I-STAT System Manual April 2021

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

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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

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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

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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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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

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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

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INTRODUCTION This Manual

1

This manual describes the i-STAT 1 Analyzer and the Data Manager software. Related sections are grouped behind tabs. Note: Not all products are available in all regions.

Intended Use

The i-STAT 1 Analyzer is intended for use with i-STAT cartridges for the in vitro quantification of various analytes in whole blood. Analyzers and cartridges should be used by healthcare professionals trained and certified to use the system and should be used according to the facility’s policies and procedures. The i-STAT System is for in vitro diagnostics use. Caution: Federal law restricts this device to sale by or on the order of a licensed practitioner.

Overview of the i-STAT System

The i-STAT System incorporates a comprehensive group of components needed to perform blood analysis at the point of care. A portable handheld analyzer, a cartridge with the required tests, and 2-3 drops of blood will allow the caregiver to view quantitative test results for blood gas, chemistry and coagulation tests in approximately two minutes. Portable printers and infrared communication devices allow all patient information obtained at the bedside to be printed on demand and transmitted to centralized information systems for record keeping and billing. The Data Manager provides system management tools including real-time monitoring of testing and operator competency.

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Components

The i-STAT System consists of:  i-STAT Cartridges  i-STAT 1 Analyzer  Portable Printer  Quality Assurance Materials • Electronic Simulator • Control Solutions • Calibration Verification Set (for cartridges)  Data Management System • • •

i-STAT 1 Downloader i-STAT 1 Downloader/Recharger Data Manager

 LIS/HIS Interface Software Selection of Components

The selection of system components is dependent on factors unique to each facility such as:  Types of tests to be performed  Number of testing sites  Number of tests per site  System administration requirements

Summary of the Procedure

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The cartridge test cycle is initiated by selecting i-STAT Cartridge from the Test menu or Quality Tests from the Administration menu. To perform cartridge testing, the operator fills a cartridge with sample, seals the cartridge with its snap or slide closure, and inserts the cartridge into the analyzer. The unit-use cartridge contains all applicable 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.

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Data Management

Test records can be transmitted to the Data Manager where they can be printed and/or transmitted to the Laboratory Information System or Hospital Information System. An optional portable printer enables the operator to print results at the point of care.

Interfacing

The Data Manager can be interfaced to a Laboratory Information System (LIS) or Hospital Information System (HIS) to automate billing and patient record keeping.

Note Regarding System Reliability

The i-STAT System automatically runs a comprehensive set of quality checks of analyzer and cartridge performance each time a sample is tested. This internal quality system will suppress results if the analyzer or cartridge does not meet certain internal specifications (see Theory 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. Rev. Date: 07-AUG-2020

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Symbol

Definition Manufacturer's lot number or batch code. The lot number or batch will appear adjacent to this symbol. Catalog number, list number, or reference number. The number adjacent to this symbol is used to reorder the product. Serial number. The serial number will appear adjacent to this symbol.

MN

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

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

Contains sufficient for < n > tests. Direct Current (DC). Alternating Current (AC). Class II Construction.

Consult instructions for use or see System Manual for instructions. Control. Signifies that the product bearing the ETL Listed mark complies with both U.S. and Canadian product safety standards: UL 61010-1: 2nd. Ed. CAN/CSA C22.2 No. 61010.1 2nd. Ed. i/immuno: Cartridges bearing this symbol must be run on i-STAT analyzers that also bear this symbol. Battery: i-STAT 1 Analyzer low battery icon (flashes on lower left side of display screen).

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Symbol

Definition Note concerning batteries: The following information is applicable to EEA (European Economic Area) countries: The directive 2006/66/EC requires separate collection of spent batteries. You are requested to dispose those batteries referred to on page 2-3 in accordance with local regulations. This product also contains a separate internal lithium battery that is not intended to be replaced by the user. See page 2-4 under "Additional Power" for more information. Separate waste collection for this electrical/electronic item indicated; Equipment manufactured / put on the market after 13 August 2005; Indicates compliance with Article 10(3) of Directive 2002/96/EC (WEEE) for the European Union (EU).

BODYYYY-MM-DD Born On Date: the label BODYYYY-MM-DD defines year, month and day of manufacture.

Do not reuse. This symbol is used for compliance with the China RoHS regulation(s). It indicates in years the Environmentally Friendly Use Period (EFUP) for the labeled electronic medical device product. As the Martel Printer is incapable of printing the ↑ or ↓ symbols, this symbol appears on the Martel printout next to results which are outside the action range limits.

<< >>

14

2

d

14 days room temperature storage at 18-30 ºC

2 months room temperature storage at 18-30 ºC

Description:

14 days room temperature storage at 18-30°C

Document Owner:

Christopher Fetters 400 College Road East Princeton, NJ 08540

Description:

m

BC

Packaging contains cartridges with barcoded pouches.

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

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

01 Feb 2010

Signifies that the product bearing the Federal Communications Commission (FCC) logo complies with the specific requirements set forth by the FCC under Rules and Regulations, Title 47, Part 15 Subpart B, for Class A devices.

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. Rev. Date: 07-AUG-2020

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Acronym

The following acronyms are listed in the i-STAT 1 System Manual

CTI IFU

Cartridge and Test Information Instructions for Use

Symbol

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

Mean

R

Range

Symbol

Na

Sodium

K

Potassium

Cl

Chloride

Glu

Glucose

Lac Crea pH PCO2 PO2 iCa BUN/UREA Hct ACTc Celite ACT ACTk Kaolin ACT PT/INR Hb TCO2 HCO3 BE (b&ecf) AnGap sO2

Lactate

cTnI CK-MB

BNP 1-6

TEST

Creatinine pH Partial pressure of carbon dioxide Partial pressure of oxygen Ionized Calcium Urea nitrogen/Urea Hematocrit Activated Clotting Time with Celite® activator Activated Clotting Time with Kaolin activator Prothrombin Time / International Normalized Ratio Hemoglobin Total carbon dioxide concentration Bicarbonate Base excess (b for blood, ecf for extra cellular fluid) Anion Gap Oxygen saturation Cardiac Troponin I Creatine Kinase MB Isoenzyme B-type Natriuretic Peptide Art: 714363-01Z

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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

The foregoing warranty shall not apply to defects resulting from: 1. Improper or inadequate maintenance by Buyer or an unauthorized person, 2. Using accessories and/or consumables that are not approved by Abbott Point of Care Inc., 3. Buyer-supplied software or interfacing, 4. Unauthorized repairs, modifications, misuse, or damage caused by disposable batteries, or rechargeable batteries not supplied by Abbott Point of Care Inc. 5. Operating outside of the environmental specifications of the product, or 6. Improper site preparation or maintenance. THE WARRANTY SET FORTH ABOVE IS EXCLUSIVE AND NO OTHER WARRANTY, WHETHER WRITTEN OR ORAL, IS EXPRESSED OR IMPLIED. ABBOTT SPECIFICALLY DISCLAIMS THE IMPLIED WARRANTIES OR MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.

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i-STAT 1 ANALYZER

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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.

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DESCRIPTION

Specifications DIMENSIONS

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

WEIGHT

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

POWER

Two 9-volt lithium batteries, or rechargeable battery.

CALIBRATION

Factory: electronic, mechanical, thermal, pressure

MEMORY/CLOCK BACKUP POWER

Lithium Battery

DISPLAY

Dot matrix supertwist liquid crystal

COMMUNICATION LINK

Infrared light-emitting diode (LED)

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

-10-46°C (14-115°F)

RELATIVE HUMIDITY

90% (maximum) non-condensing

BAROMETRIC PRESSURE

300-850 mmHg

LASER SCANNER

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

Software

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

Power

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

Battery Compartment

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

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

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

Low Battery Warning

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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Laser Barcode Scanner Window

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