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NanoEnTek ADAM-rWBC2 Instruction Manual

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Instruction Manual
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ADAM-rWBC2, residual Leukocyte Counter

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Summary of Contents for NanoEnTek ADAM-rWBC2

  • Page 1 Instruction Manual ADAM-rWBC2, residual Leukocyte Counter...
  • Page 2 Fax. +1-781-790-5649 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;...

  • Page 3: Table Of Contents

    Table of Contents Introduction General Description Technology - Mechanical Technology - residual Leukocytes Counting Product Description Packing List Front View of ADAM-rWBC2 Rear View of ADAM-rWBC2 System Installation 10-12 Environmental Requirements Power On and Initial Display General Operation 13-21 Calibration...

  • Page 4: Introduction

    Introduction ADAM-rWBC2 is an analyzing device that counts the number of residual leukocytes in a General blood component for transfusion. Targeting the leukocyte, ADAM-rWBC2 uses fluorescent Description 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: Technology - Mechanical

    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 plastic slide. The slide is then loaded onto a preci- sion stage.

  • Page 6: Technology - Residual Leukocytes Counting

    Introduction ADAM-rWBC2 is based on the staining of mammalian cell DNA using the fluorescent dye, Technology Propidium Iodide (PI), a nucleic acid dye. When used with RNase, PI stains only cellular - residual Leukocytes DNA. In the case of blood samples, white blood cells (with DNA-containing nuclei) are stained while platelets and red blood cells, (without nuclei) are not stained.

  • Page 7: Product Description

    Product Description ADAM-rWBC2 is shipped with the components listed in the table below. Once you receive Packing List your instrument, please check that all items listed below were shipped. If any items are missing or damaged, contact your local distributor or ivdst@nanoentek.com.

  • Page 8: Front View Of Adam-Rwbc2

    Performs all procedures of automatic counting. Protects the alignment of stage from external shock LOCK when ADAM-rWBC2 is being moved. Lock ADAM-rWBC2 before turning it off or moving it. Door Slide holder is inserted and ejected Display processes and results...

  • Page 9: Rear View Of Adam-Rwbc2

    PC port Power plug Description Port USB Port Port for software and firmware updates Connects USB cable to ADAM-rWBC2 and PC for PC port using a software Power Plug Connects ADAM-rWBC2 power cord to wall outlet ADAM-rWBC2, residual Leukocyte Counter...

  • Page 10: System Installation

    At low temperatures (≤10°C), allow the device to warm up for 10 minutes Requirements at ambient temperature before use. To ensure correct operation and stable performance, install ADAM-rWBC2 in a location which meets the following conditions : • Use at room temperature.
  • Page 11 Initial Display [System State] It appears when booting is not working properly. Turn off main power and restart device. If this message still appears after restarting, contact your local distributor or ivdst@nanoentek.com. Cause Error code 0x00000C00 Failure of X-axis sensor...
  • Page 12 2. Power off/on. 3. Redo initial booting again. CAUTION When you turn off the device, please remove the r-Slide from ADAM-rWBC2. This is the cause of malfunction. If this message continues to display when no r-Side is inserted, contact your local distributor or ivdst@nanoentek.com.

  • Page 13: General Operation

    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).
  • Page 14 General Operation Please check the procedure of sample preparation and testing below. Sample Preparation For more detailed information, please refer to the next page. and Testing r-Solution Sample 1. Mix sample with r-Solution & Load the mixed sample (100 μL) 2.
  • Page 15 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. 1.71 ADAM-rWBC2, residual Leukocyte Counter...
  • Page 16 General Operation WARNING Sample Preparation [Sample loading error] and Testing Be cautious of loading the correct volume(100 μL) of the sample into r-Slide. The instrument will not detect low or high sample volumes. CAUTION Avoid bubbles which may negatively affect the result. Correct volume Low volume...
  • Page 17 ( X ) Upside down inserted Wrong end inserted (No arrow) CAUTION Please insert or remove the r-slide when the slide holder is fully ejected. When the test is finished, please remove the r-slide from the slide holder. ADAM-rWBC2, residual Leukocyte Counter...

  • Page 18: Run Sample

    Start counting process by pressing RUN SAMPLE Run Sample It may take about 1 minute longer for auto focus at the initial test. The total number of leukocytes will be displayed after being automatically calculated by Result Analysis ADAM-rWBC2 software. 1.71/μL Total Number of Leukocytes...
  • Page 19 160 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. ADAM-rWBC2, residual Leukocyte Counter...

  • Page 20: Lock

    General Operation Press LOCK before turning off the device. Lock If there is no operation for 3 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 Power Off will appear.

  • Page 21: Maintenance And Cleaning

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

  • Page 22: Trouble Shooting

    Trouble Shooting Problem Cause Solution ADAM-rWBC2 does not power up No power from outlet Check power source. Bad power cord Replace or Repurchase. LED on the power button blinks and Unplug the adapter and plug it back in Problem with Windows OS the screen does not turn on to power on the device.

  • Page 23: Warranty

    Warranty If any defects occur in the ADAM-rWBC2 during one(1) year warranty period, NanoEnTek will repair or replace the defective parts at its discretion without charge. The following defects, however, are specifically excluded: Defects caused by improper operation. Repair or modification done by anyone other than NanoEnTek or an authorized agent.

  • Page 24: Technical Specifications

    Technical Specifications ADAM-rWBC2 Measuring range 1~100 cells /μL Analysis time < 1 min /test Voltage DC12V Current Objective lens 4W Green LED Camera CMOS camera Filter Excitation filter, Dichroic filter, Emission filter Weight 7 Kg Size (W×L×H) 227 × 276 × 270 mm...

  • Page 25: Product List

    Standard bead solution 7mL Accessories Barcode scanner * 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. ADAM-rWBC2, residual Leukocyte Counter...

  • Page 26: Safety Precautions

    Safety Precautions Review and follow the safety instructions below : Always ensure that the power supply input voltage matches the voltage available at your location. To avoid the danger of electric shock, install the instrument per the environmental specifications described in “Technical Specifications”. If water or other material enters the instrument, the adaptor, or power inlet, disconnect the power cord and contact an authorized service person.
  • Page 27 Dans la documentation de l’utilisateur, la déclaration doit être incluse pour attirer l’attention sur le fait qu’il peut y avoir des difficultés potentielles pour assurer la com- patibilité électromagnétique dans d’autres environnements, en raison des perturba- tions rayonnées et conduites par l’électricité. ADAM-rWBC2, residual Leukocyte Counter...

  • Page 28: Safety Symbols

    The correct disposal of your old appliance will help prevent potential negative consequences for the environment and human health. For more detailed information about disposal of your old appliance, please contact your city office, waste disposal service or visit our web-site, www.nanoentek.com. In vitro diagnostic medical device in vitro diagnostic This product conforms to UL 61010-1, CAN/CSA C22.2 No.61010-1 “Safety Requirements...

  • Page 29: Warnings

    Sample may contain infectious or bio-hazardous agents. Use of capped tubes and lint free wipes. Lint free wipes to be used one time and discarded. Waste After using r-Slides, appropriately dispose as bio-hazardous waste. Do not reuse r-Slides. ADAM-rWBC2, residual Leukocyte Counter...

  • Page 30: Technical Support

    Technical Support Visit the our Website at www.nanoentek.com for : · Technical resources, including manuals, FAQs, etc. · Technical support contact information · Additional product information and special offers. For more information or technical assistance, please call or email. NanoEnTek, Inc.
  • Page 31 ADAM-rWBC2, residual Leukocyte Counter...
  • Page 32 NESMU-AR2-001E (V.0.3) NanoEnTek, Inc. 851-14, Seohae-ro, Paltan-myeon, Hwaseong-si, Gyeonggi-do, 18531, Korea Tel :+82-2-6220-7942 Fax:+82-2-6220-7999 NanoEnTek America, Inc. 240 Bear Hill Road, Suite 101, Waltham, MA 02451, USA Tel: +1-781-472-2558 Fax: +1-781-790-5649 EC Representative MT Promedt Consulting GmbH Altenhofstrasse 80, 66386 St. Ingbert, Germany Email ivdst@nanoentek.com...

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