Technical Specifications; Fcc Compliance Information - Beurer FM 250 Manual De Instrucciones

The electrostimulation is The set intensity level is too high. Decrease the intensity level.
unpleasant.
The EMS circulation stimulator
is not being used in accordance
with these instructions for use.
My calves and feet hurt after The set intensity level is too high.
using the device. The muscles are overstim ulated.
Use of the device was inter- The batteries are flat.
rupted.
The EMS circulation stimulator
switches off automatically once
the set usage time has ended.

9. Technical Specifications

Type FM 250
Output waveform Biphasic rectangular pulses
Pulse frequency 10 Hz~ 36 Hz
Pulse length 250 μs
Output voltage 0 ~ 80 Vpp (at 500 Ω)
Voltage supply Power adapter input: 100 - 240 V~; 50/60 Hz 0.2 A;
EMS circulation stimulator Output: DC 6.0 V; 300 mA;
or
DC 6.0 V; 4 x 1.5 V AA batteries
Voltage supply DC 3.0 V; 2 x 1.5 V AAA batteries
Remote control
Battery life 1 week (for daily use of 30 minutes)
Channels 2 channels
Programs 1 program with 15 repeating pulse wave variations
Treatment time 5 - 90 minutes (in 5 minute increments)
Intensity levels 1 - 99
Operating conditions 41°F - 104°F (5°C - 40°C) at a relative humidity of 30 - 75%;
700 hPa – 1060 hPa
Storage and transportation conditions 14 °F – 131 °F (-10 °C - 55 °C) at a relative humidity of 10 - 90
%; 700 hPa – 1060 hPa
Dimensions EMS circulation stimulator: approx.
11.15 in x 14.65 x 4.37 in (283.3 x 372.2 x 111.4 mm)
Weight 3.3 lb (1.5 kg) (only EMS circulation stimulator, without batteries)
The serial number is located on the device or in the battery compartment.
Battery life: With included batteries at 500Ω approx. 8 applications (30 minutes each).
Note: If the device is not used according to the instructions specified, perfect functionality cannot be
guaranteed! We reserve the right to make technical changes to improve and develop the product.
Read the instructions for use
before you start using the
device.
Decrease the intensity level.
Take adequate breaks between
each use of the device so that
your muscles can recover.
Replace the batteries in the EMS
circulation stimulator.
Press the ON/OFF button to
switch on the EMS circulation
stimulator again.
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This device complies with European standards EN60601-1 and EN60601-1-2 (in accordance with CISPR 11,
IEC 61000-3-2, IEC 61000-3-3, IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-4, IEC 61000-4-5,
IEC 61000-4-6, IEC 61000-4-8, IEC 61000-4-11) and is subject to special precautionary measures with regard
to electromagnetic compatibility. Please note that portable and mobile HF communication systems may
interfere with this device. For more details, please contact our Customer Services at the address indicated.
This device meets the requirements of European Directive 93/42/EEC for medical devices, as well as those
of the Medizinproduktegesetz (German Medical Devices Act). For this device, a functional test and instruc-
tion in accordance with Section 10 of the Medical Devices Operator Ordinance (MPBetreibV) is not required.
10. Notes on electromagnetic compatibility
• The device is suitable for use in all environments listed in these instructions for use, including domestic
environments.
• The use of the device may be limited in the presence of electromagnetic disturbances. This could result
in issues such as error messages or the failure of the display/device.
• Avoid using this device directly next to other devices or stacked on top of other devices, as this could lead
to faulty operation. If, however, it is necessary to use the device in the manner stated, this device as well
as the other devices must be monitored to ensure they are working properly.
• The use of accessories other than those specified or provided by the manufacturer of this device can lead
to an increase in electromagnetic emissions or a decrease in the device's electromagnetic immunity; this
can result in faulty operation.
• Failure to comply with the above can impair the performance of the device.

11. FCC Compliance Information

EMS circulation stimulator FM 250
Responsible Party – U.S. Contact Information:
Beurer North America LP
1 Oakwood Boulevard, Suite 255
Hollywood, FL 33020
United States
1-800-536-0366
info@beurer.com
FCC Compliance Statement
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: 1.
This device may not cause harmful interference, and 2. This device must accept any interference received,
including interference that may cause undesired operation.
Changes or modifications to the product not expressly approved by the party responsible for compliance
could void the user's authority to operate the equipment.
NOTE:
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to
Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful inter-
ference in a residential installation. This equipment generates, uses and can radiate radio frequency energy
and, if not installed and used in accordance with the instructions, may cause harmful interference to radio
communications. However, there is o guarantee that interference will not occur in a particular installation. If
this equipment does cause harmful interference to radio or television reception, which can be determined
by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more
of the following measures:
– Reorient or relocate the receiving antenna.
– Increase the separation between the equipment and receiver.
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