i-STAT 1 is a single, revolutionary, integrated point of care handheld blood analyzer testing solution from Abbott , which accelerates the patient care decision-making process with a system that makes patient-side testing fast, easy and accurate. i-STAT 1 operates with the advanced technology of single-use i-STAT test cartridges. Together with the i-STAT System,i-STAT 1 provides health care professionals with the information they need to rapidly make treatment decisions, which lead to enhanced quality of care and improved system efficiency.
1.Get lab-quality results fast: You only need 4 steps to get accurate results in less time and at less cost.
2.Very easy to use: It’s very easy for operator to operate the machine under full set of instructions.
3.Powerful test menu: Single-use test cartridges cover a large powerful menu of testing options in one platform.
4.Powerful support: 24/7 technical support ensures that the i-STAT 1 System is supported at all times.
5.Advanced information management: Advanced technology of STAT 1 notes help integrate test results into your facility's software.
The i-STAT 1 Analyzer is intended to be used with i-STAT cartridges for the in vitro quantication of various analytes in whole blood. Analyzers and cartridges should be used by healthcare professionals trained and certied to use the system and should be used according to the facility’s policies and procedures.
With the i-STAT 1 System, the FDA has categorized the tests included on the i-STAT G, Crea, E3+, EC4+, 6+, and CHEM8+ cartridges as waived when testing is performed using venous whole blood samples collected in sodium or lithium heparin evacuated tubes. Other venous whole blood samples, capillary and/or arterial samples tested using these same cartridges on the i-STAT 1 System are categorized by the FDA as moderate complexity.
For waived testing, laboratories are required to follow the manufacturer’s requirements for the testing. They may elect to perform additional quality control testing (such as the QC required for a moderate complexity test) but this does not change the FDA categorization of the test as waived or release the laboratory’s responsibility to follow the manufacturer’s instructions for it as a waived test.
Other testing performed with the i-STAT 1 System (other than the testing performed using the aforementioned cartridges) is FDA categorized as "moderate complexity".
The i-STAT System incorporates a comprehensive group of components required to carry out 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 Central Data Station program provides system management tools including real-time monitoring of testing and operator competency.
The i-STAT System consists of:
The selection of system components is dependent on factors unique to each facility such as types of tests to be performed, number of testing sites, number of tests per site, system administration requirements.
To perform cartridge testing, the operator fills a cartridge with sample, seals the cartridge with its snap closure, and inserts the cartridge into the analyzer. Inserting the cartridge activates the analyzer. Alternatively, the cartridge test cycle can be initiated from the keypad/menu system. The unit-use cartridge contains all components to perform one or more tests including: calibrating solution, sample handling system, sensors and reagents. The analyzer automatically controls all steps in the testing cycle, which may include: fluid movement, reagent mixing, calibration and thermal control. Quality checks are performed continuously throughout the test cycle. Operator and patient IDs and patient chart information can be entered. When the test cycle is completed, results are displayed and the test record is stored.
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.
The i-STAT System automatically runs a comprehensive set of quality checks of analyzer and cartridge performance each time a sample is tested. This internal quality system will suppress results if the analyzer or cartridge does not meet certain internal specifications (see Quality Control section in System Manual for detailed information). To minimize the probability of delivering a result with medically significant error the internal specifications are very stringent. It is typical for the system to suppress a very small percentage of results in normal operation given the stringency of these specifications. If however the analyzer or cartridges have been compromised, results may be persistently suppressed, and one or the other must be replaced to restore normal operating conditions. Where unavailability of results while awaiting replacement of analyzers or cartridges is unacceptable, Abbott Point of Care Inc.recommends maintaining both a backup i-STAT System analyzer and cartridges from an alternate lot number.
Symbols can be helpful in reducing the necessity for translating important information into multiple languages, particularly where space is limited. he following symbols may be found on components of the i-STAT System.
BEFORE YOU USE THE ANALYZER
1.Install Batterie.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.
2.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.
3.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.
4.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.
5.Perform Quality Check.Use the Electronic Simulator to verify the cartridge-reading performance of new or repaired analyzers.
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 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 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.
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: Do not short circuit, incinerate or mutilate the recharegable batteries.
Low Battery Warning: The analyzer will display “Low Battery” when the On/Off key is pressed. Additionally, a flashing battery icon will display on the results screens, as well as the Test Menu and Administration Menu screens when battery replacement is needed. Data is not lost when batteries are fully discharged.
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.
Caution: i-stat 1 is the handheld blood analyzer produced by Abbott, not the STAT1 which listed in wikipedia (https://en.wikipedia.org/wiki/STAT1)
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