ComLink2 Driver

The device, decocare, is a comlink2 driver, a software library, which implements methods and functions to facilitate communication between Paradigm-compatible RF devices and data management application software using the Carelink USB stick from Medtronic (MMT-7305NA).

Device Description

decocare - the library

Decocare is the name of a python package, a re-usable suite of python source modules, which implements functions and methods to encode and decode messages compatible with the ComLink2 protocol used by the MMT-7305NA Carelink USB stick.

Usage

The library allows authors of python source code to write methods needed to implement data management software. In order to use the library, authors need to download the python package, configure their local system to use the module, write new python source code implementing the desired remote management features, then execute their newly written source.

The library contains a listing of different messages, commercially supported by Medtronic, allowing data management software to remotely communicate with compatible devices. The messages, and the list of messages made available by the library is intended to correspond directly to the list of messages currently in use by Medtronic products.

Dissemination

The source code is distributed using git, a version control system, ensuring that changes or versions of the source code are kept in sync.

A user must know how to configure and use python modules and git in order to install the software on a local PC.

The git repo, is hosted online https://github.com/bewest/decoding-carelink available as an educational resource for discussing potential applications of remote management software.

Installing

In order to run the software, the source must be retrieved, deployed and configured to run on a PC. Currently the user must know how to perform these steps, the easiest way is on the commandline:

git clone https://github.com/bewest/decoding-carelink.git

cd decoding-carelink

sudo python setup.py install

mm-* tools, investigational tools

Another set of devices are tools showing example usage of the library, and tools to investigate how the library and the serial protocol are used to communicate with the remote equipment work.

These tools facilitate use of the decocare library to exchange messages with the usb stick, to audit the operation of the usb stick, as well as to exchange and record messages with remote RF equipment for debugging and analysis.

After configuring and installing the tool, these tools allow initializing RF communications with compatible devices, exchanging a series of predefined or customized commands, and saving the results for later perusal.

These tools support communicating with remote Paradigm-compatible equipment using commands supported by Medtronic in other commercial products, in exactly the same way as those products, from the command line, shell environment. The following options allow users to control how remote equipment is uniquey addressed or distinguished from other compatible devices, and how communication begins.

--init

Send remote signal to initialize RF communication.

--serial

Only communicates with the remote equipment responding to this serial number. This matches the number, I.E. on the back of Medtronic insulin pumps.

mm-send-comm.py allows sending or customizing commands Medtronic intends to support using their own software and devices.

mm-latest.py Example showing construction of data management software using the Carelink usb and protocol. Uses same commands as Carelink in a demonstration to query the given minutes of history and pump activity.

c. Device Description

Please provide sufficient information regarding the device description, 25 which may include:

• pictures of the device (where applicable);
• engineering drawings (where applicable);
• physical, chemical and/or biological processes/principles used by the device to generate device output, if applicable;
• physical and biological characteristics of the device output, if applicable;
• samples to demonstrate the use of the device (where feasible and appropriate);
• explanation of the user interface and/or how the device interacts with other devices or with the user (medical professional and/or patient);
• explanation of the materials used in the device;
• a brief explanation of how the device is manufactured (where necessary);
• discussion of the mechanism of action and how the device and/or, if applicable, device output is used;
• for an IVD, detailed technical description of your device including instruments, reagents, components, software, principles of operation, and accessories (if there are changes to a previously cleared or approved device, then you should describe these changes);
• discussion of the scientific basis for development of the device or an explanation of expected clinical utility; and
• for a device to be submitted in a 510(k), any anticipated predicate and a descriptive comparison of the device to the predicate device.

In addition to pictures and a written description, other information about the clinical use of the device, such as a surgical technique guide or video of how the device is used in the clinical setting, may be helpful.26