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Summary of Contents for MTR+ SineBravo
- Page 1 2-Channel EMG-Biofeedback SineBravo Medical Device Operators Manual Please read this manual before using the device!
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Page 2: Table Of Contents
In the following you’ll find all information directly necessary for performing the treatment with grey background. Page I. Biofeedback-device SineBravo Delivery & Accessories / Medical Device Reporting Technical Data Explanation of Symbols Introduction – What is SineBravo ? Indication Contraindication Warnings Advice on Application of Electrodes Maintenance Warranty II. - Page 3 SineBravo Operators Manual Content Page IV. Programs V. Additional Options for Configuration of SineBravo Configuration of Custom Programs Parameters of Custom Programs Lock-Button Threshold Setting of threshold before start of treatment Automatic adjustment of threshold during treatment VI. Therapy-Control Therapy-Control...
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Page 4: Delivery & Accessories / Medical Device Reporting
Delivery & Accessories Included in the delivery: REF: 010E-087: 1 unit SineBravo, 2 dual pin lead wires to connect the electrodes, 1 single pin reference lead wire, 8 self-adhesive electrodes (40 x 40 mm), 1 stand, 4 batteries type AA and... -
Page 5: Technical Data
700-1060 hPa. During use the surface temperature of the device can be 41°C or higher, but never exceeds 48°C. The SineBravo is protected against debris larger than 12.5 mm in diameter from entering the cabinet and is not water resistant and rated IP20. -
Page 6: Explanation Of Symbols
The belt clip is for temporary relief only. During treatment it’s not necessary to hold SineBravo, since it can stand upright on a flat surface in its stand. This allows the patient to train without help while observing the success of the individual efforts. -
Page 7: Indication
- if patients cannot use the device properly, due to mental or physical limitations. - while driving a vehicle. SineBravo is an electronic device, therefore users with cardiac pacemakers may be at risk of interference. Although EMG is not expected to interfere with pacemakers, MTR + does not permit the use of the SineBravo for people with pacemakers. -
Page 8: Warnings
- SineBravo is a type BF equipment - Do not immerse SineBravo into water or any other liquids. - Do not use SineBravo in presence of flammable anesthetic mixtures with air or with oxygen or nitrous oxide. - If using rechargeable batteries be sure to use a CE approved battery charger. Never connect the SineBravo directly to the mains, to a battery charger or to any other net-powered equipment. -
Page 9: Advice On Application Of Electrodes
SineBravo Operators Manual Advice on Application of Electrodes Make sure that SineBravo is turned off (no indication visible on the LCD display). Now connect the single poled ends of the lead wires with the electrodes. The output plugs of the electrode lead wires will be plugged into the channels A or B of the SineBravo. -
Page 10: Maintenance
SineBravo has been designed to be maintenance free. Nevertheless, please adhere to the following advices: If needed, please clean SineBravo with a mild detergent, water and a damp cloth. Do not expose SineBravo to extreme humidity and do not submerge under water. -
Page 11: Operating Elements
SineBravo Operators Manual Operating Elements The START-button allows the choice of automatic (press) or manual (hold the button pressed for 3 seconds) threshold-setting. The program will start after the START-button is released. +/- buttons for +/- buttons for threshold-setting for... -
Page 12: Connections
SineBravo Operators Manual Connections Jacks to connect the electrode-lead wires of channel A and/or B, each suited for surface- electrodes or probes. Jack for the single pin EMG-reference lead wire (skin-electrode) Attention: Even if the device is used with a probe, please always connect the single pin reference... -
Page 13: The Display
SineBravo Operators Manual The Display After selecting a program with the PRG-button SineBravo shows information about those parameters in its “Home Screen” that are used in the first phase of the program (number of trials, threshold, etc.). Start the treatment by pressing or holding START, the display changes to work-screen and shows necessary information for treatment in the active phase. -
Page 14: The Info-Line
SineBravo Operators Manual The Info-Line The info line in the upper part of the screen shows always the remaining time of the entire program during treatment. Outside a treatment session, it provides more additional information: - While setting the clock or when chosing the language, it shows values to be set in plain text. -
Page 15: Basic Settings
SineBravo Operators Manual Basic Settings In all programs, even in the preset programs, individual settings can be made as follows. After you have put in four batteries type AA (s.p. 38) and you have turned on the device with the ON/OFF-button, you enter the configuration mode by pressing the SET button in the bat- tery compartment for three seconds. -
Page 16: Setup Real Time Clock
Setup Language SineBravo is able to show 6 different languages. If you are in the setting-mode of the RTC (see above), please press the SET-button for 10 seconds once again. Now you can select German-, English-, French-, Spanish-, Italian- or Polish-language with the B-buttons. -
Page 17: Preparation Of Therapy
If you are using a probe, place the single reference-electrode onto the hip bone and then insert the probe. 8. Now switch on SineBravo by pressing the central ON/OFF-button once. You can see the version of the device for 3 seconds before the last used program appears, showing its parameters. -
Page 18: Therapy With Sinebravo
1. Connect the electrodes to the device (s.p. 39) 2. Place electrodes or probe according to the instructions of your therapist 3. Switch on SineBravo with the central ON/OFF-button 4. Select the desired program with the PRG-button 5. Press START and the threshold will be set automatically by doing two short work/rest-periods. -
Page 19: Programs
2-99 sec. 2-99 sec. Options for Configuration of SineBravo Additionally to the use of pre-set programs as described in the previous chapter, SineBravo offers a great variety of possibilities to adapt the therapy-parameters according to individual needs. This concerns the pre-set programs that can vary in regard of the basic adjustments as well as the 3 customizable programs, in which the experienced therapist or user is able to create completely new programs. -
Page 20: Parameters Of Custom Programs
SineBravo Operators Manual Parameters of Custom Programs PC 1-3 are single-phase EMG-programs. With A+ the following parameters can be chosen and then altered by B+, if necessary. - Volume - (indicated in display: VOLUME) - sets the volume of sounds for feedback in steps... -
Page 21: Threshold
SineBravo Operators Manual Threshold The threshold is a target value that shall be achieved by personal effort. It is measured in microvolts and displayed for both channels in the middle line of the screen. The arrows in the middle of the bargraph on the left and right side of the display represent the thresholds. -
Page 22: Therapy-Control
Up to 200 days of treatment data is stored in the SineBravo memory. When 201 days of data are reached, consecutive days will overwrite the earliest days. For this reason the statistics will always show the actual data of the last 200 treatment days. - Page 23 The transfer of stored data can be done as follows: • Start the optional software on your PC. • Create or select the patient. Switch on the SineBravo. • • Press the LOCK-button once, if the device was locked – or twice if it was unlocked. •...
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Page 24: Statistics
SineBravo Operators Manual Statistics After termination of a treatment session SineBravo shows statistics on its screen as follows. The info-line indicates what value is shown. WORK.AVG - Work Average: The average value in microvolts of all the work-segments ex- cluding the first second of each segment. -
Page 25: Trouble Shooting Guide
SineBravo Operators Manual Trouble Shooting Guide Fault Possible Cause Solution Flat battery or no batteries Check / Replace batteries. installed in device. Remove batteries and install Battery installed in wrong according to diagrams in battery Device does not orientation. compartment. -
Page 26: Anatomy
SineBravo Operators Manual Anatomy Mark the points of electrode placement if necessary. -
Page 27: Configuration
SineBravo Operators Manual Configuration... -
Page 28: Waste Disposal / Recycling Of Batteries / Literature / Copyright
[1] European Community directive 2012/19/EU on waste electrical and electronic equipment. Recycling of Batteries The batteries should be replaced when they are drained or stop functioning. The batteries supplied with the SineBravo are recyclable. Remove the batteries from the unit and follow your local recycling guidelines. Literature A list of literature regarding the topics of this manual can be found on our website „www. -
Page 29: Electromagnetic Compatibility
IEC 60601-1-2:2020. These limits serve to the safety of the user regarding electromagnetic disturbances. The SineBravo is a Class B device and is suitable for home healthcare environments as well as typical clinical environments. - Page 30 Electromagnetic Compatibility Guidance and manufacturer’s declaration - electromagnetic Immunity The SineBravo is intended for use in the electromagnetic environment specified below. The customer or the user of the SineBravo should assure that it is used in such an environment IEC 60601...
- Page 31 Electromagnetic Compatibility Guidance and manufacturer’s declaration - electromagnetic Immunity The SineBravo is intended for use in the electromagnetic environment specified below. The customer or the user of the SineBravo should assure that it is used in such an environment Dis-...
- Page 32 Not for sale or use in the USA This device is presented by:...
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