
39
EN
6046100064L02 1702V002SE 1
7 Installation � � � � � � � � � � � � � � � � � � � � � � 17
7�1 Carrying the unit � � � � � � � � � � � � � � 17
7�2 Remove the transport locks � � � � � 17
7�3 Setting up the unit� � � � � � � � � � � � � 17
7�4 Removing the protective film from
the touch screen� � � � � � � � � � � � � � 18
7�5 Checking the SD memory card � � � 18
7�6 Checking the sterile air filter� � � � � � 18
7�7 Connecting the unit� � � � � � � � � � � � 19
7�8 Connecting the unit to the net-
work � � � � � � � � � � � � � � � � � � � � � � � 20
8 Configuring the unit � � � � � � � � � � � � � � � 22
8�1 Selecting the access level � � � � � � � 22
8�2 Entering dealer information � � � � � � 22
8�3 Language selection� � � � � � � � � � � � 22
8�4 Configuring the device with a
network connection � � � � � � � � � � � 22
8�5 Set the date and time�� � � � � � � � � � 22
8�6 Parameter selection � � � � � � � � � � � 23
8�7 Configuring a log printer � � � � � � � � 23
8�8 Configuring the label printer � � � � � 23
8�9 Configuring the network drive � � � � 23
8�10 User management � � � � � � � � � � � � 24
8�11 Setting up the calendar� � � � � � � � � 24
8�12 Touch screen � � � � � � � � � � � � � � � � 25
9 Monitoring the device with
Tyscor Pulse� � � � � � � � � � � � � � � � � � � � � 25
9�1 Network configuration � � � � � � � � � � 25
9�2 Network protocols and ports� � � � � 25
9�3 Add device � � � � � � � � � � � � � � � � � � 26
10 Test programs � � � � � � � � � � � � � � � � � � � 27
10�1 Vacuum test � � � � � � � � � � � � � � � � � 27
10�2 Bowie-Dick test � � � � � � � � � � � � � � 27
11 Logging handover and installation� � � � 28
12 Validation for commissioning � � � � � � � � 28
Operation
13 Operation � � � � � � � � � � � � � � � � � � � � � � � 30
13�1 Switching the unit on/off � � � � � � � � 30
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
EN
Contents
Important information
1 About this document � � � � � � � � � � � � � � � 3
1�1 Warnings and symbols � � � � � � � � � � 3
1�2 Copyright information � � � � � � � � � � � 3
2 Safety � � � � � � � � � � � � � � � � � � � � � � � � � � � 4
2�1 Intended purpose � � � � � � � � � � � � � � 4
2�2 Intended use� � � � � � � � � � � � � � � � � � 4
2�3 Improper use � � � � � � � � � � � � � � � � � 4
2�4 General safety information� � � � � � � � 4
2�5 Applicable guidelines and
standards � � � � � � � � � � � � � � � � � � � � 4
2�6 Qualified personnel � � � � � � � � � � � � � 5
2�7 Protection from electric shock� � � � � 5
2�8 Only use genuine parts � � � � � � � � � � 5
2�9 Transport and packaging� � � � � � � � � 5
2�10 Disposal � � � � � � � � � � � � � � � � � � � � � 5
Product description
3 Overview� � � � � � � � � � � � � � � � � � � � � � � � � 6
3�1 Scope of delivery � � � � � � � � � � � � � � 7
3�2 Accessories � � � � � � � � � � � � � � � � � � 7
3�3 Special accessories � � � � � � � � � � � � 7
3�4 Disposable materials � � � � � � � � � � � � 7
3�5 Wear parts and spare parts� � � � � � � 7
4 Technical data � � � � � � � � � � � � � � � � � � � � 8
4�1 Type plate� � � � � � � � � � � � � � � � � � � 10
4�2 Conformity assessment� � � � � � � � � 10
5 Operation � � � � � � � � � � � � � � � � � � � � � � � 11
5�1 Hygoclave 90 � � � � � � � � � � � � � � � � 11
5�2 Safety devices � � � � � � � � � � � � � � � 13
5�3 Overview of programs � � � � � � � � � � 15
5�4 Tyscor Pulse (optional) � � � � � � � � � 15
Installation
6 Requirements� � � � � � � � � � � � � � � � � � � � 17
6�1 Installation/setup room � � � � � � � � � 17
4.8 Settings ......................................................................59
4.8.1 User settings ...................................................59
4.8.2 Date and time settings.....................................59
4.8.3 Printer settings ................................................60
4.8.4 Language settings...........................................60
4.8.5 Measurement unit settings...............................60
4.8.6 Water settings .................................................60
4.8.7 Connections....................................................61
4.8.8 Ethernet connection ........................................61
4.9 Data output ................................................................63
5 Routine maintenance .............................................. 65
5.1 General table ..............................................................65
5.1.1 Cleaning the sterilisation chamber and internal
components....................................................65
5.1.2 Cleaning the door cover ..................................65
5.1.3 Cleaning the external front panel......................65
5.1.4 Cleaning the door seal.....................................65
5.1.5 Cleaning the filter in the chamber.....................65
5.1.6 Replacing the Bacterial or Bio X filter ...............65
5.1.7 Replacing the door seal...................................65
5.1.8 Cleaning the dust filter (if provided) ..................65
5.1.9 Lubricating and cleaning the screw and nut
screw ..............................................................66
5.1.10
Clean the feed tank .........................................66
5.2 Annual maintenance ...................................................66
5.3 Periodic process effectiveness and safety checks.......66
Troubleshooting
6 Troubleshooting guide...................................................67
6.1 Error Codes ................................................................67
6.2 Alarm Codes...............................................................68
6.3 Messagges.................................................................68
6.4 Reset procedures .......................................................69
6.5 Troubleshooting ..........................................................69
6.6 Message solutions......................................................72
7 Technical specifications................................................72
7.1 Water specifications (distilled or demineralized) ...........72
8 Spare parts codes..........................................................72
Contents
Important information
1 Safety standards ......................................................41
1.1 Intended users............................................................ 41
1.2 Intended use............................................................... 41
1.3 General safety warnings.............................................. 41
1.4 Operating and transport environmental conditions ...... 42
1.5 Environmental disposal instructions............................. 42
Product description
2 Equipment description ...........................................43
2.1 Variants....................................................................... 44
2.2 Main features.............................................................. 44
2.2.1 Sterilisation programs...................................... 44
2.2.2 Test programs ................................................. 44
2.2.3 Water filling systems ........................................ 44
2.2.4 Automatic sterilisation parameter control ......... 44
2.2.5 Motorised closure............................................ 44
2.2.6 Bio-X filter........................................................ 44
2.2.7 USB port ......................................................... 44
2.2.8 Serial port - RS232.......................................... 44
2.2.9 Touch screen display....................................... 44
2.2.10 LAN connection............................................... 44
2.2.11 Safety devices ................................................. 44
2.3 Accessories included in the medical device
certification ................................................................. 44
Installation
3 Installation.......................................................................... 46
3.1 First power-up...........................................................47
Operating instructions
4 Operating instructions....................................................... 48
4.1 Symbols ..................................................................... 49
4.2 Menu architecture....................................................... 52
4.3 Selecting sterilisation programs................................... 53
4.3.1 Sterilisation program types .............................. 54
4.3.2 Cycle B Diagram ............................................. 54
4.3.3 Cycle S Diagram.............................................. 54
4.4 Sterilisation program specifications ............................. 55
4.5 Putting the material to be sterilised in the chamber ..... 55
4.5.1 Preparing the material...................................... 55
4.6 Filling and draining water............................................. 56
4.6.1 Filling the feed tank.......................................... 56
4.6.2 Draining the discharge tank ............................. 56
4.7 Test programs............................................................. 57
4.7.1 Test program types.......................................... 58
4.7.2 Vacuum test (leakage test)............................... 58
4.7.3 Bowie & dick test............................................. 58
4.7.4 Helix test ......................................................... 58
4.7.5 Test diagrams.................................................. 58
6046100064L02 1702V002SE 1
7 Installation � � � � � � � � � � � � � � � � � � � � � � 17
7�1 Carrying the unit � � � � � � � � � � � � � � 17
7�2 Remove the transport locks � � � � � 17
7�3 Setting up the unit� � � � � � � � � � � � � 17
7�4 Removing the protective film from
the touch screen� � � � � � � � � � � � � � 18
7�5 Checking the SD memory card � � � 18
7�6 Checking the sterile air filter� � � � � � 18
7�7 Connecting the unit� � � � � � � � � � � � 19
7�8 Connecting the unit to the net-
work � � � � � � � � � � � � � � � � � � � � � � � 20
8 Configuring the unit � � � � � � � � � � � � � � � 22
8�1 Selecting the access level � � � � � � � 22
8�2 Entering dealer information � � � � � � 22
8�3 Language selection� � � � � � � � � � � � 22
8�4 Configuring the device with a
network connection � � � � � � � � � � � 22
8�5 Set the date and time�� � � � � � � � � � 22
8�6 Parameter selection � � � � � � � � � � � 23
8�7 Configuring a log printer � � � � � � � � 23
8�8 Configuring the label printer � � � � � 23
8�9 Configuring the network drive � � � � 23
8�10 User management � � � � � � � � � � � � 24
8�11 Setting up the calendar� � � � � � � � � 24
8�12 Touch screen � � � � � � � � � � � � � � � � 25
9 Monitoring the device with
Tyscor Pulse � � � � � � � � � � � � � � � � � � � � � 25
9�1 Network configuration � � � � � � � � � � 25
9�2 Network protocols and ports� � � � � 25
9�3 Add device � � � � � � � � � � � � � � � � � � 26
10 Test programs � � � � � � � � � � � � � � � � � � � 27
10�1 Vacuum test � � � � � � � � � � � � � � � � � 27
10�2 Bowie-Dick test � � � � � � � � � � � � � � 27
11 Logging handover and installation� � � � 28
12 Validation for commissioning � � � � � � � � 28
Operation
13 Operation � � � � � � � � � � � � � � � � � � � � � � � 30
13�1 Switching the unit on/off � � � � � � � � 30
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
EN
Contents
Important information
1 About this document � � � � � � � � � � � � � � � 3
1�1 Warnings and symbols � � � � � � � � � � 3
1�2 Copyright information � � � � � � � � � � � 3
2 Safety � � � � � � � � � � � � � � � � � � � � � � � � � � � 4
2�1 Intended purpose � � � � � � � � � � � � � � 4
2�2 Intended use� � � � � � � � � � � � � � � � � � 4
2�3 Improper use � � � � � � � � � � � � � � � � � 4
2�4 General safety information� � � � � � � � 4
2�5 Applicable guidelines and
standards � � � � � � � � � � � � � � � � � � � � 4
2�6 Qualified personnel � � � � � � � � � � � � � 5
2�7 Protection from electric shock� � � � � 5
2�8 Only use genuine parts � � � � � � � � � � 5
2�9 Transport and packaging� � � � � � � � � 5
2�10 Disposal � � � � � � � � � � � � � � � � � � � � � 5
Product description
3 Overview� � � � � � � � � � � � � � � � � � � � � � � � � 6
3�1 Scope of delivery � � � � � � � � � � � � � � 7
3�2 Accessories � � � � � � � � � � � � � � � � � � 7
3�3 Special accessories � � � � � � � � � � � � 7
3�4 Disposable materials � � � � � � � � � � � � 7
3�5 Wear parts and spare parts� � � � � � � 7
4 Technical data � � � � � � � � � � � � � � � � � � � � 8
4�1 Type plate� � � � � � � � � � � � � � � � � � � 10
4�2 Conformity assessment� � � � � � � � � 10
5 Operation � � � � � � � � � � � � � � � � � � � � � � � 11
5�1 Hygoclave 90 � � � � � � � � � � � � � � � � 11
5�2 Safety devices � � � � � � � � � � � � � � � 13
5�3 Overview of programs � � � � � � � � � � 15
5�4 Tyscor Pulse (optional) � � � � � � � � � 15
Installation
6 Requirements� � � � � � � � � � � � � � � � � � � � 17
6�1 Installation/setup room � � � � � � � � � 17
6046100064L02 1702V002SE 1
7 Installation � � � � � � � � � � � � � � � � � � � � � � 17
7�1 Carrying the unit � � � � � � � � � � � � � � 17
7�2 Remove the transport locks � � � � � 17
7�3 Setting up the unit� � � � � � � � � � � � � 17
7�4 Removing the protective film from
the touch screen� � � � � � � � � � � � � � 18
7�5 Checking the SD memory card � � � 18
7�6 Checking the sterile air filter� � � � � � 18
7�7 Connecting the unit� � � � � � � � � � � � 19
7�8 Connecting the unit to the net-
work � � � � � � � � � � � � � � � � � � � � � � � 20
8 Configuring the unit � � � � � � � � � � � � � � � 22
8�1 Selecting the access level � � � � � � � 22
8�2 Entering dealer information � � � � � � 22
8�3 Language selection� � � � � � � � � � � � 22
8�4 Configuring the device with a
network connection � � � � � � � � � � � 22
8�5 Set the date and time�� � � � � � � � � � 22
8�6 Parameter selection � � � � � � � � � � � 23
8�7 Configuring a log printer � � � � � � � � 23
8�8 Configuring the label printer � � � � � 23
8�9 Configuring the network drive � � � � 23
8�10 User management � � � � � � � � � � � � 24
8�11 Setting up the calendar� � � � � � � � � 24
8�12 Touch screen � � � � � � � � � � � � � � � � 25
9 Monitoring the device with
Tyscor Pulse � � � � � � � � � � � � � � � � � � � � � 25
9�1 Network configuration � � � � � � � � � � 25
9�2 Network protocols and ports� � � � � 25
9�3 Add device � � � � � � � � � � � � � � � � � � 26
10 Test programs � � � � � � � � � � � � � � � � � � � 27
10�1 Vacuum test � � � � � � � � � � � � � � � � � 27
10�2 Bowie-Dick test � � � � � � � � � � � � � � 27
11 Logging handover and installation� � � � 28
12 Validation for commissioning � � � � � � � � 28
Operation
13 Operation � � � � � � � � � � � � � � � � � � � � � � � 30
13�1 Switching the unit on/off � � � � � � � � 30
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
EN
Contents
Important information
1 About this document � � � � � � � � � � � � � � � 3
1�1 Warnings and symbols � � � � � � � � � � 3
1�2 Copyright information � � � � � � � � � � � 3
2 Safety � � � � � � � � � � � � � � � � � � � � � � � � � � � 4
2�1 Intended purpose � � � � � � � � � � � � � � 4
2�2 Intended use� � � � � � � � � � � � � � � � � � 4
2�3 Improper use � � � � � � � � � � � � � � � � � 4
2�4 General safety information� � � � � � � � 4
2�5 Applicable guidelines and
standards � � � � � � � � � � � � � � � � � � � � 4
2�6 Qualified personnel � � � � � � � � � � � � � 5
2�7 Protection from electric shock� � � � � 5
2�8 Only use genuine parts � � � � � � � � � � 5
2�9 Transport and packaging� � � � � � � � � 5
2�10 Disposal � � � � � � � � � � � � � � � � � � � � � 5
Product description
3 Overview� � � � � � � � � � � � � � � � � � � � � � � � � 6
3�1 Scope of delivery � � � � � � � � � � � � � � 7
3�2 Accessories � � � � � � � � � � � � � � � � � � 7
3�3 Special accessories � � � � � � � � � � � � 7
3�4 Disposable materials � � � � � � � � � � � � 7
3�5 Wear parts and spare parts� � � � � � � 7
4 Technical data � � � � � � � � � � � � � � � � � � � � 8
4�1 Type plate� � � � � � � � � � � � � � � � � � � 10
4�2 Conformity assessment� � � � � � � � � 10
5 Operation � � � � � � � � � � � � � � � � � � � � � � � 11
5�1 Hygoclave 90 � � � � � � � � � � � � � � � � 11
5�2 Safety devices � � � � � � � � � � � � � � � 13
5�3 Overview of programs � � � � � � � � � � 15
5�4 Tyscor Pulse (optional) � � � � � � � � � 15
Installation
6 Requirements� � � � � � � � � � � � � � � � � � � � 17
6�1 Installation/setup room � � � � � � � � � 17
6046100064L02 1702V002SE 1
7 Installation � � � � � � � � � � � � � � � � � � � � � � 17
7�1 Carrying the unit � � � � � � � � � � � � � � 17
7�2 Remove the transport locks � � � � � 17
7�3 Setting up the unit� � � � � � � � � � � � � 17
7�4 Removing the protective film from
the touch screen� � � � � � � � � � � � � � 18
7�5 Checking the SD memory card � � � 18
7�6 Checking the sterile air filter� � � � � � 18
7�7 Connecting the unit� � � � � � � � � � � � 19
7�8 Connecting the unit to the net-
work � � � � � � � � � � � � � � � � � � � � � � � 20
8 Configuring the unit � � � � � � � � � � � � � � � 22
8�1 Selecting the access level � � � � � � � 22
8�2 Entering dealer information � � � � � � 22
8�3 Language selection� � � � � � � � � � � � 22
8�4 Configuring the device with a
network connection � � � � � � � � � � � 22
8�5 Set the date and time�� � � � � � � � � � 22
8�6 Parameter selection � � � � � � � � � � � 23
8�7 Configuring a log printer � � � � � � � � 23
8�8 Configuring the label printer � � � � � 23
8�9 Configuring the network drive � � � � 23
8�10 User management � � � � � � � � � � � � 24
8�11 Setting up the calendar� � � � � � � � � 24
8�12 Touch screen � � � � � � � � � � � � � � � � 25
9 Monitoring the device with
Tyscor Pulse � � � � � � � � � � � � � � � � � � � � � 25
9�1 Network configuration � � � � � � � � � � 25
9�2 Network protocols and ports� � � � � 25
9�3 Add device � � � � � � � � � � � � � � � � � � 26
10 Test programs � � � � � � � � � � � � � � � � � � � 27
10�1 Vacuum test � � � � � � � � � � � � � � � � � 27
10�2 Bowie-Dick test � � � � � � � � � � � � � � 27
11 Logging handover and installation� � � � 28
12 Validation for commissioning � � � � � � � � 28
Operation
13 Operation � � � � � � � � � � � � � � � � � � � � � � � 30
13�1 Switching the unit on/off � � � � � � � � 30
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
EN
Contents
Important information
1 About this document � � � � � � � � � � � � � � � 3
1�1 Warnings and symbols � � � � � � � � � � 3
1�2 Copyright information � � � � � � � � � � � 3
2 Safety � � � � � � � � � � � � � � � � � � � � � � � � � � � 4
2�1 Intended purpose � � � � � � � � � � � � � � 4
2�2 Intended use� � � � � � � � � � � � � � � � � � 4
2�3 Improper use � � � � � � � � � � � � � � � � � 4
2�4 General safety information� � � � � � � � 4
2�5 Applicable guidelines and
standards � � � � � � � � � � � � � � � � � � � � 4
2�6 Qualified personnel � � � � � � � � � � � � � 5
2�7 Protection from electric shock� � � � � 5
2�8 Only use genuine parts � � � � � � � � � � 5
2�9 Transport and packaging� � � � � � � � � 5
2�10 Disposal � � � � � � � � � � � � � � � � � � � � � 5
Product description
3 Overview� � � � � � � � � � � � � � � � � � � � � � � � � 6
3�1 Scope of delivery � � � � � � � � � � � � � � 7
3�2 Accessories � � � � � � � � � � � � � � � � � � 7
3�3 Special accessories � � � � � � � � � � � � 7
3�4 Disposable materials � � � � � � � � � � � � 7
3�5 Wear parts and spare parts� � � � � � � 7
4 Technical data � � � � � � � � � � � � � � � � � � � � 8
4�1 Type plate� � � � � � � � � � � � � � � � � � � 10
4�2 Conformity assessment� � � � � � � � � 10
5 Operation � � � � � � � � � � � � � � � � � � � � � � � 11
5�1 Hygoclave 90 � � � � � � � � � � � � � � � � 11
5�2 Safety devices � � � � � � � � � � � � � � � 13
5�3 Overview of programs � � � � � � � � � � 15
5�4 Tyscor Pulse (optional) � � � � � � � � � 15
Installation
6 Requirements� � � � � � � � � � � � � � � � � � � � 17
6�1 Installation/setup room � � � � � � � � � 17
2 6046100064L02 1702V002SE
Contents
13�6 Preparations for steam
sterilisation � � � � � � � � � � � � � � � � � � 34
13�7 Loading the items for sterilisation
into the unit� � � � � � � � � � � � � � � � � � 36
13�8 Steam sterilising � � � � � � � � � � � � � � 37
13�9 Storing parts for sterilisation � � � � � 39
14 Documenting the sterilisation� � � � � � � � 40
14�1 Batch documentation � � � � � � � � � � 40
14�2 Automatic record output � � � � � � � � 41
14�3 Subsequent output of saved
records � � � � � � � � � � � � � � � � � � � � � 41
14�4 Printing out records� � � � � � � � � � � � 41
15 Messages on the touch screen � � � � � � 43
15�1 Note � � � � � � � � � � � � � � � � � � � � � � � 43
15�2 Information � � � � � � � � � � � � � � � � � � 43
16 Operating pauses� � � � � � � � � � � � � � � � � 45
16�1 Pause times � � � � � � � � � � � � � � � � � 45
17 Taking out of operation � � � � � � � � � � � � 45
17�1 Transport � � � � � � � � � � � � � � � � � � � 45
18 Restarting after an extended pause in
operation � � � � � � � � � � � � � � � � � � � � � � � 46
19 Maintenance� � � � � � � � � � � � � � � � � � � � � 47
19�1 Maintenance schedule � � � � � � � � � 47
19�2 Complete cleaning � � � � � � � � � � � � 48
19�3 Cleaning or replacing the door
seal � � � � � � � � � � � � � � � � � � � � � � � 50
19�4 Checking the hinge and oiling the
door spindle � � � � � � � � � � � � � � � � � 50
19�5 Clean or replacing water filters � � � 51
19�6 Changing the sterile air filter � � � � � 51
19�7 Function check � � � � � � � � � � � � � � � 52
Troubleshooting
20 Tips for operators and
service technicians� � � � � � � � � � � � � � � � 53
20�1 "Caution" messages � � � � � � � � � � � 53
20�2 "Fault" messages � � � � � � � � � � � � � 53
21 Emergency opening of the door� � � � � � 55
Appendix
22 Settings menu layout � � � � � � � � � � � � � � 56
EN