Abbott i-Stat 1 User manual

i-STAT

System Manual

Rev. Date: 08/14/06 Art: 714336-01E

Patents

CA 1,281,072; CA 1,303,175; CA 1,330,888; CA 2,002,848; CA 2,087,720; CA 2,087,966; CA 2,175,228; CA 2,193,000; CA 2,194,795; CA 2,221,178; EP 0408575; EP 0412119; EP 0434742; EP 0442969; EP 0505169; EP 0540691; EP 0543916; JP 2113412; JP 2521826; JP 2833809; JP 2948321; JP 3093274; JP 3105919; JP 3105922; JP 3137612; JP 3269553; JP 3392871; US 4,864,229; US 4,933,048; US 4,954,087; US 5,008,616; US 5,096,669; US 5,112,455; US 5,121,050; US 5,124,661; US 5,200,051; US 5,447,440; US 5,466,575; US 5,514,253; US 5,554,339; US 5,605,664; US 5,609,824; US 5,614,416; US 5,628,961; US 5,789,253; US 5,821,399; US 5,837,446; US 6,030,827; US 6,379,883; US 6,438,498; US 6,750,053; US D332,833; US D337,164

Symbol Technologies Corporation is the owner of US Patent Nos. 4,758,717; 5,130,520; 5,262,628; 5,396,055; 5,532,469.

Trademarks

i-STAT is a registered trademark of Abbott Laboratories. MediSense is a registered trademark of Abbott Laboratories. Precision and PCx are trademarks of Abbott Laboratories. Windows is a registered trademark of Microsoft Corporation.

Abbott Point of Care Inc. 104 Windsor Center Drive East Windsor, NJ 08520 • USA

Tel: (609) 443-9300 Fax: (609) 443-9310

Art: 714336-01E Rev. Date: 08/14/06

Emergo Europe P.O. Box 18510

2502 EM The Hague

The Netherlands

Tel: (31)70 345 8570

Fax: (31)70 346 7299

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 April 2008, your i-STAT®1 System Manual should be configured with the contents as listed below and in the order shown.

ITEM Art #

Cover Sheet ..................................................................................... 714336-01E

Configuration Sheet .......................................................................... 714419-01Y

Table of Contents.............................................................................. 714362-01G

Section 1 ........................................................................................... 714363-01K

Section 2 ........................................................................................... 714364-01H

Section 3 ........................................................................................... 714365-01C

Section 4 ........................................................................................... 714366-01B

Section 5 ........................................................................................... 714367-01B

Section 6 ........................................................................................... 714368-01E

Section 7 ........................................................................................... 714369-01D

Section 8 ........................................................................................... 714370-01C

Section 9 ........................................................................................... 714371-01D

Section 10 ......................................................................................... 714372-01G

Section 11 ......................................................................................... 714373-01C

Section 12 ......................................................................................... 714374-01E

Section 13 ......................................................................................... 714375-01C

Section 14 ......................................................................................... 714376-01F

Section 15 ......................................................................................... 714377-01F

Section 16 ......................................................................................... 714378-01C

Section 17 ......................................................................................... 714379-01E

Section 18 ......................................................................................... 714380-01E

Section 19 ......................................................................................... 714381-01E

Section 20 ......................................................................................... 714382-01C

Section 21 ......................................................................................... 714383-01E

Section 22 ......................................................................................... 714384-01D

CTI Sheets

Introduction ....................................................................................... 714258-01K

Sodium.............................................................................................. 714173-01H

Potassium ......................................................................................... 714174-01F

Chloride............................................................................................. 714175-01G

Urea Nitrogen/BUN ........................................................................... 714176-01H

Glucose............................................................................................. 714177-01G

Hematocrit/Hemoglobin..................................................................... 714178-01G

Ionized Calcium................................................................................. 714179-01H

/ sO

.......................................................................................... 714180-01H

pH ..................................................................................................... 714181-01J

PCO

Total Carbon Dioxide/TCO2............................................................... 716661-01D

Creatinine.......................................................................................... 714183-01K

Lactate .............................................................................................. 714184-01F

Celite ACT......................................................................................... 714185-01E

Kaolin ACT........................................................................................ 715878-01D

Prothrombin Time PT/INR................................................................. 715236-01F

Cardiac Troponin I............................................................................. 715595-01F

Creatine Kinase MB / CK-MB............................................................ 716675-01B

B-Type Natriuretic Peptide/BNP........................................................ 716969-01A

/HCO3/BE/AG........................................................................... 714182-01M

Art.: 714419-01Y Rev. Date: 03/03/08

Technical Bulletins

Analyzer Coded Messages ............................................................... 714260-01G

Hematocrit Determination in the i-STAT System

and Comparison to Other Methods. .................................................. 714261-01C

Installation Guide for the Central Data Station to

Receive Data from a Philips Clinical Data Server ............................. 714270-01B

EDTA and K3EDTA Customization for

Hematocrit on the i-STAT System..................................................... 716240-01B

ACT Test Result Options: Prewarmed vs. Non-Prewarmed

Result Calibration Modes for the i-STAT 1 Analyzer ......................... 715617-01C

Support Services............................................................................... 716144-01G

Using i-STAT

Analyzer Customization Features to

Minimize ID Entry Errors. .................................................................. 720654-01A

April 2008 Update to the Central Data Station Version 5 .................. 721106-01A

Art.: 714419-01Y Rev. Date: 03/03/08

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 ....................................................................................................................

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 - 3

Power ...................................................................................................................................................2 - 3

Disposable Batteries ............................................................................................................................ 2 - 3

Rechargeable Battery .......................................................................................................................... 2 - 3

Low Battery Warning............................................................................................................................ 2 - 3

Cartridge Port ...................................................................................................................................... 2 - 4

Test Strip Port ...................................................................................................................................... 2 - 4

Infrared Communication Window ........................................................................................................ 2 - 5

Thermal Control ................................................................................................................................... 2 - 5

Barometric Pressure Sensor ................................................................................................................ 2 - 5

Cartridge Test Cycle ............................................................................................................................. 2 - 5

Strip Test Cycle .................................................................................................................................... 2 - 5

Data Entry ............................................................................................................................................2 - 6

Storage of Results ............................................................................................................................... 2 - 6

LCD Display and Backlight .................................................................................................................. 2 - 7

Audible Indicator .................................................................................................................................. 2 - 7

Time Out .............................................................................................................................................. 2 - 7

Keypad ................................................................................................................................................. 2 - 8

i-STAT 1 Menu Tree .............................................................................................................................. 2 - 9

Test Menu ............................................................................................................................................. 2 - 10

Administration Menu ............................................................................................................................2 - 10

Analyzer Status .................................................................................................................................... 2 - 11

Data Review ......................................................................................................................................... 2 - 11

Quality Tests ......................................................................................................................................... 2 - 12

Customization ..................................................................................................................................... 2 - 13

Set Clock ............................................................................................................................................. 2 - 17

Transmit Data ....................................................................................................................................... 2 - 17

Utility .................................................................................................................................................... 2 - 17

Laser Barcode Scanner ....................................................................................................................... 2 - 18

Prompts and Messages ....................................................................................................................... 2 - 19

1 - 2

Art: 714362-01G Rev. Date: 09/13/06 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

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

DATA MANAGEMENT ............................................................................................ 8 - 1

Introduction .......................................................................................................................................... 8 - 1

Components ........................................................................................................................................ 8 - 1

Data Manager ...................................................................................................................................... 8 - 2

i-STAT Central Data Station Version 5 Software .................................................................................. 8 - 2

Downloader and Downloader/Recharger ............................................................................................. 8 - 3

IR Link .................................................................................................................................................. 8 - 3

LIS/HIS Interface .................................................................................................................................. 8 - 3

Standard Data Management Conﬁguration ......................................................................................... 8 - 4

Connecting Components ..................................................................................................................... 8 - 4

CUSTOMIZATION .................................................................................................. 9 - 1

ii Art: 714362-01G Rev. Date: 09/13/06

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

Venipuncture - Glucose Test Strip ....................................................................................................... 10 - 4

Arterial Puncture - General .................................................................................................................. 10 - 4

Arterial Puncture - Blood Gas, Electrolyte, Chemistry, and Hematocrit Tests .................................... 10 - 4

Arterial Puncture - Coagulation Tests ................................................................................................. 10 - 6

Arterial Puncture - Glucose Test Strips ............................................................................................... 10 - 6

Indwelling Line ..................................................................................................................................... 10 - 6

Skin Puncture ....................................................................................................................................... 10 - 7

Sample Transfer Devices ..................................................................................................................... 10 - 7

References ........................................................................................................................................... 10 - 8

PROCEDURE FOR HANDLING CARTRIDGES .................................................... 11 - 1

Preparation for Testing ......................................................................................................................... 11 - 1

Filling and Sealing Cartridge Using Transfer Device ............................................................................ 11 - 2

Filling and Sealing PT/INR Cartridges Using Direct Fingerstick Sampling .......................................... 11 - 2

Filling and Closing a cTnI Cartridge Using Transfer Device ................................................................. 11 - 3

Inserting and Removing the Cartridge From the Analyzer ................................................................... 11 - 4

Incorrect Procedure ............................................................................................................................. 11 - 5

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

Cautions ............................................................................................................................................... 12 - 1

Performing Patient Analysis with Cartridge – Information First Disabled ............................................ 12 - 2

Performing Patient Analysis with Cartridge – Information First Enabled ............................................. 12 - 4

Interpretation of Displayed Results ..................................................................................................... 12 - 7

Troubleshooting ................................................................................................................................... 12 - 9

PROCEDURES FOR GLUCOSE TEST STRIP TESTING ..................................... 13 - 1

Operating Guidelines for All Samples .................................................................................................. 13 - 1

Performing Patient Glucose Assay with Test Strip .............................................................................. 13 - 2

Caution ................................................................................................................................................. 13 - 4

Interpretation of Displayed Results ...................................................................................................... 13 - 5

Troubleshooting ................................................................................................................................... 13 - 6

QUALITY CONTROL .............................................................................................. 14 - 1

Overview ............................................................................................................................................. 14 - 1

Quality Control for i-STAT Cartridges and the Analyzer’s Cartridge Test Cycle ................................... 14 - 1

Controls for Blood Gas/Electrolyte/Metabolite Cartridges (Except CHEM8+ Cartridges) ................... 14 - 3

Correction of PO2 at Extreme Altitude................................................................................................. 14 - 5

Controls for CHEM8+ Cartridges ......................................................................................................... 14 - 6

RNA® Medical Hematocrit Control ....................................................................................................... 14 - 8

Meter Trax™ Controls for Hematocrit Sensor...................................................................................... 14 - 9

Controls for ACT Cartridges ................................................................................................................ 14 - 9

Controls for PT/INR Cartridges ............................................................................................................ 14 - 10

Controls for cTnI Cartridges................................................................................................................. 14 - 12

Cliniqa Liquid QC™ Cardiac Marker Controls for i-STAT .................................................................... 14 - 13

i-STAT BNP Controls ............................................................................................................................ 14 - 14

Performing Electronic Simulator Test ................................................................................................... 14 - 15

Procedure for Internal Electronic Simulator ......................................................................................... 14 - 15

Procedure for External Electronic Simulator ........................................................................................ 14 - 15

Troubleshooting Failed Electronic Simulator Test ................................................................................ 14 - 16

Checking the Thermal Probes in the i-STAT Analyzers ........................................................................ 14 - 17

Art: 714362-01G Rev. Date: 09/13/06 iii

Procedure to Check Ambient Temperature .......................................................................................... 14 - 19

Performing Control Test on Cartridge .................................................................................................. 14 - 19

Troubleshooting Out-of-Range Control Results on Cartridge ............................................................. 14 - 21

Controls for Glucose Test Strip ............................................................................................................ 14 - 21

Recommendations for Glucose Test Strips ......................................................................................... 14 - 22

Performing Control Test with Glucose Strip ......................................................................................... 14 - 22

Troubleshooting Out-of-Range Results on Test Strips ........................................................................ 14 - 24

Quality Control Log Sheets .................................................................................................................. 14 - 25

CALIBRATION VERIFICATION .............................................................................. 15 - 1

Calibration Veriﬁcation for

Blood Gas/Electrolyte/Metabolite Cartridges (Except CHEM8+ Cartridges) ....................................... 15 - 1

i-STAT Calibration Veriﬁcation Set ....................................................................................................... 15 - 2

i-STAT CHEM8+ Calibration Veriﬁcation Set ........................................................................................ 15 - 3

i-STAT Cardiac Marker Calibration Veriﬁcation Set .............................................................................. 15 - 5

i-STAT BNP Calibration Veriﬁcation Set ............................................................................................... 15 - 6

RNA® Medical Hematocrit Calibration Veriﬁcation Controls ................................................................ 15 - 7

Veriﬁcation Procedure for Hematocrit .................................................................................................. 15 - 8

Veriﬁcation Procedure for ACT ............................................................................................................. 15 - 9

Procedure for Cartridges ..................................................................................................................... 15 - 10

Troubleshooting Cartridge Tests .......................................................................................................... 15 - 11

Linearity/Calibration Veriﬁcation Test for Test Strips ............................................................................ 15 - 12

Troubleshooting Strip Tests.................................................................................................................. 15 - 13

PROFICIENCY or EXTERNAL QUALITY CONTROL TESTING ........................... 16 - 1

Purpose ................................................................................................................................................ 16 - 1

General Procedure ............................................................................................................................... 16 - 1

Procedure For Cartridges .................................................................................................................... 16 - 1

Troubleshooting ................................................................................................................................... 16 - 3

Procedure for Test Strips ..................................................................................................................... 16 - 4

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

CLEW .................................................................................................................................................. 18 - 1

Application Software ............................................................................................................................ 18 - 1

Software Updates ................................................................................................................................ 18 - 1

Updating Analyzer Software: JAMMLITE Utility ................................................................................... 18 - 2

Troubleshooting ................................................................................................................................... 18 - 8

Analyzer-to-Analyzer Software Updates .............................................................................................. 18 - 9

Performing a JAMS and CLEW update on an i-STAT 1 Analyzer using

the Customization Workspace ............................................................................................................ 18 - 10

troubleShooting the analyzer

TROUBLESHOOTING THE ANALYZER ................................................................ 19 - 1

Introduction .......................................................................................................................................... 19 - 1

Information Needed ............................................................................................................................. 19 - 1

Startup Messages ................................................................................................................................ 19 - 2

iv Art: 714362-01G Rev. Date: 09/13/06

Test Cycle Messages and Quality Check Codes ................................................................................. 19 - 3

Glucose Strip Errors ............................................................................................................................. 19 - 6

No Display ............................................................................................................................................ 19 - 7

“Cartridge Locked” Not Removed ....................................................................................................... 19 - 7

theory

THEORY .................................................................................................................. 20 - 1

Analyzer Functions ............................................................................................................................... 20 - 1

Electrochemical Measurements ........................................................................................................... 20 - 3

Determination of Test Results .............................................................................................................. 20 - 4

Determination of Cell Concentration .................................................................................................... 20 - 5

CPB ...................................................................................................................................................... 20 - 5

Determination of Coagulation Endpoints ............................................................................................. 20 - 7

Quality Control and the i-STAT System ................................................................................................ 20 - 7

Quality Control and the i-STAT Coagulation Tests ............................................................................... 20 - 13

downloader programming

DOWNLOADER PROGRAMMING AND WIRING ................................................. 21 - 1

Programming the Network Downloaders ............................................................................................. 21 - 1

Wiring the Downloaders ....................................................................................................................... 21 - 6

Central data Station

CENTRAL DATA STATION ..................................................................................... 22 - 1

i-STAT License Agreement and Warranty for Central Data Station Program ....................................... 22 - 1

Installation Of The Central Data Station............................................................................................... 22 - 3

General Procedures and Conventions ................................................................................................. 22 - 5

Customization of the Central Data Station .......................................................................................... 22 - 9

Interface Program Customization ........................................................................................................ 22 - 15

Overview of the Central Data Station Program .................................................................................... 22 - 17

Administration Tools ............................................................................................................................. 22 - 19

Instrument and Location Workspace ................................................................................................... 22 - 19

Operator Workspace ............................................................................................................................ 22 - 25

Operator List Import ............................................................................................................................. 22 - 31

Database Maintenance ........................................................................................................................ 22 - 33

Inventory Workspace ........................................................................................................................... 22 - 37

Customization Workspace ................................................................................................................... 22 - 43

User Administration Workspace .......................................................................................................... 22 - 51

Password Management ....................................................................................................................... 22 - 53

Data Viewers ........................................................................................................................................ 22 - 55

Data Export .......................................................................................................................................... 22 - 62

Monitors ............................................................................................................................................... 22 - 63

Reports ................................................................................................................................................ 22 - 65

System ................................................................................................................................................. 22 - 68

Windows Operating System and Language Support .......................................................................... 22 - 69

Art: 714362-01G Rev. Date: 09/13/06 v

Cartridge and teSt information

Cartridge and Test Information

Sodium

Potassium

Chloride

BUN/Urea

Glucose

Hematocrit/Hemoglobin

Ionized Calcium

PCO

Total Carbon Dioxide/TCO

Creatinine

Lactate

Celite ACT

Kaolin ACT

Prothrombin Time PT/INR

Cardiac Troponin I

Creatine Kinase MB/CK-MB

B-Type Natriuretic Peptide/BNP

teChniCal bulletinS

vi Art: 714362-01G Rev. Date: 09/13/06

INTRODUCTION

This Manual

Intended Use

Overview of the i-STAT System

This manual describes the i-STAT1 Analyzer and the Central Data Station software. Related sections are grouped behind tabs.

The i-STAT Portable Clinical Analyzer and the Philips Medical Systems Blood Analysis Module (formerly supplied by Agilent Technologies, and Hewlett-Packard, Inc., for the Viridia CMS Patient Monitors) are described in a separate manual.

The i-STAT 1 Analyzer is intended for use with i-STAT cartridges for in vitro quantiﬁcation of various analytes in whole blood and with the Abbott MediSense Precision PCx Blood Glucose Test Strip for the in vitro quantiﬁcation of glucose in whole blood. Analyzers, cartridges, and test strips 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.

In the USA, for the purpose of CLIA compliance, the i-STAT CHEM8+ cartridge is categorized as Waived. All other i-STAT cartridges are categorized as moderate complexity.

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. Glucose results are available from the Precision PCx Blood Glucose Test Strip in as little as 20 seconds on the handheld analyzer.

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: 714363-01K Rev. Date: 03/03/08 1-1

Components

The i-STAT System consists of:

i-STAT Cartridges

Abbott MediSense Precision PCx and PCx Plus Blood Glucose Test

Strips

i-STAT 1 Analyzer

i-STAT Portable Clinical Analyzer

Philips Medical Systems Blood Analysis Module (used in conjunction

with a patient monitor)

Portable Printer

Quality Assurance Materials

• Electronic Simulator

• Control Solutions

• Calibration Verification Set (for cartridges)

• Linearity Assessment Kit (for test strips)

Data Management System

• i-STAT 1 Downloader

• i-STAT 1 Downloader/Recharger

• IR Link for Portable Clinical Analyzer

•

Data Manager



Central Data Station (data management software for cartridges)

QC Manager (data management software for test strips)

Selection of Components

Summary of the Procedure

Data Manager Printer

LIS/HIS Interface Software

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

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. To perform glucose test strip testing, the operator selects a the glucose strip option from the menu, scans the test strip barcode, inserts the test strip into the analyzer test strip port and applies sample to the test strip. This degree of automation, along with the ability to test fresh whole blood, eliminates many sources of error as well as time-consuming and costly steps inherent in other methods.

1-2 Art: 714363-01K Rev. Date: 03/03/08

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: 714363-01K Rev. Date: 03/03/08 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.

Authorized Representative for Regulatory Affairs in the European

Community.

Contains sufﬁcient for < n > tests.

Direct Current (DC)

Alternating Current (AC)

Class II Construction

Consult instructions for use or see System Manual for instructions.

Control

Signiﬁes that the product bearing the ETL Listed mark complies with both U.S. and Canadian product safety standards:

UL 61010A-1

CAN/CSA C22.2 No. 1010.1-92

i/immuno: Cartridges bearing this symbol must be run on i-STAT analyzers that also bear this symbol.

Battery: i-STAT 1 Analyzer low battery icon (ﬂashes on lower left side of display screen).

Separate waste collection for this electrical/electronic item indicated.

1-4 Art: 714363-01K Rev. Date: 03/03/08

Symbol Definition

Separate waste collection for this electrical/electronic item indicated; Equipment manufactured / put on the market after 13 August 2005; Indicates compliance with Article 10(3) of Directive 2002/96/EC (WEEE) for the European Union (EU).

BODxxxx-xx Born On Date: the label BODxxxx-xx deﬁnes the year and month of manufacture.

Do not reuse.

This symbol is used for compliance with the China RoHS regulation(s). It indicates in years the Environmentally Friendly Use Period (EFUP) for the labeled electronic medical device product

As the Martel Printer is incapable of printing the ↑ or ↓ symbols, this symbol

<< >>

appears on the Martel printout next to results which are outside the action range limits.

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

SCAN

ABC

Symbol

DIS

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.

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

Key used to activate the display.

ENT PRT

CLR

Art: 714363-01K Rev. Date: 03/03/08 1-5

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

Symbol TEST

Cl Glu Lac

Crea

PCO

iCa

Range

Sodium

Potassium

Chloride

Glucose

Lactate

Creatinine

Partial pressure of carbon dioxide.

Partial pressure of oxygen.

Ionized Calcium

BUN/UREA

Hct

ACTc

Celite ACT

ACTk

Kaolin ACT

PT/INR

Hb TCO2 HCO3

BE (b&ecf)

AnGap

sO2

cTnI

CK-MB

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)

Anion Gap

Oxygen saturation

Cardiac Troponin I

Creatine Kinase MB Isoenzyme

BNP

1-6 Art: 714363-01K Rev. Date: 03/03/08

B-type Natriuretic Peptide

Warranty

Abbott Point of Care Inc. warrants this medical product (excluding disposable or consumable supplies) against defects in materials and workmanship for one year from the date of shipment. If Abbott Point of Care Inc. receives notice of such defects during the warranty period, Abbott Point of Care Inc. shall, at its option, either repair or replace products which prove to be defective. With respect to software or ﬁrmware, if Abbott Point of Care Inc. receives notice of defects in these products during the warranty period, Abbott Point of Care Inc. shall repair or replace software media and ﬁrmware which does not execute their programming instructions due to such defects. Abbott Point of Care Inc. does not warrant that the operating of the software, ﬁrmware or hardware shall be uninterrupted or error free. If Abbott Point of Care Inc. is unable, within a reasonable time, to repair or replace any product to a condition as warranted, Buyer shall be entitled to a refund of the purchase price upon return of the product to Abbott Point of Care Inc..

Note: Warranty rights may vary from state to state, province to province and

country to country.

Limitations of Warranty

Selling or Leasing the i-STAT System

The foregoing warranty shall not apply to defects resulting from:

1 Improper or inadequate maintenance by Buyer or an unauthorized

person,

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.

If you sell an i-STAT analyzer, please notify Abbott Point of Care Inc. so that we can enter the new owner into our software update database. If you rent an i-STAT analyzer and do not intend to provide software updates to the leaser, please notify Abbott Point of Care Inc. so that we can enter the leaser into our software database.

Art: 714363-01K Rev. Date: 03/03/08 1-7

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 and with the MediSense Precision PCx and PCx Plus Glucose Test Strips for the quantitative measurement of glucose 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

i-STAT 1 ANALYZER

Install Batteries

Check Date and Time

Check Software

Customization

Two disposable lithium batteries are supplied with the analyzer. See the Care of the Analyzer section in this manual for the procedure to install the disposable batteries. If a rechargeable battery is to be used, the disposable batteries can be used while the rechargeable battery pack is charged in the Downloader/Recharger. Charge rechargeable batteries fully before use. See the i-STAT 1 Downloader section for this procedure. When using a rechargeable battery, store the disposable battery carrier for possible future use.

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.

Caution

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.

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.

: New analyzers or analyzers that have been repaired and returned

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.

The i-STAT 1 Analyzer is shipped with the glucose test strip functionality disabled. The glucose test strip functionality can be enabled through the Customization function on the Central Data Station or analyzer.

Older i-STAT 1 analyzers may have the test strip port blocked. The test strip port can be unlocked as follows. A small ﬂat-head screwdriver is needed to remove the plug.

Art: 714364-01H Rev. Date: 03/03/08 2-1

1 Hold the analyzer with the test strip port facing you and the display

facing up.

2 Hold the screwdriver with the blade horizontal. Carefully insert the blade

into the horizontal gap under the plug.

3 Pry up gently until the plug pops free. Take care not to force the

screwdriver into the port.

4 Remove the screwdriver and then remove the plug. The plug can be

replaced if necessary.

Perform Quality Check

DESCRIPTION

Speciﬁcations

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.

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

MEMORY/CLOCK BACKUP POWER

DISPLAY

COMMUNICATION LINK Infrared light-emitting diode (LED)

OPERATING TEMPERATURE

TRANSPORT TEMPERATURE

RELATIVE HUMIDITY

BAROMETRIC PRESSURE 300-1000 mmHg

LASER SCANNER

Factory: electronic, mechanical, thermal, pressure

Lithium Battery

Dot matrix supertwist liquid crystal

15-40°C (59-104°F) for Medisense strip testing 16-30°C (61-86°F) for i-STAT cartridge testing

-10-46°C (14-115°F)

90% (maximum) non-condensing

Complies with U.S. 21 CFR 1040.10 and

1040.11 except for deviations pursuant to laser Notice No. 50, dated July 26, 2001.

EN 60825-1:1994 + A1:2002 + A2:2001

IEC 60825-1:1993 + A1:1997 + A2:2001

2-2 Art: 714364-01H Rev. Date: 03/03/08

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 four months. See under “Standardization and Calibration” in section 3 of this manual for an explanation of CLEW.

Note: Calibration information for the glucose test strips is included in the barcode

on the foil packet in which each test strip is packaged. The analyzer requires that this information be scanned or entered via the keypad before the test strip can be inserted into the analyzer.

Power

Battery Compartment

Disposable Batteries

Rechargeable Battery

There are two power options for the analyzer: disposable and rechargeable. The analyzer is shipped with two disposable 9-volt lithium batteries and a battery carrier. Lithium batteries may be ordered from i-STAT or obtained locally. ULTRALIFE lithium batteries (ULTRALIFE Batteries, Inc., Newark, NY, USA) are recommended. Only i-STAT rechargeable batteries may be used.

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.

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, 50 immunoassay cartridges, or about 1,000 glucose test strips 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.

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: Do not sho rt circui t, inc iner ate or mutilate the recharegable

batteries.

Low Battery Warning

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.

Art: 714364-01H Rev. Date: 03/03/08 2-3

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). The cartridge and test strip ports cannot be used simultaneously.

i-STAT Cartridge Port

Test Strip Port

Precision PCx and PCx Plus Blood Glucose Test Strips are inserted into the analyzer through the test strip port on the display end of the analyzer when prompted by the analyzer.

Precision PCx and PCx Plus

Glucose Test Strip Port

Infrared Communication

Window

Battery Compartment Laser Barcode Scanner

Window

2-4 Art: 714364-01H Rev. Date: 03/03/08

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

Barometric Pressure Sensor

Cartridge Test Cycle

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.

The analyzer contains a solid-state barometric pressure sensor, which determines the ambient atmospheric pressure used for the PO2 sensor calibration.

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:



 makes electrical contact with the cartridge



 identiﬁes the cartridge type



 releases calibration ﬂuid to the sensors (when applicable)



 mixes sample and reagent (when applicable)



 measures barometric pressure



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



 measures electrical signals generated by the sensors and calibration

ﬂuid (when applicable)



 displaces the calibrant solution with sample (when applicable)



 measures electrical signals generated by the sensors and sample



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

operator



 accepts chart page information



 calculates and displays results



 stores results

Strip Test Cycle

An operator starts a test strip test cycle by selecting the PCx Glucose Strip option from the Test or Quality Tests Menu.

The analyzer:



 accepts test strip lot data



 prompts the operator to insert the test strip



 prompts the operator to apply the sample



 measures electrical signals generated by the glucose sensor and sample



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

operator



 accepts chart page information entered by the operator



 calculates and displays results



 stores results

Art: 714364-01H Rev. Date: 03/03/08 2-5

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 and Strip 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 5,000 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, cartridges and test strips



Chart page data



Serial number of the Electronic Simulator



 the serial number of the analyzer



 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 Art: 714364-01H Rev. Date: 03/03/08

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

Time Out

The analyzer will beep to indicate:



 whenever a key is pressed.



 a successful barcode entry.



 sample detection on glucose test strip

tests.



 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.

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.”



 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.



 Waiting for insertion of test strip: After the prompt “Insert Strip” is

displayed, the analyzer will wait 2 minutes for the operator to insert a test strip. If a test strip 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.

Art: 714364-01H Rev. Date: 03/03/08 2-7

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

Activates the barcode scanner. Information that can be entered

SCAN

ABC

0 – 9

•

into the analyzer via the scanner includes: operator ID, patient ID, control, cartridge and test strip 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.

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.

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 Used to respond to a prompt to complete an action, such as

entering an operator or patient ID via the keypad.

Print Used to print either directly to the portable printer or to the

On/Off

2-8 Art: 714364-01H Rev. Date: 03/03/08

Used to return to the previous menu and switch between the Test and Administration Menus.

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.

i-STAT 1 Menu Tree

There are two main menus: The Test Menu and the Administration Menu. If the glucose test strip function is disabled, test strip options will not be displayed.

Test Menu Administration Menu

1- Last Result 1. Analyzer Status Temp

2- i-STAT Cartridge Pressure

3- PCx Glucose Strip 1- Patient Battery 2- Control Uses Serial CLEW Version Custom Stored Records

2- Data Review 1-Patient

2-Control 1- i-STAT Cartridge 2- PCx Glucose Strip 3- All

3-Proﬁciency 1- i-STAT Cartridge 2- PCx Glucose Strip 3- All

4-Cal Ver 1- i-STAT Cartridge 2- PCx Glucose Strip 3- All 5- Simulator 6- All 7- List

3-Quality Tests 1-Control 1- i-STAT Cartridge 2- PCx Glucose Strip

2- Proﬁciency 1- i-STAT Cartridge 2- PCx Glucose Strip

3- Cal Ver 1- i-STAT Cartridge 2- PCx Glucose Strip

4- Simulator

4- Customization 1- View

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

5- Set Clock

6- Transmit Data 1- Most Recent 2- This Month 3- Last Month 4- All

7-Utility 1- Send Software 2- Clear Memory

Art: 714364-01H Rev. Date: 03/03/08 2-9

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

3 - PCx Glucose Strip

1 - Patient 2 - Control

Options 2 and 3 are used for testing patient samples. For the glucose test strip, controls can also be tested from the Test Menu. Testing controls from the Test Menu rather than option 3 – Quality Tests under the Administration Menu may be more convenient for end users who test glucose test strip control samples on a daily basis.

Note: If the analyzer is customized with test strip

testing disabled, test strip options will not be displayed. If the analyzer 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

2-10 Art: 714364-01H Rev. Date: 03/03/08

Analyzer Status

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,

simulator and test strip 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 5,000 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.

Data Review

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 1 – i-STAT Cartridge 2 – PCx Glucose Strip 3 - All

3 - Proﬁciency 1 – i-STAT Cartridge 2 – PCx Glucose Strip 3 - All

4 - Cal Ver 1 – i-STAT Cartridge 2 – PCx Glucose Strip

3 – All

5 - Simulator All external and internal Electronic Simulator records.

6 - All All test records in the analyzer’s memory.

Art: 714364-01H Rev. Date: 03/03/08 2-11

7 - List Records are listed with

Cartridge type or PCx Glucose Strip, date and time of test, and 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 and Linearity Test for test strips)

4 - Simulator (cartridge-reading function

only)

When options 1 - 3 are selected, the operator further selects:

1 – i-STAT Cartridge

2 – PCx Glucose Strip

When testing is initiated from one of these options, the analyzer 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 or Test Strip Lot Number as applicable.

When the Quality Tests option is used, results can be reviewed according to the corresponding options under the Data Review option.

Note: The Test Menu option for test strips includes both a Patient and Control option. Results for test strip controls run from the Test and Quality Tests menus are stored together.

2-12 Art: 714364-01H Rev. Date: 03/03/08

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