IFU-USB-CDPC-01-EN

USB-CDPC-01

2023 - SEP 29

English

USB Clinical Data Port Cable (Serial via USB Cable) - Instructions For Use (IFU)

USB to USB cable for direct real-time transfer of RDT data from iaX to PC

iaX

USB-CDPC Cable

Win / Mac / Linux

Intended Use

The USB CDP Cable is intended for use by laboratory personnel, scientists, developers and engineers working on or with Rapid Diagnostic Tests (RDTs). Use cases range from characterizing the clinical performance and responsiveness of an RDT to monitoring the quality and consistency of RDTs in a production environment. Lastly, the USB CDP Cable can be used in laboratory research settings where sensitive data that cannot be shared through a network needs to be collected and analyzed in a highly secure controlled contained environment.

Overview

The USB Clinical Data Port (CDP) Cable is a device that allows you to collect and transfer data from the iaX-2101 universal Rapid Diagnostic Test (RDT) reader in real time, and save it to a computer or laptop, which is useful for on-boarding new RDTs, clinical studies and trials, manufacturing quality control, validation, etc.

Device Description

The USB CDP Cable is a small, portable device that connects to the USB Type A port of the iaX-2101 Universal reader and to a computer or laptop. The USB CDP Cable is reversible, meaning either end of the cable can be connected to either port.

Important:

Contraindications

The USB CDP Cable is not contraindicated for any specific user population or condition.

Warnings and Precautions

Do not use the USB CDP Cable in wet or humid conditions. Do not use the USB CDP Cable if it is damaged. Do not open or disassemble the USB CDP Cable.

Adverse Events

The USB CDP is a low voltage low power computer accessory that is not intended or configured for use on patients directly or indirectly, and is not a medical device. Thus, no adverse events are expected or possible. Use this link to report any anomalies:
https://assaya.com/ae

iaX Instructions for Use

Please visit: https://assaya.com/ifu-iax2101 for full instructions on how to operate the iaX-2101 device.

Instructions for Use

1. Connect one end of the USB CDP Cable to the USB Type A port of the iaX-2101 Universal reader. Plug the other end to a computer or laptop running Windows, Mac, or Linux/Ubuntu. It does not matter which end of the cable goes into the device.

2. Download a Serial port terminal program such as Putty or TeraTerm. Putty can be downloaded from here: https://the.earth.li/~sgtatham/putty/latest/w64/putty-64bit-0.79-installer.msi

3. Make note of the COM#. For example your computer may say: Prolific USB-to-Serial Comm Port (COM3) is set up and ready to go. You can also find this by going to Device Manager in your applications and looking under ‘Ports (COM & LPT)’.

4. Open Putty. Select ‘Serial’ under Connection Type. In the serial line, type the COM# of your cable (i.e. COM3). The Speed is important and must be set to 115200.

5. Go to Session, Logging, and select ‘All session output’. Unselect ‘Include Header’.Then click ‘Browse’. Choose the location of where the data files will go. For file name, type ‘TestName_&Y&M&D&T.csv’ (i.e. HIV_&Y&M&D&T.csv). This will generate a date code for each data session. Then select ‘Open’.

6. Begin reading tests with the iaX device. Putty must remain open throughout the entire data collection session.

The data from the iaX will appear in chunks of data every time an RDT is inserted into and read by the reader.
Data will appear in a text format one line at a time, and one line for every read.
The text data is separated by tab-characters, and terminated by a “EOL\r\n” character string, which marks the end of the line.

7. When you are done with your data collection session, select the Putty icon in the top left corner and press Change Settings. Under Saved Sessions, type what you would like to name the session (i.e. HIV Data). Select Apply, and then close Putty.

8. Go to the location where you previously selected the data to be saved to view the CSV file (i.e. HIV_20230927215102.csv). Open the file in Excel, or another spreadsheet application of your choice. Under Separator Options, only have ‘Tab” selected. Then Open.

9. Label the Data Headings as shown in the image. The following columns are included in the data file:

Date: The date and time of the read. Device ID: The unique identifier of the iaX reader. Test ID: The unique identifier of the RDT that was read. Result: The result of the read (positive, negative, invalid, etc.). Signal: The signal strength of the read.
Data Headings: Time, Barcode Number, Test Type, Result, CTH (Control Threshold), C1 (Control Line 1 Relative Intensity), TH1 (Test Line 1 Threshold), T1 (Test Line 1 Relative Intensity), T1 Unit, T1 QU (Test Line 1 Quantitative Units), TH2, T2, T2 Unit, T2 QU, TH3, T3, T3 Unit, T3 QU, TH4, T4, T4 Unit, T4 QU, Device Serial, Software Version, End of Line.

10. Select File, Save As…, and save the file in the format of your choice depending on the application you are using.

Troubleshooting

If you are having trouble collecting data from the iaX using the USB CDP Cable, try the following:

Make sure that the USB CDP Cable is properly connected to the iaX reader and to the computer or laptop.
Make sure that the correct serial port is selected in the Serial port terminal program.
Make sure that the baud rate (speed) is configured to 115200 in the Serial port terminal program.
Try restarting the iaX reader and the computer or laptop.

If you are still having trouble, please contact the manufacturer of the USB CDP Cable for assistance.

Storage and Disposal

Store the USB CDP Cable in a cool, dry place. Dispose of the USB CDP Cable in accordance with local regulations.

Security and Safety

The USB Clinical Data Port (CDP) Cable is a simple USB serial cable with no network connection, no RF transmitter or receiver. This makes it a very secure way to transfer data from the iaX reader to a computer. There is no risk of the data being intercepted or hacked while it is being transferred.
The USB CDP Cable is also very easy to use. Simply connect the cable to the iaX reader and to a computer, and open a serial port terminal program. You can then start collecting data immediately.

The USB CDP Cable is a safe and secure way to transfer data from the iaX reader to a computer. It is ideal for use in clinical trials, manufacturing quality control, and other applications where sensitive data needs to be protected.

Disclaimer

The USB Clinical Data Port (CDP) Cable is a device that allows you to collect and transfer data from the iaX-2101 universal Rapid Diagnostic Test (RDT) reader in real time, and save it to a computer or laptop. The USB CDP Cable is not a medical device and is not intended to be used for the diagnosis, treatment, prevention, or cure of any disease.

The information contained in this document is provided for informational purposes only and is not intended to be a substitute for professional medical advice. You should always consult with a qualified healthcare professional before making any decisions about your health or the health of others.

The manufacturer of the USB CDP Cable makes no warranties or representations, express or implied, as to the accuracy or completeness of the information contained in this document. The manufacturer disclaims all liability for any reliance on or use of the information contained in this document.

Technical Information

The USB-CDPC-01 cable is a dual end dongle style USB Type-A to USB Type-A cable with circuit boards located at either end of the cable with the USB connectors mounted directly on the circuit board. The product is made by connecting two USB to serial data cables and criss-crossing the RX and TX lines. See the block diagram below.