Software & firmware versions
Fresenius Kabi is continually refining, improving and adding new functionality to the Agilia Connect infusion pumps. This comes in the form of software or firmware updates.
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Software: computer program or application that runs on a personal computer
Firmware: the embedded code that controls the device hardware
Partner Biomedical software: software that updates the firmware on a device
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The firmware version for an infusion pump is indicated on the screen when you power on the pump. An example is shown below of an Agilia SP MC infusion pump with firmware version 4.1.
Below, the differences between software and firmware versions related to the infusion pumps, Vigilant Software Suite and Partner Biomedical software are explained.​
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When a new software version is available for, or applied to, your existing Agilia Connect infusion pumps or Vigilant Software Suite system it is the responsibility of the hospital and its related team to evaluate any workflow or clinical impact as a result of any changes.
This is due to the unique way in which each hospital uses the Agilia Connect infusion pumps and has setup their drug libraries if this feature is used.
Firmware v4.1
General letter on progressive upgrade to v4.1
Moving from firmware version:
2.2c to 2.2f (Agilia VP MC) & 2.2 to 2.2d (Agilia SP MC & Agilia SP TIVA)
Date of introduction: March 2021
Devices: Agilia SP MC & Agilia SP TIVA
Change: Correct display of Dose/Time menu title instead of saving Volume/Time
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Dose/Time infusion mode screen heading and icon is replaced by the Volume/Time heading and icon when programming an infusion.
Despite the incorrect heading and icon, the parameters for Dose/Time infusion mode programming are correctly displayed as shown below.
Devices: Agilia VP MC, Agilia SP MC & Agilia SP TIVA
Change: Incorrect display of scroll arrows in some menus
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Arrows in scroll bar do not have the right design in all menus. Arrows should be white or blue depending on the fact that items are available or not below or above the list visible on the screen.
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After the change the scroll bar arrows display always matches the defined rule.
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Devices: Agilia SP MC & Agilia SP TIVA
Change: IEC 60601-1-8 no bell icon for some alarms
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Correction of some alarm screens on which no bell icon is displayed when the alarm is muted. It has been observed for "remove completely syringe" alarm.
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This brings the behaviour in line with IEC 60601-1-8.
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Devices: Agilia VP MC, Agilia SP MC & Agilia SP TIVA
Change: IEC 60601-1-8 flashing signal for low priority alarms
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Correction of an inconsistency for some low priority alarms: the LED signal is flashing whereas it shall be constant.
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It has been detected for "discharged battery at start-up" alarm.
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This brings the behaviour in line with IEC 60601-1-8.
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Devices: Agilia VP MC, Agilia SP MC & Agilia SP TIVA
Change: Keyboard lock bypassed by pre-alarms
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A scenario is the keypad is locked and the user decides to open the door or change the syringe. At this moment if an alarm occurs, the message unlock keypad is not displayed.
In case this alarm is of high priority (e.g. Battery low) then the user cannot restart infusion without turning off the device.
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After the change the message Keypad lock is correctly displayed, and keypad unlock is possible.
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Device: Agilia SP TIVA
Change: Age and weight ranges of Kataria TCI protocol and paediatric effect site TCI use
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Based on a periodic literature review, it was found that the weight and age ranges allowed by the 2.2 software of the Agilia SP TIVA for Kataria TCI model (1-16 years old and 10-60kg) was not sufficient (insufficient sample size) to validate the model with the existing ranges.
New ranges for Kataria TCI are 3-11 years old and 15-60kg.
The Paedfusor model is confirmed with age ranges below the new Kataria model allowing users to use TCI with these patients and that model (1-16 years old and 5-60kg).
Furthermore, this literature review showed that the evidence for effect target modes was not sufficient in paediatric models.
The new pump software will no longer allow Effect site target using factory default settings. Both changes are intended to increase design compliance with the most recent literature review.
These changes are not intended to reduce patient risk as there is no suggestion that use will lead to an adverse event but to bring the newer software version devices in line with this recent literature review.
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It is up to the individual anaesthetist to decide which TCI model is appropriate for each patient.
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Device: Agilia VP MC
Change: KVO confirmation screen inconsistent after a high priority alarm
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Triggering conditions:
• The pump is in KVO infusion
• One high priority alarm occurs (apart from a downstream occlusion alarm),
• User silences the alarm
In this situation the pump is ready to restart the KVO. It means that if user presses Start key, KVO infusion resumes.
The screen on which user can press start is one screen which show VTBI=0, Duration=0 and previous infusion flow rate before KVO started which may be different from KVO flow rate.
Then, if user presses the START key, the KVO infusion is restarted at the previous KVO rate not at the displayed rate on the screen (previous infusion flow rate) where Start is displayed.
After the modification, the pump displays KVO screen stopped so that it is more understandable that pressing start will resume the KVO infusion.
Additionally, the modification of the KVO screen includes a replacement of VTBI=0 by existing KVO rate.
Moving from firmware version:
2.2f to 4.1 (Agilia VP MC) & 2.2d to 4.1 (Agilia SP MC & Agilia SP TIVA)
Date of introduction: May 2021
Devices: Agilia VP MC, Agilia SP MC & Agilia SP TIVA
Change: Introduction of variable dilution as a dilution option
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Variable Dilution comes in addition to previous dilution/concentration settings and is only available with the latest system version: Agilia Connect (v.4.1) and Vigilant Master Med (VSS 1.2.1).
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It gives more flexibility in the programming of the infusion with the addition of a new function to adapt to the common day to day work where physicians may work in concentration while nurses may work in dilution.
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Devices: Agilia VP MC, Agilia SP MC & Agilia SP TIVA
Change: WiFi Auto-documentation
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Auto-documentation for Agilia Connect pump system is available now through Wi-Fi. This wireless Auto-documentation requires a secure patient to pump association. For wireless Auto-documentation, the EMR provider must have implemented Bedside Computer assisted Medication Administration (BCMA) workflow. With Wi-Fi Auto-documentation, the system keeps the history of the pumps in all circumstances to make it fully available to the EMR even if disconnection occurs.
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Devices: Agilia VP MC, Agilia SP MC & Agilia SP TIVA
Change: Loading dose, Titration & Programmed bolus improvement
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The loading dose and programmed bolus can now be programmed in Volume/Time/Rate.
The user will thus be able to edit:
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The volume or the dose
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The duration of the bolus / loading dose
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The flow rate
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Devices: Agilia SP MC & Agilia SP TIVA
Change: Configuration of Quick Start feature
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The Quick start is a current Agilia syringe pumps’ feature which is now configurable within hidden menu for Basic Profile configuration (Basic profile configuration / Ward / Par 7: Infusion start) and in Vigilant Master Med for custom device configuration.
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Devices: Agilia SP MC & Agilia SP TIVA
Change: Keyboard lock at first in the menu
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The modification has been done to allow a faster unlocking of the keyboard: when keyboard is locked, the first item to be available when menu key is pressed will be the unlock keyboard function.
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Devices: Agilia VP MC, Agilia SP MC & Agilia SP TIVA
Change: Alarm display improvements
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Battery alarm and pre-alarm designs have been changed to descriptions to be more detailed and more understandable. A text message will appear instead of the graphic to explain what type of alarm you are facing.
Also, the maintenance icon, or wrench icon, will no longer be displayed on the alarms’ screens, even if the date is later than the maintenance date. Maintenance need information still appears at start up and corresponding menus
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Devices: Agilia VP MC, Agilia SP MC & Agilia SP TIVA
Change: Suppress contraindication ECMO and dialysis
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The IFU no longer contraindicates the concomitant use of ECMO or dialysis as a risk.
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Devices: Agilia SP MC & Agilia SP TIVA
Change: Loading dose DTBI and VTBI behaviour in dose/time and volume/time mode
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Previously, any loading dose given as part of a Dose/Volume over time mode would have been added to the total DTBI and not subtracted from the initially programmed DTBI.
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e.g. 20mg DTBI plus loading dose of 5mg means total DTBI of 25mg.
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In firmware v4.1, the loading dose is subtracted from the DTBI to be compliant with the expected behaviour of an eMR system and also the behaviour of the Agilia VP MC.
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e.g. 20mg DTBI plus a loading dose of 5mg leads to a total DTBI still of 20mg. This is broken down as 5mg through the initial loading dose and the remaining 15mg through the Dose/Volume over time mode.
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The flow rate will not change with the new behaviour in firmware v4.1 as the loading dose will now be considered a bolus at infusion start. This means the duration of the infusion will decrease but the flow rate won’t change. An example of this is shown below.
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Based on this new behavour:
• any drugs you do have programmed as a Dose/Volume over time mode that have an integrated loading dose may need to be reviewed as per the direction of your Pharmacy team.
• any users of the Agilia Connect SP syringe pumps should understand that any loading dose programmed will be subtracted from the total DTBI. e.g. To give a total DTBI of 25mg where a loading dose of 5mg will be given the DTBI should be set to 25mg.
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This change was made to align with the behaviour of the Agilia VP MC and also be electronic medical record HL7 (eMR) compliant for auto-documentation purposes.
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Moving from Vigilant Software Suite software version:
1.0.1 to 1.2.1
Date of introduction: May 2021
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System: Vigilant Software Suite: Master Med
Change: Change direct bolus, flow rate range
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Vigilant Master Med shall allow the user to specify the Direct Bolus flow rate from 50mL/hr and not from 10mL/hr.
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System: Vigilant Software Suite: Master Med
Change: Change duration range for Loading Dose and Programmed bolus
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If Loading Dose or Programmed Bolus is enabled in Vigilant Master Med should not allow to have duration as 0 second. 1 second should be the minimum.
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System: Vigilant Software Suite: Master Med
Change: Direct Bolus flow rate without decimal
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Vigilant Master Med should not allow decimals in flow rate for Direct Bolus.
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System: Vigilant Software Suite: Master Med
Change: Dataset Distribution Secondary drugs
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There is a dataset distribution issue when “clinical reminder” message is entered for a drug in Secondary. Vigilant Master Med should not allow “Clinical Reminder” for Secondary drug.
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System: Vigilant Software Suite: Master Med
Change: Vigilant Master Med IFU for TCI paediatrics models
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The following plasma concentration range information have been added for Maximum Plasma Concentration to the tooltip:
• For TCI model = Kataria: 0.01 -> 50 mcg/mL
• For TCI model = Paedfusor: 0.01 -> 50 mcg/mL
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System: Vigilant Software Suite: Master Med
Change: Dataset Distribution Secondary drugs
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There is a dataset distribution issue when “Pressure Management” is specified for a drug in Secondary. Vigilant Master Med should not allow “Pressure Management” for Secondary drug.