GRIFOLS DG Spin Instructions For Use Manual

DG Spin

DG Spin

Diagnostic Grifols, S.A.

Passeig Fluvial, 24, 08150 Parets del Vallès,

Barcelona - ESPAÑA

Tel. [34] 935 710 400 Fax [34] 935 731 132 www.grifols.com

Instrucciones de Utilización

3027662 07/2008

Instructions for Use

Instrucciones de Utilización Instructions for Use

Diagnostic Grifols, S.A. Passeig Fluvial, 24 - 08150 Parets del Vallès, ESPAÑA (SPAIN)

DG spin

Instructions for Use

PLEASE READ THESE INSTRUCTIONS FOR USE CAREFULLY BEFORE

STARTING TO WORK WITH THE

DG SPIN

CENTRIFUGE

Information about matter relating to the equipment safety can be found in the
chapter 2 “Safety information”.

The symbols used in these Instructions for Use are as follows:

DANGER!
Any kind of injure – critical or not- for people

(including patients), that only can be diminished
following the instructions shown.

WARNING!
Any kind of injure for people (including patients)

for which other protection systems are
provided, but it is convenient the RESPONSIBLE
AUTHORITY or the OPERATOR knows it.

CAUTION!
Any kind of harmful situation for equipment or

others. This situation can be diminished using
this indication or with other protections.

NOTE:
Use for clarification and complementary or

emphasised information.

Definitions:
RESPONSIBLE AUTHORITY

:

Individual or group responsible for the use and
maintenance of the equipment and for ensuring that operators are adequately
trained.

OPERATOR

:

Person operating equipment for its intended purpose. The

OPERATOR should have received appropriate training for this purpose.
QUALIFIED TECHNICIAN

:

Person responsible for the installation, reparation
and special maintenance of the equipment who has received specific training
for this purpose.

All restrictions referred to RESPONSIBLE AUTHORITY are valid for the
OPERATOR.

Equipment design and specifications are subjected to change without previous
notification.

This document is available in various languages. Translations have been carried
out from the master document in English. In case of doubt or discrepancies, what
is expressed in the master document in English will be given priority.

DG Spin

 Index

i

INDEX

1 INTRODUCTION 1-1

1.1 INTENDED USE 1-1

1.2 PURPOSE, LIMITATIONS AND OPERATORS TRAINING 1-1

1.2.1

Purpose 1-1

1.2.2

Limitations 1-1

1.2.3

Training 1-1

2 SAFETY INFORMATION 2-1

2.1 IMPORTANT SAFETY INSTRUCTIONS 2-1

2.2 EQUIPMENT LABELLING 2-3

2.3 READ BEFORE USE 2-5

3 SPECIFICATIONS OF THE CENTRIFUGE 3-1

3.1 TECHNICAL SPECIFICATIONS 3-1

3.2 ACCESSORIES 3-2

3.3 REGULATORY 3-3

4 DESCRIPTION OF THE CENTRIFUGE 4-1

4.1 GENERAL DESCRIPTION OF THE CENTRIFUGE 4-1

4.1.1

Centrifugation chamber 4-2

4.1.2

DG Spin head 4-3

4.1.3

Centrifuge cover 4-4

4.1.4

Control buttons 4-4

4.1.4.1 Centrifugation starting button 4-4

4.1.4.2 Centrifugation stopping button 4-4

4.1.4.3 Cover opening button 4-4

4.1.5

Display 4-4

4.1.5.1 Remaining centrifugation time information 4-5

4.1.5.2 Units 4-6

4.1.5.3 Warnings area 4-6

4.1.6

Security ring 4-6

5 INSTALLATION 5-1

5.1 ACTION UPON DELIVERY 5-1

5.2 INSTALLATION REQUIREMENTS 5-1

5.3 UNPACKING THE EQUIPMENT 5-2

5.4 INSTALLATION PROCEDURE 5-2

5.5 CONFIGURATION OF THE EQUIPMENT 5-3

DG Spin

Index

ii

5.5 CONFIGURATION OF THE EQUIPMENT 5-3

6 OPERATING PROCEDURE 6-1

6.1 EXECUTION OF A CENTRIFUGATION BATCH 6-1

6.2 VISUALISATION OF THE CENTRIFUGATION SPEED 6-3

6.3 CENTRIFUGATION STOP 6-4

7 MAINTENANCE 7-1

7.1 MAINTENANCE PLAN 7-1

7.1.1

Cleaning procedures 7-2

7.1.2

Decontamination of the equipment 7-3

7.1.2.1 Decontaminant liquids 7-4

8 OPERATION QUALIFICATION PROCEDURE (OQ) 8-1

8.1 REQUIRED MATERIALS 8-1

8.2 PROCEDURE FOR QUALIFICATION OF CENTRIFUGATION SPEED 8-2

8.3 PROCEDURE FOR QUALIFICATION OF THE OUT-OF-BALANCE CONTROL
SYSTEM 8-3

9 TRANSPORT AND STORAGE 9-1

10 DISPOSAL OF THE EQUIPMENT 10-1

11 WARRANTY 11-1

12 RESOLUTION OF INCIDENCES 12-1

12.1 WARNINGS OR INCIDENCES 12-1

12.2 ERROR MESSAGES 12-4

12.3 ACOUSTIC ALARM 12-4

MAINTENANCE SERVICES CARRIED OUT I

DG Spin

 Introduction

1-1

1 INTRODUCTION

THIS EQUIPMENT IS AN

IN VITRO

DIAGNOSTIC MEDICAL DEVIDE

(IVD).

These Instructions for Use, which are intended for the OPERATORS of the

DG Spin

incubator, contain all the information that is necessary for safely and

adequately working with the instrument.
Please carefully read all this information before attempting to work with the

equipment, especially on the maintenance section, the suggestions for correct use
and the information about contaminating liquids.

If you have any doubt please contact the manufacturer or corresponding
distributor before starting any operation.

These Instructions for Use should be accessible to all the personnel who work with
the instrument.

1.1 Intended use

The centrifuge

DG Spin

enables centrifugation of

DG Gel

cards.

1.2 Purpose, limitations and operators training

1.2.1 Purpose

The

DG Spin

centrifuge has been especially designed to carry out centrifugation of

a maximum of 24

DG Gel

cards in one batch. Therefore, the predefined
parameters in the instrument (speed and time) are those required to work with
this type of card.

1.2.2 Limitations

The

DG Spin

centrifuge is only prepared for the centrifugation of

DG Gel

cards as
described in section 1.1 "Intended use", and should not be used for any other type
of test different to those for which it was designed.

1.2.3 Training

Use of the

DG Spin

centrifuge does not require specific training beyond that

established by the laboratory itself.

DG-Spin

Safety Information

2-1

2 SAFETY INFORMATION

2.1 Important safety instructions

The following indications are directly related to the safety of the equipment:

DANGER!
Misuse of the equipment can impair the

protection provided by itself.

DANGER!
To avoid risk of electric shock, this equipment

should only be connected to a supply main with
protective earth.

DANGER!
This equipment works with substances that

carry a chemical or biological risk. The
established regulations for working in
laboratories in relation to the use of suitable
gloves or other personal protective means
should be followed.

DANGER!
In the event of any spillage into the equipment,

it must be isolated from the mains supply,
cleaned up and decontaminated. The instrument
must be only disassembled by a QUALIFIED
TECHNICIAN and it must not be connected
again until it has been fully inspected by the
QUALIFIED TECHNICIAN.

DG-Spin

Safety Information

2-2

WARNING!
This equipment only must be used by the

RESPONSIBLE AUTHORITY, OPERATORS and
QUALIFIED TECHNICIANS.

WARNING!
Electromagnetic compatibility and electrical

safety tests have been performed using the
cord supplied by the manufacturer. However, if
it is necessary to use another cord, be sure that
the new cord meets the following
specifications:

Cable type

: Flexible cable with insulation and
PVC cover with 3 conductors (neutral, live and
earth).

Cord length

: 2 m.

Conductor section

: 1 mm2 or higher.

Connector type

: For IEC inlet. Connector for

class I appliances.
Plug type

: Plug type used in the country where
the equipment is installed and with earth
connection.

Connector, cable and plug must comply
electrical safety requirements applicable in your
country.

CAUTION!
Using cables other than those specified may

result in increased electromagnetic emissions
and/or decreased immunity of the equipment.

DG-Spin

Safety Information

2-3

WARNING!
Basic safety precautions should always be

taken including those indicated in section 2.3
“Read before use”. Furthermore, before
installing the equipment, the rules of 5.2
“Installation requirements” section must be
read.

2.2 Equipment labelling

The

DG Spin

centrifuge is labelled with the following labels:

(4) Packaging label
(5) Identification and Basic Technical Characteristics of the equipment

label

(6) Biological risk of the Centrifugation chamber.

(1) Packaging label
Label located on the right upper part of the front of the box that is the packaging

of the

DG Spin

centrifuge.

The following symbols are used on the labels:

Serial number

Catalogue number

DG-Spin

Safety Information

2-4

Temperature range permitted during storage and
transport

Relative humidity range permitted during storage and
transport

European conformity

(2) Identification and Basic Technical Characteristics label
Label located on the rear part of the equipment containing technical information

(mains tension, frequency and power) as well as the model, serial number,
manufacturing date, name and address of the manufacturer and regulatory
information.

Symbols additional to those described are:

Manufacturing date

In vitro

diagnostic Use only

Directive 2002/96/EC on Waste Electrical and
Electronic Equipment. See chapter 10 “Disposal of the
equipment”.

DG-Spin

Safety Information

2-5

(3) Biological risk level
Located on the lateral part of the Centrifugation chamber, it indicates and warns

of the biohazard caused by possible remaining substances deposited on the
surface.

2.3 Read before use

- Use the equipment only for the purposes described in the Instructions
for Use.

- Unless specifically instructed to do so by the Instructions for Use, do
not drop or put anything into any opening in the equipment.

- Do not use the equipment if it is not working properly, or if it has
suffered any damage. Examples of defects typically include:

- Visible damage caused by dropping the equipment.

- Visible damage caused by liquid spillage.

- Visible damage caused by subjection to prolonged storage and

under unfavourable conditions or by subjection to severe
transport stresses.

- Damage to the flexible supplies cord or its plug.

- Do not use the equipment in hazardous atmosphere, or with hazardous
materials for which the equipment has not been designed.

- Do not use the equipment in the presence of inflammable gases or
volatile products.

- Do not use accessories which are not supplied or recommended by the
manufacturer.

- Do not introduce inflammable, explosive or chemical materials that
interact vigorously into the centrifuge.

- Do not lean on the centrifuge.

- The equipment may only be disassembled by a QUALIFIED
TECHNICIAN, either for internal cleaning and/or for repairing. Before
disassembling, the equipment must be unplugged.

- Before using any cleaning or decontaminating method described in
chapter 7 “Maintenance”, the equipment must be unplugged.

DG Spin

 Specifications of the Centrifuge

3-1

3 SPECIFICATIONS OF THE CENTRIFUGE

3.1 Technical specifications

MODEL

DG spin

LOAD CAPACITY

24

DG Gel cards

DG SPIN

HEAD

Removable and interchangeable

CENTRIFUGATION
CONDITIONS

Pre-programmed. Those required for

DG Gel cards

CENTRIFUGATION
SPEED

990 rpm ± 10 rpm (128.1 g ± 1.0 %)

CENTRIFUGATION
UNITS

Programmable, rpm or g

CENTRIFUGATION TIME

9 minutes

ACOUSTIC ALARM

Yes, to indicate end of centrifugation and error
situations

VOLUME OF ACOUSTIC
ALARM

Programmable, 3 levels.

SAFETY SYSTEMS

• Out-of-balance control

• Detection of door opening

• Safety closure

INTERFACE

LCD screen and Buttons

Voltage: 100–240 V ~

Frequency: 50-60 Hz

Input power: 50 W

SUPPLY

Fuses 2x T2AL 250 V, 5x20 mm

PROTECTION AGAINST
ELECTRIC SHOCK

Class: I

INSTALLATION
CATEGORY

Overvoltage category II (local level, appliances,
portal equipment, etc.)

DIMENSIONS (mm)

525 (depth) x 410 (width) x 180 (height)

DG Spin

Specifications of the Centrifuge

3-2

WEIGHT (KG)

Approximately 15 kg

Indoor use

Temperature: 15ºC to 40ºC

Maximum relative
humidity non
condensing:

80 %

Maximum altitude: 3000 m

WORK CONDITIONS

Mains supply
maximum voltage
fluctuations:

±10 % of nominal voltage

Temperature: -10 ºC to 60 ºC

TRANSPORT AND
STORAGE CONDITIONS

Maximum relative
humidity non
condensing:

85 %

USEFUL LIFE

5 years considering a normal function of 8
hours/day and 200 days/year.

WARNING!
According to regulation EN 60601-1-2, it is

recommended that relative humidity of the
room where the equipment is installed be not
less than 30%. Although the equipment may
function normally with relative humidity below
30%, in extremely dry environments
electrostatic discharge may occur that could
damage the equipment.

3.2 Accessories

CODE DESCRIPTION PRESENTATION

210364

DG Spin

Head 1

DG Spin

 Specifications of the Centrifuge

3-3

3.3 Regulatory

The

DG Spin

centrifuge comforms to the requeriments of:

- EU Directive 98/79/EC on “

In Vitro

Diagnostic Medical Devices”.

- EU Directive 2002/96/EC on “Waste electrical and electronic
equipment".