i-STAT - Point Of Care Testing Ltd

1 (01)00054749001286 2012 Abbott Point of Care Inc. All rights in USA. i-STAT is a registered trademark of theAbbott Group of Companies in various Art: 714254-00R Rev. Date: 16-OCT-12 Emergo EuropeMolenstraat 152513 BH The HagueThe NetherlandsTel: (31)70 345 8570 Fax: (31)70 346 7299 Abbott Point of Care Inc. Abbott Park, IL 60064 USAi-STAT 1 User GuideFor information related to Article 33of the EU REACH regulation (EC No.)

2 1907/2006), please referto If you haveissues logging into the website,contact Abbott at: Error, UseElectronicSimulatorHandheld detectsproblem from which itis likely to the Electronic Simulator. IfPASS, continue to use handheldAnalyzer Error, See ManualHandheld detectsproblem from which itmay not Electronic Simulator. If PASS,insert a cartridge with sampleor control. If the code does notreappear, continue to use displayDisposable batteriesdead or rechargeablebattery fullydischarged.

3 Keypadnot responding. Startswitch disposable batteries orrecharge battery. If still no display,call Support Lockeddoes not disappearafter test cyclecompletedDead battery(s). until handheld turns off. Turnhandheld on. If resets, removecartridge. If not, change or rechargebattery(s) and turn handheld Check Messages and Codes (continued) i-STAT 1 DownloaderElectronicSimulatorMartel PrinterSee System Manual for vitrodiagnostic Use: The i-STAT1 Analyzer is intended for use with i-STAT cartridgesfor the in vitro quantification of various analytes in whole 1 Downloader/Rechargeri-STAT 1 AnalyzerEG7+ i-STAT cartridgeSystem Components15 Quality Check Messages and CodesMessageCauseActionDate Invalid, Check ClockDate outside sixmonth lifetime 5-Clock Set fromAdministration Menu.

4 (Passwordprotected.)Dead Batteries,Replace BatteriesInsufficient power tocomplete a test disposable batteries orrecharge the rechargeable Out ofRange, CheckStatus pageTemperature outsideoperating range of 16to 30 handheld temperature bypressing 1 for Analyzer Status underthe Administration Menu. Movehandheld to warmer area if belowoperating range or to cooler area ifabove the or ExpiredCLEWS oftware expired that the handheld s date iscorrect. Change software if again if not Interrupted,Use AnotherCartridgeLast cartridge run the battery pack insertedproperly.

5 Check for Low Batterystartup ErrorUsually problem withsample or another cartridge. If same coderepeats more than twice, try PreburstCalibrant pack burstbefore cartridge insertedinto another cartridge - do not presson center of cartridge. Check thatcartridges have not been to PositionSampleCartridge not in another PositionedShort of Fill MarkCartridge another cartridge - fill to PositionedBeyond Fill MarkCartridge another cartridge - do not fillbeyond Fill Cancelled byOperatorUser did not respondto mandatory promptbefore handheld action Type NotRecognizedSoftware does notrecognize software.

6 Check to see ifcartridges are CollectionAcceptable Samples for Cartridges Arterial: Plain syringe, heparinized syringe labeled for analytes to be tested andfilled to capacity, or syringe with minimum volume of heparin to prevent clotting(10 U/mL of blood). For ionized calcium, use balanced heparin syringes. Mixheparinized syringes by rolling between palms for at least 5 seconds in 2directions, then invert the syringe repeatedly for at least 5 seconds. Test forlactate immediately. Samples for pH, PCO2, PO2 , TCO2 and ionized calciumshould be tested within 10 minutes.

7 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 capacityand 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 Skin puncture: Lithium heparin capillary tubes for Testing all analytes butionized calcium.

8 For all analytes including ionized calcium, use plain orbalanced 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, whilethe PT/INR test can be performed using capillary or venous samples. Use plain plastic syringes or plastic evacuated tubes with noanticoagulant, activators, or serum separators. Test sample immediately upon draw.

9 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 Indwelling line Testing for ACT:a. Fluid drip through the line must be If blood must be drawn from an indwelling line, possible heparincontamination and specimen dilution should be considered. Theline should be flushed with 5 mL of saline and the first 5 mL ofblood or six dead space volumes should be Withdraw the sample into a fresh plastic syringe with noanticoagulant, and test immediately.

10 For extracorporeal line Testing for ACT:a. Flush the extracorporeal blood access line by withdrawing 5 mL ofblood into a syringe and discard the Paper in the i-STAT Printer1. Open the paper compartment lid by pulling up on the release lever andremove any remaining Reel off a few centimeters of paper from the new paper roll, with theleading edge of the paper feeding forward from the bottom of the Sit the new paper roll in the compartment such that the leading edge isresting outside the compartment on the printer Close the lid until it snaps into ResultsWhen results do not reflect the patient s condition.