SAFETYCarefully read the COGNISION™ SYSTEM USER GUIDE entirely before using the system. The terms NOTE, CAUTION, and WARNING have specific meanings in this manual.
NOTE: provides useful information regarding a function or procedure.
CAUTION: advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure, although personal injury is unlikely.
WARNING: advises against certain actions or situations that could result in personal injury or death.
ClassificationNOTE: This device (including all connected components) is INTERNALLY POWERED TYPE BF per IEC 60601-1.
NOTE: This device (including all connected components) is not sealed and is rated IPX-0.
NoticesNOTE: The COGNISION™ Headset contains a 3.7 V, rechargeable, LiPoly battery.
NOTE: The COGNISION™ Headset is charged using a 5.0 V, 550 mA, USB-type, wall charger.
NOTE: The COGNISION™ Headset contains FCC ID:PI401B.
NOTE: The COGNISION™ System should be used at an ambient temperature range of 60-90 deg F.
CautionsCAUTION: Do not disassemble any of the COGNISION™ Headset enclosures including the Headset Control Unit, the Headset, the Electrodes, or any other plastic enclosures. Disassembly of any of these components may damage or destroy the instrument.
CAUTION: Do not attempt to sterilize any part of the COGNISION™ Headset. Steam, ETO, or other sterilization fluids may damage or destroy the instrument.
CAUTION: The COGNISION™ Headset has been designed to meet the electronic compatibility requirements of EN60601-1-2 but operation of this device may affect or be affected by other equipment in the vicinity due to electromagnetic interference (EMI). The COGNISION™ Headset also contains a Bluetooth® transceiver which also may affect other equipment.
WarningsWARNING: This device contains natural rubber latex which may cause allergic reactions.
WARNING: The COGNISION™ Headset shall only be operated from its internal battery power source.
WARNING: The COGNISION™ Headset Control Unit contains a rechargeable LiPoly battery. There is a danger of fire or explosion if the battery is mishandled. The battery cannot be serviced or replaced by anyone other than a Neuronetrix certified technician. If the instrument becomes inoperable because the battery will not recharge, please contact the Neuronetrix service center for a replacement.
WARNING: The COGNISION™ Headset shall not be used in any procedure where other electrical instruments or equipment, such as EKG instruments, defibrillators, monopolar or bipolar electrocautery equipment, magnetic resonance imaging (MRI) scanner, or other physiological monitors, are being used on the same subject.
WARNING: Traditional approaches to the placement of EEG electrodes on the scalp involve abrading the skin to reduce electrode-scalp impedance (less than 5-10 kohms is commonly recommended). Breaking the skin creates the risk of infection from blood-borne pathogens such as HIV, hepatitis-C, and Creutzfeldt-Jakob disease. With modern instrumentation amplifiers like those used in the COGNISION™ Headset and the application of an electrolytic gel per the included instructions, an electrode-scalp impedance of less than 5 kohms is not necessary. Typical values of less than 40 kohms are adequate and are easily achieved without aggressive skin abrasion. It is therefore recommended that skin not be abraded when using the COGNISION™ Headset.
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