FLOW FL-100 Depression Treatment Headset Manuel utilisateur

MANUAL

USER

Model: FL-100

START BY DOWNLOADING THE APP FLOW  DEPRESSION TREATMENT

English ...................................... 2

Swedish - Svenska .......................18

Danish - Dansk ...........................34

Dutch - Nederlands .....................50

Finnish - Suomi ..........................66

French - 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. !

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ENGLISH

Get started by downloading the app

“Flow - Depression treatment”

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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

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Flow Neuroscience AB

Södra Tullgatan 3, 211 40 Malmö, 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 16.02 - 2023-04-17

• 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.

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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.

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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.

If you experience any dryness of the skin/skin irritation after

stimulation, it is recommended to apply moisturiser to the area.

8 / ENGLISH ENGLISH / 9

8. Prerequisites

• A smartphone or other device running either

Apple iOS 12+ or Android 6.0+.

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 treatment”

app to your mobile device.

• Create an account in the downloaded “Flow

- Depression treatment” 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

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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.

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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.

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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.

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• 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 (45% 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.

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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

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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 Tullgatan 3, 211 40 Malmö, Sweden,

Web: ﬂowneuroscience.com

IP22 Water ingress protection: 22

Notiﬁed Body No.

Bluetooth Low Energy

15. Markings

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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

https://www.ﬂowneuroscience.com/support/

Flow Neuroscience AB

Södra Tullgatan 3, 211 40 Malmö, Skåne län, Sweden

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18 / SVENSKA SVENSKA / 19

SVENSKA

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FLOW FL-100 Depression Treatment Headset Manuel utilisateur

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