Abaxis i-STAT Alinity v User Manual
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Abaxis i-STAT Alinity v User Manual

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FOR VETERINARY USE ONLY
U S E R
M A N U A L
GLOBAL DIAGNOSTICS

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Summary of Contents for Abaxis i-STAT Alinity v

  • Page 1 FOR VETERINARY USE ONLY U S E R M A N U A L GLOBAL DIAGNOSTICS...

  • Page 2: System Components

    +49 6155 780 210 Product of USA +1 800 822 2947 i-STAT and Alinity are trademarks of the Abbott Group of Companies in various jurisdictions. Abaxis is a registered trademark of Abaxis, Inc. ©Abaxis 2018 APOC Artwork #755229-01 Rev. B...
  • Page 3 – EMC requirements – Part 1: General requirements. Radio/Telecommunication Regulations: Angola INACOM Instituto Angolano das Comuinicacoes Equipment Type Model Number: 189 Antigua & Barbuda ABTD Antigua & Barbuda Telecommunications Division Type Approval Certificate Number 25-TAC2513000853 i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 4 Granted Equipment Type Approval for FCC Identifier 2AAEXSDABGN in accordance with section 42 of the Telecommunications Act 2006. Type Approval Number: VRGTA/011/2017 Brunei AITI Authority for Info-communications Technology Industry of Brunei Darussalam Equipment Registration Certificate DRQ-D-BRUSIN-03-1998-7494-LPD-39421 i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 5 Ministry of Communcations & IT Equipment Type Approval, ETA Certification No: ETA – 3319/16-RLO(WR) Japan Article 2 Section 1 No. 19, 19-3, 19-3-2 Radio Type Approval, Construction Designed Certificate No: 208-160178 i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 6 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 Qatar Communications Regulatory Authority Certificate of Type Approval CRA/SA/2016/R-5837 i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 7 Uganda Communications Commission Type Approved FCC 47 CFR Part 15, Subpart C - Intentional Radiators FCC 47 CFR Part 15, Subpart E - Unlicensed National Information Infrastructure Devices FCC ID: 2AAEX-SDABGN i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 8 - Part 2: Procedure to determine the specific absorption rate (SAR) for wireless communication devices used in close proximity to the human body (Frequency range of 30 MHz to 6 GHz) i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 9 Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and maximum (or lesser) gain approved for the transmitter by Industry Canada. To reduce potential radio interference to other i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 10 Antenna gain information: Embedded Antenna: 2.5dBi (2.4 GHz), 4.8dBi (5 GHz) Frequency Tolerance: +/-20ppm Wireless Labeling The i-STAT Alinity v Analyzer includes the FCC mark and FCC module identifier. Table for Wireless Specification for the i-STAT Alinity v Analyzer Wireless Characteristic...
  • Page 11 Temperature limitations. The upper and lower limits for storage are adjacent to upper and lower arms. Serial number. The serial number will appear adjacent to this symbol. Catalog number, list number, or reference Do not reuse. i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 12 Separate waste collection for this electrical/electronic item indicated; Equipment manufactured / put on the market after 13 August 2005; Indicates compliance with Article 10(3) of Directive 2002/96/EC (WEEE) for the European Union (EU). i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 13 System Components (Continued) i-STAT Alinity v Analyzer: Used to perform cartridge testing, reviewing test results, and conducting quality control (QC) testing. i-STAT Alinity Rechargeable Battery: Provides main power source to the analyzer. i-STAT Alinity Base Station: Used to recharge the battery installed in the i-STAT Alinity v Analyzer.
  • Page 14 System Components (Continued) Intended Use The i-STAT Alinity v Analyzer is an analytical, point of care device designed for veterinary use only. The i-STAT Alinity v Analyzer with i-STAT test cartridges is intended for use in point of care or clinical laboratory settings. The i-STAT Alinity system is intended for the quantitative measurement of various analytes in arterial, venous and capillary whole blood.
  • Page 15 • Disturb the analyzer or the printer until printing is complete, since this will interrupt the printout. If printing is interrupted, realign the analyzer and the printer, or replace the analyzer in the Base Station to resume printing. i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 16 Standard precautions, such as the wearing of gloves, are designed to protect personnel from blood-borne pathogens and pathogens from other body substances. i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 17 Altitude: Up to 3,048 meters (10,000 feet) *This Lithium-Ion rechargeable battery is designed for use only with the i-STAT Alinity v Analyzer. Keep a spare, charged battery on hand at all times and store charged battery in the original packaging.
  • Page 18 Supply Unit: Output: 5.3V DC, 6.6A *The Base Station is intended for use only with the i-STAT Alinity v Analyzer. Use only the power supply shipped in the box with the Base Station. Attempting to use a differ- ent type of manufacturer’s adapter could damage the unit and cause fire or explosion hazards.
  • Page 19 Black print thermal paper 5.7 cm wide (Available from Abaxis) *Attempting to print from an i-STAT Alinity v Analyzer to any printer other than an i-STAT Alinity printer may be unsuccessful. Use only a rechargeable battery pack purchased from Abaxis designed for the i-STAT Alinity printer.
  • Page 20 The display screen Rechargeable battery is the sole displays the object within the cameras power source for the analyzer. view. The IR port sends information from the analyzer to the portable printer. i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 21 LED light will turn green, and i-STAT Alinity will appear briefly on the display screen. During the power-up sequence, the i-STAT Alinity v Analyzer performs a series of self checks. If all the self checks pass, the analyzer will display the Home Screen.
  • Page 22 Footer (right): • Software Pending Installation Button • Displays only when software has been downloaded but not installed on the analyzer * See Page 23 for screen icons and their meanings i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 23 Analyzer is locked until requirement is satisfied Analyzer warning Alerts Indicator: Displays number of alerts Alert Title Corrective Action Button: Displays corrective action pathway Alert Description: Displays cause and resolution Action Buttons: Displays options for screen navigation i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 24 • Location of details such as data entry field, help graphics, selection options Side Action Tabs: • Provide access to area or action indicated Alert Button: • Provides access to Alerts description Action Buttons: • Provide options for screen navigation i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 25 Actively Charging Bolt Indicates No Connection Actively Charging Warning Wireless Bolt Indicates Disabled Actively Charging Analyzer Wireless Locked Connecting Wireless Not Information Allowed Instructional Icons Mandatory Low Battery Software Pending Installation i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 26 Anatomy of a Box: Refrigerated storage temperature indicator: 2-8°C (35-46°F) Indicates shelf life when stored at room temperature Refrigerated storage expiration date Cartridge LOT number Location to record room temperature expiration date i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 27 Location to record room temperature expiration date 2D barcode for manufacturing quality control; not scannable Cartridge LOT number Cartridge pouch barcode Refrigerated storage expiration date Indicates shelf life when stored at room temperature Room temperature storage range i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 28 2025-10-13; new expiration date is 2025-12-13 • Room temperature expiration date cannot exceed manufacurer’s printed expiration date • Cartridge should not be returned to the refrigerator once out for more than 5 minutes i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 29 Improper handling may damage the cartridge and result in a Cartridge Quality Check Failure instead of results. • Dispose of used cartridges as biohazardous waste. Follow facility policy for disposal. www.pointofcare.abbott For Cartridge & Test Information sheets, please visit: i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 30 The VetScan E3+ cartridge containing test for Chloride (Cl) which runs on the VetScan i-STAT 1 is not currently supported and will not run on the i-STAT Alinity v Analyzer. Not all cartridges are available in all regions. Contact Abaxis Technical Support for availability in specific markets.
  • Page 31 • On screen graphics and text are provided to assist the user. • This guide does not include instruction on blood collection. Follow facility-specific guidelines. Standard precautions should be used when handling materials that may contain transmissible infectious agents. i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 32 For alpha, touch the Abc button. After entering the information, touch Enter and the analyzer will advance to the next step in the pathway. Enter OPERATOR ID and then touch Enter Enter @#& Close i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 33 Pt: 123456 Select SAMPLE TYPE Next Arterial Venous View Entered Info Capillary Unspecified Horse Other Previous Home Important Warning: Interpreting the patient result is dependent on selecting the correct sample type. i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 34 View Entered Info Previous Home If an Invalid Cartridge Type window is displayed, contact Abaxis Technical Support for additional assistance. After the analyzer successfully scans the barcode, help screens will be displayed on how to insert the cartridge. i-STAT CHEM8+...
  • Page 35 Level are also displayed. i-STAT CHEM8+ Pt: 123456 Testing - Instrument Must Remain Level Contacting Cartridge View Entered Info Cartridge locked in instrument. Do not attempt to remove the cartridge. Home i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 36 A sample may also yield results that are preceded by a greater than (>) or less than (<) symbol. These results are outside the analyzer’s measurement range. In order to determine the exact numeric result, the sample must be analyzed by a different method. i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 37 3.4 – 4.9 Ref 0.5 – 1.3 Ref 1.12 – 1.40 Ref Cl, mmol/L AnGap, mmol/L Print 8 – 25 Ref 106 – 127 Ref TCO2, mmol/L 17 – 25 Ref Page Home i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 38 Entered Info .7 - 1.5 1.12 – 1.40 Ref AnGap, mmol/L Print 8 – 25 Ref Transmit Page Symbol indicates analyzer is connected to the network To initiate transmission, touch Transmit i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 39 • Red arrow in page button - indicates one or more results on second page are not within the system range. • White arrow in page button - indicates all results on second page are within the reference range. i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 40 When running a sample selected under “Other”, reference ranges will not be displayed. Result will appear with no highlighted indicators. Resetting the analyzer to Factory Default or deleting the current profile will display results without reference ranges or highlighted indicators. i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 41 How to Perform Patient Testing (Continued) Test Reference Ranges and System Range i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 42 Alinity v Analyzer, Base Station, Printer, Rechargeable Battery and Elec- tronic Simulator It is recommended that the i-STAT Alinity v Analyzer, base station, printer, and electronic simulator be cleaned periodically or whenever visibly soiled. Standard precautions should be taken whenever working with blood or blood products.
  • Page 43 3 minutes. Sensitive Areas Avoid forcing liquid into these areas: i-STAT Alinity v Analyzer Cartridge Port 10-Pin Connector under the camera Gold contacts (2) on the outside of the battery i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 44 3 minutes. Sensitive Areas Avoid forcing liquid into these areas: Base Station 10-Pin Connector Electronic Simulator Area between protective cap Gold contact pins (2) retaining ring and white sensor area USB Port i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 45 Cleaning is necessary for the removal of visible organic soil. Disinfecting is intended to kill microorganisms. • Due to the portability of the i-STAT Alinity v Analyzer, it may be subject to splatter or splash of bodily fluids when used in proximity of patients.
  • Page 46 CLEW software and the version of the application software by navigating to More Options > Instrument Status. Software updates to the i-STAT Alinity v Analyzer are delivered twice a year. Each software update contains two elements in a single package: CLEW software and application software.
  • Page 47 Electronic Simulator test. In the event that the test does not pass, follow the prompts on the screen. Use care when handling the Electronic Simulator. Avoid touching the sensor area. i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 48 Administrator, the Quality Control Pathway may present screens not displayed in this guide. • It is essential to follow the prompts on the analyzer screen. • On screen graphics and text are provided to assist the user. i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 49 Return Scheduled QC Unscheduled QC Perform Cartridge QC Home The next step in the pathway is Scan or Enter OPERATOR ID Quality Control Test Scan or Enter OPERATOR ID Next Home i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 50 Scan CARTRIDGE POUCH barcode. Scanning is required. You must scan the barcode on the cartridge pouch. This information cannot be entered manually. Quality ControlTest i-STAT TriControl L1: 321055 Scan CARTRIDGE POUCH Barcode Next View Entered Info Previous Home i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 51 Cl, mmo/L AnGap, mmo/L Print TCO2, mmo/L Page Home Results Use Value Assignment Sheet to determine if results are in range. Follow facility policy if results are outside the assigned range. i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 52 Troubleshooting The i-STAT Alinity v Analyzer is programmed to perform quality checks throughout the testing cycle. The analyzer has several methods of notifying operators of failed quality checks. 1. Quality Check Failures • Are displayed when the analyzer identifies a problem while running a cartridge or simulator •...
  • Page 53 Review screen Results Cause Resolution Cause Resolution Cause Resolution 2-01-1.1.1 2-01 2-02-1.1.2 2-02 8-01-2.1.8 8-01 11-01-2.13.32 11-01 13-01-1.6.1 13-01 19-01-6.2.5 19-01 20-01-3.1.1 20-01 21-01-3.1.3 21-01 22-01-6.1.3 22-01 22-01-6.1.5 22-01 i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 54 26-01 26-01-6.2.4 26-01 27-01-4.1.1 27-01 28-01-4.1.2 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 i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 55 50-01 50-01-2.1.6 50-01 51-01-2.1.4 51-01 51-01-2.1.9 51-01 52-01-2.1.5 52-01 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 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 69-01-4.6.1 69-01 i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 56 69-03 69-03-7.6.2 69-03 69-04-7.6.3 69-04 70-01-1.6.3 70-01 72-01-2.1.10 72-01 72-01-2.1.11 72-01 79-01-2.3.1 79-01 80-01-3.4.1 80-01 80-01-3.4.2 80-01 80-01-3.4.3 80-01 80-01-3.4.4 80-01 82-01-1.2.1 82-01 82-01-2.10.3 82-01 87-01-3.2.1 87-01 88-01-1.6.33 88-01 89-01-2.7.32 89-01 i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 57 90-01 90-01-2.4.13 90-01 90-02-2.4.14 90-02 90-02-2.4.15 90-02 90-02-2.4.16 90-02 90-02-2.4.17 90-02 90-02-2.4.18 90-02 91-01-2.6.32 91-01 92-01-2.10.1 92-01 92-01-2.10.2 92-01 93-01-2.5.32 93-01 93-01-2.5.33 93-01 94-01-1.6.32 94-01 95-01-1.7.1 95-01 99-01-2.13.1 99-01 99-02-2.2.4 99-02 i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 58 ‘fill to’ arrow. 13. An insufficient amount of sample was used to fill the cartridge. When filling the cartridge, the sample did not reach the level indicated by the ‘fill to’ arrow. i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 59 If the same quality check failure displays, contact the system administrator for further instruction. Always scan the barcode found on the pouch that contained the cartridge in use. Scanning any other barcode can cause this error. Repeat testing i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 60 OSi software installation required. Contact the system administrator for further instructions Install the most recent OSi software. Contact the system administrator for further instructions. Abaxis Technical Support can be reached as the system administrator. i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 61 The NCi utility package must be downloaded from the Abaxis website at www.abaxis.com. It is best practice to load NCi onto a computer that is installed behind the facility’s firewall, and that has antivirus software installed on it.
  • Page 62 On the first section of the NCi screen, specify whether this NC file will be used for multiple i-STAT Alinity v Analyzers or a single analyzer. Unless your facility requires that each analyzer have its own unique security credentials, a single NC file may be used for all analyzers connecting to the same network.
  • Page 63 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 v — User Manual 650-7100 Rev. A...
  • Page 64 Network password for the proxy server. By default, bullets (••••) are displayed as you type the password. To display the actual password after typing it, click this symbol: The next section of the NCi screen is for connecting wirelessly. i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 65 Some of the options displayed on the screen depend upon the authentication type, and are noted as such. I want the i-STAT Alinity v Analyzer to connect to my facility’s WIRELESS network Select this check box to configure wireless network connectivity.
  • Page 66 DNS server address manually. Specify values for: • Preferred DNS IPv4 address of the server in decimal dot notation. • Alternate DNS IPv4 address of the server in decimal dot notation. i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 67 Name of the file that contains the client certificate. Client Key File Name of the file that contains the client key. Client Key Password Password for the client key. Username/Identity Username required by the authentication server. i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 68 Connectivity (Continued) AlinIQ NCi - Wired Network Connection I want the i-STAT Alinity v Analyzer to connect to my facility’s WIRED network To configure connectivity for a wired network, select this check box and specify values for: Authentication Type OPEN (this value is not modifiable)
  • Page 69 IPv4 address of the server in decimal dot notation Alternate DNS: IPv4 address of the server in decimal dot notation. You must specify DNS addresses if you specify a static IP address. i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 70 After supplying the information for connectivity, you are prompted to save the ancc file. The saved file can then be loaded onto a USB memory stick, and then uploaded to an i-STAT Alinity v Analyzer. At the bottom of the NCi screen, choose Save Network Connectivity (ancc) File, then click Continue.
  • Page 71 Alinity system. Follow these steps: 1. Plug the USB memory stick into the USB slot of the base station. 2. Place the i-STAT Alinity v Analyzer in the base station. 3. Touch More Options 4. Touch Instrument Options 5. Touch Network Settings 6.
  • Page 72 After you have used NCi to configure connectivity, you can test the connection. Follow the steps shown here: • To check a wired network connection, place the i-STAT Alinity v Analyzer in the base station that is connected to the facility’s network and power on the analyzer.
  • Page 73 Abaxis product. In no event will Abaxis’ liability exceed the price paid by the purchaser for the analyzers.
  • Page 74 USER DOES NOT AGREE WITH THE TERMS OF THIS EULA, END USER SHOULD NOT USE THE DEVICE. 1. INTRODUCTION. Thank you for selecting the i-STAT Alinity v (which includes certain software components (collectively, the “Device”). This EULA is a legal agreement between you (“you”, “End User”), and Abbott Point of Care Inc.
  • Page 75 SOFTWARE, SERVICES, CONTENT, AND RELATED MATERIALS, INCLUDING ANY WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE, TITLE, MERCHANTABILITY, AND NON-INFRINGEMENT. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, APOC MAKES NO WARRANTY, AND PROVIDES NO ASSURANCE, i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 76 Software or on any APOC sponsored web site. Any use of the Software by you after APOC’s publication of any such changes shall constitute your acceptance of this EULA as modified. i-STAT Alinity v — User Manual 650-7100 Rev. A...
  • Page 77 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. i-STAT Alinity v — User Manual 650-7100 Rev. A...

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