HA5 User Manual

Hematology Analyzer
ENGLISH
User manual
HA5
Automated 5-part Hematology Analyzer
Operator’s Manual

HA5 software version: 1.0.241.0
Manual Issue date: November-2017
Manual Revision: 1.0
User manual
Thank you for choosing the Biosystems HA5

automated hematology analyzer.
We believe that this instrument will definitely
help you in your daily laboratory routine.
Welcome to the Biosystems family…
Biosystems
4
Table of contents
1. Introduction...............................................................................10
1.1. Who should read this manual..............................................................10
1.2. Symbols used in the manual.................................................................10
1.3. Intended Use........................................................................................10
1.4. Disclaimer............................................................................................10
1.5. Symbols on the outside of the analyzer................................................11
1.6. Technical contact..................................................................................11
1.7. Warranty..............................................................................................12
2. Measurement technology............................................................13
2.1. Laser based cell counting.....................................................................13
2.2. Impedance based cell counting.............................................................13
2.3. Interpreting scattergrams.....................................................................14
2.4. Interpreting histograms........................................................................14
2.5. Hematology parameters.......................................................................15
2.6. 5-part differentiation of White Blood Cells..........................................16
2.7. The measurement process.....................................................................16
2.8. Supported blood collection vials..........................................................17
3. Package contents.........................................................................17
3.1. Accessories...........................................................................................18
3.2. Identifying parts of the analyzer...........................................................19
4. Installing the analyzer.................................................................20
4.1. User serviceable parts...........................................................................20
4.2. Connecting peripheral devices.............................................................21
4.2.1. Keyboard (optional)...................................................................................... 21
4.2.2. Mouse (optional).......................................................................................... 21
4.2.3. Bar code scanner (optional)........................................................................... 21
4.2.4. USB Wi-Fi Dongle (optional)....................................................................... 21
4.2.5. Network (“Ethernet”)................................................................................... 21
4.2.6. Reagent pack................................................................................................. 22
4.2.7. Reagent bottles............................................................................................. 22
4.3. Analyzer packaging material................................................................23
4.3.1. Power............................................................................................................ 23
4.3.2. External power supply................................................................................... 23
5
User manual
4.3.3. Power button................................................................................................ 23

4.3.4. Power on....................................................................................................... 24
4.3.5. Power off....................................................................................................... 24
4.3.6. Emergency power off.................................................................................... 24
4.4. Reagents handling................................................................................24
4.5. REAGENT PRECAUTION..................................................................25
4.5.1. Reagent characteristics.................................................................................. 25
4.5.2. Instructions for use – DILUENT 5 DIFF..................................................... 25
4.5.3. Instructions for use – LYSE 5 DIFF.............................................................. 27
4.5.4. Instructions for use - CLEANING SOLUTION 5 DIFF............................. 28
4.5.5. Instructions for use – REAGENT PACK 5 DIFF........................................ 30
5. Blood samples.............................................................................32
5.1. Taking the sample................................................................................32
5.2. Transporting and storing samples........................................................32
5.3. Sampling preparation...........................................................................33
5.4. Sample handing...................................................................................33
6. Menu system...............................................................................34
6.1. The screen area.....................................................................................34
6.2. Menu tree.............................................................................................34
6.3. Gestures...............................................................................................35
6.4. Tap.......................................................................................................35
6.5. Swipe....................................................................................................36
6.6. On-screen keyboard.............................................................................36
6.7. Data input............................................................................................37
6.7.1. Alphanumeric input...................................................................................... 37
6.7.2. External keyboard......................................................................................... 37
6.7.3. Barcode input............................................................................................... 38
6.7.4. Numeric input.............................................................................................. 38
6.8. Description of icons displayed ............................................................38
7. Setup...........................................................................................41
7.1. Initial setup .........................................................................................41
7.2. Settings – Customize............................................................................41
7.2.1. Appearance................................................................................................... 41
7.2.2. Languages..................................................................................................... 42
7.2.3. Units............................................................................................................. 42
7.2.4. Functionality................................................................................................ 43
7.2.4.1. Date and time......................................................................................... 43
7.2.4.2. E-mail settings........................................................................................ 43
7.2.4.3. Printout Settings..................................................................................... 44
7.2.4.4. Customization........................................................................................ 44
Biosystems
6
7.2.4.5. Profiles .................................................................................................. 45
7.2.4.6. LIS......................................................................................................... 45
7.3. Setting up reagents...............................................................................46
7.3.1. Reagent: Pack................................................................................................ 46
7.3.2. Reagent: Bulk............................................................................................... 47
7.3.3. Network Settings.......................................................................................... 49
7.3.3.1. WiFi settings........................................................................................... 50
7.3.3.2. Wired network Settings............................................................................ 50
8. Daily operation...........................................................................51
8.1. Power on..............................................................................................51
8.2. Running samples.................................................................................52
8.2.1. Introducing a Sample.................................................................................... 52
8.3. Results..................................................................................................53
8.3.1. Short (Quick) result...................................................................................... 53
8.3.2. Full result (Full screen).................................................................................. 53
8.3.3. Flags............................................................................................................. 54
8.3.4. Technical flags............................................................................................... 55
8.4. Reports.................................................................................................59
8.4.1. PDF.............................................................................................................. 59
8.4.2. Printer (Thermal).......................................................................................... 59
8.4.3. Printer (PCL5).............................................................................................. 60
8.5. Power off..............................................................................................61
9. Calibration..................................................................................62
9.1. Target values........................................................................................62
9.2. Automatic calibration..........................................................................62
9.3. Manual calibration...............................................................................63
10. QC – Quality Control.................................................................64
10.1. Expected values....................................................................................64
10.2. Assay sheets..........................................................................................65
10.3. QC diagrams........................................................................................67
10.4. QC reports...........................................................................................67
11. Database functions......................................................................69
11.1. Browsing records..................................................................................69
11.2. Database context menu........................................................................69
11.3. Selection...............................................................................................70
11.4. Moving to specific date in database......................................................70
11.5. Managing data.....................................................................................71
11.6. Sending e-mail.....................................................................................71
7
User manual
12. Maintenance...............................................................................72
12.1. Cleaning the analyzer...........................................................................72
12.2. Daily maintenance...............................................................................72
12.3. Emergency procedures.........................................................................72
12.4. Reagent pack replacement....................................................................72
12.5. Software updates..................................................................................72
12.6. Management menu...............................................................................73
12.6.1. Maintenance................................................................................................. 73
12.6.2. Prime & Drain.............................................................................................. 73
12.6.3. Clean............................................................................................................ 74
12.6.4. Service.......................................................................................................... 74
12.7. Supervision..........................................................................................75
12.7.1. History......................................................................................................... 75
12.7.2. History details............................................................................................... 75
12.7.3. About............................................................................................................ 75
12.7.4. Status bar...................................................................................................... 77
13. Technical Specifications..............................................................78
14. Reagent consumption.................................................................79
15. Performance Data.......................................................................79
16. Error messages............................................................................81
16.1. Mechanical Errors................................................................................82
16.2. Operation related errors.......................................................................82
16.3. Electronic errors...................................................................................84
16.4. System (software) errors.......................................................................84
16.5. Troubleshooting...................................................................................86
16.5.1. Measurement problems................................................................................. 86
16.6. Electrical problems...............................................................................88
16.7. Mechanical problems...........................................................................88
16.8. Hydraulic problems..............................................................................89
16.9. Network problems................................................................................89
16.10. Printer problems..................................................................................89
16.11. Certificates, standards..........................................................................90
16.12. Declaration of Conformity...................................................................90
17. Appendix A – Signs of improper sample handling......................91
17.1. Pre-analytical factors............................................................................91
17.1.1. Distinct layers............................................................................................... 91
Biosystems
8
17.1.2. Large visible bubbles..................................................................................... 91
17.1.3. Pink plasma (hemolysis)................................................................................ 91
17.1.4. Clots, gel-like substance inside vial................................................................ 92
17.2. Post-analytical factors..........................................................................92
17.2.1. Elevated PLT, decreased RBC, RDWsd/cv increased..................................... 92
17.2.2. Elevated PLT, no PLT result, noise flag(s)...................................................... 92
17.2.3. Elevated MON, lowered NEU: . .................................................................. 93
9
User manual
1. Introduction
HA5 is a small, 60 tests/hour laser scatter and impedance based hematology analy-
zer for small to medium sized laboratory use, performing 5-population analysis of
human whole blood samples.
HA5 is easy to use, uses low amounts of reagent for determining 26 hematology
parameters.
HA5’s small footprint allows operating in space-constrained environments.
1.1. Who should read this manual

This manual is written for operators of the analyzer describing the structure of
the analyzer, daily routine and basic maintenance required to keep the analyzer in
good working condition to ensure reliable and dependable operation.
1.2. Symbols used in the manual

This Operator’s Manual uses symbols listed below to indicate hazards in connection
with operating the analyzer. These symbols are used wherever such hazards arise
during operation or handling of the analyzer.
Symbol Meaning
WARNING
Risk of personal injury
BIOHAZARD
Risk of biological infection, contamination
LASER RADIATION
Risk of exposure to laser radiation
1.3. Intended Use

HA5 is a 60 tests/hour laser and impedance based IVD hematology analyzer for
laboratory use, using specific reagents, performing 5-part differential, 26 parameters
analysis of anti-coagulated human whole blood samples introduced in closed vials.
1.4. Disclaimer
The manufacturer reserves the right to:
• modify the contents of this manual without prior notice,
• change technology applied within the analyzer without prior notice,
• change technical specifications without prior notice.
Biosystems
10
The manufacturer does not warrant this manual to be 100% free of unintentional
errors.
Please note that this Manual may be revised without prior notification. The Ma-
nufacturer reserves the right to change the specifications of the product and/or the
contents of this manual as deemed necessary, without prior notice.
Pictures included in this manual may differ from the actual delivered product.
Performance and reliability are never influenced by minor visual differences between
this manual and the actual product.
1.5. Symbols on the outside of the analyzer

Symbol Meaning
WARNING
Risk of personal injury
BIOHAZARD
Risk of biological infection, contamination
CE mark
for In Vitro Diagnostic use
Address of manufacturer
Serial number
1.6. Technical contact

HA5 is a precise and accurate laboratory instrument. Its built-in safety measures
guarantee safe and reliable operation. Being a complex device, there is limited
access to internal structures provided to the end user.
HA5 is a Class 1 laser device, the embedded laser source is not exposed to the
user or service personnel. Under no circumstances should the Operator attempt
to open or remove the outer cover of the analyzer, as this may influence reliable
operation and might fool built-in safety measures and can invalidate warranty.
There are no user serviceable parts inside this analyzer. Adjustments of internal
structures and repairs of these structures should only be performed by qualified
service personnel.
Your local dealer is always ready to help you in case of malfunction. The contact
of your local dealer is available on the insert of this Manual.
Biosystems will be doing its best to resolve your problems either directly or indi-
rectly with the help of its local representative.
11
User manual
1.7. Warranty
Your HA5 comes with two years manufacturer’s warranty against workmanship
defects. Warranty claims must be made through your local representative.
Your supplier will only be able to repair and warrant operation of the analyzer as per
its specifications if all service actions are performed by qualified service personnel,
and the Warranty Label is intact.
Warranty is void if any of the below can be identified, or inoperability, malfunction
can be traced back to any of the events listed below:
• broken warranty seal;
• intentional damage and/or modification to the analyzer;
• improper use, use against instructions in this manual, against intended use;
• damage from intentional activities overriding built-in safety logic;
• natural disaster;
• uncertified power supply, or unapproved peripheral has been connected to
the analyzer;
• disassembly, repair attempt performed by unauthorized staff;
• damage rooted back to unreported shipping and/or installation induced
activities.
The manufacturer does not recommend and support modifying the operating
software of this hematology analyzer. The analyzer is able to log and track modi-
fications to the operating software.
• In the case, when the End User required or performed installation of any
software product not controlled by the manufacturer and would afterwards
experience erroneous or unreliable operation of the analyzer, or would expe-
rience erroneous results, then the manufacturer cannot accept any complaints
about operation, reliability or performance.
Exclusions: The below listed items are not covered by warranty unless they were
found damaged upon arrival to the End User. In such cases, proper complaint must
be filed along with a complaint registered with the forwarder/Distributor company:
• Batteries, external power cable
• Plastic cover elements (including transparent display cover), external reagent
tubes,
• Labels, printed material
• Internal piercing needle
2. Measurement technology
HA5 uses flow cytometry and volumetric impedance method to provide 26 hema-
tology parameters from 25µl of whole human blood samples. The measurement
cycle time is 60 seconds yielding 60 tests/hour throughput.
Biosystems
12
2.1. Laser based cell counting
Flow cytometry is a technology that simultaneously measures and then analyzes
multiple physical characteristics of single cells, as they flow in a fluid stream through
a beam of laser light. The properties measured include a particle’s relative size and
relative granularity.
These characteristics are determined using an optical-to-electronic coupling system
that records how the cell scatters incident laser light in different angles. Low angle
(few degrees) scattered light is proportional to the cell’s volume as it is scattered
from the surface of cell membrane; while high angle (few 10 degrees) scattered
light is proportional to the cell’s internal complexity as it is scattered from the
intra-cellular granules and nucleus.
2.2. Impedance based cell counting

Cells found in a blood sample have various sizes, (mostly) spherical shape with
various diameters. The size of these particles can be measured electronically.
A known direct current (I) is driven through a small opening (aperture) with known
diameter (comparable to the size of the particles, usually 70-100µm) separating
two liquid compartments containing the same conductive liquid. Particles are
suspended in the conductive liquid.
When there is only liquid in the aperture, a certain electric resistance can be mea-
sured due to the conductive characteristic of the liquid.
Particles (cells) do not conduct direct current. When a particle (red) passes through
the aperture (yellow) then the conductive cross section of the aperture filled with
conductive liquid will decrease, and a resistance different from that of the “empty”
aperture can be registered over the liquid.
The change of resistance is proportional to the size of the non-conductive particle
partially blocking the aperture. The bigger the change, the bigger the particle
passing through the aperture was.
13
User manual
2.3. Interpreting scattergrams

HA5 presents scattergrams on its screen, in printed or in electronic format. Cells
scatter light when they pass through laser beam. The level of light scattering in
straight (forward) direction is proportional to cell size. Cells also include granules,
compartmented nuclei and other organelles. This leads to side scattering of light.
Side scattering depends on cell structure (e.g. granularity). The populations are
marked with colors.
2.4. Interpreting histograms

HA5 presents histograms on its screen, in printed or in electronic format.
RBC and PLT histograms are related in such a way that the front of the RBC
histogram is magnified, and repeated as the PLT histogram.
The vertical line separating PLT and RBC regions are present on both histograms.
Biosystems
14
2.5. Hematology parameters
Parameter name Explanation Typical units

WBC White blood cell count 103/µL & 109/L
RBC Red blood cell count 106/µL & 1012/L
HGB Hemoglobin g/dL, g/L, mmol/L
HCT Hematocrit %, L/L
MCV Mean Corpuscular Volume fL
MCH Mean Corpuscular HGB pg, fmol
MCHC Mean Corpuscular HGB g/dL, g/L, mmol/L
Concentration
RDWsd/cv Red blood cell distribution width fl/%
PLT Platelet (thrombocyte) count 103/µL & 109/L
MPV Mean Platelet Volume fl
PCT Plateletcrit/thrombocrit %
PDWsd/cv Red blood cell distribution width fl/%
P-LCR% Platelet Large Cell Ratio; %
The ratio of PLT’s with volume
above 12fl compared to the total
PLT count
P-LCC Platelet Large Cell Count number 103/µL & 109/L
of PLT’s with volume above 12fl
15
User manual
Parameter name Explanation Typical units

LYM# Lymphocyte count 103/µL & 109/L
MON# Monocyte count 103/µL & 109/L
NEU# Neutrophil count 103/µL & 109/L
EO# Eosinophil count 103/µL & 109/L
BAS# Basophil count 103/µL & 109/L
LYM% Lymphocyte percentage (of WBC) %
MON% Monocyte percentage (of WBC) %
NEU% Neutrophil percentage (of WBC) %
EO% Eosinophil percentage (of WBC) %
BAS% Basophil percentage (of WBC) %
2.6. 5-part differentiation of White Blood Cells

Five-part white blood cell differential counts (so-called diffs), performed during
flow cytometry counting of blood cells, can accurately classify lymphocytes, mo-
nocytes, neutrophils, eosinophils and basophils with an error rate not exceeding
that of conventional diffs. The differential count is made on diluted and hemolyzed
specimens; hemolyzing is performed to break down RBC membranes, form stable
HGB complex and shrank WBC cells. Normal RBC’s have no nucleus; only WBC
cells remain in the solution. The size (volume) and complexity of various WBCs
are detected by the analyzer to classify cells.
2.7. The measurement process

The analyzer is able to process anticoagulated whole human blood samples in closed
sample vials. Closed tube mode is only available with certain vial types. The analy-
zer will only run a vial that has the cap on. Vials without caps are not processed.
Sample vials with cap is lowered into the sample rotor that turns the vial upside
down to allow small sample volume aspiration. The vial is pushed onto a fixed metal
sampling needle and is pierced in the upside down position. The fixed needle is
equipped with a washing head to clean the needle’s external and internal surfaces.
The sampling system takes a total of 25µl of blood, 2 x 1.2µl of which is processed
for the measurements. After sampling, the sample vial is returned to and ejected
in the top position of the vial holder. A ceramic shear valve guarantees precise
sampling volumes.
One of the 1.2µl blood samples is mixed with a lyse reagent for a dilution of
approximately 1:200. The temperature of the mixture is controlled. This mixture is
then driven through the WBC measurement head. The lysed WBC solution prior
to entering the measuring flow cell passes through an absorption measurement
window and is measured for HGB content at 540nm wavelength. The lysed WBC
solution is then focused using a combination of a 100 µm orifice and a double
hydrodynamic focusing system and is led through a perpendicular red (660 nm
Biosystems
16
wavelength) laser beam. The detector tube and amplifier collects scattered data
about each individual passing cell during the 15 seconds of measurement.
The second 1.2µl processed blood sample is moved into the mix chamber using
diluent, creating a dilution of approximately 1:1000. This mix dilution is then
forced through a 70 µm aperture with the help of a sheathing fluid, creating an
overall dilution of 1:20000 The electrical signal of each individual cell is measured
(through stainless steel and platinum electrodes and is collected for 8 seconds) for
RBC and PLT counts.
As a final step, the system empties the measuring elements and is ready to take
the consecutive sample.
2.8. Supported blood collection vials

HA5 can process human whole blood samples from closed K-EDTA sample vials.
HA5’s closed vial mode supports the following closed sample vials:
• BD Vacutanier (Ø13x75mm) or compatible
Please consult the Instructions for use of relevant primary sample vial types.
HA5 requires a minimum of 300µl of primary blood to be present in the closed
vial for safe sampling.
WARNING
Vials with rubber stoppers (caps) are designed for a limited
number of penetrations with a needle. Using a closed vial more
than 5 times poses a risk of damaging the rubber cap and causing
liquid damage in the analyzer.
Samples must be thoroughly mixed and homogenized adhering to general blood

sample collection guidelines prior to analyzing them on HA5.
3. Package contents
HA5 comes in a double cardboard packaging. The outer box provides protection
against shipping damage to the analyzer’s internal box.
17
User manual
The internal box contains the analyzer and its accessories inside protective foams.
The analyzer comes with a protective film covering the scratch resistant polycar-
bonate cover elements.
Upon arrival, carefully check the contents of the package and look for visible
damages, even on the outer packaging box. File any obvious damage through the
shipping company to be eligible for compensation and support from your local
dealer and from the manufacturer.
Packing list:
• Analyzer outer packaging box
• Accessories box
• Power supply; Power cord
• Reagent connector
• Operator’s manual
• Shipping foams (top, bottom)
• Analyzer packaging bag
• HA5 analyzer
3.1. Accessories
external power supply
(SYS1443-6512-T3)
power cord matching

your standard power
outlets
tubing set: reagent

connector with reagent
bottle caps
Always use original accessories and cables. Non-approved

electronic accessories may damage the system and can result in
electric shock.
Biosystems
18
3.2. Identifying parts of the analyzer
1
2
3
Front and right side of HA5

1. Sample vial with cap
2. Status indicator ring
3. Front camera
4. POWER/START button
5. Display with touch screen
6
7
9
10
Left and rear side of HA5

6. USB connectors
7. RJ45 (network) connector
8. Power connector
9. Reagent connector
10. ID label of analyzer with S/N and electrical data
19
User manual
4. Installing the analyzer

Note
HA5 is a precision hematology analyzer. Incorrect handling or
accidental falling of the analyzer may damage parts inside and could
influence performance.
1. Carefully remove HA5 from the shipping carton. Look for signs of damage,
such as cracks on the outer covers or loose/missing screws. If you find such
signs, please file a complaint to the shipping company to be eligible for com-
pensation and support from your local dealer and from the manufacturer.
Make sure you can find all the accessories listed in the packing list.
2. Prior to powering on HA5, allow the analyzer to reach room temperature
to avoid dew condensation. Sudden temperature changes may cause dew to
condensate on colder internal structures and can lead to damage of electronic
components.
3. Place the analyzer on a desktop bench and find a nearby grounded power outlet.
Please avoid power extension cords, use direct connection to the power outlet.
Always use the power supply packaged along with the analyzer.
4. Connect the power supply to the socket on the rear plate of the analyzer.
5. Connect the power cord to the power outlet.
6. Remove the protective foil from the analyzer’s front.
Attention
If you experience any error, like smoke, immediately disconnect the
power cord from the power outlet.
Use a fire extinguisher if necessary.
4.1. User serviceable parts

Attention
There are no user serviceable parts inside the analyzer. Please do
not attempt to open or disassemble the analyzer to avoid electric
shock or injury and will void the warranty.
Attention
There is a Class 3B visible laser (660nm) source enclosed
inside the analyzer. HA5 has internal safety locks to protect
even unintentional exposure to laser light. Do not open the
measurement head or permanent eye damage could occur.
Exposure to direct laser radiation must be avoided.
Attention
Only qualified Service Personnel are allowed to perform
adjustment and repair procedures related to internal components.
Biosystems
20
4.2. Connecting peripheral devices
HA5 offers 2 USB sockets for connecting external peripheral devices. To expand
USB connectivity options, you can connect any standard USB HUBs.
4.2.1. Keyboard (optional)

HA5 supports connecting external USB keyboards that can facilitate data entry.
The keyboard can be connected any time.
4.2.2. Mouse (optional)

HA5 supports connecting an USB mouse. The mouse can be connected any time.
If a mouse is connected, the touch screen remains operating, yet a small arrow
cursor will be displayed to track the movement of the mouse.
4.2.3. Bar code scanner (optional)

You can connect an USB bar code scanner.
USB flash drive (optional)
You can connect an USB flash drive to save reports, archive settings and database
content. The USB flash drive is also suitable to review and import data stored
externally.
4.2.4. USB Wi-Fi Dongle (optional)

It offers connectivity options to wireless networks (sending measurement reports
via e-mail). Network settings must be revised. Supported model: AmbiCom
WL250N-USB (Chipset: Ralink RT3070)
4.2.5. Network (“Ethernet”)

Connect the cable (not included) from the computer network to HA5’s RJ45
socket. Network settings must be revised.
21
User manual
4.2.6. Reagent pack

The Biosystems HA5 reagent pack provides sufficient reagent to run a specified
number of tests with HA5. The pack contains all necessary reagents. Waste must
be collected in a separate container.
The reagent pack is a single use consumable. For connection, follow the Reagent
Pack’s instructions for use.
Hematology reagent waste must be considered biohazard material.

Always follow local regulations regarding disposal of used
consumables, and reagent.
4.2.7. Reagent bottles

Biosystems HA5 is also suitable to run using reagents in individual, external rea-
gent containers, bottles. Care must be taken when connecting reagent bottles to
the system. Always pay attention to match the right line with the correct reagent.
You can shorten the tubes as necessary.
Assemble the reagent bottle caps following the sketch below:
Diluent3 Diff
System solution 3 Diff
Lyse 3 Diff
WASTE
Each tube is equipped with a label indicating which bottle to connect it to. The
caps match the standard HA5 reagent bottles.
Biosystems
22
Attention
For best results and performance, place the reagents to the same
level (on the same desk) as the analyzer.
4.3. Analyzer packaging material

Retain the packaging for return and storage.
4.3.1. Power
4.3.2. External power supply

HA5 can only be used with the supplied external power supply. The SYS1443-
6512-T3 power supply generates 12 VDC required for operation of the analyzer.
The power supply is able to operate between 100-240 VAC @ 50-60Hz. No setting
is required for input voltage selection. The power supply has standard input and
output connectors.
Upon connecting the power supply, HA5 is in low power consumption mode and
ready for operation.
Always use a grounded power outlet to avoid the risk of an electric

shock.
4.3.3. Power button

It is located on the right side of the beveled front panel. When the external power
supply is connected both to the analyzer and to the mains outlet, the analyzer can
be turned on by pushing the power button.
23
User manual
4.3.4. Power on
The single push of the START button will power on the electronics and HA5 will
display the welcome screen and the main menu automatically.
When HA5 is turning on, the screen remains dark, only backlight illumination
can be seen at the edges of the screen. This is normal.
4.3.5. Power off

HA5 is a sensitive device with liquids inside. A simple power off might leave the
system in a state that can represent potential risk to moving components and
liquids inside.
Therefore HA5 has a programmed power off sequence. It is recommended to
always follow the programmed power off sequence to avoid unreliable operation
of the structures inside the analyzer.
HA5 can be turned off by tapping the local menu button and initiating Shut-
down in the menu. To power off the analyzer, select “Shutdown”. The automatic
process will start, and the analyzer is safely powered off within 2-3 minutes. Do
not interrupt this sequence.
It is strongly recommended to power off the analyzer every day, at

the end of the daily routine. This will save electricity, and ensures
that the analyzer operates reliably on a day to day basis.
4.3.6. Emergency power off

If necessary, HA5 can be powered off by holding the power button for 4 seconds.
This method skips the preprogrammed Shutdown.
Performing an emergency power off can leave the analyzer in an

undetermined state. Not operating the analyzer after emergency
power off can result in malfunction.
Please contact your maintenance personnel to avoid damage to
the delicate internal components.
To completely and immediately power down HA5, remove the power cord plug
from the mains outlet or the power connector from the back of the analyzer.
4.4. Reagents handling

HA5 is used with special reagents. The reagents have been meticulously developed
to satisfy the analyzer’s requisites. The HA5 quality guarantee system needs the use
of these special reagents. The HA5 only recognize and accept genuine reagents.
The reagents are sensitive substances and, for this reason, require a careful handling.
Biosystems
24
4.5. REAGENT PRECAUTION
The reagents are considered chemical products.
It is recommended to wear protective gloves when installing and

replacing the reagents.
Always follow instructions of the reagents concerning reagent handling.
4.5.1. Reagent characteristics

Because the use of individual containers, the shelf life of the reagents is 4 years,
however, the stability once they are opened is 180 days.
The originals reagents of HA5 do not contain harmful ingredients for the envi-
ronment.
4.5.2. Instructions for use – DILUENT 5 DIFF

Diluent for automated hematology analysis.
Product Code Size

60118 5L
60119 10L
For in vitro diagnostic use only.
INTENDED USE
Diluent 5 Diff is a buffered, stabilized and micro-filtered electrolyte solution for
automated dilution of human blood samples, quantitative and qualitative deter-
mination of erythrocytes (RBC), leukocytes (WBC) and the leukocyte subpo-
pulations, and the measurement of thrombocytes (PLT) concentration on HA5
haematology analyzers.
The diluent should only be used with BioSystems reagents. Erroneous results may
be obtained if the reagent is applied with third party reagents.
Please refer to the instrument’s User Manual for further information.
INGREDIENTS
Sodium chloride....................................< 1.6%
Buffers...................................................< 1.1%
Stabilizers...............................................< 1.0%
Preservatives...........................................< 0.7%
In ion-free water
25
User manual
HANDLING PRECAUTIONS
• Diluent 5 Diff is environmental friendly, azide-free reagent; does not contain
harmful ingredients.
• Avoid contact with eyes, skin and clothing.
• In case of eye or skin contact flush eyes with copious amounts of water for
several minutes or wash skin area with water.
• Keep the reagent container closed when not in use.
• Wear laboratory gloves when handling the reagent.
• All body fluid samples should be considered potentially infectious materials.
Treat all blood and other potentially infectious materials with appropriate
precautions. Use gloves, masks and gowns if blood exposure is anticipated.
• Please refer to the SDS associated with the reagent.
• Use Good Laboratory Practices (GLP) when handling the reagents.
REAGENT PREPARATION
This reagent is ready for use and can be applied straight from the container; no
special reagent preparation is necessary. Leave the reagent to reach the room
temperature.
REAGENT REPLACEMENT
• Person installing the reagent must be a trained laboratory professional.
• Remove the inlet cap from the reagent container to be replaced. Cut the sealing
foil on the new reagent using a sharp object to allow the tubes go through.
Connect the reagent inlet to the new reagent container.
• Be sure that the colour on each tube, reagent container label and connector
in the back of the instrument match.
• Avoid any dust or microbial contamination of the tubing and reagents. Do
not pour and mix the remains of a reagent from a container into other one.
• Prime thoroughly the new reagent and measure backgrounds according to the
instrument’s User Manual.
• When installing a new lot of reagent, verify calibration by running control ma-
terial; recalibrate the instrument if necessary as specified in your User Manual.
REAGENT STORAGE, STABILITY AND DISPOSAL

• Store Diluent 5 Diff between +2 ºC and +35 ºC.
• The shelf life of the Diluent 5 Diff is 4 years from the date of manufacture, if
stored at the prescribed temperature range.
• Do not use reagent beyond the expiration date printed on the container label.
• The open container stability of the reagent is 6 months.
• Thaw frozen reagent and homogenize well before use by shaking.
Biosystems
26
• Dispose of waste product, unused product and contaminated packaging in
compliance with local regulations.
4.5.3. Instructions for use – LYSE 5 DIFF

Lysing reagent for automated haematology analysis.
Product Code Size

60121 1L
INTENDED USE
Lyse 5 Diff lysing reagent is a stabilized and micro-filtered lysing agent for stro-
matolysis of erythrocytes (RBC), for quantitative determination of leukocytes
(WBC), leukocyte five-part differentiation (LYM, MID, NEU, EOS, BAS) and
hemoglobin (HGB) concentration measurement in human blood on HA5 hae-
matology analyzers.
The lysing reagent should only be used with BioSystems reagents. Erroneous results
may be obtained if the reagent is applied with third party reagents.
INGREDIENTS
Surfactants.............................................< 0.5%
Buffers...................................................< 1.8%
Stabilizers...............................................< 1.1%
Preservatives...........................................< 1.0%
In ion-free water
• Lyse 5 Diff lysing reagent is environmental friendly, azide-free reagent; does
not contain harmful ingredients.
27
User manual
REAGENT PREPARATION
temperature.
REAGENT REPLACEMENT

• Store Lyse 5 Diff lysing reagent between +2 ºCand +35 ºC.
• The shelf life of the Lyse 5 Diff is 4 years from the date of manufacture, if
4.5.4. Instructions for use - CLEANING SOLUTION 5 DIFF

Cleaner solution for automated haematology analysis.
Product code Size

60120 500mL
INTENDED USE
Cleaning Solution 5 Diff cleaning reagent is a stabilized and micro-filtered deter-
gent solution for regular automated cleaning, rinsing and washing of hematology
Biosystems
28
analyzers’ capillaries, tubing and chambers, removing blood component precipitates
and lipoprotein deposits on HA5 haematology analyzers.
The cleaning reagent should only be used with BioSystems reagents. Erroneous
results may be obtained if the reagent is applied with third party reagents.
INGREDIENTS
Surfactants.............................................< 1.1%
Buffers...................................................< 1.0%
Stabilizers...............................................< 0.9%
Preservatives...........................................< 0.8%
In ion-free water
• Cleaning Solution 5 Diff reagent is environmental friendly, azide-free reagent;
does not contain harmful ingredients.
REAGENT PREPARATION
temperature.
REAGENT REPLACEMENT
29
User manual


• Store Cleaning Solution 5 Diff cleaning reagent between +2 ºC and +35 ºC.
• The shelf life of the Cleaning Solution 5 Diff is 4 years from the date of ma-
nufacture, if stored at the prescribed temperature range.
4.5.5. Instructions for use – REAGENT PACK 5 DIFF

Reagent set for automated haematology analysis
Product Code Description Size

60126 Reagent pack 5 100 t 4.3 L
60128 Reagent pack 5 400 t 6.3 L
INTENDED USE
Reagent Pack 5 Diff is a set of reagents intended to be used on HA5 haematology
analyzers.
Reagent Pack 5 Diff reagents should not be replaced with third party reagents.
Erroneous results may be obtained if the third party reagent is applied.
COMPONENTS
60126 60128
Diluent 5 Diff 3400 mL 5000 mL
Lyse 5 Diff 600 mL 1000 mL
Cleaning Solution 5Diff 300 mL 300 mL
Biosystems
30
• Reagents inside Reagent Pack 5 Diff are environmental friendly, azide-free
reagent; do not contain harmful ingredients.
REAGENT PREPARATION
This reagent pack is ready for use and can be applied straight from the container;
no special reagent preparation is necessary. Leave the reagent to reach the room
temperature.
REAGENT REPLACEMENT

• Store Reagent Pack 5 Diff between +2 ºC and +35 ºC.
• The shelf life of the Reagent Pack is 4 years from the date of manufacture, if
31
User manual

5. Blood samples
Proper handling of a hematology sample is of key importance for accurate,
dependable and reproducible results. Blood is a living tissue composed cellular
structures suspended in liquid plasma. The cellular structures are composed of cell
membranes with liquid and intracellular structures inside. Hematology analyzers
are designed to detect, calculate and classify these cellular bodies and their content.
As the cells are actually alive in the meaning of active chemical interaction with
their environment, keeping them close to their ideal environmental conditions is
important for correct analysis. Blood samples intended to be analyzed for hema-
tology purposes are sensitive to temperature, anticoagulant quantity and quality,
and mechanical effects.
Follow the guidelines below for optimal sample handling.
5.1. Taking the sample

HA5 analyzer can analyze human blood samples but is important to treat blood
samples with anticoagulant to avoid clot formation.
• Collect venous blood using (preferably K2EDTA-prefilled vacutainer) (1.5
mg/ml - 2.2 mg/ml)) anticoagulant collection tube; EDTA quantity below or
above the recommended ratio will cause false or no results due to improper
chemical treatment of blood cells. When using vials without pre-filled anti-
coagulant, there is a risk of adding unsatisfactory amount of anticoagulant, or
adding it late. In such cases an irreversible clotting procedure will start very
fast, or cannot be stopped in time, which will bind cells in a fibrin net making
hematology analysis impossible.
• Rapidly and thoroughly mix the blood with the anticoagulant.
• The anticoagulant requires approximately 15 minutes for taking its required
effect on the sample. Running the sample within the reaction time of the
anticoagulant may result in false cell counts and improper differential results.
• A clotted blood sample will give erroneous results (the plasma will have no
significant number of cells suspended anymore) and the chunks if aspirated
by the analyzer will very likely cause technical problem by clogging delicate
tubing systems inside the analyzer.
5.2. Transporting and storing samples

Blood samples can be collected and analyzed at the same place (ensuring that
the anticoagulant has 15 minutes to do its reaction) or at a different place. If it is
not possible to analyze the sample after taking it, the sample must be preserved
properly to avoid its degradation.
• Samples must be run within 6 hours.
Biosystems
32
• Samples can be stored for up to 6 hours at 15 ºC - 30 ºC or up to 10 hours
after collection when refrigerated at 2 ºC - 8 °C.
• If samples need to be transported after collection, provide a cooled environ-
ment (2 ºC - 8 °C).
• Hematology blood samples must not freeze. Avoid direct contact of sample
containers and cooling agent (cold surface, ice pack, etc.). The frozen water
will damage the structures and cellular membranes and will produce false and/
or erroneous results.
5.3. Sampling preparation

When blood is left standing for a certain time (10-60 minutes, sample dependent),
the sample will sediment; cells inside will obey gravity and will tend to sink down
forming a yellowish liquid on top with a thin layer of White Blood Cells and a
thick layer of dark red colored Red Blood Cells below.
Samples must be manually mixed and warm up before proceeding to the mea-
surement.
• Immediately prior to inserting the vial into the analyzer, gently invert the vial
then rotate it back. Repeat the cycle 5 times, not less and not more. Doing
more than 6 or less than 6 will negatively influence the result.
• Do not shake or drop the vial, air bubbles or cellular damage can appear and
can cause sampling problems with the analyzer.
• Do not place samples on rockers, homogenizers.
• Do not apply vortex mixing.
• Sample temperature must be between 15 °C - 28 °C. Lower temperatures
will interfere with homogenization; higher temperature may induce faster
degradation of cells.
• Samples must reach room temperature in a natural manner. Do not heat or
directly warm the vials not even by holding them in your palm.
• Samples must not be mixed while cold. Doing so may physically damage the
cells.
5.4. Sample handing

All body fluid samples should be considered potentially infectious materials. Treat
all blood and other potentially infectious materials with appropriate precautions.
Use gloves, masks and gowns if blood exposure is anticipated.
If blood poured out, it should be cleaned as soon as possible and the surface in
direct contact with the blood must be cleaned with an adequate disinfectant. The
same procedure applies to dried blood in surfaces. Always use gloves, masks and
gowns even if you are cleaning dried blood in surfaces.
33
User manual
6. Menu system
6.1. The screen area

HA5’s information display screen can be divided into four areas:
1
2
1. Status bar Displays active menu and instrument status

2. Page count area (when left-right swipe is available)
3. Main
information
4. Quick links Displays further functions available related to
displayed data
6.2. Menu tree

Daily routine Sampling Run FastBlank, closed vial samples
(including QC samples and
calibrator)
Results Database functions
Management Maintenance Drain, Prime, Clean, General

Service Service Personnel Only
Reagents Pack Pack usage
Biosystems
34
Individual Individual reagent containers, usage
Options Customize Appearance / Language / Units

Functionality Date / E-mail / Printout /
Customization / Patient Profiles / LIS
System History Operation log

About System info / SW upgrade
6.3. Gestures
HA5’s touch screen user interface allows operating the analyzer with light taps
and swipe actions listed below.
Taps (quick touch and release over a certain point)
Swipe (quickly moving your finger along the screen without

lifting your finger)
All actions (touch and release) are acknowledged by a small circular symbol appea-
ring at the point where the user tapped the screen, and an audible “tick” is head
if sound was enabled.
Using the above basic actions, HA5 can interpret various combined actions, so-
called gestures.
6.4. Tap
Touching (tapping) an active area (icon, data input field) will activate the co-
rresponding function, or open a sub-menu. For data input fields, an on-screen
keyboard is displayed at the top or bottom quarter of the screen depending on the
position of the data input field.
35
User manual
6.5. Swipe
HA5 is able to display data that spans over several screens (pages). Such pages are
indicated with small circles in the center near the top half of the screen.
To switch (scroll) between such screens, you need to perform a sweeping gesture
by lightly touching the screen at any point of the screen showing data, and quickly
sweep your finger in the direction of the intended scrolling action (up, down, left,
right). The screen will be scrolled in the requested direction.
6.6. On-screen keyboard

When you select to enter data, an on-screen keyboard will be displayed at the top
or the bottom quarter of the screen. The position of the keyboard depends on
the position of the data input field to avoid covering the field with the keyboard.
Biosystems
36
6.7. Data input
6.7.1. Alphanumeric input

Input fields are marked with an underscore. Tapping into any field allows editing
data. The on-screen keyboard will be displayed either in the top or in the bottom
quarter of the screen to make sure that the input filed remains visible. The cursor
is indicated by a light underscore below the character.
The on-screen keyboard allows changing symbols entered by changing the keys.
The keyboard can be changed by swiping left or right to reveal capital letters, small
letters and symbols.
SPACE adds a space at the cursor.
CLEAR deletes the entire field.
BACKSPACE erases the character left of the cursor.
6.7.2. External keyboard

If an external keyboard is connected to HA5, then keystrokes from the external
keyboard can be used to enter data into input fields.
37
User manual
Actual keyboard layout depends on the language of the user interface. Always the
standard keyboard layout is used to interpret keystrokes.
6.7.3. Barcode input

If an external barcode scanner is connected, then the read ID will be entered as
Sample ID for the consecutive measurement.
This function is only active if the measurement function is activated. Barcode
scanner data will not be interpreted as data for any other field.
To input barcodes:
• Make sure the analyzer is in measurement mode (ready to start)
• Scan the barcode with the handheld scanner
When a barcode has been recognized and interpreted, the bar-code will be entered
into the Sample ID input field.
6.7.4. Numeric input

Some data fields may require modification on a larger scale. For this purpose, HA5
offers another intuitive setting method.
Symbols ---, -- and – buttons will have decreasing effect on first, second and the
third digit, respectively.
Symbols +, ++ and +++ buttons will have increasing effect on first, second and the
third digit, respectively.
6.8. Description of icons displayed

[Daily routine] Access measurement mode and results
[Management] Access point of maintenance functions
[Reagents] Reagent menu
[Options] Settings
Biosystems
38
[System] System administration utilities
[Home] Back to the Main menu
[WiFi] WiFi network available
[ETH] Wired network available
[PrinterThermal] Thermal Printer connected
[PrinterPCL] PCL5 Printer connected
[Printer] Unknown printer connected
[Loading…] The analyzer is busy
[QuestionMark] Measurement mode selection
[Gift] New results are available
[Vial] Available measurements in the pack
[E-mail] Send selected records in an e-mail
[TSF] Save records into TXT file (Tab Separated File)
[PDF] Save selected results into PDF file
[LIS] Send results to LIS
[Uncheck] Check/uncheck selected elements.
[Drop] Discard elements
[Reset/Load] Reset to original or default values./ Load data

from external USB drive
39
User manual
[Accept] Confirm and accept elements
[Print] Print selected records
[Eject] Remove vial from sampling rotor
[Read] Read (scan) QR code
[SelectionStart] Activates multi-selection
[SameDay] Selects records of a specific date
[SameSampleID] Selects records of a specific SampleID
[CV] Calculate CV of selected results
[Jump] Jumps to given date in records database
[LoadW] Load wallpaper
[SaveRAW] Save raw measurement data
[ShutDown] Initiates shutdown sequence
[ClosePage] Closes context menu
[Calibrate] Loads mean of parameters as calibration target

(selected records)
[LoadProfiles] Load Profiles
[SaveProfiles] Save Profiles
[Full] External waste container is full. Tap for details.
[Menu] Access local menu
Biosystems
40
7. Setup
HA5 comes preprogrammed with the operating software, and has most its options
set to standard values, values that suits most laboratories.
However, you can customize these settings to make HA5 fit into your daily routine
even better. Here is a brief list of options that you are recommended to adjust or
verify to make the use of the analyzer simple and convenient.
7.1. Initial setup

Below is a recommended sequence of settings so that you can start using the
analyzer easily:
• choose a language for your analyzer
• practice gestures used on the screen
• set time and date
• set up your Laboratory information and measurement units
• set up your network and connectivity (email) (if available)
You can skip each stage; you can leave the setup wizard at any time. You can also
(re)run the wizard at any time later on.
7.2. Settings – Customize
7.2.1. Appearance
[Page1]
You can disable the visual feedback of
touchscreen gestures.
You can enable/disable audible touch
feedback.
You can change the background image.
To use Custom wallpaper, use “Custom”
setting, and load your wallpaper by acces-
sing local menu and tapping the “Load
Wallpaper” icon.
The wallpaper file must reside on a USB

memory device, named “CustomWallpa-
per.png”. Resolution must be 800 x 1280
pixels. Do not use clear white or clear
yellow images: this will impair screen
readability.
41
User manual
HA5 will confirm the new wallpaper file, or will display an error message if the
image is not of the right size, format, or it cannot be found in the root folder of
the USB memory device.
7.2.2. Languages
[Page2]
Language of the user interface can be
changes. Changes have an immediate
effect.
7.2.3. Units
[Page3]
It also allows changing measurement units
for cell count (WBC, RBC, PLT),
HGB, HCT/PCT.
Biosystems
42
7.2.4. Functionality
This menu allows setting operation related parameters.
7.2.4.1. Date and time

[Page1]
7.2.4.2. E-mail settings

[Page2]
This screen provides fields to set e-mail
account parameters used for reporting:
• Sender address
• Account e-mail address
• Account password
You can test your e-mail settings by tap-
ping the “Test E-mail settings” button.
The e-mail protocol currently supports
gmail based accounts only.
43
User manual
7.2.4.3. Printout Settings

[Page3]
You can also define some standard mes-
sages or comments to be included in a
report generated by the analyzer.
You can enter a header composed of 5
lines that will be printed on all reports.
These five lines can be left, center or
right-aligned.
Enabling “AutoPrint” will make HA5
print reports after the results are available.
(Requires connection of a printer)
Defining printout signature(s) will make
HA5 print line(s) with the defined
value(s) on the bottom of page.
Enabling “Print Technical Data” will
make HA5 print result related technical
information on the bottom of the page.
You can force HA5 use ESC/POS lan-
guage for unrecognized printers.
WARNING
Forcing an incorrect language to a printer may result in scrambled
printouts, and empty pages, even one single symbol per page!
It is possible to exclude (hide) histograms from printouts to save paper.
7.2.4.4. Customization
[Page4]
Defining Comment 1-3 values will chan-
ge header of comment fields on printouts
and user interface as well.
QC charts include only 11 parameters
(WBC, LYM%, MON%, NEU%, EO%,
BAS%, RBC, HGB, MCV, PLT, MPV)
if Short QC parameters mode is selected.
Used Reagent volume: you can define the
volume (in Liters) of the external contai-
ner collecting waste liquids. When the free
volume drops below 0.3L, there will be a
Full container symbol in the upper right
corner of the screen.
If you set 0 as volume, HA5 will not
display a warning at all.
Biosystems
44
7.2.4.5. Profiles
[Page5]
Minimum and maximum values of nor-
mal ranges can be set for each measured
parameters. Measured values will be
verified against these limits.
HA5 offers 8 slots (Human, Male, Fema-
le, Profile 4-8). Swap between profiles by
swiping up/down.
All limits can be changed. You can define
custom names for Profile 4-8.
To backup/restore Profiles tap the “Load
Profiles” or “Save Profiles” icon by acces-
sing local menu.
7.2.4.6. LIS
[Page6]
HA5 is capable of transmitting reports
using HL7 v2.5 protocol to a host com-
puter.
This page allows setting HL7 server IP
address along with the communication
port.
Automatic transmission of results can be
enabled.
By enabling repeatation of Sample ID as
Patient ID the transmitting report will
contain standard HL7 PID field which
includes the sample identification string.
Keeping HL7 connection open after
transmission can be enabled.
HL7 message format is depends on
selected version. For more information
requests for HL7 transmission protocol
document.
This page also allows setting up Biosystems Access parameters. For details, please
contact your service personnel.
45
User manual
7.3. Setting up reagents

HA5 requires reagents to run. Con-
nected reagents can be managed from
the Reagents menu. Reagents menu
has two separate branches: one for
packed and one for individual (“Bulk”)
reagents.
7.3.1. Reagent: Pack

Tap on the Reagent icon in the main
menu then select “Pack”.
A list of reagent pack will be displayed.
The active (currently used) pack will
have a green background. Inactive
packs have no coloring, expired or
empty packs will have a dark red bac-
kground.
Swiping left on a row will bring up
detailed information about the pack:
LOT number, expiration, part (orde-
ring) number, and level of the pack with
consumption data, open bottle stability
data (based on installation date) and
usage statistics.
Activation and deactivation of reagents
is possible through the local menu.
Tap the Deactivate icon to stop using
a pack. Tap the Activate icon to start
using a pack.
Disabling a pack will not delete it from the reagent database.
Biosystems
46
To add reagent packs to the system:
HA5 offers entering reagent pack data
using the onboard camera. Biosystems
provides reagent packs with QR codes.
To activate QR code reading sequence:
• tap the local menu icon
• tap the small camera Icon.
The screen will change, and you will see
a live image of what the camera “sees”.
The camera is located in the center of
the letter “o” in the HA5 text at the top
right corner of the display.
Hold the QR code in front of the analy-
zer, making sure that the code is not
curved or bent. The QR code should be
located in the center of the live image.
Use the ON/OFF button with low
ambient light and the screen will pro-
vide sufficient backlight for scanning
a QR code.
HA5 will acknowledge the QR code
with an audible tone. The data will be
entered as a new reagent pack. If you
scanned a code that already exists, Icon
will show a message.
To load codes from a USB flash drive,
use the “Load” icon.
47
User manual
7.3.2. Reagent: Bulk

Tap on the Reagent Icon in the main
menu and then select “Bulk”.
A list of individual reagents will be
displayed.
You can see the details of actual reagents

by tapping the row of a specific reagent.
The active (currently used) reagent will
have a green background. Inactive rea-
gents have no coloring, expired or
empty entries will have a dark red bac-
kground.
Swiping left on a row will bring up
detailed information about the reagent:
LOT number, expiration, part (orde-
ring) number, and level of the container
with consumption data.
Activation and deactivation of reagents
is possible through the local menu.
Tap the Deactivate icon to stop using
a pack. Tap the Activate icon to start
using a pack.
Disabling a bottle will not delete it from
the reagent database.
To add reagents to the system:
HA5 offers entering reagent data using
the onboard camera. Biosystems provi-
des reagents with QR codes.
To activate QR code reading sequence:
tap the local menu button,
tap the small camera Icon.
Hold the QR code in front of the
analyzer, making sure that the code is not curved or bent. The QR code should
be located in the center of the live image.
HA5 will acknowledge the QR code with an audible tone. The data will be entered
as a new reagent pack. If you scanned a code that already exists, Icon will show
a message.
To load codes from a USB flash drive, use the “Load” icon.
Biosystems
48
7.3.3. Network Settings
You can make the most of HA5’s ser-
vices if you let it connect to a network
with access to the Internet so that it can
create and send reports in e-mails, trans-
mit data to your laboratory information
system (LIS) and update software when
necessary.
Network availability is displayed in the
top row of the screen.
When WiFi is available (a USB WiFi
adapter is connected) then a little signal
strength icon appears in the top row.
When Wired network is availabe, a
network plug icon is displayed.
Tapping on this icon brings up the list
of available wireless networks.
Tap on a network to access its details.
Tapping on the X in the row of a net-
work will remove it from the list of
networks.
49
User manual
7.3.3.1. WiFi settings

Network connectivity supports the
following encryption protocols:
open
shared
WPA2 Personal
WPA Personal
DHCP is always assumed for WiFi.
If required, you can enter the password
for the network, and then tap “Join” to
start connecting.
For details on the network, please con-
tact the local network administrator.
7.3.3.2. Wired network Settings

Access settings by tapping the network
plug icon in the top of the screen.
Actual settings are displayed in the
lower half of the screen. Enter your
settings in the upper half of the screen.
If DHCP is enabled, you do not need
to specify network related data.
If DHCP is not supported, please
contact your network administrator
for settings.

Biosystems
50
8. Daily operation
Your daily routine will mostly consist
of powering on the analyzer, running
samples with unique sample ID’s and
creating reports.
It is good laboratory practice to run QC
material on a daily basis to ensure and
allow controlling the performance of the
analyzer on a day-to-day basis.
You will most probably create reports of
the samples run and occasionally you will
need to find earlier results of individual
patients.
All these tasks are outlined below to give
you an easy to follow guide and make
laboratory work routine and fun to do.
8.1. Power on
HA5 will mostly be waiting in stand-by mode.
Push the START button to wake up the analyzer,
the status ring on the top will change color.
The user interface will be displayed shortly, and the
analyzer is ready for work.
The fluidic system will always require initialization,
a programmed startup. This is indicated by a yellow
analyzer in measurement mode.
Tap the yellow icon to start the initializa-
tion, and will display FastBlank (system
check) results. HA5 will accept Fast
Blank values if the values are below the
following thresholds:
WBC < 0.2 103/µL
RBC < 0.05 106/µL
PLT < 40 103/µL
51
User manual
8.2. Running samples

To start measurements, tap Daily routine and then tap „Sampling”.
It is recommended to verify the accuracy of measured parameters. The practical
method is running a QC measurement using control material.
8.2.1. Introducing a Sample
The opening on top of icon for Closed vials is designed to receive

blood collection tubes of defined dimensions with caps on.
To avoid personal injury, do not put your finger into the opening.
Avoid placing objects different from a blood collection vial to
avoid damage to the analyzer.
Avoid putting tubes without caps into the sampling mechanics.
To run samples, you need to enter the Daily

routine menu.
Enter the sample ID to the input field using

the on-screen keyboard or the external ke-
yboard.
Select a profile by tapping the Profile list and
place the closed sample vial into the sample
opening on the top of the analyzer.
Avoid putting more than one barcode label onto the blood
collection tube to avoid the tube getting stuck in the sampling
mechanics.
HA5’s sampling mechanics is equipped with a cap detector.
Cap detector operation may be impaired by additional labels put
on the sample vial, and HA5 may refuse to run such tubes.
Tapping the analyzer symbol in the center will start the measurement.
HA5 will lower the sample vial into the sampling mechanics and will take a sample
with its built-in cap piercing needle.
Biosystems
52
When the sample has been taken, the vial will be returned to the
Operator.
Results will be available in a minute.
A new available result will be indicated by a small icon in the lower
right corner of the screen. Tapping this icon will take you to the
Results screen and the latest data will be displayed on the screen.
8.3. Results
HA5 can display results in two ways:
a short version of results during measurement in the lower half of the screen;
a full (detailed) view accessible in “Results” (database)
8.3.1. Short (Quick) result

The result appears in the lower half of the screen. Only 12 parameters are displa-
yed. You can tap the values for details and you can tap the scattergram/histogram
for a zoomed view.
If flags are displayed, tap on values to see flag messages.
8.3.2. Full result (Full screen)

Full, detailed results are available from the Main menu under Execution / Results.
Flags are displayed in yellow color.
53
User manual
8.3.3. Flags
The screen below intentionally contains error flags.
Biosystems
54
A small red flag indicates that the system detected a condition that requires atten-
tion. Flags next to result values indicate that the numerical result is beyond actual
minimum or maximum accepted values (normal range). Flags with yellow text
indicate technical flags, messages related to the evaluation process of the sample.
Most of these flags require the sample to be rerun.
8.3.4. Technical flags

HA5 is able to display technical warning flags. Flags can appear in various locations,
depending on significance and relevance. Flags by the Sample ID refer to sampling
or sample handling mistakes. Flags displayed in WBC and RBC groups refer to
parameter related irregularities. Technical flags rather give guidance for the user,
an indication of not operating the analyzer as recommended.
Flags have different levels of significance. Each flag has two confidence levels. As
long as results are not negatively influenced by the detected conditions, results will
be displayed along with the flags. As soon as severity of the problem goes beyond
safe result interpretation, and would impact readings, values will be dashed out.
Flag name Type Flag meaning Letter

Abnormal Diff WBC The scattergram was found S
abnormal. This may be the result
of an over-mixed sample. See
Sample handling section earlier
in the manual.
HGB Temperature RBC The reference value of R
reference error temperature sensor on HGB
head is unset. Contact Service.
High MCHC Sample MCHC is over 500 g/L. There m
was an inadequate quantity of
sample in the sampling vial.
Rerun the sample if possible.
Please observe minimum sample
volume guidelines. May also
indicate a block in the sampling
system.
Improper Voltage WBC Internal measurement related V
structures are not working
properly. Your analyzer might be
operating outside the described
environmental conditions.
Please observe environmental
requirements. Maybe cleaning is
due.
55
User manual

Improper Voltage RBC Internal measurement related v
structures are not working
properly. Your analyzer might be
operating outside the described
environmental conditions.
Please observe environmental
requirements. Run RBC
Cleaning.
Laser Packets System Low level measurement structure E
Empty error in the optical (laser)
module. Rerun sample. If the
problem persist contact Service.
Low sample Sample There was an inadequate quantity B
volume of sample in the sampling vial.
Rerun the sample if possible.
Please observe minimum sample
volume guidelines. May also
indicate a block in the sampling
system.
Overload System Too many particles have been x
detected during RBC/PLT
measurement. Some internal
bubbles may cause the error.
Do RBC Cleaning. Rerun the
sample. If the problem persists,
contact Service.0
Pressure Sensor WBC Pressure sensor detected high K
High Value pressure during measurement
process and released a valve to
avoid system damage. Rerun
sample. If the problem persist
contact Service.
Range exceeded WBC Results are outside the linearity L
range of the analyzer.
Range exceeded RBC Results are outside the linearity l
range of the analyzer.
RBC Noise RBC Verify reagents. Some bubbles n
may have formed inside the
analyzer. If the problem persists,
run RBC cleaning, prime
DILUENT and rerun the
sample.
RBC packets System Low level measurement structure e
empty error in the impedance (aperture)
module. Rerun sample. If the
problem persist contact Service.
Biosystems
56
RBC Slice errors System RBC/PLT measurement s
encountered an internal
homogeneity error. Rerun the
sample. If the problem persists,
contact Service.
Unintelligible WBC The internally prepared W
histogram sample did not meet proper
measurement criteria; sample
flow in the flow cell was not
homogenous.
Rerun the sample.
If persists, run WBC
Debubbling. If it cannot be
resolved with repeated WBC
Debubbling, contact service, as
temperature stability or liquid
flow might have been influenced.
Unstable HGB WBC Improper internal H
homogenization of sample.
Rerun the sample. If
maintenance related cleaning
actions have been omitted,
please do them now. Run WBC
Debubbling
Unstable HGB WBC The HGB measurement signaled h
baseline an error. Probably some bubbles
got stuck in the flow cell. Run
WBC Debubbling.
Unstable Voltage WBC Internal liquid flow was A
disturbed, or temporary block
of the liquid flow was detected.
Rerun the sample.
Unstable Voltage RBC Internal liquid flow was a
disturbed, or temporary block
of the liquid flow was detected.
Rerun the sample.
WBC Noise WBC The flow cell detected an N
abnormal number of disturbing
signals. This may be the result
of air bubbles blocking the flow
cell. Run a Prime All function.
57
User manual
8.4. Reports
8.4.1. PDF
HA5 is able to send reports ready to be printed via e-mail or is able to save reports
to USB HD. Reports include all entered patient data, along with reported para-
meters, scattergram, histograms and additional notes, comments created using the
analyzer during or after analysis.
8.4.2. Printer (Thermal)

HA5 is able to send report to connected thermal printer. When HA5 detects
Thermal printer is connected proper symbol will be shown on status bar.
A printer report looks as shown on the image to the right.

It is possible to hide histograms from the printout. For details, see Settings /
Printout.
Icon will acknowledge a printer as Thermal printer if it supports the ESC/POS
language.
Biosystems
58
8.4.3. Printer (PCL5)
HA5 is able to send report to connected printer which is capable to interpret PCL5
printer language. When HA5 detects PCL5 compatible printer is connected proper
symbol will be shown on status bar.
59
User manual
A printed report looks as shown on

the image on the right.
It is possible to hide histograms

from the printout. For details, see
Settings / Printout.

Note:
HA5 supports a limited set of pr-
inter languages. The printer must
support one of the following lan-
guages:
PLC5
ESC/POS
Printers not supporting the above
printer languages will trigger a printer symbol with a question mark on the screen,
and will print scrambled reports, or a lot of empty pages.
HA5 can be forced to use ESC/POS language for unknown printers. Forcing a
specific language for a printer may result in empty pages or missing, unrecognized
characters.
8.5. Power off

A regular power off can be initiated at any time. Processes that actually run the
fluidic system cannot be interrupted however.
To power off, tap the local menu button. A quick menu will be displayed offering
various actions including shutdown (power off).
Shutdown will prepare the system for a longer period of inactivity. The process
takes about a minute, after which the system will automatically power off, leaving
HA5 ready to be disconnected from the mains if necessary.
Biosystems
60
9. Calibration
HA5 as any laboratory analyzer can be calibrated. For this purpose, HA5 offers
two ways to perform this task. HA5 arrives to your laboratory factory calibrated.
Calibration is necessary if laboratory standards require it, or when maintenance
actions require you to do so. You may need to calibrate upon installing new reagents.
9.1. Target values

Calibration is performed comparing the reported values of the analyzer to a known
specimen, or standard. Hematology analyzers have their own calibrator materials
called Hematology Calibrators.
A calibrator material is made by using human samples mixed with specially treated
particles to guarantee stable values for parameters over the stability period of the
calibrator material. All calibrator products come with a list of the target values of
calibrated parameters.
It is recommended to use calibrator material.
These target values represent the standard to which your analyzer’s reported values
are compared.
9.2. Automatic calibration

HA5 offers an automatic calibration
method to keep the process as simple
as possible.
The steps of automated calibration are
as follows:
enter target values
run the calibrator material a specified
number of times
accept the calibration result
HA5 can calibrate the below measured
parameters:
WBC, RBC and PLT count
HGB, MPV, RDW and MCV value
Tick the box in front of parameters you
want to calibrate.
Enter target values either by defining
the expected values of the calibrator
found on the accompanying insert or,
scan the special barcode containing all these data using HA5’s built-in camera.
61
User manual
Insert the vial with the calibrator material into HA5’s sample opening and press
START.
HA5 will mix and run the sample and will calculate the mean values of the mea-
sured parameters. The mean value will be used to calculate the calibration factors
using the formula below
Each sample run will be listed on the

screen, with each parameter to be ca-
librated. Consequent measurements
(samples) will be displayed on small
Levey-Jennings charts, each sample
represented by a small dot. This screen
allows a quick overview of the process,
displaying calculated Mean and CV
values.
Highlighted samples can be deleted
(“Drop”) from the list of measure-
ments.
Red highlight indicates that accepting
these values would push the calibration
factor to its 30% limit. Red highlight is
intentional to demonstrate error.
“Reset” will clear values and cancel the
calibration process.
9.3. Manual calibration

HA5 also offers the option to enter calibration factors manually. Each calibration
factor can range from 0.70 to 1.30 allowing a ±30% range for adjustment.
This way the Operator can modify calibration factors parameters individually.
Manual calibration can be a much faster method than the built-in automatic
calibration service, but care must be taken when changing parameters manually.
It is recommended to verify the effects of the manual calibration

by running specimens with known values of measured
parameters.
Biosystems
62

10. QC – Quality Control

HA5, just like any laboratory analyzer needs verification of its performance from
time to time. For this purpose, HA5 offers the Quality Control service.
Quality Control is a built-in tool offering an easy method to track the performance
of HA5.
10.1. Expected values

Quality Control is performed measuring the same specimen over a period of time.
Hematology analyzers have their own control material called Control Blood.
Control blood is made by using human samples mixed with specially treated
particles to guarantee stable values for parameters over the stability period of the
control material. All control blood products come with a list of the expected values
of parameters.
Please always observe the package insert of the control material;

such products require storage in a refrigerator. Prior to using
the control material, it must reach optimal (room) temperature.
Always follow the instructions accompanying the control product.
These expected values represent the standard to which your analyzer’s reported
values are compared.
It is recommended to use control material Control Blood 5 diff, developed spe-
cifically for HA5.
63
User manual
10.2. Assay sheets

HA5 offers entering QC Assay values
via QR codes using the onboard ca-
mera. Biosystems provides Assay Sheet
values in QR code form as well. To
read the QR code, you will have to
print it then present it to the analyzer
as described below:
To activate QR code reading sequence,
tap the local menu button.
Tap the small camera icon.
Hold the printed sheet in front of the

analyzer, making sure that the sheet
is not curved or bent. The QR code
should be located in the center of the
live image.
HA5 will acknowledge the Assay Sheet
with an audible tone. The data will be
entered in the QC mode available for
measurement.
Biosystems
64
Assay sheet data can also be entered
manually.
The list of QC materials can be seen
with a manual entry point in the top
row.
Banks can be selected as targets for
measurement by ticking the box in
front of the specific row.
Banks can be deleted by ticking the box
in front of the specific row and going to
the local menu and selecting “DROP”.
Tapping the first (top) row will enter
the screen where manual definition of
parameters is possible.
With manual entry you can define ex-

pected values and tolerances along with
LOT ID and expiration date.
Your changes will only be saved if
you tap the “ACCEPT” icon. You can
cancel data entry by tapping the “RE-
SET” icon and discarding changes by
tapping the HOME icon in the top of
the screen.
QC materials (banks) once saved, can-
not be edited. If you made a mistake
and corrections must be made, please
delete the actual QC bank and enter a
new bank.
65
User manual
10.3. QC diagrams
HA5 can represent QC data in two
views. QC data are only shown if there
actual QC measurements stored in the
analyzer’s memory.
One view lists data in a graph where va-
lues of parameters are displayed against
measurements in sequence (time).
You can initiate a measurement by ta-
pping the analyzer Icon on the screen.
New QC measurements will be displa-
yed on the chart.

The second view displays records and

the respective parameter values on a
circular diagram (radar chart).
You can initiate a measurement by
tapping the analyzer icon on the screen.
New QC measurements will be displa-
yed on the chart.
Note: The number of displayed pa-
rameter depends on QC Parameter
setting (Short/All).

10.4. QC reports
HA5 can print Levey-Jennings diagram via thermal and PCL5 printer as well. To
print diagram tap “Print” button via accessing local menu.
Biosystems
66

67
User manual
11. Database functions
11.1. Browsing records

The database allows browsing records listed in rows. Swiping (scrolling) gestures
can be used to access various views of the database.
The database is arranged into three separate sets of data:
Samples, QC measurements and Calibration data, Fast Blanks
Within each set, you can browse by date
Swiping LEFT will reveal more and more detailed data of the row, record examined
Results Human   
Date Record Details
  
QC   
Date Record Details
  
Calibration   
Date Record Details
  
Fast Blank   
Date Record Details
  
Swiping the screen in the left or right direction will switch pages displayed.
Swiping the screen up or down will scroll the view up or down: you can scroll
between dates, groups of records and individual records.

11.2. Database context menu

Tap the local menu button in the lower right corner of the screen brings up a so-
called context menu screen.
The screen has operation related functions in the top. The central region has icons
representing functions related to actions corresponding to database records.
Biosystems
68
11.3. Selection
By tapping “Same Day” you can select records measured on the day of the actual
result.
By tapping “Same SID” you can select records matching same SampleID of the
actual result.
Tapping “Selection Start” will allow multi-selection of results. You will be taken
back to the database table view. You can select the END of the selection by ticking
the box in front of any sample. All samples between the “first” (where selection
started) and the “last” (the one you ticked) will be selected.
The number of selected records will be shown under the list of records. By (un)
ticking the box by the (e.g.) 16 of 273 will deselect ALL records.
11.4. Moving to specific date in database

After selecting date with date picker tap “Jump” button to move the correspon-
ding results in database list. HA5 will execute the jump operation only if database
contains records with the selected date.
69
User manual
11.5. Managing data

Tap the corresponding icon to activate the function:

print results via connected thermal or PCL5 printer
export results in TSF format to USB HD (Tab Separated File – ideal for external
processing)
e-mail results in PDF format
save reports in PDF format to USB HD
save reports in raw data format to USB HD
send results to LIS
drop selected records
CV% calculates CV data of selected results.
11.6. Sending e-mail

To e-mail, enter the address of the recipient. E-mail settings are available under
Options menu Functionality submenu.
Keeping “CC” checkbox selected will send a copy to the default e-mail address (as
defined under e-mail settings)
Biosystems
70
12. Maintenance
12.1. Cleaning the analyzer

The outer cover of HA5 is made of plastic, and polycarbonate. The back plate is
made of stainless steel.
The external plastic parts can be cleaned with lint free cloths soaked in light soa-
py water, or alcohol based cleaning materials, typically alcohol-based window or
computer display cleaning solutions.
Cleaning the stainless steel back plate should be done using alcohol based cleaning
materials, typically alcohol-based window or computer display cleaning solutions.
12.2. Daily maintenance

Clean outer surface
Check reagent connector
12.3. Emergency procedures

Cleaning
Power off
12.4. Reagent pack replacement

When a pack is empty, scan a new pack, and connect it to the analyzer.
Replacing reagent bottles
When a bottle is empty, scan a new bottle, connect it to the analyzer.
12.5. Software updates

You can initiate this process by tapping the proper button in Supervision menu
About submenu. Contact your Service team for details.
71
User manual
12.6. Management menu
12.6.1. Maintenance
Maintenance menu allows running
processes related to maintaining reliable
operation:
Priming, draining reagents
Cleaning procedures
General
12.6.2. Prime & Drain

Swiping left on the Prime line of Mainte-
nance opens the Prime menu, where the
user can instruct the analyzer to aspirate,
prime reagents individually if necessary.
Drain All will drain the system without
the need to disconnect reagents.
Drain Full will drain the system and
reagents must be disconnected.
Biosystems
72
12.6.3. Clean
It is possible to run various cleaning
actions that help keeping the system in
good working conditions:
RBC cleaning
WBC debubbling
12.6.4. Service
This menu is password protected and it
is only available for and should be used
by authorized service personnel.
73
User manual
12.7. Supervision
12.7.1. History
History will list all user activity in a log,
grouped into activity types. You can
review Information, User action, Errors.
12.7.2. History details

Swiping left on a specific line of History
will show the details of a specific message.
You can sweep up and down to access
further pages, lines.
12.7.3. About
The About screen will display instrument specific information
• SW version,
Biosystems
74
• Product ID,
• Manufacturer data,
• Service contact to your local service
personnel.
• You can restart the setting wizard
• You can initiate Remote Manage-
ment (refer to your service person-
nel)
Page 2 of About displays information about the modules in the system.
Page 3 allows accessing Software upgrade and sending or saving diagnostic files
containing information for the technical support.
75
User manual
12.7.4. Status bar
1 2 3 4 5 6
The status bar contains symbols and shortcut to main menu. Instrument statuses
are including following informations (from left to right):
home shortcut to return to Main Menu
progress symbol when fluidics action is in progress (animated)
printer symbol when printer is connected
3 versions: PCL5, ESC/POS, Unknown
wireless network symbol when wireless USB dongle is connected
Ethernet connector symbol when wired network cable is connected
Available measurement count with messages:
Sample count based on actual reagent level
Expired
Biosystems
76
Inactive
Reagent sensor indicators, when a reagent sensor is disabled.
External waste container full symbol
13. Technical Specifications

Measured parameters WBC, LYM, MON, NEU, EOS, BAS, LYM%,
MON%, NEU%, EOS%, BAS%,
HGB, RBC, HCT, MCV, RDW(sd,cv), MCH,
MCHC,
PLT, MPV, PCT, PDW(sd,cv), P-LCR, P-LCC
Scattergram WBC
Histograms RBC, PLT
Sample volume 25 µl whole blood (EDTA treated)
Throughput 60 tests / hour
Measurement Flow cytometry and Volumetric impedance
technology measurement combined with microfluidic
technology
Precision WBC< 3%, RBC< 2%, PLT < 5% MCV< 1%,
HGB< 2%
Storage capacity 10,000 (max.) test results including scattergram,
histograms and patient data
User interface LCD, 10.1”, 1280 × 800 with capacitive
touchscreen, portrait
Dimensions (HxWxD) 270 mm x 215 mm x 320 mm
Weight 9.4 kg
Power External power supply, 12 VDC
5A (100 VAC -240 VAC 50 Hz - 60 Hz);
Stable (as per power supply specifications),
Usage of UPS is recommended to overcome power
system fluctuations
Power consumption Maximum 60W
Real time clock backup Lithium battery: Maxell CR1220 (or compatible)
(3V)
Reagent use (sample) Diluent: 9.0 ml / Lyse: 1.6 ml / Cleaner: 0.2 ml
Storage conditions Temperature: 10 °C - 40 °C (50 °F - 104 °F)
Humidity: 20% - 80% relative humidity
Operating Environment Temperature: 15 °C -25 °C (59 °F - 77 °F)
Humidity: 20% - 80% relative humidity
Atmospheric pressure Instrument is designed to be operated up to
2000 m / 6500 ft above sea level (atm. press. Min:
590 mmHg/78.2 kPa)
77
User manual
WARNING: Only qualified service personnel may replace the

internal fuse and battery.
When not in use or relocating, always store the analyzer in its

original packaging to avoid physical damage.
Storing the analyzer outside the above specified environmental
conditions or outside its original packaging may impair operation
and may also cause erroneous or faulty operation.
Do not place the analyzer near a direct heat source or into direct
sunlight
The desk supporting the instrument should be flat, horizontal
and stable enough to support the weight of the analyzer and
accessories
Operating the analyzer outside the above specified environmental
conditions may impair operation and may also cause erroneous
or faulty operation.
14. Reagent consumption

All values in ml (milliliter). Values indicate worst case aspirated volumes.
Process Note iDil5 iLyse5 iClean5

Start-up Initial + wake up 58 16,5 4,8
with empty tubing
Start-up Daily routine 44 10,5 4,8
Measure sample 9 1,6 0,2

Fast Blank One attempt/cycle 9 2 0,2
Shutdown 22 2 5,0
RBC clean 4 0 0,6
De-Bubble 4,0 1,5 1
Prime iDil5 One attempt/cycle 7 0 0

Prime iLyse5 One attempt/cycle 1,0 1 0
Prime iClean5 One attempt/cycle 1,0 0 1,5

15. Performance Data

Precision (data listed for primary, and primarily derived parameters, n>30)
Biosystems
78
Parameter CV% Conditions
WBC 3 2.0 < WBC < 20.0
HGB 2 100 < HGB < 240
RBC 2 3.0 < RBC < 6.0
MCV 2 70 < MCV < 100
PLT 5 100 < PLT < 800
MPV 2 5 < MPV < 15
Accuracy (when compared to Abbott Cell-Dyn 3700)
Parameter R2 Conditions (whitepaper)

WBC 0.96 1.0 < WBC < 20.0
HGB 0.97 100 < HGB < 240
RBC 0.97 3.0 < RBC < 6.0
MCV 0.98 70 < MCV < 100
PLT 0.96 100 < PLT < 800
MPV 0.96 5 < MPV < 15
Linearity
Parameter Linearity range Notes

WBC 0 – 100
HGB 0 – 250 No flagging
RBC 0 – 8.0
MCV
PLT 0-1000 No flagging
MPV
Carry-over – High-to-Low carryover
Parameter Carryover: %
WBC <1%
RBC <1%
HGB <1%
PLT <1%
Display range
Parameter Display Limit Unit Notes

WBC 0-200 103/µl (2)
LYM 0-200 103/µl (1) WBC>1
LYM% 0-100 % WBC>1
MON 0-200 103/µl (1) WBC>1
MON% 0-100 % WBC>1
NEU 0-200 103/µl (1) WBC>1
79
User manual
NEU% 0-100 % WBC>1

EOS 0-200 103/µl (1) WBC>1
EOS% 0-100 % WBC>1
BAS 0-200 103/µl (1) WBC>1
BAS% 0-100 % WBC>1
HGB 0-500 g/l
RBC 0-12 106/µl
MCV 30-180 fl RBC>0.5
PLT 0-1000 103/µl
MPV 0-50 fl PLT>10
HCT 0-80 % MCV>30
RDWsd 1-100 fl RBC>0.5
RDWcv 1-50 % RBC>0.5
PCT 0-10 % PLT>20
PDWsd 1-20 fl PLT>10
PDWcv 1-100 % PLT>10
PLCC 0-1000 103/µl
PLCR 0-100% % PLT>20
MCH 0-50 pg MCV>30
MCHC 0-500 g/l MCV>30
Values measured below or beyond the limits listed above will be marked with
< or > symbols and the actual limit itself. E.g. PLT 1200 will be displayed as: “PLT
1000<” accompanied by a linearity range flag.
Note (1): display precision is 1 decimal digit for diff absolute counts
Note (2): If WBC is below 0.1, the diff values will NOT be displayed.
0.1 < WBC < 1.0 the diff values get an * mark
16. Error messages

The analyzer can report various errors. Error messages are displayed in a small
pop-up bubble in the lower right corner of the screen. Errors have technical details
which are useful when contacting Technical Support.
Technical Support will ask for diagnostic files to facilitate problem resolution.
Either have the analyzer connected to the Internet, or have a USB storage device
ready for saving and emailing data.
Biosystems
80
16.1. Mechanical Errors
Error message Reason for error Remedy
Shear Valve error. An error Mechanical Error Rerun operation. If
occurred while testing persists, contact Service.
Shear Valve backlash.
An error occurred while Pump not operating, Rerun operation. If
attempting to use pump. pump jammed. persists, contact Service.
Sampling Rotor error. Mechanical error. Rerun operation. If
An error occurred persists, contact Service.
while attempting to use Check whether closed
Sampling Rotor. mode sampling opening
is obstructed.
Sampling Rotor error. Mechanical error, Rerun operation. If
An error occurred sensor induced. persists, contact Service.
while attempting to
use Sampling Rotor
(Sampling Rotor invalid
position).
Valve error. An error Valve controller Rerun operation. If
occurred while attempting Error persists, contact Service.
to set valve.
Shear valve recovery The shear valve had Confirm, and run
problems moving, initialization.
but the system
resolved the error
16.2. Operation related errors

Communication error. No Internet access Consult network
An error occurred administrator.
while sending an e-mail
(connection exception).
Control assay sheet You scanned a
already exists. sheet that has been
scanned previously.
Communication error. Network error.
An error occurred while
attempting to download
software upgrade file
(unspecified error).
Consult network
administrator.
Measurement error General Contact service with error
measurement error. details.
81
User manual

QC LOT field cannot be You did not enter a Enter a LOT ID.
empty. LOT ID.
QC with defined LOT Verify LOT ID
already exists.
An error occurred while QR code faulty. Try scanning the sheet
decoding QR code again. If you fail, load
(invalid or broken QC data from a file. Contact
code). tech support for details.
Reagent detection error. Bubbles detected. Check that reagent
An error occurred while container is not empty.
attempting to calibrate
reagent sensor at Diluent
inlet.
reagent sensor at Lyse
inlet.
reagent sensor at Cleaner
inlet.
Vial Detector warning Incorrect vial Insert a correct vial.
(missing condition). inserted in sample
rotor.
Vial Detector warning No vial detected. Insert a vial, check for
(insert vial). compatibility.
Vial Detector warning A vial is detected Remove sampling vial.
(remove vial). in sample rotor,
yet selected action
requires the vial to
be removed
User error A vial got blocked, Check for obstruction.
or was incorrectly Run “Eject” from local
inserted menu.
An error occurred Incorrect email Verify settings, contact
while sending an e-mail data specified, or network administrator.
(username or password unsupported email Observe and follow
exception). client was set up. network and email setting
instructions.
Biosystems
82
16.3. Electronic errors
Camera error. An error The camera could Power off and on again.
occurred while activating not be detected. If the problem persists,
camera. use electronic files to load
data.
Contact service to
schedule a visit.
Touch screen does not Faulty touch screen Connect an external
react to gestures mouse for temporary
operation.
Contact Service
Uncertain operation of Faulty touch screen Connect an external

touch screen mouse for temporary
operation.
Contact Service
16.4. System (software) errors

Database error. An Software error, The system will try to
error occurred while corrupted file system. recover the error. If the
attempting to read/write error persists, contact
database. Tech Support.
Database error. An Software error, The system will try to
error occurred while corrupted file system. recover the error. If the
attempting to create error persists, contact
record in database. Tech Support.
Communication error. A key system element is Contact Tech Support.
An error occurred while missing.
attempting to read/write
ProductID.
Fluidics error. An A key system element Contact Tech support
unknown low-level is missing or is for guidance.
error occurred while malfunctioning.
attempting to execute
fluidics function.
unknown error occurred is missing or is for guidance.
while attempting to malfunctioning.
execute fluidics function.
83
User manual

unknown error occurred is missing or is for guidance.
while attempting to get/ malfunctioning.
set arguments of fluidics
subsystem.
Processing error. An A key system element Contact Tech support
error occurred while is missing or is for guidance.
attempting to process malfunctioning.
raw measurement data.
System error. An A key system element Contact Tech support
attempting to query malfunctioning.
active QC LOT.
Communication error. A key system element Contact Tech support
An error occurred while is missing or is for guidance.
attempting to open serial malfunctioning.
port.
attempting to play sound malfunctioning.
file.
Communication error. The printer is not Connect the printer.
An error occurred while connected. Contact Tech support
attempting to print with A key system element for guidance.
thermal printer. is missing or is
malfunctioning.
Reagent detection error. A key system element Contact Tech support
attempting to detect malfunctioning.
Diluent.
Exporting error. An No USB storage device Connect USB storage
error occurred while attached. device.
attempting to export Tab A key system element Contact Tech support
Separated File. is missing or is for guidance.
malfunctioning.
Communication error. A key system element Contact Tech support
attempting to send malfunctioning.
e-mail (unspecified
error).
An error occurred A key system element Contact Tech support
while attempting to set is missing or is for guidance.
volume. malfunctioning.
Software error A key system element Contact Tech support
is missing or is for guidance.
malfunctioning.
Biosystems
84
attempting to initiate malfunctioning.
system (unspecified
error).
Lyse.
System Solution.
Reagent system error. A key system element Contact Tech support
attempting to activate malfunctioning.
reagent (expired).
attempting to modify malfunctioning.
reagent’s tracking level.
attempting to query malfunctioning.
active reagents (inactive
or expired reagents).
attempting to read malfunctioning.
reagent sensor data.
Firmware Error A key system element Contact Tech support
is missing or is for guidance.
malfunctioning.
Remote Management IP address of Access Contact Service for
error Server is incorrect, proper setup
or a Firewall blocks
connection

16.5. Troubleshooting
16.5.1. Measurement problems
Symptom Possible cause Remedy

High BLANK values Contaminated reagents Replace reagents
85
User manual

Cold reagents Make sure reagents
reached room
temperature
Unearthed power outlet Install grounding for
power supply
Minor internal Repeat FastBlank 3-4
contamination times
Missing reagents One reagent is out Replace reagents
reported, wrong results
Reagents are not connected Verify reagent
connector
Reagent connector sealing Replace reagent pack,
failure or replace connector
Prime reagents. Look
for bubbles in the
tubes outside the
analyzer.
If the problem persists,
contact Service
Incorrect WBC Lysing reagent errors Check reagent
differentiation connector, prime Lyse
reagent 2-3 times.
Low sample volume Too low blood sample Run vials with correct
reported volume sample volume.
Check minimum
sample volume
(300ul). Run closed
cleaning.
contact Service
Leakage from rear Reagent connector sealing Replace reagents.
reagent connector failure Verify reagent
connector.
Replace reagent pack,
or replace connector
Noise flags Bubbles are trapped inside Prime reagents
critical tube sections.
Improper voltage Reagent insufficiency, or Prime DIL and LYSE
block inside the analyzer Run Rinsing function
contact Service.
Unstable voltage Reagent or sample Run WBC / RBC
insufficient. Partial cleaning (if RBC/PLT
clogging of the system values are affected)
Inform Service
Biosystems
86
16.6. Electrical problems
Instrument cannot be Power is not connected Connect power
powered on source, verify
connections
Power voltage is too high, Replace / check power
or too low supply (is LED on?)
Fuse is blown inside Contact Service
analyzer
Indicator on top/front Power voltage is too high/ Replace power supply
of the analyzer glows low
in RED or BLUE color
BEFORE power ON
Instrument powers Power system fluctuations Try to start the
down during operation analyzer again. Use a
UPS.
Contact Service
Software error message Corrupted SW system. Contact Service
16.7. Mechanical problems

Sample vial is stuck in Power outage during Start analyzer again,
sample rotor operation initiate measurement
sequence
Oversized vial, vial stuck Go to local menu and
initiate “Eject”
Mechanical Problem Mechanical error.
Contact Service
Sample vial is not Cap detector failure. Contact Service
lowered, system reports
missing vial, yet the vial
and cap are present
Sample vial is not Vial is stuck on sampling Start analyzer again,
returned to operator needle initiate measurement
sequence. Go to local
menu and initiate
“Eject”
Mechanical error (strong Contact Service
grinding noise)
Grinding noise from Mechanical blocking Try to rerun the
inside of analyzer operation. If the
problem persist,
contact Service
87
User manual

Analyzer reports empty Too low blood sample Run vials with correct
measurements volume sample volume
Clogged sampling paths Rerun sample.Contact
Service
Leakage beneath Blocked sampling valve/ Try running system
analyzer needle system cleaning. If it still
fails, contact Service
Leaking reagent connector Check reagent
connector
16.8. Hydraulic problems

Instrument reports Bad quality sample used Try to initiate a
clogging measurement. Built
in functions will
attempt to unclog
needle and apertures.
contact Service
16.9. Network problems

Network error message at HL7 or email Verify HL7 / email
the end of every sample communication is settings. Disable email
enabled (forced) but (clear account data) or
settings/network does clear HL7 settings
not comply.
Remote Management Remote Management Contact Service for
error message data are incorrect correct settings
WIFI dongle not Driver error Check supported list of
recognized WIFI chipsets
16.10. Printer problems

Scrambled printout Incorrect printer model Use Printers with
PLC5 or ESC/POS
language support
Empty pages printed Incorrect printer model Install compatible
printer. Contact Service
for instructions
Biosystems
88
Printer connected, but no Printer is not Test the printer and
printer Icon in top row of supported, USB cable USB cable with a PC.
screen is wrong
Printer is OFF Restart HA5.Make
sure to use the same
grounded electrical
outlet for HA5 and
peripherals. Test USB
sockets with an external
Keyboard or with a
USB stick (and try to
save diagnostic files to
the USB)
16.11. Certificates, standards

HA5 complies with the following standards and bears corresponding certificates
as listed below.
• EN 61010-1: 2010; (Third Edition);
• IEC 61010-2-101: 2015;
• EN 61326-2-6:2013 Standard;
• EN 55011:2009+A1:2010 Standard;
• EN 55022:2010 Standard;
• EN 61000-4-2:2009 Standard;
• EN 61000-4-3:2006+A1:2008+A2:2010 Standard;
• EN 61000-4-4:2012 Standard;
• EN 61000-4-5:2014 Standard;
• EN 61000-4-6:2014 Standard;
• EN 61000-4-11:2004 Standard;
• EN 60825-1: 2007 (Second Edition);
16.12. Declaration of Conformity

The supplier Norma Instruments Zrt. (Arany János u. 11-13, 3530 MISKOLC,
HUNGARY) hereby declares that Automated 5-part hematology analyzer, HA5
fulfils the essential obligations imposed by Article 3 and Annex 1 of the Directive
98/79/EC on “In vitro diagnostic medical devices” and achieves the performance
intended. The Manufacturer declares that the use of the a.m. device under appro-
priate conditions will not compromise the health or safety of the patient, the user
or other involved person.
89
User manual
17. Appendix A – Signs of improper sample

handling
17.1. Pre-analytical factors
17.1.1. Distinct layers

When blood is left standing for a certain time (10-60 minutes), sample dependent),
the sample will sediment; cells inside will obey gravity and will tend to sink down
forming a yellowish liquid on top with a thin layer of White Blood Cells and a
thick layer of dark red colored Red Blood Cells below.
Samples must be manually mixed prior to analysis using the analyzer.
Immediately prior to inserting the vial into the analyzer, gently invert the vial,
hold it and make sure all the liquid has flown down; then rotate it back and again
make sure all the liquid has flown down. Repeat the cycle five-six (5-6) times.
Doing more than 6 inversions or less than 5-6 inversions will negatively influence
the result.
17.1.2. Large visible bubbles

Air bubbles can cause sampling problems if the analyzer draws the small amount
required for analysis mostly from a bubble, the amount of actual sample will be far
below than the required amount, and the analyzer may falsely report low values.
If you can see big bubbles in the sample, then most probably there are invisibly
small bubbles also present in the sample. These can also reduce the required sample
amount.
Samples with bubbles inside should be let relax more before running it on the
analyzer.

17.1.3. Pink plasma (hemolysis)

Plasma above the blood cells must be clear somewhat yellowish. A discolored plas-
ma indicates sample specific problems, or handling problems (temperature, time
elapsed since taking the sample). Hemoglobin is normally located inside the Red
Blood Cells. With time, or storage temperature beyond storage range will cause the
RBCs degrade and release HGB – a red colored substance. Once HGB appears in
the plasma, the sample is not acceptable for analysis: cell counts will be incorrect.
Such samples must be rejected with an indication of sample induced technical
problem.
Biosystems
90
17.1.4. Clots, gel-like substance inside vial
When using vials without pre-filled anticoagulant, there is a risk of adding unsa-
tisfactory amount of anticoagulant, or adding it late. In such cases an irreversible
clotting procedure will start very fast, or cannot be stopped in time, which will
bind cells in a fibrin net making hematology analysis impossible. Depending on
the efficacy of the coagulation process, either all cells will be grouped into a dark
red chunk, or a considerable ratio of the cells will be bound inside the fibrin net
taking the shape and form of a dark red gel-like substance. The plasma will have
no significant number of cells suspended anymore, and the chunks if aspirated by
the analyzer will very likely cause a technical problem by clogging delicate tubing
systems inside the analyzer.
Such samples must be rejected with an indication of sample induced technical
problem.
17.2. Post-analytical factors
17.2.1. Elevated PLT, decreased RBC, RDWsd/cv increased

Samples that may have passed visual inspection or merely being hemolysed due to a
pathologic reason or infection will be reported as with RBC counts, with irregular
RBC distribution, RDWc/s parameters increased. As hemolysis is breaking up cell
membranes, PLT counts may increase due to interpretation of RBC remains as
smaller particles. WBC differentials and total counts may also become unreliable.

Normal PLT/RBC histogram Hemolysed PLT/RBC histogram
Such samples should be rested, analyzed for possible hemolysis, and rerun for
verification if possible.
17.2.2. Elevated PLT, no PLT result, noise flag(s)

Micro-bubbles introduced by accidentally dropping or shaking the sample may
interfere with PLT counts. Various sized bubbles may negatively influence cell
detection.
91
User manual

Normal PLT/RBC histogram PLT/RBC histogram with micro-
bubble interference
17.2.3. Elevated MON, lowered NEU:

• over-mixing
• Cause: shifting of NEU population, appearance of pseudo-populations.
• Can be sample-specific.
WBC scatter of a sample mixed 5 times:
EOS population (yellow)
NEU population (blue)
MON population (green)
LYM population (magenta)
This area should be as clear

as possible (grey area) it
indicates microbubbles in
sample
WBC scatter of the same
sample mixed more than 10 times:
Lots of particles detected in the

’clear’ area.
Biosystems
92
Remedy:
Leave the sample rest for 30 minutes and rerun it to obtain much better scatter
and WBC differential results.
Errata
This manual is under continuous revision and improvement. The sections listed
below are known to describe functions focusing on convenience of use that may
not yet be available in your analyzer.
Missing descriptions or functions do not impair the operation of the analyzer.
References:
• 98/79 EN Directive
• pubmed.org
• eurlex.eu
Manufacturer address Norma Instruments Zrt.

3530 Miskolc, Arany János u. 11-13
Hungary
93

HA5 User Manual

Uploaded by

Copyright:

Available Formats

You might also like

HA5 User Manual

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

HA5 User Manual

Uploaded by

Copyright:

Available Formats

Hematology Analyzer

Thank you for choosing the Biosystems HA5

Welcome to the Biosystems family…

4.3.3. Power button................................................................................................ 23

1.1. Who should read this manual

1.2. Symbols used in the manual

1.3. Intended Use

1.5. Symbols on the outside of the analyzer

for In Vitro Diagnostic use

1.6. Technical contact

2.2. Impedance based cell counting

2.3. Interpreting scattergrams

2.4. Interpreting histograms

Parameter name Explanation Typical units

Parameter name Explanation Typical units

2.6. 5-part differentiation of White Blood Cells

2.7. The measurement process

2.8. Supported blood collection vials

Samples must be thoroughly mixed and homogenized adhering to general blood

power cord matching

tubing set: reagent

Always use original accessories and cables. Non-approved

Front and right side of HA5

Left and rear side of HA5

4. Installing the analyzer

4.1. User serviceable parts

4.2.1. Keyboard (optional)

4.2.2. Mouse (optional)

4.2.3. Bar code scanner (optional)

4.2.4. USB Wi-Fi Dongle (optional)

4.2.5. Network (“Ethernet”)

4.2.6. Reagent pack

Hematology reagent waste must be considered biohazard material.

4.2.7. Reagent bottles

System solution 3 Diff

4.3. Analyzer packaging material

4.3.2. External power supply

Always use a grounded power outlet to avoid the risk of an electric

4.3.3. Power button

4.3.5. Power off

It is strongly recommended to power off the analyzer every day, at

4.3.6. Emergency power off

Performing an emergency power off can leave the analyzer in an

4.4. Reagents handling

It is recommended to wear protective gloves when installing and

Always follow instructions of the reagents concerning reagent handling.

4.5.1. Reagent characteristics

4.5.2. Instructions for use – DILUENT 5 DIFF

Product Code Size

REAGENT STORAGE, STABILITY AND DISPOSAL

4.5.3. Instructions for use – LYSE 5 DIFF

Product Code Size

• Use Good Laboratory Practices (GLP) when handling the reagents.

REAGENT STORAGE, STABILITY AND DISPOSAL

4.5.4. Instructions for use - CLEANING SOLUTION 5 DIFF

Product code Size

• Avoid any dust or microbial contamination of the tubing and reagents. Do

REAGENT STORAGE, STABILITY AND DISPOSAL

4.5.5. Instructions for use – REAGENT PACK 5 DIFF