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• Worsening of symptoms: If you experience a significant
worsening of your symptoms while using this device,
consult a physician before continuing the treatment.
7. Possible Adverse Reactions
• Some skin redness under the electrode or near the
electrode sites is normal, due to increased local blood flow
and will normally subside within approximately an hour of
the end of use.
• DO NOT apply the device over open wounds, or broken or
damaged skin. This might create further irritation and/or
skin damage.
• Skin irritation might be experienced beneath the
stimulation electrodes. In this case, electrodes should NOT
be reapplied to the irritated skin.
• Discontinue treatment if the sensation of tingling,
itching or burning under electrodes becomes severe (mild
sensation of tingling, itching or burning is normal).
• Discontinue treatment if you experience a mild headache
that does not pass within an hour after the end of a session.
• Discontinue treatment if you experience tinnitus (noise or
ringing in the ears) during or after using the device.
• Discontinue treatment in case of any other adverse
reaction from the device.
NOTE: Any serious incident that has occurred in relation to the device
should be reported to Flow Neuroscience and the local competent
authority.
8. Prerequisites
• A smartphone or other device running either Apple iOS 11+
or Android 5.0+.
9. The Treatment Program
• The Flow treatment programme consists of 10 sessions
during the first 2 weeks, as shown in the table below.
• After this first treatment period, 2 sessions are
recommended per week.
• The number of sessions you can do per week is restricted
and you can only do 1 per day.
• Each session lasts 30 minutes, plus a few minutes of
preparation time.
10. First-Time Use
• Download the “Flow - Depression” app
to your mobile device.
• Create an account in the downloaded
“Flow - Depression” app using an email
address you have access to and new
password of your choosing.
NOTE: IT security measures, including
protection against unauthorised access, are
secured in accordance with GDPR regulations.
WEEK
W1
W2
W3
W4
W5+
No. of sessions
5
5
2
2
2