GRIFOLS DG Spin User 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
1INTRODUCTION
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
2SAFETY 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 mm2or 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
3SPECIFICATIONS 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".

DG Spin Description of the Centrifuge
4-1
4DESCRIPTION OF THE CENTRIFUGE
4.1 General description of the centrifuge
Figure 1 and Figure 2 show, respectively a front and rear image of the DG Spin
centrifuge.
2
1
3
4
5
22
11
33
44
55
Figure 1: General view of the DG Spin centrifuge
(1) Centrifugation chamber
(2)
DG Spin Head
(3) Centrifuge cover
(4) Control buttons
(5) Display

DG Spin Description of the Centrifuge
4-2
7
6
10
9
8
77
66
10
99
88
Figure 2 : Rear view of the DG Spin centrifuge
(6) Main switch
(7) Fuses housing
(8) Mains cord connection
(9) Security ring housing
(10) Connection to a computer (for exclusive use of the authorised
Technical Service)
4.1.1 Centrifugation chamber
The Centrifugation chamber (Ref. (1), Figure 3) is the centrifuge area designed to
house the removable
DG Spin Head, contain any dirt caused by possible
fortuitous spillages or leaks and facilitate its cleaning.
1
2
3
11
22
33
Figure 3 : Centrifugation chamber

DG Spin Description of the Centrifuge
4-3
(1) Centrifugation chamber
(2) Lean axle and Crosshead of
DG Spin Head
(3) Motor protective cover
The Centrifugation chamber also has a protective cover (Ref. (3), Figure 3) that
protects the motor.
4.1.2
DG Spin head
The
DG Spin head is a circular support with 24 positions numbered with Card
holders (Ref. (2), Figure 4) to place the
DG Gel cards for their centrifugation.
1
2
3
11
22
33
Figure 4 : DG Spin Head
(1) Knob
(2)
DG Gel card holders
(3) Direction of centrifugation
The
DG Spin Head is removable and interchangeable with the aim of increasing
the comfort of the OPERATOR when loading and unloading the cards. To remove
it, lift it vertically by means of the Knob (Ref. (1), Figure 4) until it is released from
its Lean axle (Ref. (2), Figure 4).
To introduce the
DG Spin Head again into the centrifuge, the Crosshead of the
Lean axle has a magnetic system that facilitates correct positioning of the
DG Spin
Head.

DG Spin Description of the Centrifuge
4-4
4.1.3 Centrifuge cover
The
DG Spin centrifuge has a safety transparent cover (Ref. (3), Figure 1) with a
hinge and an electromagnetic safety closure.
4.1.4 Control buttons
The
DG Spin centrifuge has three buttons (Ref.(4), Figure 1) for control of
centrifugation.
123 11 22 33
Figure 5 : Centrifugation Control buttons
(1) Centrifugation starting button ( )
(2) Centrifugation stopping button ( )
(3) Cover opening button ( )
4.1.4.1 Centrifugation starting button
Pressing the button starts the centrifugation cycle. It is essential that the
Cover to be closed.
4.1.4.2 Centrifugation stopping button
Pressing the button centrifugation may be stopped before the established time
ends.
4.1.4.3 Cover opening button
Pressing the button, the Cover to get to inside (Ref. (3), Figure 1) of the
DG Spin centrifuge opens. The Cover will open only if the motor is completely
stopped.
4.1.5 Display
The Display (Ref. (5), Figure 1) informs the OPERATOR of the remaining time to
the end of centrifugations and speed. It also informs of possible error situations.

DG Spin Description of the Centrifuge
4-5
4
1 3 2
44
11 33 22
Figure 6 : Display
(1) Centrifugation speed information
(2) Timer information
(3) Centrifugation speed units
(4) Warnings area
4.1.5.1 Remaining centrifugation time information
In normal mode, the Display shows on the right, the time remaining up to end of
centrifugation of the batch by means of a digital counter (Ref. (1), Figure 7) and a
progress bar (Ref. (2), Figure 7). The Progress bar will be filled in as the pre-
programmed time elapses.
1
2
11
22
Figure 7: Display with a centrifugation batch in execution
(1) Remaining centrifugation time
(2) Progress bar