Overview

This document describes the functional & non-functional requirements and design specifications for the direct RS-232 Seca scale device interface with ClinSpark.

ClinSpark can be configured to work with Seca scale 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

While Foundry Health has explored wireless connectivity for Seca scale devices, this document only applies to wired communication via COM port mechanism.

Seca has published guidance on interfacing with their devices via RS-232.

Requirements

• Seca scale with RS232 interface, such as the Seca 763

• Seca 460 RS-232 adapter

• ClinSpark version 1.X or higher

• ClinSpark Agent version 1.X or higher

Scope

• Functional Requirements

• Non-functional Requirements

• Design Specifications

Out of Scope

• 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.

• ClinSpark Infrastructure specification (documented separately)

• ClinSpark Architecture specification (documented separately)

• 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 the Seca 460 RS-232 adapter.

For most customers this is accomplished through a direct connection to an available RS-232 serial COM port. Alternately, the use of a USB to RS-232 adapter cable may also be used in combination with the Seca 460.

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 Seca 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 Seca 460 RS-232 adapter to communicate via COM port mechanism. Seca may continue to develop current and new scale products to utilize the Seca 460 RS-232 interface. Foundry Health will maintain the interface through Seca scale 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:

• Seca 460 RS-232

• Seca 763 scale

• Computing devices running ClinSpark and the ClinSpark agent

The interface streams the output of the Seca scale across a COM port established with the Seca 460 RS-232 interface; no commands are necessary.

Assumptions/Restrictions

The Seca scale and RS-232 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 via General Settings component by specifying the minimum required agent version.

ClinSpark Configuration

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

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

Open

Data

Configuration Parameters

The following parameters can be optionally configured within the ClinSpark web application.

Connectivity

COM Port Settings

• Baud Rate: 1200

• Data Bits: 8

• Stop Bits: 1

• Parity: none

Operations

Per the Seca connectivity interface, “every second a complete data block of ASCII coded bytes is transmitted… Every data block starts with STX and ends with CR, LF, ETX”. Since this interface does not require a command to be written to the COM port, it is necessary to poll and receive input. Details of how the values are obtained are as follows:

• Upon the agent frame becoming visible, a thread is spawned that queries the specified COM port every 300 ms

• The user interface will default to the last COM port used

• If results are found, they are parsed for messages

• Messages must start with STX and end with CR LF ETX

• Weight messages start with A0 or A1

• Height messages start with A4

• Upon receiving a valid height or weight measurement, the ClinSpark agent user interface is updated accordingly

• Upon the user clicking the ‘OK’ button, the agent will validate that either a height or weight has been obtained

• If no values have been obtained, the agent will raise an error message to the user

Returned Values

Note: it’s possible for the agent to return a partial result.

• WEIGHT - per the Seca configuration

• HEIGHT - per the Seca configuration

ClinSpark User Interface

Roles

The interaction of the interface is facilitated by qualified users. Typically, these are staff that are responsible for facilitating data collection activities, where a Seca scale device would be found and used.

Input Modes

Data Collection component presents the ability to invoke the interface and collect data.

Open

The following is a general overview of the interface user experience within ClinSpark.

Clicking the ‘close’ icon in the upper right will prompt the user to see if they want to exit.

1. A listing of all available COM ports on data collector computer. Values are reset each time the agent becomes visible. Will default to the last used COM port so that users don’t have to reset each invocation.

2. The height and weight user interface components will show the obtained measurements as they are available.

3. Upon clicking ‘OK’, the system will ensure that at least a height or weight has been obtained. If so, the values are returned to ClinSpark. If not, an error prompt is raised.

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, after clicking ‘Invoke Device’, check the Seca scale device. A device button/setting called ‘Data Valid’ may need to be pushed (active) to ensure proper transfer of data.