Abbott i stat 1 Portable Blood Analyzer.
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: 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.
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 the 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. 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 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.
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.
DESCRIPTION
Specifications
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.
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.
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.
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.
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.
Infrared Communication Window: The Infrared Communication Window provides the analyzer with two-way communication to the Central Data Station via a Downloader, allows analyzer-to-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 that require thermal control at 37°C is inserted into the analyzer.
Barometric Pressure Sensor: The analyzer contains a solid-state barometric pressure sensor, which determines the ambient atmospheric pressure used for the PO2 sensor calibration.
Cartridge Test Cycle: An operator starts a cartridge test cycle either by inserting a cartridge into the analyzer or by selecting the i-STAT Cartridge option from the Test or Quality Tests Menu.
The analyzer:
- 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 the sample (when applicable)
- measures electrical signals generated by the sensors and samples
- accepts the operator and patient IDs scanned or entered by the operator
- accepts the chart page information
- calculates and displays results
- stores results
Data Entry: Data that can be scanned into the analyzer or entered via the keypad includes:
- 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’s 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
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, indicate a problem
with the sample, calibration, sensors, and mechanical or electrical functions of the analyzer,
They 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 the Central Data Station, 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 the Central Data Station. 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.
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
- a successful barcode entry.
- The results are ready.
- A Quality Check Message is displayed.
The analyzer can be customized to disable beeping when a key is pressed, or when results or messages are displayed.
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.
i-STAT1 Menu Tree: There are two main menus: The Test Menu and the Administration Menu. If the glucose test strip function is disabled, test strip options will not be displayed.
i-STAT CARTRIDGE
Contents
The unit-use disposable cartridge contains many of the subassemblies typically found in complex laboratory systems. Microfabricated thin film electrodes or sensors are assembled in unit-use cartridges containing: Calibrant solution in cartridges with sensors for blood gases, electrolytes, chemistries, and hematocrit
- Reagents in cartridges with sensors for coagulation
- sample handling system
- waste chamber
- An array of miniaturized sensors
- Conductive pads to make electrical contact with the analyzer
- Heating elements in cartridges require thermal control at 37 °C
The following diagram shows how a typical blood gas/chemistry cartridge is
constructed.
Sample Handling System
Parts
Function
Sensor: Channel The sensor channel directs the sample from the sample chamber to the sensors. An extension of this channel becomes a waste chamber to receive the calibrant solution as it is displaced by the sample.
Air Chamber: An air chamber is located in the blood gas/electrolyte/ chemistry/hematocrit cartridges between the sample chamber and sensor channel. This creates an air segment between the calibrant solution and the sample to prevent the two from mixing. The size of the air segment is monitored by the analyzer. Sample Chamber The sample chamber includes the sample well and the channel leading from the well up to the fill mark. When filled, the sample chamber contains sufficient sample for testing. Sample volume and placement are monitored by the analyzer.
Bladder: The bladder (concealed by the label) is connected to the sample well. The analyzer presses on the bladder to displace calibrant solution from the sensors, to move the sample from the sample chamber to the sensors, or to mix the sample and reagents.
Snap Closure: The snap closure creates an airtight seal necessary for proper fluid movement within the cartridge. The closure also ensures that calibrant and sample
remain contained within the cartridge during the testing cycle and subsequent disposal. Immunoassay cartridges, such as cTnI, use a plastic slide enclosure clip.
Air Vent: An air vent on the underside of the cartridge, beyond the fluid front, allows the calibrant and the sample to flow forward, but not out of the cartridge.
Waste Chamber: A waste chamber (beneath the cartridge label) holds calibrant fluid after it has been used.
i-STAT 1 DOWNLOADER
Function
The Downloader converts infrared transmissions of test records from the analyzer to electrical form and transmits (uploads) them to the Data Manager. The Downloader also converts electrical signals from the Central Data Station to infrared transmissions, which are transmitted (downloaded) to the analyzer. Transmission is automatic when an analyzer is placed in a Downloader. The Downloader comes in two formats:
- Downloader: A low-profile table-top unit with “arms” between which the analyzer is placed, and
- Downloader/Recharger (DR): a cradle that the analyzer is placed within.
Both Downloader formats are available for use with direct wiring (serial format) or Ethernet cabling (network format). Unless indicated otherwise, references to the Downloader apply to the Downloader/Recharger as well. The Downloader/Recharger can recharge a rechargeable battery in the analyzer. If the analyzer contains a rechargeable battery, the battery begins recharging automatically as soon as the analyzer is placed in the Downloader/Recharger. The Downloader/Recharger also has a compartment for recharging a rechargeable battery outside the analyzer.
Specifications
Power Supply
Downloader/ Recharger Indicator LEDs
Power Requirements: The Downloaders require one power outlet. The Downloader and Downloader/Recharger must be used with the AC power supply adapter supplied with them. The Downloaders are capable of supplying power to the portable printer, which reduces the number of power outlets required for downloading and printing
area
DR Affect on Ambient Operating Temperature Range
The operating temperature for an i-STAT 1 Analyzer is 16°C to 30°C. The DR and a Rechargeable Battery may raise the temperature of the i-STAT 1 Analyzer
2°C-3°C relative to the ambient temperature if:
- The Analyzer is frequently lifted and replaced into the DR
- Multiple thermally controlled cartridges are run in the Analyzer while it is in the DR.
Programming and Connections: Details for programming the Network Downloaders can be found in the Downloader Programming and Wiring section of this manual. Diagrams and instructions for connecting peripheral components to the Downloader can also be found in the Downloader Programming and Wiring section.
Transmitting Data from Downloader to the Data Manager
To transmit through a Downloader to the Data Manager, place the analyzer between the arms on the front of the Downloader with the test strip port end touching the Downloader. When properly aligned, the red proximity light will turn on, and the analyzer will automatically transmit (upload) all unsent results. (The analyzer does not need to be turned on.) Do not move the analyzer while the message “Communication in Progress” is displayed on the screen.
Transmitting Data from Downloader / Recharger to the Data Manager
To transmit data through a Downloader/Recharger, place the analyzer in the Downloader/Recharger’s cradle. When properly aligned, the blue proximity light will turn o,n and the analyzer will automatically transmit (upload) all unsent results. (The analyzer does not need to be turned on.) Do not move the analyzer while the message “Communication in Progress” is displayed on the screen
Transmitted Information: The following information is transmitted from the analyzer with each test record:
- The date and time the test was performed
- Operator ID and Patient ID or Quality Test fluid lot number
- All information entered by the operator, such as lot numbers, sample type, and comment codes
- Result(s)
- Serial number of the analyzer
- The use count of the analyzer
- Application software version in the analyzer
- Standardization software in the analyzer
Troubleshooting
The analyzer displays “Waiting to Send” until communication is established with the Central Data Station. When communication is established, the message changes to “Communication in Progress,” and the arrows circle until upload is complete. If the message does not change from “Waiting to Send” or if the Analyzer Status screen reports unsent results after the upload, refer to Support Services in the Troubleshooting section.
Charge Battery Before Use
Pua t new rechargeable battery in the external charging bay on the i-STAT®1 Downloader/Recharger for 40 hours. The battery will be 100% charged and ready for use. An analyzer with disposable batteries may be placed on the Downloader/
Recharge to download data until the rechargeable battery is ready.
Keep Battery Charged
A fully charged battery, if not periodically recharged, will self-discharge in approximately three months. Prevent self-discharge by either (1) keeping the rechargeable battery in an Analyzer that is periodically on the Downloader/
Recharger, or (2) store the rechargeable battery separately in the external charging bay on the Downloader/Recharger.
Charging the Rechargeable Battery
Placing an analyzer in a Downloader/Recharger will automatically initiate recharging of the rechargeable battery. The indicator light on top of the Downloader/Recharger will be green (trickle charge), red (fast charge), or blinking red (fast charge pending) when an analyzer with a rechargeable battery is placed in the Downloader/Recharger. No damage will be caused if an analyzer with disposable batteries installed is placed in the Downloader/Recharger.
Charging a Rechargeable Battery in the External Recharge Compartment
Placing a rechargeable battery into the recharging compartment will automatically initiate trickle recharging. The indicator light near the recharging compartment will be green when a rechargeable battery is placed in the compartment.
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