Users` Guide - Point Of Care Testing Ltd
Contents
1. I STAT 1 User Guide 2012 Abbott Point of Care Inc All rights reserved Abbott Printed in USA i STAT is a registered trademark of the Abbott Group of Companies in various jurisdictions Point of Care System Components ai CD etette i e eeeren tSTAT P o ooo N For in vitro diagnostic use S iSTAT amas O i STAT 1 Analyzer o iI STAT 1 Downloader i STAT 1 Downloader Recharger i STAT cartridge o Electronic Simulator MATTEL _ Martel Printer pH 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 Quality Check Messages and Codes Message Cause Action Date Invalid Check Clock Date outside six month lifetime of software Select 5 Clock Set from Administration Menu Password protected Dead Batteries Replace Batteries Insufficient power to complete a test cycle Replace disposable batteries or recharge the rechargeable battery Temperature Out of Range Check Status page Temperature outside operating range of 16 to 30 C Check handheld temperature by pressing 1 for Analyzer Status under the Administration Menu Move2. e 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 E Troponin I cTnl and CK MB Tests e cTnl 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 e 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 cTnl or CK MB readings e Capillary tubes and direct skin punctures e g fingersticks should not be used with the cTnl or CK MB cartridge m BNP Tests e BNP cartridges require the use of EDTA whole blood or plasma samples collected in plastic syringes or evacuated tubes containing EDTA e The use of whole blood or plasma samples containing other anticoagulants such as oxalate and citrate is not recommended e Capillary tubes and direct skin punctures e g
3. 1 3 umol L 18 1768 53 115 53 115 Quality Assurance Handheld Electronic Simulator Perform an electronic check on each handheld 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 simulator 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 1 Turn the handheld on 2 Press to access the Administration Menu 3 Press for Quality Tests Press for Simulator Scan or enter Operator ID Enter the Simulator ID Serial number Insert the simulator into the cartridge port View results on handheld s screen If PASS is displayed continue to use the handheld a ee m p 0 If FAIL is displayed for the external simulator reinsert the simulator If FAIL is displayed a second time do not use the handheld and contact your Support Services representative Thermal Probes and Room Temperature Checks See System Manual for these quality assurance procedures that are performed once or twice per year Cartridge E Immediately check temperature strip enclosed with each shipment of cartridges Follow the instructions on t
4. fingersticks should not be used with the BNP cartridge 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 Bulletins for substances and or conditions that may interfere with cartridge tests 4 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 handheld 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 To remove 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 Handheld and Downloader Clean the display and case with a gauze pad moistened with a m
5. Quality Check Messages and Codes continued Message Cause Action Analyzer Error Use Electronic Simulator Handheld detects problem from which it is likely to recover Insert the Electronic Simulator If PASS continue to use handheld Analyzer Error See Manual Handheld detects problem from which it may not recover Insert Electronic Simulator If PASS insert a cartridge with sample or control If the code does not reappear continue to use handheld No display Disposable batteries dead or rechargeable battery fully discharged Keypad not responding Start switch broken Change disposable batteries or recharge battery If still no display call Support Services Cartridge Locked does not disappear after test cycle completed Dead battery s Mechanical problem Wait until handheld turns off Turn handheld on If resets remove cartridge If not change or recharge battery s and turn handheld on O6F 16 56 01 00054749001286 Abbott Point of Care Inc Abbott Park IL 60064 e USA EC REP Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Tel 81 70 345 8570 Fax 81 70 346 7299 Art 714254 00R For information related to Article 33 of the EU REACH regulation EC No 1907 2006 please refer to PMIS abbott com If you have issues logging into the website contact Abbott at abbott REACH abbott com Rev Date 16 OCT 12
6. STAT Cartridge 3 Follow Handheld prompts 4 Scan the lot number on the cartridge pouch e Position barcode 3 9 inches from scanner window on the Handheld e Press and hold to activate the scanner e Align the red laser light so it covers entire barcode e The Handheld will beep when it reads the barcode successfully Note If cartridge pouch does not have a barcode enter lot number using numbered keys or press ENT to bypass this prompt You may ignore any letters Laser Radiation Do not stare into beam Class 2 laser product Laser Diode 650 nm Maximum Output 1 0 mW 5 Continue normal procedures for preparing the sample filling and sealing the cartridge 6 Push the sealed cartridge into the handheld port until it clicks into place Wait for the test to complete Note For ACT PT INR Hct and immunoassay testing the handheld must remain on a level surface with the display facing up during testing A level surface includes running the handheld in the Downloader Recharger 7 Review results Reviewing Test Results E The 0 key can be used to backlight the display to view results in dim lighting The backlight turns Pies Bei rill off after 90 seconds or when the 0 key is pressed 21 15 18Aug00 TSAI ECS again m Test results are displayed numerically and with bar graphs Tick marks indicate the reference ranges on the bar graphs Blood gases and their associated calculated values a
7. en Message Action Electronic Simulator Test Required Insert Electronic Simulator Stored Memory Low Place handheld in Downloader Stored Memory Full Place handheld in Downloader Upload Required Place handheld in Downloader Battery Low Replace batteries or recharge battery CLEW Expiring Update Required Update software 14 Blood Collection Acceptable Samples for Cartridges E 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 PCO PO TCO and ionized calcium should be tested within 10 minutes Test for other analytes within 30 minutes e Avoid drawing air into syringes for blood gas and ionized calcium tests e If not tested immediately remix and discard 2 drops of blood before filling cartridge e Do not use iced samples m 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 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 anal
8. en the paper compartment lid by pulling up on the release lever and remove any remaining paper 2 Reel off a few centimeters of paper from the new paper roll with the leading edge of the paper feeding forward from the bottom of the roll 3 Sit the new paper roll in the compartment such that the leading edge is resting outside the compartment on the printer casing 4 Close the lid until it snaps into place 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 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 Technical Bulletin section of the i STAT 1 System Manual Startup Messages The handheld 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 handheld can be customized to lock out the operator until the corrective action is tak
9. handheld to warmer area if below operating range or to cooler area if above the range Invalid or Expired CLEW Software expired or corrupt Verify that the handheld s date is correct Change software if expired Update again if not expired Analyzer Interrupted Use Another Cartridge Last cartridge run not completed Check the battery pack inserted properly Check for Low Battery startup warning Cartridge Error Cartridge Preburst Usually problem with sample or cartridge filling Calibrant pack burst before cartridge inserted into handheld Use another cartridge If same code repeats more than twice try another handheld Use another cartridge do not press on center of cartridge Check that cartridges have not been frozen Unable to Position Sample Cartridge not sealed Clot in sample Aberrant cartridge Use another cartridge Sample Positioned Short of Fill Mark Cartridge underfilled Use another cartridge fill to Fill Mark Sample Positioned Beyond Fill Mark Cartridge overfilled Use another cartridge do not fill beyond Fill Mark Test Cancelled by Operator User did not respond to mandatory prompt before handheld time out No action required Cartridge Type Not Recognized Software does not recognize cartridge Update software Check to see if cartridges are expired 15 Replacing Paper in the i STAT Printer 1 Op
10. he card E Verify the integrity of anew shipment of cartridges on receipt by analyzing 2 levels of i STAT controls and RNA Medical controls for hematocrit using any handheld that has passed the Electronic Simulator test and a representative sample of the lot s of cartridges received Use expected values published in the Value Assignment Sheets to verify the integrity of the cartridges m Verify that the storage conditions listed above have been maintained 11 Transmitting Results Vl iSTAT 1 Place handheld in Downloader or Downloader Recharger 2 Donot move handheld until Communication in Progress message disappears Storage Conditions and Preparation for Use Cartridges E Store at temperatures between 2 and 8 C 85 46 F Do not use after expiration date on cartridge pouch and box E Equilibrate a single cartridge for 5 minutes or a box of cartridges for 1 hour at room temperature before opening pouches m Store cartridges at room temperature for the timeframe indicated on the cartridge box Mark the cartridge box or cartridge pouches with 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 Analyzer E Storage Transport temperature 10 to 46 C 14 115 F m The handheld s operating te
11. ild non abrasive cleaner detergent soap and water alcohol 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 13 Procedure 1 Turn the handheld on and press to access the Administration Menu 2 Press 3 for Quality Tests 3 Press for Control Press ap for i STAT Cartridge if prompted Scan or enter Operator ID Enter the control lot number Scan the lot number on the cartridge pouch Fill a cartridge with the control and close the cover Insert the cartridge into the cartridge port St eS 2 oS 0 Enter chart page information if applicable 11 View results on handheld s display 12 Remove and discard cartridge when Cartridge Locked message disappears 13 Press ay for Test Options
12. ished for INRs above 6 0 Troponin cTnl ng mL ug L 0 00 50 0 0 00 0 03 0 00 0 08 Performance characteristics have not been established for cTnl values above 35 00 ng mL Represents the 0 to 97 5 range of results Represents the 0 to 99 range of results Creatinine Kinase MB ng mL ug L 0 0 150 0 OO Shae CK MB Represents the 0 to 95 range of results 6 Type Natriuretic Peptide BNP pg mL ng L 15 5000 lt 15 50 Represents the 0 to 95 range of results Celite is a registered trademark of Celite Corporation Santa Barbara CA for its diatomaceous earth products Calculated Reportable Reference Range Test Units Range arterial venous Hemoglobin Hb g dL 3 4 25 5 12 17 12 17 g L 34 255 120 170 120 170 mmol L 2 1 15 8 7 11 7 11 TCO mmol L mEq L 5 50 23 27 24 29 for all cartridges but the CHEM8 only HCO mmol L mEq L 1 0 85 0 22 26 23 28 BE mmol L mEq L 30 30 2 3 2 3 Anion Gap AnGap mmol L mEq L 10 99 10 20 10 20 s0 N A 95 98 2 Test Flags and Operator Action E Results that are not reportable due to sensor errors or interfering substances Draw a fresh sample and repeat test If results are flagged again send sample to the lab E lt gt and lt gt Results that are below or above the reportable range or dependant on results that are outside the reportab
13. le range Send sample to the lab if necessary E f and Results that are above or below the action range Follow facility procedure for samples with critical values Pt 22212111 Pt 22212111 13 07 21Aug00 i STAT EC8 Printing Test Results from a Martel Printer or i STAT Printer Without Downloader or Downloader Recharger T oo a a a Turn printer on if green power light is not on Align IR windows of handheld and printer Display results Press a5 Do not move handheld or printer until printing is complete If printer is not powered from a wall outlet turn printer off With Downloader or Downloader Recharger 1 2 d 4 Place handheld in Downloader or Downloader Recharger that is wired to printer Display results Press l A Do not move handheld or printer until printing is complete If printer is not powered from a wall unit using the AC adapter turn printer off Printing more than one result T 2 Turn the handheld on Press amp Press i 2 for Data Review Press for List Scroll through the test records using the lt and keys Press the numbered key for the test record s Press the numbered key again to deselect a record Align handheld and printer IR window or place in Downloader or Downloader Recharger attached to printer Press f Do not move handheld or printer until printing is complete If printer is not powered from a wall unit using
14. mperature range is 16 to 30 C 61 86 F E Store handhelds near the testing location or in an area close to the 10 temperature of the testing area Do not store handhelds near equipment that gives off heat or in direct sunlight Reportable and Reference Range Measured Reportable Reference Range Test Units Range arterial venous pH 6 50 8 20 7 35 7 45 7 31 7 41 PCO mmHg 5 130 35 45 41 51 kPa 0 67 17 33 4 67 6 00 5 47 6 80 TCO mmol L mEq L 5 50 23 27 24 29 on CHEM8 cartridge only PO 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 56 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 Prewarm 74 125 Prewarm Clotting Time 84 139 Nonwarm 84 139 Nonwarm Celite ACT The range from 80 1000 seconds has been verified through method comparison studies Kaolin Activated seconds 50 1000 74 137 Prewarm 74 137 Prewarm Clotting Time 82 152 Nonwarm 82 152 Nonwarm Kaolin ACT The range from 77 1000 seconds has been verified through method comparison studies Prothrombin Time PT INR 0 9 8 0 Performance characteristics have not been establ
15. on the results page and press ae for Next Level if testing another level of control Hardware Procedures Replacing Batteries 1 Slide the battery compartment door off lt 2 Tilt the handheld slightly to slide out the battery ee E carrier Q e 3 Remove the old batteries from the carrier and replace with 2 new 9V lithium batteries 4 Insert the carrier back into the compartment label facing up and electrical contacts first bs 5 Slide the battery compartment door into place Charging the Rechargeable Battery Placing a handheld 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 a handheld with a rechargeable battery is placed in the Downloader Recharger No damage will be caused if a handheld with disposable batteries installed is placed in the Downloader Recharger 12 Patient Test Procedures Cartridge Test Procedure e The i STAT 1 handheld must be customized through the Central Data Station CDS or through the handheld s Customization menu for the following option s Cartridge Information First Required AND Cartridge Lot Number Required e DO NOT insert cartridge to start test e DO NOT open cartridge pouch before scanning the barcode if applicable 1 Press D to turn on Handheld 2 Press gt i
16. re not displayed with bar graphs and reference ranges m Test results are displayed for 2 minutes or a customized time To recall the last set of results to the screen turn the handheld on and press 1 for Last Result U Pt 22212111 10 11 22Aug00 To review results from the same patient when ESTAT EG7 results are displayed press 1 for Test Options n coe and then 3 for History Scroll through test N records using the 1 and 2 keys m TCO mmol L m To review another patient s results turn the a N handheld on and press the Menu key followed by the 2 key for Data Review and the 1 key for patient Scan or enter the Patient s ID number Use the 1 and 2 keys to scroll through the test records Or press the Menu key followed by the 7 key for List Select the test record s to be reviewed and press the Enter key Reportable and Reference Range Measured Reportable Reference Range Test Units 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
17. the AC adapter turn printer off
18. ytes 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 f a second measurement is needed draw a fresh sample e For Indwelling line testing for ACT a Fluid drip through the line must be discontinued b If blood must be drawn from an indwelling line possible heparin contamination and specimen dilution should be considered The line should be flushed with 5 mL of saline and the first 5 mL of blood or six dead space volumes should be discarded c Withdraw the sample into a fresh plastic syringe with no anticoagulant and test immediately e 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 3 b Withdraw the sample into a fresh plastic syringe with no anticoagulant and test immediately E CHEM8 Cartridges
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