Loading Manual
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Rack for instruments WD 290/390 Loading Manual
These instructions apply to:
Product
Rack Instrument Rack WD 290/390
Material
110-2075
Document | Version
1005-9416 | 03
Language
EN-US English
Month | Year
12 | 2020
Copyright
2020 © Belimed AG
Rack for instruments WD 290/390 | © 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
Maintenance and cleaning work... 6
2.3
Auxiliaries... 6
2.4
Intended use... 7
2.5
Warranty... 7
2.6
Personnel requirements... 7
2.7
Summary of the safety instructions... 8
6 ...6
3
Description
3.1
Rack with fixed levels... 12
12
3.1.1
Maximum loading height per level... 15
3.2
Racks with removable levels
3.2.1
Maximum loading height per level... 18
3.3
Options
3.3.1
WRC (Wash arm Rotation Control)... 20
3.3.2
RFID (Radio Frequency Identification)
3.4
Transport cart... 22
4
Operation
4.1
Removing levels... 25
4.2
Inserting levels... 26
4.3
Loading... 28
5
Maintenance and cleaning work
5.1
Inadequate cleaning result... 32
5.2
Wash arms... 33
... 17
... 20 ... 21
25
32
5.2.1
Slide bearings... 34
5.2.2
End caps... 35
5.3
Silicone flaps... 38
6
Disposal
41
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Rack for instruments WD 290/390 | © 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 instruments WD 290/390 | © 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 instruments WD 290/390 | © 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
Maintenance and cleaning work 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
Auxiliaries Only operate the machine with original accessories from Belimed AG. Load and clean racks as stipulated. Use the appropriate transport cart or the appropriate transport system for transporting the racks.
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Rack for instruments WD 290/390 | © Belimed
Safety instructions
Only use original spare parts from Belimed AG.
2.4
Intended use The rack is intended exclusively for use with the washer-disinfectors. The rack is only intended and approved for the applications specified in this Loading Manual, namely for the cleaning and disinfection of: •
surgical instruments and other medical devices that are correctly placed in standard sieve trays.
All other applications are considered to be non-intended use. Use suitable transport carts. Note the loading height as described in Chapter 3.1.1 «Maximum loading height per level». Note the total weight of 125 kg, including the rack, screen, and wash items.
2.5
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.
2.6
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
2.7
Rack for instruments WD 290/390 | © 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.
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Rack for instruments WD 290/390 | © Belimed
Safety instructions
WARNING Risk of infection Obstruction of the wash arm rotations or insufficient water pressure lead to an inadequate cleaning result, entailing infection hazard. Check rotation of the wash arms. Check the spray openings of the wash arms for clogging. Check that the end caps are correctly seated. Check the silicone flaps in the docking devices for damage. To avoid rinse shadows, do not place instruments on top of each other. Observe the maximum loading heights. Do not overload sieve trays and baskets.
WARNING Risk of infection Damaged silicone flaps lead to a loss of water pressure and an inadequate cleaning result, entailing an infection hazard. In this case, the rack must no longer be operated without levels docked in place. Check the silicone flaps weekly for damage or wear. Replace damaged or worn silicone flaps promptly.
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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Safety instructions
Rack for instruments WD 290/390 | © Belimed
WARNING Risk of infection Missing, damaged, or soiled end caps lead to a loss of water pressure and an inadequate cleaning result, entailing an infection hazard. Before each start of program, check the correct seating of the end caps. Do not start the washing process without end caps. Check end caps for damage and clean them on a daily basis. Replace damaged or worn end caps promptly.
WARNING Risk of infection Damaged, worn, or soiled wash arms lead to an inadequate cleaning result, entailing an infection hazard. Check wash arms for damage and clean them on a daily basis. Replace damaged or worn wash arms promptly.
WARNING Risk of infection Damaged slide bearings prevent frictionless rotation of the wash arms. This leads to an inadequate cleaning result, entailing infection hazard. Check daily that the wash arms rotate without friction.
CAUTION Crushing hazard The user’s head, hands, or arms may be injured or crushed as a result of getting caught when the transfer cart is docked. Hold the transfer cart by the handle with both hands. Keep the docking area free.
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Rack for instruments WD 290/390 | © Belimed
Safety instructions
CAUTION Injury due to heavy levels Levels are heavy and may fall down. There is a risk of damage to persons and property. Firmly hold the levels with both hands.
CAUTION Loss of small parts The centering pin is necessary to ensure an optimal cleaning result. Store the centering pin safely during inspection and cleaning work.
CAUTION Risk of infection due to wash arm clogging The loading heights are maximum values specified by Belimed AG. Overloaded standard sieve trays obstruct the wash arm rotations. This leads to an inadequate cleaning result, entailing an infection hazard. Observe the specified maximum values. To ensure the optimal wash process, the optimal loading height must be validated.
CAUTION Loss of small parts The end cap and cotter pin are necessary in order to ensure an optimal cleaning result. Store the end cap and cotter pin safely during inspection and cleaning work.
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Rack for instruments WD 290/390 | © Belimed
3
Description
3.1
Rack with fixed levels Instrument rack with fixed levels are available in 6 versions:
Fig. 3-1 Instrument rack 1 level
Fig. 3-2 Instrument rack 2 levels
Fig. 3-3 Instrument rack 3 levels
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Rack for instruments WD 290/390 | © Belimed
Description
Fig. 3-4 Instrument rack 4 levels
Fig. 3-5 Instrument rack 5 levels
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Description
Rack for instruments WD 290/390 | © Belimed
Fig. 3-6 Instrument rack 6 levels
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Rack for instruments WD 290/390 | © Belimed
Description
The following individual parts are available on a rack with fixed levels:
7 1 6
5
4
3
2
Fig. 3-7 Example of the individual parts of an instrument rack 5 levels
1 Handle area 2 RFID transponder (option) 3 Docking for machine 4 Centering device 5 Coding magnets 6 Manifold 7 Closure screw on rinsing bar connection
3.1.1
Maximum loading height per level CAUTION Risk of infection due to wash arm clogging The loading heights are maximum values specified by Belimed AG. Overloaded standard sieve trays obstruct the wash arm rotations. This leads to an inadequate cleaning result, entailing an infection hazard. Observe the specified maximum values. To ensure the optimal wash process, the optimal loading height must be validated.
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Description
Rack for instruments WD 290/390 | © Belimed
CAUTION Risk of infection due to wash arm clogging The loading heights are maximum values specified by Belimed AG. Overloaded standard sieve trays obstruct the wash arm rotations. This leads to an inadequate cleaning result, entailing an infection hazard. Observe the specified maximum values. To ensure the optimal wash process, the optimal loading height must be validated.
1
2
Fig. 3-8 Example of instrument rack 5 levels
1 Chamber roof 2 Loading height 70 mm Number of levels [units]
Loading height 2 [mm]
1
600
2
270
3
160
4
105
5
70
6
50
Table 3-1 Loading heights
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Rack for instruments WD 290/390 | © Belimed
3.2
Description
Racks with removable levels Instrument racks with removable levels are available in 2 versions:
1
Fig. 3-9 Instrument racks with 4 levels with removable levels
1 Removable levels
1
Fig. 3-10 Instrument racks with 5 levels with removable levels
1 Removable levels
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Description
Rack for instruments WD 290/390 | © Belimed
The following individual parts are available on a rack with removable levels:
1
2 8 3 7
6
5
4
Fig. 3-11 Example of the individual parts of a rack with removable levels
1 Unlocking lever 2 Handle area 3 Bayonet catch 4 RFID transponder (option) 5 Docking for machine 6 Centering device 7 Coding magnets 8 Closure screw on rinsing bar connection
3.2.1
Maximum loading height per level CAUTION Risk of infection due to wash arm clogging The loading heights are maximum values specified by Belimed AG. Overloaded standard sieve trays obstruct the wash arm rotations. This leads to an inadequate cleaning result, entailing an infection hazard. Observe the specified maximum values. To ensure the optimal wash process, the optimal loading height must be validated.
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Rack for instruments WD 290/390 | © Belimed
Description
CAUTION Risk of infection due to wash arm clogging The loading heights are maximum values specified by Belimed AG. Overloaded standard sieve trays obstruct the wash arm rotations. This leads to an inadequate cleaning result, entailing an infection hazard. Observe the specified maximum values. To ensure the optimal wash process, the optimal loading height must be validated.
1
5
4
3
2
Fig. 3-12 Rack 4 levels with removable levels
1 Chamber roof 2 Loading height 435 mm 3 Loading height 270 mm 4 Loading height 105 mm 5 Removable levels
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Description
Rack for instruments WD 290/390 | © Belimed
1
4
3
2
Fig. 3-13 Rack 5 levels with removable levels
1 Chamber roof 2 Loading height 205 mm 3 Loading height 70 mm 4 Removable levels
3.3
Options
3.3.1
WRC (Wash arm Rotation Control) TIP Activation of option by Belimed-Service This option can only be activated by Belimed-Service. Allow Belimed-Service to activate the option.
TIP RFID and options board The WRC option also requires the RFID option. WRC and RFID must be installed and activated. Install WRC and RFID with hardware and options board. Activate ‹Settings› in the menu.
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