i-STAT 1 System Manual Rev Date 23 April 2018

System Manual

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i-STAT®1

System Manual

Rev. Date: 23-APR-18

Art: 714336-01O

Patents: www.abbott.us/patents Symbol Technologies Corporation is the owner of US Patent No. 5,532,469.

Trademarks i-STAT is a trademark of the Abbott Group of Companies in various jurisdictions. Windows is a trademark of Microsoft Corporation.

Abbott Point of Care Inc. 100 and 200 Abbott Park Road Abbott Park, IL 60064 • USA

Emergo Europe Prinsessegracht 20 2514 AP The Hague The Netherlands

For information related to Article 33 of the EU REACH regulation (EC No.1907/2006), please refer to pmis.abbott.com. If you have issues logging into the website, contact Abbott at: [email protected]

Art: 714336-01O

Rev. Date: 23-APR-18

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 November 2019, your i-STAT 1 System Manual should be configured with the contents as listed below and in the order shown. ITEM

Art #

Cover Sheet ..................................................................................... 714336-01O Configuration Sheet .......................................................................... 714419-01AZ Table of Contents .............................................................................. 714362-01Z Section 1 ........................................................................................... 714363-01Y Section 2 ........................................................................................... 714364-01R Section 3 ........................................................................................... 714365-01G Section 4 ........................................................................................... 714366-01C Section 5 ........................................................................................... 714367-01E Section 6 ........................................................................................... 714368-01J Technical Bulletin: The i-STAT 1 Downloader/Recharger (Model Number DRC-300)……………………………………………….728690-01G Section 7 ........................................................................................... 714369-01K Technical Bulletin: i-STAT Printer Rechargeable Battery Notice ....... 728730-01C Section 8 ........................................................................................... 714370-01D Section 9 ........................................................................................... 714371-01H Technical Bulletin: Reportable Range Customization on the i-STAT 1 Handheld……………………………………………….730009-01B Technical Bulletin: Liquid Quality Control Schedule And Lockout Customization on the i-STAT 1 Handheld…..………….730077-01C Technical Bulletin: Liquid Quality Control Pass/Fail Customization on the i-STAT 1 Handheld…..………………………….730078-01C Technical Bulletin: Positive Patient Identification (PPID) Customization on the i-STAT 1 Handheld……..……………………….730211-01C Technical Bulletin: Operator Competency Notification on the i-STAT 1 Handheld……………………………………………….730292-01B Section 10 ......................................................................................... 714372-01M Section 11 ......................................................................................... 714373-01G Section 12 ......................................................................................... 714374-01M Section 13 ......................................................................................... 714375-01F Section 14 ......................................................................................... 714376-01R Section 15 ......................................................................................... 714377-01Q Section 16 ......................................................................................... 714378-01G Section 17 ......................................................................................... 714379-01G Section 18 ......................................................................................... 714380-01K Technical Bulletin: Instructions for Updating i-STAT 1 Handheld Software Using www.pointofcare.abbott ........................... 731335-01E Technical Bulletin: Network Options for Updating the i-STAT 1 Handheld Using www.pointofcare.abbott ........................... 731336-01E Section 19 ......................................................................................... 714381-01K Technical Bulletin: Analyzer Coded Messages ................................. 714260-01T Section 20 ......................................................................................... 714382-01D Section 21 ......................................................................................... 714383-01F Section 22 ......................................................................................... 714384-01F CTI Sheets Introduction ....................................................................................... 714258-01O Sodium .............................................................................................. 714173-01Q Art.: 714419-01AZ

Rev. Date: 10-Oct-19

Potassium ......................................................................................... 714174-01P Chloride ............................................................................................. 714175-01R Urea Nitrogen/BUN ........................................................................... 714176-01R Glucose ............................................................................................. 714177-01S Hematocrit/Hemoglobin ..................................................................... 714178-01P Ionized Calcium................................................................................. 714179-01R PO2 / sO2 .......................................................................................... 714180-01N pH ..................................................................................................... 714181-01P PCO2/HCO3/BE/AG .......................................................................... 714182-01U Total Carbon Dioxide/TCO2 .............................................................. 716661-01H Creatinine .......................................................................................... 714183-01Y Lactate .............................................................................................. 714184-01P Celite ACT ......................................................................................... 714185-01Q Kaolin ACT ........................................................................................ 715878-01P Prothrombin Time PT/INR ................................................................. 715236-01N Cardiac Troponin I............................................................................. 715595-01S Creatine Kinase MB / CK-MB ............................................................ 716675-01M B-Type Natriuretic Peptide/BNP ........................................................ 716969-01J Total Beta-Human Chorionic Gonadotropin (β-hCG)………………….730474-01F Technical Bulletin: The i-STAT Total Beta-Human Chorionic Gonadotropin (β-hCG) Cartridge…………………………………………730475-01G Technical Bulletins New Ultralife 9-volt Lithium Battery for Use With the i-STAT System………………………………………...730271-01A Replacing the NiMH Rechargeable Battery in the Martel Printer Used With the i-STAT 1 Analyzer...................................................... 716625-01C Instructions for Restoring Analyzers that Produce *** for Hematocrit and Quality Check Code 23 .............................................................. 714962-01E Hematocrit Determination in the i-STAT System and Comparison to Other Methods. .................................................. 714261-01E K2EDTA and K3EDTA Customization for Hematocrit on the i-STAT System ..................................................... 716240-01D ACT Test Result Options: Prewarmed vs. Non-Prewarmed Result Calibration Modes for the i-STAT 1 Analyzer ......................... 715617-01D Support Services ............................................................................... 716144-01AI April 2008 Update to the Central Data Station Version 5 .................. 721106-01A April 2009 Update to the Central Data Station Version 5 .................. 722831-01A Using i-STAT® Analyzer Customization Features to Minimize ID Entry Errors. .................................................................. 720654-01B Updates to the i-STAT 1 Downloader/Recharger .............................. 725703-01A

Art.: 714419-01AZ

Rev. Date: 10-Oct-19

Contents INTRODUCTION..................................................................................................... 1 - 1 This Manual........................................................................................................................................... 1 - 1 Intended Use......................................................................................................................................... 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 Battery Compartment........................................................................................................................... 2 - 2 Disposable Batteries............................................................................................................................. 2 - 3 Rechargeable Battery........................................................................................................................... 2 - 3 Low Battery Warning............................................................................................................................ 2 - 3 Additional Power................................................................................................................................... 2 - 4 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 - 19 Transmit Data........................................................................................................................................ 2 - 19 Utility..................................................................................................................................................... 2 - 19 Laser Barcode Scanner........................................................................................................................ 2 - 20 Prompts and Messages........................................................................................................................ 2 - 22

Art: 714362-01Z

Rev. Date: 16-OCT-19

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 1 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 The 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

Art: 714362-01Z

Rev. Date: 16-OCT-19

IR Link................................................................................................................................................... 8 - 3 LIS/HIS Interface................................................................................................................................... 8 - 3 Standard Data Management Configuration.......................................................................................... 8 - 4 Connecting Components...................................................................................................................... 8 - 4

CUSTOMIZATION................................................................................................... 9 - 1 Overview ……………………………………………………………………………………........................... 9 - 1 Analyzer Customization Options And Default Settings ……………...................................................... 9 - 2 Preference Window: For instrument options …………………………………......................................... 9 - 3 Preference Window: For operator and patient ID options ………………….......................................... 9 - 4 Preference Window: For test options ……………………………………….…........................................ 9 - 5 Preference Window: For cartridge QC – Electronic QC settings ……….............................................. 9 - 6 Preference Window: For cartridge QC – liquid QC settings ………………........................................... 9 - 6 Preference Window: For cartridge QC – liquid QC schedule (1, 2 or 3) …........................................... 9 - 7 Preference Window: For results reporting options…………………………........................................... 9 - 8 Preference Window: For analyte enable …………………………………….…....................................... 9 - 9 Preference Window: For barcodes ……………………………………………......................................... 9 - 10 Unit Sets …………………………………………………………………………………............................... 9 - 11 General guidance for critical/action range decimal for rounding numbers……………………………...9 - 12

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................................................................................................................. 11 - 2 Filling and Sealing PT/INR Cartridges Using Direct Fingerstick Sampling........................................... 11 - 6 Inserting and Removing the Cartridge From the Analyzer.................................................................... 11 - 7 Incorrect Procedure.............................................................................................................................. 11 - 8

PROCEDURE FOR CARTRIDGE TESTING........................................................... 12 - 1

Art: 714362-01Z

Rev. Date: 16-OCT-19

iii

PROCEDURES FOR GLUCOSE TEST STRIP TESTING...................................... 13 - 1 QUALITY CONTROL............................................................................................... 14 - 1 Overview............................................................................................................................................... 14 - 1 Manufacturer’s Quality System Instructions......................................................................................... 14 - 1 i-STAT Controls for Blood Gas/Electrolyte/Metabolite Cartridges........................................................ 14 - 3 i-STAT Tricontrols for Blood Gas/Electrolyte/Metabolite Cartridges..................................................... 14 - 6 ACT Controls......................................................................................................................................... 14 - 9 PT/INR Controls.................................................................................................................................... 14 - 11 i-STAT cTnI, BNP, and CK-MB Controls............................................................................................... 14 - 12 i-STAT Total β-hCG Controls................................................................................................................. 14 - 13 Performing Electronic Simulator Test.................................................................................................... 14 - 15 Procedure for External Electronic Simulator......................................................................................... 14 - 15 Troubleshooting Failed Electronic Simulator Test................................................................................. 14 - 16 Thermal Probe Check........................................................................................................................... 14 - 17 Procedure for Testing Controls............................................................................................................. 14 - 18 Troubleshooting Out-of-Range Control or Calibration Verification Results on Cartridges................... 14 - 19 Quality Control Log Sheets................................................................................................................... 14 - 21

CALIBRATION VERIFICATION............................................................................... 15 - 1 Calibration Verification for Blood Gas/Electrolyte/Metabolite Cartridge............................................... 15 - 1 i-STAT Calibration Verification Set........................................................................................................ 15 - 2 i-STAT CHEM8+ Calibration Verification Level 1b................................................................................ 15 - 3 Calibration Verification for Blood Gas/Electrolyte/Metabolite Cartridges (i-STAT TriControls)............. 15 - 5 Verification Procedure for Hematocrit................................................................................................... 15 - 7 Verification Procedure for ACT.............................................................................................................. 15 - 8 Calibration Verification for i-STAT cTnI, BNP and CK-MB Cartridges.................................................. 15 - 9 Procedure for Cartridges...................................................................................................................... 15 - 10 Troubleshooting Cartridge Tests........................................................................................................... 15 - 10

PROFICIENCY or EXTERNAL QUALITY CONTROL TESTING............................ 16 - 1 Overview............................................................................................................................................... 16 - 1 General Procedure for Testing.............................................................................................................. 16 - 1 Reporting Results................................................................................................................................. 16 - 2 Troubleshooting and Proficiency Test Failures...................................................................................... 16 - 3

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

TECHNICAL BULLETIN: ANALYZER CODED MESSAGES iv

Art: 714362-01Z

Rev. Date: 16-OCT-19

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 - 12

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

Art: 714362-01Z

Rev. Date: 16-OCT-19

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 Total Beta-Human Chorionic Gonadotropin (ß-hCG) TECHNICAL BULLETIN: THE i-STAT TOTAL BETA-HUMAN CHORIONIC GONADOTROPIN (ß-hCG) CARTRIDGE

TECHNICAL BULLETINS

Art: 714362-01Z

Rev. Date: 16-OCT-19

INTRODUCTION

This Manual

This manual describes the i-STAT 1 Analyzer 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. The i-STAT System is for in vitro diagnostics use. Caution: Federal law restricts this device to sale by or on the order of a licensed practitioner.

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.

Art: 714363-01Y

Rev. Date: 25-AUG-19

1-1

Components

The i-STAT System consists of:  i-STAT Cartridges  i-STAT 1 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 Data Manager

 Central Data Station (data management software for cartridges)  Data Manager Printer  LIS/HIS Interface Software 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

1-2

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.

Art: 714363-01Y

Rev. Date: 25-AUG-19

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.

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.

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. Art: 714363-01Y

Rev. Date: 25-AUG-19

1-3

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.

Model number. The model number will appear adjacent to this symbol. Date of manufacture.

Manufacturer. In vitro diagnostic medical device. For prescription use only. Authorized Representative for Regulatory Affairs in the European Community. Compliance to the European directive on in vitro diagnostic devices (98/79/EC).

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. Signifies that the product bearing the ETL Listed mark complies with both U.S. and Canadian product safety standards: UL 61010-1: 2nd. Ed. CAN/CSA C22.2 No. 61010.1 2nd. Ed. 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).

1-4

Art: 714363-01Y

Rev. Date: 25-AUG-19

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).

BODYYYY-MM-DD

Born On Date: the label BODYYYY-MM-DD defines year, month and day 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 18-30 ºC.

2 months room temperature storage at 18-30 ºC.

Description:

14 days room temperature storage at 18-30°C

Document Owner:

Christopher Fetters 400 College Road East Princeton, NJ 08540

Description:

Document Owner: 01 Christopher Rev: Feb 2010 Fetters 400 College Road East Princeton, NJ 08540 (609) 454-9304 [email protected] Rev:

Packaging contains cartridges with barcoded pouches.

(609) 454-9304 2 months room temperature storage at 18-30°C [email protected]

01 Feb 2010

Symbol

SCAN ABC

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.

The following symbols are used on the i-STAT 1 keypad.

Key used to scan information into the analyzer. Key used to enter letters. Key used to enter information.

Key used to access the analyzer's menu. Key used to print a test record.

Key used to turn the analyzer off and on. Art: 714363-01Y

Rev. Date: 25-AUG-19

1-5

Symbol

DIS ENT PRT CLR

The following symbols are used on the i-STAT Portable Clinical Analyzer Keypad

Key used to activate the display. Key used to enter information. Key used to print a test record. Key used to clear an incorrect entry.

Symbol

The following symbols are used on i-STAT Value Assignment Sheets

Mean

Range

Symbol

Na K Cl Glu Lac Crea pH PCO2 PO2 iCa BUN/UREA Hct ACTc Celite ACT ACTk Kaolin ACT PT/INR Hb TCO2 HCO3 BE (b&ecf) 1-6

TEST Sodium Potassium Chloride Glucose Lactate Creatinine pH Partial pressure of carbon dioxide Partial pressure of oxygen Ionized Calcium Urea nitrogen/Urea Hematocrit Activated Clotting Time with Celite® activator

Activated Clotting Time with Kaolin activator Prothrombin Time / International Normalized Ratio Hemoglobin Total carbon dioxide concentration Bicarbonate Base excess (b for blood, ecf for extra cellular fluid)

Art: 714363-01Y

Rev. Date: 25-AUG-19

Symbol

AnGap sO2 cTnI CK-MB BNP

Warranty

TEST Anion Gap Oxygen saturation Cardiac Troponin I Creatine Kinase MB Isoenzyme B-type Natriuretic Peptide

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.

Art: 714363-01Y

Rev. Date: 25-AUG-19

1-7

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i-STAT 1 ANALYZER

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

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.

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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 June 24, 2007. EN 60825-1:1994 + A1:2002 + A2:2001 IEC 60825-1:1993 + A1:1997 + A2:2001

Software

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.

Power

There are two power options for the analyzer: disposable and rechargeable. The analyzer is shipped with a batter carrier for use with two disposable 9-volt lithium batteries. 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.

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.

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Disposable Batteries The analyzer requires two 9-volt lithium batteries. The lifetime for a set of batteries is mainly dependent on the mix of cartridges in use. Cartridges that require thermal control consume more energy because of heating. Coagulation and immunoassay cartridges consume more energy because of the longer test cycle. A minimum of 400 thermally controlled cartridge uses, about 100 coagulation cartridges, or 50 immunoassay cartridges can be expected before replacement is necessary. Backlighting, if used continuously, may reduce battery life up to 50%. Extensive laser scanning will affect battery life slightly. The lithium batteries should be removed from the analyzer when long periods, such as six months, of no use are anticipated. Rechargeable Battery

The analyzer can be powered by a nickel-metal-hydride rechargeable battery. The battery capacity for one full charge is 30% (minimum) of the capacity of one set of disposable lithium batteries (see above). If the analyzer is not in use, batteries will lose approximately 10-30% of their charge over 30 days if not recharged. Store rechargeable batteries in a cool dry place when not in use. The battery recharges when the analyzer is placed in a Downloader/Recharger. The battery pack can be removed from the analyzer and placed in the separate recharging compartment on the Downloader/Recharger. Full recharge from a discharged state takes approximately 40 hours. The analyzer will display “Low Battery” when battery recharge is needed. Caution:

Low Battery Warning

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Do not short circuit, incinerate or mutilate the recharegable batteries.

The analyzer will display “Low Battery” when the On/Off key is pressed. Additionally, a flashing battery icon will display on the results screens, as well as the Test Menu and Administration Menu screens when battery replacement is needed. Data is not lost when batteries are fully discharged.

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Additional Power

A lithium battery inside the analyzer maintains the clock/calendar and customization profile. This battery should last seven years.

Cartridge Port

Cartridges and the Electronic Simulator are inserted into the analyzer through the cartridge port on the keypad end of the analyzer. Unless the analyzer is customized to require information input before a test, inserting a cartridge or Electronic Simulator initiates the test cycle (i.e., the analyzer does not need to be turned on first).

i-STAT Cartridge Port

Infrared Communication Window

Battery Compartment

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Laser Barcode Scanner Window

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Infrared Communication Window

The Infrared Communication Window provides the analyzer with two-way communication to the Central Data Station via a Downloader, allows analyzerto-analyzer software updates, and allows analyzer-to-printer communication for printing.

Thermal Control

The analyzer contains a thermal control subsystem of thermistors and heating contact wires that controls the temperature of the sensors and fluids that come into contact with the sensors to 37°C. This subsystem is activated automatically when a cartridge containing tests which require thermal control at 37°C is inserted into the analyzer.

Barometric Pressure The analyzer contains a solid-state barometric pressure sensor, which determines Sensor the ambient atmospheric pressure used for the PO2 sensor calibration. Cartridge Test Cycle

An operator starts a cartridge test cycle either by inserting a cartridge into the analyzer or by selecting the i-STAT Cartridge option from the Test or Quality Tests Menu. The analyzer:

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makes electrical contact with the cartridge

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identifies the cartridge type

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releases calibration fluid to the sensors (when applicable)

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mixes sample and reagent (when applicable)

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measures barometric pressure

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heats the sensors to 37°C (when required by the test )

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measures electrical signals generated by the sensors and calibration fluid (when applicable)

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displaces the calibrant solution with sample (when applicable)

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measures electrical signals generated by the sensors and sample

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accepts the operator and patient IDs scanned or entered by the operator

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accepts chart page information

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calculates and displays results

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stores results

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Data Entry

Data that can be scanned into the analyzer or entered via the keypad include: 

Operator ID



Patient ID, Proficiency ID, or Simulator ID



Cartridge Lot Number



Control Lot Number



Cal Ver Kit Lot Number



Comment codes for patient and control results



Chart Page 

Sample Type



Patient Temperature - The analyzer will interpret numbers between 50.0 and 110.0 as degrees Fahrenheit and between 10.0 and 45.0 as degrees centigrade. When a patient temperature is entered, blood gas results will be displayed at both 37°C and the patient's temperature.



FIO2



Free Fields: three fields, up to 9 characters each

See the Customization section in this manual for barcode formats recognized by the analyzer. Storage of Results

The analyzer automatically stores up to 1,000 test records. A test record consists of: 

a set of results



the date and time the test was performed



the cartridge type



all information entered by barcode scanner or keypad including: 

Operator and Patient IDs



Lot numbers for controls and cartridges



Chart page data



Serial number of the Electronic Simulator



the serial number of the analyzer

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the number of times the analyzer has been used



the software and CLEW versions installed in the analyzer



the name of the analyzer’s customization profile

Quality Check Codes, which may appear during the test cycle indicating a problem with the sample, calibration, sensors, mechanical or electrical functions of the analyzer, are also stored. The Analyzer Status option under the Administration Menu lists the number of stored records as “Total” and “Unsent” records. Test records are stored as “Unsent” until the analyzer uploads data to the Central Data Station at which time the records are marked as sent. The analyzer can be customized to display a Memory Full prompt or to disable testing until data is transmitted to the Central Data Station. Otherwise, the oldest data is overwritten when the memory becomes full. Stored test records can be reviewed through the Data Review option on the Administration Menu screen described later in this section. 2-6

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LCD Display and Backlight

Test results, operator prompts and other messages are displayed on the analyzer’s LCD Screen. The backlight for the display is turned on and off by pressing the 0 key for one second. The backlight will automatically turn off after ninety seconds and when the analyzer powers down or is turned off. The backlight cannot be turned on while data entry screens are displayed.

Audible Indicator

The analyzer will beep to indicate: 

whenever a key is pressed.



a successful barcode entry.



results are ready.



a Quality Check Message is displayed.

The analyzer can be customized to disable beeping when a key is pressed or results or messages are displayed.

Time Out

The analyzer automatically turns off after a certain period of inactivity. 

Results displayed: Results are displayed for 2 minutes before the analyzer turns off provided that a mandatory Comment Code prompt is not displayed. This Inactivity Time Out default time can be increased using Customization. If a mandatory Comment Code prompt is displayed, the analyzer will turn off after 15 minutes or after the Inactivity Time Out, whichever is greater. In the case of a missed required Comment Code, results will be stored and “_ _ _” will be entered as the Comment Code.



Prompting for mandatory data when results are ready for display: The analyzer will turn off after 15 minutes or after the Inactivity Time Out, whichever is greater, if there is no response to a mandatory data prompt. A mandatory data prompt is a prompt for information that must be entered before pending results are displayed. In the case of a missed mandatory data prompt, results will not be stored and the test record will state “Test Cancelled by Operator.”

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Waiting for insertion of cartridge: After the prompt “Insert Cartridge” is displayed, the analyzer will wait 15 minutes for the operator to insert a cartridge unless the analyzer is in the Proficiency path, in which case the analyzer will wait 5 minutes. If a cartridge is not inserted, the analyzer will turn off. This timeout cannot be customized.



Other: The analyzer will turn off after 2 minutes of inactivity (no keys pressed) in all other circumstances.

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Keypad

There are 19 keys located directly below the display. When using the keypad to enter information, the number of dashes in the data entry line will indicate how many characters can be entered on the line. The dash where the next entry will be placed will flash. Key

Function

SCAN

Activates the barcode scanner. Information that can be entered into the analyzer via the scanner includes: operator ID, patient ID, control and cartridge lot number, patient chart data and comment codes. Used to move the cursor on the Set Clock screen and to move up and down the alphabet when the ABC key is pressed. The  (right arrow) key is used as a page key to move from one screen to the next. When Patient ID Recall is enabled, the  key will recall the last patient ID when the analyzer is prompting for Patient ID. The  (left arrow) key is used to backspace and clear keypad entries, and to move backward through the screens within a menu.

ABC

Used to enter alpha characters on data entry screens. When the ABC key is pressed the letter A is entered. The arrow keys are used to move up and down the alphabet. To enter a second letter, press the ABC key once to move to the next position and again to enter an A. To enter a number after a letter, press a numbered key. To erase a letter, press the ABC key to move to the next position, then use the  key to backspace and clear the letter.

0–9

Used to enter digits on data entry screens and to select menu options and stored records.

•

Enters a decimal point or a comma separator according to the analyzer’s Customization Profile. Used to turn the screen backlight on and off.

Enter

MENU Print

On/Off

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Used to respond to a prompt to complete an action, such as entering an operator or patient ID via the keypad. Used to return to the previous menu and switch between the Test and Administration Menus. Used to print either directly to the portable printer or to the portable printer attached to a Downloader. Turns the analyzer on or off. When the analyzer is on, the On/Off key must be pressed for a second to turn the analyzer off. This key is inactive when a test is in progress and when the analyzer is prompting for mandatory data.

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i-STAT 1 Menu Tree

There are two main menus: The Test Menu and the Administration Menu. . Test Menu 1- Last Result

Administration Menu 1. Analyzer Status

Temp Pressure Battery Uses Serial CLEW Version Custom Stored Records Total Unsent

2- Data Review

1-Patient 2-Control 3-Proficiency 4-Cal Ver 5- Simulator 6- All 7- List

3-Quality Tests

1-Control 2- Proficiency 3- Cal Ver 4- Simulator

4- Customization

1-View

1- Analyzer 2- ID Entry 3- Patient Tests 4- QC Tests 5- Results

2-Change

1- Analyzer 2- ID Entry 3- Patient Tests 4- QC Tests 5- Results 6- Password 7- Restore Factory Settings

2- i-STAT Cartridge

5- Set Clock

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6- Transmit Data

1- Most Recent 2- This Month 3- Last Month 4- All 5- Unsent

7-Utility

1- Send Software 2- Clear Memory 3- Receive Software

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TEST MENU The Test Menu is displayed when the analyzer is turned on using the On/Off key. The options are: 1 - Last Result 2 - i-STAT Cartridge Option 2 is used for testing patient samples. Note:

If the handheld is customized to disable testing under certain conditions, the disabled option will be listed without its number so that it cannot be selected.

ADMINISTRATION MENU Overview

The Administration Menu is accessed by pressing the Menu key from the Test Menu screen. The options are: 1 - Analyzer Status 2 - Data Review 3 - Quality Tests 4 - Customization 5 - Set Clock 6 - Transmit Data 7 - Utility

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Analyzer Status

Data Review

The Analyzer Status screen contains information about the condition or “status” of the analyzer. Fresh readings are made whenever this option is selected. Temp

Room temperature.

Pressure

Barometric pressure.

Battery

Battery voltage.

Uses

Total number of cartridge and simulator test cycles, whether or not results reported.

Serial

Serial number of the analyzer.

CLEW

Version of standardization data installed in the analyzer.

Version

Version of application software installed in the analyzer.

Custom

Customization profile name.

Stored Records

Total: The number of test records in the analyzer’s memory. The maximum storage capacity is 1,000 test records, which include records with results and Quality Check Codes for patients and controls both liquid and electronic. Unsent: The number of test records that have not been transmitted to the Central Data Station.

The Data Review function allows the operator to review stored results by the categories listed below. The number of test records stored is indicated at the bottom center of the screen as x/y where x is the record on the screen and y is the total number of stored records in the selected category. The 1 and 2 keys are used to scroll through the stored records as indicated on the bottom right and left of the screen. The most recent test record is always in the first position. The right arrow key is used to page through the screens of the displayed record. 1 - Patient

The records for a patient are recalled by scanning or entering via the keypad the Patient ID. If no Patient ID is entered, all patient tests are recalled.

2 - Control

3 - Proficiency

4 - Cal Ver

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5 - Simulator

All external and internal Electronic Simulator records.

6 - All

All test records in the analyzer’s memory.

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7 - List

Records are listed with Cartridge type, date and time of test, patient ID, control lot, proficiency ID, or Cal Ver lot and test level as applicable. Any number of test records can be selected for viewing or printing using the number keys. Pressing the number key corresponding to a record selects a record; pressing the number key a second time deselects the record. To view one or more records, select the records and press the Enter key. To print records, select the records and press the Print key.

Quality Tests

Non patient tests can be initiated from the Quality Tests menu. Options are: 1 - Control 2 - Proficiency (external quality control) 3 - Cal Ver

(Calibration Verification for cartridges)

4 - Simulator

(cartridge-reading function only)

When testing is initiated from one of these options, the handheld prompts the operator to scan or enter the Operator ID; the Control Lot Number, Proficiency ID, Cal Ver Kit Lot Number, or Simulator ID as applicable; and the Cartridge Lot Number. When the Quality Tests option is used, results can be reviewed according to the corresponding options under the Data Review option.

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Customization

Analyzers can be customized for site-specific testing characteristics and requirements. A complete list of customizable parameters and their default values can be found in the Customization section. An analyzer can be customized via the keypad or via the Central Data Station. Items that cannot be customized via the analyzer’s keypad are operator lists, test strip lists, reference and action ranges, sample types and order of items on the Chart page. The Central Data Station’s Customization function can be used to create one customization profile for all analyzers or different profiles for different locations. When the Customization function is enabled, the profiles are transmitted to the analyzers when they are placed in a Downloader. Caution: If location specific customization profiles are created, analyzers should not be moved from one location to another unless they are re-customized for the new location. This is especially important if “CPB: Automatically Adjust” or “CPB: Do Not Adjust” is included in a location-based customization profile. The CPB function adjusts hematocrit and hemoglobin results for the dilutional affect of pump fluid during cardiopulmonary bypass surgery. If an analyzer customized for the CVOR as “CPB: Automatically Adjust” is used for patients who are not on the pump, hematocrit results will be reported falsely high. If an analyzer customized as “CPB: Do Not Adjust” is used for patients who are on the pump, hematocrit results will be reported falsely low. For details on the CPB function, see the Theory section of this manual. It is recommended that only one method, the Central Data Station or the keypad, be used to customize all analyzers within a site. If both methods are in use, and the Customization function is not disabled on the Central Data Station, any changes made to the profile of an analyzer via the keypad will be overwritten the next time the analyzer is placed in a Downloader. The customization profile of an analyzer is identified in the Customization option under the Administration Menu on the analyzer. DEFAULT0 indicates that the analyzer has factory settings. When an analyzer has been customized via the Central Data Station (CDS), the name assigned to the profile by the CDS is listed. If the default or CDS profile is changed on the analyzer, the profile is listed as 00000000.

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Viewing the Customization Profile

Select 4- Customization from the Administration Menu, select 1- View then select from the Customization Menu: 1 - Analyzer 2 - ID Entry 3 - Patient Tests 4 - QC Tests 5 - Results Select a category to review. Use the ← and → keys to scroll through the preferences for each category and use the ← key to return to the Customization menu. The Customization review option on the analyzer does not display the certified operator list or the valid test strip lot list. These items can be viewed on the Central Data Station. Note: 

Outside the USA, the following changes should be considered: language, unit set, date format and decimal separator. 1 - Analyzer First page Date Format Sound Auto-transmit Memory Full Batch Mode Timeout Second page Inactivity Timeout Upload Schedule Clock Password Sync Clock Patient Record Limit Access Third page Wireless (only available with the i-STAT wireless analyzer) 2 - ID Entry 1 – Operator ID First page Minimum Length Maximum Length Repeat ID Manual Entry Code I2of5 Second page Code 128 EAN-8, EAN-13 Codabar Code 93 Code 39

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Third page Code 39 Check Digit Truncate First Truncate Last Operator List Not Certified Action Not In List Action Fourth page Warn User Print ID 2 – Patient ID First page Minimum Length Maximum Length Repeat ID ID Recall Manual Entry Second page Code I2of5 Code 128 EAN-8, EAN-13 Codabar Code 93 Third page Code 39 Code 39 Check Digit Truncate First Truncate Last Patient List Not in List Action Fourth page Lockout Override Confirmation Method Print ID 3 - Patient Tests First page Cartridge Auto-chart Cartridge Information Cartridge Barcode Cartridge Lot Number Comment Code In Range Second page Comment Code Out of Range Cart Sample Type Result Output Downloader Lockout STATNotes

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4 - QC Tests 1 – Simulator Ext Simulator Int Simulator Int Simulator Schedule Option 2 – Cartridge QC First page Pass/Fail Method Comment Code In Range Comment Code Out of Range Result Format APOC fluid Lot Scan Only Second page eVAS Name 5 - Results 1 – ACT/Ref Ranges 2 – Display Ranges 3 – Units

4 – Options First page Decimal Separator Test Selection Hematocrit Base Excess ACT-C Second page ACT-K Print Ref. Ranges

Changing the Profile

To customize via the handheld keypad, select 4- Customization from the Administration Menu, then select 2- Change. If the handheld has already been customized with a password, enter the password. If not, press the Enter key. (It is recommended that the Change function be password protected). Then make selections from the Customization menu. To change a setting, select the item by pressing the number key correponding to the item, then select the setting. Use the → key to view all items. After all items have been set, turn the handheld off to save and activate the settings. Note: 

Outside the USA, the following changes should be considered: language, unit set, date format and decimal separator. 1 - Analyzer First page Language Date Format Sound Auto-transmit Memory Full Second page Batch Mode Timeout Inactivity Timeout Upload Schedule Clock Password Sync Clock Third page Wireless (available with the i-STAT 1 wireless)

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2 - ID Entry 1 – Operator ID First page Minimum Length Maximum Length Repeat ID Manual Entry Code I2of5 Second page Code 128 EAN-8, EAN-13 Codabar Code 93 Code 39 Third page Code 39, Check Digit Truncate First Truncate Last Print ID 2 – Patient ID First page Minimum Length Maximum Length Repeat ID ID Recall Manual Entry Second page Code I2of5 Code 128 EAN-8, EAN-13 Codabar Code 93 Third page Code 39 Code 39 Check Digit Truncate First Truncate Last 3 - Patient Tests First page Cartridge Auto-chart Cartridge Information (functionality preset by analyzer firmware) Cartridge Barcode (functionality preset by analyzer firmware) Cartridge Lot Number (functionality preset by analyzer firmware) Comment Code, In Range Second page Comment Code, Out of Range Result Output Downloader Lockout 4 - QC Tests 1 – Simulator Ext Simulator Int Simulator Int Simulator Schedule Option Art: 714364-01R

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2 – Cartridge QC Pass/Fail Method Comment Code In Range Comment Code Out of Range Result Format APOC Fluid Lot Scan Only 5 - Results 1 – Units and Ranges 2 – Options First page Decimal Separator Test Selection Hematocrit Base Excess ACT-C Second page ACT-K Print Ref. Ranges 6 - Password 7 - Restore Factory Settings

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Set Clock

If the analyzer is customized with a password, the Set Clock function will be password protected. If a password has not been assigned, pressing the Enter key will display the time and date screen. Use the arrow keys to move the cursor to the digit to be changed. Use a number key to change the digit. Press Enter to accept the changes or Menu to cancel the changes. An invalid entry, such as 13 for a month, will not be accepted. The format of the date on this screen can be customized using the Central Data Station Customization function, as mm/dd/yy or dd/mm/yy. The analyzer recognizes years in which February has 29 days. The analyzer can be customized using the Central Data Station to synchronize or update the real time clock to the Central Data Station's clock at the time of each download. This option eliminates the need to reset the analyzer's clock at the beginning and end of Daylight Saving Time. Otherwise, the clock must be manually changed for Daylight Savings Time changes.

Transmit Data

Unsent test records are automatically transmitted to the Central Data Station when an analyzer is placed in a Downloader or Downloader/Recharger. In some cases it may be desirable to have the capability to retransmit data. The Transmit Data function allows transmission of data in the following manner: 1 – Most Recent 2 – This Month 3 – Last Month 4 – All 5 – Unsent Most Recent is the result from the last cartridge tested. The analyzer can be customized using the Central Data Station to apply a date range limit to the Transmit All functions. Auto-transmit is temporarily disabled when the Transmit Data option is selected to allow the user to control transmission of data.

Utility

The Utility menu can be password protected using the Customization function on the analyzer or Central Data Station. 1 – Send Software: Allows the analyzer to transmit software to another analyzer. See the Software Update section of this manual. 2 – Clear Memory: Erases results from the analyzer’s memory. Options are: 1 – Previous to 01MMMYY (where MMMYY is current month and year, such as 01JUN00) 2 – Previous to 01mmmyy (where mmmyy is previous month and year, such as 01May00) 3 – All 4 – Cancel 3 – Receive Software: Allows users to remotely request a JAMS and CLEW update for the analyzer from the CDS. See section 18 (Updating Software) for full details.

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LASER BARCODE SCANNER Laser Barcode Scanner

The barcode scanner is used to scan barcode information into the analyzer. Parameters that can be entered into the analyzer via the scanner include: operator and patient IDs, control and cartridge lot numbers, comment codes and patient chart data. The laser beam emerges from the recessed window on the front of the analyzer adjacent to the battery compartment. The laser beam automatically turns off after 3-4 seconds or after the barcode is successfully scanned.

Laser Specifications

The barcode scan engine is manufactured by Motorola Inc. or Opticon Inc. The scan engine contains a laser diode that emits laser radiation at a frequency of 650 nm. The scan engine outputs power (i.e., the power output of the engine if removed from this product) up to 1.9 mW in scanning mode. The scanner in this product only operates when the Scan key is pressed. The scan engine is intended to be used in a Class 2 device.

Warning Labels

Warning labels are shown below. The warning labels are located on the back or under-side of the analyzer, as shown. The location of the laser window from where the analyzer emits the laser beam is also shown below. Laser Barcode Scanner Window

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Caution

Do not open the analyzer. The analyzer may only be opened by factory authorized service personnel. Class 2 laser radiation when open; DO NOT stare into the laser aperture or the laser beam, or point the laser beam at other persons. Use of controls, adjustments or performance of procedures other than those specified herein may result in hazardous laser radiation exposure. Class 2 laser scanners use a low power, visible light diode. As with any bright light source, such as the sun, the user should avoid staring directly into the laser beam. Momentary exposure to a Class 2 laser is not known to be harmful.

Barcode Label Quality

To ensure that printed barcode labels are reliably read by i-STAT handhelds, the best available printing methods and settings should be used. However, as specified in the Health Industry Bar Code (HIBC) Provider Applications Standard (ANSI/HIBC 1.3-2010), the quality of printed labels should meet the minimum grade level of 1.5.

Ambient Lighting from LED Light Sources

The analyzer’s barcode scanning functionality may experience interference when scanning barcodes under ambient light from an LED light source. This interference results in the analyzer being unable to scan a barcode at all (no beep acknowledgement). When scanning barcodes under ambient light from an LED light source, it is recommended that the barcode be shielded from the ambient light when attempting to scan the barcode.

Procedure

Before scanning, check to see what information is required by the displayed prompt. Hold the analyzer 3-9 inches (8 – 23 cm) from the barcode to be scanned. An angle of about 10 degrees from perpendicular is best. Hold the analyzer and place the object to be scanned on a flat surface or, place the analyzer on a flat surface and hold the object in front of the analyzer. Avoid accidentally scanning other nearby items. Avoid pointing the beam into anyone’s eyes. STEP

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ACTION

Press and hold down the Scan key to start the barcode scanner. The analyzer emits a visible red beam.

Position the analyzer and barcode so the beam forms a red line that spans the entire barcode. Increasing distance between the barcode and analyzer lengthens the red line. The analyzer does not need to touch the barcode.

When the analyzer accepts the barcode, it will beep in acknowledgement and automatically turn off the beam. The beam will also turn off after 3-4 seconds.

View the data that was scanned by the analyzer and verify that it is correct.

Release the Scan key.

Note:

If the Scan key is released as soon as the beep is heard, the next prompt will be displayed and the information scanned will not be able to be viewed.

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PROMPTS AND MESSAGES Prompts

Either before or during the testing cycle, the analyzer will display prompts that require an operator action or keypad entry, such as “Enter Operator ID.” Prompts are described in the manual when used. Some prompts require input before results are displayed. Prompts for the following information are mandatory: 

Operator ID



Patient ID



Lot Numbers for Quality Tests



Cartridge Lot Number

Startup Messages

When the On/Off key is pressed the analyzer may display one or more startup messages. A startup warning message indicates an action that should be taken in the near future to maintain the analyzer in working condition. If the analyzer is customized to disable testing under certain conditions, a startup lockout message indicates the action that must be taken before testing is re-enabled.

Quality Check Messages

If the analyzer detects a problem during power on, a Quality Check message will be displayed indicating the action that must be taken before testing can begin. A Quality Check message will also be displayed and testing halted if the analyzer detects a problem during the test cycle. Startup messages and Quality Check messages are described in the Troubleshooting section of this manual. “Upload Required, Testing Disabled” is an example of a startup lockout message, “Battery Low ” is an example of a startup warning message, and “Unable to Position Sample” is an example of a quality check failure during the testing cycle. Note:

2-22

The “Cartridge Locked” or “Simulator Locked” prompt is always displayed when a cartridge or Electronic Simulator is inserted into the analyzer. Any attempt to remove a cartridge or Electronic Simulator before this prompt is removed from the screen may cause damage to the analyzer.

Art: 714364-01R

Rev. Date: 29-MAR-19

i-STAT CARTRIDGE

Contents

EG7+

The unit-use disposable cartridge contains many of the subassemblies typically found in complex laboratory systems. Microfabricated thin film electrodes or sensors are assembled in unit-use cartridges containing:

•

calibrant solution in cartridges with sensors for blood gases, electrolytes, chemistries and hematocrit

• • • • • • •

analysis solution in immunoassay cartridges reagents in cartridges with sensors for coagulation sample handling system waste chamber an array of miniaturized sensors conductive pads to make electrical contact with the analyzer heating elements in cartridges requiring thermal control at 37 °C

See the Cartridge and Test Information Sheets for test-specific details. The following diagram shows how a typical blood gas/chemistry cartridge is constructed.

Rev. Date: 11-Mar-14

Art: 714365-01G

3-1

Sample Handling System

Sensors

Part

Function

Sensor Channel

The sensor channel directs the sample from the sample chamber to the sensors. An extension of this channel becomes a waste chamber to receive the calibrant solution, if applicable, as it is displaced by the sample.

Air Chamber

An air chamber is located in blood gas/electrolyte/ chemistry/hematocrit cartridges between the sample chamber and sensor channel. This creates an air segment between the calibrant solution, if applicable, and the sample to prevent the two from mixing. The size of the air segment is monitored by the analyzer.

Sample Chamber

The sample chamber includes the sample well and the channel leading from the well up to the fill mark. When filled, the sample chamber contains sufficient sample for testing. Sample volume and placement are monitored by the analyzer.

Bladder

The bladder (concealed by the label) is connected to the sample well. The analyzer presses on the bladder to displace calibrant solution, if applicable, from the sensors to move the sample from the sample chamber to the sensors or to mix sample and reagents.

Snap Closure (if applicable)

The snap closure creates an airtight seal necessary for proper fluid movement within the cartridge. The closure also ensures that calibrant, if applicable, and sample remain contained within the cartridge during the testing cycle and subsequent disposal. Immunoassay cartridges, such as cTnI, use a plastic slide enclosure clip.

Air Vent

An air vent on the underside of the cartridge, beyond the fluid front, allows the calibrant and the sample to flow forward, but not out of the cartridge.

Waste Chamber

A waste chamber (beneath the cartridge label) holds calibrant fluid after it has been used.

Contact Pads

EG7+

Sample Well

3-2

Sensors

The sensors are electrodes microfabricated on silicon chips. Electrodes have chemically sensitive coatings such as ion-selective membranes and enzyme layers. In cartridges that perform coagulation tests, reagents, such as clot activators, are coated on the plastic above the sensors. Each sensor is connected to a contact pad by a signal line. The sensors respond to the calibrant solution, if applicable, and the sample by producing measurable signals related to analyte concentration. The performance characteristics for each sensor are described in the Cartridge and Test Information section. The section on theory describes the measurement principles.

Contact Pads

The contact pads conduct the signals generated by the sensors to the analyzer. In order to function properly, care must be exercised not to contaminate the contact pads during cartridge handling.

Heating Elements

All i-STAT cartridges require thermal control at 37 °C, and include heating elements on the underside of the sensor chips which are contacted and heated by the handheld’s thermal probes.

Art: 714365-01G

Rev. Date: 11-Mar-14

Standardization and Calibration

Standardization is the process by which a manufacturer establishes “true” values for representative samples. The sensors in the i-STAT cartridges are standardized against plasma methods used by major laboratory systems or, for blood gases, against tonometry. A multi-point calibration curve, the slope or sensitivity of which is defined by coefficients in the CLEW software, is derived for each sensor by this standardization process. These calibration curves are stable over many lots and only need to be adjusted if a change in a manufacturing process affects the curve or if the relationship between results on the i-STAT System and other major laboratory systems drifts. For the convenience of users, CLEW updates are scheduled two times a year. A one-point calibration is performed each time a cartridge requiring calibration is used. During the first part of the testing cycle, the calibrant solution is automatically released from its foil pack and is positioned over the sensors. The signals produced by the sensors’ responses to the calibrant solution are measured. This one-point calibration adjusts the offset of the stored calibration curve. Next, the analyzer automatically moves the sample over the sensors and the signals produced by the sensors’ responses to the sample are measured. While coefficients are used rather than graphic calibration curves, the calculation of the result is equivalent to reading the sample’s concentration from adjusted calibration curve.

Packaging

Each cartridge is sealed in a foil pouch or clear plastic portion pack for protection during storage. Labeling on the carton, box and pouch/portion pack identify:

• • • •

the panel name. the tests included in the panel. the lot number. the expiration date of the cartridge.

If the pouch/portion pack has been punctured, the cartridge should not be used. Room Temperature Storage

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30ºC 86ºF

days

tage jours giorni días dias dagen dage dagar päivää dager ŤŚŬŢŭ gün

Na K Cl Glu pH PCO2 BUN/Urea Hct

HCO3 TCO2 BE AnGap Hb

18ºC 64ºF

8ºC 46ºF

Art: 714365-01G

30ºC 86ºF 18ºC 64ºF

2ºC 35ºF

Abbott Point of Care Inc. Abbott Park, IL 60064, USA Product of Canada

Rev. Date: 11-Mar-14

EC8 +

3-3

The main supply of cartridges should be stored at 2-8°C (35-46°F). Cartridges must be at room temperature before removing them from their pouches. Allow 5 minutes for an individual cartridge and one hour for a box of cartridges to come to room temperature. Cartridges in use may be stored at room temperature (18-30°C or 64-86°F) for the time frame indicated on the cartridge box. The cartridge box and pouch contain a line used to indicate the room temperature expiration date. Disposal Although the sample is contained in the cartridge, cartridges should be disposed of as biohazardous waste, according to local, state, and national regulatory guidelines. Storage Conditions

3-4

Art: 714365-01G

Rev. Date: 11-Mar-14

PRECISION PCx and PCx™ Plus BLOOD GLUCOSE TEST STRIPS

Upon installation of the April 2012 Software Update, the Glucose Test Strip Port functionality will be permanently disabled on all i-STAT 1 Handhelds.

Note: The remaining technical information regarding the Glucose Strip Port will be removed from the i-STAT 1 System Manual by April, 2013. Please contact your Support Services representative for information on transitioning to an Abbott Diabetes Care blood glucose monitoring system.

Art: 714366-01C

Rev. Date: 31-Jan-12

Art: 714366-01C

Rev. Date: 31-Jan-12

ELECTRONIC SIMULATOR

Overview

The Electronic Simulator, external and internal, is a quality control device for the analyzer’s cartridge signal-reading function. It simulates two levels of electrical signals that stress the analyzer’s cartridge signal detection function both below and above measurement ranges. While the analyzer performs internal electronic checks and calibration during each test cycle, the Electronic Simulator test provides an independent check on the ability of the analyzer to take accurate and sensitive measurements of voltage, current and resistance from the cartridge. An analyzer will pass or fail this electronic test depending on whether or not it measures these signals within limits specified in the analyzer software. The schedule for the Electronic Simulator can be customized to meet local, state, or national accreditation requirements. A reminder message for the operator to run the external simulator can be set by the number of hours or tests on the i-STAT 1 Analyzer. The schedule for the automatic internal Electronic Simulator can be set by the number of hours or tests on the i-STAT 1 Analyzer. For details and lockout options, see the Customization section of this manual.

Relative Humidity

The Electronic Simulator test will fail if high humidity interferes with the measurements. Therefore it is not necessary to record humidity where the analyzers are in use.

Internal Simulator

When the specified time has elapsed since the last Electronic Simulator test (internal or external), the internal test will automatically be performed when a cartridge is inserted before the sample is tested, adding about 20 seconds to the testing cycle.

External Simulator

The external Electronic Simulator is a stable electronic device, which is inserted into the cartridge port. The test cycle for the external Electronic Simulator is about 60 seconds. (The test cycle for the internal simulator is shorter because it shares the initial part of the test cycle with the cartridge.)

Art: 714367-01E

Rev. Date: 29-MAR-19

Operating Characteristics

Operating Characteristics Dimensions

Height 1.9 cm Width 7.0 cm Length 9.0 cm

Weight

85 g

Operating

Same as Analyzer

Temperature

being tested

Operating Ambient

0-90% RH

Humidity

non-condensing (as shipped)

Storage Temperature

-20-50˚C (-4-122˚F)

Even when the internal Electronic Simulator is enabled, an external Electronic Simulator is needed: •

to validate an internal simulator failure.

•

to reset the internal simulator schedule if a simulator test might interrupt testing, such as in a CVOR. Note: CVOR = Cardiovascular Operating Room

•

for on-demand testing at any time.

•

to perform the thermal probe check.

The external Electronic Simulator should be stored in the box in which it is shipped and the blue cap should be replaced after each use to protect the contact pads.

Stored Result

The results of the Simulator test are stored as a distinct record in the analyzer and can be transmitted to the Data Manager.

Use

Use of the Electronic Simulator is described further in the Quality Control section of this manual.

Cleaning the Simulator

Before cleaning, cover the connector area with the blue rubber boot. This will minimize the possibility of any cleaning fluid getting into the simulator housing, thus contaminating the internal circuitry. Clean the simulator with a gauze pad moistened with any of the cleaning agents approved for the analyzer, listed on page 17-1 of this manual. Rinse the simulator using another gauze pad moistened with water and dry. DO NOT IMMERSE THE SIMULATOR IN ANY FLUID, AT ANY TIME. If the connector itself is contaminated, the user should contact their Support Representative and arrange to have the simulator returned.

Art: 714367-01E

Rev. Date: 29-MAR-19

i-STAT 1 DOWNLOADER Function

The Downloader converts infrared transmissions of test records from the analyzer to electrical form and transmits (uploads) them to the Data Manager. The Downloader also converts electrical signals from the Central Data Station to infrared transmissions, which are transmitted (downloaded) to the analyzer. Transmission is automatic when an analyzer is placed in a Downloader. The Downloader comes in two formats:  Downloader: A low-profile table-top unit with “arms” between which the analyzer is placed, and  Downloader/Recharger (DR): a cradle that the analyzer is placed within. Both Downloader formats are available for use with direct wiring (serial format) or ethernet cabling (network format). Unless indicated otherwise, references to the Downloader apply to the Downloader/Recharger as well. The Downloader/Recharger can recharge a rechargeable battery in the analyzer. If the analyzer contains a rechargeable battery, the battery begins recharging automatically as soon as the analyzer is placed in the Downloader/Recharger. The Downloader/Recharger also has a compartment for recharging a rechargeable battery outside the analyzer.

Proximity Light

Power Light Proximity Light

Infrared Transceiver

Charging Light (battery in analyzer)

Infrared Transceiver

i-STAT 1 Downloader

Recharging Compartment

Gold Charging Contacts

External Battery Pack Charging Light

i-STAT 1 Downloader/Recharger

Art: 714368-01J

Rev. Date: 02-Aug-12

Specifications

Specification

Downloader

Downloader/Recharger

Size

5.25in (13.3cm) Wide 6.75in (17.2cm) Long 2.13in (5.4cm) High

4.12in (10.4cm) Wide 10.25in (26.cm) Long 5.00in (12.7cm) High

Weight

0.6 lbs (0.27kg)

1.2 lbs (0.55kg)

Power

AC-DC power adapter or PC/Downloader adapter. Input 12V

AC-DC power adapter or PC/Downloader adapter.* Input 12V

Operating

0 to 40˚C 32 to 104˚F

Storage Temperature

-20 to 50˚C -4 to 122˚F

Pollution Degree (Allowable ambient pollution level)

Installation Category (Allowable 2 overvoltage specification)

Communication To Central Data Serial (RS232), or Station and other equipment Ethernet

Serial (RS232), or Ethernet

Communication Link To and From Analyzer

Infrared Transceiver

Indicator LEDs Power Proximity Charge

Green Red NA

NA Blue Red/Green

Configuration

By host computer

Temperature

Power Supply

Specification

Downloader and Downloader/Recharger

Input

100 - 240V~ 47 - 63 Hz .9 - .5A

Output

12V 3A max

* Recharge feature cannot be used in this configuration. Running Cartridges in an Analyzer Docked in a Downloader/ Recharger

6-2

All i-STAT cartridges may be run in Handhelds that are docked in a Downloader/ Recharger.

Art: 714368-01J

Rev. Date: 02-Aug-12

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i-STAT System

i-STAT 1 System Manual Rev Date 23 April 2018