Axion STIM-PRO I-2000 User manual

INSTRUCTION MANUAL
STIM-PRO I-2000
axion GmbH
Mollenbachstr. 13
71229 Leonberg
Germany
2460

The STIM-PRO I-2000 is a medical device. The primary
purpose is to stimulate muscles and nerves of the human
body electrically through skin (transcutaneous) and
mucous membranes (transmucosal) in order to strengthen
the immune system and to alleviate incontinence problems.
What is incontinence?
Incontinence is defined as the involuntary loss of urine,
faeces or both.
Causes and forms of incontinence
Stress incontinence - This is the most common type of
incontinence that usually aects women. At first, it only
occurs during physical exertion and then later at rest,
causing a drop-wise or radiant loss of urine. Often the pelvic
floor muscles relax. This results in a lowering of the organs
of the small pelvis. The resulting increased internal
abdominal pressure can no longer reach the urethra as a
closing pressure, but it can still reach the bladder at full
strength.
Stress incontinence is divided into three degrees of severity:
Involuntary urination
1st degree: in case of sudden, heavy stress, e. g. coughing,
laughing or sneezing
2nd degree: for light physical strain, e. g. when walking,
climbing stairs or lifting things
3rd degree: in the case of unstressed movements, standing
or lastly lying down
INTRODUCTION
2
AXION
EN

Urge incontinence (overactive bladder) - An overactive
bladder is a sudden, unsuppressable urge to urinate, which
forces the person aected to immediately go to a toilet.
Mixed incontinence - This is a mixture of urgency and
stress incontinence.
Anal incontinence - Anal incontinence can be caused by an
impairment of the sphincter muscle. It occurs after
surgeries of the sphincter muscle, such as haemorrhodial
disease or births with perineal rupture, etc. The trigger can
also be an age-related muscle decline.
Anal incontinence is also classified into 3 severity levels:
Involuntary loss of
1st degree: flatulence
2nd degree: flatulence and/or liquid faeces
3rd degree: solid faeces
The treatment of incontinence with
stimulation current
Stimulation current therapy is suitable for the treatment of
stress incontinence, overactive bladder or urge
incontinence as well as its hybrid forms and muscular
forms of anal incontinence. With this type of therapy, the
nerves and muscles in the pelvic floor area are stimulated
by a light current. The current is usually applied via a
vaginal or rectal probe.
3
STIM-PRO I-2000
EN

GENERAL DESCRIPTION
SAFETY INFORMATION
The device is a battery-operated pulse generator that gives
electrical impulses to the body via electrodes and thus
stimulates the nerves and muscles. The microprocessor of
the STIM-PRO I-2000 generates electrical pulses whose
pulse duration and frequency are preset.
Read the instructions carefully before using the device.
Keep this device out of the reach of children.
Do not place electrodes in the area of the carotid arteries!
Do not place electrodes on the front of the throat!
Be careful with stimulation over metal implants.
Do not place electrodes above your heart.
Do not use electrodes on open wounds / injuries.
Do not use if you have fever.
Do not use if you have arrhythmia.
Do not use if you have epilepsy.
Never use the device when you are operating machines.
Never use near explosive or flammable gases.
Always TURN OFF the device before placing / removing
electrodes.
Do not use on overflow incontinence
Do not use for cervical cancer
Do not use if there are metal implants in the area of
application
Do not use in case of severe local inflammation
4
AXION
EN

Do not use when using a metal containing Intrauterine
pessary (contraceptive device)
Do not use in case of severe sensory disturbances in the
area of application.
Do not use for higher level haemorrhoid disease
(when using a rectal probe)
For users of pacemakers and during pregnancy, the device
must only be used under medical supervision (!).
In case of overflow incontinence, the unit should not be
used.
The device must not be used in case of cervical cancer,
fistulas, fistulas, or the inversion of uterus / vagina.
The device must not be used in case of infections in the
vaginal or rectal area.
For hygiene reasons, the probe may only be used by one
person.
The unit must not be used if the pelvic floor is completely
denervated.
Each STIM-PRO I-2000 is fully equipped with the following
standard equipment:
1 piece EMS pelvic floor trainer
1 piece Electrode connecting cable
1 piece Storage case
2 pieces AA batteries 1.5V
1 piece Instructions manual
Depending on the variant
1 piece Vaginal or rectal probe or
4 pieces self-adhesive TENS machine pads
SCOPE OF DELIVERY
5
STIM-PRO I-2000
EN

Connecting the cable
Remove the probe from its packaging and
clean it under running water. Connect the
cable to the device and the vaginal / rectal
probe.
Insert the probe
If necessary, go to the toilet before use. The
application should be done lying down with the knees
slightly tightened. Always apply contact gel to the probe
before insertion to ensure optimum transmission of
impulses. Insert the probe slowly and gently into the vagina
or anus.
Against stress incontinence, women can use both a vaginal and
a rectal probe. A vaginal probe is recommended for the
treatment of overactive bladder and urge incontinence.
a) with a probe
Applying a vaginal probe Applying a rectal probe
The pelvic floor can be stimulated with either a rectal or
vaginal probe, or with externally attached self-adhesive
electrodes. Both applications lead to the desired eect.
However, application with probes is more ecient and is
therefore recommended.
STARTING THE STIMULATION
6
AXION
EN

Connecting the cable
Take the electrodes out of the packaging and clean the skin
before applying to remove grease, sweat or cream residue.
Connect the connecting cable to the device and to the
electrodes.
Attaching the electrodes
Place the electrode with the red connecting cable above the
pubic bone. Place the electrode with the black connection
cable either above the buttocks (see fig. 1 & 2) or
alternatively on the perineum (see fig. 3).
b) with self-adhesive TENS machine pads
Fig. 1 Electrode placing for women
Fig. 2 Electrode placing for men
Fig. 3 Alternative perineal placing for both men and women 7
STIM-PRO I-2000
EN

OPERATING THE DEVICE
TIP: For optimal treatment success, use the programs
P1 to P5 alternately on a daily basis. Thus, the pelvic floor is
stimulated optimally and there is no habituation eect.
After you have selected the desired program, please adjust
the intensity from 0-99 until a noticeable muscle contrac-
tion occurs.
Increase intensity
Decrease intensity
Turn on the device.
Press and hold the On/O button for a long time to turn the
device on. During the application, you can pause and restart
the application by briefly pressing this key.
Program selection, start of stimulation
In program mode you can choose between 5 dierent
programs. These are fully programmed - just set the
current intensity and start the treatment.
The program starts immediately when the intensity is set!
The programs run in continuous operation, recognizable by
the “C” in the display. Press the buttons or to select
a program (P1 – P5).
8
AXION
EN

If there is no noticeable muscle reaction, use more contact
gel for probes or check the placement of the adhesive
electrodes.
If you have not received any prescription from your
therapist or doctor, the recommended duration of treatment
is 20 minutes at one session per day.
Ending the stimulation
Turn o the unit by pressing and holding the power button.
Remove the adhesive electrodes and stick them back on the
protective foil, then remove the connection cables.
If you are using a probe, slowly pull it out of the vagina or anus.
Attention: To avoid cable breakage, the probe must always be
pulled out at the shaft! Clean the probe with warm water and
soap, rinse and store in a dry plastic bag.
Key lock
The control elements are locked by pressing the key lock
and cannot be inadvertently adjusted during treatment. The
key lock can be deactivated by pressing the key again.
9
STIM-PRO I-2000
EN

Front
CONSTRUCTION OF THE DEVICE
Back
10
AXION
EN

To ensure the function of the device, please change the
batteries when the low battery indicator is shown.
Make sure the power is o.
Open the battery compartment on the back of the device.
Remove the batteries.
Insert the new batteries. Please check that the polarity is
correct!
Close the battery compartment.
CHANGING BATTERIES
11
STIM-PRO I-2000
EN

Non-flammable cleaning solution (containing 70% of
alcohol) is suitable for cleaning the device.
Stains and spots can be removed with a cleaning agent.
Do not submerge the device in liquids or expose it to large
amounts of water.
Return the device to the carrying box with sponge foam to
ensure that the unit is well-protected before transportation.
If the device is not to be used for a long period of time, put
it back into the carrying box and keep it in a cool, dry place.
The packed TENS device should be stored and
transported under the temperature range of -20°C
~+60°C, relative humidity 20% ~ 95%, atmosphere
pressure 500 hPa ~ 1060 hPa.
A For safety reasons, review the following checklist once a week.
Check the device for deformation of the housing or
damage to defective output sockets.
Make sure that the descriptions and labels are not distorted.
Check the LED when the device is turned on.
Check the cables and electrodes for damage.
MAINTENANCE, TRANSPORTATION
AND STORAGE OF THE DEVICE
SAFETY CHECKS
12
AXION
EN

Should any malfunctions occur while using your device, check
the following points. If none of these can solve the problem,
please contact the customer service.
Check whether the cables are correctly connected to the
device.
The display does not turn on? Change the battery.
Check the cables for possible damage. The device may only
be used when subjected to a load.
There is no stimulation current? Check if the electrodes are
connected to the same channel correctly and if the intensity is
high enough.
The STIM-PRO I-2000 device is in compliance with the
EN 60601-1-2:2007 and 60601-1:2006 safety standards.
The device must be subjected to safety checks and
maintenance by authorized technicians before use and
each re-use, but at least every 24 months.
Please consult your distributor if there are any problems
with device and accessories.
The manual must always be carried with the device.
MALFUNCTIONS
CONFORMITY TO SAFETY STANDARDS
13
STIM-PRO I-2000
EN

01 Channel 1 channel
02 Intensity Adjustable 0 - 80 mA with a load of 500 Ohm
on each channel
03 Pulse amplitude Asymmetrical, bi-phasic square pulse
04 Output Voltage 0 - 100 V
05 Power Source 2 pieces 1.5V AA batteries
06 Size 9.2cm(L) x 6.2cm(W) x 2.9cm(H)
07 Weight 123 g
08 Frequency Pre-set, ranging from 1 - 100 Hz
09 Pulse width Pre-set, possible values: 150μs, 200μs, 250μs
10 Modes 5 pre-defined programmes P1 - P5
11 Low battery
indicator
Is shown when the batteries are empty. Replace
batteries immediately.
12 Operating
conditions
Temperature 0° C to 40° C
Relative humiditiy 30 % - 75 %
Air pressure 700 hPa - 1060 hPa
13 Note All technical values include a tolerance
of +/- 5 %
TECHNICAL DESCRIPTION
14
AXION
EN

All TENS models carry a warranty of 24 months from the
date of delivery. The warranty applies to the stimulator
only and covers both parts and labor relating thereto. The
warranty does not apply to damage resulting from improper
handling, the failure to follow the operating instructions,
loss or dropping.
Manufacturer:
axion GmbH
Mollenbachstr. 13
71229 Leonberg, Germany
www.tens-ems.com/en
1. Advice for operation
2. Degree of electrical protection
3. Do not insert the plug into the power supply socket of 230V
4. Timer
5. Low battery indicator
6. Increament
7. Decreament
8. Read the instruction manual
9. Direct current (DC)
10. Manufacturer
11. Serial number
WARRANTY
15
STIM-PRO I-2000
EN