GE AKTAcrossflow Betriebsanleitung

ÄKTAcrossflow™

Site Preparation Guide

Table of Contents

31 Introduction ..........................................................................................................

52 Site preparation overview ..................................................................................

103 Site preparation checklist ..................................................................................

2 ÄKTAcrossflow Site Preparation Guide 29-1396-59 AA

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.

ÄKTAcrossflow Site Preparation Guide 29-1396-59 AA 3

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

4 ÄKTAcrossflow Site Preparation Guide 29-1396-59 AA

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 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

ÄKTAcrossflow Site Preparation Guide 29-1396-59 AA 5

2 Site preparation overview

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.

6 ÄKTAcrossflow Site Preparation Guide 29-1396-59 AA

2 Site preparation overview

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:

ÄKTAcrossflow Site Preparation Guide 29-1396-59 AA 7

2 Site preparation overview

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

8 ÄKTAcrossflow Site Preparation Guide 29-1396-59 AA

2 Site preparation overview

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

ÄKTAcrossflow Site Preparation Guide 29-1396-59 AA 9

2 Site preparation overview

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

10 ÄKTAcrossflow Site Preparation Guide 29-1396-59 AA

3 Site preparation checklist

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