Related Manuals for Mazet Sante BioStim 2.2+
Summary of Contents for Mazet Sante BioStim 2.2+
- Page 1 Page 1 on 42 2022/09/27 MEG010XN102-A11 (ENG) User Manual Electrotherapy device BioStim 2.2+ BioStim 2.1 / 2.1+ BioStim 2.0 / 2.0+ BioStim 1.0...
- Page 2 Page 2 on 42 2022/09/27 MEG010XN102-A11 (ENG) Instructions for use & Technical description Please read these instructions carefully before using your new device! This manual is an integral part of the device and must be kept until it is destroyed. This equipment has been designed and manufactured for therapeutic use.
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Page 3: Presentation Of The Device
Page 3 on 42 2022/09/27 MEG010XN102-A11 (ENG) Presentation of the device The Biostim is an electrotherapy device that helps physiotherapists and midwives in perineal rehabilitation. The computerised technology used in the BioStim device makes it very easy to use and navigate through the menus. -
Page 4: Table Of Contents
Page 4 on 42 2022/09/27 MEG010XN102-A11 (ENG) Table of contents Presentation of the device ........................3 Description and technical information ....................5 Symbols used ..........................6 Technical specifications ........................7 Nameplate label ..........................10 Warnings ............................11 Risks residual ..........................12 Confidentiality of patient data....................... -
Page 5: Description And Technical Information
Page 5 on 42 2022/09/27 MEG010XN102-A11 (ENG) Description and technical information - This user and maintenance manual is published to facilitate the handling of your BioStim from the initial reception phase, through commissioning, to the successive stages of use and maintenance. -
Page 6: Symbols Used
Page 6 on 42 2022/09/27 MEG010XN102-A11 (ENG) 2.1 Symbols used Warning: this logo draws your attention to a specific point Operating instructions: This logo informs you that the operating instructions must be read for safe use of the appliance Type BF applied part: applied part in contact with the patient. Recycling: This appliance should be disposed of at an appropriate collection and recycling facility. -
Page 7: Technical Specifications
Page 7 on 42 2022/09/27 MEG010XN102-A11 (ENG) 2.2 Technical specifications 2.2.1 General characteristics • Operating temperature: 15°C to 40°C. • Storage temperature: -20°C to 70°C. • Operating relative humidity: 30% to 75%. • Operating altitude: < 2000 metres 2.2.2 Technical characteristics of the device •... - Page 8 Page 8 on 42 2022/09/27 MEG010XN102-A11 (ENG) 2.2.3 Different versions of the device The functionality of the different versions of the device is as follows: Number of Number of Electro pressure channels channels Biostim 1.0 Biostim 2.0 Biostim 2.1 Biostim 2.2 Each version (except version 1.0) may have additional optional software features (version +).
- Page 9 Page 9 on 42 2022/09/27 MEG010XN102-A11 (ENG) 2.2.6 Form of the currents Two-phase rectangular pulses The current is symmetrical biphasic with zero mean: the positive and negative pulses are of the same amplitude and duration Pulse width (µs) Peak amplitude (mA) Signal period = 1 / Frequency (in Hz) The waveform is constant current and does not depend on the value of the load.
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Page 10: Nameplate Label
Page 10 on 42 2022/09/27 MEG010XN102-A11 (ENG) 2.3 Nameplate label The information and characteristics are given on the back of each appliance on a label Label for "Biostim 2.2+" : Label for "Biostim 2.1 / 2.1+". Biostim 2.0" label Biostim 1.0" label or "Biostim 2.0+":... -
Page 11: Warnings
Page 11 on 42 2022/09/27 MEG010XN102-A11 (ENG) 2.4 Warnings CAUTION: Install the appliance on a flat, stable surface. Do not block any ventilation openings (no objects closer than 4cm). CAUTION: Power strips must not be placed on the floor. No other electrical appliance or power strip should be connected to the power strip. -
Page 12: Risks Residual
Page 12 on 42 2022/09/27 MEG010XN102-A11 (ENG) CAUTION: Under certain conditions, the effective value of the stimulation pulses may exceed 10 mA and 10 V. Please follow the information in this manual carefully. CAUTION: The user must pay particular attention and adapt the size of the electrodes to the area to be treated. -
Page 13: Cybersecurity
Page 13 on 42 2022/09/27 MEG010XN102-A11 (ENG) 2.7 Cybersecurity As the device and its software Biostim are computerised systems integrated into larger information systems, certain rules and good practices must be put in place to ensure the safety of patients and users. Électronique du Mazet does not supply or have control over the operating environment of its products, it is therefore the responsibility of the practitioner to ensure that the following recommendations are respected. -
Page 14: Installation Of The Appliance
Page 14 on 42 2022/09/27 MEG010XN102-A11 (ENG) Installation of the appliance Open the carton, remove the accessories and the appliance. Check the contents of the box against the packing list included with the documentation. If the appliance was stored in a cold place and there was a risk of condensation, leave the appliance to stand for at least 4 hours at room temperature, about 20°C. - Page 15 Page 15 on 42 2022/09/27 MEG010XN102-A11 (ENG) Place the electrodes or probe on the muscle you wish to work with, using the red and black connectors To do BFB, place the ème electrode (yellow tip) on a bony part (useless for stimulation) To use the pressure channels, connect the pressure kit to the pressure channels.
- Page 16 Page 16 on 42 2022/09/27 MEG010XN102-A11 (ENG) A single balloon catheter (vaginal or anal) is then connected directly behind the tap to the P1 line. For a double balloon anal probe, rectoMax type, connect the large balloon to the P1 channel (blue kit), and the small balloon to the P2 channel (red kit) On a Biostim 2.1 (or 2.1+), which has only one pressure channel, connect only the small balloon to channel P1 of the device.
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Page 17: Software Commissioning
Page 17 on 42 2022/09/27 MEG010XN102-A11 (ENG) Software commissioning 4.1 Configuration The device connects to a computer with at least the following characteristics: Windows 8, 10 or 11, or MacOS Intel Core i3 4 GB RAM Recommended resolution: at least 1366*768 To use an accessory (Blueback, BioMoov, Emy or Perifit), it is necessary to have a PC running Windows 10 or 11 equipped with a BlueTooth card 4.2 Software requirements... -
Page 18: Start-Up
Page 18 on 42 2022/09/27 MEG010XN102-A11 (ENG) 4.4 Start-up Turn the on/off switch on the back of the unit to ON "1". Check that the green power indicator light on the front of the unit is on. Run the Biostim program on the PC 4.5 Checking the connection Check that the connection is established: green home button. -
Page 19: In Case Of Problems
Page 19 on 42 2022/09/27 MEG010XN102-A11 (ENG) 4.6 In case of problems Go to the "About your Biostim" page (via the configuration menu) This page gives information about the problem and also allows you to report problems or suggestions by e-mail. 4.7 Switching off the device Disconnect the patient from the applied parts beforehand. -
Page 20: User's Manual
Page 20 on 42 2022/09/27 MEG010XN102-A11 (ENG) User's manual 5.1 Home page On launch, the software opens to the home page, which provides access to all the device's features. From any page of the application, pressing the home button will take you back to this page. Home button Green: OK Red: no connection... -
Page 21: Programs Specific To The + Version
Page 21 on 42 2022/09/27 MEG010XN102-A11 (ENG) Choice of Allows you to channels to be choose whether the used for the cursor or the primary and background image secondary moves pathways. It is possible to mix EMG and pressure Viewing the Choice of the exercise profile type of... - Page 22 Page 22 on 42 2022/09/27 MEG010XN102-A11 (ENG) 5.3.2 Version + : Free Drawing Allows you to draw a profile by clicking with the mouse on the drawing area. A click in the drawing area adds a point to the curve. To delete a point, simply click on it.
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Page 23: Launching A Programme
Page 23 on 42 2022/09/27 MEG010XN102-A11 (ENG) 5.4 Launching a programme From the program selection page, a program can be started by clicking on the button in the program description section, or on the icon in the upper right corner of the program name. A programme is composed of one or more pages that are linked after a predefined time or by an action on the lower menu of the page. - Page 24 Page 24 on 42 2022/09/27 MEG010XN102-A11 (ENG) • Zero Patient: the bottom of the screen corresponds to the minimum reached by the patient during taring This setting allows the basic tone to be erased. • Zero Biostim: minimum measurable by the device: to work in negative BFB •...
- Page 25 Page 25 on 42 2022/09/27 MEG010XN102-A11 (ENG) 5.4.3 Biofeedback Real-time Adjustment of Note indicating Maximum calibration of Real-time modification of the rest time template each channel channel levels profile (only version monitoring 5.4.3.1 Menu for selecting the areas to be displayed Pressing the button at the top right of the biofeedback pages opens a menu that allows you to choose...
- Page 26 Page 26 on 42 2022/09/27 MEG010XN102-A11 (ENG) 5.4.3.3 Version + : adjustable mode When the biofeedback has been created in adjustable mode, it is possible to change the shape of the curve during the exercise using the buttons at the top left of the page. Buttons to adjust the shape of the...
- Page 27 Page 27 on 42 2022/09/27 MEG010XN102-A11 (ENG) This curve can then be found in the summary table of the sessions in the patient file. 5.4.3.6 Version +: Blind work A "blind mode" is available to work without the feedback of contractions on the screen. This mode is activated during the session, in the zone selection menu.
- Page 28 Page 28 on 42 2022/09/27 MEG010XN102-A11 (ENG) 5.4.3.8 Review mode At the end of the program (or when the pause button is pressed), the program switches to review mode. In this mode it is possible to save the curve by clicking on the diskette in the upper left-hand corner to print it or display it again later.
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Page 29: Favourite Programmes
Page 29 on 42 2022/09/27 MEG010XN102-A11 (ENG) 5.5 Favourite Programmes In order to find frequently used programmes more quickly, they can be classified in the "Favourites" category. To do this, simply click on the icon on the bottom right of the programme name. They can then be accessed by clicking on the button in the left-hand menu of each page. -
Page 30: Patient File
Page 30 on 42 2022/09/27 MEG010XN102-A11 (ENG) 5.7.1 Version + : multi practitioner mode It is possible to activate the multi-practitioner mode in the configuration page. If this mode is activated, it is possible to assign a patient to a practitioner in the patient overview page. In the patient search page, you can add a new practitioner, or filter the list of patients by selecting a practitioner 5.8 Patient File... - Page 31 Page 31 on 42 2022/09/27 MEG010XN102-A11 (ENG) Follow-up form (right click to delete) Addition of a new form to the patient file: either pre-filled or free (mail, medical examination...) Graph of the follow-up of the different sessions of the patient All sessions are recorded.
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Page 32: Biostim Cloud
Page 32 on 42 2022/09/27 MEG010XN102-A11 (ENG) Choice of Displays the channels to average curve over a displayed profile width Choice of sessions to Printing the displayed curve Right click in the drawing area to select a portion of the curve to be printed 5.9 Biostim Cloud By activating the Biostim Cloud option : An anonymised collection of sessions is made... - Page 33 Page 33 on 42 2022/09/27 MEG010XN102-A11 (ENG) • Automatically start BFB after taring: if this option is not activated, the cursor waits for a press of the start key at the beginning of the BFB: no scrolling until this key is pressed •...
- Page 34 Page 34 on 42 2022/09/27 MEG010XN102-A11 (ENG) • Creating, modifying and deleting a custom animation: requires a background image, an image for tracking each lane, and one or more objects to catch. • Put user programs in a subdirectory Off: 5.10.1 Networking of several devices To network 2 (or more) devices, they must be on the same network, and have a common shared directory (e.g.
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Page 35: Clinical Guide
Page 35 on 42 2022/09/27 MEG010XN102-A11 (ENG) Clinical Guide 6.1 Target population The device is intended for a population over 5 years of age, which can be female or male. It should be noted that pelvic floor rehabilitation is particularly indicated for post-partum women. 6.2 Expected clinical benefits Today, based on European and French recommendations as well as on the results of studies conducted by health specialists, the device makes it possible to propose pre-established and... -
Page 36: Housing And Accessories
Page 36 on 42 2022/09/27 MEG010XN102-A11 (ENG) To ensure that the performance of the device is maintained throughout its life, it is necessary to have the device checked by Électronique du Mazet technicians every 2 years. Only Électronique du Mazet technicians or its authorised distributors are authorised to carry out maintenance and repair operations on the appliance. - Page 37 Page 37 on 42 2022/09/27 MEG010XN102-A11 (ENG) Description of the anomaly Possible causes Actions Green indicator light off - power grid problem - check the mains voltage - fuses - check and change fuses No communication with the PC (home - USB adapter - check the connections button = red house)
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Page 38: After-Sales Service And Warranty
Page 38 on 42 2022/09/27 MEG010XN102-A11 (ENG) After-sales service and warranty This appliance is guaranteed by your supplier under the conditions specified in this document, provided that : ◼ Only accessories supplied by Électronique du Mazet or its distributors should be used. ◼... -
Page 39: Transport And Storage
Page 39 on 42 2022/09/27 MEG010XN102-A11 (ENG) 11 Transport and storage The appliance must be transported and stored in its original packaging or in packaging that protects it from external damage. Store in a clean, dry place at room temperature. 12 CE declaration ÉLECTRONIQUE DU MAZET can provide the CE declaration for this device on request. -
Page 40: Emc Compliance Table
Page 40 on 42 2022/09/27 MEG010XN102-A11 (ENG) 14 EMC compliance table EMC compliance according to IEC 60601-1-2 (2014) 4th Edition (EN 60601-1-2: 2015) The BIOSTIM is intended to be used in the electromagnetic environment specified below. The customer or user of the BIOSTIM should ensure that it is used in such an environment. Emissions testing Compliance Electromagnetic environment - guidelines The BIOSTIM uses RF energy only for its internal functions. - Page 41 Page 41 on 42 2022/09/27 MEG010XN102-A11 (ENG) The BIOSTIM is intended for use in the electromagnetic environment specified below. The customer or user of BIOSTIM should ensure that it is used in such an environment. Test level IEC Level of IMMUNITY test Electromagnetic environment - guidelines 60601-1-2...
- Page 42 Page 42 on 42 2022/09/27 MEG010XN102-A11 (ENG) Your dealer / distributor : www.facebook.com/MazetSanteFrance/ mazetsante.fr...
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