Integra MEDIACLAVE 10 Operating instructions

MEDIACLAVE 10 and 30
Service Instructions
(Part No. 136960, Version V23)

MC 10/30 – Service Instructions V23
2 INTEGRA Biosciences AG
Manufacturer
INTEGRA BIOSCIENCES AG
Tardisstrasse 201
CH-7205 Zizers
Switzerland
Web Address
https://www.integra-biosciences.com
Technical Support
INTEGRA BIOSCIENCES AG
Email: [email protected]
Phone: [phone]
United States Representative
INTEGRA BIOSCIENCES CORP.
2 Wentworth Drive
Hudson, NH 03051
USA
Email: [email protected]
Phone: [phone]
Document change history
Version: Status: Name: Date: Change:
V23 Released AWa 02.07.2018 History introduced. APPENDIX: IQ/OQ re-
moved and stored in separate documents.

MC 10/30 – Service Instructions V23
INTEGRA Biosciences AG 3
136960_V23_SI_MEDIACLAVE_10_30.fm 2018-07-02
Table of Contents
1 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.1 Residual dangers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.2 Safety regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2 Instrument overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.1 Front view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.2 Side view right MEDIACLAVE 10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2.3 Rear view MEDIACLAVE 10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2.4 Side view left MEDIACLAVE 10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.5 Front cover (inside) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.6 Front view MEDIACLAVE 10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.7 Bottom view MEDIACLAVE 10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.8 Side view right MEDIACLAVE 30 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.9 Rear view MEDIACLAVE 30. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
2.10 Side view left MEDIACLAVE 30. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.11 Bottom view MEDIACLAVE 30 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3 Functional description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.1 Block diagrams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.2 Wiring diagrams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
3.3 Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
3.4 Mechanical components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
3.5 Electrical Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
3.6 Power connection for MEDIACLAVE 10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
3.7 Power connection for MEDIACLAVE 30. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
4 Service tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
4.1 Service kits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
4.2 User level dialog. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
4.3 Service level dialog (SERVICE TESTS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
4.4 Ethernet connection of the MC 10/30 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
4.5 Webserver in MC 10/30 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
4.6 USB flash drive. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
4.7 Logdata and logfiles: overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
4.8 Firmware update. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
5 Service and maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
5.1 Service concept . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
5.2 General periodic service and calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
5.3 Calibration tools (temperature and pressure) . . . . . . . . . . . . . . . . . . . . . . . . . . 99
5.4 Service parts and kits overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
5.5 Recommended service tools and accessories . . . . . . . . . . . . . . . . . . . . . . . . 104
5.6 History: Firmware (FW) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
5.7 History: Hardware (HW) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

MC 10/30 – Service Instructions V23
4 INTEGRA Biosciences AG
6 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .111
6.1 Voltage and sensor test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
6.2 Error and system messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
6.3 Miscellaneous troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
6.4 Special tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
6.5 Frequently asked questions (FAQ’s). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
7 Repair. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .135
7.1 General guidance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
7.2 Mechanical items. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
7.3 Service kits Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
7.4 Service kits Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
7.5 Service kits Actuators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163
7.6 Service kits Mains and heating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168
7.7 Calibration and adjustments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175
7.8 Decalcification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179
8 Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .181
8.1 MC 10/30 interconnection diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181
8.2 Matrix printer EPSON TM-U220 connection . . . . . . . . . . . . . . . . . . . . . . . . . . 182
8.3 Introduction to instrument qualification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183
8.4 Installation Qualification (IQ, not included) . . . . . . . . . . . . . . . . . . . . . . . . . . 184
8.5 Operational Qualification (OQ, not included) . . . . . . . . . . . . . . . . . . . . . . . . . 184
8.6 Automated Operational Qualification (OQ). . . . . . . . . . . . . . . . . . . . . . . . . . . 185

MC 10/30 – Service Instructions V23 1 Introduction
INTEGRA Biosciences AG 5
136960_V23_SI_MEDIACLAVE_10_30.fm 2018-07-02
1 Introduction
Related
documenta
tion
The service instruction manual should be used together with the Operating
instructions (OI) since common but necessary information is provided only in
the OI. In particular this applies to the following: Water supply and connections;
Interfaces; user level procedures. Corresponding version is: OI V12 and higher.
Document
versions
New information added or modified information changed since the last Service
Instructions release, is marked in red. e.g. chapter title (for new chapters) or
words/numbers (for additional info or corrections).
This allows easy and quick recognition of changes by the reader.
Software
and
Hardware
level
This service instruction (SI) manual refers to MEDIACLAVE 10/30:
- Firmware (FW) version (App) up to V02.22 and higher.
- Webserver (Web) up to V03.00 and later.
- Hardware (HW) versions up to 2017/03 and later (incl. USB port).
Note: Earlier SI versions do not include the full range of functions.
1.1 Residual dangers
1.1.1 Warning labels on the device
CAUTION
Risk of slight burns from the metallic cover of the instruments.
Due to heating up to sterilization temperature (approximately 120 °C / 248 °F)
some parts of the device may be harmful to your tissue.
Wear protective gloves if you need to operate on hot elements or wait until
they have cooled down.
CAUTION
Device may be damaged by Electrostatic Discharge.
MC 10/30 electronic boards must not be touched without taking ESD protec-
tion steps such as use of an ESD wristband or electrostatic conductive shoes.

MC 10/30 – Service Instructions V23 1 Introduction
6 INTEGRA Biosciences AG
1.2 Safety regulations
Irrespective of the safety instructions set out in this manual, applicable provi-
sions and regulations must be observed in addition; for example, GLP, GMP,
FDA, of the employer's liability insurance associations, of the health authorities
and of the trading standards authorities.
WARNING
Electrical shock if device is connected to mains.
For personal security, the MC 10/30 must be switched off and disconnected
from power supply before any installation or repair work is carried out!
Special care must be taken when adjusting the MC 10/30 modules with elec-
tricity supply switched on.
CAUTION
All persons entrusted with maintenance and repair of the MC 10/30 must have
read and understood this service instruction manual and, in particular, the
safety instructions, and must have been instructed by INTEGRA Biosciences
AG such that they are able to service the device without danger.

MC 10/30 – Service Instructions V23 2 Instrument overview
INTEGRA Biosciences AG 7
136960_V23_SI_MEDIACLAVE_10_30.fm 2018-07-02
2 Instrument overview
Differences of the two MC 10/30 versions are listed hereafter.
Note In the following picture legends numbers in brackets e.g. [11] refer to the sen-
sor/actuator number in the 3.1.2 “System block diagram” on page 17.
2.1 Front view
Property MEDIACLAVE 10 MEDIACLAVE 30
Vessel contents 10 Liter 30 Liter
Heating capacity 3 kW 9 kW
Mains voltages and connec-
tions
See “Power connection of MC 10/30” on page 46
Width/Depth/Height 48 × 55 × 64 cm 104 × 55 × 64 cm
Weight 57 kg 85 kg
Support pressure pump low volume flow pump
but for sn >=10300150
high volume flow pump
high volume flow pump
Filling pump no yes
Table 2.1 Properties of MC 10/30 versions
Safety cover
Front panel
Display
Keypad
Printer (optional)
USB Port
for USB flash drive
(mid 2012)
Fig. 2.1 Front view with panel

MC 10/30 – Service Instructions V23 2 Instrument overview
8 INTEGRA Biosciences AG
2.2 Side view right MEDIACLAVE 10
2.3 Rear view MEDIACLAVE 10
Dust baffle for Ctrl box fan
Screw for front panel
Vessel lid pos. sensor
Circuit breaker
Main contactor
Heating relay 1 and 2
Main board
I/F-cable to USB Board
(not plugged)
Fuses
Power supply
Rubber bumpers
Screw for front panel
Fig. 2.2 Electronic control box
Temp. sensor heater [26]
Control box fan
Level sensor top [10a]
Pressure sensor [9]
Check valve [42]
Support pressure pump
[17]
Main board connectors
Valve block B
Level sensor bottom [10b]
Line filter
Valve block A
Adjustment of cooling
water flow
Flow heater [11]
Fig. 2.3 Rear view without panel MC 10

MC 10/30 – Service Instructions V23 2 Instrument overview
INTEGRA Biosciences AG 9
136960_V23_SI_MEDIACLAVE_10_30.fm 2018-07-02
2.4 Side view left MEDIACLAVE 10
2.5 Front cover (inside)
Temperature sensor cou-
pling water [19]
Safety cover lock solenoid
Flow heater [11]
Heat exchanger [39]
Sterile filter [33]
Circulation pump [14]
Screws for front panel
Screws for flow heater
Fig. 2.4 Left side view without panel MC 10
Front panel
Connector board
Main switch
USB Board
Printer (optional)
Display
Magnets for printer splash
guard
Keypad attached to Front
cover (outside, not visible)
Fig. 2.5 Front cover opened
Top
Bottom

MC 10/30 – Service Instructions V23 2 Instrument overview
10 INTEGRA Biosciences AG
2.6 Front view MEDIACLAVE 10
2.7 Bottom view MEDIACLAVE 10
Safety cover lock
Safety cover position
sensor
PE-wire to USB Board (not
visible)
Nuts for heat exchanger
Connector board
Cables to main switch
Circulation pump [14]
Fig. 2.6 Front view without panel after removal of front cover MC10
Heat exchanger [39]
Stirrer motor
Circulation pump [14]
Strainer [35]
Flow heater [11]
Fig. 2.7 Bottom view without panel MC 10
rear side