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5. Precautions

Caution: Do NOT use this device without first 

consulting a doctor or other health care professional.

!

•  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:

•  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.

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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