NanoEnTek Adam rWBC2, Instruction Manual

Page 1: ...ADAM rWBC2 residual Leukocyte Counter 1 Instruction Manual ...

Page 2: ...o 18531 Korea Tel 82 2 6220 7940 Fax 82 2 6220 7999 The information in this manual is described as accurately as possible Firmware and software changes and updates may change without prior consent or notification Copyright 2018 by NanoEntek Inc All rights reserved Published in Korea Protected by patents US 7 842 157 US 7 411 680 CN 2004 8 0020890 7 other rights granted and pending Documentation NE...

Page 3: ...f ADAM rWBC2 System Installation Environmental Requirements Power On and Initial Display General Operation Calibration Sample Preparation and Testing Run Sample Result Analysis Lock Power off Maintenance and Cleaning Trouble Shooting Warranty Technical Specifications Product List Safety Precautions Safety Symbols Warnings Technical Support 4 6 7 10 13 21 11 22 23 24 25 26 28 30 31 4 5 6 7 9 10 11 ...

Page 4: ...l leukocytes in a blood component for transfusion Targeting the leukocyte ADAM rWBC2 uses fluorescent dye to perform cell dyeing and automated cell counting Automated cell counting elimi nates user bias or subjective interpretation that can be found when counting residual leu kocytes using other methods ...

Page 5: ...nd very user technique dependent NanoEntek has developed ADAM rWBC2 which is based on fluorescent microscopy techniques for counting cells ADAM rWBC2 utilizes sensitive fluorescence dye stain ing LED optics and CMOS detection to make provide accurate and reliable leukocyte detection To use ADAM rWBC2 a blood sample is mixed with a Propidium Iodide PI stain and directly pipetted onto a disposable p...

Page 6: ...es white blood cells with DNA containing nuclei are stained while platelets red blood cells and plasma without nuclei are not stained The ADAM rWBC Kit consists of r Solution and the disposable 1 test r Slide For absolute counting of residual leukocytes appropriate sample preparation is needed After mixing the sample with the r Solution and loading into the r Slide the number of total leukocytes i...

Page 7: ... damage incurred during transit must be filed with the carrier Quantity Main device 1 ADAM rWBC Kit Starter Kit with Package Insert 1 Instruction manual 1 Adapter Power cord Software Manual 1 1 Installation USB Quick Manual USB cable Barcode scanner Optional 1 1 1 1 Item CAUTION Neglecting to remove any or all shipping brackets or foam inserts prior to operation may result in damage to the equipme...

Page 8: ...vice Installation USB USB cable Instruction manual Adapter Power cord ADAM rWBC2 PC Software User Manual Barcode Scanner ADAM rWBC Kit Starter kit with package insert Quick manual Optional Cat No AD1K 050 Product Description ...

Page 9: ...rom ADAM rWBC2 Functions as unload Protects the alignment of stage from external shock when ADAM rWBC2 is being moved Lock ADAM rWBC2 before turning it off or moving it Performs all procedures of automatic counting Slide holder is inserted and ejected Display processes and results Power On Off LOCK Door LCD Power Control buttons Door Power ...

Page 10: ...cription Description USB Port 1 2 3 PC port Port for software and firmware updates Connects ADAM rWBC2 power cord to wall outlet Connects USB cable to ADAM rWBC2 and PC for using a software Power Plug Port USB Port PC port Power plug 1 2 3 ...

Page 11: ...ct with dust or other airborne particles Allow for 10 cm 4 inches minimum space around the device for proper airflow Do not place any objects on the device 1 Check the connection of ADAM rWBC2 and power cord 2 Press the power button for 2 3 seconds If you get an error message please contact your local distributor or ivdst nanoentek com If booting is successful and no errors are detected the home s...

Page 12: ...restart device If this message still appears after restarting contact your local distributor or ivdst nanoentek com System State Error Messages during booting Cause 0x00000C00 0x00007000 0x00008000 0x06000000 Failure of X axis sensor Failure ofY axis sensor Failure of Z axis sensor Failure of Locking module sensor Error code ...

Page 13: ...r settling r Slide is inserted into ADAM rWBC2 and count ed Refer to a package insert of ADAM rWBC Kit for specific instruction of use The ADAM rWBC2 must be calibrated after each start up and at least once each day of use 1 Let beads equilibrate to room temperature before use 10 minutes 2 Mix by rocking gently including upside down 3 Load 100 µL of the beads into the r Slide Let settle for 40 60 ...

Page 14: ...on Please check the procedure of sample preparation and testing below For more detailed information please refer to the next page 3 Result 2 Insert r Slide 1 Mix sample with r Solution Load the mixed sample 100 μL r Solution Sample 1 71 1 71 µL Result ...

Page 15: ... 400 µL reagent Plasma 100 µL sample 100 µL reagent 5 Load 100 µL mixed sample reagent onto a r Slide 6 Wait 4 7 minutes for sample settling 7 Insert r Slide into ADAM instrument and press RUN SAMPLE to start 8 After approximately 1 minute the result calculated as WBC per µL will be displayed automatically It may take about 1 minute longer for auto focus at the initial test Sample Preparation and ...

Page 16: ...tion and Testing CAUTION Avoidbubbleswhichmaynegativelyaffecttheresult WARNING Sampleloadingerror Becautiousofloadingthecorrectvolume 100μL ofthesampleintor Slide Theinstrumentwillnotdetectloworhighsamplevolumes Correct volume Low volume ...

Page 17: ... the arrow on the slide The instrument will not detect if slides are inserted incorrectly See pictures belowforproperinsertion CAUTION Pleaseinsertorremovether slidewhentheslideholderisfullyejected Whenthetestisfinished pleaseremovether slidefromtheslideholder O X X X Correctly inserted Upside down inserted Not fully inserted Wrong end inserted No arrow D ig it a l B io ...

Page 18: ...N SAMPLE It may take about 1 minute longer for auto focus at the initial test Note If the ADAM rWBC2 instrument is not connected to the PC software the pop up window will appear as below Select the Sample type and press the OK button to proceed with the counting process ...

Page 19: ...mber of Leukocytes General Operation When 1 cell including dust consists of more than 100 pixels or the number of cells is more than 160 in 1 frame this is considered as error frame If these error frames are more than 5 then the error message Bad Sample will be displayed on the screen Please check if the sample has any dust or cell clumping and retest Bad Sample Error Message 50 58 ...

Page 20: ...ice If there is no operation for 1 minutes the lock function will be activated automatically When the device is locked the screen will be changed as shown below If you press the power button for 2 3 seconds then Slide to shut down your PC message will appear Slide down the screen to turn off the power ...

Page 21: ...BC2 does not need regularly scheduled maintenance because ADAM rWBC2 has no consumable materials to replace Please clean the exposed surface of ADAM rWBC2 frequently or before testing using a soft cloth and isopropyl alcohol or deionized water Maintenance and Cleaning ...

Page 22: ...t turn on No power from outlet Bad power cord Problem with Windows OS Check power source Replace or Repurchase Unplug the adapter and plug it back in to power on the device Booting error message Result error message System state Bad sample Refer to the 11 page Refer to the 18 page Problem Cause Solution ...

Page 23: ...f a repair instrument It is recom mend that you save the original packing material in which the instrument was shipped This warranty should be limited to the replacement of defective products For any inquiry or request for repair service contact ivdst nanoentek com or your local distributor Defects caused by improper operation Repair or modification done by anyone other than NanoEntek or an author...

Page 24: ...L r Slide Operating environment condition Temperature Humidity Altitude Transportation storage environment condition Temperature Humidity 0 C Temperature 40 C 10 Humidity 90 Altitude 2 000 m 30 C Temperature 60 C 10 Humidity 90 Solutions r Solution Standard bead solution 25 mL Propidium Iodide PI 7 mL Storage temperature r Slides r Solution Standard bead solution 0 30 C 2 8 C 2 8 C Expiration date...

Page 25: ...allation USB Adapter Power cord Barcode Scanner Optional 1 1 1 1 1 1 1 1 1 r Solution 25mL Standard Bead Solution 7ml Instruction manual Cat No Product Contents Quantity Each component and power cord are available for purchase separately Please contact your local distributor or ivdst nanoentek com This Instruction Manual can be downloaded from the NanoEntek website www nanoentek com ...

Page 26: ...nt Never insert any objects into the air vents of the instrument as this can result in electric shock personal injury and equipment damage Plug the power cord firmly into the wall outlet and AC adapter To avoid potential shock hazard make sure that the power cord is properly grounded Be sure to position the instrument such that it is easy to disconnect Turn off an instrument before unplugging the ...

Page 27: ...mais insérer d objets dans les évents d air de l instrument car cela peut causer des chocs électriques des blessures corporelles et des dommages de l instrument Mettre le cordon d alimentation fermement dans la prise murale et l adaptateur courant alternatif Pour éviter tout risque de choc s assurer que le cordon d alimentation est correctement mis à la terre S assurer de positionner l instrument ...

Page 28: ...gnostic medical device Electric input Valtage Current Serial number LED Power On Off Meets FCC requirements per 21 CFR Part 15 This equipment has been tested and found to comply with the limits for a Class A digital device pursuant to Part 15 of the FCC Rules These limits are designed to provide reasonable protection against hatmful interference when the equipment is operated in a commercial envir...

Page 29: ...recover recyclable Keep dry Keep away from rain Disposal of your old appliance When this crossed out wheeled bin symbol is attached to a product it means the product is covered by the European Directive 2012 19 EU All electrical and electronic products should be disposed of separately from the municipal waste stream via designated collection facilities appointed by the government or the local auth...

Page 30: ...justable components inside the instrument If a malfunction is found refer to an authorized service person Do not attempt to service the equipment This manual is only available in English Failure to heed warnings may result in injury to service provider or operator Wear personal protective equipment during sampling and testing Sample may contain infectious or bio hazardous agents Use of capped tube...

Page 31: ...anuals FAQs etc Technical support contact information Additional product information and special offers For more information or technical assistance please call or email NanoEntek Inc 851 14 Seohae ro Paltan myeon Hwaseong si Gyeonggi do 18531 Korea Tel 82 2 6220 7940 Fax 82 2 6220 7999 Email ivdst nanoentek com Website www nanoentek com ...

Page 32: ...0 7999 NanoEntek America Inc 220 Bear Hill Road Suite 102 Waltham MA 02451 USA Tel 1 781 472 2558 Fax 1 781 790 564 MT Promedt Consulting GmbH Ernst Heckel Straße 7 66386 St Ingbert Germany MT Promedt Consulting Ltd Beaver House 23 38 Hythe Bridge Street Oxford OX1 2EP United Kingdom Email ivdst nanoentek com Website www nanoentek com ...