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9 / ENGLISH

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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.

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 10 sessions 

during the first 2 weeks, as shown in the table below.

•  After this first treatment period, 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

2

2

2

Summary of Contents for FL-100

Page 1: ...S T A R T H E R E N E U R O S C I E N C E MANUAL Page 03 English Page 19 Swedish Svenska USER M o d e l F L 1 0 0 ...

Page 2: ......

Page 3: ...Caution Do NOT use this device without first consulting a doctor or other health care professional ...

Page 4: ...Adverse Reactions 8 Prerequisites 9 The Treastment Programme 10 First Time Use 11 How to Perform a Treatment Session 12 Charging the Headset 13 Cleaning of the Headset 14 Device Specifications 15 Markings 16 Product Disposal 17 Contact Us 18 EMC Test Results 5 5 5 6 7 8 9 10 10 10 11 13 14 15 16 17 17 17 Don t forget to download the app Flow Depression ...

Page 5: ...accompanying smartphone app IFU Version and Issuing date Ver 09 2019 10 30 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 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 th...

Page 6: ...recaution and make sure to consult your physician under the following circumstances 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 ...

Page 7: ...nue 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 Prerequisites A smartphone or other device running either Apple iOS 11 or A...

Page 8: ...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 Adjust the length of the metal arch by sliding the back piece 3 The end of the arch should sit comfortably ...

Page 9: ...n 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 12 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 char...

Page 10: ...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 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 El...

Page 11: ... 3 30 dmax 0 053 Limit 4 00 dt s 0 000 Limit 0 50 PASS 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 EL FAST TRANSIENTS COMMON MODE BURSTS IEC 6...

Page 12: ...ningar 7 Eventuella biverkningar 8 Förutsättningar 9 Behandlingsprogrammet 10 Användning första gången 11 Hur en behandlingssession genomförs 12 Ladda headsetet 13 Rengör headsetet 14 Specifikation 15 Märkning 16 Avfallshantering 17 Kontakt 18 EMC Testresultat 21 21 21 22 23 24 25 26 26 26 27 29 30 31 32 33 33 33 Glöm inte att ladda ner appen Flow Depression ...

Page 13: ...lhörande mobilapp används Bruksanvisningens version samt datum för utförande Ver 09 2019 10 30 Produkt model FL 100 Den senaste versionen av manualen finns att ladda ner från flowneuroscience com 1 Tillverkare 2 Avsedd användning Bruksanvisning Flow 2 1 3 4 5 Metallbåge 6 Pads 7 Elektroder 8 Knapp 9 LED indikator 10 Laddningsport 11 Bakstycke Lägg tillbaka headset och tillbehör i lådan efter varje...

Page 14: ...antat t ex pacemaker ryggmärgsstimulator vagusnervstimulator aurikulär stimulator djup hjärnstimulator implanterad defibrillator cochleaimplantat implanterad hörapparat eller defibrillator eller annan implanterad metallisk eller elektronisk utrustning 6 Varningar Använd headsetet ENDAST på huvudet enligt anvisningarna och inte på andra delar av kroppen Håll headsetet torrt och utom solljus Förvara...

Page 15: ...t behandlingen vid andra eventuella biverkningar vid användning av utrustningen OBS Allvarliga incidenter som sker i samband med användning av utrustningen ska rapporteras till Flow Neuroscience och ansvarig myndigheten 8 Förutsättningar En smartphone eller annan enhet som kör Apple iOS 11 eller Android 5 0 9 Behandlingsprogrammet Under de första två veckorna med Flows behandlingsprogram rekommend...

Page 16: ...alet stimuleringssessioner är begränsat per vecka och dag Följ instruktionerna från den virtuella terapeuten i appen Följ instruktionerna i appen för hur du förbereder headsetet Instruktionerna lyder Ta ett nytt par Headset Pads från en påse 1 Fäst dem på elektroderna med hjälp av Pad hållarna ringarna 2 Justera längden på metallbågen genom att föra bakstycket framåt eller bakåt 3 Metallbågens änd...

Page 17: ...ers inaktivitet Headsetet kan startas igen genom att trycka på knappen på headsetet 12 Ladda headsetet Ladda headsetet om LED indikatorn på headsetets framsida inte blinkar när du trycker på knappen Öppna locket till laddningsporten och ladda headsetet med den medföljande Micro USB laddaren med tillhörande sladd 13 Rengör headsetet Det rekommenderas att rengöra headsetet och speciellt elektroderna...

Page 18: ...n nummer Bluetooth Low Energy PRESTANDA PARAMETER NOMINELLT VÄRDE MAX STIMULATIONS STRÖM 2 0 0 05 mA MAX STIMULATIONS SPÄNNING 24 V MICRO USB LADDARE 5 V D C BATTERI UPPLADDNINGSBART LiPo 3 7 V 250 mAh ELEKTRODSTORLEK 22 9 cm2 5 4 cm diameter VIKT 110 g VATTENINTRÄNGNINGSSKYDD IP22 FÖRVÄNTAD LIVSTID 3 ÅR ANVÄNDNINGSMILJÖ HEMMA ELLER KLINIK ANVÄNDNINGSTEMPERATUR 5 to 35 C 41 to 95 F LAGRING OCH TRA...

Page 19: ...0 053 Limit 4 00 dt s 0 000 Limit 0 50 PASS 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 EL FAST TRANSIENTS COMMON MODE BURSTS IEC 60601 1 2 IE...

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Page 23: ...flowneuroscience com ...

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