Binder CB Series - Certificates and Declarations of Conformity; EU Declaration of Conformity for CB

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CB / CB-UL, CBF / CBF-UL (E7) 01/2022 Page 190/199

25. Certificates and declarations of conformity

25.1 EU Declaration of conformity for CB

Main Page

Table of Contents2
Safety8
Personnel Qualification8
Operating Manual8
Legal Considerations8
Intellectual Property9
Structure of the Safety Instructions9
Signal Word Panel9
Safety Alert Symbol10
Pictograms10
Word Message Panel Structure11
Localization / Position of Safety Labels on the Chamber11
Type Plate12
General Safety Instructions on Installing and Operating the CO Incubator13
Precautions When Working with Gases15
Precautions When Handling Gas Cylinders17
Intended Use18
Foreseeable Misuse19
Residual Risks20
Operating Instructions21
Measures to Prevent Accidents22
CBF / CBF-UL : Resistance of the Humidity Sensor against Harmful Substances23
Chamber Description24
Chamber Overview25
Inner Chamber26
Control Panel on the Rear of the Chamber27
Instrument Panel28
Installation28
Unpacking, and Checking Equipment and Completeness of Delivery28
Guidelines for Safe Lifting and Transportation29
Storage29
Location of Installation and Ambient Conditions30
Installation and Connections33
Shelves33
Permadry™ Water Pan34
Connecting the O35
Gas Connections35
Sensor (Chamber with O 2 Control)35
Connection of the CO Gas Cylinder36
Connection of the O Gas Cylinder (Chamber with O Control with Optional Alternative Control Range 10 up to 95 Vol.-% O )37
Connection of the N Gas Cylinder (Chamber with O Control)38
Connecting the Gas Hose to the Chamber Rear (for CO )39
Gas Cylinder Connection Kits (Option)41
CBF / CBF-UL: Water Supply and Dehumidification41
General Remarks on Water Supply41
Water Supply41
Dehumidification42
Types of Suitable Water Quality42
BINDER Pure Aqua Service (Option)42
Water Supply Via Freshwater Bag (Standard)43
Scope of Delivery43
Installation and Connection of the Freshwater Bag43
Refilling the Already Installed Freshwater Bag44
Replacing the Tube Connectors for Freshwater Supply45
Water Supply Via Prefilled Water Bottle (Optional Humidification Water Set)46
Scope of Delivery46
Installation, Connection and Change of the Prefilled Water Bottle46
Water Supply Via Freshwater Can (Optional Water Container Set)48
Scope of Delivery49
Installation and Connection of the Freshwater Can (Optional Water Container Set)49
Refilling the Freshwater Can51
Electrical Connection52
Divided Inner Door with Cell Therapy Compartmentation (Optional)53
Special Model CBF 260 "Cell Therapy53
Handling and Aligning the Divided Inner Door54
Mounting the Partition Walls for Cell Therapy Compartmentation55
Functional Overview of the Mb2 Chamber Controller57
Operating Functions in Normal Display58
Display Views: Normal Display, Program Display, Chart-Recorder Display59
Controller Icons Overview60
Operating Modes62
Controller Menu Structure63
Main Menu64
Settings" Submenu65
Service" Submenu65
Principle of Controller Entries66
Performance During and after Power Failures66
Performance When Opening the Door67
Start up67
Turning on the Chamber67
Controller Settings Upon Start up68
Factory Settings69
Equilibration Time69
Operating the Duodoor™ Door Lock70
Required Gas Supply for the Chamber with O70
Hypoxic Control Range 0.2 Vol.-% up to 20 Vol.- % O (Regular)70
Alternative Control Range 10 Vol.-% up to 95 Vol.-% (Available Via BINDER INDIVIDUAL Customized Solutions)70
Control70
Activating / Deactivating CO and Humidity Control71
Control71
CB / CB-UL: Humidity Control of the Permadry™ System72
Set-Point Entry in "Fixed Value" Operating Mode73
Set-Point Entry through the "Setpoints" Menu74
Direct Setpoint Entry Via Normal Display75
Special Controller Functions Via Operation Lines76
Safety Instructions for Setting High Gas Concentrations77
Timer Program: Stopwatch Function78
Starting a Timer Program78
Performance During Program Delay Time78
Stopping a Running Timer Program79
Pausing a Running Timer Program79
Cancelling a Running Timer Program79
Performance after the End of the Program79
Time Programs80
Starting an Existing Time Program80
Performance During Program Delay Time81
Stopping a Running Time Program81
Pausing a Running Time Program81
Cancelling a Running Time Program81
Performance after the End of the Program81
Creating a New Time Program82
Program Editor: Program Management82
Deleting a Time Program83
Section Editor: Section Management84
Add a New Program Section85
Copy and Insert or Replace a Program Section85
Deleting a Program Section86
Value Entry for a Program Section87
Section Duration87
Set-Point Ramp and Set-Point Step88
Special Controller Functions Via Operation Lines90
Setpoint Entry91
Tolerance Range91
Repeating One or Several Sections Within a Time Program92
Saving the Time Program93
Week Programs93
Starting an Existing Week Program93
Cancelling a Running Week Program94
Creating a New Week Program94
Program Editor: Program Management95
Deleting a Week Program96
Section Editor: Section Management97
Add a New Program Section98
Copy and Insert or Replace a Program Section98
Deleting a Program Section99
Value Entry for a Program Section99
Set-Point Ramp and Set-Point Step Modes99
Weekday100
Start Time100
Setpoint Entry101
Special Controller Functions Via Operation Lines101
Notification and Alarm Functions102
Notification and Alarm Messages Overview102
Notifications102
Alarm Messages103
State of Alarm105
Resetting an Alarm, List of Active Alarms105
Activating / Deactivating the Audible Alarm (Alarm Buzzer)106
Tolerance Range Settings and Alarm Delay Times106
Zero-Voltage Relay Alarm Output108
Temperature Safety Devices109
Over Temperature Protective Device (Class 1)109
Overtemperature Safety Controller Class 3.1109
Safety Controller Modes110
Setting the Safety Controller110
Message and Measures in the State of Alarm111
Function Check111
User Management112
Authorization Levels and Password Protection112
Log in115
Log out116
User Change116
Password Assignment and Password Change117
Password Change117
Deleting the Password for an Individual Authorization Level119
New Password Assignment for "Service" or "Admin" Authorization Level When the Password Function was Deactivated120
Activation Code121
General Controller Settings122
Selecting the Controller's Menu Language122
Setting Date and Time122
Selecting the Temperature Unit124
Display Configuration124
Adapting the Display Parameters124
Touchscreen Calibration125
Network and Communication126
Serial RS485 Interface (Available Via BINDER INDIVIDUAL Customized Solutions)126
Ethernet127
Configuration127
Display of MAC Address128
Web Server128
E-Mail129
USB Menu: Data Transfer Via USB Interface130
General Information131
Service Contact Page131
Current Operating Parameters131
Event List132
Technical Chamber Information132
Chart Recorder Display133
Views133
Show and Hide Legend133
Switch between Legend133
Show and Hide Specific Indications134
History Display134
Setting the Parameters137
Cbf / Cbf-Ul: Humidification System138
Function of the Humidifying System138
Function of the Dehumidifying System139
Options139
APT-COM™ 4 Multi Management Software (Option)139
Silicone Access Ports 30 MM / 1.18 In, Closable from both Sides with Silicon Plugs (Option)139
Quick Sample Access (Option)140
Interior Socket 230V (Option, Available Via BINDER INDIVIDUAL Customized Solutions)141
Analog Outputs for Temperature and CO (Option)142
Data Logger Kits (Option)143
Access Port for Extra-Low Voltage (Option)143
BINDER Gas Supply Service - External Bottle Changer for CO144
Stands145
Stacking Stand (Option)145
Base on Castors (Option)145
Water Supply Sets (Optional for CBF / CBF-UL)145
Tubular Bag Set (Option)145
Humidification Water Set (Option)145
Water Container Set (Option)145
Reference Measurements146
CO Reference Measuring146
Measuring CO Concentration Indirectly Via the Ph of the Cell Medium146
Measuring CO Directly Via Chemical Indicator Tubes147
Measuring CO Directly with an Electronic Infrared Measuring Device147
Temperature Reference Measurement147
Avoiding Microbial Contamination148
Cells and Media148
Laboratory Conditions / Equipment Around the Incubator148
Working and Behavior in the Lab148
Chamber Design and Equipment of the CO Incubator149
Handling the CO Incubator150
Cleaning, Decontamination / Disinfection, and Sterilization151
Cleaning151
Decontamination / Chemical Disinfection of the Chamber153
Disinfection of the CO154
CBF / CBF-UL: Disinfection of Components of the Fresh Water Supply System154
Sensor154
Hot-Air Sterilization155
Overview155
Preparation for a Hot-Air Sterilization156
Starting the Sterilization Cycle and Running the Hot-Air Sterilization156
Prematurely Terminating the Sterilization Cycle158
Prematurely Terminating the Sterilization Cycle after Less than 4 Hours: Ineffective Sterilization158
Prematurely Terminating the Sterilization Cycle after more than 4 Hours, I.e., During the Cooling-Down Phase: Successful Sterilization159
Completing the Entire Sterilization Cycle160
Maintenance and Service, Troubleshooting, Repair, Testing161
General Information, Personnel Qualification161
CBF / CBF-UL: Replacing Components of the Humidifying / Dehumidifying System162
Replacing the Silicone Tube of the Fresh Water Supply System162
Replacing the Pump Head of the Fresh Water Supply System162
Replacing the Gas Fine Filter (Sterile Filter) for Ambient Air162
Replacing the CO163
Und O 2 /N 2 Gas Inlet Fine Filters (Sterile Filters)163
Replacing the CO Sensor164
Maintenance Intervals, Service165
Simple Troubleshooting166
General166
Heating167
Gas Cylinder Pressure too Low168
Gas Control169
Sterilization171
Humidity (CB / CB-UL)171
Humidity (CBF / CBF-UL)172
Controller172
Open Door173
Sending the Chamber Back to BINDER Gmbh173
Disposal174
Disposal of the Transport Packing174
Outer Chamber Packing174
Packing Inside the Chamber and Equipment174
Decommissioning175
Disposal of the Chamber in the Federal Republic of Germany175
Disposal of the Chamber in the Member States of the EU Except for the Federal Republic of Germany176
Disposal of the Chamber in Non-Member States of the EU178
Technical Description178
Factory Calibration and Adjustment178
Over Current Protection178
Definition of Usable Volume179
Technical Data179
Equipment and Options (Extract)182
Accessories and Spare Parts (Extract)183
Important Conversion Data for Non-SI Units186
Conversion Table for Gas Inlet Pressures, Bar - Psi186
Dimensions187
Chamber Size 56187
Chamber Size 170188
Chamber Size 260189
Certificates and Declarations of Conformity190
EU Declaration of Conformity for CB190
EU Declaration of Conformity for CBF192
Contamination Clearance Certificate194
For Chambers Located Outside the USA and Canada194
For Chambers in the USA and Canada197

Binder CB Series - Certificates and Declarations of Conformity; EU Declaration of Conformity for CB

Table of Contents

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