InDevR Vaxarray Operation Manual

2100 Central Ave, Suite 106, Boulder, CO 80301
www.indevr.com | 303.402.9100 | [e-mail]

Imaging and Analysis System

Operation Manual

© Copyright 2014-2018, InDevR, Inc.

All rights reserved

Page 2 VaxArray® Imaging and Analysis System Operation Manual CF-0159 R004

Model : VaxArray Imaging and Analysis System V1.0
Software : V1.0 or newer
Document : VaxArray® Imaging and Analysis System Operation Manual R004
Revised : June 2018

InDevR continuously optimizes products as new technologies are developed. For this reason, the right to make
technical changes is reserved. Defects caused by unauthorized alterations to the product by the user voids the
warranty. InDevR shall not be held liable for damages caused by unauthorized modifications.
This document applies only to the specified product and model number and replaces all previous revisions and
publications.
Copying, distribution and utilization without authorization are prohibited.
© 2018 InDevR, Inc.
2100 Central Avenue
Suite 106
Boulder, CO 80301
Phone: [phone]
Fax: [phone]
E-mail: [e-mail]

Page 3 VaxArray® Imaging and Analysis System Operation Manual CF-0159 R004

Table of Contents

GENERAL .......................................................................................................................................................5

DOCUMENT CONVENTIONS ...........................................................................................................................................5

SAFETY INSTRUCTIONS ..................................................................................................................................................5

CONFORMITY TO STANDARDS, NORMS AND REGULATIONS ..................................................................................................6

REGULATORY ..............................................................................................................................................................6

21 CFR Part 11 and Annex 11 ..............................................................................................................................6

INTENDED USE OF VAXARRAY IMAGING AND ANALYSIS SYSTEM ..........................................................................................6

LEGAL NOTICE .............................................................................................................................................................6

IMAGING SYSTEM OVERVIEW ........................................................................................................................................6

PACKAGE CONTENTS ....................................................................................................................................................7

OPERATING REQUIREMENTS ..........................................................................................................................................7

INSTALLATION ...............................................................................................................................................8

INSTALLATION .............................................................................................................................................................9

FRONT PANEL .............................................................................................................................................................9

Status Indicator LEDs ...........................................................................................................................................9

Power Button .......................................................................................................................................................9

Imaging Door .................................................................................................................................................... 10

REAR PANEL ............................................................................................................................................................ 10

Main Power Switch ........................................................................................................................................... 10

Transportation Lock Placeholders .................................................................................................................... 10

Hardware and Peripheral Connectors .............................................................................................................. 11

Imaging Tray Open Button ............................................................................................................................... 11

IMAGING TRAY AND SLIDE HOLDER.............................................................................................................................. 11

VAXARRAY IMAGING AND ANALYSIS SOFTWARE .......................................................................................... 12

SOFTWARE OPERATING INSTRUCTIONS ........................................................................................................ 12

SOFTWARE NAVIGATION: ........................................................................................................................................... 12

IMAGING AND ANALYZING A VAXARRAY EXPERIMENT ................................................................................. 13

STANDARD WORKFLOW ............................................................................................................................................ 13

1. START NEW EXPERIMENT ....................................................................................................................................... 14

2. SETUP EXPERIMENT .............................................................................................................................................. 15

3. PREVIEW & IMAGE ............................................................................................................................................... 17

4. REVIEW CALIBRATION CURVES ................................................................................................................................ 19

5. REVIEW RESULTS SUMMARY ................................................................................................................................... 20

6. RESULTS WORKSHEET ........................................................................................................................................... 22

7. GENERATING A REPORT ......................................................................................................................................... 22

OPENING PREVIOUSLY RUN EXPERIMENTS ................................................................................................... 24

ACCESSING VAXARRAY IMAGING AND ANALYSIS SYSTEM SETTINGS & INFORMATION ................................... 26

MANAGING USER ACCOUNTS ....................................................................................................................... 28

Adding a new User ........................................................................................................................................... 28

Removing a User .............................................................................................................................................. 28

Adding a User to a Specific User Group ............................................................................................................ 28

Changing Administrator Privileges ................................................................................................................... 29

PERMISSIONS ........................................................................................................................................................... 29

GROUPS .................................................................................................................................................................. 29

RECOMMENDED GROUPS .......................................................................................................................................... 30

Basic user .......................................................................................................................................................... 30

Service Level User ............................................................................................................................................. 30

Administration Level User ................................................................................................................................ 30

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TROUBLESHOOTING, CLEANING, AND SERVICE ............................................................................................. 31

FAILURE TO FIND AN ARRAY ....................................................................................................................................... 31

CLEANING ............................................................................................................................................................... 31

SERVICE .................................................................................................................................................................. 31

SHIPPING ................................................................................................................................................................ 32

PROPER DISPOSAL OF THE INSTRUMENT ....................................................................................................................... 32

TRADEMARKS .............................................................................................................................................. 33

SPECIFICATIONS ........................................................................................................................................... 33

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General

This manual provides all information for the setup and use of the InDevR VaxArray Imaging and Analysis System.

Document Conventions

This symbol is used to indicate safety instructions and similar important information. Follow
these instructions to avoid personal injury or damage to the instrument.

This symbol is used to indicate additional useful information.

Next

The names of keys, menus or buttons are underlined.

Safety Instructions

Caution:

1. Improper use of the instrument can impair the protective functions of the instrument.

2. The instrument may only be used by qualified personnel.

3. Do not use the instrument if any parts are damaged, e.g. mains lead, fan, fuses etc.

4. Check all electrical cords regularly for frays, broken plugs, damaged wires, knots, or

melted insulation.

5. Do not open the housing of the instrument.

6. Do not attempt any repairs or alterations except as expressly instructed in this

manual.

7. Always disconnect power before moving or cleaning the instrument.

Please follow these instructions for your own safety and the proper operation of your
instrument:

1. Read the user manual fully and completely.

2. The main supply source must meet the national regulatory requirements.

3. The power cord of the instrument must be connected to a wall outlet with a grounded

conductor.

4. The mains voltage must correspond to the range given in the specifications.

5. External devices which will be connected to the instrument must be compliant to

IEC/EN 60950-1.

6. The environment must be clean, stable and vibration-free.

7. No objects should be placed on top of the instrument.

8. Keep liquids away from the instrument.

9. Do not allow liquids to get inside of the instrument.

10. Adequate space must be available for the imaging tray when it is fully extended from

the front of the instrument.

11. Keep enough space in the back and sides of the instrument to allow access to the

power switch and proper ventilation.

12. Do not touch the imaging tray when the imaging door is open.

13. Do not open the imaging door manually.

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Conformity to standards, norms and regulations

This product complies with the essential requirements of the following European Directives, and carries the
CE marking accordingly:

Low Voltage Directive 2006/95/EC
Electromagnetic Compatibility Directive 2004/108/EC

Moreover, the instrument conforms to the following product standards:

IEC 61010-1 (Ed. 2.0) IEC 6100-3-3 (Ed. 2.0, 2008-06) IEC 6100-4-5 (Ed. 2.0, 2005-11)
IEC 61010-2-081 (Ed. 1.0); am1 IEC 6100-4-2 (Ed. 2.0, 2008-12) IEC 6100-4-6 (Ed. 3.0, 2008-10)
IEC 61326-1 (Ed. 1.0, 2005-12) IEC 6100-4-3 (Ed. 2.0, 2008-08)
IEC 6100-3-2 (Ed. 3.2, 2009-04) IEC 6100-4-4 (Ed. 2.0, 2004-07)

A copy of the Declaration of Conformity can be obtained by contacting InDevR.

Regulatory

The VaxArray Imaging and Analysis System has been designed and manufactured according to ISO­9001:2000 and EN-ISO-13485:2003 standards. The product is CE marked.

21 CFR Part 11 and Annex 11

The VaxArray Imaging and Analysis System is designed to operate within FDA 21 CFR Part 11 and Annex 11
compliant facilities. Please reference VaxArray Enabling Compliance with 21 CFR Part 11 and Annex 11 for
further details.

Intended Use of VaxArray Imaging and Analysis System

The VaxArray Imaging and Analysis System is intended for imaging and analysis of VaxArray assays
(www.indevr.com/vaxarray). The imaging system delivers images and/or calculated information relating to the
arrays imaged. The VaxArray Imaging and Analysis System is not for diagnostic or therapeutic use.

Legal Notice

The VaxArray Imaging and Analysis System is designed for the imaging and analysis of VaxArray assays. The use
of this product in combination with third party intellectual property may have implications according to patent
law. We strongly advise customers to procure appropriate licensing where required.

Imaging System Overview

The VaxArray Imaging and Analysis System is a compact desktop imaging instrument suitable for imaging and
analysis of VaxArray assays. The VaxArray Imaging and Analysis System comes with an integrated PC and built
in X/Y/Z positioning system which places the slide holder in the optimum position. The instrument employs a
fluorescence imaging system consisting of LED excitation sources and a camera to acquire images. Green
(525nm) LED excitation is integrated with accompanying excitation and emission filters. The imaging system

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includes the VaxArray Imaging and Analysis Software to manage operation of the instrument, record
experimental information, and analyze the arrays and resulting data.

The user has complete access to the PC and operating system in order to govern all access rights and enable
compliance with FDA 21 CFR Part 11 or Annex 11 guidance.

The VaxArray Imaging and Analysis System has been validated for use with the Windows 7 operating system.
Use with other operating systems has not been validated and may effect system performance.

The VaxArray Imaging and Analysis System has not been validated for use with third party software. Addition
of third party software or peripherals may effect system performance.

Updates to the VaxArray Imaging and Analysis Software will be provided at the discretion of InDevR, Inc.

Package Contents

The standard VaxArray Imaging and Analysis System package is supplied with:

• VaxArray instrument with monitor, keyboard, and mouse

• Power cord 125 V, 15A, 2.0m

• Plastic cap for transportation lock hole

• 4 Slide Holder

• VaxArray Imaging and Analysis Software

• VaxArray Imaging and Analysis System Operation Manual

Operating Requirements

• Clean laboratory environment

• Sturdy surface able to support 45 lbs (~20 kg)

• Approximate desktop space required (W x D x H): 18 x 22 x 9 inches (440 x 540 x 210 mm)

• A minimum distance of 2 inches (50 mm) on the left side and 4 inches (100 mm) on the back and front

sides of the instrument to allow for proper ventilation

• Appropriate ambient conditions, see Specifications section on page 30.

• Ethernet connection for remote support (optional)

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Installation

This section provides a description of the instrument (Figure 1) and instructions for installation. For a detailed
explanation of instrument maintenance and service, please refer to

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Troubleshooting, Cleaning, and Service.

Installation

A. The VaxArray Imaging and Analysis System is shipped with two transportation locks to avoid damage

during shipment. The two lock screws fix the position of the imaging tray during transport. One is
placed on the right side and one on the rear of the system. Remove the two transportation lock
screws and place them in the threads on the rear panel (Figure 2).

B. Install the provided transparent plastic cap into the hole of the transportation lock on the right side

of the instrument.

If the instrument is to be moved or shipped, the imaging tray must be locked to avoid
damage during transport. Please refer to
Troubleshooting, Cleaning, and Service for detailed instructions on re-installing the lock
screws.

C. Connect the USB cables of the mouse and keyboard to the USB outlets on the rear panel (Figure 2).
D. Connect the VGA monitor cable to the VGA connector on the rear panel (Figure 2).
E. Plug power cords for the instrument and monitor into grounded outlets.
F. Turn on the main instrument power source using the power switch on the rear of the instrument

(Figure 2), and power on the monitor.

Front Panel

The front panel of the VaxArray Imaging and Analysis System is shown in Figure 1.

Status Indicator LEDs

The LEDs provide the following information:
Green / Orange (left) Power on / Standby
Red (right) Error

Power Button

The instrument is switched on by pressing the power button which also turns on the internal PC.

Figure 1: Front View of VaxArray Imaging and Analysis System.

Status Indicator

LEDs

Imaging Door

Power Button

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The power switch on the rear panel must be switched on first.

Imaging Door

The self-opening and closing door provides access to the imaging tray for insertion and removal of VaxArray
slides. The opening and closing of the imaging door is initiated within the software interface.

Do not move the imaging tray manually or insert your fingers into the front door unless
you are re-installing the transportation locks (see
Troubleshooting, Cleaning, and Service for the proper procedure).

In case of system failure, the imaging tray can be opened without software control via the
rear panel (See Imaging Imaging Tray Open Button).

Rear Panel

The rear panel is shown in Figure 2.

Main Power Switch

This switch turns the main power on or off.

Transportation Lock Placeholders

The transportation locks should be stored in these placeholders for easy retrieval should the instrument
need to be shipped or moved in the future (see

Figure 2: Rear View of VaxArray.

Main Power Switch

Transportation Lock

Placeholders

Hardware &
Peripheral

Connectors

Imaging Tray Open Button

Page 11 VaxArray® Imaging and Analysis System Operation Manual CF-0159 R004

Troubleshooting, Cleaning, and Service).

Hardware and Peripheral Connectors

Multiple connection options, including VGA and USB, are provided to connect the provided mouse,
keyboard and monitor along with any other hardware or peripherals.

Imaging Tray Open Button

In the event of a system failure or other instance in which the imaging tray cannot be opened via the
software interface, this button may be used as outlined below:

• Shut down the system and switch the main power switch off.

• Switch the main power on again.

• Press the Imaging Tray Open button on the rear panel while pressing the power button on the

front panel.

• The imaging door will open and the imaging tray will extend.

Imaging Tray and Slide Holder

The four slide holder should be placed into the imaging tray with the A1 engraved on the slide holder positioned
toward the top left near the A1 of the imaging tray. The slide(s) are to be placed in the 4 slide holder with the
first slide in the left-most “Mount 1” position with the A1 well of the slide located in the top left (Figure 3).
Note that if you are performing a standard VaxArray analysis that provides a quantitative (μg/mL) result, the
leftmost slide in Mount 1 should contain the standards comprising the calibration curve in slide wells A1
through H1.

Figure 3: Imaging Tray & Slide Holder.

A1 Location