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OPTIGEN® AP3600™ AUTOMATED INSTRUMENT USER MANUAL

OPTIGEN® AP3600™ Automated Instrument User Manual

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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 third party.

OPTIGEN® is a registered trademark and AP3600™ is a trademark of Hitachi Chemical Diagnostics, Inc.

Manufactured under one or more of the 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, and Great Britain), 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


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


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


Glossary E-1

v Table of Contents


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 or replacing corroded materials if the corrosion may be due to sodium azide; contact the manufacturer for guidance on

how to clean or replace corroded parts.

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 plumbing systems.

Heavy Objects The AP3600 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 be moved regularly, the loading weight per person should be 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 securely connected.

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 close smoothly.

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 instrument performance

• 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 Pette tips


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

• Up to 50 Pettes per run.

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

monitor 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 the AP3600 instrument to the load cell for the Wash Buffer and DI water. It also connects the AP3600 instrument to the Waste container.


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


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


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.

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 sample cups.

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)


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


Wash Buffer Concentrate

FIGURE 2-10. AP3600 Consumables

Pette with Pette Tip attached Sample Cup

Antibody, and Photoreagents Transfer Tips

Symbols Used on the Equipment

TABLE 2-1. Equipment Symbols

Symbol Description

Biological hazard

Crush and Moving Parts hazard

3-1 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. The assay employs a device known as the Pette test chamber to expose patient sera simultaneously to a

number of allergens or allergen mixes.

The AP3600 system automatically performs the following processes:

1. Sample transfer of patient sera from sample vials to sample cups for the assay.

2. Rehydration of the Pette

3. Sample aspiration

4. Sample incubation. Allergen-specific IgE in the serum binds to the allergen-coated wells during the incubation period.

5. Buffer wash. This wash removes unbound serum components.

6. Antibody aspiration

7. Antibody incubation. Enzyme labeled anti-human IgE antibody binds to allergen-specific IgE bound to the allergen-coated wells.

8. Second Buffer wash

9. Photoreagent aspiration

10. Photoreagent incubation. The photoreagent mixture reacts with the labeled antibody to produce chemiluminescence.

11. Measurement of the amount of light emitted by each well. The amount of light is directly proportional to the amount of allergen-

specific IgE in the patient sera.

Proper Storage of Samples and Supplies The Wash Buffer Concentrate, Antibody, Photoreagents, and Pettes should be stored at 2-8°C. When stored at these temperatures,

the components can be used until the expiration dates printed on the individual component labels.

Sera should be stored at 2-8°C for a period of up to one week. For longer storage, samples should be frozen at -20°C.

Do not freeze kit components.

Note: Repeated freezing and thawing of sera should be avoided. Frozen samples that have been thawed should be thoroughly

mixed prior to centrifugation.

Note: Do not use kit components if signs of deterioration are present. These signs include unusual odor, turbid appearance and

other indications of contamination.


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

2. preparations are necessary. Gently invert the serum collection vial 3-5 times and label the vial with the patient’s name and draw

date. Note: Hemolyzed or lipemic serum may adversely affect the performance of the AP3600 OPTIGEN assay.

3. Allow blood to clot at room temperature in the original stoppered container for up to two hours or until coagulation occurs.

4. Centrifuge clotted blood for 10-20 minutes at 2000-3000 x g or 2500-3600 rpm in the original stoppered container.

5. Transfer serum from centrifuge vial to an appropriately labeled, clean plastic storage vial. Serum may be stored at 2-8°C for up to one

week.

Note: For longer storage, store samples frozen at -20°C. Repeated freezing and thawing of sera should be avoided. Frozen sera

that has been thawed should be thoroughly mixed before centrifugation.

6. After removal from storage and immediately prior to performing the assay, re-centrifuge the serum for 10-20 minutes at

2000-3000 x g.

7. The minimum volume of patient serum needed for a single pette test is 700 uL. Note: The sample volume

requirement is based on a Ø13 x 100 mm tube.

General Preparation

Sample Vial Preparation 1. The following sample vial sizes can be used with the AP3600 Instrument:

• 16 x 100 mm

• 13 x 100 mm

• 13 x 75 mm

2. Affix barcode labels to the sample vials so the labels are visible through the rack as shown in Figure 3-1.

• For a 100 mm tube, attach label 30 mm below the top of the tube.

• For a 75 mm tube, attach label 5 mm below the top of the tube.

FIGURE 3-1. Sample Vial Barcode Location

3. The barcode labels should meet the following specifications:

• 1D Barcode Label

• Label Size •Length: 40 mm •Width: 12 mm

• Quiet Zone •Both right and left side required •At least 10 times the minimum element width

• Symbol Zone Length •Label Width minus the Quiet Zone Width

• 2D Barcode Label


• 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.

Pette Preparation 1. Confirm the Pette(s) have not passed their expiration date. Discard expired consumables and reorder new supplies as needed. Refer

to Appendix B, "Specifications and Ordering Information".

2. Remove Pette(s) from plastic bag. Reseal plastic bag and return unused Pette(s) to the refrigerator for storage.

3. Insert a Pette tip onto the end of each Pette.

Note: The Pettes and Pette tips are disposable items. Do not reuse the Pette tip or Pette after it has been placed into the instrument.

4. Insert the Pettes into the Pette carousel. The barcode label must face the center of the Pette carousel so the barcode can be read by

the instrument. See Figure 3-2.

FIGURE 3-2. Pette in Pette Carousel

Reagent Preparation

WARNING: Do not use consumables after their expiration date.

Color Coding of Reagent Bottle Caps and the actual fill volumes in the bottles

• Photoreagent I = Green; 37 ml

• Photoreagent II = White; 37 ml

• Antibody = Blue; 55 ml

• Wash Buffer Concentrate = Clear; 50 ml


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) 16 22 27 33 38

Wash Buffer (ml) 750 1050 1350 1650 1950

Photoreagent I (ml) 13 15 18 21 24

Photoreagent II (ml) 13 15 18 21 24

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™ 20 and 0.001% sodium azide as a preservative.

WARNING:Sodium azide may react with lead and copper plumbing to form potentially explosive metal azides. On disposal,

flush the buffer with a large volume of water to prevent azide buildup. Refer to “Toxic Substances” on page 1-3

for handling, storage, and disposal instructions.

1. Allow Wash Buffer Concentrate to come to room temperature.

2. Check to see that any crystals that may have formed during refrigeration have dissolved. If crystals persist, place the tightly closed

buffer bottle into a beaker of warm water until all crystals are dissolved.

3. Remove Wash Buffer bottle from AP3600 Instrument and rinse the bottle with distilled water.

4. Gently invert the Wash Buffer Concentrate bottle several times to thoroughly mix contents.

Note: Take care not to create bubbles when mixing the contents.

5. Add the contents of the Wash Buffer Concentrate bottle (50 ml) and DI water (950 ml) to a 4L Wash Buffer bottle and mix thoroughly.

6. The Wash Buffer is ready for use.

Note: Once prepared, the Wash Buffer solution can be used for up to one month when stored at room temperature (20-25°C) or

refrigerated (2-8°C).

Reagents

1. Allow all reagent bottles (Sample Diluent, Antibody, and Photoreagents) to come to room temperature.

2. Gently swirl the bottles to mix contents.

3. The reagent is ready for use.

Note: Reagents can be used until the expiration date, if kept refrigerated (2-8°C) while not in use.

4-1 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. Wait for the Optics Check to successfully complete. Note: Allow 15 minutes for the instrument to warm up. Contact an

authorized service representative if the check fails. (The Optics Check Screen will not be displayed if the unit is already

powered on).

FIGURE 4-1. DMS Loading Screen

3. Log into the system with an appropriate account. Users should log in with a User account (User 1 through User 10).

Note: The Service account should only be selected by authorized service personnel. The Admin account is used by the lab

administrator to set up user accounts and to select desired features from Utilities and System Configuration screens.


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.


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:

• Chapter 5, Set Up & Run Wizard

• Chapter 6, Work List Screen

• Chapter 7, Results Screen

• Chapter 8, Utilities Screen

• Chapter 9, System Settings Screen

The buttons on the right side of the Home screen allow the operator to perform either of the following tasks:

• Log Off: Touch the Log Off button to log the operator out of the DMS software. The instrument will remain on.

• Shutdown: Touch the Shutdown button to exit the DMS software. To shutdown the instrument, first select “Shutdown” from

the main menu, wait until the screen turns dark and then turn the main power switch to the OFF position (0).

FIGURE 4-5. AP3600 Main Power Switch

OFF Position


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 [ ] { } ! @ # $ % ^ & * ( ) _ - = + ; : , . < > / ? \ |

• Characters are restricted to those on QWERT keyboard with no special accented foreign language letter

2. Add New User(s) Account (Maximum 10 Users)

Note: Only Administrator can provide each User with a default password and a user name. Perform Step 1, 2 and 3 in sequence.

• Step 1: Administrator creates a Default Password for new Users

• 1) Login as Admin

• 2) Select Utilities, then Manage User Accounts

• 3) Select Default Password button and enter Administrator password. Select Submit.

• 4) The current default password for new operators is displayed as *characters.

• 5) Select View adjacent to the default password entry field.

• 6) The current default password is displayed.

• 7) Press Submit to keep the current default password or enter a new default password in the entry field. Select Submit.

• 8) Administrator provides the above default password to the new Users.

• Step 2: Administrator adds a new User (Maximum 10 Users)

• 1) On Manage User Accounts screen, select the Add button

• 2) On Manage User Accounts screen, select a User, press the Delete button, and then select the Add button.

• 3) Enter name for the new User, maximum 20 characters. Select Submit.

• 4) Log off as Administrator.

• Step 3: New User enters new customized password

• 1) Login as new User using the above default password.

• 2) Select System Settings, then Change Password.

• 3) Follow instructions on the screen display to change password.

• 4) Log off as User.

• 5) Login again as new User using the new customized password.

• 6) Main Menu is displayed.

• 7) New customized password is accepted by the DMS.

3. Change Administrator password

• 1) Login as Administrator.

• 2) Select System Settings, then Change Password

• 3) Follow instructions on the screen display to change password.

• 4) Log off as Administrator.

• 5) Login again as Administrator using the new customized password.

• 6) Main Menu is displayed.

• 7) New customized password is accepted by the DMS.

4. Change User password for the current User.

• 1) Enter the current user password.

• 2) Select the Submit button.

• 3) Enter the new password.

• 4) Select the Submit button again to save the new password.

• 5) Press Cancel at any time to discard changes and return to the System Settings screen.

5-1 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.

Prepare AP3600 Instrument Perform the following steps to prepare the AP3600 instrument.

1. Confirm the transfer tip rack is filled and placed in the rack holder. Refer to Figure 5-1.

Note: The assay will not start if the rack is not fully populated.

FIGURE 5-1. AP3600 Transfer Tip Rack, Sample Vial Racks, and Sample Cup Carousel

2. Fill the sample cup carousel with new cups. Refer to Figure 5-1.

3. Fill the DI water and wash buffer bottles. Confirm there is sufficient Wash Buffer and DI water available to run the number of tests

planned.

4. Load the reagent bottles (Antibody, Photoreagent I, and Photoreagent II) on the right side of the AP3600 instrument at this time.

5. Empty the waste container. There are both high and low sensors present for the waste container to ensure that the container does not overflow during testing. Refer to Figure 5-2.

Transfer Tip

Rack

Sample Cup Carousel

Sample Vial Racks


Reagent Bottles: Antibody, Photoreagent I, and Photoreagent II

Wash Buffer, Deionized Water, and Waste Bottles

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. The pettes can be loaded in random

positions; there is no need to match the sample position.

FIGURE 5-3. Load Pettes in Carousel

Pette

Pette Tip


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. Sample Vial Rack Window

Slide the rack into the instrument as shown in Figure 5-6.

Note: The sample vial rack does not need to be filled and positions can be skipped in the 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.


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). See Figure 5-9.

FIGURE 5-9. Assigning a Panel to the Sample


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. The operator must confirm that sufficient serum is present to run all selected tests. See Figure 5-10.

FIGURE 5-10. Sample with Multiple Assigned Panels

Once all samples in the first rack have assigned panels (see Figure 5-11), press one of the following buttons to continue:

• Load: Press to continue loading sample racks. This advances the loaded rack by one position so the next rack can be loaded.

• Unload: Press to shift the loaded rack left one position so it can be removed. The sample ID and Pette test panel assignments are

discarded.

• Finish Loading: Press to proceed to the next screen if there are no more sample vial racks to load.


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. Pre-run Checklist

Note: An additional check may be added to confirm that sufficient reagents, DI water, and Wash Buffer is present.


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.

• Set to Drain if the instrument will automatically drain liquid from the Pettes at the end of testing.

FIGURE 5-13. Pre-run Checklist Run Settings

Press the Start Run button to lock the AP3600 instrument doors and begin the automated run process.

Note: To cancel the test at this time, press the Unload Racks button to move the racks back to the load/unload position for removal

from the instrument.


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.

WARNING: Pettes CANNOT be reused on the AP3600 after a test is canceled.

FIGURE 5-14. Running Tests Screen

Each Pette number is listed on the right. The Step column displays the current step. A checkmark appears in the relevant column as the

following checks are complete:

• S: Serum aspiration verified by CCD camera check

• A: Antibody aspiration verified by CCD camera check

• P: Photoreagent aspiration verified by CCD camera check

Note: For user safety, the right side cover cannot be opened once the run starts. The left side door can be opened after serum

aspiration is complete so the sample vials can be removed and appropriately stored.


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.

Cap tightly to prevent any evaporation and store the bottles in a refrigerator (2-8°C).

After the run, the operator must follow the instructions in “Rinse and Drain” on page 10-1 to flush the system tubing and pumps.

Replace the reagent bottles (Antibody, Photoreagent I & II, and Wash Buffer) with bottles filled with Deionized (DI) water.


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. Work List Status Screen

6-1 Work List Screen



6-2 Work List Screen


7-1 Results Screen

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. Completed tests are displayed in white cells.

FIGURE 7-1. Results Screen

Results Screen The Results screen shows the test results from the samples analyzed by the AP3600. The list provides information about each sample

and allows the operator to export the test results. By selecting a sample ID from the list, the operator can bring up information in the

Details screen for that sample.

The following is provided for each entry in the Results list:

• Checkbox: Check this box to view detailed information for the item when the Details button at the bottom of the screen is pressed.

• Date: Test date and time the test was completed

• Sample ID: This is the sample identification number. Often this number refers to a specific sample, but it may be the same as the

Patient ID number.

• PN: Part number for the Pette

• Lot: Lot number for the Pette


7-2 Results Screen

• 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.

• NC: Negative Blanking Control; a green checkmark appears if the NC in the Pette passed. The NC compensates for non-specific

binding.

Details Screen The Details screen shows the test results from the selected test.

FIGURE 7-2. Details Screen

Test and Sample Details Details about the selected test are displayed on the left side of the screen.

Test Details:

• Date: Date and time the test was completed

• Pette ID: Unique ID for the Pette tested with the patient sera

• Panel Name: Common name for the Pette test chamber

• Result Status: Result status for the test.

Sample Details:

• Sample ID: Unique ID for the patient sera sample

• Tested by: User name for the user logged in when the test was run

Test Results The test results for the selected test are displayed on the right side of the screen. An option to sort the results can be done by pressing

the arrow (highlighted in yellow).

7-3 Results Screen


• #: 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

• LMC: This is the chemiliuminescence unit measured for each allergen.

• Class: Displays the response number (0-6) for each allergen, with 6 representing the greatest response.

The color bar to the right also illustrates the response level; darker colors indicate a greater allergic reaction from the patient to

that particular allergen.

Details Screen Button The following buttons are provided at the bottom of the screen:

• Print: Click the Print button to print a copy of the Details screen.

7-4 Results Screen



8-1 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. Utilities Screen: Available Utilities for User 1 through User 10


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. A message appears after the check is complete indicating if the check passed or not.

FIGURE 8-3. Optics Check Passed Message


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.

The following actions can be taken on this screen:

• Click the Export To USB button to save the log file in onto a USB drive (USB ports are located on the front of the AP3600 instrument

and under the monitor.

• Click the Print File button to print the log file.

FIGURE 8-4. Log File 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.

See “Rinse and Drain” on page 10-1 for details steps on performing a flush operation.

FIGURE 8-5. Maintenance Utility Screen


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 (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. Information for the Software Update Utility is in the AP3600 Service Manual. Note: Screen not shown must be logged in at Admin level.

Panels Update Utility (Admin) The Panels Update Utility screen allows updates to panels. The updated panels must be located on an USB memory device and formatted correctly using a spreadsheet. Note: Must be logged in at the Admin level.

FIGURE 8-8. Panels Update Utility


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. Note: Screen not shown must be logged in at Admin level.

Remove All Results (Admin) The Remove All Results screen allows the removal of all previous test results. Note: Screen not shown must be logged in at Admin level.

9-1 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.

FIGURE 9-1. System Settings Screen

Language Currently English is the only language available.

Date & Time (Admin Only) 1. Select Format for the time.

2. Select Date Format for the date.

3. Select Submit when finished.

User Admin


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


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. Select the Submit button again to save the new password.

Note: Press Cancel at any time to discard changes and return to the System Settings screen.

FIGURE 9-4. Change Password Screen

Network Details (Admin Only) 1. Select this item to modify network settings of the AP3600.

• Enable DHCP: When checked, the device will use DHCP to obtain an IP address automatically from the network. When

unchecked, the following fields become available:

• IP Address: Manually specify IP address

• Netmask: Manually specify netmask

• Gateway: Manually specify gateway

• ‘Enable Network MAC: Enable or disable AP3600 network port.

FIGURE 9-5. Network Details Screen


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:

• Instrument Type: Device designation

• Instrument Name: Specify name of device for destination LIS

• Instrument State: Indicates current state of the AP3600 instrument

• IP Address: Indicates current IP address of the AP3600 instrument

• Options:

• Auto send: Enable or disable automatic sending of results to LIS

FIGURE 9-6. LIS Settings Screen


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.

• Select sample.

• Choose any panel from “Favorite Panels” or “Available Panels”.

FIGURE 9-7. Panel Favorites Screen

Export Results Automatically (Admin Only) Check the Export Results Automatically option to have all results automatically printed.

FIGURE 9-8. System Setting Screen


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. Load 8.5 x 11" paper onto the printer.

3. Power off, then power on the instrument.

4. Log in as Admin.

5. Select Utilities > Printer. Printer setup screen is displayed.

6. Select Refresh option.

7. Select the correct printer driver and listed printer device for the connected printer.

8. Select Submit option.

9. Printer is now set up for use with the instrument.

10. Printer setup screen allows ONLY one printer to be set up for use at any time.

10-1 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.

FIGURE 10-1. DI Water Bottles

2. Open the Utilities screen.

3. Press the Maintenance Utility button to open the Maintenance Utility screen for rinsing and draining the instrument.

10-2 End of Run

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:

• If a consecutive run will be performed immediately, it is not necessary to run a rinse cycle.

• If the instrument will not be run again for one day, one rinse cycle should be completed.

• If the instrument will not be run for several days, two rinse cycles should be completed.

5. A pop-up window notifies the operator once the cycle is complete.

FIGURE 10-3. Finished Rinsing Process Window

6. Once the cycle has ended, disconnect water bottles from all lines. Place all disconnected lines onto a clean, absorbent material.

7. Set the desired number of drain cycles, and then press the Start Drain Cycle button to start the cycle. Refer to Figure 10-2. The fol-

lowing number of cycles are recommended, based on when the instrument will be next used:

• If a consecutive run will be performed immediately, it is not necessary to run a drain cycle.

• If the instrument will not be run again for one day, one drain cycle should be completed.

• If the instrument will not be run for several days, two drain cycles should be completed.

8. A pop-up window notifies the operator once the cycle is complete.

FIGURE 10-4. Finished Draining Process Window

10-3 End of Run

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.

FIGURE 10-5. Shutdown Window

6. Turn the main power switch of the AP3600 instrument to the OFF position (0).

FIGURE 10-6. AP3600 Main Power Switch

Cleaning the Wash Buffer Bottle Clean the four liter Wash Buffer bottle weekly with Distilled/DI water. The Wash Buffer bottle is autoclavable.

Cleaning the Waste Bottle Clean the waste bottle as needed. The waste bottle is autoclavable.

Cleaning the Transfer Tip Waste Container Clean the Tip Waste Container as needed.

OFF Position

10-4 End of Run



Troubleshooting

The following table provides some recommended remedies for problems that may occur during operation.

Table 11-1. Troubleshooting Matrix

No Symptom Cause Remedy

1 The operation panel does not illu- minate (DMS does not start) after the power switch is turned on.

The fuse of the device has blown out.

The fuse needs to be replaced.

The power switch is broken Repair is necessary.

Electrical system failure Repair is necessary.

2 A warning is displayed after starting the operation.

The door is open. Check whether the door is closed.

Rack set Verify again that the rack is securely set to the designated location.

Pette tip is misaligned Insert the Pette tip back in or replace the Pette and tip.

Verify the content of the warning display.

Read the warning display items carefully and resolve the cause of the alarm. If the cause of the alarm is mechanical or electrical, such as sensor error display, repair is necessary.

3 There is no movement after starting the operation (sensor error warning is displayed).

Electrical system failure Repair is necessary.

Mechanical section loading failure Repair is necessary.

Drive belt failure Repair is necessary.

4 It does not perform aspiration. Insufficient amount of reagent solution

Replenish adequate amount of reagent solution.

The Pette is cracked Cancel the test, replace Pette(s), and retest with the proper volume of reagents.

5 It does not wash. Insufficient amount of wash solution

Cancel the test, replace Pette(s), and retest with the proper volume of reagents.

There is abnormality in the piping line

Repair is necessary.

11-1 Troubleshooting



11-2 Troubleshooting


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.

This instrument is intended for laboratory applications only. This instrument should not be modified or altered in any way. Alteration of this

instrument will void the manufacturer’s warranty, void the I.E.C. 61010-1 certification, and create a potential safety hazard for the user.

The AP3600 system conforms to class A standards for Electromagnetic Emissions, intended for laboratory equipment applications. It is

possible that emissions from this product may interfere with some sensitive appliances when placed nearby or on the same circuit as

those appliances. The user should be aware of this potential and take appropriate measures to avoid interference.

A-1

Regulatory Compliance



A-2 Regulatory Compliance


Specifications and Ordering Information

Physical Specifications • Dimensions: W x H x D = 1140 x 630 x 760 mm

• Weight: 170 kg (375 lbs.)

Environmental Requirements • Operating Temperature: 15 – 33 °C

• Operating Humidity: 10 – 85%, non-condensing

• Altitude: Less than 2000 m

• Over-voltage category II

Power Requirements • Input Voltage: 100 VAC to 240 VAC ± 10%

• Input Frequency: 50 /60 Hz ± 4%

• Power Consumption: 500 VA

• AP3600 Instrument Power Cord Voltage/Current:

• USA and Canada (110-120 VAC): 125V 10A power cord. Manufacturer: KAWASAKI ELECTRIC WIRE CO.,LTD. (KDK);

Model: KP-30 SVT3/18AWG.

• Countries using 200-240 VAC: 250V 7A cord. Acquire power cord locally.

WARNING: Do not use an inadequately rated power cord with the AP3600 Instrument. This may damage the instrument.

Processing Specifications • Number of Pettes Processed: Maximum of 50 Pettes per run

• 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.


Tel: +1 650 961 5501

Fax: + 1 650 969 2745

E-mail: [email protected]

www.hcdiagnostics.com

B-1 Specifications and Ordering Information

mailto:[email protected]://www.hcdiagnostics.com/



B-2 Specifications and Ordering Information


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. Refer to “Heavy Objects” on page 1-4 for details.

Installing a New System 1. Prepare the system location. The AP3600 instrument must be installed on a stable, flat surface that meets the following specifica-

tions (see Figure C-1 and Figure C-2):

• Surface Dimensions: 1800 x 1060 x 1200 mm (W x H x D)

• Supports a load of 185 kg

• 300 mm clearance (Left side)

• 300 mm clearance (Right side)

• 300 mm clearance (Rear)

FIGURE C-1. Instrument Clearances (all dimensions in mm)

C-1


C-2 Moving and Installing the System

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.

FIGURE C-3. Removing Packing Materials from Black Box

Remove cushions from Sample Distribution Nozzle Head Remove cushions from Reagent and Wash Nozzle Heads

Remove foam piece from Pette Carousel



Remove bolts to remove fixing plates

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.

FIGURE C-4. Removing Fixing Plates

5. If applicable, connect the Laboratory Information System (LIS) network cable (optional) to the Ethernet connector on the monitor.

6. Install the bottle unit attachment connector. See Figure C-5.

7. Install the correct caps with tubing for the Wash Buffer, DI water, and waste bottles. The overflow tubing and bottles should be placed

below the instrument on the waste station tray, because the overflow liquid drains by gravity. All caps are color-coded. See Figure C-5

FIGURE C-5. Install Bottle Connector and Install Bottles Under Instrument

8. Connect the AC power cord to the AP3600 instrument.

9. Close all instrument lids and covers.

10. Press the power switch on the front of the instrument to apply AC power to the instrument.

C-3

Bottle Unit Connector

Bottle Unit Connector on System

Wash Buffer and DI Tubing on System Wash Buffer, DI Water, and Waste Bottles


11. Verify the instrument properly initializes and the optical check runs successfully.

Note: The AP3600 system is now ready for normal operation.


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. Open the sera handling area door and remove all consumables and accessories in the serum handling area (sample vial racks, trans-

fer tip rack, and sample cups). Close the sera handling area door.

3. Open the dark box cover.

4. Remove any Pettes installed in the Pette carousel.

5. Tape the cushions that the system shipped with to secure the Sample Distribution Nozzle Head and Reagent and Wash Nozzle

Heads. Place foam piece over Pette Carousel. See Figure C-6.

FIGURE C-6. Securing the Nozzle Heads

6. Close the dark box cover.

C-5

Install cushions over Sample Distribution Nozzle Head Install cushions over Reagent and Wash Nozzle Heads

Place foam piece over Pette Carousel


7. Place tape to secure items inside the Sera Handlng Area of the AP3600. Install Fixing Plates. See Figure C-7.

FIGURE C-7. Place Tape to Secure Items

8. Remove the reagent bottles from the right side of the instrument.

9. Remove the Wash Buffer, DI, and waste bottles under the instrument.

10. Disconnect any USB devices or network connections to the AP3600 instrument at the Ethernet port or USB connections on the front

of the instrument and under the monitor.

11. Disconnect the power cable from the back of the AP3600 instrument and disconnect the cable from the Bottle Unit.

12. Secure the outside of the AP3600 with tape and bubble wrap. See Figure C-8.

FIGURE C-8. Place Tape and Bubble Wrap to Secure Items

13. Lift the AP3600 Instrument from the bottom of the unit and place it on a clean, flat work table (See Figure C-1) or appropriate sized

cart for moving.

Z Axis of Distribution Nozzle and X and Y Axis Fixing Plates

Sample Cup Carousel

Left Door and Top Door Rear Right Carousel

D-1 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.

1. Prepare a 10% bleach solution by using 100 ml of household bleach and adding 900 ml of DI water. This solution must be made and

used within 12 hours of decontamination.

2. Aliquot 25 ml of the 10% bleach solution into the specified or supplied diluent and antibody reagent containers. The Photoreagent

containers should remain filled with DI water. Attach antibody (with 10% bleach solution) and both Photoreagents

(with DI water) to the instrument.

3. Replace the main DI water container with the 10% bleach solution (separate container). Place the wash buffer line into the main

DI water container.

4. Perform one (1) rinse cycle (see Figure D-1). Allow the solution to stay in the lines for ten (10) minutes.

FIGURE D-1. Maintenance Utility Screen

5. Disconnect all reagent and DI water lines from bleach solution/DI water and perform one drain cycle to expel liquid from lines.

6. Place all reagent lines into bottles containing 50 ml of DI water. Place DI water & wash buffer line into DI water bottle containing 4 L of

DI water. Replace Waste Container with sampling container #1.

7. Perform one rinse cycle.

8. Sample waste from sampling container #1. Perform strip testing to determine total chlorine content.

9. If the strip test indicates zero (0) ppm, proceed to step 11. Otherwise, continue to step 10.

D-2 Maintenance

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.

11. Once strip testing returns 0 ppm result, perform 2 additional rinses.

Replacing Fuses

Required Tools and Materials • Flat screwdriver

• Replacement fuses (AC 100-120V T10A 250V; AC 200-240V T7A 250V)

Procedure 1. Turn the main power switch of the AP3600 instrument to the OFF position (0).

FIGURE D-2. AP3600 Main Power Switch

2. Unplug the AC power cord to the AP3600 instrument.

3. Use a flat screwdriver to rotate the fuse box counterclockwise to remove the fuse holder assembly.

FIGURE D-3. AP3600 Fuse Box

4. Pull out and replace the fuse.

OFF Position

D-3 Maintenance

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).

Fuse

Fuse Holder

Fuse Holder Assembly

D-4 Maintenance


Glossary

Table E-1. Glossary

Name Description

AP3600 System The AP3600 system is the instrument into which the patient sera and the Pette test chambers are placed. The AP3600 is a fully automated instrument which tests and tracks each sample after the samples and Pettes are placed into it. Operation is started from the DMS software.

DHCP (Dynamic Host Con- figuration Protocol)

The network protocol used on the AP3600 to obtain an IP address.

DMS (Data Management System)

This is the software used to run the AP3600 system.

LMC (Luminometer Count) This value refers to the amount of light emitted by each well in the Pette. The amount of light emitted by each allergen well at th end of testing is directly proportional to the amount of allergen-specific IgE in the patient serum.

Negative Blanking Control This compensates for non-specific IgE binding that may occur.

OPTIGEN®

This is the in vitro chemiluminescent assay used by the AP3600 system. OPTIGEN is a registered trademark of Hitachi Chemical Diagnostics.

Pette Test Chamber (Pette) This single use, disposable plastic device contains 36 allergens or allergen mixes and 2 controls (38 lenslets total). The Pette also contains Positive Procedural Control and Negative Blanking Control wells.

Pette Tip A single use, disposable tip is placed onto a Pette test chamber before use. When the tip is pressed down, it is opened for aspiration or draining.

Positive Procedural Con- trol

This confirms reagent performance and provides a check for correct testing procedure.

Sample Cup This plastic cup holds a patient’s serum in the sample cup carousel of the AP3600.

Sodium Azide This compound is used as a preservative in the Wash Buffer concentrate. It is highly toxic by inhalation, ingestion, or skin absorption.

Tween™

20 This non-ionic surfactant is used in the Wash Buffer concentrate to suppress non-specific reactions between antibodies, antigens, and other molecules.

E-1 Glossary



E-2 Glossary

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European Office


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United Kingdom

+44 (0) 1628 585 590

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