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Xegis G:Neo
Xegis G:Neo EP
User Manual
Document Number: MNG8.EN
Version: 1.02
Date: 04/11/2009
Made by
Micromed S.p.A.
via Giotto 2 31021 -
Mogliano Veneto (TV) -
Italy
for
Compumedics Limited
30-40 Flockhart St.,
Abbotsford 3067 , VIC -
Australia
Xegis G:Neo User Manual
SUMMARY
SUMMARY 2
INTRODUCTION 3
CAUTIONS 4
UNIT MAINTENANCE 6
DEVICE DESCRIPTION 7
MAIN TECHNICAL SPECIFICATION 8
ACCESSORIES 9
Acquisition Electrodes 9
Stimulation Accessories 9
Cables 9
OTHER ASSOCIATED DEVICES 9
Software 9
PC and interface 9
SYMBOLS 10
CONNECTORS 11
PC CONNECTION 13
Radio connection 13
Cable connection 13
INFORMATION AND COMMAND 14
Control Section 14
Information Section (LEDs and display) 15
MENU 16
Electric stimulator settings 16
Acoustic stimulator settings 17
Visual stimulator settings 18
Hardware amplifier parameters 18
Acquisition parameters 19
Trigger management 19
INTRODUCTION
The integrated modules for and multi-modality stimulators named Xegis G:Neo and Xegis G:Neo EP
are members of the Xegis series allowing to maintain all the peripherals of a complete EMG system,
including electric stimulators and a 2-channels acquisition section, within a single device able to
communicate with the other medical digital equipment of Xegis series. In the Xegis G:Neo EP model,
also visual and acoustic stimulators are included, allowing performance of EP examinations.
The devices can be controlled using the devices buttons or a PC, endowed of the acquisition
software that allows controlling completely the stimulators and beside provides the visualization,
computation and storage of the traces coming from the acquisition devices. The connection with
the PC is made via the Xegis USB interface or via the included Bluetooth.
The devices are powered from the interface cable or from the batteries: two AA 1.5V alkaline
batteries are used.
The use on board of a microcontroller allows performing the required action respecting precisely the
requested parameter as intensity, duration frequency and synchronization of the stimulation.
Using the Xegis USB interface it is possible to control the device with a portable computer, allowing
the implementation of a real portable electromyography and evoked potential system.
CAUTIONS
• INTENDED USE: the device is designed to perform electromyography or evoked potential
exams using surface electrodes, needles, and proper headphones and goggles.
• Avoid spilling materials on the device and if this were to happen DO NOT USE THE SYSTEM FOR
ANY REASON and contact your zone representative for necessary assistance.
• An authorized qualified technician or doctor must always perform the electrode application for
the recording and the use of the unit.
• The user must have a good knowledge of the set parameters and verify their correctness. Even
though the energy given as light, sound or electric impulses is limited and automatically controlled,
the Xegis family stimulators can create stimuli that provoke patient pain, especially in electrical
stimulation.
• Patients with electronic implanted systems (ex: pacemaker) should not be subjected to electrical
stimulation without having previously consulted a specialist.
• During electrical stimulation, the stimuli distribution electrodes having opposite polarity
should be kept close in order to reduce the current path in the body. In particular it is necessary to
avoid chest stimulation because it could cause a dangerous current flow through the heart.
• Use only Compumedics approved cables for the interconnection of the various components in
order to guarantee electric safety and operating characteristics (refer to ACCESSORIES section on
page 9)
• The patient must be connected to the stimulator via surface or needle EMG electrodes and
accessories; both must be compliant with 93/42/EEC Directive and ISO 10993 standard on
biocompatibility and compatibles with the device.
• The stimulators integrated in the Xegis G:Neo device must be used with surface electrodes
having a contact area suitable for the desired stimulus intensity. Current density higher than 2 mA
r.m.s./cm2 needs for special attention.
• The device is compatible only with Compumedics accessories for visual and acoustic stimulation
(refer to ACCESSORIES section on page 9)
• The DC inputs must be connected only to passive (not powered) or battery-powered devices
compliant with EN 60601-1, with a maximum signal output lower than 4.8V. Consult Compumedics to
verify the compatibility of the desired accessories.
• The serial and communication input connectors have a lock system. Excessive pulling on the
cable is useless and can damage the isolation safety.
• Do not expose the patient signal inputs to high voltage signals. Pay attention during the
connection of the electrodes, the cable for the connection with the PC or the auxiliary devices
(transducers): the inputs are very sensitive to electrostatic discharge. The pin of the connectors
identified with the ESD warning symbol should not be touched with the fingers or metallic tools
without taking proper precautions. Refer further in this section, the SYMBOLS section and the
technical manual.
• Pay attention that accessories and conductive parts, even if connected only to the patient or to
the system, do not get in touch with conductive surfaces, even if protected with protected earth
connection.
• The contemporary connection of a patient with the recorder and with a surgical unit at high
frequency can burn the contact points of the acquisition electrodes and cause possible damage to
the device.
Micromed S.p.A. declines every responsibility regarding the security, reliability and services if the
device is mishandled or however repaired by non-authorized personnel. For all modifications
regarding cables and accessories please contact Compumedics in order to guarantee the device
compatibility.
DEVICE DESCRIPTION
Acquisition Electrodes
The Xegis G:Neo and Xegis G:Neo EP devices do not include specific acquisition electrodes; they are
endowed of connectors for the use of commercially available surface or needle electrodes. Use only
electrodes compliant with current standards for biocompatibility, safety and sterility. The electrode
cables must be compliant with the pin-out of the device connector, described in the Technical
manual.
Stimulation Accessories
The stimulator can be used with headphone, goggles and electrodes for acoustic, visual and electric
stimulation respectively.
The electrodes must be used only for surface electric stimulation, the contact between electrodes
and skin must be made using a sponge or felt wet with physiological solution.
According to the desired type of stimulation connect the accessory to the proper output. For
electric stimulation it is possible to use accessories made by other brand as long as they are CE
marked and are compatible with the connector pins.
For acoustic and visual stimulation only the specific accessories are usable because they are design
to properly manage the signal output from the device.
Description Code
LED Google for visual stimulation EP GOGGLES
Calibrated headphone for acoustic stimulation EP CAP MINI
Calibrated tubal insert EP INSERT
Cables
Software
The device is fully controllable from Xegis software. The Xegis G:Neo device is supported starting
from software version 1.02.2001.
PC and interface
2005/96/EC Directive (Waste of electrical and electronic equipment): at the end of its use life
the device must be disposed separately from domestic waste to allow components recycling.
ESD warning symbol: The pins of the connectors marked with this symbol should not
be touched with the fingers or metallic tools unless proper precautions have been taken. Read the
information in the specific section of technical manual.
CONNECTORS
On Xegis devices there are the following connectors
• On front panel
o CH1, CH2 groups: for the input to channels 1 and 2, the user can connect alternatively to
the 5-pin DIN connector, the 3-pin plastic mini connector and the touch-proof
connectors. To select the desired input connectors, use the specific configuration
window in the Xegis software.
o GND: additional connection to the internal reference of the acquisition channels, usually
for the use with the touch-proof pair inputs.
o DC: 4-pin connector for the input of signals on the DC channel
o AUX 4 poles for auxiliary medical devices connection with serial communication (i.e.
oximeter, temperature probe with digital output). Currently not enabled.
PC CONNECTION
The connection with the PC is achieved via cable link towards the Xegis USB interface card or
through radio link to the Bluetooth® receiver on the PC.
Radio connection
Bluetooth® radio module is integrated in all Xegis series amplifiers. Such feature is not used at the
moment by Xegis software. Refer to SYSTEM CONFIGURATION chapter.
Cable connection
The cable is an electrical link transferring power supply and control signals to the device and the
acquired data to the PC. The cable must be connected to the 5 pin connector marked as
“INTERFACE”
The cable is an electric link and care should be taken that the isolation is maintained. The cables
and devices before the interface card cannot enter the patient area because they could not be
compliant with the requirements concerning leakage currents. When using BQ PCI PLUS interface
card, such card must be inserted in a properly isolated system
5 mt.
KEEP OUT OF
PATIENT AREA
PATIENT AREA
Control Section
• The four arrow buttons are used to move between menu to select the parameters ( , )
or change menu ( , );
• The buttons and are used to modify the values of the selected parameter;
• The (or Bluetooth) button is used the first time to switch on the device and the second time
to switch on the Bluetooth module. The third time it switches off the device and the Bluetooth
module.
• The knob is used to change the parameter values with the same function of and
buttons. In particular it is helpful to adjust stimulation intensity, frequency and duration. Pressing
the knob will start the stimulation
The switch on the rear panel is used to select the power supply source when the device is connected
via cable to the PC interface. See the related chapter in the Technical manual.
Green LED
Yellow LED
LED yellow On the side panel near the electric (Flashing) the electric stimulator is running. The LED flashes with
stimulator connector intensity and frequency proportional to the delivered stimulus.
MENU
On the display are shown several menus that allow the settings of different parameters groups: in
the bottom line there is the name or the unit measure of the parameter, in the top line there is the
parameter value.
The tables represent the device display. On the value row the parameter option are shown; the
numeric values are represented with # the limits are defined in the following description.
Start
Selection of
Intensity step
Active output
Initial phase
Stimulation
frequency
Opposite
intensity
Stimulus
Stimulus
duration
duration
phase
Trace
delay
Parameter
Available # # # + # 0.2 # #
values
- 1.0
Symbols Hz mA us Fa In St Dl Nu
shown
Delay from
Parameter
Stimulation
Stimulation
Stimulation
of stimulus
acquisition
frequency
intensity
intensity
Masking
noise
Noise
Type
side
Value # # LEFT sound YES # #
RIGHT parameters NO
BILA
symbol Hz DbH Sd * Ns DbH Dl
* It is shown the description of the stimulus
The stimuli are delivered using EP CAP MINI headphone; the following parameters can be set:
• Simulation frequency: from 0.25 Hz to 20 Hz in step of 0.25 Hz, from 20 Hz to 100 Hz in step of
0.5 Hz, a single stimulus is obtained pressing the knob with the frequency set to 0 Hz.
• Stimulation intensity: measured in dBHL, it is estimated on click stimulus. It goes from 0 to 110
dBHL in step of 5 dB
• Stimulation side: the headphone side to which the stimulus is delivered (left, right or bilateral)
• Type of stimulus: the device can deliver stimulus based on different waveform produced with an
internal signal generator or transferred from PC. The waveform internally generated are:
o 'POSIT SYM. CLICK' symmetric click starting with compression phase
o 'NEGAT SYM. CLICK' symmetric click starting with rarefaction phase
o 'ALTER SYM. CLICK' symmetric click starting with both compression and
rarefaction phase
o 'POSI ASYM. CLICK' asymmetric click starting with compression phase
o 'NEGA ASYM. CLICK' asymmetric click starting with rarefaction phase
o 'ALTE ASYM. CLICK' asymmetric click starting with both compression and
rarefaction phase
o 'POS DOUBLE CLICK' couple of click with compression phase
o 'NEG DOUBLE CLICK' couple of click with rarefaction phase
o 'ALT DOUBLE CLICK' couple of click with alternate phase
o 'SINGLE BEEP' brief sinusoidal signal with constant amplitude and fixed high
frequency
o 'SINGLE BOOP' brief sinusoidal signal with constant amplitude and fixed low
frequency
o 'ALTE BEEP & BOOP' sequence of beep and boop signal
o 'EXTERNAL SOUND x' with x = A, B, C reproduce the sound sent from PC
o ' FREQUENCY x ' with x = A, B, C make a continuous sound (sinusoid with
frequency A, B, C with adjustable edges). The sound parameters are set from PC.
o 'ALTERNATE EXT. S' alternate two external sound A and B.
• Masking noise: enable or disable the masking noise on the side opposite to stimulation side.
• Noise intensity: measured in dBHL as the stimulation, goes from 0 to 110 dB in 5 dB step.
• Delay: represents the delay between stimulus delivery and beginning of signal acquisition. Values
from 0 to 12 ms in step of 0.1 ms.
from
Stimulation
Stimulation
acquisition
frequency
hemifield
intensity
Stimulus
duration
Delay
side
Parameter
Value # # 1-10 LEFT EMIL #
RIGH EMIR
BILA FULL
symbol Hz Lm Dr SD Ty Rt
The device deliver light stimulus through the LED EP GOGGLES. The following parameters are
settable.
• Simulation frequency: from 0.25 Hz to 20 Hz in step of 0.25 Hz, from 20 Hz to 50 Hz in step of
0.5 Hz, a single stimulus is obtained pressing the knob with the frequency set to 0 Hz.
• Stimulation intensity: measured in lumen (candle/steradian). It goes from 1 to 8 Lm in step of
1 Lm.
• Stimulus duration: it is possible to set 10 different duration of the flashes made with the goggle.
• Stimulation side: the eye to which the stimulus is delivered (left, right or bilateral)
• Hemifield: the LEDs in each lens are divided in 2 circuits so it is possible to deliver the stimulus in
each hemifield. The choices are EMIL (hemifield left), EMIR (hemifield right), and FULL (full eye).
• Delay: represents the delay between stimulus delivery and beginning of signal acquisition. Values
from 0 to 12 ms in step of 0.1 ms.
High-pass filter Max signal channel 1 High-pass filter Max signal channel 1
Parameter channel 1 channel 2
Available values 0.15Hz 6.4mV 0.15Hz 6.4mV
16Hz 51.2mV 16Hz 51.2mV
Symbols shown lowb1 max s1 low b2 max s2
The full scale (maximum signal in input) and the lower band limit can be set independently for each
channel, while the upper band limit is fixed and the low pass filtering is performed through digital
filtering on the acquired signal.
Acquisition parameters
Trigger management
Value # # OUT
EXT
AUTO
Symbol hz dl Trig
The device can synchronize acquisition and stimulation using trigger signal.
Trig: the trigger enable field. If OUT is selected a trigger is output at any stimulus, select EXT to
receive the trigger from other devices or select AUTO to generate a trigger signal with adjustable
frequency without enabling the stimulation.
• Dl: Set the delay of the stimulus in relation to the trigger. The delay varies from 0 to 12 ms in
step of 0.1 ms.
• Hz: set the frequency of autonomous trigger from 0.1 to 0.5 Hz in step of 0.05 Hz, from 0.5 Hz
to 20 Hz in step of 0.25 Hz, from 20 Hz to 100 Hz in step of 0.5 Hz, from 100 Hz to 300 Hz in step of
10 Hz.
SYSTEM CONFIGURATION
• Using the batteries supply
o Insert two AA alkaline batteries respecting polarity. Refer also to technical manual.
o Verify that the batteries are properly inserted.
o Close the battery holder
o Set the rear panel switch to BATT
• If the Bluetooth connection is not active, connect the interface cable to the INTERFACE
connector on the device
• Set the Xegis software for acquisition with the Xegis G:Neo: from the acquisition protocol
window select the protocol setup window, select the tab HEADBOX and set the model to Xegis
G:Neo or Xegis G:Neo EP according to the hardware used and the interface to the interface model in
use. To enable the radio transmission function it is necessary to select the “BLUETOOTH” interface
and set the communication port number to the serial COM port made available when the Bluetooth®
device was recognized by the system (COM PORT).
NOTE: to use the Bluetooth® connection it is necessary to install the Bluetooth® in the PC and
configure the Bluetooth® to work as a serial port. Follow the instruction of the Bluetooth® adapter
manufacturer. The device must be recognize from the system as Xegis G:Neo; select the device, set
the Bluetooth® connection with passkey “0000” and remember the number of the associated serial
ports (IN and OUT) available for the communication.
The Bluetooth® radio communication may interfere with other close or linked devices if these are
not properly shielded or immune to electromagnetic interference.
It is recommended to check to the sensors working condition before starting any acquisition,
possibly using a know input signal and verifying the acquisition with the Bluetooth®
communication enabled and disabled. Errors due to electromagnetic interference can results in
irregular/intermittent functioning and noise in the acquired signal. See the Electromagnetic
compatibility chapter in the Technical Manual.
The device can be switched on also pressing the button . The device is provided of an auto switch
off system when working in autonomous mode that switches off the device after 1 minute of
inactivity if the device is not stimulating or acquiring. The device emits three beeps before switching
off and it is possible to avoid the switch off by pressing any button.
This mode should be used only when the device is not connected to the computer via cable.
PARAMETERS SETTINGS
The control signals and the functional parameters of the device are transmitted through the
connector and the cable connection from and toward the PC. A double way communication is
present to allow the parameters adjustment both from the PC and from the keyboard or knob.
All the functions can be selected from the PC keyboard or mouse via the Xegis software or with the
buttons and knob on the device. The parameters settings are shown on the device display and on
the acquisition program window on the PC monitor.
The setup parameters are loaded at the exam start up with Xegis software so in this case the default
parameters are not considered during an acquisition.
The setting of the basic parameters for the stimulation is similar in all the three stimulators.
The parameter setup for the stimulators and the acquisition section is performed in the acquisition
program setup window, respectively in the sections STIMULATORS and CHANNELS, or directly on
the parameters bar in the acquisition window during the acquisition. To set the value it is possible
either to enter the number in the textbox or to use the up/down arrows on the side of the textbox.
Refer to the software on-line help for further reference.
All the parameter settings are accessible on the stimulator and their variation is communicated to
the acquisition program.
The choice of the type of stimulator is performed with and selecting the specific settings
menu. Once the desired stimulator menu appears on the display it is possible to set its parameters.
o Select the desired parameter on the display with the or : the selected
parameter will be included between brackets like >dB<
o Using the and or the knob (only for the intensity) set the parameter values.
The stimulator menus are similar but they can be easily distinguished from the name of the intensity
measurement unit: mA for the electric stimulator, dBH for the acoustic stimulator and Lm for the
visual stimulator.
The trigger parameter (direction, delay and frequency) and the acquisition channels hardware
characteristic and the acquisition settings can be adjusted in the same mode.
During the stimulation only the parameters of the running stimulator and the one of the hardware
characteristic of the acquisition channels can be modified; during high frequency stimulation the
parameter changing can be set we some delay.
For a description of the parameters see the charter MENU on page 14.
The selection of the stimulator type (acoustic, visual, electric) can be performed on the stimulator or
it is made automatically from the PC choosing the acquisition program for the desired type of exam.
For acoustic and visual potential the acoustic and visual stimulation is selected, while for
somesthesic potential and for the electromyography exams the electric stimulation is active.
The stimulation is performed according to the settings shown on the device display.
RECORDING START
• Create a new EMG exam in Xegis software.
• Select the desired exam protocol (refer to the software on-line help)
• Connect electrodes and stimulation accessories to the patient
Be aware to apply the stimulation electrodes close to each other. The connection of two
stimulation electrodes on opposite side of the patient must be avoid because it could cause current
flow through the hart.
• Verify the connection with the patient using the IMPEDANCE CHECK software function.
A low impedance of the patient-electrode connection and the correct positioning of GND electrode
are the key factors to obtain a good recording.
This function allows also checking whether the acquisition channels work properly, since the signal
internally generated to check the impedance is processed like the acquired signal. If the impedance
of a channel not connected to the patient is low or null, or on the contrary the impedance remains
high even if the electrode is put in contact with reference electrode (G2 or the negative input for
the differential channel), do not use the device and have it checked by Compumedics technical
assistance.
• Verify that the software settings are related to the patient electrodes connection and to the
desired type of stimulus
• Start the acquisition with the command in Xegis software or pressing the button.
When the acquisition program EMG or PE is started, the PC begins the communication with the
device, switches it on and sets it according to the parameter settings. If communication problems
occur between the device and the PC, an error message appears on the monitor. If the message
does not disappear it is necessary to verify the cable connections and eventually disconnect it wait
for about 10 seconds and reconnect it once again.
• Start the stimulation from Xegis software or by pressing the knob in the device.
In the Xegis software window an error is prompted if it is selected a stimulator not compatible with
the chosen exam.
Changing in the stimulation parameters should be made when the stimulation is not active.
During electric stimulation the yellow led close to the stimulation output will blink with intensity and
frequency proportional to the stimulation current delivered to the patient. The red LED indicates the
enabling of this stimulation mode.
Radio Communication
In the Xegis software settings, select the Bluetooth® interface. The radio link is enabled by pressing
the button. After enabling the radio module, the device will show on the display the messages:
PREPARING FOR RADIO CONNECTION and RADIO LINK NOT ACTIVE.
When the acquisition is started from the software, the first phase of the connection procedure
consists in establishing the link between the device ready for the radio communication and the
receiver in the PC. When the connection is completed (the icon near the device in the status window
becomes green) the Xegis G:Neo start receiving commands and sending data.
When the radio module is switched on, the Bluetooth® stays active for 3 minutes.
If the PC does not establish a connection, the Bluetooth® switches off and can be switched on only
by pressing the button.
The device switches off by pressing the key for a long time. It also switches off automatically if it
is not connected to the PC and not active (no stimulation or acquisition active) for more than a
minute.
USE RECOMMENDATIONS
The Xegis G:Neo amplifier is a BF system, with floating applied part (isolated respect ground
potential).
Link between patient and input plugs has to be performed by means of surface or needle electrode.
Touch-proof plugs are normally used in combination with surface electrodes (black colour for
inverting input, red colour for not-inverting input). Needle electrode does normally carry a multi-pin
plug (3 or 5 pin).
As a good practice, always check input impedance levels and keep it to the lower possible values, in
particular checking ground connection (green touch-proof).
EMG and EP recordings are greatly influenced by accessory quality: the better the accessory, the
higher the acquired signal quality. Use shielded and short cables in case of high electromagnetic
disturbances. Keep the device and cables far from PC and display in order to avoid electromagnetic
interferences caused by such devices.
Electromagnetic noise level is proportional to the distance between the electrodes; so take care
when placing patient electrodes, afferent to the same amplifier, far each other. Common Mode
Rejection Ratio (CMRR) also decays in case the same electrode is connected to different amplifiers.
Take care to use this option only when clinically required.
EMG and EP examinations are worldwide widely know technique; refer to EMG and EP application
note for basic information about how to perform an examination. Advanced information can be
found in commercially available professional EMG EP manuals.