NanoEnTek Adam rWBC2 User manual

ADAM-rWBC2, residual Leukocyte Counter 1
Instruction Manual

2
All the materials in this user manual are protected by Korean and international copyright laws. They cannot be reproduced,
translated, published or distributed without the permission of the copyright owner.
ADAM-rWBC2 Instruction Manual
Website : www.nanoentek.com
NanoEntek, Inc.
851-14, Seohae-ro, Paltan-myeon, Hwaseong-si, Gyeonggi-do, 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: NESMU-AR2-001E (V.0.7)
Revision history: MAR 2018 V.0.0
SEP 2018 V.0.1
DEC 2018 V.0.2
MAY 2019 V.0.3
FEB 2022 V.0.4
SEP 2022 V.0.5
MAR 2023 V.0.6
JULY 2023 V.0.7

ADAM-rWBC2, residual Leukocyte Counter 3
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
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
11
13
13
18
19
20
20
21

4
General
Description
Introduction
ADAM-rWBC2 is an analyzing device that counts the number of residual 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.

ADAM-rWBC2, residual Leukocyte Counter 5
Technology
- Mechanical
Introduction
White blood cell counting for residual leukocytes may be performed manually using a
Nageotte chamber. Limitations to this method include (1) propensity for the staining
of artifacts; (2) is only appropriate for use with very low cell counts, (3) the testing is
time consuming and (4) interpretation may be subjective. Other devices that count
residual leukocytes can be costly and 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 plastic slide. The slide is then loaded onto a preci-
sion stage. ADAM-rWBC2 system automatically focuses on the slide, and the cells that
have been stained are scanned by a sensitive CMOS camera. The image results are au-
tomatically processed.
CMOS

6
Technology
- residual Leukocytes
Counting
Introduction
ADAM-rWBC2 is based on the staining of mammalian cell DNA using the fluorescent dye,
Propidium Iodide (PI), a nucleic acid dye. When used with RNase, PI stains only cellular
DNA. In the case of blood samples, 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
is automatically calculated and displayed on ADAM-rWBC2.

ADAM-rWBC2, residual Leukocyte Counter 7
Product Description
Packing List ADAM-rWBC2 is shipped with the components listed in the table below. Once you receive
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.
Any 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 equipment.
The shipping brackets or foam inserts must be reinstalled prior to shipping
the unit to prevent damage to the equipment.
!

8
Packing list Main device
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

ADAM-rWBC2, residual Leukocyte Counter 9
Front View of
ADAM-rWBC2
Product Description
Description
EJECT
RUN SAMPLE
Ejects the slide holder from 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

10
Rear View of
ADAM-rWBC2
Product Description
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

ADAM-rWBC2, residual Leukocyte Counter 11
Environmental
Requirements
System Installation
Power On and
Initial Display
To ensure correct operation and stable performance, install ADAM-rWBC2 in a location
which meets the following conditions :
• Use at room temperature.
• Do not expose the device to direct sunlight.
• Do not subject the device to direct or continuous vibration.
• Do not subject the device to intense magnetic or electromagnetic fields.
• Do not install the device in high-humidity environment.
• Location of device should be free from corrosive gases or other corrosive substances.
• Ensure minimal contact 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 booting is successful and no errors are detected, the home screens will be displayed
as below.
CAUTION
At low temperatures (≤10°C), allow the device to warm up for 10 minutes
at ambient temperature before use.
!
CAUTION
Do not tilt the device too much in the forward when connecting the
power cord.
Do not move the device after connecting power cord.
When you connect the power cord to ADAM-rWBC2 even without power
on the device, it will go through self diagnostic tests.
!

12
Power On and
Initial Display
System Installation
It appears when booting is not working properly.
Turn off main power and restart device.
If this message still appears after restarting,
[System State]
Error Messages during booting
Cause
0x00000C00
0x00007000
0x00008000
0x06000000
Failure of X-axis sensor
Failure of Y-axis sensor
Failure of Z-axis sensor
Failure of Locking module sensor
Error code

ADAM-rWBC2, residual Leukocyte Counter 13
General Operation
Calibration Calibration test
Prior to use ADAM-rWBC2, calibration test MUST be performed. The calibration test
should be performed to verify if optic and auxiliary structures of ADAM-rWBC2 are com-
pletely ready for the real sample test by using Standard bead solution provided in ADAM-
rWBC kit.
The device is ready to use ONLY if the calibration result is within range as indicated on the
individual Standard bead solution provided.
Refer to a package insert of ADAM-rWBC Kit for specific instruction of use.
Leukocyte-reduced samples
Samples should be tested within 48 hours after leukocyte reduction.
A sample is mixed with r-Solution for staining. After staining, the sample is loaded into r-
Slide and left to be settled. After 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 seconds.
4. Insert loaded r-Slide into ADAM-rWBC2 main device and press RUN SAMPLE to start.
WARNING
The instrument does not detect incorrectly diluted samples.
Please refer to ADAM-rWBC Kit package insert.
!
CAUTION
Avoid bubbles which may negatively aect the result.
Do not reuse r-Slide. Reusing r-Slide may result in errors.
Do not use expired r-Solution, r-Slide or Standard bead solution.
Store r-Solution at 2~8˚C. The expiration date is one year.
Do not use after the expiration date shown on the label. Opened r-Solution
may be stored at 2~8˚C and used for up to 6 months, or until the expiration
date.
!
Sample Preparation
and Testing

14
Sample Preparation
and Testing
General Operation
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-

ADAM-rWBC2, residual Leukocyte Counter 15
1. Leave the ADAM-rWBC Kit at room temperature for 10 minutes before use.
2. Carefully dispense 100 µL of well-mixed RBC or platelet or plasma sample into
a clean test tube.
3. Add 400 µL of reagent into the tube.
4. Mix the tube well
· RBC or Platelet : 100 µL sample + 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 Testing
General Operation
r-Solution
Sample
100 µL
1.71 /µL
RBC, Platelet 400 µL
Plasma: 100 µL
-Result-

16
General Operation
Sample Preparation
and Testing
CAUTION
Avoid bubbles which may negatively aect the result.
!
WARNING
[Sample loading error]
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.
!
Correct volume
Low volume

ADAM-rWBC2, residual Leukocyte Counter 17
General Operation
Sample Preparation
and Testing
WARNING
[r-Slide insert error]
Completely insert r-Slides face up, in the direction of the arrow on the slide.
The instrument will not detect if slides are inserted incorrectly. See pictures
below for proper insertion.
!
CAUTION
Please insert or remove the r-slide when the slide holder is fully ejected.
When the test is nished, please remove the r-slide from the slide holder.
!
(O )
( X )
( X )
( X )
Correctly inserted
Upside down inserted
Not fully inserted
Wrong end inserted
(No arrow)
Digital Bio

18
Run Sample
General Operation
Start counting process by pressing RUN 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.

ADAM-rWBC2, residual Leukocyte Counter 19
The total number of leukocytes will be displayed after being automatically calculated by
ADAM-rWBC2 software.
Result Analysis
1.71/μL
Total Number 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

20
Slide to shut down your PC
Lock
General Operation
Power Off
Press LOCK before turning off the device.
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.
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