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Abbott i-STAT 1 Manuals
Manuals and User Guides for Abbott i-STAT 1. We have
5
Abbott i-STAT 1 manuals available for free PDF download: System Manual, User Manual, Quick Reference Manual
Abbott i-STAT 1 System Manual (659 pages)
Brand:
Abbott
| Category:
Measuring Instruments
| Size: 32.52 MB
Table of Contents
Table of Contents
3
Contents
5
Intended Use
11
FDA Test Categorization
11
Overview of the I-STAT System
11
Introduction
11
This Manual
11
Selection of Components
12
Summary of the Procedure
12
Data Management
13
Interfacing
13
Note Regarding System Reliability
13
Symbols
13
Warranty
17
I-STAT 1 Analyzer
19
Before You Use the Analyzer
19
Install Batteries
19
Customization
19
Introduction
19
Description
20
Specifications
20
Software
20
Battery Compartment
20
Power
20
Low Battery Warning
21
Rechargeable Battery
21
Disposable Batteries
21
Additional Power
22
Cartridge Port
22
Infrared Communication Window
22
Thermal Control
23
Barometric Pressure Sensor
23
Cartridge Test Cycle
23
Data Entry
24
Storage of Results
24
LCD Display and Backlight
25
Audible Indicator
25
Time out
25
Keypad
26
I-STAT 1 Menu Tree
27
Test Menu
28
Administration Menu
28
Analyzer Status
29
Data Review
29
Quality Tests
30
Customization
31
Viewing the Customization Profile
32
Changing the Profile
32
Set Clock
35
Transmit Data
35
Utility
35
Laser Barcode Scanner
36
Laser Specifications
36
Warning Labels
36
Barcode Label Quality
37
Prompts and Messages
37
Startup Messages
38
Quality Check Messages
38
I-STAT Cartridge
39
Contents
39
Sample Handling System
40
Sensors
40
Contact Pads
40
Heating Elements
40
Standardization and Calibration
41
Packaging
41
Storage Conditions
42
Disposal
42
PRECISION Pcx and Pcx PLUS BLOOD GLUCOSE TEST STRIPS
43
Electronic Simulator
45
External Simulator
45
Internal Simulator
45
Relative Humidity
45
Cleaning the Simulator
46
Operating Characteristics
46
Stored Result
46
I-STAT 1 Downloader
47
Function
47
Power Supply
48
Specifications
48
Downloader/Recharger Indicator Leds
49
Power Requirements
49
Programming and Connections
49
Cautions
49
Transmitting Data from Downloader to the Data Manager
50
Transmitting Data from Downloader/ Recharger to the Data Manager
50
Transmitted Information
50
Charge Battery before Use
51
Keep Battery Charged
51
Charging the Rechargeable Battery
51
Troubleshooting
51
Charging Rechargeable Battery in External Recharge Compartment
52
I-STAT 1 Downloader/Recharger (Model Number DRC-300) Overview
53
Identification of the New I-STAT 1 Downloader/Recharger
54
Specifications of the DRC-300
55
Power Supply Specifications
55
DRC Indicator Leds
55
Running Cartridges in a Handheld Docked in the DRC
56
DRC Affect on Ambient Operating Temperature Range
57
Transmitting Data from the DRC to the Data Manager
57
Transmitter Information
57
Charging Batteries before Use
58
Rechargeable Battery Life
58
Charging a Rechargeable Battery While Installed in the Handheld
58
Configuring the I-STAT 1 DRC for Network Operation
58
Central Data Station (CDS) Customers
59
Data Exchange (DE) Customers
59
Restoring the Pc's Network Configuration
64
Connecting and Wiring the DRC for Network Communication
65
Configuring the I-STAT 1 DRC for Serial Operation
66
Installation Using Windows Hardware Wizard (Internet Required)
66
Installation Using a Driver Installer File
68
Connecting and Wiring the I-STAT 1 DRC for Serial Communication
71
USB Driver Uninstallation
71
Configuring the CDS Software for Serial Communication
72
USB Driver Uninstaller for Windows 2000
72
TECHNICAL BULLETIN: the I-STAT DOWNLOADER/RECHARGER (MODEL NUMBER DRC-300)
73
Portable Printer
73
Overview
73
Specifications
73
Supplies Provided with Printer
74
Power
74
Paper
74
Printing Directly from the Analyzer
75
Printing Via a Downloader
75
Printing Many Results
76
What Is Printed
76
The I-STAT Printer Overview
78
I-STAT Printer Specifications
79
I-STAT Printer Kit Components and Accessories
80
I-STAT Printer Orderable Components
80
I-STAT Printer Paper
81
I-STAT Printer Power
81
Symptoms Indicating that the Rechargeable Battery Requires Replacement
82
Installing or Replacing the Rechargeable Battery in the I-STAT Printer
82
Printing Directly from I-STAT 1 Handheld
84
Powering the I-STAT Printer Using the AC Adapter and Power Cord
84
Connecting the I-STAT Printer to a Downloader or Downloader/Recharger
85
Printing Via a Downloader or Downloader/Recharger
85
Printing Many Results
85
Printout Contents
86
Printer Cautions
86
Printer Troubleshooting
87
Cleaning the I-STAT Printer
88
I-STAT Printer Storage and Battery Check Notice
89
Printer Storage Instructions
89
Battery Check
89
Technical Bulletin: I-STAT Printer Rechargeable Battery Notice
89
Data Management
91
Introduction
91
Components
91
The Data Manager
92
I-STAT Central Data Station Version 5 Software
92
IR Link
93
LIS/HIS Interface
93
Downloader and Downloader/Recharger
93
Standard Data Management Configuration
94
Connecting Components
94
Ethernet Connection
94
Analyzer Customization Options and Default Settings
96
On the I-STAT 1 Handheld
102
Reportable Range Customization on the I-STAT 1 Handheld
107
I-STAT 1 Handheld Overview
107
I-STAT 1 Handheld General Notes and Considerations
107
Minimum Software Requirements
108
Reportable Range Limitations
108
Customizing Reportable Ranges on the I-STAT 1 Handheld Using CDS Version 5
109
Customizing Reportable Ranges on the I-STAT 1 Handheld Using I-STAT/DE
111
Confirming that the Custom Reportable Ranges Have Been Transferred to the I-STAT 1 Handheld from Cds Version 5 or I-STAT/DE
113
Liquid Quality Control Schedule and Lockout Customization on the I-STAT 1 Handheld
115
Functionality
115
QC Profile
115
General Notes and Considerations
116
QC Scheduling
116
QC Lockout
116
Customizing Liquid QC Schedules on the I-STAT 1 Handheld Using CDS Version 5
118
Customizing Liquid Quality Schedule and Lockout Features on the I-STAT 1 Handheld Using I-STAT/DE
125
New I-STAT 1 Handheld Display Screens for the Liquid QC Schedule and Lockout Customization Features
131
Technical Bulletin: Liquid Quality Control Pass/Fail Customization on the I-STAT 1 Handheld
133
Liquid Control Lot Abbreviations
134
Liquid Quality Control Pass/Fail Customization on the I-STAT 1 Handheld
135
Downloading an Electronic Value Assignment Sheet (Evas) from the APOC Website for Use with the Cds or I-STAT/DE Customization Workspaces
137
Customizing the I-STAT 1 Handheld for Liquid QC P/F Using CDS Version 5
138
Customizing the I-STAT 1 Handheld for Liquid QC P/F Using I-Stat/De
142
Confirming that the Evas Has Been Transferred to the I-Stat 1 Handheld from CDS Version 5 or I-STAT/DE
147
New I-STAT 1 Handheld Display Screens for the Liquid QC Pass/Fail Customization Feature
149
Handheld Display Messages
152
Positive Patient Identification (PPID) Customization on the I-STAT 1 Handheld
153
Identifier Formats
155
PPID Customization Options
155
Operator Competency Notification on the I-STAT 1 Handheld
163
Sample Collection
167
Specimen Collection
167
Venipuncture - General
167
Hemolysis
168
Tube Order
168
Anticoagulants
168
Venipuncture - Ph, PCO2, Electrolyte, Chemistry, and Hematocrit Tests
168
Fill Requirements
169
Mixing
169
Exposure to Air
169
Venipuncture - Coagulation Tests
170
Arterial Puncture - General
170
Arterial Puncture - Blood Gas, Electrolyte, Chemistry, and Hematocrit Tests
171
Evacuated Tubes
171
Syringes and Anticoagulant
171
Arterial Puncture - ACT Tests
172
Sample on Ice
172
Blood Flow
172
Indwelling Line
173
Skin Puncture
173
Blood Gas, Electrolyte, Chemistry
173
Blood Gas Analysis
173
Sample Transfer Devices
174
Anticoagulant
174
PT/INR Cartridges
174
Dispensers
174
References
175
Procedure for Handling Cartridges
177
Preparation for Testing
177
Select the Cartridge
177
Room Temperature
177
Filling and Sealing Cartridge Using Transfer Device
178
Filling and Sealing PT/INR Cartridges Using Direct Fingerstick Sampling
178
Filling and Closing an Immunoassay Cartridge Using a Transfer Device
179
Inserting and Removing the Cartridge from the Analyzer
180
Incorrect Procedure
181
Procedure for Cartridge Testing
183
Customizing the Handheld for Cartridge Testing Using the Handheld Keypad
184
Customizing the I-STAT 1 Handheld to Run I-STAT Cartridges
184
Customizing the Handheld for Cartridge Testing Using CDS Version 5
185
Performing Patient Analysis
188
Action Ranges
189
Interpretation of Displayed Results
189
Reference Ranges
189
Reportable Ranges
189
Flags
190
Message and Quality Check Code
191
Troubleshooting
191
Unexpected Results
191
Warning Message
191
Procedures for Glucose Test Strip Testing
193
Quality Control for I-STAT Cartridges and the Analyzer's Cartridge Test Cycle
195
Verify Newly Received Cartridges
195
Verify Performance of Analyzers Daily
195
Overview
195
Check Room Temperature Storage Daily
196
Check Thermal Control System Every Six Months
196
Controls for Blood Gas/Electrolyte/Metabolite Cartridges (Except CHEM8+ Cartridges)
197
Ampule Use
198
Before Use
198
Transfer with Capillary Tube
198
Transfer with Syringe
198
Target Values
199
Ranges
199
Controls for CHEM8+ Cartridges
200
Reactive Ingredients
200
RNA ® Medical Hematocrit Control
202
Controls for ACT Cartridges
203
Controls for PT/INR Cartridges
204
Control Target Values and Expected Ranges
204
Controls for Ctni Cartridges
206
Storage and Stability
206
Control Target Values and Ranges
206
Cliniqa Liquid QC Cardiac Marker Controls for I-STAT
207
I-STAT BNP Controls
208
Performing Electronic Simulator Test
209
Procedure for External Electronic Simulator
209
Troubleshooting Failed Electronic Simulator Test
210
Introduction
210
Checking the Thermal Probes in the I-STAT Analyzers
211
Verification for Handheld Analyzers
211
Procedure for Handheld Analyzers
211
Performing Control Test on Cartridge
212
Documentation of Results
212
Troubleshooting Out-Of-Range Control Results on Cartridge
213
Control Materials for Liquid QC and Calibration Verification
227
Control Solutions
228
Reactive Ingredients for Tricontrols Materials
228
Best Results
229
Calibration Verification for Blood Gas/Electrolyte/Metabolite Cartridges (I-Stat Tricontrols)
231
Sodium
231
Potassium
231
Chloride
231
Glucose
231
Acceptable Criteria
234
Technical Bulletin: Tricontrols Control Material for Liquid Qc and Cali-
237
Calibration Verification
237
Calibration Verification for Blood Gas/Electrolyte/Metabolite Cartridges (Except CHEM8+ Cartridges)
237
I-STAT Calibration Verification Set
238
I-STAT CHEM8+ Calibration Verification Set
239
I-STAT Cardiac Marker Calibration Verification Set
241
RNA ® Medical Hematocrit Calibration Verification Controls
243
Verification Procedure for Hematocrit
244
Verification Procedure for ACT
245
Procedure for Cartridges
246
Troubleshooting Cartridge Tests
246
Proficiency or External Quality Control Testing
247
Troubleshooting
248
Routine Care of the Analyzer and Downloader
249
Drying a Wet Analyzer or Downloader
249
Cleaning the Analyzer and Downloader
249
Removing and Replacing Disposable Batteries
250
Removing and Replacing the Rechargeable Battery
251
Updating the Software
253
Instructions for Updating I-STAT 1 Handheld Software
255
Why Do I-STAT Handhelds Need Software Updates?
255
Jammlite Process Overview
255
Choosing the Best I-STAT 1 Handheld Update Method
256
Instructions for Using this Technical Bulletin
256
Jammlite
256
Cds
256
Follow These Steps to Update with the Jammlite Utility
257
Connecting/Setting up Equipment
258
Loading JAMS/CLEW
259
Updating Your I-STAT 1 Handheld
261
Verifying Software Update
264
Gathering All Equipment
265
Determining CDS Update Path
270
Assigning JAMS/CLEW
272
CDS Update Path
274
Network Options for Updating the I-Stat 1 Handheld
275
Troubleshooting the Analyzer
295
Introduction
295
Information Needed
295
Startup Messages
296
Test Cycle Messages and Quality Check Codes
297
Error in Cartridge or Fluid Movement
298
Electrical or Mechanical Failures
299
No Display
300
“Cartridge Locked” Not Removed
300
Analyzer Coded Messages
301
Analyzer Functions
311
Microprocessor System
311
Sensor Interface
311
Theory
311
Analog Control Signals
312
Analog-To-Digital Conversion
312
Mechanical System
312
Operator Interface
312
Electrochemical Measurements
313
Potentiometric Sensors
313
The Nernst Equation
313
Activity Versus Concentration
314
Amperometric Sensors
314
Conductometric Sensors
314
Determination of Analyte Concentration
314
Determination of Test Results
314
Cpb
315
Determination of Cell Concentration
315
Hematocrit
315
Limitations of the CPB Algorithm
316
ACT and PT/INR
317
Determination of Coagulation Endpoints
317
Quality Control and the I-STAT System
317
Similarities to Traditional Laboratory Quality Control Regimen
318
Handheld Analyzer and Blood Analysis Module
321
Unit-Use Cartridge
321
Operator Sample Handling/Cartridge
322
Validating the Performance of the I-STAT System
322
Quality Control and the I-STAT Coagulation Tests
323
Quality System for Coagulation Cartridge
323
Regulatory Aspects of the Quality System for Coagulation
323
Electronic Quality Control
324
Downloader Programming and Wiring
325
Configure a Terminal Session
325
Connect to and Program the Downloader
325
Programming the Network Downloaders
325
Default Netmasks for Standard IP Networks
327
Netmasks for Other Networks
327
Configure for I-STAT 1 Data Transfer Via IR Port
328
Verify and Save Settings
328
Connecting the Network Downloader
330
Wiring the Downloaders
330
Connecting the Serial Port Downloader
332
Central Data Station 5
335
Installation of the Central Data Station
337
General Procedures and Conventions
339
Customization of the Central Data Station
343
Site Information
343
Serial Ports
344
Network
344
Interface
345
Options
346
Security
347
Interface Program Customization
349
Overview of the Central Data Station Program
351
Central Data Station Software Function Overview and Toolbar Buttons
351
Administration Tools
353
Instrument and Location Workspace
353
Delete Instrument
356
Move Instrument
356
Find Instrument
356
Edit Instrument Comment
356
Instrument and Location Summary
357
Date Range
358
Delete
358
Operator Workspace
359
Operator List Edit in Progress
359
Add Operator
360
Delete Operator
360
Move Operator
360
Find Operator
360
Update Certifications
361
Add Certification
361
Add Note
361
Edit Department Name
362
Operator and Certification Reports
362
Operator List Import
365
Export List
366
Database Maintenance
367
Archive Test Results
367
Database File
369
Statistics
369
Inventory Workspace
371
Stock
372
Startup Option
372
Orders
373
Distribution
375
Inventory Log
376
Customization Workspace
377
Password
377
Default Customization Profile
378
Location-Based Customization Profiles
378
Making Selections
379
Language Window
379
Unit Set Window
380
I-Stat Analyzer and Philips Bam Clew Windows
381
I-Stat 1 Software Window
381
Preferences Window
382
Chart Page Selection Box
383
Backup and Restore Profile
383
User Administration Workspace
385
Access
385
Creating Security Profiles
385
Deleting Security Profiles
386
Editing Security Profiles
386
Adding Users
386
Deleting a User
386
Password Management
387
User Log
387
System Logoffs
388
Manual Logoff
388
Automatic Logoff
388
Data Viewers
389
Information in Data Viewers
389
Refreshing the Data
390
Viewing Details
390
Customizing the Data Viewers
390
Editing a Record
392
Finding a Record
392
Printing Selected Records
393
Send Selected Records
393
Trending Results
393
Electronic Simulator Viewer
394
Unsent Records Viewer
394
Sent Column Values
395
Data Export
396
Monitors
397
Download Monitor
397
Interface Monitor
398
Reports
399
Reagent Management
399
Method Compliance
400
Method Competence
401
Customization: Central Data
402
Customization: I-Stat Analyzer Settings
402
System
402
Windows Operating System and Language Support
403
Cartridge Specifications
405
Ionized Calcium
406
Creatine Kinase MB / CK-MB
408
B-Type Natriuretic Peptide/Bnp
408
Cartridge Configurations and Sample Volume
410
Clinical Significance
412
Performance Characteristics
412
Cartridge Comparison
413
Factors Affecting Results
413
Bun/Urea
425
Glucose/Glu
429
Hematocrit/Hct and Calculated Hemoglobin/Hb
435
Ionized Calcium/Ica
441
PO2 and Calculated Oxygen Saturated/So2
447
PCO2 and Calculated Values for HCO3 Base Excess and Anion Gap
455
Total Carbon Dioxide/(TCO2)
461
Creatinine/Crea
465
Lactate/Lac
471
Celite Activated Clotting Time/(ACT)
477
Kaolin Activated Clotting Time
485
Prothrombin Time (PT/INR)
493
Cardiac Troponin I (Ctnl)
501
Interference Testing
507
Creatine Kinase MB/(CK-MB)
511
B-Type Natriuretic Peptide (BNP)
519
Non-Heart Failure Population - All (Age Group)
522
Non-Heart Failure Population - Males (Age Group)
522
Non-Heart Failure Population - Females (Age Group)
523
Heart Failure Population - All
523
Heart Failure Population - Males
524
Heart Failure Population - Females
524
Males (Age Group)
526
Females (Age Group)
526
Precision Data (Pg/Ml)
527
Equivalence of Whole Blood and Plasma (X-Axis)
528
Analytical Sensitivity
528
Analytical Specificity
528
Recovery
528
Test Limitations
529
New Ultralife 9-Volt Lithium Battery for Use with the I-Stat System
535
Proficiency Testing on the I-STAT System
537
Technical Bulletins
537
Replacing the Nimh Rechargeable Battery in the Martel Printer
543
Instructions for Restoring Analyzers that Produce *** for Hematocrit and Quality Check Code 23
545
Ceramic Conditioning Cartridge Usage Log
546
Maintaining the Ceramic Conditioning Cartridge
547
Procedure for Rotating the Strip
547
Procedure for Replacing the Strip
548
Hematocrit Determination in the I-STAT System and Comparison to Other Methods
549
EDTA and KEDTA Customization for Hematocrit on the I-STAT System
549
Conductivity Methods
550
Co-Oximetry Methods
550
Random Component
550
Systematic Component
550
Method-Dependent / Sample-Specific Component
551
Standards for Microhematocrit Determination
553
K2EDTA and K3EDTA Customization for Hematoctir on the I-Stat System
557
Calibration Verification and the I-STAT System
561
Stability of Calibration in the I-Stat System
562
Validating the Reportable Range
562
Representative Data
567
Analyzer Display and CDS Changes
569
I-STAT Celite ACT and I-STAT Kaolin ACT
573
Heparin Linearity Procedure
573
Support Services
579
April 2009 Update to I-STAT/DE (Version 2.0)
599
Using I-STAT Analyzer Customization Features to Minimize ID Entry Errors
605
Barcode Scanning
606
Use an Operator List
606
Exclude Operator Ids from Analyzer Printout
606
Set Max/Min ID Length
606
Set Manual Entry Check Digits
607
Force Manual Repeat ID Entry
607
Force Scanned Repeat ID Entry
607
The I-STAT System Manufacturer's Quality System Instructions
611
Updates to the I-STAT 1 Downloader/Recharger
615
The Presence of Latex Rubber in I-Stat System Components
617
Procedure Manual
619
System Overview
622
Analysis Time
622
Cartridges
622
Central Data Station or Data Manager
622
Supplies and Storage Requirements
622
Controls
623
Blood Specimens
623
Blood Collection Equipment
623
Blood Volume
624
Suitable Specimens
624
Specimen Labeling
625
Specimen Collection and Handling
625
Criteria for Specimen Rejection
626
Procedure for Analysis
626
Preparation for Use
626
Procedure for Cartridge Testing
631
Alternative Procedure
631
Results
632
Calculations
632
Displayed Results
632
Suppressed Results
632
Printing and Transmitting Results
632
Critical Results
636
Interferences
637
Quality Control
639
Daily Procedures
639
Monthly Procedures
640
Periodic Procedures
640
Calibration
645
Clinical Significance
646
Principles of Measurement
649
Troponin I/Ctni
650
Creatine Kinase MB/CK-MB
650
B-Type Natriuretic Peptide/Bnp
650
Tco2
650
Abbott i-STAT 1 System Manual (606 pages)
Brand:
Abbott
| Category:
Measuring Instruments
| Size: 32.18 MB
Table of Contents
Table of Contents
4
Potassium
10
Chloride
10
Glucose
10
Hematocrit/Hemoglobin
10
Ionized Calcium
10
Total Carbon Dioxide/Tco
10
Creatinine
10
This Manual
11
Intended Use
11
Components
12
Selection of Components
12
Summary of the Procedure
12
Data Management
13
Interfacing
13
Note Regarding System Reliability
13
Symbols
13
Warranty
17
Introduction
11
I-STAT 1 ANALYZER
19
Introduction
19
Before You Use the Analyzer
19
Specifications
20
Software
20
Power
20
Disposable Batteries
21
Rechargeable Battery
21
Low Battery Warning
21
Cartridge Port
22
Infrared Communication Window
22
Thermal Control
23
Barometric Pressure Sensor
23
Cartridge Test Cycle
23
Data Entry
24
Storage of Results
24
LCD Display and Backlight
25
Audible Indicator
25
Time out
25
Keypad
26
I-STAT 1 Menu Tree
27
Test Menu
28
Administration Menu
28
Analyzer Status
29
Data Review
29
Quality Tests
30
Customization
31
Set Clock
37
Transmit Data
37
Utility
37
Laser Barcode Scanner
38
Prompts and Messages
39
I-STAT CARTRIDGE
41
Contents
41
Standardization and Calibration
43
Packaging
43
Storage Conditions
44
PRECISION Pcx and Pcx PLUS BLOOD GLUCOSE TEST STRIPS
45
Electronic Simulator
47
Internal Simulator
47
External Simulator
47
Operating Characteristics
48
Cleaning the Simulator
48
I-STAT 1 DOWNLOADER
49
Function
49
Specifications
50
Power Supply
50
Downloader/Recharger Indicator Leds
51
Power Requirements
51
Cautions
51
Transmitting Data from Downloader to the Data Manager
52
Transmitting Data from Downloader/Recharger to the Data Manager
52
Transmitted Information
52
Troubleshooting
53
Charging the Rechargeable Battery
53
Charging Rechareable Battery in the External Recharge Compartment
60
(Model Number Drc-300)
75
Portable Printer
75
MARTEL Printer
75
Specifications
75
Supplies Provided with Printer
76
Power
76
Printing Directly from the Analyzer
77
Printing Via a Downloader
77
What Is Printed
78
Troubleshooting
79
The I-STAT Printer
80
Printer Troubleshooting
89
TECHNICAL BULLETIN: I-STAT PRINTER RECHARGEABLE BATTERY NOTICE
93
Data Management
93
Introduction
93
Components
93
Data Manager
94
Downloader and Downloader/Recharger
95
IR Link
95
LIS/HIS Interface
95
Standard Data Management Configuration
96
Connecting Components
96
Customization
111
Technical Bulletin: Liquid Qc Schedule and Lockout Customization on the
165
I-STAT 1 HANDHELD
165
Sample Collection
169
Specimen Collection
169
Venipuncture - General
169
Venipuncture - Ph, PCO2, Electrolyte, Chemistry, and Hematocrit Tests
170
Venipuncture - Coagulation Tests
172
Arterial Puncture - General
172
Arterial Puncture - Blood Gas, Electrolyte, Chemistry, and Hematocrit Tests
173
Arterial Puncture - ACT Tests
174
Indwelling Line
175
Skin Puncture
175
Sample Transfer Devices
176
References
177
Procedure for Handling Cartridges
179
Preparation for Testing
179
Filling and Sealing Cartridge
180
Inserting and Removing the Cartridge from the Analyzer
185
Incorrect Procedure
186
Procedure for Cartridge Testing
187
Procedures for Glucose Test Strip Testing
193
Quality Control
195
Overview
195
Quality Control for I-STAT Cartridges and the Analyzer's Cartridge Test Cycle
195
Controls for Blood Gas/Electrolyte/Metabolite Cartridges (I-STAT Tricontrols)
197
Controls for ACT Cartridges
203
Controls for PT/INR Cartridges
205
Controls for I-STAT Ctni, BNP and CK-MB Cartridges
206
Performing Electronic Simulator Test
208
Procedure for External Electronic Simulator
208
Troubleshooting Failed Electronic Simulator Test
209
Checking the Thermal Probes in the I-STAT Analyzers
210
Performing Control Test on Cartridge
211
Troubleshooting Out-Of-Range Control Results on Cartridge
211
Calibration Verification
225
Calibration Verification for Blood Gas/Electrolyte/Metabolite Cartridge
225
I-STAT Calibration Verification Set
226
Calibration Verification for Blood Gas/Electrolyte/Metabolite Cartridges (I-STAT Tricontrols)
229
Verification Procedure for Hematocrit
231
Verification Procedure for ACT
232
Calibration Verification for I-STAT Ctni, BNP and CK-MB Cartridges
233
Procedure for Cartridges
234
Troubleshooting Cartridge Tests
234
PROFICIENCY or EXTERNAL QUALITY CONTROL TESTING
235
Troubleshooting
236
ROUTINE CARE of the ANALYZER and DOWNLOADER
237
Drying a Wet Analyzer or Downloader
237
Removing and Replacing Disposable Batteries
238
Removing and Replacing the Rechargeable Battery
239
Updating the Software
241
Troubleshooting the Analyzer
281
Introduction
281
Information Needed
281
Startup Messages
282
Test Cycle Messages and Quality Check Codes
283
No Display
286
Cartridge Locked" Not Removed
286
Theory
297
Analyzer Functions
297
Electrochemical Measurements
299
Determination of Test Results
300
Determination of Cell Concentration
301
Cpb
301
Determination of Coagulation Endpoints
303
Quality Control and the I-STAT System
303
Quality Control and the I-STAT Coagulation Tests
308
Downloader Programming and Wiring
311
Programming the Network Downloaders
311
Wiring the Downloaders
316
Central Data Station 5
321
Installation of the Central Data Station
323
General Procedures and Conventions
325
Customization of the Central Data Station
329
Interface Program Customization
335
Overview of the Central Data Station Program
337
Administration Tools
339
Instrument and Location Workspace
339
Operator Workspace
345
Operator List Import
351
Database Maintenance
353
Inventory Workspace
357
Customization Workspace
363
User Administration Workspace
371
Password Management
373
Data Viewers
375
Data Export
382
Monitors
383
Reports
385
System
388
Windows Operating System and Language Support
389
Lactate
424
Celite ACT
469
Kaolin ACT
477
Prothrombin Time PT/INR
485
Cardiac Troponin I
493
Creatine Kinase MB / CK-MB
503
B-Type Natriuretic Peptide/Bnp
511
Total Beta-Human Chorionic Gonadotropin (Β-Hcg)
527
Gonadotropin (Β-Hcg) Cartridge
537
Technical Bulletins
537
New Ultralife 9-Volt Lithium Battery for Use with the I-STAT System
551
Replacing the Nimh Rechargeable Battery in the Martel Printer
553
Instructions for Restoring Analyzers that Produce *** for Hematocrit and Quality Check Code 23
555
Hematocrit Determination in the I-STAT System
559
EDTA and KEDTA Customization for Hematocrit on the I-STAT System
559
Support Services
579
Using I-STAT Analyzer Customization Features to Minimize ID Entry Errors
597
The I-STAT System Manufacturer's Quality System Instructions
603
Updates to the I-STAT 1 Downloader/Recharger
605
Abbott i-STAT 1 System Manual (84 pages)
Brand:
Abbott
| Category:
Blood Glucose Meter
| Size: 10.52 MB
Table of Contents
Table of Contents
11
Quick Reference Guide
3
Overview of the I-STAT System
13
Preparing the Handheld
15
Install/Change Batteries
15
Check/Change Date and Time
16
Check Software and Status
16
Entering Information into the Handheld
17
Reviewing Stored Results
18
Printing Results
19
Quality Control
20
Checking Handheld with the Electronic Simulator
21
Cleaning and Decontaminating the Handheld
22
Customizing the Handheld Settings
22
Updating the Handheld Software
23
Thermal Probe Check
23
Warranty
23
Testing Procedures for I-Stat Chemistry Cartridges
25
Precautions
26
Receipt and Storage of Cartridges & Controls
27
Using a Cartridge for Patient or Control Tests
28
Perform a Patient Test
29
Test Ranges
33
Perform a Control Test
34
Factors that Affect Results
39
Troubleshooting
39
Components and Supplies
41
Components and Supplies
42
New Operator Quiz
43
New Operator Quiz
47
System Resources
49
Symbols
50
Specifications
51
Laser Caution
52
Test and Administration Menus
53
Customizing the Handheld
54
Highlights of Customization Menu
55
Deleting Results from Handheld
56
Proficiency Testing
56
Thermal Probe Check
57
Printing Results
58
I-STAT Printer
58
Martel Printer
65
Downloader/Recharger
69
Logs
71
Quality Checks
79
Cartridge and Test Information
83
Abbott i-STAT 1 User Manual (9 pages)
Brand:
Abbott
| Category:
Measuring Instruments
| Size: 1.06 MB
Table of Contents
Quality Check Messages and Codes
1
System Components
2
Troubleshooting
3
Blood Collection
3
Replacing Paper in the I-STAT Printer
3
Unexpected Results
3
Charging Rechargeable Battery in External Recharge Compartment
4
Step/Action
4
Limitations
4
Replacing Paper in the Martel Printer
4
Patient Test Procedures
5
Cartridge Test Procedure
5
Hardware Procedures
5
Reportable and Reference Range
6
Verification of Cartridges Using 2 Levels of Specified Controls
6
Reviewing Test Results
6
Cartridge
6
Transmitting Results
7
Storage Conditions and Preparation for Use
7
Quality Assurance
7
Test Flags and Operator Action
8
Printing Test Results from a I-STAT Printer or Martel Printer
8
Without Downloader or Downloader/Recharger
8
With Downloader or Downloader/Recharger
8
Abbott i-STAT 1 Quick Reference Manual (7 pages)
For use with a CLIA Certificate of Waiver
Brand:
Abbott
| Category:
Handhelds
| Size: 4.43 MB
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