Abbott i-STAT Alinity, Quick Reference Manual

Page 1: ...i STAT Alinity Quick Reference Guide...

Page 2: ...i STATAlinity Quick Reference Guide Art 731848 01 Rev M Rev Date 25 Jul 2022 This page left intentionally blank...

Page 3: ...e available in all markets Contact your local Abbott Point of Care representative for information on available products To obtain additional product information and technical support refer to the Abbo...

Page 4: ...i STATAlinity Quick Reference Guide Art 731848 01 Rev M Rev Date 25 Jul 2022 This page left intentionally blank...

Page 5: ...ns IF BATTERY SHOWS A YELLOW OR RED BAR CONTINUE TO STEP 3 IF BATTERY HAS SUFFICIENT CHARGE CONTINUE TO STEP 4 4 HRS 1 CHECK FOR SUFFICIENT BATTERY CHARGE 2 CHARGE BATTERY IF NEEDED OR MOVE TO STEP 4...

Page 6: ...et Region Code screen proceed to STEP If not proceed to STEP 6 4 SECTION 1 4 LOCATE REGION BAR CODE a b OR 2 i STATAlinity Quick Reference Guide Art 731848 01 Rev M Rev Date 25 Jul 2022 INSTRUMENT SET...

Page 7: ...rompted scan Region Code on box or letter 3 Continue to follow prompts on the screen 4 Once the instrument powers on the Region Code Barcode alert should no longer be displayed Proceed to STEP If Aler...

Page 8: ...instrument on follow sequence and on screen instructions 1 2 3 FINISH SETTING UP THE INSTRUMENT 6 INSTRUMENT SETUP New Instruments CONT 4 i STATAlinity Quick Reference Guide Art 731848 01 Rev M Rev D...

Page 9: ...SECTION 1 Set Clock 5 Set Language 4 FINISH SETTING UP THE INSTRUMENT CONT 6 INSTRUMENT SETUP New Instruments CONT 5 i STATAlinity Quick Reference Guide Art 731848 01 Rev M Rev Date 25 Jul 2022...

Page 10: ...ot all cartridges are available in all regions Check with your local representative for availability in specific markets FINISH SETTING UP THE INSTRUMENT CONT 6 INSTRUMENT SETUP New Instruments CONT 6...

Page 11: ...SE STATION Used to recharge the battery installed in the i STAT Alinity i STAT CARTRIDGES Contains sensors and reagents for testing patient samples and quality fluids i STAT ALINITY RECHARGEABLE BATTE...

Page 12: ...ables specified or supplied for this system by Abbott Point of Care protect patients from nosocomial infections by disinfecting the instrument periodically and whenever blood is spilled or transferred...

Page 13: ...tissue can contain infectious agents and should therefore be treated as biohazardous materials The instrument can be rendered inoperative by damage caused by mishandling for example dropping the instr...

Page 14: ...or supplied for this system by Abbott Point of Care keep a spare charged battery on hand at all times store charged battery in the original packaging check with authorities for local state and or nati...

Page 15: ...d Base Station Protection provided by this equipment may be impaired if used in a manner not specified by Abbott Point of Care The instrument and its peripherals are not listed by any authority with r...

Page 16: ...lear of walkways always use the Base Station for charging Refer to the rechargeable battery Getting Started Guide on instructions for proper charging connect only Abbott Point of Care provided printer...

Page 17: ...ay take several seconds If the blue light does not illuminate check the power supply Ensure that the Base Station is connected properly and that the instrument is seated correctly in the Base Station...

Page 18: ...ate and or national requirements for disposal DO NOT operate the printer without paper pull paper through the paper mechanism Damage to the printer can result Use the paper feed button allow the power...

Page 19: ...e correct patient record was selected patient ID date and time of test etc If the record is not correct select the correct record and print If the printout still does not match the data in the instrum...

Page 20: ...nds to power up or power down the instrument BARCODE CAPTURE BUTTON Press and hold button in order to capture a barcode Audible cues indicate successful and unsuccessful barcode captures CARTRIDGE POR...

Page 21: ...N COMPONENTS AND THEIR MEANINGS After the power button is pushed and the instrument starts the power up sequence the LED light will turn green and i STAT Alinity will appear briefly on the display scr...

Page 22: ...elf checks pass at startup the instrument will display the Home Screen Anatomy of a Home Screen A HEADER Area Contains Date Time Wireless Status Battery Status B BODY Area Contains Buttons provide acc...

Page 23: ...ery as soon as possible Alerts 1 of 1 Exit Alerts If one or more startup self checks fail the instrument will display the Alerts Screen as shown in the example above Anatomy of Alerts Screen A WARNING...

Page 24: ...ample above ANATOMY OF A PATHWAY SCREEN A HEADER Identification Tab Displays details such as patient ID cartridge name liquid quality control name Header Action Tabs Provide options for screen navigat...

Page 25: ...tely Poor Battery Charging No Signal Bolt indicates active ly charging No Connection Bolt indicates active ly charging Wireless Disabled Bolt indicates active ly charging Wireless Connecting Wireless...

Page 26: ...XX XX C D ANATOMY OF A BOX A Refrigerated storage temperature indicator 2 8 C 35 46 F B Indicates shelf life when stored at room temperature C Refrigerated storage expiration date D Cartridge LOT numb...

Page 27: ...peratur F rvaring i rumstemperatur S ilytys huoneenl mm ss Oppbevaring ved romtemperatur Oda S cakl nda Saklama monate mois mesi meses meses maanden m neder m nader kuukautta m neder ay 2 months 8 C 4...

Page 28: ...ytes measured and calculated if applicable C 2D barcode for manufacturing quality control not scannable D Cartridge LOT number E Cartridge portion pack barcode F Refrigerated storage expiration date G...

Page 29: ...ch at room temperature for 5 minutes before use A box of pouched cartridges must stand at room temperature for one hour before use A cartridge allowed to come to room temperature must be labeled with...

Page 30: ...mulator is approximately 60 seconds The i STAT Alinity Electronic Simulator test provides an independent check on the ability of the instrument to take accurate and sensitive measurements of voltage c...

Page 31: ...Simulator with any instrument other than the i STAT Alinity touch the area under the cap NOTE Function provided by this equipment may be impaired if used in a manner not specified by Abbott Point of C...

Page 32: ...e Perform Electronic Simulator Test button Return Cal Ver View Disabled Cartridges Quality Control Perform Pro ciency Test Perform Electronic Simulator Test Update eVAS Quality Op ons Home More Op ons...

Page 33: ...Quality Op ons Home More Op ons Quality Op ons 16FEB2025 09 45 HOW TO PERFORM QUALITY TESTING CONT LIQUID QUALITY CONTROL For i STAT ACT Control i STAT Control or i STAT TriControl materials controls...

Page 34: ...t Quality Control Test SECTION 6 30 i STATAlinity Quick Reference Guide Art 731848 01 Rev M Rev Date 25 Jul 2022 The next step in the pathway is Scan or Enter OPERATOR ID HOW TO PERFORM QUALITY CONTRO...

Page 35: ...Date 25 Jul 2022 When using i STAT control material the barcode is on the control material for the control level being tested HOW TO PERFORM QUALITY TESTING CONT LIQUID QUALITY CONTROL CONT Scan FLUI...

Page 36: ...lso displayed After the instrument successfully scans the barcode help screens will be displayed See examples below Close and Insert Cartridge Close and Insert Filled Cartridge Immediately fold over s...

Page 37: ...action tabs are inactive until the second page of results has been viewed Occasionally numeric results will be replaced with the following symbols When displayed a new test must be performed Instrume...

Page 38: ...ap mmol L 34 Op ons Menu Page Na mmol L 129 127 136 Home View Entered Info Op ons Menu Transmit Print i STAT CHEM8 i STAT TriControl L2 321068 PASS 16FEB2025 11 01 BUN mg dL 10 8 14 Crea mg dL 1 3 0 7...

Page 39: ...F return cartridges to the refrigerator after bringing them to room temperature expose cartridges to temperatures above 30 C 86 F use a cartridge that is expired or that shows signs of damage use a c...

Page 40: ...w facility specific guidelines Standard precautions should be used when handling materials that may contain transmissible infectious agents Some regions have an alternate patient test flow Always foll...

Page 41: ...fter scanning is complete the instrument will advance to the next step in the pathway B To enter information manually touch icon A numeric keyboard displays automatically For alpha touch the Abc butto...

Page 42: ...a typical workflow Continue to follow prompts on the screen if they differ from those shown here Scan CARTRIDGE POUCH Barcode Scanning is required You must scan the barcode This information cannot be...

Page 43: ...rd backward and pause functionality Close and Insert Filled Cartridge Prepare material per manufacturer s instruction Immediately fold over snap closure until a soft click is heard and the closure is...

Page 44: ...ntered Info SECTION 7 40 i STATAlinity Quick Reference Guide Art 731848 01 Rev M Rev Date 25 Jul 2022 HOW TO PERFORM PATIENT TESTING CONT Once the cartridge is inserted Contacting Cartridge will displ...

Page 45: ...n tabs are inactive until he second page of results has been viewed Occasionally numeric results will be replaced with the following symbols When displayed a new test must be performed Instrument cann...

Page 46: ...touch Print A Wireless Wired to Base Station Determine printing method OR AnGap mmol L 42 Na mmol L 129 BUN mg dL 48 Glu mg dL 274 K mmol L 3 1 Crea mg dL 3 8 iCa mmol L 0 94 Cl mmol L 81 TCO2 mmol L...

Page 47: ...mg dL 21 Glu mg dL 92 Crea mg dL 2 1 iCa mmol L 1 33 8 14 0 7 1 5 Op ons Menu Page AnGap mmol L 42 View Entered Info Op ons Menu Print Transmit FEB2025 09 45 A Wireless BUN mg dL 21 Glu mg dL 92 Crea...

Page 48: ...as action ranges may be assigned When reference ranges are assigned they appear under the analyte result followed by Ref When action critical ranges are assigned results within this range will be hig...

Page 49: ...is being cleaned Remove a new disposable wipe from the container and squeeze to remove excess solution Gently wipe all outside surfaces noting the Sensitive Areas until all visible soil is removed Ins...

Page 50: ...should be taken whenever working with blood or blood products Remove a wipe from the container and squeeze out any excess fluid before you begin to wipe the surface Wipe all surfaces three times This...

Page 51: ...fluid before you begin to wipe the surface Wipe the front as shown flip products on back side and repeat WIPE 3X LEFT RIGHT 1 2 WIPE 3X UP DOWN SENSITIVE AREAS Avoid forcing liquid into these areas D...

Page 52: ...to wear clean gloves will result in contamination of the instrument Instruments used with multiple patients may require more frequent cleaning and disinfecting Cleaning is necessary for the removal o...

Page 53: ...ess blood added to cartridge When lling this cartridge the blood advanced past the level indicated by the ll to arrow Help Options Menu Home Cartridge Quality Check Failure Cartridge Was Over lled Cod...

Page 54: ...ONT TROUBLESHOOTING CONT SUPPORT Product Documentation and Resources Additional information related to configuration customization features and product documentation can be found at www globalpointofc...

Page 55: ...ites Equipment i STAT Alinity instrument s to be updated Base Station with power cable connected to AC mains power FAT 32 formatted USB memory device not provided by Abbott Point of Care PC with netwo...

Page 56: ...Date 25 Jul 2022 SECTION 10 HOW TO PERFORM SOFTWARE UPDATE CONT INSTALLATION 1 2 Ensure that the prerequisites on the previous page have been completed Place instrument into the base station and power...

Page 57: ...e used An expiration date expressed as YYYY MM means the product cannot be used past the last day of the month specified Manufacturer s lot number or batch code The lot number or batch will appear adj...

Page 58: ...3 of Directive 2002 96 EC WEEE for the European Union EU Do not reuse Signifies that the product bearing the Federal Communications Commission FCC logo complies with the specific requirements set for...

Page 59: ...55 i STATAlinity Quick Reference Guide Art 731848 01 Rev M Rev Date 25 Jul 2022 APPENDIX 1 SYMBOLS CONT SYMBOL DEFINITION Information Instrument Locked Low Battery Pass Warning Fail...

Page 60: ...alue Assignment Sheet GSG Getting Started Guide IFU Instructions for Use IR Infrared Radiation LED Light Emitting Diode MQSI Manufacturer s Quality System Instructions OSi Instrument Software PC Perso...

Page 61: ...BUN UREA Urea nitrogen Urea Hct Hematocrit ACTk Kaolin ACT Activated Clotting Time with Kaolin activator Hb Hemoglobin TCO2 Total Carbon Dioxide Concentration HCO3 Bicarbonate BE b ecf Base excess b f...

Page 62: ...ities that are otherwise disabled in the Software or decompile disassemble or otherwise reverse engineer the Software except as otherwise permitted by applicable law vi perform or attempt to perform a...

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Page 64: ...ers i STAT is for In Vitro Diagnostic Use Printed in the USA 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...