Injectomat Agilia En

SERVICE S

Injectomat® Agilia Technical Manual

Revision table TM Injectomat Agilia_en : ref NT 2328 / from serial n° 19140139 till ... Date

Revision

Chapter

Description

01/09/05

0

Allindex"a"

Creation

20/10/05

1

Allindex"b"

InjectomatAgilia

21/06/06

2

All index "b"

Insertion couv. charte Kabi

18/01/07

3

All index "c"

Update screen copies and spare parts list

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 cha racteristics ........................ ......... ........................ ............. 9 1.5.1

Electrical details ......................................................................................................... 9

1.5.2 1.5.3 1.5.4 1.5.5

Electronic details ........................................................................................................ 9 Mechanical details...................................................................................................... 9 Material characteristics ............................................................................................ 10 Conformity and norms......... ..................................................................................... 10

2 Description and operation .......... ............ ............ ............ ............ ............ ....... 11 2.1 Physical description ................. ................................. ......................... 11 2.1.1 2.1.2 2.1.3 2.1.4 2.1.5

The display board..................................................................................................... 12 The CPU board ........................................................................................................ 14 The power supply board........................................................................................... 18 The mechanical framework assembly............ .......................................................... 20 The mechanical plunger assembly........................................................................... 20

2.2 Operational description .................. .................. ................................. .. 21 2.2.1

Syringe maintenance and checking sub-assembly .................................................. 21

2.2.2 2.2.3

The motorisation sub-assembly ............................................................................... 21 External connection sub-assembly .......................................................................... 21

3 Description of the menus ......... ............. ............. ........................................... 23 3.1 Options menu .................................. ................................. .................... 23 3.2 Calibration menu ........................ .......................................... ......... ....... 25 3.3 After-Sales Servi ce test menu............. .................. .............................. 27 3.4 After-Sales Service options menu ........................ .............................. 27

4 Preventive maintenance ..... ............. ............................. ............. ............. ....... 29 4.1 Recommendations ................ ................................. ........................ ...... 29 4.2 Maintenance schedule ........................ .......................................... ....... 29 4.2.1 4.2.2

Preventive maintenance........................................................................................... 29 Quality control .......................................................................................................... 29

4.3 Checks.................... ....................... ....................... ....................... ......... 31 4.3.1 4.3.2 4.3.3 4.3.4 4.3.5 4.3.6

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Accessing the tests .................................................................................................. 31 Visual check ............................................................................................................. 32 Test 1, identification ................................................................................................. 32 Test 2, Maintenance................................................................................................. 33 Test 3, After-Sales Service messages ..................................................................... 34 Test 4, Events .......................................................................................................... 34

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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

Test 5, Force ............................................................................................................ 34 Test 6, Displacement ............................................................................................... 35 Test 7, Syringe holder .............................................................................................. 36 Test 8, Battery informat ion ....................................................................................... 37 Test 9, Indication........... ........................................................................................... 38 Test 10, Keyboard .................................................................................................... 38 Test 11, Life test....................................................................................................... 39 Test 12, Battery life .................................................................................................. 40 Test 13, Battery test ................................................................................................. 40 Anti-siphon arm check.............................................................................................. 41

4.3.17 4.3.18 4.3.19 4.3.20 4.3.21 4.3.22

Pressure limit alarm check ....................................................................................... 41 Linearity check ......................................................................................................... 42 End of infusion alarm and pre-alarm check.............................................................. 42 Mains/battery operation check ................................................................................. 42 Battery autonomy check........................................................................................... 42 Electrical test.......... .................................................................................................. 42

4.4 Maintenance options ................................. .......................................... 43 4.4.1 4.4.2 4.4.3 4.4.4 4.4.5

Test access .............................................................................................................. 43 SAV 1, Maintenance date ........................................................................................ 44 SAV 2, Initial set up.................................................................................................. 44 SAV 3, Data log event......... ..................................................................................... 45 Quality Control Certificate ........................................................................................ 47

4.5 Flow rate check ......... ........................................... ......... .................. ..... 49 4.5.1 4.5.2 4.5.3

Measuring by computer............................................................................................ 49 Measuring with a scale............................................................................................. 51 Measuring with a test tube ....................................................................................... 53

4.6 Cleaning and disinfecting ......................... .......................................... 55 4.7 Storage.......... ......................................... ........................ .................. ..... 55 4.8 Use of the internal battery........... ......... .......................................... .... 56

5 Diagnostic............. ............ ............ ............ ............ ............ ............ ............ ....... 57 5.1 Troubleshooting guide ......................... ................................. .............. 57 5.2 Error messa ges.............. ......... ........................................... ......... ......... 59

6 Intervention procedures................. ............ ............ ............ ............ .............. .. 63 N°1, Procedure: Display board ....................... ....................... .................... 65 N°2, Procedure: Central unit board ........................ ....................... ............ 69 N°3, Procedu re: Power supply board ........................... ............................ 73 N°4, Procedure: Syringe clamp .................. .......................................... ..... 77 N°5, Procedur e: Syringe detection system ................................ .............. 81 N°6, Procedure: Motor ...................... ....................... ....................... ............ 85 N°7, Procedure: Pressure sensor and ribbon cable kit..................... ...... 89 N°8, Procedure: Linear sensor kit ...................... .................... ................... 95 N°9, Procedure: Plunger cover and lever kit ....................... ................... 101 N°10, Procedure: Plunger kit ................................ ................................ ... 103 N°11, Procedure: Carriage kit ........................ ....................... ................... 107

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N°12, Procedure: Battery door and battery ....................... ..................... 111 N°13, Procedure: Upper case kit .......................................... ................... 113

7 Calibrations.......... ............ ............ ............ ............ ............ ............ ............ ..... 117 7.1 Calibration procedure ......................... ........................................... .... 117 7.1.1 7.1.2 7.1.3 7.1.4 7.1.5

Access to the calibrations ...................................................................................... 117 Etal 1, Force........................................................................................................... 118 Etal 2, Syringe clamp ............................................................................................. 119 Etal 3, Displacement .............................................................................................. 120 Etal 4, Linearity ...................................................................................................... 121

8 Spare parts catalogue ............ ............ ............ ............ ............ .............. ........ 123 8.1 Base........ ......... ......... ........................ .................. ................................. 123 8.2 Cover ......................... ............................ ......... .................. ................... 125 8.3 Angle bracket...... ................................. ........................................... .... 127 8.4 Plunger ................. .................. ................................. ............................ 129 8.5 Mechanical framework........... .................. ................................. ......... 131 8.6 Motor left flange ................................. ................................. .............. 133


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1 Introduction 1.1 General introduction The Injectomat Agilia syringe pump is intended for the infusion of intravenous agents with a low flow rate. Its potentiometric sensor will detect the diameter of the syringe installed to +/- 1.5 mm and propose the syringe last selected in this range. Injectomat Agilia will propose up to 50 different marks and types of syringes in sizes of 50/60 ml, 30/35 ml, 20/25 ml, 10 ml and 5 ml. Injectomat Agilia has a range of flow rates from 0.1 to 1200 ml/h according to the diameter of the syringe selected. It is the ideal instrument for intensive care units and neonatology. Injectomat Agilia is fitted at the back with an infrared cell. Fresenius Vial uses a Link system enabling several pumps to communicate through a communications system via the infrared cell and rack. Injectomat Agilia is equipped with an integrated system allowing it to be hung onto a pole or rail. Its integrated locking system allows three devices pumps to be stacked on top of one another to facilitate transportation.

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1.3 Precautions fo r us e The symbol ! which appears on the deviceís condensed user instructions recommends a complete reading of the user instructions, in accordance with norm EN 60 601-1. 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: 5 C to 40 C / 41 F to 104 F. Humidity: 20% to 90%, no condensation. Atmospheric pressure: 700 hPa to 1060 hPa.

1.4 Operation safety As soon as it is in operation, the device ensures continuous surveillance of its functions. Any internal fault or any procedural anomaly is immediately detected. Nevertheless, abnormal functioning of the device, without a defined cause, must always be brought to the attention of the qualified staff in your establishment or our After-sales service. On the first occurrence of a fault, an alarm is activated for any ± 5% flow rate difference in relation to normal flow rate. A second check activates an alarm when there is a 1 ml discrepancy in relation to the predicted infused volume or when a flow rate discrepancy of ± 20% is identified. The alarm for the most rapidly detected discrepancy is activated. Injectomat Agilia is equipped with an internal battery that ensures normal functioning during a mains power cut. In addition, a safety fuse protects the concerned mains area.

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 internal to power supply unit Battery: 6 V - 1,8 Ah. (NIMH) External power supply: 9 V CC. Power > 15 Watts.

1.5.2 Electronic details The Injectomat Agilia syringe pump contains 3 electronic boards: ! ! !

Power supply board CPU board Display board. n io t c u d o rt In

1.5.3 Mechanical details ! !

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Dimensions: H x L x W: 135 x 345 x 160 mm Weight: approximately 2.1 kg.

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1.5.4 Material cha racteristics Components 1 Syringebarrelclasp 2 Syringeflangecradle 3 Pusher 4 Pusher protector 5 Handle 6 Assembly bolt 7 Infrared cell 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27

Fixingclamp Fixing button Mainsconnection Communication port and 12-15 Vdc power Mains warning Screen Silence Alarm ON/OFF Bolus or Prime Valueselection Valueselection Valueselection Valueselection Functioning, pre-alarm and alarm warnings Validation Stop:infusionstop Menu Exit / Battery door Housing Feetandmembranes

Materials Polyamide POM Polyamide ABS Stainless steal POM Polycarbonate Aluminium+epoxy POM PA + Thermoplastic Stainless steal Polyester PC Polyester Polyester Polyester Polyester Polyester Polyester Polyester Polycarbonate Polyester Polyester Polyester ABS ABS Silicone

1.5.5 Conformity and norms Conform to the 93/42/CE Medical Directive. 0459 Safety of Electro Medical Equipements EMC (ElectroMagnetic Compatibility)

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

Detailed information concerning electromagnetic compatibility is available in the c hapter "Guidance and manufacturerís declaration on EMC" of the User Manual. n ito c u d o tr In

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2 Description and operation 2.1 Physical description Flange groove

Plunger protection

Cover

Plunger disengagement control

Angle bracket

Plunger Base

Syringe clamp

Control panel

Injectomat Agilia is made up three main parts: a base, a cover and an angle bracket. !

The cover contains: a display board. The base contains: " a CPU board " a mechanical framework assembly " a plunger unit. The angle bracket contains: " a power supply board and a battery "

!

!

"

Fixing clamp system. n o ti a r e p o d n a n o it p ir c s e D

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2.1.1 The di splay bo ard The display board is situated behind the cover control panel where all the essential parts for the man-machine interaction are contained: !

display screen information LCD display " LEDs. "

J2

J1

J3

Display board This board is connected to the various pieces of equipment by means of connectors. J1 to keyboard connector Pin 1 2 3 4 5 6 7 8 9 10

Signal A_LED COL0 COL1 COL2 LIG0 LIG1 LIG2 ON/OFF CTR GND

Description Ground KeyboardColumn0 KeyboardColumn1 KeyboardColumn2 KeyboardLine0 KeyboardLine1 KeyboardLine2 KeyboardON/OFFbutton SignalcheckorkeyboardLine3 Ground

J2 to CPU board connector

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Pin

S i g na l

Description

1 2 3 4 5 6 7 8 9

GND GND +3V3 PRES_CARTE TON/Off_ALIM GND MISO GND MOSI

Ground Ground +3.3Vpowersupply Diagnostic signal (board connection confirmed) Keyboard ON/OFF button Ground SPIbusMOSIsignal Ground SPIbusMOSIsignal

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J2 to CPU board connector Pin 10 11 12 13 14 15 16

S i gn a l GND CLK GND CSLCD/ VBAT CSLDCL/ VBAT

Description Ground SPIbusclocksignal Ground Checksignal Batterypowersupplyor+9Vmains Checksignal Batterypowersupplyor+9Vmains

17 18 19 20 21 22 23 24

GND RSLCD GND RESET/ PRES_CARTES +3V3 GND GND

Ground Checksignal(forLCDdisplay) Ground Checksignal Diagnostic signal (board connection confirmed) +3.3Vpowersupply Ground Ground

J3 to display board connector Pin 1 2 3 4

A_LED C_LED -

Description BacklightLEDsanode BacklightLEDScathode Not connected Not connected

5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

GND MOSI CLK GND GND GND GND GND GND GND GND RSLCD RESET/ CSLCD/ +3V3 GND

Ground,indicatesLCDserialaccess LCDseriallinedata LCDseriallineclock NotusedbytheLCDinserialaccess NotusedbytheLCDinserialaccess NotusedbytheLCDinserialaccess NotusedbytheLCDinserialaccess NotusedbytheLCDinserialaccess NotusedbytheLCDinserialaccess NotusedbytheLCDinserialaccess NotusedbytheLCDinserialaccess DataselectionforLCD LCDreset Chip-selectLCD +3.3Vpowersupply Ground n o ti a r e p o d n a n o it p ir c s e D

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2.1.2 The CPU board The CPU board is made up of a main micro-controller (AT91M55800A), FLASH and R AM memory and various analogue and power functions, namely: a unipolar motor control the restoration and acquisition of the different sensors ! different lines of communication (synchronous or non-synchronous serial links and Bluetooth links are options) It is connected to the display board by means of a J5 connector. ! !

A ribbon cable connects the CPU board to the power supply board via a J4 connector.

J5

J2

J3 J7

J9 on internal side

J8

J6

J4

CPU board J2 to syringe clamp connector Pin 1 2 3 4 5 6 n o ti a r e p o d n a n io t irp c s e D

GND /SW_AILET /CD_SW_AILET +3V3 ANA_DIAM_DIR GND

Description Ground Flangeswitchstate Flange switch power supply +3.3Vpowersupply Syringe clamp potentiometer state Ground

J3 to JTAG (Micro programming) connector Pin 1 2 3 4 5

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+3V3 +3V3 TCK TDO TRQT/

Description +3.3Vpowersupply +3.3Vpowersupply ATM91M55800AJTAGportsignal ATM91M55800AJTAGportsignal ATM91M55800AJTAGportsignal

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J3 to JTAG (Micro programming) connector Pin 6 7 8 9 10

TDI MR/ GND TMS GND

Description ATM91M55800AJTAGportsignal ATM91M55800AJTAGportsignal Ground ATM91M55800AJTAGportsignal Ground

J4 to power supply board connector Pin 1 2 3 4 5 6

GND GND +3V3 TON/OFF +3V3-26

Description Ground Ground +3.3Vpowersupply Not connected KeyboardON/OFFkey +3.3 V power supply safeguarded for the timestamper Ground

7 8

GND SCL_ALIM

9

SDA_ALIM

10 11

VBAT RXIR

I2C bus data signal between main (CPU) and secondary (power supply) microcontroller Batteryor+9Vmainspowersupply IrDAcellreceptionsignal

12 13 14 15 16 17 18 19 20 21 22 23 24

TXIR VBAT SCK GND TXD GND RXD GND CD_BUZ PRES_CARTES +3V3 GND GND

IrDAcellemissionsignal Batteryor+9Vmainspowersupply Serialbusclocksignal Ground Externalplugdataemissionsignal Ground Externalplugdatareceptionsignal Ground Main microcontroller buzzer control Diagnostic signal (board c onnection confirmed) +3.3Vpowersupply Ground Ground

I2C bus clock signal between main (CPU) and secondary (power supply) microcontroller

J5 to display board connector Pin 1 2 3 4 5 6 7 8

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GND GND +3V3 +3V3-26_PROT TON/Off GND MISO GND

Description Ground Ground +3.3Vpowersupply Diagnostic signal (board connection confirmed) KeyboardON/OFFkey Ground SPIbusMOSIsignal Ground

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J5 to display board connector Pin 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

MOSI GND CLK GND CSLCD/ VBAT CSLDCL/ VBAT GND RSLCD GND RESET/ PRES_CARTES +3V3 GND GND

Description SPIbusMOSIsignal Ground SPIbusclocksignal Ground Checksignal Batteryor+9Vmainspowersupply Checksignal Batteryor+9Vmainspowersupply Ground Checksignal(forLCDdisplay) Ground Checksignal Diagnostic signal (board connection confirmed) +3.3Vpowersupply Ground Ground

J6 to motor connector Pin 1 2 3 4 5 6

PHASE_A COM1 PHASE_B PHASE_C COM2 PHASE_D

Description Motorcoil1phaseA Commonmotorcoil1 Motorcoil1phaseB Motorcoil2phaseC Commonmotorcoil2 Motorcoil2PhaseD

J7 to potentiometer connector Pin 1 2 3

GND ANA_DEPLAC +3V3

Description Ground Potentiometer displacement status +3.3Vpowersupply

J8 to opto-electrical syringe detection connector


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Pin 1 2

GND /OP_ROT

Description Ground Motoroptorotationstatus

3 4 5 6

GND GND /CD_OP_ROT GND

Ground,optosignalreferencestatus Optopowersupplyreturn Optopowersupply Ground

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J9 to plunger connector Pin 1 2 3 4 5 6

GND /OP_PISTON ANA_FORCE GND /CD_OP OP_BRAS

Description Ground Optopistonstatus Forcesensorstatus Ground Optopowersupply Optoarmstatus

7 8 9 10

GND /SW_DEB__ON /SW_DEB__OFF GND

Ground Disengagement switch status Disengagements witchs tatus Ground


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2.1.3 The power supply board The power supply board is made up of a microcontroller (ATtiny26L, called the secondary microcontroller, in relation to the CPU board microcontroller and its functions) and various analogue and power functions, namely: management of power supply for all boards a battery charger ! infrared communication ! various communication lines (internal and external to boards) The power supply board is situated on the angle bracket. It ensures the power supply of the whole electronic unit from the 100 V - 240 V AC network or the external 9 V DC. It also supplies a battery charge of 1.8 Ah. ! !

J6

Mains plug connection F1 J5 on internal side

J1 J2

Power supply board This board is connected to the various pieces of equipment by means of connectors. J1 to external plug connector (8 point Binder)


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Pin 1 2 3 4

Signal SCK TXD RXD VBAT

Description Seriallinkclock Seriallinkdataemission Seriallinkdatareception Accessory power supply (provided by theboard)

5 6 7 8 9 10 11

GND RELAIS GND +9V0 GND GND

Ground Relay control (open collector) Ground Externalpowersupply (providedby the board) Not connected Ground Ground

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J2 connector to the ATtiny 26 secondary microcontroller Pin 1 2 3 4 5 6

Signal MISO +3V3 SCK MOSI /RST GND

Description ATtiny26SPIprogrammingsignal +3.3Vpowersupply ATtiny26SPIprogrammingsignal ATtiny26SPIprogrammingsignal ATtiny26SPIprogrammingsignal Ground

7

CD_ON

+3.3Vpowersupplycontrolsignal

J6 to the CPU board connector

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Pin 1 2 3 4 5 6

GND GND +3V3 TON/OFF +3V3-26

Description Ground Ground +3.3Vpowersupply Not connected KeyboardON/OFFbutton +3.3 V power supply safeguarded for the timestamper Ground

7 8

GND SCL_ALIM

9

SDA_ALIM

10 11 12 13 14 15 16 17 18 19 20 21 22 23

VBAT RXIR TXIR VBAT SCK GND TXD GND RXD GND CD_BUZ PRES_CARTES +3V3 GND

I2Cbus data signal between main (CPU) and secondary (power supply) microcontroller Batterypowersupplyor+9Vmains IrDAcellreceptionsignal IrDAcellemissionsignal Batterypowersupplyor+9Vmains Serialbusclocksignal Ground Externalplugdataemissionsignal Ground Externalplugdatareceptionsignal Ground Main microcontroller buzzer control Diagnostic signal (board c onnection confirmed) +3.3Vpowersupply Ground

24 25 26 27

GND Neutral Phase Earth

Ground Mainspowersupply Mainspowersupply Earthconnection

I2Cbus clock signal between main (CPU) and secondary (power supply) microcontroller


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J4 to powerplug connector Pin 1 2 3

Signal Neutral Phase Earth

Description Mainspowersupply Mainspowersupply Earthconnection

J5 to internal battery connector Pin 1 2 3 4

Signal +batterie GND ANA_CTN GND

Description Batterypositiveterminal Ground,batterynegativeterminal CTNpositiveterminal Ground,CTNref.

2.1.4 The mechanical framework assembly The mechanical framework assembly is made up of a motor-reducer unit which drives a rack screw-nut assembly, made up of 2 flanges and a linear sensor. The mechanical assembly also contains a photo-electric cell dedicated to monitoring the rotation of the motor.

2.1.5 The mechanical plunger assembly The mechanical plunger assembly is situated on the mechanical framework. The framework ensures the guidance of the plunger in transfer as well as the displacement of the plunger via a screw-nut system. The plunger is equipped with a disengagement control enabling it to disassociate from the screw-nut system.


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2.2 Operational de scription From an operational point of view, Injectomat Agilia is made up of 3 assemblies: ! ! !

a sub-assembly to maintain and check the correct positioning of the syringe a motorisation sub-assembly an external connection sub-assembly.

2.2.1 Syringe maintenance and checking sub-assembly The syringe is positioned in its housing and held in place by the syringe clamp. Detection of the syringe size (50/60 cc, 30/35 cc, 20/25 cc, 10 cc or 5 cc) is ensured by the potentiometric sensor positioned on the syringe clamp. The correct positioning of the syringe flanges in the groove is controlled by the flange detector.

2.2.2 The motorisation sub-assembly The motorisation sub-assembly ensures the displacement of the syringe piston. It is set in motion by a motor-reducer linked to a screw-nut system. A pinion attached to a motor shaft end and connected to an opto-electric sensor, ensures rotation control. A linear potentiometer mounted on an ALU profile ensures plunger displacement control via a rolling ball contact. A micro-switch enables the disengagement mechanism position to be checked. Correct positioning of the piston against the plunger is controlled by the anti-siphon arm. A force sensor, integrated with the plunger, detects the force exerted on the piston and triggers an alarm when the limit has been reached.

2.2.3 External connection sub-assembly The Injectomat 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 " Link communication. An infrared cell located at the back of the device. It permits exchange of information 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 me nu The options menu enables the Injectomat 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

Key in code

User

Code XXXX

Service

Code 0200

Maintenance

Code 0000

Sub-menu

Sub-menu

User options menu Service options menu Test Maintenance options test menu Maintenance options Maintenance options menu Calibration Calibration menu

s u n e m e h t f o n o it p ir c s e D

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 3.2 Calibration menu

The calibration menu is reserved for qualified staff only. Its access is protected by a secret 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, Force Etal 2, Syringe clamp Etal 3, Displacement Elal 4, Linearisation


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Description of the menus 3.3 After-Sales Se rvice tes t men u The After-Sales Service test menu is reserved for qualified personnel. It enables a series of checks that can be carried out on the Injectomat Agilia to confirm that it is operating correctly. (See chapter "Checks".) These must be carried out each time a part is replaced.

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 12 tests or checks: ! ! ! ! ! ! ! ! ! ! ! ! !

Test 1, Identification Test 2, Maintenance Test 3, After-Sales Service messages Test 4, Events Test 5, Force Test 6, Displacement Test 7, Syringe clamp Test 8, Battery information Test 9, Indication Test 10, Keyboard Test 11, Life test Test 12, Battery life Test 13, Battery test

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 mai ntenance 4.1 Recommendations The Injectomat Agilia syringe 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 srcinal 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 main tenance In order to maintain the pump’s performance, a Preventive Maintenance inspection must be carried out every 3 years. This procedure, which includes changing the battery, 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 pump’s correct operation will be impaired.

4.2.2 Quality control At the request of the health organisation, a quality check will be carried out every 12 months. A quality check (not included in the guarantee) consists of different inspection procedures as defined in the pump’s Technical Manual. Only a qualified technician may perform the quality check which must be performed using Fresenius-Vial software. For more information, kindly contact our After-Sales Service.

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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Preventive maintenance

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 selection keys scroll through the numbers and letters on the tenths, units and tens values and allow one to move to the next menu. OK validates your test selection or moves the cursor. enter starts up infusion. exit exits the screen and returns to the "preceding" menu. Bolus or purge


ag04.3_001c_en.fm

31

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 selection keys. Press "enter" to confirm.

!

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

!

Press "OK" to confirm.

!

Choose the "Test" menu using the selection keys.

!

Press "enter" to confirm. Navigate through this sub-menu using the central selection keys.

"

4.3.2 Visual c heck Check the general appearance of the case and labels and check for shock impact da mage.

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 selection keys. device information: # device name # version/revision and software production date # device code and product serial number " serial numbers: # CPU board serial number # power supply board serial number "

32

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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. "

!

4.3.4 Test 2, Maintenance This test displays: the running time since the last maintenance in hours, days or months; the date of the last maintenance service; the total running time in hours, days or months and the distance covered by the plunger in metres.

!

Test 2, press "enter". " " "

!

The "Maintenance" main menu appears. Scroll through the information using the selection keys . Choose between the proposed options "Clear" or "exit".

"RAZ", using the left selection key.

For this menu:

!

Duration: # the number of operating hours is reset to "0". " Date: # the date of the last maintenance is reset to the day’s date. " Total duration: # the total running time since the beginning remains incremented. " Total distance: # the total operating distance since the beginning remains incremented. Press "OK" to confirm and move to the next step.

!

"exit", exits the screen and returns to the "Test" menu.

"


You may exit the configuration mode at any time by pressing "EXIT"; this function cancels the modifications.

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33

4.3.5 Test 3, Af ter-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 selection keys.

!

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.

!


!

Press "enter" to display the alarm type. Press "Menu" to return to the "Test" menu.

!

4.3.7 Test 5, F orce This test displays: the force values in mV and in g, the calibrating values in mV and the calibrating date and counter.

!



!

34

The "Force" main menu appears.

Scroll through the information from screen to screen using the selection keys. " Conversion: Force: # 0 capteur in mV, # Force = 0 Kg in mV, # Force = 0 Kg in mV,

ag04.3_001c_en.fm

"

!

Date: Number: # Date and number of the calibration.

Select the "Conversion / Force" sub-menu. Hold down the disengagement lever so that the antisiphon arm is separated from the sensor. " Apply a force to the sensor, then release it: # Check the value lies between -200g and +200 g. " Apply a force of 0,4 bar using the Fresenius-Vial dynamometer. # Check that the value displayed lies between -2200g and +2800 g. "

If one"Etal1", of the values (See Force.)is outside the tolerance zone, carry out the sensor calibrating procedure !


4.3.8 Test 6, Displacement This test displays: the plunger position in mV and in mm, the calibration values in mV, the calibration date and counter and the linearisation date.

!


!

!

The main "Displacement" menu appears.

Scroll through the information from screen to screen using the selection keys. " Conversion, Position: # the plunger position in mV and mm. " Low, High: # Low and High calibration value positions. " Date, Number, Linearisation: # calibration date, # number of calibrations, # linearisation date. Select the "Conversion / Position" sub-menu. Position the spacer ref. T067058, with the plunger

"

disengaged. # The value displayed must be equal to 115 mm +/- 0.5 mm. " Position the spacer ref. T067057 with the plunger disengaged. # The value obtained must be equal to 20 mm +/- 0.5 mm. If one of the values is outside the tolerance zone, carry out the sensor calibration procedure. (See "Etal3", Displacement.) !

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35


4.3.9 Test 7, Syringe holder This test displays: the syringe diameter in mV and in mm, the calibration values in mV, the date and the calibration meter.

!


!

!

The main "Syringue holder" menu appears.

Scroll through the information from screen to screen using the selection keys. " Conversion Diameter # The syringe diameter in mV and in mm " Low Medium High: # Low, Average and High calibration value positions " Date, Number: # calibration date # number of calibrations Select the "Conversion / Diameter" sub-menu. Position the spacer V1 ref. 067053,

"

The displayed 10,5 value mm +/0.7 mm.must be equal to Position the spacer V2 ref. 067054, # The value displayed must be equal to 15,5 mm +/- 0.7 mm. " Position the spacer V4 ref. 067056, # The value displayed must be equal to 28 mm +/- 0.5 mm. If one of the values is out of the tolerance zone, carry out the sensor calibration procedure. (See "Etal2", Syringe clamp.) "

!



36

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4.3.10 Test 8, Batter y 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.

!

Test 8, press "enter". " "

The "Battery info" main menu appears. Choose between the proposed "Clear" or "exit" options.

Select "RAZ" to reset to 0 after all battery replacements.

!

"RAZ", using the left selection key "

The following "Maintenance" menu appears..

"

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 selection keys. " Conversion: Voltage: # Voltage value at the battery terminals and conversion in mV. " Conversion: Temperature: #

ag04.3_001c_en.fm

battery temperature value and conversion in mV.

!

"exit" exits the screen and returns to the "Test" menu.

!



37

4.3.11 Test 9, Indication This test checks that the indicator lights and buzzer are functioning correctly. !

Test 9, press "enter". " "

!

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.


38

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4.3.13 Test 11, Life test This test checks that the motor unit is functioning correctly by carrying out displacements between the115 mm and 20 mm positions. !


!

The "Life test" main menu appears.

Select your sub-menu using the "OK" key Flow rate: between 1 and 1200 ml/h Modify the value using the selection keys: # for the tens and hundreds increase or decrease using the double arrows # for the units, increase or decrease using the single arrows. " Press "OK" to confirm and move to the next step. "

"

"

"

!

Current: strong or weak Modify the value using the single arrow selection keys. Press "OK" to confirm and move to the next step. Displacement: forward or forward/back. Modify the value using the single arrow selection keys.

Press "OK" to confirm and start up the test. "

The following "Life test" menu appears. # The flow rate and the strength of current for the motor control are shown at the top of the screen. # The cursor moves according to the plunger’s actual forward movement and the arrow indicates the direction of the plunger’s displacement. # During the displacements, the rotation check is activated and the syringe pump indicates an error if a problem is detected.

In a forward/backward test, when the plunger reaches the 20 mm position, the plunger moves backwards. When the plunger reaches the 115 mm position, the plunger moves forward. In a’forward’ only test, when the plunger reaches the 20 mm position, the test is terminated and "Terminated" flashes on the screen at the cursor position.

!

ag04.3_001c_en.fm


"exit", exits the screen and returns to the "Test" menu.

39

4.3.14 Test 12, Battery life This test displays: the amount of battery charge; the date of the last automatic extinction; the pump’s battery running time before the pre-alarm and battery alarm were triggered; the alarm’s running time till the battery is off. !

Test 12, press "enter".

!

The, "Battery life" main menu appears.

!

Scroll through the information from screen to screen using the selection keys. " Charge Auto extinction " Pre-alarm Alarm Cut-out Press "exit" to return to the"Test" menu.

!

"Test 12" always displays information concerning the previous discharge. If the battery is 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 battery’s autonomy. At the end of the autonomy test, the device switches off. To ascertain the battery’s 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.

40

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4.3.16 Anti-siphon arm check Use a 50cc syringe. ! ! !

To carry out this procedure, exit the test mode and press "OFF", Press "ON". Position the 50 cc syringe on the device and lock it with a syringe clamp. " Place the plunger in contact with the syringe with the antisiphon arm positioned on the syringe piston. #

" "

"

"

" "

is displayed without the alarm being triggered. Select and confirm a flow rate. Press the plunger disengagement command. The "disengagement alarm" message appears on the display. Move the plunger back so that it is removed from the syringe piston, then release the disengagement lever. Press silence alarm. # The "piston head alarm" message appears on the screen. Press the piston head detection. Release the seringue head detection. The alarm reappears.

4.3.17 Pressure limit alarm chec k To carry out this procedure, exit the test mode and press "OFF",

The device will initialise the sensor once the plunger is disengaged. The pressure limit alarm test must be carried out with no pressure on the line.

!

Press "ON". Position the Fresenius Vial spring dynamometer. " Select a "B-D PLASTIPAK" 50 ml syringe, by pressing "VALIDATION". " Press "Exit" and select a medium limit: # M (medium limit) = 500 mmHg + 70 mmHg " Select a flow rate of 120 ml/h and start the infusion by pressing "START". # Check for absence of the "Occlusion alarm" message. # Check that the infusion LEDS are flashing. # Check that the alarm is triggered at a value of 500 mmHg + 70 mmHg or 0.5 < x bar < 0.85. " Re-start the test selecting a high limit # H (high limit) = 900 mmHg + 150 or 1.2 bar + 0.2 bar . "

In cases where, after the selection has been made, the measured pressure value lies outside the range, carry out the force sensor calibrating procedure (see "Etal 1 Calibrating the force sensor).

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41


4.3.18 Linearity check This test can either be carried out: ! !

using checking software using a flow rate test described in the chapter "Flow rate check"

4.3.19 End of infusion alarm and pre-alarm check !

To carry out this procedure, exit the test mode and press "OFF".

!

Press "ON". Position the 50 cc syringe on the device and lock it using the syringe clamp. " Place the plunger in contact with the syringe with the antisiphon arm positioned on the syringe piston and with a value remaining above 10 ml. Select a flow rate of 200 ml/h. " Check that the end of infusion alarm is triggered. " When the end of infusion alarm has been triggered, note the Hard Height "test 6" distance: check that X lies between 18,5 mm < X < 19,5 mm.

!

!

4.3.20 Mains/battery operatio n 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.

"

4.3.21 Battery autono my check (See test 12, Autonomy.) !

When the test is carried out on automatic, as described in test 12, autonomy must be more than 2 hours. ! When the test is carried out in normal mode, autonomy must be more than 10 hours at 2ml/h.

4.3.22 Electrical test


Carry out the electrical test according to the En/IEC 60601-1 norm.

42

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4.4 Maintenance options 4.4.1 Test access Keyboard description. Key

Function ON switches on the device. OFF switches off the device when pressed down for over three seconds. Menu/Exit accesses the test mode. The selection keys scroll through the numbers and letters on the tenths, units and tens values and move to the next menu. OK validates your test selection or moves the cursor. enter starts the infusion. exit exits the screen and returns to the previous 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 selection keys. Press "enter" to confirm.

!

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

!


!

Choose the "Maintenance options" menu using the selection keys.

!


Press "enter" to confirm. You can browse through this sub-menu using the central selection keys.

"

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43

4.4.2 SAV 1, M aintenance date This screen selects the date for the next maintenance.

!

!

The "Maintenance date" main menu appears.

Modify the day using the selection keys: for the tens, increase and decrease using the double arrows " for the units, increase and decrease using the single arrows. "

"

!

Press "OK" to confirm and move to the next step.

Modify the month using the selection keys: 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.

You can exit the configuration mode at any time by pressing "EXIT". This function cancels the modifications.

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.

"

"

!


"NO", using a single right arrow.



44

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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 4) !

The, "Data log event" main menu appears.

!


!

Press "enter" to display the alarm type. Press "Menu" to return to the "Test" menu.

!


ag04.3_001c_en.fm

45


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4.4.5 Quality Control Certificate Use this table to summarise the results obtained from the various tests. These tests can be done with a software dedicated to Injectomat.

Devicetype:

Code:

Deviceserialn°:

N°

Procedure

Obtainevdalue

1

!

Check the general appearance of the case, labels, serial number and product code.

2

!

Display the running time and the last maintenance date, test 2 (in hours, days or months). ************************************************************ ..........................

3

!

4

!

Conformity Yes No

Check the force and calibration sensor, test 5. ******************* .......................... " Press down and release the sensor, the value obtained should lie between -200 g and +200 g: ******************************************** .......................... " Apply a force of 0.4 bar to the sensor, the value obtained should lie between 2200 g and 2800 g: ******************************************** .......................... If there is too great a difference, refer to chapter 7 "Calibrations": Etal 1. Check the displacement sensor, test 6. " High position with spacer 067058, check that the value displayed is "

+ 0.5 mm: ******************************************* .......................... Low position with spacer 067057, check that the value displayed is

+ 0.5 mm: ********************************************** .......................... If there is too great a difference, refer to chapter 7 "Calibrations", Etal 3 and Etal 4. 5

!

Check the syringe clamp sensor, test 7. ************************** .......................... " High position with spacer V1 ref. 067053, check that the value displayed is "

+ 0.7 mm: ********************************************** .......................... Low position with spacer V2 ref. 067054, check that the value displayed is

"

+ 0.7 mm: ********************************************** .......................... Low position with spacer V4 ref. 067056, check that the value displayed is

+ 0.5 mm: ********************************************** .......................... If the difference is too great, refer to chapter 7 "Calibrations": Etal 2. 6

!

Check the LCD screen, all the light indicators and the buzzer, test 9....................

7

!

Check the keyboard, test 10. ************************************** ..........................

8

!

Check the anti-siphon arm.

9

!

Check the alarm limit pressure (use a Fresenius Vial dynamometer): " In variable mode adjusted to 500 mmHg

10

!

Check the end of infusion pre-alarm: " e.g.: for a flow rate of 50 ml/h with a BD 60 cc, check that the pre-alarm is triggered at 5 mn + 10 s before the end of infusion.********** ..........................

11

!

Check the end of infusion alarm: " With a BD 60 cc, check that the Hard height distance is 18.5 < x mm < 19.5. ******************************************** ..........................

12

!

Check the linearity.

< X bar <

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: ************************************* .......................... e c n a n e t in a m e v ti n e v re P

47

N°

Procedure

Obtainevdalue

13

!

Check the battery autonomy, test 8: " Recharge the battery for 6h. " Carry out test 13. " Note the battery duration information, test 12. **************** ..........................

14

!

Carry out the electrical test according to the norm EN / IEC 60601-1.

Name:

Date:

Conformity Yes

No

Visa:

Observations:


48

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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 ISDébit 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 user’s software.

To acquire the ISDébit flow rate check software, contact the Fresenius Vial Customer service department. The test procedure defined bel ow must be carrie d out with 50 ml, 30ml, 20 ml, 10ml or 5ml syringes. Equipment needed !

Scale connected to a micro-computer:

Flow r ate v alue x<5ml/h 5 ml/h < x < 30ml/h x>30ml/h ! ! ! ! ! !

Scale s ensitivity 1/10000th 1/1000th 1/100th

Multi-scale acquisition programme Test tube or beaker with 1 ml graduations Liquid: distilled water, oil Plastic Luer Lock type syringe (50 or 20 ml) Catheter extension with Luer Lock end (length 100 cm, interior diameter 2.5 mm) Needle:

Flow rate value

Type of needle

x<30ml/h

G26

x>30ml/h

G18orG21

Installation !

Following the diagram below Catheter extension support bracket

1 cm

RS232 Cord


Anti-vibration measuring table

Observe the equipment’s horizontal installation plan.

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49

!

Fill the 50 ml syringe with distilled water. Carry out a purge to eliminate any air bubbles. Lock the catheter extension female Luer Lock end to the syringe and the male Luer Lock end to the needle. Install the syringe in the pump. Fill the test tube so that the needle is submerged in the liquid (> 1 cm). " Add a few drops of oil to create an oily film on the surface of the liquid; this will avoid any measuring error due to liquid evaporation. Place the test tube in the centre of the scale tray. Place the needle in the test tube. "

! ! !

! !

The infusion line (needle/catheter extension) must not rest on the scale/testube t 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 appears on the scale display. At the end of the specified time, note the error percentage displayed on the screen.


50

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4.5.2 Measuring with a scale Equipment needed ! !

Chronometer Scale:

Flow r ate v alue x<5ml/h 5 ml/h < x < 30ml/h x>30ml/h ! ! ! ! !

Scale s ensitivity 1/10000th 1/1000 th 1/100th

Test tube or beaker with 1 ml graduations. Liquid: distilled water, oil Plastic Luer Lock type syringe (50 or 20 ml) Catheter extension with Luer Loc k end (length 100 cm, interior diameter 2.5 mm) Needle:

Flow rate value

Type of needle

x<30ml/h

G26

x>30ml/h

G18orG21

Installation !

Following the diagram below

Catheter extension bracket support

1 cm


Observe the equipment’s horizontal installation plan.

! ! ! ! ! !

! !

ag04.4_001c_en.fm

Fill the 50 ml syringe with distilled water. Carry out a purge to eliminate any air bubbles. Lock the catheter extension female Luer Lock end to the syringe and the male Luer Lock end to the needle. Install the syringe in the device. Fill the test tube so that the needle is submerged in the liquid (> 1 cm). Add a few drops of oil to create an oily film on the surface of the liquid; this will avoid any measuring error due to liquid evaporation. Place the test tube in the centre of the scale tray. Place the needle in the test tube.


51

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: 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 ) -------------------------------------------------------------------------------------------- × 100 Theoretical value –

=

Error percentage


52

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4.5.3 Measuring wi th a test tube Material needed ! ! ! ! ! !

Chronometer Test tube or beaker with 1 ml graduations Liquid: distilled water, oil Plastic Luer Lock type syringe (50 or 20 ml) Catheter extension with Luer Loc k end (length 100 cm, interior diameter 2.5 cm) Needle:

Flow rate value x<30ml/h

Type of n eedle G26

x>30ml/h

G18ouG21

Installation !

Following the diagram below Catheter extension support bracket

1 cm


Observe the material’s horizontal installation plan.

!

Fill the syringe with 50 ml of distilled water. Carry out a purge to eliminate any air bubbles. Lock the catheter extension female Luer Lock end to the syringe and the male Luer Lock end to the needle. Install the syringe in the device. Fill the test tube so that the needle is submerged in the liquid (> 1 cm). " Add a few drops of oil to create an oily film on the surface of the liquid; this will avoid any measuring error due to liquid evaporation " Place the needle in the test tube. "

! ! !


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53

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 ) -------------------------------------------------------------------------------------------- × 100 Theoretical value –

=

Error percentage


54

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4.6 Cleaning an d di sinfecting Injectomat Agilia is part of the patient's immediate environment. It is advisable to clean and disinfect the device’s external surfaces on a daily basis in order to protect patient and staff. Disconnect the device from its main supply before cleaning. Do not place in an AUTOCLAVE nor IMMERSE the device, Do not let liquids enter the device’s casing. ! If the device is placed in a high contamination risk unit, it is advisable to leave it in the room during disinfecting, after having disinfected it with amoist cloth. ! Use a cloth soaked in DETERGENT-DISINFECTANT, previously diluted with water if ! !

required, to destroy micro organisms. " Avoid abrasive scrubbing which could scratch the casing. " Do not rinse or wipe the surfaces.

Do not use : TRICHLOROETHYLENE-DICHLOROETHYLENE. AMMONIA. " AMMONIUM CHLORIDE. " CHLORINE AND AROMATIC HYDROCARBON. " ETHYLENE DICHLORIDE-METHYLENE. " CHLORIDE-CETONE. These aggressive agents could damage the plastic par ts and cause device malfunction. " "

Take car ofand withsmall ALCOHOL (20% 40%provide alcohol)the .They lead to tarnishing cracksbased in the SPRAYS plastic, and do- not 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: 10°C to 60°C / 50°F to 140°F. " Atmospheric pressure: 500 hPa to 1060 hPa. "

"

Humidity: 10% to 90%, no condensation.

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.

mod04.5&6_001c_en.fm

55


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. The maximum life of the battery achieved after several charge/discharge cycles. In case of frequent mains operations, battery life may be decrease. To limit this risk, it is recommended to use the device on the batter y mode, approximately every 4 weeks, until getting a pre-alarme battery signal


56

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5 Diagnostic 5.1 Troubleshooting guide Problem

Causes

Actions

End of infusion detected too early (at approximately 10 ml). No end of infusion pre-alarm or alarm

!

The installed syringe doesn't correspond with the syringe selected.

!

Flow rate or displacement control drift.

!

Occlusion alarm after the Device has been turned on.

!

Wrong calibration of the force sensor.

!

Force sensor out of order. Flexible circuit cut.

The installed syringe doesn't correspond with the syringe selected. ! The position sensor calibration values have drifted.

!

Occlusion alarm during the infusion.

!

The pressure limit selected is too low. Wrong calibration of the force sensor.

!

Flexible circuit cut.

!

Disengagement alarm after the device has been turned on or during the infusion.

!

Plunger head position alarm unjustified.

!

Replace or validate the right syringe brand. ! Recalibrate the position sensor (Etal 3) or with maintenance software. ! Replace or validate the right syringe brand. ! Check the position sensor calibration values and recalibrate it if necessary. ! Change the position sensor . Recalibrate and check the force sensor. ! Replace the force sensor. ! Replace the flexible circuit. !

Select a higher pressure limit. Recalibrate and check the force sensor. ! Replace the flexible circuit. ! !

The disengagement micro-switch is defective. ! Flexible circuit cut.

!

Replace the micro-switch.

!

Replace the flat ribbon cable.

Optical switch and/or anti-siphon arm finger detection are defective.

!

!

Check the anti-siphon system Check the good condition of the pusher cover internal mechanism. ! Replace the flat ribbon cable. !

Flexible circuit cut.

Syringe clamp alarm unjustified.

!

Syringe clamp potentiometer failed. Flat ribbon cable defective. ! Switch and /or flat ribbon cable flanges detection defective.

!

Display defect: LED's, 8 segments display units.

Control transistors, LED's and/or display board connection are defective.

!

The Device turns off when mains cord disconnection.

!

ag05.1_001c_en.fm

!

The battery is unplugged or the battery cable is cut. ! Battery is totally discharged. ! Power supply board defective.

Check the syringe clamp and replace the defective parts if necessary.

Check the good condition of the display board. ! Replace the LED's or the control transistors. ! Check the display board. ! Replace the display board. ! Check the connection between the CPU and display board. ! Check the battery connection. ! !

Replace the battery. Replace the power supply board.

57

ic t s o n g ia D

Problem

Causes

Actions

The power supply LED doesn't litBattery alarm while it has been completely charged.

!

Voltage regulator MAX 4376 out of order. ! Battery is totally discharged.

!

The device turns ON or turns OFF alone.

!

Keyboard out of order . Power supply board out of order.

!

!

Some keys of the keyboard does not work.

!

Keyboard out of order.

!

After a fall

!

Mechanical elements damaged.

!

Check the charging voltage Replace the power supply board if necessary. ! Replace the battery. !

Check and replace the keyboard if necessary ! Replace the power supply board and check secondary µC functionality. Check and replace the keyboard if necessary. Check the status of the housing and the mechanical system.

itc s o n g a i D

58

ag05.1_001c_en.fm

Diagnostic

5.2 Error messages Error code

Description

Action

Anomalies de commande électronique et logiciel * !

Motor rotation control.

Check the motor functioning correctly. Check the ribbon cable connection between the optical switch and CPU board. ! Check the motor optical switch functioning ! !

correctly. ! Replace the CPU board ! Perform a complete configuration of the device using the maintenance software. !

Displacement control.

!

Check the linear sensor calibration. Check the linear sensor and CPU board connection. ! Replace the CPU board. ! Perform a complete configuration of the device using the maintenance software. !

!

Ram.

Reading and writing problem of the RAM. Replace the CPU board. ! Perform a complete configuration of the device using the maintenance software. ! !

!

Flash.

!

Erasing or programming problem of the

flash Eprom. ! Replace the CPU board. ! Perform a complete configuration of the device using the maintenance software. !

Resources.

!

Crc/16 problem. Perform a complete configuration of the device using the maintenance software. If the problem remains, replace the CPU board and perform a complete configuration using the maintenance software. !

!

Control of the Crc 16µC secondary version.

!

µC secondary start up.

!

Crc/16 µC secondary is not correct. Perform a complete configuration of the device using the maintenance software. !

Watch dog set up problem of secondary µC. ! !

!

Replace the power supply board. Check the power supply / CPU flat ribbon status. ! Replace the power supply board.

µC secondary communication

!

!

!

Battery disconnection

! !

ag05.2_001c_en.fm

Check the battery wires. Check the charging voltage of the battery. Replace the battery.

59

ic t s o n g ia D

Error code

Description !

Battery charge.

Action ! ! !

!

Mains power presence.

! !

!

Battery temperature.

! !

!

Syringe clamp Potentiometer

!

Displacement linear potentiometer .

!

Pressure sensor

!

!

!

Check the battery status. Check the battery charging voltage. Replace the power supply board. Power supply problem. Replace the power supply. Power supply problem. Replace the power supply.

Check the calibration of the syringe clamp potentiometer. ! Perform a calibration of the potentiometer and check the device functioning correctly. ! If the error remains,replace the potentiometer. ! Perform a calibration of the potentiometer . Check the calibration values of the linear displacement sensor, test 6. ! Perform a calibration and check the device functionality. ! If the error remains, replace the displacement sensor. ! Perform a calibration of the sensor Check the pressure sensor, test 5. Perform a calibrationIf the error remains. ! Check the pressure sensor flat ribbon. ! If the error remains, replace the pressure sensor. ! Perform a calibration of the force sensor !

!

Syringe flanges switch

!

!

Disengagement switch

!

!

Syringe head detection optical switch.

!

itc s o n g a i D

60

Board missing

Check the syringe flanges switch functioning correctly. ! Check the flat ribbon. ! Replace the defective parts. Check the functionality of the disengagement switch. ! Check the continuity of the flat ribbon cable. ! Replace the defective parts. !

Check the functionality of the syringe head optical switch. ! Check the flat ribbon cable. ! Replace the defective parts. Check the connection between the display and the CPU board. ! Check the connection between the power supply and the CPU board. ! Replace the defective parts. !

ag05.2_001c_en.fm

Error code

Description

Action

!

LCD back light missing.

!

!

Keyboard.

!

Check the connection between the display board and the back light. ! Replace the LCD. ! If the problem remains, replace the display board.

!

Check the keyboard, test 10. Replace the keyboard.

!

If the problem remains, replace the display board. !

Analogical / digital converter.

!

Replace the CPU board. Perform a complete configuration of the device using the maintenance software. !

!

Time keeper.

!

!

Syringe parameters

!

Check the frequency of the time keeper cristal, The frequency should be equal to 32.768 kHz. ! Check the frequency of the cristal X2, the frequency should be equal to 7.3728 kHz. ! Replace the defective cristal if necessary. ! Replace the CPU board, the time keeper is integrated on the principal µC. ! Perform a complete configuration of the device using the maintenance software. Perform a complete configuration of the device using the maintenance software.

!

Configuration changing / modification.

!

Disengagement optical switch.

!

!

Perform a complete configuration of the device using the maintenance software.

! !

!

Infusion flow rate control.

!

!

Control of the motor period.

!

!

Perform a complete configuration of the device using the maintenance software. Perform a complete configuration of the device using the maintenance software.

Control of the motor direction

!

!

!

OFF key

Check the optical switch functionality. Check the flat ribbon cable. Replace the defective parts.

Perform a complete configuration of the device using the maintenance software. Perform a complete configuration of the device using the maintenance software. ! Replace the power supply board in order to check the secondary µC. ! Replace the power CPU board in order to check the principal µC. ! Replace the defective parts. ic t s o n g ia D

ag05.2_001c_en.fm

61

Error code

Description

Action

!

OFF key locked.

!

Check the OFF key functionality from the keyboard . ! Replace the keyboard if necessary. ! Replace the power supply board to check the secondary µC functionality.

!

Impossible extinction.

!

Replace the power supply board.

itc s o n g a i D

62

ag05.2_001c_en.fm

6 Intervention procedures This chapter details all the dismantling and re-assembling procedures.

s re u d e c o r p n ito n e v r e t In

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63

s re u d e c o r p n o ti n e v r te n I

64

ag06.0_001c_en.fm

Intervention procedures

N°1, Procedure: Display board Safety: For safety reasons, the technician should not intervene while 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 n°12 procedure)

Material needed: ! ! !

1 Torx T-10 screwdriver 1 Torx T-8 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.

ag06.0_0010c_en.fm

65

Dismantling

When working with electronic components, we recommend wearing an anti-static br acelet 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 CPU board flat cable (J3) from the power supply. ! Unscrew the 2 screws (marker 3) holding the cover to the base. ! Remove the upper case (marker 4), being careful not to remove the display board flat cable. Disconnect the display board flat cable at the top cover.

2

J3 3 3 4

! ! ! !

Disconnect the CPU board flat cable from display board (J2). Disconnect the display board/keyboard link at (J1). Unscrew the 4 fixing screws (marker 5) connecting the board to the top cover. Pull out the display board/display unit.

J2

5

J1 5


5 5

66

ag06.0_0010c_en.fm

! !

Disconnect the display board /display connection at (J3). Unclip and separate the display board and the display.

J3

Re-assembling

Each Injectomat Agilia has its own "CPU board" board type. Be careful not to confuse Injectomat Agilia reference numbers and order the correct one for your device.

Pay attention to the direction of the flat cable connections when assembling. ! !

Carry out the dismantling procedure in reverse order to re-assemble the unit. Carry out the regular servicing tests (see Quality Control Certificate).


ag06.0_0010c_en.fm

67


68

ag06.0_0010c_en.fm


N°2, Procedure: Central unit board Safety: For safety reasons, the technician should not intervene while the device is connected to 230V mains voltage. Unplug the power supply cord from the mains. Switch off the device.




Maintenance level: Level 3 maintenance technician (see biomedical technical training documentation).


Turn over the device. Unscrew the three Torx screws (marker 1) and pull them out (3 under the angle bracket). 1 1

1



ag06.0_0020c_en.fm

69

Dismantling


Remove the angle bracket (marker 2) being careful not to pull out the CPU board flat cable. ! Disconnect the CPU board flat cable (J3) from the power supply. ! Unscrew the 2 screws (marker 3) holding the upper case to the base. ! Remove the upper case (marker 4), being careful not to pull out the display board flat cable. Disconnect the display board flat cable at the top cover.

2

J3 3 3 4

! ! !

Disconnect the flat cables from the CPU board (J2, J5, J7, J8, J6, J4). Unscrew the fixing screws (marker 5) connecting the CPU board to the base. Remove the CPU board unit being careful not to pull out flat cable on the internal side. J5

J7

J2

J8

5


J4

70

J6

ag06.0_0020c_en.fm

! !

Disconnect the flat cable (J9). Remove the CPU board.

J9

Re-assembling When replacing the CPU board, carry out a complete configuration of the board. Each Injectomat Agilia has its own "CPU board" board type. Be careful not to confuse Injectomat Agilia reference numbers and order the correct one for your device.

Pay attention to the direction of the flat cable connections when carrying out the assembly procedure. ! !

Carry out the dismantling procedure in reverse order to re-assemble the unit. Carry out regular servicing tests (see Quality Control Certificate).


ag06.0_0020c_en.fm

71


72

ag06.0_0020c_en.fm


N°3, Procedure: Power supply board Safety: For safety reasons, the technician should not intervene when the device is connected to 230V mains voltage. Unplug the power supply cord from the mains. Switch off the device.


Material needed: ! ! ! ! !

1 Torx T-10 screwdriver 1 Torx T-8 screwdriver 1 anti-static bracelet 1 soldering iron Soldering wire "RADIEL Sn60Pb RI 1" (no cleaning when reused) or equivalent



Turn the device upside down. Unscrew the 3 Torx screws (marker 1) and pull them out (3 under the angle bracket). 1 1

1



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73

Dismantling

When working with electronic components, we recommend wearing an anti-static br acelet connected to earth and working on a foam anti-static mat.

! !

Remove the angle bracket (2) being careful not to pull out the CPU board flat cable. Disconnect the CPU board flat cable at the power supply connector (J3).

2 J3

! ! ! !

Turn over the angle bracket and unscrew the 2 Torx screws (marker 3). Disconnect and remove the battery (marker 6). Loosen the plug screw (marker 4). Unscrew the 2 cruciform screws (marker 5) from the mains socket.

5

4 J1 5

3 6 s re u d e c o r p n o ti n e v r te n I

3

74

ag06.0_0030c_en.fm

! ! ! !

Unscrew the board clamp Torx screw (marker 7). Remove the isolating plate (marker 8). Unsolder the 3 lugs at the mains plug (marker 9). Remove the power supply board.

7 9

8

Re-assembling

Each Injectomat Agilia has its own "CPU board" board type. Be careful not to confuse Injectomat Agilia reference numbers and order the correct one for your device.

Pay attention to the direction of the flat cable connections when carrying out the assembly procedure. ! !

Carry out the dismantling procedure in reverse order to re-assemble the new unit. Carry out the regular servicing tests (see Quality Control Certificate).


ag06.0_0030c_en.fm

75


76

ag06.0_0030c_en.fm


N°4, Procedure: Syringe clamp Safety: For safety reasons, the technician should not intervene when the device connected to 230V mains voltage. Unplug the power supply cord from the mains. Switch off the device.






Turn the device upside down. Unscrew the 3 fixing screws (marker 1) and pull them out (3 under the angle bracket). 1 1

1



ag06.0_0040c_en.fm

77

Dismantling


Remove the angle bracket (marker 2) being careful not to pull out the CPU board flat cable. ! Disconnect the flat cable at the power supply (J3). ! Unscrew the 2 cover fixing screws (marker 3). Remove the cover (marker 4) being careful not to pull out the display board flat cable. 2

J3 3 3

4

5

Disconnect the display board/CPU board connection flat cable from the CPU board (J5) connector. ! Unscrew the 2 plunger protection fixing screws (marker 5). Remove the plunger protection (marker 6). ! Disconnect the connectors from the CPU board (J2). !

J5 J2

6


78

ag06.0_0040c_en.fm

! ! !

Press down hard on the syringe pump disengagement lever and pull it to its maximum. Remove the flange clamp plastic pegs and unscrew the 2 fixing screws (marker 7). Unscrew the 2 fixing screws (marker 9) at the base (marker 10).

7 8

7

9 10

! ! !

9

Remove the 2 fixing screws (marker 11) and pull out the holding clip (marker 12). Pull syringe clamp kit out in a forwards direction (marker 13), locking the sensor. Remove the syringe clamp kit (marker 13). 11

12

13


ag06.0_0040c_en.fm

79

Re-assembling !

Carry out the dismantling procedure in reverse order to re-assemble the unit.

Do not forget to place the angle bracket clip between the base and the ALU profile, before fixing the unit.

! !

Calibrate the syringe clamp. Carry out the regular servicing tests (see Quality Control Certificate).

Pay attention to the direction of the flat cable connections when carrying out the assembling procedure.


80

ag06.0_0040c_en.fm


N°5, Procedure: Syringe detection system Safety: For safety reasons, the technician should not intervene when the device is connected to 230V mains voltage. Unplug the power supply cord at the mains. Switch off the device.


Material needed: ! ! ! !

1 T-10 Torx screwdriver 1 T-8 Torx screwdriver 1 soldering iron Soldering wire "RADIEL Sn60Pb RI 1" (no cleaning when reused) or equivalent

Maintenance level: Level 3 specialist technician (see biomedical technical training documentation).



1



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81

Dismantling When working with electronic components, we recommend wearing an anti-static br acelet 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 at the power supply connector (J3). ! Unscrew the 2 fixing screws from the cover (marker 3). Remove the cover (marker 4) being careful not to pull out the display board flat cable. 2

J3 3 3

4

5

Disconnect the display board/CPU board connection at the CPU board J5 connector. Unscrew the 2 plunger protection fixing screws (marker 5). Remove the plunger protection (marker 6). ! Disconnect the connectors from the CPU board at J2. ! !

J5 J2

6


82

ag06.0_0050c_en.fm

Press hard on the syringe pump disengagement lever and pull it to its maximum. Remove the flange clamp plastic pegs and unscrew the 2 fixing screws (marker 7). Remove the flange clamp (marker 8). ! Unscrew the 2 fixing screws (marker 9) at the base (marker 10) and remove the base. ! !

7 8

7

9 10

!

9

Remove the syringe clamp (marker 11).

!

Remove the 2 fixing screws (marker 12) and pull out the detection system unit (marker 13).

12 13 11

12


ag06.0_0050c_en.fm

83

Re-assembling !


Do not forget to place the angle bracket clip between the base and the ALU profile, before fixing the unit.

! !

Calibrate the syringe clamp whenever it has been dismantled and re--assembled. Carry out the regular servicing tests (see Quality Control Certificate).

Pay attention to the direction of the flat cables when carrying out the re-assembling procedure.


84

ag06.0_0050c_en.fm


N°6, Procedure: Motor Safety: For safety reasons the technician should not intervene when the device is connected to 230V mains voltage. Unplug the mains power supply cord. Switch off the device.



1 Torx T-10 screwdriver 1 T-8 Torx screwdriver 1 anti-static bracelet



Turn the device upside down. Unscrew the 3 fixing screws (marker 1) and pull them out (3 under the angle bracket.) 1 1

1



ag06.0_0060c_en.fm

85


Remove the angle bracket (marker 2) being careful not to pull out the CPU board flat cable. ! Disconnect the flat cable at the power supply connector (J3). ! Unscrew the 2 fixing screws from the cover (marker 3). Remove the cover (marker 4) being careful not to pull out the display board flat cable. 2

J3 3 3

4

5

Disconnect the strand connecting the CPU board to the motor at (J6). Unscrew the fixing screw (marker 5) connecting the motor to the base. Remove the motor (marker 6). ! !

J6

6 5 5


5 5

86

ag06.0_0060c_en.fm

Re-assembling !

Place the motor in position being careful not to damage the pinion teeth. Bring the teeth of the 2 pinons together without forcing, turning them slightly. Tighten the motor fixing cross screws, following the set order.

"

!

2 4

3 1

! !




ag06.0_0060c_en.fm

87


88

ag06.0_0060c_en.fm


N°7, Procedure: Pressure sensor and ribbon cable kit Safety: For safety reasons the technician should not intervene when the device is connected to 230V mains voltage. Unplug the mains power supply cord. Switch off the device.


Material needed: ! ! ! ! !

1 Torx T-10 screwdriver 1 Torx T-8 screwdriver 1 anti-static bracelet 1 soldering iron Soldering wire "RADIEL Sn60Pb RI 1" (no cleaning when reused) or equivalent.



Turn the device upside down. Unscrew the 3 fixing screws (marker 1) and pull them out (3 under the angle bracket). 1

1



ag06.0_0070c_en.fm

89


Remove the angle bracket (2) being careful not to pull out the CPU board flat cable. Disconnect the flat cable from the power supply (J3) connector. ! Unscrew the 2 cover fixing screws (marker 3). Remove the cover (marker 4) being careful not to pull out the display board flat cable. !

2

J3 3 3

4

5

Disconnect the display board/CPU board connection flat cable from the CPU board (J5) connector. ! Unscrew the 2 plunger protection fixing screws (marker 5). Remove the plunger protection (marker 6). ! Disconnect the connectors leading to the CPU board at J2, J7, J8 and J6. ! Unscrew the fixing screws (marker 7) connecting the CPU board to the base. !

J5 J2

J7 J8

7

6


J6 J4

90

ag06.0_0070c_en.fm

! ! !

Remove the CPU board unit being careful not to pull out the flat cable on the internal side. Disconnect the flat cable (J9). Remove the CPU board.

J9

Press hard on the syringe pump disengagement lever and pull it to its maximum. Remove the flange clamp plastic pegs and unscrew the 2 fixing screws (marker 8). Remove the flange clamp (marker 9). ! !

! ! !

Unscrew the 2 base fixing screws (marker 10) and remove them. Unscrew the 3 fixing screws (marker 12) holding the flask to the ALU profile. Take the unit apart. 12 8 9

8 12

12

10 11

ag06.0_0070c_en.fm


10

91

!

Remove the Truarc ring (marker 13). Unscrew the linking band maintaining screw (marker 14) and remove it. ! Remove the carriage kit and disconnect the flat cable (marker 15). ! Remove the plastic pegs and unscrew the 2 fixing screws (marker 16) holding the plunger flange. Remove the plunger cover with its lever (marker 17). !

17 16 16

13 14 15

! !

Unscrew the pressure sensor support (marker 19) fixing screw (marker 18) and re move it. Pull out the pressure sensor and ribbon cable kit. (marker 20). 20

18 19

18


92

ag06.0_0070c_en.fm

Re-assembling !


Do not forget to place the angle bracket clip between the base and the ALU profile before fixing the unit.

! !

Calibrate the pressure sensor. Carry out the regular servicing tests (see Quality Control Certificate).



ag06.0_0070c_en.fm

93


94

ag06.0_0070c_en.fm


N°8, Procedure: Linear sensor kit Safety: For safety reasons the technician should not intervene when the device is connected to 230V mains voltage. Unplug the mains power supply cord. Switch off the device.



1 Torx T-10 screwdriver 1 Torx T-8 screwdriver 1 anti-static bracelet 1 open-end wrench 5



Turn the device upside down. Unscrew the 3 fixing screws (marker 1) and pull them out. (3 under the angle bracket). 1 1

1



ag06.0_0080c_en.fm

95

Dismantling



2

J3 3 3

4

5

Disconnect the display board/CPU board connection flat cable from the CPU board (J5) connector. ! Unscrew the 2 plunger protection fixing screws (marker 5). Remove the plunger protection (marker 6). ! Disconnect the connectors leading to the CPU board at J2, J7, J8 and J6. ! Unscrew the fixing screw (marker 7) connecting the CPU board to the base. !

J5 J2

J7 J8

7

6


J6 J4

96

ag06.0_0080c_en.fm

! ! !


J9


! ! !


8 12

12

10 11

ag06.0_0080c_en.fm


10

97

!

Unscrew the locking nut (marker 13) and remove the gear pair (marker 14).

13 10

14

! !

Unscrew the 3 fixing screws (marker 15) holding the linearity sensor kit in place. Remove the linearity sensor kit (marker 16) being careful not to pull out the flat cable. 16

15

15

15


98

ag06.0_0080c_en.fm

Re-assembling !



! !

Calibrate the linearity sensor. Carry out the regular servicing tests (see Quality Control Certificate).



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99


100

ag06.0_0080c_en.fm


N°9, Procedure: Plunger cover and lever kit Safety: For safety reasons the technician should not intervene when the device is connected to 230V mains voltage. Unplug the mains power supply cord. Switch off the device.


Material needed: ! !

1 T-10 Torx screwdriver 1 flat screwdriver


Procedure: Access ! ! !

Turn the device upside down. Unscrew the 2 Torx screws (marker 1) and pull them out (2 under the plunger protection). Remove the plunger protection (marker 2).

1

1 2



ag06.0_0090c_en.fm

101

Dismantling


Remove the plastic pegs and unscrew the 2 fixing screws (marker 3) holding the flange and the syringe body together. ! Remove the plunger cover lever kit (marker 4).

3

4

3

Re-assembling ! !



102

ag06.0_0090c_en.fm


N°10, Procedure: Plunger kit Safety: For safety reasons the technician should not intervene when the device is connected to 230V mains voltage. Unplug the mains power supply cord. Switch off the device.







1



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103

Dismantling When working with electronic components, we recommend wearing an anti-static br acelet connected to earth and working on a foam anti-static mat. . !

Remove the angle bracket (2) being careful not to pull out the CPU board flat cable. ! Disconnect the flat cable from the power supply (J3) connector. ! Unscrew the 2 cover fixing screws (marker 3). Remove the cover (marker 4) being careful not to pull out the display board flat cable. 2

J3 3 3

4

5

!

Disconnect the display board/CPU board connection flat cable from the CPU board J5 connector. ! Unscrew the 2 plunger protection fixing screws (5). Remove the plunger protection (6). ! Disconnect the connectors leading to the CPU board (J2, J7, J8 and J6). ! Unscrew the fixing screw (marker 7) connecting the CPU board to the base. J5 J2

J7 J8

7

6


J6 J4

104

ag06.0_0100c_en.fm

! ! !


J9


! ! !


8 12

12

10 11

ag06.0_0100c_en.fm


10

105

!

Remove the Truarc ring (marker 13). Unscrew the linking band holding screw (marker 14) and remove it. ! Disconnect the flat cable (marker 15). ! Remove the carriage kit (marker 16). ! Take apart the plunger kit (marker 17) using a rotating movement to remove the pin from the flask. !

17

15 13 14 16

Re-assembling !



! ! !

Calibrate the pressure sensor. Calibrate the linear sensor. Carry out the regular servicing tests (see Quality Control Certificate).



106

ag06.0_0100c_en.fm


N°11, Procedure: Carriage kit Safety: For safety reasons the technician should not intervene when the device is connected to 230V mains voltage. Unplug the mains power supply cord. Switch off the device.



1 Torx T-10 screwdriver 1 Torx T-8 screwdriver 1 anti-static bracelet 1 flat screwdriver




1



ag06.0_0110c_en.fm

107

Dismantling



2

J3 3 3

4

5

!

Disconnect the display board/CPU board connection flat cable from the CPU board (J5) connector. ! Unscrew the 2 plunger protection fixing screws (marker 5). Remove the plunger protection (marker 6). ! Disconnect the connectors leading to the CPU board at J2, J7, J8 and J6. ! Unscrew the fixing screw (marker 7) connecting the CPU board to the base. J5 J2

J7 J8

7

6


J6 J4

108

ag06.0_0110c_en.fm

! ! !


J9


! ! !


8 12

12

10 11

ag06.0_0110c_en.fm


10

109

! ! ! !

Remove the Truarc ring (marker 13). Unscrew the linking band maintaining screw (marker 14) and remove it. Disconnect the flat cable (marker 15). Remove the carriage kit (marker 16).

15 13 14 16

Re-assembling !



! !

Calibrate the linear sensor. Carry out the regular servicing tests (see Quality Control Certificate).

Pay attention to the direction of the flat cable connections when carrying out the reassembling procedure.


110

ag06.0_0110c_en.fm


N°12, Procedure: Battery door and battery Safety: For safety reasons, the technician should not intervene when the device is connected to 230V mains voltage. Unplug the power supply cord at the mains. Switch off the device.



Maintenance level: Level 3 specialist technician (see biomedical technical training documentation.)

Procedure: Dismantling

! !

Unscrew the 2 fixing screws (marker 1) holding the battery carrier. Remove the battery carrier (marker 2).

2

1 1 s re u d e c o r p n ito n e v r e t In

ag06.0_0120c_en.fm

111

!

Disconnect the connector(J5) and remove the battery (marker 3).

3 J5

Re-assembling ! !



112

ag06.0_0120c_en.fm


N°13, Procedure: Upper case kit Safety: For safety reasons, the technician should not intervene when the device is connected to 230V mains voltage. Unplug the power supply cord at the mains. Switch off the device.






Turn the device upside down. Unscrew the 3 Torx screws (marker 1) and pull them out (3 under the angle bracket). 1 1

1



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113


Remove the angle bracket (marker 2) being careful not to pull out the CPU board flat cable. ! Disconnect the CPU flat cable at the power supply (J3) connector. ! Unscrew the 2 screws (marker 3) holding the upper case to the base. !

Remove the upper case (marker tocover. pull out the display board flat cable. Disconnect the display board 4), flat being cable careful from thenot top

2

J3 3 3 4

! ! ! !

Disconnect the CPU board flat cable at the display board (J2) connector Disconnect the display board/keyboard (J1) connection. Disconnect the 4 fixing screws (marker 5) connecting the board unit to the top cover. Remove the display board unit from the top cover.

J2

5 J1


5

5 5

114

ag06.0_0130c_en.fm

Re-assembling ! !



ag06.0_0130c_en.fm

115


116

ag06.0_0130c_en.fm

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 t he c alibrations 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.

s n o ti a r b il a C

ag07.1_001c_en.fm

117

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.

!


!

Select the menu using the selection keys. Calibration Press "enter" to confirm. " Navigate through this sub-menu using the central selection keys. "

!

7.1.2 Etal 1, Force Calibrate the force sensor by reading the ADC value for a force of 0 kg, then for 5 kg. !

Etal 1, press "enter". "

The "Force" main menu appears. # for a force of 0 kg.

"

No force is applied to the plunger, press "OK". # The device reads the value corresponding to 0 kg in mV. Wait a few seconds, then press "OK". The next "Force" menu appears. # for a force of 5 kg.

" "

"

" "

s n o it a r ilb a C

Apply a force of 5 kg, 0.8 bar using the Fresenius-Vial dynamometer. Wait a few seconds, then press "OK". Press again to confirm and memorise the calibration values.


118

ag07.1_001c_en.fm

7.1.3 Etal 2, Syringe clamp Calibrate the syringe clamp potentiometer by reading the ADC value for low, medium and high spacers. !


The "Syringe clamp" main menu appears.

"

"

Position the "low" C1 spacer ref. 067050 measuring 11 mm. Press "OK" to confirm and move to the next step.

"

The next "Syringe clamp" menu appears.

"

"

Position the "medium" C2 spacer ref. 067051, measuring 22.9 mm. Press "OK" to confirm and move to the next step.

"

The next "Syringe clamp" menu appears.

"

Position the "high" C3 spacer ref. 067052, measuring 33 mm. Press "OK" to confirm. Press "OK" again to confirm and memorise the calibration values.

" "



ag07.1_001c_en.fm

119

7.1.4 Etal 3, Displacement Calibrate the displacement sensor by reading the ADC value for high and low positions . !


The main "Displacement" menu appears.

"

Position the "low" spacer, ref. 067057, measuring 20 mm, in the flange groove. # #

" "

Position the plunger in contact with the spacer. Hold down the disengaged plunger. Press "OK" to confirm and move to the next step. The next menu appears.

"

Position the "high" spacer ref. 067058, measuring 115 mm, in the flange groove. # Position the plunger in contact with the spacer. # Hold down the disengaged plunger. Press "OK" to confirm and move to the next step. Press "OK" again to record the calibration values.

"

The following screen appears.

"

"


"

Pull the plunger out away from the 115 mm position.

"

Press "START" to begin the linearisation. Press "OK" to record the different values read during linearisation.

"


120

ag07.1_001c_en.fm

7.1.5 Etal 4, Linearity The linearisation of the displacement potentiometer consists of displacing the plunger between two calibration positions, measuring the values at different positions, then memorising these values for the linearisation and calculation of the actual plunger position. !


If the plunger is not pushed back beyond the previously measured position for a 115 mm spacer, the following menu appears.

"

"exit" exits the screen and returns to the calibration menu.

"

If the plunger is beyond the previously measured position for a 115 mm spacer, the following menu appears, # Linearity start.

" Press "start" to start linearisation. During linearisation, the following "Linearity" menu appears,


The bar graph progresses according to the linearisation progression.

"

"

"

If the progression does not detect the 20 mm position, the syringe pump moves to error. When the syringe pump detects the 20 mm position, linearisation is completed. Press "exit" to confirm linearisation.


ag07.1_001c_en.fm

121


122

ag07.1_001c_en.fm

8 Spare parts catalogue 8.1 Base

104

.....

105 101

100 102 108 103

106

107

Marker

Qty

Reference

N ame

100

1

178156

Plungerprotection

101

1

178912

Basekit

102

1

178182

Flangeclamp

103

1

178908

Syringeclampkit

104+108 105

1 1

178909 178186

Flange detection + syringe clamp potentiometer kit Membrane

106

1

178199

Syringeclampclip

107

2

178206

Foot

108

1

168026

Potentiometer

1

178103

Syringeclampribboncable

ag08.1_001c_en.fm

e u g lo a t a c ts r a p e r a p S

123

e u g o l ta a c trs a p e r a p S

124

ag08.1_001c_en.fm

Spare parts catalogue

8.2 Cover 110

111

112

113

114

Marker

Qty

Reference

N ame

110

1

178107

Displayboard

111

1

178949

Display

112

1

178905

CoverkitInjectomat

113

1

178152

Protectivewindow

114

1

178270

Keyboard

178110

Flate cable boards connection


Part number since device serial number 19452637 110

1

ag08.2_001c_en.fm

178114

Display board

178116

Flate cable boards connection

125


126

ag08.2_001c_en.fm


8.3 Angle bracket 125 126 122 123

124

120

121

127

.....

128

..... ..... ..... 129

..... ..... .....

.....

..... .....

..... : see next page

Marker

Qty

Reference

N ame

120

1

178914

Batterycarrier

121

1

178153

Articulatednut

122

1

178913

Handlekit

123

1

178130

Battery

124 125

1 1

178188 178906

IRDAwindow Anglebracket+IRDAwindowkit

126

1

178106

Powersupplyboard+binderplug

127

1

178219

Swinglockfixingbuttom

128

1

178255

Pivotnut

129

1

178257

D7bearing

e u g o l a t a c ts r a p e r a p S

Part number since device serial number 19452637

126

1

ag08.3_001c_en.fm

178113

Powersupplyboard+binderplug

127

..... ..... ..... .....

.....

.....

..... .....

.....

130

.....

131 132 133/134 .....

138 139

135

140

136 137

..... : see previous page

Repère

Qté

Référence

Désignation

Swinglock kit 178917, since device serial number 19741382


130

1

178164

Batterydoor

131

1

178163

Pivotingplate

132

1

178293

Pivotingnut

133

1

178291

Nutboltbutton

134

1

178294

Spring

135

1

178204

Screw

136

1

178162

Clamp

137

1

182108

Capscrewhandle

138

1

178298

Washer

139

1

178297

Ballslipper

140

1

178292

Shaft

128

ag08.3_001c_en.fm


8.4 Plunger

130

133 131

136 135 132

138 134

Marker

Qty

Reference

N ame

130

1

178216

Plungerconnectingband,upper

131

1

178205

Plungerconnectingband,lower

132

1

178911

Completeplungerkit

133

1

178108

CIflexibleplunger

134

1

178910

Pressuresensor+ribboncablekit

1

178117

Forcesensor

135

1

178902

Flangeandleverkit

136

1

178903

Carriagekit

1

178115

CIflexiblecarriage

137

1

173407

Disengagementswitch

138

1

178286

Forcesensorflange

1

178283

Flangespring

ag08.4_001c_en.fm


129


130

ag08.4_001c_en.fm


8.5 Mechanical framework

153

154

151

152

155

Marker

Qty

Reference

N ame

151

1

178901

Linearsensorkit

152

1

178900

Pinionmotor+circlipskit

153

1

178104

Centralunitboard

154

1

178102

CIflexibleoptomotor

155

1

190890

Motorpinionring

Part number since device serial number 19452637 153 1 167112 Centralunitboard e u g lo a t a c ts r a p e r a p S

ag08.6_001c_en.fm

131


132

ag08.6_001c_en.fm


8.6 Motor left flange

160

Marker

Qty

Reference

N ame

160

1

178907

Leftflangekit e u g lo a t a c ts r a p e r a p S

ag08.7_001b_en.fm

133


134

ag08.7_001b_en.fm

Useful addresses SALES DEPARTEMENT Fresenius Vial Le Grand Chemin, 38590 Brézins 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

SALES MANAGEMENT

Tel.: 00 33 (0) 4 76 67 10 81 Fax: 00 33 (0) 4 76 67 11 34

Fresenius Vial Le Grand Chemin, 38590 Brézins

Tél. : 00 33 (0) 4 76 67 10 76 Tél. : 00 33 (0) 4 76 67 11 40 Fax : 00 33 (0) 4 76 67 11 22

AfterSalesServiceDivisionGRENOBLE Fresenius Vial Le Grand Chemin, 38590 Brézins FRANCE

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

TRAINING DEPARTMENT

AFTER SALES SERVICE

FRANCE

Spare part department

Tel.: 00 33 (0)4 76 67 10 34

BELGIUM

FRESENIUS VIAL NV/SA Molenberglei 7 2627 Schelle BELGIUM

Tel.: 00 32 (3)8 80 73 07 Fax: 00 32 (3)8 80 50 07

GERMANY

FRESENIUS MCM AM-Neuen Berg 63749 ALZENAU 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. - siège social : Le Grand Chemin - 38590 Brézins (FRANCE) Société par Actions Simplifiées au capital de 13 744 520 Euros SIREN Grenoble B 408 720 282. Design and construction : SEDOC Technical Manual Injectomat Agilia_en

Manufacturer

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

www.fresenius-kabi.com

Injectomat Agilia En

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