Possible Adverse Reactions; Prerequisites; The Treatment Programme; First-Time Use - Flow FL-100 Bedienungsanleitung

• 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.
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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.
WEEK W1
No. of sessions 5

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.
W2 W3 W4 W5+
5 2 2 2
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