Issue
Possible Cause
No power or
The power supply
display is blank.
is not connected.
Power is not
turned on.
System beeps
The Treatment Array
and displays
is not connected
an E01 error.
properly.
System beeps
The Treatment Array
and displays
is hot (temperature
an E02 error.
exceeds 48°C) due
to being covered or
running too long.
System beeps
The Treatment
and displays
Array cable may
an E03 error.
have been removed
unexpectedly.
The temperature
sensor has
malfunctioned.
System beeps
The system has
and displays
malfunctioned.
an E04, E05,
E06, E07, E08,
E09, E10, E11
or E12 error.
32
MN 421.012 Rev 3
Solution
Plug the power supply
into a wall outlet.
Ensure the cable is
plugged into the
Controller Unit. The
Unit will beep once the
power is connected.
Press the Power button.
Unplug and re-plug the
Treatment Array and press
the start/pause button
on the Controller Unit to
continue the treatment.
If the problem persists,
contact BIOFLEX
Service.
®
In the event that the
Treatment Array gets too
hot, it will shut off until the
temperature has dropped.
The Treatment Array
needs to be cooled
for at least 15 minutes
before it is used again.
Make sure the cable
is properly connected
to the Controller.
If problem persists, contact
BIOFLEX
Service.
®
Record the error code and
contact BIOFLEX
Service
®
for further assistance.
System Specifications
Electrical Specifications
Rated voltage
Rated frequency
Operating Conditions
Temperature
Relative humidity
Atmospheric pressure
Storage Conditions
Temperature / humidity
Classification
The system is classified as a medical device. Furthermore, it is in
accordance to the Sub-clause 6 of IEC 60601-1:2012 (3.1 Edition):
CLASS II EQUIPMENT, according to the type of protection against
electric shock;
TYPE BF APPLIED PART, according to the degree of protection against
electric shock;
NOT CLASSIFIED, according to the degree of protection against harmful
ingress of water;
CONTINUOUS OPERATION, according to the mode of operation
NONE OF THE PARTS OF THE SYSTEM ARE STERILIZED
100-240V
50-60 Hz
+5°C to +40°C
15% to 93% (non-condensing)
700hPa to 1,060hPa
-25°C without relative humidity
control
+70°C at a relative humidity up to
93%, non-condensing
33
MN 421.012 Rev 3