NanoEnTek ADAM-rWBC User manual

Instruction
Manual
DigitalBio is brand name of NanoEnTek.

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 - rWBC 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]
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 © 2013 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-ARC-001E(V.4.0)
Revision history : V.0.0
V.1.0
V.1.5
V.2.0
V.2.5
V.3.0
V.3.1
V.3.2
V.3.7
V.3.8
Date: DEC 2009
Date: JAN 2010
Date: MAY 2010
Date: DEC 2010
Date: JULY 2011
Date: MAY 2011
Date: DEC 2013
Date: FEB 2014
Date: DEC 2014
Date: AUG 2017
Date: APR 2018
V.3.9
V.4.0 Date: SEP 2018

ADAM - rWBC ©2013 NanoEnTek Inc. 3
Introduction
General description
Technology - Mechanical
Technology - Viability measurement
Product description
Packing list
Front view of the ADAM-rWBC
Rear view of the ADAM-rWBC
System installation
Environmental requirements
Power on and initial display
Icon functions
General operation
Preparing the test sample
Sample preparation and testing
Operating the ADAM-rWBC
Start input
Result analysis
Maintenance and cleaning
Trouble shooting
Warranty
Technical specications
Product list
Safety precautions
Safety symbols
Warnings
Technical support
4-6
4
5
6
7-9
7
8
9
10-12
10
10
12
13-18
13
14
15
17
17
18
19
20
21
22
23-24
25
26
27
Table of Contents

4
ADAM-rWBC is an analyzing device that counts the number of
residual leukocytes in a blood component for transfusion.
Targeting the leukocyte, the ADAM-rWBC uses uorescent dye to per-
form cell dyeing and automated cell counting. Automated cell counting
eliminates user bias or subjective interpretation that can be found when
counting residual leukocytes using other methods.
Introduction
General
description

ADAM - rWBC ©2013 NanoEnTek Inc. 5
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 the ADAM-rWBC, which is based on uo-
rescent microscopy techniques for counting cells. The ADAM-rWBC uti-
lizes sensitive uorescence dye staining, LED optics and CCD detec-
tion to make provide accurate and reliable leukocyte detection.
To use the ADAM-rWBC, 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 precision stage. The ADAM-rWBC sys-
tem automatically focuses on the slide, and the cells that have been
stained are scanned by a sensitive CCD camera. The image results are
automatically processed and displayed on the instrument’s LCD screen
interface.
Introduction
Technology
- Mechanical

6
ADAM-rWBC 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 plate-
lets 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-rWBC.
Introduction
Technology
- Viability
measurement

ADAM - rWBC ©2013 NanoEnTek Inc. 7
The ADAM-rWBC is shipped with the components listed in the table follow.
Once you receive your instrument, please check that all items listed
follow 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.
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 ship-
ping the unit to prevent damage to the equipment.
Product description
Packing list
Item
Main device
rWBC Kit (Starter kit with package insert)
Instruction manual
Power cord
Fuse
Installation CD
Barcode scanner
Quantity
1
1
1
1
2
1
1

8
Control buttons
Eject
Start
Lock
Door
LCD
• Ejects the slide from the ADAM-rWBC.
• Functions as load and unload.
• Performs all procedures of automatic counting.
• Protects the alignment of stage from external
shock when the ADAM-rWBC is being moved.
☞ Lock ADAM-rWBC before turning it off
or moving it.
• Slide is inserted and ejected.
• Displays proceses and results.
Product description
Front view of
the ADAM-
rWBC
Lock
Start
Eject
Door
LCD
Control
buttons

ADAM - rWBC ©2013 NanoEnTek Inc. 9
Product description
Rear view of
the ADAM-
rWBC
USB port Power plug
Keypad port RS232C port Video port
Fans
Power switch
Fans
Power switch
Power plug
USB port
RS232C port
Keypad port
ADAM-rWBC’s cooling
ADAM-rWBC ON/OFF power
Connects the ADAM-rWBC power cord to
wall outlet
Port for connect to ADAM-rWBC PC software
Port for only QC and service
Port for only QC and service

10
CAUTION:
At low temperatures (≤10 °C), allow the device to warm up
for 10 minutes at ambient temperature before use.
To ensure correct operation and stable performance,
install the ADAM-rWBC in a location which meets the following conditions:
• Use at room temperature.
• Do not use in cold rooms.
• Not exposed to direct sunlight.
• Not subject to direct or continuous vibration.
• Not subject to intense magnetic or electromagnetic elds.
• Not installed in high humidity environments.
• Area free from corrosive gases or other corrosive substances.
• Area with very little dust or other airborne particles.
• Area with a 10 cm minimum space around the instrument for
proper air ow.
• Do not place anything on top of ADAM-rWBC device.
System installation
Environmental
requirements
Power on and
initial display
1) Check the connection of the main device power cord.
2) Make sure that the main power switch is in the “ I ” (ON) position.
(On the rear side of the main device.)
• When you turn on the ADAM-rWBC, it will go through self diagnostic
tests. If you get an error message, please contact your local distributor
or [email protected]. If boot up is successful and no errors are
detected, the home screens will be displayed as follow.

ADAM - rWBC ©2013 NanoEnTek Inc. 11
[ System init. ] If a r-Slide is detected during initial booting, this error
message will be shown.
(Trouble shooting) 1. Remove the r-Slide 2. Power off/on 3. Redo
initial booting again.
CAUTION:
When you turn off the device, please remove the r-Slide
from the ADAM-rWBC.
This is the cause of malfunction.
If this message continues to display when no r-Slide is inserted,
contact your local distributor or [e-mail].
* Error Messages during booting
[System State] It appears when booting not working properly. Turn off
main power and re-start device.
* Power switch is located back side of instrument.
If this message still appears after re-start, contact your local distributor
or [email protected].
System installation
Power on and
initial display
Error code
0x00000C00
0x00007000
0x00008000
0x06000000
Cause
Failure of X-axis sensor
Failure of Y-axis sensor
Failure of Z-axis sensor
Failure of locking module sensor

12
[Device unlocked] It appears when turning off the device without lock-
ing. Press the lock button before turn off the device.
If this message still appears after re-start, contact your local distributor
or [email protected].
Icon
System installation
Power on and
initial display
Icon functions
Features
Shows when cell counting is started
(After pressing the Start button).
Shows the slide holder is ejected
(After pressing the Eject button).
Shows the slide holder is locked
(After pressing the Lock button).
Shows the slide holder is inserted
(After pressing the Eject button with rWBC counting slide).
Display a status of the functions such as
Eject, Start, Lock or Insert.
(status of slide holder)

ADAM - rWBC ©2013 NanoEnTek Inc. 13
Precision stage calibration
Each time the ADAM-rWBC is powered on, calibration of the precision
stage is performed using the Standard beads provided in the ADAM-
rWBC Kit. Calibration is successful if the test result is within range of
the value on the vial.
Refer to the ADAM-rWBC Kit Package Insert for specic instructions.
•The ADAM-rWBC 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 shaking gently, including upside down.
3. Load 100µL of the beads into the r-Slide. Let settle for 40-60 seconds.
4. Insert bead loaded r-Slide into ADAM-rWBC main device and press
‘ ‘ to start.
For Leukocyte Reduced samples
Blood samples should be tested within 48 hours after leukocyte
reduction.
The blood sample is mixed, and an aliquot removed and diluted with
r-Solution for staining. After staining, a sample is loaded into the r-Slide
and left to settle. After settling, the r-Slide is inserted arrow end rst,
right side up, into the ADAM-rWBC and counted. Refer to the ADAM-
rWBC kit Package Insert for specic instructions.
CAUTION:
• Avoid bubbles as they may negatively affect results.
• Do not re-use r-Slides. Re-use of r-Slides may result in
errors in the result value.
• Do not use r-Solution, r-Slides or Standard beads after
their expiration date.
• Store r-Solution at 2~8 °C when not in use. The expiration data is
one year. Do not use after the expiration date shown on the
label. Open r-Solution may be stored at 2~8°C and used for up
to 6 months, but not past the expiration date.
Warning:
The instrument will not detect incorrectly diluted samples.
Also refer to ADAM-rWBC Kit Package Insert.
General operation
Preparing the
test sample

14
1. Leave the r-Kit at room temperature for 10 minutes before use.
2. Carefully dispense 100 uL of well-mixed RBC or 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 ' ' to start.
8. After approximately 3 minutes, the result, calculated as WBC per µL,
will be displayed automatically.
General operation
Sample
preparation
and testing
1. Mix sample with
r-Solution & Load sample (100μL)
2. Insert r-Slide
3. Result
r-Solution
400 µL
100 µL

ADAM - rWBC ©2013 NanoEnTek Inc. 15
Warning:
• Sample loading error
Load 100μL of sample into the r-Slide and ensure correct
lling.
The instrument will not detect in low or high sample volumes.
CAUTION:
• Avoid bubbles as theymay negativelyaffect results.
Operating the
ADAM-rWBC
Low volume
Correct volume
General operation

16
Operating the
ADAM-rWBC
•r-Slide insert error
Completely insert r-Slides face up, in the direction of the ar-
row on the slide. The instrument will not detect if slides are
inserted incorrectly.
See pictures below for proper insertion.
Correctly inserted
Upside down inserted
Not fully inserted
Adverse direction inserted
(No arrow)
( X ) ( X )
( X )( O )
General operation

ADAM - rWBC ©2013 NanoEnTek Inc. 17
Starts the counting process by the Start button input.
Once the focusing process nished after calibration step,
ADAM-rWBC will skip the focusing process for the repeated experiments.
Captures the images from the valid r-Slide measuring area and ana-
lyzes the images in memory and performs the counting process.
The number of total leukocytes will be automatically calculated by the
ADAM-rWBC software.
Start input
Result
analysis
General operation
Number of total leucocytes 1.71/µL
• Error message during result analysis
[Bad sample!]
In the event that 1 cell image contains of more than 100 pixels includ-
ing dust or the number of error frame is more than 10 frames, this error
message will be displayed on the LCD screen. The error frame occurs
when the number of cells is more than 50 in one frame. Check the
sample contains dust or cell clumping and retest.

18
ADAM-rWBC does not need regularly scheduled maintenance be-
cause ADAM-rWBC has no consumable materials to replace.
Frequent or before every testing, please clean the exposed outer
surface of ADAM-rWBC using a soft cloth and isopropyl alcohol or
deionized water.
Maintenance
and cleaning
General operation

ADAM - rWBC ©2013 NanoEnTek Inc. 19
Trouble shooting
Problem
ADAM-rWBC does
not power up.
Booting error
message
Result error
message
Solution
Check power switch on back of unit.
Check power source.
Replace or repurchase
Refer to the 11 page
Refer to the 11 page
Refer to the 12 page
Refer to the 17 page
Cause
Power switch in off position
No power from outlet
Bad power cord
[ System state ]
[ System init. ]
[ Device unlocked ]
[ Bad sample! ]

20
If any defects occur in the ADAM-rWBC during one(1) year warranty period, NanoEnTek will re-
pair or replace the defective parts at its discretion without charge. The following defects, however,
are specically excluded:
1.
2.
3.
4.
5.
6.
7.
For your protection, items being returned must be insured against possible damage or loss.
NanoEnTek cannot be responsible for damage incurred during shipment of a repair instrument.
It is recommend 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 [email protected] or your local distributor.
Warranty
Defects caused by improper operation.
Repair or modication done by anyone other than
NanoEnTek or an authorized agent.
Damage caused by substituting alternative parts.
Use of ttings or spare parts supplied by anyone other than
NanoEnTek.
Damage caused by accident or misuse.
Damage caused by disaster.
Corrosion caused by improper solvent or sample.