Overview

This document describes the functional & non-functional requirements and design specifications for the GE DINAMAP interface with ClinSpark.

ClinSpark can be configured to work with DINAMAP devices such that measurements can be initiated directly from the ClinSpark application and results can be transmitted to, viewed, reviewed and stored within ClinSpark.

The user is not required to add subject/patient identifiers or trial protocol information into the device and no data is required to be transcribed into ClinSpark. These processes happen securely and a clear audit trail is maintained.

Applicability

This document only applies to wired communication via COM port mechanism, using an official GE DINAMAP USB cable.

Requirements

• GE DINAMAP Models:

  • ProCare 100-400

  • Carescape V100

• GE Dinamap RS-232 / USB cable

• ClinSpark version 1.4.0 or greater

• ClinSpark Agent version 1.0 or greater

Scope

1. Functional Requirements

2. Non-functional Requirements

3. Design Specifications

Out of Scope

1. User Requirements Specification (URS) is not included. Foundry Health has reviewed the general requirements of the user community and used these to determine Functional and Non-Functional Requirements for this ClinSpark component.

2. ClinSpark Infrastructure specification (documented separately)

3. ClinSpark Architecture specification (documented separately)

4. ClinSpark Configuration Specification (documented separately)

GxP Applicability

This interface is intended for use within the context of clinical research and clinical trial activities and as such, the user is likely to be subject to applicable GCP regulations and guidelines.

System Impact

Subject/Patient Safety

The design of the interface has low impact on subject/patient safety, since the integrated devices are not impacted, altered or affected in any way.

They continue to function independently of ClinSpark and are intended to be used by qualified and trained users under the supervision of medical personnel.

Data Integrity

Testing has occurred to confirm data integrity upon transfer from the device to ClinSpark.

System Specifications

Functional Requirements

The interface is only supported on Windows operating systems and computers capable of interfacing with DINAMAP devices via the official GE Dinamap USB cable.

Non-functional Requirements

Authorization

The interface is intended to be installed and configured by qualified users.  In most pharmaceutical and associated life-science settings, this is typically governed through an Information Systems/Technology administrator or support team.

Once installed and configured, ClinSpark application users can leverage the interface through the regular use of the ClinSpark application.

Availability

It is expected that the interface be available at time of data collection through ClinSpark.  The DINAMAP device must be connected and configured successfully with the computer running the ClinSpark Agent and ClinSpark application, operating in a functional state.

Maintainability

The interface is reliant on the use of the GE Dinamap USB cable and DINAMAP serial DB15 accessory host port, via RS-232 communication protocol.  GE may continue to develop current and new DINAMAP products to utilize the Serial DB15 and USB interface.  Foundry Health will maintain the interface through DINAMAP devices changes that support RS-232, where applicable.

The end user is not able to conduct maintenance activities.

Design Specifications

The interface is established using the following:

• GE DINAMAP ProCare 100-400 / Carescape V100

• Official GE DINAMAP USB cable

• Computing devices running ClinSpark and the ClinSpark agent

The interface streams the output of the DINAMAP device via a COM port established with the RS-232 interface; no commands are necessary.

Assumptions/Restrictions

The DINAMAP and RS-232 (COM) connection must be connected and configured successfully with the computer running the ClinSpark Agent and ClinSpark application, operating in a functional state.  

ClinSpark Agent Component

The device interface requires a specific ClinSpark Agent version (shown at the top of this document).  This can be enforced in ClinSpark General Settings by specifying the minimum required agent version here:

ClinSpark Configuration

All configuration options have sensible defaults built into the ClinSpark Agent, and thus is is not anticipated under normal circumstances that any further server-side configuration will be required.

Here are the options for this device as seen from the ClinSpark UI:

Data

Configuration Parameters

Connectivity

COM Port Settings

• Baud Rate: 9600

• Data Bits: 8

• Stop Bits: 1

• Parity: none

• Flow control: none

Notes

Programming guide attached:

Default Baud Rate: 9600

Baud Rate can be changed through API

Leading spaces in the commands are important

Commands With Checksums Associated

Negative Acknowledge Codes

The following are response codes that can occur from the device when data cannot be read. Most notably, if the interface requests Pulse Ox data and the parameter is not supported, a ‘-5’ response will be given.

SPO2

The Dinamap interface requires interfacing with a DLL provided by GE name DinaWin.dll. This low-level interface allows for obtaining XML from the firmware of the device. SPO2 is stored as an XML element. The ClinSpark agent will look for a Result element with a name attribute with the following value: Oxygen_saturation. When / if found, the agent will return the value found in the Value XML element.

SPO2 XML Details

The following is a screenshot from GE’s interface guide.

ClinSpark User Interface

The DINAMAP stores test results in memory, and thus the interface takes great care to ensure that results that are obtained are done so within the context of the full workflow.

1. 

   Instructions - driven by DialogInstructions setting; logic in place if the user would like to ‘AutoInvoke’ (described in configuration parameters below)

2. If unchecked, only temperature and SPO2 are attempted when obtaining results; performing a temperature is required, but SPO2 is optional

3. COM ports available in user’s operating system; defaults to last used COM port

4. Initiates the process to obtain results; note: if ‘AutoInvoke’ is active, the button will not be present

Workflow

1. Initiate process by clicking ‘Invoke Device’, or if ClinSpark is configured to require a device barcode scan, the user must scan the DINAMAP barcode (or enter it if a scanner is not available)

2. If the AutoInvoke setting is ‘Yes’, the ‘OK’ button is hidden and the interface attempts to obtain values; the setting waits 3 seconds before performing the equivalent of clicking the ‘OK’ button. The 3 seconds allows the user to possibly uncheck the blood pressure item.

3. When either triggering ‘OK’ by way of user click or AutoInvoke, the interface determines if communication can be made to the device (*A command); if a connection cannot be made the user receives an error message

4. Assuming a connection can be made and not performing AutoInvoke, the ‘OK’ button is disabled

5. The time in which the tests are initiated is stored in memory; this timing variable will be used later to ascertain that results from the DINAMAP are valid.

6. If the ‘Obtain Blood Pressure’ checkbox is checked, the DINAMAP will begin inflating the cuff (NC0 command)

7. Since performing a test is an indeterminate amount of time, a poller thread begins with a sleep interval between cycles at 1 second; the poll cycle can be broken by clicking the ‘X’ in the upper right hand corner of the user interface widget

8. If the Obtain Blood Pressure option is chosen, BP results are obtained (NA command). The following values are obtained from the command:

   1. The number of seconds in which of elapsed since the last BP test

   2. Systolic

   3. Diastolic

   4. MAP

9. If the number of seconds that have elapsed from the BP call is less than the amount of time elapsed since step #5, the results are considered valid; if not another poll cycle will be initiated until results related to the test in question are available

10. Regardless of the Obtain Blood Pressure option, an attempt to obtain the temperature is made (TC command to obtain elapsed seconds and TD command to obtain the results as shown on the device regardless of how units are configured) and, like blood pressure, the number of elapsed seconds is inspected to see if the results are related to the test in question

11. Assuming step #9 (or #10 if Obtain Blood Pressure is unchecked) is valid, the RATE (RA command) and SPO2 (OA command) are read

12. With the measurements, return them from the agent to be populated in the form by ClinSpark

Countdown Timers

Two settings can be established at device/form level to include the countdown timer capability. This is only supported when using Agent version 22.1 or higher.

• TimerSeconds - this value sets the timer length. No default is present; customers must define this default value through form design.

• AutoInvoke - when timer is set, and this value is set to ‘Yes’, the countdown will start automatically when the device is invoked.

TimerSeconds

This parameter should have a default value established, so when the form is used, that value is used as part of the timer.

AutoInvoke

If this parameter exists on a form and the default item value is ‘Yes’, the Start button on the Agent window will automatically be selected for users when the device is invoked.

Error States

No Values Transmitted

In a scenario where values are not being transmitted from the device to ClinSpark, before clicking ‘Invoke Device’, check the physical connections between GE DINAMAP and the USB cable. 

Troubleshooting Windows Driver Issues

PL-2303 Chipset

GE manufactured and distributed several versions of their USB cable using the Prolific PL2303 serial bridge USB chipset.  Prolific released several revisions of the chipsets indicated by a Rev A, Rev B, etc. Additionally, each chipset is embedded with a ‘chip version’ which can be read out using a free utility provided by Prolific. GE used multiple variations of the PL2303 chipsets over the lifetime of these cables, ending with a version compatible with the latest version of Windows at that time (presumably, Windows 7).

There are no clear markings or distinctions on the cables to indicate the exact chipset is in use, or, which version of the digitally signed drivers are appropriate for each cable. However using the chip version utility, you can figure out what chip is being invoked and the version of that chip.

PL2303_CheckChipVersion_v1006.zip

Through internal testing and customer feedback we’ve confirmed so far that the GE cables used one of these PL2303 chipset revisions:

• PL2303 X

• PL2303 XA

• PL2303 HXA

• PL2303 HXD

Windows Drivers

GE developed and distributed officially signed Windows drivers to enable COM port communications with the DINAMAP devices. It is assumed that using the official GE drivers, distributed by GE, will have the highest chance for successful communication with DINAMAP devices due to their backwards compatibility through the XA and HXA chipsets. However, since the GE USB cables do not all share the same PL2303 chipsets, they also may not utilize the same drivers.

Windows operating systems by default will do their best to serve up users the appropriately matched drivers to the recognized PL2303 chipset using digitally signed OEM drivers from Prolific. These OEM drivers do not guarantee successful communication with the USB cable.

Through variations in local testing and customer feedback, we have determined the following:

• The latest Prolific OEM drivers sometimes work with older generation PL2303 X chipsets.

• The latest GE drivers always work with newer cables containing PL2303 X/XA/HXA chipsets.

• The GE build 10523 drivers do NOT work with PL2303 HXD chipsets running chipset version 1.20.0.

Foundry Health recommends that customers try using alternate drivers if they experience communication issues.

Official Prolific PL2303 chipset drivers can be downloaded from their official website: http://www.prolific.com.tw/US/ShowProduct.aspx?p_id=225&pcid=41

The following PL2303 chipsets are officially supported through Windows 10 via OEM drivers, digitally signed and distributed officially via Windows Update:

• PL2303 HXD

• PL2303 HXA

• PL2303 XA

Alternately, customers can try to use the following GE driver: