ASTODIA Instructions for Use
9
1.3.3 Caution information
• The use of the ASTODIA diaphanoscope must be carried out under the re-
sponsibility of a physician.
• In case ASTODIA starts directly after switch on in the highest light level and a
change of the highest level is not possible - then do not use ASTODIA!
• Due to its high light intensity this device may not be used in close vicinity to
the patient's eyes.
• If the ASTODIA control unit is being charged, a safety distance of at least
1.5 m has to be kept.
• In case of continuous use at maximum intensity to a fixed point on the sur-
face of the skin, temperatures of up to 48 ºC can be reached within a period
≤ 2 minutes even when device is being used in the intended use.
Due to the small surface area and short amount of time, this should not be
classed as a critical issue (see IEC/EN 60601-1).
The slight redness that can be seen after use is quickly reversible and does
not cause tissue lesions.
• ASTODIA may not be used several times on a fixed point on the surface of
the skin.
• Once ASTODIA has been switched on, the red and yellow LEDs of the hand
piece each flash three times (functional testing). ASTODIA may only be used
after the LEDs have flashed. If the LEDs do not flash as described, ASTODIA
must be serviced before being used again.
• The essential performance can be lost or degraded due to EM disturbances.
Risk of radio interference!
• According to Standard IEC/EN 60601-1-2, medical electrical equipment re-
quires special precautionary measures in regard to electromagnetic compati-
bility (EMC). Install and operate medical equipment according to the EMC in-
formation listed in the accompanying documentation. Portable and mobile RF
communication equipment may have an impact on medical electrical equip-
ment.
•
This equipment/system can produce radio interference and can interfere with
the operation of equipment in close proximity. It may be necessary to take
appropriate corrective action, such as a new direction, a new configuration of
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