Beruflich Dokumente
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EGI Operators
Manual
EGI Operators
Manual
8100040-50
December 15, 2010
CONTENTS
Preface . . . vii
GES Components . . . vii
About This Manual . . . viii
Support, Repair, and Documentation . . . ix
Chapter 1
Chapter 2
Chapter 3
Contents
Chapter 4
Chapter 5
EMC Declarations 75
Electromagnetic Emissions . . . 76
Electromagnetic Immunity . . . 77
Electromagnetic Immunity for Non-life-supporting Equipment . . . 78
Recommended Separate Distances Between Radio-frequency (RF)
Communications Equipment . . . 79
Appendix A
vi
Net Sizing 81
PREFACE
W
elcome to the EGI Operators Manual. This manual describes the core
functionalities of the Geodesic EEG System (GES) 300, which is the EGI system.
Each customer is assigned a dedicated EGI support engineer. Your EGI support
engineer will install and configure your EGI system, including all connections
required for its operation. At the time of initial installation, your EGI support engineer
will also train relevant staff in its operation. At any time you have additional
questions or wish retraining, contact your EGI support engineer.
EGI protects its software from unauthorized use by encoding the licensing data in a HASP key
(i.e., a dongle, which looks similar to a USB flash drive). All authorized Net Station users have a
HASP key that plugs into their computers USB port. If you purchased only the Net Station
software, the key is included in the software installation package. If you purchased a complete
EGI Geodesic EEG System (GES), the HASP key is attached to the carts handle.
For instructions for updating the licensing contained in your HASP, contact your EGI support
engineer.
GES Components
All GESs are based on geodesic technology. Depending upon your purchase, some or
all of the following components are included in your GES:
vii
Preface
MR (magnetic resonance)
viii
Preface
www.egi.com/suppport
supportteam@egi.com
info@egi.com
+1.541.687.7962
+1.541.687.7963
Electrical Geodesics, Inc.
1600 Millrace Drive, Suite 307
Eugene, OR 97403
USA
ix
Preface
Chapter 1
CHAPTER
SAFETY AND
MAINTENANCE
T
his chapter provides safety, maintenance, and general information about the
GES 300. Before operating your GES, it is important to understand its intended
use, required location, environmental conditions, regulatory compliance, and all
safety cautions and warnings related to all GES components. Do not use your GES
unless you understand the information provided in this chapter.
WARNING: All system components must be installed and configured by an EGI
support engineer. Deviating from the supported configuration or running the system
with non-EGI components attached can cause unexpected performance or hazards.
Note that the information in this manual is subject to change, without notice. If they are not used
in compliance with official documentation, the manufacturer declines responsibility for the
safety, reliability, and performance of GES components. It is important to only use your GES
according to the manufacturers instructions.
System Safety 16
General Safety 16
Patient Isolation 17
Operational Safety 20
Power, Connectivities, and Cables 20
Data Acquisition Computer (DAC) 21
Data Stream and File Management 22
Articulated Arms and Mounting Brackets 23
Reviewing and Analyzing EEG Data 23
HydroCel Geodesic Sensor Nets (HCGSNs) 24
Geodesic Photogrammetry System (GPS) 28
Maintenance 31
Disassembly 18
Lightning 19
Isolation Transformer 32
11
Use Requirements
This section provides general information abut how, where, and under what
conditions to use your GES 300.
Intended Use
The GES is intended to measure and record the electrical activity of the brain. It is
designed to be used with adults, children, and infants.
Environmental Conditions
The GES 300 has been designed for use under the conditions given in Table 1-1.
Table 1-1. GES 300 overall operating environment
12
Storage temperature
Operating temperature
Relative humidity
5 to 95% noncondensing
Maximum altitude
Regulatory Compliance
European Union (EU) Authorized Representative
Contact
Gerhard Frmel
Address MPS
106425.3235@compuserve.com
Models
The GES is available in two configurations: EEG-only and MRI/EEG. The GES 300 is
the EEG-only configuration and the GES 300 MR is the MRI/EEG configuration. This
manual addresses the GES 300. For all safety and use instructions related to the
GES 300 MR, contact EGI Technical Support (see page ix).
For details about earlier models of the GES (i.e., 120, 140, 200, and 250), contact EGI
Technical Support (see page ix).
13
Rating
Input: 100-240VAC, 50/60 Hz, 1.0 A
Output: 12 VDC, 3.3 A
Interference
It is your responsibility to ensure that the GES and its components are safe and
operate properly before using them.
All GESs have been tested and found to comply with the electromagnetic compliance
limits for the Medical Device Directive 93/42/EEC (EN 60601-1-2:2007 Class A and JIS T
0601-1-2:2002). See Chapter 5, "EMC Declarations, for EMC guidelines.
These limits are designed to provide reasonable protection against harmful
interference in a typical medical installation. The equipment generates radiofrequency energy and, if not installed and used in accordance with the instructions,
may cause interference to other devices in the vicinity. If this equipment does interfere
with other devices, which can be determined by turning the equipment off and on, try
to correct the interference by one or more of the following measures:
Reorient or relocate the receiving device.
Increase the separation between the equipment.
Connect the equipment to an outlet on a different circuit than the one used by
the other devices.
Consult EGI Technical Support (page ix).
14
Symbols
Table 1-2 describes the symbols used on the GES 300.
Table 1-2. GES 300 symbols
Symbol
Description
Symbol
Description
Patient-connected part
(Type BF)
Tipping hazard
Electrical hazard
Keep dry
Fragile
This side up
Temperature limits
Humidity limits
15
System Safety
This section provides warnings related to the systems components and configuration.
General Safety
WARNING: The following warnings apply to the general use of the GES.
Do not omit the isolation transformer from the GES configuration. Modifying the GES in
this fashion increases the risk of injury to the patient. Always use the isolation
transformer.
Ensure that the environment is safe. The room where the GES is used must comply with
safety requirements.
Use only approved equipment. Do not connect the GES to unauthorized equipment, as
injury or damage may result. The user is responsible for ensuring that a
reconfigured GES meets applicable local and national regulations for safety and
performance. See IEC 60601-1.
Connect only approved peripherals. Do not connect any product that is not IEC 606011approved to any port of the GES.
Avoid collisions and risks of combustion. Avoid collisions and vibrations to the GES and
pay attention to the danger of combustion when using the equipment in the presence
of flammable anesthetics.
Do not expose the GES to liquids. If liquids are spilled on the GESs electronic
components, immediately disconnect the system from all power sources. Do not use a
GES that has suffered exposure to liquids until EGI or other qualified personnel
certify that the liquid or liquid residue did not affect patient safety or device
operation.
Do not remove any parts, while the GES is powered. The GES uses potentially
dangerous line voltages, which are present within some subsystem devices. Limited
servicing may be performed by the customer, but consult EGI or other qualified
personnel for guidance.
Maintain a safe patient area. Place the isolation transformer and the data acquisition
computer, along with their attendant devices, out of patient reach (at least
1.5 meters [4.9 ft.] away). The patient area should contain only the patient, HCGSN
sensor array, and devices such as the photic stimulator.
16
Note that high electromagnetic interferences may affect EEG acquisition. Ensure that the
EEG acquisition equipment is in a room (4 or 5 meters [13 or 16 ft.] wide) free of
noise-contributing items (such as air conditioners, neon lights, televisions, mobile
phones, appliances, and medical therapy devices). If noise is still an issue, you can
use a notch filter, which attenuates signals at 50 or 60 Hz (the frequencies at which
power lines generally operate). If noise continues to be an issue, consult Chapter 5,
"EMC Declarations, or contact EGI Technical Support (page ix).
Patient Isolation
Medical equipment standards require that, even if a patient is directly attached to a
220 V source (such as by placing a moistened finger in a high voltage socket), no
current will pass through the patient to ground as a result of a device being attached.
The primary variable for determining the severity of electric shock is the electric
current that passes through the body. This current depends on the voltage and the
resistance of the path it follows through the body. Table 1-1 provides a general
framework for shock effects (Source: Nave & Nave, Physics for the Health Sciences,
3rd Ed. W.B. Saunders, 1985; also at http://hyperphysics.phy-astr.gsu.edu/hbase/
hframe.html).
Table 1-1. General framework for shock effects
Electric current
(1-second contact)
100,000 Ohms
1,000 Ohms
1 mA
100 V
1V
5 mA
500 V
5V
1,000 V
10 V
10,000 V
100 V
600,000 V
6,000 V
1020 mA
100300 mA
6A
WARNING: The following warnings apply to the isolation of patients from the GES.
Maintain patient isolation. Never touch the patient and the components outside the
patient area at the same time.
Do not bypass isolation. Do not allow patients to come into contact with an earth
ground. Touching ground bypasses isolation.
17
Connect the GES only to the power mains cord supplied with the protective ground
terminal. The presence of ground protection preserves the patients safety, as well as
your own. Check that your local electrical plant can guarantee an efficient
grounding. The grounding reliability of a GES can be ensured only when used with a
hospital-grade plug.
Connect all components of the GES (monitors, plotters, modems, etc.) to the isolation
transformer outlets. Never connect the computer or other system components directly
to a wall power socket, because the leakage currents in the computer can present an
electrical hazard to you and the patient.
Ensure electrode isolation. Prevent contact between the conductive part of the
electrodes and other conductive parts, including the ground.
Ensure patient isolation when using the Polygraph Input Box (PIB). Even though the
HCGSN 210 MR Net can be used outside of the MR environment for EEG-only
acquisition with the FICS-Compatible Net Amps 300 amplifier, DO NOT use the
HCGSN 210 MR Net when using the Polygraph Input Box (PIB) outside of the MR
environment. For details, contact EGI Technical Support (page ix).
Disassembly
WARNING: The following warnings apply to the disassemblage of the GES.
Only authorized personnel can service the equipment. Only personnel qualified for
servicing and properly authorized by the manufacturer can open the GES, access its
internal parts, or perform calibrations, changes, or repairs.
18
Do not open or disassemble the amplifier. The interior of the amplifier unit, whether
enclosed in the GES cart or not, contains no user-serviceable parts. In the event that
the amplifier requires servicing, contact EGI Technical Support (page ix) for
instructions on how to safely pack and return it to EGI for evaluation and servicing.
Do not touch the power supply. Touching any internal portion of the power supply,
while the GES is powered, could result in electrical shock or injury.
Lightning
WARNING: System isolation is designed to protect the patient even if a highvoltage source is accidentally applied to either the patient or the GES. However,
because of the large, unpredictable electrical charges involved in a lightning strike,
disconnect the patient and discontinue the data acquisition session during a
thunderstorm.
19
Use only accessories, cables, and replacement parts sold by EGI. The use of accessories
and cables other than those that ship with the GESs, with the exception of those sold
by EGI as replacement parts for internal components, may result in increased
emissions or decreased immunity of the GES.
Avoid stacking or adjoining GES equipment with other equipment. GES equipment
should not be used adjacent to or stacked with other equipment. If adjacent or
stacked use is necessary, the GES should be observed to verify normal operation in
the configuration in which it will be used.
Operational Safety
This section provides additional precautions for using GES components and features.
20
Only the HCGSN and GSNIC can be hot swapped. Remember that only the HCGSN
and GSNIC can be connected or disconnected during data acquisition. All other
cable connections, including FireWire connections, need to remain as is (connected or
disconnected) during acquisition. Otherwise, you will interrupt the data stream and
need to restart the acquisition session.
Turn the computer off before connecting the photic stimulator. Connect the photic
stimulator only when the computer is off.
Attach nothing to the amplifiers inputs when measuring gains. When measuring gains,
verify that nothing (HCGSN or articulated arm) is attached to the amplifiers inputs;
otherwise, you may receive an error message. If it is inconvenient to unplug the
HCGSN or arm before every EEG recording session, you may want to measure gains
only once a month.
Do not interrupt ECI connections during acquisition. Do not interrupt an experiment control
interface (ECI) connection (for example, by pulling out a cable), while the Workbench is
on or an acquisition session is open; otherwise, a system failure may occur.
21
22
23
When to manually mark eye channels as bad .... If you leave the Flatten Eye Channels
checkbox unselected for infant Nets, then you should manually mark the lower and
horizontal eye channels as bad to ensure that they are excluded from future
operations.
For longer recording sessions with adults and large pediatrics wearing a 32-, 64-,
or 128-channel HCGSN 120:
For all recording sessions with small pediatrics and most infants wearing any
channel count of HCGSN 120:
limit recordings to 2 hours (infant skin is more sensitive to the irritation of
extended wear);
constantly monitor the infant to prevent choking or strangulation; and
check the infant every 15 minutes for redness, pressure points, and overturned
sensors.
24
For all recording sessions with newborns and premature infants wearing any
channel count of HCGSN 120:
limit recordings to 1 hour (newborn and premature infant skin is even more
sensors.
Consult the patients attending physician. Consult each patients attending physician for
nonstandard precautions that may be needed for individual patients, especially for
pediatric patients.
Make sure you are using the correct HCGSN for each patient and monitoring session.
HCGSNs are clearly marked on their connectors with their sizing and model, but
contact supportteam@egi.com if you have any questions. Routine monitoring
HCGSNs have sponges around the electrodes in the pedestal of each sensor, are used
with a saline-based electrolyte solution, and are for routine (shorter) monitoring
sessions. Long-term monitoring (LTM) HCGSNs do not have sponges in each sensor, are
used with paste-based electrolyte, and are for extended (longer) monitoring sessions.
Monitor patients for skin irritation and comfort. Regularly monitor patients for skin
irritation and comfort for the duration the HCGSN is on the head (from application until
removal). After the HCGSN is made comfortable for the patient, check patients as follows:
Apply only properly prepared HCGSNs. Never apply an HCGSN that has not been
properly cleaned, disinfected, and rinsed.
Have patients remove all head accessories before applying the HCGSN. Ask the patient
to remove earrings, glasses, barrettes, and hair ties. These can be uncomfortable,
interfere with HCGSN application, and reduce data quality. Glasses can be
replaced after HCGSN application, if desired.
Have patients keep eyes closed when working near the eyes. Ask patients to close their
eyes while applying the HCGSN, removing the HCGSN, or adjusting sensors near the
eyes. Failure to follow this procedure can result in serious injury.
Connect the HCGSN only as directed (to the amplifier or EGI articulated arm). Do not
connect the HCGSN to any device or electrical source other than that specifically
authorized by the manufacturer and never use the HCGSN without trained supervision.
Accidental connection to a power source could result in serious injury or death.
25
Keep the HCGSNs connector dry. The HCGSNs connector is an electrical connector. To
prevent personal injury or equipment damage, keep the connector dry at all times.
Do so by keeping it above the level of the HCGSN during application so that liquid
does not run down the cables and into the connector.
Use separate clean, dry towels for each patient and each HCGSN. To prevent crosscontamination, use separate clean, dry towels for each patient and each HCGSN.
Also, do not use the same towel for both a patient and the GSN being used on that
patient.
Never use electrolyte in the disinfectant bucket or disinfectant in the electrolyte bucket.
To avoid cross-contamination, dedicate the use of the electrolyte and disinfectant
buckets for their chemical solutions only.
Use saline-based electrolyte solutions only once. Do not reuse saline-based electrolyte
solutions between patients or sessions. Dispose of them according to your institutions
guidelines.
Wrapping HCGSNs
CAUTION: Adhere to the following cautions when wrapping the patients head
and HCGSN.
Determine if wrapping the head is appropriate for individual patients. While wrapping
the head is appropriate for most adults, it is not appropriate for all patients. Consult
each patients medical professional for determination.
Determine the appropriate head wrapping for individual patients. While all head
wraps improve data quality and lengthen recording duration, stretch gauze is more
effective at doing so. However, stretch gauze is to be used only if approved by the
patients medical professional. Some patients cannot tolerate it. The alternative head
caps are looser and softer, and therefore gentler and more comfortable for patients
with sensitive skin. If using stretch gauze, wrap it gently. This minimizes the pressure
that can increase skin breakdown during longer recording sessions.
Regularly monitor patients for skin irritation and comfort. Check the patient frequently
to ensure the skins safety during longer recording sessions.
Adhere to maximum wear times. For longer recording sessions, refer to the maximum
wear times listed under Applying HCGSNs on page 24.
26
Removing HCGSNs
CAUTION: Adhere to the following cautions when removing HCGSNs.
Always pull the HCGSN off from the skin and hair before removing it. Before removing
the HCGSN with a peeling motion (working front to back), always gently pull the
HCGSN off from the patients skin and hair to reduce skin irritation and prevent skin
damage.
Only pat, never rub, skin after the HCGSN is removed. After gently splashing the skin or
rinsing the hair, always gently pat (never rub) the patients skin or hair with a clean,
dry towel to reduce skin irritation and prevent skin damage.
Cleaning HCGSNs
WARNING: Adhere to the following warnings when cleaning HCGSNs.
Handle full strength disinfectant with great care. Keep the disinfectant out of the reach
of children. At full strength, it is corrosive and can cause severe eye and skin
damage. Do not get it in your eyes or on your skin or clothing. Wear goggles (or a
face shield) and rubber gloves when handling. Harmful if swallowed. Avoid
contamination of food. Remove and wash contaminated clothing.
Avoid skin contact or ingestion of diluted disinfectant. Per the manufacturers instructions,
the disinfectant is neither a skin irritant nor a sensitization agent at the recommended
dilution. Regardless, EGI recommends avoiding skin contact or ingestion. DO NOT
SUBMERGE YOUR HANDS IN THE DISINFECTANT. See the manufacturers instructions
for the detailed precautions for handling the concentrated formula.
Do not use isopropyl alcohol, strong solvents, or an autoclave with HCGSNs. Isopropyl
alcohol or other solvents will disintegrate the sponges. An autoclaves steam
sterilization will disintegrate most epoxies and cable insulations. Any such damage is
not covered by the products warranty.
Never use electrolyte in the disinfectant bucket or disinfectant in the electrolyte bucket.
To avoid cross-contamination, dedicate the use of the electrolyte and disinfectant
buckets for their chemical solutions only.
Do not pinch or damage HCGSN wires. Be careful not to grasp the HCGSN in such a
way that you pinch or damage the HCGSNs wires.
Keep the HCGSNs connector and split wire sleeve dry. The HCGSNs connector is an
electrical connector. To prevent personal injury or equipment damage, keep the connector
dry at all times. (It is understood that a few splashed drops will be unavoidable.) To
27
prevent water damage to the connector and split wire sleeve, keep the connector high
above the HCGSN throughout the entire cleaning process. And, until the HCGSN is hung
to dry, we recommend keeping the connector enclosed in a plastic bag.
Ensure that you properly disinfect the HCGSN. Gently, but vigorously, agitate the
HCGSN back and forth in the disinfectant for prescribed period to successfully
remove any residual electrolyte (saline- or paste-based).
Do not leave the HCGSN in the disinfectant for longer than is prescribed. Be aware that
prolonged submersion in the disinfectant may damage an HCGSN and such damage
is not covered by the products warranty.
28
Moving GPSs
WARNING: Adhere to the following warnings when moving GPSs.
Use caution when moving the GPS. Due to its size and weight (77 kg [170 lb.]), use
caution when moving the GPS to prevent injury or equipment damage.
Do not tip the GPS more than 10 degrees in any direction. Due to its size and weight
(77 kg [170 lb.]), the GPS is a crush hazard.
Disconnect power before moving or disassembling the GPS. To prevent injury or
equipment damage, disconnect power from the GPS before moving or disassembling it.
Grounding GPSs
WARNING: Adhere to the following warnings when grounding GPSs.
Do not open the GPS. The interior of the GPSs gantry contains no user serviceable
parts. Furthermore, accessing the interior of the GPS can result in electrical shock or
electrocution due to the hazardous mains voltage inside. In the event that the GPS
requires servicing, contact EGI Technical Support (page ix).
Disconnect power before moving or disassembling the GPS. To prevent injury or
equipment damage, disconnect power from the GPS before moving or disassembling it.
Ensure grounding reliability. Only connect the GPS to an equivalent receptacle
marked Hospital Only or Hospital Grade.
Connecting GPSs
WARNING: Adhere to the following warnings when connecting GPSs.
Use only approved power cords. Do not use any power cord with the GES that is not
approved by EGI. For the appropriate cord, plug, and instructions for your area,
contact EGI Technical Support (page ix).
Inspect your connectors and cables. To reduce the risk of electrical shock, discontinue
the use of worn or damaged electrical connectors and cables.
29
Disassembling GPSs
WARNING: Adhere to the following warnings when disassembling GPSs.
Do not open the GPS. The interior of the GPSs gantry contains no user serviceable
parts. Furthermore, accessing the interior of the GPS can result in electrical shock or
electrocution due to the hazardous mains voltage inside. In the event that the GPS
requires servicing, contact EGI Technical Support (page ix).
Disconnect power before moving or disassembling the GPS. To prevent injury or
equipment damage, disconnect power from the GPS before moving or disassembling it.
30
Maintenance
This section discusses maintenance and service issues that will help you enhance the
performance and life of your GES. You can improve the long-term quality of your GES
by paying regular attention to its appearance and operation. The equipment must be
kept clean to ensure that the components function efficiently. A quick examination of
the GES before each use will decrease the likelihood of serious problems occurring later.
WARNING: Do not perform repairs not discussed in this manual. For service and
maintenance issues not mentioned, contact EGI Technical Support (page ix).
WARNING: The following warnings apply to the cleaning of any component of the GES.
Turn off and unplug. Before cleaning any part of the equipment, always turn off and
unplug the equipment.
No liquids, oils, or harsh cleaners. Use only a cloth dampened with mild soapy water or
isopropyl alcohol to clean the exterior of equipment housings. For HCGSN cleaning
instructions, refer to page 49 for LTM Nets and page 67 for routine Nets.
Keep dry. Make sure that no liquid enters any part of the equipment and that all
components are completely dry before reconnecting the GES to power and
restarting the equipment.
Turn off and unplug the GES (including the GPS, if present) before cleaning.
Prevent any liquid from entering any GES component.
Do not use abrasive products.
Clean the different surfaces, as follows:
Gently clean near connectors and cracks using a soft brush.
Gently clean camera lenses and monitor screens using a lint-free brush or
cloth (such as an antiscratch microfiber eyeglass cleaning cloth).
Clean external surfaces (except camera lenses and monitors) with a cloth
dampened with mild soapy water or isopropyl alcohol, taking care not to
wet any electrical contacts.
Dry with a clean, dry, lint-free cloth.
31
Isolation Transformer
Isolation transformers sometimes need their fuses replaced. No other maintenance
instructions apply to isolation transformers other than fuse replacement. For fuse
replacement instructions, refer to the transformer manufacturers operating
instructions.
32
Chapter 2
CHAPTER
LONG-TERM MONITORING
(LTM) EEG
D
ifferent materials and workflow are required for acquiring long-term monitoring
(LTM) EEG recordings than for routine (short-term) EEG recordings. Follow the
guidelines in this section when conducting LTM recordings.
Net Components
Elefix EEG paste (or equivalent)
Note: One 180 gram tube fills one
256-channel Net.
33
Steps
Schedule patient(s)
Session Setup
Patient Preparation
Apply Net
Load sensors with paste
Plug in Net
Inspect waveforms and measure sensor impedances
Position and prepare the patient
Start recording
Acquisition
Cleanup
34
front panel
rear panel
Digital
Analog
FireWire
T-junction
operating
supply
(TOS)
HydroCel GSN
sensor array
(bidirectional cable)
Hypertronics connector
For digital
I/O port
connections,
refer to your
EGI support
engineer.
For analog
input port
connections,
refer to your
EGI support
engineer.
To power supply
FireWire
(bidirectional cable)
Isolated Power
System
Power Switch
Isolation
Transformer
System
Power Plug
(with or without
optional EGI cart)
Mains Power
Figure 2-1. Core components and connections of an EGI Geodesic EEG System (GES) 300
35
Note: Remember that the EGI carts power switch should remain on, unless moving
the cart. The GES is turned on and off by turning on and off the DAC.
b) Log in to the EGI user account using the password provided by your EGI
support engineer.
2
the Dock.
b) Click the Net Station icon to launch the software. (The bouncing icon
36
the EEG recording session by clicking the Session Info button at the top
right of the EEG acquisition screen.
Figure 2-4. Patient Information pane of the Acquisition Session window (left) and EEG acquisition screen (right)
37
38
Size 6
51 54 cm
Size 7
54 58 cm
Size 8
above 58 cm
c) Make sure that the intersection of the two short lines forms an X at the top-
Identify the front and back of the Net. The front has the adjustment straps
and beads, and the back has a series of wire bundles and the spacer
sensor marked S/N.
Count two sensors away from the red nasion sensor and hook your
thumbs under the double lines of elastomer.
Rest the tension straps over your wrists.
Position your little fingers in the bottom of the back row of the Net.
Use your thumbs and little fingers to expand the Net only enough to fit it
over the patients head. Do not overstretch the Net.
39
d) While standing directly in front of the patient, apply the Net by:
pulling it straight down over the patients head with the reference
(REF/CZ) sensor on the vertex;
keeping fingers, sensors, and straps away from the patients eyes;
placing the forehead row of sensors just above the brow ridge; and
making sure that the back of the Net is snug against the patients neck and
not curled up.
e) Make sure that the reference (REF/CZ) sensor is generally aligned over the
vertex and that the nasion sensor is generally aligned over the nasion. If they
are more than 1 cm off their marks, then reapply the Net.
f) Tighten and adjust the tension straps (including the chin, eye sensor, and
back straps with the blue, red, and white beads, respectively). A snug fitting
Net maintains sensor positioning and improves data quality.
6
While adjusting the Nets sensors, gently shift sensors and make sure that:
You grasp groups of sensors, not individual sensors.
You never pinch or damage the wires.
You often check and, if needed, adjust the chinstrap.
The Net is positioned symmetrically on the head and that the midline
is straight.
The reference (REF/CZ) sensor is positioned on the vertex.
The ears are sitting correctly in the ear holes.
The mastoid sensors are positioned on the mastoids.
The nasion sensor is positioned on the nasion.
The infraorbital sensors are positioned directly below the pupils.
The facial sensors are evenly spaced.
40
chinstrap.
d) Place a pad of gauze (or a latex-free bandage) between the nasion and the
nasion tube.
8
Note: Remember that each applicator (if using more than one) fills 45 to 50 sensors.
b) Fill the applicator(s) with paste.
10 Fill the sensor pedestals with paste.
a) Start with the reference (REF/CZ) and
applicator into the pedestal, and fill it with paste to just above the rim.
d) Turn the sensor upright and press gently to make sure that it is directly
41
12 Check and correct (if necessary) data quality and sensor impedances.
a) Within Net Station, check the data quality and impedance values of all the
42
b) Fix any sensors that are displaying poor data quality or unacceptable
event marker (see Figure 2-18 on page 46) and note your log book. (For
details, refer to your EGI training and/or support engineer.)
d) Click the Save & Close button to save the impedance values in the Net
the head.
43
h) Gently unhook any caught sensors and right any sensors that are tipped.
Note: Usually only one or two sensors may be tipped by applying the Spandage.
If more than a few are tipped, then recheck the impedance values (see page 42).
i) Gently pull the sides and back down for complete coverage of the head and Net.
14 Prepare the patient for recording.
a) Describe the recording procedure to the patient.
b) Ensure that the patient is sitting/lying in an appropriate position for the
recording.
For recording sessions with adults that are longer than 24 hours:
- remove the Net every 24 hours;
- check the skin for breakdown; and
- if no breakdown is found, wash and dry the patients head, then reapply the Net.
For recording sessions with pediatrics that are longer than 12 hours:
- remove the Net every 12 hours;
- check the skin for breakdown; and
- if no breakdown is found, wash and dry the patients head, then reapply the Net.
Maintenance
schedule
Unless the patients attending physician advises otherwise, or in your judgment it seems
necessary to check more frequently, adhere to the following schedule of maintenance
during LTM sessions.
Daytime checking schedule (pediatrics and adults):
- Every two (2) hours during wakefulness
- Before falling asleep
- Every morning after awakening
Nighttime checking schedule:
- For pediatrics: every four (4) hours
- For adults: every eight (8) hours
Note: To avoid startling patients during nighttime checks, you might want to advise
them that you will be checking them while they sleep.
44
Locate sensitive areas. After the Net is applied, ask the patient if there are any
areas of pain or discomfort. Mild discomfort can be sensations such as numbness,
warmth, or itching.
Check for irritation. Tilt sample pedestals and examine the skin underneath. Check
the following areas for redness, rash, irritation, blistering, breakdown, or damage:
sensitive areas located earlier; under the nasion sensor; under the face strap nasion
tube; under cheek, forehead, and under-eye sensors; under any tipped pedestals
(reseating those pedestals); and under a minimum of five (5) locations during every
maintenance check. You may use a pen flashlight for nighttime checks.
Assess safety. When the HCGSN is worn for longer than is recommended, it is
important to check for the following signs of skin damage: increasing redness,
whitening (water logging), or cracking.
Protect the skin. If skin checks reveal localized or widespread skin irritations, do the
following:
- For widespread irritations:
Discontinue the study, remove the Net, and follow your facilitys protocols for
patient care.
- For localized skin irritation:
Very gently wipe the area dry with non-alcohol sterile gauze; pad the area
under the sensor with a square of dry gauze (one to four layers, depending
upon the protection needed); and, if the skin needs a complete rest, leave the
gauze dry (otherwise, thoroughly paste the gauze between the sensor and skin
to continue recording the channel).
Figure 2-16. Examples of possible LTM skin irritation (left three images) and padding localized irritation (far right)
45
c) For any sensors that cannot be fixed, mark them with the badc (bad channel)
event marker (see Figure 2-18) and note your log book.
46
d) Click the Save & Close button to save the impedance values in the Net
Stop recording.
From the Waveform Recorder Controls
window, click the Stop button. The
recorder controls will turn color from
pink to yellow to indicate that
recording has stopped.
Figure 2-20. Waveform Recorder Controls
window in pink record mode
Stage 4 Cleanup
As much care is needed for the patient and Net after an acquisition session as was
needed prior to it to ensure the patients continued care and the Nets condition.
Slowly remove the head wrap, working bottom to top with a peeling motion.
47
eyes.
d) Starting with the lower facial
48
While keeping the connector high above the Net to protect the connector and
split wire sleeve from getting wet:
a) Carefully turn the Net inside out.
b) Run or spray clean, warm (not hot) tap water directly into each pedestal until
all visible paste surrounding each electrode pellet has been removed.
c) Inspect the Net, especially the crevices surrounding the electrode pellets, to
water.
e) Fill the rinse bucket with clean, warm (not hot) tap water.
f) Immerse the sensor end of the Net in the water.
g) Gently, but vigorously, agitate the Net back and forth for 10 to 20 seconds to
remove any residual paste. Be careful not to grasp the Net in such a way that
you pinch or damage the wires.
49
h) Raise the Net out of the bucket and drain the rinse bucket.
i) Repeat steps e through h (above) until you have rinsed the Net a total of
four times.
j) After thoroughly rinsing the paste out of the Net, gently pat the excess water
manufacturers instructions.
Note: Be aware that the instructions are different for the concentrated and
premixed formulas.
b) Before each use, use the Control III test strips to verify the efficacy of the
disinfectant, gently and repeatedly plunge the Net up and down to ensure a
thorough disinfection.
f) Leave the Net soaking in the disinfectant for the remainder of the
10 minutes.
CAUTION: Be aware that prolonged submersion may damage a Net and
such damage is not covered by warranty.
g) Keep the timer with you so that you do not leave the Net in the disinfectant
50
51
52
Chapter 3
CHAPTER
ROUTINE EEG
MONITORING
D
ifferent materials and workflow are required for acquiring routine (short-term)
EEG recordings than for long-term monitoring (LTM) EEG recordings. Follow the
guidelines in this section when conducting routine recordings.
Net Components
Electrolyte bucket
Potassium chloride and provided
measuring spoon
Baby shampoo and provided
measuring spoon
Distilled water (recommended as substitute
for hard water)
Pipette
Tape measure
China marker (i.e., wax or grease pencil)
Clean sink area
Control III test strips
53
Steps
Schedule patient(s)
Session Setup
Patient Preparation
Acquisition
Cleanup
54
front panel
rear panel
Digital
Analog
FireWire
T-junction
operating
supply
(TOS)
HydroCel GSN
sensor array
(bidirectional cable)
Hypertronics connector
For digital
I/O port
connections,
refer to your
EGI support
engineer.
For analog
input port
connections,
refer to your
EGI support
engineer.
To power supply
FireWire
(bidirectional cable)
Isolated Power
System
Power Switch
Isolation
Transformer
System
Power Plug
(with or without
optional EGI cart)
Mains Power
Figure 3-1. Core components and connections of an EGI Geodesic EEG System (GES) 300
55
Note: Remember that the EGI carts power switch should remain on, unless moving
the cart. The GES is turned on and off by turning on and off the DAC.
b) Log in to the EGI user account using the password provided by your EGI
support engineer.
2
the Dock.
b) Click the Net Station icon to launch the software. (The bouncing icon
56
the EEG recording session by clicking the Session Info button at the top
right of the EEG acquisition screen.
Figure 3-4. Patient Information pane of the Acquisition Session window (left) and EEG acquisition screen (right)
57
58
Size 6
51 54 cm
Size 7
54 58 cm
Size 8
above 58 cm
While the Net is soaking, you can go ahead to the next step and measure
and mark the vertex.
6
c) Make sure that the intersection of the two short lines forms an X at the top-
59
Identify the front and back of the Net. The front has the adjustment straps
and beads, and the back has a series of wire bundles and the spacer
sensor marked S/N.
Count two sensors away from the red nasion sensor and hook your
thumbs under the double lines of elastomer.
Rest the tension straps over your wrists.
Position your little fingers in the bottom of the back row of the Net.
Use your thumbs and little fingers to expand the Net only enough to fit it
over the patients head. Do not overstretch the Net.
h) While standing directly in front of the patient, apply the Net by:
pulling it straight down over the patients head with the reference
(REF/CZ) sensor on the vertex;
keeping fingers, sensors, and straps away from the patients eyes;
placing the forehead row of sensors just above the brow ridge; and
making sure that the back of the Net is snug against the patients neck and
not curled up.
60
i) Make sure that the reference (REF/CZ) sensor is generally aligned over the
vertex and that the nasion sensor is generally aligned over the nasion. If they
are more than 1 cm off their marks, then reapply the Net.
j) Tighten and adjust the tension straps (including the chin, eye sensor, and
back straps with the blue, red, and white beads, respectively). A snug fitting
Net maintains sensor positioning and improves data quality.
8
While adjusting the Nets sensors, gently shift sensors and make sure that:
You grasp groups of sensors, not individual sensors.
You never pinch or damage the wires.
You often check and, if needed, adjust the chinstrap.
The Net is positioned symmetrically on the head and that the midline
is straight.
The reference (REF/CZ) sensor is positioned on the vertex.
The ears are sitting correctly in the ear holes.
The mastoid sensors are positioned on the mastoids.
The nasion sensor is positioned on the nasion.
The infraorbital sensors are positioned directly below the pupils.
The facial sensors are evenly spaced.
9
c) Most patients will not require it, but for sensitive patients:
place a pad of gauze between the chin and the chinstrap, and
61
place a pad of gauze (or a latex-free bandage) between the nasion and the
nasion tube.
10 Seat the sensors.
Firmly grasp the pedestal of each sensor, in turn, starting with the reference
(REF/CZ) and common (COM) sensors, and move it side to side in a scrubbing
motion to part the hair so that it makes direct contact with the scalp.
Note: For long hair, it may be necessary to push away the hair gently with the tip of
the pipette.
11 Plug in the Net.
a) Plug the Nets Hypertronics connector into the
12 Check and correct (if necessary) data quality and sensor impedances.
a) Within Net Station, check the data quality and impedance values of all the
62
Note: Remember that hair length, thickness, and cleanliness, as well as skin
texture and whiskers, can affect impedance.
b) Fix any sensors that are displaying poor data quality or unacceptable
event marker (see Figure 3-16 on page 65) and note your log book. (For
details, refer to your EGI training and/or support engineer.)
d) Click the Save & Close button to save the impedance values in the Net
63
the head.
h) Gently unhook any caught sensors and right any sensors that are tipped.
Note: Usually only one or two sensors may be tipped by applying the Spandage.
If more than a few are tipped, then recheck the impedance values (see page 63).
i) Gently pull the sides and back down for complete coverage of the head and Net.
14 Prepare the patient for recording.
a) Describe the recording procedure to the patient.
b) Ensure that the patient is sitting/lying in an appropriate position for the
recording.
64
Monitor the patient regularly during the recording and mark in the EEG data
(as necessary).
If marking events in the
EEG data, use the event
comment buttons that you
created with your EGI
support engineer to enter
events and comments
where and when necessary.
Stop recording.
From the Waveform Recorder Controls
window, click the Stop button. The
recorder controls will turn color from
pink to yellow to indicate that
recording has stopped.
Figure 3-17. Waveform Recorder Controls
window in pink record mode
65
Stage 4 Cleanup
As much care is needed for the patient and Net after an acquisition session as was
needed prior to it to ensure the patients continued care and the Nets condition.
66
Most patients will not require it, but for patients with especially sensitive
skin, rinse the skin and hair.
a) Gently rinse the face and hair by
While keeping the connector high above the Net to protect the connector and
split wire sleeve from getting wet:
a) Carefully turn the Net inside out.
67
b) Fill the rinse bucket with clean, warm (not hot) tap water.
c) Immerse the sensor end of the Net in the water.
d) Gently, but vigorously, agitate the Net back and forth for 10 to 20 seconds
while:
pausing to press the sponge tips with your palm to push water through
the sponges,
keeping water moving through the Net and sponges for the entire 10 to 20
seconds, and
being careful not to grasp the Net in such a way that you pinch or damage
the wires.
e) Raise the Net out of the bucket and drain the rinse bucket.
f) Repeat steps b through e (above) until you have rinsed the Net a total of
four times.
g) After thoroughly rinsing the electrolyte out of the Net, gently pat the excess
manufacturers instructions.
Note: Be aware that the instructions are different for the concentrated and
premixed formulas.
b) Before each use, use the Control III test strips to verify the efficacy of the
disinfectant, gently and repeatedly plunge the Net up and down to ensure a
thorough disinfection.
68
f) Leave the Net soaking in the disinfectant for the remainder of the
10 minutes.
CAUTION: Be aware that prolonged submersion may damage a Net and
such damage is not covered by warranty.
g) Keep the timer with you so that you do not leave the Net in the disinfectant
69
70
Chapter 4
CHAPTER
WIRING AND
CONNECTIVITIES
T
he following diagrams show the components and their power and data connections
for a typical GES 300 configuration that includes video.
See Figure 4-1 on page 72 for components.
See Figure 4-2 on page 73 for power connections.
See Figure 4-3 on page 74 for data connections.
71
72
Data Acquisition
Computer (DAC)
NetAmps
Power Supply
Articulated Arm
Core Devices
NetAmps 300
Isolation Transformer
Monitor Power
Supply (optional)
DB9-Hypergrip Adapter
Uninterruptible
Power Supply (UPS)
Legend
Optional Devices
Photic Stimulator
Components
Data Acquisition
Computer (DAC)
NetAmps
Power Supply
Mains Power
Core Devices
Output voltage
Set to 115V
Uninterruptible
Power Supply (UPS)
NetAmps 300
Isolation Transformer
Monitor Power
Supply (optional)
Other
FireWire
IEC
Legend
Optional Devices
Power Connections
73
74
Data Acquisition
Computer (DAC)
NetAmps
Power Supply
Core Devices
NetAmps 300
DB9-Hypergrip Adapter
Articulated Arm
Photic Stimulator
Other
Fire Wire
Legend
Optional Devices
Data Connections
Chapter 5
CHAPTER
EMC DECLARATIONS
T
75
Electromagnetic Emissions
Table 5-1. Electromagnetic compatibility (EMC) emissions guidelines and declarations for the GES 300
The GES 300 is intended for use in the electromagnetic environment specified below. The customer or the user
of the GES 300 should ensure that it is used in such an environment.
Emissions test
76
Compliance
Electromagnetic environmentguidance
RF emissions
CISPR 11
Group 1
The GES 300 uses RF energy only for its internal functions.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class A
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
Electromagnetic Immunity
Table 5-2. Electromagnetic compatibility (EMC) immunity guidelines and declarations for the GES 300
The GES 300 is intended for use in the electromagnetic environment specified below. The customer or the user
of the GES 300 should ensure that it is used in such an environment.
Electromagnetic environment
Immunity test
Compliance level
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
6 kV contact
8 kV air
6 kV contact
8 kV air
Electrical fast
transient/burst IEC
61000-4-4
2 kV for power-supply
lines
2 kV for power-supply
lines
1 kV for input/output
lines
1 kV for input/output
lines
Surge
IEC 61000-4-5
1 kV differential mode
1 kV differential mode
2 kV common mode
2 kV common mode
3 A/m
3 A/m
Power frequency
(50/60 Hz)
magnetic field IEC
61000-4-8
Note: UT is the a.c. mains voltage before application of the test level.
77
C h a p te r 5 : E M C D e c la r a tio n s
Compliance
level
Electromagnetic environmentguidance
3 V rms
Radiated RF
IEC 61000-4-3
3 V/m
3 V rms
d = 1.2 P
3 V/m
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects, and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the GES 300 is used exceeds the applicable RF compliance level above, the GES 300
should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating the GES 300.
b Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m.
78
(in meters)
150 kHz to 80 MHz
d = 1.2 P
d = 1.2 P
d = 2.3 P
0.01
0.12 m
0.12 m
0.23m
0.1
0.38 m
0.38 m
0.73 m
1.2 m
1.2 m
2.3 m
10
3.8 m
3.8 m
7.3 m
100
12 m
12 m
23 m
(in watts)
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can
be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating
of the transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects, and people.
79
80
Appendix A
APPENDIX
NET SIZING
All HydroCel Geodesic Sensor Nets (HCGSNs) are available in a wide range of sizes
to fit the head circumferences of small newborns to large adults. Always base your
Net size selection on the circumference of your patients head, not your patients age.
See Table A-1 for appropriate sizing.
Table A-1. Sizing chart for all HCGSNs (with sponges [routine Nets] and without sponges [LTM Nets])
General Age* or Head Size
Head
Developmental
Circumference and
Stage
Net Size
Infant
Pediatric
Adult
Males
Females
Channel Counts
Monitoring Type
34 36 cm
Neonate
Neonate
Routine
36 37 cm
Birth 2 weeks
Birth 1 month
Routine
37 38 cm
2 weeks 1 month
1 2 months
Routine
38 40 cm
1 2 months
2 3 months
Routine
40 42 cm
2 3 months
3 6 months
Routine
42 43 cm
3 5 months
6 7 months
Routine
43 44 cm
5 7 months
7 9 months
Routine
44 47 cm
7 15 months
9 21 months
Routine
47 51 cm
Pediatric Small
Pediatric Small
Routine
51 54 cm
Pediatric Large
Pediatric Large
54 56 cm
Adult Small
Adult Small
56 58 cm
Adult Medium
Adult Medium
58 61 cm
Adult Large
Adult Large
*Because childrens head sizes vary greatly, circumference (rather than age) should be the guiding factor when choosing a
Net size for children. The age range is only a general guideline. If the customer is unsure of the range of head circumferences
he or she will be testing, EGI recommends selecting at least one Net size above and one Net size below the expected range.
The approximate age range for U.S. infants is taken from the 50th percentile on the CDC Growth Charts published in May
2000. (50th percentile means that half of the infants of this age will have a larger head circumference and half will have a
smaller head circumference.) The charts are available at http://www.cdc.gov/growthcharts/.
EGI recommends that customers consult infant growth charts for their own country as growth statistics may vary.
81
82