# Meeting Minutes

## Metadata

| | |
|---|---|
| Organisation | Not stated |
| Reference | Not stated |
| Meeting | T761 Eakin Healthcare Tech File SW review - SW coding changes |
| Date | Not stated |
| Duration | Not stated |
| Attendees |  |

## Objectives

Review T761 Eakin software coding changes and related technical-file dependencies for alarms, languages, versioning, electrical safety and cybersecurity.

## Executive Summary

The meeting reviewed software changes for the Eakin technical file, with alarm changes largely completed and language changes underway. Remaining work included mute-button behaviour, clinical review, debug testing, traceability for the 17 historic software changes, and possible retrospective test data. Electrical compliance testing will be completed in-house, while cybersecurity discussion focused on USB-port and GUI controls, including whether physical locks, software controls or benefit-risk rationale are appropriate.

## Key Discussion Points

| Topic | Discussion | Outcome |
|---|---|---|
| Topic 1 | Andrew has implemented and demonstrated alarm sound changes for low, medium and high priority alarms. | See discussion |
| Topic 2 | Low, medium and high priority alarm visuals have been updated with colour and LED flash behaviour. | See discussion |
| Topic 3 | The remaining alarm question is what happens to the LED flashing behaviour when the mute button is pressed. | See discussion |
| Topic 4 | A clinician mini-review of the audible alarm changes has been pushed to next week because clinical staff are unavailable. | See discussion |
| Topic 5 | Feedback from clinicians and Adil may determine whether a longer-term usability update is needed. | See discussion |
| Topic 6 | David wants to confirm which debug commands are physically visible or effective before test scripts are written. | See discussion |
| Topic 7 | The software change request has been submitted and is expected to be reviewed on Wednesday. | See discussion |
| Topic 8 | The change request covers alarm code changes, language changes and the retrospective software version change from 1.01 to 1.02. | See discussion |
| Topic 9 | A further software release will be needed after the change request work is complete. | See discussion |
| Topic 10 | The change is expected to be treated as non-significant or non-substantial through the regulatory process. | See discussion |
| Topic 11 | The 17 historic software changes from version 1.01 to 1.02 need a gap assessment to confirm what changed and whether they are visible in code. | See discussion |
| Topic 12 | If the 17 changes are not all battery-related, additional explanation or retrospective test data may be needed for traceability. | See discussion |
| Topic 13 | Electrical compliance testing is being brought in-house and is expected to complete by around 23 July in the conservative timeline. | See discussion |
| Topic 14 | Andrew has started reviewing the 60601-1 compliance document and identifying possible test gaps. | See discussion |
| Topic 15 | The additional language work can load 18 language files, but Arabic, Vietnamese and Greek may require character or font support. | See discussion |
| Topic 16 | Cybersecurity and risk discussion covered USB port access, screen access, unauthorised interference, therapy-mode changes and whether a lock, password or benefit-risk rationale is appropriate. | See discussion |
| Topic 17 | Password protection may introduce clinical usability risk if clinicians need to intervene quickly. | See discussion |
| Topic 18 | Risk scoring for third-party interference may have high severity in neonatal scenarios but low occurrence based on field experience. | See discussion |
| Topic 19 | Rebecca is updating the risk management file and has purchased standards that may inform cybersecurity and nebuliser-port assessment. | See discussion |
| Topic 20 | Fan logic and PMS/risk-management plan updates were also reviewed as part of the technical-file follow-up. | See discussion |

## Actions

| Owner | Action | Due |
|---|---|---|
| Andrew | Confirm what happens to the alarm LED flashing behaviour when the mute button is pressed. | Not stated |
| Rebecca and clinical team | Complete the clinician mini-review of the alarm sound changes next week, including any usability input from Adil. | Not stated |
| David | Send or agree further debug commands for Andrew to test against the software. | Not stated |
| Andrew | Test the additional debug commands and confirm what is physically visible or produced on screen. | Not stated |
| Rebecca | Progress the submitted change request through the Wednesday review and gather the required close-out information. | Not stated |
| David | Complete the gap assessment of the 17 changes from software version 1.01 to 1.02 and identify where they are visible in the code. | Not stated |
| Rebecca | Incorporate David's output on the 17 software changes into the design-change or technical-file summary. | Not stated |
| Andrew | Continue the electrical compliance testing review and flag any support needed from David. | Not stated |
| Andrew | Continue the additional-language update, including character or font support for Arabic, Vietnamese and Greek, and load the translated files. | Not stated |
| Rebecca | Update the risk management file with USB port and screen-interference risks and proposed controls by Wednesday. | Not stated |
| Andrew | Review David's fan-logic document and decide whether it needs to be added to Cognidocs. | Not stated |
| Rebecca | Email the purchased standards, including 81001-5-1 and 27427, for assessment. | Not stated |
| Jacqui | Follow up with Colm to review whether the 27427 standard is applicable. | Not stated |
| Jacqui | Add Rebecca to the regular Tuesday follow-up call. | Not stated |