2. FLOW
  3. FL-100 Headset Device
FL-100 Headset Device

FLOW FL-100 Headset Device Mode d'emploi

  • Bonjour, je suis votre assistant pour ce document. J'ai lu le manuel d'utilisation du casque de traitement FL-100 de Flow Neuroscience. Ce manuel décrit comment utiliser le casque Flow pour le traitement de la dépression à domicile. Il décrit le programme de traitement, les précautions et les caractéristiques du casque. Je suis prêt à répondre à vos questions concernant ce dispositif.
  • Le casque Flow peut-il être utilisé par les moins de 18 ans?
    Combien de séances de traitement sont recommandées par semaine?
    Combien de temps dure une session de traitement ?
NEUROSCIENCE
MANUAL
USER
Model: FL-100
START BY DOWNLOADING THE APP FLOW  DEPRESSION
English ...................................... 2
Swedish - Svenska .......................18
Danish - Dansk ...........................34
Dutch - Nederlands .....................50
Finnish - Suomi ..........................66
French - Le français ..................... 82
German - Deutsch ......................98
Norwegian - Norsk .................... 114
Português: Do Brasil .................. 130
Português: Europeu .................. 146
Caution: Do NOT use this device without first
consulting a doctor or other health care professional. !
2 / ENGLISH ENGLISH / 3
ENGLISH
Get started by downloading the app
“Flow - Depression”
2 / ENGLISH ENGLISH / 3
Table of Contents
1. Manufacturer ...........................................................4
2. Intended Use ...........................................................4
3. Box Contents & the Headset ...............................4
4. Accessories ...............................................................5
5. Precautions ..............................................................6
6. Warnings ...................................................................7
7. Possible Adverse Reactions .................................8
8. Prerequisites ............................................................9
9. The Treatment Programme .................................9
10. First-Time Use ..........................................................9
11. How to Perform a Treatment Session ............ 10
12. Charging the Headset .........................................12
13. Cleaning of the Headset.....................................13
14. Device Specications ..........................................14
15. Markings.................................................................15
16. Product Disposal ..................................................16
17. Contact Us ............................................................. 16
18. EMC - Test Results .............................................162
4 / ENGLISH ENGLISH / 5
Flow Neuroscience AB
Södra Förstadsgatan 2, 211 43 Malmö, Skåne län, Sweden
• Flow is a class IIa Medical Device intended for home-
based treatment of adults (18+) diagnosed with Major
Depressive Disorder (MDD).
• Flow does not require any special training before use.
3. Box Contents
& the Headset
1. Instructions for Use
2. Micro-USB Charger & cord
3. Two Pad Holder Rings
4. Flow Headset
• Instructions on how to use the Flow headset and the
accompanying smartphone app.
• IFU Version and Issuing date: Ver 13 - 2021-09-07
• Product model: FL-100
• The latest version of this manual is also available to
download from flowneuroscience.com
1. Manufacturer
2. Intended Use
Instruction for Use – Flow
2
1
3
4
4 / ENGLISH ENGLISH / 5
5. Metal arch
6. Pads
7. Electrodes
8. Button
9. LED indicator
10. Charger port cover
11. Back piece
After each use, put the headset and other parts back in
the box.
ITEMS DEFINITION
HEADSET PADS A BOX OF FLOW PADS CONTAINING
20 POUCHES SINGLE USE
MICRO USB CHARGER A LXCP12005 CHARGER AND CORD
4. Accessories
More Pads can be ordered online at flowneuroscience.com
11
10
89
7
5
6
3
Reuse of pads may cause skin damage. Always start a
stimulation session with a new pair of Headset pads.
6 / ENGLISH ENGLISH / 7
5. Precautions
• Pregnancy (or suspected pregnancy)
• Suicidal thoughts (thoughts about ending your life)
• Bipolar disorder (or having a history of hypomanic/
manic episodes)
• Epilepsy (or having a history of seizures)
• Heart disease (or suspected heart disease)
• A neurological or neuropsychiatric condition
• Having recently had a surgical procedure
• Having a defect in neurocranium and/or an implant
inside the skull
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.
The Flow device should only be used by people over 18
years of age who have been diagnosed with depression
(Major Depressive Disorder).
Always consult a physician before making any changes to
your current medication.
Take extra precaution and make sure to consult your
physician under the following circumstances:
Caution: Do NOT use this device without first
consulting a doctor or other health care professional. !
6 / ENGLISH ENGLISH / 7
• Having an active, implanted medical device (e.g. cardiac
pacemaker, spinal cord stimulator, vagal nerve stimulator,
auricular stimulator, deep-brain stimulating electrodes,
cochlear implant, implanted hearing aid or defibrillator)
or other implanted metallic or electronic device.
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.
• 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 environments 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.
8 / ENGLISH ENGLISH / 9
• 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 / ENGLISH ENGLISH / 9
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 15 sessions
during the first 3 weeks, as shown in the table below.
• After this first treatment period, 1-2 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 5 1-2 1-2
10 / ENGLISH ENGLISH / 11
11. How to Perform a Treatment Session
• Ensure your forehead is free from any makeup or hair
products before you start.
• If you have a fringe, it is recommended that you use a
hair tie to remove it from your forehead.
• Take 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 chose in section 9 above.
• Select the next session in the app and press “Start” to
start the session. Note that how often you can use the
headset is restricted per week and day.
• Follow the instructions given by the virtual therapist in
the app.
• When told to, follow the instructions on how to prepare
the headset, as below:
Take a new pair of Headset
Pads from the pouch.
1.
Attach them to the electrodes
using the Pad Holder Rings.
2.
10 / ENGLISH ENGLISH / 11
Adjust the length of
the metal arch by
sliding the back piece.
3.
The end of the arch
should sit comfortably on
the back of your head.
4.
5.
Make sure the headset does not sit too low.
The app shows you how to correctly position the
headset using the camera on your device.
6. Before starting the stimulation, you can press and hold the
“Tingle” button in the app to test how the stimulation feels.
Hold the “Tingle” button for at least 10 seconds.
7. Start the stimulation by pressing the “Start stimulation” button
in the app.
12 / ENGLISH ENGLISH / 13
NOTE: Most users that experience reduced symptoms of
depression do so within 3-4 weeks. For a summary of safety &
clinical performance, see flowneuroscience.com
• The current will now slowly increase to its maximum of
2 mA, as shown in the app.
• If you at any point want to pause the stimulation,
press the pause button in the app or the button on the
headset.
• Follow the instructions in the app during the rest of the
session. The session will last for 30 minutes.
• When the time is up, the headset will automatically
start decreasing the current.
• Do not remove the headset before the app indicates
that the stimulation has stopped.
• The headset gives a “beep” signal when the
stimulation has finished.
• After the session, dispose of the Headset Pads and put
the Pad Holder Rings and headset back in the box.
• The headset will automatically turn itself o after a
few minutes of inactivity. Start it again by pressing the
button on the headset.
12. Charging the Headset
• Charge the headset if the LED indicator on the front of
the headset does not blink when pressing the button.
12 / ENGLISH ENGLISH / 13
• Remove the charger port cover and charge using the
supplied Micro-USB charger and cable.
• The LED indicator blinks during charging and shows a
steady light when the headset is fully charged.
• Recharging a fully flat battery takes approximately an
hour.
• Be sure to close the charger port cover again after
charging.
13. Cleaning of the Headset
• It is recommended to clean the headset and especially
the electrodes after each use.
• To clean the device, ensure that the Micro-USB cable is
not connected to the headset and remove the pads.
• Use an IPA (isopropanol) wet wipe (70% is a good
choice).
• Clean the electrodes using a circular motion.
• Neither the device nor its accessories are supplied
sterilized nor require sterilization prior to use.
14 / ENGLISH ENGLISH / 15
PERFORMANCE CHARACTERISTICS
PARAMETER NOMINAL VALUE
MAX. STIMULATION CURRENT 2.0 + 0.05 mA
MAX. STIMULATION VOLTAGE 24 V
MICRO-USB CHARGER 5 V D.C.
BATTERY RECHARGEABLE LiPo 3.7 V; 250 mAh
ELECTRODE SIZE 22.9 cm2 (5.4 cm diameter)
DEVICE WEIGHT ~110 g
WATER INGRESS PROTECTION IP22
DEVICE EXPECTED LIFETIME 3 YEARS
OPERATING ENVIRONMENT HOME OR CLINICAL ENVIRONMENT
OPERATING TEMP. RANGE 5 to 35°C (41 to 95°F)
STORAGE/TRANSPORT TEMP.
RANGE -10 to 40°C (14 to 104°F)
OPERATING HUMIDITY RANGE 10% to 93%, NON-CONDENSING
STORAGE/ TRANSPORT
HUMIDITY RANGE 10% to 93%, NON-CONDENSING
OPERATING ALTITUDE RANGE 0 – 3000 m
STORAGE/TRANSPORT
ALTITUDE RANGE 0 – 3000 m
14. Device Specifications
14 / ENGLISH ENGLISH / 15
ICON DEFINITION
Consult Instruction for Use (IFU)
Caution: Consult Accompanying Documentation
Separate collection for electrical
and electronic equipment
per EC Directive 2012/19/EU. Waste Electrical
and Electronic Equipment (WEEE).
Type BF Applied part
Manufacturing Year
Keep Dry
Manufactured by Flow Neuroscience AB
Södra Förstadsgatan 2, 211 43 Malmö, Sweden
Web: flowneuroscience.com
IP22 Water ingress protection: 22
Notified Body No.
Bluetooth Low Energy
15. Markings
16 / ENGLISH ENGLISH / 17
16. Product Disposal
• Headset Pads are cellulose sponges and can safely be
disposed of as household waste.
• The headset and charger should be disposed of as
electronic waste according to the local legislation.
17. Contact Us
If you have any questions regarding Flow, don’t hesitate to
contact customer support at support@flowneuroscience.com
Flow Neuroscience AB
Södra Förstadsgatan 2, 211 43 Malmö, Skåne län, Sweden
16 / ENGLISH ENGLISH / 17
18 / SVENSKA SVENSKA / 19
SVENSKA
Kom igång genom att ladda hem appen
“Flow - Depression”
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