InDevR Vaxarray Bedienungsanleitung

2100 Central Ave, Suite 106, Boulder, CO 80301

www.indevr.com | 303.402.9100 | indevr@indevr.com

Imaging and Analysis System

Operation Manual

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.

2100 Central Avenue

Suite 106

Boulder, CO 80301

Phone: 303-402-9100

Fax: 303-402-9300

E-mail: [email protected]om

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 

Page 4 VaxArray® Imaging and Analysis System Operation Manual CF-0159 R004

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

Page 5 VaxArray® Imaging and Analysis System Operation Manual CF-0159 R004

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.

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.

Page 6 VaxArray® Imaging and Analysis System Operation Manual CF-0159 R004

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 ISO-

9001:2000 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

Page 7 VaxArray® Imaging and Analysis System Operation Manual CF-0159 R004

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)

Page 8 VaxArray® Imaging and Analysis System Operation Manual CF-0159 R004

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

Page 9 VaxArray® Imaging and Analysis System Operation Manual CF-0159 R004

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

Page 10 VaxArray® Imaging and Analysis System Operation Manual CF-0159 R004

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

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