Hitachi OPTIGEN AP3600 User manual

OPTIGEN®AP3600™
AUTOMATED INSTRUMENT USER MANUAL

OPTIGEN®AP3600™ Automated Instrument UserManual
Rx Only

Confidentiality Notice
The materials and information contained herein are being provided by Hitachi Chemical Diagnostics to its customer solely for
customer use for its internal business purposes.
Copyright
Hitachi Chemical Diagnostics retains all rights, title, interest in and copyrights to the materials and information herein.
The materials and information contained herein constitute confidential information of Hitachi Chemical Diagnostics and customer
shall not disclose or transfer any of these materials or information to any thirdparty.
OPTIGEN® is a registered trademark and AP3600™ is a trademark of Hitachi Chemical Diagnostics, Inc.
Manufactured under one ormore ofthe following United States Patent Nos.: 3,941,876 4,031,197, 4,459,360 (and corresponding
patents issued in Canada,Australia,Japan,Spain,France,Germany,Italy,Sweden, andGreatBritain), 4,510,393, 4,558,013,5,567,
149 (and corresponding patents issued in Canada, Australia, Japan, Spain, France, Germany, Italy, Sweden, Switzerland, Austria,
Belgium, the Netherlands, Luxembourg, and Great Britain), 4,568,184, 285,485, 4,743,541 (and corresponding patents issued in
Canada, Australia, Japan, France, Germany, Sweden, Switzerland, and Great Britain), and 5,082,768 (and corresponding patent
issued in Japan).
Copyright © 2016
Hitachi Chemical Diagnostics, Inc.
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

OPTIGEN® AP3600™ AUTOMATED INSTRUMENT USER MANUAL
Table of Contents
Confidentiality Notice -ii
Copyright -ii
Table of Contents -iii
List of Figures -v
Safety 1-1
Moving Parts 1-1
Biological Hazards 1-2
Toxic Substances 1-3
Heavy Objects 1-4
Equipment Operation Safety 1-5
Introduction and System Description 2-2
OPTIGEN® Assay and AP3600 System 2-1
Features 2-1
AP3600 Instrument (Exterior) 2-2
AP3600 Instrument (Interior) 2-5
AP3600 Consumables 2-6
Symbols Used on the Equipment 2-8
Sample Preparation 3-1
Principle of the Procedure 3-1
Proper Storage of Samples and Supplies 3-1
Specimen Collection and Preparation 3-2
General Preparation 3-2
Prepare the AP3600 System for the Assay 4-1
Starting the AP3600 System 4-1
Screen Display Buttons 4-3
Manage Account and Password 4-4
Set Up & Run Wizard 5-1
Prepare AP3600 Instrument 5-1
Set Up Sample Racks Wizard Screens 5-3
Assigning Test Panels 5-5
Running Tests Screen 5-9
Completion Screen 5-10
Post-Run Steps 5-10
Work List Screen 6-1
Results Screen 7-1
Results Screen 7-1
Details Screen 7-2
iii
Table of Contents

OPTIGEN® AP3600™ AUTOMATED INSTRUMENT USER MANUAL
Utilities Screen 8-1
About Screen 8-2
Manually Start Self Check 8-2
Log File Utility Screen 8-3
Maintenance Utility Screen 8-4
Printer 8-5
LCD Backlight 8-5
Volume 8-5
Utilities (Admin) 8-6
Software Update Utility (Admin) 8-6
Panels Update Utility (Admin) 8-6
Backup –Restore Utility (Admin) 8-7
Manage User Accounts (Admin) 8-7
Remove All Results (Admin) 8-7
System Settings Screen 9-1
Language 9-1
Date & Time 9-1
Edit Laboratory Details 9-2
Change Password 9-3
Network Details 9-3
LIS Settings 9-4
Panel Favorite 9-5
Export Results Automatically 9-5
Print Results Automatically 9-6
Set Up Printer 9-6
End of Run 10-1
Rinse and Drain 10-1
Cleanup and Waste Disposal 10-3
Cleaning the Wash Buffer Bottle 10-3
Cleaning the Waste Bottles 10-3
Cleaning the Transfer Tip Waste Container 10-3
Troubleshooting 11-1
Regulatory Compliance A-1
Specifications and Ordering Information B-1
Physical Specifications B-1
Environmental Requirements B-1
Power Requirements B-1
Processing Specifications B-1
Ordering Information B-1
Moving and Installing the System C-1
Installing a New System C-1
Moving an Installed System C-5
Maintenance D-1
Cleaning and Decontamination D-1
Replacing Fuses D-2 iv
Table of Contents

OPTIGEN® AP3600™ AUTOMATED INSTRUMENT USER MANUAL
Glossary E-1
v
Table of Contents

OPTIGEN® AP3600™ AUTOMATED INSTRUMENT USER MANUAL
List of Figures
FIGURE 1-1.
Dark Box Lid
1-1
FIGURE 1-2.
Loading Area Door and Cover
1-2
FIGURE 1-3.
AP3600 Single-Use Consumables
1-3
FIGURE 1-4.
AP3600 System Base Plate
1-4
FIGURE 2-1.
AP3600 System
2-1
FIGURE 2-2.
AP3600 Front
2-2
FIGURE 2-3.
Rear Connections
2-3
FIGURE 2-4.
Transfer Tip Disposal Unit
2-3
FIGURE 2-5.
Reagent Rack and Wash Solution Supply
2-4
FIGURE 2-6.
Reagent Rack
2-4
FIGURE 2-7.
Waste, DI Water, and Wash Buffer Bottles
2-4
FIGURE 2-8.
Sera Handling Area Components
2-5
FIGURE 2-9.
Dark Box Components
2-6
FIGURE 2-10.
AP3600 Consumables
2-7
FIGURE 3-1.
Sample Vial Barcode Location
3-2
FIGURE 3-2.
Pette in Pette Carousel
3-3
FIGURE 4-1.
DMS Loading Screen
4-1
FIGURE 4-2.
DMS Login Screen
4-2
FIGURE 4-3.
DMS Login Password Screen
4-2
FIGURE 4-4.
Home Screen
4-3
FIGURE 4-5.
AP3600 Main Power Switch
4-3
FIGURE 5-1.
AP3600 Transfer Tip Rack, Sample Vial Racks, and Sample Cup Carousel
5-1
FIGURE 5-2.
Input Bottles on AP3600
5-2
FIGURE 5-3.
Load Pettes in Carousel
5-2
FIGURE 5-4.
Set Up Sample Racks Screen
5-3
FIGURE 5-5.
Sample Vial Rack Window
5-3
FIGURE 5-6.
Loaded Sample Vial Rack
5-4
FIGURE 5-7.
Read Sample Vial Barcodes
5-4
FIGURE 5-8.
Samples with no Assigned Panels
5-5
FIGURE 5-9.
Assigning a Panel to the Sample
5-5
FIGURE 5-10.
Sample with Multiple Assigned Panels
5-6
FIGURE 5-11.
Samples with Assigned Panels
5-7
FIGURE 5-12.
Pre-run Checklist
5-7
FIGURE 5-13.
Pre-run Checklist Run Settings
5-8
FIGURE 5-14.
Running Tests Screen
5-9
FIGURE 5-15.
Completion Screen
5-10
FIGURE 6-1.
Work List Status Screen
6-1
FIGURE 7-1.
Results Screen
7-1
FIGURE 7-2.
Details Screen
7-2
FIGURE 8-1.
Utilities Screen: Available Utilities for User 1 through User 10
8-1
FIGURE 8-2.
About Screen
8-2
FIGURE 8-3.
Manually Start Self Check
8-2
FIGURE 8-4.
Log File Utility Screen
8-3
FIGURE 8-5.
Maintenance Utility Screen
8-4
vi
List of Figures

FIGURE 8-6.
Printer
8-5
FIGURE 8-7.
Utility Screen Admin Level
8-6
FIGURE 8-8.
Panels Update Utility
8-6
FIGURE 8-9.
Backup –Restore Utility
8-7
FIGURE 9-1.
System Settings Screen
9-1
FIGURE 9-2.
Date and Time
9-2
FIGURE 9-3.
Laboratory Details
9-2
FIGURE 9-4.
Change Password Screen
9-3
FIGURE 9-5.
Network Details Screen
9-3
FIGURE 9-6.
LIS Settings Screen
9-4
FIGURE 9-7.
Panel Favorites Screen
9-5
FIGURE 9-8.
System Setting Screen
9-5
FIGURE 10-1.
DI Water Bottles
10-1
FIGURE 10-2.
Maintenance Utility Screen
10-2
FIGURE 10-3.
Finished Rinsing Process Window
10-2
FIGURE 10-4.
Finished Draining Process Window
10-2
FIGURE 10-5.
Shutdown Window
10-3
FIGURE 10-6.
AP3600 Main Power Switch
10-3
FIGURE C-1.
Instrument Clearances (all dimensions in mm)
C-1
FIGURE C-2.
Height Clearance for AP3600 Instrument
C-2
FIGURE C-3.
Removing Packing Materials from Black Box
C-2
FIGURE C-4.
Removing Fixing Plates
C-3
FIGURE C-5.
Install Bottle Connector and Install Bottles Under Instrument
C-3
FIGURE C-6.
Securing the Nozzle Heads
C-5
FIGURE C-7.
Place Tape to Secure Items
C-6
FIGURE C-8.
Place Tape and Bubble Wrap to Secure Items
C-6
FIGURE D-1.
Maintenance Utility Screen
D-1
FIGURE D-2.
AP3600 Main Power Switch
D-2
FIGURE D-3.
AP3600 Fuse Box
D-2
FIGURE D-4.
Fuse Holder Assembly
D-3
vii
List of Figures

1-1
Safety
Safety
No user-serviceable parts are inside the AP3600 system. For servicing issues, call Hitachi Chemical Diagnostics at 1-800-233-6278
or contact your local distributor.
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.
Moving Parts
Exercise caution when working inside the instrument. Ensure fingers, clothing, etc. do not get caught between moving parts.
The dark box lid (on the right side of the AP3600) is locked during operation. If the dark box lid is to remain open for work inside the
instrument, depress the button on the left side hinge and slide it up to secure the dark box lid.
FIGURE 1-1. Dark Box Lid
The loading area door and cover (on the left side of the AP3600) is locked until after sample aspiration.

1-2
Safety
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.

1-3
Safety
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. Sodium azide can react with lead or copper to form dangerously explosive metal azides in laboratory equipment and drain
traps. Use the following handling, storage, and disposal precautions when working with the Wash Buffer concentrate.
Handling
• Always use proper personal protective equipment, such as gloves and eye protection.
• Avoid sodium azide contact with lead or copper where there is potential for sodium azide to become metal azides.
• Avoid touching orreplacing corroded materials if thecorrosionmay bedueto sodium azide; contact the manufacturer for guidance on
how to clean or replace corrodedparts.
Storage
• Do not store tubing or other materials that may have been in contact with solutions containing sodium azide.
• Collect sodium azide waste into a plastic reservoir and label the container with the proper name.
• Clearly label all medical devices, collection containers and waste disposal fixtures that use products containing sodium azide.
Pette with Pette Tip installed
Sample Cup
Transfer Tips

1-4
Safety
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.
• If you dispose of waste using the sewer system, flush sodium azide solutions with at least 100-fold excess of water to prevent metal
azide buildup in plumbingsystems.
Heavy Objects
TheAP3600 instrument weighs approximately 170 kg (375 lbs.). If a cart is not available to move the instrument and it must be manually
moved, have four persons (minimum) lift the instrument by the base plate of the instrument (avoiding the areas outlined in red in
Figure 1-4 below). Make sure that the loading weight for each person does not exceed 55 kg (121.3 lbs).
Note: If the instrument will bemoved regularly, the loading weight perperson shouldbe 40% of each person’s weight (e.g. 60 lbs. for
a 150 lbs. person).
FIGURE 1-4. AP3600 System Base Plate
Do NOT hold AP3600 instrument in these areas

1-5
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 securelyconnected.
3. Confirm no foreign objects are located inside the instrument that will obstruct operation/movement of any parts.
4. Perform a visual inspection of all visible tubing, and confirm all tubing is securely connected.
5. Confirm the Pette carousel is installed correctly.
6. Confirm the transfer tip waste container is emptied after each run.
7. Confirm all reagent bottle caps and waste container lids are correctly placed and secured.
8. Confirm all instrument doors open and closesmoothly.

1-6
Safety
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2-1
Introduction and System
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). Each Pette contains up to 36 different allergens which are tested simultaneously. Various geographically and categorically-
specific Pettes are available. The entire procedure takes less than six hours to run 50 Pette test chambers. The results can then be
reported to the physician for consideration and treatment options.
FIGURE 2-1. AP3600 System
Features
Fully Automated
• Easy to use
• Results can be printed or downloaded directly from the AP3600 instrument
• Internal Controller to self-check instrumentperformance
• Bi-directional communication with LIS capable of supporting HL7
• Sample and result tracking handled by the AP3600 Data Management System (DMS)
Low Maintenance
• Tubing, o-rings, and syringes changed once a year, if necessary
• Disposable transfer tips, sample cups, Pettes, and Pettetips

2-2
Introduction and System
In Vitro Testing
• Minimum of 700 µl patient sera per Petterequired (Note: The sample volume is based on a Ø13 x 100 mm tube)
• Performance comparable to other in vitrotesting
Increased Throughput
• Pettes test up to 36 allergens/allergenmixes
• Up to 50 Pettes perrun.
The AP3600 system is comprised of the following components:
• AP3600 Instrument: The main instrument into which patient sera and Pette test panels are placed. See “AP3600 Instrument
(Exte- rior)” on page 2-2 and “AP3600 Instrument (Interior)” on page 2-5.
• AP3600 Consumables: The OPTIGEN assay consumables required to perform the diagnostic tests. See “AP3600
Consumables” on page 2-6.
AP3600 Instrument (Exterior)
The components on the front of the AP3600 instrument include:
Monitor: The touch screen monitor is the user interface to the AP3600 instrument. There are six USB ports located under the
moni- tor for use with USB devices (for exporting results, performing a system update, connecting a barcode scanner or a printer).
The monitor also has an LIS connection via the Ethernet port.
Note: The AP3600 instrument has several USB ports available so additional accessories (barcode scanner, printer, or USB
device) can be used with the Data Management System (DMS).
Power button: Turns power on/off to the AP3600 Instrument.
USB port: Refer to Monitor section above.
FIGURE 2-2. AP3600 Front
The components at the back of the AP3600 instrument include:
AC IN connector: This grounded 3-prong connector is for input power to the AP3600 instrument. The input power cord should
be plugged into a 3-prong grounded power outlet.
B-type USB port: This port is provided for service personnel.
Bottle unit connection: This connection is used to connect theAP3600 instrument to the load cell for the Wash Buffer and
DI water. It also connects theAP3600 instrument to the Waste container.

2-3
Introduction and System
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.
FIGURE 2-4. Transfer Tip Disposal Unit
The components at the right side of the AP3600 instrument include:
Reagent rack: This rack provides storage for reagents used with the OPTIGEN assay (Antibody, Photoreagent I, and Photoreagent
II). See Figure 2-6. Weight sensors (load cells) are located under each reagent bottle to verify there is sufficient reagent (via
weight/volume) prior to operation.
Wash Buffer and DI Water supply: This tubing is the supply for the Wash Buffer and DI water used during operation. The Wash
Buffer and DI Water bottles levels are monitored via weight sensors (load cells). See Figure 2-7.
Transfer Tip Disposal

2-4
Introduction and System
Reagent
Rack
Compartment
FIGURE 2-5. Reagent Rack Compartment and Wash Solution Supply
FIGURE 2-6. Reagent Rack
FIGURE 2-7. Waste, DI Water, and Wash Buffer Bottles
Wash Buffer and DI
Water Supply
Connections
Antibody Bottle
Photoreagent I Bottle
Photoreagent II Bottle
Wash Buffer Bottle
DI Water Bottle
Waste Bottle

2-5
Introduction and System
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 orstorage.
Sera Handling Area
The left side of the instrument contains the following components for handling the patient sera:
Distribution Nozzle Head: The distribution nozzle head uses a single-use disposable transfer tip from the transfer tip rack to transfer
patient serum from the sample vial to a sample cup.
Transfer Tip Rack: This rack holds single-use disposable transfer tips used by the dispensing nozzle head to transfer sera. The
transfer tip rack must be fully populated with 54 tips before the assay is started.
Sample Vial Racks: These racks (up to five racks with a maximum of ten vials each) hold patient samples while they are being
scanned and the patient sera is transferred into the sample cups for the assay. Load racks one at a time. After the sample barcodes
are scanned, the instrument advances the loaded rack one position to the right so the next rack can be loaded. The sera handling
area door is locked during this operation and not unlocked until sample aspiration is complete.
Sample Cup Carousel: The sample cup carousel holds 50 disposable sample cups. These cups are filled with sera by a fully
automated process. Always start loading of the carousel from Position #1. It is not necessary to fill all 50 slots with samplecups.
Note: Do not skip slots when filling the sample cup carousel.
FIGURE 2-8. Sera Handling Area Components
Dark Box
The right side of the instrument contains the following components for performing the assay:
PMT Unit: The photo multiplier tube unit measures the chemiluminescence light emitted from the wells of the Pettes following the
photoreagent aspiration and incubation.
CCD Camera: The camera at this location checks that the top well of the Pette is aspirated with patient serum and reagents.
Distribution Nozzle Head
Transfer Tip Rack (54 tips)
Sample Vial Racks
(up to 5 racks with 10 vials each)
Sample Cup Carousel
(up to 50 cups)

2-6
Introduction and System
PMT Unit
Sample
Aspiration
Nozzle
Nozzle Heads: These three heads (sample, reagent, and wash; see Figure 2-9) drive the Pettes down to open the Pette tip for
wash or aspiration of patient sera or reagent.
Pette Carousel: The Pette carousel contains up to 50 Pettes used for testing patient sera. Always load the carousel starting from
Position #1. It is not necessary to fill all 50 slots with Pettes.
Note: Do not skip slots when filling the Pette carousel.
FIGURE 2-9. Dark Box Components
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. Sample cups are placed into the
sample cup carousel.
Transfer Tips: These tips are used when transferring sera from the sample vials directly into the sample cups by the AP3600
automated process.
Pettes: These plastic test chambers hold up to 36 wells with various allergens or allergen mixes. Pettes are placed into the Pette
carousel inside the dark box. Geographically and categorically specific Pettes are available from Hitachi Chemical Diagnostics.
Pette Tips: These tips are placed onto Pettes before use. They open during aspiration of sample/reagents and washing.
Reagent Bottles: These bottles are used for holding Antibody, and Photoreagent for the OPTIGEN assay.
The bottles should be disposed after use.
Wash Buffer Concentrate Bottles: Each Wash Buffer Concentrate bottle is used to make 1 liter of Wash Buffer.
The bottles should be disposed after use.
CCD Camera
Reagent Nozzle
Wash Nozzle
Pette Carousel