MTR+ DuoBravo U User manual

Operators Manual
Biofeedback & EMG-triggered stimulation
DuoBravo U
Medical Device
Please read this manual before using the device!

Operators Manual
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Content
Please read the Operators Manual carefully
before using the device and pay attention
to all references !
In the following you’ll nd all information directly necessary for performing the treatment
with grey background.
Page
I. Biofeedback- / ETS-device DuoBravo
Delivery & Accessories / Medical Device Reporting 4
Technical Data 5
Explanation of Symbols 6
Safety Adjustments 6
Introduction – What is DuoBravo ? 7
Indication 8
Contraindication 9
Warnings 10
Advice on Application of Electrodes 11
Maintenance 12
Warranty 12
II. Display and Operating Elements
Operating Elements 13
Battery Compartment 13
Connections 14
The Display 15
The Info-Line 16
III. Preparation of DuoBravo
Basic Settings 17
Setup Real Time Clock 18
Setup Language 18
Preparation of Therapy 19

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Content
Page
IV. Therapy with DuoBravo
The Dierent Phases 20
Use of pre-set programs 21
Therapy in a phase with pure stimulation 22
Therapy in an EMG-phase 23
Therapy in an ETS-phase 24
Therapy in combined programs 24
V. Additional Options for Conguration of DuoBravo
Conguration of Free Programs 25
Parameters of Free Programs 26-29
Programming PC1 26
Programming PC2 27
Programming PC3 28
Programming PC4 29
Lock-Button 30
Threshold 30-31
Setting of threshold before start of treatment 30
Automatic adjustment of threshold during treatment 31
VI. Therapy-Control
Therapy-Control 32-33
Statistics 34-35
Trouble Shooting Guide 36
VII. Programs
Programs Urology 37-40
Anatomy 41
Conguration 42
Waste Disposal / Recycling of Batteries / Literature / Copyright 43
Electromagnetic Compatibility 44-46
Graphics 47

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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. The battery life
is approximately 12 hours or more at 20 mA per channel. The batteries can be stored for
approximately 2 years. The service life (expiry date) of electrodes, probes and electrode jelly is
printed on each package.
Accessories:
REF
011E-006: 1 unit self adhesive electrodes 40x40 (4 pieces)
011E-007: 1 unit self adhesive electrodes 40x80 (4 pieces)
011E-008: 1 vaginal probe “IncoProbe V”
011E-009: 1 rectal probe “IncoProbe R”
011E-017: 1 vaginal probe “Probe V plus”
011E-018: 1 rectal probe “Probe R plus”
Spare parts:
REF
012E-120: 1 lead wire to connect the electrodes
012F-037: 1 tube electrode jelly for probes
012E-086: 1 carrying case
012E-083: 1 single pin reference lead wire
052F-805: 4 batteries type AA
012E-081: 1 operators manual DuoBravo
DuoBravo shall only be used with original accessories.
Medical Device Reporting:
If there is a serious deterioration in the state of your health when using the medical device,
report this to your distributor or to the manufacturer and to the competent authorities of your
country.
Delivery & Accessories

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1. EMG
1.0 Dual Channel
1.1 EMG Range: 0.2 to 2000 µV RMS (continuous)
1.2 Sensitivity: 0.l µV RMS
1.3 Selectable Bandpass lter - 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. Narrow: 100 Hz +/- 5 Hz to 370 Hz +/- 10%
1.4 Notch lter: 50 Hz - 33 dbs
1.5 Common Mode Rejection Ratio: 130 dbs Minimum @ 50 Hz
1.6 Batteries: 4 x AA
1.7 Work / Rest periods: 2-99 seconds
1.8 Number of Trials: 2-99
2. Neuromuscular Stimulation
2.1 Dual Channel
2.2 0 - 90 mA into 500 ohm load, 70 mA maximum into 1000 Ohm load, 46 mA
maximum into 1500 Ohm load. (Indication only, actual intensity varies
depending on condition of skin electrodes).
2.3 Type: Constant current
2.4 Waveform: Symmetrical, rectangular, bi-phasic with net zero
DC current
2.5 Pulse width selection: 50-450 µS
2.6 Pulse Rate Selection: 1-100 Hz
2.7 Work / Rest periods: 0,5-99 seconds
2.8 Time 1 - 99 minutes
2.9 Ramp up time: 0.1 - 9.9 seconds
2.10 Preset and user programmable treatment programs
2.11 Automatic output shut o with detection of open electrode (> 0,5 mA)
The graphics of the waveform and of the intensity depending on resistance can be found on
page 91.
Dimensions: L 141,6 mm / W 74 mm / H 40,4 mm - Weight of the device: 275 g (incl. batteries)
Firmware version 3.1B or later
Wireless Link:
RF Frequency Range: 2.4000 GHz to 2.4835 GHz / RF Default Output Power: <= 1,0 mW
RF Maximum Output Power: <= 2,52 mW / Antenna Gain: 0 dBi
Max. environmental conditions for transportation: -25 to +70 degree centigrade, 0-93%
atmospheric humidity. Recommended environmental conditions for storage: -25 to +40 degree
centigrade, 0-93% atmospheric humidity. The device shall not to be stored in direct sunlight.
Allow up to one hour for the device to return to normal operating temperature if stored in
conditions below +5°C or above +40°C.
Environmental conditions for use: +5 to +40 degree centigrade, 0-93% atmospheric humidity,
air pressure 700-1060 hPa. During use the surface temperature of the device can be 41°C or
higher, but never exceeds 48°C.
The DuoBravo is protected against debris larger than 12.5 mm in diameter from entering the
cabinet and is not water resistant and rated IP20.
Technical Data

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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 o again, by pressing the
+button three-times repeatedly. Now an increasing of intensity is possible again for another
minute.
2. If the electrical circuit is interrupted during operation (> 2 mA), for example by
losing an electrode or by a broken lead wire, the device stops stimulating immediately.
3. When a phase ends and the next phase contains stimulation, the intensity is automatically set
to 8 mA and must be set to the desired setting by the user.
4. The DuoBravo features a stimulation circuit failure detection system incorporated into the
device and its software. Four pulses with a pulse width and voltage not exceeding 1µS and
6 volts are triggered before each main pulse to check the integrity of the circuit. These pulses
cannot be felt and do not eect the ecacy of the device. If a failure is detected during this test,
STIM F will display on the LCD. If STIM F is repeatedly displayed on the LCD then the unit
should be returned to the manufacturer for testing. This is an added safety protection system to
ensure each pulse generated by the device is safe for the user.

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Introduction – What is DuoBravo ?
The DuoBravo is a modern device for biofeedback and neuromuscular stimulation. The term
biofeedback refers to a method to perceive biological processes with the help of a technical
device. This instrument measures physical activity - even if there are no visible or no voluntary
muscle contractions - and converts them to optical and/or sound signals. DuoBravo is a
combined two-channel device that can be exibly used for electromyography (EMG) or EMG-
triggered stimulation (ETS) or for neuromuscular stimulation. Doctors and patients are the
intended operators for this unit.
The DuoBravo is available in three dierent versions. DuoBravo U can be used for urologic,
gynecologic and proctologic therapy while DuoBravo N is designed for neurologic and
orthopedic treatments. The combination device DuoBravo U + N contains all programs. Each
version includes preset EMG- and ETS-programs as well as multiple stimulation programs in
dierent modes. Additionally the devices have 4 customizable programs in which individual
STIM-, EMG- and/or ETS-phases and a combination can be set.
The clip on the back of the unit allows the user to fasten the device to the clothes, the unit is
intended to be supported by hand during normal use. The belt clip is for temporary relief only.
During treatment it’s not necessary to hold DuoBravo, since it can stand upright on a at
surface in its stand. This allows the patient to train or to be treated while observing the success
of the individual eorts. The muscle activity is indicated by a yellow-green bargraph on each
side of the screen and by numerical values in the bottom-line of the display.
At the end of each session, the screen automatically displays the average values of muscle
activity in this session. The DuoBravo can be used with or without connection to a personal
computer. The stored treatment data can be transmitted to the PC at a later date using a
separately available documentation tool.
This device is quality controlled and fullls all legal requirements for medical products.
Therefore this device carries the CE-sign „CE 0123“. The serial number is on the rear of the
unit.
Manufacturer: MTR+ Vertriebs GmbH
Kamenzer Damm 78, 12249 Berlin, Germany
www.mtrplus.com

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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
• Elimination of light to mid strength urinary incontinence
- Urge-incontinence
- Stress-incontinence
- Mixed-incontinence
Side indication for DuoBravo U:
• Improvement of blood ow
• Improvement of muscle spasticity
• Muscle Strengthening
- Avoidance of muscular imbalances
- Activation of muscular bers
- Muscle Fatigue
- Strengthening of atrophied muscles
- Muscle Recovery
• Conservation and extension of mobility
• Release of bodily endorphins
• General Pain Relief and Pain Therapy including but not limited to:
Arthritis
Back Pain including but not limited to:
- Chronic Back Pain
- Cervical Spine Pain
- Thoracic spine Pain
- Lumbar spine Pain
Circulation problems
Fracture Pain
Myalgia
Neuralgia
Phantom Pain
Indications

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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).
- In presence of ammable anesthetic mixtures with air or with oxygen or nitrous oxide.
- When operating machinery with a potential of danger.
- While driving a vehicle.
- By patients with epilepsy.
- If severe local inammation or thrombosis is present.
- By patients with mechanical ileus.
- By patients with febrile illnesses or infectious diseases.
- Do not use with a surgical high frequency apparatus because burn marks could occur under
neath the electrodes.
- When using metal-containing contraceptive spirals.
Please pay unconditional attention to the following basic rules:
- Do not stimulate transcerebraly (via the head).
- Do not stimulate via the Carotis-Sinus-Nerve (carotid artery).
- Do not stimulate in the area of the Sinus knot (heart).
- Do not stimulate on the Bulbous (eye).
- Do not stimulate in the Larynx-Pharynx-Area (throat / mouth).
- Do not stimulate in places with skin defects.
- Do not position the electrodes directly on the spine.
Take special care with the use of the electric stimulation:
- if stimulation is located close to osteosynthesis material (metal in the body).
- if after an operation the healing process can be interrupted through a muscle contraction.
- after acute bleeding or bone fractures with a tendency to bleed.
- during menstruation or pregnancy.
- in case of de-sensitization of the skin (damaged nerves).
- if patients cannot use the device properly, due to mental or physical limitations.

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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.
- The operator may not touch the battery contacts & patient simultaneously.
- To avoid the eects of electromagnetic interference never use the DuoBravo in the EMG-
mode, with less than 4 metres distance to a cellular telephone or near any other powerful
radio interference producing equipment that causes electrical signals etc. In the EMG Mode,
the DuoBravo may be susceptible to strong interfering radio type emissions that may lead to
temporally increased EMG microvolt readings. If suspected interference is causing a problem
with EMG readings, change position of the device and move away from any electrical
emitting equipment. The reading will immediately return to the correct value when the
interference ceases.
- The power supply of some laptop computers or devices which do not have an earth connection
may cause signicant interference aecting the DuoBravo. As a precautionary measure
please make sure that the power cord of the laptop or the devices are as far away as possible
from the lead wires of the patient. If interference persists, remove the power cable from your
computer and use it with its battery. Winding the lead wires around a limb (arm or leg) may
also help this interference.
- If device operation occurs close to short wave, microwave, cellular or other wireless
equipment, instability of the values of the stimulator could occur causing a temporary
reduction in current. Move away from the source of interference and continue the program.
- Burn marks could occur underneath the electrodes if used with surgical high frequency
apparatus.
- The application of the electrodes near the thorax can increase the risk of cardiac brillation.
- Patients with metal or electronic implants may only stimulate with permission of an
experienced doctor.
- Stimulation in the area of tumors is allowed only by instruction of an experienced doctor.
- If in the case of treatment with the incontinence probes, pain or irritation appear in the area of
the pelvis, or bleeding in-between menstruation, interrupt the therapy and consult your doctor.
- If high frequency is combined with a wide pulsewidth, please stimulate with low intensity
only.
- If you have swallowed any part of the device or any of its accessories, please contact a doctor
immediately.
- TENS and muscle stimulation should be used during menstruation or by pregnant women as
well as by children under the guidance of a doctor or therapist only.
- Please don’t use a probe during menstrual period or pregnancy.
- The DuoBravo may not be operated if the battery compartment is not closed. Before opening
the battery compartment, make sure that there are no lead wires in the jacks at the head of the
unit.
- Remove batteries and battery cover, drain water from device and allow (DuoBravo) to dry
normally for 48 hours if accidentally submerged in water.
Please, keep this device stored out of the reach of children. Do not leave the lead wires in
reach of children, since strangulation is possible due to the length of the lead wires.