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1. 64 64 666040 6694 69 44 66640860 86866 6 1 6 1 EXECUTION OF INCUBATION BATCH trennen enne 6 1 6 2 VISUALISATION OF INCUBATION TEMPERATURE 6 3 6 3 LIMER ARESEET 3e idee ste eii 6 4 64 INCUBATION TIMING 6 4 6 5 MODIFICATION OF PRE DEFINED TIMER TIME esee 6 4 6 6 INCUBATOR SWITCH 4 20 411 16 eee tnter trennen tnter nins 6 5 7 MAINTENANCE ette iier ddnde ER Terre dede 7 1 MAINTENANCE PLAN 711 Cleaning Procedures 7 1 2 Decontamination of Equipment sese 7 3 7 1 2 1 Decontamination Liquids ses 7 5 8 OPERATION QUALIFICATION OQ PROCEDURE t 8 1 8 1 REQUIRED MATERIALS esee teeth teen ne tne ntt te A 8 1 8 2 TEMPERATURE QUALIFICATION eere 8 2 8 3 PROCEDURE FOR QUALIFICATION OF TIME 8 3 8 4 PROCEDURE FOR QUALIFICATION OF CARD ELEVATOR SYSTEM 8 4 9 TRANSPORT AND STORAGE 7 retener nete 9 1 10 DISPOSAL OF THE 2 2 2 2 0020 0 40 4 00 000000 00 10 1 11 1 12 RESOLUTION OF INCIDENCES eese rennen tenent nennen 121 WARNINGS OR NCIDENCES ceeeeeeeeeeenere neret nnne entree 12 2 ERROR MESSAGES 1232 ACOUST
2. 9 e 27 11 12 10 44 DG Therm Safety Information e 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 areas of the instrument must be considered potentially biohazardous and handled with the appropriate care as specified in the laboratory s Standard Operating Procedures SOPs This equipment must be used only by the SUPERVISOR OPERATORS and QUALIFIED TECHNICIANS 2 2 2 Electrical Safety Precautions e avoid risk of electric shock this equipment should only connected to a grounded power supply e Inorderto totally disconnect the instrument from the power supply the instrument must be unplugged e the event of any liquid spillage on to the equipment it must disconnected from the electrical supply cleaned up and decontaminated The instrument must be disassembled only by a QUALIFIED TECHNICIAN and it must not be connected again until it has been fully inspected by the QUALIFIED TECHNICIAN e Electromagnetic compatibility and electrical safety tests have been performed using the cord supplied by the manufacturer e Using cables other than those specified may result in increased electromagneticemissionsand or decreasedimmunity malfunctions or damage to the equipment Basic safety precautions should
3. 47 27 11 12 10 45 3033629 DG Therm inside canada EN FR indd 48 27 11 12 10 45 DG Therm 12 RESOLUTION OF INCIDENCES During normal functioning of the DG Therm incubator certain warnings and incidences may appear that the OPERATOR can resolve without the assistance of the specialised Technical Service 12 1 Warnings or Incidences Resolution of Incidences MESSAGE DESCRIPTION VERIFICATIONS Incubator in preheating phase Temperature out of range GRIFOLS 3033629 DG Therm inside canada EN FR indd 49 gt The symbols indicate that the incubator is not yet ready to carry out an incubation batch because the Thermal block has not reached the work temperature yet Once the work temperature has been reached the luminous indicator of Temperature out of range will turn off and the timers wil indicate the predefined incubation time The temperature sensors of the DG Therm incubator detect when the temperature of the Thermal block is outside established range In this situation the incubator cannot perform any timing Verify that The incubator is not in preheating phase Display showing If after this phase the temperature of the Thermal block is outside the established margins the acoustic indicator activated with shorts sounds until a key is pressed 12 1 27 11 12 10 45 DG Therm Resolution of Incidences MESSAGE DESCRIPTION VERIFICAT
4. Execution of Incubation Batch To properly use the DG Therm incubator the following instructions should be followed e Activate the Main switch No 6 Figure 5 and verify that the Display No 4 Figure 4 is switched on The incubator enters into a preheating phase in which the timer show the symbols and the indicator of Temperature out of range n is flashing Once the work temperature is reached the indicator will be inactivated a short sound will be emitted and the timers 1 and 2 will show the predefined incubation time NOTE During the preheating phase the DG Therm incubator does not enable activating the timers Do not introduce the cards into the Thermal block until the incubator has reached the incubation temperature and the timers show the pre programmed incubation time Open the cover of incubation area A and or B where you wish to carry out the incubation batch GRIFOLS 6 1 3033629 DG Therm inside canada EN FR indd 27 27 11 12 10 44 DG Therm Operating Procedure e Place the DG Gel Cards into the slots ofthe Thermal Block No 3 Figure 6 and if required the corresponding sample tubes in the positions aligned with the cards No 4 Figure 6 With the cover open the DG Gel Cards will remain lifted up with respect to the Thermal Block thereby facilitating their positioning e Lower the cover of the incubator The cards will be introduced into the Thermal Block so as to enable better
5. area shows the flickering time e the Cover of the corresponding incubation area The opening system lifts the cards so that they can be removed easily Immediately remove the cards from the DG Therm incubator CAUTION Cards should be removed immediately after the end of incubation After stopping the timer the Termal block does not modify the temperature and therefore cards continue being incubated if they are not removed 6 2 Visualisation of Incubation Temperature The DG Therm incubator allows momentarily seeing the incubation temperature do so press P or P during the timing of an incubation batch The Display will show for a few seconds in the part of the Display corresponding to the selected button the temperature of the Thermal block at this moment After a few seconds the Display again shows the time corresponding to this timing in progress NOTE Note that the temperature visualised when any of the two buttons P or Pe are pressed o corresponds to the unique temperature of the entire Thermal blocks in other words the same temperature for Incubation area x and GRIFOLS 63 3033629 DG Therm inside canada EN FR indd 29 e 27 11 12 10 45 DG Therm Operating Procedure 6 3 Timer Reset Once the incubation batch has finished and its cards have been removed press the corresponding button P or P again to leave the DG Therm incubator ready to carry out a new timi
6. incubator emits three short sounds and a continuous one indicating that timing has stopped at this time e After a power cut during the timing of an incubation batch When it works again the DG Therm incubator will emit a continuous sound and the timer will show by flashing the value indicated at the stop time e After the preheating phase if the temperature of the Thermal block is outside established range The DG Therm incubator emits a continuous sound and the indicator Temperature out of range is displayed e In general as long as the incubator detects an error situation see section 12 2 it will emit a continuous sound CAUTION To stop the Acoustic alarm press Pa or P as appropriate If the Acoustic alarm continues contact the authorised Technical Service 12 4 GRIFOLS 3033629 DG Therm inside canada 52 e 27 11 12 10 45 Maintenance Services Log Sheet DG Therm QAISIAIAdNS Ad LOO NOLLOV ALYA 5 DOTSHOIA3IHS ON TPPOW GRIFOLS 27 11 12 10 45 3033629 DG Therm inside canada EN FR indd 53
7. not rise sufficiently when the Cover of the incubator is opened or they are not totally at the same level when it is closed verify that the DG Therm Trays are correctly positioned If the Trays are correctly positioned but the problem remains contact your authorized Technical Service 8 4 GRIFOLS 3033629 DG Therm inside canada 42 27 11 12 10 45 DG Therm Transport and Storage 9 TRANSPORT AND STORAGE WARNING The equipment must be decontaminated before N being transported and or stored If the DG Therm incubator has to be stored for a long 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 e 240 mm height x 400 mm depth x 400 mm width with packaging Approximate weight 8 Kg WARNING Only use the original packaging for transporting N the equipment GRIFOLS 9 1 3033629 DG Therm inside canada EN FR indd 43 27 11 12 10 45 3033629 DG Therm inside canada 44 27 11 12 10 45 DG Therm Disposal of the Equipment 10 DISPOSAL OF THE EQUIPMENT To dispose of the DG Therm incubator it should be completely cleaned and decontaminated and all remains of samples and reagents eliminated Once this is done it must be disposed as electronic waste according to l
8. of nominal voltage CODE DESCRIPTION PRESENTATION 213732 DG Therm Trays 6 230881 PT100 temperature probe for DG Gel 1 Cards 230879 Digital thermometer for PT100 probes 1 3 2 3033629 DG Therm inside canada EN FR indd 16 GRIFOLS 27 11 12 10 44 DG Therm Description of DG Therm 4 DESCRIPTION OF DG THERM 4 1 General Description of DG Therm Incubator Figure 4 and Figure 5 below show the front and the rear views of the DG Therm incubator Figure 4 Front View of DG Therm Incubator 1 Thermal Block 2 Protective Covers 3 Start Stop Timer Buttons and P 4 Display 5 DG Trays Figure 5 Rear View of the DG Therm Incubator GRIFOLS 4 1 3033629 DG Therm inside canada EN FR indd 17 e 27 11 12 10 44 DG Therm Description of DG Therm 6 Power Switch 7 Power Cord Connection 8 Connection to a computer for the exclusive use of the authorized Technical Service 4 1 1 Thermal Block The Thermal block shown in No 1 of Figure 6 is the area of the incubator designed to place DG Gel Cards and sample tubes for their heating at 37 for the pre established time D K D C CIC C WN YC gt eE NOI E Figure 6 Thermal Block 1 Incubation area X 2 Incubation area 3 Positions for DG Gel Cards 4 Positions for sample tubes As shown in Figure 6 the Thermal block is div
9. 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 unfavorable conditions or by subjection to severe transport stresses Damage to the flexible power supply cord or its plug e Do not use the equipment in hazardous atmosphere or with hazardous materials for which the equipment has not been designed e Do not use the equipment in the presence of inflammable gases volatile products e Do not use accessories which are not supplied or recommended by the manufacturer e equipment may only be disassembled by QUALIFIED TECHNICIAN either for internal cleaning and or for repairing Before disassembling the equipment must be unplugged e Before using any cleaning or decontaminating method described section 7 Maintenance the equipment must be unplugged 2 2 Warnings and Precautions The following indications are directly related to the safety ofthe equipment These warnings and safety precautions must be observed in order to avoid possible harm to personnel and the instrument and to avoid false test interpretations 2 2 1 General Precautions Regarding Use e Inappropriate use of this equipment can increase the risk of personal injury or damage to the equipment GRIFOLS 23 3033629 DG Therm inside canada
10. E Although the equipment does not establish any predetermined correspondence between each o Incubation area 4 or and each Timer or a due to its design it is recommended using Timer for incubations carried out in Incubation area x and Timer for incubations carried out in Incubation area In normal mode the display shows for each timer by means of a digital number and a progress bar No 3 Figure 9 the remaining incubation time The progress bar is filled in as the pre programmed time elapses Once incubation has finished and ifthe timer is not stopped the display will show flicker information on the time exceeded with respect to the pre programmed time by means of the symbol No 5 Figure 10 3 nmm mm sem Figure 9 Display with Batches in Execution 44 GRIFOLS 3033629 DG Therm inside canada EN FR indd 20 e 27 11 12 10 44 DG Therm Description of DG Therm 1 Timer information 2 Timer E information 3 Timer progress bar 4 Timer amp progress bar 5 eee 0 m um Figure 10 Display with Measurement of Time Exceeded in Timer e 5 Indication of time exceeded 4 1 4 2 Units The DG Therm incubator enables informing the OPERATOR of the incubation temperature in or in To change the option that appears on the screen consult section 5 5 Configuration of Equipment 4 1 4 3 Warnings Area This is
11. IC ALARM MAINTENANCE SERVICES LOG SHEET I ii GRIFOLS 3033629 DG Therm inside canada EN FR indd 6 27 11 12 10 44 DG Therm Introduction 1 INTRODUCTION 11 Intended Use The DG Therm Incubator is a device specifically designed to incubate DG Gel Cards and or test tubes at 37 for immunohematology applications 1 2 Principle of Operation Incubation takes place by means ofa dry heating bath at 37 C fora pre established time of 15 minutes The DG Therm incubator has two independent timers that enable carrying out two independent incubation batches 1 3 Product Limitations The DG Therm incubator is only prepared to carry out incubation of DG Gel Cards and or test tubes as described in section 1 1 Intended Use and should not be used for any other type of tests different from which it was designed for 1 4 Operator Training The use of the DG Therm incubator does not require specific training beyond that established by the laboratory itself GRIFOLS 1 1 3033629 DG Therm inside canada EN FR indd 7 27 11 12 10 44 3033629 DG Therm inside canada EN FR indd 8 27 11 12 10 44 DG Therm Safety Information 2 SAFETY INFORMATION 2 1 Read Before Use e Use the equipment only for the principle of operation described in this User Manual e Unless specifically instructed to do so do not drop or put anything into any opening in the equipment Do not use the equipment if it is not
12. IONS There has been no power cut that has stopped the work of the incubator The timers will show by flashing the value indicated at that moment and the incubator will emit shorts acoustics sounds After mains recovery the incubator will go into preheating phase but will keep the Acoustic warning activated and will show the timer flashing If the indicator is displayed switch off the incubator and switch it on again If it is still displayed after the preheating phase contact the authorised Technical Service Erroneous incubation The timing of batch 1 or 2 was time different to the pre established time and the corresponding timer is flashing This may be due to e Atimingstop by OPERATOR as described in section 6 4 The timer shows by flashing the value indicated at that moment power cut that has stopped the work of the incubator The timer will show by flashing the value indicated at that moment and will activate the Acoustic alarm Press the button corresponding to this timer to stop the Acoustic alarm so the timer is prepared for a new incubation batch 122 GRIFOLS 3033629 DG Therm inside canada 50 27 11 12 10 45 DG Therm Resolution of Incidences MESSAGE DESCRIPTION VERIFICATIONS Contact the authorised If the incubator detects Technical Service imbalance in its function that cannot be resolved by the OPERATOR the corresponding indicator is activate
13. always be taken including those indicated in section 2 1 Read Before Use Furthermore before installing the equipment section 5 2 Installation Requirements must be read 2 2 3 Precautions Associated with Technical Specifications It is recommended that the relative humidity of the room where the equipment is installed be not less than 3096 Although the equipment may function normally with relative humidity below 3096 in extremely dry environments electrostatic discharge may damage the equipment 22 GRIFOLS 3033629 DG Therm inside canada EN FR indd 10 27 11 12 10 44 DG Therm Safety Information 2 2 4 Precautions Associated with Using DG Gel Cards e Handle the DG Gel Cards following the instructions for use of the respective gel cards 2 25 Precautions Associated with Maintenance e During cleaning and or decontamination processes protective gloves must be used e Before the cleaning and decontamination procedures all samples and cards should be removed from inside the equipment e The cleaning processes of the equipment surfaces should be carried out with the equipment unplugged from the electric power supply e Any part of the equipment that could come into contact with blood serum samples or any other biological liquid should be treated as potentially contaminant e Before using any cleaning or decontamination product different to those recommended by the manufacturer the SUPERVISOR should verify with
14. asurement of time between the DG Therm incubator and the timer is less than 10 seconds GRIFOLS 83 3033629 DG Therm inside canada 41 27 11 12 10 45 DG Therm Operation Qualification 0Q Procedure NOTE Acceptance of the results enables ensuring correct function of the DG Therm incubator with respect to control of time Otherwise repeat the test by ensuring synchronisation between the chronometer and the button If after carrying out a new verification results are not accepted contact your authorised Technical Service 8 4 Procedure for Qualification of Card Elevator System To verify that the card elevator system of the DG Therm incubator functions correctly proceed as described below Verify that the DG Therm Trays of the incubator are completely introduced into their position and correctly positioned Open the Cover of the incubator and place 12 DG Gel Cards into Incubation area A Verify that all cards are kept elevated approximately 10 mm with respect to the Thermal block facilitating the insertion and removal of the cards Close the Cover of Incubation area A and verify that the DG Gel Cards are at the same level in the Thermal block Open the Cover of incubation area A again and verify that all cards rise approximately 10 mm with respect to the Block Remove the cards close the Cover of Incubation area A Repeat the procedure for Incubation area B NOTE If the cards do
15. d In this case switch off the incubator and restart again If the warning persists contact the authorised Technical Service 12 2 Error Messages When an error occurs in any element of the system the equipment will carry out the following actions Stop temperature regulation e Ignore Buttons Pi and Pez Activate the Acoustic alarm with short sounds e Activate the indicator e Show E on the Display with the corresponding error code CAUTION If the DG Therm incubator shows an error code in the Display restart the equipment If the error persists contact the authorised Technical Service and indicate the error code 12 3 Acoustic Alarm The DG Therm incubator has an Acoustic alarm that can be programmed at three levels and when configured it can be activated with the volume selected by the OPERATOR in the following situations GRIFOLS 12 3 3033629 DG Therm inside canada 51 27 11 12 10 45 DG Therm Resolution of Incidences When the correct incubation temperature is reached A short sound indicates that the preheating phase has finished the luminous indicator of Temperature out of range is inactivated and timers indicate the predefined incubation time e Once the timing of the incubation batch has been completed The Acoustic indicator will be activated with a continuous sound When timing is stopped by keeping the corresponding button pressed down The DG Therm
16. d the equipment can still be used but in addition to the regular cleaning and decontamination procedures regular at least yearly temperature and functional inspections are recommended These inspections can be performed by following the procedure given in section 8 Operation Qualification OQ Procedure 7 4 Maintenance Plan Maintenance plan is a set of operations carried out at regular intervals aimed at preserving function of the DG Therm incubator As a general rule and as long as there is no irregularity in the operation of the equipment the maintenance plan that should be followed is the following PERIOD ACTIVITY CARRIED OUT BY Whenever drops Cleaning of the of samples or Thermal block and other substances DG Therm Trays as spill on the indicated in section SUPERVISOR OPERATOR Thermal block 7 1 1 Each month Decontamination SUPERVISOR of the equipment as OPERATOR indicated in section 7 1 2 Decontamination operations carried out by the OPERATOR or any other interventions carried out by a QUALIFIED TECHNICIAN should be noted in the table titled Maintenance Services Log Sheet included at the end of this User Manual Technical assistance may be provided by your supplier or other Technical Services authorised GRIFOLS 7 1 3033629 DG Therm inside canada EN FR indd 33 27 11 12 10 45 DG Therm Maintenance WARNING N During cleaning and or decontamination processes protective gloves m
17. el DG Therm User Manual Mode d emploi Diagnostic Grifols S A RI LS Passeig Fluvial 24 08150 Parets del Vall s Barcelona ESPANA 3035615 04 2012 Tel 34 935 710 400 Fax 34 935 731 132 www grifols com 10 1242 9 24 DO 7 User Manual GRIFOLS Diagnostic Grifols S A Passeig Fluvial 24 08150 Parets del Vall s ESPANA SPAIN 3033629 DG Therm inside canada EN FR indd 1 e 27 11 12 10 44 3033629 DG Therm inside canada 2 27 11 12 10 44 PLEASE READ THESE INSTRUCTIONS CAREFULLY BEFORE STARTING TO USE THE SG WFTW INCUBATOR Information about matters relating to the equipment safety can be found in section 2 SAFETY INFORMATION The symbols used in this manual are as follows 3033629 DG Therm inside canada 3 WARNING Indicates a hazardous situation for persons including patients which has protective devices or systems Nonetheless it is advisable to notify the SUPERVISOR or the OPERATOR A CAUTION Indicates a hazardous situation that could result in material damages to the equipment or other property This situation can be avoided by following these instructions or using other types of protection NOTE Used for clarifications or additional or emphasized information 27 11 12 10 44 Definitions SUPERVISOR Individual responsible for the use and maintenance of the equipment and for ensur
18. el Cards 2 3 2 2 5 Precautions Associated with 2 3 2 2 6 Precautions Associated with Transport and Storage 2 3 2 2 7 Precautions Associated with Disposal of Equipment 2 3 2 2 8 Precautions Associated with Operating Procedures 2 4 2 29 Precaution Associated with Warranty sss 2 4 2 3 EQUIPMENT 8 2 5 3 TECHNICAL SPECIFICATIONS 3 1 TECHNICAL SPECIFICATIONS 3 2 ACCESSORIES eer ege ens 4 DESCRIPTION OF DG THERM 4 1 4 1 GENERAL DESCRIPTION OF DG THERM INCUBATOR 4 1 41 1 Thermal Block ine edd has 4 2 41 2 4 2 41 3 Start Stop Timer Buttons 4 3 ATA Display e Re desl 4 3 4 1 4 1 Timers and e Information 4 4 AREZ Units ius eese es 4 5 41 4 5 Warnings Area 4 1 5 DG Therm Trays GRIFOLS i 3033629 DG Therm inside canada 5 e 27 11 12 10 44 DG Therm Table of Contents 5 gt INSTALLA MON ertet itte trt RA ESA PGA A tet a pu 5 ACTION UPON DELIVERY 5 2 INSTALLATION REQUIREMENTS 5 3 UNPACKING THE 5 4 INSTALLATION PROCEDURE eese 5 5 CONFIGURATION OF EQUIPMENT 6 OPERATING
19. en that the system of sensors has been calibrated by the manufacturer if no function alarm is activated see table in sections 12 1 and 12 2 itis warranted that the DG Therm 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 must periodically verify that the DG Therm incubator meets its specifications This procedure can also be applied a regular basis after the product useful life in case the equipment is not disposed The Operation Qualification OQ Procedure of the DG Therm incubator consists of verifying the correct function of the following parameters e Incubation temperature e Incubation time e Card elevator system 8 1 Required Materials To qualify the operation of the DG Therm incubator the following materials are required e PTI100 temperature probe for DG Gel Cards Code 230881 e Digital thermometer for PT100 probes Code 230879 e Calibrated chronometer Precision 1 s e 12DG Gel Cards To ensure the accuracy of temperature measurements the temperature probe and the thermometer must be calibrated by using instruments controlled regularly with traceable materials at primary or secondary reference standards The calibration certificate should be attached to both sets of equipment To maintain traceability the probe and the thermometer have a label with the ser
20. has been selected press to move onto the next parameter Automatically 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 incubator are pre programmed with respect to the GMT system and therefore should not be modified the date and time has been introduced save the configuration by keeping P pressed down The equipment will emit a long and continuous acoustic signal indicating that the configuration has been successfully saved The DG Therm incubator will automatically show the pre programmed incubation time in the Display NOTE o If no button is pressed for 15 seconds changes are not recorded in the Configuration Mode NOTE To save the modification of any parameter volume units date and time it is necessary to keep or Pe 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 54 GRIFOLS 3033629 DG Therm inside canada EN FR indd 26 e 27 11 12 10 44 DG Therm Operating Procedure 6 OPERATING PROCEDURE CAUTION Do not use the DG Therm incubator if it does not work correctly or has been damaged CAUTION To handle DG Gel Cards follow the instructions for use of the gel cards 6 1
21. heating Press P or PZ to activate the timer that will indicate the incubation time of the batch of cards introduced During incubation the DG Therm incubator will show by means of the Display the remaining incubation time in minutes and seconds and will gradually complete the different elements that comprise the progress bar e Once incubation has finished the acoustic indicator will be activated to indicate to the OPERATOR that the pre established incubation time has finished and the Display will start to flash CAUTION Times showed by the timer of the DG Therm incubator incubation time and time exceeded are correct if the operator has worked as described in this section in other words without delays due to deviation from the procedure CAUTION Before pressing the button to stop timer P or Pez check which one has finished timing To do this see which display area shows the flickering time e Press P or P again to stop the corresponding timer Once the incubation has finished and ifthe timer is not FI the time that has exceeded the pre established one and the sign will flicker on the Display and the Acoustic alarm will be activated 62 GRIFOLS 3033629 DG Therm inside canada EN FR indd 28 e 27 11 12 10 45 DG Therm Operating Procedure CAUTION Before pressing the button to stop timer P or Pez check which one has finished timing To do so see which display
22. ial number calibration certificate number the calibration date and the validity period GRIFOLS 8 1 3033629 DG Therm inside canada EN FR indd 39 27 11 12 10 45 DG Therm Operation Qualification 0Q Procedure o NOTE The use of a thermometer different from the one recommended is possible as long as it complies with the following specifications Thermometer compatible for PT100 Temperature probes PT385 100 Ohm Scale division Resolution lt 0 1 C Minimum Range 20 40 Maximum uncertainty permitted thermometer plus probe 0 3 C at 37 C Connection IEC 8 2 Temperature Qualification Procedure To verify that the DG Therm incubator complies with the temperature specifications described in section 3 1 Technical Specifications proceed as described below 8 2 Verify that the DG Therm incubator is at room temperature and unplugged from the mains Connect the Temperature probe for DG Gel Cards code 230881 to the Thermometer Insert the Temperature probe for cards in position 6 of Incubation area A of the Thermal block Close the Cover ensuring that at least 30 cm of the cable of the probe is in contact with the Thermal block Plug the DG Therm incubator to the mains and switch on the Main switch No 6 Figure 5 Verify that the Display No 4 Figure 4 is switched on and wait for the preheating phase to finish The timer will indicate the predefined incubation time and
23. ided into two Incubation areas Nos 1 and 2 Each one has a capacity of 12 DG Gel cards No 3 and 12 sample tubes that are aligned with the cards No 4 42 GRIFOLS 3033629 DG Therm inside canada EN FR indd 18 27 11 12 10 44 DG Therm Description of DG Therm 4 1 2 Protective Cover The DG Therm incubator has two coverings that fold laterally No 2 Figure 4 When closed they keep the cards down to assure an optimum incubation of the DG Gel Cards 4 1 3 Start Stop Timer Buttons The DG Therm incubator has two Start Stop Buttons as shown in No 3 of Figure 4 button No 1 Figure 7 and button P No 2 Figure 7 that allow starting and stopping independently for the two incubator timers D CO G Figure 7 P and P Buttons 1 Pw Start stop timer button 2 P Start stop timer button 4 1 4 Display The Display No 4 Figure 8 informs the OPERATOR of the remaining time of incubation controlled by Timers 1 and 2 and the temperature of the Thermal block It also informs of possible error situations Figure 8 Display GRIFOLS 43 3033629 DG Therm inside canada EN FR indd 19 27 11 12 10 44 DG Therm Description of DG Therm 1 Timer information 2 Timer E information 3 Timer measurement indicator 4 Temperature units 5 Warnings area 4 1 4 1 Timers and e Information The DG Therm incubator has two independent Timers No 1 and 2 Figure 9 NOT
24. ied out by a QUALIFIED TECHNICIAN Call the nearest authorised Technical Service A 7 1 2 Decontamination of Equipment DANGER Any part of the equipment that could come into contact with blood serum samples or any other biological liquid should be treated as potentially contaminant A In order to prevent any risk of infection it is important to carry out decontamination of the instrument before performing certain operations Decontamination of the equipment should be carried out monthly or in the following cases e After spillages leaks etc of potentially contaminant liquids e Preparation of the equipment for its transport or storage GRIFOLS 3033629 DG Therm inside canada EN FR indd 35 7 3 27 11 12 10 45 DG Therm Maintenance e Before Technical Service e Equipment disposal To decontaminate the equipment proceed as indicated below e Switch off the equipment disconnect it from the mains and wait until it reaches room temperature e In case of spillages absorb the liquid with a disposable absorbent material for example paper towels gauze or paper clothes e Decontaminate the surface using a 0 5 v v aqueous solution of sodium hypochlorite To do this clean the surfaces with disposable towels or cotton balls and dampen completely by dipping into the disinfectant solution e Absorb the disinfectant solution with a disposable material e Rinse the surface with a soft detergent
25. ing that operators are adequately trained In some standards this position is referred as RESPONSIBLE BODY 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 SUPERVISOR are valid for the OPERATOR Equipment design and specifications are subject to change without prior notification 3033629 DG Therm inside canada 4 27 11 12 10 44 DG Therm Table of Contents TABLE OF CONTENTS I INTRODUCTION mrii tenete e Oe e e 1 1 LI INTENDED USE une dide re cte rti devas Ve Ded eee 1 1 12 PRINCIPLE OF nn 1 1 13 PRODUCT LIMITATIONS 14 OPERATOR TRAINING nn nennen 2 SAFETY INFORMATION hi er rp P ete 2 1 21 READ BEFORE USE A PRE e a aa 2 1 2 2 WARNINGS AND PRECAUTIONS sese 2 1 2 2 1 General Precautions Regarding 2 1 2 2 2 Electrical Safety Precautions sse 2 2 2 2 3 Precaution Associated with Technical Specifications 2 2 2 2 4 Precautions Associated with Using DG G
26. located on the left lower part of the Display No 5 Figure 8 and informs by means of symbols of alarm situations during initialisation or incubation batch These symbols are described below For more information consult section 12 1 GRIFOLS 45 3033629 DG Therm inside canada EN FR indd 21 e 27 11 12 10 44 DG Therm Description of DG Therm Contact the authorised Technical Service F Temperature out of range Batch completed with Erroneous incubation time Timer Z or and 415 DG Therm Trays DG Therm Trays No 5 Figure 4 are disposable and are located in the lower part of the incubator They are used to collect any remains of samples or any other substance from accidental spillage during the use of the equipment The Trays also form part of the card elevation system of the thermal block 46 GRIFOLS 3033629 DG Therm inside canada EN FR indd 22 27 11 12 10 44 DG Therm Installation 5 INSTALLATION 51 Action upon Delivery This equipment may be installed directly by the OPERATOR or SUPERVISOR 5 2 Installation Requirements The requirements for the place where the equipment is to be installed are as follows e Ifthe equipment has been stored in other environmental conditions different from work conditions it should be kept for at least one hour under work condition environment before being plugged in For environmental conditions See section 3 1 Technical Specifications e Space requirements I
27. ng The DG Therm incubator will show in the part of the Display corresponding to this timer the predefined incubation time 6 4 Incubation Timing Stop If for any reason it is necessary to stop the incubation timing before the established time is finished P or Pe should be keep pressed down for a few seconds The DG Therm incubator will emit some intermittent acoustic signals that will end in a continuous signal to indicate the timing stop At this point the Display will intermittently show the time indicated when the timer stopped and the indicator of Erroneous incubation time 9 will be activated CAUTION Incubation stop consists of stopping the timer but the temperature of the Thermal block is not modified and therefore cards continue being incubated if they are not removed NOTE The DG Therm incubator has two independent timers Pa and Pez Stopping a timer does not imply interruption of the second timing in progress 6 5 Modification of Pre defined Timer Time The DG Therm incubator has been programmed to carry out the incubation timing of those techniques with DG Gel Cards that require incubation at 37 Therefore the pre established incubation time is 15 minutes according to the corresponding Instructions for Use for the DG Gel Cards 64 GRIFOLS 3033629 DG Therm inside canada EN FR indd 30 27 11 12 10 45 DG Therm Operating Procedure If for some reason timing for a period of
28. o the storage and transport Check that all elements specified in the attached Packing list are included 5 4 Installation Procedure To install the DG Therm incubator proceed as follows Verify that the DG Therm Trays are completely inserted into the incubator and correctly placed Verify that the Protective Covers open correctly Verify the card elevator system as described in section 8 4 Procedure for Qualification of Card Elevator System Connect the mains cord to the incubator No 7 Figure 5 and the mains Switch on the Main switch No 6 Figure 5 Verify that the Display switches on and goes into preheating phase showing the symbols Once the preheating time has finished verify that the Display shows for the timer 1 and 2 the pre programmed time of 15 minutes The DG Therm incubator is supplied with a conformity certificate stating that the temperature ofthe thermal block 37 has been verified using instruments 5 2 GRIFOLS 3033629 DG Therm inside canada 24 e 27 11 12 10 44 DG Therm Installation calibrated by accredited entities The DG Therm incubator does not need to be readjusted during its useful life if it is used under normal working conditions 5 5 Configuration of Equipment The DG Therm incubator has some pre defined parameters that may be modified by the OPERATOR Pre defined values are the following e Acoustic signal volume High e Temperature uni
29. ocal state and national regulation DANGER This instrument should only be disassembled N 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 it GRIFOLS 10 1 3033629 DG Therm inside canada 45 27 11 12 10 45 3033629 DG Therm inside canada EN FR indd 46 27 11 12 10 45 DG Therm Warranty 11 WARRANTY The warranty conditions are established in separate documents For more information contact your distributor The warranty does not cover the following Damages caused by its initiation and functioning in environments that contravene the Instructions for Use Damages caused by accident negligence or breach ofthe Instructions for Use Damages caused for reasons of force majeure atmospheric geological phenomena etc Damages caused by incorrect handling including that carried out by technical personnel not authorized 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 Therm Trays Breakdowns or defects due to transport The replacement of equipment or components will be subject to the criteria of Standard Conditions CAUTION Repairs should be exclusively carried out by qualified personnel authorised GRIFOLS 11 1 3033629 DG Therm inside canada
30. s Do not use the DG Therm incubator if it does not work Properly or has been damaged e In order to avoid undesired over incubation or under incubation of the DG Gel Cards strictly follow the procedures described in section 6 Operating procedure e Gel cards should be removed immediately after the desired incubation time e When the incubation has finished with the timer modified by the OPERATOR the DG Therm incubator will again show the time of 15 minutes predefined by Diagnostic Grifols S A 2 2 9 Precaution Associated with Warranty e Repairs should be exclusively carried out by personnel authorised for this purpose and below the standards conditions 2 3 Equipment Labelling The DG Therm incubator has the following labels 1 Packaging Label 2 Product Label 3 Biohazard Label 1 Packaging Label The packaging label of the DG Therm incubator is located on the upper right part of the front side of the box The packaging label is shown in Figure 1 below 24 GRIFOLS 3033629 DG Therm inside canada EN FR indd 12 27 11 12 10 44 DG Therm Safety Information DG THERM SN 319 XXXXXXX f 60 213792 85 vn 3033609 Diagnostic Grifcis S A Passeig fluvial 24 08150 Parets dei Vall s SPAIN GRIFOLS Figure 1 Packaging Label The following symbols are used on the packaging lebels Serial number Catalog number Temperature range permitted during
31. storage and transport Relative humidity range permitted during storage and transport ee In vitro diagnostic medical device VD Manufacturer 2 Product Label The product label is located on the rear part of the equipment containing technical information voltage frequency and power as well as the model serial number manufacturing date name and address of the manufacturer and regulatory information The product label is as shown in Figure 2 below GRIFOLS 25 3033629 DG Therm inside canada EN FR indd 13 27 11 12 10 44 DG Therm Safety Information EY 240 V x 50 60Hz 60 Hz 219 DG THERM 213792 AAAA intertek 4003119 9 vo 319 XXXXXXX e ANSIUL D Std 61010 1 2004 FOR IN VITRO Cert to CAN CSA Std DIAGNOSTIC USE C22 2N1010 1 04 Diagnostic Grifols S A GRIFOLS Passeig Fluvial 24 08150 Parets del Vall s ESPANA SPAIN Figure 2 Product Label Symbols additional to those described before are Date of manufacture Gi Safety mark that certifies that the instrument meets the applicable USA and Canadian safety standards Intertek 3 Biohazard Label The biohazard label Figure 3 is placed on the flap of the DG Therm Trays No 5 Figure 4 and the thermal block Figure 6 It warns the OPERATOR about potential biological risks caused by remaining substances deposited on the surfaces of the incubator and especially on the trays Figure 3 Bioha
32. t is recommended to have solid horizontal area of 400 mm in width and 550 mm in depth includes space for connection to power supply e Do not place the equipment outdoors e Do not place the equipment where it could get wet e Do not place the equipment on a surface of flammable material e Do not position the equipment so that it is difficult to operate the mains switch No 6 Figure 5 Donotlet the equipment or its flexible cord come into contact with surfaces which are too hot to touch e Do not place anything on top of the equipment e The electrical installation to which the equipment will be connected should comply with the necessary requirements of power supply consumption and regulations including protective earth The plug should have a protective earth e Appliance coupler or plug shall be readily and easy accessible GRIFOLS 5 1 3033629 DG Therm inside canada 23 27 11 12 10 44 DG Therm Installation A WARNING To completely disconnect the apparatus from mains remove the mains plug from the socket outlet or the appliance coupler 5 3 Unpacking the Equipment Once the appropriate place is selected for installation unpack equipment according to the following instructions Open the upper part of the box Remove all protections and accessories Remove the protection bag and place the equipment in the chosen position Check that the equipment is not damaged due t
33. the indicator of Temperature out of range will be inactivated Switch on the Thermometer Wait for 15 minutes and verify that the thermometer temperature is within the temperature range defined in section 3 1 Technical Specifications GRIFOLS 3033629 DG Therm inside canada EN FR indd 40 e 27 11 12 10 45 DG Therm Operation Qualification 0Q Procedure e Furthermore verify that the Display temperature although do not be exactly the same than the thermometer temperature is also within the temperature range defined in section 3 1 Technical Specifications Switch off the Thermometer e Open the Cover of the DG Therm incubator and take out the Temperature probe NOTE Acceptance of the results enables ensuring correct function of the DG Therm incubator with respect to control of temperature Otherwise verify that the Temperature probe for cards is correctly placed in the position of the incubator indicated in these Instructions for Use If the results of the new verification are not accepted contact your authorised Technical Service 8 3 Procedure for Qualification of Time To verify that the timers of the DG Therm incubator function correctly proceed as described below Ensure that 1 or 2 shows the predefined incubation time of 15 minutes Press or Pez and start the timer at the same time e Wait for the incubation time to finish and verify that the difference in me
34. the manufacturer that the methods proposed will not damage the equipment e sodium hypochlorite solution is corrosive irritating for the skin and eyes and toxic if inhaled absorbed or ingested e Do not leak cleaning solution into the equipment openings e Do not disassemble the equipment in any case If there is liquid inside the cleaning and decontamination operation should be carried out by a QUALIFIED TECHNICIAN Call the nearest Technical Service 2 2 6 Precautions Associated with Transport and Storage e The equipment must be decontaminated before being transported and or stored e Only the original packaging should be used for transporting the equipment 2 2 7 Precautions Associated with Disposal of Equipment instrument should only be disassembled by authorized specialists GRIFOLS 3 3033629 DG Therm inside canada 11 27 11 12 10 44 DG Therm Safety Information When the instrument reaches the end of its useful life it must be disposed of as electronic waste according to local state and national regulations e Please note that contaminated medical devices must be disposed of as medical biohazardous waste and cannot be included in used electronic equipment recycling programs In addition certain electronic products must be returned directly to the manufacturer Contact your sales representative for return instructions 2 2 8 Precautions Associated with Operating Procedure
35. time different from the predefined one has to be done proceed as described below e Choose one of the timer 1 or 2 at rest without working e Keep their corresponding button P or P pressed down until you hear a continuous acoustic signal and the timer flashes e Next briefly press the same P P button to modify the value of the established time value Each push button corresponds to 5 minutes and the maximum time permitted is 60 minutes When the button is released the DG Therm emits a continuous acoustic signal indicating that the predefined time has been modified and the following timing will take place during the time shown by the Display at this moment CAUTION When the incubation has finished with the timer modified by the OPERATOR the DG Therm incubator will again show the time of 15 minutes predefined by Diagnostic Grifols S A 6 6 Incubator Switch Off To prolong the life of the DG Therm incubator switch it off completely by means of the Mains switch No 6 Figure 5 at the end of the working day GRIFOLS 65 3033629 DG Therm inside canada EN FR indd 31 27 11 12 10 45 3033629 DG Therm inside canada EN FR indd 32 27 11 12 10 45 DG Therm Maintenance 7 MAINTENANCE During the useful life under normalconditionsindicatedin section 3 1 Technical Specifications maintenance of DG Therm is limited to regular cleaning and decontamination operations only Once this period has passe
36. ts C e Date and time GMT tim zone NOTE The Date and Time parameters are used to maintain traceability in a log file with relevant information and possible incidences that o have occurred during the incubation phase Accessibility to this file and its use are for the exclusive use of the authorized Technical Service To modify these parameters access the Configuration Mode as described below With the equipment switched off keep the button P pressed down and turn on the Main switch No 6 Figure 5 The DG Therm incubator is initialized in Configuration Mode and enables personalizing the parameters described e In Configuration Mode the Display will show the configuration menu for the selection of the acoustic signal volume The numeration shown corresponds to the following volumes J VOL 0 Deactivated VOL 1 Medium level volume VOL 2 High volume e Press Pe to modify the value to the required level e the required level has been selected press Pii to move onto the next parameter GRIFOLS 5 3 3033629 DG Therm inside canada 25 27 11 12 10 44 DG Therm Installation e Display will automatically show the following configuration menu Selection of temperature units e To change the units press P and select the desired units or F SEL C Temperature in degrees centigrade SEL F Temperature in degrees Fahrenheit Once the level required
37. ust be used by the OPERATOR WARNING A Before the cleaning and decontamination procedures all samples and cards should be removed from inside the equipment WARNING The cleaning processes of the equipment surfaces should be carried out with the equipment unplugged from the electric mains 7 1 1 Cleaning Procedures The DG Therm incubator has been manufactured with top quality materials However biological samples saline solutions acidic or alkaline solvents should be eliminated from the exterior surface before these can cause deterioration Periodically clean the external surfaces with a damp cloth with a soft detergent The DG Therm Trays should also be cleaned No 5 Figure 4 To do this pull them outwards remove them and clean with the same cloth Once the cleaning has finished return the Trays to their position NOTE If the DG Therm Trays are deteriorated replace them 72 GRIFOLS 3033629 DG Therm inside canada EN FR indd 34 27 11 12 10 45 DG Therm Maintenance WARNING For correct functioning of the card elevator system it is necessary for the DG Therm Trays to be completely introduced into the incubator and correctly placed AN WARNING Take care of not leaking cleaning solution into the equipment openings A WARNING Do not disassemble the equipment in any case If there is liquid inside the cleaning and decontamination operation should be carr
38. with water to eliminate the odour and residual harmful chemical components Dry the surface e Dispose of contaminated materials used during the decontamination in a container for biological waste WARNING Before using any cleaning or decontamination product different to those recommended by the manufacturer the SUPERVISOR should verify with the manufacturer that the methods proposed will not damage the equipment NOTE The procedures described above do not guarantee that the equipment is totally decontaminated but it reduces the risk of contamination to a minimum 74 GRIFOLS 3033629 DG Therm inside canada EN FR indd 36 27 11 12 10 45 DG Therm Maintenance 7 1 2 1 Decontamination Liquids During handling of these liquids the following recommendations should be followed Corresponding Instructions for Use e Laboratory safety regulations Local legislation in force on prevention DANGER The sodium hypochlorite solution is corrosive A irritating for the skin and eyes and toxic if inhaled absorbed or ingested GRIFOLS 7 5 3033629 DG Therm inside canada EN FR indd 37 27 11 12 10 45 3033629 DG Therm inside canada 38 27 11 12 10 45 DG Therm Operation Qualification 0Q Procedure 8 OPERATION QUALIFICATION 00 PROCEDURE The DG Therm incubator has two non adjustable independent temperature sensors controlled by the incubator program itself Giv
39. zard Label 26 GRIFOLS 3035615 DG Therm inside canada EN FR indd 14 10 12 12 10 00 DG Therm Technical Specifications 3 TECHNICAL SPECIFICATIONS 3 1 Technical Specifications e 24sample tubes INCUBATION BATCHES ROM TEMPERATURE UNITS INCUBATION TIME 15 minutes modifiable in steps of 5 minutes to 60 minutes PREHEATING TIME Approximately 8 minutes ALARM SYSTEMS Yes two independent sensors to measure and control temperature ACOUSTIC ALARM Yes to indicate end of incubation and error situations VOLUME OF ACOUSTIC ALARM Programmable 3 levels INTERFACE LCD screen and Buttons mw PROTECTION AGAINST Class I ELECTRIC SHOCK INSTALLATION Overvoltage category II local level CATEGORY appliances portal equipment etc GRIFOLS 3 1 3033629 DG Therm inside canada 15 e 27 11 12 10 44 DG Therm DIMENSIONS Technical Specifications 325 mm depth x 295 mm width x 95 mm height or 13 in depth x 12 in width x 4 in height WEIGHT Approximately 4 kg or 9 Ibs OPERATING CONDITIONS TRANSPORT AND STORAGE CONDITIONS PROTECTION AGAINST OVERHEATING USEFUL LIFE 3 2 Accessories Maximum relative humidity non 80 96 condensing Maximum altitude 3 000 m or 9 843 ft Mains supply maximum voltage fluctuations Maximum relative humidity non 85 96 condensing 50 C 5 5 years considering normal function of 8 hours day and 200 days year 10

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