BEACMED evoStim E User Manual
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BEACMED evoStim E User Manual

Therapeutic unit for perineal reeducation by electrostimulation and surface emg biofeedback
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evoStim
®
E
Therapeutic unit 

for perineal reeducation 

by electrostimulation and 

Surface EMG biofeedback
User guide
of M.D. REF: evoStim E
(Rev. 7-2020)

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Summary of Contents for BEACMED evoStim E

  • Page 1 ® Therapeutic unit 
 for perineal reeducation 
 by electrostimulation and 
 Surface EMG biofeedback User guide of M.D. REF: evoStim E (Rev. 7-2020)
  • Page 2 BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 3: Table Of Contents

    evoStim E - User guide ® 8.1.1 Switch-ON the unit _________________________ CONTENTS 8.1.2 Switch-OFF the unit ________________________ 1 Description and Intended use ___________ 8.1.3 Select a program __________________________ 2 Indications of perineal electrostimulation 6 8.1.4 Select the type of probe in use ________________ 2.1 - Stress incontinence, _________________________...
  • Page 4 10.3 - Reset of the biofeedback sensor _____________ 10.4 - How to perform a BFB session _______________ 11 Technical features ____________________ The backlight _________________________________ 12 Trouble- shooting table _______________ BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 5: Description And Intended Use

    evoStim E - User guide ® Indications: Prevention or treatment of Description and
 incontinence, using perineal probes or surface Intended use electrodes. Perineal electro-stimulation is carried out by means of a vaginal or anal probe, characterised by a pair of electrodes.

  • Page 6: Indications Of Perineal Electrostimulation

    Pulse widths may be selected between Alternatively two treatments per day, one for urge 100 to 400 µs., depending on the patient's subjective and the other for stress may be carried out. sensation. BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 7: Indications Of Perineal Biofeedback (Bfb)

    evoStim E - User guide ® 3.1 - Recruiting Biofeedback Indications of 
 The patient has a PC test (test of pubococcygeus) perineal biofeedback
 degree 1 or lower , with "recruitment" problems of perineal muscles. The adopted technique will be (BFB) called indeed "recruitment biofeedback."...
  • Page 8 3 cm. each other along the muscle to be treated. It is always necessary a third indifferent electrode to be applied on a bony prominence. BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 9: Contra- Indications

    evoStim E - User guide ® Apart from the general contraindications of CONTRA- electrostimulation, we must consider the following INDICATIONS criteria: Specific contraindications of perineal electrostimulation. PLEASE READ CAREFULLY: absolute: pregnancy, kidney disease, lower urinary tract In the following circumstances, evoStim E must ®...

  • Page 10: Warnings And Precautions

    5. The appliance must not be used to treat painful cause symptoms such as dizziness, nausea, symptoms of unknown origin or which have vomiting, headache. been insufficiently diagnosed. BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)
  • Page 11 evoStim E - User guide ® 12. Do not apply the electrodes on the eyelids or 18. Do not use the device on a patient on which a monitoring instrument for physiological around the eyes. It could affect the intra-ocular parameters (such as ECG or others) is used pressure simultaneously.
  • Page 12 30. No repair or modification of this device or its accessories is allowed unless previously authorised in writing by the Manufacturer. 31. Avoid using the unit on more than one patient per session. BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 13: Checking The Package

    CHECKING THE
 following parts: PACKAGE Q.ty Code Description EVO-E Unit evoStim E The therapy unit evoStim E has been designed BAT/LR03-03 Kit 3 AAA alkaline batteries 1.5 V. (LR03) ® for a friendly but effective use. Before using it, you...

  • Page 14: How To Assemble The Unit

    , located at the compartment ⓒ. Close the base of the unit. b a t t e r y - ⓒ ⓓ compartment with the cover ⓓ. BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 15: Probe

    evoStim E - User guide ® 7.3 - PROBE STEP 5 - USING THE UNIT Remove the probe from the Read the chapter 8 (OPERATION) and use the unit bag, rinse under tap water if according to the therapeutic aims. it is a new probe, then 7.6 - TYPE OF PROBE VS- WAVE-SHAPE connect to the leads as...

  • Page 16: Operation

    ⑥ - Centre of the Concentric-Circles target (CCT) - Stimulation output / EMG input (§ 7.2-8.1). (§ 8.2.8) ㉕ - EMG reference (§ 7.3, § 8.1). ⑦ - Stimulation intensity (2 digits) (§ 8.1.5-8.1.7). BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)
  • Page 17 evoStim E - User guide ® Functions of the upper knob: Press and hold the knob downwards to SWITCH ON or SWITCH OFF, simply press to START THE SESSION or PAUSE it. Turn the knob to INCREASE or DECREASE the selected parameter or to UNLOCK the controls during the session.

  • Page 18: Frequent Operations

    , then turn the knob clockwise to feel a strong ⑦ ,  o  ). side of the display ( ⑰ ⑱ ⑲ ⑳ and comfortable level of stimulation. After adjusting BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 19: Start The Session

    evoStim E - User guide ® the stimulation level it is required to start the session 8.1.8 - Conclusion of the session (§ 8.1.6) otherwise stimulation stops after a few At the end of the session, make sure that the device seconds.

  • Page 20: Changing The Session Time (Min')

    ④, pressure value acquired by the balloon probe. the display will shows the current value of the ② action time (sec.), To edit it, touch area and ② BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 21: Restoring Factory Settings

    evoStim E - User guide ® Ask the patient to perform a maximal contraction. 8.3 - ACCESSORY OPERATIONS The detected pressure value (in µV) will be 8.3.1 Change the backlight intensity. automatically assumed as the new Full-Scale. By repeatedly taping the area the backlight ⑯...

  • Page 22: Replacing The Batteries

    § 7.1. If the batteries are not replaced they will still work for some minutes, then, to prevent functional problems, the unit will automatically switch off. BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 23: Programmes With Electro- Stimulation

    evoStim E - User guide ® During the action time, if the probe is properly PROGRAMMES with placed and the wires connected, the concentric ELECTRO- circles of the target are activated in sequence ⑭ STIMULATION from smallest to largest (from inside to outside). 5 programs are dedicated to perineal electro- 9.1 - Open-circuit safety cutout stimulation, by means of internal probes:...

  • Page 24: The Session Time

    9.4 - Programme STRESS 9.6 - Programme PAIN Pre-set parameters: Pre-set parameters: Frequency: 50 Hz. Frequency: 70 Hz. Pulse-width: 250 µs. Pulse-width: 50 µs. ACTION! time: 2 sec. BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 25: Programme Evocated

    evoStim E - User guide ® voluntary contraction of the perineal muscles in contact with the probe in the vaginal cavity. 9.7 - Programme EVOCATED The pre-set threshold is 8 µV and can be manually Pre-set parameters: changed (§ 8.2.8). That threshold, however, will also Frequency: 35 Hz.
  • Page 26 The frequency of STRE, MIX and EVO programs is manually adjustable from 25 to 150 Hz. (§ 8.2.3). BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 27: The Biofeedback Programme

    evoStim E - User guide ® linear bar graph , by means of a back-lit LCD ⑬ The 
 display. BIOFEEDBACK
 The goal for the patient is to activate all the 20 circles of the target , including the central one (or PROGRAMME ⑥...

  • Page 28: Valid Contraction

    30th line at least 60% of the ⑫ than zero. This situation is highlighted by the BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 29: How To Perform A Bfb Session

    evoStim E - User guide ® activation of one or more circles of the target. If you connect it to the input of the equipment by want to make a "recruitment" or "training" means of the blue cable. biofeedback, it is better that the initial signal level is 10.4.4 - Insert the probe after having properly reset.
  • Page 30 ② phases; so the patient does get ready for the next phase. The exercise ends after the pre-defined session time (normally 30 min'). BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 31: Technical Features

    evoStim E - User guide ® Biofeedback scale (FS): selectable among Technical features 2-4-8-12-16-20-24-32-40-50-60-70-80-90-100 -120-140-160-180-199 µV. Supply voltage 4,5 V by 3 alkaline batteries 1,5 Volt type AAA (LR03). Battery life: 20 hours average (variable according Electrostimulation output: 1 to 99 mA in steps of to the program and the output level set).

  • Page 32: The Backlight

    BLU to allow the user to see the onscreen controls. After 5 seconds, the blue light goes OFF but it will turn-ON again for another 5 seconds tapping the screen anywhere. BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 33: Trouble- Shooting Table

    evoStim E - User guide ® Trouble-
 shooting table Sign Comments / Suggested remedies Probable causes 12.1a - Check the batteries are inserted correctly (§ 7.1). 12.1b - Batteries are low. 12.1bb - Replace the batteries with new ones (§ 7.1). 12.1 - The unit does not switch-ON 12.1cc - If batteries had remained for a long time into an...
  • Page 34 12.5a - Remove the batteries, ON but no 12.5aa - If the problem persists, contact the manufacturer or wait a few minutes and re-insert operations are distributor. them. allowed. BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)
  • Page 35 evoStim E - User guide ® Sign Comments / Suggested remedies Probable causes 12.6a - The device is equipped 12.6aa - Verify that "zeroing" procedure was correctly with a "zeroing" system of the performed. Possibly, try to repeat it. In case, switch-OFF and pressure (§10.3).
  • Page 36 Maybe you have inadvertently the symbol ⑩ is lit pressed the button integrated in on the display and upper knob. ① the backlight slowly blinks green (if enabled) BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 37: Labelling And Symbols

    evoStim E - User guide ® Labelling 
 Reference to the catalogue and symbols Follow the user guide. Applied parts type BF The appliance emits energy in the form of electrical impulses. Battery powered Serial number Manufactured by: This product is CE marked in accordance Manufactured on: with Annex II of Directive 93/42 / EEC / MDD, under Rule 9 of Annex IX.
  • Page 38 This page has been left intentionally bllank BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)
  • Page 39 evoStim E - User guide ® Recommended separation distances between portable and mobile RF communication equipment (RF) and the EvoSTIM E unit ® The evoStim E unit is intended for use in the electromagnetic environment in which radiated RF disturbances ®...
  • Page 40 This page has been left intentionally bllank BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 41: Cleaning And Maintenance

    evoStim E - User guide ® Cleaning and
 Cleaning of electrodes and probes maintenance Any electrodes and / or perineal probes supplied with or supplied as accessories to evoStim ® equipment are a medical device. Please refer to the individual manuals for cleaning and maintenance. Clean the unit To clean the unit, screen and lead wires, use a soft, slightly damp cloth (NOT soaked) in alcohol.
  • Page 42 This page has been left intentionally blank BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)
  • Page 43 This symbol indicates that the product (as Electric or appropriated recovery or elimination. Please contact Electronic product) must be disposed of separately the BEACMED local distributor, to ask detailed from normal waste, at the end of its operational information on the program of collection and lifetime.
  • Page 44 Distributor: BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

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