Abbott i-Stat 1 User manual

i-STAT®1

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		Emergo Europe
	Tel: [phone]
			P.O. Box 18510
	Fax: [phone]
		2502 EM The Hague
			The Netherlands
		Tel: [phone]
		Fax: [phone]

©2006 Abbott Point of Care Inc. All rights reserved. Printed in USA.

Art: 714336-01E

Rev. Date: 08/14/06

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
PO2 / sO2 ..........................................................................................	714180-01H
pH .....................................................................................................	714181-01J
PCO2/HCO3/BE/AG...........................................................................	714182-01M
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

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
K2EDTA and K3EDTA Customization for	716240-01B
Hematocrit on the i-STAT System.....................................................
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.....................................................................................................................	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	- 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

Art: 714362-01G

Rev. Date: 09/13/06

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

Cartridge and Test Information

Cartridge and Test Information

Sodium

Potassium

Chloride

BUN/Urea

Glucose

Hematocrit/Hemoglobin

Ionized Calcium

PO2

pH

PCO2

Total Carbon Dioxide/TCO2

Creatinine

Lactate

Celite ACT

Kaolin ACT

Prothrombin Time PT/INR

Cardiac Troponin I

Creatine Kinase MB/CK-MB

B-Type Natriuretic Peptide/BNP

TECHNICAL BULLETINS

vi

Art: 714362-01G

Rev. Date: 09/13/06

	Introduction	1
This Manual	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.
Intended Use	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.
Overview of the	The i-STAT System incorporates a comprehensive group of components needed
i-STAT System	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)
	 Data Manager Printer
	 LIS/HIS Interface Software
Selection of	The selection of system components is dependent on factors unique to each
Components	facility such as:
	 Types of tests to be performed
	 Number of testing sites
	 Number of tests per site
	 System administration requirements
Summary of the	To perform cartridge testing, the operator fills a cartridge with sample, seals the
Procedure	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				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 Reliability
					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.

MN

Model number. The model number will appear adjacent to this symbol.

Date of manufacture.

Manufacturer

In vitro diagnostic medical device.

Authorized Representative for Regulatory Affairs in the European

Community.

Contains sufficient for < n > tests.

Direct Current (DC)

Alternating Current (AC)

Class II Construction

Consult instructions for use or see System Manual for instructions.

Control

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					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.
	Symbol					The following symbols are used on the i-STAT Portable Clinical Analyzer Keypad
			DIS			Key used to activate the display.
		ENT				Key used to enter information.
		PRT				Key used to print a test record.
		CLR				Key used to clear an incorrect entry.
							1-5
Art: 714363-01K						Rev. Date: 03/03/08

Symbol	The following symbols are used on i-STAT Value Assignment Sheets
	Mean
R	Range

	Symbol	TEST
	Na	Sodium
	K	Potassium
	Cl	Chloride
	Glu	Glucose
	Lac	Lactate
	Crea	Creatinine
	pH	pH
	PCO2	Partial pressure of carbon dioxide.
	PO2	Partial pressure of oxygen.
	iCa	Ionized Calcium
	BUN/UREA	Urea nitrogen/Urea
	Hct	Hematocrit
	ACTc	Activated Clotting Time with Celite® activator.
	Celite ACT
	ACTk	Activated Clotting Time with Kaolin activator.
	Kaolin ACT
	PT/INR	Prothrombin Time / International Normalized Ratio
	Hb	Hemoglobin
	TCO2	Total carbon dioxide concentration.
	HCO3	Bicarbonate
	BE (b&ecf)	Base excess (b for blood, ecf for extra cellular fluid)
	AnGap	Anion Gap
	sO2	Oxygen saturation
	cTnI	Cardiac Troponin I
	CK-MB	Creatine Kinase MB Isoenzyme
	BNP	B-type Natriuretic Peptide
1-6		Art: 714363-01K	Rev. Date: 03/03/08

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:

1Improper or inadequate maintenance by Buyer or an unauthorized person,

2Using accessories and/or consumables that are not approved by Abbott Point of Care Inc.,

3Buyer-supplied software or interfacing,

4Unauthorized repairs, modifications, misuse, or damage caused by disposable batteries, or rechargeable batteries not supplied by Abbott Point of Care Inc..

5Operating outside of the environmental specifications of the product, or

6Improper 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

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 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

Install Batteries	Two disposable lithium batteries are supplied with the analyzer. See the Care of the
	Analyzer section in this manual for the procedure to install the disposable batteries.
	If a rechargeable battery is to be used, the disposable batteries can be used while
	the rechargeable battery pack is charged in the Downloader/Recharger. Charge
	rechargeable batteries fully before use. See the i-STAT 1 Downloader section for
	this procedure. When using a rechargeable battery, store the disposable battery
	carrier for possible future use.
Check Date and	Press the On/Off key and check that the date and time at the top of the display are
Time	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.
	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	Use the Electronic Simulator to verify the cartridge-reading performance of new
Check	or repaired analyzers.
	Use QC protocols to verify the test strip-reading performance of new or repaired
	analyzers.

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	Lithium Battery
	Power
	Display	Dot matrix supertwist liquid crystal
	Communication Link	Infrared light-emitting diode (LED)
	Operating Temperature	15-40°C (59-104°F) for Medisense strip
		testing
		16-30°C (61-86°F) for i-STAT cartridge testing
	Transport	-10-46°C (14-115°F)
	Temperature
	Relative Humidity	90% (maximum) non-condensing
	Barometric Pressure	300-1000 mmHg
	Laser Scanner	Complies with U.S. 21 CFR 1040.10 and
		1040.11 except for deviations pursuant to
		laser Notice No. 50, dated July 26, 2001.
		EN 60825-1:1994 + A1:2002 + A2:2001
		IEC 60825-1:1993 + A1:1997 + A2:2001

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	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.
Battery	The battery compartment is located at the display end of the analyzer next to
Compartment	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.
Disposable Batteries	The analyzer requires two 9-volt lithium batteries. The lifetime for a set of batteries
	is mainly dependent on the mix of cartridges in use. Cartridges that require thermal
	control consume more energy because of heating. Coagulation and immunoassay
	cartridges consume more energy because of the longer test cycle. A minimum
	of 400 thermally controlled cartridge uses, about 100 coagulation cartridges, 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.
Rechargeable	The analyzer can be powered by a nickel-metal-hydride rechargeable battery. The
Battery	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 short circuit, incinerate or mutilate the recharegable
	batteries.
Low Battery	The analyzer will display “Low Battery” when the On/Off key is pressed. Additionally,
Warning	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	The Infrared Communication Window provides the analyzer with two-way
Communication	communication to the Central Data Station via a Downloader, allows analyzer-
Window	to-analyzer software updates, and allows analyzer-to-printer communication for
	printing.
Thermal Control	The analyzer contains a thermal control subsystem of thermistors and heating
	contact wires that controls the temperature of the sensors and fluids that come
	into contact with the sensors to 37°C. This subsystem is activated automatically
	when a cartridge containing tests which require thermal control at 37°C is inserted
	into the analyzer.

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

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

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

turned on while data entry screens are displayed.

Audible Indicator The analyzer will beep to indicate:

whenever a key is pressed.

a successful barcode entry.

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

	Results displayed: Results are displayed for 2 minutes before the
	analyzer turns off provided that a mandatory Comment Code prompt is not
	displayed. This Inactivity Time Out default time can be increased using
	Customization.
	If a mandatory Comment Code prompt is displayed, the analyzer will turn
	off after 15 minutes or after the Inactivity Time Out, whichever is greater. In
	the case of a missed required Comment Code, results will be stored and “_
	_ _” will be entered as the Comment Code.
	Prompting for mandatory data when results are ready for display:
	The analyzer will turn off after 15 minutes or after the Inactivity Time Out,
	whichever is greater, if there is no response to a mandatory data prompt.
	A mandatory data prompt is a prompt for information that must be entered
	before pending results are displayed.
	In the case of a missed mandatory data prompt, results will not be stored
	and the test record will state “Test Cancelled by Operator.”
	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					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
	ABC					letter, press the ABC key once to move to the next position and
						again to enter an A. To enter a number after a letter, press a
						numbered key. To erase a letter, press the ABC key to move to
						the next position, then use the  key to backspace and clear the
						letter.
	0 – 9					Used to enter digits on data entry screens and to select menu
						options and stored records.
		•				Enters a decimal point or a comma separator according to the
						analyzer’s Customization Profile.
						Used to turn the screen backlight on and off.
	Enter					Used to respond to a prompt to complete an action, such as
						entering an operator or patient ID via the keypad.
	MENU					Used to return to the previous menu and switch between the Test
						and Administration Menus.
	Print					Used to print either directly to the portable printer or to the
						portable printer attached to a Downloader.
	On/Off					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.

2-8

Art: 714364-01H

Rev. Date: 03/03/08

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
			1- Patient				battery
3- PCx Glucose Strip
			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
								1- i-STAT Cartridge
							3-Proficiency
								2- PCx Glucose Strip
								3- All
								1- i-STAT Cartridge
							4-Cal Ver
								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