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Dittmann TGS 440 Instruction Manual

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RADIO TENS DEVICE TGS 440
INSTRUCTION MANUAL
•
Radio TENS device for nerve stimulation with the aid of
stimulation current
•
2-channel device (TENS stimulators A and B)
•
Comfortable control of the TENS stimulators using the
remote control or directly on the stimulators
•
TENS stimulators A and B can be used and controlled
individually or simultaneously
•
Pre-programmed application sequence with therapy
duration of 30 minutes
•
20 levels for output intensity
•
Frequency range from 5 to 125 Hz
•
Pulse duration of 130/250 µs
•
Warranty: 24 months
•
Contains: 2x TENS stimulators (A and B), 1x remote
control, 2x adhesive electrode pads, 1x instruction
manual, 6x 1.5 V AAA batteries
0123
Version 1, 2014-03
KEF 439
Handelshaus Dittmann GmbH
Kissinger Straße 68
D-97727 Fuchsstadt
KEF 439
www.dittmann-gmbh.com
Handelshaus Dittmann GmbH
Kissinger Straße 68
D-97727 Fuchsstadt
www.dittmann-gmbh.com
GB
TGS 440
1

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  • Page 1 RADIO TENS DEVICE TGS 440 INSTRUCTION MANUAL KEF 439 Handelshaus Dittmann GmbH Kissinger Straße 68 D-97727 Fuchsstadt KEF 439 www.dittmann-gmbh.com Handelshaus Dittmann GmbH Kissinger Straße 68 D-97727 Fuchsstadt www.dittmann-gmbh.com • Radio TENS device for nerve stimulation with the aid of stimulation current •...

  • Page 2: Table Of Contents

    TABLE OF CONTENTS No. Topic Page Definition of symbols Basic information Characteristics of a TENS device Information concerning the TENS therapy Safety instructions General safety instructions Usage / environment for which the radio TENS device is suited Usage / environment for which the radio TENS device is not suited Application for which the radio TENS device is suited Application for which the radio TENS device is not suited Usage by children and adolescents...

  • Page 3: Definition Of Symbols

    TABLE OF CONTENTS No. Topic Page 14.0 Information concerning resistance to electromagnetic interference 15.0 Information concerning resistance to electromagnetic interference 16.0 Information concerning resistance to electromagnetic interference 17.0 Technical specification, symbols, pictograms 18.0 Warranty Dear purchaser, Congratulations on your purchase of a new radio TENS device TGS 440 and thank you for your trust.

  • Page 4: Basic Information

    Basic information Characteristics of a TENS device The radio TENS device TGS 440 is an electro-stimulation device. To this end, an electric current is transmitted through the skin to the nerves. "TENS" means "transcutaneous electric nerve stimulation". Using this convenient and comfortable radio TENS device, certain parts of the body are stimulated in a targeted manner with the effect that pain and symptoms can be relieved significantly.

  • Page 5: Safety Instructions

    SAFETY INSTRUCTIONS 3.0 Safety instructions General safety instructions 3.1.1 In case of a defect, the radio TENS device must no longer be used and must not be repaired or modified (changed) by the users themselves. If used incorrectly, the stimulation current may cause pain, injuries and burns. 3.1.2 If skin alterations, pain, swelling, discomfort or other irregularities occur during the use of the radio TENS device, you must stop the therapy immediately and...

  • Page 6: Usage / Environment For Which The Radio Tens Device Is Not Suited

    SAFETY INSTRUCTIONS 3.3.4 Unless instructed otherwise by your doctor, we recommend an average therapy duration of 30 minutes up to three times a day. 3.3.5 The sense of intensity may actually depend on the user's respective daily constitution. Therefore, the user may adjust the intensity to his/her personal individual needs using the intensity control of the radio TENS device.

  • Page 7: Application For Which The Radio Tens Device Is Not Suited

    SAFETY INSTRUCTIONS Application for which the radio TENS device is not suited 3.6.1 You must not use the radio TENS device under the following circumstances: a. heart diseases and cardiac arrhythmias (may lead to cardiac arrest), b. directly on wounds, c. on the eyes, d. for patients with pacemakers, e. parts of the body that are poorly supplied with blood, f.

  • Page 8: Usage Of The Radio Tens Device

    SAFETY INSTRUCTIONS Usage of the radio TENS device For the radio TENS device TGS 440, only use the adhesive electrode pads 3.8.1 developed especially for this device. 3.8.2 The adhesive electrode pads included in the scope of delivery may only be connected to the radio TENS device TGS 440.

  • Page 9: Areas Where The Adhesive Electrode Pads Are Applied

    SAFETY INSTRUCTIONS Areas where the adhesive electrode pads are applied 4.0.1 Each person reacts differently to an electric nerve stimulation. The positioning of the adhesive electrode pads might thus deviate from the standard positions. If the therapies are not successful, please consult your doctor as to which positioning techniques are most suitable for you.

  • Page 10: Storage / Maintenance Of The Radio Tens Device

    4.2.4 If the radio TENS device TGS 440 is subject to trade or commercial usage, a safety inspection must be performed every two years in accordance with § 6 MPBetreibV [German Medical Devices Operator Ordinance]. The safety inspections must be carried out by a company specialised in medical devices.

  • Page 11: Scope Of Delivery / Contents

    SCOPE OF DELIVERY 5.0 Scope of delivery / contents 1x instruction manual Radio TENS device TGS 440: A: TENS stimulator A (channel 1) B: TENS stimulator B (channel 2) C: Remote control KEF 439 KEF 439 Handelshaus Dittmann GmbH Handelshaus Dittmann GmbH Kissinger Straße 68...

  • Page 12: Disposal Of The Radio Tens Device

    DISPOSAL / BATTERY CHANGE 6.0 Disposal of the radio TENS device If the radio TENS device TGS 440 is to be recycled, observe the legal regulations concerning disposal. Contact your municipality or a waste disposal company for further information. Dispose of the radio TENS device in accordance with the Waste of Electrical and Electronic Equipment Directive 2002/96/EC (WEEE Directive).
  • Page 13 BATTERY CHANGE In order to open the cover lock, press on the shaded triangular area of the battery compartment of the TENS stimulator and push it outwards away from the housing of the device (Figure 3). Remove the used batteries and insert two new 1.5 V alkaline batteries (type AAA) in the battery compartment of the TENS stimulator.

  • Page 14: Designation And Functionality Of The Radio Tens Device

    OVERVIEW OF THE DEVICE FUNCTIONS 8.0 Designations and functionality of the TENS stimulators TENS stimulator A TENS stimulator B Rear side of the TENS TENS stimulator with an adhesive stimulator electrode Green LED indicator light (+) key for increasing the intensity setting of the TENS stimulator (-) key for reducing the intensity setting of the TENS stimulator 2 press stud connections to connect the adhesive electrode pad Cover of the battery compartment on the rear side of the TENS stimulator...
  • Page 15 OVERVIEW OF THE DEVICE FUNCTIONS 8.0 Designations and functionality of the remote control Remote control (front side) Green LED indicator light A (+) key for increasing the intensity setting for TENS stimulator A B (+) key for increasing the intensity setting for TENS stimulator B A/B (+) key for increasing the intensity setting simultaneously (both at the same time) for both TENS stimulators A and B ON/OFF key...

  • Page 16: Commissioning Of The Radio Tens Device

    COMMISSIONING / USAGE 9.0 Commissioning of the radio TENS device Step 1 Prior to starting a therapy session, carefully clean the skin areas in the application area using water and soap and dry it well afterwards (see Figure 6). Step 2 Insert two 1.5 V batteries (type AAA) observing the correct Figure 6 polarity (+ (positive) and - (negative) pole) in the remote...
  • Page 17 COMMISSIONING / USAGE 9.0 Commissioning of the radio TENS device Step 6 Now, press the ON/OFF key on the remote control first in order to switch it on (see Figure 12). The green LED flashes briefly for confirmation and goes out again. Now, switch on the TENS stimulator A or B (or both TENS stimulators) by pressing once on the (+) key of the respective TENS stimulator.
  • Page 18 COMMISSIONING 9.0 Functions of the radio TENS device Functions of the green LEDs of the TENS stimulators LED lights up: Standby mode / The device is ready for operation LED flashes: Operating mode / The adhesive electrodes have been applied and the device is in operation LED flashes quickly: Receive mode / The device receives the pulses from the remote control...

  • Page 19: Remote Control

    10.0 Remote control The radio TENS device TGS 440 can be controlled comfortably using the remote 4.4.1 control included in the scope of delivery. Using this remote control, the output...

  • Page 20: Examples Of The Correct Position Of The Adhesive Electrode Pads

    POSITIONING OF THE ELECTRODES 11.0 Examples of the correct position of the adhesive electrode pads...
  • Page 21 POSITIONING OF THE ELECTRODES 11.0 Examples of the correct position of the adhesive electrode pads shoulder back abdomen arms thigh thigh lower leg lower leg feet Information concerning the positioning of the electrodes The following application examples show standard positions for the positioning of the adhesive electrode pads.

  • Page 22: Malfunctions, Troubleshooting

    MALFUNCTIONS 12.0 Malfunctions, troubleshooting Malfunction Cause Solution The batteries have been The batteries of the devices Replace the used batteries inserted, but the TENS are used or have not been by new batteries. Check if stimulators and/or the inserted with the correct the batteries have been remote control do not polarity.
  • Page 23 MALFUNCTIONS 12.0 Malfunctions, troubleshooting Malfunction Cause Solution The TENS stimulation is The intensity level of the Reduce the output intensity experienced as unpleasant TENS stimulators has been of the TENS stimulators until and/or too intensive. set to too high a level. the stimulation is no longer experienced as unpleasant.

  • Page 24: Information Concerning Resistance To Electromagnetic Interference

    Guidelines and manufacturer's declaration – electromagnetic emissions The model TGS 440 is intended for use in an environment as specified below. The customer or the user of the model TGS 440 should ensure that it is used in such an environment.

  • Page 25: Information Concerning Resistance To Electromagnetic Interference

    The model TGS 440 is intended for operation in an electromagnetic environment as specified below. The customer or the user of the model TGS 440 should ensure that it is used in such an environment. Immunity tests IEC 60601 –...

  • Page 26: Information Concerning Resistance To Electromagnetic Interference

    15.0 Information on electromagnetic compatibility Guidelines and manufacturer's declaration – electromagnetic immunity The model TGS 440 is intended for operation in an electromagnetic environment as specified below. The customer or the user of the model should ensure that it is used in such an environment.

  • Page 27: Information Concerning Resistance To Electromagnetic Interference

    TGS 440 must be observed at every application site. If unusual performance characteristics are observed, additional measures might have to be taken, such as reorientation or relocation of the model TGS 440. b. Not applicable above the frequency range from 150 kHz to 80 Mhz.

  • Page 28: Technical Specification, Symbols, Pictograms

    00001 (consecutive number) Date of manufacture: 2014-03 2014-03 (year, month) The radio TENS device TGS 440 is certified in accordance with 0123 the EU Council Directive 93/42 EEC for medical devices (Medical Devices Directive). Manufacturer: Handelshaus Dittmann GmbH, Kissinger Straße...

  • Page 29: Warranty

    24 months from date of purchase. Please keep the receipt in a safe place to furnish proof of purchasing the TGS 440 TENS device in case you must assert any warranty claim. The following is not covered by the warranty:...

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