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G-Tec g.HIamp, Инструкция по эксплуатации

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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*

 

Содержание g.HIamp

Страница 1: ... 7251 22240 39 office gtec at 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 ...

Страница 2: ...___________________________________________________________________________________________________ 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 office gtec at E mail ...

Страница 3: ...ply GlobTek GTM21097 3005 17 7 USB cable 18 8 64 channel electrode connector box and multi lead connection cable 19 9 Push 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 speci...

Страница 4: ...ier 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 ...

Страница 5: ...ables 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 ...

Страница 6: ...ts 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 inter...

Страница 7: ...gh 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 ...

Страница 8: ...ipped 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 adjust...

Страница 9: ...ncy 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 av...

Страница 10: ...lowing 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 medi...

Страница 11: ...nt 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...

Страница 12: ...y 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 wh...

Страница 13: ...nnectors 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 connec...

Страница 14: ...____________________________________________ 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 ...

Страница 15: ...vice 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_o...

Страница 16: ...________________________________________________________________________________________________________ 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 ...

Страница 17: ... 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 direc...

Страница 18: ...___________________________________ 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 ...

Страница 19: ...he 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 t...

Страница 20: ... 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 disc...

Страница 21: ...supply unit GTM21097 3005 with the POWER SUPPLY connector to the POWER SUPPLY socket of g HIamp Step 2 Connect the USB cable connector USB to the USB socket of g HIamp and the PC USB connector of the cable to a USB connector of the PC Step 3 Connect the medical power supply unit to power line with the power line cord Step 4 For EEG recordings place the electrodes with conductive gel to the subject...

Страница 22: ...mV and 10 Hz is applied to the input amplifiers Impedance measurement In impedance measurement mode all electrodes are connected to the amplifier and to the subject s body The internally generated square wave 7 5 mV is supplied on the signal ground connector The signal transmission can be evaluated to calculate the electrode impedance at 10 Hz HOLD of inputs A TTL high impulse on the HOLD signal c...

Страница 23: ... 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 and below 5...

Страница 24: ...ety 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 physiological signal amplifier g HIamp 256 144 80 Channel Amplifier is in conformity with the following standards EN standards and IEC standards EN 60601 1 1996 A1 A2 A12 A13 EN 60601 2 26 2004 EN 60601 1 2 20...

Страница 25: ...k acting fuse type 20 mm Rated voltage of fuse 250 V Produced see serial number of g HIamp Producer g tec medical engineering GmbH Sierningstrasse 14 4521 Schiedlberg Austria http www gtec at Maximum voltages at the following sockets USB 5 V DC HOLD 5 V DC DIGITAL IN 5 V DC POWER SUPPLY 5 V DC Amplifier Settings for all channels of the corresponding type Sensitivity 250 mV Highpass 0 Hz Lowpass 19...

Страница 26: ...nd 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 increased ASDADC from Version 1 0 9 onward is due to an improved anti aliasing filter Digital inputs at HOLD TTL input Sensitivity 0 5 V Digital inputs at DIGITAL IN1 Digital inputs 1 8 Sensitivity 0 5 V Digital i...

Страница 27: ...Amplifier Instruction for use ____________________________________________________________________________________________________________________ V2 16 01 Page 27 Reseller GlobTek Inc Germany Hafenweg 26a 48155 Münster Germany Model number GTM21097 3005 ...

Страница 28: ...signment of g HIamp rear side connectors coding not shown USB Pin Direction Function 1 I USB Vbus 2 IO USB Data 3 IO USB Data 4 I USB ID 5 Pas Digital GND 6 Pas Shield 7 NC No internal connection 8 NC No internal connection HOLD Pin Direction Function 1 O Vcc 3 3 V 2 I Short cut analog inputs 3 Pas Digital GND ...

Страница 29: ... Digital In 2 3 I Digital In 3 4 I Digital In 4 5 I Digital In 5 6 I Digital In 6 7 I Digital In 7 8 I Digital In 8 9 Pas Digital GND 10 O Vcc 3 3V DIGTAL IN 2 Pin Direction Function 1 I Digital In 9 2 I Digital In 10 3 I Digital In 11 4 I Digital In 12 5 I Digital In 13 6 I Digital In 14 7 I Digital In 15 8 I Digital In 16 9 Pas Digital GND 10 O Vcc 3 3V ...

Страница 30: ...g tec medical engineering GmbH g HIamp USB Biosignal Amplifier Instruction for use V2 16 01 page 30 POWER SUPPLY Pin Direction Function 1 Supply V 5V 2 Supply V 0V ...

Страница 31: ... of g HIamp front side connectors Channels 001 064 A Channels 065 128 B Pin Direction Function 1 I Channel 1 2 I Channel 2 3 I Channel 3 I I I 63 I Channel 63 64 I Channel 64 65 Pas Signal GND Pin Direction Function 1 I Channel 65 2 I Channel 66 3 I Channel 67 I I I 63 I Channel 127 64 I Channel 128 65 Pas Signal GND ...

Страница 32: ...32 Channels 129 192 C Channels 193 256 D Pin Direction Function 1 I Channel 129 2 I Channel 130 3 I Channel 131 I I I 63 I Channel 191 64 I Channel 192 65 Pas Signal GND Pin Direction Function 1 I Channel 193 2 I Channel 194 3 I Channel 195 I I I 63 I Channel 255 64 I Channel 256 65 Pas Signal GND ...

Страница 33: ...V2 16 01 page 33 5V DC 30 mA Pin Direction Function 1 Supply Analog GND 0V AP 2 DNC Internal use do not connect 3 Supply Auxiliary supply 5V AP GND Pin Direction Function 1 Pas Signal GND List of abbreviations I input O output IO input output Pas passive connection DNC do not connect ...

Страница 34: ...n or decreased functional immunity of g HIamp As electric and magnetic fields may interfere with the functional reliability of the device avoid using g HIamp close to devices emitting powerful magnetic fields e g magnetic resonance machines x ray equipment Following values are below the values given by IEC 60601 1 2 for electromagnetic immunity testing Immunity test IEC 60601 test level Compliance...

Страница 35: ...omagnetic environment guidance RF emissions CISPR 11 Group 1 The g HIamp uses RF energy only for its internal function 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 The g HIamp is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power ...

Страница 36: ... differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 s 5 UT 95 dip in UT for c...

Страница 37: ... calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF IEC 61000 4 6 3 Veff 150 kHz to 80 MHz 1 1 V in V P V d 1 5 3 Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 1 1 E in V m P E d 1 5 3 80 MHz to 800 MHz P E d 1 7 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the tran...

Страница 38: ...nd 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 g HIamp is used exceeds the applicable RF compliance level above the g HIamp should be observed...

Страница 39: ...maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz P V d 1 5 3 80 MHz to 800 MHz P E d 1 5 3 800 MHz to 2 5 GHz P E d 1 7 0 01 0 35 0 35 0 70 0 1 1 11 1 11 2 21 1 3 50 3 50 7 00 10 11 07 11 07 22 14 100 35 00 35 00 70 00 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres ...

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