Atmos S 042 NPWT, Руководство по эксплуатации, Страница: 4 / 40

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1.0 Introduction
1.1 Notes on operating instructions
These operating instructions are valid from software version 1.3.
These operating instructions contain important notes on how to operate the
ATMOS
®
S 042 NPWT safely, correctly and effectively. Their reading helps to
avoid risks, and also to reduce repair costs and down-times. This increases,
amongst other things, the reliability and service-life of the device.
Please also observe the operating instructions for the dressing kits and secre-
tion canisters. The operating instructions for the ATMOS
®
S 042 NPWT presup-
pose that their contents are known.
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, even
partial, is only permitted with written permission from ATMOS.
These operating instructions must always be kept available near the de-
vice.
Care and period tests in conjunction with professional execution provide for
operational safety and readiness for use of your ATMOS
®
S 042 NPWT 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
®
S 042 NPWT will be preserved.
§
• The product ATMOS
®
S 042 NPWT bears CE marking CE 0124 according to
the EC Directive of the council for medical products 93/42/EEC and meets the
basic requirements of Appendix I of the directive.
• The product ATMOS
®
S 042 NPWT complies with all applicable requirements
of the Directive 2011/65/EC restricting the use of certain hazardous substanc-
es in electrical and electronic equipment (“RoHS”).
• The declaration of conformity and our general standard terms and condi-
tions can be obtained on our website at www.atmosmed.com.
• The quality management system applied at ATMOS has been certified ac-
cording to international standards EN ISO 13485.
• A safe function of the system as well as the conformity with the directive
93/42/ EEC is only guaranteed when the secretion canister provided by the
manufacturer is used.
• Prior to start-up please peruse chapter 2.0 „For your safety“, in order to be
prepared for any possible dangerous situations.
1.2 Intended use (indication)
Main function: Generation of a controlled negative pressure on an acute or chronic wound.
Medical indications / application: Acute and chronic wounds.
Specification of the main function: As a result of the generated controlled negative pressure
wound secretion and infected materials are transported from the wound via a wound dressing
with a connecting hose system and is then collected in a secretion canister.
Due to the negative pressure the cell growth and the blood flow are encouraged.