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Fresenius Kabi Volumat MC Agilia Instructions For Use Manual
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Fresenius Kabi Volumat MC Agilia Instructions For Use Manual

Fresenius Kabi Volumat MC Agilia Instructions For Use Manual

Volumetric infusion pump
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Volumat MC Agilia
Volumetric infusion pump
Instructions for use
Applicable to software 1.9

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Summary of Contents for Fresenius Kabi Volumat MC Agilia

  • Page 1 Volumat MC Agilia Volumetric infusion pump Instructions for use Applicable to software 1.9...
  • Page 2 Release Notes Software Date Description version May 2013 Creation July 2017 Software improvements Local contacts for servicing Complete this box with your contacts: 5315-11_master_ifu_volumat_mc_agilia_eng_US...
  • Page 3 Table of contents INTRODUCTION ....... 8 NSTRUCTIONS DESCRIPTION OF SYMBOLS ....................8 COPE ..................9 NTENDED USE ................9 ONTRAINDICATIONS ................10 SE ENVIRONMENT ......... 10 ARNINGS AND PRECAUTIONS TO BE TAKEN ..............12 ARE AREAS AND DATA SET DESCRIPTION ..............
  • Page 4 PROGRAMMING ... 37 VERVIEW TABLE OF THE AVAILABLE INFUSION MODES AND FEATURES – ....38 ROGRAMMING A ASIC NFUSION ASIC M 4.2.1 Programming a Basic infusion............38 4.2.2 Infusion start..................40 4.2.3 Monitoring a Basic Infusion - in Basic mL/h Mode ......41 .....
  • Page 5 4.8.2 Advancing an air bubble..............77 4.8.3 View event log ................... 79 4.8.4 Graphs....................80 4.8.5 Pre-programming the pump .............. 83 4.8.6 Change drug selection in Vigilant Drug'Lib mode......84 4.8.7 Call-back Alert ................... 86 4.8.8 Battery life indication ................. 87 4.8.9 Micro / Macro indication ..............
  • Page 6 11.11 B ..........110 OLUS VOLUME AT OCCLUSION RELEASE 11.12 C ................110 ALCULATION RULES 11.13 U ............111 NITS AND CONVERSION RULES 11.14 C ............... 112 OMPATIBILITY MATRIX 12 TECHNICAL CHARACTERISTICS 12.1 ................. 113 OWER SUPPLY 12.2 ................... 113 ATTERY 12.3 ...............
  • Page 7 17 SERVICING 17.1 ............... 137 ERVICE POLICY AND RULES 17.2 ............137 AINTENANCE REQUIREMENTS 17.3 ................138 UALITY CONTROL 18 RECYCLING AND DISPOSAL 19 WARRANTY 19.1 ..........140 ENERAL CONDITIONS OF WARRANTY 19.2 ................140 IMITED WARRANTY 19.3 ....140 ARRANTY CONDITIONS FOR BATTERY AND ACCESSORIES 20 ORDERING INFORMATION 20.1...
  • Page 8 Introduction Volumat MC Agilia is the large volume pump of the Agilia product line, supported by the Vigilant Drug Library for dose error reduction software management and advanced programming features. Instructions For Use: description of symbols Symbol Description Danger: Warning of an imminent hazard that could result...
  • Page 9 It is recommended that users attend a refresher training session of about 20 minutes every year. 1.3.2 Operation mode Volumat MC Agilia is a reusable device. This is a type 4 continuous operation infusion pump. Contraindications Danger: The pump is not designed for use in an explosive or flammable DANGER environment due to risk of ignition.
  • Page 10 The Volumat MC Agilia must not be used to administer enteral nutrition, patient controlled analgesia, inflammable liquids, non-water soluble solutions, unsterile fluids or fluids not suitable for infusion. Use environment The Volumat MC Agilia is intended for hospital use. Warning:...
  • Page 11 Only authorized service personnel should attempt to repair the Volumat MC Agilia.  Only use the Volumat MC Agilia for the infusion of fluids that are intended for administration using an infusion pump.  The pump must only be utilized under medical supervision.
  • Page 12 Care areas are predefined homogeneous groups of patients or units in a hospital. The Volumat MC Agilia infusion pump may be programmed for use in one of the 20 available care areas: the user must select a care area just after powering on.
  • Page 13 Description Agilia system description The Agilia infusion system comprises the following:  Volumat MC Agilia: large volume infusion pump and power cord  Volumat Disposable Administration Sets  Link Agilia: selection of rack configurations  Vigilant Drug'Lib Agilia: dose error reduction software (DERS) ...
  • Page 14 Back view Legend: Attachment Lock Knob Infrared Cell Power Cord Inlet RS232 Communication Port and DC Power Input/Output Pole Clamp Release Button Drop Sensor Connection Socket (not available in US) Symbol Location Symbol description Warning! Near Power Cord Inlet Please see section 12 Near RS232 Warning! communication port...
  • Page 15 Keypad Legend: Power Supply Indicator Status Indicators Alarm Silence Fast Decrement Down Menu Decrement Down Graph Display Increment Up Cancels Value / Moves Back Fast Increment Up to Previous Field Bolus / Prime Stop / Pause On/Off Confirms Value / Moves to Screen Next Field, Starts Infusion Information:...
  • Page 16 Display and symbols Volumat MC Agilia displays the parameters for the infusion in progress using specific symbols. Symbol Meaning Explanation A drop falling into the drip Infusion in progress chamber (see also Indicator lights for infusion in progress). STOP remains in the center of...
  • Page 17 Symbol Meaning Explanation Not selected See drug These symbols help the user Help information with programming. Lock / Unlock keypad Power disconnection alarm Pressure increase Pressure decrease Main symbols for alarm and safety features. Upper soft limit Alarms and safety exceeded features Lower soft limit...
  • Page 18 Symbol Meaning Explanation Volume to be infused Patient Battery life Macro/Micro View event log Maintenance Sound level The menu gives access to the Menu Date/time infusion options selected by the user. Locking keypad Pause Night mode Call-back Drug Data Set info Care Area Information Secondary mode...
  • Page 19 Device identification label Symbol Description Product reference / part number Product serial number Input terminal - connector Output terminal - connector Electrical fuses Alternating Current (AC) Direct Current (DC) Protection against leakage current; defibrillation-proof type CF applied part IP22 Index of protection against splashing liquids Not for use in residential areas Refer to the Instructions For Use Part included in a recycling process...
  • Page 20 The UDI (Unique Device Identifier) is represented in AIDC (Automatic Identification and Data Capture) and readable text:  (01) Product Identifier GTIN  (21) Product Serial Number  (11) Date of Manufacture  (240) Product Reference Packaging symbols Symbol Description Fragile, handle with care This way up Keep away from rain...
  • Page 21 Flowchart Prepare set and container Sections 3.4.2 Install pump Section 3.4.1, page 30 and 3.4.3, page 30 Install set in pump / Power ON Sections 3.4.5 and 3.4.6, page 34 Select Care area Section 4.3.1, page 43 Basic mL/h Care area in Vigilant V/R mode Drug'Lib mode Section 4.2, page 38...
  • Page 22 If the contents in the packaging are not complete or are damaged, please contact your Fresenius Kabi sales representative. Positioning the pump(s) The Volumat MC Agilia pole clamp may be positioned to attach to an IV pole or bed/gurney rail. on a pole...
  • Page 23 Several Agilia devices When two Agilia devices Agilia products have a can be attached to a pole are stacked together, the handle for carrying. in any order. Agilia Duo accessory Up to three devices may can be used to centralize be assembled together the power supply.
  • Page 24 Information:  For additional information about how to attach the pump on a Link Agilia, please consult the related instructions for use.  Mechanical specifications for locking the pole clamp: - Pole: Diameter : from 0.6 to 1.6 in (15 to 40 mm). - Rail : Height : from 1 to 1.4 in (25 to 35 mm).
  • Page 25 3.3.2 Install in Link Agilia rack (optional accessory) Warning:  Do not force pump during installation. If you have to force excessively, do not use the rack and contact customer service.  During installation, be sure that IV sets are not kinked or damaged when pump is mounted.
  • Page 26 5. When the rack is powered by the AC power supply, check pump display to confirm power display light is ON and listen to the audio pump signal. 6. Follow instructions as per the Link Agilia Instructions For Use.
  • Page 27 3.3.3 For use on a flat table It is recommended that the pump be attached to an IV pole or bed/gurney rail to ensure a stable location and prevent falling. 1. Check that the pole clamp is folded up against the pump. 2.
  • Page 28 4. Ensure that the device is securely attached. 3.3.5 Attaching two pumps together When two pumps are stacked together, they must be fixed to a pole. 1. Make sure both pumps have their clamp up in the folded position (see section 3.3.2). 2.
  • Page 29 3.3.6 Attaching the Agilia Duo (optional accessory) Warning: The Agilia Duo accessory is designed to connect a maximum of two pumps. 1. Insert the two black connectors of the Agilia Duo into the two black power sockets on the back of the connected pumps.
  • Page 30 Getting started 3.4.1 Installing the device Warning:  In order to ensure that all the safety features of the device are activated, the pump should be powered ON prior to being connected to the patient.  If power is supplied by the AC power supply or an external power source, check that the Power supply indicator lights up (green).
  • Page 31 To operate the SafeClip for Gravity infusion, please refer to section 4.7.3, page 75. Danger:  Fresenius Kabi recommends the use of a Back Check Valve or positive pressure infusion devices for multi-line infusions. DANGER  Position administration sets as close as possible to the patient for multi-line infusions.
  • Page 32  If there is no Back Check Valve on a gravity infusion line during a multi-line infusion, this will make it impossible to detect occlusions on the patient side, and could result in accumulation of the drug being infused in the gravity line, which could later be infused in an uncontrolled manner when the occlusion is released.
  • Page 33 3.4.4 Priming the administration set used with a bag or a bottle Warning: After priming, check that there are no air bubbles in the administration set. 1 - With a bag 1. Close the roller clamp. 2. Remove the cap from the spike. Insert the spike into the bag.
  • Page 34 3.4.5 Powering on 1. Open the pump door by lifting the door lever. 2. An auto-test checks the functionality of the pump. Make sure that all LED lights and buzzers are activated. Once the auto-test is OK, Install set is displayed. Information: ...
  • Page 35 Information: The SafeClip is automatically engaged when it is inserted into the clamp guide and the pump door is closed. 6. The Occlusivity Check System (OCS) automatically clamps the line, activates pumping and checks for the rise in pressure. The OCS test verifies the circuit and pump occlusivity at start-up, thus reducing the occurrence of unintentional gravity flow.
  • Page 36 DANGER administration set and container are maintained. Warning:  Fresenius Kabi recommends not placing the pump higher than 51.2 in (1.3 meter) above patient's heart.  The container must be hung between 8 to 32 inches (20 to 80 cm) above the pump.
  • Page 37 Programming Overview table of the available infusion modes and features Available in Care Areas Infusion Modes Available in Basic if enabled with and Features mL/h Vigilant Drug'Lib Infusion in mL/h based on V/R Enabled Configurable (Volume + Rate) Infusion in mL/h based on V/T/R Disabled Configurable (Volume + Duration + Rate)
  • Page 38 Programming a Basic Infusion – in Basic mL/h Mode The following steps are used to program a Basic Infusion. To program an infusion using the Vigilant Drug Library, see section 4.3, page 42. 4.2.1 Programming a Basic infusion 1. Press the key to power ON the pump.
  • Page 39 Warning: Ensure VTBI is not greater than actual volume in the container to avoid air in line at the end of infusion. All added or removed volumes must be taken into consideration, including the volume of fluid contained in the administration set and lost during priming (priming volume varies by administration set;...
  • Page 40 4.2.2 Infusion start 1. Open the roller clamp. Ensure that there is no fluid infusing and no air remaining inside the infusion line. 2. Connect the administration set to the patient's IV access device. Warning:  When connecting the administration set to a patient's IV access device, always use aseptic technique according to your hospital policy.
  • Page 41 4.2.3 Monitoring a Basic Infusion - in Basic mL/h Mode Legend: Power supply indicator When the pump is plugged in, the power supply indicator light will be green. When the pump is operating on battery power, the power supply indicator light is off.
  • Page 42 Programming a drug infusion in Vigilant Drug'Lib mode Warning: When infusing critical drugs, it is recommended that Vigilant Drug'Lib mode be used. The following steps should be used to program a drug that is listed in the Vigilant Drug Library. In Vigilant Drug'Lib mode, a drug name must be selected from a predefined drug library.
  • Page 43 4.3.1 Care area selection Care Area can only be selected when powering on the device. 1. Press the key to power ON the pump. Current Care Area is displayed. 2. Press C to change Care Area or press OK to confirm current Care Area.
  • Page 44 4. Press OK to confirm Care Area selection or press C to change Care Area. Information: If the previous Care Area is chosen, the new Care Area confirmation screen will indicate 'Reselect'. The selected Care Area information is displayed: - Care Area name - Author - Creation date - Modification date...
  • Page 45 4.3.2 Drug selection 1. Use the arrow keys to scroll and find drug name. 2. Press OK. Information:  The double arrow keys can be used to scroll through the drug list by alphabetical order.  Pressing both up arrow keys simultaneously = provides quick access to the drug located at the top of the drug library.
  • Page 46 4.3.3 Drug concentration selection If the drug selected has been configured to allow the concentration to be adjusted, proceed to step 1. If not, proceed to section 4.3.4. 1. Adjust the drug concentration using the arrow keys, then press OK to confirm.
  • Page 47 4.3.4 Patient weight selection The weight entry screen only appears if the drug selected uses weight for dose rate calculations. A pre-populated default weight can be configured with Vigilant Drug'Lib. 1. Use the arrow keys to enter the patient's weight. 2.
  • Page 48 3. Use the arrow keys to program the infusion duration (Dur.:), then press OK. Information:  Use the double arrow keys to change duration by an hour. Use single arrow keys to change duration by a minute.  The resulting flow rate and dose are automatically calculated and displayed.
  • Page 49 4.3.6 Infusion start 1. Open the roller clamp. Ensure that there is no fluid infusing and no air remaining inside the infusion line. 2. Connect the administration set to the patient's IV access device. Warning:  When connecting the administration set to a patient's IV access device, always use aseptic technique according to your hospital policy.
  • Page 50 4.3.7 Monitoring a drug infusion in Vigilant Drug'Lib mode Legend: Vigilant Drug'Lib mode When infusing a drug selected from the Vigilant Drug Library, will be displayed continuously on the screen. Drug name VTBI (Volume to be infused) remaining. Will decrease during the infusion. To change VTBI during an infusion, see changing VTBI in section 4.5.2.
  • Page 51 4.3.8 Programming beyond soft limits Information: Flow rate / Dose may be adjusted within authorized range. Programmable Authorized Programmable Unauthorized range range range range Default values Soft limits Accessible range Warning and confirmation Hard limits Not accessible, unauthorized range 1. A soft dose limit can be overridden. When a soft dose limit is reached, a message will be displayed at the top of the screen.
  • Page 52 Information:  Previous infusion parameters continue until new parameters are confirmed by pressing OK.  A parameter that exceeds a hard limit cannot be programmed. 3. The above or below dose limit message will alternate with the drug name and concentration at the top of the screen during infusion.
  • Page 53 Programming a Loading Dose If configured for the selected drug in the Vigilant Drug library, a loading dose can be programmed prior to starting the infusion. The following screens will appear after programming the primary infusion (see section 4.3). 4.4.1 Loading dose selection 1.
  • Page 54 4. Press start to start the loading dose. Information:  If needed, press C or to change the loading dose parameters before starting.  Once the loading dose is completed, the pump automatically starts the programmed primary infusion. 4.4.3 Loading dose interruption 1.
  • Page 55 Functions during infusion applicable for Basic mL/h and for Care Area Drug defined with Vigilant Drug'Lib 4.5.1 Flow rate and Dose titration Basic mL/h Care Area Drug defined with Vigilant Drug'Lib As defined in the Vigilant Drug Library, the flow rate or the dose may be changed during the infusion.
  • Page 56 4.5.2 Changing VTBI 1. Press the key. 2. Use the arrow keys to select 3. Press enter. 4. Use the arrow keys to modify the VTBI and press OK to confirm. 4.5.3 Viewing and clearing Volume infused 1. Press the key.
  • Page 57 4.5.4 Pausing the infusion 1. Press to stop the infusion first. 2. Press the key. 3. Use the arrow keys to select and press enter. 4. Use the arrow keys to program the pause duration in hours and minutes and press OK. 5.
  • Page 58 4.5.5 Direct bolus There are two ways to deliver a bolus dose, either through a programmed Bolus or a Direct Bolus. A direct bolus is a dose that may be delivered during the infusion by the pump. The bolus volume will result from the time the bolus key is pressed. Information: ...
  • Page 59 Information:  To change the bolus rate during primary infusion, keep the pressed for at least 3 seconds and modify the bolus rate with the arrow keys.  The bolus volume is added to the Volume Infused (VI). 4.5.6 Programmed bolus A programmed bolus is a dose that may be delivered during the infusion by the pump.
  • Page 60 Access through MENU 1. Press the key. 2. Select in the menu. 3. Press Enter. The Programmed bolus screen appears. Bolus parameters in Flow Rate Bolus parameters in Dose 4. Adjust the bolus parameters. 5. Use the arrow keys to program the bolus Volume or Dose, then press OK.
  • Page 61 7. Press start to start the bolus. Press C or to modify the bolus parameters. 8. To exit the bolus function and save the programmed bolus parameters, press exit. Information:  Primary infusion continues after bolus at previously set rate. The bolus volume is added to Volume Infused (VI).
  • Page 62 4.5.7 Secondary (Piggyback) infusions Warning: Specific administation sets are available for secondary infusions. For further information, please refer to the individual administration set labeling. Secondary infusion mode should be used with a secondary line (VL SL00-0) connected to the primary sets upper port (VL PR42-11, VL PR42-21, VL PR42-41, VL PR42-12, VL PR72-11).
  • Page 63 1. Prime the secondary administration set. 2. Hang the secondary container 12 inches higher than the primary container. 3. Press to hold the primary infusion. 4. Using aseptic technique, connect the secondary line to the upper port access on the primary line. 5.
  • Page 64 1 - Define the infusion 1. Select secondary drug when using a care area with a drug library. 2. Use the arrow keys to program carefully the secondary Volume To Be Infused. Confirm by pressing OK. 3. Use the arrow keys to program the secondary flow rate. Confirm by pressing OK.
  • Page 65 3 - End of secondary infusion When the secondary infusion is complete, a short beep is emitted and the infusion will automatically return to the programmed primary infusion. 1. Ensure that the Primary line is open. Information:  Pri VI indicates the total volume infused since it was cleared. ...
  • Page 66 4.5.8 Pressure management 1 - Accessing the pressure menu Pressure limit Current infusion line pressure The pressure parameters for the infusion can be changed (please refer to section 11.9). 1. Press the key. 2. Use the arrow keys to select 3.
  • Page 67 3 - DPS The Dynamic Pressure System (DPS) informs the user of any sudden rise or drop in pressure before the pressure limit is reached. The current DPS status is indicated with a check box. 1. Press to enable or disable the DPS function. 2.
  • Page 68 4.5.9 Lock keypad This feature can be used to lock the keypad and avoid inadvertent key presses. 1. Press the key. 2. Use the arrow keys to select 3. Press enter. Information: Keypad lock status is displayed as a icon. 4.
  • Page 69 4.5.10 Unlock keypad 1. Press the key. 2. Use the arrow keys to select 3. Press enter. Information: Keypad lock status is displayed as a icon. 4. Press to unlock the keypad. Screen will display 5. Press OK to confirm.
  • Page 70 4.5.11 Night mode activation This feature can be used to silence the key press audio and decrease the brightness of the display and infusion indicators. The access through the pump menu can be disabled in 'Basic mL/h configuration' (see section 8) or with Vigilant Drug'Lib. In that case, the pump will switch automatically to / from the night mode according to a defined time period.
  • Page 71 4.5.12 Night mode deactivation 1. Press the key. 2. Use the arrow keys to select . 3. Press enter. Information: Night mode status is displayed as (enabled) or (disabled) icon. 4. Press to deactivate night mode. Screen will display 5. Press OK to confirm.
  • Page 72 Completing an infusion 4.6.1 Near end of infusion alert Information:  In Basic mL/h mode, those parameters are adjustable with an access code in 'Basic mL/h configuration'. For additional information, please refer to the technical manual.  For a Care Area defined with Vigilant Drug'Lib, those parameters are adjustable with Vigilant Drug'Lib.
  • Page 73 4.6.2 End of infusion Information: This section describes default settings.  In Basic mL/h mode, those parameters are adjustable with an access code in 'Basic mL/h configuration' with the following range of values: - KVO rate: Off or from 1 to 20 mL/h. Default pump settings: 1 mL/h.
  • Page 74 4.6.3 Stop To stop the infusion: 1. Press the key. Information: After 2 minutes, an alarm is generated as a reminder that the infusion is stopped. 2. To restart the infusion, confirm or modify programming parameters as described in section 4.3.5 and start the infusion. 4.6.4 Power off 1.
  • Page 75 Operations for administration sets 4.7.1 Removing an administration set 1. Press the key to stop the infusion. 2. Close the roller clamp. 3. Press the key to silence the audible signal for 2 minutes. 4. Open the pump door. 5. Remove the administration set from the pump. 6.
  • Page 76 Other functions 4.8.1 Priming feature with the pump This function is accessible only if enabled with Vigilant Drug'Lib. 1. Press the key to power on the pump. The infusion mode defined in the options is displayed after the OCS screen. 2.
  • Page 77 4.8.2 Advancing an air bubble Warning:  Air that is advanced past the air detector is still in the administration set. If the volume of air is clinically significant for the patient, remove the air from the administration set.  It is recommended to ask for medical advice to assess whether the infusion can be restarted because air is still present.
  • Page 78 4. Press and hold the key to move the air past the air in line detector. Then restart the infusion. 5. Press C to cancel Advance air bubble function. Information: The air bubble advances at the same programmed rate for the volume of air setting (configured before).
  • Page 79 4.8.3 View event log This function is accessible only if enabled with Vigilant Drug'Lib. 1. Press the 2. Use the arrow keys to select . Press enter. 3. Use the arrow keys to select the desired event. Press enter. The details of the event are given. 4.
  • Page 80 4.8.4 Graphs Warning: This function allows the user to check the historical information in order to check the administered dose and changes in pressure. 1. Press 2. Use arrow keys to select desired graph. Select for pressure graph; select for rate graph. Symbols Definitions Pressure history...
  • Page 81 1 - Pressure history (in mmHg) Legend: The time and the pressure limit of the event marker are displayed on the upper line. The dotted horizontal line represents the alarm limit. The pressure limit may be adjusted during an infusion by selecting Pressure from the Menu.
  • Page 82 Example of an occulsion alarm Occlusion alarm Detailed screen of above occlusion alarm 1. Press for detailed information regarding the event.  'User limit' indicates the pressure limit.  'Pressure' is the current pressure in the line. 2. Press exit to go back to pressure history. 2 - Flow rate/Dose history Up to 12 hours of rate data is displayed.
  • Page 83 4.8.5 Pre-programming the pump The pump can be programmed before loading the administration set. 1. Press the key to power ON the pump. An Install set message appears. 2. Select prog. 3. Program the infusion as described in section 4.3.5. 4.
  • Page 84 4.8.6 Change drug selection in Vigilant Drug'Lib mode 1. Press to stop the infusion. 2. Press the key and select 3. Press enter. 4. Press OK to confirm modifying drug. 5. Select new drug and press OK to confirm. 6. Validate new drug parameters if needed by pressing OK.
  • Page 85 Previous infusion in mL/h mode Previous infusion in Dose Rate mode 7. Press OK to acknowledge new drug modification and continue programming infusion (see sections 4.3.5 and 4.3.6). Press C to select another drug. 8. Program new drug infusion (see section 4.3). Warning: When a drug is changed, the parameters are reinitialized.
  • Page 86 4.8.7 Call-back Alert Information: This function is accessible only if enabled with Vigilant Drug'Lib. Activate Call-back alert 1. Press the key and select 2. Press enter. 3. Enter a duration of time to elapse prior to alert, then press OK. Information: ...
  • Page 87 4.8.8 Battery life indication 1. Press the key. 2. Use the arrow keys to select The hours and minutes remaining for the current flow rate conditions are displayed. The shaded bar gives a visual representation of battery life. Information:  : The pump is plugged into the AC power supply.
  • Page 88 Data communication Data communication cables Warning:  Before connecting the device to any third party system, please contact your IT or biomedical department in order to perform the device configuration.  All connection and disconnection operations must be executed by qualified and appropriately trained staff only.
  • Page 89 5.1.1 Communication port description 1. Remove the protective cap of the communication port. 2. To connect the cable to the pump communication port, turn the wheel of the cable as shown. 5.1.2 USB connection and removal 1. Connect the terminated USB cable to the pump communication port. 2.
  • Page 90 Data set management Warning:  The definition of the Data Set and its upload to the device is the responsability of the hospital.  If there is no Data Set uploaded to the pump, the pump can be used in Basic mL/h mode without the protections of the Vigilant Drug'Lib software.
  • Page 91 Audible alarm signals can be adjusted in ‘Basic mL/h configuration' (see section 8). The Volumat MC Agilia has a continuous monitoring system that operates as soon as the pump is in use.
  • Page 92  It is recommended that the user is positioned in front of the Volumat MC Agilia, for best visibility of alarm display.  When the AC power is cut-off for less than 30 seconds and the...
  • Page 93 Infusion System Message Type Activation /  Action stop At start-up: administration set not loaded or High !!! Install set door open priority  Load administration set and close door. No administration set in front of the !!! Check set High upstream or downstream sensor.
  • Page 94 Infusion System Message Type Activation /  Action stop Infusion parameters have been entered but !! Waiting Medium start has not been confirmed. start priority  Check infusion parameters and press start to start the infusion. The flow rate/Dose has been modified Infusion Flashing Information...
  • Page 95 Infusion System Message Type Activation /  Action stop Verify line Before starting secondary infusion, line installation: installation should be verified: Information Secondary line should be open secondary: signal Primary line should be closed in manual open primary: mode, Primary bag should be lower in closed or automatic mode.
  • Page 96 Menu Operation Access menu or exit out of menu Select Confirm (corresponds to on the screen) Selected  / Not selected  Vigilant Basic mL/h Function Description Operation Symbol Drug'Lib mode mode Adjustment of Volume to be VTBI during • New setting Enabled Enabled infused...
  • Page 97 Vigilant Basic mL/h Function Description Operation Symbol Drug'Lib mode mode Programmed Programming a • Volume or dose Enabled Configurable bolus bolus • Rate • The parameters to set Programming a Primary/ secondary are the same as in Enabled Configurable Secondary infusion primary mode Alarm...
  • Page 98 Vigilant Basic mL/h Function Description Operation Symbol Drug'Lib mode mode • Data Set name Information on • Modification date Data set Disabled Configurable Data Set • Creation date • Version • Care Area name • Author • Creation date Information on Care Area Disabled Enabled...
  • Page 99 Options The following options have different functions that you can select or deselect to customize your Volumat MC Agilia. Operation (when the device is powered off, press Options access simultaneously on both keys, <ON> and <MENU>) Option selection (corresponds to...
  • Page 100 ENTER ENTER ENTER Option Function Choice Default Pump setting Pump [User 3] Contrast • Adjustment of screen contrast. settings Medium level Use fast increment and decrement keys [User 7] Date/Time • Date selection: mm/dd/yyyy Production plant date and • Hour selection: h/min time •...
  • Page 101 User test The following protocol provides the user with a quick check guide to ensure that the pump system is functional. Warning: It is recommended that this User test be performed before each use of the pump. 1. Check external aspect of the pump, absence of crack or visible damage.
  • Page 102 This section provides information to perform troubleshooting of the Volumat MC Agilia. Information: For additional information about issues and troubleshooting, please contact your biomedical department or Fresenius Kabi sales representative. Refer to page 2 for contacts. Issue description Recommended action The pump is not stable when mounted •...
  • Page 103 Issue description Recommended action • Connect the pump to the AC Power The power status indicator does • Contact your biomedical department or Fresenius Kabi not light up Customer Service • Connect the pump to the AC Power The device powers off on its own •...
  • Page 104 Specifications 11.1 Rates range Information: In Basic mL/h, only macro mode is available. 11.1.1 Basic mL/h rates range Default pump Rates range settings Infusion rate (mL/h) From 1 to 1500 mL/h, with 1 mL/h increments 0 mL/h Direct Bolus rate (mL/h) From 200 to 1500 mL/h, with 50 mL/h increments 1500 mL/h Programmed bolus rate From 1 to 1500 mL/h with 1 mL/h increments...
  • Page 105 11.2 Volume to be infused (VTBI) 11.2.1 Basic mL/h VTBI range Default pump Volume range settings Volume to be infused From 1 to 9999 mL, with 1 mL increments 0 mL in 'mL/h' Volume to be infused for From 1 to 2000 mL with 1 mL increments 1 mL a secondary infusion Programmed bolus...
  • Page 106 11.3 Dose range for drugs in Dose rate with Vigilant Drug'Lib mode Setting range Patient data • Increment of 0.01 from 0.25 to 0.99 Weight (kg) • Increment of 0.1 from 1 to 9.9 • Increment of 1 from 10 to 250 Concentration (Units/X mL) •...
  • Page 107 11.6 Administration set replacement interval The mechanical properties of the administration set in association with the pump are designed to maintain pumping performances for 10 liters maximum within a time limit of 96 hours. Sets should not be used for more than 96 hours or 10 liters of infusion.
  • Page 108 11.7.2 Effects of pressure variations on accuracy Accuracy with back In accordance with the NF pressure of + 39.9 kPa EN/IEC 60601-2-24 standard and Accuracy with back -1.5% ANSI/AAMI ID26:2004. pressure of + 13.33 kPa Test condition: Accuracy with back Container height: 20 in (50 cm) +1.5% pressure of - 13.33 kPa...
  • Page 109 11.9 Pressure management Values are adjustable in 'Basic mL/h configuration' option (see section 8) or with Vigilant Drug'Lib. Basic mL/h mode Vigilant Drug'Lib Description Setting range Default pump mode settings 3 levels mode The pressure limit is adjustable during an infusion (enabled by to the lower, medium or higher pre-set pressure Enabled...
  • Page 110 11.10 Occlusion alarm response time The occlusion times have been obtained by creating an occlusion with a three-way-stopcock situated immediately after a VL ST10-0 set. Occlusion times may vary if the occlusion occurs at a different place in the line or if another model of administration set is used. Occlusion alarm threshold Rate 50 mmHg...
  • Page 111 The calculated value for macro infusion is displayed rounded according to the following rules. Calculated Value Examples Calculated V = 1.3 mL, Rounded up to the nearest mL displayed V = 2 mL Rounded up to the nearest Calculated T = 1 hour 12 min 32 sec, minute displayed T = 01:13 Calculated R = 42.52 mL/h,...
  • Page 112 11.14 Compatibility matrix The following matrix provides information about software compatibility between Agilia infusion system components. Product name Agilia Infusion System requirements and version Vigilant Drug'Lib Volumat MC Agilia Link Agilia Agilia software Notes software version software version version V1.7, V1.9...
  • Page 113 Technical characteristics 12.1 Power supply Warning: Use the power cord supplied with the pump. It is mandatory to use a power cord compliant with US standards and with IEC 60227 standard. The minimum diameter for the power cord conductor must be at least 0.75 sqm.
  • Page 114 Power output 5 VDC/150 mA to power Agilia USB cable 12.5 Infrared communication Volumat MC Agilia is equipped with an infrared cell located at the back of the device. It is used for data communication with the Link Agilia rack. Function...
  • Page 115 12.8 Trumpet and start-up curves The trumpet curve shows the variations of the mean flow 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 116 12.8.1 Flow rate: 0.1 mL/h 1. 0.1 mL/h over 20 first hours on 96 hours Sampling time: 120 seconds Flow rate/Time curves: start-up and instantaneous flow rate Instantaneous rate at : 0,1 ml/h on 1st and 2nd hours Set flow rate 0,20 0,18 0,16...
  • Page 117 12.8.2 Flow rate: 1 mL/h 1. 1 mL/h over 2 first hours on 96 hours Sampling time: 10 seconds Flow rate/Time curves: start-up and instantaneous flow rate Instantaneous rate at : 1 ml/h on 1st and 2nd hours Set flow rate -0,2 Time (minutes) Trumpet curves for 2, 5, 11, 19, 31 minutes observation windows...
  • Page 118 12.8.3 Flow rate: 25 mL/h 1. 25 mL/h over 2 first hours on 96 hours Sampling time: 10 seconds Flow rate/Time curves: start-up and instantaneous flow rate Instantaneous rate at : 25 ml/h on 1st and 2nd hours Set flow rate Time (minutes) Trumpet curves for 2, 5, 11, 19, 31 minutes observation windows Trumpet curve on 2nd hour...
  • Page 119 12.8.4 Flow rate: 1500 mL/h 1. 1500 mL/h over 2 first hours on 10 Liters Sampling time: 10 seconds Flow rate/Time curves: start-up and instantaneous flow rate Instantaneous rate at : 1500 ml/h on 1st and 2nd hours Set flow rate 3000 2700 2400...
  • Page 120 Agilia Duo) in standalone are intended to be used in the electromagnetic environment specified below.  The customer or the user of the Volumat MC Agilia should assure that it is used in such an environment. The Volumat MC Agilia must not be used in the presence of intense electromagnetic fields, such as those generated by certain electrically powered medical devices.
  • Page 121 Its immunity is designed to ensure correct operation. Limitation of the emitted radiation avoids undesirable interference with other equipment. Volumat MC Agilia is classified as a Class B device according to CISPR 11 emitted radiation and should not be used outside the hospital environment.
  • Page 122 If Volumat MC Agilia 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:  Reorient or relocate the Volumat MC Agilia or patient or disruptive equipment.
  • Page 123 The Volumat MC Agilia and its accessories (Agilia USB cable and Agilia Duo) in standalone intended to be used in the electromagnetic environment specified below.  The customer or the user of the Volumat MC Agilia should assure that it is used in such an environment. Compliance Emission test...
  • Page 124 The Volumat MC Agilia and its accessories (Agilia USB cable and Agilia Duo) in standalone intended to be used in the electromagnetic environment specified below.  The customer or the user of the Volumat MC Agilia should assure that it is used in such an environment. IEC 60601-1-2 IEC 60601-2-24...
  • Page 125 If the measured field in the location where Power frequency the Volumat MC Agilia is used exceeds (50/60 Hz) 400 A / m 400 A / m the applicable magnetic field compliance...
  • Page 126 The Volumat MC Agilia and its accessories (Agilia USB cable and Agilia Duo) in standalone intended to be used in the electromagnetic environment specified below.  The customer or the user of the Volumat MC Agilia should assure that it is used in such an environment. IEC 60601-1-2 IEC 60601-2-24...
  • Page 127 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location where Volumat MC Agilia is used exceeds the applicable RF compliance level above, Volumat MC Agilia should be observed to verify normal operation.
  • Page 128 RF communication equipment and Volumat MC Agilia Warning:  The Volumat MC Agilia and its accessories (Agilia USB cable and Agilia Duo) in standalone intended to be used in an electromagnetic environment in which radiated RF disturbances are controlled.
  • Page 129 The following warnings are provided to protect staff against electric shock and protect the device from damage that can cause the device to malfunction. The Volumat MC Agilia Infusion Pump and Duo Agilia are not intended to be sterilized. Sterilization may result in damage to the device. Warning: ...
  • Page 130 14.3 Prohibited Cleaning and Disinfection agents Do not use cleaning or disinfecting agents that contain the following substances as these aggressive agents may damage the plastic parts of the device and cause the device to malfunction.  Trichloroethylene.  Abrasive detergents. ...
  • Page 131 14.5 Cleaning and Disinfection Instructions Thoroughly clean and disinfect the equipment after each patient use, before any maintenance, and on a routine basis when device is not in use in order to protect patients and staff. Warning: Protocol:  Follow the instructions provided to ensure effective cleaning and disinfecting of the equipment.
  • Page 132 4. Using a soft bristled brush, gently scrub the external surfaces of the devices and behind the pump door. Be sure to scrub along the seams and the edges of the control panel. 5. After brushing, wipe down all external surfaces of the devices, and behind the pump door, with a fresh piece of gauze dampened with cleaning agent.
  • Page 133 Device storage 15.1 Precautions for storage Warning:  The pump must be handled with care during storage.  The device should be stored in a dry and cool place.  If the device is not used during an extended period (longer than 2 months), it is recommended that the battery be removed from the device and stored.
  • Page 134 15.3 Preparing the device for storage In order to prepare the device before storage, proceed as follows: 1. Be sure that the pump is not being used on a patient. 2. Power pump OFF and remove the administration set. 3. Disconnect pump power cord and all data communication cables. 4.
  • Page 135 Warning:  Do not use Volumat MC Agilia without battery connected.  Do not disconnect battery when device operating on AC power or on battery: disconnect power cord from AC Power and power off device before disconnecting battery.
  • Page 136 16.3 Battery operating mode The device is provided with an internal battery that automatically provides power to the device in case of power failure or disconnection from AC power supply. The battery is charging when the pump is connected to AC power supply.
  • Page 137 Clean and disinfect the pump and then pack it in the provided packaging and ship to Fresenius Kabi.  Fresenius Kabi is not liable for loss or damage to the device during transport. 17.2 Maintenance requirements Warning: ...
  • Page 138 12 months. A regular quality control (not included in the guarantee) consists of various inspection operations listed in the technical manual. Please refer to the technical manual or contact your Fresenius Kabi sales representative. Information: ...
  • Page 139 Information:  For further information pertaining to waste processing regulations, contact your local Fresenius Kabi organization or the local distributor.  For additional information on how to dismantle the pump, please refer to the technical manual.
  • Page 140 Warranty 19.1 General conditions of warranty 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. 19.2 Limited warranty To benefit from the materials and workmanship guarantee from our sales...
  • Page 141 20.1 Accessories Warning: Use ONLY recommended accessories delivered with the device. Volumat MC Agilia is compatible with the range of Agilia accessories. For operating with these accessories or any further information, please contact our Sales Department. Agilia Duo 2 channels accessory for power supply centralization...
  • Page 142 20.2 Administration Sets Fresenius Kabi recommends the use of the Volumat Lines administration sets only. The use of non-recommended administration sets could result in pump damage and/or serious patient injuries. All Volumat lines have a SafeClip (blue anti-free flow clamp). To operate the SafeClip for Gravity infusion, please refer to section 4.7.3, page 75.
  • Page 143 Primary Infusion set Vented spike, 20dr/mL drip chamber without filter, PVC tube (main material), Robson clamp above BCV, BCV 30 cm below drip VL PR72-11 M46445860 chamber, 1 K-Nect 40 cm below drip chamber, 0.2 µ filter (uncharged, air eliminating) 25 cm above LL, Robson clamp, 1 K-Nect 20 cm above LL, stop flow cap Transfusion set (Not suitable for secondary infusion)
  • Page 144 20.3 Data management cables Agilia USB Communication cable for USB connection Z073550 cable (4000V isolated) 20.4 Associated software Vigilant Drug'Lib Dose Error Reduction Software (DERS) for IV pumps Z073476 Agilia CD Rom...
  • Page 145 Glossary of terms Term Description Ampere Alternating Current Agilia Range of infusion pumps manufactured by Fresenius Kabi Ampere hour AIDC Automatic Identification and Data Capture Amplitude Modulation Center for Disease Control CISPR Special International Committee on Radio Interference CT Scan...
  • Page 146 Term Description GTIN Global Trade Identification Number High Frequency Hecto Pascal H/W/D Height / Width / Depth Hertz International Electrotechnical Commission Instructions for Use Inch(es) Information Technology Intravenous Kilogram Keep Vein Open Pound Light Emitting Diode milliampere Metal Oxyde Semiconductor mL/h Milliliter per hour Magnetic Resonance Imaging...
  • Page 147 ® ® This user guide may not be reproduced in whole or in part without the written consent of Fresenius Kabi. Vigilant and Agilia registered trademarks in the name of Fresenius Kabi in selected countries.