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g.tec medical engineering GmbH
Sierningstrasse 14
A-4521 Schiedlberg
Austria
Tel.: (43)-7251-22240-0
Fax: (43)-7251-22240-39
office@gtec.at,
http://www.gtec.at
UDI
label
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
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Related Manuals for G-Tec g-USBamp
Summary of Contents for G-Tec g-USBamp
- Page 1 g.tec medical engineering GmbH Sierningstrasse 14 A-4521 Schiedlberg Austria Tel.: (43)-7251-22240-0 Fax: (43)-7251-22240-39 office@gtec.at, http://www.gtec.at label GlobTek power supply 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...
- Page 2 g.tec medical engineering GmbH g.USBamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.09 How to contact g.tec: ++43-7251-22240-0 Phone ++43-7251-22240-39 g.tec medical engineering GmbH Mail Sierningstrasse 14, 4521 Schiedlberg, Austria http://www.gtec.at office@gtec.at E-mail Page 2...
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Page 3: Table Of Contents
g.tec medical engineering GmbH g.USBamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.09 Content Important Notes ....................... 4 Introduction to g.USBamp ..................7 g.USBamp basic components ................9 Explanation of switches, connectors and LEDs ..........10 Sockets, connectors and LED on the front side..................10 Sockets, connectors and switch on the rear side .................. -
Page 4: Important Notes
g.tec medical engineering GmbH g.USBamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.09 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 ... - Page 5 g.tec medical engineering GmbH g.USBamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.09 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.
- Page 6 g.tec medical engineering GmbH g.USBamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.09 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.
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Page 7: Introduction To G.usbamp
g.tec medical engineering GmbH g.USBamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.09 Introduction to g.USBamp ® 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. - Page 8 g.tec medical engineering GmbH g.USBamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.09 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 ...
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Page 9: G.usbamp Basic Components
g.tec medical engineering GmbH g.USBamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.09 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 Page 9... -
Page 10: Explanation Of Switches, Connectors And Leds
g.tec medical engineering GmbH g.USBamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.09 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:... -
Page 11: Sockets, Connectors And Switch On The Rear Side
g.tec medical engineering GmbH g.USBamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.09 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... -
Page 12: Marking On The Top Side
g.tec medical engineering GmbH g.USBamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.09 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... - Page 13 g.tec medical engineering GmbH g.USBamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.09 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...
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Page 14: Medical Power Supply Globtek Gtm21097-3005
g.tec medical engineering GmbH g.USBamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.09 Medical power supply GlobTek GTM21097-3005 power line cord power cord socket power supply to g.USBamp 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. -
Page 15: Push-Pull Connectors
g.tec medical engineering GmbH g.USBamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.09 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 plug socket cable For connecting the self latching plug to the socket push the plug axially into the socket. -
Page 16: Measuring Biosignal Data
g.tec medical engineering GmbH g.USBamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.09 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. -
Page 17: Calibrating G.usbamp
g.tec medical engineering GmbH g.USBamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.09 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. -
Page 18: Switching Off And Storage Of G.usbamp
g.tec medical engineering GmbH g.USBamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.09 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. -
Page 19: General Notes
g.tec medical engineering GmbH g.USBamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.09 General notes Classification Safety class Type of applied part 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 %. -
Page 20: Declaration Of Conformity
g.tec medical engineering GmbH g.USBamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.09 Declaration of conformity Product name Product: g.USBamp Manufacturer g.tec medical engineering GmbH, Sierningstrasse 14, 4521 Schiedlberg, Austria Classification Safety class Type of applied part Protection against mechanical distortion and liquids IP41 Operation mode S1 (permanent operation) -
Page 21: Technical Specifications
g.tec medical engineering GmbH g.USBamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.09 Technical specifications g.USBamp Model g.USBamp Type USB biosignal amplifier Rated power consumption 7 VA Rated DC voltage Rated current of fuse 1.6 A, quick acting fuse, type 20 mm 250 V≈... - Page 22 g.tec medical engineering GmbH g.USBamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.09 Analog signal processing time and digital inputs sampling AI/DI* frequency [Hz] [samples] 1200 2400 4800 9600 19200 38400 *) Analog Signal line Delay due to the Analog Digital Converter between Analog Input and Digital Input lines. Due to the intrinsic filtering and down sampling of the ADC for analog channels, there is a delay between the analog biosignal input and digital trigger input lines.
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Page 23: Medical Power Supply
g.tec medical engineering GmbH g.USBamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.09 ADC clock extern - Sensitivity: 0 - 5 V ADC clock extern + Sensitivity: 0 - 5 V Digital outputs at SYNC OUT 0 – 3.3 V ADC sclock extern - Sensitivity: 0 –... - Page 24 g.tec medical engineering GmbH g.USBamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.09 Pin-assignment for the 6 pin socket A Pin 1 analog input 3 Pin 2 analog input 2 Pin 3 analog input 4 Pin 4 reference analog group A Pin 5 ground group A Pin 6...
- Page 25 g.tec medical engineering GmbH g.USBamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.09 Pin-assignment for the 2 pin socket POWER SUPPLY Pin 1 +5 V Pin 2 ground Pin-assignment for the 4 pin socket SC Pin 1 ground digital Pin 2 for internal use only, do not connect Pin 3 for internal use only, do not connect...
- Page 26 g.tec medical engineering GmbH g.USBamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.09 Pin-assignment for the 4 pin socket USB Pin 1 Pin 2 +Vbus Pin 3 ground digital Pin 4 Pin-assignment for the 7 pin socket DIGITAL I/O 1 Pin 1 digital input 0 Pin 2...
- Page 27 g.tec medical engineering GmbH g.USBamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.09 Power supply unit cable Pin-assignment for the 2 pin connector POWER SUPPLY Pin 1 +5 V Pin 2 ground USB cable Pin-assignment for the 4 pin connector PC USB Pin 1 +Vbus Pin 2...
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Page 28: Electromagnetic Compatibility
g.tec medical engineering GmbH g.USBamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.09 Electromagnetic compatibility Medical devices have to comply with special safety regulations regarding electromagnetic compatibility (EMC). Please keep in mind the respective precautions in this instruction for use manual before installing and operating g.USBamp. - Page 29 g.tec medical engineering GmbH g.USBamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.09 Guidance and manufacturer´s declaration – electromagnetic emission The g.USBamp is intended for use in the electromagnetic environment specified below. The customer or the user of the g.USBamp should assure that it is used in such an environment. Emission test Compliance Electromagnetic environment - guidance...
- Page 30 g.tec medical engineering GmbH g.USBamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.09 Guidance and manufacturer´s declaration – electromagnetic immunity The g.USBamp is intended for use in the electromagnetic environment specified below. The customer or the user of the g.USBamp should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level...
- Page 31 g.tec medical engineering GmbH g.USBamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.09 The g.USBamp is intended for use in the electromagnetic enviroment specified below. The customer or the user of the g.USBamp should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance Electromagnetic environment -...
- Page 32 g.tec medical engineering GmbH g.USBamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.09 Recommended separation distances between portable and mobile RF communications equipment and the g.USBamp The g.USBamp is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.