i-STAT®1 System Manual - 660 Pages

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i-STAT®1 System Manual

Catalog excerpts

Patents: www.abbott.us/patents Symbol Technologies Corporation is the owner of US Patent No. 5,532,469. Trademarks i-STAT is a registered trademark of the Abbott Group of Companies in various jurisdictions. Windows is a registered trademark of Microsoft Corporation. Abbott Point of Care Inc. Abbott Park, IL 60064 • USA Emergo Europe Molenstraat 15 2513 BH, The Hague The Netherlands Tel: +31.70.345.8570 Fax:+31.70.346.7299 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...

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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 2015, your i-STAT 1 System Manual should be configured with the contents as listed below and in the order shown. ITEM

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TECHNICAL BULLETIN: ANALYZER CODED MESSAGES

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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 PROCEDURE MANUAL

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This Manual This manual describes the i-STAT1 Analyzer and the Central Data Station software. Related sections are grouped behind tabs. 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....

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The i-STAT System consists of: i-STAT Cartridges i-STAT 1 Analyzer Portable Printer Quality Assurance Materials • Electronic Simulator • Control Solutions • Calibration Verification Set (for cartridges) Data Management System • • • i-STAT 1 Downloader i-STAT 1 Downloader/Recharger Data Manager Central Data Station (data management software for cartridges) Data Manager Printer LIS/HIS Interface Software Selection of Components The selection of system components is dependent on factors unique to each facility such as: Types of tests to be performed Number of testing sites Number of tests per...

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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. 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...

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Definition Manufacturer's lot number or batch code. The lot number or batch will appear adjacent to this symbol. Catalog number, list number, or reference number. The number adjacent to this symbol is used to reorder the product. Serial number. The serial number will appear adjacent to this symbol. Model number. The model number will appear adjacent to this symbol. Date of manufacture. Manufacturer In vitro diagnostic medical device. Authorized Representative for Regulatory Affairs in the European Community. Contains sufficient for < n > tests. Direct Current (DC) Alternating Current (AC)...

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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...

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The following symbols are used on the i-STAT Portable Clinical Analyzer Keypad Key used to activate the display. Key used to enter information. Key used to print a test record. Key used to clear an incorrect entry. The following symbols are used on i-STAT Value Assignment Sheets Na K Cl Glu Lac Crea pH PCO2 PO2 iCa BUN/UREA Hct ACTc Celite ACT ACTk Kaolin ACT PT/INR Hb TCO2 HCO3 BE (b&ecf) 1-6 TEST Sodium Potassium Chloride Glucose Lactate Creatinine pH Partial pressure of carbon dioxide. Partial pressure of oxygen. Ionized Calcium Urea nitrogen/Urea Hematocrit Activated Clotting Time with...

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AnGap sO2 cTnI CK-MB BNP TEST Anion Gap Oxygen saturation Cardiac Troponin I Creatine Kinase MB Isoenzyme B-type Natriuretic Peptide Abbott Point of Care Inc. warrants this medical product (excluding disposable or consumable supplies) against defects in materials and workmanship for one year from the date of shipment. If Abbott Point of Care Inc. receives notice of such defects during the warranty period, Abbott Point of Care Inc. shall, at its option, either repair or replace products which prove to be defective. With respect to software or firmware, if Abbott Point of Care Inc. receives...

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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. Refer to the Cartridge and Test Information section of this manual for information on analytes that can be measured using i-STAT cartridges. BEFORE YOU USE THE ANALYZER Install Batteries See the Care of the Analyzer section in this manual for the procedure to install the disposable batteries. If a rechargeable battery is to be used, the disposable batteries can be used while the rechargeable battery pack is charged in the...

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