Abbott i-STAT 1 User guide

i-STAT® 1
System Manual
Rev. Date: 20-Jan-12 Art: 714336-00L

Patents
CA 2,193,000; CA 2,194,795; CA 2,328,161; EP 0727044; EP 0805973; EP 0770209; EP 1234053;
EP 1257801; EP 1481246; JP 2948321; JP 3093274; JP 3392871; US 5,447,440; US 5,514,253;
US 5,605,664; US 5,609,824; US 5,614,416; US 5,628,961; US 5,789,253; US 5,837,446; US 6,030,827;
US 6,379,883; US 6,438,498; US 6,750,053; US 7,419,821; US 7,540,948; US 7,552,071; US 7,682,833;
US 7,723,099; US 7,263,501; US 7,910,352; US 7,912,754; US 7,923,256; US 7,918,978; USD 616,985;
USD 627,065
Symbol Technologies Corporation is the owner of US Patent No. 5,532,469.
Trademarks
i-STAT is a registered trademark of the Abbott Group of Companies in various jurisdictions. Windows is
a registered trademark of Microsoft Corporation.
Art: 714336-00L Rev. Date: 20-Jan-12
Abbott Point of Care Inc.
Abbott Park, IL 60064 • USA
©2012 Abbott Point of Care Inc. All rights reserved. Printed in USA.
For information related to Article 33
of the EU REACH regulation
(EC No.1907/2006), please refer
to pmis.abbott.com. If you have
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contact Abbott at:
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Tel: [phone]
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i-STAT 1 SYSTEM MANUAL CONFIGURATION
Please ensure that the contents of your System Manual are complete and up to date. In the event that your System
Manual does not contain the current configuration, it is recommended that you contact your i-STAT support provider.
As of October 2012, your i-STAT®1 System Manual should be configured with the contents as listed below and in the
order shown.
ITEM Art #
Cover Sheet .....................................................................................714336-00L
Configuration Sheet ..........................................................................714419-00AM
Table of Contents..............................................................................714362-00P
Section 1...........................................................................................714363-00U
Section 2...........................................................................................714364-00M
Section 3...........................................................................................714365-00G
Section 4...........................................................................................714366-00C
Section 5...........................................................................................714367-00D
Section 6...........................................................................................714368-00K
Technical Bulletin: The i-STAT 1 Downloader/Recharger
(Model Number DRC-300)……………………………………………….728690-00D
Section 7...........................................................................................714369-00H
Technical Bulletin: i-STAT Printer Rechargeable Battery Notice…….728730-00C
Section 8...........................................................................................714370-00D
Section 9...........................................................................................714371-00E
Technical Bulletin: Reportable Range Customization
on the i-STAT 1 Handheld……………………………………………….730009-00B
Technical Bulletin: Liquid Quality Control Schedule and Lockout
Customization on the i-STAT 1 Handheld……………………………...730077-00B
Technical Bulletin: Liquid Quality Control Pass/Fail Customization
on the i-STAT 1 Handheld……………………………………………….730078-00A
Technical Bulletin: Positive Patient Identification (PPID)
Customization on the i-STAT 1 Handheld……………………………...730211-00B
Technical Bulletin: Operator Competency Notification
on the i-STAT 1 Handheld……………………………………………….730292-00A
Section 10.........................................................................................714372-00L
Section 11.........................................................................................714373-00F
Section 12.........................................................................................714374-00J
Section 13.........................................................................................714375-00F
Section 14.........................................................................................714376-00M
Technical Bulletin: TriControls: Control Materials for
Liquid QC and Calibration Verification………………………………….723270-00A
Section 15.........................................................................................714377-00K
Section 16.........................................................................................714378-00F
Section 17.........................................................................................714379-00F
Section 18.........................................................................................714380-00M
Technical Bulletin: Instructions for Updating i-STAT 1
Handheld Software………………………………………………………..725708-00E
Technical Bulletin: Network Options for Updating the
i-STAT 1 Handheld………………………………………………………..725768-00E
Section 19.........................................................................................714381-00H
Technical Bulletin: Analyzer Coded Messsages……………………….714260-00N
Section 20.........................................................................................714382-00D
Section 21.........................................................................................714383-00F
Section 22.........................................................................................714384-00D
CTI Sheets
Introduction .......................................................................................714258-00N
Sodium..............................................................................................714173-00M
Potassium .........................................................................................714174-00J
Chloride.............................................................................................714175-00K
Urea Nitrogen/BUN........................................................................... 714176-00L
Glucose.............................................................................................714177-00N
Hematocrit/Hemoglobin.....................................................................714178-00L
Ionized Calcium.................................................................................714179-00L
PO2/ sO2.........................................................................................714180-00K
Art.: 714419-00AM Rev. Date: 30-Aug-12

Art.: 714419-00AM Rev. Date: 30-Aug-12
pH .....................................................................................................714181-00L
PCO2/HCO3/BE/AG..........................................................................714182-00R
Total Carbon Dioxide/TCO2..............................................................716661-00F
Creatinine..........................................................................................714183-00T
Lactate..............................................................................................714184-00M
Celite ACT......................................................................................... 714185-00N
Kaolin ACT........................................................................................715878-00M
Prothrombin Time PT/INR.................................................................715236-00N
Cardiac Troponin I.............................................................................715595-00R
Creatine Kinase MB / CK-MB............................................................ 716675-00L
B-Type Natriuretic Peptide/BNP........................................................716969-00J
Technical Bulletins
New Ultralife 9-Volt Lithium Battery For Use With the i-STAT System 730271-00A
Proficiency Testing and the i-STAT System…………………………… 714262-00AA
Replacing the NiMH Rechargeable Battery in the Martel Printer
Used With the i-STAT 1 Analyzer……………………………………….. 716625-00D
Instructions for Restoring Analyzers that Produce *** for
Hematocrit and Quality Check Code 23………………………………... 721215-00B
Hematocrit Determination in the i-STAT System
and Comparison to Other Methods……………………………………… 714261-00E
K2EDTA and K3EDTA Customization for
Hematocrit on the i-STAT System……………………………………..... 716240-00D
Calibration Verification and the i-STAT System....……………….……. 715209-00E
ACT Test Result Options: Prewarmed vs. Non-Prewarmed
Result Calibration Modes for the i-STAT 1 Analyzer………………….. 715617-00D
i-STAT Celite ACT and i-STAT Kaolin ACT
Heparin Linearity Procedure……………………………………………... 714547-00F
Support Services………………………………………………………….. 716144-00T
October 2007 Update to the Central Data Station Version 5……........ 720735-00B
April 2008 Update to the Central Data Station Version 5………………721106-00B
April 2009 Update to the Central Data Station Version 5………………722831-00A
April 2009 Update to i-STAT/DE (Version 2.0)………...………………..722832-00A
Using i-STAT®Analyzer Customization Features to
Minimize ID Entry Errors…………………………………………………...720654-00B
The i-STAT System Manufacturer’s Quality System Instructions……..721317-00D
Updates to the i-STAT 1 Downloader/Recharger……………………….725703-00A
The Presence of Latex Rubber in i-STAT System Components………721296-00A
Procedure Manual
Procedure Manual…………………………………………………………..714446-00L

Art: 714362-00P Rev Date: 10-Oct-12 i
Contents
INTRODUCTION .................................................................................................... 1 - 1
This Manual.......................................................................................................................................... 1 - 1
Intended Use........................................................................................................................................ 1 - 1
FDA Test Categorization ...................................................................................................................... 1 - 1
Overview of the i-STAT System............................................................................................................ 1 - 1
Components ........................................................................................................................................ 1 - 2
Selection of Components .................................................................................................................... 1 - 2
Summary of the Procedure.................................................................................................................. 1 - 2
Data Management ............................................................................................................................... 1 - 3
Interfacing ............................................................................................................................................ 1 - 3
Note Regarding System Reliability ...................................................................................................... 1 - 3
Symbols ............................................................................................................................................... 1 - 3
Warranty............................................................................................................................................... 1 - 7
SYSTEM COMPONENTS
i-STAT 1 ANALYZER .............................................................................................. 2 - 1
Introduction.......................................................................................................................................... 2 - 1
Before You Use the Analyzer ............................................................................................................... 2 - 1
Specifications....................................................................................................................................... 2 - 2
Software............................................................................................................................................... 2 - 2
Power................................................................................................................................................... 2 - 2
Disposable Batteries............................................................................................................................ 2 - 3
Rechargeable Battery .......................................................................................................................... 2 - 3
Low Battery Warning............................................................................................................................ 2 - 3
Cartridge Port ...................................................................................................................................... 2 - 4
Infrared Communication Window ........................................................................................................ 2 - 5
Thermal Control ................................................................................................................................... 2 - 5
Barometric Pressure Sensor ................................................................................................................ 2 - 5
Cartridge Test Cycle............................................................................................................................. 2 - 5
Data Entry ............................................................................................................................................ 2 - 6
Storage of Results ............................................................................................................................... 2 - 6
LCD Display and Backlight .................................................................................................................. 2 - 7
Audible Indicator.................................................................................................................................. 2 - 7
Time Out .............................................................................................................................................. 2 - 7
Keypad................................................................................................................................................. 2 - 8
i-STAT 1 Menu Tree .............................................................................................................................. 2 - 9
Test Menu............................................................................................................................................. 2 - 10
Administration Menu............................................................................................................................ 2 - 10
Analyzer Status .................................................................................................................................... 2 - 11
Data Review......................................................................................................................................... 2 - 11
Quality Tests......................................................................................................................................... 2 - 12
Customization ..................................................................................................................................... 2 - 13
Set Clock ............................................................................................................................................. 2 - 17
Transmit Data....................................................................................................................................... 2 - 17
Utility .................................................................................................................................................... 2 - 17
Laser Barcode Scanner ....................................................................................................................... 2 - 18
Prompts and Messages....................................................................................................................... 2 - 19

ii Art: 714362-00P Rev Date: 10-Oct-12
i-STAT CARTRIDGE ............................................................................................... 3 - 1
Contents .............................................................................................................................................. 3 - 1
Standardization and Calibration........................................................................................................... 3 - 3
Packaging ............................................................................................................................................ 3 - 3
Storage Conditions .............................................................................................................................. 3 - 4
Disposal ............................................................................................................................................... 3 - 4
PRECISION PCx AND PCx PLUS BLOOD GLUCOSE TEST STRIPS................. 4 - 1
ELECTRONIC SIMULATOR................................................................................... 5 - 1
Internal Simulator................................................................................................................................. 5 - 1
External Simulator................................................................................................................................ 5 - 1
Operating Characteristics .................................................................................................................... 5 - 2
Cleaning the Simulator......................................................................................................................... 5 - 2
i-STAT 1 DOWNLOADER....................................................................................... 6 - 1
Function ............................................................................................................................................... 6 - 1
Specifications....................................................................................................................................... 6 - 2
Power Supply....................................................................................................................................... 6 - 2
Downloader/Recharger Indicator LEDs ............................................................................................... 6 - 3
Power Requirements............................................................................................................................ 6 - 3
Cautions............................................................................................................................................... 6 - 3
Transmitting Data from Downloader to the Data Manager .................................................................. 6 - 4
Transmitting Data from Downloader/Recharger to the Data Manager................................................. 6 - 4
Transmitted Information ....................................................................................................................... 6 - 4
Troubleshooting ................................................................................................................................... 6 - 5
Charging the Rechargeable Battery..................................................................................................... 6 - 5
Charging Rechareable Battery in the External Recharge Compartment ............................................. 6 - 6
TECHNICAL BULLETIN: THE i-STAT DOWNLOADER/RECHARGER (MODEL NUMBER DRC-300)
PORTABLE PRINTER............................................................................................. 7 - 1
MARTEL Printer......................................................................................................................................... 7 - 1
Overview .............................................................................................................................................. 7 - 1
Specifications....................................................................................................................................... 7 - 1
Supplies Provided with Printer............................................................................................................. 7 - 2
Power................................................................................................................................................... 7 - 2
Loading Paper...................................................................................................................................... 7 - 2
Printing Directly from the Analyzer....................................................................................................... 7 - 3
Printing Via a Downloader.................................................................................................................... 7 - 3
Printing Many Results .......................................................................................................................... 7 - 4
What is Printed..................................................................................................................................... 7 - 4
Cautions............................................................................................................................................... 7 - 4
Troubleshooting ................................................................................................................................... 7 - 5
i-STAT Printer............................................................................................................................................. 7 - 6
TECHNICAL BULLETIN: i-STAT PRINTER RECHARGEABLE BATTERY NOTICE
DATA MANAGEMENT............................................................................................ 8 - 1
Introduction.......................................................................................................................................... 8 - 1
Components ........................................................................................................................................ 8 - 1
Data Manager ...................................................................................................................................... 8 - 2
i-STAT Central Data Station Version 5 Software .................................................................................. 8 - 2
Downloader and Downloader/Recharger............................................................................................. 8 - 3
IR Link .................................................................................................................................................. 8 - 3
LIS/HIS Interface.................................................................................................................................. 8 - 3
Standard Data Management Configuration ......................................................................................... 8 - 4
Connecting Components..................................................................................................................... 8 - 4

Art: 714362-00P Rev Date: 10-Oct-12 iii
CUSTOMIZATION .................................................................................................. 9 - 1
TECHNICAL BULLETIN: REPORTABLE RANGE CUSTOMIZATION ON THE i-STAT 1 HANDHELD
TECHNICAL BULLETIN: LIQUID QC SCHEDULE AND LOCKOUT CUSTOMIZATION ON THE i-STAT
1 HANDHELD
TECHNICAL BULLETIN: LIQUID QC PASS/FAIL CUSTOMIZATION ON THE i-STAT 1 HANDHELD
TECHNICAL BULLETIN: POSITIVE PATIENT ID CUSTOMIZATION ON THE i-STAT 1 HANDHELD
TECHNICAL BULLETIN: OPERATOR COMPETENCY NOTIFICATION ON THE i-STAT 1 HANDHELD
PROCEDURES
SAMPLE COLLECTION ......................................................................................... 10 - 1
Specimen Collection............................................................................................................................ 10 - 1
Venipuncture - General ........................................................................................................................ 10 - 1
Venipuncture - pH, PCO2, Electrolyte, Chemistry, and Hematocrit Tests .......................................... 10 - 2
Venipuncture - Coagulation Tests ........................................................................................................ 10 - 4
Arterial Puncture - General .................................................................................................................. 10 - 4
Arterial Puncture - Blood Gas, Electrolyte, Chemistry, and Hematocrit Tests.................................... 10 - 5
Arterial Puncture - ACT Tests.............................................................................................................. 10 - 6
Indwelling Line ..................................................................................................................................... 10 - 7
Skin Puncture....................................................................................................................................... 10 - 7
Sample Transfer Devices ..................................................................................................................... 10 - 8
References ........................................................................................................................................... 10 - 9
PROCEDURE FOR HANDLING CARTRIDGES .................................................... 11 - 1
Preparation for Testing......................................................................................................................... 11 - 1
Filling and Sealing Cartridge Using Transfer Device............................................................................ 11 - 2
Filling and Sealing PT/INR Cartridges Using Direct Fingerstick Sampling .......................................... 11 - 2
Filling and Closing an Immunoassay Cartridge Using a Transfer Device ............................................ 11 - 3
Inserting and Removing the Cartridge From the Analyzer................................................................... 11 - 4
Incorrect Procedure ............................................................................................................................. 11 - 5
PROCEDURE FOR CARTRIDGE TESTING .......................................................... 12 - 1
Cautions............................................................................................................................................... 12 - 1
Customizing the i-STAT 1 Handheld to run i-STAT Cartridges............................................................. 12 - 2
Performing Patient Analysis................................................................................................................. 12 - 6
Interpretation of Displayed Results ..................................................................................................... 12 - 7
Troubleshooting ................................................................................................................................... 12 - 9
PROCEDURES FOR GLUCOSE TEST STRIP TESTING..................................... 13 - 1
QUALITY CONTROL .............................................................................................. 14 - 1
Overview ............................................................................................................................................. 14 - 1
Quality Control for i-STAT Cartridges and the Analyzer’s Cartridge Test Cycle................................... 14 - 1
Controls for Blood Gas/Electrolyte/Metabolite Cartridges (Except CHEM8+ Cartridges)................... 14 - 3
Correction of PO2 at Extreme Altitude................................................................................................. 14 - 5
Controls for CHEM8+ Cartridges......................................................................................................... 14 - 6
RNA®Medical Hematocrit Control....................................................................................................... 14 - 8
Controls for ACT Cartridges ................................................................................................................ 14 - 9

iv Art: 714362-00P Rev Date: 10-Oct-12
Controls for PT/INR Cartridges............................................................................................................ 14 - 10
Controls for cTnI Cartridges................................................................................................................. 14 - 12
Cliniqa Liquid QC™ Cardiac Marker Controls for i-STAT .................................................................... 14 - 13
i-STAT BNP Controls............................................................................................................................ 14 - 14
Performing Electronic Simulator Test................................................................................................... 14 - 15
Procedure for Internal Electronic Simulator ......................................................................................... 14 - 15
Procedure for External Electronic Simulator........................................................................................ 14 - 15
Troubleshooting Failed Electronic Simulator Test ................................................................................ 14 - 16
Checking the Thermal Probes in the i-STAT Analyzers........................................................................ 14 - 17
Performing Control Test on Cartridge .................................................................................................. 14 - 18
Troubleshooting Out-of-Range Control Results on Cartridge ............................................................. 14 - 19
Quality Control Log Sheets.................................................................................................................. 14 - 21
TECHNICAL BULLETIN: TRICONTROLS CONTROL MATERIAL FOR LIQUID QC AND CALI-
BRATION VERIFICATION
CALIBRATION VERIFICATION .............................................................................. 15 - 1
Calibration Verification for
Blood Gas/Electrolyte/Metabolite Cartridges (Except CHEM8+ Cartridges)....................................... 15 - 1
i-STAT Calibration Verification Set ....................................................................................................... 15 - 2
i-STAT CHEM8+ Calibration Verification Set........................................................................................ 15 - 3
i-STAT Cardiac Marker Calibration Verification Set.............................................................................. 15 - 5
i-STAT BNP Calibration Verification Set ............................................................................................... 15 - 6
RNA®Medical Hematocrit Calibration Verification Controls ................................................................ 15 - 7
Verification Procedure for Hematocrit.................................................................................................. 15 - 8
Verification Procedure for ACT............................................................................................................. 15 - 9
Procedure for Cartridges ..................................................................................................................... 15 - 10
Troubleshooting Cartridge Tests .......................................................................................................... 15 - 10
PROFICIENCY or EXTERNAL QUALITY CONTROL TESTING........................... 16 - 1
Purpose................................................................................................................................................ 16 - 1
General Procedure for Cartridges........................................................................................................ 16 - 1
Troubleshooting ................................................................................................................................... 16 - 2
CARE AND SOFTWARE UPDATES
ROUTINE CARE of the ANALYZER and DOWNLOADER ................................... 17 - 1
Drying a Wet Analyzer or Downloader ................................................................................................ 17 - 1
Cleaning the Analyzer and Downloader............................................................................................... 17 - 1
Removing and Replacing Disposable Batteries................................................................................... 17 - 2
Removing and Replacing the Rechargeable Battery ........................................................................... 17 - 3
UPDATING THE SOFTWARE................................................................................. 18 - 1
TROUBLESHOOTING THE ANALYZER
TROUBLESHOOTING THE ANALYZER................................................................ 19 - 1
Introduction.......................................................................................................................................... 19 - 1
Information Needed ............................................................................................................................. 19 - 1
Startup Messages................................................................................................................................ 19 - 2
Test Cycle Messages and Quality Check Codes ................................................................................. 19 - 3
No Display............................................................................................................................................ 19 - 6
“Cartridge Locked” Not Removed ....................................................................................................... 19 - 6

Art: 714362-00P Rev Date: 10-Oct-12 v
TECHNICAL BULLETIN: ANALYZER CODED MESSAGES
THEORY
THEORY.................................................................................................................. 20 - 1
Analyzer Functions............................................................................................................................... 20 - 1
Electrochemical Measurements........................................................................................................... 20 - 3
Determination of Test Results .............................................................................................................. 20 - 4
Determination of Cell Concentration.................................................................................................... 20 - 5
CPB...................................................................................................................................................... 20 - 5
Determination of Coagulation Endpoints............................................................................................. 20 - 7
Quality Control and the i-STAT System................................................................................................ 20 - 7
Quality Control and the i-STAT Coagulation Tests ............................................................................... 20 - 13
DOWNLOADER PROGRAMMING
DOWNLOADER PROGRAMMING AND WIRING ................................................. 21 - 1
Programming the Network Downloaders............................................................................................. 21 - 1
Wiring the Downloaders....................................................................................................................... 21 - 6
CENTRAL DATA STATION
CENTRAL DATA STATION ..................................................................................... 22 - 1
i-STAT License Agreement and Warranty for Central Data Station Program....................................... 22 - 1
Installation Of The Central Data Station............................................................................................... 22 - 3
General Procedures and Conventions ................................................................................................. 22 - 5
Customization of the Central Data Station .......................................................................................... 22 - 9
Interface Program Customization ........................................................................................................ 22 - 15
Overview of the Central Data Station Program.................................................................................... 22 - 17
Administration Tools............................................................................................................................. 22 - 19
Instrument and Location Workspace ................................................................................................... 22 - 19
Operator Workspace............................................................................................................................ 22 - 25
Operator List Import............................................................................................................................. 22 - 31
Database Maintenance ........................................................................................................................ 22 - 33
Inventory Workspace ........................................................................................................................... 22 - 37
Customization Workspace ................................................................................................................... 22 - 43
User Administration Workspace .......................................................................................................... 22 - 51
Password Management ....................................................................................................................... 22 - 53
Data Viewers ........................................................................................................................................ 22 - 55
Data Export .......................................................................................................................................... 22 - 62
Monitors............................................................................................................................................... 22 - 63
Reports ................................................................................................................................................ 22 - 65
System ................................................................................................................................................. 22 - 68
Windows Operating System and Language Support .......................................................................... 22 - 69

vi Art: 714362-00P Rev Date: 10-Oct-12
CARTRIDGE AND TEST INFORMATION
Cartridge and Test Information
Sodium
Potassium
Chloride
BUN/Urea
Glucose
Hematocrit/Hemoglobin
Ionized Calcium
PO2
pH
PCO2
Total Carbon Dioxide/TCO2
Creatinine
Lactate
Celite ACT
Kaolin ACT
Prothrombin Time PT/INR
Cardiac Troponin I
Creatine Kinase MB/CK-MB
B-Type Natriuretic Peptide/BNP
TECHNICAL BULLETINS
PROCEDURE MANUAL

INTRODUCTION
1
Art: 714363-00U Rev. Date: 02-Aug-12 1-1
This Manual This manual describes the i-STAT1Analyzer and the Central Data Station software.
Related sections are grouped behind tabs.
Intended Use The i-STAT 1 Analyzer is intended for use with i-STAT cartridges for the in vitro
quantification of various analytes in whole blood. Analyzers and cartridges should
be used by healthcare professionals trained and certified to use the system and
should be used according to the facility’s policies and procedures.
Overview of the
i-STAT System
The i-STAT System incorporates a comprehensive group of components needed
to perform blood analysis at the point of care. A portable handheld analyzer, a
cartridge with the required tests, and 2-3 drops of blood will allow the caregiver
to view quantitative test results for blood gas, chemistry and coagulation tests in
approximately two minutes.
Portable printers and infrared communication devices allow all patient information
obtained at the bedside to be printed on demand and transmitted to centralized
information systems for record keeping and billing.
The Central Data Station program provides system management tools including
real-time monitoring of testing and operator competency.
FDA Test
Categorization
With the i-STAT 1 System, the FDA has categorized the tests included on the
i-STAT G, Crea, E3+, EC4+, 6+, and CHEM8+ cartridges as waived when testing
is performed using venous whole blood samples collected in sodium or lithium
heparin evacuated tubes. Other venous whole blood samples, capillary and/or
arterial samples tested using these same cartridges on the i-STAT 1 System are
categorized by the FDA as moderate complexity.
For waived testing, laboratories are required to follow the manufacturer’s
requirements for the testing. They may elect to perform additional quality control
testing (such as the QC required for a moderate complexity test) but this does not
change the FDA categorization of the test as waived or release the laboratory’s
responsibility to follow the manufacturer’s instructions for it as a waived test.
Other testing performed with the i-STAT 1 System (other than the testing
performed using the aforementioned cartridges) is FDA categorized as "moderate
complexity".

1-2 Art: 714363-00U Rev. Date: 02-Aug-12
Selection of
Components
The selection of system components is dependent on factors unique to each
facility such as:
Types of tests to be performed
Number of testing sites
Number of tests per site
System administration requirements
Summary of the
Procedure
To perform cartridge testing, the operator fills a cartridge with sample, seals the
cartridge with its snap closure, and inserts the cartridge into the analyzer. Inserting the
cartridge activates the analyzer. Alternatively, the cartridge test cycle can be initiated
from the keypad/menu system. The unit-use cartridge contains all components to
perform one or more tests including: calibrating solution, sample handling system,
sensors and reagents. The analyzer automatically controls all steps in the testing cycle,
which may include: fluid movement, reagent mixing, calibration and thermal control.
Quality checks are performed continuously throughout the test cycle. Operator and
patient IDs and patient chart information can be entered. When the test cycle is
completed, results are displayed and the test record is stored.
Components The i-STAT System consists of:
i-STAT Cartridges
i-STAT 1 Analyzer
i-STAT Portable Clinical Analyzer
Portable Printer
Quality Assurance Materials
• ElectronicSimulator
• ControlSolutions
• CalibrationVerificationSet(forcartridges)
Data Management System
• i-STAT1Downloader
• i-STAT1Downloader/Recharger
• IRLinkforPortableClinicalAnalyzer
• Data Manager
 Central Data Station (data management software for cartridges)
Data Manager Printer
LIS/HISInterfaceSoftware

Art: 714363-00U Rev. Date: 02-Aug-12 1-3
Data Management Test records can be transmitted to the Data Manager where they can be printed
and/ortransmittedtotheLaboratoryInformationSystemorHospitalInformation
System. An optional portable printer enables the operator to print results at the
point of care.
Interfacing The Data ManagercanbeinterfacedtoaLaboratoryInformationSystem(LIS)or
Hospital Information System (HIS) to automate billing and patient record keeping.
Note Regarding
System Reliability
The i-STAT System automatically runs a comprehensive set of quality checks of
analyzer and cartridge performance each time a sample is tested. This internal quality
system will suppress results if the analyzer or cartridge does not meet certain internal
specifications (see Quality Control section in System Manual for detailed information).
To minimize the probability of delivering a result with medically significant error the
internal specifications are very stringent. It is typical for the system to suppress a
very small percentage of results in normal operation given the stringency of these
specifications. If however the analyzer or cartridges have been compromised,
results may be persistently suppressed, and one or the other must be replaced to
restore normal operating conditions. Where unavailability of results while awaiting
replacement of analyzers or cartridges is unacceptable, Abbott Point of Care Inc.
recommends maintaining both a backup i-STAT System analyzer and cartridges
from an alternate lot number.
Symbol Definition
Attention: See instructions for use.
Caution: Risk of electrical shock.
Laserradiationhazardsymbol.
Biological Risks.
Temperature limitations. The upper and lower limits for storage are adjacent to upper
and lower arms.
Upper limit of temperature.
The upper limit for storage is adjacent to the upper arm
Use by or expiration date.
An expiration date expressed as YYYY-MM-DD means the last day the product can be
used.
An expiration date expressed as YYYY-MM means the product cannot be used past the
last day of the month specified.
Symbols Symbols can be helpful in reducing the necessity for translating important information
into multiple languages, particularly where space is limited. The following symbols
may be found on components of the i-STAT System.

1-4 Art: 714363-00U Rev. Date: 02-Aug-12
Symbol Definition
Manufacturer's lot number or batch code. The lot number or batch will appear
adjacent to this symbol.
Catalog number, list number, or reference number. The number adjacent to this
symbol is used to reorder the product.
Serial number. The serial number will appear adjacent to this symbol.
MN Model number. The model number will appear adjacent to this symbol.
Date of manufacture.
Manufacturer
In vitro diagnostic medical device.
Authorized Representative for Regulatory Affairs in the European
Community.
Contains sufficient for < n > tests.
Direct Current (DC)
Alternating Current (AC)
Class II Construction
Consult instructions for use or see System Manual for instructions.
Control
SigniesthattheproductbearingtheETLListedmarkcomplieswithbothU.S.and
Canadian product safety standards:
UL61010A-1
CAN/CSA C22.2 No. 1010.1-92
i/immuno: Cartridges bearing this symbol must be run on i-STAT analyzers that also
bear this symbol.
Battery: i-STAT 1 Analyzer low battery icon (flashes on lower left side of display
screen).

Art: 714363-00U Rev. Date: 02-Aug-12 1-5
Symbol Definition
Note concerning batteries: The following information is applicable to EEA (European
Economic Area) countries: The directive 2006/66/EC requires separate collection of
spent batteries. You are requested to dispose those batteries referred to on page 2-3
in accordance with local regulations.
This product also contains a separate internal lithium battery that is not intended to be
replaced by the user. See page 2-4 under "Additional Power" for more information.
Separate waste collection for this electrical/electronic item indicated; Equipment
manufactured / put on the market after 13 August 2005; Indicates compliance with
Article 10(3) of Directive 2002/96/EC (WEEE) for the European Union (EU).
BODxxxx-xx Born On Date: the label BODxxxx-xx defines the year and month of manufacture.
Do not reuse.
This symbol is used for compliance with the China RoHS regulation(s). It indicates
in years the Environmentally Friendly Use Period (EFUP) for the labeled electronic
medical device product
<< >> As the Martel Printer is incapable of printing the ↑or ↓symbols, this symbol appears
on the Martel printout next to results which are outside the action range limits.
14 days room temperature storage at 18-30ºC
2 months room temperature storage at 18-30ºC
Packaging contains cartridges with barcoded pouches
Signifies that the product bearing the Federal Communications Commission (FCC)
logo complies with the specific requirements set forth by the FCC under Rules and
Regulations, Title 47, Part 15 Subpart B, for Class A devices.
Symbol The following symbols are used on the i-STAT 1 keypad.
SCAN Key used to scan information into the analyzer.
ABC Key used to enter letters.
Key used to enter information.
MENU Key used to access the analyzer's menu.
Key used to print a test record.
Key used to turn the analyzer off and on.
Description: 2 months room temperature storage at 18-30°C
Document Owner: Christopher Fetters
400 College Road East
Princeton, NJ 08540
[phone]
[e-mail]
Rev: 01 Feb 2010
2
m
14
d
Description: 14 days room temperature storage at 18-30°C
Document Owner: Christopher Fetters
400 College Road East
Princeton, NJ 08540
[phone]
[e-mail]
Rev: 01 Feb 2010
BC

1-6 Art: 714363-00U Rev. Date: 02-Aug-12
Symbol The following symbols are used on the i-STAT Portable Clinical Analyzer Keypad
DIS Key used to activate the display.
ENT Key used to enter information.
PRT Key used to print a test record.
CLR Key used to clear an incorrect entry.
Symbol The following symbols are used on i-STAT Value Assignment Sheets
Mean
RRange
Symbol TEST
Na Sodium
KPotassium
Cl Chloride
Glu Glucose
Lac Lactate
Crea Creatinine
pH pH
PCO2Partial pressure of carbon dioxide.
PO2Partial pressure of oxygen.
iCa Ionized Calcium
BUN/UREA Urea nitrogen/Urea
Hct Hematocrit
ACTc
Celite ACT Activated Clotting Time with Celite®activator.
ACTk
Kaolin ACT Activated Clotting Time with Kaolin activator.
PT/INR Prothrombin Time / International Normalized Ratio
Hb Hemoglobin
TCO2 Total carbon dioxide concentration.
HCO3 Bicarbonate
BE (b&ecf) Base excess (b for blood, ecf for extra cellular fluid)

Art: 714363-00U Rev. Date: 02-Aug-12 1-7
Symbol TEST
AnGap Anion Gap
sO2 Oxygen saturation
cTnI Cardiac Troponin I
CK-MB Creatine Kinase MB Isoenzyme
BNP B-type Natriuretic Peptide
Warranty
Abbott Point of Care Inc. warrants this medical product (excluding disposable or
consumable supplies) against defects in materials and workmanship for one year
from the date of shipment. If Abbott Point of Care Inc. receives notice of such
defects during the warranty period, Abbott Point of Care Inc. shall, at its option,
either repair or replace products which prove to be defective. With respect to
software or firmware, if Abbott Point of Care Inc. receives notice of defects in
these products during the warranty period, Abbott Point of Care Inc. shall repair or
replace software media and firmware which does not execute their programming
instructions due to such defects. Abbott Point of Care Inc. does not warrant that the
operating of the software, firmware or hardware shall be uninterrupted or error free.
If Abbott Point of Care Inc. is unable, within a reasonable time, to repair or replace
any product to a condition as warranted, Buyer shall be entitled to a refund of the
purchase price upon return of the product to Abbott Point of Care Inc..
Note: Warranty rights may vary from state to state, province to province and
country to country.
Limitations of Warranty
The foregoing warranty shall not apply to defects resulting from:
1 Improper or inadequate maintenance by Buyer or an unauthorized
person,
2 Using accessories and/or consumables that are not approved by Abbott
Point of Care Inc.,
3 Buyer-supplied software or interfacing,
4 Unauthorized repairs, modifications, misuse, or damage caused by
disposable batteries, or rechargeable batteries not supplied by Abbott
Point of Care Inc..
5 Operating outside of the environmental specifications of the product, or
6 Improper site preparation or maintenance.
THEWARRANTYSETFORTHABOVEISEXCLUSIVEANDNOOTHERWARRANTY,
WHETHER WRITTEN OR ORAL, IS EXPRESSED OR IMPLIED.  ABBOTT
SPECIFICALLYDISCLAIMSTHEIMPLIEDWARRANTIESORMERCHANTABILITY
ANDFITNESSFORAPARTICULARPURPOSE.

1-8 Art: 714363-00U Rev. Date: 02-Aug-12

i-STAT 1 ANALYZER
2
Art: 714364-00M Rev. Date: 02-Aug-12 2-1
INTRODUCTION
The i-STAT 1 Analyzer is used in conjunction with i-STAT cartridges for the
simultaneous quantitative determination of specific analytes in whole blood.
Refer to the Cartridge and Test Information section of this manual for information
on analytes that can be measured using i-STAT cartridges.
BEFORE YOU USE THE ANALYZER
Install Batteries Two disposable lithium batteries are supplied with the analyzer. See the Care of the
Analyzer section in this manual for the procedure to install the disposable batteries.
If a rechargeable battery is to be used, the disposable batteries can be used while
the rechargeable battery pack is charged in the Downloader/Recharger. Charge
rechargeable batteries fully before use. See the i-STAT 1 Downloader section for
this procedure. When using a rechargeable battery, store the disposable battery
carrier for possible future use.
Check Date and
Time
Press the On/Off key and check that the date and time at the top of the display are
correct. To change the date and time, see Administration Menu in this section.
Check Software Caution: New analyzers or analyzers that have been repaired and returned or
replaced will have standard CLEW and application software. If a different CLEW and/
or application software is in use in your facility, it must be installed in new, repaired
or replaced analyzers before they are put into use. Check the Analyzer Status page
for the installed CLEW and application software. See under “Standardization and
Calibration” in section 3 of this manual for an explanation of CLEW.
Customization Analyzers can be customized for many site-specific testing requirements. See the
Customization section for a list of customizable parameters and their default values.
To change the customization profile via the analyzer keypad see “Customization”
under “Administration” in this section of the manual. To change the customization
profile via the Central Data Station, see the “Customization Workspace” in the
Central Data section of this manual.
Caution: New analyzers or analyzers that have been repaired and returned or
replaced will have the factory default settings in the customization profile, as
indicated by the DEFAULT0 on the Analyzer Status page. If analyzers in your facility
do not use the default customization profile, the appropriate customization profile
should be installed before a new, repaired or replaced analyzer is put into use.
Perform Quality
Check
Use the Electronic Simulator to verify the cartridge-reading performance of new
or repaired analyzers.
Use QC protocols to verify the test strip-reading performance of new or repaired
analyzers.

2-2 Art: 714364-00M Rev. Date: 02-Aug-12
Software
Battery
Compartment
The battery compartment is located at the display end of the analyzer next to
the laser barcode scanner window. The procedure for changing disposable and
rechargeable batteries can be found in the Routine Care of the Analyzer and
Downloader section of this manual.
Power
All analyzer functions are controlled by application software that can be updated
as additional tests and features are developed. Coefficients used to maintain the
accuracy of cartridge results over time are programmed into the analyzer via CLEW
software updates every six months. See under “Standardization and Calibration”
in section 3 of this manual for an explanation of CLEW.
There are two power options for the analyzer: disposable and rechargeable. The
analyzer is shipped with two disposable 9-volt lithium batteries and a battery carrier.
Lithium batteries may be ordered from i-STAT or obtained locally. ULTRALIFE
lithium batteries (ULTRALIFE Batteries, Inc., Newark, NY, USA) are recommended.
Only i-STAT rechargeable batteries may be used.
DESCRIPTION
Specifications DIMENSIONS Width 7.68 cm (3.035 in.)
Length 23.48 cm (9.245 in.)
Depth 7.24 cm (2.85 in.)
WEIGHT With rechargeable battery 650 grams (22.9
oz.)
With disposable battery 635 grams (22.4 oz.)
POWER Two 9-volt lithium batteries, or rechargeable
battery.
CALIBRATION Factory: electronic, mechanical, thermal,
pressure
MEMORY/CLOCK BACKUP
POWER
Lithium Battery
DISPLAY Dot matrix supertwist liquid crystal
COMMUNICATION LINK Infrared light-emitting diode (LED)
OPERATING TEMPERATURE 16-30°C (61-86°F) for i-STAT cartridge testing
TRANSPORT
TEMPERATURE
-10-46°C (14-115°F)
RELATIVE HUMIDITY 90% (maximum) non-condensing
BAROMETRIC PRESSURE 300-850 mmHg
LASER SCANNER Complies with U.S. 21 CFR 1040.10 and
1040.11 except for deviations pursuant to
laser Notice No. 50, dated July 26, 2001.
EN 60825-1:1994 + A1:2002 + A2:2001
IEC 60825-1:1993 + A1:1997 + A2:2001