GE AKTApilot Betriebsanleitung

ÄKTApilot™

Site Preparation Guide

Table of Contents

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

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

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

2 ÄKTApilot Site Preparation Guide 29-1396-54 AA

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.

ÄKTApilot Site Preparation Guide 29-1396-54 AA 3

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 re-

quirements.

•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 instal-

lation 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 ÄKTApilot Site Preparation Guide 29-1396-54 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 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 re-

quirements 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 area for

operating the ÄKTApilot system

ÄKTApilot Site Preparation Guide 29-1396-54 AA 5

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).

6 ÄKTApilot Site Preparation Guide 29-1396-54 AA

2 Site preparation overview

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

ÄKTApilot Site Preparation Guide 29-1396-54 AA 7

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 lo-

cally. 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 64-

bit

Operating system

UNICORN 5 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 computerPrinter

Access to photocopierPhotocopier

Calibrated balance with certificate (range 500

g to 5000 g)

Balance

10 literWaste flask

8 ÄKTApilot Site Preparation Guide 29-1396-54 AA

2 Site preparation overview

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

ÄKTApilot Site Preparation Guide 29-1396-54 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 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 secu-

rity 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

10 ÄKTApilot Site Preparation Guide 29-1396-54 AA

3 Site preparation checklist

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