i-STAT 1 System Manual Rev Date 23 April 2018

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].

©2018 Abbott Point of Care Inc. All rights reserved. Printed in USA.

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

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

ii

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

v

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

vi

Art: 714362-01Z

Rev. Date: 16-OCT-19

INTRODUCTION

1

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.

MN

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

2

d

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:

m

BC

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

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.

SCAN

Key used to scan information into the analyzer.

ABC

Key used to enter letters. Key used to enter information.

MENU

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

Key used to turn the analyzer off and on. 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

R

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

2

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.

Art: 714364-01R

Rev. Date: 29-MAR-19

2-1

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.

2-2

Art: 714364-01R

Rev. Date: 29-MAR-19