Drucker Diagnostics QBC STAR User manual

QBC STAR
TM
System Operator’s Manual
Fast, Simple CBC Analysis
Designed for the Point of Care
Document Number: 6000-300-000
Revision J
200 Shady Lane, Suite 170, Philipsburg, PA 16866 U.S.A. | [phone] | www.druckerdiagnostics.com

QBC STAR System Operator’s Manual
6000-300-000 ii
Drucker Diagnostics, QBC STAR, are registered trademarks of Drucker Diagnostics Inc.
Vacutainer is a registered trademark of BD.
© Copyright Drucker Diagnostics Inc, 2016. All rights reserved. No part of this publication may be reproduced, transmit-
ted, transcribed, stored in retrieval systems, or translated into any language or computer language, in any form or by any
means, electronic, mechanical, magnetic, optical, chemical, manual, or otherwise, without the prior written permission
of Drucker Diagnostics Inc, 168 Bradford Dr. Port Matilda, PA, 16870, United States of America.
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The QBC STAR complies with the emission and immunity requirements described in section 9.103 of the IEC 61326 series.
This equipment has been designed and tested to CISPR 11 Class A. In a domestic environment it may cause radio
interference, in which case, you may need to take measures to mitigate the interference.
The electromagnetic environment should be evaluated prior to operation of the QBC STAR.
Do not use this device in close proximity to sources of strong electromagnetic radiation e.g. unshielded intentional RF
sources, as these may interfere with the proper operation.
IVD
INSTRUCTIONS FOR DISPOSAL OF WEEE BY USERS IN THE EUROPEAN UNION
This product must not be disposed of with other waste. Instead, it is the user’s responsibility to dispose of their waste
equipment by handing it over to a designated collection point for the recycling of waste electrical and electronic equipment. The
separate collection and recycling of your waste equipment at the time of disposal will help to conserve natural resources and
ensure that it is recycled in a manner that protects human health and the environment. For more information about where you
can drop off your waste equipment for recycling, please contact your local city ofce, your household waste disposal service, or
where you purchased the product.
EMERGO EUROPE
Prinsessegracht 20
2514 AP The Hague
The Netherlands

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Preface
Contents
1 – Introduction............................................................................................................ 1–1
Intended Use...................................................................................................................................... 1–1
Principles of the Test.......................................................................................................................... 1–1
System Overview ............................................................................................................................... 1–2
QBC STAR Blood Collection Tubes ......................................................................................... 1–2
QBC STAR Instrument ............................................................................................................. 1–3
Instrument Self-Testing and Calibration............................................................................................. 1–4
Manual Structure ............................................................................................................................... 1–5
Getting Started .................................................................................................................................. 1–5
Use of this Manual ............................................................................................................................. 1–5
Conventions....................................................................................................................................... 1–6
Symbols Used on the Equipment ............................................................................................ 1–6
Notes, Cautions, and Warnings ............................................................................................... 1–6
Summary of Warnings and Cautions ....................................................................................... 1–7
2 – Installation and Setup............................................................................................ 2–1
Unpacking and Setup ........................................................................................................................ 2–1
Electrical Connection......................................................................................................................... 2–1
QBC STAR Specifications.................................................................................................................. 2–2
External Connections......................................................................................................................... 2–4
Printer Installation .............................................................................................................................. 2–5
Upgrading the Software..................................................................................................................... 2–6
System Setup and Utilities................................................................................................................. 2–6
To Enter Setup Mode ............................................................................................................... 2–6
LCD Contrast ........................................................................................................................... 2–7
Date and Time.......................................................................................................................... 2–7
Internal Printer.......................................................................................................................... 2–8
External Printer......................................................................................................................... 2–8
Support .................................................................................................................................... 2–8
Set Language ........................................................................................................................... 2–9
Units......................................................................................................................................... 2–9
Shipping Prep........................................................................................................................... 2–9
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QBC STAR System Operator’s Manual
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Contents
3 – Controls and Indicators......................................................................................... 3–1
General Discussion ............................................................................................................................ 3–1
Power Switch..................................................................................................................................... 3–1
“STAR” Button ................................................................................................................................... 3–2
Door Release Latch ........................................................................................................................... 3–2
Liquid Crystal Display (LCD) .............................................................................................................. 3–2
Internal Printer ................................................................................................................................... 3–3
Paper Release Lever ................................................................................................................ 3–3
Manual Advance Wheel............................................................................................................ 3–3
Setup Keypad .................................................................................................................................... 3–4
ESC Key ................................................................................................................................... 3–4
5Key ................................................................................................................................... 3–4
6 Key ................................................................................................................................... 3–4
Key ................................................................................................................................... 3–4
4 – Operation ............................................................................................................... 4–1
Summary of Operation Steps ............................................................................................................ 4–1
Turn Instrument Power On ....................................................................................................... 4–2
Prepare the QBC STAR Tube ................................................................................................... 4–2
Mix the Tube............................................................................................................................. 4–4
Tilt the Tube.............................................................................................................................. 4–5
Cap the Tube............................................................................................................................ 4–5
Insert the Tube Into the Instrument .......................................................................................... 4–6
Close the Instrument Door ....................................................................................................... 4–6
Start the Test ........................................................................................................................... 4–7
Rerunning Tubes ...................................................................................................................... 4–7
Printing of Results.................................................................................................................... 4–8
Tube Disposal ........................................................................................................................ 4–10
Power Down........................................................................................................................... 4–10
Stopping the Centrifuge................................................................................................................... 4–10
Emergency Door Unlock.................................................................................................................. 4–10
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Preface
Contents
5 – Performance and Limitations................................................................................ 5–1
Operating Ranges.............................................................................................................................. 5–1
Precision ............................................................................................................................................ 5–1
Accuracy ............................................................................................................................................ 5–2
Interfering Substances....................................................................................................................... 5–3
Limitations.......................................................................................................................................... 5–4
Expected Values ................................................................................................................................ 5–4
Controls ............................................................................................................................................. 5–5
Internal Quality Control ............................................................................................................ 5–5
Internal Electronic Quality Control Label.................................................................................. 5–5
External Liquid Controls........................................................................................................... 5–6
Proficiency Tests................................................................................................................................ 5–6
6 – Maintenance .......................................................................................................... 6–1
Cleaning............................................................................................................................................. 6–1
Disinfection ........................................................................................................................................ 6–1
Replacing Printer Paper..................................................................................................................... 6–2
7 – Troubleshooting ..................................................................................................... 7–1
General Problems .............................................................................................................................. 7–1
System Error Codes........................................................................................................................... 7–2
Tube Error Codes............................................................................................................................... 7–6
8 – Appendices............................................................................................................ 8–1
Appendix A – Limited Warranty .........................................................................................................A–1
Appendix B – Parts and Accessories.................................................................................................B–1
Appendix C – Software Upgrade Log............................................................................................... C–1
Appendix D – Contact........................................................................................................................D–1
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Contents
E – Blood Collection and Handling.............................................................................E–1
General Comments............................................................................................................................E–1
Universal Precautions for Specimen Handling ..................................................................................E–1
Venous Blood Collection (Venipuncture)............................................................................................E–2
Supplies ...................................................................................................................................E–2
Procedure.................................................................................................................................E–2
Collecting Multiple Specimens from a Single Venipuncture ....................................................E–3
Areas to Avoid When Drawing Venous Specimens..................................................................E–3
Errors to Avoid in Venous Blood Collection .............................................................................E–4
Capillary Blood Collection .................................................................................................................E–4
Supplies ...................................................................................................................................E–4
Procedure.................................................................................................................................E–4
Avoiding Hemolysis During Capillary Blood Collection............................................................E–5
F – Bibliography...........................................................................................................F–1
G – Glossary ............................................................................................................... G–1
Figures
Figure Description Page
1 QBC STAR Blood Collection Tube..................................................................................... 1–2
2 QBC STAR Instrument ....................................................................................................... 1–3
3 Symbols Used on the QBC STAR Instrument (rear) .......................................................... 1–6
4 External Connections ........................................................................................................ 2–5
5 QBC STAR Menu, Options ................................................................................................ 2-7
6 QBC STAR Menu, Date & Time ......................................................................................... 2-8
7 Power Switch..................................................................................................................... 3–1
8 QBC STAR Controls and Indicators................................................................................... 3–2
9 Printer Controls.................................................................................................................. 3–3
10 Setup Keypad .................................................................................................................... 3–4
11 Sample Vial........................................................................................................................ 4–3
12 Inverting the Sample Vial ................................................................................................... 4–3
13 Filling a Tube from Venous Blood ...................................................................................... 4–3
14 Filling a Tube from Capillary Blood.................................................................................... 4–4
15 Mixing the Tube ................................................................................................................. 4–4
16 Tilting the Tube .................................................................................................................. 4–5
17 Uncapping the Tube .......................................................................................................... 4–5
18 Seating the Cap and Float................................................................................................. 4–5
19 Inserting the Tube into the Instrument............................................................................... 4–6
20 Sample Results Printout .................................................................................................... 4–9
21 Sample Results Readout ................................................................................................... 4–9
22 Door Unlatch Access Hole............................................................................................... 4–11
23 Replacing Printer Paper..................................................................................................... 6–2
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1 – Introduction
Intended Use
The QBC STAR™ Centrifugal Hematology System provides a diagnostic hematology profile on venous
or capillary blood providing values for:
• Hematocrit
• Hemoglobin
• Mean Corpuscular Hemoglobin Concentration (MCHC)
• Platelet count
• White blood cell count
• Granulocyte count (% and number)
• Lymphocyte/monocyte count (% and number)
Principles of the Test
It has been known for many years that the grayish-white layer (buffy coat) that appears above the red
blood cells in a centrifuged hematocrit tube contains packed layers of leukocytes (white blood cells)
and thrombocytes (platelets)1-5. The QBC STAR Centrifugal Hematology System uses technologies that
make it possible to quantify the buffy coat cells.
When the QBC STAR tube is filled with blood and placed into the QBC STAR instrument, the tube is
spun at a high rate of speed causing the different types of cells in the blood to separate into layers or
bands from the most dense to the least dense. The QBC STAR System uses a special tube designed
to enhance the natural separation properties of a whole blood sample when it is centrifuged. A special
coating in the QBC STAR tube stains the two white blood cell populations (granulocytes appear orange-
yellow and lymphocytes/monocytes appear green) and the platelet layer (platelets appear yellow-orange).
The ability to quantify the cells is also enhanced by the insertion of a precision plastic float into the QBC
STAR tube that mechanically expands the buffy coat layers. The hematocrit, white blood cell counts,
and platelet count are directly measured from the cell layers. The float, whose density approximates the
buffy coat cells, will also penetrate the red blood cell layer. The QBC STAR hemoglobin measurement
is directly related to the density of the red blood cells, and is based on the depth of penetration of the
float into the red blood cell layer. Mean Corpuscular Hemoglobin Concentration (MCHC) is electroni-
cally calculated using the standard formula [(HGB / HCT) * 100]6-7.
The QBC STAR tube is also internally coated with anticoagulants that allow collection of capillary blood
directly from a skin puncture site.
The QBC STAR System is intended for in vitro diagnostic use.
WARNING
CAREFULLY OBSERVE ALL WARNINGS AND PRECAUTIONS IN THIS
MANUAL AND ON LABELING OF QBC STAR TUBES CONCERNING
THE SAFE HANDLING OF BLOOD AND BLOOD-DERIVED PRODUCTS.
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QBC STAR System Operator’s Manual
System Overview
The QBC STAR Hematology System is a self-contained, whole blood, automated hematology system.
Reported results include hematocrit, hemoglobin, total white blood cell count, combined lymphocyte
and monocyte count, granulocyte count, platelet count, and MCHC. The test can be performed from
either venous or capillary blood specimens. The system is factory preset and user calibration is NOT
required. The system is powered by a universal voltage external power supply that plugs directly into
an AC power source.
The QBC STAR Hematology System performs all tests using the QBC STAR Tube. The QBC STAR
Tube is described below. When the QBC STAR Tube is placed into the instrument, it is automatically
centrifuged and analyzed. The results are computed, displayed, and printed on the internal printer.
QBC STAR Blood Collection Tubes
The QBC STAR Tube is a two-component device. The tube assembly represents the first component.
It consists of a precision glass QBC Tube and the plastic sleeve that serves as a carrier for the tube. A
cap and float assembly comprise the second component. The float expands the buffy coat region by
a factor of ten. It does this by reducing the cross sectional area of the tube.
The QBC STAR Tube is preassembled and consists of the following components :
• 3” long precision bore glass tube with dried coatings of acridine orange, heparin, K2EDTA,
potassium oxalate, monoclonal antibody and other reagents
• A vented plug at the end of the tube
• Protective plastic sleeve
Figure 1 – QBC STAR Blood Collection Tube
Tubes are filled by capillary action with 65 to 75 µL of whole blood. This is the volume when the tube
is filled between the 2 fill lines marked on the QBC STAR Tube. The blood can come directly from a
fingerstick or from a lavender top EDTA anticoagulant only. The plug has a vent allowing air to escape
during filling of the tube. The vent closes off when the tube is capped.
After the tube assembly is filled with blood, the blood is mixed and the cap assembly is placed on the
tube. The cap consists of the following components:
• A precision molded plastic float
• A float holder
• The cap
3˝ Glass Tube
Fill Lines Vented Plug
Carrier
(Plastic Sleeve)
Acridine Orange
and other
Reagents Cap Assembly
w/ Float
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1 – Introduction
Placing the cap on the tube performs three actions simultaneously:
• Seals the tube protective plastic sleeve
• Inserts the float into the QBC STAR tube
• Closes the air vent
The density of the float is matched to the density of the buffy coat so that it centers itself in that region.
If a tube breaks during centrifugation, blood and glass are fully contained within the capped tube
protective plastic sleeve. This design provides a high degree of user and instrument protection from
exposure to blood and aerosols.
QBC STAR Instrument
The QBC STAR Instrument (Figure 2) is a compact, portable, centrifugal hematology analyzer. The instru-
ment contains a single tube centrifuge for sample mixing and for separating the blood into the various
cell populations. Analysis of the sample occurs in the centrifuge rotor after the centrifuge is finished.
A single filled QBC STAR Tube is placed into the rotor, the door is closed, and the “STAR” button
pressed to start the test process. The centrifuge cycle mixes and then separates the blood into distinct
cell layers. The instrument initially spins slowly for up to 30 seconds allowing the blood in the tube to
mix. Once this initial mixing is done, the centrifuge accelerates to a higher speed which is maintained
for 4.75 minutes. This stage separates the blood cell populations into distinct packed cell bands. After
the cell populations have been separated, the centrifuge decelerates to measure the band lengths.
Analysis of the tube occurs at the illumination/read station. This station consists of an LED light source
and optical imaging system.
Figure 2 – QBC STAR Instrument
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QBC STAR System Operator’s Manual
Hematological results are shown on the Liquid Crystal Display. Results are also automatically printed
by the internal thermal printer onto a 2.25-inch paper tape.
The instrument contains the following subsystems:
• The centrifuge for mixing and separating the blood sample
• An embedded microprocessor for machine control, blood sample analysis, and communications
• An internal printer for printing results
• A Liquid Crystal Display to show results, prompts, and messages
• USB ports for communication with optional external devices such as a keyboard, barcode scan-
ner, or external printer
• An ethernet connection for use with Laboratory Information Systems
Instrument Self-Testing and Calibration
When the instument is powered on and the door is closed, the system software performs a self-test
to verify proper operation (Or once every 8 hours if power is left on continuously). The self-test checks
such things as: centrifuge motor at various speeds, emission filter assembly, optics assembly, light
source, timing control, optical clarity and focus, internal printer, rotor timing, and setup keypad.
The instrument runs a built-in calibration check every time a sample is processed. Sample integrity
checks include: statistical matching of bandlengths, ratios and absolute values for signal levels, ratios
that are used to evaluate the quality of interfaces, measurement of float length, verification of optics
and sensors, measurement and evaluation of sample fill volume. Additional tests performed as part
of each assay cycle include centrifuge speed and electro-optical verification. Results are reported on
tube tests only if all verification and integrity tests pass.
The power-on self-test and sample integrity tests provide verification of instrument parameters includ-
ing but not limited to timing, speed, disposable integrity, and reagent stability.
In addition to these checks, the system monitors the temperature inside and outside the instrument
before and during each test. The system will allow operation of the instrument if the temperature is
higher than 32° C, but with limited reports. If the sample temperature exceeds 45° C, the unit will be-
come too hot to operate.
Since the QBC STAR instrument contains a centrifuge, centrifuge speed measurements are verified
each time a sample is processed.
If any part of the self-testing or calibration process fails, a message is displayed. Confirmation of the
success of self-tests is provided by the “Ready” message. In addition, each results printout indicates
the outcome of electronic QC.
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