Boule Medonic Series User manual

Instructions for Use
Boule Cleaning Kit Medonic
Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: info@boule.com
www.boule.com
11452-4
2019-06-18
1504093
Medonic M-Series
Intended Use
The Boule Cleaning Kit is intended for use with the Medonic M-
Series Hematology Systems. The kit contains 3 different cleaning
solutions as indicated on their labels. Using this cleaning kit at the
stated regular intervals will ensure:
-Longer lifetime of instrument tubing
-Lower risk of bacterial grow
-Lower background counts
-Increased mean time between failure (higher MTBF)
Contents
1. Enzymatic Cleaner, 450 mL, blue-colored solution
2. Hypochlorite Cleaner; 450 mL, yellow-colored solution
3. Detergent Cleaner, 450 mL, red-colored solution
The contents can be used for three full and complete cleaning cycles.
Remaining cleaning solution should be disposed of.
Storage and stability
The Boule Cleaning kit can be transported at ambient temperature
(avoid freezing, allow adaption to room temperature before use).
Always store the bottles in an upright position to avoid any leakage
from the cap.
Cleaning Interval
It is recommended to use the cleaning kit at the following time
intervals:
Less than 50 samples/day →every 6 months
More than 50 samples/day →every 3 months
100-200 samples/day →every month
Procedure
It is very important that the cleaning procedure is performed in the
correct order (or it may result in high PLT background counts).
The following order must be followed:
1) Enzymatic Cleaner (enzyme solution - blue cap)
2) Hypochlorite (2% solution - white cap)
3) Detergent Cleaner (detergent solution - red cap)
Proceed as follows:
1. Firstly, remove the diluent and lyse level sensors from their
containers.
2. Press [MENU] on the touch screen, then [ADVANCED],
then [MAINTENANCE], and then [CLEANING MENU]
to enter the Cleaning Menu.
3. Press [CLEAN CYCLE EMPTY] and wait for the system
to empty.
4. Wet a soft tissue with the proper cleaning solution (e.g. the
first time use Enzymatic Cleaner) and wipe both level
sensors clean on the outside. Then insert both level sensors
directly into the cleaning solution bottle.
5. From Cleaning Menu press [CLEAN CYCLE FILL].
Allow the system to fill up with the cleaning solution and
wait 15-30 minutes for the cleaner to work.
6. Remove both level sensors and press [CLEAN CYCLE
EMPTY]. Allow the system to empty completely.
7. Repeat step 4 to 6 using the Hypochlorite (white) followed
by the Detergent Cleaner (red).
8. Finally take a soft tissue and wet it with Diluent (not Lyse)
and wipe off any remaining cleaner from the level sensors.
Make sure that a soft and dry tissue is used to dry the level
sensors from all remaining liquid. When level sensors are
clean insert both back into the original reagent containers.
(Be sure not to interchange the Diluent and Lyse level
sensors.)
9. From Cleaning Menu press [CLEAN CYCLE FILL], wait
until this cycle is completed.
10. The background count should not exceed the recommended
values, which is stated in the User manual. Perform a
minimum of 3 background counts before analyzing the
next sample.
Notes
- As the volume in the cleaning bottles will decrease during
the cleaning cycles, be sure to secure the bottles to avoid
tilting.
- During the described cleaning process above, some
foaming might occur on the aspiration needle. Remove
foam with a soft tissue.
- In case of heavy contaminated systems, it is recommended
to warm the detergent to 45-55 °C prior to cleaning the
system.
- Only the Hypochlorite Cleaner has the ability to act as a
disinfectant, significantly reducing the number of viable
microorganisms.
- It is recommended to check calibration by running a
control after cleaning.
Precautions
-Boule Hypochlorite Cleaner (2%) contains sodium
hypochlorite (2%). The solution is skin irritating and
causes serious eye irritation. It is marked with a hazard
pictogram. The other two solutions do not contain
chemicals at a level considered to be hazardous to health.
However, all solutions should be handled with proper care,
and skin and eyes should be protected. Please read the SDS
before use. Since hypochlorite solutions are oxidizing with
a basic pH, avoid contact with materials other than those
indicated in the instructions (spills give a remaining smell
on e.g. skin and stains (bleaching) on clothes etc).
-The concentration of hypochlorite decreases with time
without invalidation of the functionality within the given
expiry. Close the container as soon as possible after use.
-Cleaners should only be used before stated expiration date.
The cleaners should be disposed of according to local
regulations. When draining through the sewage system,
always use plenty of water.
ORDERING INFORMATION AND SERVICE
Contact your local distributor for orders and support. Please have the
product number ready for orders. For other assistance contact Boule
Medical AB at phone +46 8 7447700, fax +46 8 7447720 or
For translation of this instruction and explanation to symbols see
www.medonic.se/support/.
Ordering no: Description Packaging
1504111 Boule Cleaning Kit 3 x 450 ml

Instructions for Use
Boule Cleaning Kit Medonic
Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: info@boule.com
www.boule.com
11452-4
2019-06-18
1504093
Medonic M-Series M32
Intended Use
The Boule Cleaning Kit is intended for use with the Medonic M-
Series Hematology Systems. The kit contains 3 different cleaning
solutions as indicated on their labels. Using this cleaning kit at the
stated regular intervals will ensure:
-Longer lifetime of instrument tubing
-Lower risk of bacterial grow
-Lower background counts
-Increased mean time between failure (higher MTBF)
Contents
1. Enzymatic Cleaner, 450 mL, blue-colored solution
2. Hypochlorite Cleaner; 450 mL, yellow-colored solution
3. Detergent Cleaner, 450 mL, red-colored solution
The contents can be used for three full and complete cleaning cycles.
Remaining cleaning solution should be disposed of.
Storage and stability
The Boule Cleaning kit can be transported at ambient temperature
(avoid freezing, allow adaption to room temperature before use).
Always store the bottles in an upright position to avoid any leakage
from the cap.
Cleaning Interval
It is recommended to use the cleaning kit at the following time
intervals:
Less than 50 samples/day →every 6 months
More than 50 samples/day →every 3 months
100-200 samples/day →every month
Procedure
It is very important that the cleaning procedure is performed in the
correct order (or it may result in high PLT background counts).
The following order must be followed:
1) Enzymatic Cleaner (enzyme solution - blue cap)
2) Hypochlorite (2% solution - white cap)
3) Detergent Cleaner (detergent solution - red cap)
Proceed as follows:
1. Firstly, remove the diluent and lyse level sensors from their
containers.
2. Press [Main menu] on the touch screen, then
[Maintenance], and then the arrow [>] to enter the
Cleaning Menu.
3. Press [Clean Empty] and wait for the system to empty.
4. Wet a soft tissue with the proper cleaning solution (e.g. the
first time use Enzymatic Cleaner) and wipe both level
sensors clean on the outside. Then insert both level sensors
directly into the cleaning solution bottle.
5. From Cleaning Menu press [Clean Fill]. Allow the system
to fill up with the cleaning solution and wait 15-30 minutes for
the cleaner to work.
6. Remove both level sensors and press [Clean Empty].
Allow the system to empty completely.
7. Repeat step 4 to 6 using the Hypochlorite (white) followed
by the Detergent Cleaner (red).
8. Finally take a soft tissue and wet it with Diluent (not Lyse)
and wipe off any remaining cleaner from the level sensors.
Make sure that a soft and dry tissue is used to dry the level
sensors from all remaining liquid. When level sensors are
clean insert both back into the original reagent containers.
(Be sure not to interchange the Diluent and Lyse level
sensors.)
9. From Cleaning Menu press [Clean Fill], wait until this
cycle is completed.
10. The background count should not exceed the recommended
values, which is stated in the User manual. Perform a
minimum of 3 background counts before analyzing the
next sample.
Notes
- As the volume in the cleaning bottles will decrease during
the cleaning cycles, be sure to secure the bottles to avoid
tilting.
- During the described cleaning process above, some
foaming might occur on the aspiration needle. Remove
foam with a soft tissue.
- In case of heavy contaminated systems, it is recommended
to warm the detergent to 45-55 °C prior to cleaning the
system.
- Only the Hypochlorite Cleaner has the ability to act as a
disinfectant, significantly reducing the number of viable
microorganisms.
- It is recommended to check calibration by running a
control after cleaning.
Precautions
-Boule Hypochlorite Cleaner (2%) contains sodium
hypochlorite (2%). The solution is skin irritating and
causes serious eye irritation. It is marked with a hazard
pictogram. The other two solutions do not contain
chemicals at a level considered to be hazardous to health.
However, all solutions should be handled with proper care,
and skin and eyes should be protected. Please read the SDS
before use. Since hypochlorite solutions are oxidizing with
a basic pH, avoid contact with materials other than those
indicated in the instructions (spills give a remaining smell
on e.g. skin and stains (bleaching) on clothes etc).
-The concentration of hypochlorite decreases with time
without invalidation of the functionality within the given
expiry. Close the container as soon as possible after use.
-Cleaners should only be used before stated expiration date.
The cleaners should be disposed of according to local
regulations. When draining through the sewage system,
always use plenty of water.
ORDERING INFORMATION AND SERVICE
Contact your local distributor for orders and support. Please have the
product number ready for orders. For other assistance contact Boule
Medical AB at phone +46 8 7447700, fax +46 8 7447720 or
For translation of this instruction and explanation to symbols see
www.medonic.se/support/.
Ordering no: Description Packaging
1504111 Boule Cleaning Kit 3 x 450 ml

Instructions for Use
Boule Cleaning Kit Medonic
Boule Medical AB
Domnarvsgatan 4
SE-163 53 Spånga, Sweden
E-mail: info@boule.com
www.boule.com
11452-4
2019-06-18
1504093
Medonic CA620 and CA530
Intended use
The Boule Cleaning Kit is intended for use with the Medonic
Hematology Systems CA620 and CA530. The kit contains 3
different cleaning solutions as indicated on their labels. Using this
cleaning kit at the stated regular intervals will ensure:
-Longer life time of instrument tubing
-Lower bacterial grow risk
-Lower background counts
-Increased mean time between failure (higher MTBF)
Contents
1. Enzymatic Cleaner, 450 mL, blue-colored solution
2. Hypochlorite Cleaner; 450 mL, yellow-colored solution
3. Detergent Cleaner, 450 mL, red-colored solution
The contents can be used for three full and complete rinsing cycles.
Remaining cleaning solution should be disposed of.
Storage and stability
The Boule Cleaning kit can be transported at ambient temperature
(avoid freezing, allow adaption to room temperature before use).
Always store the bottles in an upright position to avoid any leakage
from the cap.
Cleaning interval
It is recommended the following time intervals:
Less than 50 samples/day →every 6 months
More than 50 samples/day →every 3 months
100-200 samples/day →every month
Procedure
It is most important that the cleaning procedure is performed in the
correct order (or it may result in high PLT background count).
The following order must be followed:
1) Enzymatic Cleaner (enzyme solution - blue cap)
2) Hypochlorite (2% solution - white cap)
3) Detergent Cleaner (detergent solution - red cap)
Proceed as follows:
1. Firstly, remove the diluent and lyse probes from their
containers. (Note. Do NOT use any of the Cleaning Kit
solutions in the Detergent inlet. The Detergent probe shall
be left in its container during this whole procedure.)
2. Go to menu 8.3 ‘Empty System’ and press <ENTER>.
Wait for the system to empty.
3. Wet a soft tissue with the proper cleaning solution (e.g. the
first time use Enzymatic Cleaner) and wipe both level
sensors clean on the outside. Then insert both level sensors
directly into the cleaning solution bottle.
4. Go to menu 8.2 ‘Fill System’ followed by <ENTER>.
Allow the system to fill up with the cleaning solution and
wait 15-30 minutes for the cleaner to work.
5. Remove both probes and go to menu 8.3 ‘Empty System’
and press <ENTER>. Allow the system to empty
completely.
6. Repeat step 3 to 5 using the Hypochlorite (white) and then
followed by using the Detergent cleaner (red).
7. Finally take a soft tissue and wet it with diluent (not lyse)
and wipe off any remains of the cleaners from the probes.
When probes are clean insert both back into the original
reagent containers. (Be sure not to interchange the diluent
and lyse probes.)
8. Go to menu 8.2 ‘Fill System’ followed by <ENTER> and
wait until this cycle is finished.
9. Go to menu 6.2 ‘HGB photometer adjustment’ and press
digit ‘1’ on the keyboard for the photometer to
automatically adjust and wait until this cycle is finished.
10. The background (blank) count should not exceed the
recommended level as stated in the user’s manual. Perform
a minimum of 3 background (blank) counts before running
the next sample.
Notes
- As the volume in the cleaning bottles will decrease during
the cleaning cycles, be sure to secure the bottles to avoid
tilting.
- During the described cleaning process above, some
foaming might occur on the aspiration pipette; remove
such with a soft tissue.
- In case of heavy contaminated systems, it is recommended
to warm the detergent to 45-55 ° C prior to cleaning the
system.
- Only the Hypochlorite Cleaner has the ability to act as a
disinfectant, significantly reducing the number of viable
microorganisms.
- It is recommended to check calibration by running a
control after cleaning.
Precautions
-Boule Hypochlorite Cleaner (2%) contains sodium
hypochlorite (2%). The solution is skin irritating and
causes serious eye irritation. It is marked with a hazard
pictogram. The other two solutions do not contain
chemicals at a level considered to be hazardous to health.
However, all solutions should be handled with proper care,
and skin and eyes should be protected. Please read the SDS
before use. Since hypochlorite solutions are oxidizing with
a basic pH, avoid contact with materials other than those
indicated in the instructions (spills give a remaining smell
on e.g. skin and stains (bleaching) on clothes etc).
-The concentration of hypochlorite decreases with time
without invalidation of the functionality within the given
expiry. Close the container as soon as possible after use.
-Cleaners should only be used before stated expiration date.
The cleaners should be disposed of according to local
regulations. When draining through the sewage system,
always use plenty of water.
ORDERING INFORMATION AND SERVICE
Contact your local distributor for orders and support. Please have the
product number ready for orders. For other assistance contact Boule
Medical AB at phone +46 8 7447700, fax +46 8 7447720 or
For translation of this instruction and explanation to symbols see
www.medonic.se/support/.
Ordering no: Description Packaging
1504111 Boule Cleaning Kit 3 x 450 ml
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