Technical Document

Quintus 5-part Stopper

Product name Quintus 5-Part Stopper

Article No 1504373 (1 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 Stopper is a hematology reagent used for cell counting and sizing in the Quintus Series,
automated, hematology analyzers.

Active Ingredients Salts for isotonic stability < 2.5 %

Antimicrobials < 0.1 %
Buffering agents < 1.0 %

Preservatives The stopper contains 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. The shelf life for a new product is usually 12 months and upon
confirmed real-time checks can be prolonged in 3-month intervals.

Open bottle/container 3 months

stability

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

Packaging and Weight 1 liter in HDPE bottle (1.1 kg), 5 liter (5.4 kg) LDPE cubitainer packed in a cardboard box.

Package and Labels

Figure 2 – Additional CLP information

Figure 1 – Quintus 5-
part Stopper, 1L
package

Figure 3 – Label on bottle

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: info@boule.se
www.boule.se
13898-7 2016-02-02 Page 1 of 3
Technical Document
Quintus 5-part Stopper

Recycling information Part Material Weight (g)

Box Cardboard 220
Politainer including cap Plastic 100
Bottle 1L Plastic 67
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 10.8 - 11.2
Osmolality (mOsm/kg) 830 - 860
Conductivity (mS/cm) 42.7 – 43.3
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 4 – 4-diff diagram

Population Color on
(Basophil diagram) scatter diagram

WBC without Basophil BLUE

Basophil granulocytes MAGENTA

Figure 5 – Basophil diagram

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: info@boule.se
www.boule.se
13898-7 2016-02-02 Page 2 of 3
Technical Document
Quintus 5-part Stopper

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

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 8 Flow chart for manufacturing and quality control

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: info@boule.se
www.boule.se
13898-7 2016-02-02 Page 3 of 3
 Technical Document
15/ Boule Cal-5Diff G2

INTENDED USE PRECAUTIONS

Boule Cal-5Diff G2 Hematology Calibrator is manufactured for  For In-Vitro diagnostic use.
calibration of multi-parameter hematology analyzers.
 All human source material used to manufacture this product was non-
SUMMARY AND PRINCIPLES reactive for antigens to Hepatitis B and negative by tests for antibodies to
Multi-parameter hematology analyzers require regular calibration in order to HIV (HIV-1, HIV-2) and Hepatitis C using techniques specified by the
produce accurate results on patient samples. Calibration can be accomplished U.S. Food and Drug Administration. Because no known test method
by transferring information to the analyzer through fresh blood samples, which can assure complete absence of human pathogens, this product
have been assayed by reference methods. A more direct and convenient should be handled with appropriate precautions.
approach is to use a calibrator material with System Specific Values (SSV)  This product should not be disposed in general waste, but should be
assigned such as Boule Cal-5Diff G2. disposed with infectious medical waste. Disposal by incineration is
recommended.
Boule Cal-5Diff G2 is a stable suspension of red blood cells, white blood
cells and platelets. Assigned values are derived from replicate analyses on  This product is intended for use as supplied. Adulteration by dilution or
whole blood calibrated hematology analyzers (see reference procedures). A addition of any materials to the product as supplied invalidates any
user analyzes Boule Cal-5Diff G2 on their instrument and computes diagnostic use of the product.
calibration factors by comparing recovered values and assigned values.
These factors provide the basis for making adjustments to the instrument. REFERENCE PROCEDURES
WBC- A series of 1:500 dilutions are made using class A glassware. The lytic
REAGENTS reagent is placed in the initial dilution flask before diluting to volume. The
Boule Cal-5Diff G2 contains treated, stabilized human erythrocytes and a diluting agent is an isotonic solution for Beckman Coulter® instruments. The
stabilized platelet-sized component in an isotonic, bacteriostatic medium. samples are counted on a Beckman Coulter Counter Z instrument.
Fixed erythrocytes are added to simulate leukocytes.
RBC- A series of 1:50,000 dilutions are made using class A glassware. The
STORAGE AND STABILITY diluting agent is an isotonic solution for Beckman Coulter® series instruments.
Boule Cal-5Diff G2 is shipped in a thermally insulated container designed to The samples are counted on a Beckman Coulter Counter Z instrument.
keep it cool. When stored at 2-10°C, sealed vials are stable at least until the
expiration date shown on the TABLE OF EXPECTED RESULTS. Hgb- Hemoglobin concentration is determined by converting hemoglobin to
Open Vial stability is 5 days after opening when returned to refrigerator after hemiglobincyanide (HiCN) and measuring absorbance at 540 nm according to
each use. NCCLS H15-A2 and ICSH recommendations. Hemoglobin concentration is
Storage of product with cap down (inverted) might require additional mixing calculated using millimolar absorption coefficient of 11.0.
for complete resuspension of cellular components.
HCT- Microhematocrit values are done in replicate on each sample, with
INDICATION OF INSTABILITY OR DETERIORATION capillary tubes filled and centrifuged according to the NCCLS H7-A2
Inability to obtain expected values may indicate product deterioration. document. K3EDTA is used as the anticoagulant for collection of fresh
Discoloration of the product may be caused by overheating or freezing during specimens. The packed cell volume, or hematocrit, is read directly using a
shipping or storage. Darkly colored supernatant may be indicative of product precision metric scale. No correction is made for trapped plasma.
deterioration; however, moderately colored supernatant is normal and should
not be confused with product deterioration. If the recovered values are not Plt- A series of 1:125 macrodilutions are prepared using class A glassware in
within the expected ranges: 1% Ammonium Oxalate. Charged hemacytometers are allowed to stand 20-30
1. Review the calibrator product package insert and the operating minutes. Cells are counted using phase-contrast microscopy technique.
procedure of the instrument. MPV- Based on a method using latex particles.
2. Check the expiration date of the Boule Cal-5Diff G2. Discard
outdated products. ORDERING INFORMATION AND SERVICE
3. Test an additional unopened vial of Boule Cal-5Diff G2. Contact your local distributor for orders and support. Please have the catalog
number ready for orders. For other assistance contact Boule Medical AB at
INSTRUCTIONS FOR USE phone +46 8 7447700, fax +46 8 7447720 or info@boule.se.
1. Remove Boule Cal-5Diff G2 Calibrator from refrigeration and allow to
warm at ambient temperature (18-32°C) for 10-15 minutes before mixing. For translation of this instruction and explanation to symbols see
www.quintus5part.com/ support/downloads
2. After warming, mix by hand as follows:
a. Roll the tube or vial slowly between the palms eight times in an Ordering no: Description Packaging
upright position. 1504375 Boule Cal-5Diff G2 1 x 3 mL
b. Invert the tube and slowly roll it between the palms eight times. 1504376 Boule Con-5Diff G2Tri 6 x 3 mL
c. Continue to mix in this manner until all cells are completely 1504382 Boule Con-5Diff G2 Low 1 x 3 mL
suspended. Tubes stored for a long time may require extra mixing. 1504379 Boule Con-5Diff G2 Low 6 x 3 mL
1504381 Boule Con-5Diff G2 Norm 1 x 3 mL
d. Gently invert the tube 8 times immediately before sampling. 1504378 Boule Con-5Diff G2 Norm 6 x 3 mL
e. Note: Use of a Mechanical Mixer is not recommended. 1504380 Boule Con-5Diff G2 High 1 x 3 mL
3. Refer to the User’s manual for calibration procedure. 1504377 Boule Con-5Diff G2 High 6 x 3 mL
4. After open sampling, carefully wipe the rim of the tube and inside of the
cap with a lint-free tissue. Replace the cap ensuring it is on tight.
5. Return the tubes to the refrigerator within 30 minutes of use.
6. For further assistance, please contact your local distributor.

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: info@boule.se
www.boule.se
20619-1 2014-11-14 1504397_en
 Instructions for Use
Boule Con-5Diff G2
INTENDED USE b. Failure to achieve the conditions listed in 6a above may
For in vitro diagnostic use as a control to monitor the indicate instrument and/or control problems. To identify the
performance of multi-parameter hematology instruments. source of the problem see investigational procedure section.
7. For consistency and best precision data, use the three levels of the cell
SUMMARY AND PRINCIPLES control in the following order: abnormal low, normal, and abnormal high.
8. Before expiration of the current lot, good laboratory practice requires that
Boule Con-5Diff G2 Hematology Control is prepared from stabilized human a new lot of cell control be analyzed in parallel with the existing lot until
blood so that repeated measurements can be made daily to monitor the a laboratory mean is established on the new lot.
performance of hematology analyzer systems. ASSIGNED VALUES and
EXPECTED RANGES are determined on systems using specific Boule PERFORMANCE LIMITS
reagents. ASSIGNED VALUES are confirmed by multiple analysis of the
control product and should be considered a suggested average until you Individual laboratories should expect better precision than that shown in the
establish your own running mean. expected range column. Refer to your Product Manual for performance
characteristics of precision for your instrument.
REAGENTS
PRECAUTIONS
Boule Con-5Diff G2 Hematology Control contains treated, stabilized human
erythrocytes and a stabilized platelet-sized component in an isotonic,  For In-Vitro diagnostic use.
bacteriostatic medium. Fixed erythrocytes are added to simulate leukocytes.  All human source material used to manufacture this product was non-
reactive for antigens to Hepatitis B and negative by tests for antibodies to
STORAGE AND STABILITY HIV (HIV-1, HIV-2) and Hepatitis C using techniques specified by the
U.S. Food and Drug Administration. Because no known test method
Boule Con-5Diff G2 Hematology Control is shipped in a thermally insulated
can assure complete absence of human pathogens, this product
container designed to keep it cool. When stored at 2-10° C, sealed vials are
should be handled with appropriate precautions.
stable at least until the expiration date shown on the TABLE OF EXPECTED
 This product should not be disposed in general waste, but should be
RESULTS.
disposed with infectious medical waste. Disposal by incineration is
Open vial stability 14 days after opening when returned to refrigerator after
recommended.
each use.
Storage of product with cap down (inverted) might require additional mixing  This product is intended for use as supplied. Adulteration by dilution or
for complete resuspension of cellular components. addition of any materials to the product as supplied invalidates any
diagnostic use of the product.
INDICATIONS OF INSTABILITY OR DETERIORATION  Controls are not to be used as calibrators.
Inability to obtain expected values may indicate product deterioration. INVESTIGATIONAL PROCEDURE
Discoloration of the product may be caused by overheating or freezing during
shipping or storage. Darkly colored supernatant may be indicative of product If you need help in resolving control recovery problems, call our customer
deterioration, however, moderately colored supernatant is normal and should service department. To provide faster handling of your inquiry, please have
not be confused with product deterioration. If the recovered values are not the following information available when you call:
within the expected ranges:  Expiration dates and lot numbers of all reagents, the control(s) in
1. Review the control product package insert and the operating procedure of question and other levels of cell control that you use.
the instrument.  Data supporting the problem for the lot number in question.
2. Check the expiration date of the Boule Con-5Diff G2. Discard outdated  Previous cell control lot numbers and the data you have for these
products. previous lots.
3. Test an additional unopened vial of Boule Con-5Diff G2.  Data from a current reproducibility study (N=10) using a fresh whole
blood specimen and performed according to your Product Manual.
INSTRUCTIONS FOR USE  Data from your last instrument calibration.
1. Remove Boule Con-5Diff G2 Hematology Control from refrigeration
and allow to warm at ambient temperature (18-32°C) for 10-15 minutes ORDERING INFORMATION AND SERVICE
before mixing. Contact your local distributor for orders and support. Please have the catalog
2. After warming, mix by hand as follows: number ready for orders. For other assistance contact Boule Medical AB at
a. Roll the tube or vial slowly between the palms of the hands eight phone +46 8 7447700, fax +46 8 7447720 or info@boule.se
times in an upright position.
b. Invert the tube and slowly roll it between the palms eight times. For translation of this instruction and explanation to symbols see
c. Continue to mix in this manner until all cells are completely www.quintus5part.com/ support/downloads
suspended. Tubes stored for a long time may require extra mixing. Ordering no: Description Packaging
d. Gently invert the tube 8 times immediately before sampling. 1504375 Boule Cal-5Diff G2 1 x 3 mL
e. Note: Use of a Mechanical Mixer is not recommended. 1504376 Boule Con-5Diff G2 Tri 6 x 3 mL
3. Follow instruction in User’s Manual for each sampling mode. 1504382 Boule Con-5Diff G2 Low 1 x 3 mL
4. After open sampling, carefully wipe the rim of the tube and inside of the 1504379 Boule Con-5Diff G2 Low 6 x 3 mL
cap with a lint-free tissue. Replace the cap ensuring it is on tight. 1504381 Boule Con-5Diff G2 Norm 1 x 3 mL
1504378 Boule Con-5Diff G2 Norm 6 x 3 mL
5. Return the tubes to the refrigerator within 30 minutes of testing. 1504380 Boule Con-5Diff G2 High 1 x 3 mL
6. Compare instrument values to those given in the TABLE OF 1504377 Boule Con-5Diff G2 High 6 x 3 mL
EXPECTED RESULTS.
a. The instrument is considered well maintained and operating
correctly if: 95% of the recovered values fall within expected
range. No more than three consecutive values exceed the
expected range. Recovered values do not trend outside the
expected range.

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: info@boule.se
www.boule.se
20620-1 2014-11-12 1504395_en
Technical Document
14/ Boule Hypochlorite Cleaner

Product name: Boule Hypochlorite Cleaner

Article No: 1504385 (100mL)

Manufacturer: Boule Medical AB

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

Product Boule Hypochlorite Cleaner is used for maintenance and cleaning of Quintus automated
Description: hematology analyzers.

Active Ingredients: Sodium hypochlorite for lipid/protein degradation 4-5 % active chlorine
Sodium hydroxide for stability < 0.5 %
Surfactants for cleaning <1%

Preservatives: The product contains no added anti-microbial substances since the hypochlorite and high pH will
prevent growth of bacteria or molds.

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

Storage: 15 - 30 oC (59 to 86 oF). The product can be shipped at ambient temperature but avoid freezing.

Packaging and 100 milliliter, ca 125 g weight with bottle

Weight:

Warning and Contains sodium hypochlorite and sodium hydroxide

Precautions:
The Hypochlorite 4% Cleaner is classified as hazardous to health and the environment according
to CLP [Regulation (EC) no 1272/2008]. See product labeling below, detailed information is
given in the Safety Data Sheet (SDS). A translation to the indicated languages of the hazard
information is also available.
Instructions for use: Use in accordance with manufacturer’s instructions for use (IFU).
Quality Control Specifications for Hypochlorite Cleaner:
Test Specifications
pH 11.5-13.5
Hypochlorite concentration 4–5%

Product Boule Hypochlorite Cleaner is in conformance with the 98/79/EC In Vitro Diagnostic Medical
Conformity: Device Directive (IVD) using Annex III as the conformity assessment procedure.

Product Labelling:

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: info@boule.se
www.boule.se
20630-4 2016-06-23 1504385
Technical Document
Boule Hypochlorite (4%) Cleaner

Manufacturing For the manufacturing process and the specific process control points for this reagent see the
Process: 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 product
moved to stock.

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: info@boule.se
www.boule.se
20630-4 2016-06-23 1504385
 Technical Document
1/ Medonic M-series Diluent

Product name Medonic M-series Diluent

Article No 1504122 (20 liter)

Manufacturer Boule Medical AB

Domnarvsgatan4
SE–163 53 Spånga, Sweden
Telephone: 0046 8 744 77 00
Fax: 0046 8 744 77 20

Country of origin Sweden

Product Description Medonic M-series Diluent is a hematology diluent used for cell counting and sizing in the Medonic
M-series automated, hematology analyzers.

Active Ingredients Salts for isotonic stability < 2.0 %

Antimicrobials < 0.1 %
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 36 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 4-35 oC (39 to 95 oF). Avoid freezing.

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

Package and Labels

Figure 1 – Medonic M-series 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: info@boule.se
www.boule.se
11815-9 2016-01-12 Page 1 of 3
Technical Document
Medonic M-series 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.

Instructions for use Use in accordance with manufacturer’s instructions for use and follow the Instrument User’s Manual
for connection and fill instruction.

Quality Control Test Specifications

Specifications pH 6.90 - 7.10
Osmolality (mOsm/kg) 290 - 310
Conductivity (mS/cm) 17.50 – 18.00
Background test (RBC, PLT) Passed test
Total bacterial growth (CFU/100 ml) ≤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 ≤ 1.8 % ≤ 1.5 % ≤ 1.5 % ≤ 4.8 % ≤ 3.5 %

Histograms The measuring principles of the Medonic 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.

Figure 4 – Histograms for PLT, RBC and WBC

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: info@boule.se
www.boule.se
11815-9 2016-01-12 Page 2 of 3
Technical Document
Medonic M-series Diluent

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 5 - Flow chart for manufacturing and quality control

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: info@boule.se
www.boule.se
11815-9 2016-01-12 Page 3 of 3
Technical Document
2/ Medonic M-series Lyse

Product name Medonic M-series Lyse

Article No 1504123 (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 Medonic M-series Lyse is a cyanide-free hematology lytic reagent used for cell counting and sizing in
the Medonic M-series, semi-automated and automated, hematology analyzers.

Active Ingredients Quaternary ammonium salts < 0.5 %

Salts < 1.5 %

Shelf life 36 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 4-35 oC (39 to 95 oF). Avoid freezing.

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

Package and Labels

Figure 2 – Additional CLP information

Figure 1 – Medonic M-series Lyse package, politainer

in cardboard box

Figure 3 – Label on cardboard box

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: info@boule.se
www.boule.se
11811-8 2015-12-14 Page 1 of 3
Technical Document
Medonic M-series 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 the Instrument User’s Manual
for connection and fill instruction.

Quality Control Specifications:

Test Specifications
pH 7.0 ± 0.2
Osmolality (mOsm/kg) 230 ± 10
Conductivity (mS/cm) 14.5 ± 0.5
CBC Performance* Passed test
Particles (PLT/RBC channel) ≤ 0.2
Total bacterial growth (CFU/100 ml) ≤5
Appearance Clear, colorless liquid
*Performance test using calibrated blood cell counter at Boule Medicalreference laboratory. All parameters except mid cells are
tested.Accepted reference 95% to 105% of expected control blood samplevalues.

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 ≤ 1.8 % ≤ 1.5 % ≤ 1.5 % ≤ 4.8 % ≤ 3.5 %

Histograms: The measuring principles of the Medonic 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.

Figure 4 – Histograms for PLT, RBC and WBC

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: info@boule.se
www.boule.se
11811-8 2015-12-14 Page 2 of 3
Technical Document
Medonic M-series Lyse
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.

Figure 5 Flow chart for manufacturing and quality control

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: info@boule.se
www.boule.se
11811-8 2015-12-14 Page 3 of 3
Technical Document
3/ Boule Cal

INTENDED USE PRECAUTIONS

Boule Cal Hematology Calibrator is manufactured for calibration  For In-Vitro diagnostic use.
of multi-parameter hematology analyzers.
 All human source material used to manufacture this product was non-
SUMMARY AND PRINCIPLES reactive for antigens to Hepatitis B and negative by tests for antibodies
Multi-parameter hematology analyzers require regular calibration in order to to HIV (HIV-1, HIV-2) and Hepatitis C using techniques specified by
produce accurate results on patient samples. Calibration can be accomplished the U.S. Food and Drug Administration. Because no known test
by transferring information to the analyzer through fresh blood samples, method can assure complete absence of human pathogens, this
which have been assayed by reference methods. A more direct and product should be handled with appropriate precautions.
convenient approach is to use a calibrator material with System Specific  This product should not be disposed in general waste, but should be
Values (SSV) assigned such as Boule Cal. disposed with infectious medical waste. Disposal by incineration is
recommended.
Boule Cal is a stable suspension of red blood cells, white blood cells and
platelets. Assigned values are derived from replicate analyses on whole blood  This product is intended for use as supplied. Adulteration by dilution or
calibrated hematology analyzers (see reference procedures). A user analyzes addition of any materials to the product as supplied invalidates any
Boule Cal on their instrument and computes calibration factors by comparing diagnostic use of the product.
recovered values and assigned values. These factors provide the basis for
making adjustments to the instrument. REFERENCE PROCEDURES
WBC- A series of 1:500 dilutions are made using class A glassware. The
REAGENTS lytic reagent is placed in the initial dilution flask before diluting to volume.
Boule Cal contains treated, stabilized human erythrocytes and a stabilized The diluting agent is an isotonic solution for Beckman Coulter® instruments.
platelet-sized component in an isotonic, bacteriostatic medium. Fixed The samples are counted on a Beckman Coulter Counter Z instrument.
erythrocytes are added to simulate leukocytes.
RBC- A series of 1:50,000 dilutions are made using class A glassware. The
STORAGE AND STABILITY diluting agent is an isotonic solution for Beckman Coulter® series
Boule Cal is shipped in a thermally insulated container designed to keep it instruments. The samples are counted on a Beckman Coulter Counter Z
cool. When stored at 2-10°C, sealed vials are stable at least until the instrument.
expiration date shown on the TABLE OF EXPECTED RESULTS.
Open Vial stability is 5 days after opening when returned to refrigerator after Hgb- Hemoglobin concentration is determined by converting hemoglobin to
each use. hemiglobincyanide (HiCN) and measuring absorbance at 540 nm according to
Storage of product with cap down (inverted) might require additional mixing NCCLS H15-A2 and ICSH recommendations. Hemoglobin concentration is
for complete resuspension of cellular components. calculated using millimolar absorption coefficient of 11.0.

INDICATION OF INSTABILITY OR DETERIORATION HCT- Microhematocrit values are done in replicate on each sample, with
Inability to obtain expected values may indicate product deterioration. capillary tubes filled and centrifuged according to the NCCLS H7-A2
Discoloration of the product may be caused by overheating or freezing during document. K3EDTA is used as the anticoagulant for collection of fresh
shipping or storage. Darkly colored supernatant may be indicative of product specimens. The packed cell volume, or hematocrit, is read directly using a
deterioration, however, moderately colored supernatant is normal and should precision metric scale. No correction is made for trapped plasma.
not be confused with product deterioration. If the recovered values are not
within the expected ranges: Plt- A series of 1:125 macrodilutions are prepared using class A glassware in
1. Review the calibrator product package insert and the operating 1% Ammonium Oxalate. Charged hemacytometers are allowed to stand 20-
procedure of the instrument. 30 minutes. Cells are counted using phase-contrast microscopy technique.
2. Check the expiration date of the Boule Cal. Discard outdated MPV- Based on a method using latex particles.
products.
3. Test an additional unopened vial of Boule Cal. ORDERING INFORMATION AND SERVICE
Contact your local distributor for orders and support. Please have the catalog
INSTRUCTIONS FOR USE number ready for orders. For other assistance contact Boule Medical AB at
1. Remove Boule Calibrator from refrigeration and allow to warm at phone +46 8 7447700, fax +46 8 7447720 or info@boule.se.
ambient temperature (18-32°C) for 10-15 minutes before mixing.
For translation of this instruction and explanation to symbols see
2. After warming, mix by hand as follows:
www.medonic.se/ www.swelab.com/ /support/downloads
a. Roll the tube or vial slowly between the palms eight times in an
upright position. Ordering no: Description Packaging
b. Invert the tube and slowly roll it between the palms eight times. 1504025 Boule Cal 1 x 3.0 ml
1504045 Boule Cal 2 x 3.0 ml
c. Continue to mix in this manner until all cells are completely 1504022 Boule Con-Diff Tri-Level 16 parameter 6 x 4.5 ml
suspended. Tubes stored for a long time may require extra mixing. 1504020 Boule Con-Diff Low 16 parameter 1 x 4.5 ml
d. Gently invert the tube 8 times immediately before sampling. 1504176 Boule Con-Diff Low 16 parameter 6 x 4.5 ml
1504019 Boule Con-Diff Normal 16 parameter 1 x 4.5 ml
e. Note: Use of a Mechanical Mixer is not recommended. 1504043 Boule Con-Diff Normal 16 parameter 6 x 4.5 ml
1504021 Boule Con-Diff High 16 parameter 1 x 4.5 ml
3. Refer to the User’s manual for calibration procedure.
1504216 Boule Con-Diff High 16 parameter 6 x 4.5 ml
4. After open sampling, carefully wipe the rim of the tube and inside of the 1504041 Boule Con-Diff Low 16 parameter 4.5 ml
cap with a lint-free tissue. Replace the cap ensuring it is on tight. 1504040 Boule Con-Diff Normal 16 parameter 4.5 ml
1504042 Boule Con-Diff High 16 parameter 4.5 ml
5. Return the tubes to the refrigerator within 30 minutes of use.
6. For further assistance, please contact your local distributor.

Boule Medical AB
Domnarvsgatan 4,
SE-163 53 Spånga, Sweden
E-mail: info@boule.se
www.boule.se
11797-5 2014-04-09 1504052_en
Technical Document
4/ Boule Con-Diff N 5/ Boule Con-Diff L
6/ Boule Con-Diff H 7/ Boule Con-Diff Tri-L
INTENDED USE b. Failure to achieve the conditions listed in 6a above may
For in vitro diagnostic use as a control to monitor the indicate instrument and/or control problems. To identify the
performance of multi-parameter hematology instruments. source of the problem see investigational procedure section.
7. For consistency and best precision data, use the three levels of the cell
SUMMARY AND PRINCIPLES control in the following order: abnormal low, normal, and abnormal
high.
Boule Con Hematology Control is prepared from stabilized human blood so 8. Before expiration of the current lot, good laboratory practice requires
that repeated measurements can be made daily to monitor the performance of that a new lot of cell control be analyzed in parallel with the existing lot
hematology analyzer systems. ASSIGNED VALUES and EXPECTED until a laboratory mean is established on the new lot.
RANGES are determined on systems using specific Boule reagents.
ASSIGNED VALUES are confirmed by multiple analysis of the control PERFORMANCE LIMITS
product and should be considered a suggested average until you establish
your own running mean. Individual laboratories should expect better precision than that shown in the
expected range column. Refer to your Product Manual for performance
REAGENTS characteristics of precision for your instrument.
Boule Con Hematology Control contains treated, stabilized human erythro- PRECAUTIONS
cytes and a stabilized platelet-sized component in an isotonic, bacteriostatic
medium. Fixed erythrocytes are added to simulate leukocytes.  For In-Vitro diagnostic use.
 All human source material used to manufacture this product was non-
STORAGE AND STABILITY reactive for antigens to Hepatitis B and negative by tests for antibodies
to HIV (HIV-1, HIV-2) and Hepatitis C using techniques specified by
Boule Con Hematology Control is shipped in a thermally insulated container
the U.S. Food and Drug Administration. Because no known test
designed to keep it cool. When stored at 2-10° C, sealed vials are stable at least
method can assure complete absence of human pathogens, this
until the expiration date shown on the TABLE OF EXPECTED RESULTS.
product should be handled with appropriate precautions.
Open vial stability 14 days after opening when returned to refrigerator after
 This product should not be disposed in general waste, but should be
each use.
disposed with infectious medical waste. Disposal by incineration is
Storage of product with cap down (inverted) might require additional mixing
recommended.
for complete resuspension of cellular components.
 This product is intended for use as supplied. Adulteration by dilution or
INDICATIONS OF INSTABILITY OR DETERIORATION addition of any materials to the product as supplied invalidates any
diagnostic use of the product.
Inability to obtain expected values may indicate product deterioration.  Controls are not to be used as calibrators.
Discoloration of the product may be caused by overheating or freezing during
shipping or storage. Darkly colored supernatant may be indicative of product INVESTIGATIONAL PROCEDURE
deterioration, however, moderately colored supernatant is normal and should
not be confused with product deterioration. If the recovered values are not If you need help in resolving control recovery problems, call our customer
within the expected ranges: service department. To provide faster handling of your inquiry, please have
1. Review the control product package insert and the operating procedure the following information available when you call:
of the instrument.  Expiration dates and lot numbers of all reagents, the control(s) in
2. Check the expiration date of the Boule Con. Discard outdated products. question and other levels of cell control that you use.
3. Test an additional unopened vial of Boule Con.  Data supporting the problem for the lot number in question.
 Previous cell control lot numbers and the data you have for these
INSTRUCTIONS FOR USE previous lots.
1. Remove Boule Con Hematology Control from refrigeration and allow to  Data from a current reproducibility study (N=10) using a fresh whole
warm at ambient temperature (18-32°C) for 10-15 minutes before blood specimen and performed according to your Product Manual.
mixing.  Data from your last instrument calibration.
2. After warming, mix by hand as follows: ORDERING INFORMATION AND SERVICE
a. Roll the tube or vial slowly between the palms of the hands eight
times in an upright position. Contact your local distributor for orders and support. Please have the catalog
b. Invert the tube and slowly roll it between the palms eight times. number ready for orders. For other assistance contact Boule Medical AB at
c. Continue to mix in this manner until all cells are completely phone +46 8 7447700, fax +46 8 7447720 or info@boule.se
suspended. Tubes stored for a long time may require extra mixing.
d. Gently invert the tube 8 times immediately before sampling. For translation of this instruction and explanation to symbols see
e. Note: Use of a Mechanical Mixer is not recommended. www.medonic.se/ www.swelab.com/ /support/downloads

3. Follow instruction in User’s Manual for each sampling mode. Ordering no: Description Packaging
1504025 Boule Cal 1 x 3.0 ml
4. After open sampling, carefully wipe the rim of the tube and inside of the 1504045 Boule Cal 2 x 3.0 ml
cap with a lint-free tissue. Replace the cap ensuring it is on tight. 1504022 Boule Con-Diff Tri-Level 16 parameter 6 x 4.5 ml
5. Return the tubes to the refrigerator within 30 minutes of testing. 1504020 Boule Con-Diff Low 16 parameter 1 x 4.5 ml
1504176 Boule Con-Diff Low 16 parameter 6 x 4.5 ml
6. Compare instrument values to those given in the TABLE OF 1504019 Boule Con-Diff Normal 16 parameter 1 x 4.5 ml
EXPECTED RESULTS. 1504043 Boule Con-Diff Normal 16 parameter 6 x 4.5 ml
1504021 Boule Con-Diff High 16 parameter 1 x 4.5 ml
a. The instrument is considered well maintained and operating 1504216 Boule Con-Diff High 16 parameter 6 x 4.5 ml
correctly if: 95% of the recovered values fall within expected 1504041 Boule Con-Diff Low 16 parameter 4.5 ml
range. No more than three consecutive values exceed the 1504040 Boule Con-Diff Normal 16 parameter 4.5 ml
expected range. Recovered values do not trend outside the 1504042 Boule Con-Diff High 16 parameter 4.5 ml
expected range.

Boule Medical AB
Domnarvsgatan 4,
SE-163 53 Spånga, Sweden
E-mail: info@boule.se
www.boule.se
11718-6 2014-04-10 1504050_en
Techncial Document
8/ Boule Cleaning Kit

Product name Boule Cleaning Kit

Article No 1504111: Boule Enzymatic Cleaner 450 mL

Boule Hypochlorite (2%) Cleaner 450 mL
Boule Detergent Cleaner 450 mL

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 Boule Cleaning Kit is combination pack used for maintenance and cleaning of Medonic CA620/530,
Medonic M-series, Swelab AC920/970, Swelab Alfa Series and Exigo automated hematology
analyzers.

Active Ingredients Enzymatic Cleaner:

Subtilisin for proteolytic action < 0.1 %
Surfactants < 0.2 %
Stabilizers incl. salts and buffers <2%
Coloring substances << 0.1 %
Hypochlorite 2% Cleaner:
Sodium hypochlorite for lipid/protein degradation 2.0 – 2.4 % % active chlorine
Sodium hydroxide for stability < 0.05 %
Surfactants < 0.05%
Detergent Cleaner:
Sodium dodecyl sulfate for protein dissociation < 0.1 %
Surfactants < 0.2 %
Stabilizers incl. salts and buffers <1%
Coloring substances << 0.1 %

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

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 Until expiry date

stability

Storage 4 - 30 oC (59 to 86 oF). Avoid freezing.

Packaging and Weight 3 x 450 milliliter (1.6 kg) bottles packed in a cardboard box

Package and Labels

Figure 2 - Label on cardboard box

Figure 1 – Cardboard box

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: info@boule.se
www.boule.se
11969-7 2016-10-24 Page 1 of 3
Techncial Document
Boule Cleaning Kit

Figure 3 - Additional CLP information Figure 4 – Information SDS

Immediate container

Figure 5 - Bottle and label Figure 6 – Bottle and label Figure 7 – Bottle and label
Enzymatic Cleaner Hypochlorite (2%) Cleaner Detergent Cleaner

Recycling information Part Material Weight (g)

Box Cardboard 84
Bottle 450mL x3 Plastic 40 each
Warning and Not classified as hazardous according to CLP (EC regulation 1272/2008), information given on added
Precautions labels. Use good laboratory practice. Avoid contact with skin, eyes, and clothing. Do not swallow. See
SDS for further information.

Instructions for use Use in accordance with manufacturer’s instructions for use.

Quality Control Test Specifications

Specifications for pH 7.6 – 8.4
Enzymatic Cleaner Particles (PLT/RBC channel) PLT < 100 x 109/L
RBC < 0.05 x 1012/L

Quality Control Test Specifications

Specifications for Hypochlorite concentration 2.0 – 2.4 %
Hypochlorite Cleaner Particles (PLT/RBC channel) PLT < 100 x 109/L
RBC < 0.05 x 1012/L

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: info@boule.se
www.boule.se
11969-7 2016-10-24 Page 2 of 3
Techncial Document
Boule Cleaning Kit

Quality Control Test Specifications

Specifications for pH 7.6 – 8.4
Detergent Cleaner Particles (PLT/RBC channel) PLT < 100 x 109/L
RBC < 0.05 x 1012/L
Product Conformity
Directives Standards/Comments
98/79/EEC In Vitro Diagnostic Using Annex III as the
Medical Device Directive (IVD) conformity
assessment procedure
1907/2006/EC Registration,
Evaluation, Authorisation and
Restriction of Chemicals (REACH),
1272/2008/EC classification,
labelling and packaging of
substances and mixtures (CLP)
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 product moved to stock.

Figure 8 – Flow Chart Manufacturing and Quality Control

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: info@boule.se
www.boule.se
11969-7 2016-10-24 Page 3 of 3
Technical Document
10/ Boule Enzymatic Cleaner

Product name Boule Enzymatic Cleaner

Article No 1504112 (100 ml)

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 Boule Enzymatic Cleaner is used for maintenance and cleaning of Medonic CA620/530, Medonic M-
series, Swelab AC920/970, Swelab Alfa Series and Exigo automated, hematology analyzers.

Active Ingredients Subtilisin for proteolytic action < 0.1 %

Surfactants < 0.2 %
Stabilizers incl. salts and buffers <2%
Coloring substances << 0.1 %

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 Until expiry date

stability

Storage 4 - 30 oC (39 to 86 oF). Avoid freezing.

Packaging and weight 118 g total weight

Instructions for use Use in accordance with manufacturer’s instructions for use.

Package and Labels

Figure 2 - Label on bottle

Figure 1 - 100 milliliter,
plastic bottle

Figure 3 - Additional CLP information Figure 4 – Information SDS

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: info@boule.se
www.boule.se
15322-5 2016-10-24 Page 1 of 3
Technical Document
Boule Enzymatic Cleaner

Recycling information Part Material Weight (g)

Bottle Plastic 16
Warning and Not classified as hazardous according to CLP (EC regulation 1272/2008), information given on added
Precautions labels. Use good laboratory practice. Avoid contact with skin, eyes, and clothing. Do not swallow. See
SDS for further information

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 7.6 – 8.4
Particles (PLT/RBC channel) PLT < 100 x 109/L
RBC < 0.05 x 1012/L

Product Conformity Directives Standards/Comments

98/79/EEC In Vitro Diagnostic Using Annex III as the conformity
Medical Device Directive (IVD) assessment procedure
1907/2006/EC Registration,
Evaluation, Authorisation and
Restriction of Chemicals
(REACH),
1272/2008/EC classification,
labelling and packaging of
substances and mixtures (CLP)
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 product moved to stock.

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: info@boule.se
www.boule.se
15322-5 2016-10-24 Page 2 of 3
Technical Document
Boule Enzymatic Cleaner

Figure 5 - Flow Chart Manufacturing and Quality Control

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: info@boule.se
www.boule.se
15322-5 2016-10-24 Page 3 of 3
Technical Document
9/ Boule Hypochlorite 2% Cleaner

Product name Boule Hypochlorite 2% Cleaner

Article No 1504113 (500mL)

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 Boule Hypochlorite Cleaner is used for maintenance and cleaning of Medonic CA620/530, Medonic
M-series, Swelab AC920/970, Swelab Alfa Series and Exigo automated, hematology analyzers.

Active Ingredients Sodium hypochlorite for lipid/protein degradation 2.0 – 2.4 % active chlorine
Sodium hydroxide for stability < 0.05 %
Surfactants < 0.05%

Preservatives The stabilizing solution contains buffer salts but no added anti-microbial substances since the
hypochlorite and high pH will prevent growth of bacteria or molds.

Instructions for use Use in accordance with manufacturer’s instructions for use.

Storage 4 - 30 oC (39 to 86 oF). Avoid freezing.

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 Until expiry date

stability

Packaging and Weight 500 milliliter (545 g) plastic bottle

Package and Label

Figure 2 – Label on bottle

Figure 1 - 500 mL plastic bottle

Figure 3 – Information SDS

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: info@boule.se
www.boule.se
15315-4 2016-01-12 Page 1 of 2
Technical Document
Boule Hypochlorite 2% Cleaner

Recycling information Part Material Weight (g)

Bottle Plastic 40
Warning and Not classified as hazardous according to CLP (EC regulation 1272/2008), information given on
Precautions added label. Use good laboratory practice. Avoid contact with skin, eyes, and clothing. Do not
swallow. See SDS for additional information.

Quality Control Test Specifications

Specifications pH 11.5 – 12.1
Hypochlorite concentration 2.0 – 2.4 %
Particles (PLT/RBC channel) PLT < 100 x 109/L
RBC < 0.05 x 1012/L

Product Conformity Directives Standards/Comments

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

Figure 4 – Flow chart Manufacturing and Quality Control

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: info@boule.se
www.boule.se
15315-4 2016-01-12 Page 2 of 2
Technical Document
Micropipette, Plastic EDTA 20µL

Product name Micropipette 20µL, plastic

Article No 1070030 Micropipette Plastic EDTA 20µL 10x100 pcs/crt

1070039 Micropipette Plastic EDTA 20 µL 1x100pcs

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, Germany

Product Description The product 1070030 consists of:

Name Quantity Part number

Micropipette 20µL x 100 pcs 10 1070039

Label, product 10 N/A
Label, cardboard box 1 N/A
Cardboard box for package 1 N/A

Shelf life 36 months from day of manufacture. The shelf life of this product is based on actual test results in
real-time studies.

Open container Until expiry date

stability

Storage 2-30 oC (36 to 86 oF)

Technical specification Micropipette 20µL, dimensions:

Outer diameter: 1.76 mm ± 0.03 mm
Length: 27.5 mm ± 1 mm
Volume: 20 µL R: ≤ 0.5% CV: ≤ 1.0%
Treatment: EDTA (K2) 35 - 70 µg per micropipette
Intended use For laboratory use only (in vitro diagnostic). The micropipette is intended for blood collection from a
finger stick or venous sample and direct inserted into the MPA/MCI inlet of Medonic
CA620/530/Medonic M-series and Swelab Alfa automated, hematology analyzers

Instructions for use Use in accordance to instructions in Medonic CA620/530/M-series and Swelab Alfa User Manuals.

Quality Control - All micropipettes are manufactured with the proper plastic collection.
- All micropipettes contain the correct additive in proper quality.
- - In-process and finished product QC checks assure that all capillary tubes are properly
constructed, there are 100 finished micropipettes in a dispenser box, all dispenser boxes are
properly sealed and labeled.

Product Conformity - Boule Micropipette, Plastic EDTA 20µL is in conformance with the 98/79/EC In Vitro Diagnostic
Medical Device Directive (IVD) using Annex III as the conformity assessment procedure.
- 1907/2006/EC Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH),
- 1272/2008/EC classification, labelling and packaging of substances and mixtures (CLP)

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: info@boule.se
www.boule.se
11836-7 2017-06-12 Page 1 of 2
Technical Document
Micropipette, Plastic EDTA 20µL

Weight 160g, 10x100 package including cardboard box

13g, 1x100 package, no outer box

Recycling Part Material Weight (g)

information Box Cardboard 32
Container Plastic 6 each
Package

Figure 2 – Package 1070039,

1x100
Figure 1 – Package 1070030, 10x100
Label

Figure 4 – Label on 1x100 package

Figure 3 – Label on 10x100 package

Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: info@boule.se
www.boule.se
11836-7 2017-06-12 Page 2 of 2