EPIC-PLUS MANUAL LABAT s.r.l.

www.labat.it

EPIC PLUS
EVOKED POTENTIALS SYSTEM

USE AND MAINTENANCE MANUAL

Version 1.1 September ’05

CLASS IIA MDD 93/42/CEE MEDICAL DEVICE - -

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Index
0 Warnings and information

0.1 Generalities

0.2 Symbols

0.3 Warnings and information

1 Introduction

1.1 Description

1.2 User’s responsibility

1.3 Manufacturer’s responsibility

2 Set-up and maintenance

2.1 Features

2.2 Set-up

2.3 Software set-up

2.4 Maintenance

3 Operating instructions of the evoked potential

3.1 Starting the program

3.2 Patients archives

3.2.1 Patients menu

3.2.2 Insert new patient file

3.2.3 Show patient and exams’ previews

3.2.4 Exams

3.3 Starting with a new exam

1.Operative panel

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2. Visualization panel

3. Test-execution panel

3a. Impedance test

4. Graphic panel and activities

4a. Peak selection and further operations on traces

4b. Save the exame or perform a new test

5. Printing Panel

3.3.1 Further operations

1. How to compare traces

2. How to assign name and/or colors to the single traces

3. How to superimpose right and left traces

4. How to insert a clinical printing report

3.3.2 Quick test

Appendix A Technical features

Appendix B Accessories features

Appendix C Troubleshooting

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0 Warnings and information

0.1 Generalities

These operational instructions are part of this device’s documentation and they are therefore an
integral part of it.
This document supplies fundamental information for the correct use of this device. Specialized
personnel should train each user about its correct use. Please carefully read this manual before starting
using the device.

This Device offers the highest level of updated technologies in the field of the double inverse osmosis
and complies all the requirements of CEE 93/42 regulation.

For any further requests or information, please contact:

LABAT S.r.l.
Via Don Tosatto 39 30174 – Mestre (Venezia)
Phone 041 2667686 Fax 041 616124

LABAT reserves the right to change the specifications of this manual without prior notice,
No part of this manual may be reproduced in any form – electronic or mechanical – by any means,
without LABAT’s prior written permission.

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0.2 Symbols
Device icons legend

+ EPIC PLUS device

EPIC
Device that meets all the requirements of the MDD 93/42 regulation

Responsible manufacturer according to the MDD 93/42 European regulation:

Attention, read the provided manual and observe safety icons

NOTE, important information.

Class II device

BF type applied part

Functional ground

USB port

LABEL DATA

. Via Don Tosatto 39

30174 Mestre (Venezia)
Tel 041 2667686 4
0051
EPIC PLUS S.N. EPC XX ZZZ :
15 Vdc Electrical input 800 mA Weight 1500 gr Dimensions 280x280x55
WARNING! FOLLOW THIS MANUAL INSTRUCTIONS

Class II device BF type applied part

Serial number:
Information on production data and quality control are provided by the device’s serial number,
formed by:

EPC XX ZZZ
Where
EPC Indicates EPIC device
XX Last two digits of the year
ZZZ Progressive number
Example: EPC 05011: It indicates the 11th device of 2005.

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0.3 Warnings and information

To prevent damage to the device or injury to you or to others, carefully read all the following
safety precautions before using this equipment.

Keep this instruction manual with the device for future consultations.

EPIC PLUS device belongs to the electro medical devices category and can be employed to
provide diagnosis in the audio metrical field. This device is produced to operate in medical
environment, therefore it is subjected to meet the requirements of the EN 60601 regulation
concerning medical environment.

EPIC-PLUS has been created to guarantee the maximum safety. It is essential that you
carefully follow this manual’s instructions, in order not to cause damages to the device and
injuries to yourself or others.

In case of doubts about the use of EPIC-PLUS along with additional devices on the patient,
the medical personnel must contact our technicians in order to provide the highest safety
standard to the patient.

Only specialized and authorized sanitary personnel can use this device.

Check the status of the device before use. EPIC-PLUS device’s performances may decrease in
time. It is therefore necessary that specialized technicians periodically check the status of the
device.

Compatible MS-DOS TM Personal Computer provided with a communication port and

connecting cable that meets the CE requirements and further regulations concerning the
medical environment.

EPIC-PLUS must be powered through an external charger; only use 12 Volt chargers (12
Watt output) meeting the current requirements concerning electro medical devices.

Immunity to fast electrical transistors (BURST), 2KV level. This device, if subjected to
transitional disturbance created by commutation transistors (inductive load interruption,
relay contact rebounds, etc.), could lose data due to the lack of communication with the PC:
this event would be indicated by the message “warning” on the PC’s screen. In this case, it is
necessary to repeat the test again. Both patient and technician won’t encounter any safety
problem in this situation.

Keep EPIC-PLUS in a dry place and avoid any contact with water or any other kind of liquid.
In case of contact with liquid, carefully dry the EPIC-PLUS before using it; in case of
immersion in liquid or suspected penetration of liquid, do not absolutely use the device and
contact our Assistance Service.

Do not apply electrical signals on any electrical connection point of the external connectors
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and strictly follow this manual’s indications concerning the EPIC-PLUS compatible kinds of
link.

Earthing must be connected throughout at least a 4-squared mm wire to a certified earthing

connection point.

Earthing is highly recommended to ensure successful exams.

IN CASE OF FIRE OR DANGER, TURN THE DEVICE OFF AND UNPLUG THE POWER
SUPPLY WIRE.

Before any technical maintenance or in case of malfunction, disconnect the device from the
power supply network.

This device is not supplied with specific protection devices against high temperature sources
and fires.

This device is not supplied with specific protection devices against liquid penetration.

15V cc 1 A Charger External charger meeting the current requirements

concerning electro medical devices (EN 60601-1).

The use of non-authorized EPIC-PLUS accessories may void your product

warranty. LABAT is not responsible, in this case, for any damage of the product.

Storage

Functioning
Temperature: between 10 and 40 degrees.
Ambient humidity: between 30% and 90%, not condensative.
Pressure: from 700 hPa to 1060 hPa.
Carriage
Temperature: between -20 and 50 degrees.
Ambient humidity: between 20% and 80%, not condensative.
Pressure: from 500 hPa to 1060 hPa.

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1 Introduction

1.1 Description

The EPIC-PLUS device is an electronic device created for low-intensity electrical signals capture and
acoustic stimulus generation.

The EPIC PLUS device belongs to the electro medical devices category and can be employed to
provide diagnosis in the audio metrical field. This device is produced to operate in medical
environment, therefore it is subjected to meet the requirements of the EN 60601 regulation concerning
medical environment.

Only specialized and authorized sanitary personnel can use this device.

The EPIC-PLUS employs an external electrical input (15 Volt – 15 Watt), which must be supplied by
a charger complying itself the current medical requirements, through the devoted connector on the case
back panel.
This device is programmed and controlled through a Personal Computer and its specific software
named EPIC.EXE.

1.2 Composition
This device is composed by the following main components:

DESCRIPTION Function
EPIC-Plus basic unit Generation of Pure Tones (sinusoids), that can be modulated in their
amplitude if necessary; White Noise (wide band), CLICK type stimulus,
synthetized band shapes, with flexible amplitude and frequencies.
It also captures, converts and elaborates low-intensity electrical signals
through 2 independent input ports.

EPIC – PP unit Amplification and filtering for evoked potentials tests.

EPIC-Plus software Management System Software.

Manual The manual describes the physical and technical features of all the single
devices, the available versions, the installation procedure, the instruction
employment and programming. It moreover specifies the kind and
maximum length of wire to use and that can influence the EPIC-Plus EMC
functioning.

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ACCESSORIES
15V cc 1 A charger External charger meeting the current requirements concerning electro
medical devices (EN 60601-1).

Aerial transductors To stimulate the evoked potentials.

COP 10 S2 electrodes Evoked potential plotting
10 conductors screened wire Unit connection
Earth wire Unit earthing
USB wire Unit connection to the PC

NOT PROVIDED BUT NECESSARY COMPONENTS

MS~DOS Personal Computer It must be compatible to the device, supply a USB port and connection
cable meeting the CE requirements for the use in medical environment.

Every 160 gr Abrasive paste to guarantee the electrodes functionality.

Medicream Conductive paste to guarantee the electrodes functionality

1.3 User’s responsibility

1.3.1 Use by specialized personnel only

Only personnel with a specific technical knowledge can use this device.
The user must check the device before using it, to make sure it is safe and it works properly.

1.3.2 Use advice

Use this device only by following the instructions and procedures as explained in this manual.
If maintenance is required, do not use the device before it has being controlled.
Faulty parts or damaged ones must be substituted only with original LABAt spare parts.
All reparations must be effectuated by LABAT or in authorized Service Centres.
Do not substitute any part of the device without prior permission from LABAT.

1.3.3 User’s responsibility

The device user is fully responsible for any malfunction caused by unauthorized activities or
reparations effectuated by non-Labat personnel or non-authorized personnel.

1.4 Manufacturer’s responsibility

Any changes, modifications, non-authorized use of the device listed above, not expressively approved
by Labat and could void the device warranty.

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2 Set-up and maintenance

2.1 Features
Connect your EPIC-PLUS device through a USB cable of less of 3 metres long to a Personal
Computer, in order to let a specific software managing EPIC-PLUS’ functionalities.
EPIC-PLUS’ set-up is quite easy as long as you follow these installation instructions:

Insert the charger plug into the EPIC-PLUS’ socket.

Connect the EPIC-PP device by inserting the provided cable sockets into the plug on EPIC-
PLUS’ front panel.

Switch the EPIC-PLUS ON.

Make sure that the 8 LEDS on the EPIC-PLUS’ front panel are enlightened on a repetitive
sequence, for about 4 to 5 seconds (odd and even LED alternations).

Make sure that only PW led is enlightened.

Employ specific management software to effectuate Evoked Potentials tests: it is therefore
necessary to follow the provided software set-up instructions (please see the chapter “2.3
Software set-up”).

2.1.1 Front panel

+
EPIC ON CK TR CH1 CH2 S1 S2 S3

A
B

A) 10 Poles Circular Connector

This EPIC-PLUS input connector enhances the connection to the EPIC-PP preamplifying unit.
Here follows the connector pins sequence:

Pin 1 : Reverse Input Channel 1

Pin 2 : Non-reverse Input Channel 1
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Pin 3 : VCC+ Out DC V= 9 Volt 100mA max
Pin 4 : GND
Pin 5 : VCC- Out DC V= -9 Volt 100mA max
Pin 6 : A Control signal
Pin 7 : B Control signal
Pin 8 : C Control signal
Pin 9 : Non-reverse Input Channel 2
Pin 10 : Reverse Input Channel 2

All the connectors’ signals are galvanizing isolated (1500 Volt) in relation to EPIC-PLUS’ earth, in
order to guarantee a high safety level and a low electrical leakage towards the patient.
EPIC-PLUS must be connected only to the EPIC-PP device through the devoted connecting cable.
To connect the device, plug the provided cable into the device’s connector and into EPIC-PLUS’
connector. The cable is symmetrical.

B) Operating LED signals:

PW: Power supply is on

CK: this is not used
TR: ‘Trigger’ is on
C1: depending on the application
C2: depending on the application
S1: depending on the application
S2: depending on the application
S3: depending on the application

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2.1.2 Back panel

2 3 4 5 6 7 8

1 Earthing
2 Switch Switch
3 Power supply Power supply
4 USB port
5 ‘TRIGGER’ connectors (IN and OUT) Optional function
6 ‘SIGNAL’ connectors (IN and OUT) External repetition of acquired signals.
7 ‘DIG’ signals connectors (IN and OUT) Optional function not described in this technical manual.
8 ‘AUDIO OUT’ signal connectors (LEFT Acoustic signals routing to the patient
and RIGHT)

2.2 EPIC PP’s preamplifying panel

PP PREAMP
NOTCH NOTCH Active
IMP IMP Electrodes Impedance Gauge
FL1 FL1 F = 100 Hz
FL2 FL2 Necessary for electrostimulators
FL3 FL3 F = 5 Hz

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2.3 Label

. Via Don Tosatto 39

30174 Mestre (Venezia)
Tel 041 2667686 4
0051
EPIC PLUS S.N. EPC XX ZZZ :
15 Vdc Electrical input 800 mA Weight 1500 gr Dimensions 280x280x55
WARNING! FOLLOW THIS MANUAL INSTRUCTIONS

Class II device BF type applied part

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2.4 Connections

Earthing must be connected through an appropriate cable (we suggest you to use at least a 4 squared
mm cable), to a certified earthing point; earthing connection is fundamental to obtain high-level
standard tests.

‘TRIGGER’ (IN and OUT) and ‘SIGNAL’ (IN and OUT) connectors are female BNC ones, it is
therefore necessary to use coaxial cables with male BNC connectors to be able to acquire or input the
necessary signal, all outputs are current limited and all the inputs are protected by extra voltage.
In any case, avoid the application of exceeding limits high voltage compared to the ones indicated in
this manual and avoid surcharging outputs.

‘DIG’ (IN and OUT) connectors are female RCA kinds, it is therefore necessary to use male RCA
connecting cables to acquire or input the necessary signal; all outputs are current limited and all the
inputs are protected by extra voltage.
In any case, avoid the application of exceeding limits high voltage compared to the ones indicated in
this manual and avoid surcharging outputs.

‘AUDIO OUT’ (LEFT and RIGHT) are female JACK types (6.3 mm), it is therefore necessary to use
male JACK connecting cables to acquire the necessary signal to be sent to the headphones; all outputs
are current limited and all the inputs are protected by extra voltage.

In case EPIC-PLUS being used in electromagnetic noisy environments, it is recommended to employ a

linear power supply (avoid “switching” models, they emanate noises that can damage the test) that
comply current regulations on medical devices.

Do not apply more than 25 Volt tension in any case and be careful when connecting the device to
the power supply.

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2.5 Software set-up

LAP software installation is automatic; please check your installation CD’s serial number is the same
of your device (you can check it on the unit back panel).
For further informations about this subject, please refer to the “LAP Manual”, chapter 1.

2.5.1 Connections to other devices

You may connect PC and Video monitors to EPIC-plus but first make sure they have been certified as
medical devices.

PERSONAL COMPUTERS AND VIDEO MONITORS MUST BE EARTHING CONNECTED

Connections to Personal Computer / Video Monitors / USB Port

Personal Computer and Video Monitor must comply current EEC regulations and bear the CE mark
(LVD 73/23/EEC, EMC 89/336/EEC, Compliance with EN60950 safety standards and, if available,
EN 60601-1-2).

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2.6 Preventive maintenance

2.6.1 Maintenance

This device does not need specific preventive maintenance; anyway, follow these precautions:

Test the device good status before use: despite the hard case and the high resistance of the
inner electrical system, it is highly recommended to avoid making the device accidentally fall;
in case of possible damages of the device due to collisions or falls, do not use the device
and contact our Assistance Centre.

In order to minimize the risk of electrical damages both for patients and medical technicians, it is
necessary to follow these preventive maintenance instructions:

a) Every time you use EPIC-PLUS, check the integrity of the device and search for possible
damages of the plastic case or pay attention to strange noises that could indicate possible
detached parts inside the device itself.
b) Every time you use EPIC-PLUS, make sure the device is perfectly dry and no liquid has
penetrated inside it.
c) Every time you use EPIC-PLUS, check the connectors’ status and search for possible loose
connections, such as loose screws, etc.
d) Check the good functioning of the device each six months by effectuating the calibration and
setting on the measurement recognition system, along with earthing connections.
e) Check the good functioning of the device each twelve months by measuring voltage lackage
and prescribed isolations
f) In case of failure, substitute the components only with original LABAT spare parts.

2.6.2 Cleaning and disinfections

Device
Clean the device external parts at least once per day, by using a humid cotton cloth with water and
neutral detergent, to take dusts and impurities off.
DO NOT use aggressive liquids and detergents.
Do not wet the electrical connections.

Headphones and electrodes

Headphones and electrodes come into contact with the patient, therefore their maintenance and
cleaning will be proceeded as follows:

Clean the cable with a humid cotton cloth with water and neutral detergent. Make sure you do
not wet the connections plugs.

Disinfect the device by using CE branded hospital products for medical devices by checking
their label and use instruction.

DO NOT use aggressive liquids and detergents.

Do not wet the electrical connections.
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2.6.3 Calibration

EPIC-PLUS is provided with its calibrated accessories, they are guaranteed for 6 MONTHS.
Make sure calibration is checked every 6 months by specialized personnel using certified and set
instruments.

2.6.4 Environment
This device is built meeting the current regulations on impact of electronic device on the environment
and it is totally safe.
This device does not contain batteries or toxic materials.
It is produced with inert materials, which can be discharged following your local waste disposal.

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3 Operating instructions of the evoked potential

3.1 Starting the program

After the installation procedure shown in the previous chapter, LAP system is ready to be used,
calibration values of your system have been automatically recorded through the installation CD’s serial
number.

Launch the program in this way

START PROGRAMS Labat Audiological Platform

For further informations about this subject, please refer to the “LAP Manual” Chapter 1.

It is possible now to proceed with the next functions.

3.2 PATIENTS ARCHIVES

Please refer to the “LAP Manual” Chapter 1.

3.2.1 PATIENTS MENU

For further informations about this subject, please refer to the “LAP Manual” Chapter 2 (From page 4
to page 6).

3.2.2 INSERT NEW PATIENT FILE

Please refer to the “LAP Manual” Chapter 2 (Pages 7-8).

3.2.3 SHOW PATIENT AND EXAMS’ PREVIEWS

Please refer to the “LAP Manual” Chapter 2 (Pages 7-8).

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3.2.4 EXAMS

Double click on the preview to accede to the correspondent off-line test consultation.
Left click on the preview to delate the selected exam.

Double click

Note: The list of tests for the selected patient is shown from the most recent to the older.

3.3 STARTING WITH A NEW EXAM

Once the patient is selected or inserted and the PEA family of tests is chosen, click on “New Exam” in
correspondence of the kind of test you’re going to perform (ABR, VEMPs, Echog, ...).

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The image below shows the “New Exam” interface which appears after clicking on “New Exam”. It’s
composed by five main panels, all marked in the screenshot. Their numerical sequence is the same the
user commonly should follow in order to perform good tests. Before proceeding check the EPIC LED,
indicated in the figure below. If the device is correctly connected to the personal computer and
correctly interfaced with the Labat Audiological Platform the EPIC LED will be constantly green.

EPIC LED

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1. Operative panel:

Check the settings on this panel before starting the test, they’re comprehensive of the stimulus
waveform, its amplitude, its rate, the ipsi-lateral side of stimulation, the kind of output desired, the
number of sums. The operator can choose a factory protocol for testing, or change the parameters, then
save the new configuration in a costumized protocol, for further tests in the future. Anyway, default
factory protocols are scientifically checked and thought to perform good tests.
Choose the
Choose the kind of Ipsi-lateral
output: BC or AC stimulating
Headphones TDH-49 side: Left or
or insert ER3A Right

Use the up and down arrows Delete an

to obtain the preferred existing testing
stimulus intensity protocol

Click on the void field to Save a new

activate the controlateral protocol after
masking and go on with the having
up and down arrows to set its costumized it
intensity
Choose an
existing testing
Click on “Stimulus” to protocol
change the stimulus Set the number
properties Click to open the
advanced panel of sums Set the Stimulus
rate

Click to open the The Sampling section allows to

sampling option regulate the delay imposed on the
panel to set screen (commonly used to mask the
advanced options headphone EM interference) and the
like trigger window’s time which defines the x-
synchronization, axis scale in the trace screen.
preamplifier
inhibition and soft Click to set the number of inputs and
increment function. preamplifier channels from which
It’s not strictly acquire:setting one input the operator
required for can choose which channel he is
common users. going to use (CH1 or CH2). Setting
two inputs the operator can choose
from how many channels to acquire.

Click to enable the artifact automatic rejection function: “Max” and Click to set the amplifier gain and
“Threshold” regulations beside it indicate the programmable artifact the filter options: Notch, High-
definition: respectively the Maximum number of “over- Pass, Low-Pass, Preamplifier High-
threshold”samples respect to the total samples in each acquisition and the Pass filters for the selected channel.
Threshold percentage represented by the grey bounds on the ongoing
activity screen, within which the EEG should remain not to have an
artifact recognition
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2. Visualization panel:

The whole testing screen is devided in two symmetric parts. It can be chosen what to visualize
on the top side and on the bottom side by this panel. By default there will be set the ABR traces
on the top and the ong-oing activity on the bottom.

Select this button to visualize the

ABR traces and choose the ear-
side (Right, Left or Right and Left
at the same time)

Select this button Select this button to Select this button to

to visualize the visualize the visualize the Ong-
trace comparisons Latency/Amplitude oing activity
graph

3. Test-Execution panel:

The operator can now check the impedance and start with the test. To execute a re-test, just
click start again after having stopped the previous acquisition. There is no limit for the number
of retests allowed.
Click to delate
Click to check the traces from the Click to start with Click to stop the
Impedance latter to the former the test test

Check the current Check the current number

number of sums <20% of rejected artifacts

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3a) Impedance Test:

Check if the electrode’s impedance bar is into the green level for the channel(s) used to acquire. In
case of bad impedance, the operator should remove the electrodes and get a more abraded skin at the
points of application, or add conductive gel on the electrodes, in order to improve the conductivity.

Click to stop the

Impedance test
and proceed with
the exam

Impedance Bar:
Green: < 5Khom
Orange: 5-8 Khom
Red: >8 Khom

4. Graphic panel and activities:

Once the test has been stopped and also during the acquisition, Labat Audiological Platform
provides graphical functions to the operator, such as automatic and manual scale control,
smoothing filter activation, trace color.

Click to enable the Manually control the

automatic scaling of scale of the traces by
the traces, disable to the up and down-
proceed with the arrows
manual control Enter the drawing options: It will be possible to
set trace colors, to reverse the peaks,to show
latencies only for a selected trace, to visualize the
artifact threshold on the ongoing activity, to
enable and control the off-line smoothing filter

Click to enable the reversible

smoothing filter. Decrease the
frequency to improve the
smoothing power.

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4a) Peak selection and further operations on traces

During and/or after the test it is possible to marker the peaks, to consult the calculations on
interpeak latencies, to delate specific traces and displace them on the screen for better
visualizations. The figures below show how to compute these operations:

Click on this button, then on a trace
to delate it
Click on a trace to highlight it, then
you can set the peaks by right
clicking in correspondence of the
relative latency and left clicking on
the marker

Click to show peak-latencies and

interpeak calculations

Left clicking and holding on the

desired trace it will be possible to
displace it onto the screen

4b) Save the exam or perform a new test

Click on these buttons on the top-left side of the test screen, beside the printing panel to
save the current test or pass to a new exam for the same patient. Once saved the test it
will be possible to off-line consult it by double-clicking on its preview
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5. Printing panel:

Once the test is finished it is possible to select what to print and take a preview before. All the
printing settings will be kept in the saved testing protocol (please, consult the operative panel).
Click to select what to print: interpeak differences and
other operations, latency/amplitude graph, trace
comparisons, amplitudes and/or operative parameters in
base of the used protocol.

Click to preview and print

3.3.1 FURTHER OPERATIONS

Labat Audiological Platform allows more operations. The figures below show these features
and their use.

1) How to compare traces

Once the peak latencies are selected the operator can compare chosen traces to show absolute
peak latencies and inter-trace latencies:

a) Click on the button is on the top of the operative panel:

b) Click on the first trace to be compared

c) Click on the second trace to be compared
d) Labat Audiological Platform will automatically change from the trace visualization to the trace
comparison view on the visualization panel.

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Use this comparison panel

to choose a previous
comparison or delate it

The visualized calculations

are printable. Consult the
printing panel.

2) How to assign name and/or color to the single traces

Click to give a costumized
name to a single trace. By
default the trace name is
composed by stimulation
side and stimulus intensity
(i.e. R:110). Click on the
colored button is in the
beside area to set a color
for the selected trace.

3) How to superimpose right and left traces

After highliting a trace by

left clicking on it, click on
this function to visualize
the selected trace
superimposed to the
controlateral one. Click
back to disable.

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4) How to insert a clinical printing report

Click on this button is

situated beside the printing
panel to insert a clinical
report. It will
automatically appear on
the printing of the current
exam.

3.3.2 QUICK TEST

It’s shown now a quick procedure to rapidly perform a test using Labat Audiological Platform and
Epic Plus.

1) Once the patients demographic data are set proceed with “New Exam” on the correspondent
type of test.

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2) Check the EPIC LED is green and prepare the patient abrading his skin and positioning the
electrodes.

3) Check the impedance and start with the test. Once the set number of sums is reached the test
will automatically stop.
Proceed with a retest clicking again on Start.

4) Set the markers on the selected traces by right clicking on the waveform.

Note: On the top section of the testing screen you can look at the current latency in real-
time, while you scroll with the mouse along the axis, in order to ensure a precise marker
positioning.

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5) Save the test.

6) Print.

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EPIC-PLUS MANUAL
Appendix A
Technical features attachment
Product category:
Functioning :
Manual prompts:
Led signals:
Acoustic signals:
Auxiliary signals:
Signal input (EPIC-Plus) :
LABAT s.r.l.
www.labat.it
Technical features
Electronic device created for low-intensity electrical
signals capture and acoustic stimulus generation.
through USB connection
ON – OFF switch
LED indicators:
PW: power supply is on
CK: bad functioning indicator
TR: ‘Trigger’ is on
C1: selection channel 1
C2: selection channel 2
S1: depending on the application
S2: depending on the application
S3: depending on the application
BURST (programmable Frequency, Rise, Fall and Sustain)
Maximum Amplitude: 125dBspl (1000 Hz)
Frequency: from 125 to 25000 Hz
Repetition period: from 12mS to 167S
CLICK (programmable Repetition Period and Amplitude)
Maximum Amplitude: 125 dBspl
Duration: from 10uS to 100mS
Repetition period: from 12mS to 167S
NOISE (Programmable Amplitude White Noise)
Maximum Amplitude : 125 dBspl
TRIGGER OUT
Standard TTL Levels
Maximum voltage: 5mA
Duration: 1mS
TRIGGER IN
Standard TTL Levels
Impedance : 3600 Ohm (±5%)
SIGNAL OUT
Impedance : 330 Ohm (±5%)
SIGNAL IN
Impedance : 4000 Ohm (±5%)
Max signal : -2.5 / +2.5 Vpicco
Band : 10000 Hertz
DIG OUT
Standard TTL Levels
Maximum voltage : 5mA
DIG IN
Standard TTL Levels
Impedance : 3600 Ohm (±5%)
Differential Type
Impedance (single input): 1000 Ohm
Passband : DC – 10000 Hertz
Programmable Amplification: from 2 to 100
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Signal input (EPIC-PP): Differential Type
Impedance (single input): > 100 MOhm
Passband and Amplification
FL1 : 100 – 5000 Hertz
A = 11000
FL2 : Eletcrostimulation
FL3 : 5 – 5000 Hertz
A = 11000
Notch Filter: 50 Hertz (60 Hz Option)
(disconnectable)
Electrodes Impedance Meter
Test signal : 760 Hertz (±5%)

Analogical-digital conversion: 12 bit A/D converter

2 conditioned simultaneous Channels (PGA – Filters)
100Ks/s max Sampling
1 auxiliary channel
Band : DC – 10000 Hz
Signal : +2.5/-2.5 Volt
Filters: Disconnectable low-cut Filter 40dB/dec
Fmin : 10Hz Fmax : 500Hz (±5%)
High-cut filer 40dB/dec
Fmin : 10Hz Fmax : 12000Hz (±5%)
Power supply voltage: DC 15 Volt, female 5.5 x 2.1 plug
(MAX 20 Volt)
Power consumption : about 500 mA in stand-by
about 900 mA MAX
Dimensions : 275 x 250 x 50 mm
Weight : 1000 grams

Ambient conditions

Functioning
Temperature: between 10 and 40 degrees.
Ambient humidity: between 30% and 90%, not condensative.
Pressure: from 700 hPa to 1060 hPa.
Carriage
Temperature: between -20 and 50 degrees.
Ambient humidity: between 20% and 80% , not condensative.
Pressure: from 500 hPa to 1060 hPa.

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Appendix B Accessories features

ACCESSORIES
15V cc 1 A charger External charger meeting the current requirements concerning electro
medical devices (EN 60601-1).

Aerial transductors To stimulate the evoked potentials.

COP 10 S2 electrodes Evocated potential plotting
10 conductors screened cable Unit connection
Earth wire Unit earthing
USB cable Unit connection to the PC

NOT PROVIDED BUT NECESSARY COMPONENTS

MS~DOS Personal Computer It must be compatible to the device, supply a USB port and connection
cable meeting the CE requirements for the use in medical environment.

Every 160 gr Abrasive paste to guarantee electrodes functionality.

Medicream Conductive paste to guarantee electrodes functionality

15V dc 1A Power Supply

EPIC-PLUS is supplied by an external power supplier, which must meet the security standards for
electro-medical devices and provide a 15 Volt tension and at least 1 A current; the dimensions of the
plug (named DC) are 5.5 x 2.1, the positive pole must be connected to the central pin of the power
supply plug.
In case EPIC-PLUS being used in electromagnetic noisy environments, it is recommended to employ a
linear power supply (avoid “switching” models, they emanate noises that can damage the test) meeting
current regulations on medical devices.

Do not apply more than 25 Volt tension in any case and be careful when connecting the device to
the power supply.

Aerial Transducers
TDH 39 or TDH 49/50 aerial transducers models, produced by TELEPHONICS, or comparable ones
(supplied with sound-proofed supports, bow and string). TDH transducers are all internally tested and
calibrated. The supports, which come into contact with the patient, are certified.
COP 10 S2 Electrodes

The supplied electrodes for the evoked potentials acquisition are chosen between the best brands on
the market; they are certified and meet the current regulations requirements.

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Others
10 conductors screened wire
Hearting cable
USB cable
They are chosen between the best brands on the market; they are certified and meet the current
regulations requirements.

Personal Computer
The Personal Computer must meet the current 89/336 regulations on the matter of electromagnetic
device. If used in a medical environment, it must meet also the current regulations on electro medical
devices.
Every 160 gr: abrasive paste

Medicream: conductive paste

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Appendix C Troubleshooting

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Labat Audiological Platform

User manual

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1. INSTALLATION
The supplied CD-ROM will automatically install:
- Labat Audiological Platform
- Various Modules of Labat’s software (AudioLAB, EP-X, ASSR, iPort).

Warning: do not connect any of the above-mentioned instruments to the PC before the software
installation has completed.

After inserting the CD, the following screen will be displayed:

Auto-run screen

Click on the “Install” option to automatically install the software. Follow the suggestions on the
screen.

After completing the installation, the AudioLAB audiometer, the EP-X Evoked Potentials System or
the EchoLab can be connected to the PC.
No drivers’ installation is required.

An icon will be installed on the Desktop screen:

The automatic procedures for device detection as well as drivers installation will start when one of the
instruments is connected to the PC. When the following message appears, the connected unit is ready
to be used.

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Double clicking on the icon of the Labat Audiological Platform will open a user’s window.

WARNING: the “Labat Audiological Platform” can be accessed only by a user account login system.
Three users groups exist with different privileges:
1. “Administrators”: for full access to the patients’ databases, administration of the users’
accounts and testing.
2. “Examiners”: Otologists, audiologists and hearing aids dispensers. For full access to the
patients’ databases and performing of tests.
3. “Support”: Nurses and other personnel. Can only access the patients’ data. This group cannot
browse patients’ tests, change the data nor can they perform tests.

To log in the software after the installation you must use the following user account:

USER: admin
PASSWORD: 12345678

At the first login the system will ask you to enter a new password.
The Administrator is required to create a set of users accounts.

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2. LABAT AUDIOLOGICAL PLATFORM

New personalized database archives can be created and added to the Demo database included in the

software distribution by clicking on the icon .

The following figure will be displayed:

A title and a file name of your choice can be inserted in place of the created title and file name by
overwriting and then clicking on the key “New database”.

To delete a database archive, select the archive then click on the icon

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Delete

The program will display a warning. Selecting the Yes key will permanently delete the archive
selected.

The language of choice can be selected by clicking on the arrow to the right. A list of available
languages will be shown. To select click on the desired language.

Language selection

To change the present user to a new user click on Change user. The User and Password window will
be displayed again

The button Users management is used to change password, and to add or delete users in the different
categories. The ability to add or delete users is in a hierarchical concept. The higher level has control
over the lower. For example Administrators can add or delete users in the lower two groups
Examiner and Support, while Examiners can do so only in the Support area. The Support
personnel have no control.

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To introduce a new user To delete a user To change to a new password

The program will require the passwords to be changed every 6 (six) months. It will give warnings
periodically after 5 months. Please change the password or re-introduce the same password as soon as
possible. The program will give a final warning at the six-month deadline, if the password is not
changed the unit will no longer allow access for that user.

Clicking on the Printing header key will open a window to allow the introduction of name, address
and telephone number of the facility. This information will be used as header on the printed form. The
font and its size can be changed, and the text can be printed either justified to the left, right or center.

The Background key is used to change the background of this first page. Clicking on it will open the
documents’ window in search for a photograph, if it is selected it will be applied.

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The square key next to Background is used to return to the original view, while the blue dot will
invert the background and text color.

PATIENTS’ ARCHIVES

On the left of the window is the area for the Database archives. To open an archive, double click on a
Database.

Pre loaded Standard Archive

A list of the patients within that archive will appear. Selecting one of the patients will display
previously saved tests as thumbnails within the test type tab (Audiometry, AEP, ENG, OAE and
ASSR). The test type tabs will show, in parenthesis, the number of tests saved. To view a test full
screen, double click on the selected thumbnail.

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Demographic
Patients information

Types of tests

The following controls allow you create new Patients or delete Patients:

Creates patients.

Deletes patients. (Archives cannot be deleted from this area).

This button lets you move back to the previous page.

ADDING A PATIENT

To add a new patient click on the icon create patient .

Enlarge demographic screen

The Surname box will turn green.

The minimum information required by the program is:
• Surname
• Name
• Date of Birth
All other data is optional.
Clicking on the arrow to the right of the Birth date will show other demographic boxes.

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Decrease demographic screen

For future statistical purposes it is advisable to fill in the Category, Screening stage if the patient is
part of a screening protocol, and the R L Pass boxes after the test. The remaining boxes are self-
evident.

3.3.3 NOTE – In the case of the EchoLab, OAE instrument, the data will automatically be
transferred if it is inserted at the time of testing.

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3.4 PASS/FAIL BOXES

The R L Pass boxes have three possible states:

No information entered or unknown results

Right and Left ears pass

Right and Left ears fail

The R and L boxes are independent therefore a combination of symbols can be used i.e.

Right fail, Left pass or Right unknown, Left pass or

Right pass, Left fail

3.4.1.1 FAST FIND

To fast find a patient within the selected archive, click on the search icon

Search icon

The following will be displayed

Enter the Surname of the patient. The program will search as each letter is typed.

3.4.1.2

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3.4.1.3 STATISTICAL REPORTS

Clicking on the icon will display the statistics and reports window

Selection of report type

The Report type box contains a list of possible searches that can be seen and selected by clicking on
the arrow to the right of the box

Patients list – will display all patients within the parameter selected i.e. Test date From/To or/and
Birth date From/To or/and Patient category. If none of the parameters are selected then all patients
will be listed.

Check Mark

4 To select the dates simply click on the check mark key, which will turn green, and
overwrite the dates displayed with the dates wanted. To select the Patient category
click on the arrow and select from the list.
Once the search parameters are selected, clicking on the Report key will display the results in a print
preview form.

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Print icon

To print the form click on the printer icon on the left hand corner.

Screening: Statistics- Selecting the screening statistics will select all the patients
born within the time frame specified and within the category selected.

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Clicking on Report will show

Screening: Refer patients- this data search will select only the patients within the Birth dates
time frame, Category and Screening Phase that failed screening.

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Screening: Missed/Expected Refer Patients – this search will display all the patients that
have missed a screening phase or refer patients that are waiting to be re-screened

Usage Statistics- will give a report of exams made between the selected dates

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4.1.1.1 PATIENT CATEGORIES

Clicking on the patient categories’ button will display a list of available categories.

The list can be modified by adding New categories, or Delete a category. The number of patients
within the category will also be displayed. Once the changes have been made click on Done.
NOTE- within the original software there are 4 categories written in Italian, please change them and
delete the Italian.

The Services box at this time, contains only the iPort icon to access the OAE program.

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4.1.1.2 The Patients screen

Selected
patient

Test Type Tabs and Number of tests

Once an archive is selected it will display all the patients within it. Selecting a patient will display the
type and number of tests previously saved. Clicking on a test type tab will display thumbnails of the
tests within that type. Double clicking on a thumbnail will open it in order to be able to better analyze
it.

Sample ABR

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Sample audiometric test

Sample ASSR

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S2R-X Quick start

ASSR module for the Labat Audiological Platform (LAP)

Launching the module

• Create or select the patient to be tested from within LAP

• Have your Epic device properly connected to the PC and switched on.
• From the main window’s test pane, select the “ASSR” tab.
• Click on “New test”.

If the device is properly functioning, you will see a green round light near the S2R-X label on the
upper right, and the firmware version displayed at its left.

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Choosing what to view

By default, in the lower view pane you will see the incoming electrical activity from Epic. Should Epic
be switched off or not responding for any reason, S2R-X will generate a “test” signal on its own,
marking it as “Emulated Input” in the same pane, thus preventing you from thinking this is a real
signal, acquired via Epic.
In the upper pane you will see the Fast Fourier Transform of such signal (as the test begins). However
you can customize and select what to display in each view; each view has a set of rather self-
explaining buttons by means of whom you may respectively choose to view:

• FFT The FFT graph;

•
The audiogram, as if you were using the AudioLAB audiometer;
•  The incoming signal;
The keys labelled with “R”, “L”,”R/L”,”R+L”, where R means Right and L means Left, allow you to
choose between right ear’s and left ear’s set of data (left or right FFT, left or right audiogram).

The audiogram may also be displayed in a stacked fashion (R+L), ie. the audiograms are plotted within
the same grid, or in a tiled fashion (R/L), ie. the audiograms are displayed side by side.

The
button opens the Takes and Responses window (See below).

Preparing for test execution

Have the electrodes properly connected to the patient as if you were doing a standard ABR, ie negative
electrode to ipsi mastoid, positive to the vertex/forehead, mass to contralateral mastoid.

As S2R-X is connected to EPIC, the following floating, “Test execution” window appears:

Check the impedance values by pressing the “Z” button. The test execution window temporarily
disappears, and the impedance window pops up:

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The moving enlightened bars show the positive, negative and differential impedance at the electrodes.
The differential impedance should be as low as possible.

Once you’re done with the impedance check, close the Impedance window with the “X” button: the
test execution test will newly appear and the incoming activity will be captured again.

Setting test parameters.

Test parameters are accessibile in the left panel of the module.

Select the stimulation side by toggling it with the “Test: R” / “Test: L” button.
Set the stimulus intensity by adjusting the value in Intensity/“IPSI”.
Set the number of blocks of data to be sampled: Each block is 1024 samples long, and the sampling
rate is 1024 samples per second, ie 1 block per second. Please select at least 128 blocks for each take,
yielding a 2 minutes and 8 seconds test run-time.

Choose the FFT analysis precision: lower values such as 1024 may work for higher stymulus
intensities (>60 dB SPL), while you will need to set it to 8192 or above for lower intensities.

Set the ASSR stymulus features by pressing the  button, which causes the stimulus window to be
shown:

The ASSR stymulus is made up of one or more amplitude modulated sinusoidal waves: for each of
these waves you can set the carrier frequency, the modulating frequency and the amount of
modulation, given as percent value.

You may have up to 8 AM frequencies in the stymulus. The frequencies set may be saved for later
recall by means of the  button.

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Adjusting input parameters

By pressing the CH1 button in the Inputs sections of the left panel, you gain access to the following
window:

This allows you to do several tweaks to the preamplifier section of EPIC.

The Notch filter allows you to filter off the frequency range centered on the AC current frequency rate;
normally you will let this be “Not active”, otherwise you may end up corrupting the acquired signal if
you selected modulating frequencies close to the AC frequency.

In order to get a high quality and meaningful sampled waveform of the ASSR signal, you may need to
lower the preamplifier gain (“ADC gain”), when you see by the incoming signal pane that the
incoming wave gets clipped, thus assuming a “rectangular” shape. In other cases, you will see that the
amplitude of the incoming signal poorly fits the height of the incoming signal pane, meaning that
signal’s amplitude is way too low.
In any case, just act on spin control besides the gain value, wait for 1-2 seconds, and you will see the
amplitude of the signal get increased or decreased, according to the change you made.

High Pass Filter and Low Pass Filter frequency values shouldn’t be changed, as their values are
already optimal.

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Test execution and results interpretation

Start the test for the selected intensity by pressing the Start button (). The elapsed time is shown by
the counter at the right of the Test Execution window; the remaining estimated time is shown just
below.
Don’t expect the FFT graph to show up immediately when the test starts: for example, if you selected a
FFT Analysis precision of 8192 points, you will have to wait 8192/1024=8 seconds for the graph to
computed. The Sums values shows how may FFTs have been computed.

As test progresses, you will see the modulating frequencies highlighted by colored beams. A green
beam indicates that the response detection algorithm recognizes the response peak as not belonging to
the noise floor: this is done by statistical analysis over the values of the peaks in the surrounding
frequencies.

A modulating frequency highlighted by a red beam indicates that the peak is unlikely to carry a
response signal: in this case the patient isn’t probably hearing the carrier frequency at the specified
intensity.

The shown FFT graph is the result of a cumulative averaging process, very similar to the one used for
obtaining ABR waves; the consequence of this process is that true response peaks will get higher as
the test makes its way to ending, while noise peaks will tend to get flattened. The higher the number of
acquired blocks, the clearer will be the response graph.

Acquisition stops automatically as the number of the acquired blocks reachs the given limit.
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Saving sampled data and re-analyzing.

Please focus on the  button at the right of the Sums value in the Test Execution window; this is a
3-state button, each of these identified by a different icon.

In the default state ( on blue background) the sampled data won’t be saved to disk, so you will not
be able to recall it in any way.

In the Save state (( on light green background) the sampled data is saved to disk. The file name is
automatically set, and the data is recorded while the test progresses. When recording is ended, you
may simulate a new acquisition reading that sample data file, thus not requiring for the patient to be
there with electrodes attached. This makes sense whenever you desire to recompute peak response
detection using a different FFT precision or other analysis parameters. The recorded file never gets
modified or deleted by the module, and you can take it to another installation of the Labat Platform, or
send it by mail to your colleagues for independent analysis.

Once you made an acquisition while in Save state, the Replay button in the Test Execution window
gets enabled: by pressing it, S2R-X start a new acquisition reading the sampled data from disk instead
of sampling Epic’s physical analog input. The “replayed” acquisition will take only few seconds, as
data is read from disk and there is no need to wait for Epic to provide the real input.

If you want to simulated acquisition using a specific sample data file, when in Save state press again
the  button: it will show an open folder () to indicate that by pressing it you will be asked to
provide a previously saved sample data file.

Pressing again the  button will take it back to the default, no-save state.

The Takes and Responses Window

The “Takes and Responses” window collects in a spreadsheet style all the test runs made in the current
session. Each row of the spreadsheet represents a single test run (a “take”), identified by the stimulus
intensity, the number of acquired samples, and the set of yes/no results of the response peak detection
algorithm, provided for each of the carrier frequencies.

Takes are shown separatedly for the left and the right ear. You can toggle between left and right by
pressing the Left and Right buttons. On the counterhand, changing stimulation side in the main
window will cause the Takes and Responses window to follow that setting.

Double clicking a row will recall the FFT graph of the associated take.

Clicking on the first column (labelled “Use”) lets you decide if the selected take will be taken into
account for audiogram computation. The audiogram, if shown in any of the two panes of the main
window, will be immediately update to reflect the new setting.

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Saving and printing the ASSR test
Once you’re done with each test run toward the patient’s auditive threshold, S2R-X will have
computed the corresponding audiogram. To save the test for later recall, press the Save button on the
main window. When you save the test, the current view in the upper pane will be used as a preview for
the entire test to be shown in the LAP spreadsheet of test.

To print the audiogram, just press the  button in the main window.

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