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
info@boule.com
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

Summary

Intended Use

Kit Contents and Usage

Storage and Stability Guidelines

Cleaning Interval Recommendations

Cleaning Procedure Overview

Cleaner Order and Preparation

Specifies the correct sequence for using the Enzymatic, Hypochlorite, and Detergent cleaners and initial sensor preparation.

Execution of Cleaning Cycles

Details the step-by-step process for emptying, filling, and cleaning with each solution, including final checks.

Important Notes During Cleaning

Bottle Stability and Foaming

Addresses securing cleaning bottles to prevent tilting and managing potential foaming during aspiration.

Disinfection and System Checks

Highlights Hypochlorite's disinfectant role and recommends calibration checks post-cleaning.

Safety Precautions and Handling

Hypochlorite Cleaner Hazards

Details the skin and eye irritation risks associated with the Hypochlorite Cleaner and emphasizes SDS review.

General Handling and Disposal

Covers general solution handling, expiry dates, and disposal according to local regulations.

Ordering Information and Service

Instrument Specific Procedure Variations

Menu Navigation Differences

Notes variations in menu access for the Cleaning Menu on different Medonic M-Series models.

CA620 and CA530 Cleaning Procedure

Probe Handling and Inlet Restrictions

Instructs on probe removal, avoiding specific inlets, and handling the Detergent probe.

System Menu Operations

Details specific menu sequences (8.3, 8.2, 6.2) for system emptying, filling, and photometer adjustment.

Final Checks and Background Counts

Covers wiping probes, performing final fill cycles, and verifying background counts against manual specifications.

Overview

1. Function Description
2. Important Technical Specifications
3. Usage Features
4. General Procedure (Medonic M-Series and M32)
5. Specific Procedure (Medonic CA620 and CA530)
6. Maintenance Features

This document describes the Boule Cleaning Kit, an essential maintenance product for Medonic M-Series, M32, CA620, and CA530 Hematology Systems. The kit is designed to ensure the optimal performance and longevity of these instruments by providing a comprehensive cleaning solution.

Function Description

The Boule Cleaning Kit is specifically formulated to address common issues that can arise in hematology analyzers, such as bacterial growth, high background counts, and wear on instrument tubing. By regularly using the kit, users can maintain the accuracy and reliability of their Medonic systems. The kit consists of three distinct cleaning solutions, each with a specific role in the cleaning process:

1. Enzymatic Cleaner (blue-colored solution): This solution is designed to break down and remove protein-based contaminants and organic debris that can accumulate within the instrument's fluidic pathways. Its enzymatic action helps to dislodge stubborn residues, ensuring a thorough initial clean.

2. Hypochlorite Cleaner (yellow-colored solution): This solution contains 2% sodium hypochlorite and acts as a powerful disinfectant. It is crucial for significantly reducing the number of viable microorganisms within the system, preventing bacterial growth that can lead to inaccurate results and instrument malfunction. It also helps to oxidize and remove certain types of organic matter.

3. Detergent Cleaner (red-colored solution): The detergent solution is used to further clean and rinse the system, removing any remaining residues from the enzymatic and hypochlorite cleaners. It helps to ensure that the fluidic pathways are clear and free of any substances that could interfere with subsequent sample analysis.

The sequential use of these solutions ensures a comprehensive cleaning process, from breaking down organic matter and disinfecting to final rinsing, thereby extending the lifetime of instrument tubing, lowering the risk of bacterial growth, reducing background counts, and increasing the mean time between failures (MTBF) of the hematology system.

Important Technical Specifications

• Contents: The kit includes three bottles, each containing 450 mL of a specific cleaning solution:
  • Enzymatic Cleaner (blue cap)
  • Hypochlorite Cleaner (white cap)
  • Detergent Cleaner (red cap)
• Packaging: The kit is supplied as a package of 3 x 450 mL bottles.
• Ordering Number: 1504111.
• Storage: The kit should be stored at ambient temperature. Freezing should be avoided. Before use, allow the kit to adapt to room temperature if it has been exposed to cold. Bottles must always be stored in an upright position to prevent leakage.
• Stability: The concentration of hypochlorite in the Hypochlorite Cleaner decreases over time, but its functionality remains valid within the given expiry period. Users should close the container as soon as possible after use to maintain its efficacy.
• Hazard Information (Hypochlorite Cleaner): The Hypochlorite Cleaner contains 2% sodium hypochlorite, which is skin irritating and causes serious eye irritation. It is marked with a hazard pictogram. Users must handle it with proper care, ensuring skin and eye protection. The Safety Data Sheet (SDS) should be consulted before use. The other two solutions are not considered hazardous to health at the levels present.
• Disposal: Cleaners should be disposed of according to local regulations. When draining through the sewage system, plenty of water should be used.

Usage Features

The cleaning procedure is designed to be user-friendly, guiding the operator through a series of steps to ensure effective maintenance. The process involves interacting with the instrument's touch screen or menu system, as well as handling the cleaning solutions and level sensors.

General Procedure (Medonic M-Series and M32):

1. Preparation: Remove the diluent and lyse level sensors from their respective containers.
2. Access Cleaning Menu: Navigate to the "Cleaning Menu" via the instrument's touch screen: [MENU] -> [ADVANCED] -> [MAINTENANCE] -> [CLEANING MENU] (for M-Series) or [Main menu] -> [Maintenance] -> [>] (for M32).
3. Empty System: Press [CLEAN CYCLE EMPTY] (or [Clean Empty] for M32) and wait for the system to empty.
4. Initial Cleaning (Enzymatic Cleaner): Wet a soft tissue with the Enzymatic Cleaner and wipe both level sensors clean on the outside. Insert both level sensors directly into the Enzymatic Cleaner bottle.
5. Fill System: From the Cleaning Menu, press [CLEAN CYCLE FILL] (or [Clean Fill] for M32). Allow the system to fill with the cleaning solution and wait 15-30 minutes for the cleaner to work.
6. Empty System: Remove both level sensors and press [CLEAN CYCLE EMPTY] (or [Clean Empty] for M32). Allow the system to empty completely.
7. Subsequent Cleaning (Hypochlorite and Detergent): Repeat steps 4-6 using the Hypochlorite Cleaner, followed by the Detergent Cleaner.
8. Final Rinse: Wet a soft tissue with Diluent (not Lyse) and wipe off any remaining cleaner from the level sensors. Ensure the level sensors are completely dry before reinserting them into their original reagent containers. It is crucial not to interchange the Diluent and Lyse level sensors.
9. Final Fill and Background Check: From the Cleaning Menu, press [CLEAN CYCLE FILL] (or [Clean Fill] for M32) and wait for the cycle to complete. Perform a minimum of 3 background counts to ensure they do not exceed the recommended values stated in the User Manual.

Specific Procedure (Medonic CA620 and CA530):

1. Preparation: Remove the diluent and lyse probes from their containers. Do NOT use any cleaning kit solutions in the Detergent inlet; the Detergent probe should remain in its container.
2. Empty System: Go to menu 8.3 'Empty System' and press . Wait for the system to empty.
3. Initial Cleaning (Enzymatic Cleaner): Wet a soft tissue with the Enzymatic Cleaner and wipe both level sensors clean on the outside. Insert both level sensors directly into the Enzymatic Cleaner bottle.
4. Fill System: Go to menu 8.2 'Fill System' followed by . Allow the system to fill with the cleaning solution and wait 15-30 minutes for the cleaner to work.
5. Empty System: Remove both probes and go to menu 8.3 'Empty System' and press . Allow the system to empty completely.
6. Subsequent Cleaning (Hypochlorite and Detergent): Repeat steps 3-5 using the Hypochlorite Cleaner, followed by the Detergent Cleaner.
7. Final Rinse: Wet a soft tissue with Diluent (not Lyse) and wipe off any remaining cleaners from the probes. Ensure probes are clean before reinserting them into their original reagent containers. Do not interchange the Diluent and Lyse probes.
8. Final Fill and Background Check: Go to menu 8.2 'Fill System' followed by and wait until this cycle is finished. Then, go to menu 6.2 'HGB photometer adjustment' and press digit '1' on the keyboard for automatic adjustment. Perform a minimum of 3 background (blank) counts before running the next sample.

Maintenance Features

• Cleaning Interval: The recommended cleaning frequency varies based on sample throughput:
  • Less than 50 samples/day: Every 6 months
  • More than 50 samples/day: Every 3 months
  • 100-200 samples/day: Every month
• Order of Solutions: It is critical to follow the specified order of solutions: Enzymatic Cleaner, then Hypochlorite Cleaner, then Detergent Cleaner. Deviating from this order can lead to high PLT background counts.
• Foaming: During the cleaning process, some foaming may occur on the aspiration needle/pipette. This foam should be removed with a soft tissue.
• Heavily Contaminated Systems: For heavily contaminated systems, it is recommended to warm the detergent to 45-55 °C prior to cleaning.
• Disinfection: Only the Hypochlorite Cleaner acts as a disinfectant, significantly reducing microorganisms.
• Calibration Check: It is recommended to check calibration by running a control after cleaning to verify the system's accuracy post-cleaning.
• Bottle Security: As the volume in the cleaning bottles decreases during the cycles, ensure the bottles are secured to prevent tilting.
• Remaining Solution: Any remaining cleaning solution after three full and complete cleaning cycles should be disposed of.
• Expiration Date: Cleaners should only be used before their stated expiration date.

Boule Medonic Series Specifications

General

Brand	Boule
Model	Medonic Series
Category	Cleaning Equipment
Language	English