GE AKTAcrossflow Operating instructions

ÄKTAcrossflow™
Site Preparation Guide

Table of Contents
31 Introduction ..........................................................................................................
52 Site preparation overview ..................................................................................
103 Site preparation checklist ..................................................................................
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Table of Contents

1 Introduction
Purpose of this document
The purpose of this document is to give 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 ÄKTAcrossflow system.
The ÄKTAcrossflow system consists of the following components:
•ÄKTAcrossflow 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 number 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 divided between two or
three people from the customer.
It is recommended that the same people assist the GE service personnel during the in-
stallation process later on.
Site preparation tasksPersonnel
Site preparation/
installation
coordinator
•Review the site preparation guide for safety information and system re-
quirements.
•Choose the site.
•Coordinate personnel and tasks.
•Coordinate the installation timing of the system with any domestic safety
procedures and testings.
•Order required materials.
•Schedule the installation and inform 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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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 has to 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 ÄKTAcrossflow
system will be installed:
•ÄKTAcrossflow 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. The following space requirements must be fulfilled
at the bench where the ÄKTAcrossflow system will be installed:
SpecificationParameter
1200 x 600 mmMinimum bench area for operating the
ÄKTAcrossflow system
The bench must be able to support the
total weight of the system
Load capacity
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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 ÄKTAcrossflow system.
650 mm
400 mm
620 mm
The weight of the ÄKTAcrossflow system is 70 kg (monitor arm and computer not includ-
ed).
Note: •The ÄKTAcrossflow system weighs 70 kg and requires at least three people
to lift and move unless a suitable lifting device is used.
•The ÄKTAcrossflow system can be transported on a trolley capable of
supporting at least 100 kg.
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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
900 VAMax power
T 8.0 AH 250 VFuse
3Number of wall outlets
•One for the ÄKTAcrossflow system
•One for the computer
•One for the monitor
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 lo-
cally. Install the client computer equipment according to the manufacturer's
instructions.
Note:
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The ÄKTAcrossflow system consists of a ÄKTAcrossflow system separation unit, a con-
nected computer including a flat-screen monitor, and UNICORN control system. The
following table specifies the computer requirements.
SpecificationParameter
Windows®7 Professional, 32-bit or 64-
bit or
Operating system
Windows XP Professional, SP3
UNICORN v5.31 or higher versions.Control system
Note: •The computer should be installed, placed and used according to the instruc-
tions and specifications provided by the manufacturer of the computer.
•A printer should be connected to the computer.
•The computer should not be connected to a network before the installation.
User-supplied accessories and
consumables
The following equipment must be supplied by the user:
SpecificationEquipment
Printer connected to system computer
For printing the installation test report
Printer
Access to photocopier
For copying paper to the binder
Photocopier
N/AWaste flask
N/AReagent vessels
Gloves, lab coats, etc.Personal Protective Equipment (PPE)
as required
The following chemicals must be supplied by the user:
SpecificationItem
Distilled, 3 litersHigh quality water
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SpecificationItem
1000 ml 1 M sodium chloride with 0.4% acetone and 15 mM
phosphoric acid added
Acetone
Sodium chloride
Phosphoric acid
20%Ethanol
10 mMSodium hydroxide
All reagents should be filtered and degassed, and all reagents 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 ÄKTAcrossflow.
You must send the completed checklist to a GE office before GE service personnel can
install ÄKTAcrossflow. See E-mail addresses and fax numbers in Chapter 1.
Checklist
Comment/specifyN/ANOYESRequirement
General
When was the ÄKTAcrossflow system received
(month/year)?
Will the GE service personnel be required to take
site EHS (Environment, Health and Safety) or secu-
rity training before doing the installation?
Assigned personnel
Personnel are assigned as specified.
Does the personnel experience level with
the ÄKTAcrossflow system correspond to:
•new user?
•intermediate user?
•advanced user?
Will the personnel require training on how
to use the ÄKTAcrossflow 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.
Three (3) grounded wall outlets
Computer requirements
A computer has been purchased and received
Has an administrator account been creat-
ed and a logon password established for
our use?
Will the computer be connected to a net-
work?
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
Access to photocopier
Waste flask
Reagent vessels
User supplied consumables
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Comment/specifyN/ANOYESRequirement
High quality water, distilled, 3 liters
Ethanol 20%
Acetone 0.4%
(For 1000 ml 1 M sodium chloride with 0.4%
acetone and 15 mM phosphoric acid
added)
Sodium chloride 1 M
(For 1000 ml 1 M sodium chloride with 0.4%
acetone and 15 mM phosphoric acid
added)
Phosphoric acid 15 mM
(For 1000 ml 1 M sodium chloride with 0.4%
acetone and 15 mM phosphoric acid
added)
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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GE and GE monogram are trademarks of General Electric Company.
ÄKTA, ÄKTAcrossflow and UNICORN are trademarks of General Electric Company
or one of its subsidiaries.
Windows is a registered trademark 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 repre-
sentative 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
GE Healthcare Japan Corporation
Sanken Bldg. 3-25-1, Hyakunincho Shinjuku-ku, Tokyo 169-0073, Japan
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
29-1396-59 AA 01/2015 a12