Technical Document

Medonic M-series M32 Hematology Analyzer

Product name Medonic M-series M32

Manufacturer Boule Medical AB

Domnarvsgatan 4
SE–163 53 Spånga, Sweden
Telephone: +46 8 744 77 00
Fax: +46 8 744 77 20

Country of origin Sweden

Product Description The Medonic M-series M32 is a fully automatic, 3-part differential, hematology analyzer intended
for in vitro diagnostic testing of blood specimens under laboratory conditions.
Intended Use

Model configuration

Figure 1 Figure 2
Medonic M-series M32B Medonic M-series M32M

Figure 3 Figure 4
Medonic M-series M32C Medonic M-series M32S

Recycling information For recycling of the instrument see www.medonic.se/ support/downloads

Instructions for use Use in accordance with manufacturer’s instructions for use in Medonic M-series M32 User´s
Manual.

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: [email protected]
www.boule.se
21869-1 2015-03-24 Page 1 of 5
Technical Document
Medonic M-series M32 Hematology Analyzer
Instrument Specifications

Physical
Size (Instrument versions with sampler) HWD ≤ 395 x 340 x 475
Size (Instrument version without sampler) HWD ≤ 395 x 295 x 475
Weight (Instrument) ≤ 18 kg
Weight (Autoloader additional weight) The additional weight of the Autoloader including two sample
wheels is less than 6 kg
Display Depth: True color (24-bit);
Resolution: 800 x 480 pixels
Keyboard Virtual incorporated keyboard
Communication interface ports 1 USB device/4 USB host/1 LAN port
Barcode reader input Yes (via USB)

Operating Environment
Temperature 18 - 32 °C
Humidity 10% - 90%

Electrical
Main Voltage 100 - 240 V
Frequency 50 - 60 Hz
Maximum power consumptions 100 VA (operating); 50 VA (standby)

Measuring principles
MCV, MPV, RBC, WBC, and PLT Impedance
HGB Photometric
Sampling system Closed shear valve
Floating RBC/PLT discriminator Yes (position printed)
Programmable WBC Discriminator Yes
Mathematical 3-part diff. WBC calculation Yes
Parameters Reported 20-parameters:
RBC, MCV, HCT, PLT, MPV, HGB, MCH, MCHC, WBC,
RDW%, RDW abs, PCT, PDW, LPCR, LYM abs, MID abs,
GRAN abs, LYM%, MID%, GRAN%

Performance
Sample volume (Open Tube) ≤ 110 µL
Sample volume (Sampling Device) ≤ 300 µL
Sample volume (Cap Piercer) ≤ 250 µ L
Sample volume (Micro Pipette Adapter) 20 µL
Pre-diluted mode 1:200 to 1:300 using min. 20 µl
e.g. 20 µl sample to 4.5 mL diluent (1:225)
Dispenser precision (CV) ≤ 0.9%
Number of Samples per hour (Open Tube) ≥ 60 samples
Number of Samples per hour (Cap Piercer) ≥ 45 samples
Number of Samples per hour (Sampling Device) ≥ 43 samples
Built-in test / adjustment programs Yes
QC capabilities Mean, SD, CV, Levey-Jennings and Xb
System Information Indicators on parameter Yes
abnormalities
Memory capacity ≥ 50,000 samples
Reagent Stability 36 months
Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: [email protected]
www.boule.se
21869-1 2015-03-24 Page 2 of 5
Technical Document
Medonic M-series M32 Hematology Analyzer

Performance Parameter Correlation (R) Carry-over (%) Reproducibility (%)

RBC ≥ 0.98 ≤1 ≤ 0.8
MCV ≥ 0.98 N/A ≤ 0.5
HGB ≥ 0.98 ≤1 ≤ 0.6
PLT ≥ 0.95 ≤1 ≤ 2.9
WBC ≥ 0.97 ≤ 0.5 ≤ 1.6
* Typical values measured as an average of 10 measurements each on 9 different vein K2-EDTA
collected normal samples, on 3 instruments, in open tube mode.

Product Conformity Directives Standards

98/79/EEC In Vitro Diagnostic Using Annex III as the conformity assessment procedure
Medical Device Directive (IVD)
2004/108/EEC Electro Magnetic Emission EN 61326-1:2006,
Compatibility Directive (EMC) SS-EN55011:2009, +A1:2010, Class B,
with amendment 92/31/EEC EN 61000-3-2:2006
Immunity: EN 61326-1:2006,
EN 61000-4-2, -3, -4, -5, -6, -11
2006/95/EEC Low Voltage IEC 61010-1: 2001
Directive (LVD) IEC 61010-2-081:2001 + A1
IEC 61010-2-101:2002
CAN/CSA-C22.2 No 61010-1: second edition
UL 61010-1: second edition
2012/19/EU Waste of electrical --
and electronic equipment (WEEE)

Quality The instrument has been factory calibrated by Boule prior to shipment. Customers are advised to
Control/Calibration check the daily performance of the Medonic M-series M32 system with a certified blood control
authorized by Boule.

Packaging and Weight ≤ 24 kg (standard version); Double corrugated cardboard outer packaging with shock absorbent
inner packaging.

Warning and As there are no assurances of the absence of HIV, Hepatitis B or C viruses or other infectious
Precautions agents in blood samples, blood controls, calibrators and waste, these products should be handled as
potentially biohazardous. See User manual for biohazard symbol placement and further
instructions.

Customers are advised to be knowledgeable of applicable local, state and federal requirements, and
the content of effluent streams, before disposing of waste in public sewer systems or recycling
decontaminated equipment. The instructions for decontamination can be found on the Medonic
home page, www.medonic.se, under Support.

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: [email protected]
www.boule.se
21869-1 2015-03-24 Page 3 of 5
Technical Document
Medonic M-series M32 Hematology Analyzer

Histograms The measuring principles of the Medonic M-series M32 analyzers are based on impedance and
spectrophotometry principles. The number of cells for determining RBC and WBC values are counted
from a suspension of 1:40,000 for the RBC and 1:400 for the WBC dilution ratio of whole blood.

Serial number label See Figure 6 – Serial number label.

Figure 6 – Serial number label

Figure 5 – Histogram for WBC, RBC and PLT

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: [email protected]
www.boule.se
21869-1 2015-03-24 Page 4 of 5
Technical Document
Medonic M-series M32 Hematology Analyzer

For the manufacturing process and the specific process control points for this analyzer see the
Manufacturing Process
flowchart below. The process starts with components for the manufacturing of the analyzer being
checked in by the content of specification (e.g. drawings, specifications for incoming inspection)
against acceptance limits. The process is completed with final QC testing, the release by QA, and the
approved analyzer moved to stock.

Figure 7 Flow chart for manufacturing and quality control

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: [email protected]
www.boule.se
21869-1 2015-03-24 Page 5 of 5
Technical Document
Quintus Hematology Analyzer

Product name Quintus Hematology Analyzer

Manufacture Boule Medical AB

Domnarvsgatan 4
SE–163 53 Spånga, Sweden
Telephone: 0046 8 744 77 00
Fax: 0046 8 744 77 20

Country of origin Hungary - Sweden

The Quintus is a fully automatic, 5-part differential, hematology analyzer intended for in vitro
Product Description
diagnostic testing of blood specimens under laboratory conditions.

Model configuration

Figure 1 – Quintus Hematology Analyzer with Autoloader

Instructions for use Use in accordance with manufacturer’s instructions for use in Quintus User´s Manual.

Storage +5 to +35 ºC (41 to 95 ºF)

Packaging and Weight Instrument 35 kg + autoloader 12 kg. Double corrugated cardboard outer packaging with shock
absorbent inner packaging

Product Conformity Quintus analyzer is in conformance with the 98/79/EC In Vitro Diagnostic Medical Device Directive
(IVD) using Annex III as the conformity assessment procedure.
SS-EN 61010-2-101 (Low Voltage 2014/35/EU)
EN 61326 (2006) (EMC 2014/30/EU)
2012/19/EU WEEE
2011/65/EU RoHS

Quality The instrument has been factory calibrated by Boule prior to shipment. Customers are advised to check
Control/Calibration the daily performance of the Quintus system with a certified blood control authorized by Boule.

Warning and As there are no assurances of the absence of HIV, Hepatitis B or C viruses or other infectious agents in
Precautions blood samples, blood controls, calibrators and waste, these products should be handled as potentially
biohazardous. See User manual for biohazard symbol placement and further instructions.
Customers are advised to be knowledgeable of applicable local, state and federal requirements, and the
content of effluent streams, before disposing of waste in public sewer systems or recycling
decontaminated equipment. The instructions for decontamination can be found on the Boule home
page, www.quintus5part.com, under User Support

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: [email protected]
www.boule.se
13955-5 2017-01-24 Page 1 of 5
Technical Document
Quintus Hematology Analyzer

Instrument Specifications
Measuring principle, RBC, WBC, PLT Impedance
Measuring principle HGB Light source: green LED with 540 nm wavelength
Detector: light to frequency converter
Measuring principle 5-part Differential Light scattering measurement:
Optical measurement Light source: semiconductor laser diode with 650 nm wavelength and
7mW (Class IIIB laser module if the protective housing is closed)
Quartz flow cell with hydro-dynamic focusing
Detector: fiber optic coupled PIN Si photodiodes
Internal safety interlock
Aperture length and diameter WBC: 80 µm, RBC/PLT: 70 µm
Sampling system Ceramic shear valve with 3 separated primary loops
Aspirated blood volume < 110 µl
Number of Samples per hour > 60 samples
Sample type Human whole blood (K3-EDTA anticoagulant)
Parameters reported WBC, LYM, MONO, NEU, EOS, BASO, LYM%, MONO%, NEU%,
EOS%, BASO%, RBC, HCT, MCV, RDWsd, RDW cv, HGB, MCH,
MCHC, PLT, PCT, MPV, PDWsd, PDWcv, LPCR%, LPCRa
Size distributions printed for RBC, PLT and WBC differential
QC capabilities Mean, SD, CV, Levey-Jennings plots and Xb plots
Carry-over < 0.5%
Warning flags on parameter abnormalities Yes
Setable normal ranges (profile limits) Yes
Reagent and Instrument alerts Yes
Built-in test / adjustment programs Yes
Calibration Manual and SW supported automatic mode
Language available English menu and support for other languages
Software upgrade Via USB
Memory capacity 100,000 records including flags, scatter- and histograms
Data processing Intel Atom 1.6 GHz
Data store Windows® 8.1 Embedded
Display 800 x 600 color graphic LCD, portrait layout
External printing Via USB port, any Windows® 8.1 compatible printer
Virtual incorporated keyboard (External keyboard option via PS/2 or
Keyboard
USB)
External via USB port
Barcode reader
Built-in barcode reader in Autoloader unit
Peripheral ports 4 USB (2.0), Ethernet, PS/2
Barcode reader input Yes
Serial output Yes (Conformed to standard EN 60950)
Main Voltage 100 – 240 V AC
Power consumption (maximum) Max 400VA
Frequency 50 / 60 HZ
Main fuse F 10A H 250V
Operating Temperature 15-30° C (59-86 °F)
Humidity (non-condensing) Up to 80%
Instrument Dimensions HxWxD = 515 x 410 x 465 mm
Autoloader Dimensions HxWxD = 190 x 380 x 322 mm
Instrument weight ≤ 35 kg
Autoloader weight ≤ 12 kg
Diluent Consumption Approximately 51 ml per analysis cycle.
Lyse Consumption Approximately 7 ml per analysis cycle.
Stopper Consumption Approximately 1 ml per analysis cycle.

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: [email protected]
www.boule.se
13955-5 2017-01-24 Page 2 of 5
Technical Document
Quintus Hematology Analyzer

Parameter CV (%) Range (precision achieved within)

Total System
Precision WBC ≤ 3.0 4.7 x 103 / µL ≤ WBC ≤ 38 x 103 / µL
RBC ≤ 1.5 RBC ≥ 2.5 x 106 / µL
MCV ≤ 1.0 60 – 140 fL
PLT ≤5 PLT ≥ 100 x 103 / µL
HGB ≤ 1.5 HGB ≥ 6.0 g/dL
Scatter diagrams Quintus displays the results of the optical measurements in a scatter diagram representation.
• Scatter diagrams represent data in a two-dimensional plane.
• There are two scatter diagrams in the patient report: the 4-DIFF and the BASO

Population Color on
(4-diff diagram) scatter
diagram
Artifact BLACK

Lymphocytes BLUE

Monocytes GREEN

Neutrophilic MAGENTA
granulocytes
Eosinophilic ORANGE
granulocytes Figure 2 – Scatter 4-part diff

Population Color on
(Basophil scatter
diagram) diagram

WBC without BLUE

Basophiles

Basophilic MAGENTA
granulocytes

Figure 3 – Scatter basophils

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: [email protected]
www.boule.se
13955-5 2017-01-24 Page 3 of 5
Technical Document
Quintus Hematology Analyzer

Histograms Impedance based measurements are represented on histograms. These diagrams show the number of
cells against cell size.
• There are two histograms: RBC and PLT.
• Discriminators (thresholds) are displayed with red color.
• The PLT histogram is the magnified section of the left-hand side of the RBC curve.

Figure 4 – Histogram RBC Figure 5 – Histogram PLT

Serial Number label

Figure 6 – Serial number label

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: [email protected]
www.boule.se
13955-5 2017-01-24 Page 4 of 5
Technical Document
Quintus Hematology Analyzer

Manufacturing For the manufacturing process and the specific process control points for this analyzer see the flowchart
Process below. The process starts with components for the manufacturing of the analyzer being checked in by
the content of specification (e.g. drawings, specifications for incoming inspection) against acceptance
limits. The process is completed with final QC testing, the release by QA, and the approved analyzer
moved to stock.

Figure 7 - Flow chart for manufacturing and quality control

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: [email protected]
www.boule.se
13955-5 2017-01-24 Page 5 of 5
Technical Document
Quintus Autoloader

Product name Quintus Autoloader

Manufacture Boule Medical AB

Domnarvsgatan 4
SE–163 53 Spånga, Sweden
Telephone: 0046 8 744 77 00
Fax: 0046 8 744 77 20

Country of origin Sweden – Hungary

Product Description The Quintus Autoloader is a compact, easy-to-use option for users who value letting their
instrument to get on with the analyses. It makes Quintus the perfect walk-away system for
laboratories with high workload. Just pre-load up to 10 x 10 samples and let the Autoloader
do the work. It tilts and rotates every tube, to get a proper mixing, and reads its barcode. Most
standard closed EDTA tubes fit and the cap will be detected by a cap recognition sensor. Note
that emergency samples can easily be analyzed in the middle of an automated run.

Model configuration

Figure 1 – Quintus Autoloader

Instructions for use Use in accordance with manufacturer’s instructions for use in Quintus User´s Manual

Storage +5 to +35 ºC (41 to 95 ºF)

Packaging and Weight Autoloader 12 kg, Double corrugated cardboard outer packaging with shock absorbent inner
packaging

Product Conformity Quintus Autoloader is in conformance with the 98/79/EC In Vitro Diagnostic Medical Device
Directive (IVD) using Annex III as the conformity assessment procedure.
SS-EN 61010-2-101 (Low Voltage 2014/35/EU)
EN 61326 (2006) (EMC 2014/30/EU)
2012/19/EU WEEE
2011/65/EU RoHS

Quality The autoloader has been factory calibrated by Boule prior to shipment. Customers are advised to check
Control/Calibration the daily performance of the Quintus system with a certified blood control authorized by Boule.

Warning and As there are no assurances of the absence of HIV, Hepatitis B or C viruses or other infectious agents in
Precautions blood samples, blood controls, calibrators and waste, these products should be handled as potentially
biohazardous. See User manual for biohazard symbol placement and further instructions.
Customers are advised to be knowledgeable of applicable local, state and federal requirements, and the
content of effluent streams, before disposing of waste in public sewer systems or recycling
decontaminated equipment. The instructions for decontamination can be found on the Boule home
page, www.quintus5part.com, under User Support

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: [email protected]
www.boule.se
13955-5 2017-01-24 Page 1 of 5
Technical Document
Quintus Hematology Analyzer

For the manufacturing process and the specific process control points for this analyzer see the flowchart
Manufacturing below. The process starts with components for the manufacturing of the analyzer being checked in by
Process the content of specification (e.g. drawings, specifications for incoming inspection) against acceptance
limits. The process is completed with final QC testing, the release by QA, and the approved analyzer
moved to stock.

Figure 7 - Flow chart for manufacturing and quality control

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: [email protected]
www.boule.se
13955-5 2017-01-24 Page 2 of 5
Technical Document
Quintus 5-part Diluent

Product name: Quintus 5-Part Diluent

Article No: 1504291 (20 liter)

Manufacturer: Boule Medical AB

Domnarvsgatan 4
SE–163 53 Spånga, Sweden
Telephone: 0046 8 744 77 00
Fax: 0046 8 744 77 20

Country of origin Sweden

Product Description: Quintus Diluent is a hematology diluent used for cell counting and sizing in the Quintus automated,
hematology analyzers.

Active Ingredients: Salts for isotonic stability < 1.5 %

Antimicrobials < 0.2 %
Buffering agents < 0.5 %

Preservatives: The stabilizing solution contains buffer salts with anti-microbial substances to prevent contamination
of bacteria or molds, these substances are biodegradable.

Shelf life: 24 months from day of manufacture. The shelf life of this product is based on accelerated and real-
time stability studies.

Open container 3 months

stability

Storage: +4 °C and +35 °C. (~39-95 °F). Avoid freezing.

Packaging and Weight: 20 liter (21.2 kg) LDPE cubitainer packed in a cardboard box.

Package and labels

Figure 1 – Quintus 5-part Diluent package Figure 2 – Additional CLP information

Figure 3 – Label on cardboard box

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: [email protected]
www.boule.se
13892-7 2016-06-15 Page 1 of 3
Technical Document
Quintus 5-part Diluent

Recycling information Part Material Weight (g)

Box Cardboard 670
Politainer including cap Plastic 230
Warning and Not classified as hazardous according to CLP (EC regulation 1272/2008), information given on added
Precautions label. Use good laboratory practice. Avoid contact with skin, eyes, and clothing. Do not swallow.

Warning and Contains no ingredients at hazardous concentrations. Use good laboratory practice.
Precautions: Avoid contact with skin, eyes, and clothing. Harmful if swallowed.

Instructions for use: Use in accordance with manufacturer’s instructions for use and follow Operator manual for connection
and fill instruction.

Quality Control Test Specifications

Specifications pH 6.8 - 7.2
Osmolality (mOsm/kg) 315 - 350
Conductivity (mS/cm) 18.8 – 19.2
Particles (PLT/RBC channel) ≤5
Appearance Clear, colorless liquid

Product Conformity Directives Standards/Comments

98/79/EEC In Vitro Diagnostic Using Annex III as the conformity
Medical Device Directive (IVD) assessment procedure

Precision Testing Parameter RBC MCV HGB PLT WBC

(Instrument): CV ≤ 1.5 % ≤ 1.0 % ≤ 1.5 % ≤5% ≤ 3.0 %
Quintus displays the results of the optical measurements in a scatter diagram
Scatter diagrams
representation.
• Scatter diagrams represent data in a two-dimensional plane.
• There are two scatter diagrams in the patient report: the 4-DIFF and the BASO

Population Color on
(4-diff diagram) scatter diagram
Artifact BLACK
Lymphocytes BLUE
Monocytes GREEN
Neutrophil MAGENTA
granulocytes
Eosinophil ORANGE
granulocytes
Figure 4 – 4-diff diagram

Population Color on
(Basophil diagram) scatter diagram
WBC without BLUE
Basophil
Basophil MAGENTA
granulocytes

Figure 5 – Basophil diagram

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: [email protected]
www.boule.se
13892-7 2016-06-15 Page 2 of 3
Technical Document
Quintus 5-part Diluent

Histograms Impedance based measurements are represented on histograms. These diagrams show the
number of cells against cell size.
• There are two histograms: RBC and PLT.
• Discriminators (thresholds) are displayed with red color.
• The PLT histogram is the magnified section of the left-hand side of the RBC curve.

Figure 6 – RBC histogram Figure 7 – PLT histogram

Manufacturing Process For the manufacturing process and the specific process control points for this reagent see the flowchart
below. The process starts with raw materials for the manufacturing of the reagent being checked in by
the content of certificates (e.g. Batch Specific Certificate of Analysis) against acceptance limits and by
follow-up analysis of at least one specific characteristic chemical property (e.g. pH in solution). The
process is completed with final QC parameter, functional, and bacterial testing, the release by QA
accompanied by the Certificate of Analysis, and the approved reagent moved to stock.

Figure 8 - Flow chart for manufacturing and quality control

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: [email protected]
www.boule.se
13892-7 2016-06-15 Page 3 of 3
Technical Document
Quintus 5-part Lyse

Product name Quintus 5-Part Lyse

Article No 1504292 (5 liter)

Manufacturer Boule Medical AB

Domnarvsgatan 4
SE–163 53 Spånga, Sweden
Telephone: 0046 8 744 77 00
Fax: 0046 8 744 77 20

Country of origin Sweden

Product Description Quintus 5-Part Lyse is a hematology cyanide free lytic reagent used for cell counting and sizing in the
Quintus Series, automated, hematology analyzers.

Active Ingredients Surfactants < 1.8 %

Salts (Buffering substances) < 0.5 %

Shelf life 18 months from day of manufacture. The shelf life of this product is based on accelerated and real-
time stability studies.

Open container 3 months

stability

Storage +4 °C and +35 °C. (~39-95 °F). Avoid freezing.

Packaging and Weight 5 liter (5.4 kg) LDPE cubitainer packed in a cardboard box.

Package and Labels

Figure 2 – Label on cardboard box

Figure 1 – Quintus 5-part Lyse package,
politainer in cardboard box

Figure 3 – Additional warning information Figure 4 – Additional CLP information

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: [email protected]
www.boule.se
13897-8 2016-06-02 Page 1 of 3
Technical Document
Quintus 5-part Lyse

Recycling information Part Material Weight (g)

Box Cardboard 220
Politainer including cap Plastic 100
Warning and Not classified as hazardous according to CLP (EC regulation 1272/2008), information given on added
Precautions label. Use good laboratory practice. Avoid contact with skin, eyes, and clothing. Do not swallow.

Instructions for use Use in accordance with manufacturer’s instructions for use and follow Operator manual for connection
and fill instruction.

Quality Control Test Specifications

Specifications pH 2.7 – 3.0
Osmolality (mOsm/kg) 35 - 44
Conductivity (µS/cm) 1117 - 1541
CBC Performance* Passed test
Particles (WBC channel) ≤ 0.1
Appearance Clear, colorless liquid
*Performance test using calibrated blood cell counter at Boule Medical reference laboratory. All parameters except mid cells
are tested. Accepted reference 95% to 105% of expected control blood sample values.

Product Conformity Directives Standards/Comments

98/79/EEC In Vitro Diagnostic Using Annex III as the conformity
Medical Device Directive (IVD) assessment procedure

Precision Testing Parameter RBC MCV HGB PLT WBC

(Instrument) CV ≤ 1.5 % ≤ 1.0 % ≤ 1.5 % ≤5% ≤ 3.0 %

Quintus displays the results of the optical measurements in a scatter diagram representation.
Scatter diagrams
• Scatter diagrams represent data in a two-dimensional plane.
• There are two scatter diagrams in the patient report: the 4-DIFF and the BASO

Population Color on
(4-diff diagram) scatter diagram
Artifact BLACK
Lymphocytes BLUE
Monocytes GREEN
Neutrophil MAGENTA
granulocytes
Eosinophil ORANGE
granulocytes

Figure 5 – 4-diff diagram

Population Color on
(Basophil diagram) scatter diagram

WBC without Basophil BLUE

Basophil granulocytes MAGENTA

Figure 6 – Basophil diagram

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: [email protected]
www.boule.se
13897-8 2016-06-02 Page 2 of 3
Technical Document
Quintus 5-part Lyse

Histograms Impedance based measurements are represented on histograms. These diagrams show the number of
cells against cell size.
• There are two histograms: RBC and PLT.
• Discriminators (thresholds) are displayed with red color.
• The PLT histogram is the magnified section of the left-hand side of the RBC curve.

Figure 7 – RBC histogram Figure 8 – PLT histogram

For the manufacturing process and the specific process control points for this reagent see the flowchart
Manufacturing Process
below. The process starts with raw materials for the manufacturing of the reagent being checked in by
the content of certificates (e.g. Batch Specific Certificate of Analysis) against acceptance limits and by
follow-up analysis of at least one specific characteristic chemical property (e.g. pH in solution). The
process is completed with final QC parameter, functional, and bacterial testing, the release by QA
accompanied by the Certificate of Analysis, and the approved reagent moved to stock.

Manufacturing Process Control Process

Raw Material Specifications

Raw Materials
QC/QA of Raw materials

Weighing and mixing of QC of weighing

chemicals and purified water

QC of parameter testing
Parameter and QC of functional testing
functional testing QA approval for filling

Filling, packaging, and QC of labeling

QC of filling
labeling
Final weighing documented/approved

Final parameter,
QC of bacterial, parameter
functional, and and functional testing
bacterial testing

Final release of Certificate of Analysis

reagent by QA

Approved reagent in stock

QC = process control
QA = Quality assurance release/approval

Figure 9 Flow chart for manufacturing and quality control

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: [email protected]
www.boule.se
13897-8 2016-06-02 Page 3 of 3