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NAT-024

INSTRUMENT USER MANUAL

ID NOW

Summary of Contents for ID NOW NAT-024

Page 1: ...NAT 024 INSTRUMENT USER MANUAL ID NOW ...

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Page 3: ...ID NOW Instrument User Manual ID NOW Instrument User Manual ...

Page 4: ...USB with Software Update Home Clock reset User Login Software Update Power on loading Initial Admin Setup Admin password reset INITIAL ADMIN SETUP ID NOW Instrument User Manual ...

Page 5: ...HL7 orPOCTserver Patient Test Results Review Memory Export Logfile Export Results Search Results QC Test Results Logout Home Run QC Test Run Test Export Users Import Users User Name New User Remote Mode Auto Logout Network Time Date Patient Details Users Login Setup Preferences About Brightness Sound Language Assay Preference Transmission Status Setup Status Auto Sending Connectivity Lot Managemen...

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Page 7: ...3 2 Instrument Status Light 12 3 3 User Interface 12 3 4 Home Screen 13 3 5 Navigation 13 3 6 Onscreen Keyboard 13 3 7 Admin Setup 14 4 Setup Menu 17 4 1 Log In Admin Access Only 17 4 2 Users 18 4 3 Assay Preferences Admin Access Only 20 4 3 1 Sample Type Selection Admin Access Only 21 4 3 2 Early Detection Admin Access Only 21 4 4 Patient Details Admin Access Only 22 4 5 Date Admin Access Only 22...

Page 8: ...ment Admin Access Only or via POCT server 28 4 17 Auto Print Admin Access Only 30 4 18 Reset To Factory Default Admin Access Only 31 5 Preferences Menu 32 5 1 Language 32 5 2 Sound 32 5 3 Brightness 33 5 4 About 33 5 5 Instrument Information 33 6 Running a Test 34 6 1 User Login 34 6 2 Main Menu 35 6 3 First Time Use 35 6 4 Running A Test 35 7 Running a QC Test 37 7 1 Run QC Test 37 7 2 QC Test Re...

Page 9: ...12 1 6 Printing Result Error 53 12 1 7 Review Memory Error 53 12 1 8 Search Results Error 54 12 1 9 Export Results Export Logfile Errors 54 12 1 10 New User Errors 54 12 1 11 User Details Errors 55 12 1 12 Import Users Errors 56 12 1 13 Export Users Errors 56 12 1 14 Network Errors 56 12 1 15 Admin Password Errors 57 12 1 16 Miscellaneous Errors 58 12 2 Warnings 59 12 2 1 Home Warnings 59 12 2 2 R...

Page 10: ...le a test is in progress Caution Follow proper infection control guidelines for handling all specimens and related items Properly dispose of all contaminated waste according to federal state and local requirements Caution Risk of electrical shock Do not operate the instrument or the power supply if it has been opened damaged or exposed to moisture condensation or rain Caution Do not disassemble or...

Page 11: ...tion If any assay components are dropped cracked found to be damaged or open when received DO NOT USE and discard Caution Due to the high sensitivity of the assays run on the instrument contamination of the work area with previous positive samples may cause false positive results Handle samples according to standard laboratory practices Clean instruments and surrounding surfaces according to instr...

Page 12: ...uired to run each assay The reaction tubes in the Test Base contain the reagents required for amplification of the target nucleic acid and an internal control ID NOW utilizes a pair of templates similar to primers for the specific amplification of the target nucleic acid and a fluorescently labeled molecular beacon designed to specifically identify the amplified targets To perform the assay the Sa...

Page 13: ...emory allows search and retrieval Archive or export via USB Power Supply 12V DC from external AC DC supplied plug pack DC Voltage fluctuation 10 DC Current consumption 12V DC 3 0 Amps Dimensions 8 15 W x 5 71 H x 7 64 D 207 mm W x 145 mm H x 194 mm D Weight 3 0 kg Operating Environment Indoor Use 15 C to 30 C 50 F to 86 F 10 to 80 RH non condensing 0m 1 01 bar to 2000m 0 763 bar IP20 Storage 15 C ...

Page 14: ...he carrying handle when removing the instrument from the box and when transporting short distances Place instrument in a location where the air vents located in the back of the instrument will not be blocked Avoid placing the instrument in direct sunlight Inspect for any obvious signs of damage Report any damage immediately to Abbott Allow the instrument to equilibrate to room temperature for at l...

Page 15: ...ution directly onto instrument when cleaning Ensure no excess liquid is used when cleaning as it may damage the instrument Abbott recommends that the exterior instrument surfaces and the surfaces visible under the open lid be cleaned daily Clean surrounding bench area Clean instrument and surrounding areas immediately after possible patient sample contamination Do not disassemble the instrument fo...

Page 16: ...10 ID NOW Instrument User Manual ID NOW Instrument Front View 2 ID NOW INSTRUMENT at a GLANCE Lid Test Base Holder Sample Receiver Holder LED Status Indicator LCD Color Display Screen Audio Speaker ...

Page 17: ...ID NOW Instrument User Manual 11 ID NOW Instrument Back View USB Connection Power Button USB Connection x 2 Ethernet Connection Carrying Handle Power Connection ...

Page 18: ...Button for 3 seconds or longer If the unit is unattended for one hour the instrument will switch to power save mode and the screen will go black Touch the screen to return the unit to active display operation 3 2 Instrument Status Light The lower right side of the front panel of the ID NOW Instrument includes a white light This light should illuminate immediately when the instrument is powered up ...

Page 19: ... Up Down Arrows Enable navigation to scroll through menus and increase decrease setting values Home Select Home at any time to return to the Home screen 3 6 Onscreen Keyboard Q W E R T Y U I Z X C V B N M O P A S D F G H J K L 123 1 2 3 4 5 6 7 8 9 0 ABC Onscreen QWERTY Keyboard Numeric Keypad The Onscreen QWERTY Keyboard Numeric Keypad enable user input into the ID NOW Instrument Press 123 or ABC...

Page 20: ...rect press to advance to the next screen If password is incorrect press Cancel to return to the Create Admin Password screen Rescue Password Yes No Would you like to define a Rescue Password that can restore access if the Admin password is lost The Admin can set a rescue password in case the original is lost or forgotten Recovery Key OK Cancel Please refer to user manual Recovery Key Use keyboard ...

Page 21: ...OK Set the correct time using the up and down arrow keys and choose between a 12 Hour or 24 Hour display using the touch screen This screen will be displayed automatically once the date is set Press OK to advance Self Test Self Test Running self test please wait The instrument will now run a Self Test before proceeding to the Home screen Close lid to proceed Self Test If the instrument lid is open...

Page 22: ...inselectsSetupto finishconfiguringtheinstrumentandtoaddadditional users SeeSection4fordetails Alternatively the Admin can run a test by selecting Run Test When an assay or the instrument is used for the first time or following a software upgrade the user is required to run both a positive and a negative successful QC test before patient testing is allowed See Sections 6 and 7 for details If not re...

Page 23: ...Only OK User ID Password Log In allows the Admin to choose User ID password requirements to allow access to the instrument If Users do not require passwords select User ID Only and press OK If a password is preferred select User ID Password and press OK The selected option will apply to all Users with the exception of the Admin who will always be required to use a password when logging on as Admin...

Page 24: ...st be 2 to 20 characters and alphanumeric User IDs are not case sensitive Q W E R T Y U I Z X C V B N M O P A S D F G H J K L 123 Enter Password If required the instrument will prompt Admin to enter the password and press Passwords are case sensitive and must be alphanumeric The password cannot contain spaces Note A unique User ID is required for each user If a duplicate User ID is entered the ins...

Page 25: ...ed by the POCT system and indicate which assays the user is certified to run Users can use the Edit User Screen to change their password and view current Certifications Admin will also have option to set Rescue Password Note Users not managed by POCT system will not see certifications Deleting a User Home Setup Users Admin Access Only User Details User Name James Password 123password Edit User Del...

Page 26: ... Import Users Import Users Importing users from USB device Import a complete user list that has been exported from an ID NOW Instrument using a USB drive connected to the instrument Press OK to return to the User screen Note Only Users exported from an ID NOW Instrument can be imported Import Users Imported 8 users OK 4 3 Assay Preferences Admin Access Only Home Setup Assay Preferences Select Test...

Page 27: ... shown when running a test If Viral Transport Media VTM is selected only the VTM method will be shown when running a test Choose Select per Test if the instrument is intended to run both Swabs and VTM samples Users will be required to select the appropriate Sample Type each time they run a test Press OK to save the settings and return to the Setup Menu 4 3 2 Early Detection Admin Access Only Home ...

Page 28: ...splayed on Screen or on Printout by pressing Display Patient Info which will advance to a screen to choose On Screen and or On Printout Press OK to accept changes and return to Home screen 4 5 Date Admin Access Only Home Setup Date Date 3 NOV 2013 OK The Date Menu allows the Admin to set the correct date Use the up and down arrow keys and the touch screen to change the date and move between day mo...

Page 29: ...t Addresses IP Address Subnet Mask Gateway 255 255 255 0 DNS Address 100 100 100 100 100 100 100 100 100 100 100 100 Cancel OK 1 2 3 4 5 6 7 8 9 0 ABC 10 0 1 121 IP Address The Network menu allows the Admin to configure the network settings on the Instrument Functions supported include Select between DHCP and Static IP address assignment Configure IP Address Configure Subnet Mask Configure Gateway...

Page 30: ... certain screens when Connectivity activity occurs The top icon indicates an activity is in progress The middle icon indicates successful completion The bottom icon indicates an error occurred during a connectivity activity Home Setup Connectivity Connectivity ASTM LIS OK HL7 POCT 1A The Connectivity Menu allows the Admin to configure edit or control sending messages to a Laboratory Information Sy...

Page 31: ...e only persisted if the user presses the OK button Cancel will discard changes 4 11 1 IP Address Admin Access Only Home Setup Connectivity Setup IP Address 1 2 3 4 5 6 7 8 9 0 10 0 1 121 IP Address ABC Note This is for entering the IP address of the LIS HL7 or POCT server not of the ID NOW instrument itself 4 11 2 Port Number Admin Access Only Home Setup Connectivity Setup Port Number 1 2 3 4 5 6 ...

Page 32: ...he instrument will regularly attempt to send all unsent records to the connectivity server at the configured period The available selections are 5 10 15 or 30 Minutes 1 Hour and 1 Day 4 14 Clear Sent History Admin Access Only Home Setup Connectivity Clear Sent History Clear Sent History erases the time and date record for all results sent successfully This feature may be used if switching to a new...

Page 33: ...led warn or lockout mode also allows the Admin to configure a testing interval for the assay chosen lot independent In the Lockout mode when the assay frequency expires the user will be prompted to run a QC test for that particular assay before a patient test can be run In the Warn mode when the assay frequency expires it will present the user with an option to proceed Units are set as either days...

Page 34: ...run QC negative and positive controls before a patient test can be run Alternatively the user can change to a different lot which has had a valid QC negative and positive control associated with it Run QC Test Positive QC Test Negative QC Test Both QC negative and QC positive tests must generate valid results before the instrument can run a patient test Select Run QC Test and follow the steps in S...

Page 35: ...t Select Search Lots to search for a specific Lot or all Lots run for a specific assay Lot 0123456 Test Type Influenza A B Lockout Positive QC Negative QC 13 JAN 2018 SN A2ED6618 OK Cancel N A Select a lot to see its details In this example the Assay name as well as instrument serial number and the Date and Time of its QC runs will be displayed The Admin has the option to Lockout the chosen Lot he...

Page 36: ...o confirm import is in process Import QC Results Imported 12 lot QC Results OK This screen confirms Import completed successfully Note For any particular lot information on USB drive will replace information already on the instrument 4 17 Auto Print Admin Access Only Home Setup Auto Print Setup On Auto Print Reset to Factory Default Use the Auto Print menu option to configure the instrument to pri...

Page 37: ...set to Factory Default Reset to Factory Default can be accessed through the Setup screen and allows the Admin to return the instrument to the default factory settings Caution This will delete all users patient test results and QC results from the instrument It is recommended that any desired data be exported before performing this function ...

Page 38: ...rred language Select the desired language from the list When prompted press OK to save the settings The instrument will prompt to reboot the instrument for languages to take immediate effect 5 2 Sound Home Preferences Sound Sound Volume level 80 OK Keyboard Clicks On Alerts On The Instrument uses sound for the following functions A click whenever the touch screen is used Tones will sound to indica...

Page 39: ...tt group of companies or their respective owners Information about the instrument is displayed here Press Info to display further instrument information 5 5 Instrument Information Home Preferences About Info About this Device Serial No BB8F3616 Baseboard Ver 3 Core Ver 4 FAM 3 0 8 ROX 3 0 8 Tray 4 1 0 Baseboard 2 00 Application Ver 5 0 2 IP Address 172 16 0 16 MAC Address 00 04 A3 E5 AB F9 Rev ID ...

Page 40: ...he instrument is switched on or after another User has logged out the Enter User ID or Scan screen will be displayed Enter the User ID or scan using an electronic barcode reader press to advance If a password is required as specified by the Admin during Setup a prompt will appear to enter the password Press to advance Q W E R T Y U I Z X C V B N M O P A S D F G H J K L 123 Enter Password The instr...

Page 41: ...ing both a QC negative and QC positive external control before patient testing is allowed Both QC negative and QC positive tests must generate valid results before the instrument can run a patient test Select Run QC Test and follow the steps in Section 7 6 4 Running A Test From the Home screen select Run Test Home User ID 30 Jan 2018 10 12am Run Test Run QC Test Review Memory Preferences Setup Log...

Page 42: ...nce press Confirm Patient ID Run Test Patient ID 10AX425 OK Cancel Check that the Patient ID information is correct and press OK to confirm If the Patient ID is not correct press Cancel to return to the Enter Patient ID screen Run Test Edit Info Patient ID 10AX425 Name Earl Johansen DoB 11 Nov 1959 Positive Patient ID One Match OK Cancel Note If user is connected to LIS system via POCT 1A and the ...

Page 43: ...he Home screen 7 1 Run QC Test Select the QC test to be run Run QC Test ID NOW Assay Select the desired assay from the list of available assays Run QC Test Positive QC Test Negative QC Test Select and confirm a Positive or Negative QC test Confirm the test type to match the QC sample intended for testing by pressing OK and follow the on screen prompts to complete testing If the incorrect QC test h...

Page 44: ... Flu A B Negative QC Pass Actions New Test 1 Jan 2013 User ID Abbottuser1 QC Sample ID Sent DD MMM YYYY hh mm am pm When Connectivity has been configured the status of each result is displayed on the QC Test Results screen Not Sent Queued for sending as Not Sent but Auto Sending is enabled which will eventually send the record Connecting Sending Failed to send Failed to send retrying Sent followed...

Page 45: ... may be printed at the completion of a test or from the review memory screen Home Review Memory Attach the Universal Printer to the instrument Select Print The instrument will print a report on a tear off sticker The ID NOW Instrument will set the default printer to the connected printer if only one Universal Printer is connected If more than one printer is connected the instrument will set the fi...

Page 46: ... is accessible to all users from this screen 9 1 Patient Test Results Home Review Memory Patient Test Results Patient Test Results All Influenza A B Strep A RSV Back Select to choose what subset of test results to view Selecting All will display all of the Patient Test Results on the instrument whereas choosing a specific assay will display only Patient Test Results that match that assay type Pati...

Page 47: ...Sent but Auto Sending is enabled which will eventually send the record Connecting Sending Failed to send Failed to send retrying Sent followed by the send date and time No Results Saved Patient Test Results OK No results saved This screen will be displayed if the instrument has not yet been used for patient testing or following export and deletion of all results Invalid Test Results Flu A Invalid ...

Page 48: ...sults Cancel Print Send Result 9 2 QC Test Results Home Review Memory QC Test Results QC Test Results All Influenza A B Strep A Back RSV Select to choose what subset of test results to view Selecting All will display all of the QC Test Results on the instrument whereas choosing a specific assay will display only QC Test Results that match that assay type QC Test Results 10 of 99 Positive Negative ...

Page 49: ...nd Date Times based on the text entered Patient Test Results 4 of 10 Patient9 Patient8 Patient7 RSV 27 Sep 2018 07 28 Influenza A B 26 Sep 2018 07 28 Strep A 25 Sep 2018 07 28 RSV 24 Sep 2018 07 28 Patient6 For example Searching for the text Jan will return any test results where the Patient ID contains the text Jan and also any test results that were obtained during the month of January A list of...

Page 50: ...t Results Local results deleted OK Archive saved data regularly to prevent loss 9 5 Export Logfile Home Review Memory Export Logfile Export Logfile Exporting logfile to USB device If there is an issue using the instrument Abbott Technical Support may request to export a Logfile and email it to them Abbott Technical Support will use the information in the log file to assist with diagnosis of the is...

Page 51: ... 2 Turn the instrument off by pressing and holding the power button for 3 seconds or longer Step 3 Attach USB Flash Memory Drive with the required software update provided by Abbott to the instrument via the USB port located on the side of the instrument Step 4 Power up the ID NOW Instrument by pressing and holding the power button The instrument will automatically display the start up status bar ...

Page 52: ...nstrument by pressing and holding the power button The instrument will power up as normal Prior to running an assay with the new software for the first time the user is required to run a positive and negative successful QC test before patient testing is allowed See Section 6 If expected QC results are not obtained or you are unable to complete the software update please contact Abbott Technical Su...

Page 53: ...canner Order Number OPR2001ZWU1 201 Refer to the Barcode Scanner User Manual for more information Only use the Barcode Scanner provided by Abbott with the ID NOW Instrument 11 3 ID NOW USB Drive Order Number EQ004001 Abbott recommends using the ID NOW USB Drive with the ID NOW Instrument Alternatively other commercially available USB Flash Memory Drives can be used The USB must meet the following ...

Page 54: ...haracters OK Invalid Password 12 1 1 Power On Loading Error Error Please Set Clock If the internal battery fails the instrument will lose the time and date Action The Admin must log in and reset the date and time Home Setup Date Home Setup Time If this error occurs in a subsequent power up of the instrument there may be an on going time and date fault 12 1 2 Initial Admin Setup Error Error Invalid...

Page 55: ... only to the Admin Admin can Press to enter Rescue Password or to retrieve the Recovery Key for Reset Code See section 3 7 Note Passwords must be 2 to 20 characters long are case sensitive and must be alphanumeric The password cannot contain spaces Error Firmware Communications Error The instrument cannot conduct its Self Test Action Press OK to try again If the error persists reboot the instrumen...

Page 56: ...est the user can review results and instrument details but cannot run a test If this error persists tests cannot be run on the instrument However stored data can be viewed Home Review Memory Error Discard Pieces for Self Test The instrument cannot conduct its Self Test if parts of the test are inside the instrument Action Remove test pieces as shown under Running a Test and press OK to try again I...

Page 57: ...or No Configuration File Installed A configuration file has not been installed on the instrument Action Press OK to return to the Home screen Contact Abbott Technical Services Error Invalid Patient ID Patient ID must be 2 to 20 characters long are not case sensitive and must be alphanumeric The Patient ID cannot contain spaces Action Press OK to try again If the error persists while using the barc...

Page 58: ...ns closely Error Lid Open The lid must not be opened during the testing process Action Press OK Remove and dispose of all test pieces and repeat with a new test Error Test Failed The test has encountered an unrecoverable error Action Press OK Remove and dispose of all test pieces and repeat with a new test Error Invalid Frequency If the User enters a non numeric or numerical value greater than 100...

Page 59: ...t has not recognized the printer Action If printer is not connected connect it If it is connected check the printer connection Press OK to try again If this error persists completely unplug the printer reconnect to the instrument and press OK to try again Confirm the printer power supply is connected and the printer is turned on Confirm printer power LED is illuminated Confirm USB data cable is co...

Page 60: ...l Action Repeat the export process If this error persists try using a different USB drive Press OK to return to the Review Memory screen 12 1 10 New User Errors Error Maximum Users Reached A maximum of 999 users plus the Admin user can be set up Action Press OK to return to the User screen to review the Users and delete Users no longer needed This will not affect saved data Note The Admin cannot b...

Page 61: ... contain spaces Action Choose a password that meets the above criteria Error Certification Expired If user certification has expired for running an assay this error will appear When connected to middleware system Action Contact Admnistrator Note If connected to LIS system user would not be included in user list Error USB Drive Not Found The instrument has not recognized the USB drive Action If a U...

Page 62: ... Errors Error USB Drive Not Found The instrument has not recognized the USB drive Action If a USB drive is not connected connect it now If it is connected check the connection If this error persists use a different USB drive Error Export Failed The export was not successful Action Repeat the export process If this error persists ensure that the USB device has available memory If the error persists...

Page 63: ... will try again Check the network connection and apply the changes again If the error persists reboot the instrument by turning it off and then on again and attempt the changes again Error Port Number Invalid Valid ports are whole numbers between 1 and 65535 as configured and appropriate to the laboratory information system Action Use a valid port number meeting the criteria described above 12 1 1...

Page 64: ...t has failed its Self Test due to a target in the instrument not providing a correct response Action Press OK to try again or press Home to return to the Home menu Without successfully completing Self Test the user can review results and instrument details but cannot run a test Error Hardware Timeout The instrument hardware encountered an internal hardware response error Action Repeat the test If ...

Page 65: ...ent can store up to 999 patient test and 99 QC results and is now full Action To avoid overwriting stored data the Admin must export the data See Section 9 4 Export Results Alternatively Press OK to continue to run the current test Note that this will overwrite stored data Warning Heater Not At Temperature The instrument has not yet reached the required temperature Action Press OK to return to the...

Page 66: ...creen displayed To cancel the test press OK Remove and dispose of all test pieces Warning QC Frequency Exceeded If a frequency is set under warn within the QC Lockout function when the assay Frequency expires and a user attempts to conduct a patient test for that assay this warning message will appear Action Select OK to proceed with the run or select Cancel to stop the patient test and proceed to...

Page 67: ...lost The instrument will start up as it did when first received from the manufacturer and can be reconfigured by the Admin Abbott suggests exporting all user patient and QC results to a USB drive prior to resetting to factory default Press Cancel to return to the Setup menu Press OK to reset to factory default 12 2 4 User Warnings Warning Delete User If a User is deleted all data associated with t...

Page 68: ...tor for connection with supplied external Power Supply and Adaptor 12VDC 3 0 Amp maximum Hot Surface Biological Hazard Caution consult accompanying documents Restriction of Hazardous Substances Compliant Waste Electrical and Electronic Equipment Directive Compliant Serial Number IVD In Vitro Diagnostics Prescription only 13 SYMBOLS ...

Page 69: ... This device complies with part 15 of the FCC Rules Operation is subject to the following two conditions 1 This device may not cause harmful interference and 2 this device must accept any interference received including interference that may cause undesired operation ...

Page 70: ...acting Technical Support on USA 1 855 731 2288 ts scr abbott com Africa Russia CIS 44 161 483 9032 EMEproductsupport abbott com Asia Pacific 61 7 3363 7711 APproductsupport abbott com Canada 1 800 818 8335 CANproductsupport abbott com Europe Middle East 44 161 483 9032 EMEproductsupport abbott com Latin America 57 1 4824033 LAproductsupport abbott com 14 ORDERING and CONTACT INFORMATION ...

Page 71: ...his warranty is that during the warranty period Manufacturer shall replace or repair at no charge and at the Manufacturer s sole discretion any Instrument with a defective component MANUFACTURER MAKES NO OTHER WARRANTIES AND EXPRESSLY EXCLUDES ANY IMPLIED WARRANTY OF MERCHANTABILITY NONINFRINGEMENT OR FITNESS FOR A PARTICULAR USE There are no user serviceable parts in the Instrument Tampering with...

Page 72: ... THE PURCHASE PRICE OF THE INSTRUMENT IN NO EVENT WILL MANUFACTURER BE LIABLE FOR ANY INCIDENTAL INDIRECT SPECIAL CONSEQUENTIAL OR PUNITIVE LOSS OR DAMAGES IN ANY WAY RELATED TO THE INSTRUMENT OR ANY THIRD PARTY CLAIMS EVEN IF MANUFACTURER OR ITS DISTRIBUTORS ARE AWARE OF THE POSSIBILITY OF SUCH CLAIM OR DAMAGES AND NOTWITHSTANDING THE ESSENTIAL PURPOSE OF ANY REMEDY ...

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Page 76: ...bott com poct 2020 Abbott All rights reserved All trademarks referenced are trademarks of either the Abbott group of companies or their respective owners Software 2020 Axxin used under license All trademarks referenced are trademarks of their respective owners INNAT024 Rev 09 2020 02 IVD ...

Page 77: ...Abbott ID NOW Instrument User Manual US Size 210 mm x 297 mm PMS 2925 C Primary Blue PN INNAT024 Rev 9 PMS 303 C Dark Blue Date of Last Revision 9 8 2020 02 06 CMYK ...

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