SECA EMR Flash 101

Overview

This document describes the functional & non-functional requirements and design specifications for the Seca Scale EMR Flash 101 HL7 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 wirelessly 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 automatically.

Applicability

This document only applies to wireless communication with Seca scale devices using the Seca EMR Flash 101 software connectivity. Separate documentation covers the RS-232 COM interface.

Seca has published guidance on interfacing with their devices via EMR Flash 101 software on their website.

Requirements

The interface requires the following:

• A wireless capable Seca scale compatible with their ‘360 wireless’ technology

• PC connected to the Seca 456 wireless USB adapter

• PC with Seca EMR Flash 101 software and HL7 connector installed

• ClinSpark Agent version 1.1.0 or higher

• ClinSpark version 1.4.0 or higher

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.

Demonstration

The following screencast demonstrates the installation, configuration, and use of the Seca EMR Flash 101 interface in ClinSpark.

System Specifications

Functional Requirements

The interface is supported on all systems capable of meeting the requirements noted above to access and use ClinSpark / Seca technologies.

• Supports the configuration of EMR Flash 101 Seca scale device parameters via ClinSpark.

• Supports the use of standard connected device height/weight forms including an ‘Invoke device’ button to manage the data collection workflow.

• Supports the ability to send orders HL7 on a socket connection via ClinSpark Agent and receive HL7 responses from EMR Flash 101 software.

• Supports the ability to open the Seca software interface and pre-fill subject demographics and study details from ClinSpark.

• Supports the ability to collected height/weight results from Seca software and send to ClinSpark. The results will be parsed and will be used to fill the ClinSpark form.

• Supports the ability to ensure that height and weight unit of measurement match between Seca software and ClinSpark form design.

• Supports the ability to notify users under conditions where ClinSpark cannot detect and launch the Seca software on local data collection PC.

• Supports the ability to notify users under conditions where demographics have been changed in Seca software and are unable to passed into ClinSpark.

• Supports the ability to notify users under conditions where users are unable to successfully complete the order workflow in Seca software.

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 hardware and software made available to Foundry Health and their customers. It is to be expected that Seca continue to develop and support their products, and additional capabilities brought to market.

Foundry Health will maintain the interface as the Seca wireless technology is still supported, where applicable.

The end user is not able to conduct maintenance activities.

Design Specifications

The interface is established using Seca EMR Flash 101 software configured with the HL7 module. The Seca software on data collection PCs can further be integrated with the Sece scale devices via wireless mechanisms such as the Seca 456 USB adapter.

Assumptions/Restrictions

End users are responsible for the setup and configuration of their own Seca devices and PCs running the Seca EMR Flash 101 software.  End users are encouraged to work with Seca on their own setup and configuration parameters of the Seca software and hardware prior to the use of the interface in ClinSpark.

ClinSpark Configuration

General Settings

‘Device’ and ‘Direct Device Interface’ settings must be enabled for the interface to function. These settings are managed by Foundry Health ‘superadmin’ users.

Open

Device Settings

The interface relies on the presence of the ‘EMR Flash 101’ EDC device configuration profile within ClinSpark. If this configuration is not present, Foundry Health ‘superadmin’ users can establish the device details and parameters upon site request.

Open

Device Integration Form

A device integration form using the Seca EMR Flash 101 device must be setup and appropriately configured in ClinSpark.  The sensible defaults that are established using the global device configuration will typically be sufficient for most sites.

Seca EMR Flash 101 Configuration

General Configuration

The EMR Flash 101 software and accompanying HL7 module can be downloaded from the Seca support website. https://www.seca.com/en_us/support/software-download.html

Once installed, the EMR Flash 101 software must be launched and running for the interface to work. Users can verify that the software is active by confirming the presence of the SECA icon in the system tray.

Various configuration settings of the software can be accessed via the configuration menu.

Users may be prompted to provide a password to save configuration items in the EMR Flash 101 software. This password protects the configuration from unauthorized changes/use. Sites should confirm with their local administrators and/or IT departments as to what the password protected value of the software should be. Note: this password is entirely independent from ClinSpark and is not something Foundry Health can assist with.

Height and Weight Units

It will be important to ensure that the ClinSpark form items and Seca EMR configurations use the same units of measure. If these do not match, there is a possibility that values will not transmit properly between the Seca software and ClinSpark.

Using Height in Centimeters

By default, the Seca interface supports the use meters (m) as the unit of measure for height values transmitted by the HL7. Since the Seca software does not natively support the ability to configure and use height in centimeters, a configuration update in ClinSpark can instead be used to pass along the collected height value into the forms as centimeters.

Support for this parameter requires the use of ClinSpark Agent 1.5.0 or greater.

Within the Device Details in ClinSpark, a ‘superadmin’ user can add a device a setting key called ‘HEIGHTUNITS’, with the setting value of ‘cm’.

Additionally, the device parameters for HEIGHT need to be updated to clarify the description and proper measurement unit to support the Item value in centimeters.

Once these changes are made, connected forms that utilize the device profile will now ensure that the value collected for Height is passed along in centimeters, even though the Seca interface will report it as meters.

HL7 Module

The HL7 module must be configured within the EMR Flash 101 software in order for the interface to function.

Within the configuration menu, users can ‘add’ the module.

In the open dialogue, users should select the ‘HL7.sem’ file downloaded from the Seca website.

Once added, users need to verify the configuration. Clicking on the ‘Configure’ button will prompt users to save the current configuration, and then verify the default values.

The ‘Configure HL7 module’ screen should display the following default values:

These values are expected by the ClinSpark Agent as part of the interface in order to properly communicate and exchange HL7 messages between the site PC and ClinSpark. Modification of these values is not recommended.

Data Exchange

Message Exchange Workflow

1. A socket connection will be initiated via ClinSpark, through the ClinSpark Agent, to Seca EMR Flash 101 software.

2. Assuming a socket connection can be made, an HL7 order will be sent to the Seca software.

3. Upon receipt of the order, the Seca user interface will ‘screen pop’ and pre-fill demographics / study information sent from ClinSpark.

4. Additional order values, such as height and weight, are collected via Seca software.

5. User will click ‘send to EMR’, and Seca will then send the ClinSpark agent an HL7 message with the updated order results.

6. The height and weight values in order results will be parsed by ClinSpark and will be used to fill the data collection form.

ClinSpark User Interface

The following describes typical use of the interface in ClinSpark, assuming that all previously noted configurations are in place.

Roles

The interaction of the interface is facilitated by qualified users.  These users must have access to the Data Collection module and permissions to initiate the ‘invoke device’ workflow on applicable forms.

Input Modes

Users will click ‘Invoke Device’ button via Data Collection workflow.

The Seca Flash EMR 101 software will launch automatically, and pre-fill subject demographic and study details sent from ClinSpark.

Users will use EMR Flash 101 software to collect height/weight values.

Once complete, users will click ‘send to EMR’ button.

The EMR Flash 101 software will send the order to ClinSpark and minimize to system tray.

Users in ClinSpark would click the ‘OK’ button on the information modal to confirm that the order process is complete.

Height and weight values captured in the EMR Flash 101 software will now be present in the data collection form.

Error conditions

1. The Seca EMR 101 software is not running - a prompt is shown to the user saying, “​Cannot connect to Seca EMR software. Please ensure it is installed and running.​”

2. The user changes demographics in the Seca software from what ClinSpark passed it - a prompt is shown to the user saying, “​The demographics from Seca have changed. Please reacquire.​”

3. The user does not fully complete the acquisition workflow in Seca - a prompt is shown to the user saying, “​The results were not acquired from Seca. Please reacquire.​”