Front Loading Utensil Washer Disinfector Operation , Maintenance and Installation Manual sw V4.0

Front Loading Utensil Washer Disinfector (WDF)

Operation, Maintenance and Installation Manual

Table of Contents Foreword ...2 Certifications and Compliances ...2 Quality Policy ...2 Important Warranty Reminder ...2 Malmet Head Office and Factory Contact Details ...2 Safety Instructions – Warnings ...3 Intended Use ...4 1.0 Design Parameters ...4 1.1 1.2 1.3 1.4 1.5 1.6 1.7

Operating Cycles ... 5 Chemical Dosing System ... 5 Detergent ... 5 Device Features ... 7 Control Panel ... 7 Buttons & Indicators ... 8 LCD Layout ... 8

2.0

Installation and Commissioning ...9

2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9

Installation ... 9 Service Connections ... 10 Plumbing Connections ... 10 Venting ... 11 Electrical Connection ... 11 Service Connection Points ... 12 Device Dimensions ... 13 Installation clearances ... 13 Commissioning (To only be completed by qualified persons) ... 14

3.0

Loading ... 15

3.1 3.2

Lower basket configuration ... 15 Upper basket configuration ... 16

4.0

Cycle of Operation ... 17

4.1

Release of Processed items ... 18

5.0

Maintenance ... 19

5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 5.10 5.11 5.12 5.13 5.14 5.15 5.16 5.17

Daily Maintenance (Operator) ... 19 Bi - Monthly Maintenance (Site Maintenance Technician) ... 19 Recommended Preventative Maintenance Schedule (Qualified Maintenance Personnel) ... 20 Post Maintenance or Repair Safety Checks ... 21 Door Safety Test ... 21 Cycle Operation Check ... 21 Post Maintenance and Repair of Electrical Systems ... 21 Replacement of Safety Devices ... 22 Validation... 22 Requalification ... 22 Device faults ... 22 Fault indication ... 23 Operator resettable faults ... 23 Fault list ... 24 Making equipment safe after incomplete operating cycle ... 27 Error reset ... 27 Master reset (access to load in a fault condition) ... 28

6.0

Technical Specifications ... 29

6.1 6.2 6.3

Power and Water Consumption ... 29 Device specifications... 29 Wiring Diagram (3 Phase) ... 31

Warranty Statement ... 32 Issue 4

Page 1

July 2023

Front Loading Utensil Washer Disinfector (WDF)

Operation, Maintenance and Installation Manual

Foreword In order to obtain maximum life and efficiency from your Malmet Front Loading Utensil Washer Disinfector and to aid in the safe operation of the device, please read and understand this manual thoroughly and follow all instructions before operating. This device is not intended for use by persons (including children) with reduced physical, sensory or mental capabilities, or lack of experience and knowledge. Children should be supervised to ensure that they do not play with the device. The specifications supplied in this manual were in effect at time of publication, however due to Malmet (Australia)’s policy of continuous improvement, changes to these specifications may be made at any time without notice on the part of Malmet (Australia) Pty Ltd.

Certifications and Compliances ARTG Identifier:

381412

Electrical Safety Cert:

CS10975N

Watermark Cert:

WMK26630

Quality Policy Malmet’s quality management system is certified to ISO 13485:2016 and ISO 9001:2015 and guarantees the quality of this device.

Important Warranty Reminder Should you have any problems with your device, contact the company from whom you purchased it, or Malmet (Australia) Pty Ltd. It is important that the name from whom you purchased your device and the name of the installer are recorded on the front page of this manual. The installer is responsible for the correct installation, start up and demonstrating the operation of this device. They are also responsible for issuing relevant certificates of compliance (these may differ from state to state).

Malmet Head Office and Factory Contact Details Malmet (Australia) Pty Ltd 9-11 McKay Avenue PO Box 373 LEETON NSW 2705 Telephone: +61 2 6953 7677 E-mail:

[email protected]

Website:

www.malmet.com.au

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JULY 2023

Front Loading Utensil Washer Disinfector (WDF)

Operation, Maintenance and Installation Manual Safety Instructions – Warnings Please read and understand this manual before using this device, if this device is used in a manner not specified by the manufacturer protection by the device may be impaired.

Please refer to this manual for information wherever this warning symbol is displayed –

Be aware of 240V / 415V Voltage Disconnect power when servicing Mains power ISO switch must be in an accessible position easily reached and not obstructed so device can be isolated from mains power during service For the safe use of this device the responsible body should ensure that all operators are adequately trained to operate and maintain the device in its safe use Failure to maintain device as per the requirements of this manual may impair performance Only process items listed as per the design parameters in this manual Be aware of steam discharge Utensils and racks are hot to handle Safety gloves and goggles must be worn when changing detergent Be aware of hot surfaces, pipes and hoses from steam and hot water Machine to be serviced and repaired by trained personnel Safety critical devices must only be replaced by trained personnel Plumbing service connection must comply with AS/NZS 3500.1 & AS/NZS 3500.2 Not suitable for use in the presence of flammable anaesthetic mixtures with air or nitrous oxide and mode of operation as continuous

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Front Loading Utensil Washer Disinfector (WDF)

Operation, Maintenance and Installation Manual Intended Use The Malmet Front Loading Utensil Washer Disinfector is intended to be used by health service organisation personnel for the cleaning and disinfection of medical devices during an automatic cycle of the types intended to be re-used as listed in the design parameters section of this manual.

1.0

Design Parameters

The Malmet Front Loading Utensil Washer Disinfector has been designed within the following parameters: a)

To clean and disinfect during each automatic cycle a load comprised of the following re-useable medical devices. i)

345mm/305mm/240mm/210mm/185mm/140mm/110mm/100mm/80mm bowls, dishes and receivers.

ii)

300mm/255mm/220mm/160mm Kidney dishes

iii)

Large (270mmx100mm) & Small (200mmx75mm) Procedure/Instrument trays

iv)

Utensils

b)

Baskets & racks are designed to ensure that items being processed are not dislodged during the cleaning cycle; re-useable medical devices must be loaded in the appropriate holder as per the loading specifications in this manual to ensure correct processing.

c)

The wash chamber and door are self-cleaning and do not permit water or soil to remain after a properly completed cycle. Steam disinfection ensures all internal surfaces are totally clean and safe.

d)

The wash cycle is comprised of the following stages: i)

Cold Rinse

ii)

Hot Wash

iii)

Hot Rinse

iv)

Disinfection

v)

Cool Rinse

e)

The wash times and parameters are pre-set by factory but can be customized on request.

f)

Disinfection cycle is factory pre-set to 90° for 1 minute, but is able to be set to any of the common holding times used to achieve an A₀ of 600 in accordance with AS/NZS 4187:2014, Section 6.3, Table 6.1. Disinfection can also be set to achieve a target A₀ between 600 and 5000 at a specified maximum temperature.

*The efficacy of disinfection can be impaired if soil removal is incomplete before the start of the disinfection process. Users should be aware that some medical devices might require pre-treatment such as soaking or brushing before processing. Please follow the manufacturer’s instructions when processing re-useable medical devices. **High disinfection temperatures may affect some heat sensitive reusable medical devices; ensure items are disinfected as per the manufacturer’s instructions.

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Front Loading Utensil Washer Disinfector (WDF)

Operation, Maintenance and Installation Manual 1.1

Operating Cycles

The Device has three Wash Cycle Options – Eco/Normal/Intense

Eco – Light Wash Cycle 1. 2. 3.

Cold Rinse/Hot Wash Hot Rinse/Disinfection Cool down

2 Min (Disinfection Parameters Set) 20 Sec

Normal – Standard Wash Cycle 1. 2. 3. 4.

Cold Rinse Hot Wash Hot Rinse/Disinfection Cool down

2 Min 2 Min (Disinfection Parameters Set) 20 Sec

Intense – Heavy Wash 1. 2. 3. 4. 5. Note:

Cold Rinse Hot Wash Hot Rinse Disinfection Cool down

2 Min 2 Min 2 Min (Disinfection Parameters Set) 20 Sec

These times are only the Stage specific holding times and do not include filling, heating or draining.

Wash Stages Wash cycles are comprised of the following stages:

1.2

Cold Rinse:

Initial Rinse using water below 45°C

Hot Wash:

Hot Wash at 50°C with the addition of detergent

Hot Rinse:

Hot Water Rinse

Disinfection:

Disinfection Wash as per set disinfection parameters (Factory 1 minute @ 90°C)

Cool Rinse:

Final Rinse to cool processed items below 75°C

Chemical Dosing System

The chemical dosing system ensures the correct amount of process chemicals are delivered at the correct stage during each operating cycle. Chemical addition is controlled by the automatic cycle controller and will display a fault if the incorrect amount of chemical is injected. The dosing system is designed for use with Malmet Chemical; other chemicals may impair the operation of the system.

1.3

Detergent

Malmet Washer Disinfectors are designed and tested using Malmet specific detergent. To ensure intended performance and trouble-free operation use only Malmet branded detergent, failure to use correct detergent may void warranty. The detergent system delivers 30ml of concentrated detergent during the Hot Wash stage.

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Front Loading Utensil Washer Disinfector (WDF)

Operation, Maintenance and Installation Manual Detergent replacement procedure

WARNING! SAFETY GLOVES AND GOGGLES MUST BE WORN WHEN CHANGING DETERGENT AND DISPOSING OF EMPTY CONTAINERS Current Safety Data Sheet for Malmet device Detergent is available in .PDF format from Malmet’s website. www.malmet.com.au Only use Malmet approved detergent (See technical data for detergent details) 1.

Ensure area is clear of any potential hazards

2.

Ensure you are wearing appropriate PPE

3.

Move new bottle as close as practical to unit’s detergent storage location Note: Leave cap on new bottle until in position

4.

Remove empty detergent container and sit beside new detergent container

5.

Remove lid from new container, then carefully remove suction cap and hose from old container an insert into the new container and fasten cap

6.

Place lid of old container onto empty container

7.

Put new container back into position

8.

Restart device operation as normal

Disposal of Empty Detergent Bottles

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1.

When handling empty containers treat as though container is full and wear appropriate PPE as per SDS requirements

2.

Triple rinse container and puncture base to render unusable

3.

Dispose of containers as per facility chemical waste handling procedures, and/or local government requirements

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Front Loading Utensil Washer Disinfector (WDF)

Operation, Maintenance and Installation Manual 1.4

Device Features LCD Control Panel/HMI

Wash Chamber Access Door

Service Access Panel

1.5

Adjustable Machine Feet

Control Panel

Power Button

Status LED

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Back Button

Display

Page 7

Start Button

Rotary Dial & Select Button

Cycle Indication LED Halo

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Front Loading Utensil Washer Disinfector (WDF)

Operation, Maintenance and Installation Manual

1.6

1.7

Buttons & Indicators

Status LED

RED = ORANGE = GREEN =

OFF Power On & Door Open Power On & Door Closed

POWER

On/Off (Standby)

Cancel

Cancel selection or Exit to previous Menu

Select/Rotary Dial

Pushing Down in the Rotary Dial selects the highlighted item, rotating the dial navigates or changes selected fields

Start button

Commence selected cycle

Cycle Indication LED Halo

Flashes during cycle, displays solid at cycle completion

LCD Layout Wash cycle selected

Internal chamber temperature

Status A₀ value attained during cycle

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Disinfection temperature selected Page 8

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Front Loading Utensil Washer Disinfector (WDF)

Operation, Maintenance and Installation Manual 2.0

Installation and Commissioning 2.1

Installation

For correct installation and to avoid problems with this device, please use the following Installation guidelines Installations must only be carried out by a qualified and licenced tradesperson. Services as noted as required for installation of the device are to be provided by the facility and are not the responsibility of Malmet. Overcurrent protection device - A 20A circuit breaker or fuse must be installed in the building installation for the device.

Risk Assessment It is recommended a risk assessment is conducted by the user both prior to and after installation and any risks identified mitigated to an acceptable level using the hierarchy of control;

https://commons.wikimedia.org/w/index.php?curid=55610678

Handling Weights of device:

Net: 75 kg

Shipping: 84 kg

Shipping with crating: 117 kg.

• Handling of the device to installation site must be with fork lift or hand pallet truck whilst on pallet. • Before unpacking device inspect carton for any damage relating to forklift forks and damage relating to device falling over or for evidence of top loading • After unpacking the device, inspect all external panels for damage. • Remove the 4 screws and plates holding the device to the pallet. • Follow your internal manual handling guidelines to manoeuvre the device off the pallet. The device can then be placed into position by fork lift or hand pallet truck.

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Front Loading Utensil Washer Disinfector (WDF)

Operation, Maintenance and Installation Manual Disposal of Packaging • Please dispose of packaging as per facility procedures or local government requirements.

2.1.1

Positioning the WDF-3020

Model

WDF-3020

Placement

Freestanding

Access Required

Device Dimensions Height (mm)

Width (mm)

Depth (mm)

870

600

640

Front

Please allow sufficient room at front of unit for servicing purposes.

New Buildings • Service connections are normally pre-placed after planning and consultation with all interested parties. Installation is by connection to the services provided. • As the soil line (sewerage outlet) is the least flexible of all the connections, this usually influences the decision as to where to place the Front-Loading Utensil Washer Disinfector. Device drain hose is designed to fit onto an appliance waste spigot of a standard sink trap. • Potential electromagnetic or other interference between other EQUIPMENT and other devices can possibly affect the operation. Electromagnetic interference can be prevented by installing the device in non-patient areas of the facility (or similar).

2.2

Service Connections MODEL

COLD WATER

DRAIN

ELECTRICAL

WDF-3020

Solenoid valve GB¾ Male

22mm Flexible Drain Hose

415V 3 phase @ 20 Amps 50 hertz

The following service connections must be provided by the facility for installation of the device, services must comply with the specifications as per this section of the manual to ensure correct and safe operation of the device. See the Service Connection Layout Diagram 9.6 for details of device service connection points.

2.3

Plumbing Connections

These installation guidelines must be followed to ensure the device will operate as intended. Installations must be carried out by a qualified, licensed tradesperson. Water Supply – Note: Water Supply connections must comply with AS/NZS3500.1 and be Watermark Certified.

This device requires only a potable cold-water connection; the water entry point is on the lower rear right-hand side of the device when viewed from the front. Please refer to the Service connection layout diagram for exact location. A back-flow prevention device complying to AS 2845.1 is incorporated in the device.

Cold Water – Note: See device specifications table for water quality requirements Pressure:

Issue 4

100-500kPa

Temperature: 5-25°C

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Front Loading Utensil Washer Disinfector (WDF)

Operation, Maintenance and Installation Manual Nominal Flow: 10L/Min

Connection:

GB ¾” BSP

Note: Old hose sets should not be re-used; it is recommended new compliant hose sets are used on installation. Waste Connection – Note: Waste service connection must comply with AS/NZS3500.2 The device comes fitted with a 2m drain hose, with a 22mm outlet designed to fit a standard sink trap spigot, and is high temperature rated. Do not install waste into an open sink as hot water may pose a burn risk to personnel. Ensure waste connection is rated for temperatures of not less than 90°C.

2.4

Venting

No external vent pipe work is required as the device is designed to condensate all visible steam internally.

2.5

Electrical Connection

These installation guidelines must be followed to ensure the device will operate as intended and must be carried out by a qualified, licensed electrical tradesperson. The device must be installed and serviced to national wiring rules AS/NZS 3000. Model: WDF

3 Phase

415V 50Hz

20Amp

Overcurrent protection device: A 20A circuit breaker or fuse must be installed in the building installation for the device. • Devices are supplied with 2000mm power supply cord extending from the bottom rear of the device for hard wiring into Mains ISO switch. Position switch approx. 1500mm above floor level. • An ISO switch or circuit breaker must be included in the installation (not supplied by Malmet). • Mains power ISO switch must be suitably located and easily reached, approximately 1500mm above floor level adjacent to device. The 2.0m mains power lead exits the device approximately 50mm above floor level on the left-hand side of the device (when viewed from the rear). • Mains ISO switch must be marked as the disconnecting device for the equipment. • Mains ISO switch must have contact disconnection of all poles to provide full disconnection. • Mains ISO switch must be suitably placed so device will not obstruct safe access to the isolator once installed. • Ensure isolator is suitably placed so device will not obstruct safe access to the isolator once installed. • Device must be earthed. • Malmet recommends having a 30mA RCD in the mains supply fixed wiring. If the supply cord is damaged, it shall be replaced by the manufacturer or its service agent or similarly qualified person in order to avoid any potential hazard.

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Front Loading Utensil Washer Disinfector (WDF)

Operation, Maintenance and Installation Manual 2.6

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Service Connection Points

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Operation, Maintenance and Installation Manual

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2.7

Device Dimensions

2.8

Installation clearances

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Front Loading Utensil Washer Disinfector (WDF)

Operation, Maintenance and Installation Manual 2.9

Commissioning (To only be completed by qualified persons)

a) Before switching on the device make sure the DEVICE IS LEVEL and the WATER SUPPLY IS ON. Check that the DRAIN HOSE is connected. b) Turn on the power at the isolation switch and wait for device to power up. Once device has completed powering up it will display “OFF”. Press the POWER button on the front panel to power on the device, the LCD display will illuminate and display ready. c) Open the door and check that the chamber is clear and only contains the device baskets. d) Check that the sump tank screen is in place and has not dislodged. e) Check that the process chemical suction tubes have been installed into the detergent container and rinse aid container if fitted. Device will perform a priming sequence on start, if chemicals are not correctly fitted a fault will be triggered. f) Once the above checks are completed it is recommended a cycle is run to ensure correct operation and to clean and disinfect the device prior to use. Ensure the door is closed, a positive click will be heard when the door is shut completely and “READY” will be displayed on the screen. g) Press “Start” to commence the set cycle, the door lock will engage and cycle will commence. h) The cycle will progress as per the sequence of operation steps in this manual, if the controller detects any faults during the cycle these will be displayed on the screen. Note: It is recommended Installation Qualification test are performed as per the requirements of ISO 15883.1 prior to use of the device.

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Front Loading Utensil Washer Disinfector (WDF)

Operation, Maintenance and Installation Manual 3.0

Loading For the safe use of this device the responsible body should ensure that all operators are adequately trained to operate and maintain the device in its safe use. The Malmet Front Loading Utensil Washer Disinfector has two baskets for processing of re-useable medical devices of the type listed as per the design parameters. The lower basket is intended to process bowls of various sizes, while the top basket is intended to process a combination of kidney dishes and other small utensils. Open door and pull out basket to be loaded.

UPPER BASKET

LOWER BASKET

3.1

Lower basket configuration

LOWER BASKET

Bowls, dishes, or receivers of 185mm - 345mm in diameter with a depth not greater than 120mm can be loaded in the lower basket as per the above configuration

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Front Loading Utensil Washer Disinfector (WDF)

Operation, Maintenance and Installation Manual 3.2

Upper basket configuration

UPPER BASKET Large Kidney Dish Rack

Utensil Basket

The upper basket is split into two sections, a rack in the rear half for kidney dishes from 160-300mm. And a front section which can accommodate smaller bowls, gallipots and receivers. An optional utensil basket can also be used for smaller items. NOTE: Take care when loading the top basket to ensure nothing protrudes below the basket that could potentially foul the wash arm and prevent it from turning.

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Front Loading Utensil Washer Disinfector (WDF)

Operation, Maintenance and Installation Manual 4.0

Cycle of Operation • The operation can be stopped at any time by pressing the Power button to the left of the display • In an emergency power, off and isolate device at isolator/circuit breaker

1. Press the POWER button; to wake the device from Stand-by mode:

Stand-by

After a short delay display will show READY

Ready

2. Open door; and load items to be processed; display will show:

Door Open

3. When door is closed; display will show:

Ready

4. To start cycle press the start button; the door will lock, the cycle indication LED Halo around the start button will begin to flash green and the display will show each cycle stage as the automatic cycle is completed:

Cold Rinse

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Front Loading Utensil Washer Disinfector (WDF)

Operation, Maintenance and Installation Manual Cycle of Operation cont’d 5. Hot Wash; display will show:

Hot Wash

6. Disinfection; display will show:

Disinfection

7. Cool rinse; display will show:

Cool Rinse

8. Cycle Completion; on successful cycle completion the door will unlock, the cycle indication LED Halo around the start button will display solid green; display will show:

Cycle Finished

Note: The cycle summary information will remain on the screen until the door is opened for manual recording purposes. This information can be accessed through the operator level menu for the previous 5 cycles if required.

4.1

Release of Processed items

On completion of the cycle, it is recommended that all processed items are unloaded and visually inspected as clean as per the requirements AS/NZS 4187. It is recommended all items are removed on completion of the cycle and stored in a designated area to prevent any risk of contamination or mixing with unprocessed items.

If the processing status of a load or item is unknown or in question, it should be treated as unprocessed and not released.

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Front Loading Utensil Washer Disinfector (WDF)

Operation, Maintenance and Installation Manual 5.0

Maintenance All maintenance; preventative or breakdown shall be carried out by a qualified person. Failure to comply with this condition may result in unsafe conditions. Preventative maintenance must be completed as per instructions below. Failure to comply may result in warranty claims being rejected. The Malmet Front Loading Utensil Washer Disinfector is self-cleaning; however, proper care should be taken to ensure that the device is cleaned and maintained in accordance with maintenance instructions, regulatory requirements and common-sense practices.

5.1

Daily Maintenance (Operator)

a) Run the device through a cycle to bring to operating temperature and disinfect the internal wash chamber area (do not load any items). b) Wipe out the inside of the door and chamber with warm water and detergent. A wipe with disinfectant is also desirable. c) Wipe over external stainless-steel panels with a stainless-steel cleaner (do not get cleaner on the control panel). d) Wipe the front control panel with a soft cloth and mild detergent as necessary. Care should be taken not to damage the digital display or to activate a cycle (turn off power at control panel). e) Check tank mesh filter, remove and clean mesh filter of contaminates and dispose of as per facility biological waste disposal process. (Recommended minimum PPE: Gloves & Eye Protection) f) Check level in detergent bottle, replenish as necessary.

g) Visually inspect for signs of leaking fluid from the device, as these may pose a pathogenic risk. Inspect around the chamber door, beneath the device and service connection points. If a spill or leak is observed, clean up as per the facility’s infection control procedure and notify a maintenance technician to fix the cause of the leak.

5.2

Bi - Monthly Maintenance (Site Maintenance Technician)

WARNING 240/415 VOLTS! ISOLATE DEVICE FROM ELECTRICAL SUPPLY BEFORE SERVICING

HOT SURFACES! ALLOW DEVICE TO COOL PRIOR TO COMMENCING SERVICE WORKS a) Inspect for steam or fluid leaks, tighten hose clamps and glands where necessary. b) Check wash arms for free rotation. c) Check spray nozzles in wash arms are not blocked, insert a small pin into the orifice of the spray nozzle to ensure no blockages are present. If a build-up or blockage is detected, a technician should clean nozzles as per cleaning instructions below to ensure adequate performance. d) Remove temperature probe and clean off any residue or build up. e) Visually inspect build-up of residue in tank, especially in locations with poor water quality. f) Check filter in the water inlet solenoid valve and clean as necessary.

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