Related Manuals for Mazet Sante Biostim 2.2
Summary of Contents for Mazet Sante Biostim 2.2
- Page 1 Page 1 of 40 12/04/2022 MEG010XN102-A10 User Manual Electrotherapy Device Biostim 2.2 / 2.2 + BioStim 2.1 / 2.1+ BioStim 2.0 / 2.0 + Biostim 1.0...
- Page 2 Page 2 of 40 12/04/2022 MEG010XN102-A10 Instructions for Use & Technical Description Please read this entire manual carefully before using your new device! This manual is an integral part of the device and must be kept until it is destroyed. This device was designed and manufactured for therapeutic use.
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Page 3: Device Presentation
Page 3 of 40 12/04/2022 MEG010XN102-A10 1. Device Presentation The Biostim is an electrotherapy device that physiotherapists and midwives employ in perineal re-education. Biostim’s computerized technology and user-friendly menus make it very easy to use. The device's pre-set programmes allow you to perform most perineal re-education treatments, and treatments in the urogynaecological and anorectal fields. -
Page 4: Table Of Contents
Page 4 of 40 12/04/2022 MEG010XN102-A10 Table of Contents 1. Device Presentation ....................3 2. Description and Technical Information ..............5 Symbols Used ....................6 Technical Specifications ................... 7 Nameplate Label ................... 10 3. Warnings ......................11 4. Potential Risks ....................13 5. -
Page 5: Description And Technical Information
Page 5 of 40 12/04/2022 MEG010XN102-A10 2. Description and Technical Information - This manual was written to facilitate the use and maintenance of your Biostim device, from reception, to commissioning, to the successive stages of use, to maintenance. If you have questions that are not answered in this manual, please contact the manufacturer, Électronique du Mazet, or your dealer or distributor. -
Page 6: Symbols Used
Page 6 of 40 12/04/2022 MEG010XN102-A10 2.1 Symbols Used Warning: This symbol draws your attention to a specific point. Operating Instructions: This symbol informs you that the operating instructions must be read in order to use the device safely. Applied Part, Type B: Applied part that comes in contact with the patient and can be earthed. -
Page 7: Technical Specifications
Page 7 of 40 12/04/2022 MEG010XN102-A10 2.2 Technical Specifications 2.2.1 General Characteristics Operating temperature: 0°C to 40°C. • Storage temperature: -40°C to 70°C. • Operating relative humidity: 30% to 75%. • Operating altitude: < 2000 metres • 2.2.2 Technical Specifications of the Device Dimensions of housing: 33.7 x 28 x 6.7 cm •... - Page 8 Biostim 1.0 Biostim 2.0 Biostim 2.1 Biostim 2.2 Each version (except the version 1.0) can have the optional functionalities of the software (+ version). Those functions are described in the section 7.3. To activate the + version, enter the activation key in the debug page (click on the monkey wrench in the configuration page).
- Page 9 Page 9 of 40 12/04/2022 MEG010XN102-A10 2.2.6 The currents form Rectangular biphasic impulsions The current is mean-zero biphasic symmetric: - the positive and negative impulsions have the same width and time Width of impulsion (µs) Peak amplitude (mA) Period of the signal = 1 (Frequency in Hz) Frequency of the impulsions Peak amplitude maximum ≤...
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Page 10: Nameplate Label
MEG010XN102-A10 2.3 Nameplate Label The nameplate label on the back of each device provides information and characteristics. Label of the “Biostim 2.2” or “Biostim 2.2+”: Label of the “Biostim 2.1” or “Biostim 2.1+”: Label of the “Biostim 2.0” or Label of the “Biostim 1.0”... -
Page 11: Warnings
Page 11 of 40 12/04/2022 MEG010XN102-A10 3. Warnings WARNING: Install the device on a flat and stable surface. Do not obstruct the ventilation openings (no objects within 4 cm). WARNING: The multi-socket power strips must not be laid on the ground. No other electrical device, nor another power strip, may be connected to the device's power strip. - Page 12 Page 12 of 40 12/04/2022 MEG010XN102-A10 WARNING: In some conditions, the efficient value of the impulsions of stimulation can exceed 10mA and 10V. Please scrupulously respect the information given in this manual. WARNING: The user must lend a particular attention and adapt the size of the electrodes to the zone to treat.
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Page 13: Potential Risks
Page 13 of 40 12/04/2022 MEG010XN102-A10 4. Potential Risks In the event of a power failure, or if the control computer malfunctions, be sure to disconnect the cables in order to avoid the risk of burning or tetanisation. Applied parts that are too old or of poor quality can affect the quality of the contact with the patient and cause discomfort. -
Page 14: Connection Of The Accessories
Page 14 of 40 12/04/2022 MEG010XN102-A10 5.2 Connection of the accessories Connect the handheld emergency stop on the front side. Connect the cable(s) of stimulation on the track(s) A (and B) according to your use. Put the electrodes on the muscle we want to work on. - Page 15 Page 15 of 40 12/04/2022 MEG010XN102-A10 To use the pressure tracks, connect the pressure kit on the tracks. Next the probe is directly connected on the back of the tap.
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Page 16: Commissioning The Software
Page 16 of 40 12/04/2022 MEG010XN102-A10 6. Commissioning the Software 6.1 Configuration The device will connect to a computer with at least the following minimum requirements: - Windows 7, 8, or 10 - Intel Core i3 - 4 GB RAM - Recommended resolution: at least 1366*768 (minimum 1280 * 720) - To use Bluetooth accessories (Blueback, BioMoov, Emy or Perifit), it is necessary to have a PC under Windows 10 or 11 and equipped with a Bluetooth card... -
Page 17: Check Of The Connection
Page 17 of 40 12/04/2022 MEG010XN102-A10 6.5 Check of the connection Check that the connection has been established: the Home button will turn green. The red home button indicates a communication problem between the PC and the device. In this case, check the following points The module is powered on, the green indicator light on the front of the device is lit. -
Page 18: In Case Of Problem
Page 18 of 40 12/04/2022 MEG010XN102-A10 In case of problem Go to the page “About your Biostim” (through the configuration page) This page gives information on the problem. Problems can be escalated, and suggestions can be done be email in this page. 6.6 Switch off your device First disconnect the patient from the applied parts. -
Page 19: User Manual
Page 19 of 40 12/04/2022 MEG010XN102-A10 7. User Manual 7.1 Home page When launched, the software opens on the home page, which gives access to all the features of the device. From any page of the application, a press on the home button will bring you back to this page. Home button Green: OK Red: no connection... -
Page 20: Specific Programs To The + Version
Page 20 of 40 12/04/2022 MEG010XN102-A10 Choice of the channels to be used Allows you to choose for the main and whether the cursor or the secondary the background channel. It is image moves possible to mix EMG and pressure Choice of the type Viewing the exercise of animation to... - Page 21 Page 21 of 40 12/04/2022 MEG010XN102-A10 7.3.2 Version + : Draw Profile 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. 7.3.3 Version + : Draw Objects Allows you to draw an exercise only with images positioned on the screen, without having a profile to follow.
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Page 22: Launching A Programme
Page 22 of 40 12/04/2022 MEG010XN102-A10 7.4 Launching a Programme To launch a programme from the programme selection page, click on the button in the programme description or on the icon in the upper-right of the programme's button. A programme is composed of one or more pages that elapse like a slide show, either after a predefined amount of time or by clicking an option in the menu at the bottom of the page. - Page 23 Page 23 of 40 12/04/2022 MEG010XN102-A10 In the “+” version, it is possible to adjust the negative Biofeedback level to show during the exercise with the slider in the panel on the right: • Zero patient: the bottom of the screen is corresponding to the minimum reached by the patient during the calibration.
- Page 24 Page 24 of 40 12/04/2022 MEG010XN102-A10 7.4.3 Biofeedback Maximum Progress Track level in Modification in real time of the Adjustment of calibration of through route real time profile (only with + version) the rest time each track Thanks to a right click on the page, a landmark line is added at the location wanted. 7.4.3.1 + Version: adjustable profile Once the Biofeedback has been created in adjustable profile, the form of the curve can be modified during the exercise thanks to the buttons situated in the top-left corner.
- Page 25 Page 25 of 40 12/04/2022 MEG010XN102-A10 7.4.3.2 + Version: Side Panel The side panel enables you to regulate the exercise in time. To open it, click on the icon the top right-hand corner of the Biofeedback pages. Thanks to this panel, you can regulate: •...
- Page 26 Page 26 of 40 12/04/2022 MEG010XN102-A10 Or on a contraction that is too weak: detection of a contraction, but insufficient to reach the plateau The voluntary contraction does not reach the threshold 7.4.3.4 Review mode At the end of the program (or after a click on the pause button), the review mode appears. In this mode, it is possible to register the curve clicking on the diskette button in the top-left to print it or to show it again later.
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Page 27: Favourite Programmes
Page 27 of 40 12/04/2022 MEG010XN102-A10 The accessory is then used like the other probes, by choosing the channel to be used that corresponds to the probe in the BFB menu. If the Biostim is not connected to the PC, the duration of the programs is limited to 1 minute. 7.5 Favorite Programs For a quicker access to your most frequently used programmes, you can put them in the "Favourites"... - Page 28 Page 28 of 40 12/04/2022 MEG010XN102-A10 To display all the patients (including archived patients), check the box "Show archived patients". In this circumstance, archived patients have a green archive icon, and the other ones have a blue archive icon. Archiving can be reversed by clicking on the archive icon again. The first name and the name of the patient can be totally masked with the “Anonymous Display”...
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Page 29: Patient Records
Page 29 of 40 12/04/2022 MEG010XN102-A10 In the patient search page, you can add a new practitioner, or filter the list of patients by selecting a practitioner 7.8 Patient Records When a patient has been selected, you can access his/her record by clicking on his/her name in the left-hand menu. - Page 30 Page 30 of 40 12/04/2022 MEG010XN102-A10 Start the comparison of the curves selected (+ version) Delete a recording Start the same programme again Select the curves you want compare (+ version) Free comments (right click to delete) 7.8.1 + Version: Curves comparison A click on the button in the sessions table open the sessions comparison page.
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Page 31: Biostim Cloud
Page 31 of 40 12/04/2022 MEG010XN102-A10 Biostim Cloud When you activate the option Biostim Cloud: • An anonymous collection of the sessions is done • We can access to the statistics on the use of the device as well as the statistics of the other users •... - Page 32 Page 32 of 40 12/04/2022 MEG010XN102-A10 • Selection of animations: it is possible to choose the animations that you want to use. Those that are unchecked will no longer be visible in the program presentation page. Customized animations are always visible. •...
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Page 33: Clinical Guide
Page 33 of 40 12/04/2022 MEG010XN102-A10 7.10.1 Networking several devices To network two devices (or more), they must be on a same network and they must have a shared common folder (ex: T:\biostim). To share the base, you just have to indicate this folder in the option “Folder for patient data”. 8. -
Page 34: Side Effects
Page 34 of 40 12/04/2022 MEG010XN102-A10 These contraindications are not exhaustive. In case of doubt, we recommend that the user research the procedure before proceeding. 8.4 Side Effects Current medical literature does not note significant side effects involving electrotherapy. 9. Maintenance, Servicing This device has a lifespan of 5 years. - Page 35 Page 35 of 40 12/04/2022 MEG010XN102-A10 Électronique du Mazet ZA Route de Tence 43520 Le Mazet St Voy FRANCE Tel.: (+33) (0)4 71 65 02 16 Fax: (+33) (0)4 71 65 06 55 E-Mail: sav@electroniquedumazet.com Possible malfunctions: Description of the Possible causes Actions malfunction...
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Page 36: After-Sales Service And Warranty
Page 36 of 40 12/04/2022 MEG010XN102-A10 11. After-sales Service and Warranty Your supplier provides a warranty for this device under the conditions specified in this document, provided that: Only accessories provided by Électronique du Mazet or its distributors are used. ... -
Page 37: Transportation And Storage
Page 37 of 40 12/04/2022 MEG010XN102-A10 13. Transportation and Storage This device must be stored and transported in its original packaging or in a packaging able to protect it from any destructive outside forces. Store at room temperature in a clean and dry place. 14. - Page 38 Page 38 of 40 12/04/2022 MEG010XN102-A10 16. EMC compliance table EMC compliance according to IEC 60601-1-2 (2014) 4th Edition (EN 60601-1-2 : 2015) The BIOSTIM is designed 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 test Compliance Electromagnetic environment - guidelines...
- Page 39 Page 39 of 40 12/04/2022 MEG010XN102-A10 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 BIOSTIM should ensure that it is used in such an environment. Test level IEC Level of IMMUNITY test...
- Page 40 Page 40 of 40 12/04/2022 MEG010XN102-A10 ELECTRONIQUE DU MAZET ZA ROUTE DE TENCE 43520 LE MAZET SAINT VOY France Tél: +33 4 71 65 02 16 Mail: sav@electroniquedumazet.com Your dealer / distributor: www.facebook.com/MazetSanteFrance/mazetsante.fr...
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