• IFU Version & Issuing date: could be done as follow up sessions. Ver 01 - Date T BD • Each session is about 30 minutes plus a few • Product model: FL-100 minutes of preparation time. 1. Manufacturer WEEK Flow Neuroscience AB Bredgatan 4;...
7. Charging the Battery • Start the Flow MDD App and log in with email & password. • Charge/ Recharge, if LED indicator on the front • Press the Start treatment button in the app. of the headset does not blink when pressing the button.
10. Precautions • Follow the instructions in the app during the rest of the session. The session will last for 30 min. • ONLY use the device, if you are diagnosed with • When the time’s up (30 min) the headset will Major Depressive Disorder otherwise known as automatically start decrease (ramp down) the unipolar depression.
• Have an active implanted medical device, such as a • Don’t apply the headset during any activity cardiac pacemaker or neurostimulation device, creating a significant risk of injury. such as a spinal cord stimulator, vagal nerve • Don’t apply the headset while intoxicated or stimulator, auricular stimulator, or deep-brain incapacitated.
12. Possible Adverse Reactions 13. Device Specifications • Some skin redness under the electrode or near PERFORMANCE the electrode sites is normal due to increased local PARAMETER NOMINAL VALUE blood flow and will subside within approximately an MAX STIMULATION CURRENT 2.0 + 0.05 mA hour of the end of use.
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Keep Dry SUSCEPTIBILITY (80~2700MHZ) A1:2007 + A1:2010 ELECTRICAL FAST TRANSIENT/ IEC 60601-1-2: 2014 IEC 61000-4-4: 2012 PASS BURST TEST Manufactured by Flow Neuroscience AB Bredgatan 4 SURGE TEST IEC 60601-1-2: 2014 IEC 61000-4-5: 2014 PASS 211 30 Malmö, Sweden Web: flowneuroscience.com...
14. Warranty 15. Return & Refund Policy 16. Contact Us If you have any questions regarding Flow don’t hesitate to contact the customer support at support@flowneuroscience.com Flow Neuroscience AB Bredgatan 4 211 30 Malmö Skåne Län, Sweden...