Flow Neuroscience FLOW User Manual
NEUROSCIENCE
USER
MANUAL
P. 03 English
P. 19 Swedish- Svenska
START HERE
Caution: Do NOT use this device without first
consulting a doctor or other health care professional
!
ENGLISH
Table of Contents
1. Manufacturer
2. Intended Use
3. Box Contents
Don’t forget to
download the app
“Flow - Depression”
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4. Accessories
5. Precautions
6. Warnings
7. Possible Adverse Reactions
8. Prerequisites
9. The Treastment Program
10. First-Time Use
11. How to Perform a Treatment Session
12. Charging the Headset
13. Cleaning of the Headset
14. Device Specications
15. Markings
16. Contact Us
17. EMC - Test Results
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Instruction for Use – Flow
• Instructions on how to use the Flow headset and the
accompanying smartphone app.
• IFU Version and Issuing date:
Ver 02 - Date: 2019-05-06
• Product model: FL-100
4. Accessories
ACCESSORIES
ITEMS DEFINITION
FLOW PADS
MICRO USB CHARGER A LXCP12005 CHARGER AND CORD
More Pads can be ordered online at flowneuroscience.com
A BOX OF FLOW PADS CONTAINING
20 POUCHES SINGLE USE
1. Manufacturer
Flow Neuroscience AB
Bredgatan 4; 211 30 Malmö; Skåne län, Sweden
2. Intended Use
The Intended use of the Flow device is for home-based
treatment of adults (18 +) diagnosed with
Major Depressive Disorder (MDD).
3. Box Contents
1. Instructions for Use
2. Micro-USB Charger & cord
3. Two Pad Holder Rings
4. Flow Headset
After each use put the
headset and other parts
back in the box.
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5. Precautions
Caution: Do NOT use this device without first
consulting a doctor or other health care professional
Using this device poses minimal risk of injury.
Even so, it is recommended to consider multiple treatment options.
If symptoms worsen, make sure to contact a healthcare professional.
• Use the device ONLY if you have been diagnosed with
Major Depressive Disorder, otherwise known as unipolar
depression.
• Do NOT use the device if you are under the age of 18
years old.
You should always take extra precautions and do NOT use
the device before consulting a physician in case you:
• experience suicidal thoughts or fantasizing about ending
your life.
• have a history of hypomanic/manic switches or episodes.
• have been diagnosed with Bipolar Disorder.
• have a history of seizures.
• are suspected of having or have been diagnosed with
!
epilepsy.
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• have open wounds, or broken or damaged skin at the
stimulation site (this might create further irritation and/
or damaged skin).
• are pregnant or may be pregnant.
• have a pre-existing neurological or neuropsychiatric
condition.
• have an active implanted medical device such as a
cardiac pacemaker or neurostimulation device such as a
spinal cord stimulator, vagal nerve stimulator, auricular
stimulator, or deep-brain stimulating electrodes, or
implanted defibrillator, or other implanted metallic or
electronic devices.
• have a defect in the neurocranium, an implant inside the
skull, a cochlear implant, or an implanted hearing aid.
• are suspected of having or have been diagnosed with
heart disease.
• have recently had a surgical procedure.
• Do not apply the headset during any activity creating a
significant risk of injury.
• Do not apply the headset while intoxicated or
incapacitated.
• Do not apply the headset in an environment with strong
magnetic fields.
• Do not apply the headset without the supplied Headset
Pads.
• Do not apply the headset with dried-out Headset Pads
(Pads are single use).
• Do not charge the headset with any other charger than
the one supplied with the Headset.
• Worsening of symptoms: Patient MUST consult a
physician if he/she experiences a significant worsening of
depression while using this device before continuing the
treatment.
6. Warnings
• Apply the headset ONLY on the head as directed and not
on other body parts.
• Keep the headset dry and out of sunlight.
• Keep the headset out of the reach of children.
• Do not apply the headset over areas of skin that lack
normal sensations.
• Do not apply the headset outdoors or close to water.
• Do not apply the headset while driving.
7 / ENGLISH ENGLISH / 8
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.
10. First Time Use
• Download the “Flow - Depression”
app to your smartphone.
• Create an account in the
downloaded “Flow - Depression”
app using an email address you
have access to and a new password
of your choosing.
8. Prerequisites
• A smartphone or other device running Apple iOS 11+.
9. The Treatment Program
• The Flow treatment program consists of 18 sessions over
6 weeks, as shown in the table below.
• After this main treatment period, 1–2 sessions/week
could be done as follow-up sessions.
• You can only do 1 session per day.
• Each session lasts about 30 minutes, plus a few minutes
of preparation time.
11. How to Perform a Treatment Session
• Ensure your forehead is free from any makeup or hair
products.
• If you have a fringe it is recommended you use a hair tie
to remove it from your forehead.
• Tak e out the headset from the box.
• Press the button on the headset and make sure it blinks
twice. If not, charge the headset.
• Make sure Bluetooth is enabled on your smartphone.
• Start the Flow app and log in with
the email address & password you choose in 10 above.
• Select the next session in the app and press Start to start
the session. Note that how often you can use the headset
WEEK W1 W2 W3 W4 W5 W6 W7+
No. of sessions 5 5 2 2 2 2 1.2
9 / ENGLISH ENGLISH / 10
is restricted per week and day.
• Follow the instructions given by the virtual therapist in
the App.
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