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Mazet Sante Biostim 1.0, User Manual

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Mazet Sante Biostim 1.0 User Manual Download Page 6

 

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. Consult the manufacturer. 

 

 

Protective earth

 

 

Fuse

 

 

Caution: Switching the 

appliance off and on 

 

Alternating current 
 

 

Serial number 

 

Manufacturer 

 

Date of manufacture 

 

Product reference  

 

 

Unique identifier  

 

Medical device 

Summary of Contents for Biostim 1.0

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: ...yed This equipment has been designed and manufactured for therapeutic use The device is intended to be used only by physiotherapy professionals and qualified midwives If you have a problem or do not u...

Page 3: ...erineal rehabilitation treatments to be carried out in the urogynaecological and anorectal fields The main programmes available are Urogynaecological biofeedback EMG or Pressure Urogynaecological stim...

Page 4: ...he connection 18 4 6 In case of problems 19 4 7 Switching off the device 19 5 User s manual 20 5 1 Home page 20 5 2 Programme selection and customisation page 20 5 3 Programs specific to the version 2...

Page 5: ...n are technically up to date at the time of marketing However we reserve the right to make changes to the device and its documentation without any obligation to update these documents In the case of t...

Page 6: ...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 Con...

Page 7: ...ro channels Each channel has the following features Current generator Output currents of each generator adjustable from 0 to 100mA 10 Under a load impedance of 1k or more at max current the voltage is...

Page 8: ...ressure kit optional EM6055KP504 IR REMOTE CONTROL optional 2m USB cable USB CLE PC software USB drivers POWER CABLE 2 2 5 Applied parts The applied parts type BF are vaginal probes rectal probes or e...

Page 9: ...15 s to 10ms the frequency is adjustable from 1Hz to 5kHz LF modulation 1Hz to 500 Hz of the signal is possible The device complies with standard 60601 2 10 Medical electrical equipment special requi...

Page 10: ...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...

Page 11: ...Mazet or the distributor for advice on how to avoid or minimize the problem CAUTION Operation in close proximity e g 1 m to shortwave or microwave therapy EM equipment may cause instabilities in the...

Page 12: ...f burns or tetanization be sure to disconnect the cables in the event of a power failure or malfunction of the control PC Old or poor quality application parts can impair the quality of contact with t...

Page 13: ...u install Use antivirus and firewall software Check regularly in the Cloud menu for updates 2 7 2 Technical information The Biostim software is a Java program The software configurations and the datab...

Page 14: ...on Place the Biostim on a table outside the patient s environment Place the PC on the same table and connect them via USB to the back of the unit Connect the power cord to the back of the unit The pra...

Page 15: ...pressure channels connect the pressure kit to the pressure channels Place the electrodes or probe on the muscle you wish to work with using the red and black connectors To do BFB place the 3 me elect...

Page 16: ...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...

Page 17: ...requirements The following software must be installed on the computer Java 8 version 64 bits https www java com fr download FTDI Driver installation by CDM21228_Setup exe delivered with the software F...

Page 18: ...ton indicates a communication problem between the PC and the device In this case check the following points The module is powered up the green light on the front panel is on The USB cable is properly...

Page 19: ...onfiguration 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 par...

Page 20: ...on the right side of the page This description contains The name of the programme The duration of the programme A brief description In the case of a stimulation programme the current parameters are al...

Page 21: ...h U They are placed at the top of the programme list 5 3 Programs specific to the version 5 3 1 Version Adjustable Profile Allows you to define profile settings and adjust them in real time during exe...

Page 22: ...objects chosen by the user or objects related to the animation used 5 3 4 Version Chains The chaining mode allows you to create a programme by combining other programmes A profile is defined from othe...

Page 23: ...matically then release the effort for a few seconds The BioStim automatically sets the operating range Go to the next page by pressing the arrow or wait for the end of the taring time During the exerc...

Page 24: ...aring This setting allows the basic tone to be erased Zero Biostim minimum measurable by the device to work in negative BFB It is also possible to choose intermediate values 5 4 2 Stimulation The stim...

Page 25: ...ou wish to display on the screen 5 4 3 2 Version Position markers A mouse click on the page will add a marker line at the desired position Right click on the screen to add a time marker or an object t...

Page 26: ...by the patient allows taring to be adjusted during exercise Setting the Patient Zero for each channel 0 The level of the negative BFB using the sliders on each channel Events can be added to the curv...

Page 27: ...session 5 4 3 7 Version Assisted Biofeedback This mode available for adjustable programmes is activated either before starting the programme or from the side panel Stimulation is then used to reinforc...

Page 28: ...urchased To work with an accessory turn it on button on the white part of the Perifit or shake the Emy probe then click on the Bluetooth logo under the house When the accessory is connected the Blueto...

Page 29: ...Lille 2 and Lyon 1 for permission to insert a link to their 3D anatomical plates 5 7 Select a patient Clicking on the button will take you to the patient selection page This page displays the list of...

Page 30: ...arch page you can add a new practitioner or filter the list of patients by selecting a practitioner 5 8 Patient File When a patient is selected the patient s record can be accessed by clicking on the...

Page 31: ...s Pressing the button in the session table opens the session comparison page Relaunch the same program Selects the curves to be reviewed version Follow up form right click to delete Addition of a new...

Page 32: ...ou are notified of new versions and can install them directly from the software 5 10 Configuration page The configuration page allows you to configure the software The options available are Scroll Spe...

Page 33: ...program presentation page Customised animations are always visible Display the BFB pressure during stimulation only for pressure probes with electrodes type Evolys 3P from Sugar International Possibil...

Page 34: ...each lane and one or more objects to catch Put user programs in a subdirectory Off On 5 10 1Networking of several devices To network 2 or more devices they must be on the same network and have a commo...

Page 35: ...d bladder inhibition 2 Management of anal incontinence 3 Management of contractures and prolapses muscle strengthening and relaxation treatments 4 Pain management analgesic treatments 5 Management of...

Page 36: ...unplug the power cord before cleaning 7 2 Sterilization This device is not sterile The accessories are not sterile nor are they intended to be sterilised 8 Malfunction If you notice a malfunction that...

Page 37: ...gs and change them Flat trace in biofeedback windows loss of communication with the module no sensor on the input in question exit the current treatment and return to the main office check the route u...

Page 38: ...or specified by the manufacturer Machine parts and spare parts must not be replaced by the user Inappropriate use of this appliance or neglect of maintenance relieves lectronique du Mazet and its auth...

Page 39: ...ace on 14 12 2018 13 Manufacturer lectronique du Mazet is a company located in the heart of the Massif Central Originally a simple manufacturer of electronic cards over the years it has developed its...

Page 40: ...oors are covered with synthetic materials the relative humidity should be at least 30 Transients fast in bursts IEC 61000 4 4 2 kV for lines power supply electric 1 kV for lines input output 2 kV for...

Page 41: ...uch as base stations for radiotelephones cellular wireless and land mobile radios amateur radio AM and FM broadcasting and TV broadcasting cannot be predicted theoretically with accuracy To assess the...

Page 42: ...2 09 27 MEG010XN102 A11 ENG Your dealer distributor www facebook com MazetSanteFrance mazetsante fr ELECTRONIQUEDU MAZET ZA ROUTE DE TENCE 43520 LE MAZET SAINT VOY T l 33 4 71 65 02 16 Mail sav electr...

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