Gtec g.USBamp User manual

g.tec medical engineering GmbH
Sierningstrasse 14
A-4521 Schiedlberg
Austria
Tel.: [phone]
Fax: [phone]
[email protected], http://www.gtec.at
GlobTek power supply
SN:
RoHS
Instruction for use V2.16.09
Copyright 2017 g.tec medical engineering GmbH
printed Sept. 2017
The product with the above serial number is a prescription device for use in the USA
UDI
label

g.tec medical engineering GmbH g.USBamp, USB Biosignal Amplifier: Instruction for use
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How to contact g.tec:

++43-7251-22240-0
Phone

++43-7251-22240-39
Fax

g.tec medical engineering GmbH
Sierningstrasse 14, 4521 Schiedlberg, Austria
Mail

http://www.gtec.at
Web
@
[email protected]
E-mail

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Content
1Important Notes....................................................................................................... 4
2Introduction to g.USBamp ...................................................................................... 7
3g.USBamp basic components................................................................................ 9
4Explanation of switches, connectors and LEDs ................................................. 10
Sockets, connectors and LED on the front side....................................................................................... 10
Sockets, connectors and switch on the rear side .................................................................................... 11
5Marking on the top side ........................................................................................ 12
6Medical power supply GlobTek GTM21097-3005................................................ 14
7USB cable............................................................................................................... 14
8Push-Pull Connectors ........................................................................................... 15
9Safe operation of g.USBamp ................................................................................ 15
Setting up g.USBamp .............................................................................................................................. 15
Measuring biosignal data......................................................................................................................... 16
Calibrating g.USBamp ............................................................................................................................. 17
Impedance measurement........................................................................................................................ 17
Shortcut of inputs..................................................................................................................................... 17
Synchronization of multiple g.USBamps.................................................................................................. 17
Switching off and storage of g.USBamp.................................................................................................. 18
10 General notes...................................................................................................... 19
11 Declaration of conformity................................................................................... 20
12 Technical specifications..................................................................................... 21
g.USBamp................................................................................................................................................ 21
Medical power supply .............................................................................................................................. 23
13 PIN assignment................................................................................................... 23
14 Electromagnetic compatibility........................................................................... 28

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1 Important Notes
Attention
conductible parts of all electrodes must not have contact to earth or other conductible parts
the device is not protected against the effect of cardiac defibrillator discharge
the device must not be used in humans with pace-makers or electrical stimulators
the potential equalization conductor should be connected to a potential equalization conductor
of the room where g.USBamp is used
it is not allowed to use other power supply units than the original medical technical power
supply which is delivered with g.USBamp
pay attention to the precautions regarding electromagnetic compatibility (see Chapter
Electromagnetic compatibility)
the operator has to be familiar with the operation of g.USBamp and must operate the device
according to the instruction for use manual.
pay attention to avoid electrostatic discharge impulses when connecting electrode to the
safety sockets of the device (see Chapter Save operation of g.USBamp)
every time before using g.USBamp check the device and its accessories for possible
damages of connectors, sockets and cables. Cables, connectors, accessories, or other parts
of the equipment must be replaced immediately when damaged or not working correctly.
Warning and safety notice
If g.USBamp is connected to other devices (except the power supply supplied with g.USBamp) like a
PC the following leakage currents have to be checked.
Ground leakage current
Enclosure leakage current
Patient leakage current
The leakage currents must be checked if several g.USBamps are interconnected according to IEC
60601-2-49. The interconnection of several g.USBamp or the connection to other devices can
decrease the degree of protection from cardiac float (CF) to body float (BF).
Accessory equipment connected to the analog and digital interfaces must be certified according to the
respective IEC standards (e.g. IEC 60950 for data processing equipment and IEC 60601-1 for medical
equipment). Furthermore all configurations shall comply with the system standard IEC 60601-1-1.
Everybody who connects additional equipment to the signal input part or signal output part configures
a medical system, and is therefore responsible that the system complies with the requirements of the
system standard IEC 60601-1-1. If in doubt, consult the technical service department or your local
representative.

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Inspection
The manufacturer is responsible for safety, performance and reliability of the device under the
condition as supplied to the customer at the time of delivery and
a) if changes are performed by the manufacturer only and service and repair is performed by
corresponding qualified personnel only.
b) the device is used according to the instruction for use.
The device and its accessories have to be checked in intervals of two years (EN 62353:2008).

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The intended function of the equipment
Measuring, recording and analysis of electrical activity of the brain (EEG) and/or through the
attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely
found in clinical settings for the EEG.
The device must not be used for patient monitoring. The device must not be used for the
determination of brain death. Additional examinations are needed for diagnosis and no diagnosis may
be done only based on using this device.
The intended environment of use
The device must not be used in dangerous conditions such as wet rooms or explosive environments.
The relative humidity must be between 25 % and 95 %. The device must not be used in combination
with any other medical high-frequency device. The usage of a high frequency device together with
g.USBamp can result in burnings under the electrodes and could damage the biosignal amplifier.
Recommended electrodes
The manufacturer recommends EEG electrodes and gel from Grass Instruments, Co (E5GH
electrodes, EC-2 electrode cream, in the USA the electrodes must be FDA cleared).
The electrode diameter should be between 2 and 10 mm. The electrode impedance should be below 5
kOhm.
The device must not be used directly on the heart.
Properties of PC or notebook
g.USBamp requires a PC compatible desktop, notebook workstation or embedded computer running a
Microsoft Windows operating system (Microsoft Windows 10 Pro (Threshold 2), English, 64-Bit).
The table below lists optimal settings:
Hardware
Properties
CPU
2 GHz or faster processor
Harddisk
20-30 GByte
RAM
2-4 GByte
USB 2.0 port
(EHCI –enhanced
Host controller interface)
one free USB port for each g.USBamp
Prescription device
Caution: US federal law restricts the herein described devices to sale by or on the order of a
physician.

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2 Introduction to g.USBamp
g.®USBamp is a high-end biosignal amplifier with USB 2.0 technology from g.tec. The device allows
the acquisition of 16 biosignal channels such as EEG (Electroencephalogram) with 24 bit and a
sampling frequency of 38.400 Hz per channel. The amplifier has 4 potential separated groups with 4
input channels each. This allows to simultaneously record EEG using independent ground electrodes
without interference. The 4 groups can be interconnected to record e.g. 16 EEG channels with the
same ground and reference potentials.
The USB amplifier can be connected directly to a PC or notebook with an USB connector without any
additional data acquisition device needed. 16 analog to digital converters perform the simultaneous
sampling. Each analog to digital converter is operating with 2.4576 MHz and performs a 64 times
oversampling. This results in a sampling rate of 38.400 Hz for each channel. A powerful floating point
DSP performs an additional oversampling and the real-time filtering of the biosignal data. The
sampling frequency can be adjusted between 64 Hz and 38.400 Hz. Therefore, a sampling frequency
of 128 Hz yields to an over-sampling rate of 19.200 with a very high signal to noise ratio.
Furthermore, the device has an internal calibration unit and impedance check. A driven right leg (DRL)
signal for the suppression of power line interference can be generated. Standard electrodes with
safety connectors can be directly connected to g.USBamp. The device is controlled with a C language
Application Programming Interface (C API).
g.USBamp

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Highlights
EEG recording via USB
16 analog inputs with 24 Bit and 38.400 Hz sampling frequency per channel
digital filtering of the biosignal data
over-sampling to achieve a high signal to noise ratio
can be connected to a PC or notebook
simultaneous sample and hold of 16 channels
direct connection of electrodes with standard safety connector
system connectors for user specific patient cables

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3 g.USBamp basic components
g.USBamp consists of the following items:
1 g.USBamp –USB biosignal amplifier
1 GlobTek GTM21097-3005 –medical power supply unit
1 Power line cord
1 USB cable
1 Instruction for use

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4 Explanation of switches, connectors and LEDs
Sockets, connectors and LED on the front side
g.USBamp has 4 mono-polar amplification groups with separated ground and reference potentials:
Group A:
Safety sockets 1 - 4: 4 analog input channels for EEG
Push-pull connector A is connected to safety sockets 1 - 4
Group B:
Safety sockets 5 - 8: 4 analog input channels for EEG
Push-pull connector B is connected to safety sockets 5 - 8
Group C:
Safety sockets 9 - 12: 4 analog input channels for EEG
Push-pull connector C is connected to safety sockets 9 - 12
Group D:
Safety sockets 13 - 16: 4 analog input channels for EEG
Push-pull connector D is connected to safety sockets 13 - 16
Each group has its own reference socket R and ground socket G. The 4 ground sockets and reference
sockets can be connected. The calibration signals are also available on the push-pull connector on
group D. The DRL socket is for internal testing usage only.
The green LED on the left side (ON) indicates power on.
The electrostatic discharge warning symbol: electrostatic discharge impulses must
be avoided when connecting .electrodes to any of the safety sockets or push pull
connectors. Follow the steps in chapter “Save operation of g.USBamp” to avoid
electrostatic discharge impulses.
g.USBamp front side sockets, connectors and LED

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Sockets, connectors and switch on the rear side
g.USBamp rear view
POWER
POWER switch for switching ON/OFF the device
POWER SUPPLY socket for the connection of the external power supply unit
FUSE 1.6A / 250V fuse, type 20 mm, quick-acting
potential equalization conductor
SYNC OUT socket for the synchronization with another g.USBamp
SYNC IN socket for the synchronization with another g.USBamp
DIG I/O 1 socket for digital inputs and outputs
DIG I/O 2 socket for digital inputs and outputs
SC socket to disconnect the input electrodes from the amplification units. The
amplifier unit inputs are connected to ground potential.
USB USB socket for the connection with the PC or notebook

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5 Marking on the top side
do not dispose g.USBamp with domestic waste. Dispose it
via the separate collection system for electrical and
electronic equipment
applied part of type CF
follow instruction for use
safety class II
manufacturer address
device type
IP 41: Protected against particulate matter of degree 4 (wire
with diameter of 1 mm). Protection against ingress of
water of degree 1 (protection against vertical falling
water drops).
S1: Permanent operation.

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SN UB-2017.0.01
Serial number in the format
UB-Year_of_Production.Month.Number
REF 0216US
g.tec product number/code in the format xxxxxx
+EBCI7002US0/$+UB-2017.08.01N
Human readable form of UDI
Machine readable form of UDI
Prescription device in the USA
rated DC voltage
rated DC current
The figures below show the packaging of the device and the labelling of the box.
UDI label:

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6 Medical power supply GlobTek GTM21097-3005
Medical power supply
Part of the medical equipment g.USBamp is the GlobeTek GTM21097-3005. It is a 5 V DC medical
power supply unit. If the medical power supply is connected to power line the green LED shows the
correct operation of the device.
7 USB cable
Part of the medical equipment g.USBamp is the USB cable. It is a 4 pin cable used for the connection
of g.USBamp with a PC. One side has a standard USB connector (PC USB) the other side a Mini-
Snap 4-pin connector (USB).
USB cable
power line cord
power supply
to g.USBamp
power cord socket
LED

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8 Push-Pull Connectors
g.USBamp connections on the rear side rely on highly reliable self-latching connectors based on the
push-pull principle.
Connecting a plug to the corresponding socket
For connecting the self latching plug to the socket push the plug axially into the socket.
Disconnecting a plug from a socket
For disconnecting the plug from the socket pull on the outer release sleeves only.
Attention: It is not necessary to use any tool for disconnecting the plug from the socket.
9 Safe operation of g.USBamp
Setting up g.USBamp
Avoiding electrostatic discharge impulses to the safety input sockets:
Electrostatic discharge (ESD) events can harm electronic components inside your device. Under
certain conditions, ESD may build up on your body or an object, such as a peripheral, and then
discharge into another object, such as the device. To prevent ESD damage, you should discharge
static electricity from your body before you interact with any of your device.
You can protect against ESD and discharge static electricity from your body by touching a metal
grounded object (such as the potential equalization). When connecting the electrodes to the device
you should always ground yourself to remove any static charge your body may have accumulated.
To start g.USBamp for recording perform the following steps:
Step 1: Connect the medical power supply unit GTM21097-3005-5 with the POWER SUPPLY
connector to the POWER SUPPLY socket of g.USBamp.
Step 2: Connect the USB cable connector USB to the USB socket of g.USBamp and the PC USB
connector of the cable to a USB connector of the PC.
socket
plug
cable
release sleeves

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Step 3: Connect the medical power supply unit to power line with the power line cord.
The green LED of the medical power supply unit must be on. Please contact the manufacturer if the
medical power supply unit is not working correctly.
Step 4: For EEG recordings place the electrodes with conductive gel to the subject’s head according
to the international 10-20 electrode system
1
. The electrode impedance should be below 5 kOhm.
Step 5: Connect the electrodes to the sockets 1 –16, to the reference and ground sockets of
g.USBamp.
Step 6: Switch on g.USBamp with the switch on the rear side (switch position ON).
The correct operation of g.USBamp is indicated by a green LED on the front side. If the LED is not on
please control the power supply connection and the fuse of g.USBamp.
Measuring biosignal data
In measuring mode, all input channels are amplified and each channel is sampled with a 24 bit analog
to digital converter. In default mode the sampling rate is 128 Hz. The DSP performs the bandpass
filtering of each channel between 1 and 30 Hz. Additionally a 50 Hz notch filter is applied. Then the
signal is transmitted via USB to the PC.
1
Webster, J.G.,(ed.): Medical Instrumentation: Application and Design, p.194-216. Houghton Mifflin: Boston 1992.

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Calibrating g.USBamp
In calibration mode, all electrode input sockets are disconnected from the input amplifiers. Additionally
an internally generated sine wave with amplitude of 10 mV and 10 Hz is connected to the input
amplifiers.
Impedance measurement
In impedance measurement mode, sequentially to each electrode an internally generated sine wave
with 10 mV and 20 Hz is applied. The voltage loss is measured and transmitted via USB to the PC.
NOTE: The ground electrode must be connected to group D if the impedance is measured for all
groups.
Shortcut of inputs
A TTL high impulse on the SC input socket can be used to disconnect all electrode input sockets from
the input amplifiers and to connect the inputs to ground potential.
Synchronization of multiple g.USBamps
On socket SYNC OUT the digital converter clock rate can be measured. On SYNC IN it is possible to
apply the clock signal for the digital converters.

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Switching off and storage of g.USBamp
To switch off g.USBamp and to store the device correctly, please perform the following steps:
Step 1: Switch off the device with the switch on the rear side (switch position OFF). The green LED is
off.
Step 2: Disconnect all electrodes.
Step 3: Disconnect the power supply cable.
Step 4: Disconnect the USB cable.
Step 5: Disconnect the power cord from the medical power supply.

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10 General notes
Classification
Safety class II
Type of applied part CF
Protection against mechanical distortion and liquids IP41
Operation mode S1 (permanent operation)
Transportation and storage conditions
The device can be stored at temperatures between –20 to +60 degrees Celsius. The relative humidity
must be between 25 % and 95 %. Wait before usage of the device till condensed water disappeared
(wait at least 1h in a heated room).
Location details
Do not use the device near a heating system or directly in the sun. The maximal temperature of the
environment must not be above 40 Celsius or below 5 ° Celsius.
Waste disposal details
Bring the device to a recycling center or sent it back to the manufacturer.
Cleaning
You can clean the device carefully with medical rubbing alcohol. Liquid must not enter the g.USBamp.

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11 Declaration of conformity
Product name
Product: g.USBamp
Manufacturer
g.tec medical engineering GmbH, Sierningstrasse 14, 4521 Schiedlberg, Austria
Classification
Safety class II
Type of applied part CF
Protection against mechanical distortion and liquids IP41
Operation mode S1 (permanent operation)
The manufacturer declares in sole responsibility that the electroencephalograph g.USBamp is in
conformity the following standards:
IEC 60601-1: 1996 (+A1 +A2 +A12 +A13),
IEC 60601-2-26: 2004,
IEC 60601-1-2: 2003,
IEC 60601-2-25+A1: 2001,
IEC 60601-2-40: 1998.
Dr. Christoph Guger
Chief Executive Officer
Dr. Günter Edlinger
Chief Executive Officer
Schiedlberg, Sept. 2017