axion STIM-PRO Eco 2 Channel Nerve Stimulator Instruction Manual

axion STIM-PRO Eco 2 Channel Nerve Stimulator

Specifications

• Impulse Shape: Asymmetrical, 2-phase rectangular pulse
• Voltage: Not specified
• Power Supply: 1 x 9.0 Volt block battery
• Dimensions: 9.5 cm (L) x 6.5 cm (W) x 2.35 cm (H)
• Weight: 115 g including battery
• Frequency Range: 2 Hz to 150 Hz
• Pulse Width: Not specified
• Modes: 3 TENS modes with adjustable parameters: Burst, Normal, Modulation

Product Usage Instructions

• TENS (transcutaneous electrical nerve stimulation) is a method used for symptomatic relief of acute, chronic, and intractable pain.
• The purpose of the STIM-PRO Eco is to provide relief from various types of pain conditions such as muscle, joint, or bone pain; pain associated with diseases like arthritis or fibromyalgia; and conditions like lower back pain, neck pain, or tendonitis.
• Indications: TENS is used for treating a range of pain conditions as mentioned above.
• Contraindications: Ensure electrodes are only placed on healthy, unbroken skin.
• If the TENS therapy is ineffective or becomes uncomfortable, discontinue use until evaluated by a healthcare professional to prevent burns at the application site.
• To access the controls, slide down the cover to reveal the control panel.
• The device offers different modes including TENS Burst Mode (B), TENS Normal Mode (C), and TENS Pulse Width Modulation Mode (M). You can adjust the frequency, pulse width, and timer settings as per your requirement.
• To replace the battery, remove the existing battery and insert a new 9V (6LR61) block battery.
• Keep the device dry during storage and transportation to ensure its proper functioning.

FAQ

• Q: What is the purpose of TENS therapy?
• A: TENS therapy is used for symptomatic relief of various types of pain conditions such as muscle, joint, or bone pain.
• Q: How do I know if TENS therapy is working?
• A: If TENS therapy proves ineffective or uncomfortable, discontinue use until evaluated by a healthcare professional to avoid potential burns at the application site.

GENERAL INFORMATION

What is TENS?

• TENS (transcutaneous electrical nerve stimulation) is a proven procedure in pain therapy with few side effects. It is used for symptomatic relief of acute, chronic and intractable pain.

Functional principle of TENS
Transcutaneous electrical nerve stimulation is a non-invasive, drug-free method of pain management. TENS uses tiny electrical pulses sent through the skin to the nerves to alter your perception of pain. TENS does not cure a physiological problem; it only helps control pain. TENS doesn’t work for everyone, but for most patients, it helps reduce or eliminate pain.

IMPORTANT NOTICES

• Read the instructions for use before use. Make sure that you observe all warnings and safety instructions. Ignoring the instructions may result in user injury or device damage.
• Report all serious incidents that have occurred in connection with the product to the manufacturer and the competent authority of the Member State (where the user is located).
• TENS unit supplies energy to the human body using electrode pads. Electrode pads are classified separately as Class I products. CE 2460 is only valid for the therapy device, and CE is valid for electrodes (class I products).
• Consult your physician before use.

INTENDED USE

• The purpose of the STIM-PRO Eco is the symptomatic relief of acute, chronic and intractable pain. The device is used and operated by the patient himself. Use is permitted only from the age of 18 years.

INDICATIONS/CONTRAINDICATIONS

Indications
TENS is used to treat the following pain patterns: Muscle, joint or bone pain, pain associated with diseases such as arthrosis or fibromyalgia, conditions such as low back pain, neck pain or tendinitis.

Contraindications

• Patients with an implanted electronic device, such as a pacemaker or defibrillator, or any other metallic or electronic implant should not undergo TENS treatment without first consulting a physician.
• Patients with heart disease, epilepsy, cancer, fever or other illnesses must not undergo TENS treatment without prior medical consultation.
• Use the electrodes only on healthy, uninjured skin.
• If heart disease is suspected, TENS treatment should be performed only under medical supervision.
• Do not stimulate via the carotid sinus nerve, especially in patients with a known sensitivity to the carotid sinus reflex.
• The stimulation must not be applied over swollen, infected or inflamed areas or skin eruptions, such as phlebitis, thrombophlebitis, varicose veins, etc.
• The stimulation must not be applied over or in the vicinity of cancer.

Side effects

• The side effects of TENS units are generally mild, even with prolonged use. If disturbing effects occur, a physician must evaluate the further use of the device.
• Skin irritation and minor burns are possible side effects. If these occur, discontinue use and consult your doctor.

WARNINGS & SAFETY INSTRUCTIONS

Warnings

• The stimulation emitted by the device may be sufficient to cause an electric shock. An electric current of this magnitude must not flow through the rib cage (thorax) or the chest and the upper back, as it can cause cardiac arrhythmia. Do not place electrodes over the heart!
• Do not place electrodes on the front of the throat as spasms of the laryngeal and pharyngeal muscles may occur. Stimulation over the cervical cavity (throat area) may close the airway, make breathing difficult, and have negative effects on heart rhythm or blood pressure.
• Do not place electrodes on your head or in places where the electric current can flow transcerebrally (through the head).
• If TENS therapy is ineffective or becomes uncomfortable, stimulation should be discontinued until its use is re-evaluated by a physician.
• The device does not have AP/APG protection. Do not use it in the presence of explosive atmosphere and flammable mixture.
• The device may only be used according to medical advice.
• Electrodes must not be placed over the eyes, the mouth or inside the body.
• The device is to be used only when awake.
• Do not use the device during pregnancy unless prescribed by your physician.
• Simultaneous connection of a patient to a high-frequency surgical equipment and the stimulator may result in burns at the site of the stimulator electrodes and possible damage to the stimulator.
• Do not operate the product within 1 m of shortwave or microwave therapy equipment as it may produce instability in the stimulator output.

Safety instructions

• Use only original accessories from the manufacturer with your device. (see scope of delivery)
• Do not use this device for undiagnosed pain symptoms before consulting a physician.
• Do not use this device while driving, operating machinery, near water, or during activities where involuntary muscle contractions may expose the user to excessive risk of injury.
• Always turn off the unit before applying or removing TENS accessories to the skin.
• Keep this device out of the reach of children.
• The device has no curative effect.
• Electronic monitoring devices (such as ECG monitors and ECG alarms) may not function properly when electrical stimulation is used.
• The device should be cleaned with soapy water on a clean cloth after each use.
• The device is an electronic product and must therefore not be disposed of with residual waste. Further information at: https://axion.shop/en/environment-and-disposal/

MAINTENANCE, TRANSPORT, STORAGE

• The device must not be exposed to large quantities of liquids/water.
• After use, place the device back into the foam insert of the storage case for protection.
• Remove the battery and store the device in the storage case in a dry and cool place if you are not going to use it for a longer period of time.

SCOPE OF DELIVERY

• Each STIM-PRO Eco includes the following accessories, which can be reordered at www.axion.shop.

OPERATING THE DEVICE

• Slide down the cover of the device to reach the controls.

ON / OFF, Regulating the intensity

• The intensity can be adjusted stepless from 0–80mA by turning the intensity regulators on top of the device. The application starts automatically when the intensity is increased.

• The numbers 1 to 8 on the regulators indicate the current intensity.

• Connect the electrodes with the connecting cables. The device must be turned off when connecting the electrodes. The electrodes must be firmly attached to the skin.

Change mode switch

• There are three TENS modes available: (B) burst, (C) normal and (M) pulse width modulation.

TENS

Burst Mode (B)

| Burst frequency fixed at 2 Hz

Pulse width adjustable from 30 – 260 μs

---|---
TENS

Normal Mode (C)

| Frequency adjustable from 2 – 150 Hz Pulse width adjustable from 30 – 260 μs
TENS

Pulse Width Modulation Mode (M)

| This mode contains pulse width modulation. The pulse width is decreased down to 60% of the set value within 3 seconds. In the next 3 seconds, the pulse width is increased to the set value again. The parameters can be set from 2 – 150 Hz and from 30 – 260 μs.

Regulating the frequency

• The frequency is adjustable from 2 Hz to 150 Hz and determines how many electrical impulses are transmitted through the skin every second. If no instructions regarding the frequency are given in therapy, set the control to 70 – 120 Hz (Burst Mode 2Hz).

Regulating the pulse width

• The pulse width can be adjusted from 30 μs to 260 μs. It regulates the time for which the electrical signal is applied. If no instructions regarding the frequency are given in therapy, set the control to 150 – 200 μs.

Timer

• The device comes with a timer with three possible settings: 30 minutes, 60 minutes, and continuous mode. The application ends automatically when the timer runs out.

BATTERY CHANGE

The battery needs to be replaced from time to time to ensure the correct functionality of the device. Remove the battery if the device is not likely to be used for some time.

• Make sure the power is off.
• Open the battery compartment by sliding down and removing the front cover.
• Remove the battery.
• Insert the new batteries.
• Please check that the polarity is correct!
• Close the battery compartment.

LABEL

FUNCTION AND SAFETY TEST

For safety reasons, the following precautions should be carried out once a week.

• Check the device for any external damage:
  Check for deformation of the housing or damage to the electrode output sockets.

• Check that no type plates or stickers are damaged.

• Check the indication of the LEDs when switching on.

• Check cables and electrodes for damage.

• A safety check must be performed by authorized personnel at least every two years by the end of the month in which it is due.

• The instructions for use must always be carried with the unit. If there are any problems or defects, please contact your retailer.

REPAIR MINOR FAULTS YOURSELF

If the device does not work properly, the instructions below may help identify the cause of the fault. If the problem cannot be solved with any of these tips, contact the customer service.

• Check cables and connections! Have all plugs been connected correctly?
• Does the display not switch on? Change batteries.
• If a cable is externally damaged, replace it immediately with a good one. Only use original accessories.
• No current is flowing? Check that the electrodes are correctly connected to the same channel and that the current is strong enough.

CONFORMITY TO SAFETY STANDARDS
The STIM-PRO Eco device complies with the safety standards EN 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance & EN 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests.

TECHNICAL DESCRIPTION

channel
03| Pulse amplitude| Asymmetrical, bi-phasic square pulse
04| Output Voltage| 0 – 40V (Vpp), 500Ω Load
05| Power Source| 1 pc. 9,0V battery
06| Size| 9.5 cm (L) x 6.5 cm (W) x 2.35 cm (H)
07| Weight| 115 g incl. battery
08| Frequency| Adjustable from 2 – 150 Hz
09| Pulse width| Adjustable from 30 – 260 μs
10| Modes| 3 TENS modes with adjustable parameters:

B (Burst)

C (Normal)

M (Modulation)

11| Operating condition| Temperature: 10°C to 40°C Relative humidity: 40 % – 90 % Air pressure: 700 hPa – 1060 hPa
12| Transport and storage conditions| Temperature -10°C to 60°C Relative humidity: 30 % – 95 % Air pressure: 700 hPa – 1060 hPa
13| Notice| All technical values include a tolerance of ± 5 %

WARRANTY

All devices have a warranty of 24 months from the date of purchase. The warranty applies to the stimulator only and covers both parts and labor relating thereto. The warranty does not apply to damage resulting from improper handling, the failure to follow the instructions for use, loss or dropping.

CONTACT

• axion GmbH
• Mollenbachstrasse 13
• 71229 Leonberg
• Germany
• www.axion.shop

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