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These operating instructions contain important notes on how to operate the ATMOS
®
E 201 Thorax
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 safety inspections in conjunction with professional execution provide for operational safety
and readiness for use of your ATMOS
®
E 201 Thorax and are therefore a must besides regular
cleaning.
Repair work and safety inspections 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
®
E 201 Thorax will be preserved.
●
The product ATMOS
®
E 201 Thorax bears CE marking according to the EC Directive of the
council for medical products 93/42/EEC and meets the basic requirements of annex I of this
directive.
●
The product ATMOS
®
E 201 Thorax 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 certifi ed according to international
standards EN ISO 9001 and EN ISO 13485.
●
Prior to start-up please peruse chapter 2.0 „For your safety“, in order to be prepared for any
possible dangerous situations.
1.0 Introduction
1.1 Notes on operating instructions
1.2 Intended use
1.2.1 Intended use of the ATMOS
®
E 201 Thorax
Name:
ATMOS
®
E 201 Thorax
Main function:
Digital device for mobile thoracic drainage
Medical indication/application:
Recovery of the neutral vacuum in the intra pleural cavity after the occurrence of a pneumothorax or a pleural effusion by drainage
of air and secretion.
Drainage of secretion and air after a surgical opening of the thorax.
Specifi cation of the main function:
The ATMOS
®
E 201 Thorax drainage suction unit is a digital device for mobile thoracic drainage. The device is meant for the short-
term (< 30 days) application on humans. It is portable, grid independent and has an electronic monitoring system with optical and
visual status displays. The device is applied unsterile. However, the tubing systems and the secretion canister
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, which have to be
applied with the device, are sterile single use products. All thoracic catheter / drains can be applied, which are intended for thora-
cic drainage in the intended use of the manufacturer.
Application organ:
Thorax
Application time:
Short-term use on the patient (< 30 days)
Application site:
The application site is the clinical area. The application of the device may only be applied by healthcare professionals. The secreti-
on canister and the drainage hose are sterile and disposable, and can be applied in the sterile OT area.
Contraindications:
No separate application of the canister and the hose system (this means without basic device) as gravity drainage.
No application in ambulances under emergency conditions and in the home care fi eld which is not supervised by healthcare pro-
fessionals.
No Suction of fl ammable, corrosive or explosive fl uids / gases.
The product is:
Active
Sterility:
Not for the basic unit
Single-use product/reprocessing:
Reprocessing for basic device
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Detailed information about the canister please see: Intended use and function secretion canister ATMOS
®
E 201 Thorax