Fresenius Kabi Optima PT Vs ST Technical Manual PDF

SERVICES
Optima pt/vs/st
Technical Manual
Revision table
TM Optima PT-VS-ST_Int : ref NT1741 / from serial n° 18180100 till...
Date Revision Chapter Description

03/04/03 0 All index "a" Creation
20/08/07 1 Index "b" New EMC standard, spare parts up date
15/06/09 2 Index "c" Update :

2.1.2 Nurce call description pin 6 and pin 8 /
J11,
4.3.7 et 5.2 New error code Er 64,
7 Min/max of pressure value are canceled,
8 Spare parts catalogue.
1 Presentation...................................................................................................... 5
1.1 General presentation ............................................................................. 5
1.2 Operation diagram ................................................................................. 6
1.3 Precautions for use................................................................................ 7
1.4 Operation safety ..................................................................................... 7
1.5 Technical characteristics ...................................................................... 7
1.5.1 Electrical details ......................................................................................................... 7
1.5.2 Electronic details ........................................................................................................ 7
1.5.3 Mechanical details...................................................................................................... 7
1.5.4 Conformity and norms ................................................................................................ 8
2 Description and operation ............................................................................... 9

2.1 Physical description .............................................................................. 9
2.1.1 Display board and front panel .................................................................................. 10
2.1.2 The CPU board ........................................................................................................ 12
2.1.3 The power supply board and battery........................................................................ 15
2.2 Operational description ....................................................................... 17
2.2.1 Tube check and maintenance sub-assembly ........................................................... 17
2.2.2 Pumping sub-assembly ............................................................................................ 17
2.2.3 External connection sub-assembly .......................................................................... 17
3 Description of the menus .............................................................................. 19

3.1 Parameter configuration menu ........................................................... 19
3.1.1 Access to the menu.................................................................................................. 21
3.1.2 SAV1, preventive maintenance configuration ....................................................... 22
3.1.3 SAV2, tube selection configuration ....................................................................... 22
3.1.4 SAV3, "Beep" ........................................................................................................ 23
3.2 Calibration menu .................................................................................. 25
3.3 After-Sales Service test menu............................................................. 27
4 Preventive maintenance ................................................................................ 29

4.1 Recommendations ............................................................................... 29
4.2 Maintenance schedule ......................................................................... 29
4.2.1 Preventive maintenance........................................................................................... 29
4.2.2 Quality control .......................................................................................................... 29
4.3 Checks................................................................................................... 31
4.3.1 Accessing the tests .................................................................................................. 31
4.3.2 Visual check ............................................................................................................. 32
4.3.3 Operating period and maintenance date .................................................................. 32
4.3.4 Indicator lights test ................................................................................................... 32
4.3.5 Keyboard check ....................................................................................................... 33
4.3.6 Battery voltage check ............................................................................................... 33
4.3.7 Checking the last 10 alarms ..................................................................................... 33
Optima_PT-VS-ST_enTDM.fm 3
4.3.8 Checking the total operating period ......................................................................... 35
4.3.9 Checking the analogue sensor input........................................................................ 35
4.3.10 Checking the software version ................................................................................. 36
4.3.11 Checking the motor clamp (only Optima VS) .......................................................... 36
4.3.12 Checking the calibration values ............................................................................... 37
4.3.13 Checking the infusion motor..................................................................................... 37
4.3.14 Checking the last 10 events before a locking alarm or error .................................... 38
4.3.15 Checking the pressure alarm limit ............................................................................ 38
4.3.16 Flow rate check ........................................................................................................ 39
4.3.17 Air detector check .................................................................................................... 39
4.3.18 Battery autonomy check........................................................................................... 39
4.3.19 Continuity test .......................................................................................................... 40
4.3.20 Contrast check ......................................................................................................... 40
4.3.21 Timestamp check ..................................................................................................... 40
4.3.22 Quality Control Certificate ........................................................................................ 41
4.4 Cleaning and disinfecting ................................................................... 43
4.5 Storage.................................................................................................. 44
5 Troubleshooting.............................................................................................. 45
5.1 Breakdown guide ................................................................................. 45
5.2 Error messages ................................................................................... 49
6 Intervention procedures................................................................................. 53
N°1, Procedure: CPU board ....................................................................... 55
N°2, Procedure: Display board .................................................................. 59
N°3, Procedure: Pumping system ............................................................. 63
N°4, Procedure: LCD display .................................................................... 67
N°5, Procedure: Air detector board........................................................... 71
N°6, Procedure: Pressure sensor.............................................................. 75
N°7, Procedure: OCS clamp motor (if OCS is present) ........................... 79
N°8, Procedure: Power supply board ....................................................... 83
N°9, Procedure: Battery ............................................................................. 85
N°10, Procedure: Front cover, base and angle bracket .......................... 87
7 Calibration ....................................................................................................... 91
7.1 Calibration procedure.......................................................................... 91
7.1.1 Access to the calibrations ........................................................................................ 91
7.1.2 EtAL.1 Door calibration....................................................................................... 92
7.1.3 EtAL.2 Calibration of the flow rate corrective coefficient .................................... 93
7.1.4 EtAL.9 Calibrating the upstream and downstream pressure sensors ................ 94
8 Spare parts catalogue .................................................................................... 97

8.1 Upper cover .......................................................................................... 97
8.2 Base ...................................................................................................... 99
8.3 Optima pump angle bracket.............................................................. 101
44 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.
Presentation
optima01_002b_en.fm 5
1.2 Operation diagram
Presentation
6 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
Presentation
1.5.4 Conformity and norms
Conform to the 93/42/EEC Medical Directive. IP31 Protection against

0459 splashing liquid.
Safety of Electro Conform to EN/IEC 60601-1 and EN/IEC 60601-2-24. Protection against
Medical leakage current: CF
Equipements type.
EMC Conform to EN/IEC 60601-1-2 (second index) Protection against
(ElectroMagnetic and EN/IEC 60601-2-24. electric shocks: class I.
Compatibility)
Direct Courant Equipotentiality Fonctionnal earth.
Detailed information concerning electromagnetic compatibility is available in the chapter

"Guidance and manufactureris declaration on EMC" of the User Manual.
Presentation
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:

Description and operation
" a power supply board,

" the battery.
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
3 GND
4 MOSI-AFF Serial output
5 GND
6 MISO-AFF Serial input
7 GND
8 CLK-AFF Serial clock
9 GND
10 CSLCD LCD selection
11 GND
12 CSAFCL Display selected
13 GND
14 A0AFF LCD address
15 GND
16 RESET/
17 GND
J1 connector to CPU board

18 TON/OFF ON/OFF Signal
20 5V Power supply
J2 connector to LCD

1 + led VBAT + back light
2 - led - back light
3 +5V
4 /RESET /RESET
5 VSS Gnd
6 LD7 Data’s writing
7 R/W Gnd - Writing selection
9 A0AFF LCD address
16 Enable
17 LCDCS2 Chip select
18 /LCDCS1 Chip select
J3 connector to keyboard

1 COL2 Keyboard interface column
4 Line 3 Keyboard interface
6 Line1 Keyboard interface
8 TON/OFF On/Off
9 CONTRÔLE
10 GND
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
J9 J10
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

1 5V Power supply
3 GND
4 MOSI-AFFl Serial output
5 GND
6 MISO-AFF Serial input
7 GND
8 CLK-AFF Serial clock
9 GND
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
20 5V Power supply
J12 drip detector connector
1 Pulse-drip Low signal yield
2 GND
3 GND
4 CDLED-drip Control LED 5V/ 40 mA
J4 motor connector
Pin Description
1 +Reel A
2 - Reel A
3 +Reel B
4 - Reel B
J6 power supply connector

1 ALIM SECT Power supply
2 GND
3 ALIM EXT Not used
J8 battery connector

1 VBATNC + Battery
2 ANA-CTN Temperature sensor Output
3 GND
4 VBATNP + Battery before thermal fuse
J11 RS232 connector / Nurse call

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
5 GND
6 Nurse Call Normally closed contact
7 Nurse Call Common contact
8 Nurse Call Normally open contact
J10 D.C. motor connector
Pin Description
1 + DC motor
2 - DC motor
J2 sensors connector

1 GND
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 connector
Pin Description Description

1 /TST Sensor test
2 5V
3 GND
4 /DETECT Air bubble detection
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
J4 J5
J3
U1
U2
C3
Bars code
F2 L1
J2
J1
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
3 GND
4 VBAT NP
J6 battery input connector
Pin Description
1 + VBAT
2 VBAT NP
3 + Thermal sensor
4 - Thermal sensor
5 GND
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.
18
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.
Test
Maintenance tests menu
After-sales configuration
Maintenance configuration
menu
Calibration
Calibration menu
Description of the menus
optima03.1_001b_en.fm 19
Test TEst.1 operating period and maintenance date
TEst.2 LED, LCD screen, 7-segment display and buzzer test
TEst.3 keyboard test
TEst.4 display’s the battery voltage
TEst.5 display’s the last 10 alarms codes

Maintenance
TEst.6 display’s the total running time
TEst.9 display’s the analogue sensor values
TEst.A display’s the software version
TEst.C clamping motor test (VS only)
TEst.E display’s the calibration values
TEst.F infusion motor test
TEst.J display’s the code last 10 alarm codes before error
Configuration SAV.1 preventive maintenance
SAV.2 tube selection
SAV.3 Beep
Calibration EtaL.1 door calibration
EtaL.2 corrective infusion coefficient
EtaL.9 upstream and downstream pressure sensors

calibration
The maintenance menu is reserved for qualified staff only.

20 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.
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 After-
sales Service configuration menu.
You can exit the configuration mode at any time by pressing the "OFF" key.
3.1.3 SAV2, tube selection configuration

" 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.
3.1.4 SAV3, "Beep"
This option is available on Optima pump equipped with software version 1.8e minimum.
! + 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.
24
optima03.1_001b_en.fm
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.
26
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.)
28
4 Preventive maintenance
4.1 Recommendations
The Optima pump can only be checked, serviced or repaired by Fresenius Vial or by a
certified and approved maintenance service. Any abnormal functioning of the pump must be
brought to the attention of your in-house qualified technical personnel or our After-Sales
Service.
Should you need to return the pump to our After-Sales Service, it should be cleaned,
disinfected and very carefully packaged, preferably in its original packaging, before being
sent.
For all information concerning the repair and use of the pump, kindly contact our After-Sales
Service or our Sales department.
Fresenius Vial is not liable for loss or damage to the pump during its transport to our After-
Sales Service.
4.2 Maintenance schedule
4.2.1 Preventive maintenance

In order to maintain the pump’s performance, a Preventive Maintenance inspection
must be carried out every 3 years. This procedure, which includes changing the
battery, should be carried out by a qualified technician.
Any abnormal functioning or failure must be reported to the qualified technical staff in your
organisation or to our After-Sales Service. In these instances, the pump should not be used.
Important: If these maintenance procedures are not observed, the pump’s correct
operation will be impaired.
4.2.2 Quality control

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

treatment of the electrical an electronic equipment waste. Remove the
Preventive maintenance
battery from the device and return it to competent recycling organization.
optima04.1&2_001c_en.fm 29
30 optima04.1&2_001c_en.fm
4.3 Checks
In order to ensure the preventive maintenance follow-up, a regular servicing inspection is
recommended every 12 months (see "Quality Control Certificate").
Recharge the battery during 16h before starting the checking procedure !
4.3.1 Accessing the tests
Keyboard description.
Key Function
OFF switches off the device when pressed for over three seconds.
SILENCE ALARM
STOP, cancels the current test.
START validates a selection.
MODE accesses the test mode.
The selection keys scroll through the numbers and letters on the tenths,
units and tens values, and activate or de-activate the infusion menus.
ENTER validates your test selection or moves the cursor.
Activate the After-Sales Service test menu.

! Keep the "MODE" button pressed, during the device
switch on.
! Select the "Maintenance" menu and confirm.

! Type in the access code and confirm.
! Select "Test" and confirm.
! Use the selection keys to scroll through the various tests on

the LCD display.
optima04.3_002c_en.fm 31
4.3.2 Visual check
Check the general aspect of the case and labels and check for shock impact damage.
4.3.3 Operating period and maintenance date

This test displays ! tESt.1, press "START".
the Optima’s
running time since
" The running time and the last service inspection date is
its last servicing
displayed on the LCD screen.
inspection. It also
displays and " If Ctr1 flashes: service inspection is required.
modifies the "last" " Press"ENTREE" to select the date.
servicing
inspection date.
When the servicing
inspection date is
modified, the
operating time is
resetted.
When reading of this information, you can modify the date,

month and year of the service inspection date by using
the units and tens "- and+" keys. The date will be stored
in EEPROM and the running time will be reset to zero.
" A new test can be selected by confirming once again.
The test may be interrupted at any time by pressing "STOP" and a

new test may be selected.
4.3.4 Indicator lights test

This test checks ! tEeSt.2, press "START".
the correct " All the leds, 7-segment displays and the LCD lighten up.
functioning of the " When validating again
indicator lights, the # the leds and displays scroll across one by one from
LCD screen left to right (leds display, 7 segment display by
display, front panel segment and then by section of 8).
and buzzer. # An image scrolls across the LCD screen.
The test is OK if all the indicator lights have lit up and the buzzer has gone off.
You may interrupt the test at any time by pressing "STOP" and returning
to the test selection.
If the display is faulty, replace the display board (see "Display Board procedure).
32 optima04.3_002c_en.fm
4.3.5 Keyboard check
This test checks ! tESt.3, press "START".
that the keyboard
keys are
functioning " The following screen appears:
correctly. " Press each key one by one,
# The keys that have been pressed appear as a
reverse video image on the LCD screen.
If two keys or more are held down simultaneously, "beep! beep! beep!" will be heard,
indicating an error.
You may exit the test at any time by pressing

"START" for more than 3 seconds, returning to the test selection.
4.3.6 Battery voltage check

the mains or " The voltage is displayed in volts.
battery voltage in
volts or in tenths of
# If the Optima pump is running on battery, the LCD
volts.
screen displays, for example:
# If the Optima pump is running on the mains, the LCD

displays, for example:
" By confirming once again, a new test may be selected.
4.3.7 Checking the last 10 alarms

in code form the " The code for the most recent alarm is displayed at the top
last ten alarms of the LCD screen.
which have been
triggered on the
" Press the selection keys to display the following codes
Optima pump.
from 1xxx to 10xxx.
" By validating once again, a new test may be selected.
Alarm or error codes description:
Alarm Description
A10 Battery alarm
A12 End of infusion alarm
A16 Downstream occlusion alarm
A17 Air detection alarm
A18 Air volume alarm
A19 Upstream occlusion alarm
A20 Tube absence alarm
A21 Mobile clamp absence alarm.
A22 Door alarm
A23 Drip detector absence alarm
A24 Drip detector alarm: under flow
A25 Drip detector alarm: over flow
A26 Free flow
A27 Occlusion problem during auto-set
OFF Normal stop
FAIL Abnormal stop
Error Description
Er10 Internal RAM
Er20 External RAM
Er30 Check-sum Flash
Er40 Access (E2prom) Eeprom
Er50 Access Adc
Er60 Tube parameters
Er70 Motor frequency
Er80 Keyboard matrix (key press non functioning)
Er90 Check-sum Flash or software version µC secondary
Er01 Rotation (absence top turn)
Er11 Rotation (white or black too great)
Er21 Rotation (incorrect number of turns)
Er31 Automatic clamping motor
Er41 Rotation (presence top turn)
Er14 Period calculation parameters verification
Er24 Rotation direction verification
Er44 Incoherence quartz µC principal and µC secondary
Er54 Absence display board

E64 Battery perfomance is too weak
Er74 Battery disconnection (3)
Er84 Battery charge (3) fault
Er94 Battery temperature fault
Er55 µC secondary access
Error Description
Er65 Absence LCD display back light
Er85 Restart µC secondary
Er16 Date and time in µC secondary verification
Er56 Association condition output/step number
Er17 Keyboard matrix (key press and columns inactive)
Er27 Keyboard check default (path not fine tuned)
Er37 ON/OFF key locked
Er47 Switching off impossible
Er28 Language file incompatible
4.3.8 Checking the total operating period

the total period of
operation for the
" The running time is displayed on the LCD screen.
Optima pump. The
value cannot be
modified manually.
4.3.9 Checking the analogue sensor input
! tESt.9, press "START".

" The LCD screen displays:
# Upstream pressure, e.g.:

# Downstream pressure, e.g.:
# Door sensor, e.g.:
If the value is out of limits, recalibrate the force sensor. (See "EtAL9 upstream and
downstream pressure sensors calibration").
4.3.10 Checking the software version
This test displays ! tESt.A, press "START".
the software
version and
revision numbers.
# the name of the Optima pump.
# the software version.
# the date.
" Press the tenths keys to continue the test.

# the language versions.
4.3.11 Checking the motor clamp (only Optima VS)
! tESt.C, press "START".

# clamping
# unclamping
" Moving from clamping to unclamping occurs automatically

after confirming one of the two functions using the
selection keys.
" Press "START" to carry out the clamping or unclamping.
You may interrupt the test at any moment by pressing "STOP" and
returning to the test selection.
4.3.12 Checking the calibration values
This test displays ! tEStE, press "START".
the calibration
values recorded in
the EEPROM. " Move to another value using the keys.
Display Description
Por1 Hall effect sensor, door closed without tube.
Por2 Hall effect sensor, door open.
Por3 Hall effect sensor, door closed with filled tube.
PaM1 Upstream pressure, door open.
PaM2 Upstream pressure, 0 mmHg, with filled tube.
PaV1 Downstream pressure, door open.
PaV2 Downstream pressure, 0 mmHG, with filled tube.
PaV3 Downstream pressure, 750 mmHg, with filled tube.
! By confirming once again, a new test may be selected.
The value between brackets after the title is the number of calibrations carried out. The
display of the upstream and downstream pressure values is carried out according to the
number of active tubes.
4.3.13 Checking the infusion motor

This test starts the ! tESt.F, press "START".
motor without " Select an infusion flow rate (0.1 ml/h to 1000 ml/h) using
activating any the keys.
infusion alarms.
" Press "START" to confirm the flow rate and start up the
motor.
If a motor rotation problem is detected, the LCD screen disappears and

Er01, Er11 or Er21 appears on the 7-segment display. By pressing
"STOP" you may exit the error and return to the test.
The test may be interrupted at any time by pressing the "STOP" key and
a new test may be selected.
4.3.14 Checking the last 10 events before a locking alarm or error
This test enables ! teSt.J, press "START".
the visualisation of " The number of times the machine has been switched on
the codes for the since the last locking error is displayed on the LCD
last 10 events that screen.
have occurred
# "A" for an alarm. (See table teSt.5)
during operation of
the device before # "E" for an error. (See table teSt.5)
the last locking
error. " By validating once again, a new test may be seleted.
4.3.15 Checking the pressure alarm limit

To carry out this operation, exit the test mode and press "OFF".
! Carry out the following assembly
Pocket
1 m 50cm
PU M P
M a n o m e te r
T a p 3 w a ys
C o n ta in e r
! Press "ON".
" Position a tube in the device and lock the door inserting
the clamp.
" Position the manometer at the outlet of the tube.
" Select a flow rate of 125 ml/h.
" Adjust the pressure threshold to 750 mmHg.
# Let the tap run in a container.
# Start up the infusion and leave it running for 30
seconds.
# Position the tap to the manometer.
# Check that the alarm is triggered for a value of 1 bar ±
0.15 bar.
" Stop the infusion by pressing "STOP".
If the measured pressure value, depending to the limit selected is out of range, recalibrate
the pressure sensors. (See"ETAL9 Calibration of the upstream and downstream
pressure sensors".)
4.3.16 Flow rate check
! Connect the Optima pump to the mains.
Before any flow rate test, run out an infusion of 20 ml to stabilise the flow rate.
To carry out this test, we recommend to use the IS Flow rate software available with
Fresenius Vial.
! Carry out a flow rate test according to the norm EN 60601-2-24.

! Check that the flow rate error lies between - 5% et + 5%.
If the discrepancy is too significant, refer to chapter 7 "Calibration / Calibration procedure

/ EtAL2 Calibrating the flow rate corrector coefficient".
4.3.17 Air detector check

To carry out this test, exit the test mode.
! Position a tube filled with water in the device.
! Press "ON".
" Select a flow rate of 100 ml/h.
" Press "START" to start up the infusion.
" Turn the drop chamber upside down to create an air
bubble of around 5 cm.
" Check that the alarm is triggered when the air bubble
crosses the detector.
The audio alarm can be stopped by pressing "SILENCE ALARM".

(Default running time is 2 minutes.).
4.3.18 Battery autonomy check

! Recharge the battery for at least 16 hours (100% capacity).
! Press "ON".
" Position a filled tube at a flow rate of 125 ml/h, then

confirm.
" Check the battery autonomy is at least 4 hours.
4.3.19 Continuity test
Use a multimeter.
To carry out this procedure, exit the test mode. Press "OFF.
! Using a calibrated multimeter in ohms, check the presence of an electrical resistance
greater than 10 MΩ between:
" between the phase and equipotential pin.
" between the neutral and equipotential pin.
4.3.20 Contrast check

To carry out this procedure, go to the "User configuration" menu.
" Key in the access code (if asked).
" Select "LCD contrast" and confirm.
" Check that the central portion of the screen is slightly
darker and adjust the contrast if necessary using the
selection keys.
" By pressing the confirm key, you can exit the test.
4.3.21 Timestamp check

To carry out this procedure, go to the "User configuration" menu.
" Key in the access code (if asked).
" Select "Time setting" and confirm.
" Check if the date and time are correct.
If necessary, adjust the date and time using the

selection keys and the ENTER key to move
from one figure to another.
" By pressing the confirm key you can exit the test.
4.3.22 Quality Control Certificate

Use this table to summarise the results obtained from the various tests.
These tests can be done with a software dedicated to Optima.
Device type: Code: Device serial n°:
Conformity
N° Procedure Obtained value
Yes No
1 ! Check the general appearance of the case, labels, serial number and product
code.
2 ! Check the contrast.
If a fault is observed, refer to chapter ’Contrast Check’.
3 ! Check the clock. If an adjustment is needed, refer to chapter on datestamp
checking.
4 ! Display the operating period, tESt.1and the maintenance date.
5 ! Check the indicator lights, tESt.2.
6 ! Check the keyboard, tESt.3.
7 ! Display the total running time, tESt.6.
8 ! Occlusion check, tESt.F
" Connect the water manometer to the tube outlet.
" Start up test F.
" Check that there is no motor error and that the maximum pressure is above
2 bar (1500 mmHg) for the version PT and ST,
above 1.6 bar for the version ST.
9 ! Check clamping and unclamping, tESt.C. (if OCS is present) .
" Confirm the two functions.
" Check for any absence of motor alarm.
10 ! Check the drop detector (if the detector is present).
" Start up an infusion.
" Check the (green) drop indicator lights up each time a drop appears in the drop
chamber.
" Disconnect the detector.
" Check if the drop alarm is activated.
11 ! Check the air detector.
" Create an air bubble in the tube of at least 5 cm long.
" Check the presence of the air bubble alarm (sound and visual) while the air
bubble is in the air bubble detector.
12 ! Check the downstream pressure.
" Install a calibrated water manometer at the tube outlet.
" Adjust the pressure threshold to 750 mmHg.

" Start an infusion at 100 ml/h.
" Check that the downstream occlusion alarm is activated at 750 mmHh +/-125
(1 bar +/-0.15).
If there is a too great discrepancy, refer to chapter 7 "Calibration / Calibration
procedure / EtAL.9 calibrating the upstream and downstream pressure
sensors".
optfiche_002b_en.fm 41
Conformity
N° Procedure Obtained value
Yes No
13 ! Check the upstream pressure. (Only Optima VS)
" Start an infusion at 100 ml/h without drop detector.
" Clamp the tube between the drop chamber and the pump.
" Check that the upstream occlusion alarm is activated within 10 seconds.
" Unclamp.
" Check that the confirmation indicator lights up.
14 ! Check the clamp.
" Place a water pipe in the device.
" Close and open the door.
" Check that the clamp lock the tube.
# There should be no dripping at the tube outlet.
15 ! Check the battery operation.
" Disconnect the mains lead.
" Check the presence of the battery indicator.
" Reconnect the mains lead.
" Check if the battery indicator is switched off and that the mains indicator lights
up.
16 ! Check the flow rate.
Before any flow rate test, run an infusion of 20 ml to stabilise the flow rate.
" Carry out a flow rate check in accordance with the norm EN 60601-2-24.
" Check that the flow rate error is between - 5% and + 5%.
If there is too much discrepancy, refer to chapter 7 "Calibration / Calibration
procedure / EtAL.2 calibrating the flow rate corrector coefficient".
17 ! Check the battery autonomy.
" Start an infusion at 125 ml/h for 4 hours.
18 ! Carry out an electrical safety test according to norm EN 60601-1-2
Name: Date: Visa:
Observations:
42 optfiche_002b_en.fm
4.4 Cleaning and disinfecting

The pump form part of the patient's immediate environment. It is advisable to clean and
disinfect the device’s external surfaces of the device on a daily basis in order to protect
patient and staff.
! Disconnect the Base from its mains supply before cleaning.
! Do not place in an AUTOCLAVE nor IMMERSE the device, Do not let liquids enter the
device’s casing.
! If the device is placed in a high contamination risk unit, it is advisable to leave it in the
room during disinfecting, after having disinfected it with amoist cloth.
! Use a cloth soaked in DETERGENT-DISINFECTANT, previosly diluted with water if
required, to destroy micro organisms.
" Avoid abrasive scrubbing which could scratch the casing.
" Do not rinse or wipe the surfaces.
Do not use :
" ¨TRICHLOROETHYLENE-DICHLOROETHYLENE.
" AMMONIA.
" AMMONIUM CHLORIDE.
" CHLORINE AND AROMATIC HYDROCARBON.
" ETHYLENE DICHLORIDE-METHYLENE
" CHLORIDE-CETONE
These aggressive agents could damage the plastic parts and cause device malfunction.
Take car also with ALCOHOL based SPRAYS (20% -40% alcohol) .They lead to
tarnishing and small cracks in the plastic, and do not provide the neceeeary
cleaning prior to disinfection.
Disinfecting SPRAYS may be used, in accordance wih the manufacturer recommendation,

from a distance of 30 cm of the device, avoid the accumulation of the product in liquid form.
Avoid iodine-based solutions that may result in coloring some plastic parts permanently.
Please contact the appropriate service, responsible for cleaning and disinfecting products, in
your establishment for further details. Preventive maintenance
optima04.5&6_001c_en.fm 43
4.5 Storage
The device should be stored in a dry, cool place. In case of prolonged storage, the battery
should be disconnected via the battery access flap situated underneath the device.This
should be done by a qualified technician
! Storage conditions and carrying:
" Temperature: -10°C to 60°C / 14°F to 140°F.
" Atmospheric pressure: 500 hPa to 1060 hPa.
" Humidity: 10% to 90%, no condensation.
! Use conditions:
" Temperature: 5°C to 40°C / 41°F to 104°F.
" Atmospheric pressure: 700 hPa to 1060 hPa.
" Humidity: 20% to 90%, no condensation.
Fully recharge the battery before using the equipment to avoid any risks caused by micro
power cuts in the mains supply and to ensure maximum autonomy.
44 optima04.5&6_001c_en.fm
5 Troubleshooting
5.1 Breakdown guide
Message on
Meaning Causes Action
LCD display
Door open ! Hall affect sensor ! Check set installation
alarm detects that the door ! Check the presence of the
is open door magnet
! Calibration of the door
sensor
! Replace the door sensor
Clamp ! The Optima does ! Check set installation
position not detect the ! Check the securing clamp
alarm presence of the set micro switch
securing clamp ! Replace it if necessary
Set ! Wrong position of ! Check set installation
insertion the set ! Check the presence of the
alarm door magnet
! Calibration of the door
sensor
! Replace the door sensor
OCS test ! Occlusivity test ! Check set installation
Alarm not successful. The ! Check the door and carry on
pumping mechanism a calibration if necessary
does not succeed to ! Verify the good condition of
increase the the membrane. Replace it if
pressure in the IV necessary; refer to the
set during the OCS maintenance protocol : PM 0094
test
Air bubble ! Air volume ! Prime the line to remove the
alarm detected is higher air
Than the limit ! Check set installation on the
programmed air detector Verify the air
! Set is not adjustment of the air size
properly inserted in programmed
the air detector ! Replace the air detector or
air bubble board
Troubleshooting
optima05.1_001a_en.fm 45
Message on
LCD display
Drop alarm ! The container is ! Verify the volume remaining
(If drop empty on the container
detector is ! The rolling clamp ! Verify if the roller clamp is
present) is closed open
! Over-flow , under ! Verify if the air inlet cap if
flow, free flow open when the pump is used
! The position of with a bottle
the drip sensor ! Verify the positioning of the
! Drop chamber is drop detector
full ! Verify the volume of the liquid
! Drop detector is in the drop chamber
disconnected while ! Verify the IV set position
the pump is ! Verify the drip sensor is well
configured to be connected
used with ! Verify the connector if it's
! The drip sensor damaged
is connected and ! Replace the drip sensor
disconnected
Free flow ! Over-flow ! Check set installation
alarm ! Set not properly ! Check drip sensor
(in case of positioned positioning
use with
drip
sensor)
Upstream ! Upstream ! Check container

occlusion pressure in line is ! Check roller clamp
alarm too low ! Check if the set is not
! Empty container squeezed
! Check the roller ! Check the container height
clamp ! Check the air inlet cap ( if
! Air inlet cap is bottle used)
closed ( bottle ! Check the calibration values
used) ( Test 9)
! Proceed to the calibration of
pressure
! Replace the force sensor
Downstrea ! The pressure in ! Check the infusion line
m pressure line exceeds the ! Check the correspondence
alarm limit programmed between the limit programmed
and detected
! Check the pressure sensor (
Test 9)
! Proceed to the calibration of
the force sensor
! Replace the force sensor
Troubleshooting
46 optima05.1_001a_en.fm
Message on
LCD display
Air alarm ! The IV set is ! Remove the IV set and re-
present on the air install it
bubble detector but ! Carry on a calibration of the
not on the pumping door
mechanism
! The pump runs
over 24 hours, no air
bubble have
detected by the
sensor
Battery ! Low battery ! Connect the pump to the
alarm voltage mains power
! Check the charging voltage,
pump connected to the mains.
! Replace the battery
Preventive maintenance Preventive ! Preventive ! Proceed to the complete
24/10/2003 passed
maintenan maintenance date or check up of the pump and
ce time is passed update the maintenance date or
requested time ( test 1)
Problems Causes Action

Flow rate drift ! The installed set ! Check the set selection
doesn't correspond with
the set selected
! A mechanical part ! Measure the flow rate using a
which has a link with the reference set and calibrate the flow rate
pumping mechanism or correcting coefficient
the CPU board has been
changed without
calibrating the flow rate
correcting coefficient
Display defect: ! Control transistors, ! Check the LED's and display (test 2)
LED's, 8 segments LED's and/or display ! Check the good condition of the
display units board connection are display board
defective ! Replace the LED's
! Check the connector which link CPU
and display boards
! Replace the display board
The device turns off ! The battery is ! Check the battery connection
when it is unplugged or the battery ! Check the charging voltage
disconnected from cable is cut
mains power ! Battery is totally ! Replace the battery
discharged
Troubleshooting
Mains LED's does ! Mains fuses out of ! Replace Check the mains fuses
not switch ON order ! Replace the power supply board
! Power supply out of ! If the problem remains, replace the
order CPU board
Problems Causes Action
Battery alarm while ! Battery is totally ! Check the charging voltage
it has been discharged ! Replace the battery
completely charged
Battery alarm ! Power supply or CPU ! Check the charging voltage
whereas the boards are faulty ! Check the power supply mains
Optima is fuses
connected to the
! Replace the power supply if
mains
necessary.
! If the problem remains, replace the
CPU board and carry on a complete
configuration
The module MVP ! Keyboard is defective ! Check the keyboard ( test 3)
turns ON or turns ! Replace the keyboard if necessary
OFF alone ! CPU board is ! Check that there was no liquid
defective infiltration on the CPU board
! Replace the CPU board and carry
on a complete configuration of the
device
Some keys from ! Keyboard is defective ! Check the keyboard (test 3)
keyboard out of ! Replace the keyboard if necessary
order
After a fall ! Mechanical elements ! Check that the mechanical
damaged assembly and the cases are intact
Pump noisy ! Power supply and ! Fix the wires as it shown on the
CPU wires are closed to technical manual
the motor (earth wire
also)
Troubleshooting
Troubleshooting
5.2 Error messages
Error codes Meaning Action

Electronic and software command anomalies *
Er10 Internal RAM Anomaly ! Carry on a complete configuration of
the device via VP Control software
on a complete configuration
Er20 External RAM Anomaly
Er30 EPROM Anomaly
Er40 EEPROM Anomaly
Er50 ADC Anomaly ! Check the ADC

Er60 Sets parameters anomaly ! Reconfigure the module MVP with

VP Control software
Er70 Motor frequency anomaly
Er80 Keyboard anomaly ! Check and replace the keyboard if

necessary
! Check that there is no liquid
presence inside the device which could
damage keyboard and the electronics
boards
Er90 Software version ! Configuration of the device is

needed through with VP Control
Er01 Stepper motor rotation error ! Replace the motor
Er11 Stepper motor rotation error ! Check the motor coupling

See PM 0094
Er21 Stepper motor rotation error ! Replace the mechanical block

See PM 0094
Er31 OCS DC motor failure ! Check the motor clamp for OCS and
rubber O ring
! Put some grease on the clamp finger
threaded screw. Replace the rubber
O ring if necessary (p/n: 174256)
Troubleshooting
! Replace the OCS motor clamp
Er41 Stepper motor rotation error ! Replace the motor
Er14 Motor period calculation ! Reconfigure the device with VP
anomaly Control software
device
Er24 Motor rotation direction ! Check the motor rotation sensor

anomaly ! Replace the CPU board and carry
device
Er44 Quartz frequency anomaly ! Replace the quartz

device
Er54 Display board anomaly ! Check the display board connection

and replace it if necessary
Er64 ! Battery performance is ! Proceed to the battery charging.

too weak ! Replace the battery if necessary.
Er74 Battery disconnected ! Check the battery connection
Er84 Battery charging failure ! Check the charging voltage

! Ensure that the charging time is not
over 15 hours
! Replace the battery
Er94 Temperature fault ! Replace the battery

! Replace the CPU board
Er55 Access default to the ! Carry on a complete configuration of

secondary µ processor the device with VP Control software
! Replace the CPU board and Carry
device via VP Control software
Er65 Back light anomaly of LCD ! Replace the LCD

display
Er85 Impossible to start the ! Carry on a complete configuration of
secondary µ processor the device with VP Control software
Er16 ! Date / time failure ! Check the date and the time clock
Troubleshooting
Er56 ! Out put conditions / Step ! Carry on a complete configuration of

number association default the device with VP Control
Er17 ! Keyboard matrices default ! Replace the keyboard
! Check that there is no liquid
presence inside the device which could
damage keyboard and electronics
boards
Er27 ! Keyboard matrices default
Er37 ! ON/OFF key locked
Er47 ! OFF key out of order ! Replace the CPU board and carry
(no way to switch OFF the on a complete configuration of the
device) device via VP Control software
Er28 ! Language file ! Carry on a complete configuration of

incompatible the device via VP Control software
Troubleshooting
Troubleshooting
6 Intervention procedures
This chapter lists all the dismantling and re-assembling procedures.
Intervention procedures
N°1, Procedure: CPU board
Safety:
For safety reasons, the technician should not intervene while the device is in operation.
Material needed:
! 1 Posidriv Z1 screwdriver
! 1 anti-static bracelet
Maintenance level:
Level 2, specialist technician. (See biomedical technical training documentation.)
Procedure:
Access
! Pivot the Optima pump on the top of the front cover.
! Unscrew the 2 cruciform screws (marker 1), connecting the Optima angle bracket to the
base.
! Remove the angle bracket being careful not to pull out the connectors.
! Disconnect the J4 and J3 connectors, as well as the functional Earth.
! Return the Optima pump to its original position.
1
2 2
Allen key Fig. 1

! Using an Allen key, gently slide out the two screws located under the door.
! Remove the door.

! Unscrew the 4 cruciform screws (marker 2 on Fig. 1 and 2) connecting the front cover to
the base.
! Remove the front cover, being careful not to pull out the CPU board flat cable.
! Disconnect the CPU board flat cable: J2 connector and J4 connector.
2
2
Fig. 2
Do not touch the electronic boards with your hands.
Dismantling
When working with electronic components, we recommend wearing an anti-static bracelet

connected to the earth and working on a foam anti-static mat.
! Disconnect the J6, J8, J9 and J10 connectors.

! Disconnect the J1 flat cable.
! Unscrew the 3 cruciform screws (marker 3) connecting the CPU board to the front cover.
3
J1
3
J9 J6
J10
J8
! Remove the board from its housing, being careful with the display board J3 flat cable.
! Remove the CPU board.
Re-assembling
Carry out the dismantling procedure in reverse order to re-assemble the unit.
When closing the pump, ensure that the 2 cables connecting the power supply
board and the CPU board are positioned above the motor. In addition, check that the
earth wire is next to the metal support.
Incorrect positioning of one of these cables could result in a noise being heard when
the pump is in operation.
! Positioning of the earth wire.
Correct
Incorrect
! Positioning of the wires connecting the power supply board and the CPU board.
Right Wrong
Wrap an adhesive silicon cord around the CPU board J12 and J11 connectors.
! Perform a complete configuration for a new board using VP Control Maintenance
Software.
Each Optima pump has its own type of "display and CPU board"; it is important that you
do not mix up the different Optima pump references and that you order the one that
corresponds to your device.
! Carry out regular servicing checks. (See Quality Control Certificate.)

N°2, Procedure: Display board
Safety:
Material needed:
Maintenance level:
Level 2, specialist technician (see biomedical technical training documentation).
Procedure:
Access
! Unscrew the 2 cruciform screws (marker 1) connecting the Optima pump angle bracket to
the base.
! Remove the angle bracket, being careful not to pull out the connectors.
! Return the Optima pump back to its original position.
1
1
2
2
Allen key Fig. 1

! Remove the door.
the base.
2
2
Fig. 2
Dismantling

! Disconnect the J1 connector connecting the display board to the CPU board.
! Disconnect the display board J3 connector.
! Unscrew the cruciform screw (marker 3) situated on the display board, connecting it to the
front cover.
! Remove the display board.
J3
J1
J2
3
Re-assembling
Each Optima pump has its own type of "display and CPU board"; it is important that you
do not mix up the different Optima pump references and that you order the one that
corresponds to your device.
Carry out the dismantling procedure in reverse order to re-assemble the new unit.
When fixing the display board, ensure that the plastic inserts are not tightened too much
or they will be damaged.
When positioning the front case, ensure that the sealing is perfectly positioned in its
housing after re-assembling.
board and the CPU board are positioned above the motor. Also check that the earth
wire is next to the metal support.
the pump is in operation. (See photo on procedure sheet n°1.)
N°3, Procedure: Pumping system
Safety:
Material needed:
Maintenance level:
Procedure:
Access
! Unscrew the 2 cruciform screws (marker 1), connecting the Optima pump angle bracket to
the base.
! Return the Optima pump back to its original position.
1
1
2 2
Allen key Fig.1
! Using an Allen key gently slide out the two screws located under the door from their
groove.
! Remove the door.
the base.
2
2
Fig.2
Dismantling

! Using a cutter, remove the label.

! Unscrew the 2 middle cruciform screws (marker 3) located under the label.
3
3 3
3
3
4 4
! Unscrew the 2 cruciform screws (marker 4).
! Unscrew the cruciform screw (marker 5), paying attention to the washer.
! Remove the pumping system.
5
Re-assembling
When replacing the mechanical bloc, it’s recommended to read the following instruction.
! If a good metal washer and a metal pulley are already mounted, let them in place.
old aluminium pulley with washer New aluminium pulley without washer
Check that there is no axial free play on the mechanical block cam shaft.
LWhen closing the pump ensure that the 2 cables connecting the power supply
the pump is in operation. (See photo in Procedure n°1.)
N°4, Procedure: LCD display
Safety:
Material needed:
Maintenance level:
Procedure:
Access
the base.
1
2 2
Allen key Fig. 1

! Using an Allen key, gently slide out the two screws situated under the door.
! Remove the door.

the base.
2
2
Fig. 2
Dismantling

! Remove the display board. (See corresponding Procedure n°2.)

! Disconnect the J2 keyboard connector.
! Detach the LCD display.
! Remove the LCD display.
J2
Re-assembling
! Recover the self-adhesive block from the old LCD.
! Position the self-adhesive block on the LCD display, above the LCD display label.
! Position the LCD display on the display board.
! Press down the display on the display board so that the block adheres to the display
board.
the pump is in operation. (See photo on Procedure n°1)
.
N°5, Procedure: Air detector board
Safety:
Material needed:
Maintenance level:
Procedure:
Access
the base.
1
2 2
Allen key Fig. 1

! Remove the door.

the base.
2
2
Fig. 2
Dismantling

! Unclip the non-oxidizing aluminium plate (marker 3) holding the air detector board in
place.
! Unclip the board.
3
! Disconnect the J9 connector (marker 4) connecting the CPU board to the air detection
board.
! Disconnect the connector (marker 5) connecting the board to the air detector.
5
4
Re-assembling
earth wire is next to the metal support. Incorrect positioning of one of these cables
could result in a noise being heard when the pump is in operation. (See photo in
Procedure n°1.) Carry out regular servicing checks.
N°6, Procedure: Pressure sensor
Safety:
Material needed:
Maintenance level:
Procedure:
Access
the base.
1
1
2
2
Allen key Fig. 1

! Remove the door.

the base.
2
2
Fig. 2

Dismantling
When working with electronic components, we recommend wearing an anti-static

bracelet connected to the earth and working on a foam anti-static mat.
! Remove the pumping system. (See corresponding Procedure n° 3.)

! Using a cutter, unstick the "circular sticker" (marker 3).
! Unscrew the 3 cruciform screws (marker 4) situated under the "circular sticker" connecting
the tube catches to the base.
2
3
2
4 4
! Remove the tube catchings.

! Unscrew the cruciform screw which maintain the right infusion set guide to the metallic
plate and the base.
! Remove the plate.
! Unscrew the 2 screws of each pressure sensor support (marker 5) connecting the
supports to the base.
5
! Separate the pressure sensors from their support (see arrows)
! Unsolder the pressure sensor wires (marker 6).
! Remove the pressure sensors.
Re-assembling
After re-assembling the pressure sensors, calibrate them. (See ETAL9, Calibrating
the upstream and downstream pressure sensors.)

N°7, Procedure: OCS clamp motor (if OCS is present)
Safety:
Material needed:
Maintenance level:
Procedure
Access
! Pivot the Optima pump over the top of the front cover.
base.
2 1
2
Allen key Fig. 1

! Remove the door.

the base.
2
2
Fig. 2

Dismantling

! Using a cutter, unstick the 4 "circular stickers" (marker 3).

! Unscrew the 4 cruciform screws (marker 4) situated under the "circular stickers", holding
the air bubble detector case to the front cover.
4
3
4
4
4
! Separate the air detector from the case.

! Disconnect the J10 connector (CPU board).
! Unscrew the clamp (marker 6), while holding the motor reducer.
! Unscrew the 3 cruciform screws (marker 5) holding the
motor reducer to the front cover.
! Remove the motor reducer.
6
5
5
5 Intervention procedures
Re-assembling
Carry out the dismantling procedure in reverse order to reassemble the unit.
When re-assembling the motor clamp, apply a drop of silicon grease around the screw
path (marker 6).
! Carry out regular servicing checks. (See Quality Control Certificate).

N°8, Procedure: Power supply board
Safety:
Material needed:
Maintenance level:
Procedure
Access
the base.
1
! Unscrew the 2 cruciform screws (marker 4) holding the power supply shelf in place.
! Disconnect the earth wire (marker 5) and the mains connector (marker 6).
! Remove the power supply board.
Re-assembling
.
N°9, Procedure: Battery
Safety:
Material needed:
Maintenance level:
Procedure:
Access
! Unscrew the 2 cruciform screws (marker 1) connecting the Optima pump angle bracket to
the base.
! Remove the angle bracket, being careful not to pull out the connectors.
1
Dismantling
! Unscrew the 2 cruciform screws (marker 2) holding the battery in place.
! Disconnect the battery.
! Remove the battery.
Re-assembling
We recommend carrying out a complete charging and discharging cycle to guarantee that
the battery will function correctly.

N°10, Procedure: Front cover, base and angle bracket
Safety:
Material needed
! 1 soldering iron
! Soldering wire "RADIEL Sn60Pb RI 1" (no cleaning necessary) or equivalent
Maintenance level:
Level 2, specialist technician. (See biomedical technical training documentation.).
Procedure:
Access
base.
1
1
2
2
Allen key Fig.1

! Remove the door.
the base.
2
2
Fig.2
Dismantling the upper cover

! Dismantle the CPU board. (See corresponding Procedure.)
! Dismantle the display board. (See corresponding Procedure.)
! Dismantle the OCS motor clamp. (See corresponding Procedure.)
! Dismantle the air detector board. (See corresponding Procedure.)
Re-assembling the upper cover

! Re-assemble the display board. (See corresponding Procedure.).
! Re-assemble the CPU board. (See corresponding Procedure.)
! Re-assemble the OCS motor clamp. (See corresponding Procedure.)
! Re-assemble the air detector board. (See corresponding Procedure.)
Dismantling the base

! Dismantle the pumping system. (See corresponding Procedure.)
! Dismantle the tube clamp switch. (See corresponding Procedure.)
! Dismantle the pressure sensors. (See corresponding Procedure.)
Re-assembling the base

Carry out the dismantling procedure in reverse order to re-assemble the base.
Dismantling the angle bracket
! Dismantle the battery. (See corresponding Procedure.)
! Dismantle the power supply board. (See corresponding Procedure.)
Re-assembling the angle bracket

Carry out the dismantling procedure in reverse order to re-assemble the angle bracket.
7 Calibration
7.1Calibration procedure
The calibration menu is reserved for qualified staff only. Its access is protected with
a secret code.
7.1.1 Access to the calibrations
Keyboard description.
Key Function
OFF switches off the device when pressed for more than three
seconds.
SILENCE ALARM
START validates a choice.
MODE accesses the calibrating mode.
The selection keys scroll through the numbers and letters on the LCD
screen using the tenths, units and tens values.
Activate or de-activate the infusion menu.
ENTER confirms the selected calibration, or moves the cursor.
STOP cancels the current calibration.
Calibration
How to activate the calibration mode
! Keep the "MODE" button pressed, during the device switch on.
! Using the selection keys, select "Maintenance" on the
display.
! Press "START".
! Key in the access code.

! Press "START".
! Select "Calibration".Press "START".
! Using selection keys select:

" EtAL.1: calibration of the door.
" EtAL.2: calibration of the infusion flow rate corrective coefficient.

" EtAL.9: calibration of the upstream and downstream pressure sensors.
7.1.2 EtAL.1 Door calibration

This menu records ! EtAL.1, press "START".
" Por.1: close the door without tube.
the 3 door
positions in the
# Press "START".
EEPROM.
The value is read and stored in the EEPROM.
" Por.2: open the door without tube.

# Press "START".
" Por.3: position a tube filled with water and close the door.
# Press "START".
" By validating once again, another calibration can be

selected.
Press "STOP" key to exits the menu without memorising the calibration
values.
Calibration
7.1.3 EtAL.2 Calibration of the flow rate corrective coefficient
Before any flow rate test, carry out an infusion of 20 ml to stabilise the flow rate. The
adjustment range allows a correction up to -10% to +10%.
This menu adjusts ! Place a tube filled with water on the device, taking into
the device flow account the positioning of the clamp, and close the door.
rate according to ! Select a flow rate of 100 ml/h.
the used tube. ! Start the infusion.
! Perform a flow rate measurement according to the norm
601-1-2-24.
! Note the programmed flow rate and the obtained flow rate.
! EtAL.2, press "START".
" Using the selection keys, enter the programmed flow rate.
" Press the "ENTER" key to move from one field to another.
" Enter the measured flow rate.
" Press "START" to start the calculation of the new
corrective coefficient.
# if the coefficient lies between 0.9 and 1.1, you may
return to the configuration menu.
# if the coefficient does not lies between 0.9 and 1.1
the "Error" message appears.
Pressing "STOP" exits the menu without calculating the new coefficient.
Calibration
7.1.4 EtAL.9 Calibrating the upstream and downstream pressure
sensors
This menu records The Optima can operate with various tube types. The choice of tube is made through:
the pressure value
! the "MODE" key, set selection when the pump is on normal mode.
in the EEPROM
according to the ! maintenance menu and SAV 2
selected tube. The pressure calibration must be done for each type of tube active on the pump.
If a pressure sensor, the door sensor or CPU board has been changed, the calibration
values must be reset to zero for each tube. Where the CPU board has been changed, the
calibration must be carried out using maintenance software during the configuration
procedure.
Installation:
! According to the diagram below:
Pocket
1 m 50 cm
Pum p
M a n o m e te r
T a p 3 w a ys
C o n ta in e r
The manometer must be placed at the same level as the Optima pump.
Calibration
! EtAL.9, press "START".
Resetting the pressure calibrations

" Choose "YES" or "NO" using the selection keys and
confirm.
" If "YES", the calibration values for the pressure sensors
are reset to zero, for all tubes.
" If "NO", the calibration values are reset to zero only for the
tube selected.
If the calibration of the pressure sensors should be performed only for the tube selected,
it’s recommennded to choose "NO".
When choosing "YES" a calibration for all the tubes programmed should be carried out
using VP control maintenance sofware.
When changing the force sensors, the calibration should be done for all the tube available
on the pump.
The calibration described below is concerns only the active tube chosen through mode
key / set selection or maintenance / SAV 2.
" Press "CONFIRM" key to start the calibration.
Calibrating the downstream and upstream pressure sensor with the door open.
" PaV.1,PaM.1: open the door of the Optima
pump, no tube installed.
" Press "ENTER".
# The values for "downstream pressure sensor door

open" and "upstream pressure sensor door open" are
read and recorded.
Calibration
Calibrating the downstream pressure sensor at 0 mm Hg with the door closed, filled
tube installed.
" Position the tube according to the preceding diagram and
open the 3-channel tap in the direction of the Pump-
Manometer.
" Press "START", to warm up the tube.
" Wait until the pressure reaches around 750 mm Hg
(1 bar +/- 0.05 bar), and open the 3-channel tap in the
pump-container direction to lower the pressure
(0 mm Hg).
" Press "STOP" to stop infusion.
" Press "ENTER",

to record the threshold for the downstream pressure
at 0 mm Hg door closed.
Calibrating the downstream pressure sensor at 750 mm Hg with the door closed filled
tube installed.
" Position the 3 channel tap in the direction pump-manometer.
" Press "START" to start up the pump.
" Wait until the pressure reaches 750 mm Hg ±30 mm Hg
(1 bar +/- 0.05 bar).
" Press "STOP" to stop infusion.
" Press "ENTER",

to record the threshold for downstream pressure at
750 mm Hg door closed.
Calibrating the upstream pressure sensor at 0 mm Hg with the door closed filled
tube installed.
" Keep the door closed.
" Open the 3-channel tap in the direction pump-container.
" Press "ENTER",
to record the pressure, when the pressure level
is back to 0 mm Hg.
Press "STOP" key to exit the menu without memorising the calibration
values.
Calibration
8 Spare parts catalogue
8.1 Upper cover
107
100
104
102
109
110
106
101
105
111
112 103
108
Marker Qty Reference Name

100 1 199291 Upper cover kit
102 1 159602 Display board
103 1 159605 CPU board
105 1 168402 Air detection board PT/VS
105 1 168403 Air detection board ST
106 1 168938 Air detector
107 1 159899 Drip detector
108 1 168765 Air detector cover
1 174253 Sealing
109 1 159646 OCS motor reducer (only on Optima VS)
Spare parts catalogue
110 1 168349 Clamp (only on Optima VS)

1 168487 Motor reducer washer
1 168348 Clamp screw
1 199623 Truarc ring
111 1 174256 OCS O ring (only on Optima VS)
112 1 168448 Clamp cap (Optima PT-ST)
8.2 Base
207
205
208 209 210

206
203
... 200
201
202
204
...
....
.....: see following page

200 1 159610 Optima pump base
200 1 199287 Optima pump base kit
201 2 168480 Pressure sensor
2 168428 Sensor clip
202 2 168439 Sensor membrane
1 159510 Pumping system membrane
203 1 159621 Left tube guide (Optima PT-VS)
203 1 168762 Left tube guide (Optima ST)
204 1 168763 Right tube guide (Optima PT-VS)
204 1 168764 Right tube guide (Optima ST)
205 1 159604 Flexible circuit
206 1 159648 Motor
207 1 199290 Mechanical bloc
1 159679 Pump pulley

1 191156 Washer
1 168482 Belt
208 1 168497 INCA pin block
209 1 168498 Shock absorber
210 1 168379 Flask motor tube
....
....
....
....
....
.... ....
....
....
212 211
217 214
213
215
216
218
.....: see preceding page

211 168760 Clamp sleeve
212 1 168426 Optima PT-VS guillotine
212 1 168441 Optima ST guillotine
213 1 168460 Clamp shaft
214 1 168456 Clamp spring
215 168440 Membrane switch
216 159632 Support switch clamp
1 159659 Optima PT-VS bracket label

1 159660 Optima ST bracket label
217 2 159618 Feet
218 1 199276 Optima PT-VS door kit
218 1 199277 Optima ST door kit
8.3 Optima pump angle bracket
305
306
302 307
300
301
303
308

300 1 199273 Optima angle bracket kit
301 1 159613 Optima shelf
302 1 159608 Power supply board
303 1 159622 Battery pack
2 159618 Foot
304 1 159617 Handle
305 1 159639 Fixing nut

1 159627 Fixing nut insert catch
1 174255 Nut ring seal
306 1 182108 Handle screw end sleeve
307 1 159643 Clip-on M8 screw end
308 1 159623 Battery clamp
Useful addresses
TRAINING / SERVICE DEPARTMENT
Fresenius Kabi Tél. : 00 33 (0) 4 76 67 10 76
Le Grand Chemin, Tél. : 00 33 (0) 4 76 67 11 40
38590 Brézins Fax : 00 33 (0) 4 76 67 11 22
France
SPARE PARTS DEPARTEMENTS

Spare Parts Department Tel.: 00 33 (0)4 76 67 10 34
Fax: 00 33 (0) 4 76 67 11 88
It is possible that this manual contains errors or typing mistakes.

Modifications may be made in future editions.
COPYRIGHT © 2009
This document may not be reproduced in part or in whole without the written permission of
Fresenius Kabi
Design and construction : SEDOC
Technical Manual Optima PT-VS-ST_Int

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

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SERVICES

Date Revision Chapter Description

20/08/07 1 Index "b" New EMC standard, spare parts up date

15/06/09 2 Index "c" Update :

2 Description and operation ............................................................................... 9

3 Description of the menus .............................................................................. 19

4 Preventive maintenance ................................................................................ 29

8 Spare parts catalogue .................................................................................... 97

1.4 Operation safety

1.5 Technical characteristics

1.5.1 Electrical details

1.5.2 Electronic details

1.5.3 Mechanical details

Conform to the 93/42/EEC Medical Directive. IP31 Protection against

Detailed information concerning electromagnetic compatibility is available in the chapter

Angle bracket Control panel

Air bubble Front cover Door Base

! The base supports the door and contains:

! The angle bracket contains:

" a power supply board,

Display board LCD screen side.

Display board component side

J1 connector to CPU board

Pin Signal Description

Pin Signal Description

Pin Signal Description

Pin Signal Description

Pin Signal Description

J6 power supply connector

Pin Signal Description

Pin Signal Description

J11 RS232 connector / Nurse call

Pin Signal Description

J10 D.C. motor connector

Pin Signal Description

J9 air detector connector

Pin Description Description

Power supply board

J1 functional Earth connector

J3 power supply output connector

J4 battery output connector to the CPU board

2.2.1 Tube check and maintenance sub-assembly

2.2.2 Pumping sub-assembly

2.2.3 External connection sub-assembly

Description and operation

The configuration mode is activated by holding down the "MODE"

Each menu consists of sub-menus. The sub-menus can be accessed

Main Menu Key in code Sub-menu Sub-menu

TEst.2 LED, LCD screen, 7-segment display and buzzer test

TEst.3 keyboard test

TEst.4 display’s the battery voltage

TEst.5 display’s the last 10 alarms codes

TEst.6 display’s the total running time

TEst.9 display’s the analogue sensor values

TEst.A display’s the software version

TEst.C clamping motor test (VS only)

TEst.E display’s the calibration values

TEst.F infusion motor test

TEst.J display’s the code last 10 alarm codes before error