1. Manuals
  2. Brands
  3. Flow Manuals
  4. Headsets
  5. FL-100
  6. User manual

Flow FL-100 User Manual

Hide thumbs Also See for FL-100:
Table of Contents

Advertisement

Quick Links

Download this manual
Document
Core text for IFU- Flow FL-100
USER
MANUAL
Model: Flow FL-100
Get started by downloading the app "Flow - Depression treatment".
Template
Core Text Template
Doc.Id.
GR 17-015
START OF THE CORE TEXT
Doc.Id.
FL 09-04-01 TMP
Version
Page
17
1(11)
Version
03

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the FL-100 and is the answer not in the manual?

Questions and answers

Related Manuals for Flow FL-100

Summary of Contents for Flow FL-100

  • Page 1 Version Page Core text for IFU- Flow FL-100 GR 17-015 1(11) START OF THE CORE TEXT USER MANUAL Model: Flow FL-100 Get started by downloading the app “Flow - Depression treatment”. Template Doc.Id. Version Core Text Template FL 09-04-01 TMP...

  • Page 2: Table Of Contents

    17. Product Disposal 18. Contact Us 19. EMC - Test Results Instruction for Use – Flow Instructions on how to use the Flow headset and the accompanying smartphone app. IFU Version and Issuing date: Ver 17 - 2023-11-10 Product model: FL-100.

  • Page 3: Manufacturer

    Flow Neuroscience AB Södra Tullgatan 3, 211 40 Malmö, Sweden 2. Intended Use 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.

  • Page 4: Precautions

    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.

  • Page 5: Possible Adverse Reactions

    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.

  • Page 6: Prerequisites

    A smartphone or other device running either Apple iOS 12+ or Android 6.0+. 9. The Treatment Programme 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.

  • Page 7: Charging The Headset

    Core text for IFU- Flow FL-100 GR 17-015 7(11) 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.

  • Page 8: Cleaning Of The Headset

    Document Doc.Id. Version Page Core text for IFU- Flow FL-100 GR 17-015 8(11) 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.

  • Page 9: Markings

    Document Doc.Id. Version Page Core text for IFU- Flow FL-100 GR 17-015 9(11) OPERATING ALTITUDE RANGE 0–3000 m STORAGE/TRANSPORT ALTITUDE RANGE 0–3000 m 15. Markings 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.

  • Page 10: Responsible Person (Ukrp)

    The headset and charger should be disposed of as electronic waste according to the local legislation. 18. 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, Sweden 19.
  • Page 11 Document Doc.Id. Version Page Core text for IFU- Flow FL-100 GR 17-015 11(11) EMISSION LIMITS & MEASUREMENT PHENOMENON STANDARD TEST METHOD TEST LEVELS RESULT CISPR 11 30~1000 MHz ; 1~3 GHz & 3~6 GHz RADIATED RF EMISSION IEC 60601-1-2 PASS ETSI EN 301 489-1 (Measurement Uncertainty 4.24 dB)

Table of Contents