BEACMED evoStim UG User Manual
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BEACMED evoStim UG User Manual

Dual channel therapy unit for perineal electrical stimulation (pes) using intra-vaginal or intra-anal probes
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evoStim
®
UG
Dual channel therapy unit 

for perineal electrical stimulation (PES)
using intra-vaginal or intra-anal probes
User guide
of D.M. REF: evoStim UG
(Rev. 7-2020)

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Summary of Contents for BEACMED evoStim UG

  • Page 1 ® Dual channel therapy unit 
 for perineal electrical stimulation (PES) using intra-vaginal or intra-anal probes User guide of D.M. REF: evoStim UG (Rev. 7-2020)
  • Page 2 BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 3: Table Of Contents

    evoStim ® UG - User guide 8.1.1 - Switch-ON the unit ________________________ CONTENTS 8.1.2 - Quickly select a programme _________________ 1 Description and intended use ____________ 8.1.3 - The probe type selection ___________________ 2 Introducing P.E.S. ______________________ 8.1.4 - Set the stimulation level and start ____________ 3 Indications of P.E.S.
  • Page 4 9.6 - Programmes for PAIN (PAIN touch-button) _______ 9.7 - Programme for RELAXATION (RELX touch-button) 10 Technical features: ____________________ 11 Labelling and symbols _________________ 12 Trouble-shooting table _________________ BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 5: Description And Intended Use

    evoStim ® UG - User guide having to vary all the other parameters. Up to 10 Description and pre-set editable programmes may be associated to intended use each-one of the 5 touch-buttons. Pelvic floor or perineal stimulation is a popular method for treating incontinence.

  • Page 6: Introducing P.e.s

    2 points. P.E.S. improves in two ways, by increasing muscle tone and improving circulation in the pelvic area. BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 7: Indications Of P.e.s

    evoStim ® UG - User guide 3.2 - Urge incontinence, Indications of P.E.S. caused by detrusor instability. Here the most appropriate frequency is between 5 and 10 Hz, with a pulse-width of between 250 and 400 microseconds. The treatment is best performed on a daily basis for the first week, then 2 to 3 sessions 3.1 - Stress incontinence, per week for the next 3 or 4 weeks.
  • Page 8 This page is intentionally free of text BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 9: Contraindications

    evoStim ® UG - User guide Apart from the general contraindications of CONTRAINDICATIONS electrostimulation, we must consider the following criteria: Specific contraindications of the perineal electrostimulation. absolute: pregnancy, kidney disease, lower urinary PLEASE READ CAREFULLY: tract infections, tumours, post-void residual In the following circumstances, evoStim urine greater than 100 ml, vesicoureteral ®...

  • Page 10: Warnings And Precautions

    6. Do not use the device during sleep. case of inappropriate contractions may increase 7. Be careful when using the unit on a patient with the risk of suffocation. reduced sensitivity. BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)
  • Page 11 evoStim ® UG - User guide 14. Avoid placing surface electrodes over any area 20. Store the unit and accessories in the pouch for affected by acute phlebitis. storage and transportation. 15. DO NOT use the unit at a distance lower than 3 21.
  • Page 12 Directive 93/42/ EEC MDD. Before using these special accessories, it is mandatory to carefully read the instructions for use and cleaning, which must be included in their packaging. BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 13: Checking The Package

    PRECAUTIONS. evoPouch PVC carrying bag with necklace (IP02) EStim_bag Padded bag. ISTRU-evoStim UG Ures manual for MD evoStim UG. The vaginal probe model PERIPROBE PERSONAL USE OF THE PROBES! Minima (RU/VMINIMA) is normally supplied, Sonda perineale. unless otherwise requested by the Do not use perineal probes (vaginal or anal) on customer.

  • Page 14: How To Assemble The Unit

    ⓒ. Close the battery-compartment with the cover the base of the unit. If only using one lead wire, insert into ⓓ. BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 15: Connect The Probe

    evoStim ® UG - User guide the CH1 outlet as marked on the unit ( 7.6 - Type of probe Vs. wave-shape 7.3 - CONNECT THE PROBE Remove the probe from the The lead wire of each channel has two terminations bag, rinse under tap water if with 2mm plugs, one RED, one BLACK.

  • Page 16: Operation

    The push-button integrated in the knob allows the following operations: • switch-ON/OFF the unit (push and hold for 2 seconds); BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 17: The Backlight Of The Display

    evoStim ® UG - User guide • Pause the unit (by briefly pushing down the button, will not apply the normal operation of such button rather it then push again to resume), also useful as will light-ON the backlight for 10 seconds. emergency push-button;...
  • Page 18 ⑬ - Symbol low battery indicator (§ 8.1.11); ⑭ - Symbol of PAUSE state (§ 8.1.7); ⑮ - Symbol wave-shape CH2 (touch-area) (§ 8.1.3); ⑯ - Type of probe connected to CH2 (touch-area) (§ 8.1.3); BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)
  • Page 19 evoStim ® UG - User guide Main functions of the upper knob: Press-and-hold down to switch ON/OFF. 
 Press to START THE SESSION, PAUSE/RESUME. Turn to INCREASE or ① DECREASE the selected parameter or UNLOCK commands during the ⬇ session. ⑭...

  • Page 20: Quick Start

    , both labels will flash to ⑥ ② ④ position of electrodes of the probe) for either CH1 or indicate that the rotation of the knob will act on both BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 21: Open-Circuit Safety Cutout

    evoStim ® UG - User guide channels. Briefly press the button to start the Enable / Disable" and the backlight adjusting); the ① session. symbol ( ) will appear on the display. To unlock the controls, turn for at least 1/4 turn the 8.1.5 - Open-circuit safety cutout knob clockwise.

  • Page 22: Enable/Disable The "Buzzer

    (§ 7.1). backlight OFF suitable for daylight. backlight LEVEL 1, suitable for twilight. backlight LEVEL 2, suitable for the dark. backlight LEVEL 3, suitable for the dark. BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 23: Advanced Operation

    evoStim ® UG - User guide 8.2 - ADVANCED OPERATION and Pulse-width. When the stimulation programme includes a rest time, then the programme is 8.2.1 - ON/OFF + Pause characterised also by the following parameters: Rise time, Plateau time, Fall time, Rest time. For The encoder push-button allows to switch-ON and easiness, the Rise-Plateau-Fall times may be switch-OFF the unit as well as START the session...

  • Page 24: Visualise Cycle-Steps Values

    • change the value shown by turning the rotating encoder or leave it unchanged if you prefer. BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 25: Visualise Frequency Or Pulse-Width Values

    evoStim ® UG - User guide • touch again the same area to switch from one to programme includes the Rest time, the Frequency or the next cycle-step and then edit them one-by- Pulse-width shown on the display will change ⑩...

  • Page 26: Change The Session Time

    To modify the lasting of current session time, do the value (has been changed by the user) the symbol same but skip the step 1. will slowly flash. ⑨ BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 27: Select A Programme

    evoStim ® UG - User guide 8.2.8 - Select a programme For linking a different programme to the selected aim Quick Selection areas: When the unit is switched-ON, the last used • touch the area underlying the label “P” and the programme is loaded.

  • Page 28: Adjust The Stimulation Level

    The output stimulation level has to be adjusted after way, even during the session but only after having having connected the probe and inserting it ready for unlocked the unit. the session. BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 29: Start The Session

    evoStim ® UG - User guide 8.2.11 - Start the session If the user wishes to reset to the factory settings one programme, one mode/aim range or the whole set of After having adjusted the output stimulation level, programmes, there are 3 different procedures: the session must be activated within 10 seconds.
  • Page 30 Instead of switching-OFF, the unit will remain ON and the 60 programmes associated to all the 6 quick selection areas (modes/aims) will be restored with the factory settings. BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 31: The Programmes

    evoStim ® UG - User guide All the programmes from 10 to 50 (except the default THE PROGRAMMES programmes 10-20-30-40-50 which are under the IntelliSTIM function) may be edited (Frequency, ® Pulse-width, Rise time, Plateau time, Fall time and Rest time may be changed and changes will be saved even after removing the batteries).

  • Page 32: Key List Of Symbols Used In The Programme Tables

    = RISE Time (sec.) · = STIM Time (sec.) · = FALL Time (sec.) · = REST Time (sec.) = Frequency during rest (Hz.) · = Session time (min’) BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 33: Programmes For Urge Incontinence (Urge Touch-Button)

    evoStim ® UG - User guide 9.3 - Programmes for URGE incontinence F (Hz) ¹ 1 (μs) (URGE touch-button) Default programme is P10 and is subject to automatic 10 (default) 200 (auto) ® adjusting function IntelliSTIM : Frequency is 10 Hz adjustable from 1 to 20 Hz.

  • Page 34: Programmes For Stress Incontinence (Stre Touch-Button)

    120 150 for the patient. Frequencies above 50 Hz must be used with caution; if uncomfortable, it is advised to reduce the frequency. BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 35: Programmes For Mixed Incontinence (Mix Touch-Button)

    evoStim ® UG - User guide 9.5 - Programmes for MIXed incontinence ·& ·; ·( ·9 ¹ (MIX touch-button) (µs) (sec) (Hz) (Hz) (sec) (sec) (sec) (min’) Default programme is P30 and is subject to automatic adjusting function. Default Frequency is 35 Hz adjustable (def.) from 25 to 150 Hz.

  • Page 36: Programmes For Pain (Pain Touch-Button)

    Programmes from P40 to P49 are suitable to reduce pelvic pain, by means of either internal electrodes (vaginal probe) or surface electrodes. BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 37: Programme For Relaxation (Relx Touch-Button)

    evoStim ® UG - User guide 9.7 - Programme for RELAXATION (RELX touch-button) Default programme is P50. Default Frequency is 1 Hz adjustable from 1 to 4 Hz; Stimulation is continuous; no rest periods will happen. The session time is is 30 min (adjustable in steps of 5 min from 5 up to 90 min or Continuous).

  • Page 38: Technical Features

    Supply voltage 4,5 V by 3 alkaline batteries 1,5 Volt type IP22 as it is also protected from dripping. AAA (LR03). Battery life: 20 hours average (variable according to the programme and the output level set). BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 39: Labelling And Symbols

    evoStim ® UG - User guide Labelling and Reference to the catalogue 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 with Annex II of Directive 93/42 / EEC / Manufactured on: MDD, under Rule 9 of Annex IX.
  • Page 40 This page is intentionally free of text BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 41: Trouble-Shooting Table

    evoStim ® UG - User guide Trouble- shooting table Sign Comments / Probable causes Suggested remedies 12.1a - Check the batteries are inserted correctly (§ 7.1). 12.1 - The unit 12.1b - Batteries are low. 12.1bb - Replace the batteries (§ 7.1). does not switch- 12.1cc - If batteries had remained for a long time into an unused unit, 12.1c - Make sure that the...
  • Page 42 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 43 evoStim ® UG - User guide Sign Comments / Probable causes Suggested remedies 12.6 - Strange symbols 12.6aa - Try to replace the batteries (§ 7.1). randomly appear on the If the problem persists, contact the manufacturer or display. distributor. 12.7 - The buzzer cannot 12.7a - Make sure it has not been 12.7aa - If the problem persists, contact the manufacturer...
  • Page 44 This page is intentionally free of text BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 45: Cleaning And Maintenance

    evoStim ® UG - User guide 13.3 Cleaning and maintenance of perineal CLEANING AND probes MAINTENANCE Any perineal probes included or supplied as accessories with the evoStim unit are medical devices. Please refer to the individual manuals for cleaning and maintenance. 13.1 Clean the unit To clean the unit, screen and lead wires, use a soft, slightly damp cloth (NOT soaked) in alcohol.
  • Page 46 This symbol indicates that the product (as Electric or Electronic product) must be disposed of separately from normal waste, at the end of its operational lifetime. BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)
  • Page 47 evoStim ® UG - User guide Recommended separation distances between portable and mobile RF communication equipment (RF) and the EvoStim UG unit ® The evoStim UG unit is intended for use in the electromagnetic environment in which radiated RF ® disturbances are controlled.
  • Page 48 Distributor: BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

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