Fresenius Kabi Volumat Agilia User manual

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Volumat®Agilia
Technical Manual

Revisions table
TM Volumat Agilia Eng ref CC3176 
valid for pumps with serial numbers from 19830250 till…
Date Revision Chapter Description
July 5th, 2007 0All
index "a" Creation
Jan.15th, 2008 1Index "b" Insertion of Volumat MC
July 7th, 2008 2Index "c" Document only for Volumat Agilia
Sept. 15th, 2009 3Index "d"
New design
Spare parts catalogue removed from this
document: a separate document is available.
1.5.5 Update of the symbol of protection
defibrillation
April 7th, 2013 4Index "e"
Spelling corrections.
Precautions to be taken for rate test are
added.
Jan. 12th, 2015 5Index "f"
The torque value to re-assemble the OCS
clamp motor is added in the intervention
procedure no 11.
Feb. 24th, 2017 6Index "g"
§ 4.3 Training is added and a reference to it
is mentioned in each intervention procedure
(in § Maintenance level).
§ 4.4.25 - Electrical safety test: standards
are modified in the corresponding section and
in the quality control certificate.
§4.7: update of the cleaning and
disinfecting recommendations to match the
IFU contents.
§ 5.2: Error code "30" is updated.
Introduction of section 6 Intervention
procedures is updated.
A "Z" is added in front of the tools
references.
§ 7.1.3 - Etal 2, Door: the value for door
closed is modified to take into account the hall
effect sensor magnet direction.

TM_Volumat_Agilia_Eng_TDM.fm 3
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 Compliance 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 .................................................................................. 28
3.3 After-Sales Service test menu............................................................. 28
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
4.3 Training ................................................................................................. 32
4.4 Checks.................................................................................................. 33
4.4.1 Accessing the tests .................................................................................................. 33
4.4.2 Visual check ............................................................................................................. 34
4.4.3 Test 1, identification ................................................................................................. 35
4.4.4 Test 2, Maintenance................................................................................................. 36
4.4.5 Test 3, Maintenance messages ............................................................................... 37
Table of contents

44TM_Volumat_Agilia_Eng_TDM.fm
4.4.6 Test 4, Events .......................................................................................................... 37
4.4.7 Test 5, Upstream pressure....................................................................................... 38
4.4.8 Test 6, Downstream pressure .................................................................................. 38
4.4.9 Test 7, Door ............................................................................................................. 39
4.4.10 Test 8, battery information ....................................................................................... 40
4.4.11 Test 9, Signalisation ................................................................................................. 41
4.4.12 Test 10, Keyboard .................................................................................................... 41
4.4.13 Test 11, Ageing test ................................................................................................. 42
4.4.14 Test 12, Battery life .................................................................................................. 43
4.4.15 Test 13, Battery test ................................................................................................. 43
4.4.16 Test 14, Air sensor ................................................................................................... 44
4.4.17 Test 15, Clamp motor............................................................................................... 45
4.4.18 Test 16, Flow rate .................................................................................................... 46
4.4.19 Test 17, Flow rate correction.................................................................................... 47
4.4.20 Test 18, Occlusivity .................................................................................................. 47
4.4.21 Test 19, Clamp ......................................................................................................... 47
4.4.22 Checking the presence limit alarm ........................................................................... 48
4.4.23 Mains/battery operation check ................................................................................. 48
4.4.24 Battery life check...................................................................................................... 49
4.4.25 Electrical test............................................................................................................ 49
4.5 Maintenance options ........................................................................... 50
4.5.1 Access to test........................................................................................................... 50
4.5.2 SAV 1, Maintenance date ........................................................................................ 51
4.5.3 SAV 2, Initial set up.................................................................................................. 51
4.5.4 SAV 3, Data log event.............................................................................................. 52
4.5.5 Quality Control Certificate ........................................................................................ 53
4.6 Flow rate check .................................................................................... 55
4.6.1 Measuring by computer............................................................................................ 55
4.6.2 Measuring with a scale............................................................................................. 58
4.6.3 Measuring with a test tube ....................................................................................... 60
4.7 Cleaning and disinfecting ................................................................... 63
4.8 Storage.................................................................................................. 63
4.9 Use of the internal battery.................................................................. 64
5 Troubleshooting..............................................................................................65
5.1 Breakdown guide ................................................................................. 65
5.2 Errors messages.................................................................................. 71
6 Intervention procedures.................................................................................75
Procedure N°1: Battery and battery door ................................................. 77
Procedure N°2: Upper case ....................................................................... 79
Procedure N°3: Display board ................................................................... 83
Procedure N°4: CPU board ....................................................................... 87
Procedure N°5: Power supply board ........................................................ 91
Procedure N°6: Base kit ............................................................................. 95
Procedure N°7: Air detector board.......................................................... 101

TM_Volumat_Agilia_Eng_TDM.fm 5
Procedure N°8: Pumping system ............................................................ 105
Procedure N°9: Motor ............................................................................... 111
Procedure N°10: Pressure sensor ........................................................... 117
Procedure N°11: OCS clamp motor......................................................... 123
7 Calibrations................................................................................................... 127
7.1 Calibrations procedure ...................................................................... 127
7.1.1 Access to the calibrations ...................................................................................... 127
7.1.2 Etal 1, Pressures.................................................................................................... 129
7.1.3 Etal 2, Door ............................................................................................................ 131
7.1.4 Etal 3, Air sensor.................................................................................................... 132
7.1.5 Elal 4, Flow rate ..................................................................................................... 133
8 Spare parts catalogue.................................................................................. 135

66TM_Volumat_Agilia_Eng_TDM.fm

va01_001e_Eng.fm 7
Introduction
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, Volumat Agilia can be used in any units of the hospital: general wards,
paediatry, critical care, oncology....
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, 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.
Volumat Agilia can be programmed in three different modes:
No drug name,
Drug labelling,
Vigilant Drug'Lib.
The drop detector is optional. Volumat Agilia has got 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.
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.
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.
Volumat Agilia has a range of flow rates from 1 to 1200mL/h in macro mode and from 0.1 to
100ml/h in micro mode.
Volumat Agilia is fitted with an infrared cell at the back. Fresenius Kabi also offers a Link+
Agilia rack system enabling several Agilia pumps to communicate to a communications
system via the infrared cell and Link+Agilia.

8va01_001e_Eng.fm
Introduction
1.2 Operation diagram

va01_001e_Eng.fm 9
Introduction
1.3 Precautions for use
The
!
symbol visible on the device, indicates that the relevant Instructions For Use should
be read thoroughly.
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 for more details.
Use conditions:
Temperature: 5°C to 40°C / 41°F to 104°F.
Humidity: 20% to 90%, no condensation.
Atmospheric pressure: 700 hPa to 1060 hPa.
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.
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.

10 va01_001e_Eng.fm
Introduction
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
Volumat Agilia contains 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: ~ 2 Kg.
1.5.4 Material characteristics
Components Materials
1Screw cap (2) Polyamide
2Nut bolt button Polyamide
3M8 moulded screws Polyamide
4Angle bracket ABS
5Battery door ABS
6Right and left flanges Polycarbonate
7Pumping block plate Polyamide
8Moulded cover over light guide ABS
9Light 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
19 Bolt rear case POM
20 Bolt button POM
21 Bolt button pen POM

va01_001e_Eng.fm 11
Introduction
1.5.5 Compliance to standards

0459
Compliant with the 93/42/CE Medical Directive. IP22 Protection against
splashing liquid.
Safety of Electro
Medical
Equipement
Compliant with EN/IEC 60601-1 and EN/IEC 60601-2-24 Protection against
leakage current:
Defibrillation-proof type
CF applied part.
EMC
(ElectroMagnetic
Compatibility)
Compliant with EN/IEC 60601-1-2 and 
EN/IEC 60601-2-24
Protection against 
electric shocks: class II.
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
"Guidance and manufacturer’s declaration on EMC" section of the Instructions For Use.
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
Components Materials

12 va01_001e_Eng.fm
Introduction

va02_001e_Eng.fm 13
Description and operation
2 Description and operation
2.1 Physical description
Cover
Control panel
Base
Door
Air bubbles detector
Angle bracket
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,
a clamp system.
The angle bracket supports:
a power supply board,
a mains board,
a battery.

14 va02_001e_Eng.fm
Description and operation
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
J1
J3
J2
Display board
This board is connected to the other parts by means of connectors.
J1 connector to keyboard
Pin Signal Description
1A_LED Ground
2COL0 Keyboard column 0
3COL1 Keyboard column 1
4COL2 Keyboard column 2
5LIG0 Keyboard line 0
6LIG1 Keyboard line 1
7LIG2 Keyboard line 2
8ON/OFF Keyboard ON/OFF key
9CTR Keyboard control or line 3
10 GND Ground
J2 connector to CPU board
Pin Signal Description
A1 GND Ground
B1 VBAT Battery power supply or "+10V mains"
A2 +3V3-
PERM_PROT
Diagnostic signal (correct boards connection)
B2 -Not connected

va02_001e_Eng.fm 15
Description and operation
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
1A_LED Backlight LED anode
2C_LED Backlight LED cathode
3 - Not connected
4 - Not connected
5GND Ground, indicating serial access to LCD
6MOSI LCD serial data line
7CLK LCD serial line clock
8GND Not used by the LCD in serial access
9GND Not used by the LCD in serial access
10 GND Not used by the LCD in serial access
11 GND Not used by the LCD in serial access
12 GND Not used by the LCD in serial access
13 GND Not used by the LCD in serial access
14 GND Not used by the LCD in serial access
15 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
J2 connector to CPU board
Pin Signal Description

16 va02_001e_Eng.fm
Description and operation
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.
J2
J7
J4 on the inside
J11
J12
J14
J9
J1
J13
J3 J10
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
CPU board

J3 connector to downstream pressure sensor
Pin Description
1GND Ground
2+3V3_PS Power supply +3.3V filtered for pressure sensor
3V+ + Pressure sensor resistance bridge
4GND Ground
5V- - Pressure sensor resistance bridge
6GND Ground
J4 connector to upstream pressure sensor
Pin Description
1GND Ground
2+3V3_PS Power supply +3.3V filtered for pressure sensor
3V+ + Pressure sensor resistance bridge
4GND Ground
5V- - Pressure sensor resistance bridge
6GND Ground
J7 to CLAMP connector board
Pin Description
1GND Ground
2MC_OPTO2/ Opto 2 status
3MC_CD_OPTO Opto 2 power supply
4GND Ground
5MC_OPTO1/ Opto 1 status
6MC_CD_OPTO Opto 1 power supply
7GND 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
1+3V3 +3.3V power supply
2+3V3 +3.3V power supply
3TCK "Input" JTAG port signal
4TDO "Output" JTAG port signal
5TRST/ "Input" JTAG port signal
6TDI "Input" JTAG port signal
7MR/ "Input" JTAG port signal
8GND Ground
9TMS "Output" JTAG port signal
10 GND Ground
va02_001e_Eng.fm 17
Description and operation

J10 connector to opto motor
Pin Description
1GND Ground
2MP_OPTO/ Motor opto rotation state
3MP_CD_OPTO Opto power supply
4GND Opto power supply return
J11 connector to display board
Pin Description
A1 GND Ground
B1 VBAT Battery power supply or + "10V mains"
A2 +3V3-
PERM_PROT
Diagnostic signal (correct boards connection)
B2 -Not connected
A3 GND Ground
B3 +3V3 Power supply +3V3
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 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
1GND Ground
2PULSE_goutte Sensor return signal
3GND Ground
4GND Ground
5CDLED_goutte Sensor power supply
6GND Ground
18 va02_001e_Eng.fm
Description and operation

J13 connector to air detector
Pin Description
1GND Ground
2DA_ANA_AIR Analogue signal sent by the air detector
3GND Ground
4DA_DISCH Air detector reset command
5+3V3 +3.3V power supply
6DA_GAIN Air detector gain adjustment command
7+3V3 +3.3V power supply
8DA_SCL I²C bus clock signal between main micro controller
and air detector
9DA_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
B1 VBAT Battery power supply or "+10V mains"
A2 +3V3-PERM Power supply +3.3V backup for date stamper
B2 -Not connected
A3 GND Ground
B3 +3V3 +3.3V power supply
A4 TON/OFF Keyboard ON/OFF key
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
A11 +3V3 +3.3V power supply
B11 GND Ground
A12 -Not connected
B12 PRES_CARTES Diagnostic signal (good board connection)
A13 VBAT Battery power supply or "+10V mains"
B13 GND Ground
va02_001e_Eng.fm 19
Description and operation

20 va02_001e_Eng.fm
Description and operation
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
J6 J3
on the inside
J1
circular
J2
on the inside
J4
on the inside
connector
.
Power supply board
This board is connected to the other parts by means of connectors.
J1 to CPU board connector
Pin Description
A1 GND Ground
B1 VBAT Battery power supply or "+9V mains"
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
A4 TON/OFF Keyboard ON/OFF key
B4 GND Ground
A5 SCL_ALIM Signal Clock of the bus I²C clock signal between
main (CPU) and secondary micro controller (Power
supply)