Volumat MC Agilia Instructions for Use sw ver 2.3

Contents 1. INTRODUCTION ... 4 Programming modes ... 4 Infusion modes ... 4 Intended use ... 5 Precautions to be taken ... 5 2. DESCRIPTION ... 6 3. INSTALLATION ... 8 4. OPERATIONS ... 13 No drug name and flow rate ml/h modes... 13 Other infusion modes in flow rate ml/h ... 14 No drug name and dose rate mode ... 23 Loading dose ... 25 Other infusion modes in dose rate... 27 Drug labelling mode... 28 Vigilant Drug’Lib mode... 29 Special features ... 30 General operations ... 33 History... 35 5. DISPLAY AND SYMBOLS... 40 6. ALARMS AND SAFETY FEATURES ... 43 7. MENU ... 46 Permanent menu ... 46 Menu selected in option mode... 47 8. OPTIONS... 49 9. USER TEST... 54 10. PERFORMANCE... 55 Rates range ... 55 Volume to be infused (VTBI)... 55 KVO (Keep Vein Open) rate ... 55 Dose range ... 56 Infusion time ... 56 Drug library ... 56 Air detection... 56 Set replacement interval ... 56 Accuracy ... 57 Programmable pause ... 57 Pressure management ... 57 Occlusion alarm response time ... 57 Bolus volume at occlusion release ... 58 Calculation rules ... 58 Units and conversion rules ... 59

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11. TECHNICAL CHARACTERISTICS... 60 Power supply ... 60 Battery ... 60 Communication port... 60 Infrared communication ... 60 Compliance... 60 Dimensions - Weight... 61 Trumpet curves... 61 12. GUIDANCE AND MANUFACTURER’S DECLARATION ON EMC ... 63 Electromagnetic emissions - Table 201... 63 Electromagnetic immunity - Table 202 ... 64 Electromagnetic immunity - Table 204 ... 65 Recommended separation distances between portable and mobile RF communication equipment and Volumat MC Agilia - Table 206 ... 66 13. CLEANING AND USE CONDITIONS ... 67 Cleaning and disinfecting... 67 Environmental conditions... 67 Use of the internal battery... 68 Recommendations... 69 Special recommendations linked to the use of Volumat Lines: ... 70 14. SERVICES... 71 Conditions of guarantee... 71 Quality control... 71 Preventive maintenance ... 71 Servicing ... 71 Data racks, accessories and maintenance tools ... 72

Valid for software version 2.3.

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1. Introduction Volumat MC Agilia is the volumetric pump of the Agilia range, incorporating advanced features such as Dose rate, Ramp mode, Sequential mode, etc. It is intuitive and easy to learn, like all devices of the Agilia range. 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.

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.

Vigilant® Drug’Lib

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. The drug library can be customized by the user with the Vigilant® Drug’Lib software and downloaded to the device.

Note: In Drug labelling and Vigilant® Drug'Lib modes, you can select "Drug X (ml/h)" or "Drug X (dose)" to define all the parameters of an undefined drug (neither in the drug list, nor in the drug library) without changing the programming mode.

Infusion modes When flow rate mode in ml/h or dose rate mode are selected, the following infusion modes are authorized.

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ml/h

Dose rate

X

X

Volume/Time/Rate

Infusion mode

Infusion defined by a volume and a time or a flow rate.

Description

X

X

Volume/Rate

Infusion defined by a volume and a flow rate. In that case, the time is calculated automatically.

X

X

Volume/Time

Infusion defined by a volume and a time. In that case, the flow rate is calculated automatically.

X

X

Time/Rate

Infusion defined by a time and a flow rate. 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

Secondary

Infusion which enables to deliver the content of a secondary bag / bottle, by means of a secondary line connected to the main line called primary line. 3387-7_nu_volumat_MC_agilia_INT

ml/h

Dose rate

X

X

Programmed bolus

Bolus defined by its volume (or dose) and flow rate.

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 only be used by trained professionals working in hospitals and/or in road ambulances (associated to mandatory accessory Agilia Holder Ambulance).

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. Its immunity is designed to ensure correct operation. 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, 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 65 Electromagnetic Immunity).  Use in a Magnetic Resonance Imaging unit: the pump may be operated safely with the MRI Guard Agilia device only in order to prevent electromagnetic interferences. Please refer to its specific Instructions For Use.  Due to use into road ambulances, performances of Agilia IV pump can be modified. Medical staff must remain nearby the Agilia IV pump to react in an appropriate way. Please refer to Agilia Holder Ambulance Instructions For Use.  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. 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 pump must not be used to administer non-water soluble solutions or unsterile fluids.  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. 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 68 - 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. Users are invited to be aware of those alarms (see Chapter 6) and in cases where the device is used to deliver life sustaining therapies, like short half-life medications, to consider adequate provisions for back-up therapy delivery solutions. 3387-7_nu_volumat_MC_agilia_INT

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2. Description

1

2

3

4 5 10 6 9

7

8

6

1 - Handle

5 - Infrared cell

9 - Fixing button

2 - Pump door

6 - Mains power

3 - Door lever

7 - Communication port and DC power input-output

10 - Drop sensor connection socket

4 - Assembly bolt

8 - Fixing clamp

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11

12

13 14

24

23

18 22

21

20

17

16

15

19

11 - Mains indicator

17 - OK/Start/Enter

23 - BOLUS or PRIME

12 - SILENCE ALARM

18 - Indicator lights (LEDs)

24 - ON/OFF

13 - MENU

19 - Fast decrement

25 - Monitoring screen

14 - Graphic Function

20 - Decrement

15 - Correction/Back

21 - Increment

16 - STOP/PAUSE

22 - Fast increment

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(see page 12)

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3. Installation Positioning the pump(s)

on a pole

on a rail

on a table

Several Agilia devices can be assembled on a pole in any order.

When two Agilia devices are stacked together, the Agilia Duo accessory can be used to centralize the power supply.

Agilia products are easily transportable. Up to three devices (maximum) can be assembled together during transportation.

When devices are stacked together on a pole, the assembly bolts must be in the closed position.

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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.

 Unscrew the clamp screw (A) and disengage the  Fold the fixing clamp against the pump. device from the pole. Push the fixing button (B).

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. Engage the device on the rail and use the clamp screw (B) to secure it.

A

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B

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Installing the device

 Position the device securely on the rail, pole or flat  Proceed with the User test, see page 54. 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.

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.

Preparing the infusion set

 From the Volumat lines range, choose the infusion set that best suits your protocol.

 Prepare the solution container (bag/bottle) with its associated infusion line according to local facility procedures. Caution: The infusion set and the solution container must be in normal temperature conditions: +18°/+30°C. It is recommended to purge the infusion set just before starting the administration.

Purging the set used with a bag or a bottle

 With a bag...

1. Introduce the spike right down into the bag (roller clamp open, air inlet closed). 2. Press the bag in order to remove the air, and fill the drip chamber up to 1/2 to 2/3 of its capacity. 3. Hang the bag upside down, and let the liquid flow gently into the set. 4. Once the set is completely primed, close the roller clamp and check absence of air bubble.

... or a bottle 1. Introduce the spike right down into the bottle (roller clamp open, air inlet closed) 2. Close the roller clamp. 3. Hang the bottle upside down then press the drip chamber in order to fill it up to ~ 1/2 of its capacity. 4. Open the roller clamp. 5. Open the air inlet, and let the liquid flow gently into the set. 6. Once the infusion set is primed, close the roller clamp and check absence of air bubble.

For infusion sets equipped with the K-Nect needle free access, turn this component upside down during priming in order to eliminate bubbles. 10

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Installing the tubing set in the pump

 Open the pump door by lifting the door lever.

Note: The pump automatically switches on when connected to mains (see Ward option [Par 28], page 52). 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 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.

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 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.

 When the OCS test is successful, the infusion mode defined in the options is displayed (to program the infusion, see next page).

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Installing the tubing set in the pump The final installation should look like this: Place the container outside the pump

The container should be placed between 20 and 80 cm above the pump

Towards the patient

The set should be positioned in the pump so as to avoid any tension

Monitoring screen Pressure level The arrow indicates the pressure level. For details, go to page 57.

VTBI: Volume to be infused. It decreases during infusion. To modify it, press <MENU> then select "VTBI". 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. To clear it, press the key then select "ml?".

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Drop sensor presence indicators. Turns off when a drop is detected. Infusion flow in progress. You can always modify it, whenever necessary, by simply pressing the increment/ decrement keys, and then OK.

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4. Operations No drug name and flow rate ml/h modes The V/R infusion mode and No drug name programming mode are described. For another infusion mode, go to page 14; for another programming mode, go to page 28 or page 29.

1 - Flow rate/Start...

2 - Volume selection

 Choose flow rate ml/h mode (for Dose rate mode, refer to page 23) then press OK.

 Use the arrows to select the volume to be infused (VTBI), then press OK. 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. All added or removed volumes must be taken into account, including the volumes of fluids contained in the set and lost during priming that must be removed from the volume to be infused (~ 25 ml).

3 - Flow rate selection

4 - Starting the infusion

 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. 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.  Press Start to start the infusion or C to modify the Volume/Rate selection.

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Other infusion modes in flow rate ml/h The infusion mode set by default is displayed, but you can select another infusion mode (Volume/Time/Rate, Volume/Time, Time/Rate, Simple rate, Ramp, Sequence or Drops/min), provided it is preselected in the Ward option [Par 29] (see page 52). Note: The infusion mode menu is accessible before starting the infusion and in <STOP> 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. select "ml/h". Note: New ? is displayed on the screen if you choose  Press Enter. the current mode. Press this key to set new parameters.

3 - Volume/Time/Rate

or Volume/Time

 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. is automatically calculated and readjusted according to the displayed flow rate.

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Time/Rate

Simple rate

 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 39). 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.

Drops/minute mode

This infusion mode allows to convert the traditional prescription of rate in drops per minute into flow rate in ml/h.  Check the equivalent quantity of drops per ml, then press OK.  Select a volume to be infused (VTBI), then press OK.  Select a flow rate or a number of drops per minute and press OK according to the service option [Par 33] (page 53).  Press start.  Note: The default value is based on the mathematical conversion 1 drop/min = 3 ml/h (20 drops per ml). This value can differ according to the choice of drug.

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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. Note: This mode is accessible only in flow rate ml/h mode.

 Adjust the total volume to be infused with  Adjust the total infusion time in minutes with Confirm by pressing OK.

. Confirm by pressing OK. and

, in hours with

and

.

 Adjust the rise time in minutes and in hours with the arrows. 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. Else, pressing leads directly to the infusion stopping.

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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. Note: This mode is accessible only in flow rate ml/h mode.

 Regulate the volume of the first sequence with

. 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 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. The sequential program is not modified. If a sequential program is modified during a sequential infusion, only future sequences will be modified.

Description of specific functions End: End of the programming sequences Stop: Programming of a pause between two sequences KVO: Programming a KVO sequence Repeat: Up to 20 repetitions of the already programmed sequences (limited by the total VTBI).

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Manual Secondary mode (default mode) This infusion mode enables to deliver the content of a secondary bag / bottle, by means of a secondary line (secondary line or upper side line of the VL SP22 / VL ON10 / VL ON20 / VL ON30, VL ON40) connected to the VL ST22, VL TR22, VL TR43, VL SP22, VL ON10, VL ON20, VL ON30, VL ON40, VL ON11, VL ON12, VL ON12FX, VL ON21, VL ON22, VL ON22OP, VL ON22FX, VL ON42, VL ON42OP, VL ON42FX, VL ON90FX used as primary line. The different steps are to be done manually. Note: this mode is only accessible in ml/h rate mode.

 Hang secondary bag connected to primed secondary line.  Press to hold the primary infusion.  Connect secondary line to upper K-Nect needle-free access of the primary line by respecting aseptic technique. This step is not necessary for VL SP22, VL ON10, VL ON20, VL ON30, VL ON40.  Press , use the arrows to select the secondary mode, then press OK.  Close the upper clamp of the primary line.  Press OK to confirm the parameters of the primary mode to be kept on hold and access the secondary setting.

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1 - Define the infusion

2 - Secondary infusion start

 Check line installation: secondary line open,  In V/R mode, use the arrows to select the primary line closed. secondary Volume To Be Infused. Confirm by pressing OK.  Press start to launch secondary infusion.  Use the arrows to select the secondary flow rate. Confirm by pressing OK. 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.

3 - End of secondary infusion

 Once the secondary the pump stops. Press the

infusion is completed,  Press Yes to continue a secondary infusion. Go key to ackowledge. back to step 1.

Note: at the end of the secondary infusion, the endof-infusion pre-alarm is not activated, it is therefore recommended to adjust carefully the VTBI of the secondary infusion.

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 Press No to go back to the primary infusion.

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4 - Start again primary infusion

 Check the secondary line is closed, re-open the  Press start to resume primary infusion. primary line. Note: in case the drop sensor is used, it has to be  Press the key to go back to the last positioned onto the right drip chamber. The ward option [Par 30] (see page 52) allows defining the type parameters of the primary infusion. of line managed by the drop sensor. Note: the current volume infused becomes the volume infused during the primary infusion. It is displayed in bold at the bottom of the screen.

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