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ATWINC1510
User Manual
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Users Manual
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Microchip Technology ATWINC1510 Users Manual

WR19 wireless EEG headset
Documentation Rev. 2018-05-02 #014
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Table of Contents
1. About this manual ........................................................................................................................... 4
1.1. Contact information of Zeto ..................................................................................................... 4
1.2. Warranty information .............................................................................................................. 4
2. Safety information ........................................................................................................................... 5
2.1. Explanation of markings ........................................................................................................... 5
2.2. Limitations of use ..................................................................................................................... 6
2.3. Additional information ............................................................................................................. 7
2.4. Safety and performance warnings ............................................................................................ 8
2.5. Safety information for IT network .......................................................................................... 12
2.6. Precautions ............................................................................................................................ 14
3. Device overview ............................................................................................................................ 15
3.1. What is WR19?....................................................................................................................... 15
3.2. Intended use .......................................................................................................................... 16
3.3. How makes WR19 my work simpler and easier? ..................................................................... 16
4. Initial setup .................................................................................................................................... 17
4.1. Before you start ..................................................................................................................... 17
4.2. Charging the battery .............................................................................................................. 18
4.3. Installing the software ............................................................................................................ 19
4.4. Turn it on ............................................................................................................................... 20
4.5. Setting up network connection .............................................................................................. 21
4.6. Cleaning before the first use .................................................................................................. 22
4.7. Electrode setup ...................................................................................................................... 22
5. Daily use ........................................................................................................................................ 24
5.1. Donning instructions .............................................................................................................. 24
5.2. Starting the donning session .................................................................................................. 28
5.3. Position of the patient during EEG .......................................................................................... 30
5.4. Recording an EEG ................................................................................................................... 31
5.5. Joining to an EEG donning or recording session ...................................................................... 31
5.6. Interpreting an EEG recording ................................................................................................ 31
5.7. Using ECG .............................................................................................................................. 32
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5.8. Recording additional sensors .................................................................................................. 32
6. Cleaning and maintenance ............................................................................................................. 33
6.1. Cleaning instructions .............................................................................................................. 33
6.2. Battery instructions ................................................................................................................ 40
6.3. Disposal instructions .............................................................................................................. 40
7. Technical specifications ................................................................................................................. 41
7.1. WR19 device technical specifications ..................................................................................... 41
7.2. Accessories ............................................................................................................................ 42
7.3. Environmental conditions ...................................................................................................... 42
7.4. Operational characteristics..................................................................................................... 43
8. Compliance .................................................................................................................................... 44
8.1. Electromagnetic compatibility ................................................................................................ 44
8.2. Radio communication ............................................................................................................ 47
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1. About this manual
This manual is intended for the user of the Zeto WR19 wireless EEG headset device. It contains general operating instructions, precautionary measures, maintenance instructions and information for use of the device.
Please read this manual carefully and familiarize yourself with the various controls and accessories before starting to use the product.
1.1. Contact information of Zeto
Zeto support can be reached via email (support@zeto-inc.com) or by phone during office hours (PST).
Zeto, Inc.
2336, Park Ave,
Santa Clara, CA 95050
USA
Phone: +1 408 658-0737
Web: http://zeto-inc.com/
1.2. Warranty information
The device is warranted against failure of materials and workmanship for a period of 2 years from the date of delivery.
Repairs can only be performed by the manufacturer. Warranty will terminate automatically when the product is opened by any person other than qualified personnel authorized by Zeto.
The warranty does not cover the following:
• failure resulting from misuse, accident, modification, unsuitable physical or operating
environment, or improper maintenance
• failure caused by a product for which Zeto is not responsible
• damage resulting from use of non-approved accessories
• any non-Zeto products
The warranty is voided by removal or alteration of identification labels on the product or its parts. Warranty is also void in case seals on the enclosure are broken, tampering, or servicing by unauthorized personnel.
Zeto does not warrant uninterrupted or error-free operation of wired or wireless data transmission.
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2. Safety information
This section contains general warnings, explanation of markings, limitations of use, safety measures, and precautionary measures that are important for the safe use of the device.
2.1. Explanation of markings
This documentation and the device uses the following markings.
Symbol
Meaning
IP rating
Level of protection against ingress of dust and water.
Refer to instruction manual
Not following the instructions may lead to a risk.
Mandatory action
Follow the instruction to ensure safety, performance and convenience.
Consult operating instructions
Follow operating instructions.
Type BF applied part
High degree of protection against electric shock.
Safety warning
Not following the instructions will lead to a risk.
Do not push, bend, sit on, step on, push, pull or overstress flexible material
Do avoid the device from mechanical stresses.
Contains radio transmitter.
Device contains a radio transmitter, details about the radio transmission.
Instructions about the IT network.
Technical details about the required Wi-Fi network.
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2.2. Limitations of use
Limitations of use
The device is not intended for:
• clinical patient monitoring
• use in life support systems
• use when alarms based EEG classification is required
• use in sterile environment
• monitoring unconscious or sleeping patients without supervision
The product is not to be:
• used near high frequency surgical equipment
• exposed to ionizing radiation
• used on patients undergoing electro surgery
• used in oxygen rich environment (concentration > 25% at 1 atm)
• used during defibrillation – defibrillation may damage the product
The product is not:
• defibrillation proof
• suitable for sterilization
• suitable for use in explosive atmosphere
• suitable for use in presence of flammable anesthetics or gases
Do not:
• use, store or transport the device outside of the specified temperature
conditions, this may damage the device
• drop, sit on, step on, fold, push, pull or stretch the product, this can damage the
device
To ensure solid electrode performance, do not:
• use in case of the skull of the patient is not intact, or the patient has a sensitive
dermatological condition on the scalp and therefore even the very light electrode contact forces cannot be tolerated
• use in case of open wounds or infections on the scalp to avoid cross-subject
contamination
The WR19 headset is not a diagnostic tool. Any medical diagnosis related to the EEG should only be derived by a certified Physician. There are no known side effects from the use of this product.
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Limitations of use
The product is not designed to be used near magnetic resonance imaging (MRI) equipment.
2.3. Additional information
Additional information
• This device is intended for use on a healthy scalp on teen and adult humans
having a head circumference between 54-61 cm.
• EEG test subjects may be bald or may have hair. Hair must be split in a way which
allows direct connection of the electrodes to the scalp. To have a complete EEG test result, all electrodes must properly land on the scalp of the subject.
• This device is only operational when connected to a 2.4GHz Wi-Fi network. The
network shall use WPA or WPA2 encryption, and shall not use captive portal authorization. The IT network shall allow communication to the public Internet.
• When not in use for long time, store the device in half-charged state at room
temperature to promote prolonged battery performance.
• This device is designed for use in a professional healthcare facility environment.
• Using in other environments such as near to HF surgical equipment, magnetic
resonance imaging equipment, or other equipment which produces high level of EM disturbances will affect the performance of the device. In this case, the recorded biopotential waveforms may have environmental artifacts such as additional unexpected high frequency components superimposed. However, no harm to the patient or operator may occur.
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2.4. Safety and performance warnings
Safety warnings about the device
To keep your product safe, do not:
• immerse the product into any liquid
• sterilize
• expose the product to direct sunlight, or heat source of thermal radiation,
moisture, vibration, mechanical shock, excessive dust or humidity
• open, modify or disassemble the product – as that voids warranty
• use when damaged
• use when wet – if any moisture penetrates the product, have the product
checked by the manufacturer
• use caustic or abrasive cleaning agents to clean the device or electrodes
• bend cables sharp
• charge while being worn by the patient
Disposable electrodes may cause a biohazard. Do
• store clean electrodes in a separate bag
• always clean electrodes after each measurement according to the cleaning
instructions
• replace the electrodes at every 6 months or after 150 tests
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Performance warnings
This device is designed for use in a professional healthcare facility environment.
• Using in other environments such as near to HF surgical equipment, magnetic
resonance imaging equipment, or other equipment which produces high level of EM disturbances will affect the performance of the device.
• In case of EM disturbances, the recorded biopotential waveforms may have
environmental artefacts such as additional unexpected high frequency components superimposed.
• Some EM disturbances, such as mains frequency artefacts may be reduced by
using the built-in filters of the client software.
• No harm to the patient or operator may occur when using the device in an
unsupported environment.
Separation from RF communications equipment
• Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the WR19 device. Otherwise, degradation of the performance of this equipment could result.
Always use supplied accessories.
• using accessories of other types may cause a hazard of excessive heat, fire or
explosion, or may result improper operation of the device by increase emissions or decrease immunity of the device
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Safety warnings about the battery
WARNING: potential for fire or burning.
• Do not disassemble or crush the battery.
• Do not heat, or burn the battery.
• Do not throw the battery into fire or water.
• Do not swallow batteries.
• Do not short circuit batteries.
• Replacement may only be made with Battery pack specified by the
manufacturer, with correct Part Number.
• Fire or burning may occur if the customer uses Battery pack other than specified
by the manufacturer.
• The battery used in WR19 must be replaced at Zeto’s service centers only.
• The customer shall refer to the handling instructions and environmental limits.
CAUTION: The battery used in this device may present a fire or chemical burn hazard if mistreated. Do not disassemble, heat above 100 °C (212 °F) or incinerate.
To ensure battery safety, do not:
• open the device – battery is to be replaced by the manufacturer
• charge the battery while the headset is worn by a patient
• charge the headset below 0 °C or above 45 °C (below 32 °F or above 113 °F)
• store the device below -20 °C or above 45 °C (below -4 °F or above 113 °F)
Follow local regulations and recycling instructions regarding to the disposal and recycling of the device, including the internal Lithium Ion battery. Keep away from children.
First aid measures about the battery
In case of serious mishandling, the battery may leak or emit gases in case of:
• charging outside of the allowed temperature range
• storing or transporting the device outside of the allowed environmental
conditions
• mechanical impacts such as crushing, perforating, disassembling the battery
Electrolyte or other particles which leaks out from the battery is harmful to the human body. Follow the instructions below to reduce risks.
• After inhalation: Fresh air. Seek for medical assistance.
• After skin contact: Remove solid particles immediately. Flush affected areas with
plenty of fresh water (at least 15 min.) Remove contaminated cloth immediately. Seek for medical assistance.
• After eye contact: Flush the eye gently with plenty of fresh water (at least 15
min.) Seek for medical assistance.
• After ingestion: Drink plenty of water. Avoid vomiting. Seek for medical
assistance. No trials for neutralization.
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Fire and environment related accidental measures about the battery
In case of serious mishandling, the battery may catch fire.
• Suitable extinguishing media: Metal fire extinction powder, rock salt or dry sand
shall be used. In case only water is available, it can be used in large amounts.
• Extinguishing media with limited suitability: Carbon dioxide (CO
2
) is not
suitable. Water in small quantities may have adverse effects.
• Special protection equipment during fire-fighting: Contamination cloth
including breathing apparatus.
• Special hazard: battery cells may explode and release metal parts. At contact of
electrolyte with water traces of hydrofluoric acid may be formed. In this case avoid contact and take care of good ventilation. At contact of charged anode material with water extremely flammable hydrogen gas is generated.
• Attention: do not let used extinguishing media penetrate surface water or
ground water. If necessary, thicken water or foam with suitable solids. Dispose off properly.
• Environment protection measures: bind released ingredients with powder (rock
salt or sand). Dispose off according to local law and rules. Avoid leached substances to penetrate into the earth, canalization or water.
• Treatment for cleaning: in case of the battery is dismantled, small amount of
electrolyte may leak. Package the battery tightly including ingredients together with lime, sand or rock salt. Then clean with water.
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2.5. Safety information for IT network
The WR19 device streams captured EEG information to Zeto’s data center in real time. We made our best
to allow configuring this data connection as easily as possible, while maintaining industry standard security for all data.
WR19 has very little network requirements. If you have a Wi-Fi connection with a network id and password, and Internet, then you can use the WR19 on that Wi-Fi network seamlessly.
This device uses a wireless Wi-Fi connection to connect to the data center of Zeto over the Internet. The purpose of the IT network connection is to control the device, and transfer data. The device uses the IT network to:
• Identify and authorize the headset connection to the data center
• Control the headset from a local or remote IT device via the data center
• Transmit headset status, such as battery and temperature to the data center
• Transmit raw captured data to the data center
The device connects to an IT network provided by the user, not validated by the manufacturer. The WR19 device requires the following IT network:
IT network requirements
Network type:
2.4 GHz WiFi, 802.11 b/g/n
Network characteristics:
2 Mbit upstream, 1 Mbit downstream bandwidth routed to the public Internet, less than 500ms packet latency
Network configuration:
WR19 uses a network setup mode to enter Wi-Fi connection credentials. Then WR19 obtains network settings from a DHCP enabled Wi-Fi access point automatically. No further configuration is necessary.
Note: Wi-Fi networks using captive portals (requiring entering network credentials in a web browser) are not supported.
Technical specification:
The Wi-Fi access point must run a DHCP service to let connecting devices automatically configure their network settings.
The Wi-Fi access point and the underlying IT network must be configured to allow outgoing HTTPS traffic on port 443 and route data towards the public Internet.
Although cybersecurity measures of WR19 are independent of the IT network, it is advised using WPA/WPA2 Wi-Fi encryption to protect the access point from unauthorized access.
There is no requirement for opening ports on firewalls or set up any port forwarding rules.
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Warning about IT network used by multiple medical devices
Connection of the WR19 device to an IT-NETWORK/DATA COUPLING that includes other equipment could result in previously unidentified RISKS to PATIENTS, OPERATORS or third parties.
The RESPONSIBLE ORGANIZATION should identify, analyze, evaluate and control these RISKS. Subsequent changes to the IT-NETWORK/DATA COUPLING could introduce new RISKS and
require additional analysis, and changes to the IT-NETWORK/DATA COUPLING include:
• changes in the IT-network/DATA COUPLING configuration;
• connection of additional items to the IT-NETWORK/DATA COUPLING;
• disconnecting items from the IT-NETWORK/DATA COUPLING;
• update of equipment connected to the IT-NETWORK/DATA COUPLING;
• upgrade of equipment connected to the IT-NETWORK/DATA COUPLING.
No unaccepted risks have been identified and no hazardous situation may result from loss of Wi-Fi connectivity.
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2.6. Precautions
Precautions of use
Avoid cross-patient contamination
• Always clean the device and clean or replace electrodes after using according to
the clean instructions to avoid cross-patient contamination.
Special patient population
• Safety and effectiveness in children under the age of 10 have not been
established.
Handling bands
• Adjustable bands let the device align to different head sizes and head shapes.
Always open all bands fully before putting on the headset on the patient.
• Once the headset is on the head and aligned according to the instructions,
tighten the bands slowly. Avoid over-tightening the band, as excessive force may cause unnecessary inconvenience to the patient.
• Do open all bands before removing the headset.
The WR19 device is built from flexible materials. This allows the headset to align to different head shapes and sizes. Using flexible materials limit mechanical stability. Do not:
• push,
• bend,
• sit on,
• step on,
• push,
• pull or
• overstress flexible material
as it may break the headset.
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3. Device overview
3.1. What is WR19?
The WR19 is a wireless, battery operated full montage EEG headset, using dry electrode technology.
The headset provides an integrated approach for wireless acquisition and recoding of electroencephalographic (EEG) and electrocardiographic (ECG) bipotential signals. Wireless Wi-Fi technology allows the patient to move around the clinic or in the field, while real time data is collected, displayed and analyzed.
The headset uses dry electrode technology to obtain high quality EEG with no scalp preparation in just minutes. A set of patented mechanisms and a range of replaceable dry electrodes allow aligning the headset to different head shapes and sizes, while keeping electrode positions aligned to the 10-20 electrode system.
The WR19 device uses 19 EEG electrodes plus one active ground electrode to capture a full montage EEG. An additional bipolar channel allows capturing ECG time synchronized to the EEG recording. A set of built in additional sensors add more information such as head movements and photic trigger events. The headset accepts an external digital trigger signal from any other system which is recorded in sync to the EEG channels.
EEG capture is referential, using a set of pre-configured references such as average reference, or T3-T4 average reference, or Cz electrode reference. This captured data can be transformed into various montages digitally, such as bipolar longitudinal, bipolar transversal, circumferential, and so on by the processing cloud.
Electrode contact quality is continuously monitored by the system. Data segments causing non­biophysical signals due to inadequate contact quality or heavy external interferences are marked automatically.
All electrode amplifiers, and analog-to-digital converters as well as the Wi-Fi radio transmitter is all built in to the headset. All EEG and ECG channels are sampled at a time resolution of 500Hz, and precisely converted to digital data at 24 bits of resolution.
Captured data is streamed to the data processing cloud in real-time. The data processing cloud can process low-pass, high-pass and notch filtering, perform montage transformations, calculate power spectral densities both in real-time and when interpreting a previous recording. Recordings are stored in the server cloud, and available for interpretation by a local or a remote physician.
The operator of the WR19 headset can use a smartphone, tablet or a desktop computer to configure and control the headset using a client software. The client software visualizes recordings in real-time, and allows browsing in previous recordings for interpretation.
Not only a local technician can control the headset. A physician or a technician can remotely connect to a real-time recording, and verify signal quality, or may derive a diagnosis in real-time.
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