MABTECH IRIS FluoroSpot reader Manuale utente

Operating Instructions

Mabtech IRIS™

FluoroSpot/ELISpot reader

Table of Contents

Introduction �� 3

Intended use �� 3

Symbols�� 3

Labels �� 3

Contact information �� 3

Regulatory information �� 4

Quality Management System (QMS) �� 5

Safety �� 6

Product description�� 8

Overview �� 8

In this package �� 8

Cleaning/Decontamination �� 9

Disposal�� 9

Warranty �� 9

Technical specications �� 10

Setup and installation �� 11

How to use the Mabtech IRISTM FluoroSpot/ELISpot reader

Service, maintenance, and transport�� 16

To replace the fuses�� 17

Introduction

Intended use

Mabtech IRIS™: Detection of secreting cells in ELISpot and FluoroSpot assay�

For research use only�

Symbols

These symbols are shown on the reader:

Symbols Description

Complies with the directives

listed under “Regulatory

information”

S/N Serial number

Electronic waste, disposal

according to WEEE

Warning! The operating

instructions must be consulted

in all cases where this symbol

is marked�

Labels

Machine label:

Contact information

Mabtech AB

Augustendalstorget 9

SE-131 52 Nacka Strand

Sweden

Customer service:

Phone: +46 8 716 27 00

E-mail: mabtech@mabtech�com

Regulatory information

The Mabtech IRISTM FluoroSpot/ELISpot reader complies with the following directives:

Directive Applied standards

CE mark for the European Economic Area (EEA)

2014/30/EU – Electromagnetic

Compatibility Directive (EMC)

• EN 61326-1, edition 3:2013-01-11

• EN 61326-2-6, edition 2:2013-05-03

• EN 55011, edition 5:2016-04-01 +A1:2017-04-

21+A11:2020-03-06+A2:2021-04-09

• EN 61000-3-2, edition 5:2019-03-01, edition

4:2014-08-22

• EN 61000-3-3, edition 3:2013-08-23+A1:2019-08-02

2014/35/EU – Low Voltage Directive (LVD) • EN 61010-1, edition 3:2010-10-15+ A1:2019-02-22

• EN 61010-2-101, edition 2:2017-02-24

Safety test according to particular requirements for

in vitro diagnostic (IVD) medical equipment.

• EN 62471, edition 1:2008-09-12

2011/65/EU – Restriction of Hazardous

Substances Directive (RoHS)

• CENELEC EN IEC 63000, edition 1:2018-12-07

2006/42/EC – Machinery Directive (MD)

North America

FCC Part 2 • §§2�906 SDoC:2019-10-01

FCC Part 15* • §15�107:2019-10-01

• §15�109:2019-10-01

ICES-003 • Issue 7:2020-10-15

International Standards

EMC • IEC 61326-1, edition 2:2012-07-10

• IEC 61326-2-6, edition 2:2012-07-10

• CISPR 11, edition 6:2015-06-09+A1:2016-06-

23+A2:2019-01-18

• IEC 61000-3-2, edition 5:2018-01-26; edition

4:2014-05-26

• IEC 61000-3-3, edition 3:2013-05-14+A1:2017-05-18

Safety • IEC 61010-1, edition 3:2010-06-10+A1:2016-12-16

• IEC 61010-2-101, edition 2:2015-01-23

• IEC 62471, edition 1:2006-07-26

*This equipment has been tested and found to comply with the limits for a Class B

digital device, pursuant to part 15 of the FCC Rules� These limits are designed to provide

reasonable protection against harmful interference in a residential installation� This

equipment generates, uses, and can radiate radio frequency energy and, if not installed

and used in accordance with the instructions, may cause harmful interference to radio

communications� However, there is no guarantee that interference will not occur in a

particular installation� If this equipment does cause harmful interference to radio or

television reception, which can be determined by turning the equipment off and on, the

user is encouraged to try to correct the interference by one or more of the following

measures:

• Reorient or relocate the receiving antenna�

• Increase the separation between the equipment and the receiver�

• Connect the equipment into an outlet on a circuit different from that to which the

receiver is connected�

• Consult the dealer or an experienced radio/TV technician for help�

Quality Management System (QMS)

Standard Description

EN ISO 13485:2016, Edition 4:2016-03-02 • Medical devices - Quality management systems -

Requirements for regulatory purposes

EN ISO 9001:2015, Edition 5:2015-09-15 • Quality management systems – Requirements

Safety

Before you install or operate the system, you must read the safety information� There

is a risk of user injury or damage to the system if the instructions in this manual are not

followed�

Warning! Risk of personal injury if instructions are not followed�

Caution! Risk of material damage if instructions are not followed�

Note: General information or advice on optimal use of the system�

Warning! The Mabtech IRISTM FluoroSpot/ELISpot reader must only be used

by trained persons�

Warning! Do not remove the cover of the reader� Injury to eyes from UV

light can result� All internal service and maintenance work must be done by

an approved technician� Contact Mabtech for more information�

Warning! Do not keep or use ammable or non-ammable liquids near the

system. Risk of re.

Warning! Use caution when you put a microtiter plate in the reader� Risk of

injury to the ngers.

Warning! Do not look inside the machine during reading� Risk of injury to

eyes from UV light�

Warning! Follow the instructions in this manual when you lift or move the

reader� Risk of injury to the persons or damage to the system�

Warning! The instrument may not be used together with biohazardous

substances�

Warning! Do not use the instrument near sources of strong

electromagnetic radiation (e�g� unshielded intentional RF sources), as these

can interfere with the operation of the instrument�

Warning! Do not connect faulty equipment to the system� Risk of electrical

shock and damage to the system�

Warning! Connect all cables correctly when you install the system� Risk of

electrical shock�

Warning! To disconnect power, unplug either end of the power cable� Place

the reader so that the plug can be easily separated from the wall socket�

Caution! Only use the microtiter plate types specied under “Technical

specications.” Other plates can cause malfunction and electrical failure.

Caution! Do not insert microtiter plates that contain liquid� Risk of short

circuit in the reader�

Caution! Do not place objects near or on the reader� Vibrations from the

reader can make objects fall�

Product description

Overview

Number Description Number Description

1Cover 5 USB port

2Power button 6Ethernet port

3Door to plate loader 7 IEC inlet with fuse holder

4Programming switch*

*Programming switch should be set downwards

In this package

The following parts are included in the package:

• Mabtech IRISTM FluoroSpot/ELISpot reader

• USB cable

• Ethernet cable

• Power cable

• Spare fuse

• Operating Instructions (this manual)

Cleaning/Decontamination

Clean the outside of the Mabtech IRISTM FluoroSpot/ELISpot reader with a damp cloth

when needed�

Before you send the system to any third party, ll out a certicate of decontamination to

ensure that the instrument does not contain any potential contaminants.

Warning! The instrument may not be used with biohazardous substances�

Please note that Mabtech cannot accept any instrument or parts that may be

contaminated with biohazardous substances such as viable biological agents, harmful

quantities of chemicals, or radioactive materials.

Disposal

By the end of the reader life, recycle at a designated local reception point for

Waste Electrical and Electronic Equipment (WEEE)� You must not discard the

reader as household waste�

Warranty

Refer to the Mabtech General Terms & Conditions of Sale found on

http://www�mabtech�com/terms-and-conditions or the contractual agreement between

the seller and the buyer�

Caution! Failure to obey the instructions in this manual will void the

warranty�

Caution! The safety of any system or equipment that incorporates the

Mabtech IRISTM FluoroSpot/ELISpot reader is the responsibility of the person

connecting the reader to that system or equipment�

Technical specifications

Power supply

AC input voltage 100 to 240 VAC

AC input current Max 1 A @100–240 VAC

AC frequency 50 to 60 Hz

DC input voltage 5 VDC, 0�5 A max

Power consumption 100 W max

Fuses Quick-Acting F4A H, 250 VAC (H = High Breaking

Capacity (Ceramic Tube))

Operation and Maintenance

Interfaces 1 RJ45 port LAN 1000BASE-T

USB 3�0

Dimensions (H × W × D) 505 mm × 430 mm × 400 mm

Weight 25�5 kg

Environmental specications For indoor use only, +5ºC to +40ºC (+41ºF to +104ºF)

Altitude up to 2000 m

Relative humidity range: 5–95%

Pollution Degree 2

Mains supply tolerance (%) or absolute

mains supply values (voltage uctuations

of the nominal voltage)

+/-10%

Transient overvoltages Overvoltage Category II

Surge Level 3 (CM 12 ohm) & 4 (DM 2 ohm): 2 kV– 1�2/50

µs

IP class IP20

Key features

Read/calculation speed ELISpot < 2 min/plate

FluoroSpot 1 color < 5 min/plate

FluoroSpot 2 colors < 7 min/plate

FluoroSpot 3 colors < 10 min/plate

FluoroSpot 4 colors < 13 min/plate

Resolution (H × W) 2048 × 2048 pixels

Approved plate types 96-well lter plates with 0.45 µm PVDF membrane:

IPFL, MSIP, or MAIPSWU10 (with an adapter)

The Mabtech IRISTM FluoroSpot/ELISpot reader must be connected to a computer

equipped with the Mabtech ApexTM -software�

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