Diagnostic BioSystems Montage Opus365 User manual

Antigen Retrieval System
Antigen Retrieval System
Catalog No: AR365
Operator Manual

Confidential
This manual is the property of Diagnostic BioSystems and is provided to authorized distributors and
service agencies for their use. Unauthorized use and/or distribution of physical or electronic copy of
this manual is strictly prohibited.
Antigen Retrieval System
Operator Manual

Table of Contents
Section 1 Page
Unpacking and Installation 4
Instrument Packaging 4
Content Verification 4
Installation 4
Powering Up 4
Section 2
Safety Instructions 5
Caution 6
Section 3
Features 7
Section 4
User Guide 8
First Time Use 8
Before Each Use 8
Operating Instructions 9
Setting Up a Run 9
Completing a Run 10
Section 5
Cleaning And Maintenance 11
Appendices
Appendix-A - Montage OpusTM 365 Accessories 12
Appendix-B - Montage OpusTM 365 Specifications 12

Operators Manual - Montage OpusTM 365 Antigen Retrieval
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Instrument Package
The Montage OpusTM365 and its accessories are packaged in one corrugated box
Content Verification
Each Montage OpusTM365 unit includes the following:
1. Antigen Retrieval Tanks (4)
2. 24 Slide Rack (4)
3. Metal Stand (1)
4. Montage 10X EDTA pH 8.0 AR Solution (Cat No: K038-500AN) (1)
5. Montage 10X Citrate pH 6.0 AR Solution (Cat No: K035-500AN) (1)
Installation
Place the Montage OpusTM365 on a levelled surface suitable for laboratory instrumentation
1. Place Montage OpusTM365 away from direct sunlight and sources of heat or cold
2. Place the removable Heating chamber in the body. Make sure the exterior of the removable
Heating chamber is clean and that all packaging has been removed
3. Rest the lid on the removable pressure chamber until ready to use
Powering Up
Montage OpusTM365 is a 220V–240V AC 50Hz/60Hz instrument. In locations with
220V–240V AC 50Hz/60Hz power supply, simply plug the instrument into the
appropriate outlet.
A step-up transformer is required for laboratories using Montage OpusTM365 with a 110V–115V
AC 50Hz/60Hz electrical source. This step-up transformer is not supplied within the same box
as Montage OpusTM365. (Step-up transformer shall be procured by distributor locally).
Section 1 - Unpacking and installation

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Section 2 - Safety Instructions
When using the Montage OpusTM365, safety precautions should always be observed including
the following: Make sure to read and understand these instructions before using your Montage
OpusTM365 for the first time.
Make sure the voltage in your outlet is the same as the voltage indicated on your instruments
rating label.
1. To protect against risk of electric shock do not immerse the cord plug or unit in water or any
other liquid.
2. Do not touch the stationary chamber, valve or removable Heating chamber when hot
3. Unplug from outlet when not in use and before cleaning. Allow to cool stationary chamber
and removable heating chamber before cleaning or storing this instrument
4. Never yank the cord to disconnect your Montage OpusTM365 from the outlet. Instead grasp
the plug and pull to disconnect
5. Do not let the electrical cord hang over the edge of the table or countertop or touch hot
surfaces
6. Do not place on or near a hot gas or electric burner, heated oven or microwave
7. Use on a heat-resistant flat level surface only
8. Extreme precaution must be taken when moving any instrument containing hot liquids
9. Do not operate in open position
10. Do not leave instrument unattended during use
11. Do not operate your Montage OpusTM365 if the cord is damaged or if your instrument has
malfunctions or has been damaged in any manner. In order to avoid the risk of an electric shock
never try to repair this instrument by yourself. An incorrect re-assembly could present a risk of
electric shock when the Montage OpusTM365 is used
12. Do not make any modifications to the cover, the body or the pieces of your
Montage OpusTM365
13. Check that the pressure regulator knob and the pressure safety valves are in good working
order before each use
14. Never use your Montage OpusTM365 without liquids; this could cause serious damage

Operators Manual - Montage OpusTM 365 Antigen Retrieval
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15. If you have added insufficient liquid and you notice that the floating valve has not risen but
the timer is counting down, stop it by pressing the STOP button. Turn the pressure regulator
knob to steam until pressure is fully released. Remove lid and add 500ml to 600ml of water.
Then restart your process.
16. If the electric circuit is overloaded with other instruments, your instrument may not operate;
Your Montage OpusTM365 should be operated on a separate electrical circuit.
17. The rubber gasket must always be properly positioned on the underside of the lid. Check
periodically to make sure that it is clean, flexible and not cracked or torn.
Section 2 - Safety Instructions
Caution
To reduce the risk of electric shock, this instrument has a polarized plug (one blade is wider
than the other). This plug fits polarized outlets only one way; if the plug does not insert fully
in the outlet reverse the plug if it still fails to fit contact a qualified electrician. Do not attempt
to defeat this safety feature.
This unit is designed for 220V–240V AC 50Hz/60Hz usage. (A Step-up transformer or a con-
verter may be required to convert 220V–240V AC 50Hz/60Hz to local voltage and frequency).

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Section 3 - Features
Easy To Use Features
You will experience the convenience of soft-touch button settings and a countdown timer.
Regulator Knob: Up position when steaming Sliding Lock: Allows you to lock the lid pressure
Chamber: 6liter capacity
Stationary Chamber: Allows even distribution of heat
Rubber Gasket: Creates an airtight seal that is required for the instrument to operate
Safety Valve: Allows excess pressure to escape
Pressure Regulator Knob
Coll Touch
Rubber Gasket
Removeable Pressure
Chamber
Stationary
Chamber
Stainless Steel
Housing
Control Panel

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Section 4 - User Guide
First Time Use
Before using the Montage OpusTM365 Antigen Retrieval Systems, familiarize yourself with all
the safety features and components.
Wash all removable elements in warm soapy water. Remove and dry thoroughly. Wipe the outer
housing with a clean damp cloth. Never immerse the instrument in water or any other liquid.
Never clean any part in a dishwasher.
Make sure the rubber gasket is seated properly inside the lid. To ensure a correct fitting fill the
removable pressure chamber with two thirds water and run at HIGH TEMPARATURE setting for
15 minutes.
Release the pressure by turning the pressure regulator knob to steam. The floating valve will
drop.
Let the instrument cool to room temperature and then empty and clean.
Before Each Use
Always check the pressure release devices for clogging before each use.
Place the Montage OpusTM365 on a clean flat surface before starting the run.
Place the condensation reservoir on the rear of this unit until it clicks into place as shown below
Condensation Reservoir
Place the pressure regulator knob on the lid. The pressure regulator knob will not click or lock
into place. Even though it has a loose fit it is safely secured.

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Floating Valve
Cool Touch
Pressure Regulator Knob
Operating Instructions
Setting a Run
1. Montage OpusTM365 operates at a default voltage of 220V–240V AC 50Hz/60Hz
2. A Step-up transformer or a converter may be required to convert from local voltage and
frequency 220V–240V AC 50Hz/60Hz
3. Plug the cord into a wall outlet Ensure the rubber gasket and the pressure regulator are
clean and positioned accurately
4. Fill the heating chamber with Deionized water 750ml
5. Add the Antigen Retrieval buffer into the Antigen Retrieval tanks ( 200-250 ml)
6. Place the 24 slide rack into the Antigen Retrieval tanks
7. Place the Antigen Retrieval tanks in to the heating chamber (Filled with Antigen Retrieval
Buffer & Slides)

Operators Manual - Montage OpusTM 365 Antigen Retrieval
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8. Place the lid onto the instrument and turn it clockwise until it locks the lid into position
(The locking pin should CLICK into place)
9. Ensure the pressure regulator knob is closed
10. Set Number of cycles you want and press the start button
11. Set the desired temperature and timing for every cycle
12. Press START to begin the run
13. The digital display will show run time for 1st cycle
14. A count down timer will start once the set temperature reaches
15. Once Cycle completes, it will change the cycle according to set time and temperature for
each cycle, In mean time the cycle change will take approximately 60 seconds and user can
change slides as per the required test
Completing a Run
1. Upon run completion, alarm will beep. wait for 5 min and let the pressure release cool it down
till temperature have been maintained for laboratory / room environment
2. Press STOP button to stop the heating process if required in middle of the Run and wait for
5minutes and released the pressure before opening the lid, or wait for approximately 20 min-
utes for pressure to be release on its own
3. Take out the retrieval tank from the removable Heating chamber and cool down for 20 min-
utes at room temperature If required

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Section 5
Cleaning And Maintenance
Parts of the Montage Opus™365 are not dishwasher safe. Always wash the Montage Opus™
365 thoroughly after every use.
Do Not Wash This Instrument In The Dishwasher
1. Unplug the instrument from the wall outlet and let the unit cool before cleaning.
2. Wash the removable Heating chamber with warm soapy water. Rinse and dry thoroughly.
3. Wipe the outlet housing with a clean damp. Do not submerge in water.
4. To clean the condensation reservoir, you need to pull it down. Clean with warm soapy water.
Rinse and dry thoroughly. Attach to the body again by pushing lock into place. Turn the lid up-
side down, grasp the rubber gasket on either side and pull up. Clean the rubber gasket in warm
soapy water. Rinse and dry thoroughly.
Cleaning Pressure Regulator Knob
Pressure regulator knob and pressure safety valves need to be in good working order before
each use.
5. Remove lid after Montage Opus™365 has cool down
6. To remove pressure regulator knob press it down and turn it counter clockwise past the
STEAM setting and carefully remove

Operators Manual - Montage OpusTM 365 Antigen Retrieval
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Appendices
Appendix-A
Montage OpusTM365 Accessories
Description Quantity Catalog No.
Antigen Retrieval Tank 4 -
24 Slide Rack 4 -
Metal Stand 1 -
Montage 10X EDTA AR Solution 1 K038-500AN
Montage 10X Citrate AR Solution 1 K035-500AN
*Note: Temperature indicating strips are also available independent of the Montage OpusTM 365 System in packs of 10.
Catalog No. (AR 360-10TS).
Appendix-B
Montage OpusTM365 Specifications
Color Black
Weight 12.7 lbs.
Dimensions 12.8 x 12 x 14.3 inches
Electrical 220V–240V (Universal)
Slide Capacity 96 slides / run
Optimal Run Temperature Ambient to 115°C
Copyright 2021 Diagnostic BioSystems. All rights reserved.
This manual may not, in whole or in part, be copied, photocopied, reproduced, translated, or converted to any other
electronic or machine-readable form without prior written consent of Diagnostic BioSystems.
Diagnostic BioSystems is an ISO 13485-2016 Accredited Company.
All other trademarks are the property of Diagnostic BioSystems and its subsidiaries.
Diagnostic BioSystems makes every endeavor to ensure that the information contained in its support documentation is
correct and clearly stated but does not accept responsibility for any errors or omissions.
Contact Address:
6616 Owens Drive
Pleasanton, CA 94588

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Our Mission
Providing clinically relevant anatomic pathology reagents to improve the practice of pathology.
What We Do
Diagnostic BioSystems is committed to improving Immunohistochemistry (IHC) staining one
slide at a time. We focus on improving the quality of IHC staining through standardized
instrumentation, detection chemistries and advanced multiplex solutions. DBS has more than
twenty years experience in IHC assay development to help pathologists solve their most difficult
diagnostic clinical questions.
Manufacturing Accreditations
Diagnostic BioSystems maintains the highest quality standards and is committed to customer
service and support. This commitment is built on a quality system foundation.
Diagnostic BioSystems is an FDA registered medical device manufacturer, operating under FDA
21CFR Part820 Quality System Regulations and is a California Department of Public Health
(CDPH) licensed Medical Device Manufacturing facility.
The facility is also certified under Quality Management System International Standards. We
manufacture IVD/CE marked medical devices for use in the European market.

Europe
Germany
Lake Constance
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wolf[email protected]m
Mexico
Avenida Aztecas # 95, Casa 4
Colonia Pueblo de los Reyes
Alcaldia Coyoacan
CDMX, C.P. 04330
Cell: [phone]
a.herrer[email protected]
India
612, Eden Square
St. John’s Road
Secunderabad – 500003
Cell: [phone]
[email protected]
Contact your distributor for more information
And visit us at www.dbiosys.com
Montage Opus™365 Operator Manual
Toll Free: 888-896-3350
[e-mail]
Doc. No.: M0019 Rev. A
United States (Headquarters)
6616 Owens Drive
Pleasanton, CA 94588
Phone: [phone]
Fax: [phone]
[e-mail]