Technical Details; Notes On Electromagnetic Compatibility - Beurer EM 80 Manual Del Usuario

(3) Check that the electrodes are positioned properly and make sure that the
adhesive electrodes are not overlapping.
(4) Increase pulse intensity in stages.
(5) The batteries are almost empty. Replace these.
You are aware that the electrodes feel uncomfortable. What should I do?
(1) The electrodes are badly positioned. Check positioning and if necessary
reposition the electrodes.
(2) The electrodes are worn. Due to the fact that current distribution can no
longer be guaranteed evenly over the entire surface, these may lead to
skin irritation. You must therefore replace these.
The skin in the treatment area becomes red. What should I do?
Stop treatment immediately and wait until the skin has returned to normal. If
any redness beneath the electrode soon disappears, this is not dangerous
and is due to the increased circulation which has been stimulated locally.
If, however, the skin irritation remains and there is possibly itching or inflam-
mation, please consult your doctor before further use. It may possibly be
caused by an allergy to the adhesive surface.

11. Technical details

Name and model: EM80
Initial curve shape: biphase square-wave pulse
Pulse duration: 40-250 μs
Pulse frequency: 1-120 Hz
Output voltage: max. 90 Vpp (at 500 Ohm)
Output current: max. 180 mApp (at 500 Ohm)
Power supply: 3x AA batteries
Treatment time: adjustable from 5 to 90 minutes
Intensity: adjustable from 0 to 15
Operating conditions: 10°C-40°C (50°F-104°F) with a relative humidity
of 30-85%
Storage conditions: -10°C-50°C (14°F-122°F) with a relative humidity
of 10-95%
Dimensions: 170 x 125 x 48 mm
Weight: 235 g (without batteries) , 310 g (incl. batteries)
Explanation of symbols: Application part type BF
Caution! Read the instructions for Use.
The serial number is located on the device or in the battery compartment.
Note: If the device is not used according to these specifications, perfect
functioning is not guaranteed.
We reserve the right to make any technical alterations that are necessary in
order to improve and develop the product further.
This unit is in line with European Standards EN60601-1, EN60601-1-2 and
EN60601-2-10 (In accordance with IEC 61000-4-2, IEC 61000-4-3, IEC
61000-4-4, IEC 61000-4-5, IEC 61000-4-6, IEC 610004-8 and IEC 610004-
11) and is subject to particular precautions with regard to electromagnetic
compatibility (EMC). Please note that portable and mobile HF communication
systems may interfere with this unit. For more details, please contact custo-
mer service at the address indicated.
The device meets the requirements of the European Medical Products
Directive 93/42/EC and the German Medical Products Act. For this device,
a functional test and instruction in accordance with Section 5 of the Medical
Devices Operator Ordinance (MPBetreibV) is not required. It is also not neces-
sary to carry out safety checks in accordance with Section 6 of the Medical
Devices Operator Ordinance (MPBetreibV).

12. Notes on electromagnetic compatibility

WARNING!
• 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 dis-
turbances. 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.
32
The device can emit effective output values
above 10 mA, averaged over every five second
interval.