Gtec g.HIamp 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
64 channel electrode
connector box
SN:
6P-
Instruction for use
V2.16.01
Copyright 2017 g.tec medical engineering GmbH
printed July 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.HIamp, USB Biosignal Amplifier: Instruction for use
____________________________________________________________________________________________________________________
V2.16.01
Page 2
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

g.tec medical engineering GmbH g.HIamp, USB Biosignal Amplifier: Instruction for use
____________________________________________________________________________________________________________________
V2.16.01
Page 3
Content
1Important Notes....................................................................................................... 5
2Introduction to g.HIamp .......................................................................................... 8
3g.HIamp basic components.................................................................................. 10
4Explanation of switches, connectors and LEDs ................................................. 11
Sockets, connectors and LEDs on the front side..................................................................................... 11
Sockets, connectors and switch on the rear side .................................................................................... 13
5Marking on the top side ........................................................................................ 14
6Medical power supply GlobTek GTM21097-3005................................................ 17
7USB cable............................................................................................................... 18
864 channel electrode connector box and multi lead connection cable ............ 19
9Push-Pull Connectors ........................................................................................... 20
10 Safe operation of g.HIamp.................................................................................. 21
Setting up g.HIamp.................................................................................................................................. 21
Measuring biosignal data......................................................................................................................... 22
Calibrating g.HIamp................................................................................................................................. 22
Impedance measurement........................................................................................................................ 22
HOLD of inputs ........................................................................................................................................ 22
Switching off and storage of g.HIamp...................................................................................................... 22
11 General notes...................................................................................................... 23
12 Declaration of conformity................................................................................... 24
13 Technical specifications..................................................................................... 25
g.HIamp.................................................................................................................................................... 25
Medical power supply .............................................................................................................................. 26
14 Pin assignment of g.HIamp rear side connectors (coding not shown).......... 28
USB.......................................................................................................................................................... 28
HOLD....................................................................................................................................................... 28
DIGITAL IN 1............................................................................................................................................ 29
DIGTAL IN 2............................................................................................................................................. 29
POWER SUPPLY .................................................................................................................................... 30
15 Pin assignment of g.HIamp front side connectors........................................... 31
Channels 001-064 (A).............................................................................................................................. 31
Channels 065-128 (B).............................................................................................................................. 31
Channels 129-192 (C).............................................................................................................................. 32

g.tec medical engineering GmbH g.HIamp, USB Biosignal Amplifier: Instruction for use
____________________________________________________________________________________________________________________
V2.16.01
Page 4
Channels 193-256 (D).............................................................................................................................. 32
+5V DC - 30 mA....................................................................................................................................... 33
GND......................................................................................................................................................... 33
List of abbreviations................................................................................................................................. 33
16 Electromagnetic compatibility........................................................................... 28

g.tec medical engineering GmbH g.HIamp, USB Biosignal Amplifier: Instruction for use
____________________________________________________________________________________________________________________
V2.16.01
Page 5
1 Important Notes
Attention
conductible parts of all electrodes must not have contact with the 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
you must not use other power supply units than the GlobTek GTM21097-3005 which is
delivered with g.HIamp
pay attention to the precautions regarding electromagnetic compatibility (see Chapter
Electromagnetic compatibility)
the operator has to be familiar with the operation of g.HIamp 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.HIamp)
every time before using g.HIamp 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.HIamp is connected to other devices (except the power supply supplied with g.HIamp) 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.HIamps are interconnected according to IEC
60601-2-49. 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.
Visual inspection of the inside of g.HIamp might influence its electromagnetic shielding and operation.
The manufacturer does not recommend disassembly of g.HIamp, including visual inspection of the
inside of the device, without first contacting the manufacturer.

g.tec medical engineering GmbH g.HIamp, USB Biosignal Amplifier: Instruction for use
____________________________________________________________________________________________________________________
V2.16.01
Page 6
Inspection
The manufacturer is responsible for the safety, performance and reliability of the device 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.
According to (EN 62353:2008) the device and its accessories must be checked once every two years
(minimum).
Interference
g.HIamp and its components have been tested and comply with the electromagnetic compliance limits
(IEC 60601-1-2:2007 Class A). See Chapter Electromagnetic compatibility. The equipment, 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 g.tec Technical Support (see page 2, How to contact g.tec)

g.tec medical engineering GmbH g.HIamp, USB Biosignal Amplifier: Instruction for use
____________________________________________________________________________________________________________________
V2.16.01
Page 7
The intended use of the equipment
The g.HIamp amplifier is intended to be used to acquire biopotentials and transmit them to a computer
via the USB port connection. These biopotentials include for example the electroencephalogram
(EEG), electromyogram (EMG), electrooculogram (EOG), and electrocardiogram (ECG).
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.HIamp can result in burnings under the electrodes and could damage the biosignal amplifier.
Recommended electrodes
The manufacturer recommends golden re-useable cup EEG electrodes (model C32-634) from
Technomed, Co (K072016) with 1.5 m cable and electrode gel (model: E9) from Electro-cap Intl., Inc.
(K111717).
The electrode diameter should be between 2 and 10 mm. The electrode impedance should be below 5
kOhm. The electrodes must have a 1.5 mm safety connector.
The device must not be used directly on the heart.
Properties of PC or notebook
g.HIamp requires a PC compatible desktop, notebook workstation or embedded computer running a
Microsoft Windows operating system (Windows 7 or Windows 10 (Threshold 2), 64bit, Professional
English).
The table below lists optimal settings:
Hardware
Properties
CPU
Processor working at 2000 MHz
Harddisk
20-30 gigabyte
RAM
2 - 4 gigabyte
USB 2.0 port
(EHCI –enhanced
Host controller interface)
one free USB port for each g.HIamp
Prescription device
Caution: US federal law restricts the herein described devices to sale by or on the order of a
physician.

g.tec medical engineering GmbH g.HIamp, USB Biosignal Amplifier: Instruction for use
____________________________________________________________________________________________________________________
V2.16.01
Page 8
2 Introduction to g.HIamp
g.®HIamp is g.tec’s multi-channel high-end biosignal amplifier with USB technology. The device allows
the acquisition of up to 256 biosignal channels such as EEG (Electroencephalogram) with 24 bit. The
sampling frequency can be set up to 38400 Hz.
The USB amplifier can be connected directly to a PC or notebook with an USB connector without any
additional data acquisition device needed. Each channel is equipped with a synchronized analog to
digital converter to perform the simultaneous sampling. Each analog to digital converter is operating
with 614.4 kHz and performs a 16 times oversampling. This results in a sampling rate of 38400 Hz for
each channel. A powerful floating point DSP performs an additional decimation and the real-time
filtering of the biosignal data. The sampling frequency can be adjusted between 256 Hz and 38400 Hz.
Therefore, a sampling frequency of 256 Hz yields to an over-sampling rate of 2400 with a very high
signal to noise ratio.
Furthermore, the device has an internal impedance check unit. Standard electrodes with safety
connectors can be connected to g.HIamp via optionally available electrode connector boxes. The
device is controlled with a C language Application Programming Interface (C API).
g.HIamp 256-Channel Amplifier

g.tec medical engineering GmbH g.HIamp, USB Biosignal Amplifier: Instruction for use
____________________________________________________________________________________________________________________
V2.16.01
Page 9
Highlights
biosignal recording via USB
up to 256 analog inputs with 24 Bit
up to 38400 Hz sampling frequency per channel
sampling frequency
[Hz]
max. no. of
channels*)
256
256
512
256
600
256
1200
256
2400
256
4800
256
9600
144
19200
80
38400
40
*) the number of available channels depends on the purchased type of amplifier
digital filtering of all biosignal data via g.HIamp for sampling frequencies up to 4800 Hz
over-sampling to achieve a high signal to noise ratio
can be connected to a PC or notebook
simultaneous sample and hold of all available channels
connection of electrodes with standard safety connector via electrode connector boxes
system connectors for user specific patient cables

g.tec medical engineering GmbH g.HIamp, USB Biosignal Amplifier: Instruction for use
____________________________________________________________________________________________________________________
V2.16.01
Page 10
3 g.HIamp basic components
g.HIamp consists of the following items:
1
g.HIamp USB biosignal amplifier
depending on your selected type it has either
256 analog input channels for the 256-Channel Amplifier or
144 analog input channels for the 144-Channel Amplifier or
80 analog input channels for the 80-Channel Amplifier
1
64 channel electrode connector box
1
connection cable from 64 channel electrode connector box to g.HIamp
1
GlobTek GTM21097-3005 –medical power supply unit
1
Power line cord
1
USB cable
1
Instruction for use

g.tec medical engineering GmbH g.HIamp, USB Biosignal Amplifier: Instruction for use
____________________________________________________________________________________________________________________
V2.16.01
Page 11
4 Explanation of switches, connectors and LEDs
Sockets, connectors and LEDs on the front side
Example: g.HIamp 256-Channel Amplifier front side
g.HIamp has up to 4 mono-polar amplification groups with one ground socket each. The analog input
channels for EEG are connected via push-pull connectors.
g.HIamp Amplifier Type
Group A
Channels
Group B
Channels
Group C
Channels
Group D
Channels
256-Channel Amplifier
001-064
065-128
129-192
193-256
144-Channel Amplifier
001-064
065-128
129-144
Not used
145-192
Not used
80-Channel Amplifier
001-064
065-080
Not used
081-128
Not used
Not used
LED

g.tec medical engineering GmbH g.HIamp, USB Biosignal Amplifier: Instruction for use
____________________________________________________________________________________________________________________
V2.16.01
Page 12
GND:
Each group has one ground socket GND and all 4 ground sockets are
interconnected.
+5V DC
30 mA:
A total of four +5 V DC sockets providing a +5 Volt auxiliary power supply is
available. On each socket the maximum DC output current is limited to 30 mA.
The intended function of the +5 V DC power supply is to power other
appropriate applied parts of type CF only as specified by g.tec medical
engineering GmbH.
LED:
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.HIamp”
to avoid electrostatic discharge impulses.

g.tec medical engineering GmbH g.HIamp, USB Biosignal Amplifier: Instruction for use
____________________________________________________________________________________________________________________
V2.16.01
Page 13
Sockets, connectors and switch on the rear side
g.HIamp rear view
POWER
POWER
switch for switching ON/OFF the device
POWER SUPPLY
socket for the connection of the external power supply unit
FUSE
4A / 250V fuse, type 20 mm, quick-acting
DIGITAL IN 1
socket for digital inputs
DIGITAL IN 2
socket for digital inputs
HOLD
socket to enable keeping the input signal on the same signal level
USB
USB socket for the connection with the PC or notebook

g.tec medical engineering GmbH g.HIamp, USB Biosignal Amplifier: Instruction for use
____________________________________________________________________________________________________________________
V2.16.01
Page 14
5 Marking on the top side
g.HIamp 256-Channel Amplifier
g.HIamp 144-Channel Amplifier
g.HIamp 80-Channel Amplifier
do not dispose g.HIamp with domestic waste. Dispose it via
the separate collection system for electrical and electronic
equipment
applied part of type CF
follow instruction for use

g.tec medical engineering GmbH g.HIamp, USB Biosignal Amplifier: Instruction for use
____________________________________________________________________________________________________________________
V2.16.01
Page 15
safety class II
manufacturer address
Type/Typ: 256-Channel Amplifier
or
Type/Typ: 144-Channel Amplifier
or
Type/Typ: 80-Channel Amplifier
device type for 256-Channel Amplifier
device type for 144-Channel Amplifier
device type for 80-Channel Amplifier
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.
SN HA-2017.02.02
REF 7002US
+EBCI7002US0/$$+7HA-
2017.92.027
Unique Device Identification (UDI)
Serial number in the format HA-
Year_of_production.Month.Number
g.tec product number/code in the format xxxxxx
Human readable form of UDI
Machine readable form of UDI
Prescription device in the USA
rated DC voltage
rated DC current

g.tec medical engineering GmbH g.HIamp, USB Biosignal Amplifier: Instruction for use
____________________________________________________________________________________________________________________
V2.16.01
Page 16
The figures below show the packaging of the device and the labelling of the box.
UDI label:
g.HIamp
256-Channel Amplifier
REF 7002US
SN HA-2017.02.02
*+EBCI7002US0/$$+7HA-2017.92.027*

g.tec medical engineering GmbH g.HIamp, USB Biosignal Amplifier: Instruction for use
____________________________________________________________________________________________________________________
V2.16.01
Page 17
6 Medical power supply GlobTek GTM21097-3005
Medical power supply
Part of the medical equipment g.HIamp is the GlobTek 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.
Labels and LEDs on the power supply:
Power Supply
power supply connector to g.HIamp
LED
the green light indicates power on
GlobTek Inc.
manufacturer name
Power Supply for Medical Use
device type
Model: GTM21097-3005
model name
Input: 100-240V, ~1.6A max,
50-60 Hz
input voltage range, maximum current, frequency range
Output: +5V DC 6.0A
output voltage, direct current, maximum current
CAUTION: for indoor use only!
environmental usage
CE
CE mark
EN60601-1, IEC60601-1
medical normative
S/N: RoHS102746129/11
serial number in the format RoHSxxxxxxxxx/xx
power line cord
power supply
to g.HIamp
power cord socket
LED

g.tec medical engineering GmbH g.HIamp, USB Biosignal Amplifier: Instruction for use
____________________________________________________________________________________________________________________
V2.16.01
Page 18
7 USB cable
Part of the medical equipment g.HIamp is the USB cable. It is a 4 pin cable used for the connection of
g.HIamp with a PC. One side has a standard USB connector (PC USB) the other side a Mini-Snap 8-
pin connector (USB).
USB cable
Labels on the USB cable:
PC USB
USB connector to PC
USB
USB connector to g.HIamp

g.tec medical engineering GmbH g.HIamp, USB Biosignal Amplifier: Instruction for use
____________________________________________________________________________________________________________________
V2.16.01
Page 19
8 64 channel electrode connector box and multi lead connection cable
Part of the medical equipment is the g.tec 64 channel electrode connector box and the corresponding
connection cable. One 64 channel electrode connector box enables the connection of 64 electrodes
and 1 ground electrode with 1.5mm standard safety plugs to g.HIamp via the multi lead connection
cable.
64 channel electrode connector box and multi pin connection cable
Labels on the electrode connector box:
CE mark
do not dispose with domestic waste. Dispose it via the
separate collection system for electrical and electronic
equipment
follow instruction for use
6P-year.mm.nr
serial number in the format 6P-Year.Month.Number
Output to g.HIamp
socket for connector cable to g.HIamp
1-64
channels 1-64
GND
ground socket
IP40
IP 40: Protected against particulate matter of degree 4 (wire
with diameter of 1 mm). No protection against ingress of
water.
Labels on the multi pin connector cable:
Electrode-Connector/Driver-Box OUTPUT to
AMP
Connect this side to the electrode connector box
g.HIamp A/B/C/D
Connect this side to the g.HIamp

g.tec medical engineering GmbH g.HIamp, USB Biosignal Amplifier: Instruction for use
____________________________________________________________________________________________________________________
V2.16.01
Page 20
9 Push-Pull Connectors
g.HIamp 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.
socket
plug
cable
release sleeves