1. i-STAT POINT OF CARE SYSTEM

2. OVERVIEW Definition Benefits, features, specifications Functions
Components
Supplies and storage requirements
Sample collection & precautions
Method to use & maintenance
Quality control
Working principle

3. i-STAT System
The Abbott i-STAT portable clinical analyser is a true Point Of Care analyser designed to be used at the patient's bedside for critical care tests such as blood gases, electrolytes, metabolites and coagulation. There are a number of cartridges testing different combinations of analytes. This single testing system  eliminates the need for different analysers.
The fully automated i-STAT System offers a broad menu of tests for diagnostic and treatment indicators related to disease state management and clinical practice guidelines.

4. Benefits of the i-STAT System
Supports a patient-centric approach to health care
Optimises system efficiency by eliminating process
Supports quality and compliance requirements
Leverages the power of a single, integrated bedside testing solution through:
a comprehensive menu of tests
a single testing system, rather than multiple systems and protocols
standardised lab-quality bedside testing
simplified implementation, training, and regulatory requirements

5. Features of the i-STAT
Uses biosensor technology and advanced microfluidics
Automatic calibration
Fast, reliable lab accurate results in just 2 minutes
Portable - battery operated
Up to 50 results automatically stored / 5000 in STAT1
Minimal maintenance required
Small sample size required - just two drops of blood
Security features and lockout protocols assure test result integrity
Virtually eliminates manual entry errors through integrated bar code scanning (STAT 1 only)
The i-STAT analyser provides effortless connectivity with the laboratory via a state-of-the-art data management system or print directly to an external printer
Liquid quality controls available
Operator and patient ID

6. STAT1 has password protection
Wide test menu including:
Blood gases
Electrolytes
Chemistries
Coagulation
Cardiac markers (cTnI)
Haematology

7. i-STAT Analyser Specification

8. Analyzer Functions

9. System Overview
Cartridges :A single‑use disposable cartridge contains a microfabricated sensor array, a calibrant solution, fluidics system, and a waste chamber. 
Analyzer- A hand‑held analyzer into which the blood‑filled cartridge is placed for analysis automatically controls all functions of the testing cycle including fluid movement within the cartridge, calibration, and continuous quality monitoring. 
Central Data Station- A dedicated desktop computer, called the I‑STAT Central Data Station,  provides the primary information management capabilities for the I‑STAT System. 

11. Cartridges

14. Supplies and Storage requirements
General guidelines for CARTILAGES storage:
sealed in individual pouches or portion packs
main supply should be stored at a temperature between 2 to 8°C (35 to 46°F).
Should not be freezed.
Should not be returned to the refrigerator once they have been at room temperature
should not be exposed to temperatures above 30°C (86°F).
Cartridges should remain in pouches until time of use .
Expired cartilages should not be used.
Cartilages with punctured pouches should not be used.

15. Electronic Simulator
Store at room temperature
Contact pads should be protected from contamination by replacing the plastic cap and placing the Electronic Simulator in its protective case after use.
MediSense Precision Glucose Control Solutions for test strips( N/A at UAMS)
Should be store at temperatures between 4 and 30C (39 and 86F).
Each bottle of control solution is stable for 90 days after opening .
The date of opening should be written on the bottle label
The bottle should be properly and tightly closed immediately after use.

16. BLOOD SPECIMENS Blood Collection Equipment
Cartridges for
Skin puncture
Venipuncture
Arterial puncture
Anticoagulant
Blood Gas/Electrolytes/Chemistries/Hematocrit
lancet and capillary collection tube
lithium or sodium heparin collection tubes
Plain syringe or blood gas syringe with heparin
lithium or heparin
ACT
Not recommended
plain plastic syringe ×
Glucose Test Strips
lancet and capillary collection tube or direct application of sample to test strip
collection tube or syringe
lithium heparin, sodium heparin, or EDTA

17. Troponin I/ cTnI and CK-MB
Cartridges for
Skin puncture
Venipuncture
Arterial puncture
Anticoagulant
PT/INR
lancet only needed. Cartridge can be filled directly from the finger.
plain plastic syringe - ×
Troponin I/ cTnI and CK-MB
not recommended
lithium or sodium heparin collection tubes and disposable transfer device
lithium or sodium heparin
BNP
plastic EDTA collection tubes and disposable transfer device or plastic EDTA syringe
EDTA

18. Criteria For Specimen Rejection
Evidence of clotting
Specimens collected in vacuum tubes with anticoagulant other than lithium or sodium heparin (or EDTA for BNP or glucose cartridges).
Specimens for ACT or PT/INR collected in glass syringes or tubes or with anticoagulant of any kind
Syringe for pH, PCO2, PO2 and TCO2 with air bubbles in sample
Incompletely filled vacuum tube for the measurement of ionized calcium, PCO2, HCO3 or TCO2
Other sample types such as urine, CSF, and pleural fluid

19. Precautions: Avoid the Following Circumstances
Drawing a specimen from an arm with an I.V.(Intravenous Therapy).
Stasis (tourniquet left on longer than one minute before venipuncture)
Extra muscle activity (fist pumping)
Hemolysis (alcohol left over puncture site, or a traumatic draw)
Icing before filling cartridge
Time delays before filling cartridge, especially lactate, ACT, and PT/INR
Exposing the sample to air when measuring pH, PCO2, PO2 and TCO2.

20. Preparation for Use
An individual cartridge may be used after standing 5 minutes, in its pouch, at room temperature
An entire box should stand at room temperature for one hour before cartridges are used.
Glucose test strips require no preparation for use.
do not run ACT cartridges while the handheld is in the Downloader/Recharger.

21. 4 easy steps to use

22. How to use?? Power on the analyzer.
Select iSTAT cartridge on the Test Menu.
Scan or enter the operator ID or patient ID.
Select the appropriate cartridge for testing.
Cartridge to reach RT(18 – 30 °C) before use. Remove cartridge from the pouch and place on a flat surface.
Collect the blood specimen in recommended equipment and mix well.
Dispense sample slowly until it reaches the fill mark indicated on the cartridge label. Avoid bubbles and air spaces.
Seal the test cartridge by folding the plastic snap closure over the sample well.
Insert test cartridge into the iSTAT analyzer cartridge port. “Cartridge Locked” message displayed.
Cartilage activates the analyzer. “IDENTIFYING CARTRIDGE” message displayed.

24. Within 2-5 min, results are displayed
Results will display for 5 minutes before timing out and automatically powering off.
Remove the cartridge after the “Cartridge Locked” message disappears from the
display screen

25. Test Cycle
The test cycle is initiated by the insertion of a cartridge into the analyzer.  During the test cycle the following functions are performed by the analyzer:
 Electrical contact is made with the cartridge.
Cartridge type is identified
Calibration fluid is released to the sensors.
Barometric pressure is measures.
sensors are heated to 370C.
Electrical signals generated at the sensors are measure.
Calibrant solution is displaced with sample.
Electrical signals generated at the sensors are measured.
Operator and Patient ID numbers are accepted.
Blood gas parameters are accepted.
Results are calculated and displayed.
Results are stored.

26. i-STAT Preventative Maintenance
Cleaning and Decontamination
Keep the analyzer system dry. Liquid contamination may damage the analyzer system.
Clean the analyzer as needed with a disinfectant SANI-Cloth and dry. (Power Off)
Replacing Batteries
Batteries must be replaced when the flashing “Low Battery” icon appears in the left lowerdisplay screen. The operator then has a limited number of tests that may be analyzedbefore complete battery depletion

27. Software Update
The i-STAT® Analyser requires regular software updates every 6 months. If an update is not performed, then the unit will cease to function until the update occurs.
The i-STAT 1 System is designed to eliminate operator influence on delivered results.
Due to the continuous manufacturing process improvements to the i-STAT System, it is necessary to update standardization values from time to time to maintain long-term consistency of performance.
These updates are equivalent to manually adjusting calibration on a traditional laboratory analyzer.
Software updates can be performed in several ways. In most instances, the software update will be conducted in the health centre by following some simple instructions issued by the iPOCT, and involves placing the i-STAT® Analyser in the downloader at the appropriate time.

28. Quality Control QC of the ‘Analyser’
QC of the ‘analyser’ itself is achieved by use of an electronic check cartridge which simulates the signal from a real test cartridge at low and high signal points.
The response is compared with reference values programmed into the analyser firmware, taking the place of a conventional bi-level control check. This process while checking the analyser, does not Check the cartridges.

29. QC of the Test Cartridges
Due to the wide range of tests performed by the analyser, a variety of QC materials are required although the processes are simplified as far as possible.
A frozen plasma-based material is used for TnI and BNP QC.
Coagulation tests utilise a lyophilised citrated whole plasma material which is re-calcified immediately prior to use
Control of the Hb/Hct requires a specific fixed whole blood control material, similar to controls used by haematology analysers.
QC of the blood gas/chemistry cartridges is performed using routine liquid bi- or tri-level aqueous control material familiar to operators of conventional blood gas analysers.

30. Working Principle
The i-STAT analyzer is a microprocessor-controlled electromechanical instrument.
SENSORS in the cartiridges are thin film electrodes micro fabricated onto silicon chips. Sensing functionality is imparted to each electrode by a number of chemically sensitive films coated over the active region of the electrode. They are of three types
Potentiometric
Amperometric
Conductometric
Electrical signals from cartridge sensors are conducted from contact pads on the cartridge to the sensor interface circuit board which amplifies the signal to be processed further. Four signals are replayed-
Potentiometric signal, amperometric signal, an AC fluid conductivity signal , a digital identification code for the particular cartridge.

31. Analog to digital conversion converts all signals into digital form so that microprocessor can perform mathematical calculation. 8 analog signals are measured-

32. References i-STAT System Manual, 3/3/2010
i-STAT Software Upgrade Technical Bulletins
i-STAT User Guide 2010
“Chemistry by i-STAT”, Oregon Health & Science University ,Hospitals And Clinics
“i-STAT® 1 ANALYSERS ,” Quality & Safety Team & Flinders University International Centre for Point-of-Care Testing, Remote Health Atlas ,Section 11
Cameron L Martin “i-STAT – Combining Chemistry and Haematology in PoCT,” Clin Biochem Rev Vol 31 August 2010, pp.81-84

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