3
1.0 Introduction
1.1 Notes on operating instructions
●
The product ATMOS
®
Aqua clean bears CE marking according to the EC Directive of
the council for medical products 93/42/EEC and meets the essential requirements
of Appendix I of the Directive.
●
The product ATMOS
®
Aqua clean complies with all applicable requirements of the directive
2011/65/EC restricting the use of certain hazardous substances in electrical and electronic
equipment (“RoHS”).
●
The declaration of conformity and our general standard terms and conditions can be obtained
on our website at www.atmosmed.com.
●
The quality management system applied at ATMOS has been certified according to
international standards EN ISO 13485.
●
The product ATMOS
®
Aqua clean fulfils the EN 1717 by the integrated free flow outlet.
●
Prior to start-up please peruse chapter 2.0 „For your safety“, in order to be prepared for any
possible dangerous situations.
●
Subject to alterations, errors excepted.
1.2
Intended use
These operating instructions contain important notes on how to operate the ATMOS
®
Aqua clean
safely, correctly and effectively. Their reading helps to avoid risks, and also to reduce repair costs
and down-time. That increases, amongst other things, the reliability and service-life of the device.
These operating instructions serve not only for new operating personnel to be instructed in its use,
but also for use as a reference manual. Reproduction of these instructions – even in part – only with
the written permission of ATMOS.
These operating instructions must always be kept available near the device.
Care and period tests in conjunction with professional execution provide for operational safety
and readiness for use of your ATMOS
®
Aqua clean and are therefore a must besides regular
cleaning.
Repair work and period tests may be carried out only by expert personnel authorised by
ATMOS. By applying only original spare parts you will have the guarantee that operational safety,
readiness for work and the value of your ATMOS
®
Aqua clean will be preserved.
Name:
ATMOS
®
Aqua Clean
Main functions:
Device for water separation and decontamination system for
hoses used in ENT treatment units and diagnostic devices.
Med. indications/ application:
Ear irrigation, thermal nystagmus stimulation
Specification of the main function:
• The ATMOS
®
Aqua Clean separates decontaminated water
from the fresh water by the integrated free flow outlet.
• The decontamination of water and hoses is enabled by
the use of a special disinfectant (ATMOS
®
Green & Clean
WK).
Application organ:
Mouth to pharynx, auditory canal to the ear drum and the
nasal cavities
Application time:
Temporary application (less than 60 minutes)
Application site:
Application sites are clinics and practices for ENT doctors
and phoniatrists. The examination with the water separation
and decontamination system may only be executed by medi-
cally trained persons.
Contraindications:
No
The product is:
X active
□ not active
Sterility:
The water separation and decontamination system is not a
sterile product.
Single use product / reprocessing:
The device and part of the accessories are reusable. For
information on reprocessing and disinfection please see the
operating instructions.
Summary of Contents for 530.2121.0
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