Abbott i-Stat User manual

Abbott Point of Care Inc.

104 Windsor Center Drive

East Windsor, NJ 08520 • USA

USA Tech Suport: [phone]

Fax: [phone]

Emergo Europe

P.O. Box 18510

2502 EM The Hague

The Netherlands

Tel: [phone]

Fax: [phone]

i-STAT

i-STAT®1 User Guide

©2006 Abbott Point of Care Inc. All rights reserved. Printed in USA. i-STAT is a registered trademark of Abbott Laboratories.

Art: 714254-01E

Rev. Date: 07/18/06

System Components

i-STAT 1 Analyzer

i-STAT 1 Downloader

i-STAT 1 Downloader/

Recharger

For in vitro diagnostic use. See System Manual for instructions.

i-STAT cartridge

Foil Packet containing the MediSense® Precision PCx™ or PCx™ Plus Glucose Test Strip

Electronic

Simulator

Martel Printer

Intended Use: The i-STAT 1 Analyzer is intended for use with i-STAT cartridges for the in vitro quantification of various analytes in whole blood and with the Abbott Medisense® Precision PCx™ and PCx™ Plus Blood Glucose Test Strips for the in vitro quantification of glucose in whole blood.

Message	Cause	Action
Strip Error	A wet strip inserted, strip	Repeat test using proper procedure.
	pulled out during testing	Check Analyzer Status under the
	cycle, temperature of	Administration Menu for analyzer
	analyzer exceeds operation	temperature.
	temperature for strip testing
No display	Disposable batteries dead	Change disposable batteries or
	or rechargeable battery fully	recharge battery. If still no display,
	discharged. Keypad not	call Support Services.
	responding. Start switch
	broken.
Cartridge Locked	Dead battery(s). Mechanical	Wait until analyzer turns off. Turn
does not disap-	problem.	analyzer on. If resets, remove
pear after test cycle		cartridge. If not, change or recharge
completed		battery(s) and turn analyzer on.

Blood Collection

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. Samples for pH, PCO2, PO2 , TCO2 and ionized calcium should be tested within 10 minutes. Test for other analytes within 30 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.

•For venipuncture, some experts recommend drawing and discarding

asample of at least 1 mL prior to drawing samples for coagulation testing.

•If a second measurement is needed, draw a fresh sample.

•For In-dwelling line testing for ACT:

a.Fluid drip through the line must be discontinued.

b.Withdraw 2 mL of blood into a syringe and discard it.

c.Withdraw the sample into a fresh plastic syringe with no anticoagulant, and test immediately.

•For extracorporeal line testing for ACT:

a.Flush the extracorporeal blood access line by withdrawing 5 mL of blood into a syringe and discard the syringe.

b.Withdraw the sample into a fresh plastic syringe with no anticoagulant, and test immediately.

•For skin puncture testing for PT/INR, see the section on "Patient Test Procedures".

CHEM8+ Cartridges

•CHEM8+ cartridges require the use of:

a.whole blood collected in non-heparinized capillary tubes, evacuated tubes, or syringes, as long as sample is tested immediately upon draw,

b.heparinized whole blood collected in balanced heparin syringes or capillary tubes, or

c.heparinized whole blood collected in evacuated tubes containing lithium or sodium heparin, as long as the tubes are filled to capacity.

Troponin I/cTnI and CK-MB Tests

•cTnI and CK-MB cartridges require the use of either:

a.heparinized whole blood or plasma samples collected in syringes or evacuated tubes containing lithium or sodium heparin, or

b.non-heparinized whole blood or plasma samples tested within one minute of drawing from a patient into a plastic syringe or plastic evacuated tube containing no additives.

•The use of whole blood or plasma samples containing other anticoagulants such as EDTA, oxalate, and citrate will cause deactivation of the alkaline phosphatase, resulting in decreased cTnI or CK-MB readings.

•Capillary tubes and direct skin punctures (e.g. fingersticks) should not be used with the cTnI or CK-MB cartridge.

•Samples should not be used unless the blood collection tube is filled at least half full.

BNP Tests

•BNP cartridges require the use of EDTA whole blood or plasma samples collected in plastic syringes or evacuated tubes containing EDTA.

•The use of whole blood or plasma samples containing other anticoagulants such as oxalate and citrate is not reccommended.

•When drawn into an evacuated tube containing EDTA, samples should not be used unless the blood collection tube is filled at least half full.

•Capillary tubes and direct skin punctures (e.g. fingersticks) should not be used with the BNP cartridge.

Quality Check Messages and Codes

Message	Cause	Action
Date Invalid, Check	Date outside six month	Select 5-Clock Set from
Clock	lifetime of software.	Administration Menu. (Password
		protected.)
Dead Batteries,	Insufficient power to	Replace disposable batteries or
Replace Batteries	complete a test cylce.	recharge the rechargeable battery.
Temperature Out of	Temperature outside	Check analyzer temperature by
Range, Check Status	operating range of 16 to	pressing 1 for Analyzer Status under
page	30 °C.	the Administration Menu. Move
		analyzer to warmer area if below
		operating range or to cooler area if
		above the range.
Invalid or Expired	Software expired or corrupt.	Verify that the analyzer’s date is
CLEW		correct. Change software if expired.
		Update again if not expired.
Analyzer Interrupted,	Last cartridge run not	Check the battery pack inserted
Use Another	completed.	properly. Check for Low Battery
Cartridge		startup warning.
Cartridge Error	Usually problem with sample	Use another cartridge. If same code
	or cartridge filling.	repeats more than twice, try another
		analyzer.
Cartridge Preburst	Calibrant pack burst before	Use another cartridge - do not press
	cartridge inserted into	on center of cartridge. Check that
	analyzer.	cartridges have not been frozen.
Unable to Position	Cartridge not sealed. Clot in	Use another cartridge.
Sample	sample. Aberrant cartridge.
Sample Positioned	Cartridge underfilled.	Use another cartridge - fill to Fill
Short of Fill Mark		Mark.
Sample Positioned	Cartridge overfilled.	Use another cartridge - do not fill
Beyond Fill Mark		beyond Fill Mark.
Test Cancelled by	User did not respond to	No action required.
Operator	mandatory prompt before
	analyzer time out.
Cartridge Type Not	Software does not recognize	Update software. Check to see if
Recognized	cartridge.	cartridges are expired.
Analyzer Error, Use	Analyzer detects problem	Insert the Electronic Simulator. If
Electronic Simulator	from which it is likely to	PASS, continue to use analyzer.
	recover.
Analyzer Error, See	Analyzer detects problem	Insert Electronic Simulator. If PASS,
Manual	from which it may not	insert a cartridge with sample
	recover.	or control. If the code does not
		reappear, continue to use analyzer.