Miele PG 8581 Додатковий документ - Сторінка 4

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Introduction

1.1. UK Distributor Information

This machine has been supplied by Eschmann Technologies Ltd.

who are the appointed distributor for the Miele Company in

the UK. All equipment supplied by Eschmann is supported by

its nationwide network of fully trained engineers, providing

prompt and reliable maintenance and repairs, using only

high quality original spare parts.

1.2. About this Supplementary

Information Document

This Supplementary Information Document has been

created to supplement the Miele PG 8581 Operating

Instructions supplied with this machine and covers the UK

requirements of HTM 01-05 and SDCEP.

It provides essential information to help you with

routine tasks and minor issues you may encounter. This

Supplementary Information Document is not intended to

replace the Miele PG 8581 Operating Instructions which

contains all the information you might require to operate

your PG 8581 Washer

Disinfector.

Intended Use

2.1. Introduction

This PG 8581 Washer Disinfector is a Class IIb medical device

(Medical Device Regulation (EU) 2017/745). It complies with

EN ISO 15883 for validation purposes.

The Washer Disinfector can be used to clean, rinse and

thermally disinfect and dry a wide range of reusable medical

devices for dental use.

Examples of instruments suitable for cleaning and

disinfecting in the washer disinfector include:

Stainless steel scalers, spatulas and haemostats,

stainless steel retractors, needle holders, skin hooks,

tissue forceps, scissors, curettes, and other stainless

steel instruments free of deep cavities.

For best results, instruments processed in the washer

disinfector should have the following properties:

• Heat resistance to a temperature up to 95˚C

• Corrosion resistance in the presence of heat and

alkalinity

The Eschmann Dental or W T D programme must be chosen

to ensure effective cleaning of instruments.

The cleaning result must ensure that items can be

disinfected correctly and subsequent sterilisation can be

carried out.

The use of a suitable carrier (basket, module, insert, etc) is

important to ensure the adequate cleaning of the load.

Only medical and dental instruments displaying the thermo-

washer symbol or possessing a manufacturer's statement of

suitability can be processed in this washer disinfector.

2.2. Liquid Chemicals & Water

Softener

The use of liquid chemicals and a water softener helps to ensure

that the water in the cleaning process is free from deposits.

Only use approved chemicals formulated for use in Washer

Disinfectors. We only recommend and supply liquid chemicals.

The recommended chemicals have been carefully selected

to provide excellent cleaning and outstanding material

compatibility with a wide range of metals and coatings.

Take care when handling chemicals as they may contain irritant or

corrosive ingredients. Always wear protective gloves and goggles.

With all chemicals and specialised products, always observe the

manufacturer's safety conditions and follow the manufacturer's

instructions.

Using unsuitable chemicals could adversely affect items being

cleaned and components in the machine. Where a cleaning

agent is recommended on technical application grounds (e.g.

a chemical), it does not imply that Eschmann or Miele takes

responsibility for the effect of the chemicals on the items

being cleaned. Be aware that changes in formulation, storage

conditions, etc. can have a negative effect on the cleaning result.

Chemicals must only be used for the purpose they are designed

for and in the situation specified. Avoid mixing with other

chemicals to avoid dangers such as chemical reactions and

material damage.

The machine is designed for operation with water, salt, and

additive chemicals only. Organic solvents must not be used in

the machine as under certain circumstances there is a danger of

explosion.

(Although this is not the case with all organic solvents, other

problems could arise with their use, for example damage to

rubber and synthetic materials).

If the chemicals are changed to a different type, it is important

to flush out the original chemicals from the machine's system. If

this is not performed, cross contamination could occur and this

may cause damage to the machine.

2.3. User Profiles

Daily Operators

Daily operators must be instructed in operating and loading the

washer-disinfector and trained regularly to guarantee safe use..

They require knowledge of automated reprocessing of

medical devices and the relevant daily and weekly testing

regimes. Refer to Appendix 5.

Administration

More advance tasks, e.g. interrupting or cancelling a

programme, require more detailed knowledge about the

machine reprocessing of medical devices.

Alterations of adaptations of the washer-disinfector, e.g.

components used or on-site conditions require additional

specific knowledge of the washer-disinfector.

Validation processes assume specialised knowledge about

machine reprocessing of medical devices, the processes

involved and applicable standards and legislation.

Administrative settings are located in the Settings menu.

MUW216743-2