Electronic IFU Documentation

Infinium Medical

Review Instructions for Use (IFU) revision history, safety impact summaries, and download current manuals for Infinium Medical devices.

IFU Events

Document version history and downloadable Instructions for Use (IFU) files.

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

CLEO USA User's Manual 4 versions

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

CLEO User's Manual 4 versions

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

OMNI K User's Manual 3 versions

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

OMNI Express User's Manual 3 versions

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

OMNI II K User's Manual 3 versions

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

OMNI III User's Manual 3 versions

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

OMNI II User's Manual 3 versions

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

OMNI User's Manual 3 versions

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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