fresenius volumat mc agilia user manual

When a device is marked with the symbol, operators must imperatively review the corresponding Instructions for use prior to using this device. The use of infusion modes by untrained persons may lead to drug administration errors. ? Volumat MC Agilia has been tested in accordance with the electromagnetic compatibility standards applicable to medical devices. Its immunity is designed to ensure correct operation. The limitation of the emitted radiation avoids undesirable interference with other equipment such as EEG, ECG, etc. If Volumat MC Agilia is placed near devices like HF surgical equipment, X-rays, NMR, mobile phones or Wi-Fi access points, it is essential to observe a minimum distance between the Volumat MC Agilia and this equipment (see page 60 -Electromagnetic Immunity). ? The device must not be used in the presence of inflammable anaesthetic agents due to a risk of explosion. It should always be used away from all risk areas. ? The device can be disturbed by pressure or pressure variations, mechanical shocks, heat ignition sources, etc. If you wish to use the device in specific conditions, please contact our After-Sales Department. The pump must be used in a horizontal and stable position to work correctly. ? The physiological effects of medicine can be influenced by the characteristics of the device and the associated disposable (constituent material is commonly listed on the set packaging). Check that they are compatible with prescriptions, the characteristics of trumpet curves and occlusion alarm setting times in relation to the programmed flow rate. ? The device uses a Lithium-ion rechargeable battery. Incorrect handling of a Lithium-ion battery by nonqualified personnel may cause battery leakage, overheating, smoke, explosion or fire, which could result in deterioration of performance or failure.

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Contact Us to Register Your Interest Already a member. It is intuitive and easy to learn, like all devices of the Agilia range. Thanks to its various programming modes, infusion modes, customisation capabilities and its extensive set range, Volumat MC Agilia can be used in any unit of the hospital: general wards, paediatrics, intensive care, oncology, etc. Programming modes Volumat MC Agilia can be programmed in three different modes. Mode Description No drug name All infusion parameters must be defined. The drug name is not selected. It works with different infusion modes (see next table). Drug labelling The drug name is selected from a predefined drug list during infusion programming and displayed on the screen during infusion. In that case, the time is calculated automatically. In that case, the flow rate is calculated automatically. In that case, the volume is calculated automatically. X X Simple rate Infusion defined by a flow rate. This mode is only available with the optional drop sensor fixed to the drip chamber and connected to the pump. X Ramp Infusion defined by a total volume, a total infusion time, a ramp up and ramp down time and a plateau flow rate. This mode allows the flow rate to be increased gradually by intermediate stages in order to reach the plateau flow rate. X Sequential Infusion by sequences defined by volume to be infused and the infusion flow rate for each sequence. X Loading dose Initial dose defined by a time and delivered before a dose rate. Drops per minute Infusion defined by a flow rate expressed in drops per minute. X Infusion mode Description Intended use. Volumat MC Agilia is an infusion pump designed for intravenous (IV) administration of drugs, solutions, fluids, parenteral nutrition and transfusion (special set required). It must be used only by professionals (hospital staff or caregivers). Precautions to be taken.

Page 11 Installing the tubing set in the pump n Open the pump door by lifting the door lever. If not, press the key. An auto-test checks the functionality of the pump. Make sure that all LEDs and buzzers are activated. Once the auto-test is OK, a message is displayed to indicate that you can install the tubing set.The OCS test verifies the circuit and pump occlusivity to secure the pump against a risk of free flow. o 1. Align the tubing set horizontally along the tube guides so that the green connector is positioned to the right (green) and the blue clamp is positioned in front of the clamp guide (blue). 2. Insert the green connector in the green slot. 3. Position the blue clamp in its blue slot and then push the clamp to locate the spherical hinge into place. 4. Ensure that the tube is in the left tube guide, then push the door lever to close the pump door.For details, go to page 53. VTBI: Volume to be infused. It decreases during infusion. Infusion time. It decreases during infusion. Infusion in progress. Infusion indicator. Speed is related to flow rate. Battery level VI: Volume infused. It increases during infusion. Turns off when a drop is detected. Infusion flow in progress. Note: Use the fast increment key to increment VTBI per predefined levels (1 ml, 10 ml, 20 ml, 50 ml, 100 ml, 250 ml, 500 ml, 1000 ml,.). Caution: the volume setting must be the closest (less or equal) possible to the actual volume of the container. Use the arrows to modify the flow rate as required, then press OK. Note: The infusion time is calculated automatically and adjusted according to the displayed flow rate. ? Open the roller clamp. Note: The infusion mode menu is accessible before starting the infusion and in mode. 1 - Menu selection 2 - Infusion mode selection. Press the key to display the Infusion mode. In the Infusion mode screen, use the arrows to screen. If it does not appear at first, use the arrows to select a new infusion mode, then press OK.

This may also damage the protection device installed in the battery pack, resulting in damage to the equipment or injury to the user (see page 63 - Use of the internal battery). ? In case of unexpected situation regarding pump controls or environment, the state of the art safe-design will raise an alarm, stop the infusion and display an error code. When devices are stacked together on a pole, the assembly bolts must be in the closed position. 8 on a rail When two Agilia devices are stacked together, the Agilia Duo accessory can be used to centralise the power supply.Up to three devices (maximum) can be assembled together during transportation. Page 9 Using the fixing clamp The fixing clamp is only orientable when closed against the pump. It is maintained in its vertical or horizontal position with the fixing button. The following images show how to modify the pump installation, from a pole to a rail position.Push the fixing button (B).This is the recommended position for the fixing clamp when the device is placed on a flat surface.The fixing button is released automatically. Engage the device on the rail and use the clamp screw (B) to secure it. B A p Rotate the fixing clamp downward through 90 degrees. A B 9 Page 10 Installing the device n Position the device securely on the rail, pole or flat o Proceed with the User test, see page 50. The user surface and connect to the mains supply. The Volumat MC Agilia can operate with its battery, but the mains supply should be used under normal conditions to ensure the battery is charged. The mains supply indicator lights up (yellow) when power is supplied by the mains or an external supply.It is recommended if the device has not been used recently, and is mandatory in some countries to fulfill local legal requirements before each use. Preparing the infusion set n From the Volumat lines range, choose the infusion set that best suits your protocol.

16 Page 17 Sequential mode Up to 20 infusion sequences can be programmed, each with their own volumes to be infused and infusion flow rates. Pause (Stop) or Keep Vein Open (KVO) periods can also be programmed in sequential mode. Confirm by pressing OK. ? Adjust the flow rate of the first sequence with the arrows. Confirm by pressing OK. ? Choose whether or not to beep at the end of the sequence with the arrows. Confirm by pressing OK. ? Select the following sequence with. Adjust the volume. Confirm by pressing OK. ? Adjust the following sequence(s) in the same way. ? Adjust the last sequence by selecting end for the last volume to be infused. ? Check the sequential programming and confirm with OK. ? Press Start to start the infusion. Changes made in a sequential program become effective only for sequences which have not yet been executed or when the entire sequential program is restarted. A beep sound can be programmed at the end of each sequence. Note: To modify a future sequence, press the key, change the parameters of the future sequence, then press Start to confirm. The sequential program is not modified. If a sequential program is modified during a sequential infusion, only future sequences will be modified. Once the secondary infusion is completed, the user can either continue another secondary infusion, or resume the primary infusion (initial infusion) which parameters are restored. Check the primary line is closed, check the secondary volume to be infused. Confirm by pressing secondary line is connected and opened.Note: the current volume infused becomes the volume infused during the secondary infusion. It is displayed in bold at the bottom of the screen. Note: the volume infused during the primary infusion is displayed above the current volume infused. 18 Page 19 3 - End of secondary infusion. Once the secondary infusion is completed, press the key. ? Press Yes to continue a secondary infusion. Go back to step 1. ?

Select a volume to be infused (VTBI), then press OK. ? Select a volume to be infused (VTBI), then press OK. ? Select a time and press OK. ? Select a time and press OK. ? Select a flow rate and press OK. ? Press Start. ? Press Start. Note: The flow rate is calculated automatically and can Note: If you modify the flow rate, the infusion duration be modified directly only during infusion. Select a time, then press OK. ? Select a flow rate, then press OK and Start. Note: The volume to be infused (VTBI) is calculated automatically and cannot be modified directly. ? Select a flow rate, then press OK and Start. Note 1: This infusion mode only works with the drop sensor fixed on the drip chamber and connected to the pump (for installation, see page 35). If not, a warning message appears when you select this mode in the Infusion mode screen. Shut-down the pump, set the drop sensor, and restart the pump. Note 2: When no more drops are detected, it indicates that the container is empty. The infusion will be stopped and an alarm generated. This value can differ according to the choice of drug. 15 Page 16 Ramp mode This infusion mode allows, with a simple adjustment of the rise and fall times, the infusion flow rate to be increased gradually by 10 intermediate stages until the maximum plateau flow rate is reached. At the end of the infusion, the flow rate will be gradually reduced to zero. Adjust the total infusion time in minutes with Confirm by pressing OK.. Confirm by pressing OK.Confirm by pressing OK. ? Do the same for the fall time. ? Adjust the plateau flow rate with the arrows. Confirm by pressing OK. ? Press Start to start the infusion. 1 - Infusion stop 2 - Ramp-down. Press during the infusion. 3 actions are then possible. Check the ramp-down values, then press OK. ? Press to start the ramp-down. ? Press to stop the infusion. ? Press C to continue the infusion. Note: This screen is accessible only during the plateau. Pressing leads directly to the infusion stopping.

The drug library can be customized by the user with the Vigilant Drug Lib software and downloaded to the device. X Drops per minute Infusion defined by a flow rate expressed in drops per minute. Intended use Volumat MC Agilia is an infusion pump designed for intravenous (IV), administration of drugs, solutions, fluids, parenteral nutrition and transfusion (special set required). Precautions to be taken When a device is marked with the symbol, operators must imperatively review the corresponding Instructions for use prior to using this device. The use of infusion modes by untrained persons may lead to drug administration errors. Volumat MC Agilia has been tested in accordance with the electromagnetic compatibility standards applicable to medical devices. The limitation of the emitted radiations avoids undesirable interference with other equipment such EEG, ECG, etc. If Volumat MC Agilia is placed near devices like HF surgical equipment, X-rays, NMR, mobile phones or Wi-Fi access points, it is essential to observe a minimum distance between the Volumat MC Agilia and this equipment (see page 60 - Electromagnetic Immunity). The device must not be used in presence of inflammable anaesthetic agents due to a risk of explosion. It should always be used away from all risk areas. The device can be disturbed by pressure or pressure variations, mechanical shocks, heat ignition sources, etc. The pump must be used in a horizontal and stable position to work correctly. The physiological effects of medicine can be influenced by the characteristics of the device and the associated disposable (constituent material is commonly listed on the set packaging). Check that they are compatible with prescriptions, the characteristics of trumpet curves and occlusion alarm setting times in relation to the programmed flow rate. The device uses a Lithium-ion rechargeable battery.

This may also damage the protection device installed in the battery pack, resulting in damage to the equipment or injury to the user (see page 63 - Use of the internal battery). In case of unexpected situation regarding pump controls or environment, the state of the art safe-design will raise an alarm, stop the infusion and display an error code. When devices are stacked together on a pole, the assembly bolts must be in the closed position. When two Agilia devices are stacked together, the Agilia Duo accessory can be used to centralize the power supply. Agilia products are easily transportable. The following images show how to modify the pump installation, from a pole to a rail position. Unscrew the clamp screw (A) and disengage the device from the pole. Push the fixing button (B). Fold the fixing clamp against the pump. This is the recommended position for the fixing clamp when the device is placed on a flat surface. B A Rotate the fixing clamp downward through 90 degrees. Move the fixing clamp outward (A). The fixing button is released automatically. The mains supply indicator lights up (yellow) when power is supplied by the mains or an external supply. Preparing the infusion set From the Volumat lines range, choose the infusion set that best suits your protocol. Proceed with the User test, see page 50. The user test performs a complete alarms and safety features check. It is recommended, if the device has not been used recently, and is mandatory in some countries to fulfill local legal requirements before each use. Once the auto-test is OK, a message is displayed to indicate that you can install the tubing set. 1. Align the tubing set horizontally along the tube guides so that the green connector is positioned to the right (green) and the blue clamp is positioned in front of the clamp guide (blue). 2. Insert the green connector in the green slot. 3. Position the blue clamp in its blue slot and then push the clamp to locate the spherical hinge into place. 4.

Press No to go back to the primary infusion. 4 - Start again primary infusion. Check the secondary line is closed, re-open the Note: at the end of the secondary infusion, the end-ofprimary line.Press the key to go back to the last recommended to adjust carefully the VTBI of the secondary infusion.Note: in case the drop sensor is used, it has to be positioned onto the right drip chamber. Note: the current volume infused becomes the volume infused during the primary infusion. For another infusion mode, see page 14. 1 - Start-up screen 2 - Dilution units. Choose dose rate mode, then press OK. ? Use the arrows to select the dilution units. For the list of units, see page 55. Select the volume to be infused (VTBI), then press OK. 21 Page 22 7 - Flow rate selection 8 - Starting the infusion.Loading dose Once the parameters are entered, a loading dose can be infused. Page 23 11 - Loading dose settings 12 - Loading dose start. Set up the loading dose parameters and press OK. ? Press C to change the loading dose parameters. Return to step 10. ? Press Start to initiate the loading dose. 13 - Loading dose interruption. Press the key to interrupt the loading dose. Note: If you press the key twice, the loading dose is deleted. Press Start to continue with the infusion. - If you press Start, the loading dose is confirmed and the infusion continues until the end of the loading dose. At the end of the loading dose, the infusion continues with the values programmed initially at stage 8. Note: During the infusion, you can check the volume key. Note: The infusion mode menu is accessible before starting the infusion and in mode. Menu selection Infusion mode selection. Press the key to display the Infusion mode screen. Select a time, then press OK. ? Select a dose rate, then press OK and Start. Note: The volume to be infused (VTBI) is calculated automatically and cannot be modified directly. Simple rate ? Select a dose rate, then press OK and Start.

Note 1: This infusion mode only works with the drop sensor fixed on the drip chamber and connected to the pump (for its installation, see page 35). Start the pump. The Drug screen appears. ? Use the arrows to select a name in the Drug list, then press OK. By continuing to browse the website, you consent to our use of cookies. Click here to view the Privacy Policy. Manual or programmable. A risk of obstruction or a possible leak in the infusion line can thus be anticipated. There is no risk of DEHP migration into the vascular system of the patient during the IV Treatment. The risk of an unclosed roller clamp is eliminated. The efficiency of this combination is tested whenever the set is installed by performing the OCS test. The special design guarantees excellent flow rate accuracy and infusion reliability. Recalibration of the pump is not necessary. Both upstream- and downstream occlusions occurring in the line are detected enabling safe pressure management. This system makes it impossible to insert the set the wrong way round. Thanks to the high reliability of the pumps and the sets, a drop sensor is no longer necessary. Fresenius Kabi AG is a part of the Fresenius Health Care Group which is headquartered at Bad Homburg, Germany. Thanks to its various programming modes, infusion modes, customization capabilities and its extensive set range, Volumat MC Agilia can be used in any unit of the hospital: general wards, paediatry, intensive care, oncology, etc. Mode No drug name Drug labelling Vigilant Drug Lib Description All infusion parameters must be defined. The drug name is selected from a predefined drug list during infusion programming and displayed on the screen during infusion. Drug parameters are defined in a drug library: drug name, default flow rate units and values, authorized infusion modes, authorized boluses and bolus parameters, maximum flow rate and soft limit values, etc.

Ensure that the tube is in the left tube guide, then push the door lever to close the pump door. The Occlusivity Check System (OCS) automatically clamps the line, activates real pumping and checks the rise in pressure. The OCS test verifies the circuit and pump occlusivity to secure the pump against a risk of free flow. For details, go to page 53. Drop sensor presence indicators. Use the arrows to select the volume to be infused (VTBI), then press OK. Note: The infusion time is calculated automatically and adjusted according to the displayed flow rate. Open the roller clamp. Check that there is no free flow or air remaining inside the infusion line. Connect the set to the patient via the IV infusion set according to local facility procedures. Note: The infusion mode menu is accessible before starting the infusion and in mode. 1 - Menu selection 2 - Infusion mode selection Press the key to display the Infusion mode screen. Press Enter. In the Infusion mode screen, use the arrows to select a new infusion mode, then press OK. Note: New? is displayed on the screen if you choose the current mode. Select a time and press OK. Select a flow rate and press OK. Press Start. Note: If you modify the flow rate, the infusion duration is automatically calculated and readjusted according to the displayed flow rate. Select a volume to be infused (VTBI), then press OK. Select a flow rate, then press OK and start. Adjust the total volume to be infused with. Confirm by pressing OK. Adjust the total infusion time in minutes with and, in hours with and. Adjust the rise time in minutes and in hours with the arrows. Do the same for the fall time. Adjust the plateau flow rate with the arrows. Press start to start the infusion. 1 - Infusion stop 2 - Ramp-down Press during the infusion. 3 actions are then possible: Press to start the ramp-down. Press to stop the infusion. Press C to continue the infusion. Else, pressing leads directly to the infusion stopping.

Regulate the volume of the first sequence with. Adjust the flow rate of the first sequence with the arrows. Choose whether or not to beep at the end of the sequence with the arrows. Select the following sequence with Adjust the following sequence(s) in the same way. Adjust the volume. Confirm by pressing OK. Adjust the last sequence by selecting end for the last volume to be infused. Check the sequential programming and confirm with OK. Press start to start the infusion. A sound beep can be programmed at the end of each sequence. Note: To modify a future sequence, press the key, change the parameters of the future sequence, then press start to confirm. Press the key to select the secondary mode. Close the primary line. Use the arrows to select the secondary flow rate. Note: the current volume infused becomes the volume infused during the secondary infusion. Note: the volume infused during the primary infusion is displayed above the current volume infused. Check the primary line is closed, check the secondary line is connected and opened. Go back to step 1. Press No to go back to the primary infusion. Check the secondary line is closed, re-open the primary line. Press the key to go back to the last parameters of the primary infusion. Note: at the end of the secondary infusion, the end-ofinfusion pre-alarm is not activated, it is therefore recommended to adjust carefully the VTBI of the secondary infusion. Note: in case the drop sensor is used, it has to be positioned onto the right drip chamber. For another infusion mode, see page Start-up screen 2 - Dilution units Choose dose rate mode, then press OK. Use the arrows to select the dilution units. Press OK to validate your choice. 3 - Dilution values 4 - Flow rate units Select the dilution values. Press OK to validate your choice. Select the flow rate units. Open roller clamp. Check that there is no free flow or air remaining inside the infusion line.

Loading dose Once the parameters are entered, a loading dose can be infused. If you press yes, go to step 10. Select the loading dose unit. Press C to change the loading dose parameters. Return to step 10. Press start to start the loading dose Loading dose interruption Press the key to interrupt the loading dose. Press start to continue with the infusion. Press start to continue with the infusion. - If you press start, the loading dose is confirmed and the infusion continues until at the end of the loading dose. At the end of the loading dose, the infusion continues with the values programmed initially at stage 8. Note: During the infusion, you can check the volume infused by pressing the key. Menu selection Infusion mode selection Press the key to display the Infusion mode screen. Select a dose rate value and press OK. Press Start. Select a volume to be infused (VTBI), then press OK. Select a dose rate, then press OK and Start. The Drug screen appears. Use the arrows to select a name in the Drug list, then press OK. You need to select a drug from a drug library in which the drugs have been predefined with all their infusion parameters. To define a drug library, use Vigilant Drug Lib for Agilia software. Use the arrows to select a drug name in the Drug library, then press OK. Depending on the drug selected, an informative screen may appear. If the information confirms the patient s needs and the infusion provided, press OK. Infusion adjustments can be made as described in Operations on page 13. You can use the arrows to modify the adjustable parameters. Note 2: Depending on the predefined infusion mode, some parameters cannot be modified. During parameters adjustments, if the calculated flow rate is higher than the limit predefined in the drug library, the warning High flow rate is displayed. To launch the infusion, this high flow rate must be confirmed by a press on start. Press Enter. 1 - Bolus unit 2 - Bolus parameters Select the bolus unit.

Note: This screen is displayed only in Dose rate mode. Adjust the bolus parameters. Select a volume or a dose, then press OK. Return to step 1. Press start to start the bolus. Note: If you press the key again, this screen appears directly with the last bolus parameters. Note: To save the bolus parameters, press on the diskette icon. Manual bolus Press the key to interrupt the bolus. Note: During the bolus, the occlusion pressure level is set to its maximum value (750 mmhg). To start a bolus, press twice on the key: one short press, then one continuous press (activates bolus; check volume infused on screen). This volume is taken into account in the VTBI). To stop the bolus, release the key. To change the bolus rate, keep the bolus key pressed for at least 3 seconds and modify the bolus rates with the selection keys. During the bolus, the occlusion pressure level is set to its maximum value (750 mmhg). Prime set See air bubble Press the key to start-up the pump. The infusion mode defined in the options is displayed after the OCS screen. Press the key. Make sure that the set is not connected to the patient, as indicated on screen. Press OK. Press the key continuously and release the key to end priming. Note: Priming is accessible as long as the infusion has not started. Note: This feature is available only when an air alarm is triggered (air volume exceeded or air bubble in front of the air detector). The air bubble is removed without having to open the pump door. Press the key to reach function Press OK to confirm, or C to cancel the selection. Press the key continuously to force the air out of the pump. Note: This feature allows you to advance the air bubble at the same set rate for a volume equal to the volume of air defined in the alarm setting. Caution: It is recommended to ask for medical advice to assess if the infusion can be restarted because air is still present.

If the air bubble exceeds an acceptable size, or if the pump cannot be restarted because air is still present, the set should be removed from the pump and disconnected from the patient according to facility procedures for set priming or set exchange. Stop Switch-off To stop the infusion, press the key. Note: After 2 minutes, an alarm is generated as a reminder that the infusion is stopped. To restart the infusion, you must confirm (or modify) the volume, time and flow rate values, by pressing OK for each value, and finally start. Press the key to interrupt the infusion. Press the key continuously, until the Switch off screen disappears. To disconnect the pump, disconnect the mains supply, then the power lead. Press the key to access the menu and select VTBI. Modify the VTBI with the selection keys and press OK. The pressure parameters for the infusion can be defined from the pressure management menu. Press the key, use the selection keys and enter button to access the Pressure management parameters. Maximum pressure DPS Use the selection keys to define the upper pressure limit and press OK. The Dynamic Pressure System (DPS) calculates pressure differences to anticipate possible occlusion or disconnection problems. To activate the DPS, use the button. This key also allows the numerical and graphical infusion screen to be selected. Press the button with short press until you reach the history menu. Choose the history with the selection value keys. Refresh is not automatically performed when remaining in the history screen. The dotted curve represents the limit. It is also adjustable during infusion in the Pressure section of the menu. The continuous curve represents the real pressure during infusion The history is cancelled on drug change and patient change. The history runs over 2 hours. Note: On boluses and purge the pressure limit alarms are increased to their maximum level.