FLOW NEUROSCIENCE FL-100 Depression Treatment User Manual

: June 15, 2024
: FLOW NEUROSCIENCE

**FLOW NEUROSCIENCE FL-100 Depression Treatment

**

Instruction for Use – Flow

Instructions on how to use the Flow headset and the accompanying smartphone app.
IFU Version and Issuing date: Ver 17.01 – 2023-11-10
Product model: FL-100
The latest version of this manual is also available to download from flowneuroscience.com

Manufacturer

Flow Neuroscience AB
Södra Tullgatan 3, 211 40 Malmö, Sweden

Intended Use

Flow is a class IIa Medical Device intended for homebased treatment of adults (18+) diagnosed with Major Depressive Disorder (MDD).
Flow does not require any special training before use.

Box Contents & the Headset

Instructions for Use
Micro-USB Charger & cord
Two Pad Holder Rings
Flow Headset
Metal arch
Pads
Electrodes
Button
LED indicator
Charger port cover
Back piece

Box Contents & the Headset

After each use, put the headset and other parts back in the box.

Accessories

ITEMS	DEFINITION
HEADSET PADS	A BOX OF FLOW PADS CONTAINING 20 POUCHES (SINGLE USE)
MICRO USB CHARGER	A LXCP12-005 CHARGER AND CORD

More Pads can be ordered online at flowneuroscience.com

Reuse of pads may cause skin damage. Always start a stimulation session with a new pair of Headset pads.

Safety Instructions

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.

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:

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
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.

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.
Worsening of symptoms: If you experience a significant worsening of your symptoms while using this device, consult a physician before continuing the treatment.

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.

Prerequisites

A smartphone or other device running either Apple iOS 12+ or Android 6.0+.

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.

WEEK	W1	W2	W3	W4	W5+
No. of sessions	5	5	5	1-2	1-2

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.
If a card with an activation code is supplied in the box, you might need to enter it in the app before your first session.

NOTE: IT security measures, including protection against unauthorised access, are secured in accordance with GDPR regulations.

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.
Attach them to the electrodes using the Pad Holder Rings.
Adjust the length of the metal arch by sliding the back piece.
The end of the arch should sit comfortably on the back of your head.
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.
efore 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.
Start the stimulation by pressing the “Start stimulation” button in the app.

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 off after a few minutes of inactivity. Start it again by pressing the button on the headset.

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

Charging the Headset

Charge the headset if the LED indicator on the front of the headset does not blink when pressing the button.
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.

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.

Device Specifications

PERFORMANCE CHARACTERISTICS

Markings

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.
| Approved Body No.
| Bluetooth Low Energy

UK Responsible Person (UKRP)

Flow Neuroscience Ltd
Suite 1, 7th Floor
50 Broadway
London
SW1H 0BL

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.

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

EMC – Test Results

The device does not emit any radiation intended for medical purposes, neither hazardous nor potentially hazardous radiation.

EMISSION LIMITS & MEASUREMENT

IMMUNITY LIMITS & MEASUREMENT

PHENOMENON| STANDARD| TEST METHOD| TEST LEVELS| RESILT
ELECTROSTATIC DISCHARGE| IEC 60601-1-2| IEC 61000- 4-2| ±2 kV, ±4 kV, ± 6 kV, ± 8 kV – Contact Discharge ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV – Air Discharge| PASS
RF ELECTROMAGNETIC FIELDS| IEC 60601-1-2| IEC 61000-4-3| 10 V/m 80 – 2700 MHz 80 % AM at 1 kHz| PASS
ELECTRICAL FAST TRANSIENTS COMMON MODE / BURSTS| IEC 60601-1-2| IEC 61000-4-4| ± 2 kV for A.C. Power Lines 100 kHz Burst Frequency| PASS
SURGES LINE TO LINE| IEC 60601-1-2| IEC 61000-4-5| ± 0.5 kV & ±1 kV At 0°, 90°, 180°, 270° ; Repetition Rate: 60 S| PASS
SURGES LINE TO GROUND| IEC 60601-1-2| IEC 61000-4-5| ± 0.5 kV, ±1 & ±2 kV At 0°, 90°, 180°, 270°| PASS
RF COMMON MODE| IEC 60601-1-2| IEC 61000-4-6| 3 & 6 V for A.C. Main Port; 80%, 1 kHz Amplitude Modulation)
Frequency: 150kHz to 80MHz| PASS
VOLTAGE DIPS & INTERRUPTIONS| IEC 60601-1-2| IEC 61000-4-11| 0 % UT; 0,5 Cycle At 0°,
45°,90°, 135°,180°, 225°,
270°, 315°,
0 % UT; 1.0 Cycle
70 % UT; 25/30 Cycles| PASS