Alere Technologies GmbH

Löbstedter Straße 103-105

07749 Jena,
Germany

Alere™ Connectivity Pack III

Configuration Guide for Pima™ Analyser

Release date: 19-Mar-13

The information contained in this document is intended to guide Service and Repair activities.

For internal use only. Do not hand out to customers.

CCG-PIMA-02-01-EN
 AlereTM Connectivity Pack III Configuration Guide for PimaTM Analyser

Revision Notification

The following changes have been made compared to the previous version of this document.

Rev. 01: initial version

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Accessories and Information required:

Alere Connectivity Pack III - Annex to Pima Analyser User Guide (AN-02-UG-PIMA-01-xx)

Alere Connectivity Pack III

Account data of Local Service (FTP Server)

For preparation of Configuration Files:

USB memory stick to copy data to the instrument

Example configuration files, provided by Alere Technologies as compressed zip file on CD.

Microsoft XML Notepad 2007 or higher to edit configuration files (available on CD or to download Microsoft
XML Notepad please logon to www.microsoft.com/en-us/download to access the Microsoft Download
Center. Then enter “xml notepad” in the search field of the site and follow the download instructions).

PC running with Windows XP or higher

CAUTION: To protect Pima Analyser from viruses, use a designated USB stick just for software installations.
Scan your USB stick regularly with the latest update of your virus detection software installed on your PC.

DISCLAIMER: As long as not otherwise specifically agreed Alere Technologies GmbH is not responsible for
providing, configuring, maintaining and validating connectivity services that includes FTP server hardware
and further processing of result data.

Acronyms:

CSV Comma-Separated Values

FTP File Transfer Protocol
IP Internet Protocol
MD5 Message-Digest Algorithm 5
LAN Local Area Network
TCP Transmission Control Protocol
TXT Extension for Text Files
USB Universal Serial Bus
XML Common standard base syntax for data description languages
ZIP File format for data compression and archiving

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Content

1 General Description and Requirements ............................................................................................... 5

1.1 Alere Connectivity Pack III .................................................................................................................... 5

1.2 Local Area Network .............................................................................................................................. 5

1.3 Local Service (FTP server) .................................................................................................................... 6

1.4 File Data Format, Upload and Verification Process .............................................................................. 6

1.5 File Sizes and Data Traffic .................................................................................................................... 6

2 Create a Configuration File - General Procedure.................................................................................. 7

2.1 Create File for Local Service Provider ................................................................................................... 8

2.2 Create File for Access Restriction ......................................................................................................... 8

3 Error Message and Troubleshooting regarding Connectivity ............................................................... 9

4 CSV File Content and Data Columns Definitions .................................................................................. 9

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1 General Description and Requirements

This guide is used to enable the usage of the Alere Connectivity Pack III together with the Alere PimaTM CD4
Analyser or the AlereTM CD4 Analyzer, hereafter called Pima Analyser.
Please also refer to Alere Connectivity Pack III - Annex to Pima Analyser User Guide (AN-02-UG-PIMA-01-xx)
when performing the configuration steps. Pima Analyser operating software version 0.40.0 or higher is
required to use Alere Connectivity Pack III. Alere Connectivity Pack III enables sending of result data from
the archive of the Pima Analyser to a defined remote FTP server using a Local Area Network (LAN)
connected to the Pima Analyser via USB adapter. Connection between the Pima Analyser and FTP server will
be established in two stages outlined below.

Alere Connectivity Pack III

1.1 Alere Connectivity Pack III

The Alere Connectivity pack III works as an USB to LAN Adaptor is needed to establish a connection
between FTP server and Pima Analyser. All three LEDs (Red- Power, Orange- Link status, Green- Data
transfer) on the Connectivity pack III need to be illuminated.

Alere Connectivity Pack III

1. 2 Local Area Network (LAN)

Furthermore regular network cable is required to connect Alere Connectivity Pack III to FTP Server through
Local Area Network.
Requirements for the Local Area Network:
- 10Base-T/100Base-TX Ethernet (compliant to IEEE 802.3)
- IPv4 protocol
- DHCP server supporting dynamic IP address allocation
- Support for file transfer protocol (FTP)
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1. 3 Local Service (FTP server)

Local Service has to be installed with connection to the internet in order to collect the results and make
them available for remote access. Local Service acts as regular FTP server according to RFC 959.
The Local Service should be password protected.
IMPORTANT: In order to receive data from a Pima Analyser, the correct target folder needs to be available
in the root directory for the specific user of the FTP server:
The folder name for Alere Pima CD4 Analyser branded instruments is \PIMA-EXPORT.
The folder name for Alere CD4 Analyzer branded instruments is \ALERECD4-EXPORT.
Note: FTP server settings should not have restrictions in using standard FTP commands such as DELE, LIST,
PWD, and RETR. FTP server should provide sufficient quota for storing result data.

1. 4 File Data Format, Upload and Verification Process

The exported results are provided in the CSV format (comma separated values) according to RCF 4180. It is
a common used list format with extension .CSV which can be easily read or converted into every other
format for data bases.
Note: As per convention, the formats for date and time are [YYYY-MM-DD] and [HH:MM], respectively, full
stops [.] are used for float decimals.
For each assay type (CD4 assays or Bead Standard) one separate CSV file will be exported and named in the
format [device serial number]_[YYYY-MM-DD]_[HH-MM-SS]_Assay_ID_[#]_(Assay name).csv

EXAMPLE: PIMA-D-001234_2012-05-25_15-22-10_AssayID_2_(PIMA_CD4).csv
Date and time is given by the instrument at the moment of export and do not necessarily match the FTP
servers date and time, possibly located in a different time zone.
For CSV File Content and Data Columns Definitions please refer to 4 on page no. 9.
Note: Individual test results could be transferred several times in separate result files depending on use.
Upload and Verification
After file(s) upload from the Pima Analyser onto the remote server is finished, the same file(s) will be
downloaded from remote server back on the instrument and compared with the original file sent before.
If verification was successful a checksum file in the Message-Digest Algorithm 5 (md5) will be created and
uploaded onto the server as well. The md5 checksum can be used for verification of further data process
steps. Checksum files are named as the original file they belong to, but carrying the extension .md5.

Note: md5 checksum is generated according to ANSI encoding (Win1252). String is converted to an array of
bytes. Linefeed and carriage (“\r\n”) return of the result file are converted into carriage return (“\n”).
1. 5 File Sizes and Data Traffic
The file size varies depending on the amount of results included.
File File format Used when performing… File size
Result export CSV Sending results, separated files for approximately 1 kB per ten results,
each assay type minimum 1kB
Checksum files MD5 Sending results and less than 1kB
Connectivity check

EXAMPLE: Sending 200 results at once uses around 41kB in sent data.
(200 results correspond to 20kB; 20kB upload data plus 20kB download data for verification, plus 1kB
checksum file upload)
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2 Create a Configuration File - General Procedure

Up to two configuration files need to be prepared to configure the Alere Connectivity Pack III via ‹‹Local
Network››. Example files are provided by Alere Technologies. While there are no defined conventions for
file names, the following file extensions are mandatory.
iclsp Local Service Provider configuration file
iclsppw Access Restriction configuration file (optional)
Configuration files must be provided as valid XML-file.
XML file. Therefore we recommend using a special XML editor,
like XML Notepad 2007 or similar software to adapt configuration files for the Alere Connectivity Pack III.
The following description is based on a workflow using XML Notepad 2007.
Installation of XML Notepad and the example configuration files
To install XML Notepad 2007 on your computer double click on the setup file and follow the instructions.
Insert an USBB memory stick into your computer.
Create a folder onto USB memory stick named according to the instruments type:
The folder name for Alere Pima CD4 Analyser branded instruments is “Pima-Setup””.
The folder name for Alere CD4 Analyzer branded instruments is “AlereCD4-Setup”..
Unzip the example configuration files and store them in the folder just created.

Note: To upload configuration files onto the Pima Analyser it is essential to use the correct folder name.

Open Configuration Files

Start XML Notepad and open the configuration file you want to
edit from the Setup folder.

Since the extensions of the configuration files are not .xml the
file filter in the Open dialog has to be set on All files (*.*).

Edit Configuration Files

Open the whole tree view by clicking the [+] symbol will show all relevant elements.

Double click on the respective entry value at the right part of the window to change the settings.
IMPORTANT: Do not change any of the entry names in the tree view at the left side!

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Save Configuration Files

Choose ‹‹Save›› to overwrite the existing file or ‹‹Save as…›› to create a new configuration file with a
different file name. It is recommended to use unique file names, especially if creating files for several
configurations for more than one instrument. Always pay attention to use the proper file extension.

IMPORTANT: In the Save as… dialog the file filter has to be set on All files (*.*) and any standard file
extension like .xml has to be removed from file name before saving a new configuration file.

2.1 Create file for Local Service Provider

The file extension is .iclsp. Refer to 2 for opening and saving the appropriate file.
Double click to enter the values for name, server, username and password matching the local service
provider (FTP - server).

If use of Proxy Server is required then proxyHost, proxyPort, proxyUser, proxyPass data also need to be
entered in the configuration file. Contact your Network Administrator for data related to Proxy Server.
Note: These entries are case sensitive!

2.2 Create file for Access Restriction

estriction (Configuration Protection)
The file extension is .iclsppw.. Refer to 2 for opening and saving the appropriate file.

The Pima Analyser can be configured to protect Local Network feature with a password. By default, no
password is set. Password protection is optional.
op

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Double click to enter the desired password. Password has to be placed between two single quotation marks
and must contain between one and 21 characters (numbers and UPPERCASE letters only). Empty password
(empty field or two single quotation marks only) mean no password protection.

3 Error message and troubleshooting regarding Alere Connectivity Pack III

The proper function of the Alere Connectivity Pack III depends directly from the LAN connection and also
from local service.
Error Message Description Problem Solution

Sending failed Unable to send Results Check LEDs on Connectivity Pack III
Check LAN connection.
Check Configuration for Local Service.
Check FTP Server.

Unable to connect Cannot connect to proxy Check proxy server entries in Configuration file.
proxy server server
Contact your local IT personnel.

4 CSV File Content and Data Columns Definitions

File with Assay ID 2 (PIMA CD4) or Assay ID 4 (Alere CD4)

Name Data Type \ Constraints Description

Test ID Integer A none unique number for identifying single results on the
Constraint: Not empty. instrument. Test IDs will be re-used on a particular instrument after
Value: 0 < ID <1000 the related test was deleted in the instrument’s archive.

Device ID String A text identifying the device based on the serial number of the
particular instrument. This ID is globally identifying.

Assay ID Integer A number identifying a type of assay.

Constraint: Not empty.
Constraint: ID > 0
Assay Name String
Constraint: Not empty.
This ID is globally identifying the following tests
- Assay ID 2 -> Pima CD4 test
- Assay ID 4 -> Alere CD4 test
Assay name.

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Sample String, max. 21 characters. Text entered by operator while analysis.

This field might be empty.

CD3+CD4+ Integer Result value.

Value
3
[cells/mm ]
Error String The error message, shown if an error occurred.
Message
3
If this field is set (not empty), then CD3+CD4+ Value [cells/mm ]
must be ignored.

Operator String, max. 21 characters. Name of operator.

This field might be empty.

Result Date Date Format: YYYY-MM-DD Date when test was performed.

Start Time Time Format: HH:MM:SS Time when test was performed.
Barcode String Flag for barcode reading.

Values: pass, manual, fail, Value “pass” means successful reading by internal barcode reader.
empty Value “manual” means manually entered barcode.
Value “fail” means internal barcode reader unable to read barcode.

Expiry Date String Flag for expiry check.

Values: pass, fail, empty Values “pass” means a valid expiry date, “fail” not.

Volume String Flag for sample volume check.

Values: pass, fail, overruled, Value “pass” means a valid volume check.
empty Value “fail” means an abort due to incorrect volume.
Value “overruled” means incorrect volume, but continued by user.

Device String Flag for device QC.

Values: pass, fail, empty Values “pass” means valid device checks, “fail” not.
Reagent String Flag for reagent QC.

Values: pass, fail, empty Values “pass” means, valid reagent checks, “fail” not.

Software String Software version on the instrument when the particular test
Version running.

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Files with Assay ID 3 (PIMA BEADS), Assay ID 5 (Alere CD4 BEADS) or Assay ID X (Unknown)

Name Data Type \ Constraints Description

Test ID Integer A none unique number for identifying single results on the instrument.
Test IDs will be re-used on a particular instrument after the related
Constraint: Not empty. test was deleted in the instrument’s archive.

Device ID String A text identifying the device based on the serial number of the
particular instrument. This ID is globally identifying.

Assay ID Integer A number identifying a type of assay.

This ID is globally identifying the following tests

- Assay ID 3 -> Pima Bead test

- Assay ID 5 -> Alere CD4 Bead test
- This field must be empty for unknown assay type (AssayID_X)

Assay Name String Assay name. This field might be empty.

Sample String, max. 21 characters. Text entered by operator while analysis. This field might be empty.
CD3+CD4+ Integer Result value. This field might be empty.
Value
3
[cells/mm ]

Error Message String The error message, shown if an error occurred.

3
If this field is set (not empty), then CD3+CD4+ Value [cells/mm ] must
be ignored.
Operator String, max. 21 characters. Name of operator.

This field might be empty.

Result Date Date Format: YYYY-MM-DD Date when test was performed on the Pima instrument.

Start Time Time Format: HH:MM:SS Time, when test was performed on the Pima instrument.
Barcode String Flag for barcode reading.

Values: pass, manual, fail, Value “pass” means successful reading by internal barcode reader.
empty Value “manual” means manually entered barcode.
Value “fail” means internal barcode reader unable to read barcode.

Expiry Date String Flag for expiry check.

Values: pass, fail, empty Values “pass” means a valid expiry date, “fail” not.
Device String Flag for device QC.

Values: pass, fail Values “pass” means valid device checks, “fail” not.
Software String Software version on the instrument when the particular test done.
Version

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