LivaNova SCPC User manual

SCPC System
Service Manual

CP_SEM_60-03-00.002
SCPC System • Service Manual
Copyright © 2003 - 2017
LIVANOVA DEUTSCHLAND GMBH
TSSI Department
Lindberghstrasse 25
D-80939 Munich, Germany
HLM-Hotline: [phone]
Telephone: +49 - (0)89 - 32301-0
Telefax: +49 - (0)89 - 32301-777
All rights reserved. No part of this manual may be reproduced or copied in any form or by any means - be it graphic,
electronic or mechanical, including photocopying, typing, or information and retrieval systems - without written
permission of LIVANOVA DEUTSCHLAND GMBH.
Intended Use
In accordance with the applicable regulations, the SCPC System is used for operating the Stöckert Centrifugal Pump
System (SCP System).
Service Manual
Version 02/2017 – CP_SEM_60-03-00.002
Valid for SCPC System with firmware version V1.x/ V1.x / V1x

SCPC System • Table of contents
Table of contents
CP_SEM_60-03-00.002 3
1 Introduction
1.1 About this Service Manual ........................................................................................................ 5
1.1.1 Symbols used in this Service Manual ............................................................................. 5
1.1.2 The chapters in this Service Manual ...............................................................................6
2 Safety
2.1 Approvals ................................................................................................................................7
2.2 Regulations and safety instructions .......................................................................................... 7
2.2.1 Intended use ................................................................................................................ 7
Instructions for use ....................................................................................................... 7
2.2.2 Contraindications .........................................................................................................7
2.2.3 Safety instructions related to service .............................................................................8
Instructions on initial operation ................................................................................... 10
2.2.4 Electrical Safety ...........................................................................................................11
3 System description
3.1 General description................................................................................................................ 13
3.2 Design of the SCPC System ..................................................................................................... 14
3.2.1 Complete overview ...................................................................................................... 14
3.2.2 Overview of modules and individual components .......................................................... 16
3.2.3 Individual components ................................................................................................ 18
3.2.4 Touch screen module ..................................................................................................20
CPU board (ZDS 2006) ................................................................................................. 21
Interface (ZIS 0202) circuit board ................................................................................. 22
3.2.5 Card and module support assembly ............................................................................. 23
Backplane circuit board (ZBP 2004) .............................................................................24
Battery monitoring (ZAU 2002) circuit board .................................................................26
Mains monitoring (ZNU 2003) circuit board .................................................................. 27
4 User menu and service menu
4.1 User menu (summarised overview).......................................................................................... 29
4.2 Service menu ......................................................................................................................... 32
4.2.1 Overview of keys and functions in the Service menu ...................................................... 33
4.2.2 Displays in the Service menu ....................................................................................... 34
4.2.3 Calibrate current sensor .............................................................................................. 36
4.2.4 Update firmware of serial interface (ZIS) circuit board ................................................... 37
Manual installation .....................................................................................................38
4.2.5 Calibrate the touch screen ........................................................................................... 39
5 Error messages and error diagnosis
5.1 Error messages ...................................................................................................................... 41
5.1.1 Non-specific errors ...................................................................................................... 41
5.1.2 Error codes .................................................................................................................42
5.1.3 Current sensor ............................................................................................................43

SCPC System • Table of contents
4CP_SEM_60-03-00.002
6 Replacing components
6.1 Accessing SCPC System modules.............................................................................................45
6.1.1 Externally accessible modules .....................................................................................45
Battery monitoring (ZAU 2002) and Mains monitoring (ZNU 2003) ..................................45
6.1.2 Opening the SCPC System ...........................................................................................46
6.2 Batteries................................................................................................................................53
6.2.1 Removing the batteries ................................................................................................ 53
6.3 Primary-side mains connection ............................................................................................... 55
6.3.1 Removing the mains switch .......................................................................................... 55
6.3.2 Removing the mains filter ............................................................................................56
6.3.3 Clamping strip ............................................................................................................57
6.4 Rectifier.................................................................................................................................58
6.4.1 Removing the rectifier .................................................................................................58
6.5 Automatic circuit breaker........................................................................................................59
6.5.1 Removing the automatic circuit breaker ........................................................................59
6.6 Discharge resistor ..................................................................................................................60
6.6.1 Removing the discharge resistor ..................................................................................60
6.7 Fan ........................................................................................................................................ 61
6.7.1 Removing the fan ........................................................................................................ 61
6.8 Touch screen module ..............................................................................................................64
6.8.1 Removing the interface (ZIS 0202) circuit board ............................................................64
6.8.2 Removing the CPU board (ZDS 2006) ............................................................................65
6.9 Replacing circuit board components ........................................................................................67
6.9.1 Battery monitoring (ZAU 2002) circuit board ................................................................. 67
Replacing the EPROM ..................................................................................................67
6.9.2 Mains monitoring (ZNU 2002) circuit board ...................................................................68
Replacing fuses ..........................................................................................................68
6.9.3 Backplane circuit board (ZBP 2004) ..............................................................................69
Replacing fuses ..........................................................................................................69
6.9.4 CPU board (ZDS 2006) .................................................................................................70
Replacing the EPROM ..................................................................................................70
7 Appendix
7.1 Tech ni cal d ata ........................................................................................................................ 71
7.1.1 Dimensions, weights, operating conditions .................................................................. 71
7.1.2 Electrical specifications ............................................................................................... 72
UPS ............................................................................................................................73
7.1.3 Dimensions and weights of the SCPC trolley ................................................................. 74
7.2 Labelling ............................................................................................................................... 75
7. 3 P ar t n um b er s ......................................................................................................................... 77
7.4 Access o rie s ............................................................................................................................78
7.5 Part numbers of service components .......................................................................................79
7.5.1 Individual SCPC System components ............................................................................ 79
7.5.2 Touch screen module ...................................................................................................80
7.5.3 Card and module support assembly .............................................................................80
7.6 Circuit diagram....................................................................................................................... 81

SCPC System • Introduction
CP_SEM_60-03-00.002 5
1 Introduction
1.1 About this Service Manual
This Service Manual (in addition to the training courses given by LIVANOVA DEUTSCHLAND GMBH)
provides basic information on the maintenance and repair of the Stöckert Centrifugal Pump Console
System (abbreviation: SCPC System). This manual has been designed solely for use by suitably
qualified service technicians. In the interest of the safety of patients and all users:
!
Only service technicians who have been trained and duly authorised by LIVANOVA DEUTSCHLAND GMBH
may perform service on the SCPC System .
All information on the operation of the SCPC System can be found in the Operating Instructions. This
Service Manual will refer to the appropriate chapter of the Operating Instructions as required.
1.1.1 Symbols used in this Service Manual
The symbols are intended to help the user find particular text passages. The meaning of the symbols is
as follows:
!Danger! Failure to pay attention may put the health and safety of the
patient and/or the operator at risk.
!Warning! Failure to pay attention may cause damage to the machine
or other equipment.
✓A check list for a quick and safe follow-up on whether operational
steps have been carried out completely.
◗Primary list (main groups)
➜Secondary list (subgroups)

SCPC System • Introduction
6CP_SEM_60-03-00.002
1.1.2 The chapters in this Service Manual
In chapter... you will find the following information:
1Introduction ➜Symbols used in the Service Manual
➜Overview of chapters (this table)
2Safety ➜Important safety instructions for
operating and servicing the SCPC System
3 System description ➜A brief description of all service-relevant
components
4 User menu and service menu ➜Information on the available menus
5 Error messages and error diagnosis ➜A list of all error messages and
information on localising errors
6 Replacing components ➜Information on removing and replacing
service-relevant components
7Appendix ➜Technical data on all components
➜Part numbers/spare parts
➜Circuit diagram

SCPC System • Safety
CP_SEM_60-03-00.002 7
2Safety
2.1 Approvals
Like development and manufacturing, service must also be conducted in accordance with the following
standards and legal regulations:
The SCPC System is a medical device, class IIb (MDD 93/42/EEC). A Declaration of Conformity has been
issued for the SCPC System.
2.2 Regulations and safety instructions
2.2.1 Intended use
!
◗In accordance with the applicable regulations, the SCPC System is used for operating the Stöckert
Centrifugal Pump System (SCP System).
Instructions for use
◗Any use beyond this specification is not as intended. LIVANOVA DEUTSCHLAND GMBH will not
assume any liability for any damage resulting from such use. The intended use also includes
compliance with the operating instructions, as well as repair and maintenance according to the
maintenance instructions.
◗Relevant accident prevention measures according to existing local policy and employees’ health
and safety regulations must be complied with. LIVANOVA DEUTSCHLAND GMBH will not accept any
liability for damage due to non-compliance with these regulations.
◗LIVANOVA DEUTSCHLAND GMBH will not assume any liability for injuries and/or damage caused by
failure to observe the safety instructions or by the operator not taking due care. This also applies if
the operator’s duty to take due care has not been specifically expressed to the user.
2.2.2 Contraindications
◗There are no known contraindications for the SCPC System. The attending physician is solely
responsible for the use of the system.
– This device complies with the requirements of
EU Directive 93/42/EEC of the European Council for
Medical Devices.
IEC 62353 – Recurrent test and test after repair of medical
electrical equipment
IEC 60601-1-2 – EMC (Electromagnetic Compatibility)
MDD – Medical Device Directive 93/42/ EEC
DIN EN ISO 13485 – Quality Management System
UVV – Regulations for Accident Prevention

SCPC System • Safety
8CP_SEM_60-03-00.002
2.2.3 Safety instructions related to service
Note:
For additional information on general safety instructions as well as safety instructions related to use
and operation, refer to chap. 2 in the Operating Instructions.
Occupational health and safety
◗Correct handling of objects reduces mechanical stress to the spine and back muscles.
◗Do not wear metal jewellery such as rings, bracelets, etc., when performing maintenance and
service tasks.
◗Wear protective gloves when cleaning and disinfecting the SCPC System.
!
◗The SCPC System must not be used in the presence of explosive substances.
Instructions on the system
!
◗The SCPC System must only be used with the Stöckert centrifugal pump system (abbreviation:
SCP System).
◗The serial port is only intended to transmit DMS data (e.g. to another computer).
◗Make sure that the air circulation at the ventilation openings is unimpeded. Insufficient ventilation
may cause overheating.
◗Keep the following in mind when operating the SCPC system in combination with an SCP system
with a Revolution®and an Electrical Remote-Controlled Tubing Clamp:
If the speed exceeds 3200 RPM, the batteries are not charged in order to guarantee the power
supply to the Electrical Remote-Controlled Tubing Clamp.

SCPC System • Safety
CP_SEM_60-03-00.002 9
Instructions on repair and replacement
!
◗Modifications or extensions to the system or the use of spare parts which have not been tested and
approved by LIVANOVA DEUTSCHLAND GMBH may have a detrimental effect on the safety and
operation of the system. In such cases, LIVANOVA DEUTSCHLAND GMBH cannot accept any liability
or responsibility.
◗Proof must be provided for accessories and supplementary devices which have not been tested
and approved by LIVANOVA DEUTSCHLAND GMBH that their use does not represent a safety
hazard.
◗While the SCPC System is switched on, no electrical connections may be disconnected or
established. The SCPC System must be completely powered down when connecting or
disconnecting the SCP System.
◗The mains switch does not disconnect the SCPC System from the mains power supply. Disconnect
the SCPC System from the power supply completely before carrying out maintenance and cleaning
work.
!
◗Note that the SCPC System has an Uninterruptible Power Supply (UPS) which is powered by
2 batteries. When working on the device with the housing open, there is a risk of short-circuits
even if the mains cable is unplugged when the batteries are inserted and charged.
◗Note the specific design of individual electrical components depending on the region in question,
and observe the relevant mains connection regulations according to the circuit diagram in the
Appendix section.
◗It is essential that ESD protective safety measures are taken when working with components
susceptible to ESD. When removing or installing circuit boards or components susceptible to ESD,
ensure that you use ESD mats, wrist straps, or similar protective equipment.
◗Observe the ESD guidelines when packing or shipping components susceptible to ESD.
◗Always use suitable removal and insertion tools in order to avoid bending contacts (e.g. of plug
connectors) or damaging plugs or socket housings.
◗Make sure not to damage cables or their insulation on the sharp edges of panels and circuit boards
during assembly. Route the cables in a way that prevents them from being pinched by fasteners or
by the edges of panels. Secure all cables on the cable holders provided for this purpose.
◗A defective cable harness or a defective circuit board must not be repaired but must be replaced
completely. To guarantee safe and reliable operation of the system and the safety of patients and
users, only genuine spare parts from LIVANOVA DEUTSCHLAND GMBH must be used.

SCPC System • Safety
10 CP_SEM_60-03-00.002
Instructions on initial operation
◗Prior to assembly of the SCP System, you must have thoroughly read the separate operating
instructions and have become familiar with the machine functions.
◗When mounting the SCP System, ensure balanced loading. Unbalanced loading leads to instable
positioning of the SCPC System.
◗Stable positioning of the SCPC System can only be guaranteed if the system has been mounted
with the appropriate adapter plate
◗Ensure that the tubes are laid out as straight as possible and do not kink or twist the cables.
Kinked or twisted cables could pose a hazard to any persons present (causing them to stumble or
get caught up in them).
!
◗Check all cables, tubes, connectors and other accessories to make sure that they are connected
correctly, are not leaking and are in perfect working order. Replace all damaged components
immediately.
!
◗Do not use any more connectors or tubing than is necessary for operating the machine in
accordance with the regulations. Additional connectors etc. increase the risk of faults.
Instructions on cleaning and disinfection
◗The system and its components are to be regarded as potentially infectious after use. Observe the
current regulations on hygiene and safety when handling and packing the SCPC System and/or its
components.
◗Use recommended cleaning agents.
◗Ensure that no liquids or cleaning agents enter the machine housing through the vents or other
openings.

SCPC System • Safety
CP_SEM_60-03-00.002 11
2.2.4 Electrical Safety
◗Mains power quality should be that of a typical commercial or hospital environment.
◗The SCPC System must be connected to a power supply network with protective conductor (earth)
to protect the device against electric shock.
◗A potential equalization cable must be connected to a point intended for such purpose in the
operating theatre (OT).
◗Check the functional safety of all electrical connections, cables and sockets regularly.
◗Accessories and supplementary devices must comply with the relevant IEC or ISO standards (e.g.
IEC 60950 regarding information technology equipment). In addition, any configuration must meet
the requirements for medical electrical systems (see IEC 60601-1-1 or paragraph 16 of IEC 60601-1,
3rd edition). Any person connecting additional devices to medical electrical equipment is
considered a system configurer and is thus responsible for ensuring that the system meets the
standard-related requirements for systems. Please note that local legislation takes precedence
over the above-mentioned standard-related requirements.
◗The devices must only be connected by means of serial connection cables which comply with the
specifications of LIVANOVA DEUTSCHLAND GMBH (e.g. part no. 45-11-03). The end of the cable
marked with the part number must be plugged into the jack (of the LIVANOVA DEUTSCHLAND GMBH
equipment) intended for serial connection.
◗Medical electrical equipment may not be placed directly next to or on top of each other during
operation in order to avoid electromagnetic interference. If such a set-up is required for operation,
the devices must be monitored to ensure that they are functioning properly.

SCPC System • Safety
12 CP_SEM_60-03-00.002

SCPC System • System description
CP_SEM_60-03-00.002 13
3 System description
3.1 General description
The SCPC System permits the operation of the Stöckert Centrifugal Pump System (abbreviated
to: SCP System) independently from a Stöckert Heart-Lung Machine (S3/SC/CAPS).
A touch-sensitive screen (touch screen) on the front is the interface between the user and the
SCPC System. The following functions of the system are displayed or operated, depending on the
configuration:
◗Pressure control
◗Flow display
◗Temperature monitor
◗Timer
◗Level control/bubble detector
◗UPS operation
◗Operation of the SCP System

SCPC System • System description
14 CP_SEM_60-03-00.002
3.2 Design of the SCPC System
3.2.1 Complete overview
fig. 1: Overview SCPC System
SCPC System
INSTRUMENTE GMBH
25
1
3
4
6
7
17
14
15
11
10
16
9
12
13
8

SCPC System • System description
CP_SEM_60-03-00.002 15
Item Description Function
1SCPC System
2Mains power switch ➜Powering the SCPC System up/down
3Touchscreen ➜Operation and configuration of the
SCPC System:
–Pressurecontrol
– Temperature monitor
– Level control
–Bubbledetector
– Two independent timers
– Controlling the UPS operation
–Timeanddate
4Grip ➜Transportation of the SCPC System
➜Mounting of the SCP pump control panel and the
SCP drive unit
5Ventilation grills ➜Ventilation of the SCPC System (above the
mains power switch and at the bottom of the
device)
6Potential equalization point ➜Connection of the potential equalization cable
7Mains protection ➜Automatic circuit breaker 8 A
8Jack for AC power cable ➜Power supply of the SCPC System
9AC power cable
10 Retaining bracket ➜Securing the AC power cable
11 Jack for connection of the SCP pump
control panel
➜Connection of the pump control panel to the
SCPC System
12 Jack for connection to the Electrical
Remote-Controlled Tubing Clamp (ERC)
➜Connection of the ERC to the SCPC System
13 Jack for connection to the serial port ➜Connection of the Sorin Data Management
System (abbr: Sorin DMS)
14 Sensor module dual pressure ➜Connection of the sensors for pressure displays
1 and 2
15 Sensor module temperature monitor ➜Connection of the temperature probes for
temperature monitoring
16 Cover plate ➜Splash protection
17 Blanking plates ➜Covering the power module

SCPC System • System description
16 CP_SEM_60-03-00.002
3.2.2 Overview of modules and individual components
fig. 2: Overview of device components
A
B
C

SCPC System • System description
CP_SEM_60-03-00.002 17
Mod. Component contains the following service-relevant modules/components:
ASCPC System casing ◗Touch screen module (B)
◗Card and module support assembly (C) (sensor modules
and circuit boards)
◗Mains switch
◗2 batteries
◗Discharge resistor for batteries
◗Ring core transformer
◗Rectifier
◗Mains filter
◗Fan
◗Connections:
serial interface, Electrical Remote-Controlled Tubing Clamp,
SCP System
BTouch screen module ◗Touch-sensitive screen incl. display electronics
◗CPU (ZDS) circuit board
◗Interface (ZIS) circuit board
CCard and module
support assembly
◗Battery monitoring (ZAU) circuit board
◗Mains monitoring (ZNU) circuit board
◗Sensor modules (optional, depending on order)

SCPC System • System description
18 CP_SEM_60-03-00.002
3.2.3 Individual components
fig. 3: Overview of individual components
A 1
A 2
A 4
A 13
A 14
A 15
A 6
A 9
A 12
A 8
A 10
A 7
A 5
A 11
A 6
A 6_1
A 6_2
A 6_3
A 6_4
A 6_5

SCPC System • System description
CP_SEM_60-03-00.002 19
Mod. Item Description Number SP number
A1Upper casing 60-03-02
A2Lower casing
A3Housing grip, compl., consisting of:
(1) Screw cap, D 13 mm
(2) Allen bolt, 2 pcs., DIN 912, M6x60
(3) Grip
(4) Mast segment, 2 pcs., L 45mm
(5) Termination plate, 2 pcs.
96-531-015
71-115-055
60-03-35
60-03-36
60-03-37
A4Mains switch (voltage-dependent)
220-240 V/1.0 A
110-127 V/2.0 A
100 V/2.5 A
3120-F321
3120-F321
3120-F321
96-143-006
96-143-007
96-143-008
(96-143-002
obsolete)
(96-143-004
obsolete)
(96-143-005
obsolete)
A5Mains filter
220-240 V
100-127 V
FN610A-06/6
FN610-B-10
96-401-011
96-401-013
A6Batteries 96-405-003
A7Ring core transformer 96-403-058
A8Rectifier 93-154-028
A9Clamping strip (mains – ring core transformer
connection)
96-204-098
A10Discharge resistor (for battery discharge) 97-103-642
A11Automatic circuit breaker 8.0 A 96-148-115
A12Fan 96-406-003
A13SCP System Connections 97-101-901
A14Connection for Electrical Remote-Controlled
Tubing Clamp (for short: ERC)
A15Serial interface connection

SCPC System • System description
20 CP_SEM_60-03-00.002
3.2.4 Touch screen module
fig. 4: Overview of the touch screen module
B 1
B 2
B 3
B 4
Mod. Item Description Number SP number
B1SCPC Front panel, complete
(set includes assembly frame, touch screen,
Display circuit board, ZDS 2006, ZIS 0202,
EMC sealing cords, assembly material)
60-03-10
B2Display circuit board (fixed component of the
touch screen, can only be replaced as a unit)
B3CPU circuit board (ZDS) ZDS 2006 90-305-250
B4Interface circuit board (ZIS) ZIS 0202 90-305-300