Sartorius BioPAT Trace - 15 Conformity Documents

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BioPAT

Trace | Multi Trace Operating Instructions 133

Conformity Documents

15 Conformity Documents

The attached documents declare the conformity of the device with the

designated directives or standards.

Main Page

Table of Contents3
About this Document8
Introduction8
Validity8
Target Groups9
Symbols Used10
Warnings in Operation Descriptions10
Other Symbols Used10
Safety Instructions11
Intended Use11
Personnel Qualification11
General Safety Instructions12
Electrical Power12
Energy Release12
Accessories, Consumables, and Spare Parts13
Conduct in an Emergency13
Biopat ® Trace | Multi Trace Product Description14
The Basics of Electrochemical Measuring Technology15
Biosensor Principle16
Fluidic System and Sampling17
Data Transmission and Data Saving20
Equipment Supplied with the Biopat Trace | Multi Trace20
Consumables21
Biopat Trace | Biopat Multi Trace Tubing Set21
Buffer Solution21
Cleaning Solution21
Calibration Standard Solutions (Contents: 0.5 Liters)22
Membranes23
Sampling Probes23
Dialysis Probe23
Accessories for Sampling Probes24
Accessories for Dialysis Probe24
No Integrated Luer-Lock Connection)25
Accessories for the Biopat25
Trace | Multi Trace25
Design and Function26
Setting up the Device26
Biopat ® Trace | Multi Trace Measurement Methods29
Dialysis Measuring Method Using the Dialysis Probe30
Conductivity Cell Function33
Particle Filter Function34
Diffusion Module Function35
Dialysis Probe Function36
Enzyme Reactor Function37
Temperature Correction37
Transport38
Initial Installation39
Setup39
Device Setup39
Tubing Set Connectors on the Device41
Attaching the Tubing Set for the "Dialysis46
Operating Mode46
Installing the Tubing Set for the Biopat54
Connection and Removal of the Enzyme Reactor54
Connecting the Dialysis Probe56
Mounting the Membrane in the Dialysis Probe57
Ethanol in the Dialysis Probe58
Installing the Dialysis Probe into the Bioreactor59
Sterilization of the Dialysis Probe Prior to Connection59
Connecting the Dialysis Probe to the Tubing Set61
Cleaning the Dialysis Probe and Replacing the Membrane62
Loading the Software and Network Connection63
Troubleshooting66
Installing the Software66
Changing the Start Settings67
Active Access Restriction | Log in68
Assignment of Analog Outputs69
Checklist for Starting-Up Operation70
Startup73
Decommissioning74
Operation75
Basic Commands78
Start78
Standby78
Calibrate78
Single Sample79
Reference (for Dialysis Only)79
Fast Reference (Only for Dialysis)82
Menu Bar83
Menu Item "Device84
Menu Item "Display87
Print Diagram87
Calibration Values88
Calibration History88
Status88
Settings89
Menu "Schedule96
Menu "Controller100
Menu Item "Log in105
Menu Item „Information105
Data Transfer Via TCP/IP108
LED Status Messages109
Tips110
Choosing Suitable Standard Solutions110
Dialysis Mode: Referencing at the Beginning111
Of a Fermentation111
Dialysis Mode: Referencing at Low Lactate111
Concentrations111
Avoiding Contaminations in the Tubing Set112
Import Data to Excel113
Data Transfer to Excel Using an Excel Macro115
Maintenance and Servicing116
Cleaning116
Decontaminating the Tubing Set116
Contamination by Biofilm116
Causes of Contamination117
Decontaminating Connection Lines117
Decontaminating the Transport Buffer117
Decontaminating the Tubing Set117
Disposal Line | Disposal Tank118
Probe Sterilization118
Maintenance and Servicing Activities118
Device118
Tubing Set118
10 Malfunctions119
Error Messages119
Calibration Error120
Calibration Implausible120
Sensor Error121
Error in Control121
Error and Possible Causes122
Error Message: "Calibration Failed124
Transport126
12 Storage and Shipping127
Storage127
Returning the Device and Parts127
13 Disposal128
Information on Decontamination128
Decommissioning the Device128
Disposing of the Device and Parts129
Information on Disposal129
Disposal129
14 Technical Data130
Measuring Data130
Dimensions and Weights130
Installation Conditions131
Ambient Conditions131
Footprint131
Storage Conditions131
Electrical Data132
Power Supply132
Interfaces132
15 Conformity Documents133
Licensing or Trademark Information136

Sartorius BioPAT Trace - 15 Conformity Documents

Table of Contents

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