Rack for Containers Loading Manual

These instructions apply to:

Product

Rack Rack for containers WD 200

Material

643019

Document | Version

1007-4247 | 02

Language

EN-US English

Month | Year

12 | 2020

Copyright

2020 © Belimed AG

Rack for containers WD 200 | © Belimed

Content 1

Introduction

4

1.1

Purpose of these instructions... 4

1.2

Target group... 4

1.3

Changes and copyright... 4

1.4

Symbols and notices used... 4

2

Safety instructions

2.1

Declaration of conformity... 6

2.2

General safety instructions

2.2.1

Instructing Personnel... 6

2.2.2

Loading... 6

2.2.3

Resolve the error and repair... 6

2.2.4

Servicing the rack... 6

2.3

Intended use... 6

2.4

Warranty... 7

2.5

Personnel requirements... 7

2.6

Summary of the safety instructions... 8

6 ...6

3

Description

3.1

Option... 10

10

4

Loading

11

5

Maintenance and cleaning work

13

5.1

Optimize cleaning performance... 15

6

Disposal

16

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Rack for containers WD 200 | © Belimed

1

Introduction

1.1

Purpose of these instructions These instructions inform the operator how to safely and correctly load the racks. This manual constitutes a component of the product and must therefore be stored together with the product at a suitable location which is easily accessible for the operator.

1.2

Target group Instructions are a component of the product. The instructions are addressed to the following persons: •

Operator

 Read the instructions completely before working with the product.  Understand the instructions before working with the product.  Ensure that the instructions are accessible with the product at all times.

1.3

Changes and copyright The text, graphics, and data contained here represent the technical status of the product at the time of printing of this manual. Changes due to further development may occur. The original version of this document is in German (DE). This manual, including all parts thereof, are protected by copyright law. Utilization of any kind, whether for duplication, translation, or processing in other media, is not permissible without the consent of Belimed AG. The content of this manual must not be used for commercial purposes.

1.4

Symbols and notices used The following symbols and notices are used to indicate precautionary measures for handling and for occupational safety that are important to avoid harm to health and life. DANGER Indicates hazard with high risk If the hazard is not avoided, it will lead to death or serious injury. Possible consequences of the hazard.  Work steps to avoid the hazard.

WARNING Indicates hazard with medium risk If the hazard is not avoided, it can lead to death or serious injury. Possible consequences of the hazard.  Work steps to avoid the hazard.

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Rack for containers WD 200 | © Belimed

Introduction

CAUTION Indicates hazard with low risk If the hazard is not avoided, it will lead to minor or moderate injury. Possible consequences of the hazard.  Work steps to avoid the hazard.

NOTICE Warning of damage to property If warnings are not heeded, this can lead to damage to the product or nearby objects. Possible consequences of the warning.  Work steps to avoid damage to property.

TIP Tips for use Tips for use and useful information on the best possible utilization.  Helpful action.

 Work step, perform in sequence.  Partial work step, perform according to sequence. – Reaction to the completed work step. – – Reaction to all work steps. 1 Position numbers that refer to diagrams. 2 •

Indicates a list. •

Indicates a subsection of a list.

• ‹ › indicates a software text and proper noun.

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Rack for containers WD 200 | © Belimed

2

Safety instructions

2.1

Declaration of conformity With the EC Declaration of Conformity and the CE mark, Belimed AG affirms that this product complies with the essential health and safety requirements.

2.2

General safety instructions The machine and accessories may only be operated in faultless condition, which is why the following safety instructions must be complied with to avoid risks to patients and operators.

2.2.1

Instructing Personnel  Only allow trained and authorized personnel to operate the machine and auxiliaries.  Wear the required personal protective equipment, e.g., protective goggles, protective gloves, while operating the machine and during inspections and cleaning work.  Keep body parts and clothing away from automatically moving parts.  Always mop up and dry wet floors immediately.  In case of eye or skin contact with escaping fluids or steam, immediately rinse with clear water and consult a doctor.

2.2.2

Loading  Wear the required personal protective equipment, e.g., protective goggles and protective gloves, when handling the wash items.  Use the appropriate loading and unloading equipment for transporting, loading, and unloading the wash items.  Take care when transporting the wash items after completion of the cleaning process. The wash items and the racks are hot. Wear protective gloves and apron when loading or unloading.  Observe recommended loading heights.  Make sure that all medical devices to be cleaned can be optimally rinsed on all sides by the water.  Observe the loading pattern defined in the scope of the validation.

2.2.3

Resolve the error and repair  If errors or damage occur, the supervisor must be informed.  Errors may only be resolved by Belimed-Service or personnel trained and authorized by Belimed AG.  Do not perform any unauthorized repairs, changes, or manipulation in or on the product.

2.2.4

Servicing the rack  Allow the rack to cool down prior to implementation of inspection and cleaning work.  Extensive maintenance work may only be performed by personnel trained and authorized by Belimed AG.

2.3

Intended use The rack is intended for use with washer-disinfectors only. The rack is only intended and approved for the applications specified in this Loading Manual, namely for the cleaning and disinfection of:

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Rack for containers WD 200 | © Belimed

Safety instructions

•

DIN sterilization containers

•

AESCULAP Aicon® sterilization containers

All other applications are considered to be non-intended use.  Use suitable transport carts.  Coordinate the sizes of the sterilization containers and the racks with each other. Height [mm]

Depth [mm]

Width [mm]

Sterilization containers per rack [units]

185

600

300

2

Table 2-1 External dimensions and number of sterilization containers

2.4

Warranty The product must only be installed and commissioned by personnel employed by Belimed AG or personnel who have been trained by Belimed AG. Belimed AG accepts no responsibility for work performed by personnel neither directly employed by Belimed AG, nor trained by Belimed AG. No repairs or modifications in or on the product must be carried out by non-authorized personnel. Unauthorized repairs and modifications exclude any liability of the manufacturer for resulting damage to the operator and the product. Furthermore, modifications that affect operation may violate local laws and jeopardize insurance coverage in the event of malfunction. Repairs and modifications must only be carried out by personnel either directly employed by Belimed AG or trained by Belimed AG. Improperly executed repairs and modifications can entail considerable danger to both patient and operator; moreover, such actions will void the warranty claim. Furthermore, no warranty service is provided for defects caused by non-compliance with these instructions, improper use or normal wear and tear of the product. Defective components must only be replaced by original spare parts from Belimed. Only if original spare parts are used can it be ensured that the spare parts meet safety requirements. If spare parts are used that neither originate from Belimed AG, nor have not been approved by Belimed AG, the warranty is rendered void.

2.5

Personnel requirements The operating facility must ensure that this product is only operated by trained persons. Operators must have the following knowledge: •

Authorized by the operating facility.

•

Responsibilities clearly defined by the operating facility.

•

Appropriately trained.

•

Thoroughly familiarized with the product.

•

Demonstrated required technical expertise.

•

Necessary prerequisites and required means to properly execute the tasks.

•

Read and understood these instructions in full.

The operating facility clearly defines responsibilities for the operation, inspection, and cleaning work. The operating facility regularly checks compliance with the responsibilities. Non-compliance may lead to hazards for patients and operators.

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Safety instructions

2.6

Rack for containers WD 200 | © Belimed

Summary of the safety instructions Summary of all safety instructions for safe operation of the product. Safety instructions are listed in all places where hazards may arise.  Always follow the safety instructions!  Read, understand, and follow the safety instructions. DANGER Risk of infection due to contaminated racks The rack can be contaminated by the last work processes.  Wear personal protective equipment, e.g., protective gloves.  Disinfect the entire rack before disposal.  If there are technical defects, a manual chemical disinfection must be carried out.

WARNING Risk of infection due to incorrect reprocessing Incorrect reprocessing of the medical devices leads to an inadequate cleaning result, entailing an infection hazard.  It is obligatory to observe the reprocessing instructions of the medical device manufacturer.  Only prepare devices that have been recommended and released by the manufacturer for reprocessing in the washer-disinfector.

WARNING Risk of infection due to soiled wash items Contaminated wash items can lead to life-threatening infections.  Wear the required personal protective equipment, e.g., protective goggles, protective gloves, etc.  Follow local work instructions.

WARNING Risk of infection due to residues Residual contamination can lead to infections.  Wear the required personal protective equipment, e.g., protective goggles, protective gloves, etc., while performing inspection and cleaning work.

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Rack for containers WD 200 | © Belimed

Safety instructions

WARNING Risk of infection due to irregular maintenance For safe and reliable operation, regular maintenance by Belimed-Service is required.  Have regular maintenance work carried out by Belimed-Service.

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Rack for containers WD 200 | © Belimed

3

Description

1

2

4 Fig. 3-1 Rack

1 Handle 2 Rotating nozzle 3 Roller 4 Coding magnet (option)

3.1

Option Coding magnets are optionally included with the rack.  Manually install coding magnets depending on the load.

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Rack for containers WD 200 | © Belimed

4

Loading WARNING Risk of infection due to soiled wash items Contaminated wash items can lead to life-threatening infections.  Wear the required personal protective equipment, e.g., protective goggles, protective gloves, etc.  Follow local work instructions.

WARNING Risk of infection due to irregular maintenance For safe and reliable operation, regular maintenance by Belimed-Service is required.  Have regular maintenance work carried out by Belimed-Service.

CAUTION Risk of infection due to inadequate pre-cleaning Inadequate pre-cleaning can lead to deficient reprocessing.  Prior to loading for thermal disinfection, ensure that all manual pre-cleaning steps have been carefully carried out according to the description in the instructions for use of the manufacturer.

NOTICE Risk of damage due to incorrect loading and unloading Incorrect loading and unloading of the machine can lead to damage.  Follow the user manual for the machine.  Follow the loading manual for the rack.

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Loading

Rack for containers WD 200 | © Belimed

1 3

2

Fig. 4-1 Example of loading of sterilization container

1 Fixing tube (option) 2 Trough 3 Cover Loading sterilization containers  Load 2 troughs 2.  Place the troughs 2 on their short sides.  Place troughs 2 with the openings facing each another in front of the rotating nozzles.  Secure the troughs 2 with the fixing tube 1 (option). – The rotating nozzle sprays into the openings of the troughs 2.  Load 2 covers 3.  Place the covers 3 on their short sides.  Position the covers 3 at an angle with their insides facing downward. – Liquids drain away.

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Rack for containers WD 200 | © Belimed

5

Maintenance and cleaning work WARNING Risk of infection due to residues Residual contamination can lead to infections.  Wear the required personal protective equipment, e.g., protective goggles, protective gloves, etc., while performing inspection and cleaning work.

CAUTION Burn hazard At the end of a program, the rack can have a temperature of up to 80°C.  Allow the rack to cool down before removing it.

1 2 3 7

6 5 4 Fig. 5-1 Removing and installing rotation nozzles, rollers, and handles

1 Knurled screw 2 Washer 3 Rotating nozzle 4 Rollers 5 Washer 6 Clamping washer 7 Handle

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Maintenance and cleaning work

Rack for containers WD 200 | © Belimed

Cleaning the rotating nozzle  Unscrew the knurled screw 1.  Remove the washer 2.  Pull out the rotating nozzle 3.  Clean the rotating nozzle 3.  Check for possible clogging.  If necessary, remove soiling with a suitable tool, e.g., a brush or needle.  Rinse with water.  Clean the knurled screw 1.  Clean the washer 2.  Replace the rotating nozzle 3 if there is significant damage.  Install in the reverse order after cleaning. Cleaning the 8 rollers  Remove the clamping washer 6.  Remove the washer 5.  Pull off the roller 4.  Clean the roller 4.  If necessary, remove soiling with a suitable tool, e.g., a brush or needle.  Rinse with water.  Clean the clamping washer 6.  Clean the washer 5.  Replace the roller 4 if there is significant damage.  Install in the reverse order after cleaning.  Check that the roller 4 moves freely. Cleaning the 2 handles  Pull off the handle 7.  Clean the handle 7.  If necessary, remove soiling with a suitable tool, e.g., a brush or needle.  Replace the handle 7 if there is significant damage.  Install the handle 7 after cleaning.

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Rack for containers WD 200 | © Belimed

5.1

Maintenance and cleaning work

Optimize cleaning performance WARNING Risk of infection due to soiled wash items Contaminated wash items can lead to life-threatening infections.  Wear the required personal protective equipment, e.g., protective goggles, protective gloves, etc.  Follow local work instructions.

WARNING Risk of infection due to incorrect reprocessing Incorrect reprocessing of the medical devices leads to an inadequate cleaning result, entailing an infection hazard.  It is obligatory to observe the reprocessing instructions of the medical device manufacturer.  Only prepare devices that have been recommended and released by the manufacturer for reprocessing in the washer-disinfector.

Optimizing cleaning performance  Select the correct program for the wash items.  Ensure the wash items are appropriate for the rack as described in Chapter 2.3 «Intended use».  Clean the rotating nozzles daily as described in Chapter 5 «Maintenance and cleaning work».  Check the docking of the rack in the machine.  Pre-treat the wash items correctly.

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Rack for containers WD 200 | © Belimed

6

Disposal DANGER Risk of infection due to contaminated racks The rack can be contaminated by the last work processes.  Wear personal protective equipment, e.g., protective gloves.  Disinfect the entire rack before disposal.  If there are technical defects, a manual chemical disinfection must be carried out.

 Dispose of the rack in a technically correct manner in accordance with the local regulations. TIP Re-using raw materials The product is no worthless waste material. If disposed of appropriately, the raw materials can be recovered and recycled.  Re-use raw materials or dispose of properly.  Follow local specifications.

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Rack for containers WD 200 | © Belimed

Disposal

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