Abbott iStat 1 User guide

i-STAT

Abbott Point of Care Inc. 104 Windsor Center Drive East Windsor, NJ 08520 • USA USA Tech Suport: (800) 366-8020 Fax: (609) 443-9310

Emergo Europe P.O. Box 18510 2502 EM The Hague The Netherlands Tel: (31)70 345 8570 Fax: (31)70 346 7299

Art: 714254-01E Rev. Date: 07/18/06

i-STAT®1 User Guide

System Components

i-STAT 1 Analyzer

i-STAT cartridge

Foil Packet containing

the MediSense®

Precision PCx™ or

PCx™ Plus Glucose Test

Strip

i-STAT 1

Downloader

i-STAT 1 Downloader/

Recharger

For in vitro diagnostic use.

See System Manual for instructions.

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.

Electronic

Simulator

Martel Printer

Message Cause Action

Strip Error A wet strip inserted, strip

No display Disposable batteries dead

Cartridge Locked does not disappear after test cycle completed

pulled out during testing cycle, temperature of analyzer exceeds operation temperature for strip testing

or rechargeable battery fully discharged. Keypad not responding. Start switch broken.

Dead battery(s). Mechanical problem.

Repeat test using proper procedure. Check Analyzer Status under the Administration Menu for analyzer temperature.

Change disposable batteries or recharge battery. If still no display, call Support Services.

Wait until analyzer turns off. Turn analyzer on. If resets, remove cartridge. If not, change or recharge 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, PO 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

a sample 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.

2 ,

TCO

• 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 Clock

Dead Batteries, Replace Batteries

Temperature Out of Range, Check Status page

Invalid or Expired CLEW

Analyzer Interrupted, Use Another Cartridge

Cartridge Error Usually problem with sample

Cartridge Preburst Calibrant pack burst before

Unable to Position Sample

Sample Positioned Short of Fill Mark

Sample Positioned Beyond Fill Mark

Test Cancelled by Operator

Cartridge Type Not Recognized

Analyzer Error, Use Electronic Simulator

Analyzer Error, See Manual

Date outside six month lifetime of software.

Insufﬁcient power to complete a test cylce.

Temperature outside operating range of 16 to 30 °C.

Software expired or corrupt. Verify that the analyzer’s date is

Last cartridge run not completed.

or cartridge ﬁlling.

cartridge inserted into analyzer.

Cartridge not sealed. Clot in sample. Aberrant cartridge.

Cartridge underﬁlled. Use another cartridge - ﬁll to Fill

Cartridge overﬁlled. Use another cartridge - do not ﬁll

User did not respond to mandatory prompt before analyzer time out.

Software does not recognize cartridge.

Analyzer detects problem from which it is likely to recover.

Analyzer detects problem from which it may not recover.

Select 5-Clock Set from Administration Menu. (Password protected.)

Replace disposable batteries or recharge the rechargeable battery.

Check analyzer temperature by pressing 1 for Analyzer Status under the Administration Menu. Move analyzer to warmer area if below operating range or to cooler area if above the range.

correct. Change software if expired. Update again if not expired.

Check the battery pack inserted properly. Check for Low Battery startup warning.

Use another cartridge. If same code repeats more than twice, try another analyzer.

Use another cartridge - do not press on center of cartridge. Check that cartridges have not been frozen.

Use another cartridge.

Mark.

beyond Fill Mark.

No action required.

Update software. Check to see if cartridges are expired.

Insert the Electronic Simulator. If PASS, continue to use analyzer.

Insert Electronic Simulator. If PASS, insert a cartridge with sample or control. If the code does not reappear, continue to use analyzer.

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