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General| Device Type | Infusion Pump |
|---|---|
| Connectivity | Wi-Fi |
| Manufacturer | Fresenius Kabi |
| Model | AGILIA SP MC WIFI CA |
| Volume Range | 0.1 to 9999 ml |
| Accuracy | ± 5% |
| Infusion Modes | Continuous |
| Battery Life | 8 hours at 5 ml/h with battery |
| Power Supply | 100-240 V AC, 50/60 Hz |
| Flow Rate Range | 0.1 to 999.9 mL/h |
| Alarms | Occlusion, Air-in-line, Low battery |
| Display | Color |
| Compatibility | Compatible with various infusion sets and medications |
Defines the applicability of the Instructions for Use (IFU) to the Agilia SP MC WiFi device.
Specifies the intended use for adults, pediatrics, neonates for parenteral fluid delivery.
Describes the Agilia SP MC as a programmable electronic system for syringe infusion.
Lists parenteral fluids, medications, and blood/blood derivatives for infusion.
Identifies qualified and trained healthcare professionals as intended users.
Lists prohibited fluids, environments, and purposes for pump operation.
Specifies operating temperature, pressure, humidity, and altitude conditions.
Identifies key components visible from the front of the pump.
Describes bottom view and UDI representation.
Explains the function of each button on the pump's keypad.
Describes arrow keys and fast access keys for selection.
Explains meaning of different colored and flashing indicator lights.
Describes indicators for power supply and battery charge status.
Shows symbols indicating infusion in progress or stopped states.
Explains symbols for battery, pressure, keypad lock, and Wi-Fi status.
Describes functions of navigation buttons like Start, OK, Enter, New?.
Explains symbols for power disconnection, alarm silenced, pressure increase/drop.
Shows the symbol for programming a loading dose.
Explains the symbol for data set loaded.
Defines a profile for device configuration and drug library for patient groups.
Describes Basic Profile allowing infusions without pre-defined settings.
Explains custom profiles created and uploaded using a compatible DERS.
Defines drug libraries as lists of drugs with infusion rate limits.
Specifies infusion rate types: Flow rate and Dose rate.
Describes Drug X as an open entry for drugs not in the library.
Explains hard limits (cannot be overridden) and soft limits (can be overridden).
Lists infusion modes: Simple Rate, Volume/Time, Dose/Time, Volume Limit.
Explains that a data set can contain up to 19 custom profiles.
Details locations for installing the pump: on a pole, rail, rack, table.
Details the procedure for securing the pump to a pole.
Describes how to attach the pump to a bed rail or gurney rail.
Explains how to place the pump on a flat table safely.
Details the process for attaching two pumps to each other.
Outlines sequential steps for installing a syringe and powering on the pump.
Provides initial setup steps including installation, power connection, and charging.
Details the procedure for powering on the pump and its auto-test function.
Visualizes the workflow for operating the pump, from profile selection to completion.
Guides users on how to select a profile for pump configuration.
Explains how the pump detects and how to confirm the installed syringe.
Describes how to program an infusion using a specified flow rate.
Explains programming an infusion based on dose rate.
Details how to select or adjust drug concentration for dose rate programming.
Explains how to input patient weight or body surface area for dose calculations.
Details programming dose rate values and confirming them.
Explains how to program an initial loading dose before starting infusion.
Explains how to interpret the display during a flow rate programmed infusion.
Instructions for stopping an ongoing infusion and its consequences.
Describes how to adjust the infusion rate during operation.
Introduces methods for administering a bolus dose.
Details the steps for administering a direct bolus.
Explains how to program a bolus dose.
Provides steps for programming bolus volume, dose, and duration.
Instructions on how to interrupt a programmed bolus.
Describes the alerts that trigger as an infusion nears completion.
Explains what happens when an infusion is completed.
Details the procedure for safely powering off the pump.
Explains how to program an infusion using the Simple Rate mode.
Details the process of priming the infusion line to remove air.
Explains commands for accessing and navigating menus.
Lists available menus, their symbols, and associated procedures.
Explains how to view and clear the total volume or dose infused.
Details how to program a temporary pause in the infusion.
Explains how to change patient weight or body surface area settings.
Describes how to switch between day and night modes for display and sound settings.
Explains how to set a limit on the total volume to be infused.
Details how to adjust the audible alarm volume.
Explains how to view information about the currently installed syringe.
Guides users on how to access and view the pump's event log.
Lists commands for accessing and navigating pump options.
Outlines the available option groups, focusing on "Pump Settings".
Summarizes cable and Wi-Fi communication capabilities.
Explains how to connect and use Agilia cables for data transfer.
Details how to connect the RS232 communication port.
Explains the pump's Wi-Fi capabilities for connecting to a hospital system.
Describes the process of uploading a new data set to the pump.
Explains the pump's continuous monitoring system and alarm handling.
Categorizes alarms by priority (High, Medium, Low, Information) and operator response.
Provides general information about handling multiple alarms and indicator behavior.
Lists alarms related to syringe installation and mechanism issues.
Lists alarms related to syringe installation and mechanism issues.
Describes alarms triggered when a volume limit is reached or approached.
Lists alarms for reaching VTBI or approaching volume limits in these modes.
Details alarms for infusion completion, check settings, and waiting states.
Lists alarms for occlusion, pressure increase, and pressure drop.
Describes alarms for low battery and very low battery conditions.
Lists alarms for AC power failure and disconnection.
Details alarms related to keypad lock status.
Describes technical alarms and error messages.
Mentions the maximum number of syringes and where to find the list.
Provides steps for preparing the syringe and infusion line.
Details the steps to safely remove a syringe.
Guides users through the process of replacing a syringe.
Advises on when to replace the syringe based on protocols.
Lists precautions for storing the device properly.
Specifies environmental conditions for storage and transport.
Details the steps to prepare the pump before storage.
Guides on using the device after a storage period.
Lists the pump's essential features defined under standard operating conditions.
Details flow rate ranges, minimum increments, and defaults for various syringe sizes.
Specifies range, default value, and increment for VTBI.
Details range, default value, and increment for DTBI.
Specifies range, default value, and increment for infusion time.
Details concentration range, default value, increment, and volume of diluent.
Specifies ranges for patient weight and body surface area.
Details pressure mode, DPS, unit settings, and threshold storage.
States the accuracy for flow rate measurements.
Details how pressure variations affect accuracy.
Specifies accuracy for occlusion alarm response time based on rate and syringe.
Details volume accuracy for bolus doses and at occlusion release.
States the accuracy for pressure measurements.
Lists units for concentration measurements.
Lists units for dose rate measurements.
Specifies when the pump should be thoroughly cleaned and disinfected.
Lists recommended agents and agents that must be avoided for cleaning.
Details precautions for using the AC power supply.
Lists safety precautions and warnings related to the internal battery.
Details power supply voltage and cord requirements.
Lists battery type, weight, life, and recharge times.
States the typical power consumption of the pump.
Describes the serial cable and power input/output for the communication port.
Details the mode, compatibility, and speed of infrared communication.
Provides sound levels for operating conditions and alarms.
Lists compliance with electro-medical safety and EMC standards.
Provides the physical dimensions and weight of the pump.
Explains trumpet curves and provides recommendations for low flow rates.
Introduces the IEEE 802.11 transmitter and its purpose.
Details Wi-Fi technology, frequency band, modulation, security, and protocols.
Provides FCC and Canadian regulatory notices for Wi-Fi.
Lists wireless functionality references and data transport protocols.
Outlines the manufacturer's guarantee against defects.
Lists conditions required to benefit from the warranty.
Mentions that accessories may have specific warranty conditions.
Discusses the pump's intended use in electromagnetic environments and warnings.
Advises on preventing damage from ESD and environmental conditions.
Explains how EMC disturbances can affect essential performance and patient safety.
Provides guidance on ensuring correct operation and limiting emitted radiation.
Outlines the process for sending the device for servicing.
Specifies preventive maintenance frequency and requirements.
Describes quality control checks performed on the device.
Lists compatible data management cables.
Lists compatible software and their required versions.
Lists compatible racks and accessories for the system.
Lists compatible syringes with their rate and occlusion release volume.
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