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

Volumetric infusion pump
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Agilia VP
Volumetric Infusion Pump
Applicable to software version 4.1
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 4.1 Instructions For Use For Use in Healthcare Facilities and Homecare Environments...

  • Page 2: Symbol Descriptions

    Symbols used in this document Warning of a potential hazard that could result in serious personal Recommendations to be followed. injury and/or product damage if the written instructions are not followed. Labelling symbols Warning Name and address of the (Refer to the Instructions For Use) manufacturer / Date of manufacture Name and address of the Refer to the Instructions For Use...

  • Page 3: Table Of Contents

    Table of Contents INTRODUCTION ....................9 COPE ..............9 RINCIPLES OF PERATION ................9 NTENDED URPOSE ..................10 NTENDED 1.4.1 Indications ..................10 1.4.2 Contraindications................11 1.4.3 Intended users..................11 1.4.4 Intended patients................11 1.4.5 Use Environment ................12 1.4.6 Specificities for Homecare Environments........... 13 ................15 LINICAL BENEFITS ..................15...
  • Page 4 INSTALLATION ..............27 YPES OF NSTALLATIONS ............28 SING THE OTATING LAMP ) ..............29 TTACHING THE PUMP 5.3.1 Attaching to a Pole ................29 5.3.2 Attaching to a Rail ................31 5.3.3 Using on a Flat Table ................. 31 5.3.4 Attaching Two Pumps Together ............32 GETTING STARTED ..................33 LOWCHART...
  • Page 5 7.9.1 Priming the Administration Set ............50 7.9.2 Advancing an Air Bubble ..............51 7.9.3 Auto-restart..................53 7.9.4 Pre-programming the Pump ............... 54 MENUS ....................55 VERVIEW ....................56 ROFILE ....................57 RESSURE (VTBI) ............59 OLUME NFUSED ................60 EYPAD TATUS ..................62 ATTERY .................63 OLUME NFUSED ....................64...
  • Page 6 12.2 ................80 LARM ESCRIPTIONS 12.3 ................81 ENERAL EMARKS 12.4 ...................81 IST OF LARMS 12.5 ............90 UDIO NFORMATION IGNALS 13 VOLUMAT LINES 13.1 ..91 REPARING THE DMINISTRATION ET AND THE LUID ONTAINER 13.2 ........92 RIMING THE DMINISTRATION EFORE 13.3 ..........94 THER SES OF DMINISTRATION 13.4...
  • Page 7 17.2 ..............109 ATTERY RECAUTIONS 17.3 ...............110 ATTERY PERATING 18 TECHNICAL CHARACTERISTICS 18.1 ..................111 OWER UPPLY 18.2 ....................111 ATTERY 18.3 ................111 OWER ONSUMPTION 18.4 ..............112 OMMUNICATION 18.5 ..............112 NFRARED OMMUNICATION 18.6 ...............112 ENSOR ONNECTOR 18.7 ...................112 OUND EVELS 18.8 ..................113 OMPLIANCE 18.9 ..............113 IMENSIONS AND...
  • Page 8 23.4 ............131 OTIFICATION OF SERIOUS INCIDENT 24 CYBERSECURITY 24.1 IT-N .......132 YBERSECURITY AND ETWORK ENVIRONMENT 24.2 ................133 NHERENT DESIGN 24.3 ..........133 NFORMATION REGARDING CYBERSECURITY 24.4 ..............135 IREWALL CONFIGURATION 24.5 ...............135 OTENTIAL VULNERABILITIES 25 GLOSSARY OF TERMS APPENDIX: FACTORY CONFIGURATION INDEX...

  • Page 9: Introduction

    Agilia VP is a transportable and reusable device that can be used everyday. Agilia VP can be used for intermittent or continuous infusions. Agilia VP is intended for use on only one patient at a time. It can be reused indefinitely on multiple patients throughout its lifetime. Intended Purpose...

  • Page 10: Intended Use

    If infusion pump is used, the patient should still be continually assessed for any signs of potential extravasation. Warning When using Agilia VP to infuse critical medications, ensure that adequate monitoring is provided.

  • Page 11: Contraindications

    When using Agilia VP to infuse critical medications in healthcare facilities, ensure that backup pumps and administration sets are available for immediate use. Only use Agilia VP for the infusion of fluids that are intended for infusion pumps. Do not use the pump for epidural use.

  • Page 12: Use Environment

    Switch to night mode  Set the alarm volume to the minimum level 1.4.5 Use Environment Agilia VP is intended for use in the following environments:  Healthcare facilities and in pre-hospital medical ground transportation, under the supervision of trained healthcare professionals.

  • Page 13: Specificities For Homecare Environments

    For more information, refer to Agilia Holder Ambulance IFU.  For more information on using the device in specific conditions, contact your Fresenius Kabi representative. 1.4.6 Specificities for Homecare Environments Warning Product version Only pumps with software version 2.2 or above can be used in...

  • Page 14: Warnings

    Environment Considerations  Consider the following operational conditions to ensure proper device performance: - Do not expose to sun light, keep in dry place, at room temperature, normal pressure. - Keep in clean environment. - Keep away from objects which can potentially damage the device.

  • Page 15: Clinical Benefits

    EN/IEC 60601-1-8). Side-effects There is no side-effect directly associated to the use of Agilia VP. Risks for patients Failure to follow all instructions described in this document or loss or degradation of essential performance (Section 15.1, page 99.) may...

  • Page 16: Agilia Connect Infusion System

    EMR Auto-documentation Software intended to establish connection between Vigilant Bridge compatible Fresenius Kabi infusion pumps and the Electronic Medical Records (EMR) system. Infusion data is then automatically transmitted to the EMR. Vigilant Infusion Data Reporting Software...
  • Page 17 Agilia Range Description Maintenance Software Software Agilia Partner Software designed to maintain, configure, test and calibrate compatible Agilia infusion devices and accessories. Stacking Rack Systems Rack systems designed to stack 4, 6 or 8 Agilia infusion Link Agilia pumps. Agilia Link Link Agilia / Agilia Link are designed to centralize the power Link+ Agilia supply.

  • Page 18: Description

    Description Front View Figure 3.1: Front View Legend Handle Door Lever Pump Door Bottom View (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 19: Back View

    Back View Figure 3.2: Back View Legend Release Button Power Cord Inlet Drop Sensor Connection Socket Infrared Cell Rotating Pole Clamp Attachment Lock Knob RS232 Communication Port Symbol Location Description Warning See section 18, page 111. Near Power Cord Inlet Warning Near RS232 See section 10, page 78.

  • Page 20: Keypad

    Keypad 3.4.1 Keypad Description Figure 3.3: Keypad Legend Screen Decrement 3 7 9 Battery Charge Status Indicator Fast Decrement 3 7 10 Power Supply Indicator Confirm Value / Move to Next Field 3 11 On / Off Stop 3 12 Bolus / Prime / Advance Air Menu / Cancel Value / Move Back to 3 13...

  • Page 21: Power Supply

    3.4.2 Keypad Details 3.4.2.1 Selection Keys Description Arrow Keys Keys for selecting volume, time, flow rate and other values. Fast Access to Maximum Value or Top of a List Fast Access to Minimum Value or Bottom of a List Note: ...

  • Page 22: Display And Symbols

    Display and Symbols 3.5.1 Infusion Status Symbol Description Infusion in Progress This symbol shows a drop falling into the drip chamber. The drop appears in the drip chamber when an infusion is in progress. Infusion in Progress (Drop sensor connected) Infusion Stopped STOP remains in the center of the screen until the user starts the infusion again.

  • Page 23: Navigation Buttons

    3.5.3 Navigation Buttons Symbol Description start Start Confirm enter Access Function New ? Access Function and Clear Settings exit Exit Function Change Selection prog Program Function Select / Unselect See More Information Zoom in / Zoom out Move the Event Marker to the Left / Right 3.5.4 Alarms and Safety Features Symbol...

  • Page 24: Packaging

    Packaging Depending on your country, the Agilia VP packaging contents is different. System User information Agilia VP Instructions Power Components document pump For Use cord booklet (multilingual) Z019XXX Z019X00* * Product codes ending by 00 are for the multi-country versions.

  • Page 25: Fundamentals

    Custom profiles feature a specific pump configuration and a drug library. Custom profiles are not available with the pump described in this IFU (Agilia VP). Information For more information on Fresenius Kabi devices that are compatible with custom profiles, contact your Fresenius Kabi sales representative.

  • Page 26: Infusion Modes

    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 period of time...

  • Page 27: Installation

    Installation Types of Installations A pump can be installed on any of the following: Location Comments  See section 5.3.1, page 29. On a Pole Pole specifications:  Diameter: from 15 to 40 mm  See section 5.3.2, page 31. Rail specifications: On a Rail ...

  • Page 28: Using The Rotating Pole Clamp

    Location Comments  Refer to the Agilia Holder Ambulance accompanying documents. In an Agilia Holder Ambulance Do not use accessories that appear to be damaged. For more information on accessories, refer to their respective accompanying documents. Warning  The pump must be used in a horizontal and stable position to function properly.

  • Page 29: 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 30 Information When installed on a rolling stand, do not tip over the system more than 5°: it may fall.

  • Page 31: Attaching To A Rail

    5.3.2 Attaching to a Rail Only single pumps can be attached to a bed rail or gurney rail. 1. Rotate the pole clamp to the vertical position: see section 5.2.2.3, page 29. 2. Unscrew the clamp, attach to the rail, and screw the clamp until pump is fully secured to the rail.

  • Page 32: Attaching Two Pumps Together

    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 section 5.2.2.2, page 29. 2. Slide the slot on the bottom of the upper pump onto the handle of the lower pump.

  • Page 33: Getting Started

    Getting Started 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, page 91. Priming the administration set Section 13.2, page 92.

  • Page 34: Powering On

    3. Before starting the pump for the first time, you must charge the battery for approximately 6 hours. Wait until the pump is fully charged. Do not use the pump during the first charge. 4. Prepare the administration set. See section 13.1, page 91. 5.

  • Page 35: Ocs

    Screen After Powering on Description  The pump is operating on battery.  The symbol shows three different charge levels: < 30 % battery charge 30 % - 70 % battery charge > 70 % battery charge  No administration set is installed on the pump. ...

  • Page 36: Installing The Administration Set In The Pump

    Installing the Administration Set in the Pump Warning  Do not open the roller clamp until the OCS test has successfully completed.  During all manipulations of the pump with administration set (administration set installation, door opening, administration set removal), close the roller clamp and make sure the line is closed. 1.

  • Page 37: Connecting A Drop Sensor

    Connecting a Drop Sensor Using a drop sensor is recommended if the actual volume of the fluid container is not known accurately. The pump automatically detects the presence of a drop sensor. The presence of the drop sensor can be set as mandatory in the pump options.
  • Page 38 Standard Drip Chamber Drip Chamber with Central Ring (example: VL ON42) (example: VL ST00) Note: The drop sensor is equipped with two circular magnets. You can use these magnets to fix the drop sensor and the drip chamber on the right side of the pump.

  • Page 39: Pump Height

    Pump Height Warning Ideally, the volumetric pump should be level with the distal tip of the catheter (e.g., the site of fluid delivery; if accessing a central line the volumetric pump should be at the level of the patient’s heart). If the pump height is raised relative to the distal tip of the catheter (e.g., during patient transport), the increase in height of the volumetric pump can result in a temporary increase in fluid delivery or bolus until the flow rate...

  • Page 40: Operation

    Operation Flowchart Selecting a Profile Section 7.2, page 41. Basic Profile Section 4.1.1, page 25. Programming an Infusion Section 7.3, page 41. Starting an Infusion Section 7.4, page 43. Monitoring an Infusion Section 7.5, page 44. Functions during Infusion Section 7.6, page 45. Completing an Infusion Section 7.7, page 47.

  • Page 41: Selecting A Profile

    Selecting a Profile You can only select a profile if more than one profile is loaded in the pump. 1. Press to power on the pump. 2. Press OK to select Basic Profile. The OCS test is performed. Programming an Infusion ...
  • Page 42 2. Press the arrow keys to program the infusion duration (__ h __), and press OK. 3. Press the arrow keys to program the flow rate, and press OK.

  • Page 43: Starting An Infusion

    Starting an Infusion 1. Check the administration set integrity. 2. Check that no air remains in the administration set. 3. Confirm that the administration set is correctly installed in the pump. 4. Open the roller clamp. 5. Connect the administration set to the patient's access device. 6.

  • Page 44: Monitoring An Infusion

    Monitoring an Infusion Legend VI (Volume Infused). Will increase during the infusion. To clear VI, see section 8.7, page 63. Infusion Flow Rate (mL/h) To change the flow rate during an infusion, see section 7.6.2, page 45. The flow rate is displayed with the largest font size. Infusion in Progress The infusion in progress indicator displays falling drops.

  • Page 45: Functions During Infusion

    Functions During Infusion 7.6.1 Stop 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. See section 7.3, page 41. 7.6.2 Rate Titration You can adjust the flow rate during the infusion.

  • Page 46: Administering A Direct Bolus

    7.6.3 Administering a Direct Bolus Note: This feature can be activated or deactivated in the pump options. A bolus is an extra dose that a pump can deliver during an infusion. 1. During the infusion, press 2. Press bolus to confirm access to bolus function. 3.

  • Page 47: Completing An Infusion

    Completing an Infusion 7.7.1 Near End of Infusion Alert Prior to the end of an infusion, a near end of infusion alert is automatically triggered. The following happens:  An audible alarm is triggered.  An alarm message appears on the pump screen. ...

  • Page 48: End Of Infusion

    7.7.2 End of Infusion When the VTBI reaches zero, the infusion is complete. The following happens:  An audible alarm is triggered.  An alarm message appears on the pump screen.  The infusion indicator lights flash yellow.  KVO (Keep Vein Open) rate is maintained. End of infusion settings (KVO rate, Silence duration) are configurable in the pump options.

  • Page 49: Powering Off

    7.7.3 Powering off You can power off the pump as follows: 1. Press to stop the infusion. 2. Close the roller clamp. 3. Press and hold until the pump powers off. Infusion Modes You can program an infusion with the different infusion modes available, depending on the pump configuration.

  • Page 50: Simple Rate (Only With Drop Sensor)

    7.8.4 Simple Rate (only with Drop Sensor) When a Drop Sensor is connected to the pump, Simple Rate infusion mode is available. 1. Press the arrow keys to select the flow rate. 2. Press OK. When no more drops are detected, the infusion is stopped and an alarm is generated.

  • Page 51: Advancing An Air Bubble

    5. Press and hold the key to prime, or press C to cancel. 6. To end priming, release the key. 7. Make sure there is no air in the infusion line. Information  Priming is only accessible prior to starting the infusion. ...
  • Page 52 2. Press 3. Press OK to advance the air bubble. 4. Press and hold to advance the air past the air detector. 5. Restart the infusion, or press C to cancel the advance air bubble function. Information  Air that has advanced past the air detector is still in the administration set.

  • Page 53: Auto-Restart

    7.9.3 Auto-restart Auto-restart is an optional feature that alters the pump’s response when a downstream occlusion is detected. When this feature is activated, and when a downstream occlusion is detected, the following occurs:  An alert is generated to inform the user that the pressure limit is reached.

  • Page 54: Pre-Programming The Pump

    7.9.4 Pre-programming the Pump You can program the pump before installing the administration set. 1. Press to power on the pump. is displayed on top of the pump screen. Install set !!! 2. Make sure the pump door is closed. The prog symbol is displayed.

  • Page 55: Menus

    Menus Overview 8.1.1 Commands Operation Access menu or exit menu Select Confirm (corresponds to enter on the screen) Select  / Deselect  8.1.2 Menu Description Stop Menu Symbol Infusion Associated Procedure Required  Profile Displaying active profile information, page 56. ...

  • Page 56: Profile

    Stop Menu Symbol Infusion Associated Procedure Required  Maintenance Displaying maintenance information, page 75. Note: The displayed menu may change depending on the pump configuration. For more information on factory configuration, refer to Appendix: Factory Configuration, page 142. Profile Symbol Procedure Displaying active profile information You can display the active profile name as follows:...

  • Page 57: Pressure

    Pressure Symbol Procedure Modifying the pressure limit 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. ...
  • Page 58 4. Press the arrow keys to increase or decrease the pressure limit. 5. Press OK to validate. 6. Press to enable or disable the Auto-restart function (optional). 7. Press OK to confirm. 8. Press to enable or disable the DPS function (optional). 9.

  • Page 59: Volume To Be Infused (Vtbi)

    Volume To Be Infused (VTBI) Symbol VTBI Procedure Changing VTBI You can change the VTBI as follows: 1. Press 2. Press the arrow keys to select VTBI The active VTBI is displayed. 3. Press enter. 4. Press the arrow keys to modify the VTBI. 5.

  • Page 60: Keypad Lock Status

    Keypad Lock Status Symbol Procedure Locking / Unlocking the keypad You can use this feature to avoid inadvertent key presses. Note: The following features can be activated or deactivated in the pump options:  Automatic lock: The keypad will lock automatically at infusion start, or after a time-out.
  • Page 61 Unlocking the Keypad You can unlock the keypad as follows: 1. Press 2. Press enter. 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 62: Battery Life

    Battery Life Symbol Procedure Viewing the battery life You can view the battery life as follows: 1. Press 2. Press the arrow keys to select The time remaining under current flow rate conditions is displayed. The bar graph shows a visual representation of battery life. The symbol displayed shows the following: ...

  • Page 63: Volume Infused

    Volume Infused Symbol Procedure Viewing and clearing the volume infused You can view and clear the volume infused as follows: 1. Press 2. Press the arrow keys to select The total volume infused includes boluses. The length of time over which they were infused is also displayed.

  • Page 64: Pause

    Pause Symbol Procedure Programming a pause You can program a pause as follows: 1. Press to stop the infusion. 2. Press 3. Press the arrow keys to select 4. Press enter. 5. Press the arrow keys to program the pause duration in hours and minutes, and press OK.

  • Page 65: Day/Night Mode

    Day/Night Mode Symbol Procedure Switching between day mode and night mode This function switches between day mode and night mode The default night mode settings are as follows:  The key-press beep is silenced.  Infusion indicators and screen brightness are dimmed. Depending on your pump configuration, the switch between day and night mode may be managed either through this menu (manual mode), or according to pre-defined settings (auto mode).
  • Page 66 Switching from Night Mode to Day Mode You can switch to day mode as follows: 1. Press 2. Press the arrow keys to select 3. Press enter. 4. Press to activate day mode. The screen displays 5. Press OK to confirm.

  • Page 67: Flow Rate (Ml/H)

    8.10 Flow Rate (mL/h) Symbols mL/h Procedure Changing the infusion mode You can change the infusion mode as follows: 1. Press 2. Press the arrow keys to select mL/h 3. Press enter. The available infusion modes are displayed. 4. Press the arrow keys to select a new infusion mode. 5.

  • Page 68: Alarm Volume

    8.11 Alarm Volume Symbol Procedure Adjusting the alarm volume You can adjust the alarm volume as follows: 1. Press 2. Press the arrow keys to select 3. Press enter. 4. Press the arrow keys to select the alarm volume. The pump emits an alarm at the selected volume level. 5.

  • Page 69: Call-Back Alert

    8.12 Call-back Alert Symbol Procedure Activating / Deactivating the call-back alert The call-back alert notifies the user when the set time interval has elapsed. Activating the Call-back Alert You can activate the call-back alert as follows: 1. Press 2. Press the arrow keys to select 3.
  • Page 70 Deactivating the Call-back Alert You can deactivate the call-back alert as follows: 1. Press 2. Press the arrow keys to select 3. Press enter. 4. To deactivate the programmed call-back alert, press the down arrow keys to set the duration period to "Off". 5.

  • Page 71: View Flow Rate History

    8.13 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. You can view flow rate history as follows: 1. Press 2.

  • Page 72: View Pressure History

    8.14 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. You can view pressure history as follows: 1. Press 2. Press the arrow keys to select 3.

  • Page 73: View Event Log

    8.15 View Event Log Symbol Procedure Viewing the event log 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.

  • Page 74: Date / Time

    6. Press exit to return to the previous screen. 8.16 Date / Time Symbol Procedure Setting up the date and time You can set the date and time as follows: 1. Press 2. Press the arrow keys to select 3. Press enter. 4.

  • Page 75: Maintenance

    8.17 Maintenance Symbol Procedure Displaying maintenance information You can display maintenance information as follows: 1. Press 2. Press the arrow keys to select 3. Press enter. 4. Press the arrow keys to scroll through the maintenance information. The following information is displayed: ...

  • Page 76: Options

    Options Commands Operation Options access Option selection Confirm (corresponds to enter on the screen) Select  / Deselect  Selected current values are stored when the device is powered off after programming. To return to the normal menus, power off then power on again. Option Descriptions Four different option groups are available on the pump.

  • Page 77: Pump Settings

    Pump Settings The following options have different functions that you can select or deselect to customize your Agilia VP. Default Function Choice Pump Setting  Selection assistance: display or hide selection [User 1]: assistance banner at the bottom of the screen...

  • Page 78: Data Communication

    Data Communication You can connect the pump to a PC for maintenance (via Agilia Partner 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 79: User Test

    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 80: Alarms And Safety Features

    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 81: General Remarks

    Required Alarm Priority Operator Description Response  The infusion continues.  The infusion indicator lights (LEDs) yellow are ON.  The pump emits audible alarm signals. Low (!)  Awareness Depending on the alarm, the key silences the alarm for no time limit or for a defined duration. For detailed description of each alarm, please refer to List of Alarms, page 81.
  • Page 82 12.4.1 Installed Set Alarms Stops Message Priority Problem / Resolution Infusion? At start-up, the administration set is not loaded or the door is open.  Install the administration set and close the High (!!!) Install set !!! door. Note: the key silences the alarm for 2 minutes.
  • Page 83 High (!!!) integrity. OCS failure !!!  If the problem cannot be resolved, contact your Fresenius Kabi sales representative. Note: the key silences the alarm for 2 minutes. Under specific conditions, the pump asks you to open and close the door to perform the...
  • Page 84 Stops Message Priority Problem / Resolution Infusion? A value must be entered.  Enter a value and press OK to confirm. Medium (!!) Waiting settings !! Note: the key silences the alarm for 2 minutes. The infusion settings have been entered but have not been confirmed with start.
  • Page 85 Stops Message Priority Problem / Resolution Infusion? The pressure in the upstream line is too low.  Check the roller clamp.  Check the container and line.  Check the container height. Upstream High (!!!)  Check air vent (if a bottle is used). occlusion !!! ...
  • Page 86 12.4.5 Battery Alarms Stops Message Priority Problem / Resolution Infusion? The battery is discharged.  The pump will power OFF automatically within 5 minutes.  Connect the pump to a power supply Alert !!! immediately. Very low battery High (!!!) Connect to power ...
  • Page 87 12.4.7 Keypad Alarms Stops Message Priority Problem / Resolution Infusion? The keypad is locked. Information Keypad lock status signal  Unlock the keypad. The keypad is locked and the door was Keypad locked Information opened and closed. Unlock keypad to signal ...
  • Page 88 Technical Error Alarms Stops Message Priority Problem / Resolution Infusion? Technical alarm.  Contact your qualified technician or your Fresenius Kabi sales representative. High (!!!) Erxx(yyyy) !!! Note: the key silences the alarm for 30 seconds. Temperature increase.  Check device environment.
  • Page 89 4. Switch the pump off by pressing the key. Warning If the alarms persist when the pump is powered on again, do not use the device on a patient, and contact qualified biomedical engineering staff in your healthcare facility or your Fresenius Kabi sales representative.
  • Page 90 12.5 Audio Only Information Signals Stops Type Comment Activation Infusion? Pressure measurement When auto-restart is activated and a 4 beeps checking downstream occlusion is detected Beep until key is Switch mode Beep starts when action is not allowed released Start infusion at the end At the end of a pause, when the infusion 3 beeps of pause...

  • Page 91: Volumat Lines

    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. 3. Check the container, the line and access device integrity.
  • Page 92 Precautions for the use of administration sets  Use administration sets which have the smallest internal volume or “deadspace” to minimize residual volumes when administering medications or fluids at low infusion rates (e.g., less than 5mL per hour, and especially flow rates less than 0.5 mL per hour). This reduces the amount of time it takes for fluid to reach the patient, maintains delivery accuracy, and reduces occlusion detection times.
  • Page 93 13.2.1 With a Bag The following diagram shows how to prime the administration set with a bag: 1. Remove the cap from the spike and insert the spike into the bag. 2. After hanging the bag, close the roller clamp. 3.
  • Page 94 13.3 Other Uses of Administration Sets 13.3.1 Access Ports The administration set may be equipped with access ports, that can be used to connect a gravity line, a secondary line, or administer a manual bolus (needle-free port). Legend Upstream port (before the pump) Downstream port (after the pump)
  • Page 95 13.3.2 Use of Administration Sets for Gravity Infusion 13.3.2.1 Gravity Infusion (without pump) In order to use the administration set to infuse the contents of the fluid container via gravity, without the pump, release the SafeClip as follows: 1. Close the roller clamp. 2.
  • Page 96 Information  Fresenius Kabi recommends the use of a back check valve or positive pressure infusion devices when an infusion on the pump is connected to a gravity line. This will prevent the back-up of IV fluid or medication into the gravity line.

  • Page 97: Device Storage

    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. Warning If the device is not used for an extended period (longer than 2 months), it is recommended that the battery be removed from the device and put...
  • Page 98 14.4 Using the Device After Storage The device can be used immediately after storage without any cooling or warm up period. If the battery has been removed for long-term storage, contact your biomedical department in order to reinstall the battery prior to use. We recommend charging the battery for at least 6 hours.

  • Page 99: Specifications

    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...

  • Page 100: Flow Rate

    15.2 Flow Rate Default Minimum Format Range of Settings Value Increment 0.01 (0.10  9.99) Primary Infusion mL/h 1200* (10.0  99.9)  (100  1200) Direct Bolus mL/h 1200 1200  mL/h  Priming mL/h 1200 * The maximum value can be adjusted between 50 and 1200 in the pump options (Basic Profile). 15.3 Volume To Be Infused (VTBI) Default...

  • Page 101: Management

    15.6 Pressure Management Information You can change the Basic Profile’s infusion pressure settings in the pump options. See section 9, page 76. Setting Description Setting Format Default Value Mode Infusion pressure mode. 3 levels / Variable Variable Allows DPS option activation Yes / No on the pump pressure menu.

  • Page 102: Accuracy

    15.7 Accuracy Warning Accuracy (flow rate, time, volume infused, pressure) can be influenced by administration set model, administration set configuration, fluid viscosity, and fluid temperature. Note: All tests below are in accordance with the IEC 60601-2-24 standard. 15.7.1 Flow Rate Accuracy Accuracy Cumulative Flow Rate ±...
  • Page 103 15.7.4 Volume Accuracy Accuracy < 10 mL: ± 0.5 mL Direct Bolus* > 10 mL: ± 5 % Limit to Detect Upstream ≤ 1.0 mL Occlusion* Bolus Volume at Occlusion Release Bolus Volume at Occlusion Rate 50 mmHg 750 mmHg Release* 25 mL/h -0.05 ≤...

  • Page 104: Calculation Rules

    15.8 Calculation Rules Infusion Stopped During Infusion Modify V,  T is calculated according to T = V/R Modify R,  Modify T, T is calculated according to T = V/R  R is calculated according to R = V/T Modify V, ...

  • Page 105: Cleaning And Disinfecting

    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 106 16.2 Recommended and Prohibited Agents We recommend the following cleaning and disinfecting agents: 16.2.1 Recommended Agents Recommended Agent Didecyldimethylammonium chloride Cleaning (example: Wip’Anios Excel by Anios) Didecyldimethylammonium chloride Disinfecting (example: Wip’Anios Excel by Anios) 16.2.2 Prohibited Agents The following cleaning and disinfecting agents are prohibited: ...
  • Page 107 16.3.1 Cleaning Instructions Prerequisites  The pump is powered off.  The power cord and all other cables are unplugged.  The air is at room temperature (20 to 25 °C).  The operator is wearing suitable protective equipment. Protocol 1.
  • Page 108 16.3.2 Disinfecting Instructions Prerequisites  The cleaning protocol has been performed.  The pump is powered off.  The power cord and all other cables are unplugged.  The air is at room temperature (20 to 25 °C).  The operator is wearing suitable protective equipment. Protocol 1.

  • Page 109: Power Management

    Warning  The pump and its accessories can only be connected to the AC power supply with the power cord supplied by Fresenius Kabi, or with a power supply accessory from the Agilia product range.  Do not use an extension cord when connecting the pump to the AC power supply.

  • Page 110: Battery Operating

    Information  Do not replace with a battery other than the one provided by Fresenius Kabi.  Do not use the pump without the battery connected.  Do not disconnect the battery when the device is operating on AC or battery power.

  • Page 111: Technical Characteristics

    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 mm For a list of compatible power cords, refer to the System Components booklet.

  • Page 112: Sound Levels

    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 18.5 Infrared Communication The pump is equipped with an infrared cell located at the back of the...

  • Page 113: Compliance

    18.7.2 Alarms Sound Levels Sound Level (dBA) Alarm Priority High-priority Medium-priority Low-priority 18.8 Compliance Compliant with the following Index of protection against ElectroMedical standards: IP22 ingress of water or particulate Equipment Safety  IEC 60601-1 matter  IEC 60601-1-8 Compliant with the following Protection against leakage (ElectroMagnetic standard:...

  • Page 114: Trumpet Curves

    18.10 Trumpet and Start-up Curves The trumpet curve shows the variation of the mean flow rate accuracy over specific observation periods. The variations are presented only as maximum and minimum deviations from the overall mean flow within the observation window. Trumpet curves are presented below for a number of representative flow rates.
  • Page 115 18.10.1Flow Rate: 1 mL/h Legend Instantaneous flow rate Set flow rate Sampling time: 10 s Time (minutes) Figure 18.1: Start-up and instantaneous flow rate (1 mL/h over first 2 hours on 96 hours) Legend Measured variance from flow rate Error 25,1 Flow rate 12,9...
  • Page 116 18.10.2Flow Rate: 25 mL/h Legend Instantaneous flow rate Set flow rate Sampling time: 10 s Time (minutes) Figure 18.4: Start-up and instantaneous flow rate (25 mL/h over first 2 hours on 96 hours) Legend Measured variance from flow rate Error Flow rate Sampling time: 10 s -2,5...

  • Page 117: Troubleshooting

    Remove the power cord.  something abnormal (unusual noise, Contact your biomedical department or your abnormal heat or smoke). Fresenius Kabi sales representative immediately.  The pump has been dropped or was Do not use the pump.  subjected to a force that may have Contact your biomedical department or your produced internal damage.
  • Page 118 Connect the pump to the AC power supply. Then, wait few minutes without touching the keypad until the message At start-up, the pump displays: disappears and the pump starts as usual. "Software is upgrading...".  Contact your biomedical department, or your Fresenius Kabi sales representative.

  • Page 119: 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 120: Warranty

    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...

  • Page 121: Guidance And Manufacturer's Declaration On Emc

    Guidance and Manufacturer's Declaration on 22.1 Electromagnetic Compatibility Warning  The Agilia pump and its accessories are intended to be used in the electromagnetic environments specified below.  The customer or the user of the Agilia pump should ensure that it is used in such environments.
  • Page 122 The following environmental conditions related to electrostatic sensitive components (ESD standards) must be observed:  Floors coated with wood, tiles or concrete  Relative humidity of at least 30% If it is not possible to guarantee this environment, the following additional precautions must be taken: ...
  • Page 123 Warning  Use of the Agilia pump adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. ...
  • Page 124 22.4 EMC and essential performances In the case of electromagnetic disturbances, if the essential performance, Section 15.1, page 99, is lost or degraded, the consequences for the patient are as follows: overdose, underdose, delay of therapy, air embolism, trauma, exsanguination. 22.4.1 Table 1 - Guidance and Manufacturer's Declaration - Electromagnetic Emissions...
  • Page 125 IEC 60601-1-2 Compliance - - - - - - - - - - - - - - Level Electromagnetic Environment - Immunity Test Obtained by Guidance IEC 60601-2-24 the Device Test Level Electrostatic ± 6 kV contact ± 8 kV contact Floor coverings made from wood, tiles and Discharge (ESD) ±...
  • Page 126 22.4.3 Table 4 - Guidance and Manufacturer's Declaration - Electromagnetic Immunity Warning  The Agilia pump and its accessories are intended to be used in the electromagnetic environments specified below.  The customer or the user of the Agilia pump should ensure that it is used in such environments.
  • Page 127 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 128: Electromagnetic

    EMC test deviations and supplementary tests 22.4.5 To ensure compatibility with the new EMC standard IEC / EN 60601-1-2 Ed4 and special environments, specific, additional or deviating tests are listed below with respect to the basic tests, in accordance to manufacturer risk analysis. IEC 60601-1-2 Compliance level Electromagnetic...

  • Page 129: Electromagnetic

    IEC 60601-1-2 Compliance level Electromagnetic Immunity test IEC 60601-2-24 obtained environment – guidance Test level by the device Electrical Fast ± 2 kV for power ± 2 kV for power Electricity power quality should be that transient / Burst supply lines supply lines of a typical domestic, commercial or IEC 61000-4-4...

  • Page 130: 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 131: Quality Control

    The life cycle of the pump is 10 years provided that the maintenance is properly performed as described above. 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.
  • Page 132 IT security could minimize exposure to threats. These threats may include but are not limited to: data leak, data corruption, data loss, network or service outage, and so on. Fresenius Kabi strongly advises to follow IEC/ISO 80001 to manage risks regarding IT-Network and Cybersecurity. Policy recommendations ...
  • Page 133 Information Fresenius Kabi strongly advises these recommendations to be applied to all software application, including operational, maintenance and direct configuration tools.
  • Page 134 Warning Medical devices must be deployed within a secure network perimeter to prevent access from unauthorized external system(s).  Develop and maintain a Security Patch Management process to minimize system vulnerabilities. Warning Ensure physical security of the premise and the Agilia system components.
  • Page 135 Login and passwords Individual institutional Information Technology (IT) policies should identify security controls that maintain the pairing of a login and password following IEC 80001-2. Hardening The default configuration of most operating systems is not designed with security as the primary focus. Instead, default setups focus more on usability, communications and functionality.
  • Page 136 Vulnerability Typical Threat Events Lack of integrity checking Adversaries could manipulate communications undetected. Strong mutual authentication between wireless clients and Inadequate authentication between access points is needed to ensure that clients do not connect wireless clients and access points to a rogue access point deployed by an adversary. Sensitive data between wireless clients and access point should be protected using strong encryption to ensure that Inadequate data protection between...
  • Page 137 Vulnerability Typical Threat Events Software vulnerabilities A wide variety of security implications and vulnerabilities Inadequately assess security of OTS have been identified with various OTS operating systems or control protocols such as OLE, DCOM, RPC, OPC, etc. Databases with web interfaces may be vulnerable to typical web attacks like XSS, SQL injection.
  • Page 138 Glossary of Terms Term Description Amperes Alternating Current Ampere-hours AIDC Automatic Identification and Data Capture Amplitude Modulation Amperes per meter 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 Computed Tomography Decibels...
  • Page 139 Term Description Duration 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 140 Term Description lb(s) Pound(s) Light Emitting Diode Milliamperes Milliequivalents 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...

  • Page 141: Vtbi

    Term Description Remote Procedure Control RS232 Serial interface connector Serial Number SELV Safety Extra Low Voltage Asynchronous Serial Infrared Structured Query Language Transmission Control Protocol Unique Device Identifier Universal Serial Bus Test specification level Volts Volt-Amperes Volts Direct Current Volume Infused VLAN Virtual Local Area Network Virtual Private Network...
  • Page 142 Appendix: Factory Configuration Feature Availability Feature Availability Profile  V/T/R  Pressure   management Infusion Volume to be Modes   infused Keypad lock Simple Rate   status Battery life Direct Bolus   Volume Infused   Pause Prime Set ...
  • Page 143 Index Administration Set Factory Configuration 142 Change 96 First Use 33 Install 36 Flow Rate 41, 44 Other Uses 94 Prepare 91 Prime 50, 92 Glossary 138 Remove 96 Graphics Replacement Interval 96 Flow Rate History 71 Agilia Connect Infusion System 16 Pressure History 72 Air Bubble Gravity Infusion 95...
  • Page 144 Menu Storage 97 Customization 77 Symbol Descriptions 2 List 55 Monitoring 44 Table of Contents 3 Temperature Navigation Buttons 23 Operating Range 12 Near End of Infusion Alert 47 Titration 45 Night Mode 65 Training 11 Troubleshooting 117 Trumpet Curves 114 OCS 35, 36 Options 76 User Test 79...

  • Page 145: Release Notes

    This document may not be reproduced in whole or in part without the written consent of Fresenius Kabi. ® ®...

  • Page 146: Servicing

    Local Contacts for Servicing Fresenius Kabi AG Fresenius Vial S.A.S. Le Grand Chemin Else-Kröner-Str. 1 61352 Bad Homburg, GERMANY 38590 Brézins - FRANCE Tel.: +49 (0) 6172 / 686-0 www.fresenius-kabi.com...

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