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
E-mail : [email protected]
Manufactured by
NanoEnTek, Inc.
851-14, Seohae-ro, Paltan-myeon, Hwaseong-si, Gyeonggi-do, 18531, Korea
Tel. [phone]
Fax. [phone]
NanoEnTek America, Inc.
240 Bear Hill Road, Suite 101, Waltham, MA 02451, USA
Tel. [phone]
Fax. [phone]
The information in this manual is described as accurately as possible.
Firmware and software changes and updates may change without prior consent or notication.
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.0.3)
Revision history: MAR 2018 V.0.0
SEP 2018 V.0.1
DEC 2018 V.0.2
MAY 2019 V.0.3

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 o
Maintenance and Cleaning
Trouble Shooting
Warranty
Technical Specications
Product List
Safety Precautions
Safety Symbols
Warnings
Technical Support
4-6
7-9
13-21
10-12
22
23
24
25
26
28
29
30
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5
6
7
8
9
10
10
13
13
18
18
20
20
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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 uorescent
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 uorescent microscopy
techniques for counting cells. ADAM-rWBC2 utilizes sensitive uorescence 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 uorescent 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 and red blood cells, (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 [e-mail].
Any damage incurred during transit must be led with the carrier.
Quantity
Main device 1
ADAM-rWBC Kit (Starter Kit with Package Insert) 1
Instruction manual 1
Adapter & Power cord 1
Installation USB
Barcode scanner (Optional)
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
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 o or moving it.
Performs all procedures of automatic counting.
Slide holder is inserted and ejected
Display processes and results
Power On/O
LOCK
Door
LCD
Power
Control buttons
Door Power

ADAM-rWBC2, residual Leukocyte Counter 9
Rear View of
ADAM-rWBC2
Product Description
Description
USB Port
1
2
3
PC port
Port for software and rmware 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

10
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 elds.
• 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 airow.
• 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 [e-mail].
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.
!

ADAM-rWBC2, residual Leukocyte Counter 11
Power On and
Initial Display
System Installation
It appears when booting is not working properly.
Turn o main power and restart device.
If this message still appears after restarting,
contact your local distributor or [email protected].
[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

12
System Installation
Power On and
Initial Display
If a r-Slide is detected during initial booting, this error message will be shown.
▶Trouble shooting
1. Remove the r-Slide
2. Power o/on.
3. Redo initial booting again.
[System init]
It appears when turning o the device without locking.
If this message still appears after restarting,
contact your local distributor or [email protected].
[Device unlocked]
CAUTION
When you turn o 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 iv[email protected].
!
CAUTION
Press LOCK before turning o the device.
!

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 specic 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 specic 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 aect 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

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, platelet sample into a clean test tube.
3. Add 400 µL of reagent into the tube.
4. Mix the tube well (100 µL sample + 400 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
400 µL
Sample
100 µL
1.71

16
General Operation
Sample Preparation
and Testing
CAUTION
Avoid bubbles which may negatively aect 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)

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.
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

ADAM-rWBC2, residual Leukocyte Counter 19
Result Analysis
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 O
Press LOCK before turning o the device.
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
will appear. Slide down the screen to turn o the power.