Fresenius Master PCA Service Manual

TECHNICAL MANUAL
MASTER PCA
NT 0850 Rev.0
TABLE OF MODIFICATIONS
Information in this Technical manual only refers to devices belonging to the Master PCA.
q File reference : .........................................NT 0850
q Revision date :..........................................May 1999
Date Revision number Pages Modifications
May 1999
Please note: No responsibility whatsoever can be taken by Fresenius Vial S.A for any fundamental change to product specifications (specifications, performance ratings, etc.) made by non-company technician. Small repairs may be carried out by the appropriate maintenance team, at the discretion of the end user and subject to his or her responsibility. We nevertheless recommend that service personnel first attend a training course organised by Fresenius Vial S.A. It is possible that this document contains errors or typing mistakes. Changes may be made at regular intervals, for inclusion in subsequent editions.. Thank you for your understanding. COPYRIGHT © 1998 by Fresenius Vial S.A. This technical manual may not be reproduced in whole or in part without the written consent of Fresenius Vial S.A.
rev AO All Creation
Fresenius Vial S.A. - head office : Le Grand Chemin - 38590 Brézins (FRANCE) - With directory and suprevision board, capital : 90128000 F - SIREN Grenoble B 408 720 282.
NT 0850 Rev.0
NT 0850 Rev.0
TABLE OF CONTENT
1. OVERVIEW....................................................................................3
1.1. General description ....................................................................................3
1.2. Block diagram .............................................................................................3
1.3. Precautions before use ..............................................................................3
1.4. Internal safety features...............................................................................4
1.5. Technical characteristics........................................................................... 4
1.5.1. Device characteristics ..........................................................................................4
1.5.2. Biological specifications .......................................................................................7
1.5.3. Mechanical characteristics...................................................................................7
1.5.4. Dimensions / Weight ............................................................................................7
1.5.5. Electrical characteristics......................................................................................7
1.5.6. Electronic characteristics......................................................................................7
1.5.7. Master PCA Operator’s Guide..............................................................................7
1.5.8. Components used for manufacturing ..................................................................7
1.5.9. Compliance ..........................................................................................................7
1.5.10. Registrations cards.............................................................................................7
2. ELECTRONIC BOARDS ..............................................................8
2.1. CPU BOARD ................................................................................................8
2.1.1. Functional description ..........................................................................................8
2.1.2. Regulation - Power supply....................................................................................8
2.1.3. Watch dog............................................................................................................9
2.1.4. Communication modules....................................................................................10
2.1.5. Error message...................................................................................................12
2.1.6. BUS I2C .............................................................................................................14
2.1.7. Master/ Pilot link.................................................................................................15
2.1.8. Command inputs and visualisation.....................................................................15
2.1.9. Description of connectors...................................................................................19
2.1.10. Electronic layout...............................................................................................21
2.1.11. Installation layout..............................................................................................21
2.2. ALARM LEDS BOARD...............................................................................22
2.2.1. Description of the connector J1..........................................................................22
2.2.2. Electrical layout -................................................................................................22
2.2.3. Installation layout................................................................................................22
2.3. INFUSION LEDS BOARD.......................................................................... 22
2.3.1. Description of the connector J1..........................................................................22
2.3.2. Electronic layout ................................................................................................22
2.3.3. Installation layout................................................................................................22
2.4. FLEXIBLE LINK BOARD........................................................................... 23
2.4.1. Description of the connectors.............................................................................23
2.4.2. Electronic layout ................................................................................................24
2.4.3. Implantation layout.............................................................................................24
3. CONFIGURATIONS, CALIBRATIONS AND CHECK .................24
3.1. Configurations ..........................................................................................24
3.1.1. Configuration EPROM........................................................................................25
3.1.2. Flash EPROM configuration...............................................................................25
3.2. Calibrations ...............................................................................................25
3.3. Check .........................................................................................................25
3.3.1. Electrical safety tests..........................................................................................25
3.3.2. Integrated tests...................................................................................................25
3.3.3. Test mode ..........................................................................................................25
NT 0850 Rev.0 Page : 1
4. REPLACING SUB-ASSEMBLIES............................................... 29
4.1. Replacing the electronic circuit boards.................................................29
4.2. Dismounting the support .........................................................................29
4.3. Replacing the flexible circuit ...................................................................29
4.4. Replacing the handle................................................................................29
5. MAINTENANCE .......................................................................... 30
5.1. Cleaning and disinfecting ........................................................................30
5.2. Storage.......................................................................................................30
5.3. Servicing....................................................................................................30
5.4. Regular inspections - Preventive maintenance .....................................30
5.4.1. Before using checking........................................................................................30
5.4.2. Preventive maintenance.....................................................................................30
5.4.3. Internal historical saving battery.........................................................................31
6. ANNEX 1 : ILLUSTRATED PARTS LIST ................................... 33
6.1. Traceability ................................................................................................33
6.1.1. Introduction.........................................................................................................33
6.1.2. traceability table..................................................................................................34
6.2. General view..............................................................................................36
6.3. Mechanical parts list.................................................................................37
6.3.1. Aluminium support..............................................................................................37
6.3.2. Front panel .........................................................................................................37
6.3.3. cover...................................................................................................................38
6.3.4. Locker.................................................................................................................38
6.4. Electronic parts list...................................................................................39
6.4.1. Programmation pass ..........................................................................................39
6.4.2. Control and command........................................................................................39
6.4.3. Electronic............................................................................................................39
6.4.4. Patient hand switch ............................................................................................39
6.4.5. Connectors .........................................................................................................39
7. ANNEX 2 : INSTALLATION AND ELECTRONIC LAYOUTS.... 40
7.1. CPU BOARD...............................................................................................40
7.2. ALARM LEDS BOARD...............................................................................40
7.3. INFUSION LEDS BOARD ..........................................................................40
7.4. FLEXIBLE LINK BOARD ...........................................................................40
8. ADDENDA AND INFORMATIONS............................................. 41
9. USEFUL ADDRESSES............................................................... 43
Page : 2 NT 0850 Rev.0
1. OVERVIEW
1.1. General description
Information in this document only refers to devices belonging to the Master PCA. No responsibility whatsoever can be taken by Vial Medical for any fundamental change to product specifications (specifications, performance ratings, etc.) made by non-company personnel. Routine repairs may be carried out by the appropriate maintenance team, at the discretion of the end user and subject to his or her responsibility. We nevertheless recommend that Maintenance personnel first attend a training course organised by Vial Medical.
The symbol visible on the condensed instruction guide of the device, recommends the Operator Guide should be completely read, in accordance with the EN 60 601-1 Standard.
1.2. Block diagram
1.3. Precautions before use
Please consult Operator’s guide
NT 0850 Rev.0 Page : 3
1.4. Internal safety features
The Master PCA is equipped with a continuous functions inspection system activated as soon as the Master is switched ON. Any failure or anomaly in the procedure is immediately detected. Nevertheless, qualified staff of your organisation or our After Sales Service should always be notified in case of abnormal functioning ( see useful addresses, chapter 9 )
1.5. Technical characteristics
The Master PCA is controlled by a keyboard and a rotary knob. The parameters input by the user, the infusion parameters, and parameters describing the instrument status may be visualised by means of a graphic LCD screen.
1.5.1. Device characteristics
1.5.1.1. Accuracy on average delivered flow rate.
q Accuracy of the ............................................................... ± 1 %
q Accuracy on the internal diameter of the syringes..........± 2 %
1.5.1.2. Average accuracy on the bolus This table is valid for a Pilot Anæsthésia or a Pilot C.
Syringe BD PLASTIPAK 20 cc BD PLASTIPAK 50 CC
Volume 0,2 ml à 0,8 ml 0,2 ml à 2 ml average error < - 0,2 % < - 0,15 %
Used tubing: SE 1400 S
These measurements are performed in compliance with PrEN60 601-2-24 comply.
1.5.1.3. Bolus volumes and flow rates
Syringe BD PLASTIPAK 20 cc BD PLASTIPAK 50 CC
Volume 0,2 ml to 10 ml 0,2 ml to 30 ml Injection duration Flash to 15 min Flash to 15 min Minimum flow rate 0,8 ml/h 0,8 ml/h
Used tubing: SE 1400 S
The maximum flow rate is limited by the performances of Pilot C and Anæsthesia. See connected Pilot operator's guide to know the flow rate limitation.
Page : 4 NT 0850 Rev.0
1.5.1.4. Exactness and accuracy of the displayed values of massic flow rate According to concentration and massic flow rate, the Master PCA rounds the result of volumic flow rate at
the first lower value programmable on the Pilot. Conversion diagram : The following diagram allows to determine the error versus the programmed value
100000000
10000000
1000000
100000
10000
1000
Massic flowrate (µg/h)
100
10
1
0.1 1 10 100 1000 10000 100000
Concentration (µg/ml)
1.5.1.5. Exactness and accuracy of the displayed mass values of bolus As for the massic flow rate, the mass of the bolus is under rounded.
q Error on bolus mass........ ................................ < - 0,5 %
1.5.1.6. Accuracy on time
q Error on the locking time. ................................ < 1 s
1% 2% 5% Max flow rate Min flow rate
1.5.1.7. Syringes list
50cc / 60 cc 20 cc 50cc / 60 cc 20 cc
B-D Perfusion
B-D Plastipak Braun Omnifix Braun Perfusor Didactic line France Didactic Perfusion Dispomed Dipomed type P Fresenius Injectomat
NT 0850 Rev.0 Page : 5
Fresenius P Spritze
Sherwood Monoject Ivac
Map Gliss LL Map Pic indolor Terumo Tutoject type T Zeneca PFS
1.5.1.8. Pressure limit The selection values of the pressure limit threshold are changeable by configuration from the key
board.(See operator’s guide of the connected Pilot for the operating procedure and the display accuracy). The threshold values or the pressure limits applied by default are the ones programmed on the Pilot.
1.5.1.9. Pressure management
q Occlusion pre-alarm and alarms. q Disconnection / pressure drop alarm.
1.5.1.10. Occlusion alarm delay according to the infusion flow rate Correspondences tables between occlusion alarm delay and programmed flow rate for three selectable
pressure limits in three pre-adjuted threshold mode. These tables shows obviously that it is very interesting to choose, as soon as possible, the lowest alarm threshold to get the short test alarm delay.
The variable threshold mode allows to select continuously the best adapted value.
Syringe Flow rate Low limit
300 mmHg
Bd Plastipak 50 cc 1 ml/h 16’20 30’25 49’50
5 ml/h 3’40 5’19 11’30
Bd Plastipak 20 cc 1 ml/h 6’20 12’35 17’45
5 ml/h 45’’ 1’45 3’05
1 bar = 750 mmHg = 1000 hPa Used tubing: SE 1400 S
Medium limit
500 mmHg
High limit
900 mmHg
1.5.1.11. Bolus volume at occlusion ending. When occlusion is detected, the anti-bolus system is activated. By measuring the pressing dynamic
strength, the reduction of the bolus at occlusion ending is performed according to the specific characteristics of each selectable syringe.
This principle allows to much reduce this bolus whoever the flow rate and the alarm threshold adjustment be.
Syringe Flow rate Low limit
300 mmHg
Bd Plastipak 50 cc 1 ml/h < 0,1 ml < 0,2 ml < 0,2 ml
5 ml/h < 0,1 ml < 0,2 ml < 0,2 ml
Bd Plastipak 20 cc 1 ml/h < 0,1 ml < 0,1 ml < 0,1 ml
5 ml/h < 0,1 ml < 0,1 ml < 0,1 ml
Medium limit
500 mmHg
High limit
900 mmHg
1 bar = 750 mmHg = 1000 hPa Used tubing: SE 1400 S
q Note : The bolus reduction at occlusion ending is signalled by the alarm LED.
Page : 6 NT 0850 Rev.0
1.5.2. Biological specifications
Infusion liquid only comes into contact with the syringe and associated disposable.
1.5.3. Mechanical characteristics
The mechanical system consists of an aluminium support hinged to the front casing. The electrical connections and installation are effected by pushing the Pilot backwards into the support (see the Master PCA Operator’s Guide). The casing is then lowered and locked onto the Pilot.
On the button side two holes to insert fixing screws are available.
1.5.4. Dimensions / Weight
Height : 135 mm
Width : 370 mm
Depth : 240 mm
Weight : 1.9 kg approximately
1.5.5. Electrical characteristics
The Master PCA is powered from a Pilot syringe pump. The power supply characteristics are as follows :
Power supply : 5.4V to 7.2V DC.
Max. consumption : 180 mA.
Max. power consumption : 1.3 W.
1.5.6. Electronic characteristics
The Master PCA comprises the following electronic subassemblies :
CPU circuit board.
LCD graphic display.
Alarm LED circuit board.
Infusion LED circuit board.
1.5.7. Master PCA Operator’s Guide
The Master PCA Operator’s Guide included operating cautions is available on request from our Customer Service.
1.5.8. Components used for manufacturing
q Case................................Polycarbonate/ABS alloy
q Control button .................Polyacetal
q Fixing handle...................Polyamide
q Protection hood...............Polycarbonate
q Support ...........................Polyurethan painted aluminium
q Keyboard.........................Polyester
q Labels .............................Polyester
1.5.9. Compliance
See Operator's guide
1.5.10. Registrations cards
Registration information is available upon request from our After Sales Service
NT 0850 Rev.0 Page : 7
2. ELECTRONIC BOARDS
2.1. CPU BOARD
2.1.1. Functional description
The Master PCA CPU circuit board is built around on the 80C320 microcontroler used in open mode. This micro is equivalent to the 80C32, but its slightly modified structure gives an overall speed improvement.
Characteristics
EPROM 256 Ko FLASH EPROM 521 Ko RAM 128 Ko saved by a battery EEPROM 2 Kbytes for the instrument’s configuration
WATCH DOG MAX 691 resetable and safety RAM INTERNAL CLOCK PCF 8583P addressable by IC bus LED Driver 16 LED's max Keyboard Driver 16 keys max. Display 128 x 64 pixel screen graphics T6963C integrated controller. Manual adjustment of contrast Attachments RS TTL Master PCA / Pilot RS 232 PC/ Master PCA. RS 232 option Power Supply Continuous from 5.4 V to 7.2 V, includes regulator
of slight voltage drops. Battery power safety system for the RAM and the internal clock 3.6V 60 mAh.
The CPU circuit board has the following functions :
power supply and regulation of the module.
communication with the module.
link module for the Master PCA/ Pilot .
keyboard.
CPU, memory.
2.1.2. Regulation - Power supply
The regulation/power supply module consists of a linear regulator with a low drop out voltage of for which the input voltage is supply by the Pilot battery and then regulated.
2.1.2.1. ON/OFF command The ON/OFF key of the device is connected to the CD ON input line of the Pilot. A short press on this key
switch on the power supply of the Pilot. Then, the Pilot battery supplies the necessary energy to the Master PCA (mains or battery). When pressing ON/OFF button, the microprocessor knows the status of the button by reading TOFF by the input line from U24. It prepares the switch off mode and sends the command to turn off the voltage to the Pilot using RS 232 interface from the Pilot.
Page : 8 NT 0850 Rev.0
2.1.2.2. Protection of the power supply
4 . 6 5 V
0 V
R eset
WDOG
T < 1 0 0 m s
T < 1 0 0 m s
In case of breakdown of power supply, the Pilot battery provides the necessary energy to the two devices. When the Master PCA is switched off, an internal battery saves the RAM in order to keep patient’s history,
and the internal clock continues to be supplied. The battery is recharged when the device is in use. When the instrument is not in use, the minimum life expectation for a fully charged battery is 2 months. The battery voltage of the Pilot is present on the connector subD 15 points J2, connecting the Pilot to the Master PCA.
the minimum supplied voltage which does not provoke the resetting of the device is 5.1 V.
the maximum supply voltage is 7.2 V
.
J2 Description
6 VBAT
14 VBAT
5 GND
13 GND
2.1.2.3. Pre-alarms and alarms Alarms and pre-alarms are identical to those of the Pilot. The alarm status parameters of the Pilot is
transmitted via the RS 232 interface to the Master PCA.
2.1.2.4. Battery voltage levels This voltage is measured at the battery terminals lead of the Pilot.
pre-alarm : 5,8 V min / 6,0 V max.
alarm : 5,6 V min / 5,8 V max.
The voltage drop between the input of the instrument’s regulator and the battery is due to the internal fuse of the Pilot and various connections between. This voltage drop is 0.5 V max. for a current of 350 mA.
the battery voltage of the Pilot can be measured inTP4
2.1.3. Watch dog
The watch dog manage the RESET line, the rising voltage of VP of the circuit voltage Vp to safety (RAM, INTERNAL CLOCK), the switching of the CE line of the RAM to keep the integrity of the data in the RAM in case of drop of the power supply is broken. The voltage V.P. is supplied by the battery BT1. The timer is activated by the signal WDOG generated by the output socket comprised of circuit U22 (
2.1.3.1. Voltage of Power Supply the signal RESET is activated for a standard voltage value, after regulation, of : 4,65 V ± 0,15 V.
2.1.3.2. Resetting
5.00 V
maximum reset time of WDOG : 100 ms.
activation of signal RESET : 200 ms.
power supply voltage = 5.00 V ± 0.25 V.
NT 0850 Rev.0 Page : 9
2.1.4. Communication modules
The CPU circuit board has 3 serial interface plug. Connection socket for the Master PCA/ Pilot .
RS 232-1 plug.
RS 232-2 plug (optional).
2.1.4.1. Plug socket for the Master PCA/ Pilot Series linking TTL of full duplex communication between the Pilot and the CPU.
2.1.4.2. Communication Master PCA/ Pilot Two-directional series link TTL
4800 Baud set valueTransmission data speed : 31250 Baud by software configuration
Transmission data format :
1 start bit 7 data bit 1 even parity bit 1 stop bit
The signals are found on the male connector SubD 15 points J2 (connection Master PCA/ Pilot).
J2 Description
2 RXD Pilot
10 TXD Pilot
3 GND power supply
2.1.4.3. RS 232-1 connector This connector is used for several types of communication.
2.1.4.3.1 Connection PC/ Master
Bi-directional series data RS 232-1 Bus
Transmission data speed : 4800, 9600, 19200 Baud selectable in
configuration menu
Transmission data format : 1 start bit
7 data bit 1 even parity bit 1 stop bit
Page : 10 NT 0850 Rev.0
2.1.4.3.2 Communication Master/ Printer
This mode is permanently available when the instrument is being used to print histories. Bi-directional link RS232 :
Transmission speed : 9600 Baud Transmission format : 1 start bit
8 data bit 0 parity bit 1 stop bit
The control of flux is carried out by a hardware link between the DTR pin of the printer to the RTS pin 8 of the Master PCA.
When the RTS pin is at + 12 V, the Master PCA considers that the printer is ready to receive some text.
When the printer is not connected, the RTS pin is set to - 12 V ; and the PCA therefore sends no text.
The socket signals for the 3 modes of communication are found on the female connector SubD 9 points J7.
J7 Description
2 RXD 3 TXD 7 CTS 8 RTS 5 GND
2.1.4.4. RS 232-2 connector (Optional)
The unused series link RS 232 is reserved for future extensions. The socket signals are found on the female connector sub D 9 points J6.
J6 Description 2 RXD 3 TXD 7 CTS 8 RTS 5 GRD
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