Document Doc.Id. Version Name of document GR 21-005 01 Issued by (Name/Signature) Date Isac Salman 2021-02-17 Approved by (Name/Signature) Date Erik Rehn 2021-02-17 RECORD HISTORY VER 1 CHANGE First issue (edited copy of GR 17-015 Core text for IFU- Flow FL-100 ver12) ISSUED BY DATE Isac Salman 2021-02-17 Template Doc.id.
Document Doc.Id. Version Name of document GR 21-005 01 Approval Table 1 PROJECT MANAGER YES 1.1 Coherence to specifications & technical documentation ✓ 1.2 Procedures are safe, effective, accurate & complete ✓ 1.3 Illustrations are technically accurate ✓ 1.4 Warnings & cautions included where necessary ✓ 1.5 Project Manager Signature Approved MARKETING & SALES YES 2 2.1 Document & language is accurate (Proofread) ✓ 2.2 Material is professional ✓ 2.
Document Doc.Id. Version Name of document GR 21-005 01 START OF THE CORE TEXT USER MANUAL Model: FL-100 Page: 03 English Get started by downloading the app “Flow - Depression”. Template Doc.Id.
Document Doc.Id. Version Name of document GR 21-005 01 Table of Contents 1. Manufacturer 5 2. Intended Use 5 3. Box Contents & the Headset 5 4. Accessories 6 5. Precautions 6 6. Warnings 7 7. Possible Adverse Reactions 7 8. Prerequisites 8 9. The Treatment Programme 8 10. First-Time Use 8 11. How to Perform a Treatment Session 9 12. Charging the Headset 10 13. Cleaning of the Headset 10 14. FCC 10 15. Compliance Notice 11 14. Device Specifications 12 15.
Document Doc.Id. Version Name of document GR 21-005 01 Instruction for Use – Flow - Instructions on how to use the Flow headset and the accompanying smartphone app. - IFU Version and Issuing date: Ver 2020-08-21 - Product model: FL-100. - The latest version of flowneuroscience.com. this manual is also available to download from 1. Manufacturer Flow Neuroscience AB Baltzarsgatan 23; 211 36 Malmö; Skåne län, Sweden 2.
Document Doc.Id. Version Name of document GR 21-005 01 4. Accessories ACCESSORIES DEFINITION ITEMS HEADSET PADS A BOX OF HEADSET 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. 5. Precautions Using this device poses minimal risk of injury.
Document Doc.Id. Version Name of document GR 21-005 01 - 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.
Document Doc.Id. Version Name of document GR 21-005 01 - 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.
Document Doc.Id. Version Name of document GR 21-005 01 11. 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.
Document Doc.Id. Version Name of document GR 21-005 01 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. 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.
Document Doc.Id. Version Name of document GR 21-005 01 communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: ● ● ● ● Reorient or relocate the receiving antenna.
ISEDC Radiation Exposure Statement: This equipment complies with ISEDC radiation exposure limits set forth for an uncontrolled environment . This transmitter must not be co‐located or operating in conjunction with any other antenna or transmitter. énoncé d'exposition aux rayonnements de l'isedc: Cet équipement est conforme aux limites d'exposition aux rayonnements de l'isedc pour les environnements non contrôlés.
Document Doc.Id. Version Name of document GR 21-005 01 14. Device Specifications PERFORMANCE CHARACTERISTICS PARAMETER NOMINAL VALUE MAX. STIMULATION CURRENT 2.0 + 0.05 mA MAX. STIMULATION VOLTAGE 24 V MICRO-USB CHARGER 5 V D.C. BATTERY RECHARGEABLE LiPo 3.7 V; 250 mAh ELECTRODE SIZE 22.9 cm2 (5.4 cm diameter) DEVICE WEIGHT ~110 g WATER INGRESS PROTECTION IP22 DEVICE EXPECTED LIFETIME 3 YEARS OPERATING ENVIRONMENT HOME OR CLINICAL ENVIRONMENT OPERATING TEMP.
Document Doc.Id. Version Name of document GR 21-005 01 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. Waste Electrical and Electronic Equipment (WEEE). Type BF Applied part Manufacturing Year Keep Dry Manufactured by Flow Neuroscience AB Baltzarsgatan 23, 211 36 Malmö, Sweden Web: flowneuroscience.
Document Doc.Id. Version Name of document GR 21-005 01 16. 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. 17. Contact Us If you have any questions regarding Flow, don’t hesitate to contact customer support at support@flowneuroscience.com Flow Neuroscience AB Baltzarsgatan 23; 211 36 Malmö; Skåne län, Sweden 18.
Document Doc.Id. Version Name of document GR 21-005 01 IMMUNITY LIMITS & MEASUREMENT STANDARD TEST METHOD 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 IEC 61000-4-4 ± 2 kV for A.C.
