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ABL90 FLEX
RADIOMETER ABL90 FLEX User Manual
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II
Appendix -
Traceability to the primary standards at
Radiometer
326
328
Table of Contents
Default Chapter
9
Table of Contents
9
Setup
21
Setup Menu Structure
23
Analyzer Security
24
Programs
24
General Security
24
Operators and Passwords
25
Access Profiles
28
Analysis Setup
30
Program
30
Syringe/Capillary Modes
30
Setting up a New Measuring Mode
31
Selecting a Parameter Profile
31
Disabled Versus Deselected Parameter
31
Editing Name of Button
31
Selecting a Default Layout
32
Reference Ranges and Critical Limits
32
Selecting Sample Type
32
Selecting Sex
32
Setting Age Group Limits
33
Setting Reference and Critical Limits for each Parameter
34
Reportable Ranges
35
Patient Report Setup
36
Program
36
Creating a Layout
36
Editing a Layout
37
Patient ID Layout
37
Default Values
38
Editing Patient Result Layout
39
Sample Pre-Registration Setup
40
Sample Age Evaluation Setup
41
Calibration Schedule Setup
42
Program
42
Editing the Settings
42
Available Calibration Schedule Options
42
Quality Control Setup
43
Program
43
Manual Quality Control (QC) Solutions
43
Quality Control Schedule Setup
44
QC Ranges
46
QC Input Setup
48
QC Statistics
49
Westgard Rules Setup
50
Reference
52
Rilibäk Ranges
52
Replacement Setup
55
Program
55
Replacement Schedule Setup
55
Recommended Replacement Intervals
56
User Activities
57
Adding a User Activity
57
Editing a User Activity
58
Deleting a User Activity
58
Maintenance Planning
59
Replacement Warnings
60
Parameters and Input Setup
61
Program
61
Parameter Setup
61
Units Setup
63
User-Defined Patient Data Items
64
User-Defined Notes
66
Analyzer Settings
67
Program
67
Analyzer Identification
67
Time/Date Setup
68
Acoustic Signal Setup
69
Barometer Setup
70
Languages
71
Communications Setup
72
Program
72
RADIANCE Connection Setup
72
LIS/HIS Connection Setup
73
Automatic Data Transmission Setup
75
Automatic Data Request Setup
77
Patient Lookup Setup
78
QA Portal Connection Setup
79
Disk Functions Setup
80
Program
80
Automatic Archiving Setup
80
Automatic Backup Setup
82
Printers
83
Program
83
Printer Setup
83
Automatic Printing
84
Corrective Actions
85
Program
85
Explanation of Corrective Actions
86
Miscellaneous Setup
87
Program
87
List of Options
87
Selecting Hbf Correction
88
Analyzer Messages
89
Setting the Time for the Screen Saver to Appear
89
Setup Default Settings
90
Calibration Schedule
92
Quality Control Setup
92
Replacement Setup
93
General Setup
93
Print Setup
98
Contents of Setup Settings
99
Parameters Group
99
General Group
100
Schedules, Etc
101
Interfacing Facilities
102
Connecting a Mouse
102
External Barcode Reader
103
Sample Counter
104
Purpose
104
Description
104
Disk Functions Setup Programs
106
General Information
106
Disk Functions Programs
106
Definitions
106
Data Storage Options
106
Disk Handling Rules
106
Creating a WDC Report
107
Purpose
107
Backing up All Data
108
Purpose
108
Restoring All Data
110
Purpose
110
Exporting Data Logs
111
Purpose
111
Importing/Exporting Archives
112
Purpose
112
Exporting an Archive
112
Importing an Archive
112
Deleting an Archive
112
Saving Setup
113
Purpose
113
Loading/Restoring Setup
114
Purpose
114
Wet Section
116
Introduction
116
Definition
116
Contents of Wet Section
116
Wet Section Diagram
117
Diagram
117
Measuring Processes
118
Introduction
118
General Information
118
Prior to Measurement
118
Heating
118
Solutions
118
Waste Removal
118
Patient Samples
119
Measuring Process
119
Rinse Process
120
Calibration
121
Po 2 Calibration
121
Pco , Cglu, Clac Calibration
121
Cna + , Cca 2+ , Ccl - Calibration
121
Oxi Calibration
121
Automatic QC
122
Measuring Process
123
Manual QC Samples
123
Electronics
125
General Information
126
Inlet Positioning
127
Printer Unit
128
Sample Mixer (for Safepico Only)
128
Sensors and Measuring Technologies
129
Overview
130
General Construction
130
Sensors
130
General Measuring Principles
131
Introduction
131
Activity Vs. Concentration
131
Conversion of Activity to Concentration
131
Calibration
132
General Information
133
Definition
133
Frequency
133
Calibration Solutions
133
The Calibration Equation
134
Definition
134
Use
134
Deriving the Calibration Line
134
Scale
134
Sensitivity
135
Definition
135
Updating
135
Status
135
Measurement
136
Sample Measurements
136
Corrections
136
Quality Management
137
Introduction
137
System/ Analysis Checks
137
Calibration
140
Measurement
140
Reference Electrode
141
Background Information about the Reference Electrode
142
Purpose
142
Fixed Potential
142
Use
142
Construction of the Reference Electrode
143
Diagram
143
Parts and Functions
143
Ph and Electrolyte Sensors
144
Construction of the Ph and Electrolyte Sensors
145
Diagram
145
Parts and Description
145
Measuring Principle of the Ph and Electrolyte Sensors
146
Potentiometric Measuring Principle
146
Electrode Chain
146
Parts and Description
146
Electrode Chain Potential
146
Unknown Potential
147
Ion-Sensitive Membrane
147
Nernst Equation
147
Activity and Concentration
147
Calibration of the Ph and Electrolyte Sensors
148
Introduction
148
2-Point Calibration
148
Calibration Levels
148
Calibration
148
Measurement - Ph and Electrolytes
149
Measurement
149
Checks
149
Pco Sensor
150
Sensor
150
Construction of the Pco
150
Diagram
151
Parts and Description
151
Construction of the Pco
151
Sensor
151
Measuring Principle of the Pco Sensor
152
Electrode Chain
152
Measuring Process
153
Calibration of the Pco Sensor
154
Introduction
154
Sensor
154
Calibration Levels
154
Sensitivity
154
Measurement - Pco
155
Measurement
155
Checks
155
Measurement - Pco 2
155
Po 2 Sensor
156
Measuring Principle of the Po 2 Sensor
156
Measuring Principle of the Po Sensor
156
Calculations
157
Measuring Sequence
157
Optical System for Po
157
Calibration of the Po 2 Sensor
158
Sensitivity
158
Status
159
Measurement - Po
159
Checks
159
Metabolite Sensors
160
Construction of the Metabolite Sensors
161
Basic Description
161
Diagram
161
Parts and Description
161
Zero Current
161
Calibration of the Metabolite Sensors
162
Sensitivity
162
Measurement - Metabolites
163
Measurement
163
Checks
163
Measuring Principle of the Metabolite Sensors
164
Measuring Process
165
C Thb and Derivates
166
General Information
167
Measured Parameters
167
Construction
167
Measurement Cycle
168
Absorbance
169
Total Absorbance
169
Continuous Spectrum
169
Spectrum Examples
170
Determining Concentrations
170
Matrix of Constants
171
Calibration of the Optical System
172
Calibration Materials
172
Zero Point
172
Cuvette Path Length
172
Thb Calibration Frequency
172
Correcting for Interferences
173
Hbf Versus Hba
173
Deviation of Results
173
Detecting Hbf
173
Repressing Spectra
173
Residual Spectrum
174
Measurement and Corrections
175
Oximetry Parameters
175
Bilirubin
175
Restrictions
176
References
178
User-Defined Corrections
180
General Information
180
Purpose of Use
180
User-Defined Corrections
181
Correction Factors for Ph and Blood Gases
182
Correction Factors for Oximetry Parameters
183
Allowed Corrections
183
Cthb
183
Fcohb
184
Fmethb
184
Fhbf
184
FO Hb and Fhhb
184
Ctbil
185
Correction Factors for Electrolyte and Metabolite Parameters
186
Resetting Corrections to Default Values
186
Performance Characteristics
187
General Information
188
Definition of Terms
189
Bias
189
Reference Methods
189
Coefficient of Variation (CV%)
191
Confidence Intervals
191
Repeatability/Reproducibility
191
Total Analytical Error
191
Test Conditions
192
Performance Test Results - Chart Description
193
Modes
193
Number of Measurements
193
Performance Test Results - Ph
194
Reference Method
194
Bias Prim.ref
194
Performance Test Results - Pco
194
Performance Test Results - Po
195
Reference Method
195
Performance Test Results - Ck
195
Bias
195
Prim.ref
195
Sec.ref
195
Performance Test Results - Cna
196
Reference Method
196
Bias Prim.ref
196
Performance Test Results - Ccl
196
Sec.ref
196
Performance Test Results - Cca
197
Reference Method
197
Bias Prim.ref
197
Performance Test Results - Cglu
197
Performance Test Results - Clac
198
Reference Method
198
Performance Test Results - Cthb
199
Reference Method
199
Performance Test Results - so
200
Reference Method
201
Bias Bias
201
Prim.ref
201
Sec.ref
201
Performance Test Results - FO Hb
201
Performance Test Results - Fcohb
201
Bias Prim.ref
201
Performance Test Results - Fmethb
202
Reference Method
202
Bias Prim.ref
202
Performance Test Results - Fhhb
203
Reference Method
204
Performance Test Results - Bilirubin
204
Bias
204
Prim.ref
204
Sec.ref
204
External Test Results
204
Interference Tests
206
Ph/Blood Gas
206
Electrolytes
207
Oximetry Parameters
211
Ctbil Sensitivity for MCHC Variations
212
Anticoagulants (Sampling)
214
List of References
215
Parameters
217
General Information
218
Symbols
219
Ranges and Limits
220
Derived Parameters
220
Measured Parameters
221
Sample Type
221
Units
221
Default Values
221
Measured Parameters
222
General Information
222
Pco
222
Baro
223
Cthb
223
FO Hb
224
Fcohb
224
Fmethb
224
Fhhb
225
Cca
225
Ccl
226
Cglu
226
Clac
226
Ctbil
226
Definition
226
Fo (I)
229
Input Parameters
229
Vco
230
Fcohb(1)
230
Derived Parameters
231
General Information
231
Acid-Base Derived Parameters
231
Oxygen Derived Parameters
232
Units and Numerical Format of Derived Parameters
235
Calculated Versus Estimated Parameters
235
Electrolyte Parameters
235
Possible Ranges and Precision (Number of Decimals)
236
Ph(T)
236
Ch (T)
236
Chco
236
Cbase(B)
236
Cbase(Ecf)
236
Chco 3 (P)
236
Chco (P,St)
239
List of Equations
239
Ctco (P)
240
Ph(St)
241
Hct
241
Po (A)/Fo (I)
242
Po (A,T)/ FO (I)
243
P50
243
P50(T)
243
P50(St)
244
Po (A-A)
244
Po (A-A,T)
244
Cto 2
245
Cto (AV )
245
Cto (X) (or C )
245
Q · V O 2
246
Fshunt
247
Fshunt(T)
248
Ri(T)
248
FO Hb
249
Fhhb
250
Anion Gap,K
250
Anion Gap
250
Cca 2+ (7.4)
250
Mosm
250
Fhbf
250
Po (X,T)
251
VCO 2 /V(Dry Air)
252
VO 2 /V(Dry Air)
252
Oxyhemoglobin Dissociation Curve (ODC)
253
ODC Equations
253
The ODC Reference Position
253
The ODC Displacement
254
The Actual ODC Position
255
Determining the Actual Displacement
255
Coordinates on the ODC
257
Conversion of Units
258
SI Units
258
Temperature
258
Ck , Cna , Ccl
258
Cca 2
258
Pressure
258
Cthb
258
Ctco
258
Cglu
259
Clac
259
Ctbil
259
Default Values
260
Values
260
References
261
Solutions
263
General Information
264
Introduction
264
Solution Pack
264
Lot
264
In Vitro Diagnostic Use
264
Expiration Date
264
Storage
264
Material Safety Data Sheets
264
Solutions
265
Use
265
Pouch Volume
265
Composition
265
Certificate of Traceability
267
10. Messages
269
List of Analyzer Messages
270
General Information
312
Statistical Parameters
313
Control Ranges (for Manual QC Only
314
User Control Ranges (for Manual QC Only
315
Statistics Factor and Statistics Range
319
Temperature Corrections (for Manual QC Only
320
I Appendix - Quality Control
321
Temperature Corrections for Ph, Pco and Po
321
Westgard Rules
322
Plot Lines
322
Rule 1 2S
323
Rule
323
Rule 2 2S
323
Rule R
324
Rule 10
324
Evaluation Procedure
325
Quality Control Evaluation
325
Appendix - Traceability to the Primary Standards at Radiometer
327
Introduction
328
Traceability
329
Pco and Po
329
Cca
330
Ccl
330
Cglu
330
4
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RADIOMETER ABL90 FLEX Specifications
General
Brand
RADIOMETER
Model
ABL90 FLEX
Category
Measuring Instruments
Language
English
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