Abbott i-STAT 1

Abbott i-STAT 1

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PROCEDURE MANUAL FOR THE i-STAT SYSTEM

6

REV. DATE: 16-Oct-12 ART: 714446-00L

Table of Contents

Default Chapter3
- Table of Contents3
- Contents5
- Intended Use11
- FDA Test Categorization11
- Overview of the I-STAT System11
Introduction11
- This Manual11
- Selection of Components12
- Summary of the Procedure12
- Data Management13
- Interfacing13
- Note Regarding System Reliability13
- Symbols13
- Warranty17
I-STAT 1 Analyzer19
- Before You Use the Analyzer19
  - Install Batteries19
  - Customization19
- Introduction19
- Description20
- Specifications20
- Software20
- Battery Compartment20
- Power20
- Low Battery Warning21
- Rechargeable Battery21
- Disposable Batteries21
- Additional Power22
- Cartridge Port22
- Infrared Communication Window22
- Thermal Control23
- Barometric Pressure Sensor23
- Cartridge Test Cycle23
- Data Entry24
- Storage of Results24
- LCD Display and Backlight25
- Audible Indicator25
- Time out25
- Keypad26
- I-STAT 1 Menu Tree27
- Test Menu28
- Administration Menu28
- Analyzer Status29
- Data Review29
- Quality Tests30
- Customization31
  - Viewing the Customization Profile32
  - Changing the Profile32
- Set Clock35
- Transmit Data35
- Utility35
- Laser Barcode Scanner36
  - Laser Specifications36
  - Warning Labels36
  - Barcode Label Quality37
- Prompts and Messages37
  - Startup Messages38
  - Quality Check Messages38
I-STAT Cartridge39
- Contents39
- Standardization and Calibration41
- Packaging41
- Storage Conditions42
- Disposal42
PRECISION Pcx and Pcx PLUS BLOOD GLUCOSE TEST STRIPS43
Electronic Simulator45
- External Simulator45
- Internal Simulator45
- Relative Humidity45
- Cleaning the Simulator46
- Operating Characteristics46
- Stored Result46
I-STAT 1 Downloader47
- Function47
- Power Supply48
- Specifications48
- Downloader/Recharger Indicator Leds49
- Power Requirements49
- Programming and Connections49
- Cautions49
- Transmitting Data from Downloader to the Data Manager50
- Transmitting Data from Downloader/ Recharger to the Data Manager50
- Transmitted Information50
  - Charge Battery before Use51
  - Keep Battery Charged51
- Charging the Rechargeable Battery51
- Troubleshooting51
TECHNICAL BULLETIN: the I-STAT DOWNLOADER/RECHARGER (MODEL NUMBER DRC-300)73
Portable Printer73
- Overview73
- Specifications73
- Supplies Provided with Printer74
- Power74
- Paper74
- Printing Directly from the Analyzer75
- Printing Via a Downloader75
- Printing Many Results76
- What Is Printed76
- Printing Many Results85
Technical Bulletin: I-STAT Printer Rechargeable Battery Notice89
Data Management91
- Introduction91
- Components91
  - The Data Manager92
  - I-STAT Central Data Station Version 5 Software92
- IR Link93
- LIS/HIS Interface93
- Downloader and Downloader/Recharger93
- Standard Data Management Configuration94
- Connecting Components94
  - Ethernet Connection94
  - Analyzer Customization Options and Default Settings96
- On the I-STAT 1 Handheld102
- Technical Bulletin: Liquid Quality Control Pass/Fail Customization on the I-STAT 1 Handheld133
Sample Collection167
- Specimen Collection167
- Venipuncture - General167
- Venipuncture - Ph, PCO2, Electrolyte, Chemistry, and Hematocrit Tests168
- Venipuncture - Coagulation Tests170
- Arterial Puncture - General170
- Arterial Puncture - Blood Gas, Electrolyte, Chemistry, and Hematocrit Tests171
  - Evacuated Tubes171
  - Syringes and Anticoagulant171
- Arterial Puncture - ACT Tests172
  - Sample on Ice172
  - Blood Flow172
- Indwelling Line173
- Skin Puncture173
  - Blood Gas, Electrolyte, Chemistry173
  - Blood Gas Analysis173
- Sample Transfer Devices174
- References175
Procedure for Handling Cartridges177
- Preparation for Testing177
  - Select the Cartridge177
  - Room Temperature177
- Filling and Sealing Cartridge Using Transfer Device178
- Filling and Sealing PT/INR Cartridges Using Direct Fingerstick Sampling178
- Filling and Closing an Immunoassay Cartridge Using a Transfer Device179
- Inserting and Removing the Cartridge from the Analyzer180
- Incorrect Procedure181
Procedure for Cartridge Testing183
- Customizing the Handheld for Cartridge Testing Using the Handheld Keypad184
- Customizing the I-STAT 1 Handheld to Run I-STAT Cartridges184
- Customizing the Handheld for Cartridge Testing Using CDS Version 5185
- Performing Patient Analysis188
- Action Ranges189
- Interpretation of Displayed Results189
- Troubleshooting191
  - Unexpected Results191
  - Warning Message191
Procedures for Glucose Test Strip Testing193
- Quality Control for I-STAT Cartridges and the Analyzer's Cartridge Test Cycle195
  - Verify Newly Received Cartridges195
  - Verify Performance of Analyzers Daily195
- Overview195
  - Check Room Temperature Storage Daily196
  - Check Thermal Control System Every Six Months196
- Controls for Blood Gas/Electrolyte/Metabolite Cartridges (Except CHEM8+ Cartridges)197
  - Ampule Use198
  - Before Use198
  - Transfer with Capillary Tube198
  - Transfer with Syringe198
  - Target Values199
  - Ranges199
- Controls for CHEM8+ Cartridges200
- Reactive Ingredients200
- RNA ® Medical Hematocrit Control202
- Controls for ACT Cartridges203
- Controls for PT/INR Cartridges204
- Control Target Values and Expected Ranges204
- Controls for Ctni Cartridges206
  - Storage and Stability206
  - Control Target Values and Ranges206
  - Cliniqa Liquid QC Cardiac Marker Controls for I-STAT207
- I-STAT BNP Controls208
- Performing Electronic Simulator Test209
- Procedure for External Electronic Simulator209
- Troubleshooting Failed Electronic Simulator Test210
- Introduction210
  - Checking the Thermal Probes in the I-STAT Analyzers211
    - Verification for Handheld Analyzers211
    - Procedure for Handheld Analyzers211
  - Performing Control Test on Cartridge212
  - Documentation of Results212
  - Troubleshooting Out-Of-Range Control Results on Cartridge213
- Sodium231
- Potassium231
- Chloride231
- Glucose231
- Acceptable Criteria234
Technical Bulletin: Tricontrols Control Material for Liquid Qc and Cali-237
Calibration Verification237
- Calibration Verification for Blood Gas/Electrolyte/Metabolite Cartridges (Except CHEM8+ Cartridges)237
- I-STAT Calibration Verification Set238
- I-STAT CHEM8+ Calibration Verification Set239
- I-STAT Cardiac Marker Calibration Verification Set241
- RNA ® Medical Hematocrit Calibration Verification Controls243
- Verification Procedure for Hematocrit244
- Verification Procedure for ACT245
- Procedure for Cartridges246
- Troubleshooting Cartridge Tests246
Proficiency or External Quality Control Testing247
- Troubleshooting248
Routine Care of the Analyzer and Downloader249
- Drying a Wet Analyzer or Downloader249
- Cleaning the Analyzer and Downloader249
- Removing and Replacing Disposable Batteries250
- Removing and Replacing the Rechargeable Battery251
Updating the Software253
- Instructions for Updating I-STAT 1 Handheld Software255
- Why Do I-STAT Handhelds Need Software Updates?255
- Jammlite Process Overview255
- Choosing the Best I-STAT 1 Handheld Update Method256
- Instructions for Using this Technical Bulletin256
- Jammlite256
- Cds256
- Follow These Steps to Update with the Jammlite Utility257
- Connecting/Setting up Equipment258
- Loading JAMS/CLEW259
- Updating Your I-STAT 1 Handheld261
- Verifying Software Update264
- Gathering All Equipment265
- Determining CDS Update Path270
- Assigning JAMS/CLEW272
- CDS Update Path274
- Network Options for Updating the I-Stat 1 Handheld275
Troubleshooting the Analyzer295
- Introduction295
- Information Needed295
- Startup Messages296
- Test Cycle Messages and Quality Check Codes297
  - Error in Cartridge or Fluid Movement298
  - Electrical or Mechanical Failures299
- No Display300
  - “Cartridge Locked” Not Removed300
  - Analyzer Coded Messages301
- Analyzer Functions311
  - Microprocessor System311
  - Sensor Interface311
Theory311
- Analog Control Signals312
- Analog-To-Digital Conversion312
- Mechanical System312
- Operator Interface312
- Electrochemical Measurements313
- Determination of Test Results314
- Cpb315
- Determination of Cell Concentration315
- Determination of Coagulation Endpoints317
- Quality Control and the I-STAT System317
- Quality Control and the I-STAT Coagulation Tests323
Downloader Programming and Wiring325
- Configure a Terminal Session325
- Connect to and Program the Downloader325
- Programming the Network Downloaders325
- Wiring the Downloaders330
- Connecting the Serial Port Downloader332
Central Data Station 5335
- Installation of the Central Data Station337
- General Procedures and Conventions339
- Customization of the Central Data Station343
  - Site Information343
  - Serial Ports344
  - Network344
  - Interface345
  - Options346
  - Security347
- Interface Program Customization349
- Overview of the Central Data Station Program351
- Central Data Station Software Function Overview and Toolbar Buttons351
- Administration Tools353
- Instrument and Location Workspace353
  - Delete Instrument356
  - Move Instrument356
  - Find Instrument356
  - Edit Instrument Comment356
  - Instrument and Location Summary357
  - Date Range358
  - Delete358
- Operator Workspace359
  - Operator List Edit in Progress359
  - Add Operator360
  - Delete Operator360
  - Move Operator360
  - Find Operator360
  - Update Certifications361
  - Add Certification361
  - Add Note361
  - Edit Department Name362
  - Operator and Certification Reports362
- Operator List Import365
- Export List366
- Database Maintenance367
  - Archive Test Results367
  - Database File369
  - Statistics369
- Inventory Workspace371
  - Stock372
  - Startup Option372
  - Orders373
  - Distribution375
  - Inventory Log376
- Customization Workspace377
  - Password377
  - Default Customization Profile378
  - Location-Based Customization Profiles378
  - Making Selections379
  - Language Window379
  - Unit Set Window380
  - I-Stat Analyzer and Philips Bam Clew Windows381
  - I-Stat 1 Software Window381
  - Preferences Window382
  - Chart Page Selection Box383
  - Backup and Restore Profile383
- User Administration Workspace385
  - Access385
  - Creating Security Profiles385
  - Deleting Security Profiles386
  - Editing Security Profiles386
  - Adding Users386
  - Deleting a User386
- Password Management387
  - User Log387
  - System Logoffs388
  - Manual Logoff388
  - Automatic Logoff388
- Data Viewers389
  - Information in Data Viewers389
  - Refreshing the Data390
  - Viewing Details390
  - Customizing the Data Viewers390
  - Editing a Record392
  - Finding a Record392
  - Printing Selected Records393
  - Send Selected Records393
  - Trending Results393
  - Electronic Simulator Viewer394
  - Unsent Records Viewer394
  - Sent Column Values395
- Data Export396
- Monitors397
  - Download Monitor397
  - Interface Monitor398
- Reports399
  - Reagent Management399
  - Method Compliance400
  - Method Competence401
  - Customization: Central Data402
  - Customization: I-Stat Analyzer Settings402
- System402
- Windows Operating System and Language Support403
- Cartridge Specifications405
- Ionized Calcium406
- Creatine Kinase MB / CK-MB408
- B-Type Natriuretic Peptide/Bnp408
  - Cartridge Configurations and Sample Volume410
  - Clinical Significance412
  - Performance Characteristics412
  - Cartridge Comparison413
  - Factors Affecting Results413
  - Bun/Urea425
  - Glucose/Glu429
  - Hematocrit/Hct and Calculated Hemoglobin/Hb435
  - Ionized Calcium/Ica441
  - PO2 and Calculated Oxygen Saturated/So2447
  - PCO2 and Calculated Values for HCO3 Base Excess and Anion Gap455
  - Total Carbon Dioxide/(TCO2)461
  - Creatinine/Crea465
  - Lactate/Lac471
  - Celite Activated Clotting Time/(ACT)477
  - Kaolin Activated Clotting Time485
  - Prothrombin Time (PT/INR)493
  - Cardiac Troponin I (Ctnl)501
  - Interference Testing507
  - 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 - All523
  - Heart Failure Population - Males524
  - Heart Failure Population - Females524
  - Males (Age Group)526
  - Females (Age Group)526
  - Precision Data (Pg/Ml)527
  - Equivalence of Whole Blood and Plasma (X-Axis)528
  - Analytical Sensitivity528
  - Analytical Specificity528
  - Recovery528
  - Test Limitations529
  - New Ultralife 9-Volt Lithium Battery for Use with the I-Stat System535
  - Proficiency Testing on the I-STAT System537
Technical Bulletins537
- Replacing the Nimh Rechargeable Battery in the Martel Printer543
- Instructions for Restoring Analyzers that Produce *** for Hematocrit and Quality Check Code 23545
- EDTA and KEDTA Customization for Hematocrit on the I-STAT System549
- Calibration Verification and the I-STAT System561
- I-STAT Celite ACT and I-STAT Kaolin ACT573
- Heparin Linearity Procedure573
- Support Services579
- April 2009 Update to I-STAT/DE (Version 2.0)599
- Using I-STAT Analyzer Customization Features to Minimize ID Entry Errors605
- The I-STAT System Manufacturer's Quality System Instructions611
- Updates to the I-STAT 1 Downloader/Recharger615
- The Presence of Latex Rubber in I-Stat System Components617
- Procedure Manual619

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