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Hitachi OPTIGEN AP3600 User Manual

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AUTOMATED INSTRUMENT USER MANUAL

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Summary of Contents for Hitachi OPTIGEN AP3600

  • Page 1 ™ ® OPTIGEN AP3600 AUTOMATED INSTRUMENT USER MANUAL...
  • Page 2 AP3600™ Automated Instrument User Manual ® OPTIGEN Rx Only...
  • Page 3 630 Clyde Court Mountain View, California 94043 U.S. and Foreign Patents Pending All rights reserved. No part of this book may be reproduced in any form without written permission from Hitachi Chemical Diagnostics, Inc. Doc.No.0953, Rev 07 Date: May 2019...

  • Page 4: Table Of Contents

    OPTIGEN® AP3600™ AUTOMATED INSTRUMENT USER MANUAL Table of Contents Confidentiality Notice Copyright Table of Contents -iii List of Figures Safety Moving Parts Biological Hazards Toxic Substances Heavy Objects Equipment Operation Safety Introduction and System Description ® OPTIGEN Assay and AP3600 System Features AP3600 Instrument (Exterior) AP3600 Instrument (Interior)
  • Page 5 OPTIGEN® AP3600™ AUTOMATED INSTRUMENT USER MANUAL Utilities Screen About Screen Manually Start Self Check Log File Utility Screen Maintenance Utility Screen Printer LCD Backlight Volume Utilities (Admin) Software Update Utility (Admin) Panels Update Utility (Admin) Backup – Restore Utility (Admin) Manage User Accounts (Admin) Remove All Results (Admin) System Settings Screen...
  • Page 6 OPTIGEN® AP3600™ AUTOMATED INSTRUMENT USER MANUAL Glossary Table of Contents...
  • Page 7 OPTIGEN® AP3600™ AUTOMATED INSTRUMENT USER MANUAL List of Figures FIGURE 1-1. Dark Box Lid FIGURE 1-2. Loading Area Door and Cover FIGURE 1-3. AP3600 Single-Use Consumables FIGURE 1-4. AP3600 System Base Plate FIGURE 2-1. AP3600 System FIGURE 2-2. AP3600 Front FIGURE 2-3.

  • Page 8: List Of Figures -V

    FIGURE 8-6. Printer FIGURE 8-7. Utility Screen Admin Level FIGURE 8-8. Panels Update Utility Backup – Restore Utility FIGURE 8-9. FIGURE 9-1. System Settings Screen FIGURE 9-2. Date and Time FIGURE 9-3. Laboratory Details FIGURE 9-4. Change Password Screen FIGURE 9-5. Network Details Screen FIGURE 9-6.

  • Page 9: Safety

    Hitachi Chemical Diagnostics is not responsible for any injury or damage caused by the use of the AP3600 system for purposes other than that for which it is intended or by modifications of the AP3600 system not performed by Hitachi Chemical Diagnostics or an authorized agent.

  • Page 10: Biological Hazards

    FIGURE 1-2. Loading Area Door and Cover Biological Hazards Human sera and items contaminated with human sera should be disposed of according to your country’s requirements. Personal Protec- tive Equipment (PPE) should be used while handling patient sera. Common PPE might include, but is not limited to the following: gloves, gowns, laboratory coats, face shields or masks, eye protection, or other devices The sample cups, Pettes, transfer tips, and Pette tips used in the AP3600 are single-use disposable products.

  • Page 11: Toxic Substances

    Sample Cup Transfer Tips FIGURE 1-3. AP3600 Single-Use Consumables For routine maintenance, as discussed in this manual, use only Hitachi Chemical Diagnostics tubing in the AP3600 system to ensure that there is no leakage. Toxic Substances The Wash Buffer concentrate contains sodium azide as a preservative. This substance is highly toxic by inhalation, ingestion, or skin absorption.

  • Page 12: Heavy Objects

    Disposal • Follow local, State and Federal regulations regarding handling and disposal of hazardous waste, including potentially explosive mate- rials such as accumulated or concentrated sodium azide. • Contain waste in plastic receptacles intended for hazardous material as per Material Safety Data Sheet (MSDS) guidelines. •...

  • Page 13: Equipment Operation Safety

    Equipment Operation Safety The operator should verify the following before operating the AP3600 system to ensure the system remains safe for use: 1. Confirm there is no liquid leakage inside or outside the instrument. 2. Confirm the power cable is securely connected. 3.
  • Page 14 This page intentionally left blank Safety...

  • Page 15: Introduction And System Description

    Introduction and System Description OPTIGEN Assay and AP3600 System ® The AP3600 system is designed for easy and efficient in vitro allergy testing using only a small amount of patient sera to measure a patient’s sensitivity to specific allergens or allergen mixes. It is fully automated and requires only the initial setup performed by the laboratory technician: prepare the patient sera, load the sera into the AP3600 system, and load the required Pette test chambers (Pettes).

  • Page 16: Ap3600 Instrument (Exterior)

    In Vitro Testing • Minimum of 700 µl patient sera per Pette required (Note: The sample volume is based on a Ø13 x 100 mm tube) • Performance comparable to other in vitro testing Increased Throughput • Pettes test up to 36 allergens/allergen mixes •...

  • Page 17: Figure 2-3. Rear Connections

    FIGURE 2-3. Rear Connections The following component is provided on the left side of the AP3600 instrument: Transfer tip disposal: This container collects single-use transfer tips after they have transferred sera from the sample vials to the AP3600 sample cups. Dispose of tips according to facility standard practices for biological waste. Transfer Tip Disposal FIGURE 2-4.

  • Page 18: Figure 2-7. Waste, Di Water, And Wash Buffer Bottles

    Wash Buffer and DI Water Supply Reagent Connections Rack FIGURE 2-5. Reagent Rack Compartment and Wash Solution Supply Compartment Antibody Bottle Photoreagent I Bottle Photoreagent II Bottle FIGURE 2-6. Reagent Rack Wash Buffer Bottle DI Water Bottle Waste Bottle FIGURE 2-7. Waste, DI Water, and Wash Buffer Bottles Introduction and System...

  • Page 19: Ap3600 Instrument (Interior)

    AP3600 Instrument (Interior) The interior AP3600 instrument components can be accessed when the assay is not being performed. The dark box lid (on the right side of the instrument) remains locked after the assay is started. The door in the sera handling area (on the left side of the instrument) is locked while patient sera is being transferred, but unlocks after sample aspiration is complete to allow the operator to remove sera vial racks for future use or storage.

  • Page 20: Ap3600 Consumables

    Note: Do not use consumables after their expiration date. Check expiration dates before use and reorder supplies as needed. See “Ordering Information” on page B-1. Several consumable items from Hitachi Chemical Diagnostics are required for the OPTIGEN assay. These are shown in Figure 2-10 and include: Sample Cups: These plastic cups are used to hold sera that will be aspirated into the Pettes.

  • Page 21: Figure 2-10. Ap3600 Consumables

    Pette with Pette Tip attached Sample Cup Wash Buffer Concentrate Antibody, and Photoreagents Transfer Tips FIGURE 2-10. AP3600 Consumables Introduction and System...

  • Page 22: Symbols Used On The Equipment

    Symbols Used on the Equipment TABLE 2-1. Equipment Symbols Symbol Description Biological hazard Crush and Moving Parts hazard...

  • Page 23: Sample Preparation

    Sample Preparation This chapter provides an overview of the patient sera and OPTIGEN assay preparation required before using the AP3600 system. Principle of the Procedure The AP3600 OPTIGEN assay is an in vitro test for use in the semi-quantitative determination of circulating allergen-specific IgE concentrations in human serum.

  • Page 24: Specimen Collection And Preparation

    Specimen Collection and Preparation Handle all patient samples as recommended for any potentially infectious human sera or blood specimens. Follow universal precautions or other guidelines as established by your institution when handling patient specimens. 1. Collect a venous blood sample into a serum separator vial or red-top vial. The patient need not be fasting, and no special preparations are necessary.

  • Page 25: Figure 3-2. Pette In Pette Carousel

    • Label Width •12 mm; width for the sample tube in the Sample Rack • Quiet Zone •2.5 mm (both right and left side) • Symbol Zone •7 mm x 7 mm 4. During the DMS sample setup, the operator will be instructed to place the rack into the AP3600 instrument. The barcode labels must face the left side of the rack.
  • Page 26 Table 3-1. Reagent Amount Required for Different Numbers of Pette Runs Reagents 10 Pettes 20 Pettes 30 Pettes 40 Pettes 50 Pettes Antibody (ml) Wash Buffer (ml) 1050 1350 1650 1950 Photoreagent I (ml) Photoreagent II (ml) Wash Buffer The Wash Buffer Concentrate is used for preparing the Wash Buffer. When correctly diluted, the Wash Buffer contains 0.01M phosphate buffered saline with 0.1% Tween™...

  • Page 27: Prepare The Ap3600 System For The Assay

    Prepare the AP3600 System for the Assay This chapter describes the steps for powering up the AP3600 system and logging into the DMS software before running OPTIGEN assays on patient sera. Starting the AP3600 System 1. Verify the AP3600 instrument is powered on. 2.

  • Page 28: Figure 4-2. Dms Login Screen

    FIGURE 4-2. DMS Login Screen 4. Enter the password for the selected user and press arrow key. FIGURE 4-3. DMS Login Password Screen 5. The program opens to the Home screen shown in Figure 4-4. Prepare the AP3600 System for the Assay...

  • Page 29: Screen Display Buttons

    FIGURE 4-4. Home Screen 6. Click the Set-Up & Run button to open the test run wizard. This wizard is discussed in Chapter 5, Set Up & Run Wizard. Screen Display Buttons All the DMS screens can be accessed by pressing one of the following screen display buttons in the Home screen. For more information on each screen, refer to the following chapters: •...

  • Page 30: Manage Account And Password

    Manage Account and Password 1. Password Requirements • Minimum 6 characters and maximum 20 characters • At least 1 number • At least 1 upper case letter • At least 1 lower case letter • At least 1 special character including [ ] { } ! @ # $ % ^ & * ( ) _ - = + ; : , . < > / ? \ | •...

  • Page 31: Set Up & Run Wizard

    Set Up & Run Wizard The Set Up & Run wizard is a sequence of software screens and instructions for starting the OPTIGEN assay. Patient sera should be prepared before launching the wizard. For more information on preparing samples before placing them into the AP3600 instrument, refer to Chapter 3, Sample Preparation.

  • Page 32: Figure 5-2. Input Bottles On Ap3600

    Reagent Bottles: Antibody, Photoreagent I, Wash Buffer, Deionized Water, and Waste Bottles and Photoreagent II FIGURE 5-2. Input Bottles on AP3600 6. Attach a Pette tip to each Pette, and load it into the Pette carousel, starting at position #1 and leave no empty spaces between pettes. Load the Pettes into the carousel so that the barcode label faces the inside of the instrument.

  • Page 33: Set Up Sample Racks Wizard Screens

    Set Up Sample Racks Wizard Screens The first wizard screen requests the operator to load the first sample vial rack (of up to ten vials). See Figure 5-4. FIGURE 5-4. Set Up Sample Racks Screen Confirm the sample vials are loaded with sufficient volume and their barcodes face the rack window. FIGURE 5-5.

  • Page 34: Figure 5-6. Loaded Sample Vial Rack

    FIGURE 5-6. Loaded Sample Vial Rack Press the Read Barcode button to have the AP3600 instrument scan the sample vial barcodes for tracking. See Figure 5-7. FIGURE 5-7. Read Sample Vial Barcodes Wait for the AP3600 instrument to finish scanning before continuing. Set Up &...

  • Page 35: Assigning Test Panels

    Assigning Test Panels The next wizard screen displays the assigned Pette. The Pette test panels must be assigned to each sample at this time. FIGURE 5-8. Samples with no Assigned Panels Press the field for the Sample ID(s) missing Panel assignments (displayed in dark/light red cells). The Edit Sample Details screen opens. Select the desired panel(s) that will be used with the patient sera from the Available panels: list at the bottom of the screen (For additional information on Favorite Panels, please refer to section 9-System Settings).

  • Page 36: Figure 5-10. Sample With Multiple Assigned Panels

    Press Submit after all panels have been added to return to the Set Up Sample Racks screen. Press Cancel to discard changes made on the Edit Sample Details screen. Each selected panel can be deleted individually by pressing the X next to the panel name. Note: A single sample can be run with several Pettes, but the AP3600 instrument is not able to measure patient serum volume in the sample vial.

  • Page 37: Figure 5-11. Samples With Assigned Panels

    FIGURE 5-11. Samples with Assigned Panels Pre-Run Checklist When loading is complete, the wizard opens a pre-run checklist (see Figure 5-12). Press the button next to each item on the list to verify the steps have been completed, or press Start Run if run settings have been selected. FIGURE 5-12.

  • Page 38: Figure 5-13. Pre-Run Checklist Run Settings

    Run Settings After each item in the checklist has a green check (see Figure 5-12), the run settings can be verified. Touch the following fields to configure the following: • Drain: This field configures the instrument drain settings following assay completion. •...

  • Page 39: Running Tests Screen

    Running Tests Screen Once testing has started, the Running Test screen appears (see Figure 5-14). A timer appears that counts down to the testing completion time. Note: Do not turn off the power to the AP3600 at any time during analysis. Doing so will cause loss of patient results. If the run needs to be canceled during testing, press the Cancel Run button at any time.

  • Page 40: Completion Screen

    Completion Screen FIGURE 5-15. Completion Screen When the testing is complete, the results can be viewed in the DMS software (see Chapter 7, Results Screen). If desired, click the Export Raw Results button to save the results in a pdf file for copying over the network or onto a USB drive. Post-Run Steps Remove all reagent bottles (Antibody, Photoreagent I, and Photoreagent II) from the AP3600 instrument.

  • Page 41: Work List Screen

    OPTIGEN® AP3600™ AUTOMATED INSTRUMENT USER MANUAL Work List Screen The Work List screen displays the list of scheduled assays. If the AP3600 system uses the Laboratory Information System (LIS), the work list is automatically loaded. In addition, the Work List also displays the status of the test. FIGURE 6-1.
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  • Page 43: Results Screen

    OPTIGEN® AP3600™ AUTOMATED INSTRUMENT USER MANUAL Results Screen The Results screen (see Figure 7-1) shows the list of all results taken from completed tests. Select the checkbox to the left of the desired results to view the Details screen for the selection. Note: Tests that failed to complete are displayed in red cells.

  • Page 44: Details Screen

    OPTIGEN® AP3600™ AUTOMATED INSTRUMENT USER MANUAL • SN: Serial number for the Pette • Panel Name: Panel name for the Pette tested with the sample • PC: Positive Procedural Control; a green checkmark appears if the PC in the Pette passed. The PC confirms reagent perfor- mance and provides a check for correct testing procedure.
  • Page 45 OPTIGEN® AP3600™ AUTOMATED INSTRUMENT USER MANUAL • #: This shows the allergen sequence in the Pette. • Allergen: This lists the common name of the allergens tested in the particular Pette tested with the sample. • Code: CLSI allergen code •...
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  • Page 47: Utilities Screen

    Utilities Screen The Utilities screen provides access to various utilities for setting up the AP3600 system. Note: The following utilities are available to operators logged in with the User 1 through User 10 accounts. Screens available to operators logged in with the Service accounts are not discussed below. FIGURE 8-1.

  • Page 48: About Screen

    About Screen The About screen provides system information that may be useful when troubleshooting issues. All user accounts have access to this screen. FIGURE 8-2. About Screen Manually Start Self Check Ensure all doors are securely closed. Then select the Manually Start Self Check item to run an optical self check of the AP3600 instrument.

  • Page 49: Log File Utility Screen

    Log File Utility Screen Open the Log File Utility screen to view the event log files for on any date. This screen may be useful when troubleshooting issues. Select the desired date from the list on the left side of the screen to view the event data on the right. Each event has a timestamp and the event text.

  • Page 50: Maintenance Utility Screen

    Maintenance Utility Screen The Maintenance Utility screen allows the operator to configure the number and start AP3600 system rinse and drain cycles. Click the Rinse or Drain + and - buttons to increase/decrease the number of cycles that will be run. Note: The system must be flushed after each run is complete.

  • Page 51: Printer

    Printer Use this screen to determine what printer types are supported. FIGURE 8-6. Printer Screen LCD Backlight Use this screen to configure the flat panel display brightness. Volume Use this screen to configure the DMS software alerts volume. Utilities Screen...

  • Page 52: Utilities (Admin)

    Utilities (Admin) The Utilities screen provides access to various utilities for setting up the AP3600 system. Note: The following utilities are available to users logged in at the Admin level only. FIGURE 8-7. Utility Screen Admin level Software Update Utility (Admin) Software updates should only be performed by qualified personnel.

  • Page 53: Backup - Restore Utility (Admin)

    Backup - Restore Utility (Admin) The Backup – Restore Utility screen allows configuration files to be backup to a USB memory device and restored from a USB memory device. Note: Must be logged in at Admin level. FIGURE 8-9. Backup - Restore Utility Manage User Accounts (Admin) The Manage User Accounts screen allows users to have individual names and passwords.
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  • Page 55: System Settings Screen

    System Settings Screen The System Settings screen provides screens for configuring default system settings for the logged in user. Note: The following utilities are available to operators logged in with the User 1 through User 10 and Admin accounts. Screens available to operators logged in with the Service accounts are not discussed below. User Admin FIGURE 9-1.

  • Page 56: Edit Laboratory Details

    FIGURE 9-2. Date and Time Edit Laboratory Details (Admin Only) 1. Select this item to input Laboratory information: Name, Address, Phone Number, Fax Number and email if available. FIGURE 9-3. Laboratory Details System Settings Screen...

  • Page 57: Change Password

    Change Password (Refer to Section 4 for more password options) 1. Select this item to change the log in password for the current user. 2. Enter the current user password. 3. Select the Submit button. 4. Enter the new password. 5.

  • Page 58: Lis Settings

    LIS Settings (Admin Only) 1. Select this item to modify LIS settings of the AP3600 • LIS Connection: • Port Number: Specify port number of destination LIS • Tx State: Indicates current state of the AP3600 LIS connectivity • Instrument Information: •...

  • Page 59: Panel Favorite

    Panel Favorite Using Panel Favorites 1. Option 1: Apply Panel Favorites to all samples at once. • After reading the sample barcode, the AP3600 will ask to “Apply Favorites?”. • Select Submit to apply panel favorites to all samples. 2. Option 2: Select panels for each sample individually. •...

  • Page 60: Print Results Automatically

    Print Results Automatically Check the Print Results Automatically option to have all results automatically printed. Note: If this option is selected, sample details cannot be edited. Refer to “Details Screen Buttons” on page 7-3 Set up Printer (Admin Only) 1. Connect a printer to the instrument. 2.
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  • Page 63: End Of Run

    End of Run Perform the procedures in this chapter following the completion of each assay. CAUTION: Do not clean the PMT unit of the AP3600 Instrument. Rinse and Drain 1. Remove the reagents and Wash Buffer from the AP3600 instrument. Replace all four reagent bottles and the Wash Buffer with bot- tles containing DI water.
  • Page 64 FIGURE 10-2. Maintenance Utility Screen 4. Set the desired number of rinse cycles, and then press the Start Rinse Cycle button to start the cycle. The following number of cycles are recommended, based on when the instrument will be next used: •...

  • Page 65: Cleanup And Waste Disposal

    Cleanup and Waste Disposal 1. Remove and discard all used Pettes from the carousel. 2. Remove and discard all used sample vials and sample cups. 3. Empty the transfer tip waste container. 4. Empty the waste container. 5. If no other tests will be run at this time, the system can be shut down. Return to the Home screen and select Shutdown. In the win- dow that appears, select Shutdown now to power down the monitor.
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  • Page 67: Troubleshooting

    OPTIGEN® AP3600™ AUTOMATED INSTRUMENT USER MANUAL Troubleshooting The following table provides some recommended remedies for problems that may occur during operation. Table 11-1. Troubleshooting Matrix Symptom Cause Remedy The operation panel does not illu- The fuse of the device has blown The fuse needs to be replaced.
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  • Page 69: Regulatory Compliance

    OPTIGEN® AP3600™ AUTOMATED INSTRUMENT USER MANUAL Regulatory Compliance The AP3600 system is certified to meet the I.E.C. 61010-1 standard for safety of laboratory equipment. Certified products are safe to use when operated in accordance with the instruction manual. This safety certification does not extend to other equipment or accesso- ries that may be connected to the AP3600 system.
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  • Page 71: Specifications And Ordering Information

    Processing Time: One run completes in 5.5 hours (excludes automatic waste solution operation) Ordering Information ® To order AP3600 accessories or OPTIGEN Allergy Testing Kits, contact Hitachi Chemical Diagnostics or an authorized representative. Hitachi Chemical Diagnostics, Inc. Tel: +1 650 961 5501 Fax: + 1 650 969 2745 E-mail: sales@hcdiagnostics.com...
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  • Page 73: Moving And Installing The System

    OPTIGEN® AP3600™ AUTOMATED INSTRUMENT USER MANUAL Moving and Installing the System Refer to this procedure if the system is being moved or installed. Before moving the AP3600 system, contact the local Hitachi Chemical Diagnostics service representative for detailed information. WARNING:The AP3600 Instrument weighs approximately 170 kg (375 lbs.). Four persons are required to assist when lifting the system.
  • Page 74 OPTIGEN® AP3600™ AUTOMATED INSTRUMENT USER MANUAL FIGURE C-2. Height Clearance for AP3600 Instrument 2. Remove tape from the exterior of the instrument. Open the dark box and serum handling area covers. 3. Remove tape and cushions from the Sample Distribution Nozzle Head and Reagent and Wash Nozzle Heads. See Figure C-3. Remove cushions from Reagent and Wash Nozzle Heads Remove cushions from Sample Distribution Nozzle Head Remove foam piece from Pette Carousel...
  • Page 75 OPTIGEN® AP3600™ AUTOMATED INSTRUMENT USER MANUAL 4. Remove tape from the inside of the instrument. Remove fixing plates from Nozzle Head by removing bolts. Re-screw bolts into the tapped holes which were used for the fixing plates. Remove bolts to remove fixing plates FIGURE C-4.
  • Page 76 11. Verify the instrument properly initializes and the optical check runs successfully. Note: The AP3600 system is now ready for normal operation. Moving and Installing the System...
  • Page 77 Moving the System Note: Ensure that the packing material used to ship the instrument is available for moving the system components to the new location. A cart is recommended for moving the system. 1. Turn off the AP3600 system using the power switch on the front of the instrument. 2.
  • Page 78 7. Place tape to secure items inside the Sera Handlng Area of the AP3600. Install Fixing Plates. See Figure C-7. Z Axis of Distribution Nozzle and Sample Cup Carousel X and Y Axis Fixing Plates FIGURE C-7. Place Tape to Secure Items 8.

  • Page 79: Maintenance

    Maintenance This chapter provides basic maintenance tasks that can be performed by an operator. Please contact your local Hitachi Chemical Diagnostics service representative for information and assistance in performing any other corrective maintenance procedures on the AP3600 system. Cleaning and Decontamination Perform the following steps to clean and decontaminate the AP3600 system.

  • Page 80: Replacing Fuses

    10. Repeat steps 7 and 8 until the strip test indicates zero (0) ppm. Refill reagent and DI water containers to 50 ml and 4 L respectively to ensure sufficient DI water is available to perform rinses. The reagent containers should be refilled after two rinse cycles. The main container should be refilled after 5 rinse cycles.
  • Page 81 Fuse Fuse Holder Fuse Holder Assembly FIGURE D-4. Fuse Holder Assembly 5. Reinstall the fuse holder and rotate the fuse box clockwise to secure it. 6. Reinstall the AC power cord to the AP3600 instrument. 7. Turn the main power switch of the AP3600 instrument to the ON position (I). Maintenance...
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  • Page 83 IgE in the patient serum. Negative Blanking Control This compensates for non-specific IgE binding that may occur. This is the in vitro chemiluminescent assay used by the AP3600 system. OPTIGEN is a registered trademark of Hitachi Chemical OPTIGEN ® Diagnostics.
  • Page 84 OPTIGEN® AP3600™ AUTOMATED INSTRUMENT USER MANUAL This page intentionally left blank Glossary...
  • Page 85 Hitachi Chemical Diagnostics, Inc. Hitachi Europe Ltd. Whitebrook Park, Lower Cookham Road Maidenhead, Berkshire, SL6 8YA United Kingdom +44 (0) 1628 585 590 Please contact your distributor for customer service and warranty terms. © 2016 Hitachi Chemical Diagnostics, Inc. All rights reserved.

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