Volumat Agilia - Technical Manual - Eng

MEDICAL DEVICES
Volumat® Agilia
Technical Manual
Revisions table
TM Volumat Agilia_int: ref TM 3176 
valid for pumps with serial numbers from 19830250 till…
Date Revision Chapter Description

05/07/07 0 All index "a" Creation
15/01/08 1 Index "b" Insertion Volumat Mc
07/07/08 2 Index "c" Only TM Volumat Agilia
15/12/09 3 Index "d" Charte 2009

spare parts catalogue removed from this
document, a document is available for spare
parts.
1.5.5 Update symbol of protection defibrillation
Spelling corrections.
07/04/13 4 Index "e" Precautions to be taken for rate test were
added.
The torque value to re-assemble the OCS clamp

12/01/15 5 Index "f" motor is added in the intervention procedure no
11.
Table of contents
1 Introduction ...................................................................................................... 7
1.1 General introduction .............................................................................. 7
1.2 Operation diagram ................................................................................. 8
1.3 Precautions for use................................................................................ 9
1.4 Operation safety ..................................................................................... 9
1.5 Technical characteristics .................................................................... 10
1.5.1 Electrical details ....................................................................................................... 10
1.5.2 Electronic details ...................................................................................................... 10
1.5.3 Mechanical details.................................................................................................... 10
1.5.4 Material characteristics ............................................................................................ 10
1.5.5 Conformity to standards ........................................................................................... 11
2 Description and operation ............................................................................. 13

2.1 Physical description ........................................................................... 13
2.1.1 The display board..................................................................................................... 14
2.1.2 CPU board ............................................................................................................... 16
2.1.3 The power supply board........................................................................................... 20
2.1.4 The mains board ...................................................................................................... 23
2.1.5 The air detection board ............................................................................................ 24
2.2 Operational description ....................................................................... 25
2.2.1 Administration set check and maintenance sub-assembly ...................................... 25
2.2.2 Pumping sub-assembly............................................................................................ 25
2.2.3 External connections sub-assembly......................................................................... 25
3 Description of the menus .............................................................................. 27

3.1 Options menu ....................................................................................... 27
3.2 Calibration menu .................................................................................. 29
3.3 After-Sales Service test menu............................................................. 29
3.4 Maintenance options menu ................................................................. 29
4 Preventive maintenance ................................................................................ 31

4.1 Recommendations ............................................................................... 31
4.2 Maintenance schedule ......................................................................... 31
4.2.1 Preventive maintenance........................................................................................... 31
4.2.2 Quality control .......................................................................................................... 31
TM_VolumatAgiliaCE_intTDM.fm 3
4.3 Checks ................................................................................................. 33
4.3.1 Accessing the tests .................................................................................................. 33
4.3.2 Visual check ............................................................................................................. 34
4.3.3 Test 1, identification ................................................................................................. 35
4.3.4 Test 2, Maintenance................................................................................................. 36
4.3.5 Test 3, Maintenance messages ............................................................................... 37
4.3.6 Test 4, Events .......................................................................................................... 37
4.3.7 Test 5, Upstream pressure....................................................................................... 38
4.3.8 Test 6, Downstream pressure .................................................................................. 38
4.3.9 Test 7, Door ............................................................................................................. 39
4.3.10 Test 8, battery information ....................................................................................... 40
4.3.11 Test 9, Signalisation ................................................................................................. 41
4.3.12 Test 10, Keyboard .................................................................................................... 41
4.3.13 Test 11, Ageing test ................................................................................................. 42
4.3.14 Test 12, Battery life .................................................................................................. 43
4.3.15 Test 13, Battery test ................................................................................................. 43
4.3.16 Test 14, Air sensor ................................................................................................... 44
4.3.17 Test 15, Clamp motor............................................................................................... 45
4.3.18 Test 16, Flow rate .................................................................................................... 46
4.3.19 Test 17, Flow rate correction.................................................................................... 47
4.3.20 Test 18, Occlusivity .................................................................................................. 47
4.3.21 Test 19, Clamp ......................................................................................................... 47
4.3.22 Checking the presence limit alarm ........................................................................... 48
4.3.23 Mains/battery operation check ................................................................................. 48
4.3.24 Battery life check ...................................................................................................... 49
4.3.25 Electrical test ............................................................................................................ 49
4.4 Maintenance options ........................................................................... 50
4.4.1 Access to test ........................................................................................................... 50
4.4.2 SAV 1, Maintenance date ........................................................................................ 52
4.4.3 SAV 2, Initial set up .................................................................................................. 52
4.4.4 SAV 3, Data log event .............................................................................................. 53
4.4.5 Quality Control Certificate ........................................................................................ 55
4.5 Flow rate check .................................................................................... 57
4.5.1 Measuring by computer............................................................................................ 57
4.5.2 Measuring with a scale............................................................................................. 60
4.5.3 Measuring with a test tube ....................................................................................... 62
4.6 Cleaning and disinfecting ................................................................... 65
4.7 Storage.................................................................................................. 65
4.8 Use of the internal battery.................................................................. 66
5 Troubleshooting.............................................................................................. 67
5.1 Breakdown guide ................................................................................. 67
5.2 Errors messages.................................................................................. 73
44 TM_VolumatAgiliaCE_intTDM.fm
6 Intervention procedures ................................................................................ 77
Procedure N°1: Battery and battery door ................................................. 79
Procedure N°2: Upper case........................................................................ 81
Procedure N°3: Display board ................................................................... 85
Procedure N°4: CPU board ....................................................................... 89
Procedure N°5: Power supply board......................................................... 93
Procedure N°6: Base kit ............................................................................. 97
Procedure N°7: Air detector board .......................................................... 103
Procedure N°8: Pumping system ............................................................ 107
Procedure N°9: Motor ............................................................................... 113
Procedure N°10: Pressure sensor ........................................................... 119
Procedure N°11: OCS clamp motor......................................................... 125
7 Calibrations................................................................................................... 129
7.1 Calibrations procedure ...................................................................... 129
7.1.1 Access to the calibrations ...................................................................................... 129
7.1.2 Etal 1, Pressures.................................................................................................... 131
7.1.3 Etal 2, Door ............................................................................................................ 133
7.1.4 Etal 3, Air sensor.................................................................................................... 134
7.1.5 Elal 4, Flow rate ..................................................................................................... 135
8 Spare parts catalogue .................................................................................. 137
TM_VolumatAgiliaCE_intTDM.fm 5
66 TM_VolumatAgiliaCE_intTDM.fm
1 Introduction
1.1 General introduction
Volumat Agilia is the volumetric pump of the Agilia range, our generation of intuitive and
easy to learn infusion devices.
Thanks to its various programming modes, infusion modes, customisation capabilities and an
extensive sets range, the Volumat Agilia can be used in any units of the hospital: general
wards, paediatry, critical care, oncology....
The Volumat Agilia can be:

 Used as a stand alone device thanks to the mounted "swinglock" clamp that allows its
fixation on a rail or a pole.
 Stacked together with other Agilia devices thanks to its integrated locking system allowing
three Volumat Agilia pumps to be stacked on top of one another to facilitate transportation.
Easy to carry, the Volumat Agilia is ideal for transporting patients.
The similar user interface across the entire Agilia range facilitates the acquisition of
confidence in all the Agilia devices and reduces the time needed for training and
maintenance.
The Volumat Agilia can be programmed in three different modes:

 No drug name,
 Drug labelling,
 Vigilant Drug'Lib.
The drop detector is optional. The pump is equipped with a patented auto-test called "OCS
test" (Occlusivity Check System) that checks the correct working order of the pump in
association with its administration set, thus preventing any risk of free flow.
The Volumat Agilia works with the Volumat Lines: these dedicated sets are equipped with a
silicone pumping segment and a SafeClip that automatically clamps the line to avoid any risk
of free-flow when the door is opened.
The Volumat Agilia has its own control keyboard and a LCD screen. It has an internal battery
which ensures a minimum battery life of 8 hours for a flow rate of 125ml/h.
The Volumat Agilia has a range of flow rates from 1 to 1200 ml/h in macro mode and from
0.1 to 100 ml/h in micro mode.
The Volumat Agilia is fitted with an infrared cell at the back. Fresenius Kabi also offers a
Link+ Agilia rack enabling several Agilia pumps to communicate to a communication system
via the infrared cell and the Link+ Agilia.
Introduction
va01_001e_int.fm 7
1.2 Operation diagram
Introduction
8 va01_001e_int.fm
1.3 Precautions for use
The ! symbol visible on the device, indicates that the relevant Instructions For Use manual
should be read thoroughly.
The Volumat Agilia has been tested in accordance with the standards applicable to
electromagnetic compatibility of the medical devices. Its immunity makes helps to ensure
correct operation. The limitation of the radiation emitted avoids undesirable interference with
other equipment such as EEG, ECG, etc. If a Volumat Agilia is placed near devices such as
surgical equipment HF, X-rays, NMR, mobile phones or Wifi points, then minimal distances
between equipment must be respected.
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 could be disturbed by pressure or pressure variations, mechanical shocks, heat
ignition sources, etc. Please contact our Technical Service, if you wish to use devices in
specific conditions. The pump must be used in a horizontal and stable position to work
correctly.
The physiological effects of medicine may be influenced by the characteristics of the device
and the associated tubing (the constitution material is normally listed on the tubing
packaging). Check that the prescriptions are compatible with the characteristics of the
trumpet curves and with the 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 a non qualified personnel may cause leakage, heat, 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.
Fresenius Kabi cannot, in any circumstances, be held responsible for any medical or other
problem due to incorrect use of the device.
Kindly consult the Instructions For Use manual for more details.
Use conditions:
 Temperature : 5°C to 40°C / 41°F to 104°F.
 Humidity : 20% to 90%, no condensation.
 Atmospheric pressure : 700hPa to 1060hPa.
1.4 Operation safety

As soon as it is in operation, the device ensures continuous surveillance of its functions. 
Any internal fault or any procedural anomaly is immediately detected. Nevertheless, abnormal
functioning of the device, without a defined cause, must always be brought to the attention 
of the qualified staff in your establishment or our Technical Service.
The Volumat Agilia is equipped with an internal battery that ensures normal functioning
during a mains power cut. In addition, 2 safety fuses protect the electrical mains concerned.
Introduction
va01_001e_int.fm 9
1.5 Technical characteristics
1.5.1 Electrical details

 Power supply : 100V - 240V~/ 50-60Hz with functional earth
 Max. consumption : 180mA
 Max. power : 15VA
 Fuse : T1AH 250V - 2xAT internal to power supply unit
 Battery : 7.2V - 2.2Ah. (LI-ion)
 External power supply : 9VDC. Power > 15W.
 Communication port and 11-30VDC power.
1.5.2 Electronic details

The Volumat Agilia is composed of 5 electronic boards:
 Power supply board
 Mains board
 CPU board
 Display board
 Air detection board
1.5.3 Mechanical details

 Dimensions: H x W x D: 135 x 190 x 170mm
 Weight: approximately 2kg.
1.5.4 Material characteristics
Component Material
1 Screw cap (2) Polyamide
2 Nut bolt button Polyamide
3 M8 moulded screws Polyamide
4 Angle bracket ABS
5 Battery door ABS
6 Right and left flanges Polycarbonate
7 Pumping block plate Polyamide
8 Moulded cover over light guide ABS
9 Light guide Polycarbonate
10 Window Polycarbonate
11 Moulded base ABS
12 Base right tube guide Polyamide 6
13 Base left tube guide Polyamide 6
14 Cover central hook Polyamide 6
15 Cover Right and left hook Polyamide 6
16 Infrared window Polycarbonate
17 Excentric bolt POM
18 Bolt front case POM
Introduction
19 Bolt rear case POM

20 Bolt button POM
21 Bolt button pen POM
10 va01_001e_int.fm
Component Material
22 Air detector support ABS
23 Door ABS
24 Door plate Polyarylamide
25 Moulded lever + hooks Polyarylamide
26 Right and left door hinge Polyamide 6
27 OCS fuse Polyacetal
28 OCS unclamping finger Polyamide
29 Mechanical spring cap Polyamide
30 OCS detector cradle Polyarylamide
31 Pumping block Polyamide
32 Star motor ring Polyacetal
33 Motor pulley Polyamide
34 Cam shaft pulley Polyamide
35 Belt idler pulley Polyamide
36 Belt idler lever Polyacetal
37 Rotation control disk Polyamide
38 Pumping finger PA6-12
39 Pumping bloc Polyarylamide
40 Moulded cam shaft PA66
41 Bearing motor support Polyarylamide
42 Magnet support ABS
43 Membrane TF3 STE
44 Membrane frame Polypropylene
45 Back foot LSR
46 Front foot LSR
47 RJ11 stopper TPE EPTR
48 Connector stopper TPE EPTR
49 Star motor shock absorber Elastomere
1.5.5 Compliance to standards
 Conform to the 93/42/EEC Medical Directive. IP22 Protection against

0459 splashing liquid.
Safety of Electro Compliant with EN/IEC 60601-1 and EN/IEC 60601-2-24 Protection against
Medical standards leakage current:
Equipement Defibrillation-proof type
CF applied part.
EMC Compliant with EN/IEC 60601-1-2 and EN/IEC 60601-2- Protection against 
(ElectroMagnetic 24 standards electric shocks: class II.
Compatibility) Functional earth.
The functional earth is directly connected to the mains plug. It reduces the residual current
which could cause interference to ECG or EEG devices.


Detailed information concerning electromagnetic compatibility is available in the
Introduction
"Guidance and manufacturer’s declaration on EMC" chapter of the Instructions for use
manual.
va01_001e_int.fm 11
Introduction
12 va01_001e_int.fm
2 Description and operation
2.1 Physical description
Angle bracket
Air bubbles detector Cover
Base Door
Control panel
The Volumat Agilia pump is made up of 3 main parts: an angle bracket, a cover and a base.
 The cover contains:
 a display board.
 The base supports:

 a CPU board,
 an air bubble detector board,
 an OCS system,
 a pump motor mechanism,
 an air bubble detection,
Description and operation
 a clamp system.
 The angle bracket supports:

 a power supply board,
 a mains board,
 a battery.
va02_001e_int.fm 13
2.1.1 The display board
The display board is situated underneath the front of the command panel and contains all the
essential parts for man-machine interaction:
 Keyboard
 Synoptics and control indicators
 LCD screen
 Buzzer
J2
J1
J3
Display board
This board is connected to the other parts by means of connectors.
J1 connector to keyboard
Pin Signal Description

1 A_LED Ground
2 COL0 Keyboard column 0
5 LIG0 Keyboard line 0
8 ON/OFF Keyboard ON/OFF key
9 CTR Keyboard control or line 3
10 GND Ground
J2 connector to CPU board


A1 GND Ground
B1 VBAT Battery power supply or "+10V mains"
A2 +3V3- Diagnostic signal (correct boards connection)
PERM_PROT
B2 - Not connected
14 va02_001e_int.fm
J2 connector to CPU board

A3 GND Ground
B3 +3V3 +3.3V power supply
A4 TON/OFF Keyboard ON/OFF key
B4 MISO SPI bus MISO signal
A5 GND Ground
B5 MOSI SPI bus MOSI signal
A6 GND Ground
B6 CLK SPI bus clock signal
A7 GND Ground
B7 RESET/ Control signal
A8 RSLCD Control signal (intended for LCD display)
B8 CSLCD/ Control signal
A9 CSLDCD/ Control signal
B9 CD_BuZ_AFF Buzzer command
A10 GND Ground
B10 S_ANA_DOOR Analogue signal sent by "DOOR" sensor
A11 +3V3 +3.3V power supply
B11 GND Ground
A12 - Not connected
B12 PRES_CARTES Diagnostic signal (correct board connection)
A13 VBAT Battery power supply or "+10Vmains"
B13 GND Ground
J3 to display connector
Pin Description
1 A_LED Backlight LED anode
2 C_LED Backlight LED cathode
3 - Not connected
4 - Not connected
5 GND Ground, indicating serial access to LCD
6 MOSI LCD serial data line
7 CLK LCD serial line clock
8 GND Not used by the LCD in serial access
16 RSLCD Command selection /LCD data

17 RESET/ LCD reset
18 CSLCD/ LCD Chip select
19 +3V3 +3.3V power supply
20 GND Ground
va02_001e_int.fm 15
2.1.2 CPU board
The CPU board is made up of a main micro controller, FLASH and RAM memories and
various analogue or power functions, namely:
 Two single step bipolar motor commands
 A power supply cut out - elevator type (BOOST)
 Adjustment of and acquisition from different sensors
 Different lines of communication (synchronous or non-synchronous serial link, optional
Bluetooth connection).
The CPU board is connected to the display board by means of the J2 connector.
A ribbon cable connects it to the power supply board by means of the J14 connector.
J11
J7 J3 J10
J4 on the inside
J13 J12
J9
J14
J2 J1
CPU board
J1 connector to pumping motor
Pin Description
1 +BOBINEA + motor A coil
2 -BOBINEA - motor A coil
3 +BOBINEB + motor B coil
4 -BOBINEB - motor B coil
J2 to OCS motor connector
Pin Description
1 +BOBINEA + motor A coil
2 -BOBINEA - motor A coil
3 +BOBINEB + motor B coil

4 -BOBINEB - motor B coil
16 va02_001e_int.fm
J3 connector to downstream pressure sensor
Pin Description
1 GND Ground
2 +3V3_PS Power supply +3.3V filtered for pressure sensor
3 V+ + Pressure sensor resistance bridge
4 GND Ground
5 V- - Pressure sensor resistance bridge
6 GND Ground
J4 connector to upstream pressure sensor
Pin Description
1 GND Ground
2 +3V3_PS Power supply +3.3V filtered for pressure sensor
3 V+ + Pressure sensor resistance bridge
4 GND Ground
5 V- - Pressure sensor resistance bridge
6 GND Ground
J7 to CLAMP connector board
Pin Description
1 GND Ground
2 MC_OPTO2/ Opto 2 status
3 MC_CD_OPTO Opto 2 power supply
4 GND Ground
5 MC_OPTO1/ Opto 1 status
6 MC_CD_OPTO Opto 1 power supply
7 GND Ground
8 /S_CLAMP CLAMP opto status
9 /S_CD_CLAMP CLAMP opto power supply
10 GND Ground
J9 to JTAG connector (micro programming)
Pin Description
3 TCK "Input" JTAG port signal
4 TDO "Output" JTAG port signal
5 TRST/ "Input" JTAG port signal
6 TDI "Input" JTAG port signal
7 MR/ "Input" JTAG port signal

8 GND Ground
9 TMS "Output" JTAG port signal
10 GND Ground
va02_001e_int.fm 17
J10 connector to opto motor
Pin Description
1 GND Ground
2 MP_OPTO/ Motor opto rotation state
3 MP_CD_OPTO Opto power supply
4 GND Opto power supply return
J11 connector to display board
Pin Description
A1 GND Ground
B1 VBAT Battery power supply or + "10V mains"
A2 +3V3- Diagnostic signal (correct boards connection)
PERM_PROT
B2 - Not connected
A3 GND Ground
B3 +3V3 Power supply +3V3
B4 MISO SPI bus MISO signal
A5 GND Ground
B5 MOSI SPI bus MOSI signal
A6 GND Ground
B6 CLK SPI bus clock signal
A7 GND Ground
B7 RESET/ Control signal
A8 RSLCD Control signal (intended for LCD display)
B8 CSLCD/ Control signal
A9 CSLDCD/ Control signal
B9 CD_BUZ_AFF Buzzer command
A10 GND Ground
B10 S_ANA_DOOR Analogue signal sent by the "DOOR" sensor
A11 +3V3 Power supply +3.3V
B11 GND Ground
A12 - Not connected
B12 PRES_CARTES Diagnostic signal (correct board connection)
A13 VBAT Battery power supply or "+10V mains"
B13 GND Ground
J12 connector to drop detector
Pin Description
1 GND Ground
2 PULSE_goutte Sensor return signal

3 GND Ground
4 GND Ground
5 CDLED_goutte Sensor power supply
6 GND Ground
18 va02_001e_int.fm
J13 connector to air detector
Pin Description
1 GND Ground
2 DA_ANA_AIR Analogue signal sent by the air detector
3 GND Ground
4 DA_DISCH Air detector reset command
6 DA_GAIN Air detector gain adjustment command
8 DA_SCL I²C bus clock signal between main micro controller
and air detector
9 DA_SDA I²C bus data signal between main micro controller
and air detector oscillator
10 GND Ground
J14 connector to power supply board
Pin Description
A1 GND Ground
A2 +3V3-PERM Power supply +3.3V backup for date stamper
B2 - Not connected
A3 GND Ground
B3 +3V3 +3.3V power supply
B4 GND Ground
A5 SCL_ALIM I²C bus clock signal between main micro controller
(CPU) and secondary (Power supply)
B5 SDA_ALIM I²C data signal between main micro controller
(CPU) and (Power supply)
A6 GND Ground
B6 RXIR Infrared cell reception signal
A7 TXIR Infrared cell emission signal
B7 GND Ground
A8 SCK Serial bus clock signal
B8 GND Ground
A9 RXD External plug data reception signal
B9 TXD External plug data emission signal
A10 GND Ground
B10 CD_BUZZ_ALIM Buzzer command
B11 GND Ground
A12 - Not connected

B12 PRES_CARTES Diagnostic signal (good board connection)
B13 GND Ground
va02_001e_int.fm 19
2.1.3 The power supply board
The power supply board is made up of a micro controller (ATmega48, as a secondary in
relation to the one on the CPU board and in relation to its attributed functions) and the
different analogue or power functions, namely:
 Management of the power supply for all the boards
 A battery charger
 An Infrared interface
 Different lines of communication (internal and external to the boards)
 A buzzer
The power supply board is situated on the angle bracket. It is used to supply power to the
electronic unit from the 100V - 240VCA network or, externally, from 9VCC. It also charges a
2.2Ah battery.
J1
J2 on the inside
circular J4 on the inside

connector
J6
J3 on the inside
Power supply board

J1 to CPU board connector
Pin Description
A1 GND Ground
A2 +3V3-PERM Power supply +3.3V backed up for the time stamper
B2 - Not connected
A3 GND Ground
B3 +3V3 Power supply +3.3V

B4 GND Ground
A5 SCL_ALIM Signal Clock of the bus I²C clock signal between
main (CPU) and secondary micro controller (Power
supply)
20 va02_001e_int.fm
Pin Description
B5 SDA_ALIM Signal Data of the I²C bus data signal between main
(CPU) and secondary (Power supply) micro
controller
A6 GND Ground
B6 RXIR Infrared cell reception signal
A7 TXIR Infrared cell emission signal
B7 GND Ground
A8 SCK Serial bus clock signal
B8 GND Ground
A9 RXD External plug data reception signal
B9 TXD External plug data emission signal
A10 GND Ground
B10 CD_BUZ_ALIM Buzzer command
B11 GND Ground
A12 - Not connected
B12 PRES_CARTES Diagnostic signal (good board connection)
B13 GND Ground
J2 connector to mains connector

1 Neutral Mains power supply
2 Phase Mains power supply
3 GND Ground
J3 connector to secondary micro controller

1 MISO “Output” SPI programming signal
3 SCK “Input” SPI programming signal
4 MOSI “Input” SPI programming signal
5 /RST “Input” SPI programming signal
6 GND Ground
J4 connector to internal battery

1 +BATTERIE +Battery
2 ANA_CTN +CTN
3 GND Ground battery and CTN reference
va02_001e_int.fm 21
J5 connector to external plug

1 SCK Serial connection clock
2 TXD Serial connection data emission
3 RXD Serial connection data reception
4 +5V Power supply accessories (supplied by the board)
5 GND Ground
6 RELAIS Relay command (open collector)
7 GND Ground
8 +10V0 External power supply (supplied by the board)
9 GND Ground
10 GND Ground
22 va02_001e_int.fm
2.1.4 The mains board
The mains board contains the mains plug, the ECG filter as well as F1 and F2 fuses.
It is the interface between the mains and the power supply board. The mains board is situated
on the angle bracket. It enables the power supply board to be changed without the need for
soldering.
J2
J1 on the inside
F2 F1
Mains board
J1 connector to power supply board connector

3 GND Ground
J2 connector to mains

3 GND Functional earth
va02_001e_int.fm 23
2.1.5 The air detection board
The air detection board is made up of an input amplifier and an output amplifier which are
linked to the ceramic elements for reception and emission.
The air detection board is fixed to the base. It transmits the air bubbles volume in the
administration set in the form of analogue data to the CPU board.
J1
J3 J2
J2
Air detection board

Pin Description
1 GND Ground
2 DA_ANA_AIR Analogue signal sent by the air detector
3 GND Ground
4 DA_DISCH Air detector command reset
6 DA_GAIN Air detector adjustment gain command
8 DA_SCL I²C bus clock signal between main micro controller
and air detector oscillator
9 DA_SDA I²C bus data signal between main micro controller
and the air detector oscillator
10 GND Ground

J2 to ceramic elements for emission
J3 to ceramic elements for reception

24 va02_001e_int.fm
2.2 Operational description
From an operational point of view, the Volumat Agilia pump is made up of 3 sub-assemblies:
 a sub-assembly to maintain and to check the correct positioning of the administration set.
 a motorisation sub-assembly.
 an external connection sub-assembly.
2.2.1 Administration set check and maintenance sub-assembly

The administration set is positioned along the front part panel held in place by the door.
The front part is equipped with four detection systems:
 A detector to check the position of the door (closed /open).
 A photoelectric cell to detect the presence of the administration set clamp.
 An ultra-sound detector to detect the presence of air bubbles in the administration set.
 Detection of the pressure is ensured by two piezo-resistant sensors allowing the pressure
level control in the administration set.
2.2.2 Pumping sub-assembly

The pumping sub-assembly contains the peristaltic pumping mechanism.
The mechanism is made up of a camshaft that creates a wave-like movement in a bank of 12
"fingers". The displacement of these ’fingers’ is controlled by the CPU board, while turning it
displaces the liquid at the programmed flow rate.
The camshaft is driven by a stepper-motor and a reduction gearbox assembly via a toothed
belt.
A photoelectric cell and a rotation palette, situated on the camshaft end, to control the motor/
pumping system rotation.
2.2.3 External connections sub-assembly

Volumat Agilia has 2 plugs situated at the back of the angle bracket:
 a mains supply plug
 a 8 point Binder plug which, together with various specific Fresenius Kabi accessories,
enables the following functionalities:
 Continuous external power supply
 Nurse call
 Serial link.
An infrared cell is located at the back of the device. It permits information to be exchanged
with the Link+ Agilia: the information can then be transmitted by dedicated communication
cables.
va02_001e_int.fm 25
26
va02_001e_int.fm
3 Description of the menus
3.1 Options menu
The options menu enables the Volumat Agilia to be adapted to the specific needs of each
department. It accesses the menus that customise the infusion parameters.
Fresenius Kabi recommends the presence of its qualified staff, or a member of your
Technical Department, who will assist you in implementing the configuration procedures you
wish to select.
The options mode is activated by holding down the "Menu" key

when the device is switched on.
The following options menu is displayed:

 User,
 Service,
 Maintenance.
Each menu is made up of sub-menus. 

The sub-menus can be accessed by using the "ENTER" key.
To access some of the sub-menus, you need to type in an access code. This code can be
defined and/or de-activated in the Service mode. As long as the device is kept switched on,
the code does not need to be keyed in again.
Main Menu Key in code Sub-menu Sub-menu

User
User options menu
Service Code 0200
Service options menu
Maintenance Code XXXX
Test
Maintenance options test
menu
Maintenance options
Maintenance options menu
Calibration
Calibration menu
Description of the menus

Only the maintenance menu is described in this document. 
For more information concerning the other menus, kindly consult the 
Instructions For Use manual.
va03.1_001e_int.fm 27
28
va03.1_001e_int.fm
3.2 Calibration menu

The calibration menu is reserved for qualified staff only. Its access is protected by a
code. To find out about the operating mode for the various calibrations, refer to the
"Calibrations" chapter.
This menu enables the calibration of:
 Etal 1, Pressures,
 Etal 2, Door,
 Etal 3, Air sensor,
 Etal 4, Flow rate.
3.3 After-Sales Service test menu

The After-Sales Service test menu is reserved for qualified personnel. It enables a series of
checks that can be carried out on the Volumat Agilia to confirm that it is operating correctly.
(See chapter "Checks".)

The After-Sales Service tests can also be carried out more quickly and simply from
a PC using our maintenance software. (Contact our Technical Service department
for more details.)
The After-Sales Service test menu contains a series of 19 tests or checks:
 Test 1, Identification,
 Test 2, Maintenance,
 Test 3, Maintenance messages,
 Test 4, Events,
 Test 5, Upstream pressure,
 Test 6, Downstream pressure,
 Test 7, Door,
 Test 8, Battery information,
 Test 9, Indication,
 Test 10, Keyboard,
 Test 11, Ageing test,
 Test 12, Battery life,
 Test 13, Battery test,
 Test 14, Air sensor
 Test 15, Clamp motor,
 Test 16, Flow rate,
 Test 17, Flow rate correction,
 Test 18, Occlusivity,
 Test 19, Clamp.
3.4 Maintenance options menu

Maintenance options menu allows to enter parameters for the 3 following options:
 SAV 1, Maintenance date,
 SAV 2, Initial set up,
 SAV 3, Data log event.
va03.3&4_001e_int.fm 29
30
va03.3&4_001e_int.fm
4 Preventive maintenance
4.1 Recommendations
The device can only be checked, serviced or repaired by Fresenius Kabi or by a certified and
approved maintenance service. Any abnormal functioning of the pump must be brought to the
attention of your in-house qualified technical personnel or our Technical Service.
Should you need to return the pump to our Technical Service, it should be cleaned,
disinfected and very carefully packaged, preferably in its original packaging, before being
sent.
For all information concerning the repair and use of the pump, kindly contact our Technical
Service or our Sales department.
Fresenius Kabi is not liable for loss or damage to the pump during its transport to our
Technical Service.
4.2 Maintenance schedule
4.2.1 Preventive maintenance

In order to maintain the pump’s performance, a Preventive Maintenance inspection must be
carried out every 3 years. This procedure, which includes changing the battery, replacing the
membrane, should be carried out by a qualified technician.
Any abnormal functioning or failure must be reported to the qualified technical staff in your
organisation or to our Technical Service. In these instances, the pump should not be used.

Important: 
If these maintenance procedures are not observed, the pump’s correct operation will
be impaired.
4.2.2 Quality control

At the request of the health organisation, a quality check will be carried out every 12 months.
A quality check (not included in the guarantee) consists of different inspection procedures as
defined in the pump’s Technical Manual. Only a qualified technician may perform the quality
check which must be performed using Fresenius Kabi software.
For more information, kindly contact our Technical Service.

Recycling of obsolete batteries and devices: Before disposal, remove
battery from the device. Batteries and devices with this label must not be
disposed of with the general waste. They must be collected separately
and disposed of according to local regulations. For further information
pertaining to waste processing regulation, contact your local Fresenius
Preventive maintenance
Kabi.
va04.1&2_001e_int.fm 31
32 va04.1&2_001e_int.fm
Maintenance préventive
4.3 Checks
A quality control certificate is available at the end of this section.


In order to ensure the smooth running of the checking procedure, recharge the
battery for 16 hours beforehand.
4.3.1 Accessing the tests
Keyboard description.
Key Function
ON switches on the pump.
OFF switches it off when pressed for over three seconds.
SILENCE ALARM
STOP
MENU/EXIT accesses the test mode.
The selection keys scroll through the numbers and letters on the
tenths, units and tens values and allow one to move to the next
menu.
OK validates your test selection or moves the cursor.
enter starts up infusion.
exit exits the screen and returns to the "previous" menu.
Bolus or priming
va04.3_001e_int.fm 33
Moving to the After-Sales Service test mode.
 Press "MENU/EXIT" key.
 Keep it pressed down and press "ON".
 When the "Options" main menu displays,
release "MENU/EXIT" and "ON" keys.
 Choose your "Maintenance" menu using the selection keys.

 Press "enter" to confirm.
 The "Maintenance" menu displays.

 Key in the code.
 Press "OK" to confirm.
 Choose the "Test" menu using the selection keys.

 Navigate through this sub-menu using the central
selection keys.


You may exit the configuration mode at any time by pressing "MENU/EXIT";
this function cancels the modifications.
4.3.2 Visual check

Check the general appearance of the case and labels and check for shock impact damage.
34 va04.3_001e_int.fm
4.3.3 Test 1, identification
This test displays:
the device information screen, serial numbers screen, language information screen, zone
information screen and boot information screen. 
 Test 1, press "enter".

 The main menu "Identification" displays.
 Scroll through the information using the selection keys.

 device information:
 device name
 version/revision and software production date
 device code and product serial number
 serial numbers:
 CPU board serial number
 power supply board serial number
 language information:
 language name, version and revision
 date the language file was created
 zone information:
 zone parameter number, version and revision
 date the parameter file was created
 date of the last manual modification
 boot information:
 boot version/revision
 boot creation date
 Press "exit" to return to the "Tests" menu.
va04.3_001e_int.fm 35
4.3.4 Test 2, Maintenance
the running time since the last maintenance service in hours, days or months; the date of the
last maintenance service; the total running time in hours, days or months and the number of
cycles executed by the pumping unit.

 The main "Maintenance" menu displays.
 Scroll through the information using the selection keys.
 Choose between the proposed options "Reset" 
or "Exit".
 "RAZ", using the left selection key.

The following "Maintenance" menu displays.
For this menu:

 Running time:
 the number of operating hours is reset to "0".
 Date:
 the date of the last maintenance is reset to the day’s date.
 Total running time:
 the total running time since the beginning remains
incremented.
 Total distance:
 the number of cycles executed since the start remains
incremented.
 "Exit", leaves the screen and allows to return to the "Test" menu.
36 va04.3_001e_int.fm
4.3.5 Test 3, Maintenance messages
This test displays information concerning the Technical Service interventions.
Test 3, press "enter".

 The "Messages" main menu displays.
 Scroll through the information from screen to screen using

the selection keys.
 Press "exit" to return to the "Test" menu. 



It is necessary to use "Product maintenance software" to write messages in Test 3.
4.3.6 Test 4, Events

This test displays the list of the alarms stamped with date and time.

 The "Events" main menu displays.

the selection keys.
 Press "enter" to display the alarm type.
 Press "MENU/EXIT" to return to the "Test" menu.

va04.3_001e_int.fm 37
4.3.7 Test 5, Upstream pressure
This test displays the upstream pressure value in mV, the calibration values of the different
upstream pressures in mV, the date and calibration counter.
 Test 5, select "enter".

 The "Upstream pressure" main menu displays.

the selection keys.
 Conversion:
 Sensor value in mV
 Calibration door open in mV
 Calibration 0 mmHg in mV
 Sensor zero adjustment offset in LSB
 Date:
Number:
 Date and number of calibration.
 Select "exit" to return to the "Test" menu.


Refer to chapter 7, "Calibration / Calibration procedure / Etal 1 pressure", if one of the
values is out of range.
4.3.8 Test 6, Downstream pressure

the downstream pressure value in mV, the calibration values for the different downstream
pressures in mV, the date and calibration counter.

 The main menu, "Downstream pressure" 
displays.
 Scroll through the information from screen to screen, using

the selection keys.
 Conversion: 
State:
 Sensor value mV,
 Door open calibration in mV,

 Calibration 0 mmHg in mV,
 Calibration 760 mmHg in mV,
 Sensor zero adjustment offset in LSB,
 Date:
Number:
 Date and number of calibrations.
38 va04.3_001e_int.fm


Refer to chapter 7, "Calibration / Calibration procedure / Etal 1 pressure", if one of the
values is out of range.
4.3.9 Test 7, Door

the door value in mV and its state, the calibration values in mV, the date and calibration
counter.

 The main menu "Door" displays.
 Scroll through the information, from screen to screen, using

the selection keys.
 Conversion 
State
 Door open calibration value in mV,
 Intermediary door calibration value in mV,
 Door closed calibration value in mV.
 Date,
Number:
 Calibration date,
 Number of calibrations,


Refer to chapter 7, "Calibration/Calibration procedure / Etal 2 door, if one of the values is
out of range.
va04.3_001e_int.fm 39
4.3.10 Test 8, battery information
the battery running time displayed in hours, days and months;
the number of discharge cycles equivalent to the number of hours of battery use / 7h;
the start date for the battery running time counter; the battery voltage in mV and in 1/100
volts; the battery temperature in mV and in 1/10 °C.
The current charge/discharge in LSB and mA.
 Test 8, select "enter".

 The "Battery info" main menu displays.
 Choose between the "Clear" 
and "exit" options that appear.



Select "Clear" to reset to 0 after all battery replacements.
 "Clear", using the left selection key
 The "Battery Info" menu displays.
 Duration:
 the number of battery operating hours is reset to "0",
resetting the number of cycles to"0".
 Cycles:
 the number of cycles is reset to "0".
 Start date:
 Only the total battery running time since the beginning
remains incremented.

the selection keys.
 Conversion:
Voltage:
 Voltage value at the battery terminals and conversion
in mV.
 Conversion:
Temperature:
 battery temperature value and conversion in mV.
 Conversion:
Current:
 the value of the current consumed or on charge and

its conversion in LSB.
 Press "exit" to return to the "Test" menu.
40 va04.3_001e_int.fm
4.3.11 Test 9, Signalisation
This test checks that the indicator lights and buzzer are functioning correctly.

 The main screen displays.
 All LED and the mains LED are lit up.
 Press "OK" to start the test.

 The "Signalisation" main menu displays.
 Check that the LED, LCD and the two buzzer tones
are functioning correctly.
 "exit", exits the screen and returns to the "Test" menu for the
entire duration of the test.
4.3.12 Test 10, Keyboard

This test checks that the keyboard is functioning correctly.

 The "Keyboard" main menu displays.
 Press all the keys one by one, for example:

 Press "Bolus/Purge"
 the corresponding circle on the screen becomes dark.
 Press the "MENU/EXIT" key, for a long time to exit the

screen and return to the "Test" menu for the entire duration
of the test.
va04.3_001e_int.fm 41
4.3.13 Test 11, Ageing test
This text checks the motor block/pumping system is functioning correctly as well as the pump
occlusivity.

 The main, "Ageing test" menu displays.


When the pump is fitted with a tube, open the 
administration set clamp by pressing the bolus key.
 Select your submenu using the "OK" key.

 Flow rate: between 0.1 and 1200ml/h
Modify the value using the following selection keys:
 for the hundreds and tens, use the double arrows to
increase or decrease
 for the units, increase or decrease using the single
arrows.
 Press "OK" to validate and to move to the next step.
 Mode: Go forward or synchro or go forwards/backwards

or backwards
Modify your choice using the single arrow selection keys.
 Press "OK" to confirm and move to the next step.
 Steps numbers or turns number: 

Content or value lying between 1 and 9999
Modify the value using the single arrow selection keys
 Current: high, low, auto or error.

Modify the value using the single arrow selection keys,
 Press "OK" to confirm and start up the test.
 The "Ageing test" menu displays:

 The flow rate and current category for the
motor command are displayed at the top
of the screen.
 The number of steps decreases according to
the actual change for the number of steps.

During the test, the rotation control is activated and the device set in error if a problem is
detected.
In a test with a defined number of steps/cycles or using a synchro mode, the test ends
when the requested position is reached.
42 va04.3_001e_int.fm
4.3.14 Test 12, Battery life
the amount of battery charge; the date of the last automatic extinction; the pump’s battery
running time before the pre-alarm and battery alarm were triggered; the alarm’s running time
till the battery is off.

 The "Battery life" main menu displays.

the selection keys.
 Charge
Auto extinction
 Pre-alarm
Alarm
Cut-out
 Press "exit" to return to the"Test" menu.


"Test 12" always displays information concerning the previous discharge. If the battery is
replaced, all the parameters on test 8 must be reset to zero.
4.3.15 Test 13, Battery test

This test discharges the battery completely and measures the time taken for the alarms and
pre-alarms to be triggered, as well as the duration of the power cut.

 If the pump is connected to the mains,
the "Battery test/Disconnect mains" menu displays.
Carrying out the battery test does not require the presence 
of an operator to note the battery life.
At the end of the battery life test, the device switches off. 
To read the battery life, connect the device 
to the mains power and select "test 12" : 
the battery life must be > 6h30.


Once the battery life has been obtained, test 13 accelerates the battery discharge. If the
battery is changed, all the parameters for test 8 must be reset to zero.
va04.3_001e_int.fm 43
4.3.16 Test 14, Air sensor
the air detector value in mV, the calibration values in mV, the date and calibration counter.

 The main "Air sensor" menu displays.

the selection keys.
 Conversion: 
State: water/air
 Air sensor value in mV
 Calibration without administration set in mV
 Calibration with administration set and air in mV
 Calibration with administration set and water in mV
 Frequency during calibration
 Frequency shift variance.
 Date:
Number:
 Date and number of calibrations.
 Press "exit" to return to the "Test"menu.


Refer to chapter 7, "Calibration / Calibration procedure / Etal 3 calibration of the air
detector", if the values are out of range.
44 va04.3_001e_int.fm
4.3.17 Test 15, Clamp motor
This test checks the clamp motor is functioning correctly when carrying out displacement.

 The main "Clamp motor" menu displays.
 Select your sub-menu using the "OK" key.
 Mode: declamping, continuous, go back, go forward or

initialise.
Modify the choice using the selection keys.
 Press "OK" to validate and move to the next step.
 Steps numbers: Auto or a value from 1 to 1000

Modify the value using the single arrow selection keys,
 Frequency: Auto or a value lying between 10 and 500 Hz

Modify the value using the single arrow selection keys.
 Press "OK" to validate and start up the test.
 The "Clamp motor" menu displays:

 The displacement mode and the motor 
position for the motor command appear at the
top of the screen.
 The number of steps decreases according to

the actual change for the number of steps.
During the test, the rotation control is activated and the device set in error if a problem is
detected.
In a test with a defined number of steps/cycles or using a "declamping" displacement
mode, the test ends when the requested position is reached.

va04.3_001e_int.fm 45
4.3.18 Test 16, Flow rate
This test checks the flow rate coefficient performed in the flow rate calibration procedure.
(Etal 4)
 Carry out a flow rate test that conforms to the EN-60-601-2-24 standard 
(see chapter 4.5" Flow rate check").
 Check that the flow rate error lies between - 5% and +5%.



Before any flow rate test, carry out an infusion of 25 ml to warm up the administration set.

 The "Flow rate" main menu displays: 
The "default values" are:
 Flow rate 100ml/h
 Volume 25ml
 Duration 0h15



The IS flow rate software dedicated to this procedure is available from Fresenius Kabi.
Any flow rate test using the "default values" menu with a minimum/maximum volume
indication is facilitating the checking of the result obtained when this test is carried out with a
scale or a test administration set.


Refer to chapter 7, "Calibration/Calibration procedure / Etal 4 flow rate calibration", if the
value is out of range.
46 va04.3_001e_int.fm
4.3.19 Test 17, Flow rate correction
This test displays the flow rate corrective coefficient on the device, the date and 
calibration counter.
 Test 17, press"enter".

 The main "Flow rate correction" menu displays.

the selection keys.
 Correction:
 The device flow rate corrector coefficient is displayed as a
percentage.
 Date:
Number:
 Calibration date and number.
4.3.20 Test 18, Occlusivity

This test is dedicated exclusively to product development.
4.3.21 Test 19, Clamp

This test displays the presence or absence of the administration set clamp, and its position.

 The main "Clamp" menu displays.
Clamp checking, test 19.

 Door open without administration set, check
 Clamp: absent
 Position: open.
 Insert the tube clamp in open position, check
 Clamp: present
 Position: open.
 Close the door with administration set, check
 Clamp: present
 Position: closed.
 Open the door, check

 Clamp: present
 Position: closed.
Check that the tube clamp is closed.

va04.3_001e_int.fm 47
4.3.22 Checking the presence limit alarm
To carry out this operation, exit the test mode and press "OFF".
 Carry out the following assembly:
Bag
1m
50 cm
Manometer
3-way stopcock
T
Pump
Container
 Press the "ON/OFF"key.

 Place the administration set on the device and close to
the door.
 Place the manometer at the tube outlet.
 Select a flow rate of 125ml/h.
 Adjust the pressure threshold to 750mmHg.
 Open the 3-way stopcok to a container.
 Start the infusion and leave it running for 30 seconds.
 Position the 3-way stopcok on the manometer side.
 Check that the alarm is triggered for a value of 1bar 
± 0.15bar.
 Stop the infusion cycle by pressing "STOP".

When the value of the measured pressure, lies outside of the limit selected, recalibrate
the pressure sensors (see "Etal 1 Upstream and downstream pressure sensors
calibration").
4.3.23 Mains/battery operation check

 To carry out this procedure, exit the test mode pressing the "OFF" key.
 Connect the device to the mains.

 Check the functioning of mains presence LED (plug-

shaped indicator).
 Disconnect the device from the mains.

 Check that the mains indicator goes out.
48 va04.3_001e_int.fm
4.3.24 Battery life check
 Carry out a complete battery recharge before proceeding with the test. 
The duration of the charging procedure is:
 <6h device switched off
 <20h device functioning
(See test 12, Battery life)
 When the test has been carried ou automatically, as described in test 13, the battery life
must be greater than 6.30 hours.
 When the test is carried out in normal functioning mode, the battery life must be an
average of 8h for a flow rate of 125ml/h.
4.3.25 Electrical test

Carry out the electrical test according to EN/IEC 60601-1 standard.
va04.3_001e_int.fm 49
4.4 Maintenance options
4.4.1 Access to test
Keyboard description.
Key Function
ON, switches on the device.
OFF stops the device by pressing for more than three seconds.
MENU/EXIT, accesses the options menu.
The selection keys are used to scroll through the numbers and
letters on the tenths, units and tens and move to the next menu.
OK, validates your choice or moves the curser.

enter, starts up infusion.
exit, exits the screen and returns to the preceding menu
50 va04.3_001e_int.fm
Moving to the Maintenance mode
 Press "MENU/EXIT".
 Keep it pressed down while pressing "ON".
deselect "MENU/EXIT" and "ON".
 Select "Maintenance" menu using the selection keys.

 The "Maintenance" menu displays:

 Key in the code.
 Choose the "Maintenance options" menu using the

selection keys.

 You can browse through this sub-menu using the central
selection keys.



You can exit the configuration mode at any time by pressing "MENU/EXIT". 
This function cancels the modifications.
va04.3_001e_int.fm 51
4.4.2 SAV 1, Maintenance date
This screen selects the date for the next maintenance.
 The "Maintenance date" main menu displays.
 Modify the day using the selection keys:

 for the tens, increase and decrease using the double arrows
 for the units, increase and decrease using the single arrows.
 Modify the month using the selection keys:

 increase and decrease using the single arrows,
 press the "downward double arrow" for a Clear month.
 Proceed as above to modify the year.

4.4.3 SAV 2, Initial set up

This screen activates the initial configuration when the device is next switched on.
 The "Initial set up" main menu displays.
 Modify your selection using "yes" or "no":

 "YES", using a single left arrow.
 "NO", using a single right arrow.

52 va04.3_001e_int.fm
4.4.4 SAV 3, Data log event
This test displays the list of the alarms stamped with date and time (like Test 4).
 The "Data log event" main menu displays.

the selection keys.
 Press "enter" to display the alarm type.

 Press "MENU/EXIT" to return to the "Test" menu.
va04.3_001e_int.fm 53
54
va04.3_001e_int.fm
4.4.5 Quality Control Certificate

Use this table to summarise the results obtained from the various tests. 
These tests can be carried out using a software dedicated to the Agilia devices.
Device type: Code: Device serial n°:
Conformity
N° Procedure Value Obtained
Yes No
1  Check the general appearance of the case, label containing serial number and
product code.
2  OCS check:
 Switch the device on.
 Install an administration set filled with water.
 Check OCS.
3  Check the upstream pressure (without drip detector): *********** ..........................
 Start a 100ml/h infusion without a drop detector.
 Clamp the administration set between the drop chamber and the pump.
 Check that the Upstream occlusion alarm is triggered before 30 seconds.
 Unclamp the tube.
 Press "silence alarme".
 "Start" displays.
Refer to chapter 7 "Calibration / Calibration procedure / EtAL1 pressure
calibration", if one of the values is out of range.
4  Check the downstream pressure.
 Install the water manometer at the administration set outlet.
 Set the pressure threshold at 750mmHg.
 Start infusion at 100ml/h.
 Check that the Downstream occlusion alarm is triggered at 750mmHg +125 
(1bar + 0.15).
Refer to chapter 7 "Calibration / Calibration procedure / EtAL1 pressure
calibration", if one of the values is out of range.
5  Check the drop detector "if present".
6  Check the air detector.
 Start the test with at a flow rate of 500ml/h,
 Create an air bubble in the administration set with a minimum length of 5 cm.
 Check the presence of the air bubble alarm (sound and visual) when the air
bubble passes through the air bubble detector.
Refer to chapter 7, "Calibration / Calibration procedure / EtAL3 calibration of the
air detector", if the values are out of range.
7  Display the running time and the last maintenance date, test 2 (in hours, days or
months). ************************************************************* ..........................
8  Check the LCD screen, all light indicators and buzzer, test 9. ** ..........................
9  Check the keyboard, test 10. ************************************** ..........................
vafiche_001e_int.fm 55
Conformity
N° Procedure Value Obtained
Yes No
10  Check the occlusivity, test 11.
 Connect the water manometer at the administration set outlet.
 Press the Bolus key to unclamp the administration set.
 Start the test with at a flow rate of 500ml/h and confirm all other steps.
 Check that no motor error is triggered and that the maximum pressure lies
between 1.9bar and 2.5bar in maximum 45 seconds.
11  Check the clamp motor, test 15.
 Validate the clamping and unclamping.
 Check for absence of motor alarm.
12  Check the clamp, test 19.
 Close the door without the administration set.
 Check the message:
 clamp "absent",
 position "opened".
 Insert the tube and close the door.
 Check the message:
 clamp "present",
 position "closed".
13  Check the flow rate.
Before any flow rate test, carry out an infusion of 25 ml to ’warm up’ the
administration set.
 Carry out a flow rate test in conformity with EN-60-601-2-24 standard.
 Check that the flow rate error lies between - 5% and + 5%.
Refer to chapter 7, "Calibration / Calibration procedure / Etal 4 flow rate
calibration", if the value is out of range.
14  Check the battery life, test 13:
 Recharge the battery for 6 hours (device off).
 Carry out the test according to test 13.
 Note the battery running time information, test 12: *********** ..........................
it should be > 6h30
15  Carry out the electrical test according to EN / IEC 60601-1 standard
Name: Date: Visa:
Observations:
56 vafiche_001e_int.fm
4.5 Flow rate check
4.5.1 Measuring by computer

Measuring the flow rate using a computer requires Fresenius Kabi IS Flow rate software.
For further information, contact our Technical Service.
The operating mode defined in this software follows the infusion pump norm protocol which
is adapted to the user’s software.
Use a new administration set [otherwise, make a hole in the filter of the administration set
(if equipped with) and use this set for maximum 10 calibrations]. 
Do not recycle medical water.
Keep the container clean changing it as often as necessary.
Make sure the environmental temperature is between 18°C and 30°C.


To acquire the IS flow rate software, contact the Fresenius Kabi Customer service.
Equipment needed
 Scale connected to a micro-computer:
Flow rate value Scale sensitivity
x < 5ml/h 1/10000th
5ml/h < x < 30ml/h 1/1000th
x > 30ml/h 1/100th
 Multi-scale acquisition programme
 Test tube or beaker with 1ml graduations
 Liquid: distilled water, oil.
 Catheter extension with Luer Lock end (length 100cm, internal diameter 2.5mm)
 Needle:
Flow rate value Type of needle
x < 30ml/h G26
x > 30ml/h G18 or G21 Preventive maintenance
va04.4_001e_int.fm 57
Installation
 Following the diagram below:
Catheter extension bracket support
50 cm
1 cm
RS 232
Anti-vibration measuring table
cable



Observe the equipment horizontal installation plan.
 Fill the container with 600ml or more of distilled water.
 Connect an administration set with the container.
 Connect the canula with the distal end 
of the administration set.
 Fit the administration set on to the pump.
 Fill the administration set with water. Take care that 
no air is in the administration set before the measurement 
is started.
 Fill the test tube or the beaker with some water ensuring 
the canula is dipped in the water (> 1cm).
 Add several drops of oil to create a greasy film on the
surface of the water. This way the user will avoid any
measurement error due to evaporation of the water.
 Place the test tube or the beaker in the centre of the scale
platform ensuring is not in touch with the scale.
 Place the canula inside the test tube or the beaker ensuring
that it is dipped in the water.


The infusion line (needle/catheter extension) must not rest on the scale/test tube
unit.
 Press "ON" (device on mains power mode).
 Prime the infusion line using the "BOLUS" key.
 Check for the absence of air bubbles.
58 va04.4_001e_int.fm
Operating mode


The software operates according to the operating mode described in the 
EN 60601-2-24 standard for infusion pumps.
 Start the acquisition programme for the scale.

 Enter the necessary programme data without confirming the
flow rate.
 Adjust the device to the specific flow rate.
 Confirm the flow rate on the micro-computer to enable self-
adjustment of the scale.
 Start infusion by pressing "VALIDATION", when 00.00
appears on the scale display.
 At the end of the specified time, note the error percentage
displayed on the screen.
va04.4_001e_int.fm 59
4.5.2 Measuring with a scale
(if equipped with) and use this set for maximum 10 calibrations].
Equipment needed
 Chronometer
 Scale:
Flow rate value Scale sensitivity
x < 5ml/h 1/10000th
5ml/h < x < 30ml/h 1/1000th
x > 30ml/h 1/100th
 Test tube or beaker with 1ml graduations.
 Liquid: distilled water, oil
 Catheter extension with Luer Lock end (length 100cm, internal diameter 2.5mm)
 Needle:
x < 30ml/h G26
x > 30ml/h G18 or G21
Installation
Catheter extension bracket support
50 cm
1 cm



Observe the equipment horizontal installation plan.

 Connect an administration set with the container.
 Connect the canula with the distal end of the administration
set.
 Fit the administration set on to the pump.
 Fill the administration set with water. Take care that no air is
in the administration set before the measurement is started.
60 va04.4_001e_int.fm
 Fill the test administration set or the beaker with some water
ensuring the canula is dipped in the water (> 1cm).
 Place the test tube or the beaker in the centre of the scale
platform ensuring is not in touch with the scale.
 Place the canula inside the test tube on the beaker ensuring


The infusion line (needle/catheter extension) must not rest 
on the scale/test tube unit.
 Press "ON" (device on mains power mode).
 Prime the infusion line using the "BOLUS" key.
 Check for the absence of air bubbles.
Operating mode
 Carry out a flow rate selection.


For low flow rates (< 5ml/h), confirm or wait 1 hour for infusion to stabilise. For high flow
rates, wait 10 to 30 minutes after the end of the infusion.
 Carry out the scale taring: 00.00 g.
 Start the infusion by pressing "VALIDATION", and start the
chronometer (if necessary, note the chronometer value).
 After one hour, press "STOP" to stop the test.
 Note the value (in grams) of the "infused" liquid.
 Calculate the difference between the theoretical value and
the real value.

1gram = 1ml.
 The error percentage is calculated according to the following
formula:
 Measured value – Theoretical value 
--------------------------------------------------------------------------------------------------- ¥ 100 = Error percentage
Theoretical value
va04.4_001e_int.fm 61
4.5.3 Measuring with a test tube
(if equipped with) and use this set for maximum 10 calibrations].
Material needed
 Chronometer
 Test tube or beaker with 1ml graduations
 Liquid: distilled water, oil
 Catheter extension with Luer Lock end (length 100cm, internal diameter 2.5cm)
 Needle:
x < 30ml/h G26
x > 30ml/h G18 or G21
Installation
Catheter extension support bracket
50 cm
1 cm



Observe the material horizontal installation plan.

 Connect a giving set with the container.
 Connect the canula with the distal end of the giving set.
 Fit the giving set on to the pump.
 Fill the giving set with water. Take care that no air is in the
tube before the measurement is started.

 Fill the test tube or the beaker with some water ensuring the
canula is dipped in the water (> 1cm).
 Place the canula inside the test tube or the beaker ensuring
62 va04.4_001e_int.fm
Operating mode
 Carry out a flow rate selection.


For low flow rates (< 5ml/h), confirm and wait 1 hour for the infusion to stabilise. For
higher flow rates, wait 10 to 30 minutes after the end of the infusion.
 Start the infusion by pressing "VALIDATION" and start the
chronometer (if necessary, note the chronometer value).
 When the volume has been totally infused in the test tube,
calculate the difference between the theoretical value and
the real value:
Real flow rate = 50ml / time in hours
 The error percentage is calculated according to the following formula:
 Measured value – Theoretical value 
--------------------------------------------------------------------------------------------------- ¥ 100 = Error percentage
Theoretical value
va04.4_001e_int.fm 63
64
va04.4_001e_int.fm
4.6 Cleaning and disinfecting

The device is part of the patient's immediate environment. It is advisable to clean and
disinfect the device’s external surfaces on a daily basis in order to protect patient and staff.
 Disconnect the device from its main supply before cleaning.
 Do not place in an AUTOCLAVE nor IMMERSE the device, Do not let liquids enter the
device’s casing.
 If the device is placed in a high contamination risk unit, it is advisable to leave it in the
room during disinfecting, after having disinfected it with amoist cloth.
 Use a cloth soaked in DETERGENT-DISINFECTANT, previously diluted with water if
required, to destroy micro organisms.
 Avoid abrasive scrubbing which could scratch the casing.
 Do not rinse or wipe the surfaces.



Do not use :
TRICHLOROETHYLENE-DICHLOROETHYLENE.

AMMONIA.

 AMMONIUM CHLORIDE.
 CHLORINE AND AROMATIC HYDROCARBON.
 ETHYLENE DICHLORIDE-METHYLENE.
 CHLORIDE-CETONE.
These aggressive agents could damage the plastic parts and cause device malfunction.

Take care with ALCOHOL based SPRAYS (20% - 40% alcohol). They lead to
tarnishing and small cracks in the plastic, and do not provide the necessary
cleaning prior to disinfection.
Disinfecting SPRAYS may be used, in accordance wih the manufacturer recommendation,
from a distance of 30 cm of the device, avoid the accumulation of the product in liquid form.
Please contact the appropriate service, responsible for cleaning and disinfecting products, in
your establishment for further details.
4.7 Storage
The device should be stored in a dry, cool place. In case of prolonged storage, the battery
should be disconnected via the battery access flap situated underneath the device.This
should be done by a qualified technician.
 Storage conditions and carrying:
 Temperature: -10°C to +60°C / 14°F to 140°F.
 Atmospheric pressure: 500hPa to 1060hPa.
 Humidity: 10% to 90%, no condensation.
Fully recharge the battery before using the device to avoid any risks caused by micro power
cuts in the mains supply and to ensure maximum autonomy.
va04.5&6_001e_int.fm 65
4.8 Use of the internal battery
This device is provided with Li-Ion battery. When the device is disconnected from the mains, it
automatically switches to battery mode.
Before starting for the first time, charge the battery for approx. 5 hours by connecting the
power supply cord without using the device.
If possible, if not using device for an extended period (higher than 2 months), remove it from
the device and store it in a place according to recommended use conditions. If not possible to
remove battery or for a short period (lower than 2 months), it is recommended to charge the
battery at least once a month, by leaving the device connected on mains power supply 8
hours at least (device OFF).
You can also recharge a Lithium-ion battery whenever convenient, without the full charge /
discharge cycle necessary to get full capacity when fully charged.
In order to maximize the life time and the performances of the battery:
 Use and store in a cool place.
 In use, leave the device connected to mains power supply to maintain the charge of the
battery and the maximum capacity when possible.
Lithium Ion rechargeable battery, handle with care !

 Do not incinerate or place near an open flame.
 Do not drop, crush, puncture, modify or disassemble battery.
 Do not use the battery that is severely scarred or deformed.
 Do not short terminals.
 Do not expose to high temperatures.
 Do not replace by a battery other than that specified by manufacturer.
 Do not charge or discharge otherwise than in the device.
66 va04.5&6_001e_int.fm
5 Troubleshooting
5.1 Breakdown guide
Displayed
Meaning Cause Action
message
Door opened  The Hall effect  Check that the magnet is
alarm sensor detects that present on the door
the door is open  Calibrate the door sensor
 Replace the door sensor
Administration  The pump does  Check the position of the
set position not detect the administration set and the clamp.
alarm presence of the Close the door.
safety clamp  Check the clamp detection
opto and replace if necessary
Administration  Incorrect  Check the administration set
set insertion administration set position
alarm position  Check that the magnet is
present on the door
 Calibrate the door sensor
 Replace the door sensor
 At start-up:  Install the administration set

administration set and close the door
not installed or
door opened
OCS test failure  The pumping  Check the administration set
alarm mechanism has position
not managed to  Check the pressure sensors
raise the pressure calibration
in the line during  Check the integrity of the
the OCS test. membrane and replace it if
necessary
 Check the installation of the
administration set and its integrity
 Check the integrity of the door
 If the problem persists,
contact the Technical Service
Air bubble alarm  The volume of  Remove the air bubbles
air detected in the present by rebooting the
line exceeds the administration set
limit  Check the air bubble size
setting
 Calibrate the air detector
 Replace the air detector
 Air bubble  Remove the air bubble by

Troubleshooting
detected at start- priming the administration set

up or in stop mode
va05.1_001e_int.fm 67
Displayed
message
Flow rate  Flow rate has  Check the flow rate and
flashing alarm been modified but confirm with the OK key
has not been
confirmed
End of infusion  The remaining  Check if the volume remaining
pre-alarm VTBI is less than  in the container corresponds to
5% of the initially the remaining VTBI. If necessary,
programmed VTBI prepare a container for a new
or 5 minutes or  infusion sequence. If a drop
5 ml remain before detector is present, the end of
the initially infusion pre-alarm is disactivated
programmed VTBI and can be defined as an option.
is reached
End of infusion  VTBI delivered.  Press Stop to define the new
alarm KVO activated infusion parameters (if
conforming with necessary).
the configuration
Drop detector  The drop  Check the drop detector
alarm (if used detector is not position
with this correctly  Check the integrity of the drop
accessory) positioned detector
 Check the drop detector
connection
 Try the device using another
drop detector
 If the trouble keeps up, check
the connection on the device
 Replace the component if
necessary
 The drop  Connect the drop detector to

detector has been the pump and to the drip
connected then chamber
disconnected
 The drop
detector is
disconnected
when the pump is
configured to
function with it
Under flow rate  Flow rate  Check the container
alarm detected by the  Check the roller clamp
drop detector is  Check that liquid forms
lower than the set properly approx. 20 drops / ml
flow rate
Troubleshooting
68 va05.1_001e_int.fm
Displayed
message
Over flow rate  Flow rate  Check the administration set
alarm detected by the position
drop detector is  Check the drop detector
greater than the position
set flow rate  Check the liquid volume in the
drip chamber
 Check the fluid temperature
 Check that liquid forms
properly approx. 20 drops / ml
Uncontrolled  At the start or  Check the drop detector and
flow rate alarm  when stopped, free the administration set
flow is detected by installations
the drop detector
High flow rate  Upper soft limit  Check the liquid volume in the
warning exceeded, drip chamber
conforming with  Check the fluid temperature
the drug  Check that liquid forms
parameters set in properly approx. 20 drops / ml
the drug library
Weak flow rate  Lower soft limit  Check the liquid volume in the
warning exceeded, drip chamber
conforming with  Check the fluid temperature
the drug  Check that liquid forms
parameters properly approx. 20 drops / ml
defined in the drug
library
Pressure  In-line pressure  Check whether the infusion
increase rises. This warning line is occluded (clamp or 3-way
warning can be selected as stopcock closed, catheter
an option blocked, line creased, etc.)
Pressure drop  Fall in pressure  Check the downstream Luer
warning in the infusion line. lock connection and the integrity
This warning can of the whole line
be selected as an
option
Occlusion pre-  In-line pressure  Check the infusion line
alarm has reached   Define the pressure threshold
50 mmHg below
the programmed
threshold
Troubleshooting
va05.1_001e_int.fm 69
Displayed
message
Upstream  The pressure  Check the container and the
occlusion alarm level in the line
pumping system  Check the roller clamp
upstream line is  Check that the administration
too low set is not pinched
 The container is  Check the height of the
empty container
 The roller  Check the air inlet stopper
clamp is closed (when used with a bottle)
 The air inlet  Calibrate the pressure
stopper is closed sensors
(when used with a
 Replace the upstream
bottle)
pressure sensor
 Only if the drop
detector is absent.
The upstream line
pressure is too
weak
Downstream  The  Check whether the infusion
occlusion alarm downstream line is occluded
pressure for the  Check that the pressure
pumping system threshold is set at an appropriate
has exceeded the level
programmed  Calibrate the pressure
pressure threshold sensors
 Replace the downstream
pressure system
Battery pre-  Weak battery  Connect the device to the
alarm charge level mains
Battery alarm  Battery  Immediately connect the

discharged device to the mains
(automatic switch  Replace the battery if there is
off of the device in not enough life left
5 minutes)
Battery  Uncharged  Connect to mains power
uncharged battery supply and wait till the battery is
alarm charged
Mains  Mains  Press on silence to stop the
disconnected disconnection warning
warning  Check that there is enough
battery charge left for the
expected duration of the infusion
 If the disconnection location
cannot be found:
Troubleshooting
 check the mains power

supply connection
Preventive  Maintenance  Carry out a complete check
maintenance date reached for the device and update the
requested maintenance date (test 2)
70 va05.1_001e_int.fm
Problem Cause Recommended action
Flow rate  A mechanical part of the  Carry out a flow rate test,
variance too great pumping mechanism or the calibrate the infusion corrector
CPU board has been coefficient
changed without the  Redo the test to ensure that the
calibration of the infusion correction is right
corrector coefficient being
carried out
Display default:  LED and/or connectors  Check the general state of the
segments, LED defective display board
 Check the contrast
 Check the connectors
 Replace the display board
The device  Battery is completely  Check the battery connection
switches off when discharged  Charge the battery
it is disconnected
 Replace the battery
from the mains
The mains  Mains fuses are out of  Replace the mains fuses
indicator does not order  Check that the mains connector
light up has been correctly connected
 Replace the power supply board
Battery alarm  Battery is completely  Check the charging voltage
while it has been discharged  Replace the battery
correctly charged
The device  Defective keyboard  Check and replace the keyboard
switches on or off if necessary
on its own  Defective CPU board  Replace the CPU board and
reconfigure completely
The keyboard  Defective keyboard  Check and replace the keyboard
keys do not work if necessary
After a fall  Mechanical elements  Check the integrity of the
damaged mechanical unit and the cases
 Check the state of the battery
Troubleshooting
va05.1_001e_int.fm 71
Troubleshooting
72 va05.1_001e_int.fm
Diagnostic
5.2 Errors messages
Error
Description Recommended action
Code
Software and electronic command faults
01  Rotation check  Check correct functioning of the motor.
 Check the flexible Cl Opto and CPU board
connection.
 Check the correct functioning of the motor
optical switch rotation.
 Replace the CPU board.
 Carry out a complete configuration using
the maintenance software.
10  RAM  Replace the CPU board.

11  Flash  Flash memory deleting or programming

problem.
 Replacing the CPU board.
12  Resources  Crc/16 problem.

 Carry out a complete configuration for the
device using the maintenance software. If the
problem persists, replace the CPU board and
carry out a complete configuration.
13  Version /secondary Crc16  Secondary Crc/16 µC version is incorrect.

µC check  Carry out a complete configuration using
14  Secondary µC starting up  There is a problem of the secondary µC

again. watch dog.
 Replace the power supply board.
15  Secondary µC  Check the state of the power supply/CPU

communication board connection ribbon cable.
16  Disconnected battery  Check the battery connection.

 Check the battery charging voltage.
 Replace the battery.
17  Battery charge  Check the status of the battery.

 Check the battery charge voltage.
 Check the battery.
18  Mains presence  Check the status of the mains fuses.

Diagnostic
va05.2_001e_int.fm 73
Error
Code
19  Battery temperature  Check the battery status.
20  3.3 V missing of power  Check the status of the ribbon cable

supply connection between power supply board and
CPU board.
21  Secondary µC / coulometer  Contact the Technical Service.

power supply board
communication
22  Clamp opto switch  Check the opto functioning.

 Check the status of the ribbon cable
connection.
 Replace the opto switch.
23  Clamp motor optical switch  Check the functionality of the clamp opto
motor switch.
 Check the flexible CI.
 Replace faulty part(s).
24  Unclamping  Select test 15.

 Check the status of the clamp motor.
 Check the connector.
 Replace the motor.
25  Door Hall effect sensor  Select test 7.

 Check the "open or closed" door detection.
 Check the Hall effect; change the Hall
effect if necessary.
 Perform a calibration of the door.
26  Board missing  Check the connection between the display

board and the CPU board.
 Check the connection between the power
supply board and the CPU board.
 Replace the faulty part(s).
27  LCD black-light missing  Check the connection between the display

board and the Back light.
 Replace the LCD display.
 If the problem persists, replace the display
board.
28  Keyboard  Check the keyboard test 10.

 Replace the keyboard and check its
functionality.
 If the problem persists, replace the display
board.
29  Analogue/digital converter  Replace the CPU board.

 Carry out a complete configuration check
using the maintenance software.
Diagnostic
74 va05.2_001e_int.fm
Error
Code
30  Date Time stamp  Check the frequency of the X1 quartz
which drives the date time stamp. Its
frequency must equal 32.768 kHz.
 Check the frequency of the X2 quartz. Its
frequency must equal 32.768 kHz.
 Replace one of the cristals if necessary.
 Replace the CPU board, the Date Time
stamp is integrated in the main
Microcontroller.
31  Administration sets  Carry out a complete configuration using

parameters the maintenance software.
32  Default "language" loading  Carry out a complete configuration using

configuration the maintenance software.
33  Air detector  Select test 14.

 Check the status of the air detector using
an administration set filled with water and air.
 Calibrate the detector.
34  Infusion flow rate check  Carry out a complete configuration using

35  Motor period check  Carry out a complete configuration using

36  Motor rotation direction  Carry out a complete configuration using

check the maintenance software.
37  OFF key  Carry out a complete configuration using

 Replace the power supply board to check
the functionality of the secondary µC.
 Replace the CPU board to check the
functionality of the main µC.
 Replace faulty parts.
38  OFF key locked  Check the functionality of the keyboard

OFF key.
 Replace the keyboard if necessary.
 Replace the power supply board and
check the secondary µC functionality.
39  Impossible to switch off  Replace the power supply board.
40  Drop detector  Detector detection unstable.

 Check the CPU board/detector connection.
 Replace the CPU board
Diagnostic
va05.2_001e_int.fm 75
Error
Code
41  Upstream pressure sensor  Select test 5.
out of range  Check the change in the state of the
sensor by applying pressure to the sensor.
 Check the connections.
 Calibrate the upstream pressure sensor.
42  Downstream pressure  Select test 6.

sensor out of range  Check the change in state of the sensor by
applying a pressure on the sensor.
 Check the connections
 Calibrate the downstream pressure
sensor.
99  Activation of the watch dog  Replace the power supply board to check
the functionality of the secondary µC.
 Replace the CPU board to check the
functionality of the main µP.
 Carry out a complete configuration, when
replacing the CPU board, using the
maintenance software.
Diagnostic
76 va05.2_001e_int.fm
6 Intervention procedures
This chapter details all the dismantling and re-assembling procedures.
Intervention procedures
va06.0_001a_int.fm 77
78
va06.0_001a_int.fm
Intervention procedure
Procedure N°1: Battery and battery door
Safety:
For safety reasons, the technician should not intervene when the device is connected to the
mains voltage.
Disconnect the power supply cord from the mains.
Switch off the device.
Material needed:
 1 Torx T-10 screwdriver
 1 anti-static bracelet
Maintenance level:
Level 3, specialist technician (see technical training program. This document is available
upon request to our Technical Service whose data are indicated in the "Useful addresses"
section in this manual).
Procedure:
Dismantling
 Unscrew the 2 fixing screws (marker 1) holding the battery door in place.
 Remove the battery door (marker 2).
2
1
1
va06.0_0110a_int.fm 79
 Disconnect the J4 connector and remove the battery (marker 3).
3
J4
Re-assembling
 Carry out the dismantling procedure in reverse order to re-assemble the unit.
 Carry out the regular servicing tests (see Quality Control Certificate).
80 va06.0_0110a_int.fm
Procedure N°2: Upper case
Safety:
mains voltage.



Disconnect the battery before opening the device (see procedure n°1).
Material needed:
Maintenance level:
Procedure:
Access
 Turn the device upside down.
 Unscrew the 3 Torx screws (marker 1) and remove them.
1
1
1
va06.0_0011e_int.fm 81



Do not touch the electronic boards with your hands.
Dismantling


When working with electronic components, we recommend wearing an anti-static bracelet
connected to earth and working on a foam anti-static mat.
 Remove the angle bracket (marker 2) being careful not to pull out the CPU board flat
cable.
 Disconnect the flat cable connecting the CPU board to the power supply at J1.
 Pull out the RJ45 stopper (marker 3).
 Unscrew the 2 screws (marker 4) holding the upper case (marker 5) to the base.
2
J1
4
4 5
 Remove the upper case (marker 5), being careful not to pull out the display board flat
cable.
82 va06.0_0011e_int.fm
 Disconnect the flat cable connected to the CPU board from the display board at J2.
J2
Re-assembling
va06.0_0011e_int.fm 83
84
va06.0_0011e_int.fm
Fiches d’intervention
Procedure N°3: Display board
Safety:
mains voltage.



Material needed:
Maintenance level:
Procedure:
Access
1
1
1



va06.0_0021c_int.fm 85
Dismantling


cable.
2
J1
4 4
5
cable.
 Disconnect the flat cable connected to the CPU board from the display board at J2.
6
J1
6
J2
86 va06.0_0021c_int.fm
 Disconnect the keyboard/display board connection at (J1).
 Unscrew the 4 fixing screws (marker 6) holding the board to the upper cover.
 Remove the display board/display unit.
 Disconnect the display board /display connection at (J3).
 Unclip and separate the display board from the display.
J3
Re-assembling
va06.0_0021c_int.fm 87
88
va06.0_0021c_int.fm
Procedure N°4: CPU board
Safety:
mains voltage.



Material needed:
Maintenance level:
Procedure:
Access
1
1
1



va06.0_0031e_int.fm 89
Dismantling


cable.
2
J1
4
4
5
cable.
 Disconnect the flat cable connecting the CPU board to the display board at J2.
90 va06.0_0031e_int.fm
 Disconnect the flat cables connected to the CPU board at:
 J2 and J13
 J7, J3 and J10
 J4 and J12
 J1
 Unscrew the fixing screws (marker 6) holding the CPU board to the flange.
J7 J13
J3 J10
J2
J4
J12 J1
 Remove the CPU board unit being careful not to pull out the flat cable on the inside.
 Disconnect the flat cables (J14 and J11) if necessary.
J11
J14
va06.0_0031e_int.fm 91
Re-assembling

When replacing the CPU board, carry out a complete configuration of the device. Each
Volumat Agilia has its own CPU board model. Be careful not to invert the different
Volumat Agilia references. Order the one that corresponds to your device.
92 va06.0_0031e_int.fm
Procedure N°5: Power supply board
Safety:
mains voltage.



Material needed:
 1 14" wrench
Maintenance level:
Procedure:
Access
1
1
1



va06.0_0040e_int.fm 93
Dismantling


cable.
 Disconnect the flat cable (marker 4) connecting the CPU board to the power supply at J1.
 Lift the stopper and loosen the nut from the plug (marker 3).
2
J1
 Unscrew the Torx screw (marker 9) from the holding board.

 Remove the power supply board.
9
94 va06.0_0040e_int.fm
Re-assembling



Don’t forget to set insulator between the power supply and the mains boards.
va06.0_0040e_int.fm 95
96 va06.0_0040e_int.fm
Procedure N°6: Base kit
Safety:
mains voltage.



Material needed:
 1 anti-static bracelet.
Maintenance level :
Procedure:
Access
1
1
1



va06.0_0050e_int.fm 97
Dismantling


cable.
 Remove the RJ45 stopper (marker 3).
2
J1
4 4
5
cable.
98 va06.0_0050e_int.fm
 Disconnect the flat cables connected to the CPU board at:
 J2 and J13
 J7 and J3 and J10
 J4 and J12
 J1
 Unscrew the holding screws (marker 6) holding the CPU board to the flange.
J7 J13
J3 J10
J2
J4
J12 J1
 Remove the CPU board.
va06.0_0050e_int.fm 99
 Unscrew the button screw (marker 7) and pull it out.
 Push the button and turn it to the left and remove it.
 Remove the spring.
 Unscrew the 2 screws (marker 8) on either side of the right and left flanges being careful
not to damage the air bubble board.
8
 Pivot the device on its front side.

 Unscrew the screw (marker 9) positioned under the base.
 Remove the pumping plate (marker 10).
 Unscrew the screws (marker 11) positioned under the base.
10
11
9
11
100 va06.0_0050e_int.fm
 Remove the left flange (marker 12).
 Take out the right flange (marker 13).
12
13
 Separate the base kit (marker 14) from the motor kit (marker 15).
14 15 Fiches d’intervention
va06.0_0050e_int.fm 101
Re-assembling
102 va06.0_0050e_int.fm
Procedure N°7: Air detector board
Safety:
mains voltage.



Material needed:
Maintenance level:
Level 3, specialist technician, (see technical training program. This document is available
Procedure:
Access
1
1
1



va06.0_0060b_int.fm 103
Dismantling


cable.
2
J1
4
4 5
cable.
J2
104 va06.0_0060b_int.fm
 Unscrew the 2 screws (marker 6) of the air detector board (marker 7).
7 6
 Remove the board being careful not to pull out the flat cable.
 Disconnect the flat cable connected to the board at J1.
J1
Re-assembling
 Calibrate the air bubble detector.
va06.0_0060b_int.fm 105
106 va06.0_0060b_int.fm
Procedure N°8: Pumping system
Safety:
mains voltage.



Material needed:
Maintenance level:
Procedure:
Access
 Unscrew the 3 Torx screws (marker 1) and remove them (3 under the angle bracket).
1
1
1



va06.0_0070b_int.fm 107
Dismantling


cable.
 Unscrew the 2 screws (marker 4) holding the upper case (marker 5) to the base
2
J1
4
4
5
cable.
 Disconnect the flat cable leading from the CPU board to the display board at J2.
108 va06.0_0070b_int.fm
 Disconnect the flat cable connected to the CPU board at:
 J2 and J13
 J7, J3 and J10
 J4 and J12
 J1
 Unscrew the holding screws (marker 6) holding the CPU to the flange.
J7 J13
J3 J10
J2
J4
J12 J1
 Remove the whole CPU board being careful not to pull out the flat cable on the inside.
va06.0_0070b_int.fm 109
 Pull out the spring.
 Unscrew the screw (marker 8) holding the left flange.
 Pivot the device on its front.

 Unscrew the Torx screw (marker 9) positioned under the base.
 Unscrew the screw (marker 11) positioned under the base
10
11
110 va06.0_0070b_int.fm
12
 Remove the pumping system.
Re-assembling
va06.0_0070b_int.fm 111
112 va06.0_0070b_int.fm
Procedure N°9: Motor
Safety:
mains voltage.



Material needed:
 1 4" wrench
 1 small cruciform screwdriver
Maintenance level:
Procedure:
Access
1
1
1 Fiches d’intervention



va06.0_0080b_int.fm 113
Dismantling


cable.
2
J1
4
4 5
cable.
114 va06.0_0080b_int.fm
 Disconnect the flat cables leading to the CPU board at:
 J2 and J13
 J7 and J3 and J10
 J4 and J12
 J1
J7 J13
J3 J10
J2
J4
J12 J1
va06.0_0080b_int.fm 115
 Pivot the device on its front.

10
11
116 va06.0_0080b_int.fm
12
 Pull out the pumping system.
va06.0_0080b_int.fm 117
 Unscrew the 4 motor fixing nuts (marker 12).
12
12
12
12
 Pull out the 4 screws, and remove the motor with its silenblocks.
Re-assembling
 Put the motor in position, motor wires on the left side of the mechanical bloc using a weak
loctite ref. 248 to fix the motor with its nuts.
 Moderately tighten the motor fixing nuts in a diametrically opposite sequence (marker 12).
12
12
12
12
118 va06.0_0080b_int.fm
Procedure N°10: Pressure sensor
Safety:
mains voltage.



Material needed:
Maintenance level:
Procedure:
Access
1
1
1



va06.0_0090b_int.fm 119
Dismantling


cable.
2
J1
4
4 5
cable.
120 va06.0_0090b_int.fm
 Disconnect the flat cables leading to the CPU board at:
 J2 and J13
 J7, J3 and J10
 J4 and J12
 J1
J7 J13
J3
J10
J2
J4
J12 J1
va06.0_0090b_int.fm 121
 Pivot the device on its front side.

10
11
122 va06.0_0090b_int.fm
 Pull out the left flange (marker 12).
 Pull out the pumping system.
12
 Unscrew the 2 upstream sensor and downstream sensor screws (markers 13 and 14).
14
13
va06.0_0090b_int.fm 123
 Pull out the sensor.
Re-assembling
 Calibrate the sensors.
124 va06.0_0090b_int.fm
Procedure N°11: OCS clamp motor
Safety:
mains voltage.



Material needed:
 1 Torx T-10 screwdriver or electric screwdriver with a torque of 0.55 Nm.
 1 small flat screwdriver.
Maintenance level:
Procedure:
Access
1
1
1



va06.0_0100f_int.fm 125
Dismantling


cable.
2
J1
4
4 5
 Remove the upper case (marker 5) being careful not to pull out the display board flat
cable.
126 va06.0_0100f_int.fm
 Unscrew the 2 fixing screws (marker 6) holding the motor to the flange.


This procedure should be handled with care in order to avoid any damage of the air
bubble detector board/flat cable when using a scew driver.
 Using a small flat screwdriver, apply a light pressure in order to disengage the motor
positioning spigot (marker 7).
va06.0_0100f_int.fm 127
 Remove the motor (marker 7).
Re-assembling


Check the right position of the OCS motor fins when assembling the motor kit. The fins
should be left side OCS optical sensor board.
 Position the OCS motor into the flask, wires position as indicated by marker 8 (left side
and at the bottom).
 Screw the 2 fixing screws (marker 6) holding the motor to the flask.
 Check that the motor is clipped correctly (marker 9).
8 6
9
128 va06.0_0100f_int.fm
7 Calibrations
7.1 Calibrations procedure


The calibration menu is reserved for qualified staff only. Its access is protected by a
secret code.
7.1.1 Access to the calibrations
Keyboard description
Key Function
ON switches on the device.
OFF switches off the device when held down for more than three
seconds.
Menu/Exit accesses the calibrating mode.
The selection keys scroll through the numbers and letters on the
LCD screen using the tenths, units and tens values. 
Activate or de-activate the infusion menu.
OK confirms the test selection or moves the cursor.
start starts the infusion
exit exits the screen and returns to the "Test" menu.
Calibrations
va07.1_001e_int.fm 129
How to activate the "Calibration" configuration mode
 Press "MENU/EXIT".
 Keep it held down while pressing "ON/OFF".
release "MENU/EXIT" and "ON/OFF" keys.
 Select your menu using the selection keys.

 Maintenance
 The "Maintenance" menu displays.

 Key in your code.
 Select the menu using the central selection keys.

 Calibration
 Navigate through this sub-menu using the central
selection keys.




You may exit the configuration mode at any time by pressing "MENU/EXIT";
this function cancels the modifications.
Calibrations
130 va07.1_001e_int.fm
7.1.2 Etal 1, Pressures
Calibrating the pressures consists in calibrating the upstream and downstream pressures in
several phases.



A new administration set must be used for this procedure.
 Etal 1, press "enter".

The main "Pressures" menu displays.
 Open the door and remove the administration set.

 Press "OK" to reset the search to zero.


 The calibration values for upstream and downstream

pressures appear in mV starting at 0.
 In "Pressures: door opened" phase.
 The "Pressures: door closed: unclamp" menu displays.

 Position the tube and close the door.
 Press "OK" to move to the next step.
 Unclamping in progress.
 The motor starts positionning
 The "Calibrating pressure" menu, 0mmHg with a tube

appears in mV, 
the manometer should indicate "0" mmHg (0 bar)
Calibrations
va07.1_001e_int.fm 131
 The "pressure calibration" menu, 760mmHg with tube 
appears in mV.
 Apply a pressure of 760mmHg (around 1bar) at the tube
outlet.
 Press "OK" to validate and move to the next step.
 The "Pressure calibration" menu, 0mmHg with tube

appears in mV.
 Decrease the pressure to 0mmHg (0bar).
 Press "OK" to validate and move to the next step


 Press a second time to confirm and save the calibration

values.
 If the values are out of the ranges, a message specify the

non-conformity appears.
 Restart the calibration procedure.

Calibrations
132 va07.1_001e_int.fm
7.1.3 Etal 2, Door
Calibrating the door consists of calibrating the door’s Hall Effect sensor in several phases.

 The main "Door" menu displays.
 Open: open the door.

 Press "OK" to validate and move to the next step.
The value is read and recorded. It should lie between
1400 < X < 1800mV.
 Intermediate: place the calibration tool referenced

067059 with the door in the intermediate position.
 Press "OK" to validate and move to the next step.

 The value is read and recorded.
 Closed: shut the door.
 Press "OK" to validate and move to the next step.

 The value is read and recorded. This value should lie
between 1500 < X < 2700mV.
 Press again to confirm and save the calibration values.
 If the values are out of range, a message indicating the

non-conformity appears: press "Exit"..

Calibrations
va07.1_001e_int.fm 133
7.1.4 Etal 3, Air sensor
The air sensor calibration consists in calibrating the air detector board in several phases




 The main menu "Air sensor" displays.
 Perform a flow rate measurement according to
instructions described in paragraph "4.5 Flow rate check".
 Press "OK" to launch the resonance search.

 Wait the stop of resonance phase
 Resonance frequency calibration phase with a tube and

water:
 Water tube: the air detector value in mV.
 Frequency: current frequency value in KHz.

 Water tube: the air detector value in mV. The value
must lie between 600 < X < 2400mV.
 Frequency: the resonance frequency for this phase.
 Press "OK" to validate and move to the next phase.
 Resonance frequency calibration phase without a tube.

 Remove the pump tube and shut the door.
 Without the tube: the air detector value in mV. The
value must be X < 300mV.
 Frequency: the resonance frequency for this phase.
 Calibration resonance frequency, with tube and air

 Put a tube with air in place and close the door.
 Air detector value in mV. The value must lie 
between X < 300mV.
 Frequency: resonance frequency for this phase.
 Press "OK" to validate and move to the next phase.
 Press "OK" again to confirm and save the calibration

values.
 If the values are out of range, a message specifies the

non coformity: press "Exit".

Calibrations
134 va07.1_001e_int.fm
7.1.5 Elal 4, Flow rate
The flow rate calibration consists in defining the device coefficient corrector to calibrate the
pump.




 The main menu "Flow rate" displays.
 Flow rate: the infusion flow rate, 100ml/h, enables 
the speed of the motor rotation to be defined.
 Turns: the number of motor cycles to execute 100.
 Perform a flow rate measurement according 

to instructions described in paragraph "4.5 Flow rate check".
 "Unclamping" and "Motor clamp start-up" phase.
 Coefficient corrector calibration.

 Flow rate: infusion flow rate, 100ml/h, enables 
the speed of the motor rotation to be defined.
 Cycles: number of motor cycles to execute100.
 Calibration in progress, wait till the end of the cycle.
 The volume measured by the pump is displayed.

 If necessary, correct the value, using the selection keys,
after comparing it with the measured volume obtained
during the same test.
 The correction is displayed in %, it is calculated from the

corrective coefficient programmed in the device.
The value of the corrective coefficient must lie between 
80 < X <110.
 Press "OK" to save the flow rate correction.

Calibrations
va07.1_001e_int.fm 135
Calibrations
136 va07.1_001e_int.fm
8 Spare parts catalogue
Refer to the spare parts catalogue.
Spare parts catalogue
va08.0_001d_int.fm 137
Spare parts catalogue
138 va08.0_001d_int.fm
Useful addresses
CUSTOMER SERVICE
Fresenius Kabi
Le Grand Chemin,
F-38590 Brézins
Tel.: +33 (0) 4 76 67 11 11
Fax: +33 (0) 4 76 67 11 34
TRAINING DEPARTMENT /
TECHNICAL DEPARTMENT
Fresenius Kabi Tel. : +33 (0) 4 76 67 10 76 
Le Grand Chemin, or +33 (0) 4 76 67 11 40
F-38590 Brézins or +33 (0) 4 76 67 60 73
Fax : +33 (0) 4 76 67 11 22
SPARE PARTS DEPARTMENT

Fresenius Kabi Tel. : +33 (0) 4 76 67 10 34
Le Grand Chemin, Fax : +33 (0) 4 76 67 11 88
F-38590 Brézins
This document may contain inaccuracies or typographical errors.

Modifications may thus be done and will be included in later editions.
Because of the evolution of the standards, lawful texts and material, the characteristics indicated by the
text and the images of this document are applicable only for the device that it accompanies.
This document may not be reproduced in whole or in part without the written consent 
of Fresenius Kabi.
Injectomat® and Agilia® are registered trademarks in the name of Fresenius Kabi in selected
countries.
Fresenius Vial S.A.S. - Le Grand Chemin - F-38590 Brézins

Société par Actions Simplifiées au capital de 13 744 520 Euros
SIREN Grenoble B 408 720 282.
Technical Manual Volumat Agilia_int

Fresenius Vial S.A.S
Le Grand Chemin
38590 Brézins
France
Tel: +33 (0)4 76 67 10 10
Fax: +33 (0)4 76 67 11 34
www.fresenius-kabi.com A Company of Fresenius Kabi

Volumat Agilia - Technical Manual - Eng

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MEDICAL DEVICES

Date Revision Chapter Description

15/01/08 1 Index "b" Insertion Volumat Mc

07/07/08 2 Index "c" Only TM Volumat Agilia

15/12/09 3 Index "d" Charte 2009

The torque value to re-assemble the OCS clamp

2 Description and operation ............................................................................. 13

3 Description of the menus .............................................................................. 27

4 Preventive maintenance ................................................................................ 31

8 Spare parts catalogue .................................................................................. 137

The Volumat Agilia can be:

The Volumat Agilia can be programmed in three different modes:

1.4 Operation safety

1.5.1 Electrical details

1.5.2 Electronic details

1.5.3 Mechanical details

1.5.4 Material characteristics

19 Bolt rear case POM

1.5.5 Compliance to standards

 Conform to the 93/42/EEC Medical Directive. IP22 Protection against

 The base supports:

 The angle bracket supports:

Pin Signal Description

J2 connector to CPU board

Pin Signal Description

Pin Signal Description

16 RSLCD Command selection /LCD data

J1 connector to pumping motor

J2 to OCS motor connector

3 +BOBINEB + motor B coil

J4 connector to upstream pressure sensor

J7 to CLAMP connector board

J9 to JTAG connector (micro programming)

7 MR/ "Input" JTAG port signal

J11 connector to display board

J12 connector to drop detector

2 PULSE_goutte Sensor return signal

J14 connector to power supply board

A12 - Not connected

circular J4 on the inside

Power supply board

J1 to CPU board connector

A4 TON/OFF Keyboard ON/OFF key

J2 connector to mains connector

Pin Signal Description

J3 connector to secondary micro controller

Pin Signal Description

J4 connector to internal battery

Pin Signal Description

3 GND Ground battery and CTN reference

Pin Signal Description

J1 connector to power supply board connector

Pin Signal Description

Pin Signal Description

Description and operation

Air detection board

J1 to CPU board connector

J3 to ceramic elements for reception

2.2.1 Administration set check and maintenance sub-assembly