abbott point of care istat value assignment sheets

• Abbott Manuals
• Medical Equipment
• i-STAT Alinity
• Operation manual

Abbott i-STAT Alinity Operation Manual

• Quick reference manual (64 pages)
• page of 296 Go / 296

Table of Contents

Troubleshooting.

• I-STAT ALINITY INSTRUMENT - END USER LICENSE AGREEMENT
• Regulatory Compliance
• Definitions and Terminology
• I-STAT Alinity Reference
• Complete I-STAT Alinity System Overview
• I-STAT Alinity Instrument
• Principles of Operation
• More Options
• Calibration of the I-STAT Alinity Instrument
• Specifications
• Wireless Labeling
• Precautions and Limitations
• Messages and Troubleshooting
• Quality Check Failure Codes
• Cleaning and Disinfecting
• I-STAT Alinity Results Screen
• Interpreting Results
• I-STAT Alinity Rechargeable Battery
• I-STAT Alinity Base Station Specifications
• I-STAT Alinity Electronic Simulator
• Perform Electronic Simulator Testing
• Perform the Thermal Probe Check
• I-STAT Alinity Printer
• Manufacturer's Quality System Instructions
• Liquid Quality Controls
• I-STAT Controls and I-STAT Tricontrols
• I-STAT ACT Controls
• Calibration Verification (Cal Ver)
• Calibration Verification Testing and I-STAT Tricontrols Calibration Verification Solutions
• I-STAT Cartridges
• I-STAT Cartridge Components
• Receiving a New Shipment of Cartridges
• Software Updates
• Software Update and Installation Using USB Memory Device Via Base Station
• Software Update and Installation Via Abbott Managed Server or the Aliniq Sdi, and a Wired Network Connection
• Software Update and Installation Via Abbott Managed Server or the Aliniq Sdi, and a Wireless Network Connection
• Aliniq Network Connectivity for I-STAT (Nci)
• Aliniq Nci - Network Connectivity for I-STAT
• Aliniq Nci - General Section
• Aliniq Nci - Proxy Server Connection
• Aliniq Nci - Wireless Network Connection
• Aliniq Nci - Wired Network Connection
• Aliniq Nci - Save the Network Connectivity (Ancc) File
• Aliniq Nci - Copy NC (Ancc) File Onto a USB Memory Stick
• Aliniq Nci - Upload an NC (Ancc) File to an Instrument
• Aliniq Nci - Customization and Connectivity
• Aliniq Nci - Determining Success or Failure
• Aliniq Cwi - Customization Workspace for I-STAT
• Best Practices
• Getting Started
• Cwi - Home Page
• Manage Healthcare Organization
• Overview - Healthcare Organization
• Manage Users
• Manage and Assemble Profiles
• Creating a Category
• General Settings Category
• Basic Functions
• Communications
• Operator Actions
• Critical Callback
• I-STAT Reserved
• Operator Settings Category
• List Actions
• Operator Expiration
• Patient Settings Category
• Patient Information and Positive Patient Identification (PPID)
• Analyte Settings Category
• Sample Types
• Enable/Disable Analyte
• Adjustments
• ACT (Activated Clotting Time)
• Critical Tests
• Quality Settings Category
• Electronic Simulator
• QC Notifications
• Liquid QC (Quality Control) Schedules
• Cal Ver Schedules
• User Defined Message Category
• Training Settings Category
• Statnotes Category
• Selection List
• Selection List with Text Box
• Delivery System
• Patient Temperature
• Manage Sets
• Result Notes Category
• Repeat Test Item
• Action Range Comment
• QC Auto Fail Comment
• Connectivity Settings Category
• Connectivity Map
• Assemble a Profile
• Install a Profile from a USB
• Aliniq Cwi - Customization Workspace for I-STAT Troubleshooting

Advertisement

Quick Links

• 1 Principles of Operation
• Download this manual
• Messages and Troubleshooting 67
• Troubleshooting 92
• Troubleshooting 105

Related Manuals for Abbott i-STAT Alinity

Summary of Contents for Abbott i-STAT Alinity

• Page 2 Patents: ©20 1 Abbott. All rights reserved. All trademarks referenced are trademarks of either the Abbott group of  companies or their respective owners.  i-STAT Alinity – System Operations Manual Art: 746981-01 Rev. I Rev. Date: 19‐Oct‐2021...

Page 3: Table Of Contents

• Page 4 1.13 - Software Updates Software Update and Installation using USB memory device via Base Station..... 97 Software Update and Installation via Abbott Managed Server or the AlinIQ SDi, and a Wired Network Connection..................101 Software Update and Installation via Abbott Managed Server or the AlinIQ SDi, and a Wireless Network Connection...................
• Page 5 *Patient Settings Category....................173 ID Entry........................174 Patient Information and Positive Patient Identification (PPID).........177 Summary........................178 *Analyte Settings Category....................179 Units......................... 180 Sample Types......................181 Ranges........................182 Enable/Disable Analyte.................... 185 Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745538-01 Rev. R...
• Page 6 Connectivity Map..................... 245 Summary........................246 Assemble a Profile ......................247 Install a Profile from a USB....................249 3.5 - AlinIQ CWi – Customization Workspace for i-STAT Troubleshooting 251 Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745538-01 Rev. R...

Page 7: Foreword

Page 8: i-stat alinity instrument - end user license agreement.

• Page 9 APPLICABLE. HOWEVER, SOME STATES DO NOT ALLOW LIMITATIONS ON HOW LONG AN IMPLIED WARRANTY LASTS, SO THE ABOVE LIMITATION MAY NOT APPLY TO YOU. THIS WARRANTY GIVES Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746982-01 Rev. E...
• Page 10 Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746982-01 Rev. E...
• Page 11 APOC may have under trade secret, copyright, patent or other laws. The provisions of Sections 2, 5, 6, 7, 8 and 11 shall survive the termination of this EULA. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746982-01 Rev. E...
• Page 12 Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746982-01 Rev. E...

Page 13: Regulatory Compliance

• Page 14 Type approval and homologation of equipment pursuant to Section 50 of The Electron Communication Act 2011 Type Approval CTYPE-01305 and CTYPE-01306 Bolivia Autoridad de Regulación y Fiscalización de Telecomunicaciones y Transportes Type Approval ATT-DJ-RA-H-TL-LP 46/2018 i-STAT Alinity — System Operations Manual Art: 746983-01 Rev. H Rev. Date: 11-Nov-2020...
• Page 15 Certificate. No: KY1504003 China Radio Transmission Equipment Type Approval CMIIT ID: 2019AJ8315 Colombia Communications Regulatory Commission (CRC) - Exempt Costa Rica Superintendencia de Telecomunicaciones approval 04979-SUTEL- DGC-2017 i-STAT Alinity — System Operations Manual Art: 746983-01 Rev. H Rev. Date: 11-Nov-2020...
• Page 16 CERTIFICATE OF TYPE APPROVAL per HKCA 1039 Issue 6, June 2015 India Ministry of Communcations & IT Equipment Type Approval, ETA Certification No: ETA – 3319/16- RLO(WR) i-STAT Alinity — System Operations Manual Art: 746983-01 Rev. H Rev. Date: 11-Nov-2020...
• Page 17 Autorite de Regulation des Technologies de Communication (ARTEC) No 17/026/ARTEC/DG/DHCT/SSS/test Maldives Communications Authority of Maldives Type Approval CAM- TAC2019-03 Mauritius Information & Communication Technologies Authority (ICTA) Type Approval Certificate Reference Number: TA/2017/0214 i-STAT Alinity — System Operations Manual Art: 746983-01 Rev. H Rev. Date: 11-Nov-2020...
• Page 18 Homologacion, Code: TRSS39479, Report: 2158-2017-MTC/29.CGH.CH Applied Technical Standard: PNAF-R.M. No. 187-2005-MTC/03, pub. 04/03/2005 – R.M. No. 777-2005-MTC/03, pub. 11/05/2005 Philippines National Telecommunications Commission Type Acceptance Certificate No. ESD-1714467C i-STAT Alinity — System Operations Manual Art: 746983-01 Rev. H Rev. Date: 11-Nov-2020...
• Page 19 Telecommunications (Terminal Equipment and Public Networks) Regulations, No. 10 or 2002 Certification of Type Approval, Certificate No.:LCT/AP17.118D St. Maarten Bureau of Telecommunication and Post Type Approval Certificate no 2017/018-b/TA i-STAT Alinity — System Operations Manual Art: 746983-01 Rev. H Rev. Date: 11-Nov-2020...
• Page 20 FCC 47 CFR Part 15, Subpart E - Unlicensed National Information Infrastructure Devices FCC ID: 2AAEX-SDABGN Vietnam Ministry of Information and Communications Type Approval Certificate No: C0031280217AE01A2 i-STAT Alinity — System Operations Manual Art: 746983-01 Rev. H Rev. Date: 11-Nov-2020...
• Page 21 European Union (EU) WEEE Directive 2012/19/EU European Union (EU) REACH Regulation 1907/2006/EC European Union (EU) Packaging and Packaging Waste Directive 94/62/EC Federal Communications Commission (FCC) Statement (United States only) i-STAT Alinity — System Operations Manual Art: 746983-01 Rev. H Rev. Date: 11-Nov-2020...
• Page 22 For product available in the USA/Canada market, only channels 1-11 can be operated. Selection of other channels is not possible. If this device is to be operated in the 5.15~5.25GHz frequency range, it is restricted to indoor environments only. i-STAT Alinity — System Operations Manual Art: 746983-01 Rev. H Rev. Date: 11-Nov-2020...
• Page 23 Antenna: Laird Technologies, Mini-NanoBlade Antenna gain information: Embedded Antenna: 2.5dBi (2.4 GHz), 4.8dBi (5 GHz) Frequency Tolerance：+/-20ppm ** See website for Declaration of Conformity for associated EMC/RED/LVD standards. i-STAT Alinity — System Operations Manual Art: 746983-01 Rev. H Rev. Date: 11-Nov-2020...
• Page 24 Alinity — System Operations Manual Art: 746983-01 Rev. H Rev. Date: 11-Nov-2020...

Page 25: Symbols

• Page 26 Symbol Definition/Use Software update is available. i-STAT Alinity — System Operations Manual Art: 745579-01 Rev. K Rev. Date: 16-May-2022...
• Page 27 Table 3: Wireless Network Status Symbol Definition/Use Best Very good Good Fair Poor No Connection Wireless disabled Wireless connecting Table 4: Wired Network Status Symbol Definition/Use Connected Disabled i-STAT Alinity — System Operations Manual Art: 745579-01 Rev. K Rev. Date: 16-May-2022...
• Page 28 Signifies that the product bearingt he ETL Listed mark complies with both U.S. and Canadian product safety standards: UL 61010-1: 3rd Ed; Am.1 CAN/CSA C22.2 No. 61010-1-12 3rd Ed. (R2017) +U1;U2 Electrical hazard Attention: See instructions for use. i-STAT Alinity — System Operations Manual Art: 745579-01 Rev. K Rev. Date: 16-May-2022...
• Page 29 Rules and Regulations, Title 47, Part 15 Subpart B, for Class A devices. The near-patient testing symbol illustrates that a device can only be used in a near-patient setting by a health worker, professional or trainee. i-STAT Alinity — System Operations Manual Art: 745579-01 Rev. K Rev. Date: 16-May-2022...
• Page 30 Table 6: Control related Symbol Definition/Use Control Table 7: For use on i‑STAT Value Assignment Sheets Symbol Definition/Use Mean Range i-STAT Alinity — System Operations Manual Art: 745579-01 Rev. K Rev. Date: 16-May-2022...
• Page 31 Base excess (b for blood, ecf for extracellular fluid) AnGap Anion Gap Oxygen saturation eGFR Estimated Glomerular Filtration Rate eGFR-a Black/African-American Estimated Glomerular Filtration Rate GFAP Glial Fibrillary Acidic Protein UCH-L1 Ubiquitin Carboxy-terminal Hydrolase L1 i-STAT Alinity — System Operations Manual Art: 745579-01 Rev. K Rev. Date: 16-May-2022...
• Page 32 Quality Check Failure Quick Reference Guide R-VAS Rilibak Value Assignment Sheet ReVAS Rilibak Electronic Value Assignment Sheet Software Update Traumatic Brain Injury Universal Serial Bus Value Assignment Sheet i-STAT Alinity — System Operations Manual Art: 745579-01 Rev. K Rev. Date: 16-May-2022...

Page 33: Definitions And Terminology

• Page 34 Group of features used to define the behavior of an instrument. Selections made in this setting group are names, IP addresses and ports of other systems with which the i-STAT Alinity is to communicate information. Cardiopulmonary Bypass Surgery Setting. The CPB function adjusts hematocrit and hemoglobin results for the dilutional effect of pump fluid during cardiopulmonary bypass surgery.
• Page 35 Observations Connectivity mapping for test records. Area for entering IP address and network port for the POC data manager. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 747018-01 Rev. H...
• Page 36 IQCP guidelines. This is one of five categories that is required to build a profile. Ranges Healthcare organization-defined ranges for reference, action and reportable. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 747018-01 Rev. H...
• Page 37 Message created to display on the instrument before any selections are made. User Role There are 3 user roles in the CWi. The roles define what CWi privileges each user has. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 747018-01 Rev. H...
• Page 38 Organization Manager Primary is the only role that can assign additional healthcare organization managers. This is also the contact person if Abbott Point of Care should need to contact the healthcare organization. It is imperative that this role be updated if this individual needs to be changed.
• Page 40 This page intentionally left blank. i-STAT Alinity — System Operations Manual Art: 746989-01 Rev. A Rev. Date: 02-Oct-2016...

Page 41: I-Stat Alinity Reference

• Page 42 Base Station Provides recharging, printing, and network connectivity capabilities to the instrument. i-STAT Alinity — System Operations Manual Art: 745526-01 Rev. H Rev. Date: 04-Mar-2021...
• Page 43 Alinity. Electronic Simulator Provides an independent check on the instrument's ability to take accurate and sensitive measurements of voltage, current and resistance from the cartridge. i-STAT Alinity — System Operations Manual Art: 745526-01 Rev. H Rev. Date: 04-Mar-2021...
• Page 44 Alinity — System Operations Manual Art: 745526-01 Rev. H Rev. Date: 04-Mar-2021...

Page 45: I-Stat Alinity Instrument

Page 46: principles of operation.

• Page 47 IEEE802.11 a/b/g/n wireless module. Connectivity to the i‑STAT Alinity portable printer is available via infrared communication or through wired connection to the printer employing the Base Station. i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
• Page 48 Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...

Page 49: More Options

• Page 50 More Options. If permission levels are set via Data Management, at least one operator must have permission level of Key Operator or Supervisor. i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
• Page 51 NCi utility. When the instrument is configured, this button will become active and enable is the default. Disable Prevents instrument from communicating via wireless transmission. i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
• Page 52 This method of QC testing must be set up via a customization profile as well as activation in the data management system. i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
• Page 53 • remove the USB and reinsert • ensure that the USB is formatted Install from Server View Disabled Cartridges Cartridges are disabled due to expired QC. i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
• Page 54 Reserved for future use. Delete Profile Follow prompts on screen to delete the customization profile installed on instrument. Profile Status List of information regarding customization profile loaded on instrument. i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
• Page 55 Displays lists to be deleted. Choose list(s) and follow prompts on the screen to complete. List Status Displays information pertaining to patient, operator and cartridge lot list. i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
• Page 56 See Software Updates section of this manual for complete details for downloading and installing software via the Abbott Managed Server. i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
• Page 57 See the section Instrument Clock Date/Time Synchronization for details. Set Units Set Date Format i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
• Page 58 If the instrument does not detect the USB drive, try the following: • remove the USB and reinsert • make sure the USB is formatted. i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
• Page 59 Disabling stops the instrument from communicating with the wireless Delete Network Settings Follow prompts to complete this action. Network Status List of information associated with wireless and wired communication. i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
• Page 60 Perform Conditioning Cartridge Touch this button to perform conditioning procedure using a conditioning cartridge. Contact Technical Support or local representative to obtain the conditioning cartridge and instructions for use. i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
• Page 61 Touch the character until the additional options display at the bottom of the keypad: After several seconds, the additional characters will disappear allowing the operator to continue typing without requiring any additional keystrokes. i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
• Page 62 The Synchronize Clock with Data Manager check box is only available on the Set Clock screen when the instrument is configured to communicate with a data manager. i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...

Page 63: Calibration Of The I-Stat Alinity Instrument

Page 64: specifications, page 65: precautions and limitations.

• Page 66 • make any unauthorized repairs or modifications to this product as this may cause personal injury or damage to the unit. NOTE: • Protection provided by this equipment may be impaired if used in a manner not specified by Abbott Point of Care. • Operators should use standard precautions whenever handling the instrument, cartridge, and peripherals to protect themselves from blood-borne pathogens.

Page 67: Messages And Troubleshooting

• Page 68 2-01-1.1.1 2-01 2-02-1.1.2 2-02 8-01-2.1.8 P / BB 8-01 11-01-2.13.32 11-01 13-01-1.6.1 13-01 17-01-8.2.1 17-01 18-01-8.2.2 18-01 19-01-8.2.3 19-01 20-01 20-01-3.1.1 21-01-3.1.3 21-01 22-01-6.1.3 22-01 22-01-6.1.5 22-01 i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
• Page 69 28-01 29-01-4.1.3 29-01 30-01-6.1.4 30-01 30-01-6.1.7 30-01 30-02-4.1.4 30-02 31-01-4.1.5 31-01 31-02-6.1.16 31-02 32-01-4.1.6 32-01 33-01-4.1.8 33-01 34-01-4.1.11 34-01 35-01-4.1.7 35-01 36-01-4.1.10 36-01 37-01-4.1.9 37-01 38-01-4.1.12 38-01 i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
• Page 70 53-01-2.9.3 53-01 57-01-2.4.1 57-01 59-01-4.5.1 59-01 60-01-1.6.2 C / AA 60-01 63-01-2.9.1 63-01 63-01-2.9.2 63-01 66-01-2.2.1 66-01 66-01-2.2.2 66-01 66-01-2.2.3 66-01 68-01-2.4.2 68-01 69-01-3.6.1 69-01 69-02-3.6.2 69-02 i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
• Page 71 90-01 90-01-2.4.5 90-01 90-01-2.4.6 90-01 90-01-2.4.7 90-01 90-01-2.4.8 90-01 90-01-2.4.9 90-01 90-01-2.4.10 90-01 90-01-2.4.11 90-01 90-01-2.4.12 90-01 90-01-2.4.13 90-01 90-02-2.4.14 90-02 90-02-2.4.16 90-02 90-02-2.4.17 90-02 90-02-2.4.18 90-02 i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
• Page 72 123-01 124-01-5.1.25 124-01 125-01-5.1.26 125-01 126-01-5.1.27 126-01 127-01-5.1.1 127-01 127-01-5.1.3 127-01 128-01-5.1.5 128-01 129-01-5.1.7 129-01 130-01-5.1.8 130-01 131-01-5.1.10 131-01 132-01-5.1.15 132-01 133-01-5.1.20 133-01 134-01-5.1.16 134-01 134-01-5.1.17 134-01 i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
• Page 73 149-01 150-01-5.2.4 150-01 150-01-5.2.9 150-01 151-01-5.2.5 151-01 151-01-5.2.10 151-01 152-01-5.2.11 152-01 165-01-8.1.1 165-01 166-01-8.1.2 166-01 167-01-8.1.3 167-01 170-01-8.1.4 170-01 171-01-8.1.5 171-01 172-01-8.1.6 172-01 173-01-8.1.7 173-01 174-01-8.1.8 174-01 i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
• Page 74 System Administrator Note: If code displays after operator repeats testing, instruct the operator to perform conditioning using a Conditioning Cartridge. Contact Technical Support or local representative for Conditioning Cartridge and instructions for use. i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
• Page 75 Cartridge was rejected during the testing cycle. Probable causes: • Excess sample was added to the cartridge • Operator pressed too hard on the center of the cartridge i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
• Page 76 Simulator insertion. Ensure the Simulator is fully inserted. The Simulator is fully inserted when the click is heard. If the same quality check failure displays, contact the system administrator for further instruction. Reserved for future use. i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...
• Page 77 Conditioning Cartridge. Ensure the Conditioning Cartridge is fully inserted. The Conditioning Cartridge is fully inserted when the click is heard. If the same quality check failure displays, contact the system administrator for further instruction. i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022...

Page 78: Cleaning And Disinfecting

Page 79: i-stat alinity results screen.

• Page 80 ￮ Customized Action Range • Instrument Status • Quality Options • Administrative Options • Instrument Options Displays information associated with the test Prints result to i‑STAT Alinity printer i-STAT Alinity — System Operations Manual Art: 745531-01 Rev. G Rev. Date: 04-Mar-2021...

Page 81: Interpreting Results

• Page 82 The following section provide examples for various analytes, when the analyzer is customized with Align IQ CWI. Not all cartridges are available in all regions. Ability to run a cartridge is controlled by the instrument and by region. i-STAT Alinity — System Operations Manual Art: 745531-01 Rev. G Rev. Date: 04-Mar-2021...
• Page 83 (critical) range. ￮ White arrow in page button - indicates all results on second page are within the reference range. i-STAT Alinity — System Operations Manual Art: 745531-01 Rev. G Rev. Date: 04-Mar-2021...
• Page 84 Alinity — System Operations Manual Art: 745531-01 Rev. G Rev. Date: 04-Mar-2021...

Page 85: I-Stat Alinity Rechargeable Battery

Page 86: specifications.

• Page 87 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 respect to suitability for use in oxygen-enriched atmospheres.
• Page 88 Alinity — System Operations Manual Art: 745529-01 Rev. G Rev. Date: 04-Mar-2021...
• Page 89 1.5 - i-STAT Alinity Base Station Overview The primary function of the Base Station is to charge the rechargeable battery while it is attached to the i‑STAT Alinity instrument. The Base Station is intended for use only with the i‑STAT Alinity instrument.

Page 90: I-Stat Alinity Base Station Specifications

Page 91: precautions and limitations, page 92: troubleshooting, page 93: i-stat alinity electronic simulator, page 94: precautions and limitations, page 95: cleaning and disinfecting.

• Page 96 Alinity — System Operations Manual Art: 745530-01 Rev. D Rev. Date: 16-May-2022...

Page 97: Perform Electronic Simulator Testing

• Page 98 Perform a test using the Electronic Simulator i-STAT Alinity — System Operations Manual Art: 745578-01 Rev. C Rev. Date: 04-Mar-2021...

Page 99: Perform The Thermal Probe Check

• Page 100 Alinity — System Operations Manual Art: 745578-01 Rev. C Rev. Date: 04-Mar-2021...

Page 101: I-Stat Alinity Printer

Page 102: principles of operation, page 103: specifications, page 104: precautions and limitations, page 105: troubleshooting.

• Page 106 4. Reconnect the power cord. Then, press the power button to turn the printer on. Attempt to print a record from the instrument. If a printer failure occurs, contact Technical Support. i-STAT Alinity — System Operations Manual Art: 745525-01 Rev. E Rev. Date: 04-Mar-2021...

Page 107: Cleaning And Disinfecting

• Page 108 Alinity — System Operations Manual Art: 745525-01 Rev. E Rev. Date: 04-Mar-2021...

Page 109: Manufacturer's Quality System Instructions

• Page 110 Alinity — System Operations Manual Art: 745532-01 Rev.D Rev. Date: 04-Mar-2021...

Page 111: Liquid Quality Controls

• Page 112 Electronic value assignment sheets (eVAS or ReVAS) may be downloaded to a customized instrument via the Abbott Managed Server, the SDi, or USB. See the System Operations Manual for information and instruction on creating customization profiles. Selection of eVAS or ReVAS must be made during the creation of the profile.
• Page 113 Reactive ingredients for i-STAT Control materials: Analyte Control Level 1 Control Level 2 Control Level 3 Na (mmol/L) K (mmol/L) Cl (mmol/L) Glu (mmol/L) Urea (mmol/L) iCa (mmol/L) Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745533-01 Rev. H...
• Page 114 Na is the analyte tested, Na (Sodium). mmol/L, mEQ/L are the units of measurement. Mean is the mean or average level of sodium (Na). Range is the acceptable range of sodium (Na) levels. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745533-01 Rev. H...

Page 115: I-Stat Act Controls

• Page 116 4. Place the end of the transfer device into the sample well of the cartridge and fill the cartridge to the fill mark. 5. Close cartridge and begin testing immediately. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745533-01 Rev. H...

Page 117: Calibration Verification (Cal Ver)

Page 118: calibration verification testing and i-stat tricontrols calibration verification solutions.

• Page 119 Electronic value assignment sheets (eVAS or ReVAS) may be downloaded to a customized instrument via the Abbott Managed Server, the SDi, or USB. See the System Operations Manual for information and instruction on creating customization profiles. Selection of eVAS or ReVAS must be made during the creation of the profile.
• Page 120 Cal Ver Level 2 Cal Ver Level 3 Cal Ver Level 4 Cal Ver Level 5 Na (mmol/L) K (mmol/L) Cl (mmol/L) Glu (mmol/L) Urea (mmol/L) 44.6 Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745537-01 Rev. F...
• Page 121 The following is an example of the mean and range for level 2 Cal Ver solution taken from a Value Assignment Sheet: Mean Range Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745537-01 Rev. F...
• Page 122 Na is the analyte tested, Na (Sodium). mmol/L, mEQ/L are the units of measurement. Mean is the mean or average level of sodium (Na). Range is the acceptable range of sodium (Na) levels. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745537-01 Rev. F...

Page 123: I-Stat Cartridges

• Page 124 Cartridge Box Information Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745524-01 Rev. I...
• Page 125 Cartridge Pouch Information Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745524-01 Rev. I...
• Page 126 Cartridge Portion Pack Information Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745524-01 Rev. I...

Page 127: I-Stat Cartridge Components

• Page 128 Sample Well The area on the cartridge where the sample is introduced into the sample chamber. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745524-01 Rev. I...
• Page 129 Potentiometric sensors utilize two important concepts. The first concept is the Nernst Equation which relates the measured potential to the activity of the ion being measured. It is written as: E = E° + RT/nF ln a Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745524-01 Rev. I...
• Page 130 3. The measured signal generated by the analyte in the test solution For potentiometric sensors, the analyte activity in the sample is calculated from the Nernst equation according to: = S log (a sample calibrant sample calibrant Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745524-01 Rev. I...
• Page 131 (Nikolsky equation), these effects can be minimized. By characterizing the reference electrode in different solutions, effects of matrix on the reference junction potential can also be minimized. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745524-01 Rev. I...

Page 132: Receiving A New Shipment Of Cartridges

• Page 133 • The instrument and its peripherals are not listed by any authority with respect to suitability for use in oxygen-enriched atmospheres. • Follow manufacturer's recommendations for handling and storing samples drawn into lithium or balanced heparin. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745524-01 Rev. I...
• Page 134 Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 745524-01 Rev. I...

Page 135: Software Updates

• Page 136 The display of this message is the indication that the installation is complete and it is safe to remove the instrument and USB memory device from the Base Station. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 754496-01 Rev. E...
• Page 137 Note: It is recommended that Electronic Simulator Test be completed immediately following a software update. Depending on the instrument customization, testing may be disabled until an Electronic Simulator Test with passing result is completed. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 754496-01 Rev. E...
• Page 138 Alinity system. Before reformatting, make sure you copy any files on the USB memory device to a safe location on your PC because reformatting will delete all files from the memory device. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 754496-01 Rev. E...

Page 139: Software Update And Installation Via Abbott Managed Server Or The Aliniq Sdi, And A Wired Network Connection

• Page 140 7. When the installation is complete, the instrument will display a message indicating that new software has been installed. The display of this message is the indication that it is safe to resume normal operation of the instrument. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 754496-01 Rev. E...
• Page 141 • Remove the instrument and re-seat it on the Battery status indicator does not indicate battery is charging Base Station • Ensure the Base Station is getting power (Blue light on Base Station is illuminated) Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 754496-01 Rev. E...
• Page 142 • The healthcare organization network is allowing the instrument to connect to the internet in order to have access to the Abbott Managed Server or SDi. Repeated attempts to update software via wired Follow the procedure to perform software update...

Page 143: Software Update And Installation Via Abbott Managed Server Or The Aliniq Sdi, And A Wireless Network Connection

• Page 144 7. When the installation is complete, the instrument will display a message indicating that new software has been installed. The display of this message is the indication that it is safe to resume normal operation of the instrument. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 754496-01 Rev. E...
• Page 145 • The instrument is running software version OSi05 or later • Network Services for software update enabled on instrument • The battery charge level is no less than 51% Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 754496-01 Rev. E...
• Page 146 Network Configuration file installed • The healthcare organization network is allowing the instrument to connect to the internet in order to have access to the Abbott Managed Server or to connect to the SDi Repeated attempts to update software via wireless...
• Page 148 This page intentionally left blank. i-STAT Alinity — System Operations Manual Art: 746987-01 Rev. A Rev. Date: 02-Oct-2016...

Page 149: Aliniq Nci - Network Connectivity For I-Stat

• Page 150 Installing NCi: • Navigate to the Abbott Point of Care website • Find the link to the NCi utility • Follow the instructions on the screen When the installation of NCi completes, this icon will appear on the desktop: To run NCi, double click the icon. On the first screen of the NCi that displays, select the type of instrument as i‑STAT Alinity.

Page 151: Aliniq Nci - General Section

• Page 152 Click this option to edit an existing NC file. Navigate to the folder containing the NC file you wish to edit. The next section of the NCi screen is for configuring a connection to a proxy server. i-STAT Alinity — System Operations Manual Art: 747079-01 Rev. F Rev. Date: 28-Apr-2020...

Page 153: Aliniq Nci - Proxy Server Connection

• Page 154 The next section of the NCi screen is for connecting wirelessly. i-STAT Alinity — System Operations Manual Art: 747079-01 Rev. F Rev. Date: 28-Apr-2020...

Page 155: Aliniq Nci - Wireless Network Connection

• Page 156 IP Address IPv4 address of instrument in decimal dot notation. Example: 172.16.254.1 ￮ Subnet Mask IPv4 mask that defines the Subnet in decimal dot notation. Example: 255.255.255.0 i-STAT Alinity — System Operations Manual Art: 747079-01 Rev. F Rev. Date: 28-Apr-2020...
• Page 157 Name of the file that contains the Certificate Authority certificate. Client Certificate File Name of the file that contains the client certificate. Client Key File Name of the file that contains the client key. i-STAT Alinity — System Operations Manual Art: 747079-01 Rev. F Rev. Date: 28-Apr-2020...
• Page 158 Client Key Password Password for the client key. Username/Identity Username required by the authentication server. i-STAT Alinity — System Operations Manual Art: 747079-01 Rev. F Rev. Date: 28-Apr-2020...

Page 159: Aliniq Nci - Wired Network Connection

• Page 160 IPv4 address of the server in decimal dot notation Alternate DNS: IPv4 address of the server in decimal dot notation. Note: You must specify DNS addresses if you specify a static IP address. i-STAT Alinity — System Operations Manual Art: 747079-01 Rev. F Rev. Date: 28-Apr-2020...

Page 161: Aliniq Nci - Save The Network Connectivity (Ancc) File

Page 162: aliniq nci - copy nc (ancc) file onto a usb memory stick, page 163: aliniq nci - customization and connectivity.

• Page 164 Alinity — System Operations Manual Art: 747079-01 Rev. F Rev. Date: 28-Apr-2020...
• Page 165 Network Connectivity for i-STAT Alinity Worksheet 1 of 2 1A - The configuration will be used for: Multiple instruments Enter a name for configuration (maximum 53 characters) 1D Configuration Name: 2A - Using a Proxy Server to Access Internet 2B Select either HTTP or Socks HTTP Yes/No Socks Yes/No Enter IP address and port of the proxy server 2C Proxy Server Address: Port: 2D Proxy Server User Name: 2E Proxy Server Password: If connection to a Wireless Network is required, complete information below 3A - Connect to Wireless Enter Name of the wireless local area network (WLAN) 3B Network Name (SSID): If connection to a single access point is required, Enter BSSID 3C Connect to a specific Access Point (BSSID): 3D Authentication Type: For Personal Authentication, select one of the following options PERSONAL WPA Personal Yes/No WPA2 Personal Yes/No WPA2/WPA Personal Yes/No Enter PSK Passphrase (8 to 63 characters), or 64-digit HEX key 3E Network Security Key: Select either Automatic (DHCP) or Static IP Address Option 3F IP Address Mode: Automatic (DHCP) Yes/No Static IP Address Yes/No If Static IP Address Option is selected, enter IP Address, Subnet Mask and Optional Default Gateway 3G IP Address: 3H Subnet Mask:...
• Page 166 Network Connectivity for i-STAT Alinity Worksheet 2 of 2 For Enterprise Authentication, select one of the following options Enterprise WPA Personal Yes/No WPA2 Personal Yes/No WPA2/WPA Personal Yes/No Select one of three EAP Methods and complete security credential information for selected option 3N EAP Method TLS TTLS/MSCHAPv2 PEAPv0/EAP-MSCHAPv2 3O Server Name: Server Name: Server Name: 3P CA Certificate File: CA Certificate File: CA Certificate File: 3Q Client Certificate File: Client Certificate File: Username/Identity: 3R Client Key File: Client Key File: Password: 3S Client Key Password: Client Key Password: Anonymous ID: anonymous 3T Username/Identity: Username/Identity: Password: Anonymous ID: anonymous If connection to a Wired Network is required, complete information below 4A - Connect to Wired 4B Authentication Type: open 4C IP Address Mode: Automatic (DHCP) Yes/No...
• Page 168 This page intentionally left blank. i-STAT Alinity — System Operations Manual Art: 746988-01 Rev. A Rev. Date: 02-Oct-2016...

Page 169: Aliniq Cwi - Customization Workspace For I-Stat

Page 170: best practices.

• Page 171 In order to ensure the security of users' customizations, profiles and other data, Abbott Point of Care establishes the healthcare organization (HCO). This is done once. At the time the HCO is created, an HCO primary manager must be identified. The HCO primary manager is the person responsible for the CWi.
• Page 172 On the Home page, next to the 'Welcome' is the email address of the user who is logged on. Next to the email address is a " " gear icon. Click on the icon to open the User Settings screen. The password and i-STAT Alinity — System Operations Manual Art: 746298-01 Rev. M Rev. Date: 13-Oct-2022...
• Page 173 4. Enter the password created by the user and click the "Log in" button. If 5 failed attempts are made, the system will lock out the user. The lockout will last for one hour, unless the user resets their password. i-STAT Alinity — System Operations Manual Art: 746298-01 Rev. M Rev. Date: 13-Oct-2022...

Page 174: Cwi - Home Page

• Page 175 Displays the email address of the user who Email address of user is logged on and the name of the Healthcare Organization only HCO Name as assigned by Abbott Point of Care Command Provides link for password to be changed Line and language chosen.
• Page 176 Alinity — System Operations Manual Art: 746298-01 Rev. M Rev. Date: 13-Oct-2022...

Page 177: Manage Healthcare Organization

Page 178: best practices, page 179: manage users, page 180: getting started.

• Page 181 Healthcare Organization Manager Point of Care Super User Point of Care Coordinator To delete these specifications, click Discard. To save them, Click Next and the Summary tab displays. i-STAT Alinity — System Operations Manual Art: 746303-01 Rev. K Rev. Date: 19-Oct-2021...
• Page 182 The Search field is used to find free-field text (i.e. email addresses or user names) in the User Workspace table. The Filter option is used to limit what is displayed in the User Workspace table. i-STAT Alinity — System Operations Manual Art: 746303-01 Rev. K Rev. Date: 19-Oct-2021...

Page 183: Manage And Assemble Profiles

Page 184: best practices, page 185: creating a category.

• Page 186 ￮ Search for Operator ID on Operator List ￮ Operator ID on Operator List-Certification Expired Action ￮ Operator ID not on Operator List Action • Operator Expiration ￮ Operator Certification Expiration Notification Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
• Page 187 ￮ Apply CPB Protein Algorithm to Hematocrit Setting • Adjustments ￮ BE Equation ￮ eGFR Equation ￮ eGFR Variants • ACT ￮ ACTk Mode ￮ Stop ACT Test • Critical Tests Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
• Page 188 ￮ Manage Items ￮ Manage Sets Connectivity Settings • Connectivity Map ￮ Test Records ￮ Device Events ￮ Operator List ￮ Patient List ￮ Cartridge List ￮ Log Events Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

Page 189: General Settings Category

Page 190: basic functions.

• Page 191 • Previous to go back to the previous screen • Discard to undo changes • Finish Later to create a draft • Next to open the next tab Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

Page 192: Date

Page 193: communications, page 194: operator actions.

• Page 195 Operator selects the most appropriate. Rejection comments will be attached to the test record and can be viewed under the Review Results > Patient Results > Rejected Patient Results Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
• Page 196 Mandatory Prompt the operator for a mandatory entry. Cartridge testing cannot continue until information is entered. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
• Page 197 For example, "3-6,7-9" is a valid selection, but "3-6,6-9" is not. • Entering consecutive commas or hyphens is invalid. For example, "2--5", "2-5,,7-10", and "2,-5" are all invalid ranges. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
• Page 198 • Previous to go back to the previous screen • Discard to undo changes • Finish Later to create a draft • Next to open the next tab Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

Page 199: Critical Callback

• Page 200 Use the Mod 11 algorithm when creating entry operator or patient IDs. Mod 10 check digit on manual Use the Mod 10 algorithm when creating entry operator or patient IDs. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
• Page 201 Patient Last Name. See the information Minimum Length shown earlier in this section. Maximum Length Scan Mask Manual Check Digit Method Scan Entry Check Digit Method Barcode Type Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
• Page 202 • Previous to go back to the previous screen • Discard to undo changes • Finish Later to create a draft • Next to open the next tab Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

Page 203: Print

Page 204: i-stat reserved, page 205: operator settings category.

• Page 206 For example, "3-6,7-9" is a valid selection, but "3-6,6-9" is not. • Entering consecutive commas or hyphens is invalid. For example, "2--5", "2-5,,7-10", and "2,-5" are all invalid ranges. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
• Page 207 Display the entire operator ID. Partially Display Operator ID Display only the last 3 digits of the operator ID. Hide Operator ID Display none of the operator ID. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
• Page 208 • Previous to go back to the screen displayed previous to this screen • Discard to undo changes • Finish Later to create a draft • Next to open the next tab Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

Page 209: List Actions

• Page 210 Operator List and allow access to the test pathway for testing to be performed. Lockout user Deny access if an operator's ID is not on the Operator List. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
• Page 211 • Previous to go back to the previous screen • Discard to undo changes • Finish Later to create a draft • Next to open the next tab Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

Page 212: Operator Expiration

Page 213: patient settings category, page 214: id entry.

• Page 215 Whether to use a check digit when scanning a value to create an operator or Method patient ID. No check digit on scan entry Do not use a check digit when creating operator or patient IDs. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
• Page 216 IDs. Mod 10 check digit on scan Use the Mod 10 algorithm when creating entry operator or patient IDs. Barcode Type Select all that apply. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

Page 217: Patient Information And Positive Patient Identification (Ppid)

Page 218: summary, page 219: analyte settings category, page 220: units, page 221: sample types, page 222: ranges.

• Page 223 Note: Never enter a null (blank) value for the Custom Reportable range for Low or High. The values can be left as -99999.9 for Low or 99999.9 for High. Note: Range customization may not apply to all cartridge types. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
• Page 224 • Previous to go back to the previous screen • Discard to undo changes • Finish Later to create a draft • Next to open the next tab Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

Page 225: Enable/Disable Analyte

Page 226: hematocrit.

• Page 227 • Previous to go back to the previous screen • Discard to undo changes • Finish Later to create a draft • Next to open the next tab Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

Page 228: Adjustments

Page 229: act (activated clotting time), page 230: critical tests, page 231: quality settings category, page 232: electronic simulator, page 233: qc notifications.

• Page 234 A list of comments created by the CWi user. Operator selects the most appropriate. The comment will be attached to the test record. Each comment can be 20 characters in length including spaces. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
• Page 235 USB port on the Base Station. Manual The operator manually compares the Cal Ver results to a Value Assignment Sheet downloaded or printed from the Abbott Point of Care website at: https:// www.globalpointofcare.abbott/en/support/ istat-brand/vas-i-stat-alinity.html...
• Page 236 The file type uploaded onto the i‑STAT Alinity for the use of the Pass/Fail Determination feature. Select either: eVAS Select for all countries except Germany. ReVAS Select only if you are in Germany. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
• Page 237 • Previous to go back to the previous screen • Discard to undo changes • Finish Later to create a draft • Next to open the next tab Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

Page 238: Liquid Qc (Quality Control) Schedules

• Page 239 Cartridge QC Profile cannot be a dependent cartridge in another Cartridge QC Profile within the same schedule. It can be a dependent cartridge in a Cartridge QC Profile belonging to a different schedule. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
• Page 240 • Previous to go back to the previous screen • Discard to undo changes • Finish Later to create a draft • Next to open the next tab Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

Page 241: Cal Ver Schedules

• Page 242 QC Fluids Select up to 6 different fluids in 1 QC schedule. Selections must not be duplicated. After fluids have been selected, click Update QC Profile. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

Page 243: Summary

Page 244: user defined message category, page 245: summary, page 246: basic functions.

• Page 247 On the screen that displays, enter values for the scenario you are creating. When all information has been entered, click Update Training Scenario. The scenario that was created displays on a screen similar to the one shown here: Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

Page 248: Summary

Page 249: statnotes category.

• Page 250 Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

Page 251: Data Entry

• Page 252 Determine the format used to enter data. Select either: Numeric Only Data will be entered only as numbers. Alphanumeric Data will be entered as either letters or numbers. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
• Page 253 ID numbers, and if so, which algorithm is used. Allowable values are: No check digit on manual Do not use a check digit when creating entry operator or patient IDs. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
• Page 254 When the specifications for this item are complete, in the lower right corner of the screen: • Click Publish to complete the item so it will appear on the Manage Items list • Click Discard to delete the item Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

Page 255: Selection List

• Page 256 • Click Publish to complete the item so it will appear on the Manage Items list • Click Discard to delete the item Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

Page 257: Selection List With Text Box

Page 258: mode.

• Page 259 Prompt the operator for a mandatory entry. If the override feature is chosen by the operator no further action is required and the instrument will advance to the next screen. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
• Page 260 Repeat this process for all STATNotes items that will be needed for the ventilator mode that is being built. Once all STATNotes items have been selected for the ventilator mode click Save. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
• Page 261 When finished, choose from the options shown at the bottom of the screen: • Click Publish to complete the item so it will appear on the Manage Items list • Click Discard to delete the item Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

Page 262: Delivery System

• Page 263 The delivery system does not have settings or measurements. Example: Room Air. Once No Page is selected, click Save. Mode The delivery system has various modes. Example: Ventilator. Once Mode is selected, click Save. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
• Page 264 When finished, choose from the options shown at the bottom of the screen: • Click Publish to complete the item so it will appear on the Manage Items list • Click Discard to delete the item Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

Page 265: Patient Temperature

Page 266: manage sets.

• Page 267 When finished, choose from the options shown at the bottom of the screen: • Next to open the next tab for this Category • Discard to undo changes Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

Page 268: Summary

Page 269: result notes category, page 270: data entry.

• Page 271 Entry, mandatory Prompt the operator for a mandatory entry. Cartridge testing cannot continue until information is entered. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
• Page 272 For example, "3-6,7-9" is a valid selection, but "3-6,6-9" is not. • Entering consecutive commas or hyphens is invalid. For example, "2--5", "2-5,,7-10", and "2,-5" are all invalid ranges. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
• Page 273 When the specifications for this item are complete, choose from the options in the lower right corner of the screen: • Click Publish to complete the item so it will appear on the Manage Items list • Click Discard to delete the item Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

Page 274: Selection List

• Page 275 • Click Publish to complete the item so it will appear on the Manage Items list • Click Discard to delete the item The Result Notes Item Name list displays and now includes the Selection List item that was just created. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

Page 276: Selection List With Text Box

Page 277: repeat test item, page 278: action range comment, page 279: qc auto fail comment, page 280: manage sets.

• Page 281 ￮ underscore ( _ ) • does not begin with the characters APOC (in upper or lower case) • is a unique name within this healthcare organization Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...
• Page 282 Description Optional. When finished, choose from the options shown below: • Next to open the next tab for this Category • Discard to undo changes. Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

Page 283: Summary

Page 284: connectivity settings category, page 285: connectivity map, page 286: summary, page 287: assemble a profile.

• Page 288 Optional categories may also be selected for the profile. When selections are complete, choose from the options shown at the bottom of the screen: Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

Page 289: Install A Profile From A Usb

• Page 290 Rev. Date: 02-Nov-2022 i-STAT Alinity — System Operations Manual Art: 746300-01 Rev. N...

Page 291: Aliniq Cwi - Customization Workspace For I-Stat Troubleshooting

• Page 292 Patient List from the data management system. Check the Connectivity Settings Category to confirm the IP address is programmed for Patient List. i-STAT Alinity — System Operations Manual Art: 746304-01 Rev. H Rev. Date: 29-Oct-2019...
• Page 293 Follow the instructions in this manual to set Auto via eVAS or Manual. i-STAT Alinity — System Operations Manual Art: 746304-01 Rev. H Rev. Date: 29-Oct-2019...
• Page 294 Best practice would be to save all assigned profiles in a file on a healthcare organization manager's computer. If a profile needs to be loaded onto an instrument while the system is down, upload can be i-STAT Alinity — System Operations Manual Art: 746304-01 Rev. H...
• Page 295 USB. Temporary loss of user access to AlinIQ CWi will not affect profiles already loaded onto instruments. i-STAT Alinity — System Operations Manual Art: 746304-01 Rev. H Rev. Date: 29-Oct-2019...
• Page 296 Alinity — System Operations Manual Art: 746304-01 Rev. H Rev. Date: 29-Oct-2019...

Rename the bookmark

Delete bookmark, delete from my manuals, upload manual.

• NEWS & EVENTS
• PRESS RELEASES
• PRESS CONTACTS
• EXECUTIVE TEAM
• RESPONSIBILITY
• SOCIAL IMPACT
• SUSTAINABILITY
• ABBOTT FUND

Reducing Risk with Reliable Point-of-Care Testing

Id now delivers results in minutes where they're needed most, helping to diagnose covid-19..

Diagnostics Testing | May.27, 2020

Our ID NOW test for COVID-19 is the fastest molecular point-of-care rapid test available today and has been delivering reliable results when and where they're needed.

The availability and ease-of-access of ID NOW, which delivers results in minutes rather than a day or more, is helping to reduce the spread and risk of infection by diagnosing COVID-19 in society by detecting more positive results than would otherwise be found.

We're seeing studies being conducted to understand the role of ID NOW in ways that it was not designed to be used. In particular, the NYU study results are not consistent with other studies.

An interim analysis of a study examining ID NOW’s performance in urgent care clinics shows ≥94.7% in positive agreement (sensitivity) and ≥98.6% negative agreement (specificity) when compared to two different lab-based PCR reference tests. Those early results, part of two ongoing multi-site clinical studies , are happening in the real-world situations found in urgent care clinics and strongly suggest ID NOW — which delivers results in minutes, not days — performs best when people are tested earlier after they first experience symptoms.

While we understand no test is perfect, test outcomes depend on a number of factors including patient selection, specimen type, collection, handling, storage, transport and conformity to the way the test was designed to be run. ID NOW is intended to be used near the patient with a direct swab test method.

It is our responsibility to provide healthcare professionals and the public with accurate information, and that's why we're doing the following:

• Further clarifying our product information to provide better guidance to healthcare providers that negative results should be considered in the context of a patient's recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. Negative results should be presumed negative, but if inconsistent with clinical signs and symptoms or necessary for patient management, should be tested with an alternative molecular assay. We are also reinforcing proper sample collection and handling instructions. We are communicating this to our customers.
• Continuing to optimize this test as the world learns more about this virus. We're working to incorporate those learnings into the test as we do with all of our diagnostics tests. Abbott has been working in collaboration with FDA throughout the emergency use authorization (EUA) process.

The world needs a variety of tests in labs and at the point of care if we are to help reduce the spread and risk of infection by diagnosing COVID-19. ID NOW is an important tool in that equation. Helping people is the goal, which is why we're developing and continually optimizing as many tests as we can across all of our diagnostics platforms.

What Others Are Saying

From those using ID NOW for real-world testing as well as the view from those who understand diagnostic testing best:

"Our experience has been that the Abbott tests are catching the sick people and that they are not having any significant false-negative rates," Detroit Mayor Mike Duggan told the Detroit News. "We're entirely confident."

In a segment on some of the latest coronavirus developments and in response to the FDA statement concerning ID NOW, CBS News medical contributor Dr. David Agus stated (timestamp 1:21) "The company has said that NYU did it wrong and there's some methodology issues. What I do know is that every test has false negatives. It's not because necessarily the technology is bad. But it's because there may not be virus in the nose and the mouth when you put a swab in. We do it there because that's where droplets come out. But they may be elsewhere in the body at a very low level. So it’s in a sense not the technology’s fault but the biology. And so we’re never going to get a test that will tell us 100% if there's virus if we’re only looking in those two areas at the present time."

Physicians Immediate Care Senior Medical Director Dr. Warren Wollin told Fox Business's Stuart Varney that he has confidence in ID NOW and its COVID-19 testing for use at his 43 clinics in the Midwest. "We've been using the Abbott COVID-19 test now for almost seven weeks and I feel very confident in its accuracy," Wollin said. "I saw the NYU study that came out. I believe that it’s an anomaly. ... The NYU study did not do point-of-care testing, it was a very small sample size and it wasn’t peer quality reviewed."

And on CNN, John R. Hackett Jr., PhD, from Abbott’s Diagnostics business, said the NYU study is an "outlier."

"The New York study — and this is not a peer reviewed publication — at this point they've posted their study so there hasn’t been a quality review on the study itself," Hackett told Wolf Blitzer  (timestamp 1:20). “It is really an outlier relative to other studies that have been published as well as the feedback we're getting from the real world. And when I talk about real world, this is the hundreds of testing sites that are in hospitals, mobile units, municipalities, urgent care clinics, a variety of different settings that are utilizing this test on a regular basis. Their feedback — as long as the test is run properly — is that the results are very effective and they see tremendous value in this."

Hackett, an expert in infectious disease and diagnostic testing, pointed to other studies that have shown much different results when compared the NYU numbers.

"And, in the same week, Dr. Po Tu from the Everett Clinic in Washington, he presented data on a study that he has going there he had 91% sensitivity and 100% specificity," Hackett said. "Now, this is far more in line with the other published studies. And so again, it indicates that there is something going on with this NYU study. It is clearly an outlier from data that’s been seen in general."

This story was originally published on May 19, 2020. It was updated to include reference to our   announcement  on interim clinical study data on ID NOW COVID-19 rapid test.

The ID NOW COVID-19 EUA has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories and patient care settings. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

BinaxNOW: Expiration Dates and Facing the "Kraken"

What to know about your at-home tests as COVID-19 continues to evolve.

Abbott Scholars Ready to Join the Fight Against Diabetes

Abbott Fund scholarship program trains future healthcare workers to make a difference in their community. 

5 Sugar Substitute Ideas for People With Diabetes

A sugar substitute allows diabetics to have their cake and eat it, too. Here are five options.

Gentle Stretches to Help Lower Back Pain

These gentle stretches can temporarily relieve pain and stiffness from too much sitting. Make them a part of your routine for a healthy and strong back.

Your Guide to Recovering from Heart Surgery

Are you a candidate for heart surgery? This guide offers answers to some common questions about heart surgery aftercare.

• HEALTHCARE PROFESSIONALS
• ABOUT ABBOTT
• GLOBAL WEBSITES
• TERMS & CONDITIONS
• PRIVACY POLICY
• CONSUMER HEALTH DATA PRIVACY POLICY
• myAbbott Privacy Preferences
• ADVERTISING PREFERENCES

FOLLOW ABBOTT

© 2024 Abbott. All Rights Reserved. Please read the Legal Notice for further details.

Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.

YOU ARE ABOUT TO EXIT FOR ANOTHER ABBOTT COUNTRY OR REGION SPECIFIC WEBSITE

Please be aware that the website you have requested is intended for the residents of a particular country or region, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions. The website you have requested also may not be optimized for your specific screen size.

DO YOU WISH TO CONTINUE AND EXIT THIS WEBSITE?