iStat Portable Clinical Analyzer User manual
Portable Clinical Analyzer
& Test Cartridges
Manufacturer:
i-STAT Corporation
104 Windsor Center Drive
East Windsor, NJ 08520 • USA
USA Tech Suport: (800) 366-8020
Fax: (609) 443-9310
Art: 714199-00D Rev. Date: 06/29/04
Emergo Europe
P.O. Box 18510
2502 EM The Hague
The Netherlands
Tel: (31)70 345 8570
Fax: (31)70 346 7299
User Guide
System Components
▲
Infrared
Light-
Emitting
Diode
▲
Display
Screen
▲
Soft
Keys
▲
Key
Pad
Cartridge Port
Power-on
Indicator
▲
IR
Link
Cradle
Analyzer
Calibrant
(beneath
▲
IR Link/Printer Cradle
Connected to Printer
Power
Switch
▲
▲
▲
Paper Advance
▲
Solution
label)
Snap
Cover
AC Adapter
▲
▲
Port
Cartridge
Contact Pads
▲
▲
Sensors
▲
▲
Sample Well
IR Receiver
Cradle
▲
IR Link
▲
Status Light
Contact Pads
▲
▲
Plug to Central
Data Station
Electronic
Simulator
▲
For in vitro diagnostic use.
See System Manual for instructions.
Intended Use: The i-STAT® Portable Clinical Analyzer is intended for use with
i-STAT cartridges for the in vitro quantification of various analytes in whole
blood.
© Copyright 2004. i-STAT Corporation. All Rights Reserved.
Quality Check Messages and Codes
Blood Collection
MESSAGE ACTION EXPLANATION
SIM Use Electronic Simulator Simulator must be used once every 24
BAT
SFT Update software Software will expire 15 days after SFT is
Date Invalid Check clock on Status Page. The software checks for an unrealistic date.
Dead Batteries Replace Batteries The analyzer does not have enough power
TEMPERATURE OUT OF
RANGE
CARTRIDGE ERROR Use another cartridge
CARTRIDGE TYPE NOT
RECOGNIZED
CARTRIDGE PREBURST Use another cartridge Calibrant released too soon. Take care not
SAMPLE POSITIONED
SHORT OF FILL MARK
SAMPLE POSITIONED
BEYOND FILL MARK
INSUFFICIENT SAMPLE Use another cartridge Cartridge is underfilled or bubbles trapped
UNABLE TO POSITION
SAMPLE
CARTRIDGE NOT
INSERTED PROPERLY
ANALYZER ERROR
ANALYZER ERROR
SYSTEM INTERRUPTED Use another cartridge Conditions such as batteries removed be-
Invalid or Expired CLEW Update software Software expired or corrupt. Verify that the
Replace batteries soon Approximately 50 more cartridges can
Check Status Page. Use another
cartridge.
Use another cartridge The analyzer could not identify the type of
Use another cartridge Sample did not reach fill mark. Tilt
Use another cartridge Cartridge is overfilled. Fill new cartridge
Use another cartridge Inadequate seal; sample overflowed well;
Reinsert cartridge Push cartridge straight through door until it
Use Electronic Simulator If the analyzer passes the simulator check,
See System Manual See System Manual
hours, or as needed for regulatory compliance.
be tested.
first displayed.
Check Status Page. If date is correct, call
Technical Services.
to complete the testing cycle.
The analyzer is too warm or too cool, or
the room is too warm or too cool.
The analyzer detected a problem with the
calibrant solution.
cartridge inserted. Check software version.
Check to see if cartridges are expired.
to press over cartridge label area.
cartridge to aid sample flow into sample
chamber.
to fill mark. Press on snap closure, and not
over sample well when closing.
in sample.
sample clotted; snap closure left open.
will go no further.
continue to use. If not, call i-STAT Technical
Services.
fore analyzer deactivated when cartridge
is still in analyzer.
analyzer’s date is correct.
Acceptable Samples for Cartridges
Arterial: Plain syringe, heparinized syringe labeled for analytes to be
tested and filled to capacity, or syringe with minimum volume of heparin to
prevent clotting (10 U/mL of blood). For ionized calcium, use balanced
heparin syringes. Mix heparinized syringes by rolling between palms for
at least 5 seconds in 2 directions, then invert the syringe repeatedly for at
least 5 seconds. Test for lactate immediately. Test for other analytes within
10 minutes.
• Avoid drawing air into syringes for blood gas and ionized calcium
tests.
• If not tested immediately, remix and discard 2 drops of blood before
filling cartridge.
• Do not use iced samples.
Venous: Collection tube with lithium or
sodium heparin filled to capacity and mixed
by gentle inversion at least 10 times. Test
within 10 minutes.
• Do not leave tourniquet on for more
than 2 minutes.
• Do not draw above an I.V.
Skin puncture: Lithium heparin capillary
tubes for testing all analytes but ionized
calcium. For all analytes including ionized calcium, use plain or balanced
heparin capillary tubes. Test immediately.
• Allow alcohol to dry over puncture site before collecting sample.
• Do not “milk” finger or heel while collecting sample.
Coagulation Tests:
• The ACT test can be performed using venous or arterial samples,
while the PT/INR test can be performed using capillary or venous
samples.
• Use plain plastic syringes or plastic evacuated tubes with no
anticoagulant, activators, or serum separators.
• Test sample immediately upon draw.
• Some experts recommend drawing and discarding a sample of at
least 1 ml prior to drawing samples for coagulation testing.
• If a second measurement is needed, draw a fresh sample.
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