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

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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

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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, 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.

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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

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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

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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

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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.