Fresenius Kabi Agilia VP Instructions For Use Manual
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Fresenius Kabi Agilia VP Instructions For Use Manual

Fresenius Kabi Agilia VP Instructions For Use Manual

Volumetric infusion pump
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Agilia VP
Volumetric Infusion Pump
Applicable to software version 4.3
Instructions For Use
For Use in Healthcare Facilities and Homecare Environments

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Summary of Contents for Fresenius Kabi Agilia VP

  • Page 1 Agilia VP Volumetric Infusion Pump Applicable to software version 4.3 Instructions For Use For Use in Healthcare Facilities and Homecare Environments...

  • Page 2: Symbols Description

    Symbols Description Symbols used in this document Danger: Warning of an imminent hazard Caution: Warning of a potential hazard that could result in serious personal injury that could result in minor personal injury and/or product damage if the written and/or product damage if the written instructions are not followed.
  • Page 3 Unique Device Identifier Indicates the authorised representative in Switzerland...

  • Page 4: Table Of Contents

    Table of contents Symbols Description 1 Introduction 1.1 Scope........................8 1.2 Principles of Operation..................8 1.3 Intended Purpose....................8 1.4 Intended Use......................8 1.5 Clinical benefits....................12 1.6 Side-effects......................13 1.7 Risks for patients....................13 1.8 Cybersecurity Safety considerations..............13 2 Agilia Connect Infusion System 3 Description 3.1 Front View......................17 3.2 Bottom View (Device Identification Label)............17 3.3 Back View......................18 3.4 Keypad........................19...
  • Page 5 7 Operation 7.1 Flowchart......................38 7.2 Selecting a Profile....................38 7.3 Programming an Infusion..................38 7.4 Starting an Infusion....................39 7.5 Monitoring an Infusion..................40 7.6 Functions During Infusion..................41 7.7 Completing an Infusion..................42 7.8 Infusion Modes....................43 7.9 Other Functions....................44 8 Menus 8.1 Overview......................49 8.2 Profile........................50 8.3 Pressure......................50 8.4 Volume To Be Infused (VTBI)................52 8.5 Keypad Lock Status.....................53...
  • Page 6 12 Alarms and Safety Features 12.1 Introduction......................69 12.2 Alarm Descriptions....................69 12.3 General Remarks....................70 12.4 List of Alarms.....................70 12.5 Audio Only Information Signals.................78 13 Volumat Lines 13.1 Preparing the Administration Set and the Fluid Container........80 13.2 Priming the Administration Set Before Use............81 13.3 Other Uses of Administration Sets..............82 13.4 Removal and Replacement of Administration Sets...........84 14 Device Storage...
  • Page 7 18.3 Power Consumption..................99 18.4 Communication Port..................99 18.5 Infrared Communication..................99 18.6 Drop Sensor Connector..................99 18.7 Sound Levels.....................99 18.8 Compliance......................100 18.9 Dimensions and Weight...................100 18.10 Trumpet and Start-up Curves................101 19 Troubleshooting 20 Recycling 21 Warranty 21.1 General Warranty Conditions................107 21.2 Limited Warranty....................107 21.3 Warranty Conditions for Accessories..............107 22 Guidance and Manufacturer's Declaration on EMC 22.1 Electromagnetic Compatibility.................108...

  • Page 8: Introduction

    The Agilia VP infusion pump can be used for intermittent or continuous infusions. The Agilia VP infusion pump is intended for use on only one patient at a time. It can be reused indefinitely on multiple patients throughout its lifetime.

  • Page 9: Intended Users

    When using the Agilia VP infusion pump to infuse critical medications in healthcare facilities, ensure that backup pumps and administration sets are available for immediate use. Only use the Agilia VP infusion pump for the infusion of fluids that are intended for infusion pumps.

  • Page 10: Use Environment

    It is recommended that users attend a refresher training session of about 20 minutes every year. For training, contact your Fresenius Kabi sales representative. 1.4.4 Intended Patients The Agilia VP infusion pump is intended to be used according to healthcare facilities protocols on patients with the following characteristics: Patient Characteristics Male / Female...
  • Page 11 In early versions, all homecare functionalities are unavailable. If your software version is not compatible with homecare environments, contact your Fresenius Kabi sales representative. Environment Considerations ■ Consider the following operational conditions to ensure proper device performance: –...

  • Page 12: Clinical Benefits

    1.5 Clinical benefits Clinical benefits are achieved through the functions provided to the intended users, which has a positive impact on patient management. Clinical benefits of Agilia VP infusion system are the following: ■ Provide a controlled and accurate system for the infusion of large volume of drugs, fluids and blood products (volume delivery accuracy of the system is ±5%, flow rate adjustable...

  • Page 13: Side-Effects

    EN/IEC 60601-1-8). 1.6 Side-effects There is no side-effect directly associated to the use of the Agilia VP infusion pump. 1.7 Risks for patients Failure to follow all instructions described in this document or loss or degradation of essential...

  • Page 14: Cybersecurity Recommendations

    ■ When not in use, the Agilia VP pump is securely stored. ■ When not in use, the Agilia VP Serial or USB Cables are disconnected and securely stored. ■ Secure storage access is restricted to authorized personal only.

  • Page 15: Agilia Connect Infusion System

    Vigilant Centerium Software intended to report status of compatible Software Suite Fresenius Kabi infusion devices according to the identified installed base for fleet management, to store and distribute datasets to connected infusion devices and to report distribution status, besides supporting system maintenance operations.
  • Page 16 Agilia range Description Maintenance Software Software Agilia Partner Software designed to maintain, configure, test and calibrate compatible Agilia infusion devices and accessories. Accessories Link Agilia Stacking Rack Systems Agilia Link Rack systems designed to stack 4, 6 or 8 Agilia infusion Link+ Agilia pumps.

  • Page 17: Description

    3 Description 3.1 Front View Figure 1: Front View Legend Handle Door Lever Pump Door 3.2 Bottom View (Device Identification Label) Figure 2: Bottom View Legend Device Identification Label On the device identification label, the UDI (Unique Device Identifier) is presented in machine-readable form (AIDC - Automatic Identification and Data Capture - technology) and as text:...

  • Page 18: Back View

    ■ (01) Product Identifier GTIN ■ (21) Product Serial Number ■ (11) Date of Manufacture ■ (240) Product Reference For more information on device identification label symbols, see Symbols Description page 2. 3.3 Back View Figure 3: Back View Legend Release Button Power Cord Inlet Drop Sensor Connection Socket...

  • Page 19: Keypad

    3.4 Keypad 3.4.1 Keypad Description Figure 4: Keypad Legend Screen Infusion Indicator Lights Battery Charge Status Indicator Decrement Power Supply Indicator Fast Decrement On / Off Confirm Value / Move to Next Field Bolus / Prime / Advance Air Stop Fast Increment Menu / Cancel Value / Move Back to Previous Field...
  • Page 20 Description Fast Access to Maximum Value or Top of a List Fast Access to Minimum Value or Bottom of a List NOTE: ■ Fast increment and decrement keys have been programmed with different levels corresponding to standardized volumes of bags and bottles. ■...

  • Page 21: Display And Symbols

    3.5 Display and Symbols 3.5.1 Infusion Status Symbol Description Infusion in Progress (Basic Profile + Custom Profiles with a drug list) The drop appears in the drip chamber when an infusion is in progress. Infusion in Progress (Drop sensor connected) Infusion Stopped STOPPED STOPPED remains in the center of the screen until the user...

  • Page 22: Packaging

    Drop in pressure NOTE: For more information on alarms, see Alarms and Safety Features on page 69. 3.6 Packaging Depending on your country, the packaging contents of the Agilia VP infusion pump is different: Agilia VP Instructions System User information...
  • Page 23 Packaging weight: Approximately 530 g. Packaging consists of: Recycled cardboard. INFORMATION ■ It is the healthcare facility’s responsibility to check the pump integrity upon reception. ■ If the packaging contents are incomplete or damaged, contact your Fresenius Kabi sales representative.

  • Page 24: Fundamentals

    ■ a comprehensive list of medications and fluids to be infused (optional): a drug list without limits on drug infusion rates. INFORMATION For more information on Fresenius Kabi devices that are compatible with custom profiles, contact your Fresenius Kabi sales representative. 4.2 Drug List...

  • Page 25: Infusion Modes

    4.2.1 Infusion Modes An infusion can be started according to the following modes: Infusion Mode Description Volume / Time / Rate This infusion mode gives access to the 3 infusion parameters (V/T/R) (V, T, R) Volume / Rate Infusion of a programmed volume of fluid at a programmed rate (V/R) Volume / Time Infusion of a programmed volume of fluid over a programmed...

  • Page 26: Installation

    5 Installation 5.1 Types of Installations A pump can be installed on any of the following: Location Comments On a Pole ■ Attaching to a Pole on page Pole specifications: ■ Diameter: from 15 to 40 mm On a Rail ■...

  • Page 27: Using The Rotating Pole Clamp

    Location Comments In an ■ Refer to the Agilia Holder Ambulance Agilia Holder Ambulance accompanying documents. WARNING ■ The pump must be used in a horizontal and stable position to function properly. ■ Use recommended Agilia accessories to ensure stability and prevent the pump from falling.

  • Page 28: Attaching The Pump(S)

    5.2.2.1 Folding the Clamp Down (outward) You can fold the clamp down as follows: 1. Push the release button. 2. Fold the clamp outward. 5.2.2.2 Folding the Clamp Up (inward toward the pump) You can fold the clamp up as follows: 1.
  • Page 29 For more information on installing the pump on a pole, consult the pole’s Instructions For Use. CAUTION When installed on a rolling stand, make sure it can accommodate the weight of the pump and accessories. Check with your biomedical department. 5.3.2 Attaching to a Rail Only single pumps can be attached to a bed rail or gurney rail.
  • Page 30 5.3.4 Attaching Two Pumps Together You can attach two pumps together either for transport, or before fixing them to a pole. 1. Fold both pumps’ pole clamps up: see Folding the Clamp Up (inward toward the pump) on page 28. 2.

  • Page 31: Getting Started

    6 Getting Started 6.1 Flowchart Once the pump is installed at the bedside, you must follow the steps below in order to install an administration set and power on the pump. Preparing the administration set and the fluid container Section 13.1 Priming the administration set Section 13.2 (Manual) Section 7.11.1 (Pump Feature)

  • Page 32: Powering On

    4. Successively acknowledge the screens listed in the table below. Screen After Powering on Description Startup screen: the following information is Agilia VP v.04.3 displayed: ■ Product name / Ward name ■...

  • Page 33: Installing The Administration Set In The Pump

    Screen After Powering on Description ■ No administration set is installed on the pump. Install set !!! ■ Install set !!! is displayed on top of the screen. Install an administration set. See Installing the Administration Set in the Pump on page 33.

  • Page 34: Connecting An Agilia Drop Sensor

    3. Align the fully primed administration set horizontally along the tube guides so that the green connector is on the right (green), and the SafeClip (blue anti- free-flow clamp) is in front of the clamp guide (blue). 4. Insert the green connector into the green slot [A]. 5.
  • Page 35 2. Press the drop sensor clip and align the vertical part of the drop sensor with the drip chamber’s air vent. 3. Release the clip. 4. Check the following: ■ The drop sensor and the drip chamber are in a vertical position. ■...

  • Page 36: Pump Height

    INFORMATION Use only a drop sensor provided by Fresenius Kabi. When a drop sensor is detected on a pump, the following happens: ■ Simple Rate infusion mode is available and recommended, ■ Programmable infusion ranges are different. INFORMATION For transport during infusion, the pump with a drop sensor connected on it must be installed on a rolling stand.
  • Page 37 ■ Minimize the height difference between the pump and the patient and avoid changes in the height of the pump (example: during transport of critically ill patients) to prevent unintended fluctuations in the flow rate. ■ During the infusion, if the infusion pump is moved 1 m above the patient, a bolus (up to 0.35 mL) may occur.

  • Page 38: Operation

    7 Operation 7.1 Flowchart Selecting a Profile (Section 7.2) Custom Profile Basic Profile (with a Drug List) (Section 4.1.1) Programming an Infusion (Section 7.3) Starting the Infusion (Section 7.4) Monitoring the Infusion (Section 7.5) Functions during Infusion (Section 7.6) Completing the Infusion (Section 7.7) 7.2 Selecting a Profile You can only select a profile if more than one profile is loaded in the pump.

  • Page 39: Starting An Infusion

    ■ To change the infusion mode, see Infusion mode on page 58. mL / 00h00min mL/h Volume to be infused 1. Press the arrow keys to program the Volume to be Infused (VTBI) and press to select (Press to select the VTBI from pre-defined values: 0.1 mL, 10 mL, 20 mL, 50 mL, 100 mL, 250 mL, 500 mL, etc.) INFORMATION ■...

  • Page 40: Monitoring An Infusion

    CAUTION Prior starting an infusion, check the infusion line integrity to ensure the Agilia infusion pump correct functioning. 1. Check that no air remains in the administration set. 2. Confirm that the administration set is correctly installed in the pump. 3.

  • Page 41: Functions During Infusion

    7.6 Functions During Infusion 7.6.1 Stop mL / 04h59min STOPPED mL/h Volume to be infused To stop the infusion, press After 2 minutes, an alarm is generated as a reminder that the infusion is stopped. To restart the infusion, first confirm or modify the programming settings, then start the infusion.

  • Page 42: Completing An Infusion

    BOLUS (mL) Press and hold Rate: 1200 mL/h 4. To administer a direct bolus, press and hold 5. Monitor the volume infused on the main display until the desired bolus is reached. 6. To stop the bolus, release the key. The infusion resumes its previous rate after the bolus is delivered.

  • Page 43: End Of Infusion

    Silencing Near End of Infusion Alert Near end of infusion !! 0.2 mL / 00h01min mL/h VI:0mL Press to silence the alarm. The infusion will continue until the VTBI reaches zero. 7.7.2 End of Infusion WARNING The KVO (Keep Vein Open) function shall not be used with critical or life-sustaining drugs, as it may lead to critical harm for the patient.

  • Page 44: Other Functions

    To select an infusion mode, see Infusion mode on page 58. For more information on calculation rules, see Calculation Rules on page 91. 7.8.1 Volume / Time / Rate (V/T/R) 1. Press the arrow keys to select the VTBI and press the arrow key to select OK. 2.
  • Page 45 NOTE: This feature can be activated or deactivated in the pump options. Prime set Disconnect patient during priming 1. Press to power on the pump. 2. Press 3. Make sure the administration set is not connected to the patient, as indicated on screen. 4.

  • Page 46: Auto Restart

    Air bubble !!! 1. Press to silence the audible signal for 2 minutes. Air bubble !!! Advance air bubble ? 2. Press 3. Press OK to advance the air bubble. Air bubble !!! Press and hold to advance air bubble 4.
  • Page 47 – If the pressure does not decrease, the downstream occlusion alarm is generated. Alert !!! Wait during pressure measurement checking CAUTION When infusing with critical drugs or on vulnerable patients (such as young pediatric patients), pay special attention to configuring Auto-restart to meet clinical requirements.

  • Page 48: Powering Off

    Install set !!! 10.0 mL / 00h12min 50.0 mL/h exit 5. Press the key to select exit in order to confirm or press the arrow key to select in order to reprogram. 6. When ready, install the administration set. 7. Press the key to select start in order to start the infusion, or press the arrow key to select in order to change the settings.

  • Page 49: Menus

    8 Menus 8.1 Overview 8.1.1 Commands Operation Access menu or exit menu Select (correspond to arrow keys) Confirm (corresponds to enter on the screen) Select ☑ / Deselect ☐ 8.1.2 Menu Description Menu Symbol Stop Infusion Associated Procedure Required Profile ■...

  • Page 50: Profile

    Menu Symbol Stop Infusion Associated Procedure Required View pressure history ■ View Pressure History on page 62. View event log ■ View Event Log on page 62. Date / Time ■ Date / Time on page 63. Maintenance ■ Maintenance on page 64.
  • Page 51 The pump pressure limit is pre-defined in the pump options in one of the following modes: ■ 3 levels (low , medium , high The pressure limit is adjustable according to 3 pre-set values. ■ Variable The pressure limit is adjustable within a pre-defined range. When the pressure limit is reached, an occlusion alarm is triggered.

  • Page 52: Volume To Be Infused (Vtbi)

    8. Press the arrow keys to select to enable or disable the DPS function (optional). 9. Press to select OK in order to confirm. WARNING To avoid the presence of air and to minimize the amount of time it takes the pump to recognize an occlusion and generate an alarm while infusing at low rates (e.g., less than 5 mL per hour, and especially flow rates less than 0.5 mL per hour): To minimize the occlusion detection time and the time to trigger the...

  • Page 53: Keypad Lock Status

    8.5 Keypad Lock Status Symbol Procedure Locking / Unlocking the keypad You can use this feature to avoid inadvertent key presses. NOTE: The following feature can be activated or deactivated in the pump options: ■ Unlock code: The user must enter a code to unlock the keypad. Locking the Keypad Keypad lock status enter...

  • Page 54: Keypad Automatic Lock

    1. Press 2. Press to select enter. Keypad lock status Keypad lock status Code: Unlock code enabled Unlock code disabled 3. Unlock the keypad as follows: ■ If a code is required, press the keys to enter the unlock code. The keypad is unlocked. ■...

  • Page 55: Battery Life

    Keypad auto lock Automatic AUTO lock: enter 3. Press to select enter. AUTO Keypad auto lock Automatic lock: 4. Press the arrow keys to set the Automatic lock to yes The keypad will lock automatically at infusion start. If the keypad is unlocked during the infusion, it will lock again automatically after a configured time-out.

  • Page 56: Volume Infused

    The bar graph shows a visual representation of battery life. The symbol displayed shows the following: ■ : The pump is plugged into the AC power supply. ■ : The pump is operating on battery. 8.8 Volume Infused Symbol Procedure Viewing and clearing the volume infused Volume infused 0.43...

  • Page 57: Day/Night Mode

    2. Press 3. Press the arrow keys to select 4. Press to select enter. 5. Press the arrow keys to program the pause duration in hours and minutes, and press to select OK. 6. Press the arrow keys to select yes or no to activate the Start infusion at pause end feature.

  • Page 58: Infusion Mode

    Switching from Day Mode to Night Mode or from Night Mode to Day Mode Day/Night mode enter You can switch to night mode or day mode as follows: 1. Press 2. Press the arrow keys to select 3. Press to select enter. Day/Night mode 4.

  • Page 59: Alarm Volume

    Infusion mode mL/h Volume/time/rate Volume/rate Volume/time New ? 4. Press the arrow keys to select a new infusion mode. 5. Press OK to apply the selected infusion mode to the current infusion settings, or New? to apply the selected infusion mode and clear the infusion settings. 8.12 Alarm Volume Symbol Procedure...
  • Page 60 Activating the Call-back Alert Call-back alert --/--/---- --h--min enter You can activate the call-back alert as follows: 1. Press 2. Press the arrow keys to select 3. Press enter. Call-back alert 12/07/2023 20h26min 05h00min 12/07/2023 15h26min 4. Press the arrow keys to set the interval in hours and minutes (__ h __min) before the alert.

  • Page 61: View Flow Rate History

    Call-back alert --/--/---- --h--min 23/06/2015 13h20 4. To deactivate the programmed call-back alert, press the down arrow keys to set the duration period to "Off". 5. Press OK. 8.14 View Flow Rate History Symbol Procedure Viewing flow rate history This function allows the user to check the current infusion’s history information in order to verify the dose administered.

  • Page 62: View Pressure History

    ■ Flow rate history is not stored after powering off. 8.15 View Pressure History Symbol Procedure Viewing pressure history This function allows the user to check the current infusion’s history information in order to verify changes in pressure. View pressure history enter You can view pressure history as follows: 1.

  • Page 63: Date / Time

    The event log displays details of the last events that occurred on the pump. Events are stored in the log even after the pump is powered off and on again. The log can store up to 1500 events. Older events are overwritten. NOTE: When the AC Power is disconnected for a period of time, or when the batteries are not operating, the log file is kept in a non-volatile memory for approximately 10 years.

  • Page 64: Maintenance

    3. Use the arrow keys to set the Day, Month, Year, Hours and Minutes. 4. Press to select OK to save your changes. 8.18 Maintenance Symbol Procedure Displaying maintenance information Maintenance SN: Z018720/10220507 Maintenance date: 31/12/2025 enter You can display maintenance information as follows: 1.

  • Page 65: Options

    9 Options This section describes the options available to configure the pump’s behavior and the menus displayed. 9.1 Accessing the Pump Configuration Options Display the pump configuration options as follows: Pump off, simultaneously press The Options screen is displayed. See Pump Settings on page 66 for details on the Pump settings options.

  • Page 66: Pump Settings

    If the wrong access code is entered, error is displayed. The Default access code may be modified using Agilia Partner Maintenance Software. 9.4 Pump Settings The following options have different functions that you can select or deselect to customize your Agilia VP. Function Choice Default Pump Setting ■...

  • Page 67: Data Communication

    10 Data Communication You can connect the pump to a PC for maintenance (via Agilia Partner Maintenance Software). 10.1 Data Communication Cables INFORMATION ■ Only use recommended Agilia cables. ■ All connections and disconnections must be performed by qualified and appropriately trained staff.

  • Page 68: User Test

    11 User Test The following protocol provides the user with a quick integrity check guide to ensure that the pump system is functional. Perform this user test before each use of the pump. 1. Check the external appearance of the pump for the absence of cracks or other visible damage.

  • Page 69: Alarms And Safety Features

    12 Alarms and Safety Features 12.1 Introduction Agilia VP has a continuous monitoring system that begins when the pump is started. When an alarm is triggered, a message is displayed on the pump screen. We recommend that the user stand in front of the pump to read the message before acknowledgment.

  • Page 70: General Remarks

    Alarm Priority Required Description Operator Response Low (!) Awareness ■ The infusion continues. ■ The infusion indicator lights (LEDs) yellow are ON. ■ The pump emits audible alarm signals. ■ Depending on the alarm, the silences the alarm for no time limit or for a defined duration.
  • Page 71 Message Priority Stops Problem / Resolution Infusion? High (!!!) There is no administration set in front of the Check set upstream or downstream sensor. installation ■ Check the administration set installation. NOTE: the key silences the alarm for 2 minutes. High (!!!) The door is open (during the infusion, or while the Door opened...
  • Page 72 Close the roller clamp, check the administration set installation, check the door integrity, check the administration set integrity. ■ If the problem cannot be resolved, contact your Fresenius Kabi sales representative. NOTE: the key silences the alarm for 2 minutes. Information...

  • Page 73: Pressure Alarms

    Message Priority Stops Problem / Resolution Infusion? Medium (!!) A value must be entered. Waiting settings !! Enter a value and press OK to confirm. NOTE: the key silences the alarm for 2 minutes. Medium (!!) The infusion settings have been entered, but the Waiting start infusion has not been started with start key.
  • Page 74 Message Priority Stops Problem / Resolution Infusion? High (!!!) The pressure in the upstream line is too low. Upstream occlusion !!! Check the roller clamp. Check the container and line. Check the container height. Check air vent (if a bottle is used). Check for kinked line.

  • Page 75: Battery Alarms

    12.4.5 Battery Alarms Message Priority Stops Problem / Resolution Infusion? High (!!!) The battery is discharged. Alert !!! Very The pump will power OFF automatically within low battery 5 minutes. Connect to Connect the pump to a power supply power and wait immediately.

  • Page 76: Keypad Alarms

    12.4.7 Keypad Alarms Message Priority Stops Problem / Resolution Infusion? Information The keypad is locked. Keypad lock signal status Unlock the keypad. Information The keypad is locked and the door was opened Keypad locked signal and closed. Unlock keypad Unlock the keypad. to continue 12.4.8 Drop sensor Message...
  • Page 77 Priority Stops Problem / Resolution Infusion? High (!!!) Technical alarm. Erxx(yyyy) !!! Contact your qualified technician or your Fresenius Kabi sales representative. NOTE: the key silences the alarm for 30 seconds. Low (!) Temperature increase. High internal temperature ! Check device environment.

  • Page 78: Audio Only Information Signals

    4. Switch the pump off by pressing the key. CAUTION If an alarm persists after restarting the pump, do not use it and contact your biomedical department or a Fresenius Kabi representative. 12.5 Audio Only Information Signals Type Comment Stops...
  • Page 79 Type Comment Stops Activation Infusion? Air advance 1 beep Repeated every 5 seconds Administration set 1 beep Repeated every 5 seconds prime...

  • Page 80: Volumat Lines

    13 Volumat Lines 13.1 Preparing the Administration Set and the Fluid Container Agilia Volumat Lines are supplied sterile and are indicated for single use. 1. Prepare the fluid container according to your healthcare facility’s protocol. 2. Select a Volumat Line. CAUTION Check the container, the line and access device integrity.

  • Page 81: Priming The Administration Set Before Use

    ■ Do not use in conjunction with positive pressure infusion devices that could generate back pressure higher than 2000 hPa (1500 mmHg): doing so will damage the administration set and the pump. ■ For administration sets with two spikes, only open one line at a time. ■...

  • Page 82: Other Uses Of Administration Sets

    1. Remove the cap from the spike and insert the spike into the bag. 2. After hanging the bag, close the roller clamp. 3. Fill the drip chamber approximately 1/2 full. 4. Slowly open the roller clamp for priming. Invert the needle-free port while priming, and gently tap the valve to remove all air. 5.
  • Page 83 Figure 9: Needle-Free Ports Legend Upstream port (before the pump) Downstream port (after the pump) INFORMATION ■ Use aseptic technique when accessing the ports. ■ Stop the infusion before accessing the ports. ■ Do not use the upstream access ports to deliver a manual bolus into the line.

  • Page 84: Removal And Replacement Of Administration Sets

    13.3.2.2 Gravity Infusion in Parallel with a Pump Figure 11: Gravity Infusion (in parallel with a pump) WARNING Mixing different drugs in the same infusion line can result in chemical instability or a loss of the intended therapeutic effects. Avoid mixing drugs in the same infusion line whenever possible.
  • Page 85 13.4.2 Changing an Administration Set 1. Remove the administration set. See Removing an Administration Set on page 84. 2. Install another administration set, and follow the steps described in the flowchart. Flowchart on page 31. INFORMATION Properly dispose of used administration sets as per the healthcare facility’s guidelines.

  • Page 86: Device Storage

    14 Device Storage 14.1 Precautions for Storage ■ Handle the device with care during storage. ■ Store the device in a cool, dry place. The storage area must be clean and organized. ■ Clean and disinfect the device prior to storage. 14.2 Storage and Transport Conditions Observe the following conditions for storage and transport: ■...

  • Page 87: Specifications

    15 Specifications INFORMATION The range of settings and default values described in this section correspond to the factory configuration. Range of settings and default values may be adjusted in the pump options. 15.1 Essential Features The pump’s essential features are defined in standard operating conditions: Feature Refer to Flow Rate Accuracy...

  • Page 88: Volume To Be Infused (Vtbi)

    15.3 Volume To Be Infused (VTBI) Format Range of Settings Default Minimum Increment Value VTBI 0.1 ➔ 9999 (0.1 ➔ 99.9) (100 ➔ 9999) Direct Bolus 0.1 ➔ 60* * 60 mL with drug, 20 mL without drug 15.4 Infusion Time Format Range of Default...

  • Page 89: Accuracy

    Setting Description Setting Format Default Value Unit Pressure unit selection. mmHg / kPa / PSI mmHg Limit Stored The last pressure limit adjustment is Enabled / Disabled Disabled automatically stored in memory for the next startup. DPS Stored The last DPS adjustment is Enabled / Disabled Disabled automatically stored in memory for the...
  • Page 90 15.7.2 Effects of Pressure Variations on Accuracy Accuracy Effects of Pressure Back pressure Accuracy (from mean values) Variations on Flow Rate + 39.9 kPa ~ - 3% Accuracy* + 13.33 kPa ~ - 1.5% - 13.33 kPa ~ + 1.5% Effects of Negative Container Height Accuracy (from mean values)

  • Page 91: Pressure Accuracy

    15.7.4 Volume Accuracy Accuracy Direct Bolus* ≤ 10 mL: ± 0.5 mL > 10 mL: ± 5% Limit to Detect ≤ 1.0 mL (without drop sensor) Upstream Occlusion* ≤ 0.7 mL (with drop sensor) Limit to Detect Flow -70% ≤ X ≤ +250% Rate Deviation with Drop Sensor * Test condition: Back pressure: 0 mmHg, Container height: 50 cm...
  • Page 92 V = Volume To Be Infused, T = Infusion Time, R = Rate Calculated value Examples Rounded up to the nearest mL ■ Calculated V = 1.8 mL ■ Displayed V = 2 mL Rounded up to the nearest minute ■...

  • Page 93: Cleaning And Disinfecting

    16 Cleaning and Disinfecting To avoid the risks of infection and microbial transmission, make sure to adequately clean and disinfect the equipment. WARNING ■ The disinfecting procedure must be done immediately after cleaning. Disinfecting the pump without prior cleaning is not effective. ■...

  • Page 94: Instructions For Cleaning And Disinfecting

    CAUTION The following cleaning and disinfecting agents are prohibited: ■ Trichloroethylene ■ Abrasive detergents ■ Undiluted alcohol These aggressive agents may damage the plastic parts of the pump and cause it to malfunction. 16.3 Instructions for Cleaning and Disinfecting Follow the instructions provided to ensure effective cleaning and disinfecting of the equipment. ■...

  • Page 95: Disinfecting Instructions

    Make sure the pump remains damp for at least 1 minute. Set down the pump, and wipe down the silver handle, the attachment lock knob, the screw clamp and the release button. Open the pump door, and gently wipe down the exposed surfaces (tube guides, blue clamp).

  • Page 96: Power Management

    ■ Incorrect handling of a Lithium-ion battery. ■ Replacement of the battery by inadequately trained personnel. CAUTION Do not replace with a battery other than the one provided by Fresenius Kabi. Always manipulate the battery with the pump turned off and the power cord unplugged.
  • Page 97 INFORMATION During operation, leave the device connected to the power supply in order to maintain the battery's charge and maximum capacity, and to maximize battery lifetime and performance. The essential performance and behaviour of the device are not affected during charging.

  • Page 98: Technical Characteristics

    18 Technical Characteristics 18.1 Power Supply It is mandatory to use an Agilia power cord compliant with the IEC 60227 standard. The power cord conductor must have a cross section of at least 0.75 mm². For a list of compatible power cords, refer to the System Components booklet. 100 V - 240 V ~ / 50 / 60 Hz with functional earth Power supply AC Power...

  • Page 99: Power Consumption

    18.3 Power Consumption The pump typically consumes about 4.3 W in standard operating conditions. 18.4 Communication Port The connector located at the back of the device allows data communication with a PC. Serial Cable TTL output Power Input 10 V / 15 W to power supply the product Power Output 5 VDC / 150 mA to power Agilia USB cable.

  • Page 100: Compliance

    18.7.2 Alarms Sound Levels Alarm Range for sound alarm volume adjusted Range for sound alarm volume adjusted Priority at minimum at maximum (see Alarm Volume on page 59) (see Alarm Volume on page 59) Range values Measured Range values Measured values values High...

  • Page 101: Trumpet And Start-Up Curves

    18.10 Trumpet and Start-up Curves WARNING Starting an infusion at flow rate below 5 mL/h may cause a delay in medication delivery due to a longer start-up time. The trumpet curve shows the variation of the mean flow rate accuracy over specific observation periods.
  • Page 102 Legend Measured variance from flow rate 25,1 12,9 Error Flow rate -4,2 -3,7 -7,7 -11,7 Sampling time: 10 s -43,2 Time (minutes) Figure 13: Trumpet curves for 2, 5, 11, 19, 31 minutes observation windows (1 mL/h over first 2 hours on 96 hours) Legend Measured variance from 31,7...
  • Page 103 18.10.2 Flow Rate: 25 mL/h Legend Instantaneous flow rate Set flow rate Sampling time: 10 s Time (minutes) Figure 15: Start-up and instantaneous flow rate (25 mL/h over first 2 hours on 96 hours) Legend Measured variance from flow rate Error -2,5 -4,3...

  • Page 104: Troubleshooting

    Remove the power cord. abnormal (unusual noise, abnormal heat or ■ Contact your biomedical department or your smoke). Fresenius Kabi sales representative immediately. The pump has been dropped or was subjected to ■ Do not use the pump. a force that may have produced internal damage.
  • Page 105 The battery is completely discharged: charge the AC power supply. the battery. ■ Contact your biomedical department or your Fresenius Kabi sales representative. At start-up, the pump displays: "Software is ■ Connect the pump to the AC power supply. upgrading...".

  • Page 106: Recycling

    Technical Manual. INFORMATION ■ For more information on waste processing regulations and dismantling, contact your Fresenius Kabi sales representative or the local distributor. ■ Follow healthcare facility policy regarding proper disposal after use.

  • Page 107: Warranty

    21 Warranty 21.1 General Warranty Conditions Fresenius Kabi guarantees that this product is free from defects in material and workmanship during the period defined by the accepted sales conditions, except for the batteries and the accessories. 21.2 Limited Warranty To benefit from the materials and workmanship guarantee from our Fresenius Kabi sales representative or authorized agent, make sure to observe the following conditions: ■...

  • Page 108: Guidance And Manufacturer's Declaration On Emc

    22 Guidance and Manufacturer's Declaration on 22.1 Electromagnetic Compatibility DANGER Do not use Agilia pumps in an MRI environment unless in an Agilia MRI Guard. WARNING ■ The Agilia pump and its accessories are intended to be used in the electromagnetic environments specified below.

  • Page 109: Electromagnetic Compatibility And Interference Guidance

    ■ Use of anti-static equipment ■ Preliminary user discharge (explained below) ■ Anti-static clothing The best precaution is preliminary user discharge on a grounded metal object such as a rail, a pole or a metal part located at the rear of the Agilia pump. For maintenance operations performed on the Agilia pump, place the device on a conductive working surface, and wear a special ESD conductive wristband.

  • Page 110: Emc And Essential Performances

    If the Agilia pump is placed near RF communication equipment such as cell phones, DECT phones or wireless access points, RFID reader & tags,... It is essential to observe a minimum distance between the Agilia pump and this equipment specified above. If the Agilia pump causes harmful interference or if it is itself disrupted, the user is encouraged to try to correct the interference by one of the following actions: ■...
  • Page 111 Emission Test Compliance Obtained by the Electromagnetic Environment Device - Guidance The Agilia pump is suitable for Conducted emissions 150 kHz - Class 5 use in automotive environments. 108 Mhz CISPR25 Radiated emissions 150 kHz - Class 3 2.5 Ghz CISPR25 22.4.2 Table 2 - Guidance and Manufacturer's Declaration - Electromagnetic Immunity WARNING...
  • Page 112 Immunity Compliance Electromagnetic Environment - Guidance Test 60601-1-2 Level Obtained by - - - - - - - - - the Device 60601-2-24 Test Level Voltage dips, < 5% Ut < 5% Ut AC power quality should be that of a typical commercial short (>...
  • Page 113 Immunity Compliance Electromagnetic Environment - Guidance Test 60601-1-2 Level Obtained by - - - - - - - - - the Device 60601-2-24 Test Level Portable and mobile RF communication equipment should be used no closer to any part of the Agilia pump (including cables), than the recommended separation distance calculated from the transmitter frequency equation.
  • Page 114 22.4.4 Table 6 - Recommended Separation Distances Between Portable and Mobile RF Communication Equipment and the Agilia Pump INFORMATION ■ The Agilia pump and its accessories are intended for use in electromagnetic environments in which radiated RF disturbances are controlled. ■...
  • Page 115 Immunity IEC 60601-1-2 Compliance level obtained Electromagnetic test IEC 60601-2-24 by the device environment – Test level guidance Discharge ± 8 kV contact ± 8 kV contact Wooden, tiled or (ESD) IEC ± 15 kV air ± 15 kV air concrete flooring, with 61000-4-2 a relative humidity...
  • Page 116 Immunity IEC 60601-1-2 Compliance level obtained Electromagnetic test IEC 60601-2-24 by the device environment – Test level guidance Near field 385 MHz, PM 18Hz, 27 V/m 385 MHz, PM 18Hz, 27 V/m For minimal distance radiated RF 450 Mhz, 1 KHz, 28 V/m 450 Mhz, 1 KHz, 28 V/m approach 30 cm 710 MHz, PM 217 Hz, 9 V/m...
  • Page 117 Immunity IEC 60601-1-2 Compliance level obtained Electromagnetic test IEC 60601-2-24 by the device environment – Test level guidance Power 30 A / m 400 A / m If necessary, the frequency power magnetic field (50 / 60 Hz) should be measured magnetic in the intended field IEC...
  • Page 118 Immunity IEC 60601-1-2 Compliance level obtained Electromagnetic test IEC 60601-2-24 by the device environment – Test level guidance Voltage 0% Ut (100% dip in Ut) for 0,5 0% Ut (100% dip in Ut) for 0,5 Electricity power dips, short cycle at 0°, 45°, 90°, 135°,180°, cycle at 0°, 45°, 90°, 135°,180°, quality should be that interruptions...

  • Page 119: Servicing

    3. Pack the device in the provided packaging. 4. Ship the device to Fresenius Kabi. INFORMATION ■ Fresenius Kabi is not liable for loss or damage to the device during transport. ■ For more information on servicing, contact your Fresenius Kabi sales representative.

  • Page 120: Quality Control

    INFORMATION If the device needs upgrading, Fresenius Kabi or its representative will provide relevant instructions. It is the healthcare facility's responsibility to follow Fresenius Kabi’s instructions. 23.3 Quality Control A quality control check (not included in the guarantee) consists of various inspection operations listed in the technical manual.

  • Page 121: Real Time Location System Tag

    1. Locate a 44 x 34 mm area on the side panel of the pump. The tag must be positioned in the greyed area as shown below. Figure 18: Agilia VP range of pumps (right panel) CAUTION The installation of the RTLS tag on the pump must respect the integrity of the pump housing.

  • Page 122: Use Environment

    24.2 Use environment The RTLS tags must be used in the same operational conditions as for the Agilia pump. Use Environment on page 10. 24.3 Tag Compliance CAUTION Be sure that used RTLS tags are in compliance with latest local radio equipments and electrical safety directives and standards.

  • Page 123: A Glossary Of Terms

    A Glossary of Terms Term Description Amperes Alternating Current Ampere-hours AIDC Automatic Identification and Data Capture Amplitude Modulation Amperes per meter American Society of Anesthesiologists BPSK Binary Phase Shift Keying Body Surface Area Calorie Complementary Code Keying Centers for Disease Control CISPR Special International Committee on Radio Interference CT Scan...
  • Page 124 Term Description Electrocardiogram ECMO ExtraCorporeal Membrane Oxygenation Electroencephalogram Electromagnetic compatibility ErXX Error message Electrostatic Discharge Federal Communications Commission Frequency Modulation Feet File Transfer Protocol General Public License GTIN Global Trade Item Number H/W/D Height / Width / Depth High Frequency Hectopascals HTTP HyperText Transfer Protocol...
  • Page 125 Term Description mL/h Milliliters per hour mmHg Millimeters of Mercury mmol Millimole Metal Oxyde Semiconductor Magnetic Resonance Imaging mW/sr Milliwatts per steradian Not Applicable Network File System Nuclear Magnetic Resonance Occlusivity Check System OFDM Orthogonal Frequency Division Multiplexing Object Linking and Embedding Open Platform Communications Operating Room Off-The-Shelf...
  • Page 126 Term Description Unique Device Identifier Universal Serial Bus Test specification level Volts Volts per meter Volt-Amperes Volts Direct Current Volume Infused VLAN Virtual Local Area Network Virtual Private Network Vrms Root Mean Square Voltage VTBI Volume to Be Infused Watts Wi-Fi Protected Access Cross-Site Scripting...

  • Page 127: B Appendix: Factory Configuration

    B Appendix: Factory Configuration Menus Feature Availability Feature Availability Profile Infusion mode ✓ Pressure management ✓ Alarm volume ✓ Volume to be infused ✓ Call-back alert ✓ Keypad lock status ✓ View flow rate history Battery life ✓ View pressure history Volume infused ✓...
  • Page 128 Index Day Mode Dimensions Administration Set Disinfecting Change Drop Sensor 34, Install Other Uses Prepare Prime 44, Electromagnetic Guidance Remove Environment Operating Conditions Replacement Interval Essential Features Agilia Connect Infusion System Event Log Air Bubble Advance Specifications Alarm Factory Configuration Adjust Volume First Use List...
  • Page 129 Infusion (continued) Patient Characteristics Status Description Stop Power Cord Infusion Modes 25, Powering Off Installation Powering On Installation on a Rail Power Supply 20, Intended Products Pre-programming Intended Use Pressure Management Modify Limit Operating range Keypad Priming Description Manual Prime Locking / Unlock Prime With Pump Unlock code...
  • Page 130 Temperature Operating range Storage and Transport Conditions V/T/R Titration Volume Infused Training VTBI 52, Troubleshooting Trumpet Curves Warranty Weight Users User Test...

  • Page 131: Release Notes

    This document may not be reproduced in whole or in part without the written consent of Fresenius Kabi. Vigilant® and Agilia® are registered trademarks in the name of Fresenius Kabi in selected countries. Made in France...
  • Page 132 Local contacts for servicing Fresenius Kabi AG Fresenius Vial S.A.S. Else-Kröner-Str. 1 Le Grand Chemin 61352 Bad Homburg, GERMANY 38590 Brézins - FRANCE Tel.: +49 (0) 6172 / 686-0 www.fresenius-kabi.com...

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