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General| Manufacturer | Fresenius Medical Care |
|---|---|
| Category | Medical Equipment |
| Product Name | GranuFlo |
| Intended Use | For use in hemodialysis |
| Composition | Sodium chloride, acetic acid |
| Storage Conditions | Store at room temperature |
Details the various components and their part numbers for the dissolution unit.
Specifies electrical (120 VAC, 15 amp GFI) and water (ANSI/AAMI/ISO standards) needs.
Details unit dimensions, weight, leveling requirements, and floor drain needs.
Highlights critical warnings regarding tank access, product handling, electrical safety, and operation.
Details warnings related to specific procedures like flushing, disinfection, and gravity testing.
Emphasizes water quality standards for hemodialysis and physician's role in prescription.
Advises caution regarding computer control, assembly, disinfection, and mixing limitations.
Details the sequence and function of each operation within the Dissolution Cycle.
Details the sequence and function of each operation within the Rinse Cycle.
Guides on starting the Rinse Cycle, ensuring correct valve positions and water source.
Describes the FILL, RECIRCULATE, and DRAIN operations within the Rinse Cycle.
Provides instructions for inspecting and cleaning the spray ball for proper operation.
Details checks required before starting the dissolution cycle, including filter and water.
Instructions for safely adding dry acid granules into the dissolution tank.
Describes the sequence and function of operations like FILL, MIX, DEAERATION, HOMOGENIZE.
Guidance on visually inspecting the unit for any defects or potential issues.
Instructions for cleaning the exterior surfaces of the dissolution unit.
Procedure for disinfecting the unit using sodium hypochlorite (bleach).
Details conditions and procedures for filter removal and replacement.
Information on sensor replacement, which must be performed by a qualified technician.
Explains how to use the PAUSE button to temporarily halt operations.
Describes the use of STEP MODE for controlling operations step-by-step.
Details how to shut down the unit using the main power switch or plug.
Provides instructions for troubleshooting stationary or clogged spray balls.
Defines indicator lights and control panel buttons for unit operation.
Provides definitions for common terms and acronyms used in the manual.
Procedures for disposing of residual solution from filter housing and hydrometer cylinder.
Occasions and procedures for discarding the entire tank solution.
Steps for preparing the unit and determining product quantity before mixing.
Detailed instructions for mixing dry acid concentrate with water.
Step-by-step guide for verifying the first batch of mixed concentrate.
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