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Agilia Syringe Pumps

Injectomat TIVA Agilia Technical Manual Feb 2010

Technical Manual

128 Pages

File Type: PDF

File Size: 2.59 MB

File Name: injectomat_tiva_agilia_technical_manual_feb_2010.pdf

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Page 1

SERVICES

Injectomat® TIVA Agilia Technical Manual

Revision table TM Injectomat TIVA Agilia_Int: ref NT 3295 / n° série de 20251700 à ... Date

Revision

Chapter

Description

15/10/07

Alll index "c"

Creation

15/05/09

index "d"

Update of the boards connectors, spare parts catalogue removed from this document, a document is available for spare parts.

15/02/10

Index "e"

1.5.5. Update symbol of protection defibrilation.

1 Introduction ... 7 1.1 General introduction ... 7 1.2 Operation diagram ... 8 1.3 Precautions for use... 9 1.4 Operation safety ... 9 1.5 Technical characteristics ... 9 1.5.1 1.5.2 1.5.3 1.5.4 1.5.5

Electrical details ... 9 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... 17 The mechanical framework assembly ... 19 The mechanical plunger assembly... 19

2.2 Operational description ... 20 2.2.1 2.2.2 2.2.3

Syringe maintenance and checking sub-assembly ... 20 The motorisation sub-assembly ... 20 External connection sub-assembly ... 20

3 Description of the menus ... 21 3.1 Options menu ... 21 3.2 Service option menu ... 22 3.2.1 3.2.2 3.2.3 3.2.4

Menu acess ... 22 SAV 1, Maintenance date ... 23 SAV 2, Initial set up ... 23 SAV 3, Data log event... 24

3.3 Calibration menu ... 25 3.4 After-Sales Service test 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

Accessing the tests ... 31 Visual check ... 32 Test 1, identification ... 32

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4.3.4 4.3.5 4.3.6 4.3.7 4.3.8 4.3.9 4.3.10 4.3.11 4.3.12 4.3.13 4.3.14 4.3.15 4.3.16 4.3.17 4.3.18 4.3.19 4.3.20 4.3.21 4.3.22 4.3.23

Test 2, Maintenance... 33 Test 3, After-Sales Service messages ... 34 Test 4, Events ... 34 Test 5, Force ... 34 Test 6, Displacement ... 35 Test 7, Syringe holder ... 36 Test 8, Battery information ... 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 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 Quality Control Certificate ... 43

4.4 Flow rate check ... 45 4.4.1 4.4.2 4.4.3

Measuring by computer... 45 Measuring with a scale... 47 Measuring with a test tube ... 49

4.5 Cleaning and disinfecting ... 51 4.6 Storage... 51 4.7 Use of the internal battery... 52

5 Diagnostic... 53 5.1 Troubleshooting guide ... 53 5.2 Error messages... 55

6 Intervention procedures... 59 N°1, Procedure: Display board ... 61 N°2, Procedure: Central unit board... 65 N°3, Procedure: Power supply board ... 69 N°4, Procedure: Syringe holder... 73 N°5, Procedure: Syringe detection system ... 77 N°6, Procedure: Motor... 81 Fiche n°7 : Nappe de débrayage ... 85 N°8, Procedure: Pressure sensor and ribbon cable kit... 91 N°9, Procedure: Linear sensor kit ... 97 N°10, Procedure: Plunger cover and lever kit... 103 N°11, Procedure: Plunger kit ... 105 N°12, Procedure: Carriage kit ... 109 N°13, Procedure: Battery door and battery ... 113 N°14, Procedure: Upper case kit ... 115 44

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7 Calibrations... 119 7.1 Calibration procedure ... 119 7.1.1 7.1.2 7.1.3 7.1.4 7.1.5

Access to the calibrations ... 119 Etal 1, Force ... 120 Etal 2, Syringe holder ... 121 Etal 3, Displacement ... 122 Etal 4, Linearity ... 123

8 Spare parts catalogue ... 125

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1 Introduction 1.1 General introduction Injectomat TIVA Agilia syringe pump focuses on anaesthesia requirements. The device can be used to administer IV anaesthetic drugs in TCI mode and other IV drugs following standard infusion profiles (continuous flow rate, bolus and induction dose). This device is an open system. This device combines ease of use the most complete set of features, including PK models. The drug libraries can be adjusted thanks to Vigilant Drug Lib software. TCI: Target Controlled Infusion. TIVA: Total Intravanous Anaesthesia. PK: Pharmacokinetic. IV: Intravenous. Injectomat TIVA Agilia is a syringe pump with dose rate functions. Thanks to its several securities and to the Vigilant Drug’ Lib coming with a drug library, Injectomat TIVA Agilia is particulary suitable for specialty wards. Injectomat TIVA Agilia is fitted at the back with an infrared cell. Fresenius Kabi uses a Link system enabling several pumps to communicate through a communications system via the infrared cell and rack.

Introduction

Injectomat TIVA 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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1.2 Operation diagram

Introduction

100-240V - 50/60Hz

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1.3 Precautions for use The symbol ! which appears on the device’s condensed user instructions recommends a complete reading of the user instructions, in accordance with norm EN 60 601-1. Fresenius Kabi cannot, in any circumstances, be held responsible for any medical or other problem due to incorrect use of the device. Kindly consult the 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 TIVA 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: 100V - 240V~/ 50-60Hz with functional Earth ! Max. power: 15VA ! Fuse: T2AH 250V internal to power supply unit ! Battery: 6V - 1,8Ah. (NiMH) ! External power supply: 9V CC. Power > 15 W.

1.5.2 Electronic details The Injectomat TIVA Agilia syringe pump contains 3 electronic boards: ! Power supply board ! CPU board ! Display board.

Introduction

1.5.3 Mechanical details ! Dimensions: H x L x W: 135 x 345 x 160mm ! Weight: approximately 2.1kg.

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1.5.4 Material characteristics

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28

Components Syringe barrel clasp Syringe flange cradle Pusher Pusher protector Handle Assembly bolt Infrared cell Fixing clamp Fixing button Mains connection Communication port and 12-15 Vdc power Mains warning Screen Silence Alarm ON/OFF Bolus or Prime Value selection Value selection Value selection Value selection Functioning, pre-alarm and alarm warnings Validation Stop: infusion stop Menu / Historic C / Back Battery door Housing Feet and membranes

Materials Polyamide Polyoxymethilene+polyamide Polyamide Acrylonitrile-styrene-butadiene Stainless steal POM Polyoxymethilene+polyamide Aluminium + epoxy Polyoxymethilene+polyamide Thermoplastic Stainless steal Polyester Polycarbonate Polyester Polyester Polyester Polyester Polyester Polyester Polyester Polycarbonate Polyester Polyester Polyester Polyester Acrylonitrile-styrene-butadiene Acrylonitrile-styrene-butadiene 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. Defibrillation-proof type CF applied part. Protection against electric shocks: class II. Functional earth.

Introduction

Detailed information concerning electromagnetic compatibility is available in the chapter "Guidance and manufacturer’s declaration on EMC" of the User Manual.

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2 Description and operation 2.1 Physical description Flange groove

Plunger protection

Cover

Plunger disengagement control

Angle bracket

Base Control panel

Plunger Syringe Holder

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

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Description and operation

! 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.

2.1.1 The display board 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

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

Description Ground Keyboard Column 0 Keyboard Column 1 Keyboard Column 2 Keyboard Line 0 Keyboard Line 1 Keyboard Line 2 Keyboard ON/OFF button Signal check or keyboard Line 3 Ground

J2 to CPU board connector

Description and operation

Pin 1 2 3 4 5 6 7 8 9

Signal GND PRES_CARTE TON/Off_ALIM VBAT MISO GND MOSI +3V3 CLK

Description Ground Diagnostic signal (board connection confirmed) Keyboard ON/OFF button Battery power supply or +9V mains SPI bus MOSI signal Ground SPI bus MOSI signal +3.3V power supply SPI bus clock signal

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J2 to CPU board connector Pin 10 11 12 13 14 15 16 17 18 19 20

Signal GND CSLCD/ GND CSLDSL/ +3V3 RSLCD GND RESET/ VBAT PRES_CARTES GND

Description Ground Check signal Ground Check signal +3.3V power supply Check signal (for LCD display) Ground Check signal Battery power supply or +9V mains Diagnostic signal (board connection confirmed) Ground

J3 to display board connector

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

Description Backlight LEDs anode Backlight LEDS cathode Not connected Not connected Ground, indicates LCD serial access LCD serial line data LCD serial line clock Not used by the LCD in serial access Not used by the LCD in serial access Not used by the LCD in serial access Not used by the LCD in serial access Not used by the LCD in serial access Not used by the LCD in serial access Not used by the LCD in serial access Not used by the LCD in serial access Data selection for LCD LCD reset Chip-select LCD +3.3V power supply Ground

Description and operation

Pin 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

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2.1.2 The CPU board The CPU board is made up of a main micro-controller (AT91M55800A), FLASH and RAM 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.

J3 J7

J9 on internal side

CPU board J2 to syringe holder connector Pin 1 2 3 4 5 6

GND /SW_AILET /CD_SW_AILET +3V3 ANA_DIAM_DIR GND

Description Ground Flange switch state Flange switch power supply +3.3V power supply Syringe holder potentiometer state Ground

Description and operation

J3 to JTAG (Micro programming) connector Pin 1 2 3 4 5 6 7 14

+3V3 +3V3 TCK TDO TRQT/ TDI MR/

Description +3.3 V power supply +3.3 V power supply ATM91M55800A JTAG port signal ATM91M55800A JTAG port signal ATM91M55800A JTAG port signal ATM91M55800A JTAG port signal ATM91M55800A JTAG port signal ag02_003d_en.fm

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

GND TMS GND

Description Ground ATM91M55800A JTAG port signal Ground

J4 to power supply board connector Pin 1 2 3

GND TON/OFF +3V3-26 PROT

SCL_ALIM

5 6

VBAT SDA_ALIM

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

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

Description Ground Keyboard ON/OFF key +3.3V power supply safeguarded for the timestamper I2C bus clock signal between main (CPU) and secondary (power supply) microcontroller Battery or +9V mains power supply I2C bus data signal between main (CPU) and secondary (power supply) microcontroller Ground IrDA cell reception signal +3.3V power supply IrDA cell emission signal Ground Serial bus clock signal +3.3V power supply External plug data reception signal Ground External plug data emission signal Diagnostic signal (board connection confirmed) Battery or +9V mains power supply Main microcontroller buzzer control Ground

J5 to display board connector

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GND +3V3-26_PROT TON/OFF VBAT MISO GND MOSI +3V3 CLK GND CSLCD/ GND CSLDCL/ +3V3

Description Ground Diagnostic signal (board connection confirmed) Keyboard ON/OFF key Battery or +9V mains power supply SPI bus MOSI signal Ground SPI bus MOSI signal +3.3V power supply SPI bus clock signal Ground Check signal Ground Check signal +3.3V power supply

Description and operation

Pin 1 2 3 4 5 6 7 8 9 10 11 12 13 14

J5 to display board connector Pin 15 16 17 18 19 20

RSLCD GND RESET/ VBAT PRES_CARTES GND

Description Check signal (for LCD display) Ground Check signal Battery or +9V mains power supply Diagnostic signal (board connection confirmed) Ground

J6 to motor connector Pin 1 2 3 4 5 6

PHASE_A COM1 PHASE_B PHASE_C COM2 PHASE_D

Description Motor coil 1 phase A Common motor coil 1 Motor coil 1 phase B Motor coil 2 phase C Common motor coil 2 Motor coil 2 Phase D

J7 to potentiometer connector Pin 1 2 3

GND ANA_DEPLAC +3V3

Description Ground Potentiometer displacement status +3.3V power supply

J8 to opto-motor Pin 1 2 3 4 5 6

GND /OP_ROT GND GND /CD_OP_ROT GND

Description Ground Motor opto rotation status Ground, opto signal reference status Opto power supply return Opto power supply Ground

J9 to plunger connector

Description and operation

Pin 1 2 3 4 5 6 7 8 9 10

GND /OP_PISTON ANA_FORCE GND /CD_OP OP_BRAS GND /SW_DEB__ON /SW_DEB__OFF GND

Description Ground Opto piston status Force sensor status Ground Opto power supply Opto arm status Ground Disengagement switch status Disengagement switch status 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 100V - 240V AC network or the external 9V DC. It also supplies a battery charge of 1.8Ah. J3

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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Signal SCK TXD RXD VBAT GND RELAIS GND +9V0 GND GND

Description Serial link clock Serial link data emission Serial link data reception Accessory power supply (provided by the board) Ground Relay control (open collector) Ground External power supply (provided by the board) Ground Ground

Description and operation

Pin 1 2 3 4 5 6 7 8 9 10

J2 connector to the ATtiny 26 secondary microcontroller Pin 1 2 3 4 5 6 7

Signal MISO VTG SCK MOSI /RST GND CD_ON

Description ATtiny26 SPI programming signal +3.3V power supply ATtiny26 SPI programming signal ATtiny26 SPI programming signal ATtiny26 SPI programming signal Ground +3.3V power supply control signal

J6 to the CPU board connector Pin 1 2 3 4

GND TON/OFF +3V3-26 PROT SCL_ALIM

5 6

VBAT SDA_ALIM

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

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

J4 to powerplug connector

Description and operation

Pin 1 2 3

Signal NEUTRAL PHASE EARTH

Description Mains power supply Mains power supply Earth connection

J5 to internal battery connector Pin 1 2 3 4 18

Signal + BATTERIE GND ANA_CTN GND

Description Battery positive terminal Ground, battery negative terminal CTN positive terminal Ground, CTN ref. ag02_003d_en.fm

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.

Description and operation

The plunger is equipped with a disengagement control enabling it to disassociate from the screw-nut system.

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2.2 Operational description From an operational point of view, Injectomat TIVA 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 (50/60ml, 30/35ml, 20/25ml, 10ml or 5 ml) 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 aluminium 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 TIVA Agilia has 2 plugs situated at the back of the angle bracket:

Description and operation

! a mains supply plug ! an 8 point Binder plug which, together with various specific Fresenius Kabi 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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