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
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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

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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
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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
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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

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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

MC 10/30 – Service Instructions V23 2 Instrument overview
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2.8 Side view right MEDIACLAVE 30
Vessel lid pos. sensor
Main contactor
Circuit breaker
Heating relays 1 and 2
Main board
Fuses
Power supply
Screw for front panel
Filling pump [5]
Fill valve [7]
Fig. 2.8 Right side view without panel MC 30

MC 10/30 – Service Instructions V23 2 Instrument overview
12 INTEGRA Biosciences AG
2.9 Rear view MEDIACLAVE 30
Control box fan
Level sensor top [10a]
Temp. sensor heater [26]
Support pressure pump
[17]
Main board connectors
Flow heater [11]
Pressure sensor [9]
Check valve [42]
Valve block B
Sterile filter [33]
Level sensor bottom [10b]
Valve block A
Adjustment of cooling
water flow
Fig. 2.9 Rear view without panel MC 30

MC 10/30 – Service Instructions V23 2 Instrument overview
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2.10 Side view left MEDIACLAVE 30
Safety cover lock solenoid
Screws for front panel
Temperature sensor
coupling water [19]
Screws for flow heater
Flow heater
Heat exchanger [39]
Circulation pump [14]
Fig. 2.10 Left side view without panel MC 30

MC 10/30 – Service Instructions V23 2 Instrument overview
14 INTEGRA Biosciences AG
2.11 Bottom view MEDIACLAVE 30
Note Due to the weight of the MEDIACLAVE 30 hoisting gear is required to turn over
the instrument for inspection of the bottom. Pay attention to any projecting
parts!
Heat exchanger [39]
Fill valve [7]
Stirrer motor
Circulation pump [14]
Strainer [35]
Filling pump [5]
Fig. 2.11 Bottom view without panel MC 30
rear side
front side

MC 10/30 – Service Instructions V23 3 Functional description
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3 Functional description
This chapter describes particular electronic and mechanic components and
modules regarding to operating mode and purpose.
3.1 Block diagrams
The block diagram gives an overview of the function of the instrument. A ver-
sion of the system block diagram is also presented in the Web Interface (see
4.5 “Webserver in MC 10/30” on page 78). If there are any questions regarding
concept, structure and technical functions of the MC 10/30, it is strongly
recommended to use the block diagrams. Especially helpful is the system block
diagram. It shows all elements involved in the physical process. e.g. valves,
pumps, etc. and also their positions in the system.
3.1.1 Electrical block diagram
The electric block diagram contains all elements of the instrument, which are
controlled by the program.

MC 10/30 – Service Instructions V23 3 Functional description
16 INTEGRA Biosciences AG
Fig. 3.1 Electric block diagram
Drawing Number:Date: Project:
Created: Title: Changed / Nr: Released:
Name:
INTEGRA BIOSCIENCES AG
TARDISSTRASSE 201 CH-7205 ZIZERS SWITZERLAND
Display 240x128 blue
Display top side
2
Heating relay 1&2
RS232(1)
PC
Ethernet
interface
RS232 (2)
external
printer
1
Power supply 24V
Main switch
Stirrer motor
Temperature probe media
Safety cover position sensor
Safety cover lock
Electrical Block Diagram Mediaclave ll Mediaclave ll
12.01.2007MLi
136973_10_Electrical_Block_Diagram_Mediaclave_10.dsf
136973_10
AUX
contact
Mainboard
Main contactor
Vessel pressure sensor
Circuit breaker
Buzzer
Support pressure valve
Dispense pressure valve Air vent valve
Drain valve
Cool valve
Heat exchanger vent valve
GMu 31.10.2013
Level sensor top
Foot
switch
Temperature sensor coupling media Temperature sensor heater
Ambient pressure sensor
Overtemperature protectors
Control box fan
Internal
printer
Safety cover position sensor 2
External
valve
Key pad
Connectorboard
Rear panel fan
Level sensor bottom
Support Pressure Pump
Circulation Pump
Safety cover position sensor 1
Line filter
GMu 31.10.2013
Mains
Circulation heater
M
USB
Board
USB Flash
Drive
Pump current sensing board
1) Option introduced/ available (since 2014/03)
1)

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3.1.2 System block diagram
Fig. 3.2 System block diagram

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The numbering of the elements in the system block diagram is used throughout
this manual for identification of elements:
Symbol Explanation Symbol Explanation
Electromagnetic valve
Heater
Heat exchanger
Motor and pump
Sensors for temperature,
pressure or level
Silencer
Quick disconnect
Throttle
Check valve
Filter
Safety valve
Fig. 3.3 Symbols used in the system block diagram
ID Description ID Description
5Filling pump
(MEDIACLAVE 30 only) 20 Stirrer
7Fill valve
(MEDIACLAVE 30 only) 26 Overtemperature sensor
8 Drain valve 33 Sterile filter
9 Vessel pressure sensor 34 Cooling water throttle
10 Level sensor a) top, b) bottom 35 Strainer
11 Heater 36 Heat exchanger vent valve
14 Circulation pump 37 Dispense pressure valve
15 Cool valve 38 Dispense throttle
16 Silencer 39 Heat exchanger
17 Support pressure pump 40 Support pressure valve
18 Medium temperature sensor 41 Air vent valve
19 Coupling water temperature sensor 42 Check valve
Table 3.1 Elements in the system block diagram

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3.2 Wiring diagrams
3.2.1 Overview main board
Note At the RTC-RAM battery the gray dot must be located to the lower left!
Fig. 3.4 Main board MC 10/30 with test points and fuses
X203
BOOTS
NORMAL
X316
F304
F303
F305
F307
Reset button
Microcontroller indicator
(running if flashing)
Bootstrap switch
X401
X408
X414
X411
X407
X1200
X409
X1007
X802 X1008
X1015
X1011 X1016
X1000
X1005
X1100X1010
X904X905 X903
X902
X901X906
X1101X1009
X500
X508
X602 X506 X606 X501 X600
X609
X505 X605 X503 X504 X700
X507
X701
X601 X604
X413
X608
X603
X1007
TP334 TP341
TP329
TP319
TP325
TP324
TP322
TP333
TP321
TP330
TP335
TP338
TP336
TP327
TP323
TP332
TP700
TP320
TP340
TP800
TP339
TP337
TP328
TP301
D607
D203
D310
D312
D313
D311
D604 D504 D503 D505
D608 D600 D502 D506
D603 D601 D606
GINT
GLOG
GLOG
GLOG GLOG
VINT1
VINT3
VINT4
VINT2
to USB Board
RTC-RAM
battery
X317

MC 10/30 – Service Instructions V23 3 Functional description
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Connectors to actuators
A lit LED always indicates an active actuator
Test points TPnnn on the main board
The voltages are measured against ground (GINT,GLOG) which is TP 335.
Items with values in columns Target value and Error threshold are measured by
internal sensors. See “11 System voltages” on page 60.
Actuator [ID] Connector Indicator
(LED) Remark
Air vent valve [41] X600 D600
Circulation pump [14] X701 - See next line
Current sensor board [kit] for circu-
lation pump
X701
X1000
pn 136576 a
a. Option introduced/available (since 2014/03).
Cool valve [15] X504 D504
Dispense pressure valve [37] X501 D502
Drain valve [8] X605 D604
Fill valve [7] X606 D506 MEDIACLAVE 30
Filling pump [5] X507 - MEDIACLAVE 30
Heat exchanger vent valve [36] X505 D505
Heating relay 1 X601 D601
Heating relay 2 X603 D603
Main contactor X604 D606 Protected by overtem-
perature switches
(X608)
Safety cover lock X602 -
Stirrer motor [20] X700 -
Support pressure pump [17] X609 D607
Support pressure valve [40] X503 D503
Table 3.2 Actuator ID’s, connectors and LEDs on Main board
Voltage Test point(s) Target value Error threshold
VREF TP319 5.0 V
VLOG TP320 5.0 V 4.65 … 5.35 V
VAREF TP321 4.762 V
3V3 TP322 3.3 V 3.0 … 3.6 V
VISO12 TP323 12.0 V
+18V TP324
V18NEG TP325 -18.0 V -14 … -20 V
V5NEG TP326 -5.0 V -4.0 … -6.0 V
VISO TP327 5.0 V
GLOG TP328, TP334,
TP340, TP341 Ground
VOP TP329 12.0 V 11 … 13 V
SENS TP330
GISO TP332
/RESET_C167 TP333
GINT TP335 Ground
Table 3.3 Test points on main board