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Communications Regulatory Authority

Certificate of Type Approval CRA/SA/2016/R-5837

Saudi Arabia

Ministry of Communication and Information Technology (MCIT)

Conformity Certificate TA 24012017-24012019-18944

Serbia

Confirmation of Conformity – R&TTE Number P1617182700

Singapore

Info-communications Media Development Authority

Regulation 20(6) of the Telecommunications (Dealers) Regulations (Cap

323, Rg 6)

Registration Number: N0123-17 (5 GHz)

Registration Number: N0074-17 (2.4 GHz)

South Africa

Independent Communications Authority of South Africa Radio

Equipment Type Approval TA-2018/3846

Sri Lanka

Telecommunications Regulatory Commission of Sri Lanka, TRC/SM/

MISC/00041/17/WIFI-106

St. Lucia

National Telecommunications Regulatory Commission (Saint Lucia)

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

xix

i-STAT Alinity — System Operations Manual

Art: 746983-01 Rev. H

Rev. Date: 11-Nov-2020

Summary of Contents for i-STAT Alinity

Page 1: ......

Page 2: ...Manual Art 746981 01 Rev I Rev Date 19 Oct 2021 Patents ZZZ DEERWW XV SDWHQWV 20Ϯ1 Abbott All rights reserved All trademarks referenced are trademarks of either the Abbott group of companies or their respective owners 3ULQVHVVHJUDFKW 3 ...

Page 3: ...itations 27 Messages and Troubleshooting 29 Quality Check Failure Codes 29 Cleaning and Disinfecting 40 1 3 i STAT Alinity Results Screen 41 Interpreting Results 43 1 4 i STAT Alinity Rechargeable Battery 47 Principles of Operation 47 Specifications 48 Precautions and Limitations 48 1 5 i STAT Alinity Base Station 51 Specifications 52 Precautions and Limitations 53 Troubleshooting 54 Cleaning and ...

Page 4: ...ns and Limitations 94 1 13 Software Updates 97 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 105 2 AlinIQ Network Connectivity for i STAT NCi 109 ...

Page 5: ...tting Started 140 3 4 Manage and Assemble Profiles 143 Best Practices 144 Creating a Category 145 General Settings Category 149 Basic Functions 150 Date 152 Communications 153 Operator Actions 154 Critical Callback 159 Print 163 i STAT Reserved 164 Summary 164 Operator Settings Category 165 List Actions 169 Operator Expiration 172 Summary 172 Patient Settings Category 173 ID Entry 174 Patient Info...

Page 6: ...tion List 215 Selection List with Text box 217 Mode 218 Delivery System 222 Patient Temperature 225 Manage Sets 226 Summary 228 Result Notes Category 229 Data Entry 230 Selection List 234 Selection List with Text box 236 Repeat Test Item 237 Action Range Comment 238 QC Auto Fail Comment 239 Manage Sets 240 Summary 243 Connectivity Settings Category 244 Connectivity Map 245 Summary 246 Assemble a P...

Page 7: ...supported by dedicated professionals who excel in engineering medical technology training and service Abbott Point of Care is dedicated to manufacturing high quality and reliable instrumentation We look forward to serving your needs vii i STAT Alinity System Operations Manual Art 746982 01 Rev E Rev Date 02 Nov 2022 ...

Page 8: ...E LOSS CORRUPTION OR THEFT OF DATA VIRUSES SPYWARE LOSS OF PROFITS OR INVESTMENT USE OF THE SOFTWARE WITH HARDWARE OR OTHER SOFTWARE THAT DOES NOT MEET APOC S SYSTEMS REQUIREMENTS OR THE LIKE WHETHER BASED IN CONTRACT TORT INCLUDING NEGLIGENCE PRODUCT LIABILITY OR OTHERWISE EVEN IF APOC AND OR ITS SUPPLIERS OR EITHER OF THEIR REPRESENTATIVES HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES AND...

Page 9: ...o comply with any of its terms or conditions including without limitation if you make any attempts to copy the Software or transfer any copy of the Software or any portion thereof to another party or any attempt to modify the Software in any way Upon termination you must immediately cease using the Software Any termination of this EULA shall not affect APOC s rights hereunder 5 PRIVACY For details...

Page 10: ... s publication of any such changes shall constitute your acceptance of this EULA as modified 10 EXPORT LAW The Software is subject to U S export control laws and may be subject to export or import regulations in other countries Unless in compliance with applicable law and specifically authorized in writing by the APOC prior to any Software access You shall not export the Software under any circums...

Page 11: ...d applicable federal law Neither this EULA nor any of Your rights or obligations hereunder may be assigned by You in whole or in part without the prior written approval of APOC Any other attempted assignment shall be null and void Headings are included for convenience only and shall not be considered in interpreting this EULA As used in this EULA the word including means including but not limited ...

Page 12: ...xii i STAT Alinity System Operations Manual Art 746982 01 Rev E Rev Date 02 Nov 2022 ...

Page 13: ...cid electrolytes Safety requirements for portable sealed secondary cells and for batteries made from them for use in portable applications International UN Manual of Tests and Criteria Recommendations on the Transport of Dangerous Goods Section 38 3 Lithium Batteries International IEC 60950 1 Information Technology Equipment Safety Part 1 General Requirements EMC Regulations USA FCC 47 CFR Part 15...

Page 14: ...ons Act 1992 and Telecommunications Labelling Notice for Customer Equipment and Customer Cabling Instrument 2015 made under section 407 of the Telecommunications Act 1997 Bahamas Utilities Regulation Competition Authority URCA Type Approval UCRA_TA 2017_023 FCC ID 2AAEX SDABGN Barbados Complies with GOVERNMENT OF BARBADOS TELECOMMUNICATIONS UNIT Division of Energy Telecommunications MED Approval N...

Page 15: ...nfo communications Technology Industry of Brunei Darussalam Equipment Registration Certificate DRQ D BRUSIN 03 1998 7494 LPD 39421 Burkina Faso ARCEP Type Approval 2017 000031 Autorite de Regulation des Communications Electroniques et des Postes Authority of Regulations of Communications Electronic and Posts Canada Industry Canada RSS 210 Licence Exempt Radio Apparatus Category I Equipment Certifi...

Page 16: ... 2014 53 EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 EN 300 328 Wideband transmission systems Data transmission equipment operating in the 2 4 GHz ISM band and using wide band modulation techniques Harmonised Standard covering the essential requirements of article 3 2 of Directive 2014 53 EU EN 301 893 5 GHz RLAN Harmonised Standard covering the essential requirements of arti...

Page 17: ... of Telecommunications Approval 1031 16 041 Lesotho Lesotho Communications Authority Lesotho Communications Authority Act 2012 Section 5 Libya General Authority for Communications Type Approval Certificate No 343 C1 2017 Madagascar 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 ...

Page 18: ...ectrum Management as required by notices under Section 134 1 g of the New Zealand Radiocommunications Act 1989 Oman Telecommunication Regulatory Authority Approval Number TRA TA R 4501 17 Pakistan Pakistan Telecommunication Authority PTA Type Approval Certificate TAC NO 9 197 2017 Peru Ministerio De Transportes Y Comunicaciones Certificado De Homologacion Code TRSS39479 Report 2158 2017 MTC 29 CGH...

Page 19: ... GHz Registration Number N0074 17 2 4 GHz South Africa Independent Communications Authority of South Africa Radio Equipment Type Approval TA 2018 3846 Sri Lanka Telecommunications Regulatory Commission of Sri Lanka TRC SM MISC 00041 17 WIFI 106 St Lucia National Telecommunications Regulatory Commission Saint Lucia Telecommunications Terminal Equipment and Public Networks Regulations No 10 or 2002 ...

Page 20: ...ications Regulatory Authority Telecom Equipment Registration Certificate ER53962 17 under Law No 3 of 2003 Uganda Uganda Communications Commission Type Approved Uruguay Unidad Reguladora de Servicios de Comunicaciones VU20181105 015044 USA 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 Vietn...

Page 21: ... exposure to electromagnetic fields Frequency range of 300 MHz 3 GHz EN 62209 1 Measurement procedure for the assessment of specific absorption rate of human exposure to radio frequency fields from hand held and body mounted wireless communication devices Part 1 Devices used next to the ear Frequency range of 300 MHz to 6 GHz EN 62209 2 Human exposure to radio frequency fields from hand held and b...

Page 22: ...ice This product contains transmitter module FCC ID 2AAEX SDABGN IC 7228C SDABGN SAR RF Exposure Notice This equipment complies with FCC IC radiation exposure limits set forth for an uncontrolled environment and meets the FCC radio frequency RF Exposure Guidelines in Supplement C to OET 65 and RSS 102 of the IC Industry Canada radio frequency RF Exposure rules Under Industry Canada regulations thi...

Page 23: ...ain 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 xxiii i STAT Alinity System Operations Manual Art 746983 01 Rev H Rev Date 11 Nov 2020 ...

Page 24: ...xxiv i STAT Alinity System Operations Manual Art 746983 01 Rev H Rev Date 11 Nov 2020 ...

Page 25: ...irect current DC Alternating current AC For prescription use only For use with the i STAT Alinity Instrument only Battery status fully charged Battery status approximately charged Battery status charge needed soon Battery status charge immediately Battery actively charging Indicates battery actively charging xxv i STAT Alinity System Operations Manual Art 745579 01 Rev K Rev Date 16 May 2022 ...

Page 26: ...Symbol Definition Use Software update is available xxvi i STAT Alinity System Operations Manual Art 745579 01 Rev K Rev Date 16 May 2022 ...

Page 27: ...ttery 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 xxvii i STAT Alinity System Operations Manual Art 745579 01 Rev K Rev Date 16 May 2022 ...

Page 28: ...f manufacture Manufacturer Consult instructions for use or see System Operations Manual for instructions Note the following information In vitro diagnostic medical device A mark that indicates conformity to the legal requirements of the appropriate European Union EU Directive s with respect to safety health environment and consumer protection Signifies that the product bearingt he ETL Listed mark ...

Page 29: ...piration date expressed as YYYY MM DD means the last day the product can be 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 adjacent to this symbol Importer in the European Community Class II Construction Signifies that the product bearing the Federal C...

Page 30: ...trol related Symbol Definition Use Control Table 7 For use on i STAT Value Assignment Sheets Symbol Definition Use Mean R Range xxx i STAT Alinity System Operations Manual Art 745579 01 Rev K Rev Date 16 May 2022 ...

Page 31: ...REA Urea nitrogen Urea Hct Hematocrit Hb Hemoglobin TCO2 Total Carbon Dioxide Concentration HCO3 Bicarbonate BE b ecf Base excess b for blood ecf for extracellular fluid AnGap Anion Gap sO2 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...

Page 32: ... Radiation LED Light Emitting Diode MQSI Manufacturer s Quality System Instructions OSi Instrument Software PC Personal Computer POC Point of Care QC Quality Control QCC Quality Check Code QCF Quality Check Failure QRG Quick Reference Guide R VAS Rilibak Value Assignment Sheet ReVAS Rilibak Electronic Value Assignment Sheet SU Software Update TBI Traumatic Brain Injury USB Universal Serial Bus VAS...

Page 33: ...ouch Not all analytes are measured some are calculated using the measured results of other analytes Analyte Settings Group of features used to define the behavior of an instrument Selections made in this setting group are considered basic and common to most instruments within a healthcare organization It is also possible to make selections that are applicable to an entire healthcare organization T...

Page 34: ...STAT Alinity is to communicate information CPB Cardiopulmonary Bypass Surgery Setting The CPB function adjusts hematocrit and hemoglobin results for the dilutional effect of pump fluid during cardiopulmonary bypass surgery Create from Existing Using a previously created category or profile to create a new one CTI Cartridge and Test Information CWi Customization Workspace for i STAT Data Entry To e...

Page 35: ... not determined by the purple top tube used for patient testing in the laboratory LIS Laboratory Information System MAC Media Access Control Manage Items Items get responses An item is an on screen prompt that requires a response by the operator Items are grouped together in sets Sets are assigned to a cartridge type for example EG7 CHEM8 When cartridge testing is performed the defined set of item...

Page 36: ... s temperature during the time of testing The temperature entered here will be used to calculate patient temperature adjusted blood gas results PEAPv0 Protected Extensible Authentication Protocol Version 0 PPID Positive Patient Identification Profile There are five required categories General Patient Operator Analyte and Quality Settings The remaining five are optional Profiles are assigned to an ...

Page 37: ...ide information about the patient s status at the time of testing STATNotes are used primarily though not exclusively for the recording of ventilator parameters They can be mandatory or optional The STATNotes will be transmitted along with the results to the data manager Summary Display of all details within a Profile or Category TKIP Temporal Key Integrity Protocol wireless network authentication...

Page 38: ...ger User who has the permission to access all functions of the CWi but is limited to creating user roles of Point of Care Coordinator or Point of Care Super User User Role POCC User who has the permission to access all functions of the CWi but is limited to creating user role of Point of Care Super User User Role Point of Care Super User User with view only permission for functions of the CWi Vend...

Page 39: ......

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: ...w Note Note Regarding System Reliability The i STAT System automatically runs a comprehensive set of quality checks of analyzer and cartridge performance each time a sample is tested This internal quality system will suppress results if the analyzer or cartridge does not meet certain internal specifications see Quality Control section in System Operations Manual for detailed information To minimiz...

Page 42: ...k with your local representative for availability in specific markets Note that the component representations shown in the table are not drawn to scale i STAT Alinity System Components i STAT Alinity Instrument Portable ergonomically designed handheld analytical instrument used to perform in vitro diagnostic testing with the use of i STAT cartridges Base Station Provides recharging printing and ne...

Page 43: ...d on sensors on the top of the cartridge The instrument and cartridge work together to generate a clinically meaningful result Printer Provides the ability to print all results patient tests quality control etc generated by the i STAT Alinity Electronic Simulator Provides an independent check on the instrument s ability to take accurate and sensitive measurements of voltage current and resistance ...

Page 44: ...6 i STAT Alinity System Operations Manual Art 745526 01 Rev H Rev Date 04 Mar 2021 ...

Page 45: ...Check with your local representative for availability in specific markets Note To configure the instrument s printing method refer to the i STAT Alinity Printer Principles of Operation Verify the instrument for cartridge testing Note Verification is only required once per cartridge type per instrument Prior to using an instrument requiring a specific cartridge type verify the instrument supports t...

Page 46: ...in the micro fabricated electro chemical sensors located in the i STAT single use disposable cartridges As a result the measurement technology used by the instrument and the principles governing operations associated with the generation of test results remain unchanged from the existing on market i STAT instruments These fully automated dedicated microprocessor controlled operations include Motion...

Page 47: ...mprove readability The instrument employs a five inch diagonal backlit LCD in landscape orientation The keypad was implemented with a resistive touchscreen enabling a user wearing multilayer surgical gloves to perform data entry A full QWERTY and numeric touchscreen keyboard enhances the informational content that can be entered and stored with a test i STAT Alinity is equipped with a 1D 2D barcod...

Page 48: ...10 i STAT Alinity System Operations Manual Art 745527 01 Rev N Rev Date 13 Oct 2022 ...

Page 49: ...tation design allows the battery to be charged without detaching it from the instrument The fuel gauge in the battery pack accurately measures the battery capacity while also providing protection against short circuit over current and over voltage More Options This section describes the selections and information found behind the More Options button From the Home Screen touch More Options and this...

Page 50: ... be protected if permission levels are set If they are not all selections will be open to all operators In this case facility policy should outline what users are allowed to access what functions under More Options If permission levels are set via Data Management at least one operator must have permission level of Key Operator or Supervisor 12 i STAT Alinity System Operations Manual Art 745527 01 ...

Page 51: ...ulator Results Proficiency Results Quality Check Code Results Star Out Results Canceled Results Instrument must be customized to allow for the cancelling of a test All Results Display of all results on instrument regardless of testing pathway Transmit Unsent Results Force the transmission of all results in the instrument Instrument must be customized to transmit results via wired or wireless trans...

Page 52: ...ault Touching View Action Critical Ranges will reveal the ranges set for this analyte via a customization profile Note No ranges are the default Instrument Status Important information such as firmware version barometric pressure and profile name are listed here Quality Options Quality Control Perform Unscheduled QC When liquid QC testing is not scheduled via a customization profile or if an addit...

Page 53: ...n the screen to perform testing Update eVAS Install from USB Follow prompts on the screen to install instrument software Note Some preformatted USB flash drives may not work with the Alinity system To avoid issues reformat the drive using a Windows PC before using the USB flash drive with the Alinity system If the instrument does not detect the base station try the following remove the instrument ...

Page 54: ...Operator Event Log Reserved for future use Administrative Options Profile Management Install Profile from USB Follow prompts on the screen to install instrument software If the instrument does not detect the Base Station try the following remove the instrument and re seat it on the Base Station check to ensure that the Base Station is getting power blue light illuminated If the instrument does not...

Page 55: ...deleted Test Record Status List of information regarding test records stored on instrument Administrative Options List Management Update All Lists Function used to update patient operator and cartridge lot list A customization profile enabling lists must be in use on the instrument Delete Lists Displays lists to be deleted Choose list s and follow prompts on the screen to complete List Status Disp...

Page 56: ...ht illuminated If the instrument does not detect the USB drive try the following remove the USB and reinsert make sure the USB is formatted as display message indicates Install Pending Instruct instrument to install software update Check for Update When Abbott Managed Server connectivity is set up on the instrument touching this button causes the instrument to check for new software If a new versi...

Page 57: ...appearance will change See the section Keypad changes for languages using diacritical marks for details Set Clock Note When the instrument is configured to communicate with a data manager the instrument will automatically synchronize its date and time with the data manager s time See the section Instrument Clock Date Time Synchronization for details Set Units Set Date Format 19 i STAT Alinity Syst...

Page 58: ...ues reformat the drive using a Windows PC before using the USB flash drive with the Alinity system If the instrument does not detect the Base Station try the following remove the instrument and re seat it on the Base Station check to ensure that the Base Station is getting power blue light illuminated If the instrument does not detect the USB drive try the following remove the USB and reinsert mak...

Page 59: ...irmware Delivery and or Profile Update as desired For additional information related to the use of SDi see the AlinIQ SDi User Guide In either case use of the NCi is required to enable the instrument to make a network connection to the chosen server Enable Disable Wireless This must be enabled in order for the instrument to have the ability to communicate wirelessly Use of the NCi utility is requi...

Page 60: ...unning Applications Software information Used primarily by technical support Set Region Code Touch this button and follow prompts on screen to complete the region code setup 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 ...

Page 61: ...splay keys that have a small white dot in the upper right hand corner as shown 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 23 i STAT Alinity System Operations Manual Art 745527 01 Rev N Rev Date 13 Oct 2022 ...

Page 62: ...rect time is displayed on the Home screen before performing cartridge testing For instrument time synchronization to occur the instrument must also have a wired or wireless connection to the network hosting the data manager The instrument may attempt to synchronize time when it is communicating with a data manager to send results or receive lists The instrument will also attempt to synchronize tim...

Page 63: ...eveloped the internal simulator that functions as a signal checking mechanism on every cartridge inserted The internal simulator is a combination of hardware and software that tests the ability of the instrument to accurately read sensor signals The instrument performs an internal simulator test on every cartridge run The internal simulator simulates potentiometric amperometric and conductiometric...

Page 64: ...ng with maximum saturation temperature of 50ºC 122ºF Display 5 in 800 x 480 pixels with touchscreen measured diagonally Power source Lithium Ion Rechargeable Battery 3 65 nominal VDC 19 3 Wh Exterior materials No natural or synthetic rubber latex is used anywhere on the exterior of this product the product packaging or the accessories Wireless Labeling The i STAT Alinity instrument includes the FC...

Page 65: ...uch as a patient bed Placing the instrument on an unstable surface may cause the instrument to fall Place the instrument on a tabletop or counter to minimize the likelihood of a fall always place the instrument and peripherals on a stable surface or in a location where they will not cause injury if dropped use only the accessories and consumables specified or supplied for this system by Abbott Poi...

Page 66: ...er body substances These precautions are based on the assumption that blood body fluids and tissue can contain infectious agents and should therefore be treated as biohazardous materials For more information refer to the CDC NIH manual Biosafety in Microbiological and Biomedical Laboratories 4th edition 1999 or to the WHO Laboratory Biosafety Manual 2nd edition 2003 The instrument can be rendered ...

Page 67: ... alert condition presents itself when an action is required Some alerts need the operator s immediate action for example Critically Low Battery and others may require the administrator s attention for example Low Memory The alert displays on the screen and the display persists until the operator takes action Touching the Alert button displays additional details Example of an Alert Screen Alert Tit...

Page 68: ... determine the cause and resolution 1 In the table below in the first column find the QCF code as found in Review Results 2 Identify the pathway in which the failure occurred and in the Cause column find the cause number then see Quality Check Failure Causes for the description in the Resolution column find the resolution letter then see Quality Check Failure Resolutions for corrective action Qual...

Page 69: ... 25 01 6 1 13 5 X 5 F 25 01 25 01 6 1 14 5 X 5 F 25 01 26 01 6 2 1 X F 26 01 26 01 6 2 2 X F 26 01 26 01 6 2 3 X F 26 01 26 01 6 2 4 X F 26 01 27 01 4 1 11 G F 27 01 28 01 4 1 2 G F 28 01 29 01 4 1 3 G F 29 01 30 01 6 1 4 6 W 12 F 30 01 30 01 6 1 7 6 W 12 F 30 01 30 02 4 1 4 6 H 12 F 30 02 31 01 4 1 5 7 G 7 F 31 01 31 02 6 1 16 7 X 7 F 31 02 32 01 4 1 6 G F 32 01 33 01 4 1 8 G F 33 01 34 01 4 1 11...

Page 70: ... 13 2 B B C AA 48 01 49 01 3 3 1 14 U 14 V 49 01 50 01 2 1 1 G F C AA 50 01 50 01 2 1 2 G F C AA 50 01 50 01 2 1 3 G F C AA 50 01 50 01 2 1 6 G F C AA 50 01 51 01 2 1 4 G F C AA 51 01 51 01 2 1 9 G F C AA 51 01 52 01 2 1 5 G F C AA 52 01 53 01 2 9 3 T T T 53 01 57 01 2 4 1 B B D 57 01 59 01 4 5 1 B B D 59 01 60 01 1 6 2 B B C AA 60 01 63 01 2 9 1 D D D 63 01 63 01 2 9 2 D D D 63 01 66 01 2 2 1 B B...

Page 71: ...1 3 4 4 G F 80 01 82 01 1 2 1 B B D 82 01 82 01 2 10 3 B B D 82 01 87 01 3 2 1 G F 87 01 88 01 1 6 33 B B C AA 88 01 89 01 2 7 32 B B C AA 89 01 90 01 2 4 3 D D D 90 01 90 01 2 4 4 D D D 90 01 90 01 2 4 5 D D D 90 01 90 01 2 4 6 D D D 90 01 90 01 2 4 7 D D D 90 01 90 01 2 4 8 D D D 90 01 90 01 2 4 9 D D D 90 01 90 01 2 4 10 D D D 90 01 90 01 2 4 11 D D D 90 01 90 01 2 4 12 D D D 90 01 90 01 2 4 13...

Page 72: ...01 99 01 2 13 1 G F C AA 99 01 99 02 2 2 4 C AA 99 02 119 01 5 1 28 G F 119 01 120 01 5 1 21 G F 120 01 121 01 5 1 22 G F 121 01 122 01 5 1 23 G F 122 01 123 01 5 1 24 G F 123 01 124 01 5 1 25 G F 124 01 125 01 5 1 26 G F 125 01 126 01 5 1 27 G F 126 01 127 01 5 1 1 17 G 17 F 127 01 127 01 5 1 3 17 G 17 F 127 01 128 01 5 1 5 16 G 16 F 128 01 129 01 5 1 7 G F 129 01 130 01 5 1 8 9 G 9 F 130 01 131 ...

Page 73: ...1 143 01 5 2 6 3 G 3 F 143 01 144 01 5 1 19 G F 144 01 145 01 5 1 2 7 G 7 F 145 01 146 01 5 1 4 6 H 12 F 146 01 146 01 5 1 6 6 H 12 F 146 01 148 01 5 1 18 G F 148 01 149 01 5 2 3 G F 149 01 149 01 5 2 8 G F 149 01 150 01 5 2 4 G F 150 01 150 01 5 2 9 G F 150 01 151 01 5 2 5 G F 151 01 151 01 5 2 10 G F 151 01 152 01 5 2 11 G F 152 01 165 01 8 1 1 17 X 17 F 165 01 166 01 8 1 2 18 X 18 F 166 01 167 ...

Page 74: ... Probable causes Bubbles in the sample Too little sample used to fill the cartridge Clots in the sample 6 Excess blood was added to the cartridge When filling the cartridge the blood advanced past the level indicated by the fill to arrow 7 Sample was rejected during the testing cycle Probable cause Snap closure not secure 8 An insufficient amount of blood was used to fill the cartridge When fillin...

Page 75: ... testing cycle Probable causes Bubbles in the sample Insufficient mixing of sample used to fill the cartridge Wrong sample type 17 Cartridge was rejected during the testing cycle Probable causes Excess sample was added to the cartridge Used cartridge inserted 18 Cartridge was rejected during the testing cycle Probable causes Bubbles in the sample Microclots in the sample Used cartridge inserted Sn...

Page 76: ...blood to the level indicated by the fill to arrow Repeat testing with a freshly filled cartridge Carefully observe the help provided throughout the testing pathway If the same quality check failure displays contact the system administrator for further instruction I Instrument did not reset correctly Perform an electronic simulator test If the test results in a PASS the instrument is ready for use ...

Page 77: ...ghout the testing pathway If the same quality check failure displays contact the system administrator for further instruction X Draw new sample Repeat testing with a freshly filled cartridge Carefully observe the help provided throughout the testing pathway If the same quality check failure displays contact the system administrator for further instruction Y Cartridge pouch must be out of the refri...

Page 78: ... the Quick Reference Guide The graphics below are a visual representation of the wiping procedure for disinfection Note When cleaning and disinfecting the instrument the rechargeable battery must be attached 40 i STAT Alinity System Operations Manual Art 745527 01 Rev N Rev Date 13 Oct 2022 ...

Page 79: ...rtridge Name 2 Sample identification PT 123456 3 Analyte Name 4 Result value 5 Units of Measurement UOM 6 Audible Que 7 Date and time when test was completed 16FEB2025 09 45 8 Options Menu 9 Wireless Signal strength when customized 10 Battery strength For information on analytes available in a cartridge configuration unit of measure and the result value options see the i STAT Cartridge IFU 41 i ST...

Page 80: ...Results Transmit Unsent Results View Action Ranges and Analyte Info Customized Action Range Instrument Status Quality Options Administrative Options Instrument Options Displays information associated with the test Prints result to i STAT Alinity printer 42 i STAT Alinity System Operations Manual Art 745531 01 Rev G Rev Date 04 Mar 2021 ...

Page 81: ... a cartridge is controlled by the instrument and by region Calculated Result Indicator A star beside an analyte indicates a calculated result as shown in the example below Suppressed Results Stars Various conditions cause results to be suppressed The instrument displays stars referred to as a star out as shown in the example below Reasons such as those listed below may produce starred out results ...

Page 82: ...upport with regard to lot number in question Suppressed Results Out of range Under some conditions results may be preceded by the symbols for greater than or less than This can occur when results are outside the system s measurement ranges for the analyte Facility Policy should be in place to advise end users on additional course of action if necessary Below is an example of a result that is great...

Page 83: ... by both color and an arrow Yellow in the result area indicates that the result is outside of the reference range but is not within the action range sometimes known as an abnormal result The arrow indicates if the result is high or low Red in the result area indicates that the result is within the action critical range The arrows indicate if the result is high or low Red arrow in page button indic...

Page 84: ...46 i STAT Alinity System Operations Manual Art 745531 01 Rev G Rev Date 04 Mar 2021 ...

Page 85: ...e battery level Testing is disabled when the battery level is insufficient to perform a cartridge test An alert displays when the battery level approaches the level at which testing is disabled Instructions for attaching the battery are found in the i STAT Alinity Rechargeable Battery Getting Started Guide For a full list of all battery icons available for display on the instrument see the Quick R...

Page 86: ...al use A fully discharged battery will be 100 charged and ready for use after 4 hours use only a rechargeable battery pack purchased from Abbott Point of Care use only the accessories and consumables specified 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 a...

Page 87: ... 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 In the event of a battery leaking do not allow any leakage to come into contact with the skin or eyes If contact has been made wash the affected area with copious amounts of water and seek medical advice 49 i STAT Alin...

Page 88: ...50 i STAT Alinity System Operations Manual Art 745529 01 Rev G Rev Date 04 Mar 2021 ...

Page 89: ...lling and using the Base Station refer to the i STAT Alinity Base Station Getting Started Guide Description The i STAT Alinity Base Station charges the battery that is attached to the instrument powers the instrument when docked powers the instrument when the instrument is docked and cartridge testing is being performed provides connection to the printer provides for wired ethernet connection upda...

Page 90: ...o 90 non condensing with maximum saturation temperature of 34ºC 93 2F Testing Environment Indoors on a dry clean horizontal stable surface Avoid nearby vibration equipment such as centrifuges Avoid direct sunlight Altitude up to 3 048 meters 10 000 feet Storage range Temperature and humidity 10 to 60ºC 14 to 140ºF 10 to 90 non condensing with maximum saturation temperature of 50ºC 122ºF External P...

Page 91: ...ke any unauthorized repairs or modifications to this product as it may cause personal injury or damage to the unit NOTE The AC adapter power supply plug acts as a disconnect device for the Base Station and therefore the AC socket outlet must be installed or located near the Base Station and must be easily accessible if the Base Station needs to be unplugged When correctly connected to power the bl...

Page 92: ...lue light does not illuminate check to make sure that the Base Station is plugged into an appropriate power source Cleaning and Disinfecting Complete instructions for cleaning and disinfecting are found in the Quick Reference Guide The graphics below are a visual representation of the wiping procedure for disinfection 54 i STAT Alinity System Operations Manual Art 745528 01 Rev G Rev Date 16 May 2...

Page 93: ...e In this document see information in the section Perform Electronic Simulator Testing Principles of Operation The Electronic Simulator has a ceramic insert on the testing end When the Electronic Simulator pathway is initiated and the simulator is inserted the instrument contacts the ceramic strip as it would the contact pads on a cartridge The ceramic strip isolates the pins from the protective g...

Page 94: ...ns to this product use the Electronic 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 Care The instrument can become contaminated with blood during use Operators should use standard precautions whenever handling the instrument cartridge and peripher...

Page 95: ...ions for cleaning and disinfecting are found in the Quick Reference Guide The graphics below are a visual representation of the wiping procedure for disinfection 57 i STAT Alinity System Operations Manual Art 745530 01 Rev D Rev Date 16 May 2022 ...

Page 96: ...58 i STAT Alinity System Operations Manual Art 745530 01 Rev D Rev Date 16 May 2022 ...

Page 97: ...in the instrument software Electronic Simulator The Electronic Simulator is a quality control device used to evaluate the i STAT Alinity instrument s ability to read the electronic signal from a cartridge The test cycle for the Electronic Simulator is approximately 60 seconds Relative humidity The Electronic Simulator test will fail if high humidity interferes with the measurements It is therefore...

Page 98: ...Perform a test using the Electronic Simulator 60 i STAT Alinity System Operations Manual Art 745578 01 Rev C Rev Date 04 Mar 2021 ...

Page 99: ...in its thermal uniformity and stability 2 From the Home screen touch More Options Quality Options Perform Electronic Simulator Test and then follow the screen prompts 3 Remove the cap from the end of the Electronic Simulator and insert the Electronic Simulator into the instrument 4 When results are displayed the difference between the thermal probes can be viewed on the instrument s screen by touc...

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Page 101: ...Name of test Patient ID Quality Test ID Test result s Sample type selected Date and time the test was performed Operator ID Lot number of the cartridge Lot number of liquid quality material Serial number of the instrument Application software version in the instrument Standardization software in the instrument The printer is recharged using a power adapter connected to an outlet For additional inf...

Page 102: ...ge key to advance the page if applicable 4 Ensure that the instrument and the printer are on a flat level and horizontal surface Align the instrument s IR port with the printer IR window 5 Touch Print Selected An audible beep is heard when the instrument has successfully transmitted all results to the printer Printer may still be printing when beep is heard 64 i STAT Alinity System Operations Manu...

Page 103: ...ery pack 4 8 V Operational range Temperature and humidity 15 to 40ºC 59 to 104ºF 20 to 90 Non condensing relative humidity Storage range Temperature and humidity 20 to 50ºC 4 to 122ºF 10 to 90 Non condensing Communication link Infrared or Serial RJ11 Paper black print thermal paper 5 7 cm wide Available from Abbott Point of Care 65 i STAT Alinity System Operations Manual Art 745525 01 Rev E Rev Da...

Page 104: ...tion problems NOTE The instrument and its peripherals are not listed by any authority with respect to suitability for use in oxygen enriched atmospheres In the event of a battery leaking do not allow any leakage to come into contact with the skin or eyes If contact has been made wash the affected area with copious amounts of water and seek medical advice If a printout appears inconsistent with a p...

Page 105: ...e printout begins Then let go of both buttons 3 Check to see that the resulting printout is clear and complete The printer is not printing over a wired connection to the Base Station The POWER indicator light is green or orange and the STATUS indicator light is green If the printer is close to a fluorescent light Reposition the printer or shield the infrared radiation IR window to prevent direct l...

Page 106: ...iled printer to System Administrator 002 Reset the failed printer 1 Turn off the printer and unplug the power cord 2 Open the battery compartment and unplug the battery 3 Leave the battery unplugged for at least 10 seconds Then reconnect the battery and close the battery compartment 4 Reconnect the power cord Then press the power button to turn the printer on Attempt to print a record from the ins...

Page 107: ...onnect the battery and close the battery compartment 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 Cleaning and Disinfecting Complete instructions for cleaning and disinfecting are found in the Quick Reference Guide The graphics below are a visual representation of th...

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Page 109: ...mperature 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 its new expiration date See Cartridge Box Information A cartridge is used immediately after it is removed from its pouch 4 Ensure Thermal Probe Check is Performed Ensure the thermal probe check is performed with t...

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Page 111: ...l solutions do not contain human serum or serum products but they do contain buffers and preservatives Storage Store refrigerated at 2 to 8ºC 35 to 46ºF until the printed expiration date on the box and ampule labels Unopened ampules of control solutions can also be maintained at room temperature 18 to 30ºC or 64 to 86ºF for up to 5 days Do not use control solutions past the labeled expiration date...

Page 112: ...the instrument one or more alert messages may display Read the message carefully and perform the functions necessary to evaluate and or clear the alert The Home screen will display when the alerts have been successfully managed 2 From the Home screen touch More Options Quality Options Quality Control Select the button that is appropriate for the testing Continue to follow the prompts on the screen...

Page 113: ...nsferring the control solution capillary tube Plain capillary tubes are recommended to transfer aqueous control solution from the ampule to the cartridge Capillary tubes with sufficient fill capacity are required For example when filling a cartridge that requires 95 µl use a 150 µl capillary tube To use a capillary tube 1 Place a clean dry finger over one end of the tube and insert open end of the...

Page 114: ...8 4 4 6 iCa mmol L 0 90 1 35 1 58 Lac mmol L 8 30 3 00 1 63 Crea mg dL 4 65 1 59 0 65 PCO2 mmHg 65 40 26 PO2 mmHg 63 120 163 H pH 7 025 7 390 7 610 Evaluating QC Results Ranges The following is an example of the mean and range for level 1 control taken from a Value Assignment Sheet Mean Range Na mmol L mEq L 120 116 125 Na is the analyte tested Na Sodium mmol L mEQ L are the units of measurement M...

Page 115: ... assurance that products derived from human blood will not transmit infectious disease Ranges Assigned ranges are found on i STAT Value Assignment Sheets VAS located on https www globalpointofcare abbott en support istat brand vas i stat alinity html Follow facility policy regarding control results that do not fall within assigned ranges Disposal Dispose of this product as biohazardous waste accor...

Page 116: ...tly for 1 minute then inverting slowly for 30 seconds Note To minimize foaming of the control sample avoid vigorous or rapid mixing motion G Visually inspect the control vial to ensure the sample is fully reconstituted If not discard and repeat from step A H IMMEDIATELY Transfer the solution from the vial into the cartridge using a plastic transfer pipette or a non anticoagulated plastic syringe C...

Page 117: ...ld always be used to assess new lots of reagent before results are reported 3 Verify that results have not been affected by maintenance or repair procedures The user cannot perform any maintenance procedures on the i STAT Alinity System The software in the instrument is updated periodically Calibration verification solutions could be tested to verify that the system performs as before the upgrade ...

Page 118: ...ration Verification and solutions can also be maintained at room temperature 18 to 30 C or 64 to 86 F for up to 5 days Do not use i STAT Calibration Verification and i STAT TriControls Calibration Verification solutions past the labeled expiration date on the box and ampule labels Ampule use Barcode on the ampule must be scanned before the ampule is opened i STAT Calibration Verification and i STA...

Page 119: ...ince aqueous based solutions such as controls lack the buffering capabilities of whole blood the transfer process from ampule to cartridge must be more expedient than with a patient sample Refer to the value assignment sheets posted on the Abbott Point of Care website at www globalpointofcare abbott Procedure 1 Press Power and allow the instrument to power on Note After powering on the instrument ...

Page 120: ... and begin testing immediately Transferring the Cal Ver solution capillary tube Plain capillary tubes are recommended to transfer aqueous control solution from the ampule to the cartridge Capillary tubes with sufficient fill capacity are required For example when filling a cartridge that requires 95 µl use a 150 µl capillary tube To use a capillary tube 1 Place a clean dry finger over one end of t...

Page 121: ...2 mmHg 96 65 40 26 12 PO2 mmHg 40 63 120 163 500 H pH 6 550 7 025 7 390 7 610 7 850 Evaluating Cal Ver Results Ranges Calibration throughout the reportable range of each analyte is verified if each analyte value falls within the corresponding range in the Value Assignment Sheet If a result for a level falls outside the assigned range follow laboratory policy Contact Technical Support for troublesh...

Page 122: ...yte 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 84 i STAT Alinity System Operations Manual Art 745537 01 Rev F Rev Date 02 Nov 2022 ...

Page 123: ...globalpointofcare abbott Cartridge Specifications Shelf Life Refrigerated at 2ºC to 8ºC 35ºF to 46ºF until expiration date Refer to the cartridge box for room temperature storage requirements Preparation for Use Individual cartridges may be used after standing five minutes at room temperature An entire box of cartridges should stand at room temperature for one hour All cartridges should be used im...

Page 124: ...Cartridge Box Information 86 i STAT Alinity System Operations Manual Art 745524 01 Rev I Rev Date 02 Nov 2022 ...

Page 125: ...Cartridge Pouch Information 87 i STAT Alinity System Operations Manual Art 745524 01 Rev I Rev Date 02 Nov 2022 ...

Page 126: ...Cartridge Portion Pack Information 88 i STAT Alinity System Operations Manual Art 745524 01 Rev I Rev Date 02 Nov 2022 ...

Page 127: ...dge or the calibrant pack area in the middle of the cartridge 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 89 i STAT Alinity System Operations Manual Art 745524 01 Rev I Rev Date 02 Nov 2022 ...

Page 128: ...t solution if applicable and the sample to prevent the two from mixing The size of the air segment is monitored by the instrument Calibrant Pack During the first part of the testing cycle the calibrant solution is automatically released from the foil pack and is positioned over the sensors The foil pack may be pierced with improper cartridge handling If fluid is released prematurely a Quality Chec...

Page 129: ...t of the stored calibration curve Next the instrument automatically moves the sample over the sensors and the signals produced by the sensors responses to the sample are measured While coefficients are used rather than graphic calibration curves the calculation of the result is equivalent to reading the sample s concentration from an adjusted calibration curve Types of cartridge sensors Sensors ar...

Page 130: ...ed to the measuring electrode while current generated by the resulting oxidation or reduction reactions in the test system is measured The current generated is directly proportional to the concentration of the analyte An enzyme can be added to a layer on or near an amperometric sensor to produce electroactive species from analytes of interest that cannot themselves be oxidized or reduced Conductom...

Page 131: ...tentials By including selectivity coefficients in the Nernst equation 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 93 i STAT Alinity System Operations Manual Art 745524 01 Rev I Rev Date 02 Nov 2022 ...

Page 132: ...he cartridge in a container for biohazardous waste in accordance with your facility s policies and with local state and national regulatory guidelines keep the cartridge and the instrument at the temperature of the room where they are to be used Condensation on a cold cartridge can prevent proper contact with the instrument DO NOT use a cartridge if either the refrigerated or room temperature date...

Page 133: ...hority 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 95 i STAT Alinity System Operations Manual Art 745524 01 Rev I Rev Date 02 Nov 2022 ...

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Page 135: ...Alinity instrument s to be updated Base Station with power cable connected to AC mains power Formatted USB memory device PC with network connection to the Abbott Point of Care website https www globalpointofcare abbott en support istat brand istat alinity html Before attempting to update software from USB prepare a USB memory device using the following steps 1 Obtain a FAT32 formatted USB 2 0 memo...

Page 136: ...igate to More Options Instrument Options Software Installation Install From USB 2 Follow the on screen instructions 3 When presented with the name of the software package to be installed record the name before proceeding this information may be used at the end of the procedure to verify that the software update has been completed Press Next to continue with the installation of the software package...

Page 137: ... instrument 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 99 i STAT Alinity System Operations Manual Art 754496 01 Rev E Rev Date 02 Nov 2022 ...

Page 138: ...nt does not detect a software package on the USB memory device Verify the following then repeat the software update procedure remove the USB memory device from the Base Station and insert into a Windows PC verify that one and only one apkg file is present at the top level of the directory structure of the USB memory device The apkg should not be in a subfolder verify the name of the apkg file is i...

Page 139: ...to the internet if using the Abbott Managed Server or to the SDi server See AlinIQ NCi Network Connectivity for i STAT for instructions on configuring instrument for network connection The wired connection must be enabled If the healthcare organization network requires use of a proxy to access the internet the Proxy Server settings must also be configured 2 The instrument is placed in the powered ...

Page 140: ...ormed at different times if needed The i STAT Alinity will display the following symbol on the Home screen in the lower right hand corner if software is downloaded but not installed Touch this icon to display the Software Installation menu Touch the Install Pending button to install the software 4 Follow the on screen instructions to continue with software installation 5 When presented with the na...

Page 141: ...e software update completed check the software status page From the Home screen navigate to More Options Instrument Options Software Installation Software Status If the Firmware name displayed on the Software Status page matches that which was recorded during the software update procedure this indicates that the software update was completed Symptom Action to take Battery status indicator does not...

Page 142: ...nutes after screen going blank Verify the following as described in the prerequisites then repeat the software update procedure i STAT Alinity instrument s with appropriate Network Configuration file installed Base Station with power cable connected to AC mains power Ethernet Cable connected to healthcare organization network The healthcare organization network is allowing the instrument to connec...

Page 143: ...work Connectivity for i STAT for instructions on configuring instrument for network connection The wireless connection must be enabled If the healthcare organization network requires use of a proxy to access the internet the Proxy Server settings must also be configured 2 The instrument has a wireless connection to the healthcare organization network To verify A Home screen shows symbol in the upp...

Page 144: ...inity will display the following symbol on the Home screen in the lower right hand corner if software is downloaded but not installed Touch this icon to display the Software Installation menu Touch the Install Pending button to install the software 4 Follow the on screen instructions to continue with software installation 5 When presented with the name of the software package to be installed recor...

Page 145: ...status page From the Home screen navigate to More Options Instrument Options Software Installation Software Status If the Firmware name displayed on the Software Status page matches that which was recorded during the software update procedure this indicates that the software update was completed Symptom Action to take Check for Update button is not enabled Verify the following as described in the ...

Page 146: ...lid bars or greater Instrument is reporting a valid IP address for the wireless connection i STAT Alinity instrument s with appropriate 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 network c...

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Page 149: ... to connect wired wireless both to the network define the network to which the instruments are to connect SSID authentication protocol supply network access credentials for the network that is username password security certificates keys identify connection details proxy server IP address and DNS server address modes etc a worksheet found at the end of this section is provided as an aid to gather ...

Page 150: ...he first screen of the NCi that displays select the type of instrument as i STAT Alinity Upon selecting i STAT Alinity the NCi screen used to create NC files for i STAT Alinity instruments displays Note NCi consists of one screen for creating NC files though it must be scrolled to be viewed in its entirety For this reason the screen is shown here in sections 112 i STAT Alinity System Operations Ma...

Page 151: ...ctual NCi screen The configuration will be used for Select one of these radio buttons Multiple instruments Use this NC file for multiple instruments This is the default Note This option may not be available if your facility requires individual Enterprise Security Certificates for each instrument Instrument This NC file will apply only to one instrument If this option is selected the instrument s s...

Page 152: ...folder containing the NC file you wish to copy Note Attempting to rename an NC file causes unpredictable results Instead use the function Copy info from an existing file and save the file to a new name Edit an existing file 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 ...

Page 153: ...isplays the following prompts Proxy Server Type Select either HTTP HTTP proxy intercepts web access Socks Provides proxy service for UDP data and DNS look up operations in addition to web access Proxy Server Address Required IP address of the proxy server Port Port used by the proxy server The default is 8080 Proxy Server User Name Network name of the proxy server Proxy Server Password Network pas...

Page 154: ...The next section of the NCi screen is for connecting wirelessly 116 i STAT Alinity System Operations Manual Art 747079 01 Rev F Rev Date 28 Apr 2020 ...

Page 155: ...ox to configure wireless network connectivity Network Name SSID Name of the wireless local area network WLAN Connect to a specific Access Point BSSID Select this check box to connect to a single wireless access point WAP by specifying its unique BSSID Specify the BSSID address in this format DD DD DD DD DD DD DD where D is a hexadecimal digit Typically this is the media access control MAC address ...

Page 156: ...e Enterprise Authentication Types is selected refer to the Options for Enterprise Authentication Types sections for the security credential fields that will be enabled Network Security Key Enter the PSK passphrase 8 to 63 characters or 64 digit HEX key By default bullets are displayed as you type the key IP Address Mode Select either Automatic DHCP Obtain IP addresses and networking parameters aut...

Page 157: ...cted the instrument will automatically select which band to use Select one of the check boxes to limit the instrument to that band only 2 4G 5G Options for Enterprise Authentication Types When Authentication Type selected is WPA Enterprise WPA2 Enterprise or WPA2 WPA Enterprise the options shown here are enabled EAP Method Select one of the following TLS TTLS MSCHAPv2 PEAPv0 EAP MSCHAPv2 Validate ...

Page 158: ...Client Key Password Password for the client key Username Identity Username required by the authentication server 120 i STAT Alinity System Operations Manual Art 747079 01 Rev F Rev Date 28 Apr 2020 ...

Page 159: ...ion Type OPEN this value is not modifiable IP Address Mode Select one of these values Automatic DHCP Obtain IP addresses and networking parameters automatically from a DHCP server Use the following IP Address Select this button to use a static IP address Note If you specify a static IP address you must also specify DNS addresses IP Address IPv4 address of instrument in decimal dot notation 121 i S...

Page 160: ...he following Automatic DHCP Obtain IP addresses and networking parameters automatically from a DHCP server Use the following IP Address 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 Note You must specify DNS addresses if you specify a static IP address 122 i STAT Alinity System Operations Manual ...

Page 161: ...r may display with the prompts shown below Note Best practice is to select Save which will save the file to the Downloads directory Opening NC ancc files in a text editor is not recommended Do you want to open or save filename ancc Open Open the ancc file in a text editor Save Save the file to the Downloads directory Save as Save the file to a specified destination Note If you use this option make...

Page 162: ...g steps to copy the ancc file onto the USB memory stick 1 Plug the USB memory stick into the USB slot of the computer A message displays indicating that the operating system recognizes the drive and it is ready to use 2 From the Start menu click Computer Downloads 3 In the displayed list find the filename ancc file and right click on it 4 Click Send to drive name and press Enter This loads the fil...

Page 163: ...s network and power on the instrument On the instrument screen in the upper right corner the ethernet symbol displays indicating an active connection To check a wireless network connection remove the i STAT Alinity instrument from the base station On the instrument screen in the upper right corner the wireless internet symbol displays This symbol represents a strong signal Some or all of the bars ...

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Page 165: ...pecific 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 S...

Page 166: ...name 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 Static IP Address Yes No If Static IP Addres...

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Page 169: ...ecifics of the profile are determined by the needs of the operating location As an example for an instrument used in the NICU it may be necessary to turn off the instrument s sound to avoid disturbing the infants or to prompt operators to perform required quality control testing Customization also enables the administrator or POCC to establish action ranges based on a variety of age ranges In addi...

Page 170: ...en in the event that one HCO manager is unavailable other HCO managers can use the system One HCO manager only is specified as the primary Only a primary HCO manager can assign the role of healthcare organization manager to another CWi user Getting Started The function of CWi is to customize the i STAT Alinity instrument Users of CWi may wish to verify information for their site edit user informat...

Page 171: ...within the CWi the primary Health Care Organization manager One HCO manager only is specified as the primary The primary HCO manager has permission to access all functions of the CWi including creating other CWi users Prerequisites The healthcare organization information required by Abbott Point of Care includes name of the healthcare organization facilities city postal code country language For t...

Page 172: ...y are as follows Must be 8 to 20 characters long and contain 3 of the 4 example Pr86h22h uppercase character lowercase character number special character Cannot contain ampersand blank space less than symbol control character May not reuse last 10 passwords 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 i...

Page 173: ...ate to https www globalpointofcare abbott en support istat brand istat alinity html 2 Click on the link for AlinIQ CWi 3 Log in with the user s email address and click the Next button 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 133 i STAT...

Page 174: ...t alinity html does not open the application contact Technical Support for further assistance CWi Home page The Home page is the first screen displayed after you log in to CWi The CWi Home page consists of the following 134 i STAT Alinity System Operations Manual Art 746298 01 Rev M Rev Date 13 Oct 2022 ...

Page 175: ...ut Logs out of CWi 2 Work Area Description Define instrument behavior for your clinical setting Define your Healthcare Organization Define roles and permissions for AlinIQ CWi users 3 Link to Work Area Manage and Assemble Profiles Link to the workspace where customization options are defined Manage Healthcare Organization Manage Users Details about each workspace and its features are discussed in ...

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Page 177: ...anager is the person responsible for the CWi A healthcare organization must always have one Primary Healthcare Organization manager If the Primary Healthcare Organization manager needs to be replaced contact Technical Support Abbott Point of Care is responsible for establishing the healthcare organization within the CWi the primary healthcare organization manager One healthcare organization manage...

Page 178: ...ch healthcare organization should establish its own best practices Getting Started The healthcare organization information required by Abbott Point of Care includes name of the healthcare organization city postal code country language For the primary healthcare organization manager specify email address first and last names contact information 138 i STAT Alinity System Operations Manual Art 746301...

Page 179: ...anization Manager has permission to access all functions of the CWi including creating other CWi users except for the primary healthcare organization manager Other healthcare organization managers can only assign the roles of Point of Care Super User and Point of Care Coordinator Point of Care Coordinator POCC has permission to access all functions of the CWi program but is limited to assigning th...

Page 180: ... Point of Care Command Line Actions On the upper right corner of the screen in addition to Create the command line includes these actions View CWi user can be viewed Change Change information for a CWi user Delete Delete a CWi user Back Go back to previous page To create a user in the upper right corner of the screen click Create This screen displays 140 i STAT Alinity System Operations Manual Art...

Page 181: ... name Last name Language Select a language from the drop down list Role Select one of the following from the drop down list 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 141 i STAT Alinity System Operations Manual Art 746303 01 Rev K Rev Date 19 Oct 2021 ...

Page 182: ...d deletes these specifications Save saves the user as defined 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 142 i STAT Alinity System Operations Manual Art 746303 01 Rev K Rev Date 19 Oct 2021 ...

Page 183: ... Profile or Category so modifications can be made easily When using this action the user will be required to rename the Profile or Category and then make the desired changes to the features Change Manage Profile and all Categories can be changed without renaming View Select a Profile or Category for viewing to determine the enabled features Delete Remove a Profile or Category from the Manage and A...

Page 184: ...GFR is being used this feature is required If Liquid QC and or Cal Ver Schedules are used A list of the site s areas and the cartridges used in each area can be helpful when creating the Quality Settings Category Contact the IT department or patient registration If using barcoded patient armbands or labels Ensure that the type of barcode on the armband or label is enabled in the Patient Settings C...

Page 185: ...ings Operator Settings Quality Settings Patient Settings Analyte Settings In addition to the required categories there are optional categories that can be included in a profile User Defined Message Training Settings STATNotes Result Notes Connectivity Settings Note Profiles are created by assembling categories When creating profiles for the first time it is necessary to create categories first Det...

Page 186: ...lts Test Cancellation Test Selection Accession Specimen ID Entry Critical Callback Critical Callback Documentation Print Test Result Printout i STAT printing Operator Settings ID Entry List Actions 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 Notificati...

Page 187: ... Custom Sample Types Sample Type Entry Options Ranges Enable Disable Analyte Apply Globally Apply by Panel Hematocrit Hematocrit Setting Calibration by Laboratory Hematology Analyzer Apply CPB Protein Algorithm to Hematocrit Setting Adjustments BE Equation eGFR Equation eGFR Variants ACT ACTk Mode Stop ACT Test Critical Tests 147 i STAT Alinity System Operations Manual Art 746300 01 Rev N Rev Date...

Page 188: ...edules Frequency Cal Ver Schedules Frequency User Defined Message User Defined Message Training Settings Basic Functions Training Mode Training Pathway Cartridges Operator Direct Observation Checklist Training Scenarios STATNotes STATNotes Manage Items Manage Sets Result Notes Result Notes Manage Items Manage Sets Connectivity Settings Connectivity Map Test Records Device Events Operator List Pati...

Page 189: ...ish to stop viewing Click Create and follow the instructions below Note All required categories have a default setting named with the APOC prefix In addition the settings are populated with default values You are prompted to specify a name for the settings and an optional description General Settings Name Required Specify a name that is from 4 to 40 characters long and consists only of the followi...

Page 190: ...t will power down after the chosen number of seconds have elapsed Training Mode Active The instrument will power down after the chosen number of seconds have elapsed Software Updates Software Expiration Warning Number of days prior to the expiration of the instrument software to display a warning message on the screen Allowable values are 0 through 30 The default is 15 days The following is an exa...

Page 191: ...ault Memory full notification at instrument start up When the instrument is powered up a start up alert will display indicating the memory is full The operator is prompted to clear the memory otherwise old records may be overwritten Lockout all Testing Pathways until memory is cleared Testing will be suspended until the memory is cleared Lockout message displays on the instrument at start up When ...

Page 192: ... mm yy Date Display Select one of these options for the format of the date as it is displayed on the instrument The default is dd mm yyyy dd mm yyyy mm dd yyyy ddMMMyyyy When finished choose from the options shown at the bottom of the screen Previous to go back to the previous screen Discard to undo changes Finish Later to create a draft Next to open the next tab 152 i STAT Alinity System Operatio...

Page 193: ...s down All Unsent Results Lists eVAS All unsent results Operator Patient Cartridge Lists if enabled and eVAS if new version available will be communicated and transmitted to or from the data management system and network service when the instrument powers down Wireless Communications Enables wireless communication for the i STAT Alinity instrument The default setting is enabled Uncheck the box to ...

Page 194: ...nsmitted to the data management system only those that are accepted will go through to the LIS EMR Rejected results will not be sent to the LIS EMR Rejection Comment Select either option Optional The operator is prompted to enter a comment for rejecting test results Mandatory The operator is prompted to enter a mandatory comment for rejecting test results Rejection Comment Style Controls display o...

Page 195: ...CWi user The comments will display on the instrument screen when a result is rejected 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 155 i STAT Alinity System Operations Manual Art 746300 01 Rev N Rev Date 02 Nov 2022 ...

Page 196: ...y Accession or Specimen ID number generated from facility LIS when a test is ordered Enable Select the check box to enable prompting for an entry If you select the check box to enable prompting choose one of these options Optional Prompt the operator for entry of the accession specimen ID number The operator may skip this prompt Mandatory with Override Prompt the operator for a mandatory entry If ...

Page 197: ...tained The first position the position farthest to the left is numbered position 1 The scanmask field will accept a text input consisting of numbers 1 9 commas and hyphens to identify the scanmask selection If for example the barcode reads abcdefghi1234567890 and the selection pattern is 2 5 8 11 14 then the barcode will be interpreted as befgh2345 If the selection pattern is 3 4 then the barcode ...

Page 198: ...rator or patient IDs Mod 11 check digit on manual entry Use the Mod 11 algorithm when creating operator or patient IDs Mod 10 check digit on manual entry Use the Mod 10 algorithm when creating operator or patient IDs Scan Entry Check Digit Method Whether to use a check digit when scanning a value to create an operator or patient ID No check digit on scan entry Do not use a check digit when creatin...

Page 199: ...allback is read to the caregiver Refer to the options below If Positive Patient Identification PPID is enabled this information is automatically populated Options Enable Select this check box to enable comments If comments are enabled select one of these options Optional Comment is optional Mandatory Comment is required Format Determine the format used to enter data Select either Numeric Only Data...

Page 200: ...ion 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 Manual Check Digit Method If a facility uses a supported check digit algorithm when creating operator or patient IDs the i STAT Alinity can verify the entered ID format by calculating the check digit and comparing it to the entered ID number If the check digits do not ma...

Page 201: ...t Identification PPID is enabled this information is automatically populated Note For Patient First Name options see the section for Patient Last Name Options Options are the same for both Caregiver ID Operator enters the caregiver s last name or ID for confirmation when a critical callback is read to the caregiver Format Note Caregiver ID options for Format Entry Type Minimum Length Maximum Lengt...

Page 202: ...y the CWi user Operator selects the most appropriate The comment will be attached to the test record Each comment can be 17 characters in length including spaces Comment Field Prompt Specify the text up to 17 characters to display on the instrument as a prefix to a comment Note The prefix specified as Comment Field Prompt will display with a comment For example if the Comment Field Prompt built is...

Page 203: ...ll contain Operator ID as per the Operator ID Presentation settings see Operator Settings category When not checked printouts will contain the entire Operator ID Print Operator Name as per the Operator Name Presentation setting When checked printouts will contain Operator Name as per the Operator Name Presentation settings see Operator Settings category When not checked printouts will contain the ...

Page 204: ... Once the settings are confirmed click on the Publish button to finalize them A Category can be added to a Profile only when the publish status is completed When finished choose from the options shown at the bottom of the screen Previous to go back to the previous screen Discard to undo changes Finish Later to create a draft Publish to make settings available to use in a Profile 164 i STAT Alinity...

Page 205: ...not work for the profile being assembled click Finish to stop viewing Click Create and follow the instructions below Note All required categories have a default setting named with the APOC prefix In addition the settings are populated with default values You are prompted to specify a name for the settings and an optional description Operator Settings Name Required Specify a name that is from 4 to ...

Page 206: ...the selection of specific character positions to be retained The first position the position farthest to the left is numbered position 1 The scanmask field will accept a text input consisting of numbers 1 9 commas and hyphens to identify the scanmask selection If for example the barcode reads abcdefghi1234567890 and the selection pattern is 2 5 8 11 14 then the barcode will be interpreted as befgh...

Page 207: ...Use the Mod 11 algorithm when creating operator or patient IDs Mod 10 check digit on manual entry Use the Mod 10 algorithm when creating operator or patient IDs Scan Entry Check Digit Method Whether to use a check digit when scanning a value to create an operator or patient ID No check digit on scan entry Do not use a check digit when creating operator or patient IDs Mod 11 check digit on scan ent...

Page 208: ...he instrument screen after all required fields are complete but before the cartridge is inserted The cartridge help screens include the collect and mix sample and fill cartridge graphics When finished choose from the options shown at the bottom of the screen 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 n...

Page 209: ...ator s access to the test pathway if the operator ID is expired Unscheduled QC Test Pathway Choose one of these options Warn user and prompt to continue Display a warning message to the operator that certification has expired and provide a Continue tab to allow access to the test pathway for testing to be performed Lockout user Deny access if an operator s certification is expired Training Test Pa...

Page 210: ...continue Display a warning message to the operator stating that the operator s ID is not on the 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 Training Test Pathway Determine an operator s access to the test pathway if the operator s ID is expired Warn user and prompt to continue Display a warn...

Page 211: ... s ID is not on the 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 When finished choose from the options shown at the bottom of the screen Previous to go back to the previous screen Discard to undo changes Finish Later to create a draft Next to open the next tab 171 i STAT Alinity System Operat...

Page 212: ...en Previous to go back to the previous screen Discard to undo changes Finish Later to create a draft Next to open the next tab Summary The Summary is a collapsed view of the settings that can be expanded to provide a complete display The Summary should be reviewed prior to Publish Once the settings are confirmed click on the Publish button to finalize them A Category can be added to a Profile only...

Page 213: ...ck Create and follow the instructions below Note All required categories have a default setting named with the APOC prefix In addition the settings are populated with default values You are prompted to specify a name for the settings and an optional description Patient Settings Name Required Specify a name that is from 4 to 40 characters long and consists only of the following characters 0 through...

Page 214: ...nly as numbers Alphanumeric Data will be entered as either letters or numbers Entry Type Determine how the data will be entered into the i STAT Alinity instrument Select one of the following Allow Scan and Manual Entry Allow barcode scan or manual data entry Scan Only Allow barcode scan data entry only Manual Entry Only Allow manual data entry only Minimum Length Enter the minimum data characters ...

Page 215: ...al Check Digit Method If a facility uses a supported check digit algorithm when creating operator or patient IDs the i STAT Alinity can verify the entered ID format by calculating the check digit and comparing it to the entered ID number If the check digits do not match the ID is rejected Note The i STAT Alinity System supports the Mod 10 and Mod 11 check digit algorithms described in the HL7 Tabl...

Page 216: ...hm when creating operator or patient IDs Mod 10 check digit on scan entry Use the Mod 10 algorithm when creating operator or patient IDs Barcode Type Select all that apply 176 i STAT Alinity System Operations Manual Art 746300 01 Rev N Rev Date 02 Nov 2022 ...

Page 217: ...mation is not in the Patient List Patient age and sex prompt is required if reference and action ranges are built with age and sex applied in Analyte Settings In order to display results for eGFR the Prompt for age and sex if Patient List is Not Enabled or information is not in the Patient List option must be enabled Note Sex types displayed on the instrument for manual entry of Age and Sex are Ma...

Page 218: ...birth When this option is selected if Gender is available from the patient list patient gender will be used for items that require patient sex reference ranges action ranges eGFR and the operator will not be prompted to enter patient sex When finished choose from the options shown at the bottom of the screen Previous to go back to the previous screen Discard to undo changes Finish Later to create ...

Page 219: ... Finish to stop viewing Click Create and follow the instructions below Note All required categories have a default setting named with the APOC prefix In addition the settings are populated with default values You are prompted to specify a name for the settings and an optional description Analyte Settings Name Required Specify a name that is from 4 to 40 characters long and consists only of the fol...

Page 220: ...f you change units for an analyte you may also need to adjust reference ranges action ranges and custom reportable ranges for that analyte When finished choose from the options shown at the bottom of the screen Previous to go back to the previous screen Discard to undo changes Finish Later to create a draft Next to open the next tab 180 i STAT Alinity System Operations Manual Art 746300 01 Rev N R...

Page 221: ...y Sample Type Entry Options Determine whether the operator is prompted to enter the type of sample used Enable Unselect the check box if you do not want to prompt the operator for the sample type Optional User is prompted to enter optional sample type Mandatory with override User is prompted to enter mandatory sample type If the override feature is chosen by the operator no further action is requi...

Page 222: ...le to enter only the low and high range independent of sample type age or sex To make reference ranges sample type dependent check the box in the Apply column and choose the sample types applicable by clicking the down arrow in the Sample Type column The sample types displayed are either the default types or the types customized in the Sample Types section of the Analyte Settings category Referenc...

Page 223: ...ges Restrict the display range to custom values For example healthcare organization managers may wish to limit the display ranges to values that have been verified using calibration verification materials Set the low and high values Narrowing the reportable range of certain tests may affect the presentation of other dependent test results In the table below if any of the results in the first colum...

Page 224: ...Cl Anion Gap K Anion Gap TCO2 Anion Gap PO2 sO2 Click Update to save changes to analyte or click Cancel to discard Repeat this process for all analytes needed When finished selecting all ranges for all desired analytes choose from the options shown at the bottom of the screen Previous to go back to the previous screen Discard to undo changes Finish Later to create a draft Next to open the next tab...

Page 225: ...es except BhCG Example glucose is available on CHEM8 and EC8 If glucose is not to be reported when an EC8 is tested disable the glucose by panel cartridge type The glucose would display when the CHEM8 cartridge is tested because it was not disabled on the CHEM8 cartridge When finished choose from the options shown at the bottom of the screen Previous to go back to the previous screen Discard to un...

Page 226: ...surgery However the facility may validate its use for other patient populations known to have protein levels significantly lower than the normal adult population Note If an instrument customized as CPB always apply is used for patients who are not on the pump it is possible that the hematocrit results will be reported falsely high If an instrument customized as CPB never apply is used for patients...

Page 227: ...hown at the bottom of the screen Previous to go back to the previous screen Discard to undo changes Finish Later to create a draft Next to open the next tab 187 i STAT Alinity System Operations Manual Art 746300 01 Rev N Rev Date 02 Nov 2022 ...

Page 228: ...ent of pH disturbances Select either option Extra Cellular Fluid Base Excess of Extracellular Fluid BEecf BEecf HCO3 24 8 16 2 pH 7 4 This is the default Blood Base Excess of Blood BEb BEb 1 0 014 Hb HCO3 24 8 1 43 Hb 7 7 pH 7 4 eGFR Equation MDRD default CKD EPI 2009 eGFR Variants Select one of these options Display both eGFR and Black African American eGFR Display only eGFR Display only Black Af...

Page 229: ...nly pre warm is the default Non warm ambient temperature result calibration Stop ACT Test Determines whether an operator can stop an ACT test while it is being performed Select the check box to enable stopping a test This is the default Unselect the check box to prevent an operator from stopping a test When finished choose from the options shown at the bottom of the screen Previous to go back to t...

Page 230: ...provide a complete display The Summary should be reviewed prior to Publish Once the settings are confirmed click on the Publish button to finalize them A Category can be added to a Profile only when the publish status is completed When finished choose from the options shown at the bottom of the screen Previous to go back to the previous screen Discard to undo changes Finish Later to create a draft...

Page 231: ...ofile being assembled click Finish to stop viewing Click Create and follow the instructions below Note All required categories have a default setting named with the APOC prefix In addition the settings are populated with default values You are prompted to specify a name for the settings and an optional description Quality Settings Name Required Specify a name that is from 4 to 40 characters long a...

Page 232: ...ator every n days Determines how frequently the external electronic simulator is tested Specify a number of days in the range 0 365 The default is 0 which turns off testing Note Abbott Point of Care manufacturer s requirement is for the electronic simulator to be tested every 6 months 182 days When finished choose from the options shown at the bottom of the screen Previous to go back to the previo...

Page 233: ... the CWi for automatic eVAS updates If the instruments are not connected to CWi the eVAS must be loaded onto each instrument using the USB port on the Base Station Manual The operator manually compares the liquid QC 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 and...

Page 234: ...ptional Prompt the operator for an optional entry Mandatory Prompt the operator for a mandatory entry Cartridge testing cannot continue until information is entered Comment Style Determines how comments are displayed on the instrument when a Liquid Quality Control result is out of acceptable range Choose either of these options Comment List Comments must be chosen from a selection list See below f...

Page 235: ...o 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 and indicates on the instrument whether the Cal Ver test passed or failed Results Display Format Determines whether the Cal Ver results displayed on the instrument are either Numeric Cal Ver results are displayed in numeric form...

Page 236: ...ist or can be entered as text Choose either of these options Comment List Comments can only be chosen from the selection list Comment List with text box Operator will be prompted to choose a comment or to type a comment into the text box provided It is a one or the other selection by the operator A maximum of 6 comments can be displayed with a text box Comments A list of comments created by the CW...

Page 237: ...way only Patient and proficiency testing is disabled until the cartridge lot number is available in the cartridge list Lockout Do not allow the test to be run until the lot number has been added to the list of cartridges Cartridge QC Warning Screen Enable Cartridge QC Warning Screen Select this check box to display a warning screen on the instrument when the i STAT cartridge QC is due If you selec...

Page 238: ...rom the drop down list Example Every 2nd Thursday of the month Every n days starting on mmddyy Schedule liquid QC to run according to a time interval and a start date The time interval is a number of days in the range 28 to 90 Select the start date from the pop up calendar Time This option is enabled only when a value other than Off has been specified for Frequency Testing due at HH mm Time of day...

Page 239: ...hen an E3 cartridge can be selected as its dependent The CHEM8 is the parent and the E3 is the dependent When QC testing is done for the CHEM8 cartridge and the result is a pass for sodium then the E3 cartridge is also considered as having passed the test for sodium Option to select one or more cartridges as dependents Choose a dependent by selecting the check box next to the cartridge name Note A...

Page 240: ... Fail Determination with eVAS After fluids have been selected click Update QC Profile When finished choose from the options shown at the bottom of the screen Previous to go back to the previous screen Discard to undo changes Finish Later to create a draft Next to open the next tab 200 i STAT Alinity System Operations Manual Art 746300 01 Rev N Rev Date 02 Nov 2022 ...

Page 241: ...osen from the drop down list Example Every 2nd Thursday of the month Time This option is enabled only when a value other than Off has been specified for Frequency Testing due at HH mm Time of day when Cal Ver is due to be done Specify a value for hours and minutes in the range 00 00 to 23 59 Default is 00 00 midnight Grace period Additional amount of time allowed before and after testing due time ...

Page 242: ...t When QC testing is done for the CHEM8 cartridge and the result is a pass for sodium then the E3 cartridge is also considered as having passed the test for sodium Option to select one or more cartridges as dependents Choose a dependent by selecting the check box next to the cartridge name Note All analytes used within the facility should be included in liquid QC and Cal Ver testing schedules Note...

Page 243: ...Summary should be reviewed prior to Publish Once the settings are confirmed click on the Publish button to finalize them A Category can be added to a Profile only when the publish status is completed When finished choose from the options shown at the bottom of the screen Previous to go back to the previous screen Discard to undo changes Finish Later to create a draft Publish to make settings avail...

Page 244: ... the characters APOC in upper or lower case is a unique name within this healthcare organization Description Optional Provide any information that helps the user know how or why the category was named or created When finished choose from the options shown at the bottom of the screen Discard to undo changes Next to open the next tab User Defined Message The screen for entry of the user defined mess...

Page 245: ...ults created in the training scenarios This will provide standardized training material for the individual overseeing point of care testing To create new category settings click on Create The screen displays the default name TemporaryName Change the name using the specifications shown below Training Settings Name Required Specify a name that is from 4 to 40 characters long and consists only of the...

Page 246: ...d to remain competent The super user trainer observes the operator performing the skills and communicates to the POCC administrator that the operator successfully completed the list A text box displays and up to 40 characters can be entered To save click Add Observation This will display another text box for an additional item When all items have been entered specify an identifier for the revision...

Page 247: ...rio 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 207 i STAT Alinity System Operations Manual Art 746300 01 Rev N Rev Date 02 Nov 2022 ...

Page 248: ... the settings that can be expanded to provide a complete display The Summary should be reviewed prior to Publish Once the settings are confirmed click on the Publish button to finalize them A Category can be added to a Profile only when the publish status is completed When finished choose from the options shown at the bottom of the screen Previous to go back to the previous screen Discard to undo ...

Page 249: ...detail Items listed with names that begin with APOC are predefined Details of each APOC predefined item can be viewed by clicking on the item and then clicking on View If the predefined item satisfies the needs of the customer no further action is required and the item is ready to be added to a set If changes to the APOC predefined item are required follow the instructions for Create from Existing...

Page 250: ...210 i STAT Alinity System Operations Manual Art 746300 01 Rev N Rev Date 02 Nov 2022 ...

Page 251: ...ection describes creating a Data Entry item that will prompt the operator to supply information either using the keypad or by scanning 211 i STAT Alinity System Operations Manual Art 746300 01 Rev N Rev Date 02 Nov 2022 ...

Page 252: ...lect one of the following Entry optional Prompt the operator for an optional entry Entry mandatory with override 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 Entry mandatory Prompt the operator for a mandatory entry Cartridge testing cannot continue until information is e...

Page 253: ...e starting number must be smaller than the ending number For example 3 5 is a valid range but 5 3 is not Selection ranges cannot overlap The end of each number range must be smaller than the beginning of the next number range 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 Manual C...

Page 254: ...ck digit when creating operator or patient IDs Mod 11 check digit on scan entry Use the Mod 11 algorithm when creating operator or patient IDs Mod 10 check digit on scan entry Use the Mod 10 algorithm when creating operator or patient IDs Barcode Type Select all that apply When the specifications for this item are complete in the lower right corner of the screen Click Publish to complete the item ...

Page 255: ...erride 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 Entry mandatory Prompt the operator for a mandatory entry Cartridge testing cannot continue until information is entered Each item for the selection list is defined next Click Edit Selection List A text box displays Ente...

Page 256: ... Click Publish to complete the item so it will appear on the Manage Items list Click Discard to delete the item 216 i STAT Alinity System Operations Manual Art 746300 01 Rev N Rev Date 02 Nov 2022 ...

Page 257: ...try Prompt Select one of the following Entry optional Prompt the operator for an optional entry Entry mandatory with override 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 Entry mandatory Prompt the operator for a mandatory entry Cartridge testing cannot continue until inf...

Page 258: ...le below for examples Note All STATNotes items must be available before a Mode item can be created Example the table below shows the various ventilator modes and the corresponding STATNotes items Table 3 2 Modes Examples Only Mode STATNotes Items A C Set Rate Vt FIO2 PEEP PS Heliox CMV Set Rate Vt FIO2 PEEP PS Heliox N CPAP Vt PIP FIO2 PEEP PS iNO Heliox N HFOV HZ AMP Delta P Bias Flow FIO2 218 i ...

Page 259: ... steps will be completed Item Name Required Specify a name that is from 1 to 20 characters long and does not begin with the characters APOC in upper or lower case is a unique name within this healthcare organization Item Prompt on Analyzer Required Specify a prompt that is from 1 to 20 characters long and does not begin with the characters APOC in upper or lower case is a unique name within this h...

Page 260: ... are to be assigned to the page select STATNotes Page STATNotes Items In the box directly below STATNotes Items click the arrow to display the drop down list Select all items that should be used on the instrument to prompt for responses for the ventilator mode being built Items must be unique and chosen only once Repeat this process for all STATNotes items that will be needed for the ventilator mo...

Page 261: ...PIP Also the STATNotes Item shown as None will not display on the instrument Follow the same steps as described above for every mode 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 221 i STAT Alinity System Operations Manual Art 746300 01 Rev N Rev Date 02 Nov 2022...

Page 262: ...able above BNC delivery system requires 3 STATNotes items To check whether these STATNotes items exist Click Manage and Assemble Profiles STATNotes Manage Items The screen displays all existing items If all of the STATNotes items needed for delivery system BNC are included in the list this means that the delivery system item can be built It is also important to note when checking the STATNotes lis...

Page 263: ...o the next screen Entry mandatory Prompt the operator for a mandatory entry Cartridge testing cannot continue until information is entered The fields on this screen are Selection List A list of oxygen delivery systems identified with a page name Each delivery system will have No Items Mode or STATNotes Page applied Selection List Entry Name of the page for the delivery system Example BNC Select ST...

Page 264: ...ystems Pages being built click Add Selection List Entry then repeat all steps from Selection List Entry through STATNotes Page instruction Below is an example of a Delivery System with 4 Selection List entries Note The STATNotes Items shown in the examples above may not match the prompt displayed on the i STAT Alinity Example APOC FIO2 will display on the instrument as FIO2 Also the STATNotes Item...

Page 265: ...escription Optional Entry Prompt Select one of the following Entry optional Prompt the operator for an optional entry Entry mandatory with override 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 Entry mandatory Prompt the operator for a mandatory entry Cartridge testing can...

Page 266: ...nstrument Click on Manage Sets Create This screen displays On this screen specify STATNotes Set Name Required Specify a name that is from 1 to 20 characters long and does not begin with the characters APOC in upper or lower case is a unique name within this healthcare organization Description Optional STATNotes Items Select up to 6 items from the drop down boxes to create the set Do not duplicate ...

Page 267: ...r or lower case blank space underscore _ does not begin with the characters APOC in upper or lower case is a unique name within this healthcare organization Description Optional Provide any information that helps the user know how or why the category was named or created When finished choose from the options shown at the bottom of the screen Next to open the next tab for this Category Discard to u...

Page 268: ...d view of the settings that can be expanded to provide a complete display The Summary should be reviewed prior to Publish Once the settings are confirmed click on the Publish button to finalize them A Category can be added to a Profile only when the publish status is completed When finished choose from the options shown at the bottom of the screen Previous to go back to the previous screen Discard...

Page 269: ... whether the set will display in the Patient pathway or the Control and Cal Ver pathway Continue through the process until the set is published Once a set is published it is available for assigning to a cartridge type when building a Result Note The information below will explain the process in detail Begin building an item Click on Manage and Assemble Profile Result Notes Manage Items Create The ...

Page 270: ...nalyzer Required Specify a prompt that is from 1 to 20 characters long and does not begin with the characters APOC in upper or lower case is a unique name within this healthcare organization Description Optional Entry Prompt Select one of the following Entry optional Prompt the operator for an optional entry Entry mandatory with override Prompt the operator for a mandatory entry If the override fe...

Page 271: ...try mandatory Prompt the operator for a mandatory entry Cartridge testing cannot continue until information is entered 231 i STAT Alinity System Operations Manual Art 746300 01 Rev N Rev Date 02 Nov 2022 ...

Page 272: ...position 1 The scanmask field will accept a text input consisting of numbers 1 9 commas and hyphens to identify the scanmask selection If for example the barcode reads abcdefghi1234567890 and the selection pattern is 2 5 8 11 14 then the barcode will be interpreted as befgh2345 If the selection pattern is 3 4 then the barcode will be cd Individual position selections that are separated by a comma ...

Page 273: ...t IDs Mod 11 check digit on manual entry Use the Mod 11 algorithm when creating operator or patient IDs Mod 10 check digit on manual entry Use the Mod 10 algorithm when creating operator or patient IDs Scan Entry Check Digit Method Whether to use a check digit when scanning a value to create an operator or patient ID No check digit on scan entry Do not use a check digit when creating operator or p...

Page 274: ...elect one of the following Entry optional Prompt the operator for an optional entry Entry mandatory with override 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 Entry mandatory Prompt the operator for a mandatory entry Cartridge testing cannot continue until information is ...

Page 275: ... 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 235 i STAT Alinity System Operations Manual Art 746300 01 Rev N Rev Date 02 Nov 2022 ...

Page 276: ...ription Optional Entry Prompt Select one of the following Entry optional Prompt the operator for an optional entry Entry mandatory with override 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 Entry mandatory Prompt the operator for a mandatory entry Cartridge testing cannot...

Page 277: ...on Description Optional Entry Select one of the following Entry optional Prompt the operator for an optional entry Entry mandatory with override 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 Entry mandatory Prompt the operator for a mandatory entry Cartridge testing cannot...

Page 278: ...iption Optional Entry Prompt Select one of the following Entry optional Prompt the operator for an optional entry Entry mandatory with override 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 Entry mandatory Prompt the operator for a mandatory entry Cartridge testing cannot ...

Page 279: ...cify a prompt that is from 1 to 20 characters long and does not begin with the characters APOC in upper or lower case is a unique name within this healthcare organization Description Optional Entry Prompt Select one of the following Entry optional Prompt the operator for an optional entry Entry mandatory with override Prompt the operator for a mandatory entry If the override feature is chosen by t...

Page 280: ...l items exist a Result Notes set can be created When creating a Result Notes set the patient or control and Cal Ver testing pathway needs to be determined for the Result Notes Set Once a set is created it can be applied to cartridges After patient testing or control and Cal Ver testing is performed using a cartridge the Result Notes item will be displayed on the instrument Use Manage Sets Create T...

Page 281: ...en finished choose from the options shown at the bottom of the screen Discard to undo changes Publish to create the set After a Result Notes set has been published click Done Create Result Notes On the command line click Create Result Notes Name Required Specify a name that is from 4 to 40 characters long and consists only of the following characters 0 through 9 A through Z or alphabet appropriate...

Page 282: ... Optional When finished choose from the options shown below Next to open the next tab for this Category Discard to undo changes 242 i STAT Alinity System Operations Manual Art 746300 01 Rev N Rev Date 02 Nov 2022 ...

Page 283: ...ter to create a draft Next to open the next tab Summary The Summary is a collapsed view of the settings that can be expanded to provide a complete display The Summary should be reviewed prior to Publish Once the settings are confirmed click on the Publish button to finalize them A Category can be added to a Profile only when the publish status is completed When finished choose from the options sho...

Page 284: ...s from 4 to 40 characters long and consists only of the following characters 0 through 9 A through Z or alphabet appropriate for language in upper or lower case blank space underscore _ does not begin with the characters APOC in upper or lower case is a unique name within this healthcare organization Description Provide any information that helps the user know how or why the category was named or ...

Page 285: ...Instrument Clock Date Time Synchronization in section 1 2 i STAT Alinity Instrument for details If all the IP addresses in the Connectivity Map are the same the instrument may synchronize time during any of the data manager communication sessions for example transmitting results or receiving lists If the IP addresses in the Connectivity Map are not all the same the instrument will synchronize time...

Page 286: ...utton to finalize them A Category can be added to a Profile only when the publish status is completed When finished choose from the options shown at the bottom of the screen Previous to go back to the previous screen Discard to undo changes Finish Later to create a draft Publish to make settings available to use in a Profile 246 i STAT Alinity System Operations Manual Art 746300 01 Rev N Rev Date ...

Page 287: ...lt Notes Connectivity Settings To begin defining a profile from the Home page click Manage and Assemble Profiles Profile Create This screen displays This screen has the following options Profile Name Required Specify a name that is from 4 to 40 characters long and consists only of the following characters 0 through 9 A through Z or alphabet appropriate for language in upper or lower case blank spa...

Page 288: ...the details of the category exit the Summary screen by clicking the X When finished selecting categories choose from the options shown at the bottom of the screen Previous to go back to the previous screen Discard to undo changes Finish Later to create a draft Next to open the next tab To select all the categories for a profile follow the same steps as described for General Settings Select one cat...

Page 289: ...3 Place the instrument on the Base Station Power on the instrument 4 Navigate to More Options Administrative Options Profile Management Install Profile from USB 5 Follow the prompts on the screen to begin the installation process 6 The Activate USB Drive screen displays 2 check boxes Both boxes must display a green check mark for the installation to proceed If necessary troubleshooting steps are l...

Page 290: ...250 i STAT Alinity System Operations Manual Art 746300 01 Rev N Rev Date 02 Nov 2022 ...

Page 291: ...Settings Category to confirm that sound is enabled on the profile assigned to the instrument Follow CWi instructions in this manual to make necessary changes Date display is incorrect on i STAT Alinity Check General Settings Category for Date Display Follow CWi instructions in this manual to make necessary changes i STAT Alinity wireless function does not work Check General Settings Category to co...

Page 292: ...o confirm the IP address is programmed for operator list i STAT Alinity will not upload cartridge lot list Check to confirm Search Cartridge List for Cartridge Lot Number is enabled in the Quality Settings Category on the profile assigned to the instrument If not enabled follow CWi instructions in this manual to enable Search Cartridge List for Cartridge Lot Number to load the cartridge list from ...

Page 293: ... appear as available for application to a cartridge Follow the instructions in this manual to create a STATNotes set Category created does not appear in the list of available categories when creating a profile Categories must be in the Published status to appear as available when creating a profile Cartridge QC Lot List is applied and defined in CWi and data management system but QC or Cal Ver res...

Page 294: ... on the instrument are correct Follow NCi instructions in this manual to make necessary changes to network settings 4 Check Connectivity Map in customization profile to confirm at least one of the following is Enabled and has the correct IP Address and Port of the data manager Test Results Operator List Cartridge List Patient List Follow CWi instructions in this manual to make necessary changes 5 ...

Page 295: ...erformed from USB Temporary loss of user access to AlinIQ CWi will not affect profiles already loaded onto instruments 255 i STAT Alinity System Operations Manual Art 746304 01 Rev H Rev Date 29 Oct 2019 ...

Page 296: ...256 i STAT Alinity System Operations Manual Art 746304 01 Rev H Rev Date 29 Oct 2019 ...

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