Fresenius Optima PT, Optima VS, Optima ST Service manual
TECHNICAL
MANUAL
OPTIMA PT-VS-ST
TECHNICAL MANUAL
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 1 Index "b" New EMC standard, spare parts up date
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
3.1.3
3.1.4
SAV1, preventive maintenance configuration ....................................................... 24
SAV2, tube selection configuration ....................................................................... 24
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
Optima_PT-VS-ST_enTDM.fm 3
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
7.1.3
7.1.4
EtAL.1 Door calibration....................................................................................... 94
EtAL.2 Calibration of the flow rate corrective coefficient .................................... 95
EtAL.9 Calibrating the upstream and downstream pressure sensors ................ 96
44 Optima_PT-VS-ST_enTDM.fm
8 Spare parts catalogue.................................................................................... 99
8.1 Upper cover .......................................................................................... 99
8.2 Base..................................................................................................... 101
8.3 Optima pump angle bracket.............................................................. 103
Optima_PT-VS-ST_enTDM.fm 5
66 Optima_PT-VS-ST_enTDM.fm
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.
optima01_002b_en.fm 7
Presentation
1.2 Operation diagram
Presentation
8 optima01_002b_en.fm
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
optima01_002b_en.fm 9
Presentation
1.5.4 Conformity and norms
0459
Safety of Electro
Medical
Equipements
EMC
(ElectroMagnetic
Compatibility)
Direct Courant Equipotentiality Fonctionnal earth.
Conform to the 93/42/EEC Medical Directive. IP31 Protection against
splashing liquid.
Conform to EN/IEC 60601-1 and EN/IEC 60601-2-24. Protection against
leakage current: CF
type.
Conform to EN/IEC 60601-1-2 (second index)
and EN/IEC 60601-2-24.
Detailed information concerning electromagnetic compatibility is available in the chapter
"Guidance and manufactureris declaration on EMC" of the User Manual.
Protection against
electric shocks: class I.
Presentation
10 optima01_002b_en.fm
2 Description and operation
2.1 Physical description
Angle bracket
Control panel
Air bubble
Front cover
Door
Base
detector
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.
optima02_002b_en.fm 11
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.
Pin n°1
J1
Display board LCD screen side.
Pin n°1
J2
J3
Pin n°1
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
2 VBAT Battery voltage
3GND
4 MOSI-AFF Serial output
5GND
6 MISO-AFF Serial input
7GND
8 CLK-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
Description and operation
12 optima02_002b_en.fm
J1 connector to CPU board
Pin Signal Description
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
6 LD7 Data’s writing
7 R/W Gnd - Writing selection
8 LD6 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
2 COL1 Keyboard interface column
3 COL0 Keyboard interface column
4 Line 3 Keyboard interface
5 Line 2 Keyboard interface
6 Line1 Keyboard interface
7 Line 0 Keyboard interface
8 TON/OFF On/Off
9 CONTRÔLE
10 GND
optima02_002b_en.fm 13
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.
J1 J2
J4
J3
Pin n°1
J7
J6
J10J9
J8
J11
J12
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
2 VBAT Battery voltage
3GND
4 MOSI-AFFl Serial output
5GND
6 MISO-AFF Serial input
7GND
8 CLK-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
Description and operation
14 optima02_002b_en.fm
J12 drip detector connector
Pin Signal Description
1 Pulse-drip Low signal yield
2 GND
3GND
4 CDLED-drip Control LED 5V/ 40 mA
J4 motor
Pin Description
1 +Reel A
2 - Reel A
3 +Reel B
4 - Reel B
J6 power supply
Pin Signal Description
1 ALIM SECT Power supply
2 GND
3 ALIM EXT Not used
J8 battery
Pin Signal Description
1 VBATNC + Battery
2 ANA-CTN Temperature sensor Output
3GND
4 VBATNP + Battery before thermal fuse
connector
connector
connector
J11 RS232 connector / Nurse call
Pin Signal Description
1 TxD-PC Data reception from PC
2 RTS-PC Request to send from PC
3 DTR-PC PC terminal ready
4 RXD-PC Transmission of data to PC
5GND
6 Nurse Call Normally open contact
7 Nurse Call Common contact
8 Nurse Call Normally closed contact
J10 D.C. motor
Pin Description
1 + DC motor
2 - DC motor
connector
Description and operation
optima02_002b_en.fm 15
J2 sensors 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
8 GND
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
J9 air detector
Pin Description Description
1 /TST Sensor test
2 5V
3GND
4 /DETECT Air bubble detection
connector
Description and operation
16 optima02_002b_en.fm
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.
J6
J5
J4
J3
U1
U2
C3
Bars code
F2
J1
L1
J2
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
2 GND
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
4 VBAT NP
optima02_002b_en.fm 17
Description and operation
J6 battery input connector
Pin Description
1+ VBAT
2 VBAT NP
3 + Thermal sensor
4 - Thermal sensor
5GND
Description and operation
18 optima02_002b_en.fm
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.
optima02_002b_en.fm 19
Description and operation
Description and operation
20 optima02_002b_en.fm
3 Description of the menus
3.1 Parameter configuration menu
The configuration menu adapts the Optima to the particular needs of each department. It
accesses the menus that customise the infusion parameters.
Fresenius Vial recommends the presence of its qualified staff, or a member of your Technical
Department, who will assist you in implementing the configuration procedures you wish to
select.
The configuration mode is activated by holding down the "MODE"
key when the device is switched on.
The following menus are displayed:
! User setting,
! Wards setting,
! Maintenance.
Each menu consists of sub-menus. The sub-menus can be accessed
by using the "START" key.
To access some of the sub-menus, you need to type in an access code. This code can be
defined and/or de-activated in the Service configuration mode. As long as the device is kept
switched on, the code does not need to be keyed in again.
Main Menu Key in code Sub-menu Sub-menu
User setting Code XXXX
User setting menu
Wards setting Code 0200
Wards setting menu
Maintenance This code will be communicated at the end of the maintenance
technician training.
Te st
Maintenance tests menu
After-sales configuration
Maintenance configuration
menu
Calibration
Calibration menu
optima03.1_001b_en.fm 21
Description of the menus
Te st
TEst.1
operating period and maintenance date
Maintenance
Configuration
Calibration
TEst.2
TEst.3
TEst.4
TEst.5
TEst.6
TEst.9
TEst.A
TEst.C
TEst.E
TEst.F
TEst.J
SAV.1
SAV.2
SAV.3
EtaL.1
LED, LCD screen, 7-segment display and buzzer test
keyboard test
display’s the battery voltage
display’s the last 10 alarms codes
display’s the total running time
display’s the analogue sensor values
display’s the software version
clamping motor test
display’s the calibration values
infusion motor test
display’s the code last 10 alarm codes before error
preventive maintenance
tube selection
Beep
door calibration
EtaL.2
EtaL.9
The maintenance menu is reserved for qualified staff only.
corrective infusion coefficient
upstream and downstream pressure sensors
calibration
Description of the menus
22 optima03.1_001b_en.fm
3.1.1 Access to the menu
Key Function
ON switches on the device.
OFF switches off the device and exits the configuration mode when
pressed for more than three seconds.
SILENCE ALARM
MODE accesses the configuration mode.
The selection keys scroll through the numbers and letters, the tenths,
units and tens values.
Activate or de-activate choices.
ENTER moves the cursor.
START validates a selection.
STOP cancels the current configuration.
Activate the After-Sales Service test menu.
! Keep the "MODE" button pressed, during the device
switch on.
" The various menus are displayed.
! Select the "Maintenance" menu and confirm.
! Type in the access code and confirm.
! Select "Sav" and confirm.
! Use the selection keys to scroll through the various tests on
the LCD display.
optima03.1_001b_en.fm 23
Description of the menus
3.1.2 SAV1, preventive maintenance configuration
! SAV1, press "START".
" The running time since the last maintenance in hours and
the date are displayed on the LCD screen.
" To move the cursor use the enter key.
" Use the selection keys to modify a field.
" By validating once again, the new running time and date
are memorised and you may return to the After-sales
Service menu.
By pressing "STOP" you can cancel the modification and return to the Aftersales Service configuration menu.
You can exit the configuration mode at any time by pressing the "OFF" key.
3.1.3 SAV2, tube selection configuration
! SAV2, press "START".
" The list of available tubes is displayed on the LCD screen.
The tubes which have already been calibrated for pressure are marked with a "v".
" Select the tube using the keys.
" Press "START" to save the tube selection.
" When the device is switched on, the selected tube will
appear on the display unit.
By pressing "STOP", the modification is cancelled and you can return to the
After-sales Service configuration menu.
You can exit the configuration mode at any time by pressing the "OFF" key.
Description of the menus
24 optima03.1_001b_en.fm
3.1.4 SAV3, "Beep"
This option is available on Optima pump equipped with software version 1.8e minimum.
!
SAV3, press "START".
! + 10 s. (not activated)
! + 0 s. (activated)
" Select your choice using the key.
# 10 s: the audible alarm "Beep" is triggered every 10
seconds.
# 0 s: the audible alarm "Beep" is triggered every 0
second.
" Press "START" to record your selection.
By pressing "STOP", the modification is cancelled and you can return to the
After-sales Service configuration menu.
You can exit the configuration mode at any time by pressing the "OFF" key.
optima03.1_001b_en.fm 25
Description of the menus
Description of the menus
26 optima03.1_001b_en.fm
Description of the menus
3.2 Calibration menu
The calibration menu is reserved for qualified staff only. Its access is protected by a
secret code. To find out about the operating mode for the various calibrations, refer
to the "Calibrations" chapter.
This menu enables manual calibration of:
!
ETAL.1: the door,
!
ETAL.2: the corrective coefficient for the infusion flow rate by tube type,
!
ETAL.9: the upstream and downstream pressure sensors.
optima03.3_001b_en.fm 27
Description of the menus
Description of the menus
28 optima03.3_001b_en.fm
Description of the menus
3.3 After-Sales Service test menu
The After-Sales Service test menu is reserved for qualified personnel. It enables a series of
checks that can be carried out on the Optima pump to confirm it is operating correctly. (See
chapter "Checks"). These must be carried out each time parts are replaced.
The After-Sales Service tests can also be carried out more quickly and simply from a PC
using our maintenance software. (Contact our After-Sales Service department.)
The Service test menu contains a series of 17 tests or checks:
!
tESt.1: operation period and maintenance date display
!
tESt.2: indicator lights test
!
tESt.3: keyboard test
!
tESt.4: battery voltage test
!
tESt.5: display’s the last 10 alarms codes
!
tESt.6: display’s the total operating period
!
tESt.9: display’s the analogue sensor values
!
tESt.A: display’s the software version
!
tESt.C: clamping motor test (only Optima VS)
!
tESt.E: display’s the calibration values
!
tESt.f: infusion motor test
!
tESt.J: display’s the last 10 alarm codes before error
A log of more than 760 time-stamped events can be consulted using our maintenance
software "VP Control". (Contact our After-Sales Service department.)
optima03.4_002b_en.fm 29
Description of the menus
Description of the menus
30 optima03.4_002b_en.fm
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