Miele A 204 Injector Unit Instruction Manual

June 12, 2024
Miele

Miele A 204 Injector Unit

Product Information

The product is an Injector unit, specifically designed for use with cleaning machines. It is compatible with various cleaning machines and is suitable for cleaning ophthalmological instruments. The product comes with a set of sieves with a 5 mm mesh size. The packaging of the product should be properly disposed of.
It is important to follow the safety instructions and warnings provided in the user manual of the cleaning machine. The product should be checked before each program start, ensuring it is properly connected to the cleaning machine. Ophthalmological instruments should be classified and placed accordingly. Diamantmesser should be placed in an extended state. If there are any issues with the pH level, Miele should be contacted for analysis and resolution.

For any queries or technical problems, customers can contact Miele through the contact details provided in the Operating Instructions or visit www.miele- professional.com.

Product Usage Instructions

  1. Ensure that the product is properly connected to the cleaning machine before starting any program.
  2. Classify and place ophthalmological instruments properly.
  3. Place Diamantmesser in an extended state.
  4. If there are any pH level issues, contact Miele for analysis and resolution.

Important warnings
Information which is important for safety is highlighted in a thick framed box with a warning symbol. This alerts you to the potential danger of injury to people or damage to property.
Read these warning notes carefully and observe the procedural in‐structions and codes of practice they describe.

Notes
Information of particular importance that must be observed is high‐lighted in a thick framed box.

Additional information and comments
Additional information and comments are contained in a simple frame.

Operating steps
Operating steps are indicated by a black square bullet point.

Example

  •  Select an option using the arrow button and save your choice with OK.

Display
Certain functions are shown in display messages using the same font as that used for the function itself in the display.

Example
Settings menu.

Re-usable medical devices can be reprocessed using this mobile unit in a Miele washer-disinfector. Follow the instructions for your washer-disinfector as well as the instructions of the medical device manufacturer on how to reprocess their items by machine.
Internal cleaning and disinfection to an appropriate standard is only possible with instruments which can be sufficiently dismantled and with adequate use of injector nozzles, irrigation sleeves and adapters. The reprocessing result of the inside of instruments must be checked as necessary using a test other than a visual check.
The A 204 mobile injector unit is intended the reprocessing ophthalmic instruments only.
This mobile injector unit has two levels.
The top level is equipped with different connections for reprocessing lumened instruments, e.g. for rinsing- and suction hand pieces and cannula. Instruments are fitted in silicone holders and fittings in the rack in the mobile injector unit and secured to hose connectors. The lower level can be loaded with inserts and mesh trays for reprocessing instruments without lumen. The mesh insert in the lower level must not be removed.
Narrow lumened instruments, e.g. Sauter cannula or rinsing- and suction hand pieces, require the suds solution to be filtered. To do this the injector manifolds in the top level each have to be fitted with a Miele A 800 tubular filter. The tubular filter is supplied with its own fit‐ting instructions.

The mobile unit can be used in the following washer-disinfectors

  • PG 8582
  • PG 8582 CD
  • PG 8592

Medical devices for reprocessing are referred to as the wash load if they are not more closely defined.

Queries and technical problems
If you have any queries or technical problems that you would like to discuss please contact Miele. Contact details can be found at the back of the Operating Instructions for your Washer-Disinfector or go to www.miele- professional.com.

Items supplied

  • A 204 Mobile injector unit with two levels, height 365 mm, width 531 mm, depth 542 mm
  • with spray arm magnets for spray arm monitoring

Items supplied

  • 1 x E 476, 50 holders for micro-instruments, Ø 4 to 8 mm, for use in mesh trays with a 5 mm grid
  • 1 x E 477, 20 holders for micro-instruments, for use in mesh trays with a 5 mm grid
  • 11 x E 447, Luer Lock adapters   for Luer Lock
  • 11 x E 517, Luer Lock adapters for Luer Lock
  • 6 x E 790, 4 Luer-Lock /  Luer Lock adapters
  • 5 x E 791, 4 Luer-Lock / Luer adapters
  • 11 silicone tubes with Luer-Lock adapter for Luer-Lock , 160 mm long

Optional accessories
The following and other accessories are available to order from Miele

  • A 800, reusable tubular filter with a filtration grade of ≥ 0.07 mm, 405 mm long, Ø 22.5 mm
  • E 142, DIN mesh trays with a 5 mm grid and 2 hinged handles, height 45/55 mm, width, 255 mm, depth 480 mm
  • E 479, 50 holders for Ø 4 mm micro instruments, for use in mesh trays with a 5 mm grid

Disposal of the packing material
The packaging is designed to protect against transportation damage. The packaging materials used are selected from materials which are environmentally friendly for disposal and should be recycled.
Recycling the packaging reduces the use of raw materials in the manufacturing process and also reduces the amount of waste in landfill sites. Ensure that any plastic wrappings, bags etc. are disposed of safely and kept out of the reach of babies and young children. Danger of suffocation.

Warning and Safety instructions
To avoid the risk of accidents and damage to this mobile unit please read these instructions carefully before using it for the first time.
Keep these instructions in a safe place where they are accessible to users at all times.
Please also read the Operating instructions for your washer-dis‐infector and pay particular attention to the Warning and Safety instructions.

  • This mobile unit is only for use in the areas of application as defined in the Operating instructions. Components such as the jets must only be replaced with Miele accessories or original parts. Any other application, modification or change is unauthorized and could be dangerous.
    Miele cannot be held liable for damage caused by unauthorized use or incorrect operation.

  • Inspect all mobile units, baskets, modules and inserts daily as de‐ scribed in the “Maintenance” section in the Operating instructions for the washer-disinfector.

  • Only items which have been declared by their manufacturer as suitable for machine reprocessing may be processed. The manufac‐turer’s specific reprocessing instructions must be observed. Disposable instruments must not be put into the machine for processing.

  • Ophthalmic instruments should only by reprocessed in a washer- disinfector specifically dedicated for this application. This way there is no risk of residues from other disciplines being deposited in narrow lumened hollow instruments.
    Synthetic cover nets, e.g. Miele A2 or A3 cover nets, must not be used in this washer-disinfector.

  • When reprocessing ophthalmic instruments do not dispense rins‐ing agent.

  • The processing programme used should include thermal disinfec‐tion, and must be suitable for the material quality of the wash load.

  • The last but one and the final rinse should be carried out with dem‐ ineralised water wherever possible.

Miele cannot be held liable for damage caused by non-compliance with these Warning and Safety Instructions.
Ophthalmic instruments should only by reprocessed in a washer-disinfector specifically dedicated for this application. This way there is no risk of residues from other disciplines being depos‐ited in narrow lumened hollow instruments.
Synthetic cover nets, e.g. Miele A2 or A3 cover nets, must not be used in this washer-disinfector.
When reprocessing ophthalmic instruments do not dispense rinsing agent.

Before loading the machine and before starting a programme

  •  Check that fittings such as irrigation sleeves and injector nozzles are securely screwed into position.

Make sure that all screw connectors are fitted with injector nozzles, adapters, silicone tubes with LuerLock connectors or blind stoppers to ensure that all rinsing fittings in use are supplied with sufficient standardised pressure.
Damaged fittings such as injector nozzles, adapters and silicone tubes with Luer-Lock connectors must not be used.
Rinsing positions not in use do not have to be fitted with blind stoppers.

  • Check that spray arms are rotating freely.
  • Check spray arm jets for blockages.
  • Check that the mobile unit is correctly connected to the water sup‐ply in the washer-disinfector.

Areas of application

Loading ophthalmic instruments
For validation purposes please make sure that you follow the loading instructions given on the template.

  • To minimise the risk of injury, the mobile unit should be loaded from the back forwards and unloaded in the reverse order.
  • Before connecting hollow instruments, please make sure that all hollow sections and cannulae are free of blockages. Otherwise the cleaning solution will not be able to access all areas properly.
  • The cannulae and other hollow instruments should be flushed through with a spray of water as soon as possible after use on pa‐tients, preferably whilst still in the theatre. This is to prevent residual blood or medication causing a blockage in the narrow lumen and endangering internal cleaning.
  • Narrow lumen instruments require the suds solution to be fil‐tered prior to use. The injector manifolds should each be fitted with a A 800 tubular filter for this purpose. The tubular filter is supplied with its own instructions.
  • Instruments must not touch each other during reprocessing.

Loading lumened instruments

  • Cannulae with Luer lock connectors should be screwed into the ap‐ propriate Luer lock adapters in the top level of the mobile injector unit.

Connect cannulae with Luer connectors to the Luer lock adapter in the injector unit using a connection piece e.g. Luer lock / Luer

.

  • Screw long hollow instruments to flexible hose connectors using Luer-Lock adapters.
  • When processing hollow instruments with several connectors, such as rinsing and suction hand pieces, each connector needs to be se‐cured to a hose.
  • Hollow instruments with a  connector should be connected to the hose using an E 790 Luer lock / Luer lock connector.
  • Fit hollow instruments securely into the silicone holders on the rack in the injector unit.
  • Space the silicone holders in the rack according to the size of the instruments.
  • Unscrew hollow instruments after successful reprocessing.

Any hollow items that have become disconnected from their injector nozzles, adapters or holders during processing must be re-processed.

Mesh tray E 142 for ophthal‐mic instruments
Instruments must not touch each other during reprocessing.

  • Light, delicate instruments without lumen can be secured in the mesh tray using E 476 or E 479 silicone holders and E 477 silicone connectors.

If mesh trays are used in the lower level of the unit, E 479 silicone holders have to be used in order to hold the instruments securely.

To ensure that all surfaces are cleaned and rinsed thoroughly

  • Hinged instruments, e.g. scissors, clamps and forceps should be opened up and then placed in the tray.
  • Diamond knives must be opened up and then placed in the tray.
  • Straight instruments should also be secured using E 477 silicone connectors to prevent the risk of them slipping out during reprocessing.

Mesh trays and cassettes from other manufacturers
Non-Miele mesh trays, cassettes and other containers can be used for reprocessing instruments in Miele washer-disinfectors if they have been risk assessed and specified as suitable for such use and if reprocessing procedures have been successfully validated with their use.

Hollow instruments must be tested within the frame‐work of quality assurance tests.

  • Residual water must be expelled from hollow instruments using medical compressed air. This procedure also verifies that lumen are clear.
  • The pH value of displaced water can be checked using litmus paper (grade ≤ 0.5). The pH value should lie between 5 and 8.

If the test result is negative

  • In the event of a blockage or reduced clearance, remove the offending particles or blockage manually.

Then, even if the pH value is neutral

  • Reprocess the hollow instruments.

If the pH is still not neutral after reprocessing, contact Miele to arrange for further analysis of the problem.

Test point for measuring water pressure

The test point on the front right can be used for measuring water pressure for performance checks and for validation according to EN ISO 15883.

  • To measure water pressure replace the existing fixture with a Luer Lock adapter, e.g. E 447.

References

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