| Table of Contents |
|---|
Overview
The Suntech Oscar 2 ABPM is a portable ambulatory blood pressure monitor designed to be worn by subjects for an extended period of time, typically 24 hours or greater, allowing users to gather continuous, interval-based data on blood pressure variations throughout the day and night. It is equipped with motion tolerance capabilities and a noise-reduced night mode, ensuring precise measurements while maintaining maximum patient comfort. Additionally, Oscar 2 devices including SyphygmoCor technology enable Central Blood Pressure Measurement capability that has been validated to inter-arterial catheter in a compact, ambulatory device.
The Suntech Oscar 2 ABPM device is interfaced with ClinSpark via the ClinSpark Agent. The interface is delivered transparently through the Clinspark core application with all device interactions taking place via ClinSpark forms. The device follows an Enroll > Collect > Upload workflow with specific ClinSpark forms for each of the required steps.
Installation
Agent 23.3 (or later) is required for the Suntech Oscar 2 device integration. All of the required software to interface with the SunTech device is included in the ClinSpark Agent Installation Package and no additional installation or software is required. The device profile must be provisioned into the target ClinSpark environment. Additionally, the asynchronous job to populate uploaded data as study data must be added to Administration > Support > Async Job Management in the target environment.
Collection Workflow & Forms
Collection of ABPM data from the SunTech Oscar 2 device follows a Device Enrollment > Recording > Data Upload workflow. Additionally, to facilitate downstream workflows in ClinSpark, uploaded data is synchronized from Volunteer Monitoring Data to Study Forms via an asynchronous job. The workflow is detailed below:
The SunTech Oscar 2 is enrolled in ClinSpark by invoking the device via an enrollment form with specific parameter / default item value pairs included to configure device behavior / programming and link the device to the study subject.
ABPM Data collection / interval-based recordings are collected for the period defined by the study protocol / setup (Note: There is a maximum of 250 recordings on the device for each upload. This is a limitation of the device hardware)
The recordings on the SunTech Oscar 2 device are uploaded to ClinSpark as Volunteer Monitoring Data by invoking the device via an upload form. Both the collected data and additional parameters included on the upload form are returned to the form and provide details about the upload (e.g. Upload Count) and additional details about the device. (e.g. Serial Number, Model Number, Firmware version, etc.)
Data uploaded via the integration and populated as Volunteer Monitoring Data is asynchronously returned to the ClinSpark associated upload form as Study Form Data.
Enrolling a Device
At the time of invocation, it is necessary to ensure a number of prerequisites are in place:
The device is powered on and connected to a ClinSpark workstation with a USB A to USB micro data cable (many common cables only provide charging capabilities and will not work).
A compatible version of ClinSpark is installed and running on the collection workstation.
The enrollment form includes the required/desired configuration parameters and has been made available for use on a Study / Activity Plan
| Info |
|---|
Device enrollment forms for the SunTech ABPM integration include both parameters captured from the device and parameters that configure device recording behavior (see https://foundryhealth.atlassian.net/wiki/spaces/DEV/pages/edit-v2/3983081473#Configuration-Parameters). |
Enrollment is initiated by invoking the device from the target study enrollment form (for details, see https://foundryhealth.atlassian.net/wiki/spaces/DEV/pages/edit-v2/3983081473#Enrollment-Form).
During enrollment, ClinSpark will confirm if there is existing ABPM data on the device. If data is found, ClinSpark will present a warning that any existing data will be deleted, then allow the user to proceed with the erase and enroll or cancel the process. As part of the enrollment process, all existing data on the device will be deleted.
Upon successful enrollment, the device is associated with the ClinSpark subject and subsequent uploads for the ClinSpark subject will be checked to ensure the device used during upload matches the enrolled device.
Collecting ABPM Data
After enrollment, the device is ready to begin the study ABPM recording period.
| Info |
|---|
Note, the device will not begin interval-based recording until it has been disconnected from the ClinSpark workstation. |
If the AUTOSTART parameter has been configured to Yes, the device will automatically start interval-based recording after 5 minutes have elapsed. Otherwise, the first recording must be manually initiated by depressing button A (start / stop button). The device will then continue to collect ABPM recordings at the defined intervals and in accordance with its enrolled configuration up to a maximum of 250 recordings.
| Note |
|---|
If there is at least 10 minutes until the next period start from the time the recording is manually initiated then the next recording will occur at the defined period start, otherwise the first interval recording will be at the next scheduled interval time. |
Uploading Collected ABPM Data
After the desired recording period has elapsed and ABPM data has been collected on the device, data can be uploaded to ClinSpark by invoking the device using an upload form configured with specific parameters (for details, see https://foundryhealth.atlassian.net/wiki/spaces/DEV/pages/edit-v2/3983081473#Upload-Form). The prerequisites for the upload process mirror those of device enrollment.
During upload, ClinSpark will check to confirm the device being used for the upload matches the current subject. If a mismatch is found, ClinSpark will warn of the mismatch and allow the user to proceed with the upload or cancel the upload process.
| Info |
|---|
All data on the device is erased after a successful upload. |
Form Design
As detailed in the description of device workflows, the SunTech ABPM device integration uses 2 forms to facilitate the enrollment and upload workflows.
Enrollment Form
The SunTech ABPM device profile includes a number of parameters that can be used on an enrollment to configure device behavior. It is not necessary to include all parameters in the enrollment form as device defaults can be used, but it is often advisable to do so (in the case that it is desirable to have a clear definition / record of the device configuration used on a study). Additionally, a number of parameters should always be included as they facilitate traceability of data sources / originators or support core functions (e.g. DEVICEID).
Required Enrollment Parameters |
|---|
DEVICEID |
MODEL |
UIFIRMWARE |
BPFIRMWARE |
DAYSTART |
DAYINTERVAL |
NIGHTSTART |
NIGHTINTERVAL |
Optional Enrollment Parameters |
|---|
BTNA |
BTNB |
BTNC |
RETRY |
DITHER |
DISPLAY |
BEEP |
MAXPRESSURE |
AUTOSCHED |
Upload Form
| Note |
|---|
To see many of the parameters necessary to build an upload form during Device Integration Form Import, the Monitoring Type on the Device Profile must be temporarily changed to the default blank value while building the form. If key parameters are not visible when importing the device integration forms, setting the Monitoring Type to the default blank value during form design will make them visible. Additionally, it is critical that the Monitoring Type be set back to Client once form design is completed for the integration to function correctly. |
SunTech integrated upload forms are composed of 2 key elements. The first part of the upload form is used during / necessary to perform the upload action and contains the parameters necessary to invoke the device and retrieve the saved ABPM records. The second part of the upload form is used to populate the individual ABPM recording records asynchronously after the upload has completed. These 2 “parts” are implemented as 2 Item Groups on the ClinSpark upload form.
The second item group is used by the asynchronous job to populate the data back to study forms once it has been uploaded to Volunteer Monitoring Data. To accommodate this workflow, the second item group on the form should be set up as a repeating item group with the “User Add” option toggled ON
Additionally, it is necessary to protect the second item group from manually initiated user entry by configuring a new role and using it to add a Role Restriction to the Item Group.
Device Profile / Parameters
Clinical Parameters
Parameter Name | Description |
|---|---|
Systolic | Systolic pressure value in mmHg |
Diastolic | Diastolic pressure value in mmHg |
MAP | Mean Arterial Pressure value in mmHg |
HR | Heart Rate value in BPM |
PP | Pulse Pressure value in mmHg. Calculated as the result of Systolic - Diastolic. |
Configuration Parameters
The following options configure device behavior during the collection period and are configured as parameters during device enrollment
Parameter Name | Description | Valid Values | Default Value |
|---|---|---|---|
BTNA | Enables / disables button A on the device (manual recording start / stop) Note: This button is always enabled for 30 minutes after enrollment to allow Study Start / first collection | Yes, No | Yes |
BTNB | Enables / disables button B on the device (toggle day / night mode) Note: Toggling this button mode does not affect day / night timing or interval programming, it only enables / disables beeps | Yes, No | Yes |
BTNC | Enables / disables button C on the device (manual recording start / stop) | Yes, No | Yes |
RETRY | Enables / disables automatic retry of failed recordings (see Error Codes section for additional detail on identifying recording failures and retried records) | Yes, No | Yes |
DITHER | Enables / disables timepoint dithering. In this mode, the device will skew recording start up to 5 minutes before or after the scheduled time. Also referred to as the standard / interval toggle Note: The dither function is only available in recording periods with DAYINTERVAL or NIGHTINTERVAL > 15 mins | Yes, No | No |
DISPLAY | Enables / disables device blinding. When DISPLAY is set to No, device will not display results after each recording | Yes, No | Yes |
BEEP | Enables / disables device beep at each recording start / end Note: This setting is only applicable to day mode - in night mode beeps are always suppressed | Yes, No | Yes |
MAXPRESSURE | Defines the maximum pressure the cuff will inflate to in mmHg | Number in NNN format (e.g. 280) | 280 |
INITPRESSURE | Defines the initial pressure the cuff will inflate to in mmHg | Number in NNN format (e.g. 160) | 160 |
AUTOSCHED | Defines whether the device should automatically start the study as configured or require a manual start (push of button A after enrollment / disconnection from PC) for the defined automatic intervals to begin | Yes, No | No |
DAYSTART | Defines the start of the day period. During this period, the device will display a sun icon on the LCD and will beep at recording start / stop (assuming BEEP is configured to Yes) | Time in 24-hr HHMM format (e.g. 0900) | n/a - required |
DAYINTERVAL | Defines the interval for day period recordings. Intervals are expressed in minutes. | 5, 10, 15, 20, 30, 45, 60, 90, 120 | n/a - required |
NIGHTSTART | Defines the start of the night period. During this period, the device will display a moon icon on the LCD and will NOT beep at recording start / stop. | Time in 24-hr HHMM format (e.g. 2100) | n/a - required |
NIGHTINTERVAL | Defines the interval for night period recordings. Intervals are expressed in minutes. | 5, 10, 15, 20, 30, 45, 60, 90, 120 | n/a - required |
Other Device Parameters
DEVICEID - Indicates the unique serial number of the device
MODEL - Indicates the device model information
UIFIRMWARE - Indicates the UI firmware version on the device
BPFIRMWARE - Indicates the blood pressure firmware version on the device
CBPFIRMWARE - Indicates the central blood pressure firmware version on the device at the time of invocation. If CBP functionality is unavailable, the static text ‘CBPERR’ will be collected.
TIMEPOINTID - Timepoint ID (item group data id) variable of timepoint where an upload occurred. This is used by the asynchronous job to populate the uploaded Volunteer Monitoring Data back to the associated ClinSpark upload form.
UPLOADCOUNT - Indicates the number of records present during an upload action
BPINDEX - Indicates the on device index in ABPM storage for a specific BP record
BPSOURCE - Indicates why the recording was started. Value can be one of or a combination of the following: Manual = 1, Dosage = 2, Scheduled = 4, Retry = 8, Other = 16 (e.g., Manual + Retry = 9, Scheduled + Retry = 12, etc.)
BPSTART - Indicates the time the recording was started
BPSTOP - Indicates the time the recording completed
BPCOMMAND - Command used to start device
BPVALID - Indicates the validity of the transmitted event. Note that for typical device collection / recording failures, validity of the event should be interpreted using BPERRORCODE.
BPBITTESTCODE - Bit test code.
BPSTATUS - Previously, this value was provided as an indicator of the status of the transmitted event. This parameter is provided with the integration, but has been deprecated by SunTech. Status should be inferred using BPVALID and BPERRORCODE instead.
BPTESTCODES - Test code associated with the transmitted event.
BPERRORCODE - Error code associated with event. This contains critical information about the failure reason for unsuccessful recordings (for details, see https://foundryhealth.atlassian.net/wiki/spaces/DEV/pages/edit-v2/3983081473#BPERRORCODE-Reference-Values-from-Suntech)
EVENTINDEX - Index in ABPM storage associated with transmitted event
EVENTCODE - Code associated with transmitted event
EVENTSUBCODE - Subcode associated with transmitted event
EVENTDATE - Date of transmitted event
EVENTLASTBPCOUNT - Indicates the count of the last BP record encountered.
EVENTDATALENGTH - Length of event data
EVENTDATA - Encoded event data from device
Data
Volunteer Monitoring Data
Upon upload, data from the SunTech ABPM device is returned to ClinSpark as Volunteer Monitoring Data and can be viewed on the Volunteer Management record
Study Form Data
Additionally, an asynchronous job polls the database for newly uploaded SunTech ABPM records and populates the data to the upload form's repeating Item Group as Study Data.
| Info |
|---|
For details of individual parameter values and their meanings, see https://foundryhealth.atlassian.net/wiki/spaces/DEV/pages/edit-v2/3983081473#Device-Profile |
Reports/Dashboards
Clinical Data Report
Transfer Data Report
Example Files
n/a
Errors / Troubleshooting
BPERRORCODE Reference Values from Suntech
Existing Data on Device During Enrollment
Uploading Data to Mismatched Subject
Notes
n/a