LivaNova CP5 User manual

CP5
Service Manual

CP5 • Service Manual
Copyright © 2011 - 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.
Service Manual
Version 02/2017 - CP_SEM_60-00-60.001

CP5 • Table of contents
CP_SEM_60-00-60.001 3
Table of contents
1 Introduction
1.1 About the Service Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.1.1 Symbols used in the Service Manual. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.1.2 Chapters in the Service Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
1.2 Terminology and abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2Safety
2.1 Approvals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
2.2 Regulations and safety instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
2.2.1 Use in accordance with regulations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.2.2 General safety instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.2.3 Operational safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.2.4 Electrical safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
2.2.5 Safety instructions for routine maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.2.6 Safety instructions for service technicians . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.3 Safety features of the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
3 System description
3.1 General description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.1.1 CP5 components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.1.2 General overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3.2 Service-relevant assemblies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
3.2.1 Assembly overview – Control panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Circuit board computer board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Circuit board keys and LEDs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
Circuit board inverter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
Circuit board fan control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
3.2.2 Assembly overview – drive unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
Circuit board motor control (ZPR 0801) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25
3.3 Information on flow sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
3.3.1 Flow sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
3.3.2 Functional diagram of flow probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
3.3.3 Sensor module for flow measurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29
4 Key icons and display (brief overview)
4.1 Key icons and displays on the control panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
4.2 Key icons and displays on the system panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
Key icons and displays of the system menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35

CP5 • Table of contents
4CP_SEM_60-00-60.001
5 Fault messages and troubleshooting
5.1 Fault messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37
5.1.1 Unspecified faults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37
5.1.2 Fault messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38
Faults in the sensor modules or sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40
6 Replacing components
6.1 Pump control panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41
6.1.1 Open pump control panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
6.1.2 Replacing control panel components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43
Replacing the circuit board fan control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43
Replacing circuit boards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44
Replacing the touch screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47
Removing the shaft encoder. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
6.2 Drive unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50
6.2.1 Opening the drive system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50
6.2.2 Replace drive unit components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Motor control board (ZPR 0801) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Connecting cable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .53
6.3 Replacing circuit boards/sensor module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .55
6.4 Connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
6.4.1 Circuit boards connectors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
FCI plug connector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
RIA plug connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .58
Phoenix plug and socket. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .58
AMP plug and socket. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59
7Appendix
7.1 Technical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
7.1.1 Dimensions, weights, operating conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
7.1.2 Electrical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62
7.1.3 General specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62
7.2 Labelling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
7.3 Part numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65
7.4 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
7.5 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
7.6 Service component part numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .67
7.6.1 Pump control panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .67
7.6.2 Drive unit and emergency system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
7.6.3 Sensor module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69
7.7 Wiring diagrams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .70

CP5 • Introduction
CP_SEM_60-00-60.001 5
1 Introduction
1.1 About the Service Manual
This Service Manual (along with the training given by LIVANOVA DEUTSCHLAND GMBH) provide basic
information on the maintenance and repair of your Sorin Centrifugal Pump System CP5. 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 CP5.
All information on the operation of the CP5 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 the 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 observe these safety instructions may put the life or
health of the patient and/or the user at risk.
!Warning! Failure to observe these safety instructions may cause damage to
the machine or other property.
✓A check list that can be used to quickly and safely check if operational steps
have been carried out completely.
◗Primary list (main groups)
➜Secondary list (subgroups)

CP5 • Introduction
6CP_SEM_60-00-60.001
1.1.2 Chapters in the Service Manual
In chapter... you will find the following information:
1 Introduction – Symbols in the Service Manual
– Overview on chapters (this table)
– Terminology and abbreviations
2 Safety – Important safety instructions for the operation of the CP5
– Safety instructions for service technicians
3 System description – Description of all service-relevant components
4 Key icons and display Brief overview:
– Key icons and displays on the pump control panel
– Key icons and displays on the system panel
5 Fault messages and troubleshooting – List of all fault messages and fault isolation tips
6 Replacing components – Information and instructions on the removal and
installation of components
7 Appendix – Technical data and components
– Part numbers / spare parts

CP5 • Introduction
CP_SEM_60-00-60.001 7
1.2 Terminology and abbreviations
◗S5 Stöckert S5, modular heart-lung-machine
(in this case: the overall system)
◗C5 Sorin C5, compact heart-lung machine
(in this case: the overall system)
◗CP5 Sorin Centrifugal Pump System for use with the
Revolution®
◗Revolution®
(or: centrifugal blood pump)
Sorin Revolution®Centrifugal Blood Pump
(disposable)
◗APC Air Purge Control:
a system component of the S5 and C5 that facilitates the
controlled removal of bubbles from bubble traps.
◗Electrical remote-controlled tubing
clamp (tubing clamp or ERC for short)
Tubing clamp for clamping the arterial line automatically
during an alarm (bubble alarm, level alarm or “negative
flow”).
◗Optimised bypass A blood circuit during extracorporeal circulation (ECC)
that does not use a venous reservoir.
◗ECC Extracorporeal circulation
◗HLM Heart-lung machine
◗UPS Uninterruptible power supply
◗CAN Controller area network (CAN bus)
◗OT Operating theatre
◗LED Light emitting diode
◗LCD Liquid crystal display
◗rpm Revolutions per minute
◗l/min Litres per minute
◗mmHg or kPa Unit of pressure: 1 mmHg = 0.133 kPa; 1 kPa = 7.5 mmHg
◗ESD Electro Static Discharge

CP5 • Introduction
8CP_SEM_60-00-60.001

CP5 • Safety
CP_SEM_60-00-60.001 9
2Safety
2.1 Approvals
Like development and manufacturing, service must also be conducted in conformance with the
following standards and statutes:
The CP5 is a class IIb medical device under the Medical Products Law (MDD 93/42). A Declaration of
Conformity has been issued for the CP5.
2.2 Regulations and safety instructions
2.2.1 Use in accordance with regulations
!
◗The Sorin Centrifugal Pump (CP5) is a cardiopulmonary bypass speed control device indicated for
use exclusively with the Sorin Revolution®, for speed-controlled pumping through the
cardiopulmonary bypass circuit.
Any use outside this specification is not in accordance with the regulations.
LIVANOVA DEUTSCHLAND GMBH will not assume any liability for any damage resulting from such
use. Usage in accordance with regulations also includes compliance with the operating
instructions and routine maintenance.
◗The national regulations for accident prevention and all other internationally accepted health and
safety regulations must be complied with. LIVANOVA DEUTSCHLAND GMBH will not accept any
liability for any damage resulting from non-compliance with these regulations.
◗LIVANOVA DEUTSCHLAND GMBH will not assume any liability for any injuries and/or damage
to property caused by failure to observe the safety or operating instructions or by the user not
exercising due care. This also applies if the user’s duty to exercise due care has not been stated
expressly.
– Declaration of Conformity
IEC 60601-1 – Medical Electrical Equipment-Part 1: General
Requirements for Safety
IEC 60601-1-2 – EMC (electromagnetic compatibility)
MDD – Medical Device Directive 93/42 EEC
DIN EN ISO 13485 – Quality Management System

CP5 • Safety
10 CP_SEM_60-00-60.001
2.2.2 General safety instructions
◗The CP5 has been designed in accordance with the accepted safety standards using state-of-the-
art technology. Nevertheless, the patient, the user or property may be put at risk during operation.
!
◗The CP5 may only be used and maintained by trained and qualified personnel.
◗The CP5 may not be used near explosive materials.
Use in accordance
with regulations:
See chapter 2.2.1
on page 9
◗The CP5 should only be used when in perfect working order. The device must be used in accordance
with its intended purpose, and the relevant safety and operating instructions must be observed.
◗The operating instructions for the CP5 should be kept close to the device at all times. Incomplete or
illegible operating instructions must be replaced immediately.
◗The following also applies to the CP5 when used in combination with the S5 or C5 (overall system):
In accordance with the European Medical Device Directive (MDD) 93/42 EEC and the national
standards based on this directive, the CP5 must be subjected to a regular maintenance inspection
by an authorised service technician. The inspection must be carried out on the overall system after
every 1000 operating hours or at least every 12 months, whichever comes first. The regular
maintenance inspection of the CP5 is carried out together with the regular maintenance inspection
of the overall system based on the operating hours of the overall system.
◗In addition to the operating instructions, the relevant legal, general and any other binding
regulations concerning the prevention of accidents must be observed.
◗In order to cover situations which are clinic-specific and outside of normal routines, e.g. certain
working procedures, the operating instructions must be supplemented with relevant instructions
(supervision and registration requirements, etc).
◗An S5 or C5 (or a compatible system) is required in order to use the CP5. For firmware information,
see inside front cover and the separate operating instructions for the S5 or C5. Only authorised
service technicians are permitted to upgrade the relevant firmware.
◗If you detect modifications affecting the safety or performance of the CP5 (when the system is not
being used in the OT): do not use the device and have it checked by an authorised service
technician immediately.
◗Do not modify, alter or extend the CP5 unless the changes have been tested and approved by
LIVANOVA DEUTSCHLAND GMBH. LIVANOVA DEUTSCHLAND GMBH cannot assume liability or
responsibility for unauthorised modifications or changes.
◗Keep the device clean! This will prevent malfunction caused by contamination..