Fresenius Injectomat 2000 MC Service Manual

TECHNICAL MANUAL

Injectomat 2000 MC

TABLE OF CHANGES

The information given in this document only concern devices of Injectomat 2000 MC / Pilot Delta

Technical reference N° ...............................................NT 1023

Revision date: ............................................................02/07/02

Applicable from serial N°.............................................18091461

Date Revision no. Pages concerned Changes

01/08/00 A0 all creation

• Reference Injectomat 2000 MC / Pilot

02/07/02 B0 55 & 61

Delta RS232 HE13 power supply board,

• Equivalence table

TABLE OF CONTENT

1 OVERVIEW.......................................................................................... 5

1.1. Block diagram .............................................................................................................. 5

1.2. Precautions before use................................................................................................6

1.3. Overall product specifications...................................................................................... 6

1.3.1. Biological specifications ............................................................................................ 6

1.3.2. Mechanical specifications.......................................................................................... 6

1.3.3. Dimensions................................................................................................................ 6

1.3.4. Electrical specifications.............................................................................................6

1.3.5. Electronic specifications............................................................................................ 6

1.3.6. Injectomat 2000 MC / Pilot Delta Operator's guide................................................... 6

2 ELECTRONIC BOARD........................................................................7

2.1. MOTOR POWER SUPPLY AND CONTROL BOARD................................................. 7

2.1.1. Functional description ............................................................................................... 7

2.1.2. Description of connectors........................................................................................ 14

2.1.3. Electrical layout....................................................................................................... 16

2.1.4. Installation layout..................................................................................................... 16

2.2. CPU BOARD.............................................................................................................. 16

2.2.1. Functional description ............................................................................................. 16

2.2.2. Description of connectors........................................................................................ 19

2.2.3. Electrical layout....................................................................................................... 21

2.2.4. Installation layout..................................................................................................... 21

2.3. DISPLAY BOARD ...................................................................................................... 21

2.3.1. Overview................................................................................................................. 21

2.3.2. Functional description ............................................................................................. 21

2.3.3. Description of connectors........................................................................................ 23

2.3.4. Power consumption................................................................................................. 24

2.3.5. Electrical layout....................................................................................................... 24

2.3.6. Implantation layout..................................................................................................24

3 Configurations..................................................................................24

3.1. Configuration of the pressure functionalities.............................................................. 24

3.2. Configurations of the various parameters.................................................................. 24

3.3. CHECKING THE PILOT............................................................................................. 29

3.3.1. The After Sale Service test ..................................................................................... 29

3.3.2. Running time tESt.1............................................................................................ 30

3.3.3. Lights test tESt.2................................................................................................30

3.3.4. Key board test tESt.3 .......................................................................................... 30

3.3.5. Battery voltage display tESt.4 ............................................................................. 31

3.3.6. Last 10 alarms codes tESt.5 .............................................................................. 31

3.3.7. Total running time tESt.6.................................................................................... 32

3.3.8. TTL Serial link test: tESt.7................................................................................... 32

3.3.9. Serial link test: tESt.8.......................................................................................... 32

3.3.10. Strength on the plunger display: tESt.9............................................................ 33

3.3.11. Software version tESt.A.....................................................................................33

3.3.12. Analog input display tESt.B ............................................................................... 33

3.3.13. Driving block position display tESt.C ................................................................. 34

3.3.14. Calibration values display tESt.E.......................................................................34

3.3.15. Syringe type display tESt.F ............................................................................... 34

3.3.16. Displays of the last 10 events before the last blocking error tESt.J.................. 34

3.3.17. Drug library tESt.L............................................................................................. 34

4 REPLACING SUB-ASSEMBLIES.....................................................34

NT 1023 Rev.B0 page : 1

4.1. Mounting the flexible circuit........................................................................................ 35

4.2. Wiring the components on the flexible circuit............................................................. 35

4.2.1. Mounting the potentiometer.....................................................................................36

4.2.2. Wiring the potentiometer.........................................................................................37

4.2.3. Plug holder connector ............................................................................................. 37

4.2.4. Lubricating the mechanical parts............................................................................. 37

5 MAINTENANCE.................................................................................39

5.1. Recommendations .....................................................................................................39

5.2. Cleaning and disinfection...........................................................................................39

5.3. Storage.......................................................................................................................39

5.4. Routine inspections.................................................................................................... 39

5.4.1. Checking before use ...............................................................................................40

5.4.2. Checking protocol (Technical manual).................................................................... 40

5.5. Technical check procedure PILOT anaesthesia 2 .....................................................42

5.6. Checking disengagement system ..............................................................................43

5.7. Checking force sensor ............................................................................................... 44

5.8. Checking back-pressure ............................................................................................44

5.9. Checking registered syringe list /syringe list label...................................................... 45

5.10. Checking Mains/Battery operation ........................................................................... 45

5.11. Checking linearity..................................................................................................... 45

5.11.1. Equipment used .................................................................................................... 45

5.11.2. Operating mode..................................................................................................... 45

5.12. Checking end of infusion..........................................................................................46

5.12.1. End of infusion pre-alarm......................................................................................46

5.12.2. End of infusion alarm............................................................................................. 46

5.13. Checking the Led's and keyboard............................................................................ 47

5.14. Battery autonomy test...............................................................................................47

5.15. Continuity test........................................................................................................... 47

5.16. Trouble Shooting...................................................................................................... 48

5.17. Error message Er(-)0, Er01, Er(-)2, Er03, CFPc...................................................... 49

5.18. Flow rate control protocol: flow rate measurement with computer...........................49

5.18.1. Equipment used: ................................................................................................... 50

5.18.2. installation..............................................................................................................50

5.18.3. Operating mode..................................................................................................... 51

5.18.4. Installation drawing................................................................................................ 51

5.19. Flow rate control: flow rate control measurement with scales.................................. 51

5.19.1. Equipment used: ................................................................................................... 51

5.19.2. Installation .............................................................................................................52

5.19.3. Operating mode..................................................................................................... 52

5.20. Flow rate control: flow rate measurement using a test tube..................................... 53

5.20.1. Equipment used .................................................................................................... 53

5.20.2. Installation .............................................................................................................53

5.20.3. Operating mode..................................................................................................... 53

6 ANNEX 1: ILLUSTRATED PARTS LIST........................................... 54

6.1. Subassembly traceability table................................................................................... 54

6.1.1. Introduction.............................................................................................................. 54

6.1.2. Replacement parts table ......................................................................................... 54

6.2. Exploded views and related parts lists .......................................................................55

6.2.1. Mechanical part list.................................................................................................. 55

6.2.2. Electronical parts list ............................................................................................... 60

6.2.3. Operator’s guide of Injectomat 2000 MC / Pilot Delta(NU)...................................... 61

Page : 2 NT 1023 Rev.B0

6.2.4. Labels......................................................................................................................61

7 ANNEX 2: ELECTRONIC LAYOUT................................................... 62

7.1. Rear door wiring.................................................... Fehler! Textmarke nicht definiert.

7.2. Power supply and control board.................................................................................62

7.2.1. Electronic layout...................................................................................................... 62

7.2.2. Installation layout..................................................................................................... 62

7.3. CPU board.................................................................................................................. 62

7.3.1. Electronic layout...................................................................................................... 62

7.3.2. Installation layout..................................................................................................... 62

7.4. Display board ............................................................................................................. 62

7.4.1. Electronic layout...................................................................................................... 62

7.4.2. Installation layout..................................................................................................... 62

8 ADDENDA AND INFORMATION BULLETINS.................................... 1

9 USEFUL ADDRESSES........................................................................4

NT 1023 Rev.B0 page : 3

Page : 4 NT 1023 Rev.B0

1 OVERVIEW

keeper

1.1. Block diagram

Ext

12/15V

15W

230V

EPROM

512K x 8

UART

RAM

8K x 8

interface

Power supply

Battery

EEPROM

16K

Bus

BUS

SPI

ON / OFF

CPU

Time

DC-DC

Converter

Watch

dog

opto

Interface

ADC

Motor
driver

Step

by step

motor

Motor
rotation
sensor

Syringe
barrel
sensor

Antisiphon
sensor

Occlusion
strength
sensor

Displacement
sensor

Nurse
call
(option)

RS232

Keyboard

Master

Buzzer

LCD
driver

LED
driver

LCD

Display

LED

Display

Disengagement
Switch

Flange
Switch

NT 1023 Rev.B0 page : 5

1.2. Precautions before use

Please consult the user guide

1.3. Overall product specifications

1.3.1. Biological specifications

Infusion liquid only comes into contact with the syringe and associated disposable.

1.3.2. Mechanical specifications

Device operation is based on a "lead screew/nut" principle. The mechanism pushes the piston of a sy­ringe, of a given diameter, in a linear manner.

1.3.3. Dimensions

q H x L x D 120 x 330 x 155 mm.
q CarrWeight 2.2 kg approximately.

1.3.4. Electrical specifications

q Power supply 230V - 50-60 Hz.(Check on the pump the identification label).
q Maximum consumption 23 VA.
q Fuse F2 100 mAT 250V IEC 127
q Battery 6V - 1.2Ah./1.3 Ah
q External power supply 12 - 15 DC - 15W

1.3.5. Electronic specifications

The Injectomat 2000 MC / Pilot Delta syringe pump is fitted with 3 circuit boards whose features vary in
line with product specifications and options.

q Motor power supply and control board.
q CPU board.
q Keyboard display board.

1.3.6. Injectomat 2000 MC / Pilot Delta Operator's guide

Operator's Guide can be obtained from our After Sales Service (see chapter 10.Useful addresses).

Page : 6 NT 1023 Rev.B0

2 ELECTRONIC BOARD

2.1. MOTOR POWER SUPPLY AND CONTROL BOARD

2.1.1. Functional description

In order to simplify wiring the motor power supply control board concentrates 6 functional modules, which
may be described separately:

q power supply module,
q motor control module,
q analog output module,
q disengage and anti-siphon opto switch module,
q microswitch input module,
q optional nurse call and RS232 interface module.

2.1.1.1. Power supply module
The power supply module consists of a cut-out power unit. It supplies all electronic components and

charges a 1,1 -1,2 or 1,3 Ah backup battery from a mains voltage input or a 12/15 volt DC power source. It
generates the + 5V and Vbat voltage required by the electronic components. Finally it comprises an
ON/OFF switch controlling the various power supplies.

2.1.1.1.1. Mains power supply

The mains power supply generates a DC voltage ranging from 10 and 16 volts for a maximum current of
1,2 A.

J1 mains input connector: 1 phase

2 neutral
Transformer: TR1(see Electrical chart), 15VA output voltage: 9 Vac
Fuse protection: F2 Principal characteristics chap1.1
Primary filtering 4.7 nf 4000 V HR capacitor, type DS1510 VDE
Secondary filtering C10 Chemical Capacitor

Output voltage measured on TP3 for mains voltage: 230V measured (±± 10%)

Min Max Unit
power off: 14 16 V dc
7 ohm charged on J4: 10 16 V dc
primary current charged: 80 mA ac
Maximum voltage 16 volts limited by the diode D 41
Minimum voltage 10 volts limited by the mains voltage - 10% and U1(MAX 652)

voltage higher than 10 volts.

NT 1023 Rev.B0 page : 7

2.1.1.1.2. External 12-15V AC/DC power supply

The DC power supply input is designed to provide the syringe pump with a constant, external power
source, such as a 12V battery.

Maximum input voltage ± 15 volts protection against polarity inversion by the PR2 WO4 diode bridge.
Minimum input voltage ± 11 volts 1.2 A limited by input voltage MAX 625 and loss, diode bridge on the PR2.
Limitation ± 16 volts maximum for through D 41.

2.1.1.1.3. Cut-out charger/controller

The controller is powered either from the mains or from an external DC power source. It generates a
maximum voltage of 6.9V VBC, as required to charge the 1.1/1.2 Ah gelified lead battery, connected to
J4, and power the electronic components.

J4 Connector: 1 battery +

2 battery -

VBC power comes directly from the battery if neither the mains nor the external power source are con­nected. Otherwise power, from an external source, supplies the electronic components and charges the
battery via diode D8 and the delayed protection fuse, F1, 1.6A.

Maximum fuse resistance 0.5 Ohms
Controller operation is indicated by two signals responsible for reporting operation using an external

power source either mains power or the external DC power unit.
LDSECT 10 mA drives a diode which checks that the SECT diode is on, using a TTL signal, with + 5V

pull up collector open, mains presence active at 0.
Cut-out controller: U1(MAX625) output voltage 7.05V 1.3 A min
Output voltage measured on J4.1
for 230 V mains:

Min. Max. Unit
Power OFF 3 mA charge on J4. : 6.7V 7V V DC
8 ohm charge on J4: 6.5V 7V V DC

On J4 the voltage must never exceed 7V, the maximum voltage of the charged battery.
The 6.5 minimum voltage is higher than the battery pre-alarm threshold.

2.1.1.1.4. ON/OFF control

The VBAT and + 5V control system is implemented using the following circuits: U2 4011, U4 4528 and an
G6AK 234P flip-flop relay.
This system is powered, at all times, by the VBC voltage.

2.1.1.1.4.1 System:

3 inputs:
TON ON key dry contact/GND
TOFF OFF key dry contact/GND
CDALIM active TTL signal with voltage cut-out

2 ouputs:
VBAT Battery power/mains power.
OFF TTL signal collector, + 5V PULL-UP open, OFF key pressed down, active at 0

Page : 8 NT 1023 Rev.B0

2.1.1.1.4.2 Operation:

Press TON briefly to turn power on.
Press TOFF continuously (5s<t<7s) to turn power off during a technical Failure.
Press OFF 3 seconds to power OFF via CDALIM micro signal.
The device can set ON or OFF via an external. Master module using the CD ON or CD OFF signal.

2.1.1.1.5. VBAT and + 5V power supply

VBAT voltage corresponds to mains voltage taken directly from the power unit/charger. Voltage is not
controlled. It powers the display system and the motor, both of which are heavy duty energy consumers.

This voltage is available on TP1 and J2

Min Max

VBAT 6,5V 7V

The + 5V ± 5% is generated, using VBAT voltage, by the NS 2931 V3 controller low drop-out 0.6V for a
100 mA output current.

It is thus possible to make the best possible use of the battery. This voltage is available on TP2.
The 5V rise time must be greater than 100 ms to allow for the RESET function on the CPU board.

2.1.1.2. Motor control module
The control module of step by step motor is equipped with a gear reduction of 89.286. which makes the

double threaded screw 2 mm turn.

- One motor step is equivalent to 0.8233 µm of linear displacement of the driving bloc.

- One motor turn is equivalent to 22.4 µm of linear displacement of the driving bloc.

2.1.1.2.1. Motor control

Injectomat 2000 MC / Pilot Delta motor control is implemented by a stepper motor driver, dual pole con­trol module for a motor - UBB 5N model - (11.5 Ohm coil) built using an ST L293E IC7 motor control cir­cuit.

It features two functional modules:
The motor control electronic parts, built around the L293E U13 circuit, optimises consumption and opti-

mal motor torque according to the pump flow rate.

2.1.1.2.1.1 Input signals

These signals are generated by the CPU board microprocessor and available on J02.
They drive the U15 ULN2803 circuit.

2.1.1.2.1.2 Output signals

These signals are connected to the motor coils via J5 connector.

Phase A A Motor phase control J2.5
Phase B B Motor phase control J2.6
Phase C C Motor phase control J2.7
Phase D D Motor phase control J2.8
I Motor current reduction control J2.9
B00ST Booster activation and regulation current J2.10

NT 1023 Rev.B0 page : 9

2.1.1.2.1.3 Booster module

BOOST = 0 The motor is powered via VBAT voltage.
BOOST = 1 Booster function activated, the motor is powered at 12 Volts.
L2 reactor, D18 diode, C15 capacitor and T8 transistor assembly allows a voltage of 12 V +/- 2 volts to

be obtained from VBAT.
This voltage is available on TP5.
The uncoupling frequency, 100 kHz, is generated by U9 oscillator, the booster is activated when the

boost line is at 1.

2.1.1.2.1.4 Soft-start module

The soft-start module, which is designed around the T9 transistor and C21 capacitor allows the pick up
current of the uncoupling elevator to be limited when BOOST goes to 1.

2.1.1.2.1.5 Current regulation module

BOOST = 1 and I = 1 regulation motor current module is activated.
The regulated current in the motor is 240 mA +/- 10% per motor phase.
The signals amplitude and current image are available in TP6 and TP7.
The current image of each coil is compared to a fixed level, which is implemented from the Divider bridge

using R31, R41/R37 and R42.
The control is achieved through the U11 toggle, via a divider bridge by inhibition or confirmation of the

L293E control H bridge driving the CE1 and CE2 inputs.
The calibrating frequency of 25 kHz is supplied by the U10 toggle.

2.1.1.2.1.6 Reduction current module

When the Boost signal sets at 0, the I line is used as current reducer.

I = 1 The H divider bridge is controlled by the A, B,C and D lines.
I = 0 The H divider bridge is inhibited, the coils are not forwarded.

According to its rotation frequency (step/second), the motor is driven in one of the 3 control modes.

Mode Frequency motor (step/second) Control description
Phase 1 from 0 to 32.3 Current reduction one ON supply
Phase 2 from 32.3 to 90 No current reduction and regulation, one ON supply
Phase 3 from 90 to 850 Current reduction, booster ON two supply

Page : 10 NT 1023 Rev.B0

2.1.1.3. Analog output module
The analog output module is built around a 10 bit, 5 channel analog/digital converter (MC 145053 U17)

with an SPI bus.
The following SPI CLK, SI, SO, CSADC bus signals are available on connector J2:
In addition the component generates an end of conversion signal (EOC).
The CDANA signal, which is active when set to 1, controls the transistor T14 IRFD 9120 which digitally
drives VREF. This voltage supplies the sensors and serves as a reference value for the ADC convertor.
All the test points are concentrated on connector J9.
Measurement of VREF on J9.7
VREF Pulsated signal of 5Volt ± 0.25V.

 Convertor input:

ANO VBAT battery voltage measurement.
AN1 not in use
AN2 internal occlusion gauge bridge
AN3 NU
AN4 Absolute potentiometric position sensor

2.1.1.3.1. Battery voltage measurement

VBAT voltage is measured using a peak detection circuit comprising D19, R59, R60 and C23 in order to
overcome the lower voltage created by the motor's pulsing demand for current.
The voltage is available on J9.3.

For VBAT = 6.5V, V(J9.3)= 4V ± 10% motor running at 150 ml/h

2.1.1.3.2. Gauge bridge interfaces

The only Injectomat 2000 MC / Pilot Delta includes a force sensor fixed on the pusher.

2.1.1.3.2.1 Force sensor characteristics

Sensor technical Complete bridge with 4 gauges
Impedance 350 Ohms ± 15% or 1 KOhms ± 15%
Measurement range 0 to 150 N
Surcharge 250 N
Zero

< ± 10mV
Sensibility 8.5 to 12 mV at 150 N
zero derivation

2.1.1.3.2.2 Operation

85 µV /year

The force sensor generates a differential voltage proportional to the force sensor applied on the driving
bloc. This force is amplified by a gain of 200 +/- 20% via an amplifier built around U18 TLC 251. The po­tentiometer P1 allows the offset to be compensated and for any other offset to be reset from the begin­ning. The sensor measurement chain transfer function can be defined by calibrating the sensor with two
known forces.

AN3 J9.4 Pulsated amplitude signal sets at 0.6 V +/- 0.05 V for no force applied on the driving bloc

2.1.1.3.2.3 Force sensor connector

J8.1 VREF Gauge bridge power supply (+)
J8.2 S(-) Out put Gauge bridge (-)
J8.3 S(+) Out put Gauge bridge (+)
J8.4 GND Gauge bridge power supply (-)

NT 1023 Rev.B0 page : 11

2.1.1.3.3. Driving bloc position sensor

The absolute position of the driving bloc is obtained by a potentiometric sensor driven by a movement of
the driving bloc.

The transfer function of the sensor can be characterised by calibration in two known positions.
The sensor is powered by a pulsated voltage. The output is filtered by R62 and C22 linked directly to the

input AN4 (J2)
Potentiometer connector:

J3.1 VREF
J3.2 Center point J9.2
J3.3 GND

2.1.1.4. Opto switch module
The opto switch module comprise 2 optical switches:

q A motor rotation detection switch
q A syringe position head detector switch

2.1.1.4.1. Motor rotation opto

The opto switch is mounted on a disk which is pierced with a hole and assembled on the motor.
It is used to check motor rotation, the opto diode is controlled in pulse mode to save energy.
The optical switch is connected on J5.

Control T11 transistor Current limitation (R51) at 8mA
Output T10 transistor TTL level
J2.14 Control signal CDOPT1 activate at 1
J2.11 Output signal SOPT1 activate at 1
J5.7 Diode anode
J5.8 Diode cathode
J5.10 Transistor transmitter
J5.9 Transistor collector
TdON max 100 µsec
TdOFF max 200 µsec

An anti-rebound device made of U20 flip-flop, reshapes the SOPT1 signal.
The CDOPT1 and SOPT1 are emitted by the CPU board, and available on J2 connector

2.1.1.4.2. Anti-siphon opto switch

The opto switch is mounted on the plunger holder, it is used to check the presence or not of the syringe
head.

 It is connected on J8 connector.

Control T12 Transistor Current limitation (R52) 8mA
Output T13 Transistor TTL level
Control signal CDOPT2 activate at 1 J2.15
Output signal SOPT2 activate at 1 J2.12
Anode diode J8.6
Cathode diode J8.5
Transistor transmitter common ground J8.10
Transistor collector J8.7
SOPT2 0V Anti - siphon present
SOPT2 5V Anti - siphon missing

Page : 12 NT 1023 Rev.B0

J8 is the ribbon cable linking the occlusion, disengagement and position sensors located on the syringe
pump driver.
The CDOPT2 and SOPT2 signals are emitted by the CPU board and available on J2 connector.
The opto diode is powered by pulsated voltage in order to save energy.

2.1.1.5. Micro switch module

2.1.1.5.1. Disengagement micro - switch

The microswitch is mounted on the driving bloc ribbon cable. The centre point of the microswitch is con­nected to the ground.

The signals are available on J2 connector.

J8.8 DEB/ON NU
J8.9 DEB/OFF OV engaged / 5V disengaged
J8.10 GRD

2.1.1.5.2. Nurse call option

This is implemented by a monostable inverter relay RL2, whose two contacts and common point are
available on J6 connector, the relay is driven by the BUZ signal which also drives the buzzer on the dis­play board.

J6.6 common point
J6.7 contact normally open cut out power 24V/ 1A
J6.8 contact normally shut

2.1.1.5.3. RS 232 option

The RS232 option interface RXD1 and TXD1 signals, in compliance with the V24 standard, signals come
from the UART 2691 serial link external controller on the CPU board. It is implemented using a U19 LT
1180 CS circuit, associated with +/- 12V voltage generator, C31, C32, C33, C34 capacitors. This circuit
is operational only if the pins 2 and 5 of J6 are short-circuited.

J6.1 output transmits data TX1
J6.2 +5V (DSR)
J6.3 input receives data RX1
J6.4 GND
J6.5 confirmation (DTR)
J6.17 CTS
J6.18 RTS

2.1.1.5.4. Configuration link and Master plug

The syringe pump Injectomat 2000 MC / Pilot Delta may be fitted to master module connected to the SUB
15 points plug located on the pump rear panel.

The module master communication link is done by the RX2 and TX2 signals.

J6.13 +VBAT Master power
J6.14 RX2 Receive data
J6.15 TX2 Transmit data
J6.16 GND Master ground
J6.9 CD-ON Syringe pump ON via master
J6.10 CD-OFF Syringe pump OFF via master
J6.12 I-SECT Master led main signal
J6.11 I-OPTOM Motor rotation opto master control signal
J6.19 BUZ Pilot buzzer command signal

NT 1023 Rev.B0 page : 13

2.1.2. Description of connectors

2.1.2.1. J1 mains connector

Pin description

1 Neutral
2 Phase

2.1.2.2. J2 board / CPU connection

Pin Description

1 + 5V controlled power supply
2 GND power supply
3 + VBAT power supply
4 GND power supply
5 phase A motor control
6 phase B motor control
7 phase C motor control
8 phase D motor control
9 I signal motor control
10 BOOST signal booster command
11 sopt1 opto rotation module out put
12 sopt2 opto anti-siphon module out put
13 not in use
14 cdopt1 opto rotation control module
15 cdopt2 opto anti-siphon module control
16 OFF signal off key pressed ON/OFF
17 SECT mains power on signal power supply
18 CDALIM power cut signal
19 LDSECT mains LED control
20 CTS clear to send
21 DEB/OFF disengage signal active, set to 0
22 RTS request to send
23 OCC/OFF occlusion signal active, set to 0
24 BUZ nurse call relay control
25 EOC end of conversion ADC
26 CSADC selection bus SPI ADC
27 CLK clock bus SPI ADC
28 SI data IN bus SPI ADC
29 SO data out bus SPI ADC
30 CDANA analog sensor power control
31 RX2 receive data TTL line 2
32 TX2 transmit data TTL line 2
33 TXD1 transmit data TTL line 1
34 RXD1 receive data TTL line 1
35 TOFF OFF key
36 TON ON key
37 + VBAT power supply
38 GND power supply
39 + 5V power supply
40 GND power supply

Page : 14 NT 1023 Rev.B0

2.1.2.3. J3 potentiometric sensor connector

Pin Description

1 VREF
2 centre point
3 GND

2.1.2.4. J4 internal battery connector

Pin Description

1
2

2.1.2.5. J5 motor connector

Pin Description

1 + VBAT
2 + VBAT
3 PHASE D
4 PHASE C
5 PHASE B
6 PHASE A
7 opto rotation anode diode/ + 5V
8 opto rotation cathode diode
9 opto rotation collector transistor
10 opto rotation transmitter transistor / GND

battery +
battery -

2.1.2.6. J6 rear panel connector
The connector on the rear panel concentrates signals from the external gauge bridge, the optional RS232

series link, the nurse call relay output and the configuration series link.

Pin Description

1 TX1 transmit data line 1
2 + 5V power supply
3 RX1 receive data line 1
4 GND power supply
5 DTR interface confirm
6 APP-INF COM nurse call relay common point
7 APP-INF NO nurse call relay normally open
8 APP-INF NF nurse call relay normally closed
9 CD ON external ON
10 CD OFF external OFF
11 I-OPTON motor control out put
12 I-SECT main led
13 + V BAT external power plug
14 RX 2 receive data line 2
15 T X 2 receive data line 2
16 GND power supply
17 CTS clear to send
18 RTS Request to send
19 BUZ buzzer external control

2.1.2.7. J7 external DC power supply connector

Pin Description

1 External power +/­2 External power -/ +

2.1.2.8. J8 pump ribbon cable connector
The pump ribbon cable connector concentrates all the signals from the sensors located in the plunger:

disengage microswitch, gauge bridge and anti-siphon opto switch.

NT 1023 Rev.B0 page : 15

Pin Description

1 + VREF + internal gauge bridge
2 E1 internal gauge bridge/occlusion input on
3 E2 internal gauge bridge/occlusion input off
4 GND internal gauge bridge
5 C DOPT2 anti-siphon cathode diode
6 + 5V opto anti-siphon anode diode / + 5V
7 S OPT 2 opto anti-siphon collector transistor
8 DEB / ON disengage microswitch on
9 DEB / OFF disengage microswitch off
10 GND

♦ Important: Disassemble the ribbon cable holder on the supply board before extracting the me-

chanical assembly from the lower housing.

2.1.2.9. J9 Test Points

Pin Description

1 GND
2 out put position sensor
3 out put low battery control
4 out put force sensor amplifier
5 N.U.
6 out put optical switch motor control
7 force and position sensor voltage Ref.
8 out put optical switch syringe led detection

2.1.3. Electrical layout

(Refer to Annex 2)

2.1.4. Installation layout

(Refer to Annex 2)

2.2. CPU BOARD

Overview

 The CPU board is fitted to Injectomat 2000 MC / Pilot Delta version, around a 80C32 microproces-

sor used in open mode. It concentrates all the peripheral devices directly connected to the 80C32
bus. It is connected to the power supply board by a 40 contacts ribbon cable and to the display
board by fixed connectors. It forms a single unit, with the display board, which is fixed to the front
panel.

 The CPU board uses CMOS technology in order to minimise power consumption.
 Current used: 5 Volts 80 mA maximum.

2.2.1. Functional description

The CPU board comprises six functional units:

q Ram rom decoding processor
q Reset WATCH DOG
q Parallel port extensions

display/keyboard interface,
motor interface,
sensor interface.

Page : 16 NT 1023 Rev.B0

q SPI BUS
q Asynchronous serial link
q Optical sensor

2.2.1.1. RAM ROM decoding processor
Decoding is carried out by an IC3 80C32 circuit, running at 12 MHz, clocked by Q1. It is used in open

mode, with the EA*/VP line connected to GND.
Address/data de-multiplexing is carried out by a 74HC573 U3.
On this BUS are implemented:

32 Ko static RAM U6
27C040 512 Ko U4

2.2.1.2. Reset watch-dog
The RESET WATCH-DOG module comprises two TL7705 U10 and U11 circuits.
Operation: the U10 circuit generates RESET signals, active at 1, for the processor and the UART; RST*

active at 0 generates RESET signals for the other peripheral devices.
The signals are activate in two cases:

q when the system is powered up,
q as soon as the WATCH-DOG circuit is triggered. It remains active until the power is turned off.

2.2.1.2.1. Reset at power-up

The TL 7705 circuit guarantees the minimum duration of the reset lines, in the active state, once the + 5V
voltage has exceeded the circuit operating threshold (4.75V). It returns to the active state, if the + 5V volt­age drops below the threshold or if the RESTIN* (U11.2) is at 0. The line is driven by the WATCH-DOG
module.

The duration of the reset, in the active state, at power-up is set by the C10 capacitor 220nF 100 ms.

2.2.1.2.2. Watch-dog

The WATCHDOG circuit comprises the following elements: U10, U11, C12, D2, D1, R4, C11.
When powered up the capacitor C12 is charged by the U10 circuit, via diode D1.

The charge is maintained at a threshold of over 1.5 V during operation.
The software writes, every 1 ms. This writing generates a 5V/1µs impulse on the U7.10 output, which re-

charges the capacitor C12 via a high pass peak detector circuit made up C8, D3, D2. The C12 capacitor
discharges in resistor R4.

When the software stops, the capacitor C12 completely discharges. The U11 RESTIN* line falls to 0 and
the RESET signals are activated, stopping all syringe-pump control operations in the inactive state. Fault
signals, the blinking FAIL diode and the continuous BUZZER are stuck in an active state.

WATCH-DOG trigger time is less than 400 ms.

2.2.1.3. Keyboard/display interfacing

2.2.1.3.1. Display registers

The display system is made of LED’s and of a 2 lines of 20 characters LCD graphic screen. The U7 cir­cuit allows to address the matrix of the LED’s, the U8 circuit allows the writing and reading in the display
controller.

The LED’s matrix are DIG0 to DIG7 and SEG0 to SEG7.
The FAIL LED shows the device is failed, the command is inverted to be active by default at RESET. It is

active at 1 on the display board. The FAIL diode is out of the matrix to be able to light on when the micro­possor does not work.

NT 1023 Rev.B0 page : 17

2.2.1.3.2. Buzzer

The BUZZER command is inverted and controls the transistor, T3, which is mounted as a common trans­mitter. Working in parallel, the transistor collector drives the BUZZER on the display board and the nurse
call relay on the motor control power supply board. After starting the pump, the BUZZER is activated for
added safety.

BUZZ signal: J5 pin 6 and J3 pin 24 50 mA 6.75 Volts maximum.

2.2.1.3.3. Keyboard register

The keyboard is based on a 6 x 3 matrix, with 2 separate keys - TON and TOFF - with 1 common point
(GND). They turn power ON and OFF respectively and are connected to the display board. TON and
TOFF signals only transits via the CPU board.

The columns of the keyboard are driven by the same signals as the columns in the display matrix, thus
facilitating simultaneous keyboard and display monitoring. Register U15 reads the status of the three key­board lines, LIG1, LIG2 and LIG3 in order to check whether a key has been activated.

2.2.1.3.4. Motor control register

The U12 motor control register generates 4 motor phase signals, A,B,C and D, the I current control sig­nal, the motor rotation opto control CDOPT1 signal and the BOOST BOOSTER control signal.

2.2.1.3.5. Sensor status register

The U16 sensor status register reads the microswitch digital sensors and the syringe pump opto switch.

2.2.1.4. SPI bus EEPROM
The SPI bus is synchronous series communication bus using various peripheral circuits. The SPI bus is

driven by the 80C32 ports.
The Injectomat 2000 MC / Pilot Delta syringe pump has 2 peripheral devices on the SPI bus:

q The EEPROM 16 Ko 24C128 U12 located on the CPU board.
q The MC 145053 analog/digital converter located on the motor board.

This bus has 2 communication lines: 80C32 (see electrical diagrams)

Micoprocessor Ports

CLK clock generated by the microprocessor P 1.1
SI peripheral to processor data (input) P 1.2

2.2.1.5. Asynchronous serial links
The Injectomat 2000 MC / Pilot Delta syringe pump is fitted with two asynchronous serial links.

RS232 option line 1
TTL configuration serial link line 2

2.2.1.5.1. RS232 serial link

The RS232 serial link is implemented using the U8 SCC2691 circuit, which controls asynchronous com­munication, and RS232 interface circuit which is located on the motor power supply board.

The circuit is clocked by quartz Q2 at 3.6864 MHz. It includes a programmable baud rate generator. It
generates interrupts on the ITRS232 line connected to the processor at INTO.

The SCC2691 is on the microprocessor bus. It drives the RXD1 receive data signals on J3 (pin 34) and
TXD1 transmit data signals on J3 (pin 35).

The RS232 option is reserved for dialogue with the host computer responsible for monitoring or control­ling the system.

Page : 18 NT 1023 Rev.B0

2.2.1.5.2. TTL serial link

The TTL serial link is driven by the serial link controller inside the microprocessor. It uses one of the in­ternal timers to generate its baud rate, from the basis of the processor 12 MHz clock. The serial link
drives the TXD2 transmit data and RXD2 receive data lines. The input and output lines are buffered by
the U9 74HC14 buffer trigger inverter circuit.

The lines are available on J3.

TX2 J3 pin 33
RX2 J3 pin 34

This serial communication line is reserved for Injectomat 2000 MC / Pilot Delta software configuration
and, when appropriate, for connecting an external MASTER module.

2.2.1.6. Opto switch sensors
Injectomat 2000 MC / Pilot Delta syringe pump opto switch sensors are for piston pressure and syringe

body presence and motor rotation.
The syringe body opto switch interface is located on the CPU board. It is implemented using transistors

T1, T2 and T3. Resistor R9 limits current in the diode to 8 mA.

2.2.1.6.1. Opto switch body syringe measurement.

q Note: The CI opto and the obturator are specific to the Injectomat 2000 MC / Pilot Delta equipped

with "flange detector" and are not compatible with previous versions.

q 2 opto devices allow to detect 2 syringe sizes: 60 cc and 20 cc.

J2.1 opto diode +5V anode
J2.2 opto cathode common point and transistor transmitter
J2.3 opto 1 transistor collector
J2.4 opto 2 transistor collector

Control signal: CODPT3 activate at 1 driven by microprocessor line T0.
Output signal: SOPT4 activate at 1 register U16 D1 address $ C000
Output signal: SOPT3 activate at 1 register U16 D0 address $ C000

.

SOPT3 SOPT4
Syringe clamp detection alarm, high position 1 0
60 cc detection 1 1
20 cc detection 0 1
Syringe clamp detection alarm, low position 0 0

The motor rotation and piston presence opto switch interfaces are located on the POWER SUPPLY
BOARD.

2.2.1.6.2. Motor rotation opto switch

Control signal: CDOPT1 activate at 1
Output signal: SOPT1 activate at 1

2.2.1.6.3. Piston presence opto switch (anti-siphon)

Control signal: CDOPT2 activate at 1
Output signal: SOPT2 activate at 1

2.2.2. Description of connectors

2.2.2.1. J1 not used
This connector is not used for the moment but it will be used for a future evolution of the software.

NT 1023 Rev.B0 page : 19

2.2.2.2. J2 Opto switch - syringe body connector

Pin Description

1 ground
2 flange switch
3 opto +5 V diode anode
4 cathode diode transmitter transistor opto 1 and opto 2 common points
5 collector transistor opto 1
6 collector transistor opto 2

2.2.2.3. J3 Power supply/CPU ribbon cable
 A 40 channel ribbon cable is soldered directly to J3, linking the power supply and the CPU.

Pin Description

1 + 5V controlled power supply
2 GND "
3 + VBAT "
4 GND "
5 A phase motor control
6 B phase "
7 C phase "
8 D phase "
9 I signal "
10 BOOST signal "
11 SOPT1 opto rotation module output
12 SOPT2 opto anti-siphon module output
13 APINF nurse call independent from buzzer signal
14 CDOPT1 opto rotation module control
15 CDOPT2 opto anti-siphon module control
16 OFF ON/OFF key depressed signal
17 SECT mains power supply on signal
18 CDALIM power cut signal
19 LDSECT mains LED control
20 CTS Clear to send line 2
21 DEB/OFF disengage active at 0 signal
22 RTS Request to send line 2
23 OCC/OFF occlusion active at 0 signal
24 BUZ nurse call relay control
25 EOC end of conversion ADC
26 CSADC selection SPI ADC bus
27 CLK clock SPI ADC bus
28 SI data INSPI ADC bus
29 SO data out SPI ADC bus
30 CDANA analogue sensor power supply control
31 RX2 receive TTL data line 2
32 TX2 transmit TTL data line 2
33 TXD1 transmit TTL data line 1
34 RXD1 receive TTL data line 1
35 TON ON key
36 TOFF OFF key
37 + VBAT power supply
38 GND
39 + 5V
40 GND

2.2.2.4. J4 Display board interconnection

Pin Description

1 SEG1 display matrix line 1
2 SEG2 display matrix line 2
3 SEG3 display matrix line 3
4 SEG4 display matrix line 4

Page : 20 NT 1023 Rev.B0

5 SEG5 display matrix line 5
6 SEG6 display matrix line 6
7 SEG7 display matrix line 7
8 SEG8 display matrix line 8
9 COL1 display matrix column 1
10 COL2 display matrix column 2
11 COL3 display matrix column 3
12 diode FAIL control
13 RDCRT current reduction control
14 LIG1 keyboard interface line 1
15 LIG2 keyboard interface line 2
16 LIG3 keyboard interface line 3
17 LDSECT mains LED lighting control
18 + 5V power supply
19 VBAT power supply
20 GND power supply

2.2.2.5. J5: Display/CPU connection

Pin Description

1 TON ON key
2 TOFF OFF key
3 SI SPI bus
4 CLK SPI bus
5 CSLCD bus
7 VBAT power supply
8 GND power supply

2.2.3. Electrical layout

(Refer to Annex 2)

2.2.4. Installation layout

(Refer to Annex 2)

2.3. DISPLAY BOARD

2.3.1. Overview

The display board is mounted directly beneath the front plate of the syringe pump. It brings together all
the facilities for operator/device dialogue: Keyboard, buzzer and display.

It is connected to the CPU by rigid connectors, forming a sandwich, with the former, held in place by
struts.

The soft keyboard is connected to the display board.

2.3.2. Functional description

The display board comprises four modules:

q The electroluminescent display,
q The keyboard interface,
q The liquid crystal display,
q The buzzer.

2.3.2.1. Electroluminescent display
The electroluminescent display is made of eighteen LED's and five 7 segment display units, with the dec-

imal point, except two of them which are marked (*) in the table below.

NT 1023 Rev.B0 page : 21

The diodes and display units are driven in a multiplexed, 8 segments x 8 digit matrix. The LED's and dis­play units are mounted with a common cathode.

The 8 segments are driven by signals SEG0 to SEG7 and the 8 digit by signals DIG0 to DIG7.
The 2 LED’s, "MAIN PRESENCE" and "FAIL" are controlled independently of the matrix.

2.3.2.1.1. LED’s table

The following table lists the various diodes used in different models.

Ref Name Type Seg Dig

LD1 Mains On yellow * *
LD2 Body Alarm red 1 0
LD3 Piston Alarm red 2 0
LD4 ml green 5 1
LD5 Battery green 7 1
LD6 Fail red * *
LD7 Alarm red 4 to7 0
LD8 Worm screw 3 green 2 1
LD9 Prealarm orange 1 to 4 2
LD10 Occlusion Alarm red 0 0
LD11 Worm screw 2 green 3 1
LD12 Infusion End Alarm orange 0 2
LD13 Worm screw 1 green 4 1
LD14 NU
LD15 Connection to PC green 0 1
LD16 disengagement alarm red 3 0
LD17 ml/h green 5 1
LD18 Battery Alarm red 5 2
LD19 Validation Demand green 1 1

2.3.2.1.2. Seven segment display units

Ref Name Type Seg Dig

U3 hundreds green 0 to 7 6
U4 tens green 0 to 7 5
U5 units green 0 to 7 4
U6 tenths orange 0 to 7 3
U2 thousands green 0 to 7 7

2.3.2.2. Keyboard interface

The keyboard is an 18 key matrix keyboard. The keys are arranged in 3 rows of 6, with two separate keys
with a common point (GND), TON and TOFF, and power on and off switches, connected to J2.

Ref Digit Ligne

SILENT 2 2
STOP 1 2
VALIDATION 0 2
PURGE 3 2
BOLUS 2 0
DECAL 4 0
SELINC 3 0
SELDEC 2 1
ENTER 3 1
HISTO 4 1

Description of the connector

J2. 1 DIG 5
J2. 2 DIG 4

Page : 22 NT 1023 Rev.B0

J2. 3 DIG 3
J2. 4 DIG 2
J2. 5 DIG 1
J2. 6 DIG 0
J2. 7 LINE 0
J2. 8 LINE 1
J2. 9 LINE 2
J2. 10 TON
J2. 11 TOFF
J2. 12 GND

2.3.2.3. LCD display unit
The LCD display unit is "chip on glass" type, the controller is fixed on the glass. It has 2 lines of 20 char-

acters.
The BUS gestion is multiplexed with the command of SEG0 and SEG7.
It has a double powered retrolighting.
The power supply of the LED pair, one by one, allows an optimum light for a minimum consumption.

2.3.2.4. The buzzer
The buzzer is an auto-exit buzzer supplied by VBAT.
It is driven by the BUZZ signal, available on connector J3, pin 6, which is generated by the CPU board. It

is mounted in parallel with the optional nurse call circuit, located on the motor power supply board.

2.3.2.5. Time keeper
Real time device DS1307

2.3.3. Description of connectors

2.3.3.1. J2 Display board / CPU board connection

Pin Description

1 SEG0 display matrix and command LCD display line 1
2 SEG1 display matrix and command LCD display line 2
3 SEG2 display matrix and command LCD display line 3
4 SEG3 display matrix and command LCD display line 4
5 SEG4 display matrix and command LCD display line 5
6 SEG5 display matrix and command LCD display line 6
7 SEG6 display matrix and command LCD display line 7
8 SEG7 display matrix and command LCD display line 8
9 COL1 display matrix and keyboard column 1
10 COL2 display matrix and keyboard column 2
11 COL3 display matrix and keyboard column 3
12 FAIL diode FAIL control Fail
13 RDCRT display control writing command
14 LIG1 keyboard interface line 1
15 LIG2 keyboard interface line 2
16 LIG3 keyboard interface line 3
17 LDSECT LED mains lighting control LED sector
18 + 5V power supply
19 VBAT power supply
20 GND power supply

2.3.3.2. J3 CPU board connection

Pin Description

1 TON ON key
2 TOFF OFF key
3 SI bus SPI

NT 1023 Rev.B0 page : 23

4 CLK bus SPI

OPT

OK

OK

OK

OK

OK

OK

OK

OK

OK

5 CSLCD bus SPI
6 BUZZ BUZZER control
7 VBAT power supply
8 GND power supply

2.3.4. Power consumption

Main supply (without battery) Battery supply (without main supply)

measurement made on the battery

0 ml/h 1200 ml/h 0 ml/h 1200 ml/h

31 mA / 230v ~ 47 mA / 230v ~

< 125 mA / 6,0 VDC 700 mA / 6,0 VDC

2.3.5. Electrical layout

(Refer to Annex 2)

2.3.6. Implantation layout

(Refer to Annex 2)

3 Configurations

Fresenius Vial recommends the presence of its qualified personnel or of a trained member of the Technical Department of your es­tablishment to help you implement the configuration procedures you wish to choose.

Note: press STOP to cancel modification at any time - Press to leave configuration mode at any time.

3.1. Configuration of the pressure functionalities

Moving to the pressure configuration mode: press +

Press Configuration mode Valid. Choice

Pres 1 : variable threshold mode.

Pres 2 :pressure limit by syringe capacity.

: Pres appears on display.

Pres 1
900 mmHg

50/60 ml syringes

Pres 2
50 cc 800 mmHg

20 ml syringes

Pres 2
20 cc 600 mmHg

Note: at any time, it is possible to press START key to store programmed
values and resume Pres 2.

Press ( ) to select

preset pressure limit at a value sets
between 100 and 900 mmHg at power on

or use the last programmed value (___)

from 100 to 900 mmHg

from 100 to 900 mmHg

Valid.

Pres 3 : pressure drop warning level.

Pres 3
100 mmHg

from 50 to 1100 mmHg (disable this
warning 0 mmHg)

3.2. Configurations of the various parameters

Moving to configuration of the various parameters mode, press simultaneously + : Par appears on display.

Press Configuration mode Valid. Display

Par 1 : preset parameters at power on.

Par1

(parameters: flow rate, rate mode unit, drug
name, drug concentration, patient weight)

Press ( ) to select

use last parameters
preset parameters:

flow rate: 00.0 ml/h

Page : 24 NT 1023 Rev.B0

Valid.

rate mode proposed :ml/h

OK

OK

OK

OK

OK

OK

OK

OK

OK

OK

OK

OK

OK

OK

OK

OK

OK

OK

OK

OK

OK

OK

OK

OK

OK

OK

OK

OK

OK

patient weight,
V/T values : preset at last
values before selection

Par 2 : syringe selection type.

Par 3: maximum flow rate selectable via the

keyboard.

Par2
SEL4

50 ml syringe

Par3
50 cc 800 ml/h

20 ml syringe

Par3
20 cc 550 ml/h

Par 4 : selectable syringes/syringe list restric-

tion.

Par 5 : prime compulsory.

Par 6 : rapid infusion start up.

BD Plastipak
50 cc

Par 5

Par 6

Press Configuration mode Valid. Display

Par 7 : KVO rate.

KVO = 1.0 ml/h
KVO = 2.0 ml/h

SEL3 only one syringe per capacity with

automatic confirm

SEL4 multisyringe mode

from 0.1 to 1200 ml/h

from 0.1 to 600 ml/h

selectable syringe on display
not selectable on display

Selection for any syringe

priming compulsory
no priming compulsory

running rapid infusion start up
no rapid infusion start up

Press ( ) to select

From 0.1 to 5 ml/h

Valid.

Par 9 : RS 232 baud rate.

Par A : empty syringe mode (finish on occlu-

sion).

Par B : frequency of maintenance and date of

next maintenance

Par C : drug library (see page 9)

Par D : syringe flanges detection.

Par E : pre-programmed bolus dose rate and

volume preset value at power on

Par 9

4800, 9600, 19200 Bauds

19200

Par A

activated
disabled

Par B 200 h
12/05/2000

from 1 hour to 9 999 hours of continuous
use (preset at 3 000 hours)

Note : select 0000h to desable

Par B 200 h
12/05/2000

Select date and shift to next item by
pressing OK key.

Note : select 00/00/0000 to desable date
of next maintenance mode

Note: at any time, it is possible to press START key to store programmed
parameters and resume Par B.

ADRENALIN

Drug library configuration

200ng/ml

Par D

activated
disabled

Par E

use the last rate and volume settings
used a preset fixed value for rate

volume = 0.1 ml

Preset

fixed

value

50 ml syringe

Par E
50cc 800.0 ml/h

20 ml syringe

From 50.0 to 1200.0 ml/h

From 50.0 to 600.0 ml/h

Par E
20cc 600.0 ml/h

Par F : bolus rate value at power on

Par F

use the last set rate setting

Page : 28 NT 1023 Rev.B0

used a preset fixed value

OK

OK

OK

OK

OK

OK

OK

Preset

fixed

value

Par G : rate mode selection

Par J : mains disconnection warning inhibition.

Par P : name of the service

Important: measurements of the friction forces on the plunger stoppers do not show stable characteristic. For this reason, we recommend not
to use Star mode (Par6).

50 ml syringe

Par F
50cc 800.0 ml/h

20 ml syringe

Par F
20cc 600.0 ml/h

Ml/h

Par J

Par P
ICU 15210 ____

From 50.0 to 1200.0 ml/h

From 50.0 to 600.0 ml/h

Activate or disable rate mode with .
Shift to the next item by pressing OK OK

key

activated
inhibited

inhibited
mains disconnection warning active

Select the service name

3.3. CHECKING THE PILOT

 N.B.: the tests outlined below do not include the occlusion tests, the flow rate tests, the electrical safety tests,

etc.

3.3.1. The After Sale Service test

The ASS test is activated by pressing simultaneously on the keys:

and

until following display:

TESt.1

The validation LED flashes.If
The device display, for example:

START

is not pressed, within 3 seconds, the device returns to normal running.

Test1Test1

0h0h

The keys , and

START

allows to scroll in the following list:

 "TEst.1TEst.1" = displays running time with zero reset if necessary and service date modification
 "TEst.2TEst.2" = tests all indicator lights (LED's, 7-segment display unit AND LCD screen)
 "TEst.3TEst.3" = tests keyboard.
 "TEst.4TEst.4" = displays battery voltage

NT 1023 Rev.B0 page : 29

 "TEst.5TEst.5" = displays code of last 10 alarms.

STOP

STOP

 "TEst.6TEst.6" = displays total running time.
 "TEst.7TEst.7" = TTL serial link test.
 "TEst.8TEst.8" = RS232 serial link test.
 "TEst.9TEst.9" = displays force on plunger.
 "TEst.ATEst.A" = software version, check sum, loading date and language.
 "TEst.BTEst.B" = displays ADC analog inputs.
 "TEst.CTEst.C" = displays driving block position.
 "TEst.ETEst.E" = displays calibration values.
 "TEst.FTEst.F" = displays calibration syringe type.
 "TEstTEst.JJ" = displays of the last 10 events before the last blocking error.
 "TEst.LTEst.L" = drugs library.

3.3.2. Running time tESt.1tESt.1

This test allows to display, first, the running time in hours, days and months.

Press on

START

gives the maintenance date. This date may actualised with the key board.

3.3.3. Lights test tESt.2tESt.2

This test allows to check the lighting of LED’s of the front panel, of the 7 segments display and of the LCD screen.
First, all the items light at the same time and then light one after another.

This test can be stopped at any time by pressing

3.3.4. Key board test tESt.3tESt.3

This test allows to test the correct functioning of every key. The message “Test 3” is permanently displayed.
When pressing on a key, its name displayed on the screen

OFF Switch off

SIAL Alarm silent / Information keys
STOP Stop infusion

START

START Validation (note: pressing longer than 2 seconds on this key, drives back

to tests choice)

BOLUS

BOLU Bolus manual control

DECAL Moving the traveller

INC Increase

DEC Decrease

OK

OK Enter, validation

OPT

OPT Options menu

Page : 30 NT 1023 Rev.B0

1 2 3

6 : DEC +

1 : INC +++
2 : INC ++

4 5 6

3 : INC +
4 : DEC +++
5 : DEC ++

Nota: ON, can’t be tested
If several keys are pressed simultaneously, the device displays “Err” and gives an alternative "BIP".

The key works normally: the message “OFF”is displayed as soon as pressed, the device is switched off if
pressed more than one second.

3.3.5. Battery voltage display tESt.4tESt.4

This test displays the battery voltage over 5 digits. The voltage is calculated in accordance with corresponding ana­log input value and calibrating values. The values used are those for escape from an alarm or pre-alarm (6.3 V) or
starting an alarm (5.7 V).

The display is in volts and tenths of volts. The display is continuously updated according to the voltage changes.
The battery and mains LED's are also updated. The battery LED begins to flash if the voltage displayed is below the

calibrated pre-alarm threshold and stops flashing if the voltage is above the pre-alarm output threshold.
Press the CONFIRM key to select another test.

3.3.6. Last 10 alarms codes tESt.5tESt.5

This test displays the codes of the last 10 events on the display units. Three types of events are memorised :

q ALARM
q ERROR
q SWITCH OFF: two cases

Normal SWITCH OFF by pressing the OFF key.
Abnormal SWITCH OFF due to misfonctioning.

When an alarm goes off, an “AA” is displayed followed by a number identifying the alarm:

Alarm Description

10 battery
11 syringe clamp
12 end of infusion
13 volume limit
14 disengagement
15 plunger head
16 occlusion
25 Flange
26 Main line disconnection

NT 1023 Rev.B0 page : 31

In case of error, an “E” is displayed followed by error number:

Error Description

01 rotation control
03 communication

32 / 52 / 72 / 82 segment advance check

44 CPU / UART frequency control
50 ADC access self-test
52 advance check during take-up

14 / 60 checking coherence of syringe parameters (incoherence of the syringe diameter in relation

to the number of motor steps for 0.1 ml calculated when the syringe is confirmed)

70 incorrect motor frequency (motor step period too big or too small, calculated from the sy-

ringe diameter and the selected flow rate)
72 advance check over the whole length
80 important electromagnetic interference’s or bad key board.

16 / 55 Time keeper

18 Max infused (1,7l) reached
28 Language file error

24 / 34 / 44 / 56 Software error

66 LCD error

The error codes: 10 (internal Ram self-test(+)

20 (external Ram self-test(+)
30 (EEPROM check-sum self-test) and
40 (EEPROM access)

These errors cannot be stored in the EEPROM; the running of the device is too pertubated to allow it to write in the
EEPROM.
When normally stop, the “OFF” message is displayed.
For abnormal stop “OFF” + flashing "F" (Fail) are displayed on the LCD screen.
The events are numbered from 0 to 9. 0 is the last event, 9 is the eldest one.

The keys and allows to scroll the events one way or the other
Example:

Test 5 8Test 5 8

E 01E 01

Means: event N° 8 was a type 01 error (rotation control)

3.3.7. Total running time tESt.6tESt.6

Use this test to display the total running time of the Pilot. Unlike “Test 1" which resets the time at zero when the
service date is modified, it is not possible to modify this time manually.

Example:

Test 6Test 6

28 H28 H

3.3.8. TTL Serial link test: tESt.7tESt.7

This test allows to verify the TTL serial link TTL (80C32), by placing a plug on which the Rx and Tx lines are " short­circuited "(pin 2 and 3).

If link is correct: LTOKLTOK is displayed
If link is not correct or if plug is not connected: LTER LTER is displayed

3.3.9. Serial link test: tESt.8tESt.8

Page : 32 NT 1023 Rev.B0

This test allows to verify the RS 232 serial link (2691), by placing a plug on which the Rx and Tx, RTS and CTS,
DSR and +5 V lines are "short-circuited" (pin 2 and 3), (7 and 8),(4 and 6)

LROKLROK = RS 232 correct link.
LRERLRER = break between Tx and Rx
NORCNORC = - break between RTS and CTS,

- break between DSR and + 5 V

- no plug

3.3.10. Strength on the plunger display: tESt.9tESt.9

This test displays the strength applied on the plunger. The strength is calculated according to the value of the corre­sponding analogue input and the calibrating values. The display is in grams. The value is continually updated ac­cording to changes in the strength value.

3.3.11. Software version tESt.AtESt.A

This test allows to display the software number version, the check sum and the loading date.

OK

Press on

allow to display the language.

Example:

rst

1

screen

Test A V01.1a

OCFO 01/12/2000

nd

2

screen

Test A Français

V01.0 09/09/1998

Press on for other language screen

3.3.12. Analog input display tESt.BtESt.B

This test allows to read the hexadecimal value of the 5 analogic inputs and of the 3 converter test inputs. The chan­nel number is displayed above this value.

Example

Test B M

200

The keys and allows to pass from one channel to an other.
The analogue inputs are divided as follows:

0 battery voltage
1 N.U.
2 force sensor
3 NU
4 potentiometer displacement

NT 1023 Rev.B0 page : 33

L converter zero test, between 0000 and 0004 if correct
M converter mid-scale test, between 01FB and 204 if correct
H converter full-scale test, between 03B and 3FF if correct

3.3.13. Driving block position display tESt.CtESt.C

This test displays the position of the driving block. The position is calculated in relation to the value of the corre­sponding analogue input and calibrating values. The display is in mm and tens of mm. The value is continually up­dated as the driving block moves. The value displayed is ± 0,1 mm.

3.3.14. Calibration values display tESt.EtESt.E

This test allows to show the calibration values stored in the EEPROM.
Every value is displayed on 3 digits.
The first line gives the shorted name of the value.

Example:

Test E LOWTest E LOW

082082

The keys and allows to pass from one channel to an other.

bat1 alarm and pre-alarm battery voltage: 6.3 V
bat2 pre-alarm battery voltage: 5.9 V
bat3 alarm battery voltage: 5.7 V
HIGH displacement potentiometer with large 115.0 mm spacer
LOW displacement potentiometer with small 20.0 mm spacer
0G force meter with 0 kg
5Kg force meter with 5 kg

3.3.15. Syringe type display tESt.FtESt.F

This test displays the type of syringe fitted to the Pilot. The type is defined with the indications given by the optos of
the syringe clamp.

The type of syringe is displayed with its capacity: 20cc (20/25cc), 50cc (50/60cc). The capacity may not be dis­played if the parameters in EEPROM indicate that certain types of syringes are not included. When the syringe
clamp is in the higher and the lower position 4 dashes are displayed.

The display is constantly updated in relation to changes in the syringe clamp system.

3.3.16. Displays of the last 10 events before the last blocking error tESt.JtESt.J

This test allows to display the 10 last events before the last blocking error.

3.3.17. Drug library tESt.LtESt.L

This test allows to read the name, the author and the date of the protocol library registered in the device.

4 REPLACING SUB-ASSEMBLIES

q Important: Disassemble the flexible circuit holder on the supply board before extracting the mechanical as-

sembly from the lower box.

q Important: Device operation must be completely checked after all intervention inside the device.

Page : 34 NT 1023 Rev.B0

4.1. Mounting the flexible circuit

diam.12 tube

q Important: Handle the flat cable with great care when mounting this sub-assembly: damage to the flat cable

will result in complete disassembly of the mechanical block.

Fitting the flat cable

1. Take the flat cable and, using the "flat cable insertion" tool, wind the flat cable on the opposite side to the 10­point connector in the tool slot, keeping the flat cable tightened, wind it onto the equipment.

hood

2. Take the black hood of the flat cable insertion equipment and position it on the wound flat cable part.

3. Insert the driving block cover and the input bearing on the diam. 12 tube, in the proper direction for mounting
the various components.

Important: The input bearing flange must be placed on the side external to the driving block cover.

q Visually check that the "input bearing + driving block cover" are properly mounted on the tube.

4. Insert the "flat cable insertion" tool in the diam. 12 tube on the input bearing side.

q The perpendicular flat cable parts are placed in the slits found at the ends of the tube.

5. Remove the black hood and the flat cable insertion equipment.

6. Correctly position the flat cable in the two slits visible at each end of the tube.

Important: The flat cable must not be twisted inside the tube.

7. Place the flexible circuit guards at both ends of the tube, passing the flat cable between the two holding lugs

8. Place the diam. 12 tube on the driving block making match the indexing finger of the driving block with the hole
of the tube (opposite side of the 10 point connector)

flat cable

9. Match up the flexible circuit hole with the driving block holder centring tube.

10. Secure the clamping collar onto the driving block using two 2.5 x10 screws and two washers.

4.2. Wiring the components on the flexible circuit

q Important: it is essential that the component mounting direction be respected.

1. Position the strut (1.5mm) between the 4 pin photo switch and weld the syringe head detection photo switch
flattening it against the flat cable.

Important: use a silicone between the optical switch and the flat ribbon cable. The silicon should not be over the
soldering area.

NT 1023 Rev.B0 page : 35

Important: verify there is no resistor continuity between the optical switch axis stop and the flat ribbon cable.

Photo switch

2. Weld the disengaging switch flattening it against the flat cable.(at roughly 1.5 mm).

3. Cut the part of the flat cable corresponding to the back pressure microswitch of version A2 (see cutting zone in
the diagram below).

Disengaging switch

Diam 12 tube

Syringe head detection

Photo switch
anode long lug

Weld the disengaging microswitch without flattening it against the flat cable (at roughly 1.5 mm).

4. Weld the force sensor wires

Important: when disassembling a force sensor, take care not to damage the welding pellets.

green wire

lower marking

5. Pass the flat cable in the force sensor oblong.

Important: When disassembling the flexible circuit from the driving block holder, take care not to detach or dam­age the holder protection square. The purpose of this square is to hold the flexible circuit correctly in place and
avoid short-circuits with the holder.

6. Mount the force sensor on the driving block holder using a TF HC M4x10 screw with weak lactate.

Important: avoid all contact between the force sensor and its holder.

7. Mount the contact plate on the force sensor using a TF M4x10 screw with weak loctite.

Important: Before calibrating the force sensor, adjust the threshold voltage (0.6V + 0.05V) using an oscilloscope
between pin 1 (earth) of J09 and pin 4 of J09 (square pulse).

Important: The device must be in the calibration mode (EtA9), obtained by simultaneously pressing the SILENCE
ALARM key, the bolus key and the "ON" key.

8. Check that the amplitude of the square pulse increases when a manual force is exerted on the force sensor.
When the force is removed from the sensor, the signal must return to the initial position.

Otherwise, check that the sensor is correctly mounted (sensor/holder friction).

4.2.1. Mounting the potentiometer

1. Disassemble the reducer flask end shield.

Page : 36 NT 1023 Rev.B0

2. Mount the potentiometer on the flask (take the nut on a thread).

3. Position the flask in equipment T 300 869 and lock it in place using the knurled screw.

4. Position the potentiometer in the equipment and bring it up against the end shield.

5. Tighten the potentiometer.

6. Extract the flask from equipment T 300 869.

7. Mount the pinion on the potentiometer (match up the indexing half flat).

q The pinion large diameter must be flattened against the potentiometer.

8. With the potentiometer facing you, turn the pinion in an anticlockwise direction until it blocks, then turn it 1/4 of
a turn in the opposite direction.

9. Mount the moving mechanical assembly on the reducer frame.

10. Insert the flask on the guides and rack.

q Check the position of the input bearing which must be on the driving block side.
q Important: Take care not to damage the flexible circuit when mounting (folding).

11. Secure the end shield using the three M3x3 TC screws.

12. Secure the input bearing using the two M3x3 TC screws.

4.2.2. Wiring the potentiometer

1. Weld the 3 wires perpendicular to the lugs by placing them in the holes.

Important: Do not fold the potentiometer lugs

2. Mount the pinion and the potentiometer matching the indexing half flat with the

3

21

brown
red

black

small diameter of the pinion towards the potentiometer.

1
2
3

3. Mount the pinion hocking diameter 4 Truarc ring using a pair of flat mose fliers bearing down on the potenti­ometer shaft half flat.

4. With the pinion facing you, turn the potentiometer anticlockwise until it blocks, then turn it 1/4 of a turn in the
opposite direction.

5. Disengage the moving assembly and slide it until it blocks against the reduction gear flange.

6. See EtA6EtA6 calibrating test for the calibration of the potentiometer (section 3.2.2.).

4.2.3. Plug holder connector

If the total pins on the plug holder connector does not correspond to the total pins on the power supply board con­nector, the connecting method should be done as follows:

plug holder

straight

Power supply board

4.2.4. Lubricating the mechanical parts

NT 1023 Rev.B0 page : 37

NOTE: Use silicon grease exclusively.
Parts to be lubricated:

The two mechanical block guide rods
The screw rod
The top of the rack at guide level
The full length of the rack teeth
The disengaging spring housing in the 1/2 nut
The inside of the mechanical block.

Page : 38 NT 1023 Rev.B0

5 MAINTENANCE

5.1. Recommendations

The qualified technicians in your establishment or our After-Sales Service should be notified of any abnormal op­eration of the device.

For further information concerning troubleshooting or usage procedure, please contact our After-Sales Service or
our Commercial Department. (see Useful Addresses, chapter 10).

If the device has to be returned to our After-Sales Service, it must be packed very carefully, if possible in its original
packaging before being sent.

FRESENIUS VIAL is not liable for loss or damage to the device during transport to our After-Sales Service.

5.2. Cleaning and disinfection

The syringe pump forms a 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.

q Disconnect the power cable from the wall socket before commencing cleaning.
q Do not place in an AUTOCLAVE, nor IMMERSE the device, and do not allow liquids to enter either the de-

vice's casing, or it's power supply cover.

q 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.

- Neither rinse, nor wipe surfaces.

q If the device is located in a high contamination risk unit, it is advisable to leave it in the room during aerial

disinfection, after having disinfected it in using a moist cloth.

q Do not use:

- TRICHLOROETHYLENE-DICHLOROETHYLENE,

- AMMONIA,

- AMMONIUM CHLORIDE,

- CHLORINE and AROMATIC HYDROCARBON,

- ETHYLENE DICHLORIDE-METHYLENE CHLORIDE,

- CETONE,

- BASED CLEANING PRODUCTS.

q These aggressive agents could damage the plastic parts and lead to apparatus malfunctions.
q Take care with ALCOHOL BASED SPRAYS (20-40% alcohol); They lead to tarnishing of, and small cracks

in, the plastic, and do not provide the requisite cleansing action prior to disinfection.

q Please contact the appropriate service, handling cleaning and disinfection products within your es-

tablishment, for further details.

5.3. Storage

In the case of prolonged storage time, disconnect the battery through the battery door located below the PILOT.
This operation should be made by a fully competent technician.

Storage place should be dry and temperate.

q Temperature between 0 and 40°.
q Maximum relative humidity 85%, no condensation.

After storage, a full recharge of the battery is recommended before putting the syringe pump into use, in order to
avoid any risk caused by micro power cuts in the mains supply and to insure maximum autonomy.

5.4. Routine inspections

NT 1023 Rev.B0 page : 39

In order to ensure an optimal functioning of the device, regular servicing inspections and tests are recommended
every 24 months. A servicing procedure should include the points listed below. These service checks are not cov­ered by any contract or agreement with FRESENIUS VIAL and are under the responsibility of user’s technical staff.
For further information, please contact our After-Sale-Service.

q NOTE: Incorrect servicing inspections may cause wrong functioning of the PILOT.

5.4.1. Checking before use

(see Operator’s guide)

5.4.2. Checking protocol (Technical manual)

In order to ensure that the device is functioning optimally, regular servicing inspections and tests are recommended
every 24 months.

A servicing check procedure should include the points listed below.
For further information, please contact our After-Sales Service.
The following servicing tests must be performed in accordance with the instructions defined in the Technical Man-

ual.

q Note: Failure to comply with these maintenance procedures could damage the device and lead to functional

failures.

5.4.2.1. Checking the syringe clasp detection arm

You have the tool test T301521-B.

1. Start the device by pressing the ON key.

2. Place a syringe plunger head, (take off the plunger from the syringe body) under the anti-siphon arm to stop the
syringe plunger head detection alarm.

3. Pull the syringe clasp to the higher position and press the flange detection switch.

q Ensure the syringe head alarm is present.

3. Place the tool reference T301385B with the clasp on the biggest diameter, then move the tool to check the 4
diameters

q For the 2 biggest diameters, the Injectomat 2000 MC / Pilot Delta should display 50 ml capacity.
q For the 2 smallest diameters, the Injectomat 2000 MC / Pilot Delta should display 20 ml capacity.

4. Take off the test tool, then place the syringe clasp in lower position and press on the flange detection switch

q Ensure the syringe clasp alarm is present.

You do not have the tool test T301521-B.

1. Start the device by pressing the ON key.

2. Place the syringe clamp in open position and press the flange detection switch.

q Ensure the syringe clasp alarm is present.

3. Place and clamp with the syringe clasp, every syringe type of the list registered in the PILOT

q Ensure right detection for each syringe capacity

4. Take off the syringe then place the syringe clasp in low position and press on the flange detection switch

q Ensure the syringe clasp alarm is present.

5.4.2.2. Checking the flange detection system

1. Start the device by pressing the ON key.

2. Place a syringe in the Injectomat 2000 MC / Pilot Delta and clamp it with the clasp.

Ensure right detection of the syringe.

Page : 40 NT 1023 Rev.B0

3. Place a syringe on the Injectomat 2000 MC / Pilot Delta with flange OUT of the provided slot. Put on the syringe
clasp.

Ensure the syringe clasp alarm is present.

5.4.2.3. Checking anti-siphon arm

q NOTE: this check should be done for every type of syringe registered on the PILOT

1 Start the device by pressing the ON key.
2 Place and clamp a syringe in the Injectomat 2000 MC / Pilot Delta with the clasp and pull the drive into max-

imum forward position to be sure the drive is not in contact with the head of the syringe.

3 When anti-siphon arm is in low position:

q Ensure plunger head presence detection alarm is present.

4 When anti-siphon arm is in high position:

q Ensure plunger head presence detection alarm is present.

5 For one of the registered syringes, correctly placed (clasp and drive in good position)/

q Ensure plunger head presence detection alarm is absent.

6 Pull the anti-siphon arm to check it is correctly fixed.
NOTE: If anti-siphon arm is dismounted, use stop-screw-glue when remounting.

NT 1023 Rev.B0 page : 41

5.5. Technical check procedure PILOT anaesthesia 2

For preventive maintenance, periodical check is recommended. Use the technical manual for good running of the
procedure.

NOTE: Make a full battery charge (16 hours) before starting check procedure.

5.6. Checking disengagement system

1.Start the device.

NT 1023 Rev.B0 page : 43

2.Place a 50/60 ml syringe in the PILOT

3.Activate the disengaging lever.

q Ensure an acoustic and visual alarm is present.

4.Maintain the disengagement lever in high position and move the driving block

q Check easy driving block displacement (manual displacement).

5.Release the lever

q Ensure there is no alarm.
q Check driving block locking.

5.7. Checking force sensor

1. Proceed to test 9 (see section 3.3: checking the PILOT)

2. Use the disengagement system to pull the pusher backward so no force is applied to the sensor.

q Displayed value should be between 0 and 100 g

3. Press and release the force sensor

q Displayed value should be between 0 and 100 g

4. Apply a known force (about 5 Kg) on the pusher.

q Displayed value should be 5 Kg +/- 250g.

5.8. Checking back-pressure

NOTE: The Injectomat 2000 MC / Pilot Delta initiates the sensor after pusher engagement. When testing back­pressure, the infusion should be started with no pressure on the line.

1. Start the device by pressing the ON key.

2. Place a manometer (or any other pressure measuring instrument) at the syringe outlet.

3. Select BD 60 ml Syringe.

4. Select the Medium Limit Pressure by pressing the LIMIT PRESSURE key.

q M = (medium limit pressure) = 500 mmHg +/- 75 or 0.65 bar ± 0.1 bar.

4. Select maximum flow rate

5. Start the infusion (press START/CONFIRM).

q Ensure there is no acoustic and visual alarm (back-pressure Led off),
q Check infusion indicators are flashing.
q Check visual and acoustic alarm for a 500 mmHg +/- 75 or 0.65 bar ± 0.1 bar pressure.

NOTE: If the pressure value measured according to the selection made falls outside the reference values, refer to
the "EtA9EtA9 " calibration test (see Chap.3.2.3.).

NOTE: Before calibrating the force sensor, check the voltage between point J09.1 (earth) and J09.4 using an oscil­loscope. Voltage value = 0.6 V + 0.05 V (square pulse).

Page : 44 NT 1023 Rev.B0

5.9. Checking registered syringe list /syringe list label.

This test allows to check if the list of syringes registered in the Injectomat 2000 MC / Pilot Delta is in accordance
with the list printed on the label.

Proceed to HH test (section 3.3: CHECKING THE PILOT)

5.10. Checking Mains/Battery operation

1. Connect the device to a mains supply and check the presence of the mains Led (permanent yellow LED on).

2. Disconnect the device from the mains.

3. Connect the device battery lugs to a stabilised supply set at 6.3 V.

Important: Respect the +/-" polarities.

4. Place the device in the normal operating mode.

5. Select a syringe (from the syringes proposed by the PILOT) and validate.

6. Select a flow rate and validate.

7. Set the voltage on the stabilised supply between 5.8 V. and 6 V.

q The battery discharge pre-alarm is activated

NOTE: The acoustic alarm can be temporarily silenced (2 minutes) by pressing the SILENCE ALARM key.

8. Turn down the voltage of the stabilised supply.

Check the battery discharge prealarm is activated between 5.6 and 5.8 Volts.

NOTE: If the values indicated above are not respected, refer to the "EtA4EtA4" test (Section: 3.2.1).

5.11. Checking linearity

Carry out this test to check the displacement of the driving block for a 50/60 ml B-D Plastipak syringe at a flow rate
of 50 ml/h. Any non-correspondence between the value measured and the table value indicates a mechanical and
electronic failure which could cause flow rate errors.

A checking software ISCTRL allow to carry out this test automatically (call FRESENIUS VIAL After-Sale- Service for
further information)

5.11.1. Equipment used

q Stop clock
q Electronic calliper
q 50 ml B-D Plastipak syringe

5.11.2. Operating mode

1. Switch the device on by pressing on the ON key.

2. Place a 50/60 ml B-D Plastipak syringe on the device.

over view

3. Measure the distance X (in millimetres) as shown on the diagram -> X

1

4. Select a 50 ml B-D Plastipak syringe.

5. Select a flow rate of 50 ml/h.

NT 1023 Rev.B0 page : 45

6. Start the infusion by pressing on the CONFIRMATION key and start the stop clock at the same time.

7. Stop the infusion after 50 min, then measure X again -> X

8. The displacement X= X1 - X

in mm, must comply with the values indicated below.

2,

2

Table of "distance X" displacement measurements

NOTE: For precise measurement avoid any movement of the pusher during measurement.

Time Displacement in mm, for a flow rate selection of 50 m

minutes seconds minimum Average Maximum

50 00 74.96 75.72 76.47
50 30 75.71 76.47 77.24
51 00 76.46 77.23 78.00
51 30 77.21 77.99 78.77
52 00 77.96 78.74 79.53
52 30 78.71 79.50 80.30
53 00 79.46 80.26 81.06
53 30 80.21 81.02 81.83
54 00 80.95 81.77 82.59
54 30 81.70 82.53 83.35
55 00 82.45 83.29 84.12
55 30 83.20 84.04 84.88
56 00 83.95 84.80 85.65
56 30 84.70 85.56 86.41
57 00 85.45 86.32 87.18
57 30 86.20 87.07 87.94
58 00 86.95 87.83 88.71
58 30 87.70 88.59 89.47
59 00 88.45 89.34 90.24
59 30 89.20 90.10 91.00
60 00 89.95 90.86 91.77
60 30 90.70 91.62 92.53
61 00 91.45 92.37 93.30
61 30 92.20 93.13 94.06
62 00 92.95 93.89 94.83

q Important: if the distance measured does not correspond to the value indicated on the table refer to

"EtA6EtA6" Calibration mode.

5.12. Checking end of infusion

5.12.1. End of infusion pre-alarm

1. Start the device.

2. Select a 60 ml B-D PLASTIPAK syringe, 20 ml full.

3. Select a flow rate of 120 ml/hr.

q For normal flow rates, the end of infusion pre-alarm is activated 5 minutes before end of infusion.
q For higher flow rates (50 ml/hr), the pre-alarm is activated when the volume remaining to be infused equals

10% of total syringe capacity.

4. Ensure the end of infusion pre-alarm is present.

5. Press the SILENCE ALARM key to silence the acoustic alarm and check the end of infusion alarm (see in

5.4.2.7.2.).

5.12.2. End of infusion alarm

1. At the end of infusion:

Page : 46 NT 1023 Rev.B0

q Check the acoustic and visual end of infusion alarm.

over view

2. Measure the " hard height ": X, with 18.6 < X < 19.5 for a 50 ml B- D PLASTIPAK syringe.

q Important:

For accurate checking of the hard height, do not move the driving block when measuring.

3. If X value is out the tolerated ones see " Eta6", section 3.2.,CALIBRATION.

5.13. Checking the Led's and keyboard

Refer to tSt2tSt2 and tSt3tSt3 (see section 3.2.: CALIBRATION)

5.14. Battery autonomy test

1. Medium battery autonomy is 7 hours (minimum 5) when the device operates with a 50 ml B-D PLASTIPAK sy­ringe at a flow rate of 5 ml/hr (without Master module connection type)

2. The battery discharge pre-alarm warns the user the remaining autonomy is roughly 60 minutes (at 5 ml/h) be­fore infusion will completely stop (total battery discharge alarm).

3. Battery recharging time is 16 hours minimum (100% of its capacity).

5.15. Continuity test

Using an multimeter connected ohmmeter, check the presence of an infinite electrical resistance between:

q phase and metal tube,
q neutral and metal tube.

NT 1023 Rev.B0 page : 47

5.16. Trouble Shooting

Problem Causes

• Perfusion end detected too
early (about 10 ml).

• Syringe used does not fit to selected one.

• No occlusion prealarm and

alarm at perfusion end.

Major variation in flow rate or
displacement control.

• Occlusion alarm when

switching on.

• Occlusion alarm when work­ing.

• Disengagement alarm when
switching on.

• Detection syringe piston un­suitable alarm.

• Syringe barrel holder unsuit­able alarm.

• Syringe flange detection un­suitable alarm.

• Syringe used does not fit to selected one.

• Syringe used does not fit to selected one.

• Bad calibration of strength sensor.

• strength sensor out of order.

• Cut in flexible circuit.

• Pressure limit selected too low.

• Bad calibration of strength sensor.

• Disengagement microswitch out of order.

• Opto sensor and/or obturator of syringe piston out of or-

der.

• Opto sensor and/or obturator of syringe holder out of or­der.

• Flange detection switch and/or connectic out of order.

• Bad display : segments or

LED’s.

• Driving transistors and/or connectic of display board out of
order.

• Alarm without error code. • Wrong power supply (6,9V) See MAX 652

• Bad CPU board.

• In case of drop….. • Check mechanic set and centring of diameter 12 tube

See exploded view.

Page : 48 NT 1023 Rev.B0

5.17. Error message Er(-)0, Er01, Er(-)2, Er03, CFPc

Error code Error code definition Cause
ER (-) 0

Device self test on start up was
not successful

Er10
Er20
Er30
Er40

Electronic control + soft­ware anomaly

Internal RAM anomaly
External RAM anomaly
EPROM anomaly
Eeprom anomaly

Check Sum: faulty RAM, EPROM,
EEPROM

When rewriting EEPROM on switching
off the device the Check Sum is re­written in the memory to save the pa­rameters.

r If the Hard cutoff circuit time is
shorter than the Soft circuit time, the
device is switched off before EEPROM

is fully written: Check Sum not conform
Er50
Er60
Er70

Er80

ER0 1
Problem detected in motor con­trol mechanism or in the motor
itself.
ER(-) 2*
Plunger advance checking has
detected a error greater than the
acceptable one (+)-) from 1 to 7:
info: A.S.S.
Er32

Er52
Er72

ADC anomaly
Syringe parameters

anomaly
Motor frequency anomaly

Keyboard anomaly

Motor supply failure Motor rotation photo switch + associ-

Mechanical advance
checking anomaly

Short distance anomaly
Slack adjustment anomaly
All length anomaly

r Er(-)0 or CFPc: When the device is

in CFPc reconfiguration is compulsory:

faulty WATCH DOG

Faulty keyboard or short circuit in the

keyboard or excessive electromagnetic

interference.

ated circuits brake.

Potentiometer or ADC Often connector

calibration or position potentiometer

unscrewed

Er82
ER(-)4

Possible misfonctioning

Er14
Er24
Er34

CFPc
The device self-test on configu­ration was not satisfactory

Flow rate anomaly
Motor and flow rate calcu-

lation parameters anoma­lies

Motor period calculation
anomaly
Motor rotation direction
anomaly

Flow rate / period calcula­tion anomaly
Configuration anomaly Erroneous parameters.

Functioning or configuration wrong pa-

rameters

5.18. Flow rate control protocol: flow rate measurement with computer

NT 1023 Rev.B0 page : 49

The test procedure outlined below can be carried out with a 50 ml or 20 ml syringe. The operating mode described
below, reflects the flow rate Measurement software used by Fresenius Vial according to the Pr EN 60-601-2-24
Standard for Infusion pumps. It is up to the user to adapt this procedure to the software he uses.

5.18.1. Equipment used:

q Scales coupled to a microcomputer

scales sensitivity (in compliance with IEC 601.1 standard, 2nd part):

flow rate value (x) scale sensivity

x ≤ 5 ml/h

5 ml/h < x 30 ≤ ml/h

1/10000e

1/1000e

x > 30 ml/h 1/100e

q Multi scales acquisition program
q Test tube or beaker with 1 ml graduating
q Liquid: distilled water +/ oil)
q Luer Lock type plastic syringe (50 or 20 ml)
q Catheter extension with Luer Lock end piece (length 100 cm, inside diameter 2.5 mm).
q Needle:

flow rate value (x) nodale type

x < 30 ml/h G 26

x ≤ 30 ml/h G 18 ou G 21

5.18.2. installation

1. The equipment should be installed according to the installation drawings shown in below.

q Important: Make sure that the horizontal installation plane is respected.

2. Fill the syringe with 50 ml of distilled water. Prime if necessary to eliminate any air bubbles.

3. Secure the female Luer Lock end piece of the catheter extension onto the syringe and the male Luer Lock end
piece onto the needle.

4. Install the syringe onto the device.

5. Fill the test tube with water ensuring that the needle is dipped in the liquid (1 cm) and add several drops of oil in
order to create a greasy film on the surface of the liquid. In this way the user will avoid any measurement error
due to evaporation of the liquid.

6. Place the test tube in the centre of the scales platform.

7. Place the needle inside the test tube.

q Important: The infusion line (needle/catheter extension) must not be in contact or rest on the Scales/test

tube assembly at any time.

8. Start the device by pressing on the ON key (Injectomat 2000 MC / Pilot Delta in mains supply mode) then prime
the infusion line using the PRIME/BOLUS key.

q Important: check that there are no air bubbles.

Page : 50 NT 1023 Rev.B0

5.18.3. Operating mode

q Remark: the software works following the operating mode described in the Pr EN 60-601-2-24 Standard for

infusion pumps.

1. Start the acquisition program for the scales.

2. Enter the data necessary to carry out the program without validating the flow rate.

3. Adjust the scales to the specified flow rate.

4. Confirm the flow rate on the microcomputer so that the automatic setting of the scales can take place.

5. Start infusion when 00.00 appears on the scales display screen.

6. When the specified time is over, note the error percentage displayed on the screen.

5.18.4. Installation drawing

catheter extension support stand

RS 232 cord

anti-vibration measurement table

5.19. Flow rate control: flow rate control measurement with scales

q In compliance with IEC 601.2 standard, 2nd part - 62D standard project for infusion pumps.

5.19.1. Equipment used:

q Stop clock
q Scales - scales sensitivity:

flow rate value (x) scale sensivity

x ≤ 5 ml/h

5 ml/h < x ≤ 30 ml/h

x > 30 ml/h 1/100e

q Test tube or beaker with 1 ml graduating
q Liquid: distilled water +/ oil)

1/10000e

1/1000e

q Luer Lock type plastic syringe (50 or 20 ml)
q Catheter extension with Luer Lock end piece (length 100 cm, inside diameter 2.5 mm)
q Needle:

flow rate value (x) needle type

x < 30 ml/h G 26
x ≤ 30 ml/h

G 18 ou G 21

NT 1023 Rev.B0 page : 51

5.19.2. Installation

1. The equipment should be installed according to the installation drawings shown in 5.18.3.

Remark: Make sure that the horizontal installation plane is respected.

2. Fill the syringe with 50 ml of distilled water. Prime if necessary to eliminate any air bubbles.

3. Secure the female Luer Lock end piece of the catheter extension onto the syringe and the male Luer Lock end
piece onto the needle.

4. Install the syringe on the device following the instructions described in the Operator's Guide (See Operator's
Guide PILOT anaesthesia 2, Chap. 3: positioning the syringe).

5. Fill the test tube with water ensuring that the needle is dipped in the liquid (1 cm) and add several drops of oil in
order to create a greasy film on the surface of the liquid. In this way the user will avoid any measurement error
due to evaporation of the liquid.

6. Place the test tube in the centre of the scales platform.

7. Place the needle inside the test tube.

Important: The infusion line (needle/catheter extension) must not be in contact or rest on the Scales/test tube as­sembly at any time.

8. Start the device by pressing on the ON key (Injectomat 2000 MC / Pilot Delta in mains supply mode) then drain
the perfusion line using the PRIME/BOLUS key.

Important: check that there are no air bubbles.

5.19.3. Operating mode

1. Select the flow rate

q Important: for low flow rates (< 5 ml/hr) validate and wait for the infusion to stabilise for 1 hour. For higher

flow rates, 10 to 30 minutes are sufficient for this stabilisation.

2. Set the scales at 00.00 g

3. Start infusion by pressing on the START/CONFIRM key and set off the stop clock at the same time (if neces­sary make a note of the stop clock start value).

4. The test lasts for 1 hour. When over, press on the STOP key to stop the infusion.

5. Note the value in grams of "infused" liquid.

6. Calculate the difference between the design value and the real value.

Remark: 1 gram = 1 ml.

7. The error percentage can be calculated from this difference.

Formula:

Measured value - Design value

X 100 = percentage

D designed value

Page : 52 NT 1023 Rev.B0

5.20. Flow rate control: flow rate measurement using a test tube

5.20.1. Equipment used

q Stop clock
q Test tube or beaker with 1 ml 0.5 ml graduating
q Liquid: distilled water +/ oil)
q Luer Lock type plastic syringe (50 or 20 ml)
q Catheter extension with Luer Lock end piece (length 150 cm, inside diameter 2.5 mm).
q Needle

flow rate value (x) needle type

x < 30 ml/h G 26
x ≤ 30 ml/h

5.20.2. Installation

1. The equipment should be installed according to the installation drawings shown in 5.18.3.

q Remark: Make sure that the horizontal installation plane is respected.

G 18 ou G 21

2. Fill the syringe with 50 ml of distilled water. Prime if necessary to eliminate any air bubbles.

3. Secure the female Luer Lock end piece of the catheter extension onto the syringe and the male Luer Lock end
piece onto the needle.

4. Install the syringe on the device.

5. Fill the test tube with water ensuring that the needle is dipped in the liquid (1 cm) and add several drops of oil in
order to create a greasy film on the surface of the liquid. In this way the user will avoid any measurement error
due to evaporation of the liquid.

6. Place the needle inside the test tube.

5.20.3. Operating mode

1. Select the flow rate

q Important: for low flow rates (5 ml/h) validate and wait for the infusion to stabilise for 1 hour. If possible, use

a smaller test tube guaranteeing greater precision in ml reading. For higher flow rates, 10 to 30 minutes
are sufficient for this stabilisation.

2. Start infusion by pressing on the START/CONFIRM key and set off the stop clock at the same time (if neces­sary make a note of the stop clock start value).The length of the test is determined by the time necessary for a
50 ml infusion in the test tube.

3. Calculate the difference between the design value and the real value.

Real flow rate =

50 ml

Time in hours

4. The error percentage is calculated from this difference (Measurement error +/-1%),

Measured value - Design value

X 100 = percentage

D designed value

NT 1023 Rev.B0 page : 53

6 ANNEX 1: ILLUSTRATED PARTS LIST

6.1. Subassembly traceability table

6.1.1. Introduction

This chapter allows the technician to find which component has been changed on the product, also to order the right
part when it necessary for the pump maintenance.

6.1.2. Replacement parts table

The table below list the main modification made to improve the product. The Injectomat 2000 MC / Pilot Delta serial
number should be used when looking for components.

Equivalence table for

Injectomat 2000 MC / Pilot Delta

Serial N° From:

16685686

To : 18091461
Display board
CPU board
Power supply and control board

Eprom
Upper case IEC kit
Upper case export kit
Lower case IEC kit
Lower case DIN kit
Lower case NL kit
Lower case IS kit
Wired motor
Battery connector
Potentiometer wired

167549 167566

167568 167543

167557 167537 (Injectomat)

167991-V1.1a 167991-V1.2a

199250 199250

199251 199251

199200 199200

199201 199201

199202 199202

199203 199203

167965 167965

167961 166901

167963 167963

From:

18091461

167536 (Pilot Delta)

Page : 54 NT 1023 Rev.B0

6.2. Exploded views and related parts lists

6.2.1. Mechanical part list

Upper and lower cases

NT 1023 Rev.B0 page : 55

6.2.1.1. Upper case
Reference Repère Quantity Designation

167744 99 1 Diam.17.5 Pilot Delta
167681 99 1 Diam.17.5 Injectomat
167476 100 1 Syringe clamp Pilot Delta
167516 100 1 Syringe clamp Injectomat
167458 113 1 Syringe clamp shaft
167361 102 1 Diam 5 retaining ring
167310 103 1 Syringe clamp compression spring
167452 104 1 Injected PC opto support
168343 111 1 PILOTE ANES window
167679 112 1 Injectomat 2000 MC German front panel
168159 112 1 Pilot Delta French front panel
167627 1 Injected Diam.6 block
199560 1 Female hybrid M3x12 spacer
167067 1 CPU board protector film
167632 1 Buzzer foam
167042 122 2 Opto
167178 123 1 Flange pilot opto IC
167462 124 1 Pilot 20/60 cc shutter
167377 125 1 Flange pilot switch joint
167365 126 1 ALPS SKHCAF switch
167376 127 1 Flange pilot switch support
199618 128 1 TCB 2.2 x 8 Eco-Syn screw
199518 129 1 Flexible stiffened washer
167632 1 Buzzer bell foam

6.2.1.2. Lower case

Reference Repère Quantity Designation

170685 105 1 9 points Sub d
170687 106 1 15 points Sub d
177201 115 1 16 VA transformer
167942 117 1 Main socket support
167093 107 1 Buzzer bell
167285 108 1 Socket support
167200 109 1 3 points female socket
167432 110 1 Injected buzzer adjustment button
167059 1 Guide rail (Pilot Delta)
167514 1 Guide rail (Injectomat)
167299 1 Buzzer adjustment washer
167297 1 Buzzer flexible washer
167249 119 6 Adhesive black block
174019 120 1 6V 1.2/1.3 Ah battery
166901 121 1 Wired Battery sockets HE 13
167122 1 flexible Circuit retainer, Injected
167355 1 Main socket fiber joint

Page : 56 NT 1023 Rev.B0

Mechanical plunger unit PILOT anaesthesia 2

NT 1023 Rev.B0 page : 57

6.2.1.3. Plunger / mechanism unit

Ref.: Diag. Ref. Number Component

167360 200/207 2 Diam. 3.5 mm retaining ring
167465 201 1 Half nut spring cap
167469 202 1 Half nut spring
167460 203 1 Disengagement came
167471 204 1 Upper machined half nut
167472 206 1 Lower machined half nut
167475 208 1 Tube retainer
167281 209 1 Mechanical block + injected pad
167275 210 1 Flexible circuit clip
167271 220 1 Flexible circuit
167241 221 1 Complete disengagement shaft
167292 222 1 Diam.12 tube(version 20/60 ml)
167403 223 1 Injected centring ring
177203 1 O ring (to be placed in the centring ring)
177204 1 Inox plate (To be placed between the centring ring and the flask)
167291 224 1 Anti-siphon arm
167521 225 1 Pusher housing (injectomat)
167382 225 Pusher housing (Pilot Delta)
167259 226 1 Pusher housing clip
167442 227 1 Injected M 0.5 rack
167683 228 1 Diam. 36 protective sticker
167384 229 1 Injected contact plate
167132 230 1 Force sensor
173408 232 1 OMRON microswitch
162311 249 1 RP I 131 type photo inter
167288 253 1 C pusher support
167497 254 1 Pusher protection film
168231 256 1 Disengagement finger
167298 258 2 Flexible circuit protector
167272 259 1 Pusher/tube fastener
190714 260 1 Retaining ring
167385 261 1 Anti-siphon came
167264 1 Anti-siphon spring
167260 270 1 Disengagement lever
167245 271 1 Disengagement lever spring
167056 272 1 Pusher cover (Pilot Delta)
167519 272 1 Pusher cover (Injectomat)
167464 205 1 Half nut spring shaft
167487 257 1 Disengagement shaft bearing

Page : 58 NT 1023 Rev.B0

Motor reduction bloc

Mechanical kits

NT 1023 Rev.B0 page : 59

6.2.1.4. Motor reduction block

Reference Diag. Ref. Number Component

176443 294 1 Injected M5 gear
167963 296 1 HE13 wired potentiometer
167128 300 1 Motor rotation photo switch
168401 301 1 Support opto
167111 302 1 Motor rotation blade
167082 303 1 Pilot 2 Ph motor
167153 304 1 Pilot motor gear
167101 305 1 R100 reduction gear mainframe

6.2.1.5. Mechanical kits

Reference Diag. Ref. Number Component

170416 1 Main cord
167969 105/6/8/9 1 HE13 wired socket support C/D (Pilot Delta)
199188 105/6/8/9 1 HE13 wired socket support C/D (Injectomat)
167659 122/123 1 HE13 wired opto printed circuit
199136 298 1 pilot anest 2 mechanical kit

6.2.2. Electronical parts list

6.2.2.1. VA Power supply board

Reference Diag. Ref. Number Component

167536 116 1 Injectomat 2000 MC / Pilot Delta RS232 HE13 power

supply board (Pilot Delta)

167537 116 1 Injectomat 2000 MC / Pilot Delta RS232 HE13 power

supply board (Injectomat)

6.2.2.2. led display board

Reference Diag. Ref. Number Component

167566 114 1 PILOT Anaesthesia 2/B 9 LEDS display board

6.2.2.3. CPU board

Reference Diag. Ref. Number Component

167543 178 1 CPU board W. flange det. ANT + HE13

Warning

A Injectomat 2000 MC / Pilot Delta CPU Board should never be used on Pilot C, and vice versa. A CPU board is
configured for one device type only. This configuration include the calibration modes depends to the components
characteristics, the syringe list specific to the product code and the pump serial number located on the pump iden­tifical label stacked on the lower housing.

Page : 60 NT 1023 Rev.B0

6.2.3. Operator’s guide of Injectomat 2000 MC / Pilot Delta(NU)

It is possible to get this Operator’s guide, references:169540 (Injectomat 2000 MC in German), 169545 (Injectomat
2000 MC in English), 169610 (Pilot Delta in French) on simple request to our commercial service (see useful ad­dresses chapter 9).

6.2.4. Labels

6.2.4.1. Door Label

FR DIN IS BNF IT SP S B P
167892 167892 167892 167892 167892 167892 167892 167892 167892

6.2.4.2. Danger selection label

FR DIN IS BNF IT SP S B P
167741 167979 167776 167811 167778 167858 167886 167692 167692

6.2.4.3. Battery door label

FR DIN IS BNF IT SP S B P
167196 167196 167196 167196 167196 167196 167196 167196 167196

6.2.4.4. Main DANGER label (inside)

FR DIN IS BNF IT SP S B P
171091 171091 171091 171091 171091 171091 171091 171091 171091

6.2.4.5. Mains label(outside)

FR DIN IS NL IT SP S B P
168197 168197 168197 168197 168197 168197 168197 168197 168197

NT 1023 Rev.B0 page : 61

7 ANNEX 2: ELECTRONIC LAYOUT

7.1. Power supply and control board

7.1.1. Electronic layout

Designation DESIGN. REF

Motor power supply and control board ( 5/5 X A3) D1A0DB000

7.1.2. Installation layout

Designation DESIGN. REF

Motor power supply and control board Pilote Delta
(1/1 x A3)
Motor power supply and control board Injectomat 2000MC
(1/1 x A3)

7.2. CPU board

7.2.1. Electronic layout

Designation DESIGN. REF

CPU board (3/3 x A3) D1A0EY00

7.2.2. Installation layout

Designation DESIGN. REF

CPU board PILOTE AILETTE RS232 (C) (1/2 x A3 only) D3A0EY00

D3A0DB004
D3A0DB005

7.3. Display board

7.3.1. Electronic layout

Designation DESIGN. REF

Display board Pilote anesthesie 2 (3/3 x A3) D197GT000

7.3.2. Installation layout

Designation DESIGN. REF

Display board Pilote anesthesie 2 (2/2x A3) D397GT000

Page : 62 NT 1023 Rev.B0

NT 1023 Rev.B0 page : 63

8 ADDENDA AND INFORMATION BULLETINS

NT 0818 Rev.A1

NT 1023 Rev.B0

NT 0818 Rev.A1

9 USEFUL ADDRESSES

All requests for information or documentation (technical file, tubing catalogue or commercial documenta­tion should be addressed to:

CUSTOMER SERVICE INTERNATIONAL

Fresenius Vial

Le Grand Chemin, 38590 Brezins FRANCE

Tel.: [phone]or 10 54
Fax: [phone]

AFTER-SALES SERVICES

INTERNATIONAL Fresenius Vial

Le Grand Chemin, 38590 Brezins FRANCE

BELGIUM FRESENIUS NV/SA Belgique

DIVISION VIAL MEDICAL

Tel.: [phone]
Fax: [phone]

Tel.: [phone]

Fax: [phone]
Molenberglei 7
2627 Schelle
BELGIQUE

GERMANY

Changes may be made at regular intervals, for inclusion in subsequent editions.

This technical manual may not be reproduced in whole or in part without the written consent of Fresenius Vial S.A.

FRESENIUS MCM

AM-NEUNEN BERG 8
63749 ALZENAU
GERMANY

It is possible that this document contains errors or typing mistakes.

COPYRIGHT © 1998, Fresenius Vial S.A

Tel.: [phone]

Fax: [phone]

Fresenius Vial S.A. - head office: Le Grand Chemin - 38590 Brezins (FRANCE)

With directory and supervisor board - capital 90128000 F - SIREN Grenoble B 408 720 282

NT 1023 Rev.B0