it - E-mail: [email protected]

Rev. 00 del 12/03/10 14/16
Cap.9 –W A R NI N G S
Pay special attention to use of the knobs in order not to jeopardise the
effectiveness of the treatment.
Use the device only with electrical systems compliant with Safety Standards in
force.
The device has IP20 protection rating (see chap. “Technical features”). It must
not be used in the immediate vicinity of liquids because it is not protected from
their entrance.
Do not use the device in the immediate vicinity of mobile phones (keep them at
least a few meters away).
Operating near (for example 1 metre away) a short wave or microwave therapy
device can cause instability in the output of the stimulator.
Do not connect the patient with TEKRA XCRT and an HF surgical device at the
same time, to avoid danger for the patient and for the device itself.
The device works according to its specifications if the atmosphere is kept at a
temperature between 5° and 40° C and less than 80% humidity. The same
conditions must be maintained during transportation and storage.
In case of malfunctioning and failures, do not use the device but send it to be
repaired.
Do not operate near flammable substances.
Do not use gel and accessories other than those supplied.
It is of the utmost importance to inform the patient about the type of sensations
which must be perceived during the therapy. Should he perceive that the
sensation is no longer the correct one, you must intervene immediately,
stopping the session by the controls and disconnecting the solenoids.
If the intensity of the output set or its regulation cause excessive heating or pain
in the treated zone, the intensity must be reduced immediately or the application
must be stopped.
Keep the device out of the reach of children.
C a p . 1 0 –T E C H N I C AL F E A T U RE S
1 0 . 1 –Power supply
Internal power supply: MPU60-108
PRI: 100 - 240V 47 - 63Hz SEC: 24V- 2,62A

Rev. 00 del 12/03/10 15/16
1 0 . 2 –Output features
CAPACITIVE
Max power intensity (B): 300W
Frequency (f): 250 KHz
1 0 . 3 –Other features
Size: 26x16x10h [cm]
Weight: 1.7 [Kg] Class: IIb Type: BF
Classification for entrance of liquids: IP20
Safety in presence of flammable anaesthetic gas: it is not category AP or APG
Device for functioning: continuous
Manufactured according to Standards:
EN 60601-1 (2007) –Medical electrical equipment: General safety standards
EN 60601-1-1 (2003) –Collateral safety standard
EN 60601-1-2 (2003) –Collateral standard: Electromagnetic compatibility –
Provisions and tests
EN 60601-1-4 (1997): Collateral standard: Programmable electrical medical
systems
EN60601-1-4/A1 (2000) General requirements for safety of programmable
devices.
EN 980-2003 and EN 1041 –Graphical symbols for labelling of electrical
medical devices
C a p . 1 1 –B A S I C S U P P L Y A N D A C C E S SO R I E S
1 1 . 1 –Basic supply
TEKRA XCRT is complete with:
Device
1 capacitive therapy knob
1 capacitive therapy reference plate
Series number (S.N)
Identification code of TEKRA CT
S.N. TKCT AA XXXX
Identification number of device
Year of manufacture

Rev. 00 del 12/03/10 16/16
1 set of capacitive electrodes
1 power cable
1 pack of TEKRA cream
1 User manual
1 1 . 1 –Accessories and consumption material
The following is the list of accessories which can be purchased apart to increase the
supply of the device or to replace worn elements:
- knob for capacitive therapy
- capacitive reference plate
- electrodes for capacitive therapy
- GEL TEKRA ARTI 1000ml
C a p . 1 2 –B I B L I O G RA P H Y
C. Menarini, M. Menarini: Manuale di terapia fisica, Aulo Gaggi Editore,
Bologna 1985
M. Moselli, M. Manca: Fisioterapia pratica, Ed. Minerva Medica, Torino 1993
B. Gialanella, G. D’alessandro, R. Santoro: Terapia fisica pratica, ED.
Marrapese, Roma 1997
Vasta: Manuale pratico illustrato di terapia fisica, ED. Marrapese, Roma 1998
Cisari, G. Severini: Fisioterapia clinica pratica, Edi-ermes, Milano 1999
T.Thorossian: ElectroMagnetic field therapy, Ed. NeoMedica, Vienna 1999
G. Nanni, G. S. Roi, D. Vasapollo: Le lesioni muscolari dell’arto inferiore
nello sportivo, ED. Marrapese, Roma 2000