Cognionics CGX Quick-20m User manual

Quick-20m
This manual includes operating instructions, maintenance instructions, and
general information for use of the CGX Quick-20m.
Carefully read this manual to familiarize yourself with the headset, software, and
accessories before use.
CGX A Cognionics Company
Description
The Quick-20m is a wireless, battery-
operated 10-20 montage EEG headset
utilizing dry sensor technology. The
headset provides an integrated
approach to the wireless acquisition of
EEG signals. A seated patient is free to
exhibit natural movements while real-
time data is collected.
The Quick-20m includes advanced
amplification and shielding to reject
ambient electrical noise.
The headset obtains high-quality
EEG with minimal scalp preparation.
Patented mechanisms and a range
of replaceable dry sensors align
to various head shapes and sizes,
maintaining sensor positions in a
standard 10-20 layout. EEG channels
are digitized with 24 bits of resolution
at 500 Hz. The Quick-20m is suitable
for general-purpose EEG.
Caution: Federal law restricts this device to sale by or on the order of a physician.

2
Warnings
The Quick-20m is intended to be used to acquire
the electroenchephalogram (EEG) and transmit it
wirelessly to a computer.
The Quick-20m headset is not a diagnostic tool. Any
medical diagnosis related to the EEG should be derived by
a certied physician.
This Device Is Not Intended For The Following Uses:
• monitoring of patients in a clinical environment
• on patients undergoing surgery
• on patients on life support systems
• use in sterile environments
• use with sleeping patients
Do Not Use This Product In These Situations:
• near high-frequency surgical equipment
• if exposed to radio-band, ionizing, microwave, infrared,
ultraviolet, or gamma radiation
• in oxygen-rich environments (concentration > 25%
at 1 atm)
• in wet environments (i.e., steam rooms)
• in the presence of ammable anesthetics or gases
• in the presence of heavy machinery
• in dusty environments
Precautions For The Practitioner
• Check if your patient has a sensitive dermatological
condition causing sensor intolerance.
• To avoid cross-patient contamination, do not use with
patients having open wounds or scalp infections.
Patient Considerations
• This device is intended for human use only.
• Patient should have a healthy scalp.
• This device ts teens and adults with a head
circumference from 52 to 62 cm.
• Do not use with infants or neonates.
• Patients may or may not have hair.
• All sensors must be able to contact the patient’s scalp.
• The entire headset may come into contact with the
patient’s skin.

3
Warnings
Disposable Sensors
• Store clean sensors in the provided jars.
• Clean sensors after each session following instructions on
Page 16.
• Replace sensors at or before their stated lifecycle limits
(Specications, Page 18), or if they appear worn.
Always Use Supplied Accessories
Using accessories other than those supplied with your
Quick-20m system may result in damage or diminished
ecacy of the system.
The Quick-20m uses two AAA Alkaline or NiMH batteries.
Follow care and handling instructions provided by the
battery manufacturer.
Avoid Cross-Patient Contamination
Always inspect patient head to ensure skin surface is clean
and free of open wounds prior to use of EEG.
Clean the device and clean or replace sensors after use
following the cleaning instructions on Page 15 to avoid
cross-patient contamination.
Care Instructions
The Quick-20m is constructed of exible materials to
improve comfort and t. These materials are prone to
breakage under extreme conditions. Do not drop, sit on,
step on, fold, push, pull or stretch the product.
Patient Will Be In Direct Contact With:
• Sensors
• Headset
Safety Warnings
Do not:
• Sterilize the product.
• Immerse the product in any liquid.
• Expose the product to excessive: vibration, moisture or
humidity, mechanical shock, or dust.
• Disassemble or modify the product. This will void the
warranty.
• Use caustic or abrasive cleaners on the headset or
sensors.
NOTE: The EMISSIONS
characteristics of this
equipment make it suitable
for use in industrial areas and
hospitals (CISPR 11 class
A). If used in a residential
environment (for which
CISPR 11 class B is normally
required) this equipment
might not oer adequate
protection to radio-frequency
communication services.
The user might need to take
mitigation measures, such as
relocating or re-orienting the
equipment.

4
Cybersecurity
The Quick-20m does not pose an inherent cybersecurity
risk. The wireless bluetooth system relies on a built-in
security encryption method utilizing 128-bit AES encryption.
Performance Warnings
The Quick-20m is designed for use in a professional
healthcare facility by a trained healthcare professional.
• Use in environments near HF surgical equipment,
magnetic resonance imaging equipment, or other
equipment which produces a high level of EM
disturbances will aect the performance of the device.
• In case of EM disturbances, the recorded bio-potential
waveforms may have environmental artifacts including
unanticipated high frequency components.
• No harm to the patient or operator may occur when using
the device in an unsupported environment.
Performance Degradation
The Quick-20m presents no additional risk to the operator
or patient should the performance or ecacy of the system
be diminished.
Warnings
The Quick-20m is MR Unsafe.
Keep it outside the MRI
scanner room.

5
Symbol Title Of
Symbol
Standard Title Of Standard Description Of Symbol
Prescription
Only
21 CFR 801.15(c)(1)(i)(F)
21 CFR 801.109
Labeling - Medical device;
prominence of required
label statements.
Labeling - Prescription
devices.
Requires a prescription
in the United States of
America.
Caution: In the United
States of America, federal
law restricts this device to
sale or use by, or on the
order of, a physician.
Serial
Number
ISO 15223-1:2016 Medical devices: Symbols
to be used with medical
device labels, labeling
and information to be
supplied.
Part 1: General
Requirements
Indicates th
manufacturer’s serial
number so that a specic
medical device can be
identied.
Manufacturer ISO 15223-1:2016 Medical devices: Symbols
to be used with medical
device labels, labeling
and information to be
supplied.
Part 1: General
Requirements
Indicates the medical
device manufacturer, as
dened in EU Directives
90/385/EEC, 93/42/EEC
and 98/79/EC.
Keep Dry ISO 15223-1:2016 Medical devices: Symbols
to be used with medical
device labels, labeling
and information to be
supplied.
Part 1: General
Requirements
Indicates a medical
device that needs to be
protected from moisture.
Consult
Instructions
For Use
ISO 15223-1:2016 Medical devices: Symbols
to be used with medical
device labels, labeling
and information to be
supplied.
Part 1: General
Requirements
Indicates the need for
the user to consult the
instructions for use.
Caution ISO 15223-1:2016 Medical devices: Symbols
to be used with medical
device labels, labeling
and information to be
supplied.
Part 1: General
Requirements
Indicates the need for
the user to consult the
instructions for use for
important cautionary
information such as
warnings and
precautions that cannot,
for a variety of reasons,
be presented on the
medical device itself.
Warnings