schwa-medico TENStem eco basic Instructions For Use Manual
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schwa-medico TENStem eco basic Instructions For Use Manual

Transcutaneous 2-channel nerve and muscle stimulation
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HOLISTIC HEALTH
TENStem eco
basic
transcutaneous 2-channel
nerve and muscle stimulation
Instructions for use REF 10001787 Version 13 Last updated: 2023-05-30
EN

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Summary of Contents for schwa-medico TENStem eco basic

  • Page 1 HOLISTIC HEALTH TENStem eco basic transcutaneous 2-channel nerve and muscle stimulation Instructions for use REF 10001787 Version 13 Last updated: 2023-05-30...
  • Page 2 INSTRUCTIONS FOR USE - TENStem eco basic...

  • Page 3: Table Of Contents

    Contents General information Terms Intended purpose Safety instructions 1.3.1 General safety instructions 1.3.2 Application-related safety instructions 1.3.3 Special safety instructions Contraindications 1.4.1 General contraindications 1.4.2 Special contraindications for low-frequency electrostimulation with TENS in pregnant women 1.4.3 Special contraindications for muscle stimulation Side effects 1.5.1 Special side effects for nerve stimulation 1.5.2 Possible side effects of muscle stimulation...
  • Page 4 INSTRUCTIONS FOR USE - TENStem eco basic Special functions and possibility of editing programmes Locking the programme selection Locking and unlocking Switching the signal generator off and on Special functions for devices from series A and B Special functions for devices from series C Special functions for devices from series D “Edit”...

  • Page 5: General Information

    In these instructions for use, "patient" means a person (male, female or diverse) on whom the TENStem eco basic is used. The term also applies if the device is operated by a person other than the patient themself and regardless of whether the use of the TENStem eco basic in the specific case is medically necessary or is used with a medical purpose.

  • Page 6: Safety Instructions

    Caution: Pain can indicate serious disorders in the body and must be clarified by a doctor. Even if applying the TENStem eco basic has good success and leads to distinct pain relief, this is not to be equated with curing the cause of the pain.

  • Page 7: Application-Related Safety Instructions

    it is to be used in. Wait for at least 30 minutes. Otherwise, condensation that forms inside the device may result in electrical shock, fire, damage to the device and/or personal injury. For commercial use in Germany, the operator is required, as per Section 11 of the Ordi- nance on Operators of Medical Devices (MPBetreibV), to conduct technical safety controls for the product in regular and appropriate intervals.

  • Page 8: Special Safety Instructions

    30 cm (12 inches) to the TENStem eco basic (including its accessories). Non-compliance may lead to inferior device performance or faulty operation.
  • Page 9 comfort, circulatory reactions, muscle pain and other complaints. The most frequent con- sequence of overload is pain in the muscles after the training. Pain and irritation of tissues connected to the muscles - such as ligaments, tendons, joints and bones - are also possible. Muscle overload due to electrical muscle stimulation can occur particularly during the first training units.

  • Page 10: Contraindications

    Muscle pain should not occur during the training session; constant muscle tension must be avoided. Contraindications 1.4.1 General contraindications When am I not allowed to use the TENStem eco basic or use it only after consulting the doctor in charge? • Patients with electronic implants such as pacemakers or pumps •...

  • Page 11: Special Contraindications For Low-Frequency Electrostimulation With Tens In Pregnant Women

    1.4.2 Special contraindications for low-frequency electrostimulation with TENS in pregnant women The following applies in addition to the general contraindications for TENS: • The use of TENS during pregnancy should always be agreed with the attending doctor and the midwife, taking into account the benefits and risks. •...

  • Page 12: Possible Side Effects Of Muscle Stimulation

    INSTRUCTIONS FOR USE - TENStem eco basic • A slight, non-persistent reddening of the skin following stimulation in the area of the elec- trodes is normal, as blood circulation is stimulated by the TENS application. • If prolonged redness, burning, itching or skin blisters should occur under the electrodes or around the electrode site following stimulation, you must consult the doctor before further TENS application.

  • Page 13: Operation

    Operation Simple quick guide for the self-application of TENS Check and, if necessary, clean areas of skin for electrode placement In general, keep the corresponding areas of skin dry, especially free from oil and cream. Connect electrode cables to the electrodes. Red and white plugs have no significance for you, only for therapists and special applications.

  • Page 14: Operation Of The Control Unit ("Device")

    Operation of the control unit (“device”) 2.2.1 Controls The TENStem eco basic was designed for the stimulation of nerves and muscles in humans. All settings can be made using the buttons. The LCD display shows the different operating states. 1. LCD display 2.

  • Page 15: Keypad

    Preparation for stimulation 2.3.1 Insert batteries Before putting the TENStem eco basic into service, the batteries supplied are to be insert- ed into the battery compartment (see also section “Changing the batteries”). Please ensure the correct polarity when inserting the batteries.

  • Page 16: Positioning Of Electrodes

    INSTRUCTIONS FOR USE - TENStem eco basic 2.3.3 Positioning of electrodes The self-adhesive electrodes included in the scope of delivery meet the quality requirements according to the register of assistive products PG 09.99.01. The electrodes are intended for multiple use. With normal use, the electrodes have a working life of at least 30 days. They lose their adhesion over time and should be replaced.

  • Page 17: Switching The Control Unit ("Device") On And Off

    “Ready” mode. Pressing the button again in “Ready” or “Stimulation” mode: A single audio signal will sound, the TENStem eco basic switches off. The device automat- ically switches off if no button has been pressed for two minutes and no stimulation has been started.

  • Page 18: Programme Overview

    INSTRUCTIONS FOR USE - TENStem eco basic Programme overview Pro- Name Area of application Type Timer gramme (min) Standard Acute nociceptive pain, acute and chronic neuropathic pain For novice users Standard (weak- Like Novice 1, just a little gentler For novice users...
  • Page 19 Frequency Pulse width Description in Hz in μs Both channels are operated with the same frequency and pulse width. Both channels are operated with the same frequency and pulse width. Both channels are operated with the same frequency and pulse width. Channel 1: Channel 1 operates at 100 Hz and 200 µs.

  • Page 20: Overview Of Electrode Placement

    INSTRUCTIONS FOR USE - TENStem eco basic Overview of electrode placement Shoulder/neck pain I Neck pain I | 2-channel use Cervicobrachialgia (shoulder-arm syndrome) Shoulder pain Thoracic spine | Crossed positioning Thoracic spine Radiculopathy (lower back) Lumbar spine I...
  • Page 21 Lumbar spine II | Crossed positioning SI joint | Crossed positioning Sciatic pain Sciatic pain II Knee joint osteoarthritis pain | Tension headaches I Crossed positioning Tension headaches II Migraine...
  • Page 22 INSTRUCTIONS FOR USE - TENStem eco basic Trigeminal neuralgia mandibular nerve Trigeminal neuralgia maxillary nerve Carpal tunnel syndrome Hand pain Hand pain Glove use Foot pain | Sock use 1-channel placement Achilles tendon pain Ankle pain...
  • Page 23 Hip pain | 2-channel use Golfer's elbow (ulnar epicondylitis) Tennis elbow (epicondylitis lateralis) Kaada stimulation RECHTSHÄNDER LINKSHÄNDER Placement for muscle stimulation of the Amputation pain | stump pain quadriceps musculature Amputation pain | phantom pain...

  • Page 24: Special Functions And Possibility Of Editing Programmes

    INSTRUCTIONS FOR USE - TENStem eco basic Special functions and possibility of editing programmes Locking the programme selection Press and hold the left button and the P button at the same time for three seconds (two seconds for devices from series A and B): The programme selection function of the P button and the editing function for programme parameters are locked.

  • Page 25: Edit" Mode For Therapists

    (min. 75 µs). Pressing the E or button saves the set parameters and exits “Edit” mode. The TENStem eco basic automatically switches off if no button has been pressed for two minutes. No changes are saved in this case.

  • Page 26: Memory Recall" Mode

    Press and hold the left enter “Memory Recall” mode. If there are no values in the TENStem eco basic memory, "ZERO" will appear on the LCD display for two seconds and the TENStem eco basic will return to "Ready" mode. Otherwise, the LCD display will show the parameters of the last therapy session.

  • Page 27: Technical Information

    Technical information Symbols Attention! The product has some non-apparent risks. Please comply with the safe- ty precautions contained in the instructions for use! Attention! The instructions for use must be followed in order to use the product safely. Application part of the BF model Galvanically isolated application component with higher level of protection against an electric shock to the body,but not directly to the heart! Manufacturer...

  • Page 28: Technical Data

    INSTRUCTIONS FOR USE - TENStem eco basic Technical data 2-channel electrostimulation device with separate outputs and twelve integrated pro- grammes (three additional “user programmes” from series C and four additional “user pro- grammes” from series E). Voltage supply 6.0 V (4× 1.5 V battery AAA type Micro, e.g. LR03) or 4.8 V (4x1.2 V battery AAA), approximately 3 hours running time,...

  • Page 29: Changing The Batteries

    Time Changing the batteries The voltage of the batteries is monitored by the TENStem eco basic. If this falls below 3.7 V, the battery symbol appears on the LCD display. It is then necessary to insert four new 1.5 V batteries (AAA, e.g.

  • Page 30: Device Return And Disposal

    INSTRUCTIONS FOR USE - TENStem eco basic waste, but must be disposed of properly. The chemical name of the pollutant is indicated under the dustbin symbol. You are legally obliged to return used batteries. You can return used batteries to a municipal collection point or to your local retailer. As a distributor of...

  • Page 31: Classification

    See "Accessories" for electrode care. 6.10 Combining The TENStem eco basic may only be combined with the articles listed in the scope of deliv- ery and under "Accessories". 6.11 Technical safety controls (Section 11 MPBetreibV)

  • Page 32: Scope Of Delivery

    INSTRUCTIONS FOR USE - TENStem eco basic Functional safety – Testing the output signals at a load resistance of 1 kΩ (current and voltage) – Testing the output signals at an ANSI load resistance (current and voltage) – Testing the frequency –...

  • Page 33: Accessories

    4 pieces Fabric electrodes The glove and sock electrodes used in combination with the TENStem eco basic stimu- late the entire hand or foot/ankle. By using them, the sometimes problematic attaching of self-adhesive electrodes can be circumvented. Do not use the glove or sock electrodes on injured or diseased skin! Do not touch any metallic or electronic objects (e.g.

  • Page 34: Rubber Electrodes

    INSTRUCTIONS FOR USE - TENStem eco basic Article Size Quantity 10005382 Stimulation gloves 1 pair 10005381 Stimulation gloves 1 pair 10005380 Stimulation gloves 1 pair 10005360 Stimulation socks 1 pair 10005359 Stimulation socks 1 pair 10005361 Stimulation socks 1 pair...

  • Page 35: Troubleshooting

    Troubleshooting Please contact the manufacturer or the distributor if you need help starting, using or main- taining the device or if you have an unexpected operation or incident to report. Problem Possible cause Proposed solution The device The batteries have not been Insert the batteries in the correct will not switch on.
  • Page 36 35630 Ehringshausen - Germany T +49 (0) 64 43 83 33 - 113 F +49 (0) 64 43 83 33 - 119 export@schwa-medico.de www.schwa-medico.de 0482 Pierenkemper GmbH Am Geiersberg 6 35630 Ehringshausen - Germany © 2023 schwa-medico GmbH www.pierenkemper.eu Subject to errors and changes.

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