Fresenius Kabi Volumat MC Agilia User manual

Volumat MC Agilia
Volumetric InfusionPump
Instructions forUse

2
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 ............................................................................................................ 20
Loading dose .............................................................................................................................................. 22
Other infusion modes in dose rate.............................................................................................................. 24
Drug labelling mode.................................................................................................................................... 25
Vigilant Drug’Lib mode................................................................................................................................ 26
Special features .......................................................................................................................................... 27
General operations ..................................................................................................................................... 30
History......................................................................................................................................................... 32
5. DISPLAY AND SYMBOLS......................................................................................................................... 36
6. ALARMS AND SAFETY FEATURES ........................................................................................................ 39
7. MENU ......................................................................................................................................................... 42
Permanent menu ........................................................................................................................................ 42
Menu selected in option mode.................................................................................................................... 43
8. OPTIONS.................................................................................................................................................... 45
9. USER TEST................................................................................................................................................ 50
10. PERFORMANCE........................................................................................................................................ 51
Rates range ................................................................................................................................................ 51
Volume to be infused (VTBI)....................................................................................................................... 51
KVO (Keep Vein Open) rate ....................................................................................................................... 51
Dose range ................................................................................................................................................ 52
Infusion time ............................................................................................................................................... 52
Drug library ................................................................................................................................................. 52
Air detection................................................................................................................................................ 52
Set replacement interval ............................................................................................................................. 52
Accuracy ..................................................................................................................................................... 53
Programmable pause ................................................................................................................................. 53
Pressure management .............................................................................................................................. 53
Occlusion alarm response time .................................................................................................................. 53
Bolus volume at occlusion release ............................................................................................................. 54
Calculation rules ......................................................................................................................................... 54
Units and conversion rules ......................................................................................................................... 55
Contents

3
11. TECHNICAL CHARACTERISTICS............................................................................................................ 56
Power supply .............................................................................................................................................. 56
Battery ........................................................................................................................................................ 56
Communication port.................................................................................................................................... 56
Infrared communication .............................................................................................................................. 56
Compliance................................................................................................................................................. 56
Dimensions - Weight................................................................................................................................... 57
Trumpet curves........................................................................................................................................... 57
12. GUIDANCE AND MANUFACTURER’S DECLARATION ON EMC .......................................................... 59
Electromagnetic emissions - Table 201...................................................................................................... 59
Electromagnetic immunity - Table 202 ....................................................................................................... 59
Electromagnetic immunity - Table 204 ....................................................................................................... 60
Recommended separation distances between portable and mobile RF communication equipment and
Volumat MC Agilia - Table 206 .................................................................................................................. 61
13. CLEANING AND USE CONDITIONS ........................................................................................................ 62
Cleaning and disinfecting............................................................................................................................ 62
Environmental conditions............................................................................................................................ 62
Use of the internal battery........................................................................................................................... 63
Recommendations...................................................................................................................................... 64
Special recommendations linked to the use of Volumat Lines: .................................................................. 64
14. SERVICES.................................................................................................................................................. 66
Conditions of guarantee.............................................................................................................................. 66
Quality control............................................................................................................................................. 66
Preventive maintenance ............................................................................................................................. 66
Servicing ..................................................................................................................................................... 66
Data racks, accessories and maintenance tools ........................................................................................ 67
Data management . .................................................................................................................................... 68
Maintenance CD and tools ......................................................................................................................... 68

4
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, 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.
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 (either in the drug list, or 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 authorised.
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, authorised infusion modes, authorised boluses and bolus
parameters, maximum flow rate and soft limit values, etc.
The drug library can be customised by the user with the Vigilant®Drug’Lib
software and downloaded to the device.
ml/h Dose rate Infusion mode Description
X X Volume/Time/Rate Infusion defined by a volume and a time or a flow rate.
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 deliversthe content of a secondary bag /
bottle, by means of a secondary line connected to the
main line called primary line.

5
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

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 non-
qualified 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 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. 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.
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.
X Drops per minute Infusion defined by a flow rate expressed in drops per
minute.
ml/h Dose rate Infusion mode Description

6
2. Description
1- Handle 5 - Infrared cell 9 - Fixing button
2- Pump door 6 - Mains power 10 - Drop sensor connection
socket
3- Door lever 7 - Communication port
and DC power input-output
4- Assembly bolt 8 - Fixing clamp
1
2
3
8
4
5
7
6
10
9

7
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 (see page 12)
15 - Correction/Back 21 - Increment
16 - STOP/PAUSE 22 - Fast increment
23
22 21
16
20 19
18 17
11 12
24
13
14
15
25

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

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.
nUnscrew the clamp screw (A) and disengage the
device from the pole. Push the fixing button (B).
oFold the fixing clamp against the pump.
This is the recommended position for the fixing
clamp when the device is placed on a flat surface.
pRotate the fixing clamp downward through
90 degrees.
qMove 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
B
B
A

10
Installing the device
nPosition the device securely on the rail, pole or flat
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.
oProceed 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.
Preparing the infusion set
nFrom the Volumat lines
range, choose the
infusion set that best
suits your protocol.
oPrepare 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.
Purging the set used with a bag or a bottle
pWith 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 into the set.
4. Once the set is completely primed, close the
roller clamp and check absence of air bubbles.
... 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 into the
set.
6. Once the infusion set is primed, close the roller
clamp and check absence of air bubbles.

11
Installing the tubing set in the pump
nOpen the pump door by lifting the door lever.
Note: The pump automatically switches on when
connected to mains (see Ward option [Par 28],
page 48). 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.
o1. 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.
pTheOcclusivity 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.
qWhen the OCS test is successful, the infusion
mode defined in the options is displayed (to
program the infusion, see next page).

12
Installing the tubing set in the pump
The final installation should look like this:
Monitoring screen
Place the container
outside the pump
The set should be positioned in the pump so as to
avoid any tension
The container should
be placed between
20 and 80 cm
above the pump
Towards the patient
Infusion time. It decreases
during infusion.
Infusion in progress.
Infusion indicator. Speed is
related to flow rate.
VI: Volume infused. It increases during
infusion. To clear it, press the key then
select "ml?".
Battery level
Pressure level
The arrow indicates the
pressure level.
For details, go to
page 53.
Infusion flow in progress. You can always modify it,
whenever necessary, by simply pressing the increment/
decrement keys, and then OK.
VTBI: Volume to be infused. It decreases during infusion.
To modify it, press <MENU> then select "VTBI".
Drop sensor presence
Turns off when a drop
indicators.
is detected.
Towards the patient

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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 25 or page 26.
1 - Flow rate/Start... 2 - Volume selection

Choose flow rate ml/h mode (for Dose rate mode,
refer to page 20) 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 Cto modify the
Volume/Rate selection.

14
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 48).
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
screen. If it does not appear at first, use the arrows to
select "ml/h".

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. 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 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 time and press OK.

Press Start.
Note:The flow rate is calculated automatically and can
be modified directly only during infusion.

15
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 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.
Drops/minute mode
This infusion mode convertsthe 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 49).

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.

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.
Note:This mode is accessible only in flow rate ml/h mode.

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 .
Confirm by pressing OK.

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:

Press to start the ramp-down.

Press to stop the infusion.

Press Cto continue the infusion.
Note: This screen is accessible only during the
plateau. Pressing leads directly to the
infusion stopping.

Check the ramp-down values, then press OK.

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.
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 beep sound can be programmed at the end of
each sequence.
Note: Tomodifyafuturesequence,pressthe key,changetheparametersofthefuturesequence,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).

18
Secondary mode
This infusion mode deliversthe content of a secondary bag / bottle, by means of a secondary line
connected to the main line called primary line. 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.
Note: this mode is only accessible in ml/h rate mode (except : ramp, sequential and drops/min modes).

Press the key to select the secondary mode.

Close the primary line.

Press OK to confirm the parameters of the primary mode and access the secondary mode.
1 - Define the infusion 2 - Secondary infusion start

In V/R mode, use the arrows to select the
secondary volume to be infused. Confirm by pressing
OK.

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.

Check the primary line is closed, check the
secondary line is connected and opened. Press Start
to start the infusion or Cto modify the Volume/ Rate
selection

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.

Press No to go back to the primary infusion.
4 - Start again 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-of-
infusion 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. The ward
option [Par 30] (see page 48) allows defining the type
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.

20
No drug name and dose rate mode
V/R infusion mode is described. 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.
Note: You can select "unit/ml" or "unit/Xml". For the list
of units, see page 55. These units are preselected in
the Ward option [Par 20] (see page 48).

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.

Press OK to validate your choice.