BEACMED evoStim P User Manual
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BEACMED evoStim P User Manual

Therapeutic unit for perineal reeducation by electrostimulation and biofeedback (pressure)
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evoStim
®
P
Therapeutic unit 

for perineal reeducation 

by electrostimulation and
biofeedback (pressure)
User guide
of M.D. REF: evoStim P
(Rev. 7-2020)

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

  • Page 3: Table Of Contents

    evoStim P - User guide ® 8.1 - FREQUENT OPERATIONS ______________ 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 ________________________ 1.1 - Intended use ____________________________ 8.1.4 Select the type of probe in use _____________ 2 Indications of perineal electrostimulation 7 8.1.5 Set the stimulation level...
  • Page 4 10.2 - Pre-set parameters of the biofeedback programme (BFB) ____________________________________ 10.3 - Reset of the biofeedback sensor _________ 10.4 - How to perform a biofeedback session _____ 11 Technical features ________________ The back-light (“BL”) _________________________ BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 5: Description And Intended Use

    evoStim P - User guide ® Perineal electro-stimulation is carried out by Description and 
 means of a vaginal or anal probe, characterised by intended use a pair of electrodes. The therapeutic goal is the improvement of voluntary control of the perineal musculature (in case of stress incontinence) or the reflex inhibition of the detrusor muscle (in the case P is a therapeutic unit intended for...
  • Page 6 This page has been left intentionally blank BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 7: Indications Of Perineal Electrostimulation

    evoStim P - User guide ® selected between 100 to 400 microseconds, Indications of 
 depending on the patient. perineal 
 2.2 - Urge incontinence electrostimulation It is caused by detrusor instability. Here the most appropriate frequency is between 5 and 10 Hz, 2.1 - Stress incontinence, with a pulse-width of between 250 and 400 It is frequently due to sphincter deficiency.
  • Page 8 Alternatively two treatments per day, one for urge and the other for stress may be carried out. BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 9: Indications Of Perineal Biofeedback

    evoStim P - User guide ® We can identify 2 pathological situations each Indications of 
 corresponding to a biofeedback techniques: perineal
 3.1 - Recruiting Biofeedback biofeedback The patient has a PC test (test of pubococcygeus) degree 1 or lower, with "recruitment" problems of the perineal muscles.
  • Page 10 (coughing or sudden efforts). BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 11: Contra- Indications

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

  • Page 12: Warnings And Precautions

    5. The unit must not be used to treat painful could cause symptoms such as dizziness, symptoms of unknown origin or which have nausea, vomiting, headache. been insufficiently diagnosed. BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)
  • Page 13 evoStim P - 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 14 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 15: Checking The Package

    Padded bag or rigid plastic handbag Do not use the perineal probes (vaginal or anal) ISTRU-evoStim P User manual for MD evoStim P. on different patients. The probes are for personal use. This is to prevent the transmission of The probe Periprobe VAG-2STFW is...

  • Page 16: Preparing The Unit

    If only cover ⓓ. using one lead, insert into the ⓒ ⓓ CH1 outlet as marked on the unit ( BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 17: Connect The Probe

    evoStim P - User guide ® 7.3 - CONNECT THE PROBE 7.5 - USING THE UNIT Read the chapter 8 (OPERATION) and use the Remove the probe from the unit according to the therapeutic aims. bag, rinse under tap water if it is a new probe, then 7.6 - TYPE OF PROBE VS- WAVE-SHAPE connect to the leads.

  • Page 18: Operation

    ⑤ - Touch-area buzzer enable/disable (§ 8.3.2). - Stimulation output connector (§ 7.2). ㉕ ⑥ - Centre of the Concentric-Circles target (CCT) - Pressure input (from the balloon) (Bf.P). (§ 8.2.8). BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)
  • Page 19 evoStim P - 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 20: Frequent Operations

    ( , After adjusting the stimulation level, it is required The label of the selected program will appear in to start the session (§ 8.1.6), otherwise the reverse. BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 21: Start The Session

    evoStim P - User guide ® stimulation stops after a few seconds and, after a of the probe, as this could damage them over time. few minutes, the unit switches off. Rinse the probe thoroughly under tap water, dry thoroughly and store in the original bag. 8.1.6 Start the session 8.2 - OPTIONAL OPERATIONS Briefly push the button...

  • Page 22: Modify The Frequency (Hz)

    The detected pressure value (in cmH O) will be the desired value. automatically assumed as the new Scale. BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 23: Restore The Factory Settings

    evoStim P - User guide ® 8.2.9 - Restore the factory settings 8.3 - ACCESSORY OPERATIONS If the default program parameters have been 8.3.1 Change the backlight intensity. changed by the user, the button of the selected By repeatedly taping the area the backlight ⑯...

  • Page 24: Replacing The Batteries

    To replace the batteries, see the section 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 25: Programmes With Electrostimulation

    evoStim P - User guide ® Each programme has pre-defined and optimised PROGRAMMES with
 parameters; However, it is possible to modify one ELECTROSTIMULATION or more parameters (except the pulse width which is automatically defined): • Frequency (in Hz) see the section 8.2.3 5 programmes are dedicated to perineal electro- •...

  • Page 26: Open-Circuit Safety Cutout

    60 min' (in steps of 5), or select continuous stimulation (the symbol C). Each programme offers a session time range, according to the intended therapeutic purpose. BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 27: Programme Mixed

    evoStim P - User guide ® 9.5 - Programme MIXED 9.7 - Programme EVOCATED Pre-set parameters Pre-set parameters Frequency: 35 Hz. Frequency: 35 Hz. Pulse-width: 200 µs. Pulse-width: 350 µs. ACTION! time: 3 sec. ACTION! time: 3 sec. RELAX time: 6 sec. RELAX time: 8 sec.
  • Page 28 IntelliSTIM® system. However, you can edit them The easiness for the patient to turn-ON the whole manually (§ 7.2.4, 7.2.5). target (the centre) will depend on the Full-Scale BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)
  • Page 29 evoStim P - User guide ® Before using the balloon probe, for the treatment of pressure biofeedback, it is essential to connect the male Luer-lock connector of the tube that comes out of the probe to the female Luer-lock connector coming from the biofeedback equipment.

  • Page 30: The Biofeedback Programme

    Full-Scale (FS). The lower circles of the target, including the central one (or the FS, the easier the exercise, and vice-versa. all 40 segments of linear bar). BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 31: Valid Contraction

    evoStim P - User guide ® 10.1 - Valid contraction 10.2 - Pre-set parameters of the biofeedback programme (BFB) To be valid, a contraction should remain on the centre of the target at least 60% of the ⑥ Full-Scale (FS): 20 cmH O (Editable by selecting ACTION! time.

  • Page 32: How To Perform A Biofeedback Session

    10.4.3 - Insert the probe (not to introduce the contract and relax, for a pre-defined number of probe into the vaginal cavity prior to connect the seconds. The visual command to contract consists tube). BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 33: Technical Features

    evoStim P - User guide ® Technical 
 in the label and in the YELLOW features back-lighting of the LCD display. The visual command to relax instead consists in the label and in the GREEN back- Electrostimulation output: 1 to 99 mA in steps lighting of the LCD display.

  • Page 34: The Back-Light ("Bl")

    2 mm protected but it will turn-ON again for another 5 seconds plugs. - 1 pressure inlet channel with "Luer-lock"; tapping the screen anywhere. BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)
  • Page 35 evoStim P - User guide ® 2 - When the unit is in the PAUSE state, the backlight colour is GREEN flashing 3 - In the biofeedback programme, during the ACTION! phase, a YELLOW backlight will exhort the patient to perform a contraction. 4 - In the biofeedback programme, during the ACTION! phase, a steady GREEN...

  • Page 36: Trouble- Shooting Table

    12.3b - The batteries are low. 12.3bb - Replace the batteries with new ones (§ 7.1). off. BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)
  • Page 37 evoStim P - User guide ® Sign Comments / Probable causes Suggested remedies 12.4a - Be sure to carefully follow the steps specified in the user manual (§ 8.1.5). 12.4bb - To unlock the controls and allow the intensity 12.4b - The device is equipped with a adjustment during a treatment session, make a Control Lock system to prevent clockwise rotation of the knob fully clockwise and then...
  • Page 38 12.8 - The buzzer 12.8a - Make sure it has not been 12.8aa - If the problem persists, contact the cannot be heard. disabled (§ 8.3.2). manufacturer or distributor. BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)
  • Page 39 evoStim P - User guide ® Sign Comments / Probable causes Suggested remedies 12.9 - Stimulation is 12.9aa - The output circuit connection to the patient is no longer felt by the interrupted. Check the connection of cables and patient. 12.9a - The "open circuit protection"...
  • Page 40 150 KHz to 80 MHz (m) 80 MHz to 800 MHz (m) 800 MHz to 2,5 GHz (m) 0,01 0,117 0,117 0,233 0,37 0,37 0,74 1,17 1,17 2,33 11,7 11,7 23,3 BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

  • Page 41: Labelling And Symbols

    evoStim P - 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 Manufactured on: with Annex II of Directive 93/42 / EEC / MDD, under Rule 9 of Annex IX.

  • Page 42: Cleaning And Maintenance

    (the release of battery acid, could irreparably damage it). NOT allowed any repair or modification of this device or its accessories unless previously authorised in writing by the Manufacturer. BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)
  • Page 43 Electronic product) must be disposed of for an appropriated recovery or elimination. Please separately from normal waste, at the end of its contact the BEACMED local distributor, to ask operational lifetime. detailed information on the program of collection and recovery for this product.
  • Page 44 Distributor: BEACMED s.r.l. - Via Monte Bianco, 12 - 27040 Portalbera PV (Italia)

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