Electronic IFU Documentation

Infinium Medical

IFU Events

Device	Version	Applies to	Summary of Changes	Safety Impact	Date
CLEO USA User's Manual	4	Monitors made after 2/1/2025	CE mark updated, harmonized labeling	No Impact	3/4/2025
	3	All	CO2 section diagram updated	No Impact	5/17/2024
	2	All	Added Date and harmonized IFU #	No Impact	12/14/2022
	1	All	Formatting update	No Impact	11/30/2022


CLEO User's Manual	4	Monitors made after 2/1/2025	CE mark updated, harmonized labeling	No Impact	3/4/2025
	3	All	CO2 section diagram updated	No Impact	5/17/2024
	2	All	Added Date and harmonized IFU #	No Impact	12/14/2022
	1	All	Formatting update	No Impact	11/30/2022


OMNI K User's Manual	3	Monitors made after 2/1/2025	CE mark updated, harmonized labeling	No Impact	3/4/2025
	2	All	Added Date and harmonized IFU #	No Impact	12/14/2022
	1	All	Formatting update	No Impact	11/30/2022


OMNI Express User's Manual	3	Monitors made after 2/1/2025	CE mark updated, harmonized labeling	No Impact	3/4/2025
	2	All	Added Date and harmonized IFU #	No Impact	12/14/2022
	1	All	Formatting update	No Impact	11/30/2022


OMNI II K User's Manual	3	Monitors made after 2/1/2025	CE mark updated, harmonized labeling	No Impact	3/4/2025
	2	All	Added Date and harmonized IFU #	No Impact	12/14/2022
	1	All	Formatting update	No Impact	11/30/2022


OMNI III User's Manual	3	Monitors made after 2/1/2025	CE mark updated, harmonized labeling	No Impact	3/4/2025
	2	All	Added Date and harmonized IFU #	No Impact	12/14/2022
	1	All	Formatting update	No Impact	11/30/2022


OMNI II User's Manual	3	Monitors made after 2/1/2025	CE mark updated, harmonized labeling	No Impact	3/4/2025
	2	All	Added Date and harmonized IFU #	No Impact	12/14/2022
	1	All	Formatting update	No Impact	11/30/2022


OMNI User's Manual	3	Monitors made after 2/1/2025	CE mark updated, harmonized labeling	No Impact	3/4/2025
	2	All	Added Date and harmonized IFU #	No Impact	12/14/2022
	1	All	Formatting update	No Impact	11/30/2022

Infinium Medical

IFU Events

Device: CLEO USA User's Manual

Version: 4 Applies to: Monitors made after 2/1/2025 Summary of Changes: CE mark updated, harmonized labeling Safety Impact: No Impact Date: 3/4/2025

Version: 3 Applies to: All Summary of Changes: CO2 section diagram updated Safety Impact: No Impact Date: 5/17/2024

Version: 2 Applies to: All Summary of Changes: Added Date and harmonized IFU # Safety Impact: No Impact Date: 12/14/2022

Version: 1 Applies to: All Summary of Changes: Formatting update Safety Impact: No Impact Date: 11/30/2022

Device: CLEO User's Manual

Version: 4 Applies to: Monitors made after 2/1/2025 Summary of Changes: CE mark updated, harmonized labeling Safety Impact: No Impact Date: 3/4/2025

Version: 3 Applies to: All Summary of Changes: CO2 section diagram updated Safety Impact: No Impact Date: 5/17/2024

Version: 2 Applies to: All Summary of Changes: Added Date and harmonized IFU # Safety Impact: No Impact Date: 12/14/2022

Version: 1 Applies to: All Summary of Changes: Formatting update Safety Impact: No Impact Date: 11/30/2022

Device: OMNI K User's Manual

Version: 3 Applies to: Monitors made after 2/1/2025 Summary of Changes: CE mark updated, harmonized labeling Safety Impact: No Impact Date: 3/4/2025

Version: 2 Applies to: All Summary of Changes: Added Date and harmonized IFU # Safety Impact: No Impact Date: 12/14/2022

Version: 1 Applies to: All Summary of Changes: Formatting update Safety Impact: No Impact Date: 11/30/2022

Device: OMNI Express User's Manual

Version: 3 Applies to: Monitors made after 2/1/2025 Summary of Changes: CE mark updated, harmonized labeling Safety Impact: No Impact Date: 3/4/2025

Version: 2 Applies to: All Summary of Changes: Added Date and harmonized IFU # Safety Impact: No Impact Date: 12/14/2022

Version: 1 Applies to: All Summary of Changes: Formatting update Safety Impact: No Impact Date: 11/30/2022

Device: OMNI II K User's Manual

Version: 3 Applies to: Monitors made after 2/1/2025 Summary of Changes: CE mark updated, harmonized labeling Safety Impact: No Impact Date: 3/4/2025

Version: 2 Applies to: All Summary of Changes: Added Date and harmonized IFU # Safety Impact: No Impact Date: 12/14/2022

Version: 1 Applies to: All Summary of Changes: Formatting update Safety Impact: No Impact Date: 11/30/2022

Device: OMNI III User's Manual

Version: 3 Applies to: Monitors made after 2/1/2025 Summary of Changes: CE mark updated, harmonized labeling Safety Impact: No Impact Date: 3/4/2025

Version: 2 Applies to: All Summary of Changes: Added Date and harmonized IFU # Safety Impact: No Impact Date: 12/14/2022

Version: 1 Applies to: All Summary of Changes: Formatting update Safety Impact: No Impact Date: 11/30/2022

Device: OMNI II User's Manual

Version: 3 Applies to: Monitors made after 2/1/2025 Summary of Changes: CE mark updated, harmonized labeling Safety Impact: No Impact Date: 3/4/2025

Version: 2 Applies to: All Summary of Changes: Added Date and harmonized IFU # Safety Impact: No Impact Date: 12/14/2022

Version: 1 Applies to: All Summary of Changes: Formatting update Safety Impact: No Impact Date: 11/30/2022

Device: OMNI User's Manual

Version: 3 Applies to: Monitors made after 2/1/2025 Summary of Changes: CE mark updated, harmonized labeling Safety Impact: No Impact Date: 3/4/2025

Version: 2 Applies to: All Summary of Changes: Added Date and harmonized IFU # Safety Impact: No Impact Date: 12/14/2022

Version: 1 Applies to: All Summary of Changes: Formatting update Safety Impact: No Impact Date: 11/30/2022

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