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Related Manuals for MTR+ DuoBravo U
Summary of Contents for MTR+ DuoBravo U
- Page 1 Biofeedback & EMG-triggered stimulation DuoBravo U Medical Device Operators Manual Please read this manual before using the device!
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Page 2: Table Of Contents
Operators Manual Content Please read the Operators Manual carefully before using the device and pay attention to all references ! In the following you’ll find all information directly necessary for performing the treatment with grey background. Page I. Biofeedback- / ETS-device DuoBravo Delivery &... - Page 3 Operators Manual Content Page IV. Therapy with DuoBravo The Different Phases Use of pre-set programs Therapy in a phase with pure stimulation Therapy in an EMG-phase Therapy in an ETS-phase Therapy in combined programs V. Additional Options for Configuration of DuoBravo Configuration of Free Programs Parameters of Free Programs 26-29...
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Page 4: Delivery & Accessories / Medical Device Reporting
Delivery & Accessories Included in the delivery: REF: 010E-089: 1 unit DuoBravo U (Urology), 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 1 operators manual With regular average use, the expected service life of DuoBravo is 5 years. -
Page 5: Technical Data
Operators Manual Technical Data Dual Channel EMG Range: 0.2 to 2000 µV RMS (continuous) Sensitivity: 0.l µV RMS Selectable Bandpass filter - 3db Bandwidth, a. Wide: 18 Hz +/- 4 Hz to 370 Hz +/- 10% - Reading below 235 microvolts 10 Hz +/- 3 Hz to 370 Hz +/- 10% - Reading above 235 microvolts b. -
Page 6: Explanation Of Symbols
Operators Manual Explanation of Symbols Safety Adjustments 1. The +buttons become inactive after one minute running time of a stimulation program to avoid an unintentional increase of intensity . This lock is switched off again, by pressing the +button three-times repeatedly. Now an increasing of intensity is possible again for another minute. -
Page 7: Introduction - What Is Duobravo
(ETS) or for neuromuscular stimulation. Doctors and patients are the intended operators for this unit. The DuoBravo is available in three different versions. DuoBravo U can be used for urologic, gynecologic and proctologic therapy while DuoBravo N is designed for neurologic and orthopedic treatments. -
Page 8: Indication
Operators Manual Indications With advice of a physician or physiotherapist, DuoBravo can be used by the patient without any help to support muscle training for: Main indication for DuoBravo U: • Elimination of light to mid strength faecal incontinence •... -
Page 9: Contraindication
Operators Manual Contraindications DuoBravo may not be used in the following cases: - By patients with electronic implants like pumps or a pace maker (as functional disturbances can occur). - By patients with myocardial damage (damage to the cardiac muscle) or arrhythmia (inconsistent heart beat). -
Page 10: Warnings
Operators Manual Warnings - DuoBravo is type BF equipment and may not immersed in liquids. - If using rechargeable batteries be sure to use a CE approved battery charger. Never connect the DuoBravo directly to the mains, to a battery charger or to any other mains powered equipment. -
Page 11: Advice On Application Of Electrodes
Operators Manual Advice on Application of Electrodes Make sure that DuoBravo 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 DuoBravo. -
Page 12: Maintenance
Operators Manual Maintenance DuoBravo has been designed to be maintenance free. Nevertheless, please adhere to the following advices: If needed, please clean DuoBravo with a mild detergent, water and a damp cloth. Do not expose DuoBravo to extreme humidity and do not submerge under water. You may clean the lead wires with a damp cloth. -
Page 13: Operating Elements
Operators Manual Operating Elements The START-button allows the choice of automatic (press) or manual (hold the button for 3 seconds) threshold-setting if an EMG-or ETS-program is chosen. The program will start after the START-button is released. +/- buttons for +/- buttons for threshold-setting and threshold-setting and setting of intensity... -
Page 14: Connections
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 reference- lead wire if you are using an EMG-program. -
Page 15: The Display
Operators Manual The Display After selecting a program with the PRG-button DuoBravo shows information about those parameters in its “Home Screen” that are used in the first phase of the program (stimulation fre- quency, pulse width, 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 16: The Info-Line
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: - When selecting a program, the target of the treatment is indicated in abbreviations. (REHAB = Rehabilitation / MIXED = mixed incontinence, etc.). -
Page 17: Basic Settings
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. 65) and you have turned on the device with the ON/OFF-button, you enter the configuration mode by pressing the SET button in the battery compartment for three seconds. -
Page 18: Setup Real Time Clock
Operators Manual Setup Real Time Clock Before first use of DuoBravo the integrated “Real Time Clock” should be set. It’s necessary later for therapy-control. DuoBravo has a small battery that will support the clock with energy for several years. For this reason, there is no need to set again, even if the 4 main batteries have been substituted or removed. -
Page 19: Preparation Of Therapy
Operators Manual Preparation of Therapy 1. Open the battery compartment at the back by pushing down the lid and insert 4 batteries type AA by hand according to the instructions on page 51. Then shut the battery-compartment. 2. Please make sure, that DuoBravo is switched off (no indication in LCD-display). Connect the single pin ends of the electrodes plugs with the surface-electrodes or with a probe. -
Page 20: The Different Phases
Operators Manual The Different Phases DuoBravo offers programs that can consist of one or more phases. There are basically three different types of these phases which can be therapeutically combined in a useful way. a) EMG (= Electromyography) - purely active biofeedback training is carried out. The patient tightens the muscle according to the requirements in the display for the specified time and then releases it again. -
Page 21: Use Of Pre-Set Programs
- DuoBravo U (Urology) = 12 programs Use of pre-set programs 1. Connect the electrodes to the device (s.p. 83) 2. -
Page 22: Therapy In A Phase With Pure Stimulation
Operators Manual Therapy with DuoBravo Therapy in a phase with stimulation In phases with work/rest-rhythm you can support treatment success by active muscle contraction during work-period effectively. Please take care that the muscle will relax in rest- periods completely. In display DuoBravo shows the fist as symbol for “work” and the open hand for “rest”. -
Page 23: Therapy In An Emg-Phase
Operators Manual Therapy with DuoBravo Therapy in an EMG-phase The device indicates a pre-set rhythm of work and rest, that the patient shall execute as precisely as possible. During work-period the symbol of the fist with up arrow is seen on the screen. The feedback regarding the success of your own muscular activities is given by the increasing numbers in the lowest line and by the yellow/green bargraph on each side of the display. -
Page 24: Therapy In An Ets-Phase
Operators Manual Therapy with DuoBravo Therapy in an ETS-phase An ETS-phase is similar to an EMG-phase, which means, that you follow the rhythm of work and rest, given by the device, with your muscular activities. If you succeed reaching the threshold the term BRAVO is indicated in the infoline of the display and the device stimulates your muscles automatically. -
Page 25: Additional Options For Configuration Of Duobravo
1. Switch on DuoBravo with the ON/OFF-button 2. Select PC1, PC2, PC3 or PC4 with the PRG-button. In DuoBravo U these custom programs are 13-16. In the left upper corner of the screen PC1-PC4 will be indicated. 3. Keep the SET-button in the battery-compartment pressed for 3-5 seconds. Then DuoBravo changes to programming mode and the bars beside the first parameter that can be set are flashing. -
Page 26: Parameters Of Free Programs
Operators Manual Parameters of Custom Programs Programming PC1 PC1 is a multi-phase program for passive stimulation only. With A+ the following parameters can be chosen and then altered by B+, if necessary. - Type of stimulation - (indicated in display: CON / SYN / ALT) - sets whether stimulation shall be continuously or in work/rest-rhythm. -
Page 27: Programming Pc2
Operators Manual Parameters of Custom Programs Programming PC2 PC2 is a single-phase EMG-program. 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 1-10 - Duration of work-period (WORK) - sets the time one single muscle contraction is held for - Duration of rest-period (REST) - sets the time of relaxation after contraction... -
Page 28: Programming Pc3
Operators Manual Parameters of Custom Programs Programming PC3 PC3 is a single-phase ETS-program. 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 1-10. -
Page 29: Programming Pc4
Operators Manual Parameters of Custom Programs Programming PC4 PC4 is a multi-phase program, in which each of the max. 5 phases can be configured in STIM-, EMG- or ETS-mode. Press SET to select consecutive phases. If you want to change a configured program and you do not need all the phases, please set the first phase that is no longer needed to “OFF”. -
Page 30: Lock-Button
Operators Manual Lock-Button If required, the therapist can lock out all of programs. To do this, select the desired program and press the LOCK-button with a thin pin. For this you can use the electrode connector. You’ll hear a short beep and the symbol of a padlock appears on screen. -
Page 31: Automatic Adjustment Of Threshold During Treatment
Operators Manual Threshold Automatic adjustment of threshold during treatment Once the threshold is set, it will stay the same for the entire duration of the treatment until you make a new setting - except if you have selected “automatic threshold adjustment.” In this case, the threshold would be adjusted during the treatment according to your performance. -
Page 32: Therapy-Control
Operators Manual Therapy-Control DuoBravo displays statistics after each program has been completed. All values of this completed session, which are named in pages 74-75 will be indicated on the screen automatically. With A+ you can scroll through the statistics. DuoBravo saves these statistics to its memory for download to the optional documentation tool. - Page 33 Operators Manual Therapy-Control The additional documentation tool is required to transfer the stored data to a PC. An electronic patient record, can easily be created. This optional documentation tool is very helpful for therapists for statistical reports. To transfer the data please insert the USB dongle, which is supplied with the documentation tool, into the computer.
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Page 34: Statistics
Operators Manual Statistics After termination of a treatment session DuoBravo shows statistics on its screen as follows. 1) WORK.AVG - Work Average: The average value in microvolts of all the work-segments excluding the first second of each segment. 2) REST.AVG - Rest Average: The average value of the rest-segments excluding the first second. - Page 35 Operators Manual Statistics 6) WORK DEV - Average deviation (per second) of work: It is the average deviation of the quarter-second samples from the average value in the second in which they occur (excluding the first second of each work-segment). If deviation is more than 20% it is considered problematic.
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Page 36: Trouble Shooting Guide
Operators Manual Trouble Shooting Guide Fault Possible Cause Solution Check electrodes and replace if Electrode lost adhesion to skin. necessary. Trip off - Elec- Electrode to dry Replace electrode. trode symbol flashing, current Lead wire not connected Check lead wire connections and won’t increase properly. -
Page 37: Programs Urology
Operators Manual Programs Urology Progr.: 01 STIM + EMG alternating - Urology Phase 1 Mode STIM - EMG alternating Frequency Stim Pulse duration µS Ramp up time secs Ramp down time secs Stim time secs Rest time stim secs Work time EMG secs Rest time EMG secs... - Page 38 Operators Manual Programs Urology Progr.: 05 Stress 2 - Urology Phase 1 Phase 2 Phase 3 Phase 4 Phase 5 Phase time Number of cycles Mode Frequency work Pulse duration µS Ramp up time secs Ramp down time secs Work time secs Stim time secs...
- Page 39 Operators Manual Programs Urology Progr.: 08 Mixed incontinence - Urology Phase 1 Phase 2 Phase 3 Phase 4 Phase 5 Phase time Number of cycles Mode Frequency work Pulse duration µS Ramp up time secs Ramp down time secs Work time secs Rest time secs...
- Page 40 Operators Manual Programs Urology Progr.: 12 Strength Endurance + Explosive Force 1 - Urology Phase 1 Phase 2 Phase 3 Phase 4 Phase 5 Phase time Mode Frequency work Pulse duration µS Ramp up time secs Ramp down time secs Work time secs Rest time...
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Page 41: Anatomy
Operators Manual Anatomy Mark the points of electrode placement if necessary. -
Page 42: Configuration
Operators Manual Configuration... -
Page 43: Waste Disposal / Recycling Of Batteries / Literature / Copyright
Operators Manual Waste Disposal In accordance with European regulations [1], used electrical and electronic equipment may not be discarded in household or unsorted municipal waste. Use separate collection facilities. Contact your local government or council for information regarding the collection systems available. If electrical appliances are disposed of in landfills or dumps, hazardous substances can leak into the ground water and get into the food chain damaging the health and well being of people and animals. -
Page 44: Electromagnetic Compatibility
Operators Manual Electromagnetic Compatibility If the device is used according to the instructions given in this manual, it corresponds to the safety requirements for medical electrical systems IEC 60601-1. DuoBravo was checked and is in accordance with the limits set for medical products in the standard IEC 60601-1-2:2020. These limits serve to the safety of the user regarding electromagnetic disturbances. - Page 45 Operators Manual Electromagnetic Compatibility Guidance and manufacturer’s declaration - electromagnetic Immunity The DuoBravo is intended for use in the electromagnetic environment specified below. The customer or the user of the DuoBravo should assure that it is used in such an environment IEC 60601 Electromagnetic Immunity Test...
- Page 46 Operators Manual Electromagnetic Compatibility Guidance and manufacturer’s declaration - electromagnetic Immunity The DuoBravo is intended for use in the electromagnetic environment specified below. The customer or the user of the DuoBravo should assure that it is used in such an environment Dis- IMMUNITY Test...
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Page 47: Graphics
Operators Manual Graphics Waveform: PW = Pulse Width Intensity depending on resistance:... - Page 48 Operators Manual Not for sale or use in the USA This device is presented by:...
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