Abbott i-STAT 1

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Art: 714369-00H Rev. Date: 03-Aug-12

THE i-STAT PRINTER

OVERVIEW

This section describes the instructions for using the new i-STAT Printer, which is used to print results from

all models of the i-STAT 1 Analyzer (handheld).

Note: This printer cannot be used with the i-STAT Portable Clinical Analyzer (PCA).

Power

Button

Paper

Feed

Button

Power

Indicator

Status

Indicator

Window

Paper

Release

Lever

Power

Button

Paper

Feed

Button

Power

Indicator

Status

Indicator

Window

Paper

Release

Lever

Data

Connection

Power

Connection

Main Page

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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