1
About this document � � � � � � � � � � � � � � � 3
1�1
Warnings and symbols � � � � � � � � � � 3
Contents
1�2
Copyright information � � � � � � � � � � � 3
Important information
Contents
2
Safety � � � � � � � � � � � � � � � � � � � � � � � � � � � 4
1
About this document � � � � � � � � � � � � � � � 3
2�1
Intended purpose � � � � � � � � � � � � � � 4
1�1
Warnings and symbols � � � � � � � � � � 3
2�2
Intended use � � � � � � � � � � � � � � � � � � 4
1�2
Copyright information � � � � � � � � � � � 3
2�3
Improper use � � � � � � � � � � � � � � � � � 4
Safety � � � � � � � � � � � � � � � � � � � � � � � � � � � 4
2
Important information
Important information
2�4
General safety information � � � � � � � � 4
2�1
Intended purpose � � � � � � � � � � � � � � 4
1
About this document � � � � � � � � � � � � � � � 3
2�5
Applicable guidelines and
1 Safety standards ...................................................... 43
2�2
Intended use � � � � � � � � � � � � � � � � � � 4
Installation � � � � � � � � � � � � � � � � � � � � � � 17
7
1�1
Warnings and symbols � � � � � � � � � � 3
standards � � � � � � � � � � � � � � � � � � � � 4
2�3
Improper use � � � � � � � � � � � � � � � � � 4
7�1
Carrying the unit � � � � � � � � � � � � � � 17
1.1
Intended users ............................................................ 43
1�2
Copyright information � � � � � � � � � � � 3
2�6
Qualified personnel � � � � � � � � � � � � � 5
7�2
2�4
Remove the transport locks � � � � � 17
General safety information � � � � � � � � 4
1.2
Intended use ............................................................... 43
2�7
Protection from electric shock � � � � � 5
2
Safety � � � � � � � � � � � � � � � � � � � � � � � � � � � 4
2�5
Applicable guidelines and
7�3
Setting up the unit � � � � � � � � � � � � � 17
1.3
General safety warnings .............................................. 43
2�8
Only use genuine parts � � � � � � � � � � 5
� 3
2�1
Intended purpose � � � � � � � � � � � � � � 4
standards � � � � � � � � � � � � � � � � � � � � 4
7�4
Removing the protective film from
1.4
Operating and transport environmental conditions ...... 44
2�9
Transport and packaging � � � � � � � � � 5
� 3
2�2
Intended use � � � � � � � � � � � � � � � � � � 4
2�6
Qualified personnel � � � � � � � � � � � � � 5
the touch screen � � � � � � � � � � � � � � 18
2�10 Disposal � � � � � � � � � � � � � � � � � � � � � 5
1.5
Environmental disposal instructions............................. 44
� 3
2�3
Improper use � � � � � � � � � � � � � � � � � 4
2�7
Protection from electric shock � � � � � 5
7�5
Checking the SD memory card � � � 18
2�4
General safety information � � � � � � � � 4
� 4
2�8
Only use genuine parts � � � � � � � � � � 5
7�6
Checking the sterile air filter� � � � � � 18
2�5
Applicable guidelines and
� 4
2�9
Transport and packaging � � � � � � � � � 5
7�7
Connecting the unit � � � � � � � � � � � � 19
standards � � � � � � � � � � � � � � � � � � � � 4
� 4
2�10 Disposal � � � � � � � � � � � � � � � � � � � � � 5
7�8
Connecting the unit to the net-
Product description
2�6
Qualified personnel � � � � � � � � � � � � � 5
Product description
� 4
work � � � � � � � � � � � � � � � � � � � � � � � 20
2�7
Protection from electric shock � � � � � 5
3
Overview� � � � � � � � � � � � � � � � � � � � � � � � � 6
� 4
2 Equipment description ........................................... 45
8
Configuring the unit � � � � � � � � � � � � � � � 22
2�8
Only use genuine parts � � � � � � � � � � 5
3�1
Scope of delivery � � � � � � � � � � � � � � 7
8�1
Selecting the access level � � � � � � � 22
2.1
Variants ....................................................................... 46
2�9
Transport and packaging � � � � � � � � � 5
3�2
Accessories � � � � � � � � � � � � � � � � � � 7
� 4
Product description
8�2
Entering dealer information � � � � � � 22
2.2
Main features .............................................................. 46
2�10 Disposal � � � � � � � � � � � � � � � � � � � � � 5
3�3
Special accessories � � � � � � � � � � � � 7
� 5
3
Overview� � � � � � � � � � � � � � � � � � � � � � � � � 6
8�3
Language selection � � � � � � � � � � � � 22
2.2.1 Sterilisation programs ...................................... 46
3�4
Disposable materials � � � � � � � � � � � � 7
� 5
3�1
Scope of delivery � � � � � � � � � � � � � � 7
8�4
Configuring the device with a
2.2.2 Test programs ................................................. 46
3�5
Wear parts and spare parts � � � � � � � 7
� 5
network connection � � � � � � � � � � � 22
3�2
Accessories � � � � � � � � � � � � � � � � � � 7
2.2.3 Water filling systems ........................................ 46
� 5
4
Technical data � � � � � � � � � � � � � � � � � � � � 8
8�5
Set the date and time� � � � � � � � � � � 22
3�3
Special accessories � � � � � � � � � � � � 7
Product description
2.2.4 Automatic sterilisation parameter control ......... 46
� 5
4�1
Type plate � � � � � � � � � � � � � � � � � � � 10
8�6
3�4
Parameter selection � � � � � � � � � � � 23
Disposable materials � � � � � � � � � � � � 7
Overview� � � � � � � � � � � � � � � � � � � � � � � � � 6
3
2.2.5 Motorised closure ............................................ 46
4�2
Conformity assessment � � � � � � � � � 10
8�7
Configuring a log printer � � � � � � � � 23
3�5
Wear parts and spare parts � � � � � � � 7
3�1
Scope of delivery � � � � � � � � � � � � � � 7
2.2.6 Bio-X filter ........................................................ 46
8�8
Configuring the label printer � � � � � 23
5
Operation � � � � � � � � � � � � � � � � � � � � � � � 11
4
Technical data � � � � � � � � � � � � � � � � � � � � 8
3�2
Accessories � � � � � � � � � � � � � � � � � � 7
2.2.7 USB port ......................................................... 46
8�9
Configuring the network drive � � � � 23
5�1
Hygoclave 90 � � � � � � � � � � � � � � � � 11
4�1
Type plate � � � � � � � � � � � � � � � � � � � 10
3�3
Special accessories � � � � � � � � � � � � 7
8�10 User management � � � � � � � � � � � � 24
2.2.8 Serial port - RS232 .......................................... 46
5�2
Safety devices � � � � � � � � � � � � � � � 13
4�2
Conformity assessment � � � � � � � � � 10
3�4
Disposable materials � � � � � � � � � � � � 7
� 6
8�11 Setting up the calendar � � � � � � � � � 24
2.2.9 Touch screen display ....................................... 46
5�3
Overview of programs � � � � � � � � � � 15
Operation � � � � � � � � � � � � � � � � � � � � � � � 11
5
3�5
Wear parts and spare parts � � � � � � � 7
� 7
8�12 Touch screen � � � � � � � � � � � � � � � � 25
5�4
Tyscor Pulse (optional) � � � � � � � � � 15
2.2.10 LAN connection ............................................... 46
5�1
Hygoclave 90 � � � � � � � � � � � � � � � � 11
� 7
Technical data � � � � � � � � � � � � � � � � � � � � 8
4
9
Monitoring the device with
2.2.11 Safety devices ................................................. 46
5�2
Safety devices � � � � � � � � � � � � � � � 13
� 7
4�1
Type plate � � � � � � � � � � � � � � � � � � � 10
Tyscor Pulse � � � � � � � � � � � � � � � � � � � � � 25
2.3
Accessories included in the medical device
5�3
Overview of programs � � � � � � � � � � 15
� 7
4�2
Conformity assessment � � � � � � � � � 10
9�1
Network configuration � � � � � � � � � � 25
certification ................................................................. 47
5�4
Tyscor Pulse (optional) � � � � � � � � � 15
� 7
Installation
9�2
Network protocols and ports � � � � � 25
5
Operation � � � � � � � � � � � � � � � � � � � � � � � 11
� 8
9�3
Add device � � � � � � � � � � � � � � � � � � 26
5�1
Hygoclave 90 � � � � � � � � � � � � � � � � 11
6
Requirements � � � � � � � � � � � � � � � � � � � � 17
10
5�2
Safety devices � � � � � � � � � � � � � � � 13
6�1
Installation/setup room � � � � � � � � � 17
10 Test programs � � � � � � � � � � � � � � � � � � � 27
10
5�3
Overview of programs � � � � � � � � � � 15
Installation
10�1 Vacuum test � � � � � � � � � � � � � � � � � 27
Installation
5�4
Tyscor Pulse (optional) � � � � � � � � � 15
11
10�2 Bowie-Dick test � � � � � � � � � � � � � � 27
Requirements � � � � � � � � � � � � � � � � � � � � 17
6
11
3 Installation .......................................................................... 48
11 Logging handover and installation � � � � 28
6�1
Installation/setup room � � � � � � � � � 17
13
3.1
First power-up ...........................................................49
12 Validation for commissioning � � � � � � � � 28
6046100064L02 1702V002SE
15
Installation
15
6
Requirements � � � � � � � � � � � � � � � � � � � � 17
6�1
Installation/setup room � � � � � � � � � 17
6046100064L02 1702V002SE
Operation
Operating instructions
13 Operation � � � � � � � � � � � � � � � � � � � � � � � 30
4 Operating instructions ....................................................... 50
13�1 Switching the unit on/off � � � � � � � � 30
17
13�2 Touch screen � � � � � � � � � � � � � � � � 30
4.1
Symbols ..................................................................... 51
17
13�3 Time preset� � � � � � � � � � � � � � � � � � 32
6046100064L02 1702V002SE
4.2
Menu architecture ....................................................... 54
13�4 Monitoring the device with
4.3
Selecting sterilisation programs ................................... 55
Tyscor Pulse � � � � � � � � � � � � � � � � � 32
4.3.1 Sterilisation program types .............................. 56
13�5 Opening and closing the door � � � � 33
4.3.2 Cycle B Diagram ............................................. 56
4.3.3 Cycle S Diagram .............................................. 56
4.4
Sterilisation program specifications ............................. 57
4.5
Putting the material to be sterilised in the chamber ..... 57
4.5.1 Preparing the material ...................................... 57
4.6
Filling and draining water ............................................. 58
4.6.1 Filling the feed tank .......................................... 58
4.6.2 Draining the discharge tank ............................. 58
4.7
Test programs ............................................................. 59
4.7.1 Test program types .......................................... 60
4.7.2 Vacuum test (leakage test) ............................... 60
4.7.3 Bowie & dick test ............................................. 60
4.7.4 Helix test ......................................................... 60
4.7.5 Test diagrams .................................................. 60
7�3
Setting up the unit � � � � � � � � � � � � � 17
Installation � � � � � � � � � � � � � � � � � � � � � � 17
7
7�4
Removing the protective film from
7�1
Carrying the unit � � � � � � � � � � � � � � 17
the touch screen � � � � � � � � � � � � � � 18
7�2
Remove the transport locks � � � � � 17
7�5
Checking the SD memory card � � � 18
7�3
Setting up the unit � � � � � � � � � � � � � 17
7�6
Checking the sterile air filter� � � � � � 18
7�4
Removing the protective film from
7�7
Connecting the unit � � � � � � � � � � � � 19
7
Installation � � � � � � � � � � � � � � � � � � � � � � 17
the touch screen � � � � � � � � � � � � � � 18
7�8
Connecting the unit to the net-
7�1
Carrying the unit � � � � � � � � � � � � � � 17
7�5
Checking the SD memory card � � � 18
work � � � � � � � � � � � � � � � � � � � � � � � 20
7�2
Remove the transport locks � � � � � 17
7�6
Checking the sterile air filter� � � � � � 18
7�3
Configuring the unit � � � � � � � � � � � � � � � 22
Setting up the unit � � � � � � � � � � � � � 17
8
7�7
Connecting the unit � � � � � � � � � � � � 19
7�4
8�1
Removing the protective film from
Selecting the access level � � � � � � � 22
7�8
Connecting the unit to the net-
the touch screen � � � � � � � � � � � � � � 18
8�2
Entering dealer information � � � � � � 22
work � � � � � � � � � � � � � � � � � � � � � � � 20
7�5
Checking the SD memory card � � � 18
8�3
Language selection � � � � � � � � � � � � 22
EN
8
Configuring the unit � � � � � � � � � � � � � � � 22
7�6
Checking the sterile air filter� � � � � � 18
8�4
Configuring the device with a
8�1
Selecting the access level � � � � � � � 22
EN
7�7
Connecting the unit � � � � � � � � � � � � 19
network connection � � � � � � � � � � � 22
8�2
Entering dealer information � � � � � � 22
7�8
8�5
Set the date and time� � � � � � � � � � � 22
Connecting the unit to the net-
8�3
Language selection � � � � � � � � � � � � 22
work � � � � � � � � � � � � � � � � � � � � � � � 20
8�6
Parameter selection � � � � � � � � � � � 23
8�4
Configuring the device with a
8�7
Configuring a log printer � � � � � � � � 23
8
Configuring the unit � � � � � � � � � � � � � � � 22
network connection � � � � � � � � � � � 22
8�8
Configuring the label printer � � � � � 23
8�1
Selecting the access level � � � � � � � 22
8�5
Set the date and time� � � � � � � � � � � 22
8�9
Configuring the network drive � � � � 23
8�2
Entering dealer information � � � � � � 22
8�6
Parameter selection � � � � � � � � � � � 23
8�10 User management � � � � � � � � � � � � 24
8�3
Language selection � � � � � � � � � � � � 22
8�7
Configuring a log printer � � � � � � � � 23
8�11 Setting up the calendar � � � � � � � � � 24
8�4
Configuring the device with a
8�8
Configuring the label printer � � � � � 23
8�12 Touch screen � � � � � � � � � � � � � � � � 25
network connection � � � � � � � � � � � 22
8�9
Configuring the network drive � � � � 23
8�5
Set the date and time� � � � � � � � � � � 22
9
Monitoring the device with
8�10 User management � � � � � � � � � � � � 24
8�6
Parameter selection � � � � � � � � � � � 23
Tyscor Pulse � � � � � � � � � � � � � � � � � � � � � 25
8�11 Setting up the calendar � � � � � � � � � 24
8�7
Configuring a log printer � � � � � � � � 23
9�1
Network configuration � � � � � � � � � � 25
8�12 Touch screen � � � � � � � � � � � � � � � � 25
8�8
Configuring the label printer � � � � � 23
9�2
Network protocols and ports � � � � � 25
9
Monitoring the device with
8�9
Configuring the network drive � � � � 23
9�3
Add device � � � � � � � � � � � � � � � � � � 26
Tyscor Pulse � � � � � � � � � � � � � � � � � � � � � 25
8�10 User management � � � � � � � � � � � � 24
10 Test programs � � � � � � � � � � � � � � � � � � � 27
9�1
Network configuration � � � � � � � � � � 25
8�11 Setting up the calendar � � � � � � � � � 24
10�1 Vacuum test � � � � � � � � � � � � � � � � � 27
9�2
Network protocols and ports � � � � � 25
8�12 Touch screen � � � � � � � � � � � � � � � � 25
10�2 Bowie-Dick test � � � � � � � � � � � � � � 27
9�3
Add device � � � � � � � � � � � � � � � � � � 26
9
Monitoring the device with
11 Logging handover and installation � � � � 28
10 Test programs � � � � � � � � � � � � � � � � � � � 27
Tyscor Pulse � � � � � � � � � � � � � � � � � � � � � 25
10�1 Vacuum test � � � � � � � � � � � � � � � � � 27
12 Validation for commissioning � � � � � � � � 28
9�1
Network configuration � � � � � � � � � � 25
10�2 Bowie-Dick test � � � � � � � � � � � � � � 27
9�2
Network protocols and ports � � � � � 25
11 Logging handover and installation � � � � 28
9�3
Add device � � � � � � � � � � � � � � � � � � 26
12 Validation for commissioning � � � � � � � � 28
10 Test programs � � � � � � � � � � � � � � � � � � � 27
Operation
10�1 Vacuum test � � � � � � � � � � � � � � � � � 27
13 Operation � � � � � � � � � � � � � � � � � � � � � � � 30
10�2 Bowie-Dick test � � � � � � � � � � � � � � 27
13�1 Switching the unit on/off � � � � � � � � 30
11 Logging handover and installation � � � � 28
13�2 Touch screen � � � � � � � � � � � � � � � � 30
Operation
12 Validation for commissioning � � � � � � � � 28
13�3 Time preset� � � � � � � � � � � � � � � � � � 32
13 Operation � � � � � � � � � � � � � � � � � � � � � � � 30
13�4 Monitoring the device with
13�1 Switching the unit on/off � � � � � � � � 30
Tyscor Pulse � � � � � � � � � � � � � � � � � 32
13�2 Touch screen � � � � � � � � � � � � � � � � 30
13�5 Opening and closing the door � � � � 33
13�3 Time preset� � � � � � � � � � � � � � � � � � 32
Operation
13�4 Monitoring the device with
13 Operation � � � � � � � � � � � � � � � � � � � � � � � 30
Tyscor Pulse � � � � � � � � � � � � � � � � � 32
13�1 Switching the unit on/off � � � � � � � � 30
13�5 Opening and closing the door � � � � 33
13�2 Touch screen � � � � � � � � � � � � � � � � 30
13�3 Time preset� � � � � � � � � � � � � � � � � � 32
13�4 Monitoring the device with
Tyscor Pulse � � � � � � � � � � � � � � � � � 32
13�5 Opening and closing the door � � � � 33
1
EN
Contents
EN
13�6 Preparations for steam
sterilisation � � � � � � � � � � � � � � � � � � 34
13�7 Loading the items for sterilisation
4.8
Settings ......................................................................61
into the unit � � � � � � � � � � � � � � � � � � 36
EN
4.8.1 User settings ...................................................61
13�8 Steam sterilising � � � � � � � � � � � � � � 37
13�9 Storing parts for sterilisation � � � � � 39
4.8.2 Date and time settings .....................................61
4.8.3 Printer settings ................................................62
14 Documenting the sterilisation� � � � � � � � 40
4.8.4 Language settings ...........................................62
14�1 Batch documentation � � � � � � � � � � 40
14�2 Automatic record output � � � � � � � � 41
4.8.5 Measurement unit settings ...............................62
14�3 Subsequent output of saved
4.8.6 Water settings .................................................62
records � � � � � � � � � � � � � � � � � � � � � 41
4.8.7 Connections ....................................................63
14�4 Printing out records � � � � � � � � � � � � 41
4.8.8 Ethernet connection ........................................63
15 Messages on the touch screen � � � � � � 43
4.9
Data output ................................................................66
15�1 Note � � � � � � � � � � � � � � � � � � � � � � � 43
5 Routine maintenance .............................................. 69
15�2 Information � � � � � � � � � � � � � � � � � � 43
16 Operating pauses � � � � � � � � � � � � � � � � � 45
5.1
General table ..............................................................69
16�1 Pause times � � � � � � � � � � � � � � � � � 45
5.1.1 Cleaning the sterilisation chamber and internal
17 Taking out of operation � � � � � � � � � � � � 45
components ....................................................69
17�1 Transport � � � � � � � � � � � � � � � � � � � 45
5.1.2 Cleaning the door cover ..................................69
18 Restarting after an extended pause in
5.1.3 Cleaning the external front panel ......................69
operation � � � � � � � � � � � � � � � � � � � � � � � 46
5.1.4 Cleaning the door seal .....................................69
19 Maintenance� � � � � � � � � � � � � � � � � � � � � 47
5.1.5 Cleaning the filter in the chamber .....................69
19�1 Maintenance schedule � � � � � � � � � 47
5.1.6 Replacing the Bacterial or Bio X filter ...............69
19�2 Complete cleaning � � � � � � � � � � � � 48
5.1.7 Replacing the door seal ...................................69
19�3 Cleaning or replacing the door
5.1.8 Cleaning the dust filter (if provided) ..................69
seal � � � � � � � � � � � � � � � � � � � � � � � 50
5.1.9 Lubricating and cleaning the screw and nut
19�4 Checking the hinge and oiling the
screw ..............................................................70
door spindle � � � � � � � � � � � � � � � � � 50
5.1.10 Clean the feed tank .........................................70
19�5 Clean or replacing water filters � � � 51
19�6 Changing the sterile air filter � � � � � 51
5.2
Maintenance ...............................................................70
19�7 Function check � � � � � � � � � � � � � � � 52
5.3
Periodic process effectiveness and safety checks .......70
Troubleshooting
Troubleshooting
20 Tips for operators and
6 Troubleshooting guide
service technicians� � � � � � � � � � � � � � � � 53
20�1 "Caution" messages � � � � � � � � � � � 53
6.1
Error Codes ................................................................71
20�2 "Fault" messages � � � � � � � � � � � � � 53
6.2
Alarm Codes ...............................................................72
1
21 Emergency opening of the door� � � � � � 55
6.3
Messagges .................................................................72
6.4
Reset procedures .......................................................73
6.5
Troubleshooting ..........................................................73
1
6.6
Message solutions ......................................................76
Appendix
7 Technical specifications
22 Settings menu layout � � � � � � � � � � � � � � 56
7.1
Water specifications (distilled or demineralized) ...........76
1
8 Spare parts codes
..........................................................76
2
...................................................71
................................................76
EN
604610
41