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Roche cobas b 123 User Manual
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Roche Diagnostics
Instructions for Use · V
ersion 13.0
281
cobas b 123 POC system
10 Software functions
Configu
ring oper
ato
r settin
gs
p
T
o delete an operator
1
Ut
i
lities > Configuration > Operato
rs
Figure 10-43
Operator settings screen
2
Select the operator tha
t you wan
t to delete. Then, press the
De
lete
button.
s
280
282
Table of Contents
Table of Contents
5
Publication Information
2
In this Chapter Chapter
3
Contact Addresses
4
Edition
4
In this Chapter Chapter
5
In this Chapter Chapter
6
Intended Use
7
Intended User
7
Use Environment
7
Symbols and Abbreviations
7
In this Chapter Chapter
10
In this Chapter Chapter
11
What Is New in this Version
12
In this Chapter Chapter
12
Safety Information 1
15
Safety Information
16
Safety Classifications
17
Operator Qualification
18
Safe and Proper Use of the System
18
Safety Precautions
18
Installation and Deinstallation
19
Operating Conditions
19
Biohazardous Materials
20
Electrical Safety
20
Consumables
21
Mechanical Safety
21
Reagents and Working Solutions
22
Incorrect Results
23
Software and Data Security
24
Instrument Damage
25
Safety Labels on the Instrument and Consumables
26
General Description 2
27
System Information
29
Accessory Information
30
System Components
31
Visual Identification
31
Front Door
32
Measuring Chamber Module
32
Printer
32
Rear Panel
33
Interfaces: Hardware Version 1
35
Interfaces: Hardware Version 2
37
Barcode Scanner
38
Imaging Scanner (Optional)
39
User Interface Module
40
Consumable Information
41
Sensor Cartridge
41
Sensor Phases
42
BG Sensors
43
ISE Sensors
44
Glu/Lac Sensors
45
Fluid Pack
46
Cobas B 123 Autoqc Pack (Optional)
49
Specifications 3
51
Measurement Parameters
55
Performance Data
55
Precision (Sample Mode: Normal)
55
Pco 2
57
Hct
60
Lac
61
Glu
62
Thb
62
Cohb
64
Hhb
65
Methb
65
Bili
66
Precision (Sample Mode: Micro Sample)
66
Hct
68
Pco 2
68
Thb
68
Cohb
70
Methb
70
Bili
71
Hhb
71
Linearity (Normal Sample)
72
Material: Prepared Whole Blood
72
Material: Tonometered Whole Blood
72
Linearity (Micro Sample)
73
Material: Prepared Dialysis Solution
73
Material: Prepared Whole Blood, Including Bilirubin
73
Material: Tonometered Whole Blood
73
Correlation to Other Methods
74
Material: Prepared Whole Blood
74
Material: Prepared Whole Blood, Including Bilirubin
74
Hhb (Cobas B 123 POC System with COOX Module)
75
Methb (Cobas B 123 POC System with COOX Module)
75
O 2 Hb (Cobas B 123 POC System with COOX Module)
75
Pco
75
Thb (Cobas B 123 POC System with COOX Module)
75
Bili
76
Cohb (Cobas B 123 POC System with COOX Module)
76
Hct
76
SO (Cobas B 123 POC System with COOX Module)
76
Comparison of Micro Samples to Normal Samples
78
Glu
78
Lac
78
Sample Throughput
79
Sample Measurement Time
80
Sample Volumes
81
Sample Types
82
Calibrations
83
Environmental Parameters
84
Instrument
84
Sensor Cartridge
84
Temperature/Humidity/Stability
84
Fluid Pack
85
QC Material
85
Acoustic Noise Level
86
Classification (According IEC/ISO)
86
Dimensions
86
Electrical Data
86
Product Data
86
Weight
86
Holding Points
87
Printer
88
User Interface Module
89
Barcode Scanner
90
Imaging Scanner (Optional)
92
Theoretical Foundations 4
93
Assigning Unit Formats to Parameters
95
Selecting between Ph and H + Unit Formats
96
Conversion Table for Units
97
Parameters and Calculations
97
Standard Values and Ranges
97
Temperature
97
Chco
98
Ctco 2 (P)
98
Equations
98
FO Hb
98
BE Ecf
99
SO (C)
99
Ctco 2 (B)
101
Cto
101
Ph St
101
Aado
102
Chco 3 - St
102
Pao
102
A/Ao
103
Avdo
103
Shunt (Qs/Qt)
104
Nca
105
Shunt Estimated (Qs/Qt Est )
105
Ch T
106
Pao
106
Pco
106
Ph T
106
A/Ao
107
Aado
107
RI T
107
BE Act
108
Hct(C)
108
Mchc
108
Osm
109
Osm Opt
109
Osm Opt Gap
109
Heart Minute Volume (Q T )
110
Oer
110
PF Index
110
Bibliography
111
Lac Clearance 1H
111
Calibration Principle
113
Functional Principle
114
Oximeter Module (Optional)
114
Reference and Critical Values
115
Reference/Normal Ranges
115
Critical Ranges
117
Assigning Reference and Critical Ranges
118
Monitoring Reference and Critical Ranges on Measurement Reports
121
Assigning a Correlation Factor to a Parameter
122
Installation and Put out of Operation 5
127
Installation
129
Location
129
Installing the Instrument
131
For Less than 24 Hours
134
For more than 24 Hours
134
Put out of Operation
134
Putting the Instrument out of Operation
135
Preparing the Instrument for Transportation
136
Measurement 6
137
Preanalytics
139
Sample Collection
139
Whole Blood
139
And Hct Measurements
140
Anticoagulants
140
Sample Collection, Specifically for Glucose and Lactate Measurements
140
Sample Collection Containers
141
Sample Collection, Specifically for Bilirubin Measurements
141
Sample Collection, Specifically for Dialysis Solution Measurement
141
Capillary Tubes
142
Roche MICROSAMPLER PROTECT
142
Sample Collection Container Accessories
142
Syringes
142
Sample Handling
143
Whole Blood
143
Dialysis Solution
144
Interferences
145
Substances Without Effect on BG, Ph, ISE, Glu, Lac and Hct
145
Substances Without Effect on Thb, so , Hb Derivatives and Bilirubin
147
Substances with Effect on BG, Ph, ISE, Glu, Lac and Hct
148
Substances with Effect on Thb, so , Bilirubin and Hb Derivatives
149
General Information
152
Limitations of Clinical Analysis
152
Plausibility Check for Neonatal Bilirubin Measurements
152
Configuring Measurement Input Values
154
Configuring the Measurement Results Screen
156
Configuring the Parameter Selection Field
157
Creating User-Defined Parameter Groups
158
Performing a Measurement
160
Measurement Modes
169
Entering Measurement Input Values
170
Measurement Results and Reports
173
Measuring Database
175
Acid Base Maps
176
Patient Trend Diagrams
177
Quality Control 7
179
General QC Concept
181
Important Information for Evaluating QC Results
183
Performing QC Measurements
184
QC Results and Reports
191
QC Database
192
Levey-Jennings Graphs
193
Performing a Proficiency Test Measurement
194
Configuring the QC Scheduler
199
Defining and Configuring QC Materials
203
Configuring QC Rules and Consequences
207
Configuring QC Settings
209
Evaluating QC Measurement Results
211
Multirules
212
Removing QC Consequences
215
QC Troubleshooting
218
Troubleshooting Autoqc Module Blockages
219
Calibration 8
221
Calibration Schemes
223
General Information
223
2P Calibration
225
Automatic Calibrations
225
PO 2 Calibration
225
System Calibration
225
Monitoring
226
Oximeter Calibration
226
Recalibration
226
Standby Calibration
226
Standby Shifting
226
Wash Cycle
227
Calibration for "Ready
228
User-Activated Calibrations
228
Calibration Database
229
Configuring Calibration Settings
230
Calibration Verification Control 9
233
General Information
235
Installing Autocvc Packs
236
Performing an Autocvc Measurement
238
Managing CVC Results in the QC Database
240
Configuring Analytical Measurement Ranges
241
Software Functions 10
245
General Software Information
247
Overview Tab
251
Description of the Screen Areas
252
Workplace Tab
255
Instrument Tab
256
Utilities Tab
257
Instrument Databases
258
Logging on and off
260
Connecting USB Storage Devices
261
Configuring System Settings
262
Configuring Network Connection Settings
269
Configuring Operator Settings
278
Changing Security Levels
282
Performing Software and Language Updates
284
Exporting and Importing Configuration Settings
285
Audit Trail
286
Available Printout Reports
288
Consumable Change 11
297
Disinfection Procedures
299
Disinfecting the Instrument
301
Changing Consumables
303
Additional Information for Consumable Changes
307
Troubleshooting 12
311
General Information
313
Alarm Area and Buttons
314
System Stops
316
Defects
320
Warnings
321
Information Alarms
322
Status Messages on the Measurement Report
323
Calibrating Oximeter Parameters that Are Not Calibrated
324
Calibrating Sensor Parameters that Are Not Calibrated
324
Calibration and QC Troubleshooting for Parameters
324
Removing QC Locks or Warnings from Oximeter Parameters
325
Removing QC Locks or Warnings from Sensor Parameters
325
Performing Sensor Cartridge Wetting Routines
326
Checking the Fluid Pack Valve Positions
327
Barcode Scanner Troubleshooting
328
Creating Troubleshooting Reports and Log Files
329
Depot Repair
330
4
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Roche cobas b 123 Specifications
General
Brand
Roche
Model
cobas b 123
Category
Medical Equipment
Language
English
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