NOVA BIOMEDICAL Nova Primary 63438 Instructions For Use Manual
  1. Manuals
  2. Brands
  3. NOVA BIOMEDICAL Manuals
  4. Measuring Instruments
  5. Nova Primary 63438
  6. Instructions for use manual
NOVA BIOMEDICAL Nova Primary 63438 Instructions For Use Manual

NOVA BIOMEDICAL Nova Primary 63438 Instructions For Use Manual

Glucose analyzer
Hide thumbs
Table of Contents

Advertisement

Quick Links

Download this manual
63438
Only
Nova Primary
Glucose Analyzer
Instructions for Use
Manual

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the Nova Primary 63438 and is the answer not in the manual?

Questions and answers

Subscribe to Our Youtube Channel

Related Manuals for NOVA BIOMEDICAL Nova Primary 63438

Summary of Contents for NOVA BIOMEDICAL Nova Primary 63438

  • Page 1 63438 Only Nova Primary Glucose Analyzer Instructions for Use Manual...
  • Page 3 Nova Biomedical is a registered trademark of Nova Biomedical. Copyright Printed in the U.S.A. Copyright 2024, Nova Biomedical, Waltham, MA 02454. Technical Assistance For technical assistance inside the United States and Canada, call Nova Biomedical Technical Services at: U.S.A.: 1-800-545-NOVA (1-781-894-0800)
  • Page 4 For technical assistance outside the United States and Canada, call your local Nova subsidiary or authorized distributor. Nova Biomedical recommends users report any serious incidents/adverse events back to Nova Biomedical or Nova Biomedical's Authorized Representative as well as to their local Competent Authority as required. Nova Biomedical Benelux B.V.
  • Page 5 NOVA BIOMEDICAL SYMBOL DIRECTORY In vitro diagnostic medical device Batch code Serial Number Caution Temperature limitation Consult instructions for use Use by YYYY-MM-DD Biological risk Electronic Waste Catalog number Authorized Representative in the European Commission Manufactured by Laser Radiation - Do Not Stare Into...
  • Page 6 Revision History Rev. Release Description 12-2021 Initial Release 06-2023 FDA 510(k) review and IVDR compliance updates 09-2024 Updates to include latest software features...
  • Page 7 able of onTenTs Table of Contents Introduction                                             1-1 About This Manual  1-1 Safety  1-1 Installation and Use  1-2...
  • Page 8 rimary lucose NstructioNs for aNual Maintenance                                            4-1 Change Sensor and/or Membrane Cap  4-1 Change Calibrator Pack4-2 Change Probe 4-3...

  • Page 9: Table Of Contents

    able of onTenTs Appendix                                              A-1 Specifications A-1 Quality Control A-1 Analytical Specificity A-2...
  • Page 10 rimary lucose NstructioNs for aNual TOC-4...
  • Page 11 ntroductIon ntroductIon This manual provides all necessary instructions for the routine operation and upkeep of the Nova Primary Glucose Analyzer. Please read this manual carefully. It has been prepared to help you attain optimum performance from your analyzer. WARNING: Blood samples and blood products are potential sources of infectious agents.
  • Page 12 2. The Nova Primary must accept any interference received, including interference that may cause undesired operation. Changes and Modifications not expressly approved by Nova Biomedical Corporation can void your authority to operate this equipment under the Federal Communications Commission rule.
  • Page 13 Nova Biomedical recommends using 70% reagent alcohol (v/v) or isopropyl alcohol (IPA) for cleaning the various analyzer surfaces or components when required. When using alcohol, use a lint-free cloth lightly dampened with the cleaning reagent to wipe down the analyzer surfaces.
  • Page 14 rimary lucose NstructioNs for aNual 1.6 I ntended ests erforMed lInIcal tIlIty Intended Use The Nova Primary Glucose Analyzer System is indicated for in vitro diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination of Glucose in lithium heparinized venous whole blood and plasma.
  • Page 15 ntroductIon References 1. CLSI Guideline GP44-A4. Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline - Fourth Edition. 2. CLSI Guideline GP41, 7th Edition. Collection of Diagnostic Venous Blood Specimens. 3. Jacobs., Kasten, DeMott, and Wolfson, ed. 1990. Laboratory Test Handbook. Lexi-Comp Inc.
  • Page 16 rimary lucose NstructioNs for aNual...

  • Page 17: Getting Started

    ettinG tarted ettIng tarted The Nova Primary Glucose Analyzer is pictured below. 1. Touch-screen Display 2. Printer 3. Sampler 4. Door/Front Panel...
  • Page 18 rimary lucose NstructioNs for aNual 1. Sampler Assembly 2. Sensor/Well Assembly 3. Syringe Assembly 4. Waste Pump 5. Calibrator Cartridge 2.1 a nalyzer tartuP rocedure The Nova Primary Glucose Analyzer is a semi-automated instrument. When the Nova Primary Analyzer is powered on, it automatically loads the required operating sequences and launches the Graphical User Interface (GUI) on the touch screen display.
  • Page 19 ettinG tarted 2.2 t nterface During the initial installation, an Administrator User Account and Password must be created to log into the analyzer’s User Interface. This Administrator account is then used to create any additional Administrator or User accounts and passwords required for other operators. User Names must be a minimum of 3 alphanumeric characters and are not case sensitive.
  • Page 20 rimary lucose NstructioNs for aNual 2.2.2 tatus The Status Bar at the top of the screen shows the current Analyzer Status, Date and Time, next Scheduled Event, Calibrator Pack status, System Events, the currently logged in Operator (when login is required), and time to completion. Analyzer System Operator...
  • Page 21 ettinG tarted Scheduled Events – press the Scheduled Events icon to display the next scheduled event’s date and time. If a scheduled calibration is due in less than 5 minutes the icon will be displayed with a yellow background and a countdown timer indicating how much time is left before the calibration will begin.
  • Page 22 rimary lucose NstructioNs for aNual 2.3 d estInatIon creens The Destination Screens are accessed to analyze patient and Quality Control samples, review test results, and to configure, maintain, and service the Nova Primary Analyzer. Destination Screens are displayed below the Status Bar on the touchscreen display and change to the selected Destination.
  • Page 23 ettinG tarted 2.3.1 The Logs screen provides access to the analyzer Audit, Error, Calibration, and Maintenance Logs. Select the button of the log to display to show any entries for the current date. The Set Dates button on the bottom of each log screen allows the operator to enter a date range of the log entries to display.
  • Page 24 rimary lucose NstructioNs for aNual Audit Log – the Audit Log contains the date and time and the operator ID that an auditable action was performed. For a list of recorded activities, see Section 7.6 Auditable Actions. Event Log - The Event Log will display the date and time an event occurs and a brief description of the event.

  • Page 25: Q Uality C Ontrol (Qc)

    ettinG tarted 2.3.3 ervIce The Service screen contains advanced user and service only functions. Please refer to Chapter 7 Advanced User Functions. Install Software – used by your local Nova Service representative to update analyzer software when a new release is made available.
  • Page 26 rimary lucose NstructioNs for aNual 2.3.5 onfIguratIon The Configuration screen provides a way to customize the analyzer for the location where it will be used. General – select the General button to enter an analyzer ID and location and select from several options to customize the analyzer as desired.
  • Page 27 ettinG tarted 2.3.8 esults Istory The Results History screen displays all samples for the current date. The date range can be modified to show additional samples. Selected samples can be printed or exported to a USB device. 2.3.9 Press Shut Down to shut down the analyzer. An "Are You Sure?" popup will be displayed, select Yes to shut down the analyzer.
  • Page 28 rimary lucose NstructioNs for aNual 2-12...

  • Page 29: S Ample A Nalysis

    ample nalySiS aMPle nalysIs The Nova Primary Glucose Analyzer System was designed for in vitro diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination of Glucose in lithium heparinized venous whole blood and plasma samples. 3.1 a nalyzIng a hole...
  • Page 30 rimary lucose NstructioNs for aNual 8. The analyzer displays the sample results on the screen. If enabled, the on-board thermal printer prints the results. If not enabled, press the Print button to print the results, if desired. 9. Results within the expected normal range are displayed with a green checkmark Results below the expected range are displayed with a red down-arrow , results above the expected range are displayed with a red up-arrow...
  • Page 31 ample nalySiS 3.2 a qc s nalyzIng a aMPle To analyze a Quality Control sample: 1. Verify that the analyzer is READY for a QC sample analysis. 2. If necessary, press the Destinations button then, select QC to display the QC screen. 3.
  • Page 32 rimary lucose NstructioNs for aNual 3.3 r ecallIng aMPle esults Previously analyzed sample results are retained indefinitely in the analyzers database. These samples can be recalled for review, printed, and exported to a USB device as a .csv file for use in an offline spreadsheet. Samples can also be rerun by first selecting a sample, then pressing the Rerun button.
  • Page 33 ample nalySiS 5. To export samples to a USB drive, a. Insert a USB drive in the USB connector on the back of the analyzer. b. Select the sample data to export. Use the Set Dates button to recall data from a specific time frame then select the data to export.
  • Page 34 rimary lucose NstructioNs for aNual 4. To expand the date range of the displayed samples, press the Set Dates button and enter the starting and ending date range for samples to be displayed. Press the green checkmark to display the results or press the red to cancel.
  • Page 35 aintenance aIntenance The following section provides detailed information and directions for maintaining the Nova Primary Analyzer. To access the maintenance functions from the Destinations overlay, press the Maintenance button to display the available system maintenance functions. From the Maintenance Menu, the operator can change the Glucose membrane cap and sensor, Calibrator Pack, Sample Probe, Syringe Assembly, and Pump Tubing.
  • Page 36 rimary lucose NstructioNs for aNual 4. Unlock the Glucose sensor from the chamber. 5. Remove the sensor from the chamber. 6. Remove the old membrane cap and discard it. 7. Wipe the tip of the glucose sensor with a lintless tissue dampened with deionized water to remove any residue from the old membrane cap, then dry the sensor with a lintless tissue.
  • Page 37 aintenance 4.3 c hange robe WARNING: Exposure to Blood Borne Pathogens. Follow established Good Laboratory Practices (GLP). Gloves and protective clothing are recommended. To change the Sample Probe 1. From the Destinations overlay, select Maintenance then select Change Sample Probe. 2.
  • Page 38 rimary lucose NstructioNs for aNual The syringe will retract. 4. After the syringe fully retracts, loosen the plunger thumbscrew. 5. Push the plunger up into the syringe. 6. Unscrew the syringe by turning the barrel counterclockwise. 7. Press Install Syringe 8.
  • Page 39 aintenance 4.5 c hange ubIng WARNING: Exposure to Blood Borne Pathogens. Follow established Good Laboratory Practices (GLP). Gloves and protective clothing are recommended. To change the Pump Tubing 1. From the Destinations overlay, select Maintenance then select Change Pump Tubing. 2.
  • Page 40 rimary lucose NstructioNs for aNual...
  • Page 41 onfiguration and etup onfIguratIon and etuP The Nova Primary configuration and setup options are used to customize the analyzer’s User Interface to meet each location’s operating requirements. This section explains the available options and their function. 5.1 g eneral General configuration settings include the following options: •...
  • Page 42 rimary lucose NstructioNs for aNual 5.2 P araMeter Parameter settings include the following options: • Lower Limit – enter the lower limit of expected values. Results that fall below this limit are flagged with a red down arrow. • Upper Limit – enter the upper limit of expected values.
  • Page 43 onfiguration and etup 2. Enter an Operator Name in the box provided. User Names must be 3-25 alphanumeric characters and are not case-sensitive. User names can include dashes (-) and underscores (_) but no spaces or special characters (!,@,#,$,%,^,&,*,/,<). 3. Enter a Password for the User Account. Passwords must be 8-25 alphanumeric characters and are case-sensitive.
  • Page 44 rimary lucose NstructioNs for aNual 5. Select the Privilege Level for the User Account (Basic, Intermediate, or Administrator). Refer to the chart below for detailed user functionality. Configuration Basic Interm. Admin Basic Interm. Admin Analysis Menu Run Sample Modify General Analysis Settings Create/Edit Users...
  • Page 45 onfiguration and etup 6. Set the number of days after which the password will expire. For example, if this number is set to 30 days, the password will expire every 30 days. The end user will be required to create a new password every 30 days upon logging in to the system. The same password cannot be used twice.
  • Page 46 rimary lucose NstructioNs for aNual 4. When adding a List field, a popup window is displayed to add a field Name of up to 20 alphanumeric characters including space, dash -, and underscore _. If Required is selected, a sample analysis cannot begin until the field has a valid entry. If the name contains illegal characters or is too long, a red exclamation icon is displayed.
  • Page 47 roubleshooTing roubleshootIng The Nova Primary continuously monitors the status of all electromechanical components, consumables, and software processes to ensure the analyzer is operating correctly. In the event an error condition is identified, the analyzer will display a system event icon in the Header Bar to notify the user of the problem.
  • Page 48 rimary lucose NstructioNs for aNual 6.2 e vent All system events that have occurred are recorded in the analyzer’s Event Log. To access the event log: 1. Press the Destinations button then select the Logs button. 2. Press the Event button to display the Events screen. 3.
  • Page 49 If the recommendations given here do not resolve the problem, contact Nova Technical Services for troubleshooting assistance. FOR TECHNICAL ASSISTANCE CALL: USA: 1-800-545-NOVA CANADA: 1-800-263-5999 OTHER COUNTRIES: Contact the local Nova Biomedical Sales Office or authorized Nova Biomedical Distributor. 6.3.1 vent odes Slope Error The sensor slope is calculated during each calibration sequence.

  • Page 50: Analysis

    Drift error is displayed, and the sequence is terminated. Recommended Solutions: 1. Recalibrate the analyzer. 2. If the Temperature Drift error reoccurs, contact Nova Biomedical Technical Support. Waste Well Not Available The Dilution Well is monitored by the system to determine a ready/not ready status. If the well is not ready, a Waste Well Not Available error is displayed, and the sequence is terminated.

  • Page 51: Analysis

    3. Confirm the sample probe air detector is connected to the analyzer. 4. Replace the sample probe. 5. Contact Nova Biomedical Technical Support. System Probe Not Available At the start of an analysis sequence, the state of the system (Sample) probe air detector is verified.
  • Page 52 2. Verify the sample probe air detector is connected to the analyzer. 3. Replace the sample probe assembly. 4. Contact Nova Biomedical Technical Support. Probe Error If the Hct sensor calibration fails, a Probe Error is displayed, and the analysis terminates.

  • Page 53: A Dvanced U Ser F Unctions

    dvAnced Unctions dvanced unctIons Advanced user functions are available in the Service menu for use as needed. These include software updates, advanced troubleshooting resources and an extended shutdown procedure if the analyzer will be unused for an extended period of time. 7.1 I nstallIng oftWare...
  • Page 54 rimary lucose NstructioNs for aNual 7.3 s ysteM ackflush System Backflush positions the sample probe to allow easy access to the dilution well. The backflush tool (syringe with tubing and threaded adapter) can be connected to the dilution well waste outlet port to backflush the dilution well assembly in the event it becomes blocked.
  • Page 55 dvAnced Unctions 7.4 c lear Data can be cleared from the analyzer’s database if desired. Please note that the Clear Data function DOES NOT save a copy of the data before permanently deleting it from the analyzer. Export any Patient data, QC data, and logs you wish to save before clearing the data. The analyzer will shut down and restart to complete the archiving process.

  • Page 56: Results

    rimary lucose NstructioNs for aNual 7.6 a udItable ctIons The following are the actions recorded in the Primary's Audit Log: General Activity System Started System Calibrations System Prime Sequences Flush Well Sequences Sample Analysis Sequence QC Sample Analysis Sequence Export System Configuration Import System Configuration Operator Logging In Operator Logging Out...

  • Page 57: Flowpath Service

    dvAnced Unctions Service Actions Enter Service Screen Install New Software Perform Flowpath Service Perform System Backflush Perform Long Term Shutdown Clear Print Queue Exit Service Screen 7.7 r esource ssues Resource Issues may provide additional information to Technical Support and Service representatives on the status of the analyzer’s electronic and electromechanical components.
  • Page 58 rimary lucose NstructioNs for aNual...
  • Page 59 Healthcare facilities should follow federal, state, and local guidelines for testing quality control materials. At a minimum, Nova Biomedical recommends that each laboratory performs the following minimum QC procedures (External Ampule QC) on each analyzer: During every 24 hours of testing, analyze one normal and one abnormal level of control.
  • Page 60 rimary lucose NstructioNs for aNual a.3 a nalytIcal PecIfIcIty Interference testing was performed according to the Interference Testing in Clinical Chemistry; Approved Guideline - Third Edition: CLSI EP07-A3. Testing was done using lithium heparinized venous whole blood and plasma collected from consenting donors. No significant interference (<10%) was observed up to the following concentration levels: Table A-1 Interfering Substances Causing No Clinically Significant Effect on Test Results...
  • Page 61 ppendix Table A-2 Interfering Substances Causing No Clinically Significant Effect on Test Results (Plasma) Acetaminophen 20 mg/dL Hydroxyurea 0.8 mg/dL Acetoacetate 2 mmol/L Ibuprofen 2.4 mmol/L Acetylsalicylic Acid 3.62 mmol/L Intralipid 1.0% solution 107 μmol/L Ammonium Chloride Lactate 6.6 mmol/L Ascorbic Acid 50 mg/dL Maltose...

  • Page 62: Analytical Performance Studies

    Nova Biomedical conducted a method comparison study in a clinical laboratory setting comparing three Nova Primary Glucose Analyzers to two YSI 2300 Analyzers. The protocol was based upon methods described in Method Comparison and Bias Estimation Using Patient Samples;...
  • Page 63 ppendix Glucose Blood Bias Plot Nova Primary Differences vs Average YSI Results Medical Decision Levels -100 YSI Average Results (mg/dL) Fig 4 Glucose Plasma Bias Plot Nova Primary Differences vs Average YSI Results Medical Decision Levels -100 YSI Average Results (mg/dL) Fig 8...

  • Page 64: Precision

    rimary lucose NstructioNs for aNual a.4.2 recIsIon a.4.2.1 W IthIn recIsIon erforMance Within-run precision was assessed for aqueous (QC/Linearity), whole blood, and plasma specimens by measuring 20 replicates of targeted sample concentrations on three analyzers. The average, SD, and CV% for each analyzer for each sample type and level were calculated. The pooled average, SD, and CV% from all 3 analyzers for each QC level were calculated.
  • Page 65 ppendix Nova Primary Whole Blood Within Run Precision Whole Blood Level 1 n = 20 Analyzer GP01 Analyzer GP02 Analyzer GP03 Pooled Mean (mg/dL) Whole Blood Level 2 n = 20 Analyzer GP01 Analyzer GP02 Analyzer GP03 Pooled Mean (mg/dL) Whole Blood Level 3 n = 20 Analyzer GP01...
  • Page 66 rimary lucose NstructioNs for aNual Nova Primary Plasma Within Run Precision Plasma Level 1 n = 20 Analyzer GP01 Analyzer GP02 Analyzer GP03 Pooled Mean (mg/dL) Plasma Level 2 n = 20 Analyzer GP01 Analyzer GP02 Analyzer GP03 Pooled Mean (mg/dL) Plasma Level 3 n = 20 Analyzer GP01...

  • Page 67: Whole Blood Run-To-Run Precision Performance

    ppendix a.4.2.2 W hole lood recIsIon erforMance To simulate total run-to-run precision for whole blood, samples of targeted concentrations were run in triplicate in ten separate runs during a single day. Each analyzer was calibrated between triplicate runs. The average SD and CV% for each analyzer for each level were calculated.

  • Page 68: Quality Control And Plasma Run-To-Run Precision Performance

    rimary lucose NstructioNs for aNual a.4.2.3 q ualIty ontrol and lasMa recIsIon erforMance Estimates of the run-to-run precision were determined for each level of Quality Control and plasma. Statistical analysis included individual and pooled analyzer imprecision from 3 analyzers. The plasma samples were altered to decrease or increase the glucose levels. Nova Primary Quality Control Run-to-Run Precision Quality Control Level 1...
  • Page 69 ppendix Nova Primary Plasma Run-to-Run Precision Plasma Level 1 n = 80 Analyzer GP01 Analyzer GP02 Analyzer GP03 Pooled Mean (mg/dL) Plasma Level 2 n = 80 Analyzer GP01 Analyzer GP02 Analyzer GP03 Pooled Mean (mg/dL) Plasma Level 3 n = 80 Analyzer GP01 Analyzer GP02 Analyzer GP03 Pooled Mean (mg/dL)

  • Page 70: Calibrator Pack

    Pdates Healthcare facilities will be notified by Nova Biomedical Technical Support or a local dealer when a software update becomes available. Customer communication is through a Customer Information Bulletin that is forwarded to primary contacts within each healthcare facility.

  • Page 71: Operating System Patches

    Microsoft . This requires a time-limited password that changes daily and is available only after contacting Nova Biomedical Technical Support or your local distributor. Outgoing ports from the firewall become temporarily enabled for the duration of the download. The SH-2 signature from Microsoft protects the download image.

  • Page 72: Malware Control

    Nova Primary software is built on a virtual computer-controlled and physically accessed only by Nova Biomedical Information Technology resources. The virtual computer is scanned for viruses daily. The introduction of malware is not possible through physical access. The virtual computer is exclusively utilized to create Nova Primary software.

  • Page 73: Data Import

    ppendix a.8.9.1 d MPort Data import operations on USB Storage devices are limited to software and security updates as detailed above. "Autorun" is disabled at the operating system level. Transferring malware or a virus from the storage device would require operating system access. This is protected by a time-limited password that changes daily and is available only after contacting Nova Biomedical Technical Support or your local distributor.

  • Page 74: Ordering Information

    rimary lucose NstructioNs for aNual a.10 o rderIng nforMatIon Description ....................Reference Number Calibrator Cartridges Nova Primary Calibrator Cartridge 450 Sample ..............63162 Nova Primary Calibrator Cartridge 150 Sample ..............63167 Sensors and Membranes Nova Primary Glucose Sensor ..................63231 Nova Primary Glucose Membrane ..................63230 QC and Linearity Nova Primary Ampuled Control ..................63164 Nova Primary Linearity Level 1 ..................63165...

  • Page 75: Theory

    heory heory This section explains the instrument theory of the Nova Primary Glucose Analyzer. b.1 t oInt alIbratIon The analyzer uses a 2-point calibration to set the glucose sensor slope and verify sensor performance. The Calibrator Pack contains the standards that are used for this purpose. Calibration can be initiated manually by pressing CALIBRATE from the Destinations overlay and will also occur automatically at regular intervals.

  • Page 76: Warranty

    Subject to the exclusions and upon the conditions specified below, Nova Biomedical or the authorized Nova Biomedical distributor warrants that he will correct free of all charges including labor, either by repair, or at his election, by replacement, any part of an instrument which fails within one (1) year after delivery to the customer because of defective material or workmanship.

Table of Contents