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Kurabo QuickGene-Auto12S, Руководство по эксплуатации

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QuickGene-Auto12S 
QuickGene-Auto24S 
 

 

Ver. CEIVD2.0

 

 

 

Operation Manual 

 

Содержание QuickGene-Auto12S

Страница 1: ...QuickGene Auto12S QuickGene Auto24S Ver CEIVD2 0 Operation Manual ...

Страница 2: ......

Страница 3: ... The contents of this document are subject to change without prior notification Our company shall not be liable for Any violation of patent right of a third party or other rights through use of data described in this document Any failure or damage caused by installation relocation remodeling maintenance or repair carried out by any party other than our company or other than a contractor designated...

Страница 4: ...tal explanations etc Intended Use QuickGene Auto12S QuickGene Auto24S with QuickGene AutoS DNA Blood Kit is intended to isolate high quality genomic DNA automatically from human whole blood sample Generally DNA isolated by the system is useful for PCR based analysis like HLA typing or karyotyping to know patients genotype before transplantation and for Next Generation Sequencing NGS for selection ...

Страница 5: ... a grounding terminal Do not handle the power plug with wet hands Do not use with a voltage other than the indicated voltage and avoid branch connections or extension cords Do not use with a damaged power plug or a loose socket If there is dust on the prongs of the power plug or on the plug socket remove it with a dry cloth When you disconnect the plug from the outlet be sure to hold the power plu...

Страница 6: ... handling or disposing of infectious materials follow local municipal waste ordinances for proper disposal provisions to reduce the environmental impact of waste electrical and electronic equipment WEEE QuickGene Auto12S QuickGene Auto24S Kit Hereafter the QucickGene Auto12S AuickGene Auto24S Kit is referred to as a dedicated kit in this document Refer to the procedures for use of the dedicated ki...

Страница 7: ...pen fire Wear proper gloves mask and protective goggles for cleaning work Samples Use proper gloves mask and protective goggles for handling samples with a risk of infection Ultraviolet Light UV Irradiating Function Operation of the UV irradiating function of this system will cause ultraviolet small amount leakage from the front door and its peripheral part joints with exteriors etc Exposure to ul...

Страница 8: ...ous substances etc When inserting your hands into the device be sure to wear protective gloves Read operation manual Read and understand operation manual before using this equipment Biohazard Risk Label This label indicates a biohazard risk Warning Hot Surface Risk of burns do not touch immediately after operation Warning hands pinching Keep hands away Warning Hazardous voltage Risk of electrical ...

Страница 9: ...instructions for use SN Serial number European Authorized Representative Do not dispose of this product as unsorted municipal waste Humidity limitation Caution Consult accompanying documents Temperature limitation Recyclable materials In Vitro Diagnostic Medical Device CE Marking Product Name Label QuickGene Auto12S QuickGene Auto24S ...

Страница 10: ...uickGene Auto12S QuickGene Auto24S and dedicated kit No liability is assumed for the results regardless of the purpose of use Validation of performance on samples shall be based on the judgment and responsibility of the user When using this device please thoroughly read this document and abide by the safety rules of your facility ...

Страница 11: ...nfirmation of Articles to be Prepared 2 2 Preparation of Reagents 2 3 Preparation for Operation 2 4 Operation of DNA RNA Isolation 2 5 Collection of Isolation Samples 2 6 After Operation 3 Cleaning and Maintenance p 27 3 1 Daily Maintenance 3 2 Weekly Maintenance 3 3 Half a Year Maintenance 3 4 How to replace the power fuse 4 Before Concluding as a Failure p 31 4 1 Troubleshooting Appendix A p 33 ...

Страница 12: ...x QuickGene Auto12S QuickGene Auto24S Operation Manual ...

Страница 13: ...are explained The isolation operation is explained The procedures for cleaning and maintenance are explained The handling procedures when you consider a failure has occurred are explained 1 2 3 4 1 Installation Procedures 2 How to Operate 3 Cleaning and Maintenance 4 Before Concluding as a Failure ...

Страница 14: ...xii QuickGene Auto12S QuickGene Auto24S Operation Manual ...

Страница 15: ... location exposed to direct sunlight or in the proximity of a heating or cooling appliance This may cause a shortened lifetime or failure Block the sunlight by closing curtains or blinds as necessary Install QuickGene Auto12S QuickGene Auto24S on a location which is well ventilated and not dusty Install QuickGene Auto12S QuickGene Auto24S on a location with minimal sudden temperature fluctuation W...

Страница 16: ...on as shown below for normal safe use Required footprint Width 68 cm Depth 92 cm Height 79 cm Installation location of QuickGene Auto24S Please install this device in an indoor location as shown below for normal safe use Required footprint Width 103 cm Depth 92 cm Height 80 cm 20 cm 10 cm 10 cm 20 cm 10 cm 79 cm 92 cm 68 cm 20 cm 10 cm 10 cm 10 cm 20 cm 80 cm 103 cm 92 cm ...

Страница 17: ...ce LED white light Heating block 25 60 C User s interface 7 TFT LCD touch screen 800 400 Operating environment Item Specification Temperature 15 30 C Humidity 30 80 relative humidity non condensing Input power 100 240 V 50 60Hz Overvoltage category definition Transient overvoltage category II Table tolerance weight QuickGene Auto12S 55 kg QuickGene Auto24S 80 kg Operating parameters Item Specifica...

Страница 18: ...r more people are needed for carrying QuickGene Auto12S 4 or more people are needed for carrying QuickGene Auto24S Follow the instructions to unpack the device 1 2 1 Remove the outer carton four foam pieces and take out the device Wooden carton dimension QuickGene Auto12S 70 x 85 x 85 cm GW 105 kg QuickGene Auto24S 85 x 104 x 93 cm GW 143 kg Caution ...

Страница 19: ...gent holder and syringe head from inside the instrument and cut the cable tie of Reagent holder 1 2 3 Remove the foam between the Y2 axis and worktable from inside the instrument and cut the cable tie of Collection holder 1 2 4 Take out the Collection holder remove the wing screw and take out the UV lamp then install it ...

Страница 20: ...o24S Operation Manual 1 1 2 5 Plug in the Power Cable and turn on the rear power switch 1 2 6 Turn on the main switch Orange Do not obstruct the mains plug or position the equipment where the connection to the mains line can be accidentally disconnected Warning ...

Страница 21: ... carton before using the device If any item is missing please contact your distributor Main Unit Operation Manual Power Cable Reagent Holder Collection Holder O ring Plastic tank UV Lamp Grease Item QuickGene Auto12S QuickGene Auto24S Main Unit 1 1 Operation Manual 1 1 Power Cable 1 1 Reagent Holder 1 2 Collection Holder 1 2 O Ring 12 24 Plastic Tank 3 6 UV lamp 1 1 Grease 1 1 ...

Страница 22: ...eration Manual 1 1 4 Device Overview The names of parts and their functions are explained below QuickGene Auto12S Interior View of QuickGene Auto12S Operation panel USB Port Power Switch Front Door Ventilation hole AC inlet Holder guide upper Holder guide under Heater ...

Страница 23: ... QuickGene Auto12S QuickGene Auto24S Operation Manual 1 QuickGene Auto24S Interior view of QuickGene Auto24S Operation panel Power Switch Ventilation hole AC inlet USB Port Front Door Heater Holder guide upper Holder guide under ...

Страница 24: ...When door is opened during the isolation operation the alert is showed up on the panel 1 6 Implemented Protocols Protocol Name Automatic Process Relevant Sample Final Product Remarks DNA WHOLE BLOOD Full Auto Whole Blood 200 µl DNA IVD RUO DNA TISSUE Semi Auto Tissue 5 mg DNA RUO RNA CULTURE CELL Semi Auto Cultured cell 1x106 cells RNA RUO RNA BLOOD Semi Auto Leukocyte 1x107 cells RNA RUO RNA TISS...

Страница 25: ...s and the lamp socket inserting position Insert the UV lamp and amount on the lamp socket 1 Insert the UV lamp along the vertical groove of the lamp socket to the end 2 Turn the UV lamp clockwise 90 to mount on the lamp socket Turn until a clicking sound is heard NB To remove the UV lamp follow the reverse order of above Lamp Socket Lamp Socket Side Align the center vertical lamp socket and the me...

Страница 26: ...1 Installation Procedures 12 QuickGene Auto12S QuickGene Auto24S Operation Manual 1 ...

Страница 27: ... conducting isolation work QuickGene Auto12S or QuickGene Auto24S Main Unit and Accessories Refer to 1 4 Checking of Packed Contents and confirm that all are included Other articles to prepare The following articles shall be prepared NB They are not included in the package of this system but must be separately prepared QuickGene AutoS DNA Blood Kit 48 reactions kit 2 0 mL Micro Tubes as sample tub...

Страница 28: ...he expiry date is indicated on the outer box of the reagent kit Reagent strips QuickGene AutoS DNA Blood Kit include reagent strips Following items are included each wells of reagent strips Name of parts reagent Quantity Volume Position Notes Lysis Buffer 270 µl 1 Wash Buffer 750 µl 2 3 positions 99 Ethanol 270 µl 3 Elution Buffer 250 µl 4 Short Tip 2 pcs 5 Tip pack 1 pc 6 Cartridge 1 pc 7 Pressur...

Страница 29: ... elution tube in the Collection holder 2 Open the lid of Reagent holder and put the strip into the holder 3 Close the lid of the reagent holder 4 Set 1 ml long tip at the 6 of reagent strips Note Confirm tip packs is correctly set before setting 1 ml long tip 5 Check adaptors are correctly set on the cartridges and close the lid ...

Страница 30: ...ote The collection holder need to be set into the holder guide under During the heating block is hot about 50 C please be careful of getting burn due to touch on the heating block Be careful not to hit your head against the front door when setting the holder to the equipment 8 Put the Reagent holder into the device Note The cartridges should be set at the front side of the device 9 Lock the reagen...

Страница 31: ...10 Put the sample tube into the well between long tip and 99 Ethanol of reagent strip Press it to the end Note Open the lid of tube and set the specific position Please refer to the kit handbook for sample preparation If you set inappropriate sample cartridges may clog Warning ...

Страница 32: ...ome position about all moving parts When the heater temperature reached to 25 C the touch panel shows the Home screen Each parts means as follows S Cylinder operation vertical movement Z Dispenser operation vertical movement Y1 Dispense unit operation back and forth movement Y2 Switching operation 4 At the Home screen select the Normalized protocol blue Customized protocol green or System purple E...

Страница 33: ...eed the isolation Then processing will be started During the operation please close the door If door is opened since a warning page is displayed please close the door and press continue to go on the isolation Or if you want to stop protocol please press terminate When you select Yes the operation will be terminated and the screen will go back to the Home screen When you select No the operation wil...

Страница 34: ...D button upper right corner You can stop the processing at the middle of the protocol if you press the Pause button When you press the Pause button you can select Stop or Continue If you press the Continue button the device will continue the running If you press the Stop button warning page will show up At this warning page When you press No the device will continue the protocol and the touch pane...

Страница 35: ...w to operate the Customized protocol 1 Press the CUSTOMIZED PROTOCOL 2 Choose Protocol Note When the protocol is not installed the following page will be showed up If you need customized protocol please contact to your distributor How to use the System purple 1 Press the SYSTEM ...

Страница 36: ...u can check Model name serial number and software version will be showed up DEMO run Used by manufacturers and distributors UV lamp UV irradiation Before start of UV irradiation please make sure front door has been closed the Collection holder and the Reagent holder has been removed 1 Press OK to start UV irradiation Warning ...

Страница 37: ...and continue for 5 minutes 3 Press Pause button to stop UV irradiation 4 Press Stop if you really want to terminate UV irradiation Press Continue if you want to continue UV irradiation Delivery mode Used by manufacturers and distributors As usual if you proceed the operation this screen will be showed up ...

Страница 38: ...2 How to Operate 24 QuickGene Auto12S QuickGene Auto24S Operation Manual 2 Device test Used by manufacturers and distributors This function is only for engineer use ...

Страница 39: ... Note The isolation sample may be spilt if the collection tube holder is tilted Take out while holding the handle of the collection tube holder with one hand and supporting the bottom surface of the holder with the other hand 2 Securely close the cap of microtubes collection tubes on Collection tube holder 3 Take out the Collection holder from the device 4 Collect the microtubes collection tubes ...

Страница 40: ... tubes from the Collection holder and dispose of waste fluid and waste tubes Waste fluid and waste tubes should be disposed in accordance with customer s infectious waste treatment manuals Post Treatment of Device Refer to 3 Cleaning and Maintenance and carry out system maintenance as necessary 1 Close the front door The isolating operation is now completed When the operation is to be continued st...

Страница 41: ...olution 2 chlorine bleach Water Use distilled or deionized water Strong detergents may dissolve carrier and worktable surface coatings Use only recommended cleaning agents Chlorine solution can pit equipment and metal Use adequate amounts or repeated applications of 70 ethanol or water until chlorine residue is no longer visible II Decontamination Procedure using 0 1 Sodium Hypochlorite I Between ...

Страница 42: ...llection holder If Collection holder has been contaminated loosen the wing screw of Plastic tank and take it off Wash Collection holder with water and air dry then replace the new Plastic tank and tight the screw Notice the direction Front For Waste Tube iii Clean Piercing Needles Wipe with 70 ethanol iv Clean system worktable Wipe with 0 1 Sodium Hypochlorite and 70 ethanol ...

Страница 43: ... At Home screen select System ii At System screen select UV lamp iii Make sure the front door already has been closed Press OK button to start the UV irradiation iv If it is necessary you can press Pause button 3 3 Half a Year Maintenance It is recommended to replace O ring every half a year It may be changed up to your frequency of use i Use a sharp blade to cut off old O ring ii Put grease on O ...

Страница 44: ...e holder from AC inlet If this time is the first time changing then it will two pcs of fuse inside it One is in use the other one is for back up ii Take out the in use broken one fuse and replace the new one iii Make sure the fuse is installed in the middle Two side silver parts red frame should be exposed outside iv Insert the fuse holder to AC inlet Ensure the direction is correct If it is avail...

Страница 45: ...ical service UV lamp is not working 1 UV lamp was installed incorrect 2 The wire connect to the UV starter was not inserted well 3 Door is not closed or UV sensor is not sensed 1 Follow operation manual and re install 2 Contact to local distributor 3 Close the door and check the UV sensor LED light is not working The wire connect to the TFT board was not inserted well or broken Contact to local di...

Страница 46: ...e install 2 Follow operation manual and put it in the right position 3 Contact to local distributor Elution tube is empty 1 Plastic tank is not installed correctly 2 Is waste tube and elution tube put well 3 Y2 axis motor is not working 1 Follow operation manual and re install 2 Follow operation manual and put it in the right position 3 Contact to local distributor Machine stop when it is performi...

Страница 47: ...ame P N QGAutoS Reagent Holder 40321310411 Name P N QGAutoS Grease 40311310440 A 2 Warranty Warranty period is one 1 year from delivery of system Free repair warranty is applied when failure occurs during normal use conditions of use in accordance with precautions in this manual etc during warranty period Repair fee will be charged for cases below even if warranty has not expired Improper use dama...

Страница 48: ...ustomer Consultation Desk Kurabo Industries Ltd Advanced Technology Division Bio Medical Department Osaka 14 30 Shimokida cho Neyagawa Osaka 572 0823 Technical Support TEL 81 72 820 3079 FAX 81 72 820 3095 Tokyo 2F 7 1 2 chome Nihonbashi honcho Chuo ku Tokyo 103 0023 TEL 81 3 3639 7077 FAX 81 3 3639 6998 URL http www kurabo co jp bio A 5 Precautions for Transportation When system is to be transpor...

Страница 49: ...Osaka 572 0823 Japan Printed in Japan The contents of this document are subject to change without prior notification Kurabo Industries Ltd is not liable for violation of any patent rights or other rights of a third party caused by the use of data described in this document All rights are reserved Any defective issues with missing or disarranged pages will be rectified ...

Страница 50: ...t GmbH Borkstrasse 10 48163 Muenster Germany Kurabo Industries Ltd Advanced Technology Division Bio Medical Department 14 30 Shimokida cho Neyagawa City Osaka 572 0823 Japan 15 30 30 80 KURABO INDUSTRIES LTD ...

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