IC Medical Update: Instructions for Use (IFUs) and Operating Manuals

We would like to inform you that updates have been made to the Instructions for Use (IFUs) and Operating Manuals for the following products:

1. Hydrophobic ULPA Filters: Product IFU, document number ICM-001-1736 SAFEGUARD BLUE® Hydrophobic ULPA Filter with built-in Fluid Trap, Warnings, Cautions and Instruction, updated to reflect safe fluid usage, listing fluid volume limits, safety precautions, and visual indicators, to identify Australian Sponsor name and address, and to update the address for the UK Responsible Person.
2. Smoke Evacuators Model 450D and 460: Operating and Installation Manual for Crystal Vision Model 450D (document number ICM 450-9000) and Operating and Installation Manual for Crystal Vision Model 460 (document number ICM-460-9000) have been updated to revise the contraindication related to fluid suction, to align documentation with the device design and intended use, which allows limited fluid suction when the input filter used is IC Medical’s SAFEGUARD BLUE® Hydrophobic ULPA Filter with Built-in Fluid Trap, identify Australian Sponsor name and address, and update the address for the UK Responsible Person.​​​​​​

These updates are part of IC Medical’s ongoing commitment to regulatory compliance and do not affect the safety, performance, or intended use of the products.

We recommend reviewing the revised IFUs to ensure your documentation is up to date.

The updated IFUs are available below for download.