Fresenius Kabi OPTIMA PT-VS-S User manual

TECHNICAL MANUAL
TECHNICAL
MANUAL
OPTIMA PT-VS-ST
From Serial N° 18180100 till ...

Revision table
TM Optima PT-VS-ST_en : ref NT1741
Date Revision Chapter Description
03/04/03 0 All index "a" création
20/08/07 1Index "b" New EMC standard, spare parts up date

Optima_PT-VS-ST_enTDM.fm 3
1 Presentation...................................................................................................... 7
1.1 General presentation ............................................................................. 7
1.2 Operation diagram ................................................................................. 8
1.3 Precautions for use................................................................................ 9
1.4 Operation safety ..................................................................................... 9
1.5 Technical characteristics ...................................................................... 9
1.5.1 Electrical details .........................................................................................................9
1.5.2 Electronic details ........................................................................................................ 9
1.5.3 Mechanical details...................................................................................................... 9
1.5.4 Conformity and norms.............................................................................................. 10
2 Description and operation............................................................................. 11
2.1 Physical description ............................................................................ 11
2.1.1 Display board and front panel .................................................................................. 12
2.1.2 The CPU board ........................................................................................................ 14
2.1.3 The power supply board and battery........................................................................ 17
2.2 Operational description ....................................................................... 19
2.2.1 Tube check and maintenance sub-assembly........................................................... 19
2.2.2 Pumping sub-assembly............................................................................................ 19
2.2.3 External connection sub-assembly .......................................................................... 19
3 Description of the menus .............................................................................. 21
3.1 Parameter configuration menu ........................................................... 21
3.1.1 Access to the menu.................................................................................................. 23
3.1.2 SAV1, preventive maintenance configuration ....................................................... 24
3.1.3 SAV2, tube selection configuration ....................................................................... 24
3.1.4 SAV3, "Beep" ........................................................................................................ 25
3.2 Calibration menu .................................................................................. 27
3.3 After-Sales Service test menu............................................................. 29
4 Preventive maintenance ................................................................................ 31
4.1 Recommendations ............................................................................... 31
4.2 Maintenance schedule ......................................................................... 31
4.2.1 Preventive maintenance........................................................................................... 31
4.2.2 Quality control .......................................................................................................... 31
4.3 Checks................................................................................................... 33
4.3.1 Accessing the tests .................................................................................................. 33
4.3.2 Visual check ............................................................................................................. 33
4.3.3 Operating period and maintenance date.................................................................. 34
4.3.4 Indicator lights test ................................................................................................... 34
4.3.5 Keyboard check ....................................................................................................... 35
4.3.6 Battery voltage check............................................................................................... 35
4.3.7 Checking the last 10 alarms..................................................................................... 35

44Optima_PT-VS-ST_enTDM.fm
4.3.8 Checking the total operating period ......................................................................... 37
4.3.9 Checking the analogue sensor input........................................................................ 37
4.3.10 Checking the software version ................................................................................. 38
4.3.11 Checking the motor clamp (only Optima VS) .......................................................... 38
4.3.12 Checking the calibration values ............................................................................... 39
4.3.13 Checking the infusion motor..................................................................................... 39
4.3.14 Checking the last 10 events before a locking alarm or error .................................... 40
4.3.15 Checking the pressure alarm limit............................................................................ 40
4.3.16 Flow rate check ........................................................................................................ 41
4.3.17 Air detector check .................................................................................................... 41
4.3.18 Battery autonomy check........................................................................................... 41
4.3.19 Continuity test .......................................................................................................... 42
4.3.20 Contrast check ......................................................................................................... 42
4.3.21 Timestamp check ..................................................................................................... 42
4.3.22 Quality Control Certificate ........................................................................................ 43
4.4 Cleaning and disinfecting ................................................................... 45
4.5 Storage.................................................................................................. 46
5 Troubleshooting..............................................................................................47
5.1 Breakdown guide ................................................................................. 47
5.2 Error messages ................................................................................... 51
6 Intervention procedures.................................................................................55
N∞1, Procedure: CPU board ....................................................................... 57
N∞2, Procedure: Display board .................................................................. 61
N∞3, Procedure: Pumping system ............................................................. 65
N∞4, Procedure: LCD display .................................................................... 69
N∞5, Procedure: Air detector board........................................................... 73
N∞6, Procedure: Pressure sensor.............................................................. 77
N∞7, Procedure: OCS clamp motor (if OCS is present) ........................... 81
N∞8, Procedure: Power supply board ....................................................... 85
N∞9, Procedure: Battery ............................................................................. 87
N∞10, Procedure: Front cover, base and angle bracket .......................... 89
7 Calibration .......................................................................................................93
7.1 Calibration procedure.......................................................................... 93
7.1.1 Access to the calibrations ........................................................................................ 93
7.1.2 EtAL.1 Door calibration....................................................................................... 94
7.1.3 EtAL.2 Calibration of the flow rate corrective coefficient .................................... 95
7.1.4 EtAL.9 Calibrating the upstream and downstream pressure sensors ................ 96

Optima_PT-VS-ST_enTDM.fm 5
8 Spare parts catalogue.................................................................................... 99
8.1 Upper cover .......................................................................................... 99
8.2 Base..................................................................................................... 101
8.3 Optima pump angle bracket .............................................................. 103

66Optima_PT-VS-ST_enTDM.fm

optima01_002b_en.fm 7
Presentation
1 Presentation
1.1 General presentation
The Optima pump is a new pump based on the same pumping mechanism as the MVP
pump. It is used for infusion of intravenous agents.
There are three types of the Optima pump:
PT: for standard PVC tubes with a drop detector.
VS: for standard PVC tubes. The drop detector is optional. The pump is equipped with an
automatic occlusion checking system (OCS).
ST: for silicon tubes equipped with a drop detector.
The Optima pump has its own control keyboard and distinct displays. It has an internal
battery which ensures a minimum autonomy of 4 hours for a flow rate of 125 ml/h.
A choice of easily accessible configurations enables optimal use of the functions according to
the needs of each department.

8optima01_002b_en.fm
Presentation
1.2 Operation diagram

optima01_002b_en.fm 9
Presentation
1.3 Precautions for use
The symbol which appears on the device’s condensed user instructions recommends a
complete reading of the user instructions, in accordance with norm EN 60 601-1.
Fresenius Vial cannot, in any circumstances, be held responsible for any medical or other
problem due to incorrect use of the device.
Kindly consult the user manual for more details.
1.4 Operation safety
As soon as it is in operation, the device ensures permanent surveillance of its functions. Any
internal fault or any procedural anomaly is immediately detected. Nevertheless, abnormal
functioning of the device, without a defined cause, must always be brought to the attention of
the qualified staff in your establishment or our After-sales Service.
The Optima pump contains an internal battery which ensures normal functioning during a
mains power cut. In addition, two fuses protect the affected mains area.
1.5 Technical characteristics
1.5.1 Electrical details
!External power supply: 100 - 240 Vac.
!Max. consumption: 50 VA.
!Battery: 6 V - 2.7/ 3 Ah - NIMH.
!Fuse: 2 x 630 mA T IEC 127.
1.5.2 Electronic details
The Optima volumetric pump has 4 electronic boards:
!CPU board
!Display board
!Power supply board
!Air detector board
1.5.3 Mechanical details
!Dimensions: H x L x W: 135 x 175 x 145 mm.
!Weight: approx. 2.9 kg
!

10 optima01_002b_en.fm
Presentation
1.5.4 Conformity and norms
Detailed information concerning electromagnetic compatibility is available in the chapter
"Guidance and manufactureris declaration on EMC" of the User Manual.
0459
Conform to the 93/42/EEC Medical Directive.IP31 Protection against
splashing liquid.
Safety of Electro
Medical
Equipements
Conform to EN/IEC 60601-1 and EN/IEC 60601-2-24. Protection against
leakage current: CF
type.
EMC
(ElectroMagnetic
Compatibility)
Conform to EN/IEC 60601-1-2 (second index)
and EN/IEC 60601-2-24.
Protection against
electric shocks: class I.
Direct Courant Equipotentiality Fonctionnal earth.

optima02_002b_en.fm 11
Description and operation
2 Description and operation
2.1 Physical description
The Optima pump is made out of a front cover,a base and an angle bracket.
!The front cover contains:
"a display board linked to the control panel,
"a CPU board,
"an air detector board,
"the OCS system if OCS is present.
!The base supports the door and contains:
"the pump body unit.
!The angle bracket contains:
"a power supply board,
"the battery.
Angle bracket
Front cover
Control panel
Door
Air bubble
Base
detector

12 optima02_002b_en.fm
Description and operation
2.1.1 Display board and front panel
The display board is situated under the control panel and contains all the essential parts for
the man-machine interaction:
!keyboard,
!synoptic and control indicators,
!7-segment displays,
!LCD screen.
Display board LCD screen side.
Display board component side
This board is connected to the various equipment by means of connectors:
J1 connector to CPU board
Pin Signal Description
1 5V Power supply
2VBAT Battery voltage
3GND
4MOSI-AFF Serial output
5GND
6MISO-AFF Serial input
7GND
8CLK-AFF Serial clock
9GND
10 CSLCD LCD selection
11 GND
12 CSAFCL Display selected
13 GND
14 A0AFF LCD address
15 GND
16 RESET/
17 GND
J1
Pin n°1
J2
J3
Pin n°1
Pin n°1

optima02_002b_en.fm 13
Description and operation
18 TON/OFF ON/OFF Signal
19 VBAT Battery voltage
20 5V Power supply
J2 connector to LCD
Pin Signal Description
1 + led VBAT + back light
2- led - back light
3+5V
4/RESET /RESET
5VSS Gnd
6LD7 Data’s writing
7 R/W Gnd - Writing selection
8LD6 Data’s writing
9 A0AFF LCD address
10 LD5 Data’s writing
11 LD4 Data’s writing
12 LD3 Data’s writing
13 LD2 Data’s writing
14 LD1 Data’s writing
15 LD0 Data’s writing
16 Enable
17 LCDCS2 Chip select
18 /LCDCS1 Chip select
J3 connector to keyboard
Pin Signal Description
1 COL2 Keyboard interface column
2COL1 Keyboard interface column
3 COL0 Keyboard interface column
4Line 3 Keyboard interface
5 Line 2 Keyboard interface
6Line1 Keyboard interface
7 Line 0 Keyboard interface
8TON/OFF On/Off
9 CONTRÔLE
10 GND
J1 connector to CPU board
Pin Signal Description

14 optima02_002b_en.fm
Description and operation
2.1.2 The CPU board
The CPU board contains a 80C32 micro-processor. It is connected to the display board by
means of the J1 connector.
CPU board
Info: Pin 1 of connector J1 is opposite to that indicated by the CPU board screen printing.
J1 display board connector
Pin Signal Description
1 5V Power supply
2VBAT Battery voltage
3GND
4MOSI-AFFl Serial output
5GND
6MISO-AFF Serial input
7GND
8CLK-AFF Serial clock
9GND
10 CSLCD LCD selection
11 GND
12 CSAFCL Display selected
13 GND
14 A0AFF Address LCD
15 GND
16 RESET/
17 GND
18 GNDTON/OFF Signal ON/OFF
19 VBAT Battery voltage
20 5V Power supply
J4
J3 J1 J2
J12
J7
J10J9
J11
J8
J6
Pin n°1

optima02_002b_en.fm 15
Description and operation
J12 drip detector connector
J4 motor connector
J6 power supply connector
J8 battery connector
J11 RS232 connector / Nurse call
J10 D.C. motor connector
Pin Signal Description
1 Pulse-drip Low signal yield
2GND
3GND
4CDLED-drip Control LED 5V/ 40 mA
Pin Description
1 +Reel A
2- Reel A
3 +Reel B
4- Reel B
Pin Signal Description
1 ALIM SECT Power supply
2GND
3 ALIM EXT Not used
Pin Signal Description
1 VBATNC + Battery
2ANA-CTN Temperature sensor Output
3GND
4VBATNP + Battery before thermal fuse
Pin Signal Description
1 TxD-PC Data reception from PC
2RTS-PC Request to send from PC
3 DTR-PC PC terminal ready
4RXD-PC Transmission of data to PC
5GND
6Nurse Call Normally open contact
7 Nurse Call Common contact
8Nurse Call Normally closed contact
Pin Description
1 + DC motor
2- DC motor

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Description and operation
J2 sensors connector
J9 air detector connector
Pin Signal Description
1GND
2/PRES_CLAMP CLAMP presence
3 CD_CLAMP/ CLAMP detector power supply
4+AMPLI_AM Input + ampli sensor upstream pressure
5 - ALIM_AM Upstream pressure sensor power supply return
6- AMPLI_AM Input - ampli upstream pressure sensor
7 + ALIM_AM Upstream pressure sensor power supply
8GND
9 - Hall effect sensor power supply
10 GND
11 ANA_HALL Hall effect sensor output
12 + AMPLI_AV Input + ampli downstream pressure sensor
13 - ALIM_AV Downstream pressure sensor power supply
return
14 - AMPLI_AV Input - ampli downstream pressure sensor
15 + ALIM_AV Downstream pressure sensor power supply
16 GND
17 ET OPTO State of sensor
18 GND
19 +5 V 5 V power supply
20 -Power supply sensor return
Pin Description Description
1 /TST Sensor test
25V
3GND
4/DETECT Air bubble detection

optima02_002b_en.fm 17
Description and operation
2.1.3 The power supply board and battery
The power supply board is positioned on the angle bracket. It supplies power to the electronic
unit from the 230 VAC network. It also ensures a battery charge of 2.7/3 Ah.
Power supply board
This board is connected to the various parts by means of connectors. F2 is time-delayed
fuses of 630 mAT.
J1 functional Earth connector
J2 Mains connector
Pin Description
1 PH Phase (100 - 240 Vac)
2 N Neutral (100 - 240 Vac)
J3 power supply output connector
Pin Description
1 9V Sect 9V output convertor AC/DC
2GND
3 9V Ext 9V external power supply not used
J4 battery output connector to the CPU board
Pin Description
1+Vbat
2+Thermal sensor
3GND
4VBAT NP
F2
J1
J3
J4 J5
J6
U1
U2
L1
J2
C3
Bars code

18 optima02_002b_en.fm
Description and operation
J6 battery input connector
Pin Description
1+VBAT
2VBAT NP
3 + Thermal sensor
4- Thermal sensor
5GND

optima02_002b_en.fm 19
Description and operation
2.2 Operational description
From an operational point of view, the Optima pump is made up of 3 sub-assemblies:
!a sub-assembly to maintain to check the correct positioning of the tube,
!a motorisation sub-assembly,
!an external connection sub-assembly.
2.2.1 Tube check and maintenance sub-assembly
The tube is positioned along the front part and held in place by the door.
The front part is equipped with four detection systems:
!a detector to check the closed /open position of the door,
!an ultra-sound detector to detect the presence of air bubbles in the tube.
!The pressure detection is ensured by two piezo-resistant sensors.
2.2.2 Pumping sub-assembly
The pumping sub-assembly contains the peristaltic pumping mechanism.
The mechanism is made up of a camshaft that creates a wave-like movement in a bank of 14
’fingers’. The displacement of these ’fingers’ is controlled by the CPU board, while turning it
displaces the liquid at the programmed flow rate.
The cam shaft is driven by a stepper-motor and a reduction gearbox assembly via a toothed
belt.
An optical disc attached to the end of the cam shaft controls its rotation.
2.2.3 External connection sub-assembly
The Optima contains two connectors located at the rear of the lower case:
!an RS 232 connector/Nurse call,
!a connector dedicated to the drip detector.

20 optima02_002b_en.fm
Description and operation