QBC Diagnostics Star User manual

QBC STAR™
System Operator’s/Service
Manual
2006/02
QBC D
iagnostics
Inc.
Document Number: L–000867 200 Innovation Blvd., Suite 212
Revision:
A
State College, PA 16803 USA
877.231.3115

QBC Star™ System User’s Manual
ii L–000867(A)
Revi-
sion Date Pages Reason
A
02/06
All
Updates for software version 3.0
QBC, QBC Star, Adams, and Vacutainer are registered trademarks of QBC Diagnostics Inc.
© Copyright
QBC Diagnostics Inc
, 2006. All rights reserved. No part of this publication may be repro-
duced, transmitted, 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

L–000867(A) iii
Preface
otherwise, without the prior written permission of
QBC Diagnostics Inc
, 200 Innovation Blvd., Suite 212
State College, PA, 16803, United States of America.
VS–0226
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
Specifi cations
.....................................................................................................................
2–2
External Connections
...........................................................................................................................
2–4
Connecting an External Printer
...................................................................................................
2–4
Updating System Software
..................................................................................................................
2–6
System Setup and Utilities
...................................................................................................................
2–6
To Enter Setup Mode
.................................................................................................................
2–6
LCD Contrast
.............................................................................................................................
2–7
Date and Time
...........................................................................................................................
2–7
Disable Auto LCD (Contrast)
......................................................................................................
2–8
Save Data
..................................................................................................................................
2–8
Print Data
..................................................................................................................................
2–8
Shipping Prep.
...........................................................................................................................
2–8
More Options
............................................................................................................................
2–8
3 – Controls and Indicators ....................................................................................................3–1
General Discussion
..............................................................................................................................
3–1
Power Switch
......................................................................................................................................
3–1
“Star” Button
......................................................................................................................................
3–2

QBC Star™ System User’s Manual
iv L–000867(A)
Door Release Latch
..............................................................................................................................
3–2
Liquid Crystal Display (LCD)
.................................................................................................................
3–2
Contents
Printer
.................................................................................................................................................
3–3
Paper Release Lever
...................................................................................................................
3–3
Manual Advance Wheel
.............................................................................................................
3–3
Floppy Disk Drive
.................................................................................................................................
3–4
Floppy Disk Indicator
..................................................................................................................
3–4
Floppy Disk Eject Button
............................................................................................................
3–4
Setup Keypad
......................................................................................................................................
3–5
ESC Key
....................................................................................................................................
3–5

Key
....................................................................................................................................
3–5

Key
....................................................................................................................................
3–5
Key
....................................................................................................................................
3–5
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
.............................................................................................................................
4–6
Printing of results
.......................................................................................................................
4–7
Tube Disposal
.........................................................................................................................
4–10
Power Down
............................................................................................................................
4–10
Stopping the Centrifuge
....................................................................................................................
4–10
Emergency Door Unlock
....................................................................................................................
4–10
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
Key
Key
Key
Key

L–000867(A) v
Preface
External liquid controls
...............................................................................................................
5–6
Profi ciency Tests
..................................................................................................................................
5–6
Contents
6 – Maintenance .....................................................................................................................6–1
Cleaning
.............................................................................................................................................
6–1
Disinfection
.........................................................................................................................................
6–1
Replacing Printer Paper
........................................................................................................................
6–2
Replacing Fuses
...................................................................................................................................
6–3
7 – Troubleshooting ................................................................................................................7–1
General Problems
................................................................................................................................
7–1
Error Codes and Messages
..................................................................................................................
7–2
G – Glossary .......................................................................................................................... G–1
A – Limited Warranty ............................................................................................................. A–1
B – Parts and Accessories ...................................................................................................... B–1
C – Software Update Log ...................................................................................................... C–1
D – Contacts .......................................................................................................................... D–1
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

L–000867(A) vii
Preface
F – Bibliography .....................................................................................................................F–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 Power Switch
......................................................................................................................
3–1
6 QBC
STAR
Controls and Indicators
......................................................................................
3–2
7 Printer Controls
...................................................................................................................
3–3
8 Floppy Disk Drive Controls and Indicators
............................................................................
3–4
9 Setup Keypad
......................................................................................................................
3–5
10 Sample Vial
.........................................................................................................................
4–3
11 Inverting the Sample Vial
.....................................................................................................
4–3
12 Filling a Tube from Venous Blood
........................................................................................
4–3
13 Filling a Tube from Capillary Blood
......................................................................................
4–4
14 Mixing the Tube
..................................................................................................................
4–4
15 Tilting the Tube
...................................................................................................................
4–5
16 Uncapping the Tube
............................................................................................................
4–5
17 Seating the Cap and Float
...................................................................................................
4–5
18 Inserting the Tube into the Instrument
................................................................................
4–6
19 Sample Results Printout
.......................................................................................................
4–9
20 Sample Results Readout
......................................................................................................
4–9
21 Door Unlatch Access Hole
.................................................................................................
4–11
22 Replacing Printer Paper
.......................................................................................................
6–2
23 Replacing Fuses
...................................................................................................................
6–3

QBC STAR™
System User’s Manual
QBC Diagnostics Inc.

L–000867(A) 1–1
1 – Introduction
Intended Use
The
QBC STAR
™ Centrifugal Hematology System provides a diagnostic hematology profi le 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 hematocrit tube contained packed layers of leukocytes (white blood cells) and thrombo-
cytes (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 fi lled 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 heaviest to the lightest. The
QBC STAR
System uses a special tube designed to enhance the natural sepa-
ration 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 fl oat 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 fl oat, 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 fl oat into the red blood cell layer. Mean corpuscular hemoglobin
concentration (MCHC) is electronically 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.

QBC STAR™ System User’s Manual
1–2 L–000867(A)
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 Mean Corpuscular Hemoglobin Concentration (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 internal 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 fi rst component. It
consists of a precision glass QBC tube and the plastic sleeve that serves as a carrier for the tube. A cap and
fl oat assembly comprise the second component. The fl oat expands the buffy coat region by a factor of ten.
It does this by reducing the cross section area of the tube. See Figure 1.
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, K
2
EDTA, potas-
sium oxalate, monoclonal antibody and reagents
• a vented plug at the end of the tube
• a tube carrier
Figure 1 – QBC STAR Blood Collection Tube
Tubes are fi lled by capillary action with 65 to 75 µL of whole blood. (This is the volume when the tube is
fi lled between the 2 fi ll lines marked on the
QBC STAR
tube.) The blood can come directly from a fi ngerstick
or from a Vacutainer™ brand blood collection tube or equivalent (lavender top only). The plug has a vent
allowing air to escape during fi lling of the tube. The vent closes off when the tube is capped.
After the tube assembly is fi lled with blood, the tube is mixed and the cap assembly is placed on the tube.
The cap consists of the following components:
• A precision molded plastic fl oat
• A fl oat holder
•
The cap

L–000867(A) 1–3
1 – Introduction
Placing the cap on the tube performs two actions simultaneously:
• It seals the tube carrier
• It inserts the fl oat into the
QBC STAR
tube
The density of the fl oat is matched to the density of the buffy coat so that it centers itself in that region.
The fl oat expands the buffy coat by a factor of ten during centrifugation.
If a tube breaks during centrifugation, blood and glass are fully contained within the capped tube carrier. This
design provides a high degree of user and instrument protection from exposure to blood and aerosols.
QBC STAR Instrument
The
QBC STAR
Instrument is a compact, portable, centrifugal hematology analyzer. The instrument 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 while the centrifuge is running. See Figure 2.
A single fi lled
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 8 to 12 seconds typically (up to 30 seconds) allowing the blood in
the tube to mix. Once mixing is done, the centrifuge accelerates to a higher speed which is maintained for
4
3
/
4
/4 /
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 a dual light source and optical detector
system.
Figure 2 – QBC STAR Instrument