schwa-medico UROstim 2 User manual

HOLISTIC HEALTH
Instruction for use Art. No. 10006805
UROstim 2
INCONTINENCE TREATMENT DEVICE

schwa-medico Instructions for use - UROstim 2
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Contents
1. Important instructions 3
Intended purpose 3
Safety instructions / warnings for the
product UROstim 2 4
Contraindications 6
Side eects 7
2. Incontinence - what is it? 8
The most common forms and
causes of urinary incontinence 8
The most common forms and
causes of faecal incontinence 9
Treating incontinence 9
Electrostimulation treatment 9
3. Function of the UROstim 2 10
Control elements 10
4. Operating the UROstim 2 11
Preparation for treatment 11
Application of electrodes for incontinence,
programmes 1 through 5, 7through 8 12
Attaching the electrodes for pain therapy,
programme 6 14
Commissioning 16
Programme selection 16
Starting stimulation 16
Setting the intensity 16
Stopping the stimulation 17
Locking the device 17
Timer setting 17
Saving and recalling the operating
parameters 17
Programming the changeable
programmes P1-P8 18
Buzzer setting 18
Switch o the device 18
Charging the integrated accumulator 19
Battery return and disposal 19
5. Description of programmes 20
6. Technical specifications and general
information 22
Technical data 22
Classification 22
Warranty 22
Warranty 22
Description of the symbols 22
Care and cleaning 23
Scope of delivery 23
Compatibility of accessories 24
7. Accessories 24
Vaginal and rectal electrodes 24
Self-adhesive electrodes 26
Other accessories 27
8. Programme overview 29
Dear Customer,
We are pleased that you have decided to purchase a UROstim 2. In these instructions
for use, you will read everything you need to know for application, along with
valuable tips and advice for treatment. We therefore ask that you read them carefully
before using your device for the first time.

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1. Important instructions - please read before use!
Intended purpose
Use and indications
The UROstim 2 is a medical device. It is used for transcutaneous (transcutaneous:
through the skin by means of skin electrodes) and transmucosal (transmucosal:
through the mucous membrane, by means of vaginal electrodes and rectal electrodes)
electrical stimulation of the muscles and nerves in humans. The UROstim 2 is designed
to relieve symptoms associated with overactive bladder and various forms of urinary
incontinence such as stress incontinence, urge incontinence, mixed incontinence and
faecal incontinence. In addition, acute and chronic pain of all kinds can be treated
with the use of a pain programme.
Treatment with the UROstim 2 can be carried out in a clinical or home environment
by users (doctors, therapists, nurses, etc.) and/or patients after instruction. Treatment
can be administered several times a day and as long-term therapy.
Target group
The UROstim 2 can be used to treat all persons who are mentally and physically
capable of placing the electrodes and adjusting the current strength, taking into
account the contraindications, or who are capable of expressing pain or a desire to
modify or end treatment in the case of non-independent treatment.
The use of the vaginal and rectal electrode accessories is only approved for adolescent
and adult patients.
The product can also be used by laypeople.
They must have read and understood the instructions for use, especially the chapters
"Contraindications" and "Safety instructions / warnings", before using the product for
the first time. If anything is unclear, it is essential to consult a healthcare professional
(or the manufacturer).
Detailed medical questions, especially regarding contraindications, may only be
clarified by the attending physician or family doctor. If the product is prescribed by a
doctor's prescription, the user/patient must be given instruction before their first use.
Attention: Incontinence or pain can indicate serious disorders in the body and must
be clarified by a doctor. Even if the use of UROstim 2 is successful, this does not
necessarily mean that the cause of the condition has been cured. Please also pay
particular attention to the contraindications for the vaginal and rectal electrodes.

schwa-medico Instructions for use - UROstim 2
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Safety instructions / warnings
for the product UROstim 2
Please read the instructions for use carefully prior to using the device!
Keep for later reference!
1 Never use the product if it is not working properly or if
it has been damaged.
If malfunction or errors unexpectedly occur, please contact our service
technicians. Service and repairs may only be performed by authorised
specialists to ensure safety and maintain the warranty (you can find the
addresses on the last page of the Instruction for use).
Caution: If the product is modified, suitable inspections and tests must be
carried out to ensure the further safe use of the device.
2Caution:Only use after prior consultation with a physician
Electrical stimulation therapy should never be applied above or through the
head, directly on the eyes, under the roof of the mouth, at the front of the
neck (particularly the carotid sinus) or when using electrode surfaces placed
on the chest and upper back or crossing the heart.
Warning: The application of electrode surfaces next to the thorax may
increase the risk of atrial fibrillations. In the case of electrode installations
in the chest area, intensive higher-frequency stimulation (from approx.
15Hz) can lead to disturbance of breathing activity during stimulation.
3Warning: The product may not be used while operating machines or
during activities that require a higher degree of attention. This applies
especially in trac!
4 Keep water and other liquids away from the product,
because otherwise uncontrolled current flows may occur, electric shocks
are possible, and the product would be damaged. The vaginal and rectal
electrodes can be lightly moistened with water or ultrasound gel for more
comfortable insertion.
5The product may only be used with original accessories.
The use of other accessories (especially electrodes with a smaller electrode
area than 2cm2) can lead to improper operation. The electrodes in the
scope of delivery can be used without any problems.
6Caution: Simultaneous connection of the patient to an ME (medical
electrical) device for high-frequency (HF) surgery can cause burns below
the electrode areas of the product and result in damage to the stimulation
current device.
7Caution: Operation immediately next to (e.g. 1 m away from) an ME
device for shortwave or microwave therapy may cause fluctuations in the
output levels of the product, resulting in painful eects.

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8Caution: Portable HF telecommunication devices (radio equipment,
mobile telephones) (including their accessories such as e.g. antenna cables
and external antennas) should not be used within a distance less than 30cm
(12 inches) to the UROstim 2 (including its accessories). Non-compliance
may lead to inferior device performance or faulty operation
9Caution: The use of this device directly next to other devices or stacked on
top of them should be avoided because it may result in malfunction. If the
use as previously described is nevertheless necessary, this device and the
other devices should be monitored to establish that they are working
properly.
10 Applying the electrodes:
a. The product should only be connected to one patient at a time.
b. Before applying the electrodes, clean the skin surface where the electrodes
will be applied. Otherwise, faulty operation cannot be ruled out.
c. Make sure that no metallic objects such as jewellery or piercings come
into contact with the electrodes during stimulation, as this may result
in localised burns.
d. Tattoo inks can contain metallic pigments which, under the influence
of current, can in rare cases cause high current densities and skin
damage. -> Wherever possible, stimulation in areas of the body with
tattoos should be avoided. If it is not possible, stimulation in these
areas of the body should be observed with closer attention and ended
immediately in the event of an emergency.
e. Current densities above 2 mA/cm2on all electrode surfaces may require
increased operator attention or painful eects may occur.
f. Caution: Place the electrodes on the skin so that the electrode surface
makes full and even contact with the skin. Make sure additionally that
the distance between the electrodes is at least 2 cm. Otherwise, too
high current densities can occur and thus painful skin lesions can occur
on the skin.
g. In patients with metal implants who have sensory disturbances in the
area of the metal, special caution should be taken when stimulating
and placing electrodes in this area. The sensation disturbance may
tempt users to increase the setting of the stimulation intensity and lead
to skin irritation with reddening of the skin or pain in the area of the
metal. In this case, it is necessary to stop the stimulation.
11 Do not drop the product or handle it improperly.
Apply only at temperatures of 10°C - 40°C, a relative air humidity of 30%-
75% and air pressure between 70 kPa and 106 kPa). Therefore do not use
the product e.g. in the bathroom or in a similarly humid environment.
Warning: Do not operate the device in the vicinity of potentially
explosive and/or flammable substances or fumes!

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Contraindications
In general, treatment with the UROstim 2 is tolerated very well. In the case of the
following contraindications, however, it should not be used or should only be used
in consultation with the attending physician:
»Users with electronic implants such as pacemakers or pumps
»Users with heart rhythm disturbances
»Users with susceptibility to fits (epilepsy)
»Users with skin/mucous complaints (such as wounds, eczema, radiation damage) in
the area of the electrodes
»Users with malignant conditions in the stimulation area
»Users with pathogenic infections (e.g. tuberculosis, osteomyelitis) in the stimulation
area
»Users with phlebitis and blood clots (thrombophlebitis and thrombosis) in the
stimulation area
»Users at increased risk of bleeding as a result of illness or medications, or with fresh
bleeding in the stimulation area
»Users who are pregnant
»Users with IUDs (for contraception)
Caution: If you expose this device to sudden temperature changes from
cold to warm, do not switch the device on until it has reached the same
temperature as its environment that it is to be used in; wait for at least
30min. Otherwise, condensation that forms inside the device may result in
electrical shock, fire, damage to the device and/or personal injury.
12 Careful supervision is recommended if the product is used in the vicinity of
children. Keep the product and its packaging out of reach of children.
Risk of strangulation from the cables and wires of this device and its
accessories!
13 Store the product in its original packaging to protect it from damage and
impurities.
14 For commercial use in Germany, the operator is required as per § 11
ordinance on operators of medical devices to conduct technical safety
controls for the product in regular and appropriate intervals. The
manufacturer recommends performing technical safety controls on the
product every 24 months. Please observe the legal requirements that
apply in your country.
15 Caution! Please also observe the instructions for use of the self-adhesive
electrodes or the vaginal/rectal electrodes, especially the safety instructions
contained therein.

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»Users with severe sensitivity disorders (sensory disorders) in the area of application
»Users with severe local inflammation
Caution! When using vaginal electrodes or rectal electrodes:
Please note the additional contraindications described in the instructions for use
of the vaginal/rectal electrodes!
Side eects
Treatment with the UROstim 2 is easy and simple. It is a well-tolerated therapy with
very few side eects.
The following side eects may occur:
»Pain:Pain or an intensification of existing pain may occur with strong and prolonged
application. To avoid pain as much as possible, you should carry out the first
treatments with a weaker current and over a shorter period of time.
»Skin or mucous membrane intolerance can occur as a reaction to the electrodes,
the electrode gel or the current pulses themselves. Users who experience long-
lasting redness, burning, itching or blisters under the electrodes or in the electrode
system following stimulation should consult their doctor before further stimulation.
A slight, non-persistent reddening of the skin, on the other hand, is normal,
as blood circulation is improved by the treatment.
»Muscle pain in the sense of muscle soreness can occur when muscle stimulation is
prolonged and too intense. To avoid this, you should work with shorter and less
intense stimulation, especially in the first treatments.

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2. Incontinence - what is it?
Incontinence is the involuntary leakage of urine, stool or both. Millions of people
suer from this disease.
The most common forms and causes of urinary incontinence
In the case of stress incontinence, urine first begins to leak in drips or streams during
physical exertion and then later while at rest. It is mainly women who are aected.
Stress incontinence is divided into three degrees of severity:
1. Involuntary leakage of urine during sudden heavy exertion, e.g. when coughing,
laughing, sneezing.
2. Involuntary urination even during light physical exertion, e.g. when walking,
climbing stairs or lifting objects.
3. Involuntary urination while standing, without change in abdominal pressure, and
finally even while lying down.
The causes of stress incontinence lie in a defect of the occlusion apparatus, usually as a
result of untrained or overstretched pelvic floor muscles, such as after heavy births. A
hormone deficiency, often caused by age, also plays a role in women.
Urge incontinence is a strong urge to urinate, even with small amounts of urine, that
can lead to premature urination. Urge incontinence occurs as part of the overarching
clinical picture of overactive bladder, which can also occur without urine leakage and is
only manifested as a frequent urge to urinate. The cause of overactive bladder and
urge incontinence is increased work by the bladder muscles. Overactive bladder can
also be treated with the UROstim 2; the treatment is the same as for urge incontinence.
Urge incontinence and stress incontinence also often occur in mixed form.
Another form of urinary incontinence is overflow incontinence, where the bladder
cannot suciently empty due to a drainage obstruction. The cause can be, for example,
an enlargement of the prostate.
Last but not least is reflex incontinence, in which the bladder empties uncontrollably. It
occurs after spinal cord injuries, among other things.

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The most common forms and causes of faecal incontinence
Faecal incontinence is also divided into 3 degrees of severity:
Degree 1: Uncontrolled release of gas
Degree 2: Uncontrolled release of gas and liquid stool
Degree 3: Uncontrolled release of solid stool
Faecal incontinence can be caused by damage to the muscular occlusion apparatus. It
occurs after childbirth, perineal tears or other injuries, such as surgery on the pelvic
floor or sphincter. A regression of the musculature is also caused by ageing.
A reduction in sensation in the rectum with a lack of information about the state of
filling and firmness also leads to incontinence. This is caused by nerve injuries,
e.g. from operations such as those for haemorrhoidal disease.
Treating incontinence
The treatment of incontinence depends on its cause. It can be treated with medication,
physical therapy such as pelvic floor exercises and stimulation current treatment or
surgical procedures. For all treatments, a medical examination and diagnosis is required
before starting!
Electrostimulation treatment
Electrostimulation treatment is suitable for the treatment of stress incontinence,
overactive bladder or urge incontinence as well as its mixed forms and muscular forms
of faecal incontinence. This form of treatment uses a light current to stimulate the
nerves and muscles in the area of the pelvic floor. The current is administered via skin
electrodes or electrodes inserted into the vagina (vaginal electrodes) or rectum (rectal
electrodes).
Treatment can be given in combination with other therapies such as pelvic floor
exercises and medication, or as a stand-alone application. Operating the
electrostimulation unit is easy to learn and is explained to the patient by their doctor or
physiotherapist.
Applications can be done in the privacy of home. Electrostimulation treatment can also
help to relieve pain. For this reason, the UROstim 2 oers special programmes that can
be used for specific pelvic pain.

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3. Function of the UROstim 2
Control elements
All settings can be made using the buttons. The display visualises the dierent
operating states.
1Display (see A-F)
2 Menu buttons
3Modification keys
3A Intensity channel 1
3B Intensity channel 2
The 3A and 3B buttons can be used
in Edit mode to change various
parameters.
4On/o button
5 Accumulator slot (rear)
6Output sockets
7Socket for charging cable
8ON/OFF slide switch
4
2
1
3A 3B
5
66 7
8

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AAccumulator charge status
full
empty
BDisplay of the selected
programme:
U = URO standard programme
P = UserProgramme
CProgramme duration or
remaining programme time
DCurrent intensity of each channel in mA (milliampere) in 0.5 mA increments.
EDisplay of programme phases
Rising phase: Working phase:
Falling phase: Rest phase:
FLocking active:
Only intensity can be changed
4. Operating the UROstim 2
Preparation for treatment
After unpacking the UROstim 2 and accessories, check whether the integrated
accumulator still has sucient voltage. When you switch on the unit, you can see the
battery’s status by the battery symbol. If the UROstim 2 can no longer be switched
on, the accumulator voltage is probably too low. If this is the case, charge the device.
»Turn the device o.
»Connect the charging cable for the power supply unit and let the accumulator
charge.
»In the next step, connect the electrode cables to the self-adhesive electrodes or to
the VSP-1 or RSP-1.
»This step is not necessary for the other vaginal and rectal electrodes, as they are
already permanently connected to the cable.
F
E
D
C
B A

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Application of electrodes for incontinence, programmes 1 through 5,
7through 8
Now place the electrodes. The self-adhesive electrodes are stuck to the skin at the
application points. The current that flows out of a channel consists of the positive
pole, the anode, and the negative pole, the cathode. The red cable connector that
connects the TENS unit to the electrode represents the anode. The blue cable
connector represents the cathode. It should be noted that with biphasic pulses, the
poles are constantly changing.
Attention: For both monophasic and biphasic programmes, it is recommended to
place the anode at the point where the pain is greatest.
1. Attached above the pubic bone and the gluteal cleft
Select contact points so that muscle twitches are felt at some intensity.
Anode (red) Cathode (blue)
Anode (red) Cathode (blue)
2. Dam
Place the anode (red) above the pubic bone (see picture above). Cathode (blue)
as pictured below.
Cathode (blue) Cathode (blue)

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3. Vaginal and anal appliance
Tip: This form of training also
works well if stimulation by
means of skin electrodes is more
dicult as a result of being
overweight!
Women can choose to use the
vaginal or rectal electrode to treat
stress incontinence. For the treatment of overactive bladder and urge incontinence,
the vaginal electrode is preferable.
4. Tibial nerve stimulation
The contact point of the electrode marked in red (red
connector on the electrode cable) is found by using the
width of the hand as a measurement. Place the edge of the
hand on the centre of the knuckle as shown, with the upper
edge of the hand indicating the centre of the electrode
position.
Attach the electrode marked in blue as shown and connect
it to the blue connector on the cable.
5. Electrode system for menstrual cramps
The contact points of the electrodes as described under 4.
oron the lower abdomen as in the illustration on the right.
Now connect the electrode cables to the device by inserting
the connectors into the corresponding sockets at the
bottom of the unit. Lie down or sit down so that you are
comfortable, and the treatment can now begin.
6. Sacral stimulation
The electrodes are stuck to both sides of the sacrum
asshown in the illustration (Foramina S2, S3).
Placement of the rectal
electrode
Placement of the
vaginal electrode
Placement of
the electrodes
Placement of the
electrodes

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Back pain Shoulder pain one
channel
two channels
11
2
2
Shoulder/neck pain
Neck pain
Tennis elbow
(epicondylitisradialis)
Golfer's elbow
(ulnarepicondylitis)
Hip osteoarthritis
(only one channel)
Attaching the electrodes for pain therapy, programme 6
Anode red cable connector Cathode blue cable connector

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Sciatica pain
Knee joint arthritis pain
Ankle pain
Achilles tendon pain
Trigeminus neuralgia
Migraine
Tension headache
Carpal tunnel syndrome
Joint inflammation
Polyneuropathic pain
Polyneuropathic pain,
withstimulation socks,
onechannel
Channel
1
with stimulation gloves,
onechannel
Channel
1
Attention! Stimulation
socks and gloves must be
well moistened!

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Amputation pain,
stumppain
Amputation pain,
phantompain
Postherpetic neuralgia,
stick electrodes in mirror
image on the unaected
half of the body
Commissioning
Turn the device on with the -key. The UROstim 2 will start with the programme number
that was last used. If the lock is active, the key will appear at the top left of the display.
Programme selection
Use the -key to switch to the next programme or the key on the left to switch
to the previous programme. However, this is only possible when the unit is not locked.
The programmes 1 - 8 marked with "U" are called up first. Then come the
programmable programmes 1 - 8 marked with a "P". Once the last programme has
been reached, the next button press will switch back to programme 1 (U1).
Starting stimulation
First place the electrodes on the desired body parts and connect the electrode cables
to the electrodes and the device. After the desired programme has been selected via
the -key or the locked device has been started directly with the desired programme,
stimulation can be started by pressing the two -keys.
Setting the intensity
Using the modification buttons , you can adjust the intensity for the respective
channel to a comfortable value at any time. It can be set anywhere in the range
between 0 - 100 mA.

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ATTENTION: Safety switch
To prevent the intensitylevel from changing unintentionally,the unit locks automatically
after the last setting if it is not operated within 5 seconds. The symbol will appear in
the display. To remove the lock, you only have to press the key, then all settings can
be adjusted again without locking.
If the electrodes are not correctly connected to the device or placed on the skin, the
intensity will be reset to zero from a current of 10mA.
Important: To adjust the intensity more quickly, you can hold down the keys or
buttons. Now adjustment will be much faster.
Stopping the stimulation
Stimulation can be stopped at any time by pressing (2 seconds) the button or
the button.
After the total running time of the programme has elapsed, the stimulation will stop
automatically.
Locking the device
Select the desired programme for the patient with the key (see chapter Description
of the programmes). Pressing the button of the right channel for 3 seconds and
simultaneously pressing the button locks the unit with the preset programme.
A key will now appear on the display to the right of the programme number.
The patient can only use this one programme. To unlock, repeat the procedure
and press the buttons and again.
Timer setting
You can use the device with or without the timer function. To deactivate the timer (preset
to the corresponding programme run time), press the buttons and of the left
channel simultaneously for a period of 3 seconds. The display will now change to TIMER.
By pressing the button again, you can now switch to the "TIMER OFF" mode. The
symbol ''---'' will appear in the display. Now press the button to accept your timer
modification.
Saving and recalling the operating parameters
Press and hold the button for 3 seconds to access the date/time settings. Press
and hold the right button and the button for 3 seconds to enter the memory
recall mode.

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Date/Time Mode
Two numbers are shown in the LCD display. The left number stands for the date, the
right number for the time. Pressing the left button increases the date by one day
at a time (max. 30). Pressing the left button decreases the date by one day
(min. 1). Pressing the right button increases the time by one hour (max. 23).
Pressing the right button decreases the time by one hour (min. 0). Pressing the
button saves the set parameters and exits the date/time mode. The date and time are
counted continuously. The UROstim 2 will switch o if no button is pressed for
2minutes and no changes are saved.
Memory recall mode
If there are no values in the UROstim 2 memory, "ZERO" will
appear for two seconds in the LCD display and the UROstim 2
will return to "Ready mode". Otherwise, the LCD display will
show the operating parameters of the last therapy session
(see fig.):
programme used = P-01
Frequency = 100 Hz
Pulse width = 200 µs
Therapy time = 00 min 44 s
Therapy day = 5th
Therapy session = 3rd
Programming the changeable programmes P1-P8
By repeatedly pressing the key, you can call up the individual parameters of the
respective programme. The flashing indicates which parameter you can change at
the moment using the or key. Changeable parameters are the frequency, the
pulse width and the time. For programmes P2 - P5, working time and break time can
also be set.
For fixed programmes U1-U8, only the time can be changed.
Buzzer setting
Press the left button and the button simultaneously to access the buzzer
settings. Press the button to switch the buzzer on or o. Press the button to
save your selection and exit the buzzer settings.
Switch o the device
You can switch o the device at any time by pressing the button.
If the battery voltage is insucient (empty) or the device is not operated for more
than 2 minutes, it will switch o automatically.

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Charging the integrated accumulator
The battery’s voltage status can be seen on the top right of the display as a battery
with 4 segments. If the voltage drops into the critical range (1 segment or less),
the unit will switch o and can no longer be operated.
You now have to charge the battery:
»Set the slide switch (no. 8) to the OFF position.
»Connect the charging cable in the socket between the two outputs for the
electrodes (input no. 7).
»Now connect the other end of the charging cable to a socket - indicator lamp lights
up red (= charging).
»The charging process is finished when the indicator light changes from red to
green.
»First disconnect the device with the charging cable from the socket, then you can
remove the charging cable.
8
7
Attention! After charging, do not forget to set the slide switch back to the
ON position. This way you can continue your therapy as usual.
Battery return and disposal
In connection with the sale of products containing batteries, which also includes
accumulators, we are legally obliged to inform you of the following pursuant to
Section 18 (1) of the Battery Act (BattG):
The dustbin symbol ( ) indicates batteries containing harmful substances and the
fact that batteries may not be disposed of with household waste, but must be
disposed of properly. The chemical name of the pollutant is indicated under the
dustbin symbol.
You are legally obliged to return used batteries.
You can return used batteries to a municipal collection point or to your local retailer.
As a distributor of batteries, we are also obliged to take back used batteries, although
our take-back obligation is limited to used batteries of the type that we carry or have
carried in our range as new batteries.
You can therefore either return used batteries of the aforementioned type to us with