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This user manual describes the proper use of CEFALY DUAL Enhanced.
CEFALY DUAL Enhanced is for patients diagnosed by a physician with migraines per the FDA cleared indications.
Lists conditions where the device should not be used to avoid adverse events.
Explains special conventions used in the manual, such as warning and caution box indicators.
Provides essential warnings and cautions for safe operation, including usage restrictions.
Lists and describes common, uncommon, and rare side effects experienced during or after using the device.
Details the components included in the CEFALY DUAL Enhanced migraine treatment kit, numbered 1-6.
Provides a physical description of the CEFALY DUAL Enhanced device and its electrode.
Explains the alarms and LED flashes used by the CEFALY DUAL Enhanced for feedback on operations.
Offers recommendations for using the CEFALY DUAL Enhanced effectively, including skin cleansing and electrode care.
Instructions for opening the package and identifying the components of the CEFALY DUAL Enhanced kit.
Guidance on fully charging the CEFALY DUAL Enhanced battery before first use.
Emphasizes cleansing skin before each session for electrode adherence and provides instructions.
Instructions on how to open the electrode packet and prepare it for use.
Guides on correctly positioning the electrode on the forehead using a mirror and checking for a secure fit.
Explains how to attach the CEFALY DUAL Enhanced device to the electrode on the forehead.
Details how to select the ACUTE program for migraine attacks, activated by pressing the device button once.
Describes how the device's indicator light signals the ACUTE program is active during the session.
Explains sensations during an ACUTE treatment, including intensity increase and potential skin redness.
Guides on ending an ACUTE treatment, removing the device and electrode, and storing them properly.
Instructions for selecting the PREVENT program for daily treatment, including selection, monitoring, and expectations.
Describes how the device's indicator lights signal the PREVENT program is active during the session.
Explains sensations during a PREVENT treatment, including intensity increase and potential skin redness.
Guides on ending a PREVENT treatment, removing the device and electrode, and storing them properly.
Instructs users to press the device button to stabilize intensity if discomfort occurs during the first 14 minutes.
Details how to manually increase intensity by long-pressing the device button within the first 14 minutes.
Explains how to stop a treatment session by removing the device from the electrode.
Addresses interruptions due to poor electrode grip or movement, indicating device disconnection.
Provides instructions for cleaning magnetic contacts, electrodes, charging dock, and USB cable.
Specifies recommended temperature, humidity, and pressure ranges for using and storing the device.
Advises on disposing of the CEFALY DUAL Enhanced and its battery according to local regulations.
Addresses a long beep issue, citing low battery charge as a cause and suggesting a recharge.
Troubleshoots the device turning off, suggesting electrode adhesion, secure attachment, or low battery.
Troubleshoots lack of stimulation, covering electrode adhesion, attachment, desensitization, and intensity.
Addresses high intensity by recommending gradual increases or stabilizing pulses at a tolerable level.
Explains how to increase intensity for low sensation by pressing and holding the device button.
Explains skin redness is usually harmless, but advises checking for acrylate allergy.
Addresses uncommon side effects like headaches and nausea, suggesting medical consultation.
Troubleshoots the device not powering on, suggesting checking charge, electrode adhesion, and security.
Explains key symptoms of migraine headaches, including duration, pain characteristics, and associated symptoms.
Discusses migraine triggers and suggests practices to help avoid migraine attacks.
Presents technical data of the device, including output current, pulse width, service life, dimensions, and weight.
Details the specific parameters for ACUTE and PREVENT treatment programs, such as frequency and duration.
Details electrical specifications and device temperature limits during operation.
Provides information on the device's battery and the requirements for the USB power adapter.
Advises on safe usage distances for RF equipment and manufacturer's declaration on emissions.
Details the 60-Day Money-Back Guarantee and limited warranty terms for the CEFALY DUAL Enhanced.
Provides background on CEFALY Technology, its mission, and its approach to migraine treatment.
Defines key terms used in the manual, such as Migraine, Aura, and Contraindications.
Explains the meaning of symbols used throughout the user manual for clarity.
General| Power Source | Rechargeable battery |
|---|---|
| Battery Type | Lithium-ion |
| Charging Time | Approximately 2 hours |
| Compatibility | Compatible with CEFALY electrodes |
| Certification | CE marked, FDA cleared |
| Technology | Transcutaneous Electrical Nerve Stimulation (TENS) |
| Electrode Type | Self-adhesive electrode |
| Treatment Duration | Acute: 60 minutes; Prevent: 20 minutes |
| Dimensions | 55 x 45 x 15 mm |
| Device Type | External Trigeminal Nerve Stimulation (e-TNS) device |
| Indication | Acute and preventive treatment of migraine |
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