GE ÄKTApilot Site Preparation Manual

ÄKTApilot
Site Preparation Guide
Table of Contents
31 Introduction ..........................................................................................................
52 Site preparation overview ..................................................................................
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Table of Contents
1 Introduction
Purpose of this document
The purpose of this document is to provide the information you need to fully prepare your site for the installation and testing of the system.
A site preparation checklist is included in this document.
You must return this checklist to GE before GE Service personnel can install and test the system.
WARNING
The product must be installed and prepared by GE personnel or a third party authorized by GE.
Scope of this document
This Site Preparation Guide covers the ÄKTApilot system.
The ÄKTApilot system consists of the following components:
ÄKTApilot system separation unit
Computer including a flat-screen monitor
UNICORN™ control system
Feedback to GE
Make sure to read the entire Site Preparation Guide and complete the Site preparation checklist in Chapter 3.
Return the completed Site preparation checklist to the GE service office in your region. You will find E-mail address and fax numbers to the GE service office in your region under:
www.gelifesciences.com/contact .
If your region is not listed, select the nearest region.
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1 Introduction
Assign personnel for site preparation tasks
The site preparation tasks listed in the following table can be assigned to more than one person at the customer site.
It is recommended that the same people assist the GE service personnel during the subsequent installation process.
Site preparation tasksPersonnel
Site preparation/ installation coordinator
Review the site preparation guide for safety information and system re­quirements.
Choose the site.
Coordinate personnel and tasks.
Coordinate the installation timing of the system with any domestic safety procedures and testings.
Order the required materials.
Schedule the installation and inform the relevant personnel of the instal­lation date.
Laboratory personnel/ Primary users
Review the safety information.
Make sure that all customer-provided materials for the installation are present at the site.
Facilities personnel
Make sure that the installation requirements are met for:
-
Space at the installation site
-
Environmental conditions
-
Biosafety
-
Ventilation and waste collection
-
Electrical supply
-
Safety and installation materials
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1 Introduction
2 Site preparation overview
Introduction
Before the product is delivered, you must prepare the site according to the instructions in this chapter.
Select the site
Select a site that complies with national and international requirements for biosafety.
WARNING
Spread of biological agents. The operator must take all necessary
actions to avoid spreading hazardous biological agents. The facility must comply with the national code of practice for biosafety.
General site requirements
The following requirements must be fulfilled at the location where the ÄKTApilot system will be installed:
ÄKTApilot is intended for indoor use only
The instrument units must not be installed in a dusty environment
The instrument units must not be exposed to direct sunlight
Space requirements
Prepare a stable laboratory bench with a height of 1200 mm. The following space re­quirements must be fulfilled at the location where the ÄKTApilot system will be installed:
SpecificationParameter
1200 x 600 mmMinimum bench area for placement of
the ÄKTApilot system
2000 x 800 mmRecommended minimum bench areafor
operating the ÄKTApilot system
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2 Site preparation overview
The ÄKTApilot system can be installed on a mobile trolley. The dimensions for the Universal Table trolley are:
Width: 1200 mm
Depth: 800 mm
Height: 720-920 mm
The computer and screen have their own specifications and requirements. Make sure to follow these when connecting them.
Note:
WARNING
Access to power cord. Do not block access to the power cord. The
power cord must always be easy to disconnect.
Dimensions and weight
The following illustration shows the dimensions of the ÄKTApilot system.
900 mm
540 mm
750 mm
The weight of the ÄKTApilot system is 114 kg (monitor arm and computer not included).
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The ÄKTApilot system is shipped in a wooden crate with the following dimensions:
Width: 1200 mm
Depth: 760 mm
Height: 1350 mm
The system is delivered on a pallet that will add an extra weight of 20 kg.
Since the ÄKTApilot system weighs 114 kg, four people are required to safely lift the system out of the crate and onto either the workbench or a trolley.
Note:
Environmental requirements
The installation site must comply with the following specifications:
SpecificationParameter
4°C to 40°CAmbient temperature, operation
20% to 95%, non-condensingRelative humidity
840 to 1060 mbarAtmospheric pressure
Electrical requirements
SpecificationParameter
100 to 240 V ACSupply voltage
50/60 HzFrequency
800 VAMax power
10 A/250 V or 16 A/125 VFuse
4Number of wall outlets
One for the ÄKTApilot system
One for the computer
One for the computer screen
One spare outlet for extra valves
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2 Site preparation overview
WARNING
Protective ground. The product must always be connected to a
grounded power outlet.
Computer requirements
The computer is either supplied as part of the system delivery or obtained lo­cally. Install the client computer equipment according to the manufacturer's instructions.
Note:
The ÄKTApilot system consists of a ÄKTApilot system separation unit, a connected computer including a flat-screen monitor, and UNICORN control system. The following table specifies the computer requirements.
SpecificationParameter
Windows®7 Professional, 32-bit or 64­bit
Operating system
UNICORN 5 or higher versions.Control system
Note:
The computer should be installed, placed and used according to the instruc­tions and specifications provided by the manufacturer of the computer.
A printer should be connected to the computer.
The computer should not be connectedto a network before the installation.
User-supplied accessories and consumables
The following equipment must be supplied by the user:
SpecificationEquipment
Printer connected to system computerPrinter
Access to photocopierPhotocopier
Calibrated balance with certificate (range 500 g to 5000 g)
Balance
10 literWaste flask
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SpecificationEquipment
4 to 5 additional vesselsReagent vessels
According to the system specificationInlet and Outlet tubing
Wipes, syringes, etc.General laboratory equipment
Gloves, lab coats, etc.Personal Protective Equipment (PPE)
as required
The following chemicals must be supplied by the user:
SpecificationItem
For example, WFI/MQ purifiedHigh quality water
1% in high quality water
0.4% in 1 M sodium chloride
Acetone
20%Ethanol
pH 4.00 (200 ml)
pH 7.00 (200 ml)
pH 10.00 (200 ml)
Calibration solutions for pH
Approximately 2, 12 and 110 mS/cmConductivity solutions
All solutions should be filtered and degassed, and all solutions should have relevant certificates.
Note:
Other product specifications
SpecificationParameter
< 70 dB(A)Noise
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3 Site preparation checklist
Introduction
Read the previous chapters in this Site Preparation Guide before completing the checklist.
Complete the checklist in this chapter to make sure that all necessary preparations have been made for the installation of ÄKTApilot.
You must send the completed checklist to a GE office before GE service personnel can install ÄKTApilot. See details in Chapter 1.
Checklist
Comment/specifyN/ANOYESRequirement
General
When was the ÄKTApilot system received (month/year)?
Will the GE service personnel be required to take site EHS (Environment, Health and Safety) or secu­rity training before doing the installation?
Assigned personnel
Personnel are assigned as specified.
Does the personnel experience level with the ÄKTApilot system correspond to:
new user?
intermediate user?
advanced user?
Will the personnel require training on how to use the ÄKTApilot system?
Site selection
Site complies with requirements for biosafety
General site requirements are fulfilled
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Comment/specifyN/ANOYESRequirement
Space requirements
Space is available as specified.
Environmental requirements
The proper environmental conditions are fulfilled as specified.
Ambient temperature
Relative humidity
Atmospheric pressure
Electrical requirements
Electrical requirements are fulfilled as specified.
Four (4) grounded wall outlets
Computer requirements
A computer has been purchased and received
Has an administrator account been creat­ed and a logon password established for our use?
Will the computer be connected to a net­work?
Is there on-site IT support available if needed?
Are the computer requirements fulfilled?
User supplied equipment
Personal Protective Equipment (PPE) as required (e.g., gloves, lab coats, etc.)
Printer connected to the system computer
Calibrated balance with certificate (range 500 g to 5000 g)
Access to photocopier
Waste flask, 10 liters
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Comment/specifyN/ANOYESRequirement
4-5 reagent vessels
Inlet and Outlet tubing according to the system specification
General laboratory equipment (e.g., wipes, syringes, etc.)
User supplied consumables
High quality water, filtered, 10 liters
Ethanol 20%, 3 liters
Acetone
1% in high quality water, 10 liters
0.4% in 1 M sodium chloride, 5 liters
pH solutions, pH 4.00, 7.00 and 10.00
Conductivity solutions, approximately 2, 12 and 110 mS/cm
Additional information
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Customer contact information
Date (dd-mmm-yyyy)
Company/Customer name
Company/Customer representative
Name
Address
Email
Phone number
AdvancedIntermediateBeginnerCustomer experience level
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3 Site preparation checklist
GE and GE monogram are trademarks of General Electric Company.
ÄKTA and UNICORN are trademarks of General Electric Company or one of its subsidiaries.
Firefox is a trademark of Mozilla Corporation.
Google chrome is a trademark of Google Inc.
Windows and Internet Explorerareregistered trademarks of Microsoft Corpora­tion.
All other third party trademarks are the property of their respective owner.
© 2015 General Electric Company – All rights reserved. First published Jan. 2015
All goods and services are sold subject to the terms and conditions of sale of the company within GE Healthcare which supplies them. A copy of these terms and conditions is available on request. Contact your local GE Healthcare repre­sentative for the most current information.
GE Healthcare Europe GmbH Munzinger Strasse 5, D-79111 Freiburg, Germany
GE Healthcare UK Limited Amersham Place, Little Chalfont, Buckinghamshire, HP7 9NA, UK
GE Healthcare Bio-Sciences Corp. 800 Centennial Avenue, P.O. Box 1327, Piscataway, NJ 08855-1327, USA
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For local office contact information, visit www.gelifesciences.com/contact
GE Healthcare Bio-Sciences AB Björkgatan 30 751 84 Uppsala Sweden
www.gelifesciences.com/contact
29-1396-54 AA 01/2015 a18
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