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Fresenius Kabi Agilia VP User Manual

Fresenius Kabi Agilia VP
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Agilia VP
Volumetric Infusion Pump
Applicable to software version 4.1
Instructions For Use
For Use in Healthcare Facilities and
Homecare Environments

Table of Contents

Questions and Answers:

Fresenius Kabi Agilia VP Specifications

General IconGeneral
TypeVolumetric Infusion Pump
VTBI (Volume To Be Infused)0.1 - 9999 ml
Infusion Rate Range0.1 - 1200 mL/h
Flow Rate Accuracy±5%
Bolus RateUp to 1200 mL/h

Summary

1 Introduction

1.1 Scope

Defines the applicability and scope of the Instructions for Use (IFU) for the Agilia VP pump.

1.2 Principles of Operation

Explains the Agilia VP as a programmable electronic medical system for fluid delivery.

1.3 Intended Purpose

States the device's purpose as an infusion pump and accessories for IV fluid administration.

1.4 Intended Use

Details the intended use, indications, contraindications, users, patients, and environments for the Agilia VP.

1.5 Clinical benefits

Highlights the advantages of the Agilia VP infusion system for patient management.

1.7 Risks for patients

Outlines potential risks such as overdose, underdose, trauma, or electric shock if instructions are not followed.

3 Description

3.1 Front View

Provides a visual overview of the front panel and components of the Agilia VP pump.

3.2 Bottom View (Device Identification Label)

Details the device identification label, including UDI information on the pump's bottom view.

3.3 Back View

Illustrates the rear view of the Agilia VP pump, identifying various ports and connectors.

3.4 Keypad

Describes the function of each key on the Agilia VP keypad for user interaction.

3.5 Display and Symbols

Explains the various symbols, icons, and status indicators shown on the Agilia VP display.

3.6 Packaging

Details the contents of the Agilia VP pump packaging based on country variations.

4 Fundamentals

4.1 Profiles

Explains the concept of profiles for device configuration and drug library management.

4.2 Infusion Modes

Describes the different modes available for starting an infusion on the Agilia VP pump.

5 Installation

5.1 Types of Installations

Outlines the various locations and methods for installing the Agilia VP pump.

5.2 Using the Rotating Pole Clamp

Details the description and usage of the rotating pole clamp for securing the pump.

5.3 Attaching the pump(s)

Provides instructions on how to attach the pump to different mounting systems.

6 Getting Started

6.1 Flowchart

Presents a flowchart outlining the initial setup steps for the Agilia VP pump.

6.2 Using the Pump for the First Time

Guides the user through the initial setup and connection of the Agilia VP pump.

6.3 Powering on

Details the procedure for powering on the Agilia VP pump and initial checks.

6.4 Installing the Administration Set in the Pump

Provides step-by-step instructions for correctly installing the administration set.

6.5 Connecting a Drop Sensor

Explains how to connect and check the installation of a drop sensor.

6.6 Pump Height

Describes the importance of pump height and its effect on infusion delivery.

7 Operation

7.1 Flowchart

Presents a flowchart detailing the sequence of operations for using the Agilia VP pump.

7.2 Selecting a Profile

Guides the user on how to select a profile on the Agilia VP pump.

7.3 Programming an Infusion

Details the steps required to program an infusion using the V/T/R mode on the pump.

7.4 Starting an Infusion

Provides instructions on how to safely start an infusion after programming.

7.5 Monitoring an Infusion

Explains how to monitor an ongoing infusion using the pump's display and indicators.

7.6 Functions During Infusion

Covers essential functions that can be performed while an infusion is in progress.

7.7 Completing an Infusion

Describes the procedures for handling the end of an infusion, including alerts.

7.8 Infusion Modes

Details the different modes available for programming and running infusions.

7.9 Other Functions

Covers additional functions such as priming, air bubble management, and auto-restart.

8 Menus

8.1 Overview

Provides an overview of the pump's menu structure and commands.

8.2 Profile

Explains how to display and manage active profile information on the pump.

8.3 Pressure

Details how to modify the pressure limit settings and understand pressure management.

8.4 Volume To Be Infused (VTBI)

Guides the user on how to change the Volume To Be Infused (VTBI) setting.

8.5 Keypad Lock Status

Explains how to lock and unlock the keypad to prevent inadvertent key presses.

8.6 Battery Life

Describes how to view the current battery life status of the Agilia VP pump.

8.7 Volume Infused

Details how to view and clear the total volume infused during operation.

8.8 Pause

Explains how to program a pause in the infusion and restart it.

8.9 Day/Night Mode

Covers switching between day and night modes for optimal screen visibility.

8.10 Flow Rate (mL/h)

Details how to change the infusion mode, including flow rate settings.

8.11 Alarm Volume

Guides the user on how to adjust the alarm volume level for audible alerts.

8.12 Call-back Alert

Explains how to activate or deactivate the call-back alert feature.

8.13 View Flow Rate History

Allows users to view the historical data of flow rate during infusions.

8.14 View Pressure History

Enables users to check the historical pressure readings during infusions.

8.15 View Event Log

Provides access to the pump's event log for troubleshooting and auditing.

8.16 Date / Time

Describes how to set or adjust the date and time on the Agilia VP pump.

8.17 Maintenance

Details how to display maintenance information and upcoming service requirements.

9 Options

9.1 Commands

Defines the commands used for accessing and navigating through pump options.

9.2 Option Descriptions

Provides descriptions for different option groups available on the pump.

9.3 Pump Settings

Details various settings that can be selected or deselected to customize the Agilia VP.

10 Data Communication

10.1 Data Communication Cables

Provides information on data communication cables and their usage for PC connectivity.

11 User Test

12 Alarms and Safety Features

12.1 Introduction

Introduces the continuous monitoring system and alarm handling of the Agilia VP pump.

12.2 Alarm Descriptions

Describes the different levels of alarm priorities and their characteristics.

12.3 General Remarks

Provides general remarks on alarm behavior, configurability, and priority handling.

12.4 List of Alarms

Lists various alarms, their priority, and potential problems or resolutions.

12.5 Audio Only Information Signals

Details the types of audio signals and their activation for information and alerts.

13 Volumat Lines

13.1 Preparing the Administration Set and the Fluid Container

Guides on preparing the administration set and fluid container according to protocols.

13.2 Priming the Administration Set Before Use

Explains the recommended procedure for priming the administration set to displace air.

13.3 Other Uses of Administration Sets

Covers additional uses of administration sets, including access ports and gravity infusion.

13.4 Removal and Replacement of Administration Sets

Provides instructions for removing, changing, and the replacement interval for administration sets.

14 Device Storage

14.1 Precautions for Storage

Outlines essential precautions to be taken when storing the Agilia VP device.

14.2 Storage and Transport Conditions

Specifies the recommended temperature, pressure, humidity, and altitude for storage.

14.3 Preparing the Device for Storage

Details the step-by-step procedure for preparing the pump before placing it into storage.

14.4 Using the Device After Storage

Provides guidance on using the device after it has been in storage.

15 Specifications

15.1 Essential Features

Lists the essential features of the Agilia VP pump as defined in standard operating conditions.

15.2 Flow Rate

Details the range of settings and default values for flow rates in different infusion modes.

15.3 Volume To Be Infused (VTBI)

Specifies the range of settings and default values for Volume To Be Infused (VTBI).

15.4 Infusion Time

Lists the range of settings and default values for infusion time calculations.

15.5 Air Detection

Provides specifications for total air volume detection and air bubble filter settings.

15.6 Pressure Management

Details the modes, units, and settings for pressure management in the pump.

15.7 Accuracy

Presents accuracy specifications for flow rate, pressure variations, and occlusion alarms.

15.8 Calculation Rules

Explains the calculation rules used by the pump for V, T, and R in different infusion modes.

16 Cleaning and Disinfecting

16.1 When to Clean and Disinfect the Pump

Specifies the conditions and frequency for cleaning and disinfecting the pump.

16.2 Recommended and Prohibited Agents

Lists recommended cleaning agents and prohibited chemicals to maintain the pump.

16.3 Instructions for Cleaning and Disinfecting

Provides detailed instructions for performing cleaning and disinfecting procedures.

17 Power Management

17.1 AC Power Supply Precautions

Outlines precautions for using the AC power supply and connecting the pump.

17.2 Battery Precautions

Details important precautions related to the Lithium-ion rechargeable battery.

17.3 Battery Operating Mode

Explains the device's internal battery function and charging procedures.

18 Technical Characteristics

18.1 Power Supply

Specifies the AC power supply requirements and protective fuse details.

18.2 Battery

Provides characteristics, weight, and battery life specifications for the device.

18.3 Power Consumption

States the typical power consumption of the pump in standard operating conditions.

18.4 Communication Port

Describes the connector for data communication with a PC.

18.5 Infrared Communication

Details the pump's infrared communication capabilities and specifications.

18.6 Drop Sensor Connector

Specifies the power output for the drop sensor connector.

18.7 Sound Levels

Presents operating pump sound levels and alarm sound levels.

18.8 Compliance

Lists the electro-medical equipment safety, EMC, and particular standards compliance.

18.9 Dimensions and Weight

Provides the physical dimensions and weight of the Agilia VP pump.

18.10 Trumpet and Start-up Curves

Explains trumpet curves and their use in assessing flow rate accuracy.

19 Troubleshooting

20 Recycling

21 Warranty

21.1 General Warranty Conditions

Outlines the general warranty conditions for the Agilia VP product.

21.2 Limited Warranty

Details the conditions required to benefit from the materials and workmanship guarantee.

21.3 Warranty Conditions for Accessories

States that batteries and accessories have specific warranty conditions.

22 Guidance and Manufacturer's Declaration on EMC

22.1 Electromagnetic Compatibility

Provides guidance on electromagnetic compatibility for the Agilia pump in specified environments.

22.2 Electrostatic Discharge (ESD)

Explains the risks of electrostatic discharge and precautions for sensitive components.

22.3 Electromagnetic Compatibility and Interference Guidance

Offers guidance on compatibility with electromagnetic interference and standards.

22.4 EMC and essential performances

Details EMC emissions and immunity, and consequences of performance degradation.

23 Servicing

23.1 Information on Device Servicing

Provides instructions for sending the device for servicing and information on transport.

23.2 Maintenance Requirements

Outlines mandatory preventive maintenance and warnings regarding device modification.

23.3 Quality Control

Describes the procedure for performing quality control checks on the device.

23.4 Notification of serious incident

Instructs on reporting any serious incidents related to the device to the manufacturer.

24 Cybersecurity

24.1 Cybersecurity and IT-Network environment

Discusses the IT-Network characteristics and policies for Fresenius Kabi infusion systems.

24.2 Inherent design

Covers the security mechanisms integrated into the Agilia system pumps design.

24.3 Information regarding cybersecurity

Recommends compliance with IT policies and outlines security best practices.

Network configuration

Provides recommendations for network installation and use consistent with security best practices.

24.4 Firewall configuration

Ensures that firewall ports are allowed and unnecessary traffic is blocked.

24.5 Potential vulnerabilities

Identifies known vulnerabilities in typical IT networks and their associated threat events.

25 Glossary of Terms

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