New Age Tekra Life Portable Diathermy User Manual

Portable diathermy
Tekra life
User manual
Instructions

ATTENTION:
READ CAREFULLY
THE INSTRUCTIONS BEFORE USE

PRESENTATION

TEKRA LIFE belongs to the new line of electromedical instruments for physiotherapy.
The reduced dimensions, the facility of use, and the versatility are the principal characteristics of this innovative line of products.
1.1 – What is TEKRA LIFE?
The constant research in the field of medical devices has brought to the creation of the new system for diathermy therapy, constituted by the generator TEKRA LIFE. The innovative software inserted inside the instrument allows the generation of Radiofrequency waves for therapeutic purposes for the treatment of common pathologies (lesions, accidents, illnesses) through the use of preset programs ready for use. The technological innovation and the facility of employment make it an extremely versatile and innovative product in the electromedical instruments field.
1.2 – What is TEKRA LIFE for?
With TEKRA LIFE is possible to apply radiofrequency technology with benefic effects on the reconstruction of the bone tissue and, in general, for the regeneration of damaged tissues, in order to obtain an antalgic, antinflammatory, antiedemic effect.
1.3 – Who is TEKRA LIFE for?
TEKRA LIFE finds home therapy the best environment to express completely its own potential thanks to the simplicity and versatility of the product. The reduced dimensions, moreover, allow us to transport it easily.
ATTENTION
For home use, please follow your doctor’s indications.

INDICATIONS AND CONTRAINDICATIONS

2.1 – Indications
The most common pathologies that healed with radiofrequency are those up to the apparatus osteo-muscle-tender. They are particularly suitable for the treatment of:

• Inflammatory and degenerative arthropathies;
• edemas;
• wrinkles;
• muscular contractures;
• cellulite;
• stretch marks.

We always suggest asking and following your doctor’s instructions for diagnosis and therapy application.
2.2 – Contraindications
Radiofrequency waves have a few counter-indications common to all the devices which work with endogenic production of heat.

• presence of metallic fragments;
• pregnancy;
• tumors;
• tuberculosis;
• acute inflammatory process;
• cutaneous lesions;
• pacemakers;
• alterations of the sensibility.

OPERATION

NOTE
Before applying the radiofrequency, check the side effects and consult a doctor.
3.1 – Handpiece connection and application
Connect the cable of the handpiece to the output socket of the exit of the instrument.
Insert the connectors and rotate until the connections coincide with the output socket;
once inserted, screw it until the end to fix firmly the cable to the instrument. Always use the handpiece with the cream in the endowment.
3.2 – Device power supply
TEKRA LIFE must be used to connect the device to the power supplier and a regular electricity plug.
3.3 – Turn on the device
To turn on TEKRA LIFE press the key (2) – ON/OFF.
3.4 – Program selection
Turn on the device and find the text PROG. Choose the desired program using the keys (+)/(-)
The preset programs are 15 and are indicated by the letter “P” (see programs table).
The Free programs are 5 and are indicated by the letter “U”.
Programs Table

3.5 – Start the therapy
When the display shows the requested program press START to begin the therapy;
Once pressed START, the display will show the remaining time.
3.6 -Setting the output intensity
Intensity is already set but can be adjusted manually. Go to the INTEN menu using the keys↑ and ↓ change the parameter according to the patient’s needs using the (+)/(-) keys.
NOTE: in case of pain or excessive heat, turn down the temperature by pressing the key (-) or interrupt the therapy by pressing PAUSE.
3.7 – Setting Time
It’s possible to increase the program duration (Timer) to have a long therapy for some hours or for night applications, up to eight hours. To adjust the Timer during the operation of a program use the keys ↑ and ↓ go to the TIME menu, then change the parameter with (+)/(-). Each push increases or decreases for 5 minutes.
3.8 – End or interrupt the session
If you want to interrupt before the end press the key 2 PAUSE: once for a break (to continue press START); twice to finish the program.
3.9 – Turn off the device
To turn off the instrument press and hold the key 2 ON/OFF for some seconds. If after the end of a program the instrument is not used, it automatically turns off after a few minutes.
3.10 – Symbols on display
MAIN FEEDING: power supply through electrical power (charger connected).

FREE PROGRAMS

4.1 – Setting
To access the setting of free programs from the PROG menu area it is necessary to use the keys (+) / (-) and go to the list of programs starting with U. Confirm and with go to INTEN, FREQ, and TIME menu and change the parameters as desired with the keys (+)/(-). Once the parameters have been selected press key 2 START to start the selected therapy. When the device will be turned off the program will be saved.

To set correctly the parameters in the free protocols, we give you a few guidelines in the following chart: in the first column, you’ll find the available parameters with the respective setting values, while in the second column we list the areas of affiliation and the relative type of applications.

APPLICATIONS

5.1 – Therapy planning
The application should be made every day, with the most suitable program for your pathology, until the symptoms disappear or are sensibly reduced. At the end of the therapy, if the problem is still present, consult your physician.
5.2 – Position to keep during the sessions
The ideal position is the most relaxed one, with the body extended supine or prone according to the zone of application. The position must be maintained during all the sessions.

POWER SUPPLY

TEKRA LIFE must be supplied by power mains with the feeder in the endowment.
6.1 – Use precautions

1. not to short-circuit the terminals.
2. to avoid provoking sparks or flames, above or around the battery.

MAINTENANCE

7.1 – Headpiece
The cable of the connection must be periodically checked to verify the absence of cracks that are the possible causes of electric dispersion; periodically clean the handpiece with a damp cloth.
7.2 – Device and feeder
To clean both the feeder and the instrument, it’s recommended to use a damp cloth. Don’t use in any case liquid, because these devices are not protected from their entry (IP20).
7.3 – Feeder substitution
Check the state of the isolations (wrap and cables) of the feeder, before connecting it. If it’s damaged, even if partially, immediately replace the feeder.
7.4 – Immediate maintenance
Immediate maintenance must be executed by New Age Italia or authorized personnel if one of the following situations happens:

• external mechanical solicitations (ex. serious falls);
• strong overheating (ex. if left next to sources of intense heat);
• some liquids can be penetrated inside the device;
• the feeder, the wrap, or other parts of the instrument are damaged, broken, or lacking;
• the functionality of the instrument appears altered.

For safety, we recommend never operating with accessories (es. headpiece and feeder) different from the furnished ones as the endowment of the base.
The frequency of maintenance, functional control, and verification of correspondence to the safety norms EN60601-1 for the medical devices should be performed with a secure-tester annually. The useful life of the tool is guaranteed only by the firm if such maintenance is regularly effected.
PLEASE NOTE
It is recommended to have the controls performed annually only by New Age Italia; the device can be sent directly to the laboratories of assistance or delivered to the retailer where it has been purchased.

Assistance:
New Age Italia srl
Via De Brozzi, 3 – 48022 Lugo (RA)
Tel 0545/32019 – Fax 0545/369028
asstecnica@newageitalia.it

WARNINGS

Pay particular attention to the employment of the headpiece not to compromise the effectiveness of the treatment.
Use the instrument only with electric structures conforming to the actual safety Norms.
The instrument has a degree of protection IP20 (see Chap. “Technical features”) and does not use close to liquids, because it’s not protected from their entry.
Do not use close cellular telephones (maintain at least one meter of distance).
To operate close (less than 1 meter) to an instrument with short waves therapy or microwaves, because it can produce instability in the emission.
Don’t simultaneously connect the patient with the TEKRA LIFE and a surgical instrument HF, to avoid dangers for the patient and for the instrument.
The device works according to its specifications if the environment is maintained to a temperature between 5° and 40° C and with dampness inferior to 80%. The same conditions must be maintained during the transport and the store.
In case of malfunctions and breakdowns, it is opportune to exclusively send the device to the mother company.
It’s recommended not to operate in proximity to inflammable substances.
Don’t use gel and different accessories from those furnished in the endowment.
It’s important to inform the patient about the type of feeling to perceive during the therapy, to immediately intervene or interrupt the session by switching off the device or removing the solenoids, in case of different or incorrect perceptions.
If the power or its regulation cause elevated heating or pain in the treated zone it is necessary to immediately reduce the intensity of stimulation or eventually interrupt the application.
Keep away from children.

TECHNICAL FEATURES

9.1 – Power supply
PRI: 230V ~ 50Hz SEC: 12V – 1,4A
9.2 – Output features
Max power intensity: 30W
Frequency (f): 500 kHz
9.3 – Other features

Dimensions: 175x105x40h [mm] > Weight: 400 [g] > Class: II°
Type: BF
Classification to liquids entry: IP20
Safety in presence of inflammable anesthetic gas: it’s not of AP or APG category
Device for working: Continuous
Built following rules
EN 60601-1 (2007) – Electromedical devices: general safety rules
EN 60601-1-2 (2003) – Collateral Rules: Electro-magnetic compatibility – Prescriptions and tests
EN 60601-1-4 (1997): Collateral Rule: Programmable electromedical devices
EN 980-2003 en-EN 1041 – symbols for electromedical devices.

SYMBOLS

| TYPE BF DEVICE
---|---
| ATTENTION, READ THE ENCLOSED DOCUMENTS

0123

| THIS DEVICE IS MARKED ACCORDING TO DIRECTIVES CEE 93/42 AND 2007/47/CE.

ENDOWMENT OF BASE / ACCESSORIES

11.1 – Basic Endowment
Device
Feeder
N. 1 headpiece
Instructions
Carrying case
11.2 – Accessories and consumed materials
Feeder
Headpiece

BIBLIOGRAPHY

• 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
• G. Nanni, G. S. Roi, D. Vasapollo: Le lesioni muscolari dell’arto inferiore nello sportivo, ED. Marrapese, Roma 2000

DECLARATION OF CONFORMITY
New Age Italia Srl
Via De Brozzi, 3 — 48022 Lugo (RA)
Tel 0545/32019 — Fax 0545/369028
P. Iva 02299101200
in the person of its legal representative, Mr. Bamabi Manuel declares that the following class II b device:
Brand Name: New Age Italia
Model: TEKRA LIFE
is a MADE IN ITALY product, made by New Age Italia W.;
is up to the requisites prescribed in EEC Directive 93/42CEE concerning health regulations and absorbed by Legislative Decree no. 46 of February 24th. 1997:
that the procedure for the evaluation of conformity described in Annex II to the above-mentioned Directive has been duly performed; and that the following harmonized standards have been applied:

EN60601-1: 2007
EN60601-1-2: 2001
EN60601-1-4: 1997
EN 60601-2-10: 2001
EN 980: 2002

The notified authority no. 0123 has, in virtue of the certificate G2120778453003, issued permission to apply a CE conformity mark to the above- mentioned regulations prescribed in EEC Directive 93/42CEE and 2007/47/CE
Lugo, 02-03-2013

www.newageitalia.it
NewAge Italia Srl
Via De Brozzi, 3
Lugo (RA) 48022
Tel. +39.0545.32019
NEW AGE HAS BEEN MARKED ACCORDING TO
THE DIRECTIVE UNI EN ISO
9001-2008 AND UNI CEI EN 13485-2004.
New Age Italia s.r.l.
Sede Legale: Via Gramsci, 206 – Castel Maggiore (Bo)
Sede Amministrativa: Via De Brozzi, 3 – 48022 Lugo (RA)
Tel +39 0545/32019 –
Fax +39 0545/369028
www.newageitalia.it
info@newageitalia.it
P. Iva 02299101200
Registro A.E.E. Iscrizione
N. IT08020000002336
proArte grafica
Your Medical System

References

• New Age | Apparecchiature elettromedicali per riabilitazione e fisioterapia

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