NeuroTrac® MyoPlus Pro

1. 1. EMG
   1. 1.0 Single channel EMG
   2. 1.1 EMG Range: 0.2 to 2000 μV RMS (continuous)
   3. 1.2 Sensitivity: 0.l μV RMS
   4. 1.3 Accuracy: 4% of μV reading +/-0.3 μV at 200 Hz
   5. 1.4 Selectable Bandpass filter – 3db Bandwidth,
      1. a. Wide: 18 Hz +/- 4 Hz to 370 Hz +/- 10% – Reading below 235 microvolts 10 Hz +/-3 Hz to 370 Hz +/- 10% – Reading above 235 microvolts
      2. b. Narrow: 100 Hz +/- 5% to 370 Hz +/- 10%
   6. 1.5 Notch filter: 50 Hz (Canada 60Hz) – 33 dbs (0. 1% accuracy)
   7. 1.6 Common Mode Rejection Ratio: 130 dbs Minimum @ 50 Hz
   8. 1.7 Work / Rest periods: 2-99 seconds
   9. 1.8 Number of Trials: 2-99
2. 2. NMES, TENS and ETS
   1. 2.1 Single channel Stimulator
   2. 2.2 Amplitude: 0-90 mA into 500 Ohm load – actual mA will tend to be less than indicated due to Electrode impedance: at 1000 Ohms load (Electrodes in poor condition) the maximum will be limited to 86 mA, at 1500 Ohms load the maximum will be limited to 65 mA.
   3. 2.3 Type: Constant current, maximum output voltage 180 Volts +10 / -30 Volts
   4. 2.4 Waveform: Symmetrical, rectangular, bi-phasic with net zero DC current
   5. 2.5 Pulse width selection: 50-450 μS in predefined, 50-330μS in custom (10% accuracy)
   6. 2.6 Pulse rate selection: 2-100 Hz (5% accuracy)
   7. 2.7 Work / Rest periods: 2-99 seconds
   8. 2.8 Time 1 – 99 minutes
   9. 2.9 Ramp up time: 0.1 – 9.9 seconds
   10. 2.10 Preset and user programmable treatment Programs
   11. 2.11 Automatic output shut off with detection of open electrode above 10 mA (+/- 2mA).

Battery:
Battery set: 4 x 1.5V, AAA battery.
Low battery indication at 4.2-4.4 volts +/- 0.2 volts, automatic shut off when voltage drops below the low indication. Replace the batteries immediately!
The device goes off automatically when not in use (energy saving): for example when in settings and no key is pressed over 1 minute when in stimulation mode (home screen) and all channels are 0mA.

Expected average battery set life [of standard 850 mAh, alkaline]:
14-18 hours in STIM, 28 hours in EMG mode.

Expected service life:
5 years. Careful use and maintenance extend the life of the unit over the service life limit.

Environmental Conditions for use:
+5 to +40 degrees Centigrade. 15-90% Humidity.

Environmental conditions for storage & transport:
-25 to +70 degrees Centigrade. 15-90% Humidity.

Physical:
Dimensions: Length 150 mm, Width 89 mm, Depth 35 mm.
Weight: MyoPlus Pro device: 140g (without batteries).

Clinical Benefits:
The intended clinical benefits of the different modes of the NeuroTrac MyoPlus Pro devices are:

NMES

• Treatment of stress and urge urinary stress incontinence, with an improvement of symptoms, reduction in leakage, and improvement in bladder control

TENS

• Reduction in pain in patients with pelvic pain
• Treatment of stress and urge urinary stress incontinence, with an improvement of symptoms, reduction in leakage, and improvement in bladder control

EMG

Biofeedback of muscle activity, leading to:

• Improved muscle control, motor recovery, and improvement in muscle strength in patients with stroke and/or paresis
• Reduction in pain in patients with pelvic pain
• Improved muscle control in patients with stress and urge urinary incontinence
• Reduction in symptoms in patients with faecal incontinence

ETS

• Rehabilitation of weak muscles in patients with stroke and/or paresis, with motor recovery and improvement in muscle strength
• Treatment of stress and urge urinary stress incontinence, with an improvement of symptoms, reduction in leakage, and improvement in bladder control
• Reduction in symptoms in patients with faecal incontinence

Clinical Safety:
The clinical risks identified in the clinical data, including the review of clinical literature, PMS, and materiovigilance were:

• Pain and discomfort (including pain and discomfort due to high-intensity stimulation)
• Skin irritation (including erythema, rash)
• UTI or vaginal infection
• Worsening of leakage

Warnings:
Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.:

•  This unit must be used with the guidance of a clinician or therapist. This includes the selection of the type of vaginal probe/skin electrodes and placement of skin electrodes.
• Type BF equipment, Continuous Operation.
•  Do not insert lead wires into a mains power supply.
• Do not immerse the unit into water or any other substance.
• The unit is not protected from the ingress of water droplets from a shower of rain if used outside the carrying case.
• Do not use this unit in the presence of a flammable anaesthetic gas mixture and air or with Oxygen or Nitrous Oxide.
• This device is 4 x AAA Batteries operated. If using rechargeable Nickel Metal Hydride batteries, be sure to use a CE-approved battery charger. Never connect this unit directly to a battery charger or to any other mains-powered equipment. We advise not to use Ni-Cad rechargeable batteries. Caution: Do not use lithium batteries unless they comply with IEC60086-4.
• To avoid the effects of electromagnetic interference, never use this unit in the EMG Mode, within 4 meters of a cellular telephone or near any other powerful radio interference-producing equipment that causes electrical sparks etc. In the EMG mode, this unit may be susceptible to strong interfering radio-type emissions that may lead to temporarily increased EMG microvolt readings. The reading will immediately return to the correct value when the interference ceases. (Remember that a relaxed muscle should read below 3.5 μVolts).
• Patient electrodes including all skin surface electrodes, vaginal and rectal probes are for single patient use only!
• Keep out of reach of children.
• Ensure that children do not inhale or swallow small parts.
• Do not use stimulation on your facial area unless you are under strict guidance from a qualified clinician.
• The application of electrodes near the thorax may increase the risk of cardiac fibrillation.
• Operation in close proximity (e.g. 1m) to shortwave or microwave therapy equipment may produce instability in the stimulator output.
• Simultaneous connection of a patient to high-frequency surgical equipment may result in burns at the site of the stimulator electrodes and possible damage to the stimulator.
• No modification of this equipment is allowed!
• The battery cover must be closed prior to the use of the device.

Contra-indications and precautions:

NMES (Neuromuscular Electrical Stimulation).

Neuromuscular Stimulation should not be used by:

• Patients fitted with demand-style cardiac pacemakers
• During pregnancy (unless medically advised)
• Patients with undiagnosed pain conditions
• Do not place electrodes:
  – Over carotid sinus nerves
  – Over larynx or trachea
  – Inside mouth
  – On anaesthetised or desensitised skin
  – Do not drive a vehicle while the device is stimulating and attached to your body
  – Do not apply stimulation across or through the head, directly on the eyes, covering the mouth, on the front of the neck (especially the carotid sinus) or via electrodes placed on the chest and upper back or crossing over the heart.
• Skin irritation from the treatment of NMS or EMG itself does not generally occur. However, rubber electrodes may irritate some skin types, therefore, in this case we recommend to use hypoallergenic self adhesive electrodes.
• The patient should only use the unit for what it was prescribed for
• Do not immerse the unit in water or any other liquid substance
• Do not use stimulation on your facial area unless you are under strict guidance from a qualified clinician.
• Do not apply stimulation across or through the head, directly on the eyes, covering the mouth, on the front of the neck (especially the carotid sinus) or via electrodes placed on the chest and upper back or crossing over the heart.

EMG

There are no precautions when using EMG unless used for pelvic floor exercise or assessment. But EMG should not be used:

• During menstrual period
• If symptoms of bladder infection are present
• With patients who have diminished mental capacity or physical competence who cannot handle the device properly

Indications for Use:

NMES
• Stress urinary incontinence
• Overactive bladder (urge urinary incontinence)
TENS
• Pelvic Pain.
• Overactive bladder (urge urinary incontinence).
EMG
• Biofeedback for muscle rehabilitation after stroke and/or paresis
• Biofeedback for Pelvic Pain
• Stress urinary incontinence
• Overactive bladder (urge urinary incontinence)
• Faecal incontinence
ETS
• Muscle rehabilitation after stroke and/or paresis
• Stress urinary incontinence
• Overactive bladder (urge urinary incontinence)
• Faecal incontinence.