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AtmoSafe

Atmos AtmoSafe Operating Instructions Manual

English
AtmoSafe
Operating Instructions
GA1GB.220101.0
2017-02 Index: 14
Table of contents
1.0 Introduction
1.1 Notes on operating instructions ............................3
4.0 Setting up and starting up
5.0 Operation
5.2.4 Prelter ................................................................11
5.2.5 Check on supply voltage ..................................... 11
5.3 Settings ............................................................... 11
6.0 Cleaning and care
6.1 General information on cleaning and disinfection 15
7.0 Maintenance and Service .................................16
9.0 Accessories and spare parts
ATMOS
MedizinTechnik GmbH & Co. KG
Ludwig-Kegel-Straße 16
79853 Lenzkirch Germany Phone +49 7653 / 689-0 Fax: +49 7653 / 689-190
+49 7653 / 689-493 (Service Center)
atmos@atmosmed.de
www.atmosmed.com
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All rights regarding these operating instructions, in particular the right of reproduction and dissemination, and that of translation, are reserved. No part of these operating instructions may be reproduced in any form (by photostat,
microlm, or other processes) without prior written
permission of ATMOS MedizinTechnik GmbH & Co. KG or by using electronic systems processed, duplicated, or disseminated. The information contained in these operating
instructions may be changed or amended without prior
announcement and does not represent any liability on the part of ATMOS MedizinTechnik GmbH & Co. KG.
© ATMOS MedizinTechnik GmbH & Co. KG, 1999
Printed by: ATMOS MedizinTechnik GmbH & Co. KG
1.0 Introduction
!
1.1 Notes on Operating Instructions
• These operating instructions contain important notes
on how to operate the ATMOSafe safely, correctly and effectively. Therefore, they are intended not only for new
operating personnel to be instructed in its use, but also for use as a reference manual. They help to avoid risks,
and also to reduce repair costs and down-times. Further­more, reliability and service-life of the equipment will be
increased. For these reasons these operating instructions
must always be kept available near the device. Prior to rst use please peruse the chapter 2.0 “For your
safety”.
The basic principles are:
Judicious and careful work provides best protection against accidents!
Maintenance and repair work may be carried out only by
expert personnel authorised by ATMOS. In case of repairs you should insist that only original spare parts are used. You
will then have the warranty that operational safety, readiness for work and the value of your device will be preserved.
• The product ATMOafe bears CE marking CE 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 ATMOSafe 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 certied according to international standards EN
ISO 13485.
• ATMOS will supply a service manual containing detailed circuit descriptions and schematics as well as informa­tion on adjustment and servicing to service organizations authorized by ATMOS.
• Reprints (also in extracts) only with permission in written form by ATMOS.
Short cuts / symbols contained in these operating instructions:
• Indicating a list
- Subdivision of a list/activity
The recommended sequence must be followed in each
case!
) Indicating particularly important advice!
ª Describing the effect of an activity
1.2 Function
• The AtmoSafe is an electrically operated medical device, cleaning the air in medically used rooms from fume and gas constituents arising from vaporising of human or
animal tissue. This fume arises typically when using laser
or electro-surgical devices and is consisting as a rule of
water vapour, aerosol, and organic gases.
• The AtmoSafe improves the environmental conditions in the operating theatre:
- Reduction of the dust load by removing respirable particles
- Improvement of view
- Removal of foul-smelling and partly toxic organic gases
- Evacuation and ltering of hazardous bio-aerosol
(ltration of viruses)
• The AtmoSafe draws in the fume-laden air through a de-
vice positioned at the surgical application part or through a separate hose, manually held near the application part.
By means of a high-efciency lter the drawn-in air is
cleaned of the hazardous matter and returned again into the ambient air.
• Cleaning of the air refers to constituents like aerosol,
which is being retained by means of an ULPA high-ef­ciency particle lter, as well as to organic gases, which,
amongst other characteristics, feature a smell unpleasant for human beings, retained by a special gas lter.
1.3 Explanation of symbols
Caution, observe operating instructions!
Equipment safety fuse Foot switch
Potential equalisation Filter Anaesthetic-tested
Application part type CF, de-
protected
Delayed stop period Stop Display: Filter to be changed
Base ow Operation ow Alternating current
Follow operating instructions! (blue)
Start
Display: Air passage blocked
Unit must not be exposed to explosive
anaesthetic gases
Protected for use in explosive atmospheres
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2.0 For your safety
2.0 For your safety
• The AtmoSafe has been designed in accordance with IEC 601/ EN 60601. The equipment con-
forms to VDE Safety Class I. It must only be connected to a properly installed earthed socket.
• Before connecting the device it needs to be checked whether the requested mains voltage of
the device matches the mains voltage of the mains power supply.
• The AtmoSafe may be used only by trained staff under supervision (IEC 601-1 / EN 60601-1).
• Following transportation at low temperatures (<0°C) the appliance must be held for up to six
hours at ambient temperature before rst start-up. If the AtmoSafe is not acclimatized, it may not be used.
• The suction hose must never come into direct contact with the evacuation position in order to
avoid suction adherence on the tissue.
• Check device, power cable, accessories, connection cables and hoses for damage before
start-up. Defect cables and hoses must be replaced immediately. Check functions of the device prior to using it!
• Disconnection from supply network only by pulling the mains plug! First the plug is to be pulled
from the wall socket. Then disconnect the connection line from the device.
• Never touch plug or line with wet hands.
• Please observe the ambient conditions stated in the technical data (chapter 10.0).
• Pay attention to maximum stability of the installation surface.
• The device must only be operated in rooms designated for medical use. The AtmoSafe is not designed to be used in an explosion-hazardous environment. Explosion-hazardous areas
may be caused by the use of ammable anaesthetics, skin cleansing products and skin disin­fectants. The suction opening of the hose should not lie on the oor Evacuation of explosive endogenous gases (e.g. methane) from the intestinal tract is also prohibited.
• The foot switch must be suitable for use in areas subject to explosion hazards. Foot switches used on operation theatres must have a watertight switching element (IPX 8).
• This product is not re-sterilizable. Repeated reuse of components which are marked with a is forbidden. In case of repeated reuse these components lose their function and there is a high infection risk.
• The AtmoSafe may be operated only in rooms used for medical purposes, but not in areas subject to explosion hazards and in oxygen rich environments.
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• Do not allow any liquid to get into the device or be sucked in. If liquids have penetrated the device, it may not be operated again until it has been checked by the customer service centre.
• The AtmoSafe meets the immunity to interference requirements of IEC 601-1-2 / EN 60601-1-2
EMC
„Electromagnetic Compatibility – Medical Electrical Devices“.
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2.0 For your safety
• ATMOS is not liable for personal injury and damage to property if
- no original ATMOS parts are being used,
- the advice for use in these operating instructions is not being observed,
- assembly, new settings, alterations, extensions and repairs have been carried out by person-
nel not authorised by ATMOS.
Sterile
Hospital Grade
• In the surgical invasive sterile area sterile parts only may be used. Hoses, application parts, as
well as instruments, must be used either as sterile single-use part or sterilised multiple-use part.
• Power cables must correspond to the applicable national regulations. The suitability for medical applications must be ensured in particular.
• In case of leaks in the system the indication for suction adherence may fail.
• With very low power setting at the HF surgical device auto activation may possibly not function.
• In case of high electromagnetic and performance-related interference the sensitivity of auto activation must be reduced.
• Please note: A medical insulating transformer with earth leakage monitor or any similar safety system acc. to EN 60 601-1 is required, if several devices are connected over one common
power supply. The transformer must correspond to the power consumption of all the devices to be
connected.
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3.0 Intended use
Name: AtmoSafe Main functions: Smoke extraction system for use in con-
junction with smoke or gas producing medical appliances,
like laser and high-frequency surgical appliances, cauter-
ises, oscillation saw, and methods like the removal of bone
cement in revision endoprosthetics. Medical indications / application: For extraction and
ltering of evaporated burn-off products arising with thermal
medical operations by vaporisation of tissue.
For extraction and ltering of aerosols, emitted by oscillation saws (e.g. in autopsy).
For extraction and ltering of vapours arising when two com-
ponent adhesives or cement mixtures are mixed and used
(e.g. in implant surgical work). Specication of the main function: The AtmoSafe draws
in the fume-laden air through a device positioned at the sur­gical application part or through a separate hose, manually
held near the application part. By means of a high-efciency lter the drawn-in air is cleaned of the hazardous matter and
returned again into the ambient air. Cleaning of the air refers
to constituents like aerosols, which is being retained by means of an ULPA high-efciency particle lter.
Application organ: No specic application organ Application time: Short-term use on the patient
(< 30 days).
Application site: The application site is the clinical, outpa-
tient as well as the practices area. The application of the
device may only be performed by medically trained and introduced staff .
Contraindications: No application outside of the medical
sector. No suction of ammable, corrosive and explosive
substances.
The product is: X active □ not active Sterility: Not necessary Single-use product / reprocessing: The device and part of
the accessories are reusable. For information on reprocess­ing and disinfection, please see the operating instructions.
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4.0 Setting up and starting up
4.1 Illustrations
Fig. 1. AtmoSafe Overall view
Operator panel
Mains lter
 Filter locking
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4.0 Setting up and starting up
Fig. 2. Display and control elements
ON/OFF switch  Start button manual
 Stop button manuel Presetting buttons Air ow display Filter capacity display
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