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Abbott iStat 1 - Frank`s Hospital Workshop

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1. CHEM8 HC03 mmol L mEq L BE mmol L mEq L Anion Gap mmol L mEq L AnGap s09 Reportable Range Reference Range arterial venous 3 4 25 5 12 17 12 17 34 255 120 170 120 170 2 1 15 8 7 11 7 11 5 50 23 27 24 29 1 0 85 0 22 26 23 28 30 30 G2 a3 eels 10 99 10 20 10 20 0 100 95 98
2. Date Invalid Check Date outside six month Select 5 Clock Set from anticoagulant and test immediately Clock lifetime of software ale al Menu Password 5 cree Mel panicle testing tor PIANA sg iho SeClOnOn Patient Test Dead Batteries Insufficient power to Replace disposable batteries or OENES Replace Batteries complete a test cylce recharge the rechargeable battery CHEM8 Cartridges Temperature Out of Temperature outside Check analyzer temperature by Range Check Status operating range of 16 to pressing 1 for Analyzer Status under CREME GANTIAOES TEQUE Meuse page 30 C the Administration Menu Move a whole blood collected in non heparinized capillary tubes analyzer to warmer area if below evacuated tubes or syringes as long as sample is tested operating range or to cooler area if immediately upon draw AaS b heparinized whole blood collected in balanced heparin syringes or Invalid or Expired Software expired or corrupt Verify that the analyzer s date Is capillary tubes or CLEW correct Change software if expired _ l _ Update again if not expired c heparinized whole blood collected in evacuated tubes containing re ve ra I d RTO T F lithium or sodium heparin as long as the tubes are filled to die hoe ai ai APLANO E sano ERO AY PACK ieee it Use Another completed properly Check for Low Battery CAPAGILY Cartridge startup warning Troponin I cTni and CK MB Tests Cartridge Error Usually problem with sample Use another
3. REF O6F 16 57 Abbott Point of Care Inc 104 Windsor Center Drive East Windsor NJ 08520 e USA USA Tech Suport 800 366 8020 Fax 609 443 9310 EC REP 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 c 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 c Abbott System Components i STAT cartridge ewe Foil Packet containing F the MediSense iaia Precision PCx or Sore i STAT 1 Analyzer PCx Plus Glucose Test Strip i STAT 1 Electronic Downloader Simulator iI STAT 1 Downloader Recharger Martel Printer Mialee For in vitro diagnostic use l 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 Message Cause Action BHeeoecyen Strip Error A wet strip inserted strip Repeat test using proper procedure pulled out during testing Check Analyzer Status under the Acceptable Samples for Cartridges cycle temperature of Administration Me
4. Touch the drop to the well allowing cartridge to draw sample in DO NOT load catridge with a needle Confirm sample volume lines up with top of RED FILL LINE diagram Close the cTnl CK MB or BNP cartridge a First anchor the cartridge in place by using the thumb and index finger of one hand to grasp the cartridge from its side edges away from the sample inlet b Use the thumb of the other hand to slide the plastic closure clip to the right until it locks into place over the sample well Note When sliding the closure clip the index finger of that same hand should not be placed directly across from the thumb as this could result in the sample being pushed onto the user s glove This index finger should be placed just above the position of the sliding clip during closure or not at all Insert cartridge into cartridge port Grasp the catridge slide cover between your first finger and thumb using the thumb recess Hold the analyzer in place with one hand With the other gently guide the cartridge into the analyzer releasing the cartridge only after it is fully inserted The analyzer must remain on a level surface with the display facing up Quring testing Motion of the analyzer during testing can increase the frequency of suppressed results or quality check codes Select tests to be reported if prompted Enter sample type on chart page if applicable View results on analyzer s display Remove cartridge after Cartridge Loc
5. l ae a 7 key for List Select the test record s to be reviewed and press the Enter printing is complete key 6 If printer is not powered from a wall Martel Printer IR LED outlet turn printer off With Downloader or Downloader Recharger 1 Place analyzer in Downloader or Downloader Rechrager that is wired to the printer Display results Press the Print key Do not move analyzer or printer until printing is complete Reportable and Reference Range Measured l Reportable Test Units p Reference Range Range arterial venous Sodium Na mmol L mEq L 100 180 138 146 138 146 Potassium K mmol L mEq L 2 0 9 0 3 5 4 9 3 5 4 9 Chloride Cl mmol L mEq L 65 140 98 109 98 109 Glucose Glu mmol L 1 1 38 9 3 9 5 8 3 9 5 8 mg dL 20 700 70 105 70 105 g L 0 20 7 00 0 70 1 05 0 70 1 05 Lactate Lac mmol L 0 30 20 00 0 36 1 25 0 90 1 70 mg dL 2 7 180 2 3 2 11 3 8 1 15 3 Creatinine Crea mg dL 0 2 20 0 0 6 1 3 0 6 1 3 umol L 18 1768 53 115 53 115 pH 6 5 8 2 7 35 7 45 7 31 7 41 PCO9 mmHg 5 130 35 45 41 51 kPa 0 67 17 33 4 67 6 00 5 47 6 80 TCO9 mmol L mEq L 5 50 23 27 24 29 on the CHEM8 cartridge only P09 mmHg 5 800 80 105 kPa 0 7 106 6 10 7 14 0 lonized Calcium iCa mmol L 0 25 2 50 1 12 1 32 1 12 1 32 mg dL 1 0 10 0 4 5 5 3 4 5 5 3 Urea Nitrogen BUN mg dL 3 140 8 26 8 26 Urea mmol L 1 50 2 9 9 4 2 9 9 4 mg dL 6 300 17 5
6. sample application into the test cartridge it is possible to bring the cartridge to the finger for easier application Do ensure that the instrument remains on a flat vibration free surface for testing cTni CK MB and BNP Cartridge Test Procedures The i STAT cTnl CK MB and BNP cartridges can only be used with the i STAT 1 Analyzer bearing the symbol The analysis time for the cTnl and BNP cartridges is 10 minutes The anlysis time for CK MB cartridges is 5 minutes Before testing cTnl CK MB or BNP cartridges on the i STAT 1 Analyzer the analyzer must be customized through the Central Data Station CDS or through the analyzer s Customization menu for the following option s 1 Cartridge Information First Required AND Cartridge Lot Number Required or 2 Cartridge Barcode Required Information First Customization Test Procedure Press the O On Off key to turn analyzer on Press 2 for i STAT Cartridge from the Test Menu Scan or Enter Operator ID Repeat if prompted Scan or Enter Patient ID Repeat if prompted Scan Cartridge Lot number from the cartridge portion pack Do n e e o Remove cartridge from portion pack Handle the cartridge by its edges Avoid touching the contact pads or exerting pressure over the center of the cartridge 10 11 12 13 Following thorough mixing of the sample discard 1 drop from the delivery device to clear unseen bubbles Hang drop s slightly larger than round target well
7. start the barcode scanner The analyzer emits a visible red beam Position the analyzer and barcode so the beam forms a red line that spans the entire barcode Increasing distance between the barcode and analyzer lengthens the red line The analyzer does not need to touch the barcode When the analyzer accepts the barcode it will beep in acknowledgement and automatically turn off the beam The beam will also turn off after 3 4 seconds Printing more than one result Turn the analyzer on Press the Menu key Press 2 for Data Review Press 7 for List Scroll through the test records using the lt and gt keys mope ae ee e Press the numbered key for the test record s Press the numbered key again to deselect a record 7 Align analyzer and printer IR window or place in Downloader or Downloader Recharger attached to printer Press the Print key 1 iSTAT Transmitting Results 1 Place analyzer in Downloader or Downloader Recharger 2 Donot move analyzer until Communication in Progress il message disappears _ Storage Conditions and Preparation for Use Cartridges Store at temperatures between 2 and 8 C 35 46 F Do not use after expiration date on cartridge pouch and box Equilibrate a single cartridge for 5 minutes or a box of cartridges for 1 hour at room temperature before opening pouches E Store cartridges for 2 weeks at room temperature Mark the cartridge box or cartridge pouches w
8. than round target well Touch the drop to the well allowing cartridge to draw sample in DO NOT load catridge with a needle Confirm sample volume lines up with top of RED FILL LINE diagram Close the cTnl CK MB or BNP cartridge a first anchor the cartridge in place by using the thumb and index finger of one hand to grasp the cartridge from its side edges away from the sample inlet b use the thumb of the other hand to slide the plastic closure clip to the right until it locks into place over the sample well Note When sliding the closure clip the index finger of that same hand should not be placed directly across from the thumb as this could result in the sample being pushed onto the user s glove This index finger should be placed just above the position of the sliding clip during closure or not used at all Insert the cartridge into the cartridge port Grasp the catridge slide cover between your first finger and thumb using the thumb recess Hold the analyzer in place with one hand With the other gently guide the cartridge into the analyzer releasing the cartridge only after it is fully inserted Scan the Cartridge Lot number from the cartridge portion pack Scan or Enter Operator ID Repeat if prompted Scan or Enter Patient ID Repeat if prompted The analyzer must remain on a level surface with the display facing up during testing Motion of the analyzer during testing can increase the frequency of suppressed r
9. turn analyzer on Press 2 for i STAT Cartridge from the Test Menu Scan or enter operator ID Repeat if prompted Scan or enter patient ID Repeat if prompted oe Sy s Remove cartridge from pouch Handle a cartridge by its edges Avoid touching the contact pads or exerting pressure over center of cartridge 6 Following thorough mixing of the sample direct syringe tip pipette tip or capillary tube into the sample well Dispense sample until it reaches the fill mark on the cartridge 7 Fold the snap cover over the sample well until it snaps into place Press on round tab not over sample well 8 Insert cartridge into cartridge port For ACT and PT INR cartridges keep analyzer on a level surface with the display facing up during testing 9 Select tests to be reported if prompted 10 Enter sample type and blood gas parameters on chart page if applicable 11 View results on analyzer s display 12 Enter Comment Code if prompted 13 Remove cartridge after Cartridge Locked message disappears The analyzer is ready for the next test immediately PT INR Cartridge Test Procedure Caution The i STAT PT INR cartridge is designed to accept a sample between 20 and 45 microliters A single drop of blood from either a finger puncture or as formed at the tip of a syringe will typically be within this range If a larger volume is delivered to the sample well use caution when closing the cartridge as excess blood may be expelled
10. view results in dim lighting The backlight turns off after 90 seconds or when the 0 key is Pt 22212111 13 07 21Aug00 pressed again i STAT EC8 Ping 22212111T Pt 22212111 Pt 14253647 13 07 21Aug00 21 15 18Aug00 a 11 10 22JUNO0 11 10 210N00 Test results are displayed numerically and with AA j bar graphs Tick marks indicate the reference ear ranges on the bar graphs Blood gases and their associated calculated values are not displayed with bar graphs and reference ranges i STAT EC8 i STAT EC8 Test results are displayed for 2 minutes or a customized time To recall the last set of results to the screen turn the analyzer on and press 1 for Last Result Printing Test Results To review results from the same patient when anes results are displayed press 1 for Test Options eee and then 3 for History Scroll through test TOC Without Downloader or Downloader Recharger records using the 1 and 2 keys Pom mmHg 1 Turn printer on if green power light is not on To review another patient s results turn the HCO moik 2 Align IR windows of analyzer and printer af analyzer on and press the Menu key followed ah l oe by the 2 key for Data Review and the 1 key for Pae 3 Display results patient Scan or enter the Patient s ID number j 4 Press the Print key i Use the 1 and 2 keys to scroll through the test 5 Do not move analyzer or printer until S3 records Or press the Menu key followed by the
11. 6 17 56 Hematocrit Hct PCV 10 75 38 51 38 51 Fraction 0 10 0 75 0 38 0 51 0 38 0 51 Celite Activated seconds 50 1000 74 125 Prewrm 74 125 Prewrm Clotting Time 84 139 Nonwrm 84 139 Nonwrm CeliteACT The range from 80 1000 seconds has been verified through method comparison studies Kaolin Activated seconds 50 1000 74 137 Prewrm 74 137 Prewrm Clotting Time 82 152 Nonwrm 82 152 Nonwrm Kaolin CT The range from 77 1000 seconds has been verified through method comparison studies Test Units Prothrombin Time INR PT Reportable Range arterial 0 9 8 0 Performance characteristics have not been established for INRs above 6 0 Troponin cTnl ng mL ug L Performance characteristics have not been established for cTnl values above 35 00 ng mL 0 00 50 00 Represents the 0 to 97 5 range of results Represents the 0 to 99 range of results Creatine Kinase MB ng mL ug L CK MB 0 0 150 0 Represents the 0 to 95 range of results B Type Natriuretic Peptide BNP pg mL ng L 15 5000 Represents the 0 to 95 range of results Reference Range venous 0 00 0 03 0 00 0 08 00d 3 9 lt 15 50 Celite is a registered trademark of Celite Corporation Santa Barbara CA for its diatomaceous earth products Calculated Test Units Hemoglobin Hb g dL g L mmol L TCO9 mmol L mEq L on all cartridges but the
12. cartridge If same code e cTnl and CK MB cartridges require the use of either or cartridge filling fare more than twice try another o l l analyzer a heparinized whole blood or plasma samples collected in syringes ea E TEENETE 7 i n or evacuated tubes containing lithium or sodium heparin or E a ES nacre ect ee eee cartridge inserted into on center of cartridge Check that b non heparinized whole blood or plasma samples tested within one analyzer cartridges have not been frozen minute of drawing from a pateni Imo a plastic syringe or plastic Unable to Position Cartridge not sealed Clot in Use another cartridge evacuated tube containing no additives Sample sample Aberrant cartridge e The use of whole blood or plasma samples containing other Sample Positioned Cartridge underfilled Use another cartridge fill to Fill anticoagulants such as EDTA oxalate and citrate will cause Short of Fill Mark Mark deactivation of the alkaline phosphatase resulting in decreased cTnl or Sample Positioned Cartridge overfilled Use another cartridge do not fill CK MB readings Beyond Fill Mark beyond Fill Mark e Capillary tubes and direct skin punctures e g fingersticks should not Test Cancelled by User did not respond to No action required be used with the cTnl or CK MB cartridge Operator mandatory prompt before analyzer time out e Samples should not be used unless the blood collection tube is filled at least half full Cartridge Type Not Soft
13. cohol or 10 bleach solution Rinse with another pad moistened with water and dry Replacing Paper in the Martel Printer 1 Squeeze the front and back of the paper cup to open 2 Remove remaining paper by pressing the Paper feed button Do not pull paper through printer mechanism 3 Reel off a few centimeters of paper from the new paper roll and check that the end has a clean straight edge 4 Slide the leading edge of the paper through the paper entry slot until you feel resistance Paper feeds from underneath the roll 5 Press the Paper Feed button and feed the paper through the printer mechanism 6 Keep the Paper Feed button depressed until the paper passes through the paper exit slot 7 Sit the new paper roll in the paper cup and close the lid Procedure Turn the analyzer on Press the 3 key for PCx Glucose Strip Press the 2 key for Control Scan or enter Operator ID Scan or enter Low Level Control lot number Scan or enter test strip lot number Open foil test strip packet and remove test strip o MN p oS SPY 5 Insert into test strip port 9 Apply control solution 10 Enter chart page information if applicable 11 View results on analyzers display Enter Comment Code if applicable 12 Remove strip 13 Press 1 for Test Options and 1 for Next Level if testing another level of control Hardware Procedures Replacing Batteries 1 Slide the battery compartment door off 2 Tilt the analyzer slig
14. ess the 1 key for Test Options on the results page and press 1 for Next Level if testing another level of control Test Strip E Analyze Low and High Precision Control Solutions when a new lot number of test strips is opened E Analyze the Low and High Precision Control Solutions using the test strip lot number in use on a daily basis Analyze control solutions when test strip glucose result is questioned when diabetes medication plan is adjusted when strips have been exposed to temperatures outside the storage conditions Control ranges are programmed into the analyzer when the test strip lot number is scanned or entered into the analyzer and control results will be displayed with the acceptable ranges as well as Pass or Fail Analyzer Storage Transport temperature 10 to 46 C 14 115 F E The analyzer s operating temperature range is 16 to 30 C 61 86 F E Store analyzers near the testing location or in an area close to the temperature of the testing area Do not store analyzers near equipment that gives off heat or in direct sunlight Quality Assurance Analyzer Electronic Simulator Perform an electronic check on each analyzer in use once a day with either the internal or external Electronic Simulator or as needed for regulatory compliance The internal simulator check is initiated every 24 hours or according to a customized schedule when a cartridge is inserted into the cartridge port If the internal s
15. esults or quality check codes Select tests to be reported if prompted Enter sample type on chart page if applicable View results on analyzer s display a oF ot ee en E 10 11 12 13 PCx Glucose Test Strip Procedure Press the O On Off key to turn the analyzer on Press 3 for PCx Glucose Strip A Press 1 for Patient Scan or enter operator ID Repeat if prompted Scan or enter patient ID Repeat if prompted Scan or enter test strip lot number Press 1 for Arterial Capillary or 2 for Venous sample if prompted Open foil packet remove test strip and insert into analyzer test strip port with black contact bars facing up and forward Apply drop of blood to target area of test strip Cover the entire area Do not touch the test strip after sample is applied If test fails to start after second drop applied or if more than 30 seconds have passed discard test strip and repeat the test Enter chart page information if applicable View results on analyzer s display Enter Comment Code if applicable Remove and discard test strip e Do not handle test strip with wet or dirty hands e Do not scan the barcode of another test strip e Do not use test strips that are wet scratched or damaged in any way e Do not re use test strips Scanning Laser Radiation Do not stare into beam Class 2 laser product r Laser Diode 650 nm Maximum Output 1 0 mW Press and hold down the Scan key to
16. for more than 2 minutes e Do not draw above an I V E 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 e Allow alcohol to dry over puncture site before collecting sample e Do not milk finger or heel while collecting sample E Coagulation Tests e The ACT test can be performed using venous or arterial samples while the PT INR test can be performed using capillary or venous samples e Use plain plastic syringes or plastic evacuated tubes with no anticoagulant activators or serum separators e Test sample immediately upon draw e For venipuncture some experts recommend drawing and discarding a sample of at least 1 mL prior to drawing samples for coagulation testing e If asecond measurement is needed draw a fresh sample e 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 e For extracorporeal line testing for ACT Quality Check Messages and Codes a Flush the extracorporeal blood access line by withdrawing 5 mL of blood into a syringe and discard the syringe Message Cause sf Action b Withdraw the sample into a fresh plastic syringe with no
17. from the cartridge Skin Punctures 1 Remove cartridge from foil pouch and place the cartridge on a flat surface 2 Prepare lancet device and set aside until needed 3 Clean and prepare the finger to be sampled Allow finger to dry thoroughly before sampling Charging Rechargeable Battery in 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 STEP ACTION 1 The battery pack has two labels one for orientation in the analyzer and one for orientation in the Downloader Recharger With the label with the Downloader facing up and the electrical contact end of the pack facing the contacts in the battery compartment insert the pack into the compartment as shown on the label 2 Toremove the battery after it is charged back the pack out of the compartment Full recharge from a discharged state takes approximately 40 hours Caution If you are using rechargeable batteries use only rechargeable batteries and recharging equipment supplied by your i STAT distributor Other batteries and rechargers may affect test results and pose other hazards to operators and patients Cleaning the Analyzer and Downloader Clean the display and case with a gauze pad moistened with a mild non abrasive cleaner detergent soap and water al
18. htly to slide out the battery carrier 3 Remove the old batteries from the carrier and replace amp e A with 2 new 9V lithium batteries ue 4 Insert the carrier back into the compartment label facing up and electrical contacts first 5 Slide the battery compartment door into place 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 Prick the bottom side of the fingertip with the lancet device Gently squeeze the finger developing a hanging drop of blood and perform the test with the first sample of blood Avoid strong repetitive pressure milking as it may cause hemolysis or tissue fluid contamination of the specimen 6 Touch the drop of blood against the bottom of the sample well Once in contact with the sample well the blood will be drawn into the cartridge 7 Apply sample until it reaches the fill mark indicated on the cartridge Fold the sample closure over the sample well Press the rounded end of the closure until it snaps into place Note To further simplify the
19. imulator result is PASS the cartridge test proceeds and the simulator results are stored If FAIL is displayed for the internal simulator reinsert the cartridge or use an external simulator The external simulator check is performed as follows Turn the analyzer on Press the Menu key to access the Administration Menu Press the 3 key for Quality Tests Press the 4 key for Simulator Scan or enter Operator ID Enter the Simulator ID Serial number Insert the simulator into the cartridge port View results on analyzer s screen SP oe eS SY S If PASS is displayed continue to use the analyzer 10 If FAIL is displayed for the external simulator reinsert the simulator If FAIL is displayed a second time do not use the analyzer and contact your Support Services reprersentative Thermal Probes and Room Temperature Checks See System Manual for these quality assurance procedures that are performed once or twice per year Non Information First Customization Test Procedure al Remove cartridge from portion pack Do not immediately dispose of the portion pack as the cartridge lot number listed on it will be scanned into the analyzer during the testing procedure Handle the cartridge from its edges Avoid touching the contact pads or exerting pressure over the center of the cartridge Following thorough mixing of the sample discard 1 drop from the delivery device to clear unseen bubbles Hang drop s slightly larger
20. ith the room temperature expiration date Do not expose to temperatures above 30 C 86 F Do not return cartridges to the refrigerator after room temperature equilibration m Use cartridge immediately after opening pouch If the pouch has been punctured the cartridge should not be used PCx and PCx Plus Glucose Test Strips E Store at temperatures between 4 and 30 C 39 86 F Do not freeze Keep out of direct sunlight Do not use after expiration date on the barcode label Do not cut the test strip in half or attempt to use only a portion of it After opening foil packet use test strip promptly Test Flags and Operator Action 4 View the data that was scanned by the analyzer and verify that it is correct 5 Release the Scan key Results that are not reportable due to sensor errors or interfering substances Draw a fresh sample and repeat test If results are flagged Note If the Scan key is released as soon as the beep is heard the next again send sample to the lab prompt will be displayed and the information scanned will not be able to be viewed E lt gt and lt gt Results that are below or above the reportable range or dependant on results that are outside the reportable range Send sample to the lab if necessary Reviewing Test Results E tandJ Results that are above or below the action range Follow facility The 0 key can be used to backlight the display procedure for samples with critical values to
21. ked message disappears The analyzer is ready for the next test immediately Cartridge Check temperature strip enclosed with each shipment of cartridges If the windows are clear or if the A or B windows are blue or the 1 or 2 windows are red the cartridges should be accepted If the C or D windows are blue or the 3 or 4 windows are red contact Support Services see System Manual Verify the integrity of a new shipment of cartridges on receipt by analyzing 2 levels of i STAT controls and RNA Medical or Hematronix Meter Trax controls for hematocrit using any analyzer that has passed the Electronic Simulator test and a representative sample of the lot s of cartridges received Use expected values published in the fluids package inserts to verify the integrity of the cartridges Verify that the storage conditions listed above have been maintained Procedure 1 Turn the analyzer on and press the Menu key to access the Administration Menu 2 Press the 3 key for Quality Tests 3 Press the 1 key for Control 4 Press the 1 key for i STAT Cartridge 5 Scan or enter Operator ID 6 Enter the control lot number 7 Enter the cartridge lot number 8 Fill a cartridge with the control and close the cover 9 Insert the cartridge into the cartridge port 10 Enter chart page information if applicable 11 View results on analyzer s display 12 Remove and discard cartridge when Cartridge Locked message disappears 13 Pr
22. ns for substances and or conditions that may interfere with cartridge tests and to section 13 of the i STAT 1 System Manual for causes of lower or higher than expected glucose results when using the tests strips Patient Test Procedures Cartridge Test Procedure 1 Remove cartridge from pouch Handle a cartridge by its edges Avoid touching the contact pads or exerting pressure over center of cartridge 2 Following thorough mixing of the sample direct syringe tip pipette tip or capillary tube into the sample well Dispense sample until it reaches the fill mark on the cartridge 3 Fold the snap cover over the sample well until it snaps into place Press on round tab not over sample well 4 Insert cartridge into cartridge port For ACT and PT INR cartridges keep analyzer on a level surface with the display facing up during testing Do not attempt to remove cartridge while Cartridge Locked message is displayed Scan or enter operator ID Repeat if prompted Scan or enter patient ID Repeat if prompted Select tests to be reported if prompted Enter sample type and blood gas parameters on chart page if applicable View results on analyzer s display Enter Comment Code if prompted a Se SS p O Remove cartridge after Cartridge Locked message disappears The analyzer is ready for the next test immediately Cartridge Test Procedure Information First Press the On Off key to
23. nu for analyzer analyzer exceeds operation temperature Arterial Plain syringe heparinized syringe labeled for analytes to be tested temperature for strip testing and filled to capacity or syringe with minimum volume of heparin to prevent No display Disposable batteries dead Change disposable batteries or clotting 10 U mL of blood For ionized calcium use balanced heparin or rechargeable battery fully recharge battery If still no display syringes Mix heparinized syringes by rolling between palms for at least discharged Keypad not call Support Services 5 seconds in 2 directions then invert the syringe repeatedly for at least 5 responding Start switch seconds Test for lactate immediately Samples for pH PCO PO TCO broken and ionized calcium should be tested within 10 minutes Test for other Cartridge Locked Dead battery s Mechanical Wait until analyzer turns off Turn analytes within 30 minutes 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 e If not tested immediately remix and discard 2 drops of blood before filling cartridge e Avoid drawing air into syringes for blood gas and ionized calcium tests e 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 e Do not leave tourniquet on
24. out of range there may be a problem with the cartridge lot number Use another lot number or repeat the test using another method and refer to Support Services Information in the Troubleshooting section of the i STAT 1 System Manual Startup Messages The analyzer performs self checks when it is turned on If a condition that should be corrected in the near future but that will not affect results is detected a warning is displayed The operator presses the 1 key to access the Test Menu The analyzer can be customized to lock out the operator until the corrective action is taken Message Action Electronic Simulator Test Required Insert Electronic Simulator PCx Glucose Strip Control Required Test controls Stored Memory Low Place analyzer in Downloader Stored Memory Full Place analyzer in Downloader Upload Required Place analyzer in Downloader Battery Low Replace batteries or recharge battery CLEW Expiring Update Required Upgrade software Acceptable Samples for PCx and PCx Plus Glucose Test Strips Arterial and venous Syringe or tube with lithium heparin sodium heparin or EDTA Test within 30 minutes E Skin puncture direct application of sample to test strip or capillary tube with lithium heparin sodium heparin or EDTA Test immediately Limitations Interfering substances in the patient s sample may cause an increase or decrease in a result Refer to the Cartridge and Test Information Sheets and Technical Bulleti
25. ware does not recognize Update software Check to see if Recognized cartridge cartridges are expired BNP is Analyzer Error Use Analyzer detects problem Insert the Electronic Simulator If e BNP cartridges require the use of EDTA whole blood or plasma Electronic Simulator from which it is likely to PASS continue to use analyzer samples collected in plastic syringes or evacuated tubes containing rECOVSR EDTA Analyzer Error See Analyzer detects problem Insert Electronic Simulator If PASS R o Manual from which it may not insert a cartridge with sample The use of whole blood or plasma samples containing other CNT AP RRS ne code hoes ten anticoagulants such as oxalate and citrate is not reccommended reappear continue to use analyzer e When drawn into an evacuated tube containing EDTA samples should not be used unless the blood collection tube is filled at least half full e Capillary tubes and direct skin punctures e g fingersticks should not be used with the BNP cartridge Troubleshooting Unexpected Results When results do not reflect the patient s condition repeat the test using a fresh cartridge and sample If results are still suspect test the lot of cartridges in use with i STAT control solutions If the controls are in range there may be an interfering substance in the sample Check the Cartridge and Test Information sheets for the test in question Test by another method to verify the result If the controls are

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