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DG Spin

 

Procedure for Qualification of the Operation (OQ)

 

 

8-1 

8

 

OPERATION QUALIFICATION PROCEDURE (OQ) 

The 

DG Spin

 centrifuge has two non-adjustable independent time basis controlled 

by the centrifuges program itself. Given that the speed has been calibrated by the 

manufacturer, if no function alarm is activated (see sections 12.1 and 12.2), it is 
warranted that 

DG Spin

 centrifuge will correctly work for all its useful life, without 

any additional calibration. 
However, the procedure described below aims to provide a method for those 

laboratories which, under a quality management system, should periodically verify 
that the 

DG Spin

 centrifuge works under specifications.  

The Operation Qualification Procedure (OQ)

 

of the

 DG Spin

 centrifuge consists 

of verifying the correct function of the following parameters: 

-

 

Centrifugation speed 

-

 

Balance control system  

8.1

 

Required materials  

To qualify operation of the 

DG Spin

 centrifuge the following materials are 

required: 

-

 

Calibrated optical tachometer 

-

 

24 

DG Gel

 cards 

To warranty the veracity of measurements, these materials should be calibrated 

using instruments controlled regularly with traceable materials at primary or 
secondary reference standards.  

 

NOTE: 
The use of any tachometer is possible as long 
as it complies with the following specifications:  
Tachometer: Optical 
Scale division (rpm):

 

≤

1 rpm

 

 

Range (rpm): 1.00 - 99,999 rpm 
Maximum uncertainty permitted: 

±  3 rpm

 

Detection distance: < 35 cm with visible red 
light 

 

 

Summary of Contents for DG Spin

Page 1: ...s 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 ...

Page 2: ...Diagnostic Grifols S A Passeig Fluvial 24 08150 Parets del Vallès ESPAÑA SPAIN DG spin Instructions for Use ...

Page 3: ...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...

Page 4: ...sponsible 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 maste...

Page 5: ...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 ...

Page 6: ...nation 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 INCIDE...

Page 7: ...s 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 ...

Page 8: ...rotective 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 ...

Page 9: ...g 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 applica...

Page 10: ...ust 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...

Page 11: ... 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 chapte...

Page 12: ...aused 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 w...

Page 13: ...mable 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...

Page 14: ... 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 ...

Page 15: ...s 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 ...

Page 16: ...l 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 2 2 1 1 3 3 4 4 5 5 Figure 1 General view of the DG Spin centrifuge 1 Centrifugation chamber 2 DG Spin Head 3 Centrifuge cover 4 Control buttons 5 Display ...

Page 17: ...ty 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 1 1 2 2 3 3 Figure 3 Centrifugation chamber ...

Page 18: ...Gel cards for their centrifugation 1 2 3 1 1 2 2 3 3 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 T...

Page 19: ...r 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...

Page 20: ...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 1 1 2 2 Figure 7 Display with a centrifugation batch in execution 1 Remaining centrifugation time 2 Progress ...

Page 21: ...ontact the Technical Service Batch completed with Erroneous centrifugation time The Cover centrifuge is opened Out of balance during centrifugation Centrifugation speed out of the range 4 1 6 Security ring The DG Spin centrifuge is open under normal conditions plugged by pressing the button However if it is necessary to open it in case of power cut or malfunction of the electromagnetic security cl...

Page 22: ...e that the ring is protected by the aforementioned lid WARNING Before use the Security ring check that the centrifuge is unplugged and the DG Spin Head is not moving DANGER The use of the Security ring disconnects immediately the motor However take in mind that the DG Spin Head can still move ...

Page 23: ... for additional installation of at least 300 mm around the centrifuge No person or any dangerous material should be within this area whilst the centrifuge is in operation Do not place the equipment out of doors Do not place the equipment where it could get wet Do not place the equipment on an inflammable material surface Do not position the equipment so that it is difficult to operate the mains sw...

Page 24: ...that the Display shows the centrifugation time Press and remove the internal protection that protects the DG Spin Head Remove the DG Spin Head from the Centrifugation chamber and verify that all the Card holders Ref 2 Figure 4 of the DG Spin Head are perfectly placed and held by the corresponding pivot Close the Centrifuge cover by pressing the front central part Ensure that the Cover is completel...

Page 25: ...gation speed units rpm Date and time GMT time zone NOTE The Date and Time parameters are used to maintain traceability in a log file with relevant information and possible incidences that have occurred during the centrifugation phase Accessibility to this file and its use are for the exclusive use of the authorised Technical Service To modify these parameters access the Configuration mode as descr...

Page 26: ...matically the Display will show flickering digits corresponding to the Date YYYY MM DD and the Time HH MM Press to modify the value of each field and to move onto the next field The date and time of the centrifuge are pre programmed with respect to the GMT system and therefore should not be modified Once the date and time has been introduced save the configuration by keeping pressed down The equip...

Page 27: ...fication of any parameter volume units date and time it is necessary to keep pressed down until the indicator emits the long and continuous acoustic signal Otherwise the OPERATOR will leave the Configuration mode without recording the changes made ...

Page 28: ...ing and remove the DG Spin Head by pulling up vertically until it is released from the Lean axle Place the DG Spin Head on a flat surface Place DG Gel cards in the Card holders Ref 2 Figure 4 of the DG Spin Head to be centrifuged CAUTION The number of DG Gel cards in the DG Spin Head should always be an even number and distributed symmetrically in such a way that the motor load is balanced For exa...

Page 29: ...er as shown by Figure 8 Figure 8 Cards orientation in the Card holders NOTE The DG Spin centrifuge can work with interchangeable DG Spin Head available as accessory Code 210364 The use of more than one DG Spin Head enables improving the performance of the equipment In other words the OPERATOR may prepare a second DG Spin Head with new cards whilst centrifugation of a prior batch is in progress For...

Page 30: ...Spin Head from the inside of the centrifuge To carry out a new centrifugation batch load the DG Spin Head with the new cards and close the Cover The timer will automatically show the pre programmed centrifugation time NOTE Once a centrifugation batch has finished it is not possible to start another whilst the Cover has not been opened Once opened the OPERATOR should remove the centrifuged cards to...

Page 31: ... emit some intermittent acoustic signals that will end in a continuous signal to indicate the centrifugation stop At this point the Display will intermittently show the time indicated when the timer stopped and the indicator of Erroneous centrifugation time will be activated To silence the acoustic alarm press or To carry out a new centrifugation batch open the Cover by pressing load the DG Spin H...

Page 32: ...Operating Procedure 6 5 WARNING If centrifugation is stopped the cards should be invalidated Reliable results can only be obtained if the cards are subject to a complete and continuous centrifugation only once ...

Page 33: ... or on the DG Spin Head Cleaning of the Chamber and the DG Spin Head as indicated in section 7 1 1 Cleaning procedures RESPONSIBLE AUTHORITY OPERATOR Each month Decontamination of the equipment as indicated in section 7 1 2 Decontaminant liquids RESPONSIBLE AUTHORITY OPERATOR Decontamination operations carried out by the OPERATOR or interventions carried out by a QUALIFIED TECHNICIAN should be not...

Page 34: ...ials However biological samples saline solutions acid or alkaline solvents should be eliminated from the exterior surface before these can cause deterioration Cleaning of the external surfaces should be carried out periodically with a damp cloth with a soft detergent WARNING Take care of not leaking cleaning solution into the equipment openings WARNING Do not disassembly the equipment in any case ...

Page 35: ...nate the equipment proceed as indicated below Open the Cover of the centrifuge by pressing and remove the DG Spin Head Switch off the equipment and disconnect it from the mains In case of spillages absorb the liquid with a disposable absorbent material for example paper towels gauze or paper clothes Decontaminate the surfaces Chamber Cover DG Spin Head Card holders etc using a 0 5 v v aqueous solu...

Page 36: ...escribed above do not guarantee that the equipment is totally decontaminated but it reduces the risk of contamination to a minimum 7 1 2 1 Decontaminant liquids During handling of these liquids the following recommendations should be followed Corresponding Instructions for Use Laboratory safety regulations Local legislation in force on prevention DANGER The sodium hypochlorite solution is corrosiv...

Page 37: ...G Spin centrifuge works under specifications The Operation Qualification Procedure OQ of the DG Spin centrifuge consists of verifying the correct function of the following parameters Centrifugation speed Balance control system 8 1 Required materials To qualify operation of the DG Spin centrifuge the following materials are required Calibrated optical tachometer 24 DG Gel cards To warranty the vera...

Page 38: ...trifuge to the mains and activate the Main switch Ref 6 Figure 2 Verify that the Display Ref 5 Figure 1 is switched on and the timer indicates the predefined centrifugation time Open the Cover of the DG Spin centrifuge and remove the DG Spin Head Place 24 DG Gel cards in the corresponding Card holders Place the DG Spin Head and close the Cover Press to start a centrifugation batch Wait for 20 seco...

Page 39: ...fore independent verification of the timer is not necessary NOTE Acceptance of the results enables ensuring correct function of the DG Spin centrifuge with respect to control of speed and time Otherwise repeat the procedure If the results of the new verification are not accepted contact your authorised Technical Service 8 3 Procedure for qualification of the out of balance control system The DG Sp...

Page 40: ...ed and that the out of balance indicator is activated in the Warning area of the Display during centrifugation NOTE The centrifugation stop enables ensuring correct function of the DG Spin centrifuge with respect to out of balance control system Otherwise contact your authorised Technical Service ...

Page 41: ... period of time it is recommendable to pack it as for transportation The required environmental storage conditions are those indicated in section 3 1 Technical specifications The space requirements for storing the equipment are as follows Size 320 mm height x 635 m depth x 530 mm width with packaging Approximate weight 18 Kg WARNING Only use the original packaging for transporting the equipment ...

Page 42: ...g of electronic waste DANGER This instrument should only be disassembled by authorised specialists CAUTION When the instrument is at the end of its useful life local legislation procedures in force should be followed to dispose of it In the EU the DG Spin centrifuge is considered as waste and is subject to selective collection under European Directive 2002 96 EEC relating to waste from electrical ...

Page 43: ...ological phenomena etc Damages caused by incorrect handling including that carried out by technical personnel not authorised by Diagnostic Grifols S A Parts of plastic or rubber as well as enamel and paints that have deteriorated due to knocks or usage except in the case of a manufacture defect The DG Spin Head except in the case of a manufacture defect Breakdowns or defects due to transport The r...

Page 44: ...etrically in the DG Spin Head The cards are properly placed in the Card holders The DG Spin Head is in perfect condition verify the absence of knocks deep scratches etc The DG Spin Head has all the Card holders in their position The DG Spin Head is properly placed in the corresponding axle Once the cause that led to the imbalance is corrected close the Cover press and verify that the out of balanc...

Page 45: ...pen The indicator disappears when the Cover is closed Otherwise ensure that the Cover is properly closed and if the situation is not corrected switch of the equipment and contact the Technical Service If when is pressed the Open cover indicator flashes verify that there is no previous centrifugation batch that has not been unloaded in the centrifuge To do this open the Cover and remove the DG Spin...

Page 46: ... of the cards Switch off the centrifuge and restart again If the error is detected again contact the Technical Service The out of balance sensor does not work correctly The equipment has detected an error in the out of balance control system during implementation of the centrifugation The equipment stops centrifugation and activates the Acoustic alarm Press or to stop it Open the Cover remove the ...

Page 47: ...ists contact the Technical Service and indicate the error code 12 3 Acoustic alarm The DG Spin centrifuge has an Acoustic alarm that can be programmed on three levels and when configured it is activated with the volume selected by the OPERATOR in the following situations Once the centrifugation batch in execution is completed The acoustic indicator will be activated with a long and continuous soun...

Page 48: ...new centrifugation it is necessary to open the Cover If there is any error during centrifugation Imbalances centrifugation speed out of range incorrect function of out of balance control systems fault in the Cover opening system excess current consumption of the motor etc the DG Spin centrifuge emits some short sounds and the corresponding indicator is displayed CAUTION To stop the Acoustic alarm ...

Page 49: ...CIOS DE MANTENIMIENTO REALIZADOS MAINTENANCE SERVICES CARRIED OUT Modelo Nº de Serie Fecha de Instalación Model Serial Number Installation date FECHA DATE ACCIÓN REALIZADA WORK CARRIED OUT TÉCNICO OPERADOR TECHNICIAN OPERATOR TÉCNICO AUTORIDAD RESPONSABLE TECHNICIAN RESPONSIBLE AUTHORITHY ...

Page 50: ...enance Services Carried out II Modelo Nº de Serie Fecha de Instalación Model Serial Number Installation date FECHA DATE ACCIÓN REALIZADA WORK CARRIED OUT TÉCNICO OPERADOR TECHNICIAN OPERATOR TÉCNICO AUTORIDAD RESPONSABLE TECHNICIAN RESPONSIBLE AUTHORITHY ...

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