i-STAT 1 System Manual Update April 2021

A ► ADD SHEET

◄ D DESTROY SHEET

Item

Art#

A D

i-STAT 1 System Manual Section 8: Data Management i-STAT 1 System Manual Section 8: Data Management

714370-01F 714370-01E (or lower)

A D

i-STAT 1 System Manual Section 9: Customization i-STAT 1 System Manual Section 9: Customization

714371-01I 714371-01H (or lower)

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Procedures Tab i-STAT 1 System Manual Section 10: Sample Collection i-STAT 1 System Manual Section 10: Sample Collection

714372-01O 714372-01N (or lower)

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i-STAT 1 System Manual Section 11: Cartridge Handling i-STAT 1 System Manual Section 11: Cartridge Handling

714373-01I 714373-01H (or lower)

Care and Software Updates Tab Technical Bulletin: Instructions for Updating the i-STAT 1 Handheld Using www.pointofcare.abbott Technical Bulletin: Instructions for Updating the i-STAT 1 Handheld Using www.pointofcare.abbott

731335-01H

A D A D

Technical Bulletin: Network Options for Updating the i-STAT 1 Handheld Using www.pointofcare.abbott Technical Bulletin: Network Options for Updating the i-STAT 1 Handheld Using www.pointofcare.abbott

731335-01G (or lower) 731336-01H 731336-01G (or lower)

Downloader Programming and Wiring Tab i-STAT 1 System Manual Section 21: Downloader Programming and Wiring

714383-01G (or lower)

Technical Bulletins Tab Technical Bulletin: Replacing the NiMH Rechargeable Battery in the Martel Printer

716625-01C (or lower)

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Technical Bulletin: Support Services Technical Bulletin: Support Services

716144-01AK 716144-01AJ (or lower)

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Technical Bulletin: Using i-STAT Analyzer Customization Features to Minimize ID Entry Errors

720654-01B (or lower)

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Technical Bulletin: Updates to the i-STAT 1 Downloader / Recharger

725703-01A

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END © 2021 Abbott Point of Care Inc., 100 and 200 Abbott Park Road, Abbott Park, Il 60064 • USA i-STAT is a trademark of Abbott.

Art.: 731669-01P

Rev. Date: 27-Apr-2021

Page 2 of 2

i-STAT 1

System Manual

Rev. Date: 02-APR-2021

Art: 714336-01P

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

Trademarks i-STAT is a trademark of Abbott. Windows is a trademark of Microsoft Corporation.

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

Emergo Europe Prinsessegracht 20 2514 AP The Hague The Netherlands

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

©2021 Abbott Point of Care Inc. All rights reserved. Printed in USA. Art: 714336-01P

Rev. Date: 02-APR-2021

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 May 2021, your i-STAT 1 System Manual should be configured with the contents as listed below and in the order shown. ITEM

Art #

Cover Sheet ... 714336-01P Configuration Sheet ... 714419-01BD Table of Contents ... 714362-01AD Section 1 ... 714363-01Z Section 2 ... 714364-01T Section 3 ... 714365-01H Section 4 ... 714366-01C Section 5 ... 714367-01F Section 6 ... 714368-01K Section 7 ... 714369-01N Section 8 ... 714370-01F Section 9 ... 714371-01I Section 10 ... 714372-01O Section 11 ... 714373-01I Section 12 ... 714374-01N Section 13 ... 714375-01F Section 14 ... 714376-01S Section 15 ... 714377-01R Section 16 ... 714378-01G Section 17 ... 714379-01I Section 18 ... 714380-01K Technical Bulletin: Instructions for Updating i-STAT 1 Handheld Software Using www.pointofcare.abbott ... 731335-01H Technical Bulletin: Network Options for Updating the i-STAT 1 Handheld Using www.pointofcare.abbott ... 731336-01H Section 19 ... 714381-01K Technical Bulletin: Analyzer Coded Messages ... 714260-01T Section 20 ... 714382-01D End of Life (EOL) Notification – Central Data Station (CDS)………...765814-01A CTI Sheets Introduction ... 7142258-01P Technical Bulletins New Ultralife 9-volt Lithium Battery for Use With the i-STAT System………………………………………...730271-01A Instructions for Restoring Analyzers that Produce *** for Hematocrit and Quality Check Code 23 ... 714962-01E K2EDTA and K3EDTA Customization for Hematocrit on the i-STAT System 716240-01D ACT Test Result Options: Prewarmed vs. Non-Prewarmed Result Calibration Modes for the i-STAT 1 Analyzer ... 715617-01D Support Services ... 716144-01AK

Art.: 714419-01BD

Rev. Date: 27-Apr-2021

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 Description... 2 - 2 Test Menu... 2 - 10 Administration Menu... 2 - 10 Laser Barcode Scanner... 2 - 20 Prompts and Messages... 2 - 22

i-STAT CARTRIDGE... 3 - 1 Contents... 3-1 Sample Handling System... 3-2 Standardization and Calibration... 3-3 Packaging... 3-3 Storage Conditions... 3-3 Disposal... 3-3

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 DOWNLOADER/RECHARGER... 6 - 1 Overview... 6-1 Identification of the i-STAT 1 Downloader/Recharger ... 6-2 Specifications of the DRC-300 ... 6-3 Power Supply Specifications ... 6-3 DRC-300 Indicator LEDs ... 6-3 Power Requirements ... 6-4 Cautions ... 6-4 Running Cartridges in a Handheld Docked in the DRC-300 ... 6-4 DRC-300 Effect on Ambient Operating Temperature Range ... 6-4 Transmitting Data From the DRC-300 to i-STAT/DE... 6-5

Rev. Date: 28-APR-2021

Art: 714362-01AD

i

Transmitted Information ... 6-5 Charging Batteries before Use ... 6-5 Rechargeable Battery Life ... 6-5 Charging a Rechargeable Battery While Installed in the Handheld ... 6-6 Charging a Rechargeable Battery in the External Recharge Compartment ... 6-6 Configuring the i-STAT 1 DRC-300 for Network Operation ... 6-6 Connecting and Wiring the DRC-300 for Network Communication ... 6-14 Configuring the i-STAT 1 DRC-300 for USB Serial Operation ... 6-15 Option 1: Installation Using Windows Hardware Wizard ... 6-15 Option 2: Installation Using a Driver Installer File ... 6-17 Connecting and Wiring the DRC-300 for Serial Communication ... 6-20 USB Serial Driver Uninstallation ... 6-21 Configuring the RALS RRC for USB Serial to Network Communication ... 6-21

PORTABLE PRINTER... 7 - 1 Overview... 7 - 1 Specifications... 7 - 2 i-STAT Printer Kit Components and Accessories... 7 - 3 Orderable Components... 7 - 3 i-STAT Printer Paper ... 7 - 4 i-STAT Printer Power ... 7 - 4 Printing Directly from the i STAT 1 Handheld... 7 - 7 Printing Via a Downloader/Recharger... 7 - 8 Printing Many Results... 7 - 8 Printout Contents... 7 - 9 Printer Cautions... 7 - 9 Printer Troubleshooting... 7 - 10 Cleaning the i-STAT Printer... 7 - 11 i-STAT Printer Storage and Battery Check ... 7 - 11

CONNECTIVITY AND DATA MANAGEMENT OPTIONS... 8 - 1 Overview... 8 - 1 Components... 8 - 1 i-STAT 1 Analyzer Data Items... 8 - 1 i-STAT Device Connectivity Options... 8 - 2 i-STAT/DE... 8 - 3 Info HQ... 8 - 4

CUSTOMIZATION... 9 - 1 Overview ... 9-1 Caution... 9-1 Analyzer Customization Options and Default Settings ... 9-2 For Instrument Options ... 9-3 For Operator and Patient ID Options ... 9-4 For Test Options ... 9-5 For Cartridge QC – Electronic QC Settings ... 9-6 For Cartridge QC – Liquid QC Settings ... 9-7 For Cartridge QC – Liquid QC Schedule (1, 2 or 3) ... 9-8 For Results Reporting Options... 9-9 For Analyte Enable ... 9-10 For Barcodes ... 9-10 Unit Sets ... 9-11 Procedures for Customization Using the Analyzer Keypad ... 9-12 To Change the Date and Time... 9-12 Check Software ... 9-13 Change Units and Ranges... 9-14 Change Test Selection... 9-15

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Art: 714362-01AD

Rev. Date: 28-APR-2021

PROCEDURES SAMPLE COLLECTION... 10 - 1 Specimen Collection... 10 - 1 Venipuncture - General... 10 - 1 Venipuncture - pH, PCO2, Electrolyte, Chemistry, and Hematocrit Tests... 10 - 2 Venipuncture - Coagulation Tests... 10 - 4 Arterial Puncture - General... 10 - 4 Arterial Puncture - Blood Gas, Electrolyte, Chemistry, and Hematocrit Tests... 10 - 5 Arterial Puncture - ACT Tests... 10 - 6 Indwelling Line... 10 - 7 Skin Puncture... 10 - 7 Sample Transfer Devices... 10 - 8 References... 10 - 9

PROCEDURE FOR HANDLING CARTRIDGES... 11 - 1 Preparation for Testing... 11 - 1 Filling and Sealing Cartridge... 11 - 2 Filling and Sealing PT/INR Cartridges Using Direct Fingerstick Sampling... 11 - 6 Inserting and Removing the Cartridge From the Analyzer... 11 - 7 Incorrect Procedure... 11 - 8

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

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

Rev. Date: 28-APR-2021

Art: 714362-01AD

iii

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

CARE AND SOFTWARE UPDATES ROUTINE CARE of the ANALYZER and DOWNLOADER... 17 - 1 Drying a Wet Analyzer or Downloader ... 17 - 1 Cleaning the Analyzer and Downloader... 17 - 1 Removing and Replacing Disposable Batteries... 17 - 2 Removing and Replacing the Rechargeable Battery... 17 - 3

UPDATING THE SOFTWARE... 18 - 1

TROUBLESHOOTING THE ANALYZER TROUBLESHOOTING THE ANALYZER... 19 - 1 Introduction... 19 - 1 Information Needed... 19 - 1 Startup Messages... 19 - 2 Test Cycle Messages and Quality Check Codes... 19 - 3 No Display... 19 - 6 “Cartridge Locked” Not Removed... 19 - 6

TECHNICAL BULLETIN: ANALYZER CODED MESSAGES

THEORY THEORY... 20 - 1 Analyzer Functions... 20 - 1 Electrochemical Measurements... 20 - 3 Determination of Test Results... 20 - 4 Determination of Cell Concentration... 20 - 5 CPB... 20 - 5 Determination of Coagulation Endpoints... 20 - 7 Quality Control and the i-STAT System... 20 - 7 Quality Control and the i-STAT Coagulation Tests... 20 - 12

END OF LIFE (EOL) NOTIFICATION: CENTRAL DATA STATION (CDS)

CARTRIDGE AND TEST INFORMATION Cartridge and Test Information

TECHNICAL BULLETINS

iv

Art: 714362-01AD

Rev. Date: 28-APR-2021

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. For information on the analytes that can be measured using i-STAT Cartridges, refer to the Cartridge and Test Information (CTI) sheets or Instructions for Use (IFU), located at www.pointofcare.abbott.

BEFORE YOU USE THE ANALYZER Install Batteries

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

Check Date and Time Press the On/Off key and check that the date and time at the top of the display are correct. To change the date and time, see Administration Menu in this section. Check Software

Caution: New analyzers or analyzers that have been repaired and returned or replaced will have standard CLEW and application software. If a different CLEW and/or application software is in use in your facility, it must be installed in new, repaired or replaced analyzers before they are put into use. Check the Analyzer Status page for the installed CLEW and application software. For steps to verify the software, see Procedures for Customization using the Analyzer Keypad in Section 9 of this manual. 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 Section 9 in this manual 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 i-STAT/DE, see the “i-STAT/DE User Guide” located at www.pointofcare.abbott. Caution: New analyzers or analyzers that have been repaired and returned or replaced will have the factory default settings in the customization profile, as indicated by the DEFAULT0 on the Analyzer Status page. If analyzers in your facility do not use the default customization profile, the appropriate customization profile should be installed before a new, repaired or replaced analyzer is put into use.

Perform Quality Check

Use the Electronic Simulator to verify the cartridge-reading performance of new or repaired analyzers. Use QC protocols to verify the test strip-reading performance of new or repaired analyzers.

Art: 714364-01T

Rev. Date: 05-APR-2021

2-1

DESCRIPTION

Specifications DIMENSIONS

Width 7.68 cm (3.035 in.) Length 23.48 cm (9.245 in.) Depth 7.24 cm (2.85 in.)

WEIGHT

With rechargeable battery 650 grams (22.9 oz.) With disposable battery 635 grams (22.4 oz.)

POWER

Two 9-volt lithium batteries, or rechargeable battery.

CALIBRATION

Factory: electronic, mechanical, thermal, pressure

MEMORY/CLOCK BACKUP POWER

Lithium Battery

DISPLAY

Dot matrix supertwist liquid crystal

COMMUNICATION LINK

Infrared light-emitting diode (LED)

OPERATING TEMPERATURE 16-30°C (61-86°F) for i-STAT cartridge testing TRANSPORT TEMPERATURE

-10-46°C (14-115°F)

RELATIVE HUMIDITY

90% (maximum) non-condensing

BAROMETRIC PRESSURE

300-850 mmHg

LASER SCANNER

Complies with U.S. 21 CFR 1040.10 and 1040.11 except for deviations pursuant to laser Notice No. 50, dated June 24, 2007. EN 60825-1:1994 + A1:2002 + A2:2001 IEC 60825-1:1993 + A1:1997 + A2:2001

Software

All analyzer functions are controlled by application software that can be updated as additional tests and features are developed. Coefficients used to maintain the accuracy of cartridge results over time are programmed into the analyzer via CLEW software updates every six months. See under “Standardization and Calibration” in Section 3 of this manual for an explanation of CLEW.

Power

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

Battery Compartment

The battery compartment is located at the display end of the analyzer next to the laser barcode scanner window. The procedure for changing disposable and rechargeable batteries can be found in the Routine Care of the Analyzer and Downloader section of this manual.

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Art: 714364-01T

Rev. Date: 05-APR-2021

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

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

Low Battery Warning

Rev. Date: 05-APR-2021

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

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

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Additional Power

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

Cartridge Port

Cartridges and the Electronic Simulator are inserted into the analyzer through the cartridge port on the keypad end of the analyzer.

i-STAT Cartridge Port

Infrared Communication Window

Battery Compartment

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Art: 714364-01T

Laser Barcode Scanner Window

Rev. Date: 05-APR-2021

Infrared Communication Window

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

Thermal Control

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

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

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

Rev. Date: 05-APR-2021

•

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

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Data Entry

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

Operator ID

•

Patient ID, Proficiency ID, or Simulator ID

•

Cartridge Lot Number

•

Control Lot Number

•

Cal Ver Kit Lot Number

•

Comment codes for patient and control results

•

Chart Page •

Sample Type

•

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

•

FIO2

•

Free Fields: three fields, up to 9 characters each

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

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

a set of results

•

the date and time the test was performed

•

the cartridge type

•

all information entered by barcode scanner or keypad including: •

Operator and Patient IDs

•

Lot numbers for controls and cartridges

•

Chart page data

•

Serial number of the Electronic Simulator

•

the serial number of the analyzer

•

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 i-STAT/DE 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 i-STAT/DE. 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.

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Rev. Date: 05-APR-2021

LCD Display and Backlight

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

Audible Indicator

The analyzer will beep to indicate: •

whenever a key is pressed.

•

a successful barcode entry.

•

results are ready.

•

a Quality Check Message is displayed.

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

Time Out

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

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

•

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

Rev. Date: 05-APR-2021

•

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

•

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

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Keypad

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

Function

SCAN

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

ABC

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

0–9

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

•

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

Enter

MENU

2-8

Used to respond to a prompt to complete an action, such as entering an operator or patient ID via the keypad. Used to return to the previous menu and switch between the Test and Administration Menus.

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.

Art: 714364-01T

Rev. Date: 05-APR-2021

i-STAT 1 Menu Tree

There are two main menus: The Test Menu and the Administration Menu. . Test Menu

Administration Menu

1- Last Result

1. Analyzer Status

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

2- Data Review

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

3-Quality Tests

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

4- Customization

1-View

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

2-Change

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

2- i-STAT Cartridge

5- Set Clock

Rev. Date: 05-APR-2021

6- Transmit Data

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

7-Utility

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

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

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

ADMINISTRATION MENU Overview

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

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Analyzer Status

Data Review

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

Room temperature.

Pressure

Barometric pressure.

Battery

Battery voltage.

Uses

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

Serial

Serial number of the analyzer.

CLEW

Version of standardization data installed in the analyzer.

Version

Version of application software installed in the analyzer.

Custom

Customization profile name.

Stored Records

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

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

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

2 - Control

3 - Proficiency

4 - Cal Ver

Rev. Date: 05-APR-2021

5 - Simulator

All external and internal Electronic Simulator records.

6 - All

All test records in the analyzer’s memory.

Art: 714364-01T

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