Arka

a Software Audiological Platform

by Horentek s.r.l.

Quick Operation Guide

Rev. 1 - 11.06.2018
EN translation 12.06.2018
 Arka – Quick operation Guide

1. Introduction ............................................................................................................................................... 3
2. Installation ................................................................................................................................................. 3
3. Log On to the Arka Platform .................................................................................................................... 3
4. Patient Archives........................................................................................................................................ 4
4.1. Insert a New Patient................................................................................................................................ 4
4.2. Patients Categories and Statistics ........................................................................................................... 5
4.3. Security Backup...................................................................................................................................... 5
5. Software Modules ...................................................................................................................................... 5

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 Arka – Quick operation Guide

1. Introduction
Arka is the Audiological platform developed by Horentek that collects the operating software modules
of its clinical instrumentation; the plug-in software included are:

- HEKTO: the software module that manages the HEKTO products line, the PC-based audiometers
- iLink: the data exchange service for the EMIXI device, the Otoacoustic Emissions Analyzer with
AABR option.

With Arka, customers can manage, from a single point of access, personal data and clinical pathways for
their patients.

The software and manuals of the equipment are supplied on CD ROM.

2. Installation
The CD provided is self installing, but the configuration of the operating system can prevent the automatic
execution. In this case, manually start the file " ArkaInst_Horentek.exe" from the CD ROM.
The installation procedure loads into the system the device drivers, which will be recognized at the first
connection.
Wait for the complete installation of the driver before connecting the device to the computer.

3. Log On to the Arka Platform

Access to Arka is based on a system of personal password-protected accounts, divided into three hierarchical
groups: "Administrators", "Doctors/Audiometrists/Hearing Care Professionals", "Nursing/Employees".
Administrators: they have full control of the software and of the accounts of the other groups. Can
enable/disable users, insert/delete new users, change passwords.
Doctors/Audiometrists/Hearing Care Professionals: have full access to the equipment and patient data.
May enter new accounts of their own group and of the group "Nurses/Employees", but cannot neither
eliminate nor enable/disable them; They can change the password of the "Nurses/Employees" group.
Nurses/Employees: they only have access to patient personal data, not to health (sensitive) data.

It is advised not to add new accounts in the Administrators group, but to use the two alternative groups.
The first access to the platform must be done with the administrator account:

User: Admin
Password: 01234567

The passwords for all your accounts expires after 6 months, the users/admins must renew their own password
every six months; the software remembers each user the need to renew the password at the end of the fifth
month of validity.

The non-renewal of the password will disable the account.

Contact your system administrator to reactivate a disabled account.

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4. Patients Archives
The archive is the data structure where Arka stores and retains both the personal data of patients and the
examinations done. The software can handle a virtually indefinite number of archives.
The software is provided with a sample file named "SAMPLE_Archive" containing a test patient and some
examples.
We suggest you to use this sample file to familiarize yourself with the functions of the software.

When uninstalling the Arka Platform, the archive sample is removed.

Do not store in the sample archive patients or exams.

In accordance with the Italian law no. 196/2003, the archives are protected by encryption, so only users with
a password can access the data of the patients, according to the privileges associated with their account.
Archives can be created, viewed and deleted permanently from any user that can access the platform and
whose account is active.

4.1 . Insert a new patient

In order to run tests on a new patient, you must register "Name", "Last Name" and "Date of Birth" of the
patient; saving personal data is automatic, just press the button "Yes" to the request of the software "Save the
changed data?".

Caution: Deleting a patient will permanently erase all his exams too.
Deleting an exam is always irreversible and occurs without requiring confirmation

Among the fields prepared to gather patient information you can find general records, such as:
date and place of birth, profession, full address of residence, phone number and e-mail, code of the Health
Card (SSN) as an alternative to the tax code.
Also available are clinical fields as: "History" and "Diagnosis / Prescriptions", where you can enter a text of
greater length to describe the patients’ medical history and their therapeutic-diagnostic indications.

Please note the information specifically designed for the management of infants undergoing newborn hearing
screening; for this purpose, the patient registry field presents, in the upper right box with dropdown menu
"Screening Stage" and the boxes "DX", "SX".

The boxes show:

- the newborn screening phase
- the result of the last screening test (TEOAE,DPOAE or AABR) on both ears of the newborn; the green flag
(
) means PASS, the red cross () means REFER.
The question mark (
) means NOT DEFINED: there is not any screening exam from which to retrieve the
information.

The PASS or REFER information is automatically updated by the software when you download to the PC
the exams, OAE or AABR, done with the Emixi. The test done with Emixi come with the Pass/
Refer

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information, and test ear and Screening Phase, together with the “Code”1 field of the patient demographic, if
entered by the operator before running the test.

In this way information is collected that Arka can use to print reports of screening described in the section
"Categories patients and Statistics".

Boxes of personal information file dedicated to the outcome of the screening test may be updated manually
with a simple click of the mouse. Repeated clicking on each cell involve the cyclical passage through the
three states described above: PASS, REFER and NOT DEFINED.
Although this does not alter the outcome of any screening test is recommended to be careful not to
inadvertently change these indications2.

4.2. Statistics and Patient Categories

On each archive you can perform statistics and print reports by different criteria; the analysis can be further
customized using the definition of specific "categories" of patients.
Categories can be defined by the users according to their classification criteria; each patient must then be
associated with a category during registration of personal data.

The categories can be added at any time. The elimination of a category associated with at least one patient is
inhibited until the patient remains associated.
In the sample archive is proposed a list of four categories.
The "Patients Categories" page shows the number of patients associated with each category.

We highlights the particular usefulness of statistics designed to give support to neonatal hearing screening;
with a few clicks and the collection of the personal data of the patients, you can have reports that summarize:

1. The total of the tested patients

2. The number of patients examined at each stage of the screening (on a screening model in three
stages)
3. The number of patients PASS, REFER and not yet re-examined (probable MISSED) for each phase
4. The number of refer unilateral (with specific indication of the side) or bilateral

It is also possible to print all the names of “REFER” patients or “MISSED” and apply additional filters to the
period of birth, the screening stage or category.

4.3. Safety Backup

Arka does not store backup copies of the archives; for this reason, we suggest that you periodically make a
safety copy of all patients’ records.
To do this, go to the program installation folder in "C: \ Arka \" (where C: is the drive letter of your hard disk
system) and copy the entire folder "Archives" that contains all its files platform.

5. Software Modules
The access mode to the instrumentation is common to all modules.

1
Refer to the Emixi device manual to know the constraints of the field "code" used in the device for otoacoustic emission and A-
ABR.
2
The ability to manually change the condition on the data sheet, reflects the need to update the patient's condition even after
audiological evaluation of the third phase of the protocol of neonatal hearing screening.

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The exams are divided according to the instrument required and are grouped under the tabs "Audiometries",
"Timpanometries", "OAEs", etc.
After Selecting the tab of interest, you will have the full range of tests that the equipment can perform.
It is possible to preview the exams, if test is available, even without opening the module software
management tool; in this way you can have a quick overview of the patient situation.
It is possible to analyze in detail the individual exam, in its module software, with a double click on its
preview.
Click on "New examination" to run a new test, this will open the module of the instrument required3.

For all informations regarding the individual modules, refer to the user manual received with the equipment.

3
The message "required module not available" indicates that an attempt was made to perform an examination that is not available on
the ordered configuration.

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