Volumat Technical Manual

SERVICES
Volumat Agilia
Technical Manual
Revision table TM Volumat Agilia_en : ref NT 1872 / from serial n 19830250 till ... Date
05/07/07
Revision
0
Chapter
All index "a"
Description
Creation
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 1.5.2 1.5.3 1.5.4 1.5.5 Electrical details ....................................................................................................... 10 Electronic details ...................................................................................................... 10 Mechanical details.................................................................................................... 10 Material characteristics ............................................................................................ 10 Conformity and norms .............................................................................................. 11
2 Description and operation ............................................................................. 13

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

3.1 Options menu ....................................................................................... 27 3.2 Calibration menu .................................................................................. 29 3.3 After-Sales Service test menu............................................................. 31 3.4 After-Sales Service options menu ...................................................... 31
4 Preventive maintenance ................................................................................ 33

4.1 Recommendations ............................................................................... 33 4.2 Maintenance schedule ......................................................................... 33
4.2.1 4.2.2 4.3.1 4.3.2 4.3.3 4.3.4 4.3.5 4.3.6 Preventive maintenance........................................................................................... 33 Quality control .......................................................................................................... 33 Accessing the tests .................................................................................................. 35 Visual check ............................................................................................................. 36 Test 1, identification ................................................................................................. 37 Test 2, Maintenance................................................................................................. 38 Test 3, After-Sales Service messages ..................................................................... 39 Test 4, Events .......................................................................................................... 39
4.3 Checks.................................................................................................. 35
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4.3.7 4.3.8 4.3.9 4.3.10 4.3.11 4.3.12 4.3.13 4.3.14 4.3.15 4.3.16 4.3.17 4.3.18 4.3.19 4.3.20 4.3.21 4.3.22 4.3.23 4.3.24 4.3.25 4.4.1 4.4.2 4.4.3 4.4.4 4.4.5 4.5.1 4.5.2 4.5.3
Test 5, Upstream pressure....................................................................................... 40 Test 6, Downstream pressure .................................................................................. 40 Test 7, Door ............................................................................................................. 41 Test 8, battery information ...................................................................................... 42 Test 9, Signalisation ................................................................................................ 43 Test 10, Keyboard.................................................................................................... 43 Test 11, Ageing ....................................................................................................... 44 Test 12, Battery life .................................................................................................. 45 Test 13, Battery test ................................................................................................. 45 Test 14, Air detector................................................................................................. 46 Test 15, Motor clamp ............................................................................................... 47 Test 16, Flow rate .................................................................................................... 48 Test 17, Flow rate correction.................................................................................... 49 Test 18, Occlusivity .................................................................................................. 50 Test 19, Clamp......................................................................................................... 51 Counter pressure check ........................................................................................... 51 Mains/battery operation check ................................................................................. 52 Battery autonomy check........................................................................................... 52 Electrical test ............................................................................................................ 52 Access to test........................................................................................................... 53 SAV 1, Maintenance date ........................................................................................ 54 SAV 2, Initial set up.................................................................................................. 54 SAV 3, Data log event.............................................................................................. 55 Quality Control Certificate ........................................................................................ 57 Measuring by computer............................................................................................ 59 Measuring with a scale............................................................................................. 61 Measuring with a test tube ....................................................................................... 63
4.4 After-Sales Service options ................................................................ 53
4.5 Flow rate check .................................................................................... 59
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 Error messages.................................................................................... 73
6 Intervention procedures................................................................................. 77
Procedure n1 : Upper case....................................................................... 79 Procedure n2 : Display board .................................................................. 83 Procedure n3 : Central unit board .......................................................... 87 Procedure n4 : Power supply board........................................................ 91 Procedure n5 : Base kit ............................................................................ 95 Procedure n6 : Air detector board ......................................................... 101 Procedure n7 : Pumping system ........................................................... 105 Procedure n8 : Motor .............................................................................. 111
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Procedure n9 : Pressure sensor ............................................................ 117 Procedure n10 : OCS clamp motor ....................................................... 123 Procedure n11 : Battery and battery door............................................. 131
7 Calibrations................................................................................................... 133
7.1 Calibration procedure ........................................................................ 133
7.1.1 7.1.2 7.1.3 7.1.4 7.1.5 Access to the calibrations ...................................................................................... 133 Etal 1, Pressure...................................................................................................... 135 Etal 2, Door ............................................................................................................ 137 Etal 3, Air detector.................................................................................................. 138 Elal 4, Flow rate ..................................................................................................... 139
8 Catalogue of Spare Parts............................................................................. 141

8.1 Base..................................................................................................... 141 8.2 Cover ................................................................................................... 143 8.3 Angle bracket...................................................................................... 145 8.4 Flanges................................................................................................ 147 8.5 Motor ................................................................................................... 149
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1 Introduction
1.1 General introduction
Volumat Agilia is a volumetric infusion pump with flow rate functions. It is very intuitive and easy to learn, like all products of the Agilia family. The infusion and pressure monitoring, the didactical messages and symbols minimize the risks during infusion. Thanks to its built-in security systems and to the Vigilant DrugLib mode which uses data from a drug library, Volumat Agilia is particularly suitable for speciality wards and basic ICUs. Volumat Agilia can be programmed in three different modes: ! No drug name, ! Drug labelling, ! Vigilant DrugLib. The drop detector is optional. The pump is equipped with an automatic occlusion checking system (OCS). The Volumat Agilia pump has its own control keyboard and a LCD screen. It has an internal battery which ensures a minimum autonomy of 8 hours for a flow rate of 125 ml/h. A large choice of configuration parameters enables optimal use of the functions according to the needs of each department. 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. Volumat Agilia is fitted with an infrared cell at the back. Fresenius Vial uses a Link system enabling several pumps to communicate to a communications system via the infrared cell and rack. Volumat Agilia is equipped with an integrated system allowing it to be attached to a pole or rail. Its integrated locking system allows three Volumat Agilia devices pumps to be stacked on top of one another to facilitate transportation.
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Introduction
1.2 Operation diagram
Introduction
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1.3 Precautions for use

The ! symbol visible on the device, indicates that the relevant operator guide 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 pump 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 After-Sales Department, 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 Vial cannot, in any circumstances, be held responsible for any medical or other problem due to incorrect use of the device. Kindly consult the User Manual for more details. ! Temperature : 5C to 40C / 41F to 104F. ! 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 After-sales service. The Volumat Agilia pump 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.
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Introduction
1.5 Technical characteristics

1.5.1 Electrical details
! ! ! ! ! ! ! Power supply : 100 V - 240 V~/ 50-60 Hz with functional Earth Max. consumption : 180 mA Max. power : 15 VA Fuse : T1AH 250 V - 2xAT internal to power supply unit Battery : 7.4 V - 2.2 Ah. (LI-ion) External power supply : 9 V CC. Power > 15 Watts. Communication port and 11-30 Vdc power.
1.5.2 Electronic details

The Volumat Agilia pump contains 5 electronic boards: ! ! ! ! ! Power supply board Mains board CPU board Display board. Air detection board
1.5.3 Mechanical details

! Dimensions: H x L x W: 145 x 135 x 130 mm ! Weight: approximately 2.1 kg.
1.5.4 Material characteristics

Components Screw cover (2 sockets) Nut locking button 8 moulded screws Angle bracket Battery holder Right and left flange Pumping block plate Moulded cover over light guide Light guide Window Moulded base Base right tube guide Base left tube guide Central hook cover Right and left hook cover IRDA window Excentric screw Front case lock Rear case lock Handle lock Handle lock Pen Materials Polyamide Polyamide Polyamide ABS ABS Polycarbonate Polyamide ABS Polycarbonate Polycarbonate ABS Polyamide 6 Polyamide 6 Polyamide 6 Polyamide 6 Polycarbonate POM POM POM POM POM
Introduction
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21
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22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48
Components Air detector support Door Inner door Moulded lever + hooks Right and left door hinge OCS fuse OCS declamping finger Block stopper spring OCS detector cradle Pumping block Star motor ring Motor pulley Cam shaft pulley Belt idler pulley Belt idler lever Optical rotation control disk Pumping finger Moulded cam shaft Bearing motor support Optima magnet support Membrane Membrane frame Sp400/Vp500 back foot VP500 front foot RJ11 stopper Connector stopper Star motor shock absorber
Materials ABS ABS Polyarylamide Polyarylamide Polyamide 6 Polyacetal Polyamide Polyamide Polyamide Polyamide Polyacetal Polyamide Polyamide Polyamide Polyacetal Polyamide PA6-12 PA66 Polyarylamide ABS TF3 STE Polypropylene LSR LSR TPE EPTR TPE EPTR Elastomere
1.5.5 Conformity and norms

Conform to the 93/42/CE Medical Directive. 0459 Safety of Electro Medical Equipement EMC (ElectroMagnetic Compatibility) Conform to EN/IEC 60601-1 and EN/IEC 60601-2-24 IP22 Protection against splashing liquid. Protection against leakage current: CF type. Protection against electric shocks: class II. Functional earth.
Conform to EN/IEC 60601-1-2 and EN/IEC 60601-2-24
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 manufacturers declaration on EMC" chapter of the User Manual. Introduction va01_001a_en.fm 11
Introduction
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2 Description and operation

2.1 Physical description
g Angle bracket Air bubble detector Cover
Base Control panel
Door
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 " a clamp system ! The angle bracket supports: " a power supply board, " a mains board, " a battery
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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
J2 J3
J1
Display board This board is connected to the various pieces of equipment by means of connectors. J1 connector to keyboard Pin 1 2 3 4 5 6 7 8 9 10 Description and operation Signal A_LED COL0 COL1 COL2 LIG0 LIG1 LIG2 ON/OFF CTR GND Description Ground Keyboard column 0 Keyboard column 1 Keyboard column 2 Keyboard line 0 Keyboard line 1 Keyboard line 2 Keyboard ON/OFF keys Keyboard control or line 3 Ground
J2 connector to CPU board Pin A1 B1 A2 B2 Signal GND VBAT +3V3PERM_PROT Description Ground 10V battery power supply +mains Diagnostic signal (correct board connection) Not connected
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J2 connector to CPU board Pin A3 B3 A4 B4 A5 B5 A6 B6 A7 B7 A8 B8 A9 B9 A10 B10 A11 B11 A12 B12 A13 B13 Signal GND +3V3 TON/OFF MISO GND MOSI GND CLK GND RESET/ RSLCD CSLCD/ CSLDCD/ CD_BuZ_AFF GND S_ANA_DOOR +3V3 GND PRES_CARTES VBAT GND Description Ground +3V3 power supply Keyboard ON/OFF keys SPI bus MISO signal Ground SPI bus MOSI signal Ground SPI bus clock signal Ground Control signal Control signal (intended for LCD display) Control signal Control signal Buzzer command Ground Analogue signal sent by "DOOR" sensor +3V3 power supply Ground Not connected Diagnostic signal (good board connection) 10V battery power supply or +mains Ground
J3 to display connector Pin 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 A_LED C_LED GND MOSI CLK GND GND GND GND GND GND GND GND RSLCD RESET/ CSLCD/ +3V3 GND Description Backlight LEDs anode Backlight LEDs cathode Not connected Not connected Ground, indicating serial access to LCD LCD serial data line LCD serial line clock Not used by the LCD in serial access Not used by the LCD in serial access Not used by the LCD in serial access Not used by the LCD in serial access Not used by the LCD in serial access Not used by the LCD in serial access Not used by the LCD in serial access Not used by the LCD in serial access Command selection /LCD data LCD reset LCD chip select +3,3 V power supply Ground
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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 1 2 3 4 +BOBINEA -BOBINEA +BOBINEB -BOBINEB Description Terminal + motor A coil Terminal - motor A coil Terminal + motor B coil Terminal - motor B coil
J2 to OCS motor connector Pin 1 2 3 4 +BOBINEA -BOBINEA +BOBINEB -BOBINEB Description Terminal + motor A coil Terminal - motor A coil Terminal + motor B coil Terminal - motor B coil
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J3 connector to downstream pressure sensor Pin 1 2 3 4 5 6 GND +3V3_PS V+ GND VGND Description Ground Power supply +3V3 filtered for pressure sensor Sensor + pressure sensor resistance bridge Ground Terminal - pressure sensor resistance bridge Ground
J4 connector to upstream pressure sensor Pin 1 2 3 4 5 6 GND +3V3_PS V+ GND VGND Description Ground Power supply +3V3 filtered for pressure sensor Power supply + pressure sensor resistance bridge Ground Terminal - pressure sensor resistance bridge Ground
J7 to C.I CLAMP connector Pin 1 2 3 4 5 6 7 8 9 10 GND MC_OPTO2/ MC_CD_OPTO GND MC_OPTO1/ MC_CD_OPTO GND /S_CLAMP /S_CD_CLAMP GND Description Ground Opto 2 state Opto 2 power supply Ground Opto 1 state Opto 1 power supply Ground CLAMP opto state CLAMP opto power supply Ground
J9 to JTAG connector (micro programming) Pin 1 2 3 4 5 6 7 8 9 10 +3V3 +3V3 TCK TDO TRST/ TDI MR/ GND TMS GND Description +3,3 V power supply +3,3 V power supply "Input" JTAG port signal "Output" JTAG port signal "Input" JTAG port signal "Input" JTAG port signal "Input" JTAG port signal Ground "Output" JTAG port signal Ground
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J10 connector to opto motor Pin 1 2 3 4 GND MP_OPTO/ MP_CD_OPTO GND Description Ground Motor opto rotation state Opto power supply Opto power supply return
J11 connector to display board Pin A1 B1 A2 B2 A3 B3 A4 B4 A5 B5 A6 B6 A7 B7 A8 B8 A9 B9 A10 B10 A11 B11 A12 B12 A13 B13 GND VBAT +3V3PERM_PROT GND +3V3 TON/OFF MISO GND MOSI GND CLK GND RESET/ RSLCD CSLCD/ CSLDCD/ CD_BUZ_AFF GND S_ANA_DOOR +3V3 GND PRES_CARTES VBAT GND Description Ground Battery power supply or + 10V mains Diagnostic signal (good board connection) Not connected Ground Power supply +3V3 Keyboard ON/OFF key SPI bus MISO signal Ground SPI bus MOSI signal Ground SPI bus clock signal Ground Control signal Control signal (intended for LCD display) Control signal Control signal Buzzer command Ground Analogue signal sent by the "DOOR" sensor Power supply +3V3 Ground Not connected Diagnostic signal (good board connection) Battery power supply or +10Vmains Ground
J12 connector to drop detector Description and operation Pin 1 2 3 4 5 6 GND PULSE_goutte GND GND CDLED_goutte GND Description Ground Sensor return signal Ground Ground Sensor power supply Ground
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J13 connector to air detector Pin 1 2 3 4 5 6 7 8 9 10 GND DA_ANA_AIR GND DA_DISCH +3V3 DA_GAIN +3V3 DA_SCL DA_SDA GND Description Ground Analogue signal sent by the air detector Ground Air detector reset command +3V3power supply Air detector gain adjustment command +3V3 power supply I bus clock signal between main micro controller C and air detector I bus data signal between main micro controller C and air detector oscillator Ground
J14 connector to power supply board Pin A1 B1 A2 B2 A3 B3 A4 B4 A5 B5 A6 B6 A7 B7 A8 B8 A9 B9 A10 B10 A11 B11 A12 B12 A13 B13 GND VBAT +3V3-PERM GND +3V3 TON/OFF GND SCL_ALIM SDA_ALIM GND RXIR TXIR GND SCK GND RXD TXD GND CD_BUZZ_ALIM +3V3 GND PRES_CARTES VBAT GND Description Ground Battery power supply or + mains10V Power supply +3V3 backup for date stamper Not connected Ground +3V3 power supply Keyboard ON/OFF key Ground I bus clock signal between main micro controller C (CPU) and secondary (Power supply) I data signal between main micro controller C (CPU) and (Power supply) Ground IrDA cell reception signal IrDA cell emission signal Ground Serial bus clock signal Ground External plug data reception signal External plug data emission signal Ground Buzzer command +3V3 power supply Ground Not connected Diagnostic signal (good board connection) Battery power supply or + mains 10V Ground
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2.1.3 The power supply board

The power supply board is made up of a micro controller (ATmega48, said to be 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 IrDA 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 100 V - 240 V CA network or, externally, from 9 V CC. It also charges a 2.2 Ah battery.
J1
J2 on the inside circular connector J6 J4 on the inside
J3 on the inside
Power supply board This board is connected to the different pieces of equipment by means of connectors. J1 to CPU board connector Pin A1 B1 A2 B2 A3 B3 A4 B4 A5 GND VBAT +3V3-PERM GND +3V3 TON/OFF GND SCL_ALIM Description Ground Battery power supply or mains +9V Power supply +3V3 backed up for the time stamper Not connected Ground Power supply +3V3 Keyboard ON/OFF key Ground Signal Clock of the bus I clock signal between C main (CPU) and secondary micro controller (Power supply)
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J1 to CPU board connector Pin B5 SDA_ALIM Description Signal Data of the I bus data signal between main C (CPU) and secondary (Power supply) micro controller Ground IrDA cell reception signal IrDA cell emission signal Ground Serial bus clock signal Ground External plug data reception signal External plug data emission signal Ground Buzzer command +3V3 power supply Ground Not connected Diagnostic signal (good board connection) Battery power supply or mains +9V Ground
A6 B6 A7 B7 A8 B8 A9 B9 A10 B10 A11 B11 A12 B12 A13 B13
GND RXIR TXIR GND SCK GND RXD TXD GND CD_BUZ_ALIM +3V3 GND PRES_CARTES VBAT GND
J2 connector to mains connector Pin 1 2 3 Signal Neuter Phase GND Description Mains power supply Mains power supply Ground
J3 connector to secondary micro controller Pin 1 2 3 4 5 6 Signal MISO +3V3 SCK MOSI /RST GND Description Output SPI programming signal +3.3 V power supply Input SPI programming signal Input SPI programming signal Input SPI programming signal Ground
J4 connector to internal battery Pin 1 2 3 Signal +BATTERIE ANA_CTN GND Description Battery positive terminal CTN positive terminal Ground, battery negative terminal and CTN reference
J5 connector to external plug Pin 1 Signal SCK Description Serial connection clock
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J5 connector to external plug Pin 2 3 4 5 6 7 8 9 10 Signal TXD RXD +5V GND RELAIS GND +10V0 GND GND Description Serial connection data emission Serial connection data reception Power supply accessories (supplied by the board) Ground Relay command (open collector) Ground External power supply (supplied by the board) Ground Ground
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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 Mains board This board is connected to the different pieces of equipment by means of connectors. J1 connector power supply board Pin 1 2 3 Signal Neuter Phase GND Description Mains power supply Mains power supply Ground F1
J2 connector to mains Pin 1 2 3 Signal Neuter Phase GND Description Mains power supply Mains power supply Functional Earth
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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 reception element and the emission element, respectively. The air detection board is fixed to the base. It transmits the volume air bubbles in the tube in the form of analogue data to the CPU board. . J1 J3 J2 J2
Air detection board This board is connected to the different pieces of equipment by means of connectors. J1 to CPU board connector Pin 1 2 3 4 5 6 7 8 9 10 GND DA_ANA_AIR GND DA_DISCH +3V3 DA_GAIN +3V3 DA_SCL DA_SDA GND Description Ground Analogue signal sent by the air detector Ground Air detector command reset +3V3 power supply Air detector adjustment gain command +3V3 power supply I bus clock signal between main micro controller C and air detector oscillator I bus data signal between main micro controller C and the air detector oscillator Ground
J2 to emission element connector J3 to element emission connector
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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 tube. ! a motorisation sub-assembly. ! an external connection sub-assembly.
2.2.1 Tube check and maintenance sub-assembly

The tube is positioned along the front part and 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 tube clamp. An ultra-sound detector to detect the presence of air bubbles in the tube. Detection of the pressure is ensured by two piezo-resistant sensors.
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 12fingers. The displacement of these fingers is controlled by the CPU board, which ensures the liquid is displaced 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 are situated on the camshaft end. These control rotation motor/pumping system.
2.2.3 External connection sub-assembly

Volumat Agilia has 2 plugs situated at the back of the angle bracket: ! a mains supply plug ! an 8 point Binder plug which, together with various specific Fresenius-Vial accessories, enables the following: " 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.
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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 Vial 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 User Service Maintenance
Key in code Code XXXX
Sub-menu User options menu
Sub-menu
Code 0200 Service options menu Code 0000 Test Maintenance options test menu Maintenance options Maintenance options menu Calibration Calibration menu Description of the menus 27
Only the maintenance menu is described in this document. For more information concerning the other menus, kindly consult the User Manual.
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Description of the menus
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Description of the menus 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, Pressure, Etal 2, Door, Etal 3, Air detector, Elal 4, Flow rate.
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Description of the menus 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 After-Sales 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, After-Sales Service 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, Life test, Test 12, Battery life, Test 13, Battery test, Test 14, Air detector Test 15, Motor clamp, Test 16, Flow rate, Test 17, Flow rate correction, Test 18, Occlusivity, Test 19, Clamp.
3.4 After-Sales Service options menu

The After-Sales Service options menu provides the following options: ! SAV1, Maintenance date, ! SAV 2, Initial set up, ! SAV 3, Data log event.
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4 Preventive maintenance
4.1 Recommendations
The Volumat Agilia pump can only be checked, serviced or repaired by Fresenius Vial 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 After-Sales Service. Should you need to return the pump to our After-Sales 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 After-Sales Service or our Sales department. Fresenius Vial is not liable for loss or damage to the pump during its transport to our AfterSales Service.
4.2 Maintenance schedule

4.2.1 Preventive maintenance
In order to maintain the pumps performance, a Preventive Maintenance inspection must be carried out every 3 years. This procedure, which includes changing the battery, 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 After-Sales Service. In these instances, the pump should not be used.
Important: If these maintenance procedures are not observed, the pumps 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 pumps Technical Manual. Only a qualified technician may perform the quality check which must be performed using Fresenius-Vial software. For more information, kindly contact our After-Sales Service.
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Preventive maintenance
At the end of the device life, return it to an organization competent in the treatment of the electrical an electronic equipment waste. Remove the battery from the device and return it to competent recycling organization.
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Maintenance prventive
4.3 Checks
A quality control checking 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 stops infusion. Menu/Exit accesses the test mode. The navigation buttons 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 "preceding" menu. Bolus or purge
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Moving to the After-Sales Service test mode. ! Press "Menu/Exit". ! Keep it pressed down and press "ON". ! When the "Options" main menu appears, release "Menu/Exit" and "ON".
! Choose your "Maintenance" menu using the navigation buttons. ! Press "enter" to confirm.
! The "Maintenance" menu appears. ! Key in the code.
! Press "OK" to confirm. ! Choose the "Test" menu using the navigation buttons. ! Press "enter" to confirm. " Navigate through this sub-menu using the central navigation buttons.
You may exit the configuration mode at any time by pressing "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.
Preventive maintenance 36
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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" appears.
! Scroll through the information using the navigation buttons. " 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.
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4.3.4 Test 2, Maintenance

This test displays: 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 appears. Scroll through the information using the navigation buttons. Choose between the proposed options "Reset" or "Exit".
! "RAZ", using the left selection key. The following "Maintenance" menu appears. 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 days 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 returns the user to the last "Test" menu.
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4.3.5 Test 3, After-Sales Service messages

This test displays information concerning the After-Sales Service interventions.

"
The "Messages" main menu appears.
! Scroll through the information from screen to screen using the navigation buttons. ! Press "exit" to return to the "Test" menu.
4.3.6 Test 4, Events

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

"
The "Events" main menu appears.
! Scroll through the information from screen to screen using the navigation buttons. ! Press "enter" to display the alarm type. ! Press "Menu" to return to the "Test" menu.
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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 appears.
! Scroll through the information from screen to screen using the navigation buttons. " Conversion: # Sensor value in mV # Calibration open door in mV # Calibration 0 mmHg in mV # Sensor zero adjustment offset in LSB " Date: Number: # Date and calibration number. ! Select "exit" to return to the "Test" menu.
Refer to chapter 7, "Calibration/Calibration procedure / Etal 1 pressure", if the variance is too high.
4.3.8 Test 6, Downstream pressure

This test displays: 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 pressurer" appears.
! Scroll through the information from screen to screen, using the navigation buttons. " 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: # Number and date of calibration.
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! Select "exit" to return to the "Test" menu.
Refer to chapter 7, "Calibration/Calibration procedure / Etal 1 pressure", if the variance is too high.
4.3.9 Test 7, Door

This test displays: the door value in mV and its state, the calibration values in mV, the date and calibration meter. !

"
The main men, "Door" appears.
! Scroll through the information, from screen to screen, using the navigation buttons. " 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, ! Select "exit" to return to the "Test" menu.
Refer to chapter 7, "Calibration/Calibration procedure / Etal 1 pressure, if the variance is too high
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4.3.10 Test 8, battery information

This test displays: 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 appears. Choose between the "Clear" and "exit" options that appear.
Select "RAZ" to reset to 0 after all battery replacements. ! "RAZ", using the left selection key
"
The "Battery Info" menu appears, as shown.
"
" "
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.
! Scroll through the information, from screen to screen, using the navigation buttons. " 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.
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4.3.11 Test 9, Signalisation

This test checks that the indicator lights and buzzer are functioning correctly. !

" "
The main screen appears. All LEDS and the mains LED are lit up.
! Press "OK" to start the test. " The "Signalling" main menu appears. # Check that the LEDS, 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 appears.
! Press all the keys one by one, for example: " Press "Bolus/Purge" # the corresponding circle on the screen becomes dark. ! Press the "EXIT" key, for a long time to exit the screen and return to the "Test" menu for the entire duration of the test.
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4.3.13 Test 11, Ageing

This text checks the motor block/pumping system is functioning correctly as well as the pump occlusivity. !

"
The main, "Ageing" menu appears.
When the pump is fitted with a tube, open the tube clamp by pressing the bolus button. ! Select your submenu using the "OK" key. " Flow rate: between 0,1 and 1200 ml/h Modify the value using the following navigation buttons: # 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 set or go forwards/backwards or backwards Modify your choice using the single arrow navigation buttons. Press "OK" to confirm and move to the next step. Number of steps or number of cycles: Content or value lying between 1 and 9999 Modify the value using the single arrow navigation buttons Press "OK" to confirm and move to the next step. Current: Weak, strong, auto or error. Modify the value using the single arrow navigation buttons, Press "OK" to confirm and move to the next step.
"
"
"
"
! Press "OK" to confirm and start up the test.

"
The following, "Ageing", menu appears:. # 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.
! Press "exit" to return to the "Test" menu.
During the test, the rotation check is activated and the device moves to the error state if a problem is detected. In a test with a defined number of steps/cycles or using a "setting" displacement mode "setting", the test ends when the designated position is reached.
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4.3.14 Test 12, Battery life

This test displays: the amount of battery charge; the date of the last automatic extinction; the pumps battery running time before the pre-alarm and battery alarm were triggered; the alarms running time till the battery is off. ! Test 12, press "enter". ! The, "Battery life" main menu appears.
! Scroll through the information from screen to screen using the navigation buttons. " 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 changed, all the parameters for 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. ! Test 13, press "enter". ! If the material is connected to the mains, the "Battery test" menu appears.
Carrying out the battery test does not require the presence of an operator to note the batterys autonomy. At the end of the autonomy test, the device switches off. To ascertain the batterys running time, the device is simply plugged into the mains and "test 12" selected.
Once the autonomy 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.
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4.3.16 Test 14, Air detector

This test displays: the air detector value in mV, the calibration values in mV, the date and calibration counter. !

"
The main, "Air detector" menu appears.
! Scroll through the information, from screen to screen, using the navigation buttons. " Conversion: State: water/air # Air sensor value in mV # Calibration without tube in mV # Calibration with tube and air in mV # Calibration with tube and water in mV # Resounding frequency during calibration # Resonance frequency 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 variance is too high.
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4.3.17 Test 15, Motor clamp

This test checks the clamp motor is functioning correctly when carrying out displacement. !

"
The main "Clamp motor" menu appears.
! Select your sub-menu using the "OK" key. " Mode: declamping, continuous, go back, go forward or initialise. Modify the choice using the navigation buttons.
"
Press "OK" to validate and move to the next step. Number of steps: Auto or a value from 1 to 1000 Modify the value using the single arrow navigation buttons, Press "OK" to validate and move to the next step. Frequency: Auto or a value lying between 10 and 500 Hz Modify the value using the single arrow navigation buttons.
"
"
"
! Press "OK" to validate and start up the test.
"
The "Clamp motor" menu appears, as shown. # 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 check is activated and the device moves to the error state 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 designated position is reached.
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! Press "exit" to return to the "Test" menu.
4.3.18 Test 16, Flow rate

This test checks the corrector coefficient detailed in the flow rate calibration. (Etal 4) ! Carry out a flow rate test that conforms to the EN-60-601-2-24 norm (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 tube. !

"
The "Flow rate" main menu appears. The "default values" are: # Flow rate 100ml/h # Volume 25 ml # Duration 0h15
The IS flow rate software dedicated to this procedure is available from Fresenius Vial.
Any flow rate test using the "default values" menu ends with a minimum/maximum volume indication, facilitating the checking of the result obtained when this test is carried out with a scale or a test tube.
Refer to chapter 7, "Calibration/Calibration procedure / Etal 4 flow rate calibration", if the variance is too high.
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4.3.19 Test 17, Flow rate correction

This test displays the corrector coefficient for the device flow rate, the date and calibration counter.
Test 17, press"enter".

"
The main, "Flow rate correction" menu appears.
! Scroll through the information, from screen to screen, using the navigation buttons. " Correction: # The device flow rate corrector coefficient is displayed as a percentage. " Date: Number: # Calibration date and number. ! Press "exit" to return to the "Test" menu.
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4.3.20 Test 18, Occlusivity

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

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

"
The main, "Clamp" menu appears.
" " "
Clamp: Present or absent. Position: Closed or open. Press "exit" to return to the "Test" menu.
4.3.22 Counter pressure check

To carry out this operation, exit the test mode and press "OFF". ! Set the device up as illustrated below:
Pocket
1m Manometer Tap 3 channels
PUMP
50cm
Container
When the value of the measured pressure, according to the selection carried out, lies outside of the reference values, recalibrate the pressure sensors (see "Etal 1 Upstream and downstream pressure sensor calibration").
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! Press "ON". " Place the tube on the device and fix it to the door and the clamp. " Place the manometer at the tube outlet. " Select a flow rate of 125 ml/h. " Adjust the pressure threshold to 750 mmHg. # Open the tap over a container. # Carry out the infusion and leave it for 30 seconds. # Position the tap on the manometer side. # Check that the alarm is triggered for a value of 1 bar 0,15 bar. " Stop the infusion cycle by pressing "STOP".
4.3.23 Mains/battery operation check

! To carry out this procedure, exit the test mode and press "OFF". ! Connect the device to the mains. " Check the functioning of mains presence LED (plugshaped indicator). ! Disconnect the device from the mains. " Check that the mains indicator goes out.
4.3.24 Battery autonomy check

! Carry out a complete battery recharge before proceeding with the test. The duration of the charge is: " <6h device switched off " <20h device functioning (See test 12, Battery autonomy) ! When the test has been carried ou automatically, as described in test 13, the autonomy must be greater than 6 hours. ! When the test is carried out in normal functioning mode, the autonomy must be an average of 8 h for a flow rate of 125 ml/h.
4.3.25 Electrical test

Carry out the electrical test according to En/IEC 60601-1 norm.
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4.4 After-Sales Service 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, accesses the options menu. The navigation buttons 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
Moving to the After-Sales Service configuration ! Press "Menu/Exit". ! Keep it pressed down while pressing "ON". ! When the "Options" main menu appears, deselect "Menu/Exit" and "ON".
! Select "Maintenance" menu using the navigation buttons. ! Press "enter" to confirm.
! The "Maintenance" menu appears. ! Key in the code.
! Press "OK" to confirm. ! Choose the "Maintenance options" menu using the navigation buttons. ! Press "enter" to confirm. " You can browse through this sub-menu using the central navigation buttons.
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You can exit the configuration mode at any time by pressing "EXIT". This function cancels the modifications.
4.4.2 SAV 1, Maintenance date

This screen selects the date for the next maintenance. ! The "Maintenance date" main menu appears.
! Modify the day using the navigation buttons: " for the tens, increase and decrease using the double arrows " for the units, increase and decrease using the single arrows.
"
Press "OK" to confirm and move to the next step.
! Modify the month using the navigation buttons: " increase and decrease using the single arrows, # press the "downward double arrow" for a RAZ month.
"
Press "OK" to confirm and move to the next step.
! Proceed as above to modify the year. ! Press "OK" to confirm.
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 appears.
! Modify your selection using "yes" or "no": " "YES", using a single left arrow. Preventive maintenance
"
"NO", using a single right arrow.
! Press "OK" to confirm.
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4.4.4 SAV 3, Data log event

This test displays the list of the alarms stamped with date and time.(as Test ! The, "Data log event" main menu appears.
4)
! Scroll through the information from screen to screen using the navigation buttons. ! Press "enter" to display the alarm type. ! Press "Menu" to return to the "Test" menu.
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Maintenance prventive
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 dedicated Volumat software.
Device type:
Code:
Device serial n:
N 1 2
Procedure
Value Obtained
Conformity Yes No
! Check the general appearance of the case, labels, serial number and product code. ! Check the upstream pressure:************************************* .......................... " Launch a 100 ml/h infusion without a drop detector. " Clamp the tube between the drop chamber and the pump. " Check that the Upstream occlusion alarm is triggered before 15 seconds have passed. " Unclamp. " Check that the validation indicator is flashing. If there is too great a variance, refer to chapter 7 "Calibration / Calibration procedure / EtAL1 pressure calibration. ! Check the downstream pressure. " Install the water manometer at the tube outlet. " Set the pressure threshold at 750 mmHg. " Start infusion at 100 ml/h. " Check that the Downstream occlusion alarm is triggered at 750 mmHg +/-125 (1 bar +/-0,15). If there is too great a variance, refer to chapter 7 "Calibration/Calibration procedure / EtAL1 pressure calibration. ! Check the drop detector "if present". ! Check the air detector. " Start the test, " Create an air bubble in the tube 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. If there is too great a variance, refer to chapter 7, Calibration: Etal 3. ! Display the running time and the last maintenance date, test 2 (in hours, days or months). ************************************************************* .......................... ! Check the LCD screen, all light indicators and buzzer, test 9. ** .......................... ! Check the keyboard, test 10. ************************************** .......................... ! Check the occlusivity, test 11. " Connect the water manometer at the tube outlet. " Start the test. " Check that no motor error is triggered and that the maximum pressure is greater than 2 bar (1500 mmHg). ! Check the motor clamp, test 15. " Validate the two functions. " Check for absence of motor alarm.
4 5
6 7 8 9
10
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N 11
Procedure ! Check the clamp, test 19. " Close the door without the tube. " Check that the message "Insert tube" is displayed. " Insert the tube without the clamp and close the door. " Check the message "absent" is displayed. " Insert the clamp and close the door. " Check the "present" message is displayed.
Value Obtained
Conformity Yes No
12
! Check the flow rate. Before any flow rate test, carry out an infusion of 25 ml to warm up the tube. " Carry out a flow rate conformity test for norm EN-60-601-2-24. " Check that the flow rate error lies between - 5% and + 5%. If there is too great a variance, refer to chapter 7, "Calibration / Calibration procedure/infusion flow rate corrector co-efficient": Etal 4. ! Check the battery autonomy, 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: *********** .......................... ! Carry out the electricity test according to norm EN / IEC 60601-1
13
14
Name:
Date:
Visa:
Observations:
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4.5 Flow rate check

4.5.1 Measuring by computer
Measuring the flow rate using a computer requires Fresenius Vial ISDbit software. For further information, contact our After-Sales Service. The operating mode defined in this software follows the infusion pump norm protocol which is adapted to the users software.
To acquire the ISDbit flow rate check software, contact the Fresenius Vial Customer service department.
Equipment needed ! Scale connected to a micro-computer: Flow rate value x < 5 ml/h 5 ml/h < x < 30ml/h x > 30 ml/h ! ! ! ! ! Scale sensitivity 1/10000th 1/1000th 1/100th
Multi-scale acquisition programme Test tube or beaker with 1 ml graduations Liquid: distilled water, oil. Catheter extension with Luer Lock end (length 100 cm, interior diameter 2.5 mm) Needle: Type of needle G26 G18 or G21
Flow rate value x < 30ml/h x > 30 ml/h Installation
! Following the diagram below
Catheter extension bracket support
50 cm
1 cm
Line RS 232 RS 232
Anti-vibration measuring table
Observe the equipments horizontal installation plan.
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! ! ! ! ! ! !
! !
Fill the container with 600 ml or more of distilled water. 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 (> 1 cm). 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 scales 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). " Carry out a purge of the infusion line using the "BOLUS" key. " Check for the absence of air bubbles.
Operating mode
The software operates according to the operating mode described in the standard EN 60601-2-24 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 selfadjustment 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.
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4.5.2 Measuring with a scale

Equipment needed ! Chronometer ! Scale: Flow rate value x < 5 ml/h 5 ml/h < x < 30ml/h x > 30 ml/h ! ! ! ! Scale sensitivity 1/10000 th 1/1000 th 1/100 th
Test tube or beaker with 1 ml graduations. Liquid: distilled water, oil Catheter extension with Luer Lock end (length 100 cm, interior diameter 2.5 mm) Needle: Type of needle G26 G18 or G21
Flow rate value x < 30ml/h x > 30 ml/h
Installation ! Following the diagram below
Catheter extension bracket support
50 cm
1 cm
Observe the equipments horizontal installation plan. ! ! ! ! ! Fill the container with 600 ml or more of distilled water. 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 (> 1 cm). ! 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 canula inside the test tube on the beaker ensuring that it is dipped in the water.
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The infusion line (needle/catheter extension) must not rest on the scale/test tube unit. ! Press "ON" (device on mains power mode). " Carry out a purge of 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 (< 5 ml/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 INFUSION" to stop the test. ! Note the value (in grams) of the "infused" liquid. ! Calculate the difference between the theoretical value and the real value.
1 gram = 1 ml. ! The error percentage is calculated according to the following formula: ( Measured value Theoretical value ) -------------------------------------------------------------------------------------------------Theoretical value
100 = Error percentage
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4.5.3 Measuring with a test tube

Material needed ! ! ! ! ! Chronometer Test tube or beaker with 1 ml graduations Liquid: distilled water, oil Catheter extension with Luer Lock end (length 100 cm, interior diameter 2.5 cm) Needle: Type of needle G26 G18 ou G21
Flow rate value x < 30ml/h x > 30 ml/h
Installation ! Following the diagram below
Catheter extension support bracket
50 cm
1 cm
Observe the materials horizontal installation plan. ! ! ! ! ! Fill the container with 600 ml or more of distilled water. 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 (> 1 cm). ! 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 canula inside the test tube on the beaker ensuring that it is dipped in the water.
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Operating mode ! Carry out a flow rate selection.
For low flow rates (< 5 ml/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 syringe has been totally infused in the test tube, calculate the difference between the theoretical value and the real value: Real flow rate = 50 ml / time in hours ! The error percentage is calculated according to the following formula: ( Measured value Theoretical value ) -------------------------------------------------------------------------------------------------Theoretical value
100 = Error percentage
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4.6 Cleaning and disinfecting

Volumat Agilia is part of the patient's immediate environment. It is advisable to clean and disinfect the devices 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 devices 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 car of with ALCOHOL based SPRAYS (20% - 40% alcohol) .They lead to tarnishing and small cracks in the plastic, and do not provide the neceeeary 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: 10C to 60C / 50F to 140F. " Atmospheric pressure: 500 hPa to 1060 hPa. " Humidity: 10% to 90%, no condensation. Preventive maintenance Fully recharge the battery before using the equipment to avoid any risks caused by micro power cuts in the mains supply and to ensure maximum autonomy.
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4.8 Use of the internal battery

This device is provided with NiMH battery. When the device is disconnected from the main, it automaticaly 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 rechrageable 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 temperature. Do not replace by a battery other than that specified by manufacturer. Do not charge or discharge otherwise than in the device.
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5 Troubleshooting
5.1 Breakdown guide
Displayed message Meaning Door open alarm Cause Action
! The Hall effect ! Check that the magnet is sensor detects that present on the door the door is open ! Calibrate the door sensor ! Replace the door sensor ! The pump does not detect the presence of the security clamp ! Incorrect tube position ! Check the position of the tube and the clamp. Close the door. ! Check the clamp detection opto and replace if necessary ! Check the tube position ! Check that the magnet is present on the door ! Calibrate the door sensor ! Replace the door sensor
Tube position alarm
Tube insertion alarm
! At start-up: tube ! Install the tube and close the not installed or door door open OCS test failure ! The pumping alarm mechanism has not managed to raise the pressure line during the OCS test. ! Check the tube position ! Check the pressure sensors calibration ! Check the integrity of the membrane and replace it if necessary ! Check the installation of the tube and its integrity ! Check the integrity of the door ! If the problem persists, contact the After-Sales Service ! Remove the air bubbles present by rebooting the tube ! Check the air bubble size setting ! Calibrate the air detector ! Replace the air detector ! Remove the air bubble by purging the tubing
Air bubble alarm ! The volume of air detected in the line exceeds the limit
! Air bubble detected at the start- up or at the end Flashing flow rate warning ! Flow rate has been modified but has not been confirmed
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Troubleshooting
! Check the flow rate and confirm with the OK key
Displayed message
Meaning Pre-alarm end of infusion
Cause ! The remaining VAP is less than 5% of the initially programmed VAP or 5 minutes or 5 ml remain before the initially programmed VAP is reached ! VAP delivered. MVO activated conforming with the configuration ! The drop detector is not correctly positioned ! The drop detector is disconnected when the pump is configured to function with it
Action ! Check if the volume remaining in the container corresponds to the remaining VAP. If necessary, prepare a container for a new infusion sequence. If a drop detector is present, the end prealarm is stopped and can be defined as an option. ! Press Stop to define the new infusion parameters (if necessary). ! Check the drop detector position ! Check the integrity of the drop detector ! Check the drop detector connection ! Try the device using an other drop detector ! If the trouble keep up, check the connection ont he device ! Replace the component if necessary ! Connect the drop detector to the pump and to the drop counter chamber ! ! Check the container ! Check the wheel clamp ! Check that liquid forms properly (approx. 20 drops / ml) ! Check the tube position ! Check the drop detector position ! Check the chamber liquid level ! Check the fluid temperature ! Check that liquid forms properly (approx. 20 drops / ml)
End of infusion alarm
Drop detector alarm (if used with this component)
! The drop detector has been connected then disconnected ! Under flow rate alarm ! Flow rate detected by the drop detector is lower than the set flow rate
Flow rate alarm ! Flow rate detected by the drop detector is greater than the set flow rate
Troubleshooting
Flow rate not being checked alarm
! Check the drop detector ! At the start or when stopped, free installation and the tube flow is detected by the drop detector
68
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Displayed message
Meaning High flow rate warning
Cause ! Upper soft limit exceeded, conforming with the medication parameters set in the Medication Library ! Lower soft limit exceeded, conforming with the medication parameters defined in the Medication Library
Action ! Check the chamber liquid level ! Check the fluid temperature ! Check that liquid forms properly (approx. 20 drops / ml) ! ! Check the chamber liquid level ! Check the fluid temperature ! Check that liquid forms properly (approx. 20 drops / ml) !
Weak flow rate warning
Rise in pressure ! Line pressure ! Check whether the infusion warning (DPS) rises. This warning line is occluded (clamp or tap closed, catheter blocked, line can be selected creased, etc.) Drop in pressure warning (DPS) ! Fall in pressure ! Check the downstream Luer in the infusion line. lock connection and the integrity of the whole line This warning can be selected as an option ! Line pressure has reached 50 mmHg below the programmed threshold ! Check the infusion line ! Define the pressure threshold
Occlusion prealarm
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Troubleshooting
Upstream ! The pressure occlusion alarm level in the pumping system upstream line is too low ! The container is empty ! The wheel clamp is closed ! The air inlet stopper is closed (when used with a bottle) ! Only if the drop detector is absent. The upstream line pressure is too weak
! Check the container and the line ! Check the wheel clamp ! Check that the tubing is not pinched ! Check the height of the container ! Check the air inlet stopper (when used with a bottle) ! Calibrate the pressure sensors ! Replace the upstream pressure sensors
Displayed message
Meaning
Cause
Action ! Check whether the infusion line is occluded ! Check that the pressure threshold is set at an appropriate level ! Calibrate the pressure sensors ! Replace the downstream pressure system ! Connect the device to the mains
Downstream ! The occlusion alarm downstream pressure for the pumping system has exceeded the programmed pressure threshold
Battery prealarm
! Weak battery charge level
Battery alarm
! Battery discharged (automatic switch off of the device in 5 minutes) ! Uncharged battery ! Mains disconnection
! Connect the device to the mains immediately ! Replace the battery if there is not enough life left ! Connect to mains power supply and wait till the battery is charged ! Press on silence to stop the warning ! Check that there is enough battery charge left for the expected duration of the infusion ! If the disconnection location cannot be found: " check the mains power supply connection ! Carry out a complete check for the device and update the maintenance date (test 2)
Battery uncharged alarm Mains disconnected warning
Preventive maintenance requested
! Maintenance date reached
Troubleshooting 70
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Problem Flow rate variance too great
Cause ! A mechanical piece connected to the pumping mechanism or the CPU board has been changed without the calibration of the infusion corrector coefficient being carried out ! LEDs and/or connecter technology defective
Remedy ! Carry out a flow rate test, calibrate the infusion corrector coefficient ! Redo the test to ensure that the correction was right
Display defaut: segments, LEDS
! Check the general state of the display board ! Check the contrast ! Replace the LEDs ! Check the connector technology ! Replace the display board ! Check the battery connection ! Charge the battery ! Replace the battery ! Replace the mains fuses ! Check that the mains connector has been correctly connected ! Replace the power supply board ! Check the charge voltage ! Replace the battery ! Check and replace the keyboard if necessary ! Replace the CPU board and reconfigure completely ! Check and replace the keyboard if necessary ! Check the integrity of the mechanical unit and the cases ! Check the state of the battery
The device switches off when it is disconnected from the mains The mains indicator lights do not light up
! Battery is disconnected ! Battery is completely discharged ! Mains fuse out of service
Battery alarm when it has been correctly charged The device lights up or switches off on its own The keyboard keys do not respond If dropped
! Battery is completely discharged ! Defective keyboard ! Defective CPU board ! Defective keyboard
! Mechanical elements deteriorated
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Troubleshooting
Troubleshooting 72
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Diagnostic
5.2 Error messages

Error Code Description Recommended action
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 opto rotation. ! Replace the central unit board. ! Carry out a complete configuration check using the maintenance software. ! Replace the central unit board. ! Carry out a complete configuration check using the maintenance software. ! Flash memory deleting or programming problem. ! Replacing the central unit board. ! Carry out a complete configuration check using the maintenance software. ! 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. ! Secondary Crc/16 C version is incorrect. ! Carry out a complete configuration check using the maintenance software. ! There is a problem in the activation of the secondary C watch dog. ! Replace the Power supply board. ! Check the state of the Power Supply/CPU board connection ribbon cable. ! Replace the power supply board. ! Check the battery connection. ! Check the battery charge voltage. ! Replace the battery. ! Check the state of the battery. ! Check the battery charge voltage. ! Replace the battery. ! Check the state of the mains fuses. ! Replace the power supply board. Diagnostic 73 ! Check the battery state. ! Replace the battery.
10 11
! Ram
! Flash
12
! Resources
13 14 15 16 17 18 19
! Version /secondary Crc16 C check ! Secondary C starting up again. ! Secondary C communication ! Disconnected battery
! Battery charge
! Mains presence ! Battery temperature
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Error Code
Description ! 3.3 V loss of power supply
Recommended action ! Check the state of the ribbon cable connection into power supply board and CPU board. ! Contact the After-Sales Service.
20 21 22
! Secondary C / coulometer power supply board communication ! Clamp opto fork
! Check the opto functioning. ! Check the state of the ribbon cable connection. ! Replace the opto forks. ! Check the functionality of the clamp opto motor. ! Check the flexible CI. ! Replace faulty part(s). ! ! ! ! Select test 15. Check the state of the clamp motor. Check the connector technology. Replace the motor.
23
! Clamp opto motor fork
24
! Declamping
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. ! Check the connection between the display board and the central unit board. ! Check the connection between the power supply board and the central unit board. ! Replace the faulty part(s). ! Check the connection between the display board and the Back light. ! Replace the LCD display. ! If the problem persists, replace the display board. ! Check the keyboard test 10. ! Replace the keyboard and check its functionality. ! If the problem persists, replace the display board. ! Replace the CPU board. ! Carry out a complete configuration check using the maintenance software.
26
! Board absence
27
! LCD black-light absence
28
! Keyboard
29
! Analogue/digital converter
Diagnostic 74
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Error Code
Description ! Date Time stamp
Recommended action ! 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 quartzes if necessary. ! Replace the CPU board, the Date Time stamp is integrated in the main Microcontroller. ! Carry out a complete configuration check using the maintenance software. ! Carry out a complete configuration check using the maintenance software. ! Carry out a complete configuration check using the maintenance software. ! Select test 14. ! Check the state of the air detector using a tube with water and air. ! Calibrate the detector. ! Carry out a complete configuration check using the maintenance software. ! Carry out a complete configuration check using the maintenance software. ! Carry out a complete configuration check using the maintenance software. ! Carry out a complete configuration check using the maintenance software. ! Replace the power supply board to check the functionality of the secondary C. ! Replace the CPU board to check the functionality of the main C. ! Replace faulty parts. ! Check the functionality of the keyboard OFF key. ! Replace the keyboard if necessary. ! Replace the power supply board and check the secondary C functionality. ! Replace the power supply board. ! Detector detection unstable. ! Check the CPU board/detector connection. ! Replace the CPU board ! Carry out a complete configuration check using the maintenance software.
30
31 32 33
! Tube parameters ! Default "language" loading configuration ! Air detector
34 35 36 37
! Infusion flow rate check ! Motor period check ! Motor rotation direction check ! OFF key
38
! OFF key locked
39 40
! Impossible to switch off ! Drop detector
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75
Diagnostic
Error Code
Description ! Upstream pressure sensor outside tolerance
Recommended action ! Select test 5. ! Check the change in the state of the sensor by applying pressure to the sensor. ! Check the connections. ! Calibrate the sensor. ! Select test 6. ! Check the change in state of the sensor by applying a pressure on the sensor. ! Check the connections ! Calibrate the sensor. ! Replace the power supply board to check the functionality of the secondary C. ! Replace the CPU board to check the functionality of the main l. ! Calibrate the device completely, when replacing the CPU board, using the maintenance software.
41
42
! Downstream pressure sensor outside tolerance
99
! Activation of the watch dog
Diagnostic 76
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6 Intervention procedures
This chapter details all the dismantling and re-assembling procedures.
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77
Intervention procedures
78
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Fiches dintervention
Procedure n1 : Upper case

Safety:
For safety reasons, the technician should not intervene when the device is connected to 230V mains voltage. Disconnect the power supply cord from the mains. Switch off the device.
Disconnect the battery before opening the device (see procedure n11).
Material needed:
! 1 Torx T-10 screwdriver ! 1 anti-static bracelet
Maintenance level:
Level 3, specialist technician (see biomedical technical training documentation).
Procedure: Access
! Turn the device upside down. ! Unscrew the 3 Torx screws (marker 1) and remove them (3 under the angle bracket). 1 1 1
Do not touch the electronic boards with your hands.
79
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
3
! Remove the upper case (marker 5), being careful not to pull out the display board flat cable. ! Disconnect the flat cable connected to the CPU board from the display board at J2.
J2
Intervention procedures va06.0_0010a_en.fm80
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).
81
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Procedure n2 : Display board

Safety:
Material needed:
Maintenance level:
Procedure: Access
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83
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
3
! Remove the upper case (marker 5), being careful not to pull out the display board flat cable. ! Disconnect the flat cable connected to the CPU board from the display board at J2.
6 J1 6 J2
6 6
84
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! ! ! ! !
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
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85
86
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Procedure n3 : Central unit board

Safety:
Material needed:
Maintenance level:
Procedure: Access
87
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
! Remove the upper case (marker 5), being careful not to pull out the display board flat cable. ! Disconnect the flat cable connecting the CPU board to the display board at J2.
Intervention procedures 88
! 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 J3 J13 J10 J2
J4 6
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
89
Re-assembling
When replacing the CPU board, reconfigure the board completely. 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.
Procedure n4 : Power supply board

Safety:
Material needed:
! 1 Torx T-10 screwdriver ! 1 14" wrench ! 1 anti-static bracelet
Maintenance level:
Level 3, specialist technician (see biomedical technical training documents).
Procedure: Access
Do not touch the electronic boards with your hands. va06.0_0040a_en.fm 91
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. ! 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.
Intevention procedures 92
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Re-assembling
Dont forgiven to set insulator between the power supply and the mains board.
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93
Intevention procedures
94
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Procedure n5 : Base kit

Safety:
Material needed:
! 1 Torx T-10 screwdriver ! 1 anti-static bracelet.
Maintenance level :
Procedure: Access
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95
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. ! Remove the RJ45 stopper (marker 3). ! Unscrew the 2 screws (marker 4) holding the upper case (marker 5) to the base. 2 J1 4 4
3
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! 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 J3 J13 J10 J2
J4 6
J12
J1
! Remove the CPU board.
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97
! Unscrew the button screw (marker 7) and pull it out. " Turn the button 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 screw (marker 11) positioned under the base.
10
11 9
11
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! Remove the left flange (marker 12). ! Take out the right flange (marker 13). 12
13
! Separate the base kit (marker14) from the motor kit (marker 15).
14
15
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99
Re-assembling
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Procedure n6 : Air detector board

Safety:
Material needed:
Maintenance level:
Level 3, specialist technician, (see biomedical technical training documentation).
Procedure: Access
! Turn the device upside down. ! Unscrew the 3 Torx screws (marker 1) and remove them (3 under the angle bracket). 1 1
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101
Dismantling
3
J2
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! Unscrew the 2 screws (marker 6) of the air detector board (marker 7).
6 7 ! 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
! Carry out the dismantling procedure in reverse order to re-assemble the unit. ! Calibrate the air bubble detector. ! Carry out the regular servicing tests (see Quality Control Certificate). Intervention procedures va06.0_0060a_en.fm 103
104
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Procedure n7 : Pumping system

Safety:
Material needed:
Maintenance level:
Level 3, specialist technician (see biomedical technical training documentation)
Procedure: Access
va06.0_0070a_en.fm
105
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. ! Remove the RJ45 stopper (marker 3). ! Unscrew the 2 screws (marker 4) holding the upper case (marker 5) to the base 2 J1 4 4
3
! Remove the upper case (marker 5), being careful not to pull out the display board flat cable. ! Disconnect the flat cable leading from the CPU board to the display board at J2.
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! Disconnect the flat cable connected to the CPU board at: " J2 and J13 " J7, J3 and J10 " J4 and J10 " J1 ! Unscrew the holding screws (marker 6) holding the CPU to the flange. J7 J3 J13 J10 J2
J4 6
J12
J1
! Remove the whole CPU board being careful not to pull out the flat cable on the inside. ! Unscrew the button screw (marker 7) and pull it out. " Turn the button to the left and remove it. " Pull out the spring.
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107
! 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. Remove the pumping plate (marker 10). Unscrew the screw (marker 11) positioned under the base
10
11
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! Remove the left flange (marker. 12).
10
! Remove the pumping system.
Re-assembling
Intervention procedures 109 ! Carry out the dismantling procedure in reverse order to re-assemble the unit. ! Carry out the regular servicing tests (see Quality Control Certificate).
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110
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Procedure n8 : Motor
Safety:
Material needed:
! ! ! ! 1 Torx T-10 screwdriver 1 anti-static bracelet 1 4" wrench 1 small cruciform screwdriver
Maintenance level:
Procedure: Access
Do not touch the electronic boards with your hands. va06.0_0080a_en.fm 111
Dismantling
3
! Remove the upper case (marker 5), being careful not to pull out the display board flat cable. ! Disconnect the flat cable leading from the CPU board to the display board at J2.
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! Disconnect the flat cables leading 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 J3 J13 J10 J2
J4 6
J12
J1
! Remove the whole CPU board being careful not to pull out the flat cable on the inside.
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113
! Pivot the device on its front. ! Unscrew the button screw (marker 7) and pull it out. " Turn the button to the left and remove it. " Pull out the spring. ! Unscrew the screw (marker 8) holding the left flange.
! Unscrew the Torx screw (marker 9) positioned under the base. ! Remove the pumping plate (marker 10). ! Unscrew the screw (marker 11) positioned under the base.
10
11
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! Remove the left flange (marker 12).
12
! Pull out the pumping system.
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115
! Unscrew the 4 motor fixing nuts (marker 12).
12 12
12 12
! Pull out the 4 screws, the 4 plastic spacers, the 4 silentblocks and remove the motor.
Re-assembling
! Place the 4 screws (marker 13) in the 4 motor fixing screw holes. ! Position the 4 plastic spacers (marker 14) and the 4 silentblocks (marker 15) at the end of the 4 screws. ! Put the motor in position, sliding the belt. The strand is situated towards the top. ! Moderately tighten the motor fixing nuts in a diametrically opposite sequence (marker 12).
13
14 15 12
12
12 12
116
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Procedure n9 : Pressure sensor

Safety:
Material needed:
Maintenance level:
Procedure: Access
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117
Intervention sheets
Dismantling
3
! Remove the upper case (marker 5), being careful not to pull out the display board flat cable.
Intervention sheets 118
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! Disconnect the flat cable leading from the CPU board to the display board at J2. ! Disconnect the flat cables leading 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 board to the flange. J7 J3 J13 J10 J2
J4 6
J12
J1
! Remove the whole CPU board being careful not to pull out the flat cable on the inside.
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119
Intervention sheets
! Unscrew the button screw (marker 7) and pull it out. " Turn the button to the left and remove it. " Pull out the spring. ! Unscrew the screw (marker 8) holding the left flange.
! ! ! !
Pivot the device on its front side. Unscrew the Torx screw (marker 9) positioned under the base. Remove the pumping plate (marker 10). Unscrew the screw (marker 11)positioned under the base.
10
11
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! 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).
13
14
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121
Intervention sheets
! Pull out the sensor.
Re-assembling
! Carry out the dismantling procedure in reverse order to re-assemble the unit. ! Calibrate the sensors. ! Carry out the regular servicing tests (see Quality Control Certificate).
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Procedure n10 : OCS clamp motor

Safety:
Material needed:
Maintenance level:
Procedure: Access
va06.0_0100a_en.fm
123
Dismantling
3
! Remove the upper case (marker 5) being careful not to pull out the display board flat cable.
va06.0_0100a_en.fm
! Disconnect the flat cable leading from the CPU board to the display board at J2. ! Disconnect the flat cables leading to the CPU board at: " J2 and J13 " J7, J3 and J10 " J4 and J12 " J1 ! Unscrew the holding screw (marker 6) holding the CPU board to the flange. J7 J3 J13 J10 J2
J4 6
J12
J1
! Pull out the whole CPU board being careful not to pull out the flat cable on the inside.
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125
! Unscrew the button screw (marker 7) and pull it out. " Turn the button to the left and remove it. " Pull out the spring. ! Unscrew the screw (marker 8) holding the right flange to the base. 8
! ! ! !
Pivot the device on its front. Unscrew the Torx screw (marker 9) positioned under the base. Remove the pumping plate (marker 10). Unscrew the screw (marker 11) positioned under the base
10
11 9
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! Remove the right flange (marker 12).
12
! Unscrew the screw (marker 13) holding the board. ! Remove the board.
13
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127
! Unscrew the 2 fixing screws (marker 14) holding the motor to the flange.
14
14
! Using a small flat screwdriver, apply a light pressure in order to disengage the motor positioning spigot (marker 15).
15
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! Remove the motor (marker 16).
16
Re-assembling
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129
130
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Procedure n11 : Battery and battery door

Safety:
Material needed:
Maintenance level:
Procedure: Dismantling
! Unscrew the 2 fixing screws (marker 1) holding the battery door in place. ! Remove the battery door (marker 2).
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131
! Disconnect the J4 connector and remove the battery .(marker 3). 3
J4
Re-assembling
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7 Calibrations
7.1 Calibration 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.
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133
Calibrations
How to activate the calibration configuration mode ! Press "EXIT". ! Keep it held down while pressing "ON". ! When the "Options" main menu appears, release "EXIT" and "ON".
! Select your menu using the selection keys. " Maintenance ! Press "enter" to confirm. ! The "Maintenance" menu appears. ! Key in your code.
! Press "OK" to confirm. ! Select the menu using the selection keys. " Calibration ! Press "enter" to confirm. " Navigate through this sub-menu using the central selection keys.
You may exit the configuration mode at any time by pressing "EXIT"; this function cancels the modifications.
Calibrations 134
va07.1_001a_en.fm
7.1.2 Etal 1, Pressure

Calibrating the pressure consists of calibrating the upstream and downstream pressure in several phases. .
A new tube must be used for this procedure. ! Etal 1, press "enter". The main, "Pressure" menu appears.
"
Open the door and remove the tube.
"
Press "OK" to reset the search to zero.
! The calibration values for upstream and downstream pressure appear in mV starting at 0.
"
In "open door" phase. fournir
"
Press "OK" to validate and move to the next step.
! The "Declamping shut door pressure" menu appears. " Position the tube and shut the door.
"
Press "OK" to move to the next step. # Declamping in progress.
# The motor is put in place
! The "Calibrating pressure" menu, 0 mmHg tube appears in mV, the manometer indicating "0"
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Calibrations
"
Press "OK" to validate and move to the next step.
! The "pressure calibration" menu, 760 mmHg tube appears in mV. " Apply a pressure of 760 mmHg (of around 1 bar) at the tube outlet. " Press "OK" to validate and move to the next step.
! The "Pressure calibration" menu, 0 mmHg tube appears in mV. " Raising the pressure: pressure at 0 mmHg (0 bar).
" "
Press "OK" to validate and move to the next step Press a second time to confirm and save the calibration values. fournir
"
If the values are outside the tolerated values, a message specify the no-conformity appears.
"
Redo the calibration.
Calibrations 136
va07.1_001a_en.fm
7.1.3 Etal 2, Door

LCalibrating the door consists of calibrating the doors Hall Effect sensor in several phases. !
Etal 2, press "enter".

"
The main, "Door" menu appears.
"
Open: opens the door. # Press "OK" to validate and move to the next step. The value is read and recorded. It should lie between 1400 < X <1800 mV. Intermediate: place the calibration tool with the door in the intermediate position. Ref. 067059
"
# Press "OK" to validate and move to the next step. # The value is read and recorded.
"
Shut: 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 <2700 mV. Press again to confirm and save the calibration values. fournir
"
If the values are outside the tolerated values, a message appears when exiting.
fournir
"
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Calibrations
7.1.4 Etal 3, Air detector

The air detector consists of calibrating the air detector in several phases.
A new tube must be used for this procedure. !

" "
The main menu, "Air detector" appears. Place a tube filled with water in position and shut the door
" "
Press "OK" to launch the resonance search. Wait the stop of resonance phase
! Resonance frequency calibration phase with a tube of 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 <2400 mV. # Frequency: the resonance frequency for this phase.
fournir
"
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 lie between X <300 mV. # Frequency: the resonance frequency for this phase. " Press "OK" to validate and move to the next phase. ! Calibration resonance frequency, air tube " Put a tube with air in place and close the door. # Air detector value in mV. The value must lie between X <300 mV. # Frequency: resonance frequency for this phase. " Press "OK" to validate and move to the next phase.
"
fournir
fournir
Press "OK" again to confirm and save the calibration values. fournir
"
If the values are outside the tolerated values, a message will appear when exiting.
fournir
Calibrations
"
138
va07.1_001a_en.fm
7.1.5 Elal 4, Flow rate

The flow rate calibration consists of defining the device coefficient corrector to calibrate the pump.
A new tube must be used for this procedure. !

"
The main menu, "Flow rate" appears. # Flow rate:ithe infusion flow rate, 100 ml/h, enables the speed of the motor rotation to be defined. # Cycles: the number of motor cycles to execute 100.
"
Press "OK" to validate and move to the next phase. "Declamping" and "Motor start-up" phase.
"
! Coefficient corrector calibration. # Flow rate:infusion flow rate, 100 ml/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 keys, after comparing it with the measured volume obtained during the same test. Press "OK" to validate and move to the next phase. The correction is displayed in %, it is calculated from the coefficient corrector. The value must lie between 80 < X <110. fournir
" "
"
"
fournir
"
Press "OK" to save the flow rate corrector factor.
va07.1_001a_en.fm
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Calibrations
Calibrations 140
va07.1_001a_en.fm
8 Catalogue of Spare Parts

8.1 Base
107 108 103 100 101 102 106 104
110
105
109
Marker 100 101 102 103 104 105 106 107 108 109 110
Qty 1 1 1 1 1 1 1 2 1 1 1
Reference 179 900 179053 179051 179351 179055 179151 179152 179910 179908 179907 179353
Name Door kit Pole lever Door Door pin Membrane Right hinge Air detector kit Downstream sensor kit Upstream sensor kit Sensor spring blade Catalogue of Spare Parts 141 Left hinge
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Catalogue of Spare Parts
142
va08.1_001a_en.fm
8.2 Cover
200
201
202
203
204
200 201 202 203 204
1 1 1 1 1
179164 179001 179901 178152 178502
Cover central hook Display board Volumat cover kit Window Keyboard
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143
Marker
Qty
Reference
Name
144
va08.2_001a_en.fm
8.3 Angle bracket

314 317 300 301 302 303 304/305 312 313 319 320
306 307
308 309 310 311
315 316
318
Marker 300 301 302 303 304 305 306 307 308 309 310 311 312 313 314 315 316 317 318 319 320
Qty 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
Reference 178917 178163 182108 178204 178291 178294 178293 178257 178292 178164 178294 178297 178298 179033 178913 178300 178188 179003 178206 179906 179902
Name Fixing nut kit Pivoting plate Belt nut Screw Lock button Stainless steel spring Nut pivot pin D7 shoulder bend ring Elbow bend pin Battery door Stainless steel spring Ball pad Stainless steel washer Battery Handle kit Connector stopper IRDA window Mains board Foot Angle bracket kit Power supply board 145 Catalogue of Spare Parts
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146
va08.3_001a_en.fm
Catalogue des pices dtaches
8.4 Flanges
409 400 401
402
403 404 405 407 408
406
Marker 400 401 402 403 404 405 406 407 408 409
Qty 1 1 1 1 1 1 1 1 1 1
Reference 179014 179158 179904 179011 179355 179155 179031 179354 179905 179000
Name RJ11 plug Plug stopper Right flange kit Flexible OCS CI Cradle spring blade Clamp detector cradle OCS motor Cradle pin Left flange kit CPU board 147 Catalogue of Spare Parts
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148
va08.4_001a_en.fm
Catalogue des pices dtaches
8.5 Motor
502
504
500
505
501
506
503
Marker 500 501 502 503 504 505 506
Qty 1 1 1 1 1 1 1
Reference 179159 179163 179363 179902 179903 179015 179162
Name Cam shaft pulley Silent block Pumping block kit Motor kit Cl Opto block pump Optical disk Catalogue of Spare Parts 149 Motor pulley
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150
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Useful addresses
SALES DEPARTEMENT Fresenius Vial Le Grand Chemin, 38590 Brzins CUSTOMER SERVICE Tel.: 00 33 (0) 4 76 67 10 81 or 00 33 (0) 4 76 67 10 54 or 00 33 (0) 4 76 67 11 08 Fax: 00 33 (0) 4 76 67 11 34 Tel.: 00 33 (0) 4 76 67 10 81 Fax: 00 33 (0) 4 76 67 11 34
SALES MANAGEMENT
TRAINING DEPARTMENT Fresenius Vial Le Grand Chemin, 38590 Brzins Tl. : 00 33 (0) 4 76 67 10 76 Tl. : 00 33 (0) 4 76 67 11 40 Fax : 00 33 (0) 4 76 67 11 22
AFTER SALES SERVICE
FRANCE
After Sales Service Division GRENOBLE Fresenius Vial Le Grand Chemin, 38590 Brzins FRANCE Spare part department
Tel.: 00 33 (0) 4 76 67 10 76 Tel.: 00 33 (0) 4 76 67 11 40 Fax: 00 33 (0) 4 76 67 11 22
Tel.: 00 33 (0)4 76 67 10 34 Tel.: 00 32 (3)8 80 73 07 Fax: 00 32 (3)8 80 50 07
BELGIUM
FRESENIUS VIAL NV/SA Molenberglei 7 2627 Schelle BELGIUM FRESENIUS MCM AM-Neuen Berg 63749 ALZENAU GERMANY
GERMANY
Tel.: 49/60 23 97 22-0 Fax: 49/60 23 43 06
It is possible that this manual contains errors or typing mistakes. Modifications may be made in future editions. COPYRIGHT 2007, Fresenius Vial S.A.S. This document may not be reproduced in part or in whole without the written permission of Fresenius Vial S.A.S. Fresenius Vial S.A.S. - sige social : Le Grand Chemin - 38590 Brzins (FRANCE) Socit par Actions Simplifies au capital de 13 744 520 Euros SIREN Grenoble B 408 720 282. Design and construction : SEDOC Technical Manual Volumat Agilia_en
Manufacturer Fresenius Vial S.A.S Le Grand Chemin 38590 Brzins France Tel: +33 (0)4 76 67 10 10 Fax: +33 (0)4 76 67 11 34 A Company of Fresenius Kabi
www.fresenius-kabi.com

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SERVICES

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

2.2 Operational description ....................................................................... 25

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

4 Preventive maintenance ................................................................................ 33

4.4 After-Sales Service options ................................................................ 53

4.5 Flow rate check .................................................................................... 59

8 Catalogue of Spare Parts............................................................................. 141

1.2 Operation diagram

1.3 Precautions for use

1.4 Operation safety

1.5 Technical characteristics

1.5.2 Electronic details

1.5.3 Mechanical details

1.5.4 Material characteristics

1.5.5 Conformity and norms

Conform to EN/IEC 60601-1-2 and EN/IEC 60601-2-24

2 Description and operation

Base Control panel

Description and operation

2.1.1 The display board

Description and operation

2.1.2 CPU board

J4 on the inside J13 J12

Description and operation

Description and operation

Description and operation

2.1.3 The power supply board

J2 on the inside circular connector J6 J4 on the inside

Description and operation

A6 B6 A7 B7 A8 B8 A9 B9 A10 B10 A11 B11 A12 B12 A13 B13

Description and operation

Description and operation

2.1.4 The mains board

Description and operation

2.1.5 The air detection board

J2 to emission element connector J3 to element emission connector

Description and operation

2.2 Operational description

2.2.1 Tube check and maintenance sub-assembly

2.2.2 Pumping sub-assembly

2.2.3 External connection sub-assembly

Description and operation

Description and operation

3 Description of the menus

Main Menu User Service Maintenance

Key in code Code XXXX

Sub-menu User options menu

Description of the menus

Description of the menus 3.2 Calibration menu

Description of the menus

Description of the menus

Description of the menus 3.3 After-Sales Service test menu

3.4 After-Sales Service options menu

Description of the menus

Description of the menus

4.2 Maintenance schedule

4.2.2 Quality control

4.3.1 Accessing the tests

! The "Maintenance" menu appears. ! Key in the code.

4.3.2 Visual check

4.3.3 Test 1, identification

Test 1, press "enter".