Atmos S 201 Thorax User manual

E349855
GA1GB.710201.0
2023-09 Index: 45
Operating Instructions
ATMOS S 201 Thorax
English
These operating instructions are valid from software version 3.0.54

2
Table of contents
1.0 Introduction.....................................................4
1.1 Notes on operating instructions ...................................... 4
1.2 Explanation of pictures and symbols .................................. 5
1.3 Intended purpose .................................................. 8
1.3.1 Intended purpose ATMOS S 201 Thorax ............................... 8
1.3.2 Intended purpose secretion canister 2 l (REF 312.1150.5)
and secretion canister 2 l without water lock (REF 312.1140.0) ............ 9
1.3.3 Intendedpurposesecretioncanister2lStandard(REF312.1120.0) ....... 11
1.3.4 Intended purpose hose system...................................... 12
1.4 Function ......................................................... 15
1.5 Transport and storage ............................................. 15
2.0 For your safety .................................................16
2.1 General safety instructions ......................................... 16
2.2 Danger for users, patients, and third parties .......................... 16
2.3 Avoiding damage to the device...................................... 20
2.3.1 General information ............................................... 20
3.0 Setting up and starting up .......................................22
3.1 Scope of delivery .................................................. 22
3.2 Device overview................................................... 22
3.3 Start-up.......................................................... 24
3.3.1 Battery charging. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
3.3.2 Secretion canister ................................................. 25
3.3.3 Connecting the hose system ........................................ 28
3.4 Hybrid option REF 312.1090.0....................................... 28
3.4.1 Prerequisites for operating the secretion canister
for temporary gravity drainage with the device switched o.........29
3.4.2 Filling the water lock ............................................... 29
3.4.3 Leakage test ...................................................... 29
3.4.4 Switching from active drainage to passive gravity drainage .............. 30
4.0 Operation ......................................................31
4.1 Explanation of the display .......................................... 31
4.2 Buttons and display symbols ....................................... 32
4.2.1 Buttons .......................................................... 32
4.2.2 Display symbols ................................................... 33
4.3 Explanation of the display in key lock modes .......................... 33
4.3.1 Key lock mode with bubbles ........................................ 33
4.3.2 Key lock mode with bar chart ....................................... 33
4.4 Switching on...................................................... 34
4.5 Leakage test ...................................................... 34
4.6 Function ......................................................... 36
4.6.1 Target vacuum .................................................... 36
4.6.2 Gravity drainage mode ............................................. 36
4.6.3 Suction .......................................................... 37
4.7 Key lock.......................................................... 38

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4.8 Therapy process .................................................. 39
4.8.1 Short time display ................................................. 39
4.8.2 Long time display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
4.8.3 Transfer of therapy data............................................ 41
4.8.4 Reading out the therapy data ....................................... 42
4.9 User settings ..................................................... 43
4.10 Switchingothedevice ............................................ 46
5.0 Warning messages ..............................................47
6.0 Function .......................................................50
6.1 Hose rinsing ...................................................... 50
6.2 Gravity drainage mode while using the drainage system ................ 50
6.3 Operation of the secretion canister for temporary gravity drainage ...... 50
7.0 Accessories, consumables, and spare parts ........................52
7.1 Attachment of the universal bracket (accessories) ..................... 53
7.2 Attaching the carrying strap ........................................ 53
8.0 Cleaning and care ...............................................54
8.1 General information on cleaning and disinfection...................... 54
8.2 Cleaning the device surface......................................... 55
8.3 Cleaning the device surface......................................... 55
8.4 Recommended disinfectants........................................ 55
8.5 Hygiene plan ..................................................... 56
9.0 Maintenance and service ........................................57
9.1 Basic instructions ................................................. 57
9.2 Repairs .......................................................... 57
9.3 Sending in the device .............................................. 57
9.4 Handling of batteries .............................................. 57
9.5 Changing the fuse ................................................. 58
10.0 Troubleshooting ................................................59
11.0 Technical data ..................................................61
11.1 ATMOS S 201 Thorax............................................... 61
11.2 Secretioncanister2l .............................................. 62
11.3 Hose system...................................................... 63
12.0 Disposal/recycling ..............................................65
12.1 Expected service life ............................................... 65
13.0 Notes on EMC (Electromagnetic compatibility) .....................66
13.1 Guidance and manufacturer’s declaration – ambient conditions ......... 66
13.2 Guidance and manufacturer’s declaration – key features................ 66
13.3 Guidance and manufacturer’s declaration – warnings .................. 66

4
§
1.0 Introduction
1.1 Notes on operating instructions
These operating instructions are valid from software version
3.0.54.
These operating instructions contain important notes on
how to operate the ATMOS S 201 Thorax safely, correctly and
eectively.
These operating instructions serve not only for new operating
personnel to be instructed in its use, but also for use as a
reference manual. This document may only be reprinted, either
in part or in whole, with written permission from ATMOS.
These operating instructions must always be kept
available near the device.
Care and periodic tests in conjunction with professional
execution provide for operational safety and readiness for use
of your ATMOS S 201 Thorax and are therefore a must besides
regular cleaning.
Maintenance, repairs, and periodic tests may only be carried
out by persons who have the appropriate technical knowledge
and who are familiar with the product. To carry out these
measures, the person must have the necessary test devices
and original spare parts.
• The product ATMOS S 201 Thorax bears the CE marking
CE 0124 in accordance with EU Council Directive 93/42/EEC
concerning medical devices and meets the basic requirements
of Annex I to this directive.
• The product ATMOS S 201 Thorax complies with all applicable
requirements of the directive 2011/65/EU restricting the use
of certain hazardous substances in electrical and electronic
equipment (‘RoHS’).
• The Declarations of Conformity and our General Terms and
Conditions can be viewed on our website at www.atmosmed.
com.
• The quality management system applied at ATMOS has been
certiedaccordingtointernationalstandardENISO13485.
• Prior to start-up, please peruse chapter ‘2.0 For your safety’
on page 16 in order to be prepared for any possible
dangerous situations.
These operating instructions are valid for the following devices:
ATMOS S 201 Thorax 312.1000.0
ATMOS S 201 Thorax 312.1080.0

5
1.2 Explanation of pictures and symbols
In the operating instructions
DANGER
Warning of a danger that will result in immediate fatal or serious injury. Observe the necessary
measures.
WARNING
Warning of a danger that can cause fatal or serious injury. Observe the necessary measures.
CAUTION
Warning of a danger that can cause minor injury. Observe the necessary measures.
NOTICE
Notice of a danger that can damage the product or other objects. Observe the necessary
measures.
Warning of a danger that can cause fatal or serious injury.
i
Notice of potential material damage.
Useful information on the handling of the device.
1. Action. Proceed step by step.
»Result of an action.
·General information, numeration
-Sub-numeration
click Engage,checkcorrectt.
Follow the arrows
Move, plug in this direction.
Please press where dot indicates
Activate the optional foot switch
Replace
Check

6
On device, type plate, and packaging
Follow operating instructions (blue)
Consult operating instructions
Warning, pay special attention
This device complies with the relevant requirements of EU regulations.
This device complies with the relevant requirements of EU regulations.
UL Mark
MEDICAL EQUIPMENT
withrespecttoelectricalshock,re,and
mechanical hazards only in accordance with
UL60601-1/ ANSI/AAMI ES60601-1 (2005)/
CAN / CSA – C22.2 No. 60601-1 (2008)
This device complies with the relevant requirements of the Eurasian Economic
Union.
Manufacturer
Date of manufacture
Country of manufacture
REF Article number
UDI UniqueDeviceIdentierofamedicaldevice
MD Medical device
SN Serial number
LOT Batch code
IP X0 Specicationofthedegreeofprotectionagainsttheingressofsolidsandmoisture
AppliedparttypeCFdebrillatorprotected
Professional disposal
Use-by date

7
Do not reuse
STERILE EO Sterilised using ethylene oxide
Non-sterile
Single sterile barrier system with internal protective packaging
Single sterile barrier system with external protective packaging
Protection class II device
Fuse
Do not use if the packaging is damaged and observe the operating instructions
Fragile, handle with care
Keep dry
Keep away from sunlight
Temperature limit
Humidity limitation
700
1060
Atmospheric pressure limitation
UDI application identier
(01) UDI-DI:Identicationofthemanufacturerandthedevice
(10) Batch code
(11) Date of manufacture
(13) Packing date
(17) Expiry date
(21) Serial number

8
1.3 Intended purpose
1.3.1 Intended purpose ATMOS S 201 Thorax
Product name: ATMOS S 201 Thorax
Main functions: The ATMOS S 201 Thorax is a device for mobile, digital
cardiothoracic drainage. The system generates a
controlled vacuum close to the patient and has an
electronic monitoring system which shows the actual
vacuum measured at the patient’s side and the air leak.
The objective therapy data are shown in colour on the
display in real time and in a graph of therapy process.
Error conditions are automatically indicated by visual and
acoustic warning messages.
Intended use: Restoration of the (natural) negative pressure in the
pleuralcavitybydrainingoairanduids
Intended users / user prole: • Trained physicians
• Trained healthcare professionals
Prerequisite: Users must not be hard of hearing or deaf and
must have adequate visual faculty
Intended patient target groups: Patients of all age groups with and without restrictions
Medical conditions to
be diagnosed, treated or
monitored:
Accumulatedairanduidsinthethorax(pleuralcavity,
mediastinum, pericardium) that must be drained,
monitored, and balanced in a controlled manner
Organ(s) applied to: Thorax (pleural cavity, mediastinum, pericardium)
Duration of application: For short-term application (< 30 days) on humans
Use environment: Hospital/clinic environments
Patient selection criteria: Patients who require cardiothoracic drainage (pleural,
mediastinal, pericardial drainage)
Indications: • After surgical opening of the thorax (especially after
cardiac surgical interventions)
• Pneumothorax
• Pleuraleusion
• Haemothorax
• Pleural empyema
• Chylothorax
• Other similar conditions
Medical contra-indications: • Not for cardiothoracic drainage therapy in which no
vacuum should be applied to the patient
Other contra-indications: • No separate use of the secretion canister and the hose
system (i.e., without the device) for short- or long-term
gravity drainage (more than 60 minutes)
• No application in emergency and rescue situations
• Not in the homecare area that is not supervised by
healthcare professionals
• Nodrainageofammable,corrosive,orexplosiveuids/
gases

9
Warnings: The following complications may occur during
cardiothoracic drainage:
• Pain due to irritation of the intercostal nerves
• Injury of lung parenchyma / air leak
• Reexpansion pulmonary oedema
• Eusionretention
• Tension pneumothorax
• Cutaneous/subcutaneous emphysema
The product is: active
Sterility / specic microbial
state:
• The device is used in non-sterile condition.
• A sterile secretion canister or a low-germ secretion
canister can be used
• Hose system is sterile.
Single-use device / reprocessing: • The device is intended for multiple use. The device and
part of the accessories are reusable. For information on
reprocessing, cleaning and disinfection, please see the
operating instructions.
• Secretion canister and hose system are single-use
devices.
For detailed information on the secretion canister and hose system, please refer to the
separate intended uses.
1.3.2 Intended purpose secretion canister 2 l (REF 312.1150.5) and secretion
canister 2 l without water lock (REF 312.1140.0)
Product name: Secretioncanister2l–(REF312.1150.5)
Secretioncanister2lwithoutwaterlock(REF312.1140.0)
Main functions: The secretion canister passes on the controlled vacuum
generated by the ATMOS S 201 Thorax. Fluids and air are
drained through the secretion hose and collected in the
secretioncanister.Viabalancingscales,theamountofuid
in the secretion canister is readable and documentable.
Anintegratedbacterialandvirallterprotectsthedevice
against possible contamination and oversuction. For
protectionpurposes,thepop-ovalveopensincaseof
overpressure in the secretion canister.
Cover caps ensure proper closure and disposal.
Applies exclusively to the 2 l secretion canister (REF
312.1150.5):
An optional water lock visualises the patient’s leak in
bubbles.
Intended use: Collectionofuidsandairfromthethorax.
Balancingoftheamountofuid.
Applies exclusively to the 2 l secretion canister (REF
312.1150.5):
• Optional visualisation of air leak in bubbles
• Water lock as one-way valve when using the secretion
canister and the hose system (i.e., without the device)
for temporary gravity drainage

10
Intended users / user prole: • Trained physicians
• Trained healthcare professionals
Prerequisite: Users must not be hard of hearing or deaf and
must have adequate visual faculty
Intended patient target groups: Patients of all age groups with and without restrictions
Medical conditions to
be diagnosed, treated or
monitored:
Accumulatedairanduidsinthethorax(pleuralcavity,
mediastinum, pericardium) that must be drained,
monitored, and balanced in a controlled manner
Organ(s) applied to: Thorax (pleural cavity, mediastinum, pericardium)
Duration of application: • Secretion canister with device: For short-term use on the
patient (< 30 days)
Applies exclusively to the 2 l secretion canister (REF
312.1150.5):
• Secretion canister for gravity drainage: For temporary
use on the patient (< 60 minutes)
Use environment: Hospital/clinic environments
The secretion canister and the hose system are sterile
single-use devices that can be used in the sterile operating
theatre environment.
Patient selection criteria: Patients who require cardiothoracic drainage (pleural,
mediastinal, pericardial drainage)
Indications: • After surgical opening of the thorax
• Pneumothorax
• Pleuraleusion
• Haemothorax
• Pleural empyema
• Chylothorax
• Other similar conditions
Medical contra-indications: • Not for cardiothoracic drainage therapy in which no
negative pressure should be applied to the patient
Other contra-indications: • No application with cardiothoracic drainage systems
other than ATMOS S 201 Thorax and ATMOS E 201
Thorax
• No application in emergency and rescue situations
• Not in the homecare area that is not supervised by
healthcare professionals
• Nodrainageofammable,corrosiveorexplosiveuids/
gases
Applies exclusively to the 2 l secretion canister (REF
312.1150.5):
• No separate use of the secretion canister and the hose
system (i.e., without the device) for short- or long-term
gravity drainage (more than 60 minutes)
Applies exclusively to the 2 l secretion canister without
water lock (REF 312.1140.0):
• No separate use of the secretion canister and the hose
system (i.e., without the device) for gravity drainage

11
Warnings: The following complications may occur during
cardiothoracic drainage:
• Pain due to irritation of the intercostal nerves
• Injury of lung parenchyma / air leak
• Reexpansion pulmonary oedema
• Eusionretention
• Tension pneumothorax
• Cutaneous/subcutaneous emphysema
The product is: not active
Sterility / specic microbial
state:
Secretion canister is sterile
Single-use device / reprocessing: Secretion canister is a single-use device
1.3.3 Intended purpose secretion canister 2l Standard (REF 312.1120.0)
Product name: Secretioncanister2lStandard
Main functions: The secretion canister passes on the controlled vacuum
generated by the ATMOS S 201 Thorax. Fluids and air are
drained through the secretion hose and collected in the
secretioncanister.Viabalancingscales,theamountofuid
in the secretion canister is readable and documentable.
Anintegratedbacterialandvirallterprotectsthedevice
against possible contamination and oversuction. For
protectionpurposes,thepop-ovalveopensincaseof
overpressure in the secretion canister.
Cover caps ensure proper closure and disposal.
An optional water lock visualises the patient’s air leak in
bubbles.
Intended use: • Collectionofuidsandairfromthethorax
• Balancingoftheamountofuid
• Optional visualisation of air leak in bubbles
• Water lock as one-way valve when using the secretion
canister and the hose system (i.e., without the device) for
temporary gravity drainage
Intended users / user prole: • Trained physicians
• Trained healthcare professionals
Prerequisite: Users must not be hard of hearing or deaf and
must have adequate visual faculty
Intended patient target groups: Patients of all age groups with and without restrictions
Medical conditions to
be diagnosed, treated or
monitored:
Accumulatedairanduidsinthethorax(pleuralcavity,
mediastinum, pericardium) that must be drained,
monitored, and balanced in a controlled manner
Organ(s) applied to: Thorax (pleural cavity, mediastinum, pericardium)
Duration of application: • Secretion canister with device: For short-term use on the
patient (< 30 days)
• Secretion canister for gravity drainage: For temporary
use on the patient (< 60 minutes)
Use environment: Hospital/clinic environments
Patient selection criteria: Patients who require cardiothoracic drainage (pleural,
mediastinal, pericardial drainage)

12
Indications: • After surgical opening of the thorax
• Pneumothorax
• Pleuraleusion
• Haemothorax
• Pleural empyema
• Chylothorax
• Other similar conditions
Medical contra-indications: • Not for cardiothoracic drainage therapy where no
negative pressure should be applied to the patient
Other contra-indications: • No application with cardiothoracic drainage systems
other than ATMOS S 201 Thorax and ATMOS E 201
Thorax
• No use if a sterile secretion canister is required for
therapeutic reasons
• No application in emergency and rescue situations
• Not in the homecare area that is not supervised by
healthcare professionals
• Nodrainageofammable,corrosiveorexplosiveuids/
gases
• No separate use of the secretion canister and the hose
system (i.e., without the device) for short- or long-term
gravity drainage (more than 60 minutes)
Warnings: The following complications may occur during
cardiothoracic drainage:
• Pain due to irritation of the intercostal nerves
• Injury of lung parenchyma / air leak
• Reexpansion pulmonary oedema
• Eusionretention
• Tension pneumothorax
• Cutaneous/subcutaneous emphysema
The product is: not active
Sterility / specic microbial
state:
Low-germ secretion canister
Single-use device / reprocessing: Secretion canister is a single-use device
1.3.4 Intended purpose hose system
Product name: • Hose system
• Hose system with connector small
• Hose system with connector medium
• Hose system with connector large
• Hose system with Y-connector medium
• Hose system with Y-connector large

13
Main functions: The double lumen hose system passes on the controlled
vacuum generated by the device. The secretion hose
drainsuidsandairintothesecretioncanister.The
measuring and rinsing hose measures and regulates the
vacuum existing on the patient’s side. A bacterial and
virallteronthemeasuringandrinsinghoseprotectsthe
device against contamination with bacteria and viruses. At
denedtimeintervals,avalveopensinordertodirectair
through the measuring and rinsing hose into the secretion
hoseandtoushuids,coagula,andotherblockagesinto
the secretion canister.
Patient-related chest tubes are attached to the hose
system by a connector.
The sealing plug is used to ensure that the leakage test is
carried out safely.
The hose clamp is intended for clamping the hose system,
i.e., when changing canisters.
Intended use: • Transportofuidandairfromthethorax
• Measurement and regulation of negative pressure on
the patient’s side
Intended users / user prole: • Trained physicians
• Trained healthcare professionals
Prerequisite: Users must not be hard of hearing or deaf and
must have adequate visual faculty
Intended patient target groups: Patients of all age groups with and without restrictions.
Medical conditions to
be diagnosed, treated or
monitored:
Accumulatedairanduidsinthethorax(pleuralcavity,
mediastinum, pericardium) that must be drained,
monitored, and balanced in a controlled manner
Organ(s) applied to: Thorax (pleural cavity, mediastinum, pericardium)
Duration of application: For short-term application (< 30 days) on humans
Use environment: Hospital/clinic environments
Patient selection criteria: Patients who require cardiothoracic drainage (pleural,
mediastinal, pericardial drainage)
Indications: • After surgical opening of the thorax
• Pneumothorax
• Pleuraleusion
• Haemothorax
• Pleural empyema
• Chylothorax
• Other similar conditions
Medical contra-indications: • Not for cardiothoracic drainage therapy in which no
negative pressure should be applied to the patient

14
Other contra-indications: • No application with cardiothoracic drainage systems
other than ATMOS C 051 Thorax, ATMOS S 201 Thorax
and ATMOS E 201 Thorax
• No application in emergency and rescue situations
• Not in the homecare area that is not supervised by
healthcare professionals
• Nodrainageofammable,corrosiveorexplosiveuids/
gases
Applies exclusively in conjunction with the secretion
canister 2 l without water lock (REF: 312.1140.0) and with
the secretion canister 800 ml (REF: 317.1000.0):
• No separate use of the secretion canister and the hose
system (i.e., without the device) for gravity drainage
Warnings: The following complications may occur during
cardiothoracic drainage:
• Pain due to irritation of the intercostal nerves
• Injury of lung parenchyma / air leak
• Reexpansion pulmonary oedema
• Eusionretention
• Tension pneumothorax
• Cutaneous/subcutaneous emphysema
The product is: not active
Sterility / specic microbial
state:
Hose system is sterile
Single-use device / reprocessing: Hose system is a single-use device

15
1.4 Function
General description
This product is a device for mobile, digital cardiothoracic drainage. The device is meant for the
short-term (< 30 days) application on humans. It is portable, mains independent and has an
electronic monitoring system with optical and acoustic status display.
Principles of operation and its mode of action
Thedeviceisanelectricallydrivendeviceandtakesmedicaleectasasystemincombination
with a secretion canister and a hose system.
The system creates the (natural) vacuum in the pleural cavity after a pneumothorax or a pleural
eusionbydrainingoairandsecretion.Thesystemisfordrainageofsecretionandairafter
surgical opening of the thorax.
The hose system is rinsed with air at regular intervals to prevent the collection of debris in the
secretion hose. This measure also prevents secretion from entering into the measuring and
rinsinghoseorthatasyphoneectiscreated.
The device is equipped with a rechargeable battery. A charging unit which is located within the
suction device guarantees for the secure charging of the battery. Therefore, it is impossible to
overcharge the battery.
Bacterialandviralltersinthesecretioncanisterandmeasuringhosepreventcontaminated
secretions from entering the device. As accessories a universal connection and a carrying strap
can be ordered separately. These enable attachment to the patient’s bed, for example, as well as
mobilisation.
Essential requirements
• To generate and maintain vacuum
1.5 Transport and storage
Onlytransportthedeviceinashippingcontainerwhichispaddedandoerssucient
protection.
Aftertransportofthedeviceattemperaturesbelow0°Corpriortorststart-up,itshouldbe
kept at room temperature for at least six hours. If the device is not acclimatised, it may not be
used as damage to the diaphragm of the pump could occur.
If damage occurs during transport:
1. Document and report damages in transit.
2. Fill in form QD 434 ‘Delivery complaint/return shipment’.
3. Send the device to ATMOS (see chapter ‘9.3 Sending in the device’ on page 57).
Environmental conditions for transport and storage
• Temperature range: −10...+50°C
• Relative air humidity: 30...95%
• Air pressure: 700...1060 hPa

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2.0 For your safety
The safety of the ATMOS S 201 Thorax complies with the accepted standards of technology and the
guidelines of the German Medical Devices Act.
2.1 General safety instructions
Report all serious incidents that have occurred in connection with this product to the
manufacturer and your national competent authority.
Familiarise yourself with the device in good time so that you are capable of operating it at any
time.
Never operate the device if it shows any obvious safety defects.
Only a fully functional product meets the safety requirements of users, patients, and third parties.
Therefore, please observe the following instructions on your product:
2.2 Danger for users, patients, and third parties
WARNING
Electric shock due to unsuitable mains power connection, incorrect handling of the product,
or damage to product components.
Burns, cardiac arrhythmias and even fatal injury are possible.
• Do not operate the device if it has been dropped. In this case, clean and disinfect the device and
send it to ATMOS for repair.
• If the device has fallen: Check the device for visible damage. A leakage test is recommended. If
the leakage test fails or the housing is damaged, the device is defective and must not be
operated. In this case, clean and disinfect the device and send it to ATMOS for repair.
• Prior to each use, check for damage to the device and the power cable. Do not operate the
device if you notice any damage. In this case, clean and disinfect the device and send it to ATMOS
for repair.
• Damaged cables must be replaced.
• You can only disconnect the device from the power supply by pulling out the power plug.
• Position the device so that it can always be disconnected from the power supply easily.
• Whendisconnectingthedevicefromthemainspowersupply,pullthepowerplugrstandthen
the device plug.
• Disconnect the device from the mains power supply before cleaning or disinfecting it.
• Never touch the plug or power cable with wet hands.
• Never immerse the device in water or other liquids.
• Do not take a shower or bath with the device!
• The device is not sterilisable.
• Use the power cable only in dry surroundings. The surroundings must be non-conductive.
• Do not allow liquids (such as disinfectants or secretion) to enter the device or power cable.
• Ensure that no liquid enters the device. If liquid gets into the device, operation of the device must
cease immediately. In this case, clean and disinfect the device and send it to ATMOS or an
authorised service partner for repair.
• If disinfectant has penetrated the device, then it must be dried thoroughly and subsequently an
eciencycontrolmustbeconducted.Acheckshouldbecarriedouttoseewhetherthetarget
vacuumisreachedwhenthesystemisclosedandwhetheraow>10l/minisestablishedafter
a while when the system is open. If not, it must not be operated until it has been checked by an
authorised service partner or ATMOS Service centre.
• Only use original accessories and original spare parts from ATMOS. This applies to the power
cable in particular.
• Follow the instructions on periodic tests in chapter ‘9.0 Maintenance and service’ on page 57.

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• Assembly, new settings, alterations, extensions, and repairs may only be carried out by
authorised persons.
• Do not modify the device without the manufacturer’s permission.
WARNING
Risk of infection from non-sterile products!
Deadly diseases can be transmitted.
• Never use components marked with more than once. These components are intended for
single use only.
• Repeated reuse of components which are marked with a is forbidden. This product is not
re-sterilisable. In case of repeated reuse, these components lose their function and there is a
high infection risk.
• Only use sterile packaged parts when the packaging is undamaged.
• Prior to use, check the packaging of the sterile products, the secretion canister system, and the
hose system for intactness. Do not use defective secretion canisters or hose systems.
• Repeated reuse of secretion canisters and hose systems can lead to infections.
• Secretion canisters and hose system should only be used once on every patient.
• For hygienic reasons, we recommend an exchange of both secretion canister and hose system at
the same time.
WARNING
Risk of infection due to patient secretion on the device!
Deadly diseases can be transmitted.
• Always wear disposable gloves if you could come into contact with secretion.
• Clean and disinfect the device after every use.
• Clean and disinfect the device according to the operating instructions.
• The device must not be used following oversuction.
WARNING
Ensure that the device is always functional and ready for use
Your patient can be severely injured.
• Ensure that the device is always ready for use.
• Place the device where it is easily accessible.
• Perform a function check after each use.
• ATMOS recommends always having another suction device ready at hand. This allows you to
treat the patient and perform suctioning even in the event of device failure.
• Please observe the notes on the electromagnetic compatibility (EMC) of the device.
• If the device has fallen: Check the device for visible damage. A leakage test is recommended. If
the leakage test fails or the housing is damaged, the device is defective and must not be
operated. In this case, clean and disinfect the device and send it to ATMOS for repair.
• The device and the secretion canister must always be used in a vertical position. If the device
should tilt, it must be placed upright again in order to guarantee faultless operation. If you are
unsure whether the secretion canister works properly, we advise you to replace the secretion
canister to ensure the patient’s safety.
• The device should not be carried by the hose system.
• Prior to every use, the device should be checked for leakages at the start of therapy (see chapter
‘4.5 Leakage test’ on page 34). Leaking connections could lead to a wrong evaluation of the
patient’s status and could prolong the therapy. Thus, please check all connections for leakages to
prevent the intrusion of additional air.
• The leakage test is recommended to check for leakages prior to each application.
• The warning message ‘Device in critical tilt’ serves as preventive information to avoid
malfunctioncausedbythedevicetiltingover(forexample,ablockedbacterialandvirallterin
the secretion canister).

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• The leakage test function and the warning message ‘Device in critical tilt’ are activated in the
factory settings. If these functions are not desired, they can be deactivated in the user settings
(see chapter ‘4.9 User settings’ on page 43).
• Minimal leakages can indicate small leaks in the system or irregularities in the course of
therapy.Thiscanbeexcludedbyclampingthepatientcatheterandasaresult,theowvalueis
reduced to zero. If not, check all the connections on the device, the connectors as well as the
Luerlockcapforleakage.Ifthereisstillonlyaminimalowvalueillustrated,thenthereisan
internalleakageinthesystemwhichcannotberectiedbytheuser.Thiswillbecompensated
bythesystembutillustratedasaminimalowvalue.
• If the secretion canister tips over during temporary gravity drainage, the functionality of the
water lock for gravity drainage is no longer guaranteed. The vacuum at the patient’s end
ceases, thus posing a risk of a renewed pneumothorax.
• When using the ATMOS S 201 Thorax with hybrid option, the water lock in the secretion
canistermustbelled.Gravitydrainageisperformedwiththedeviceswitchedo.
• The ATMOS S 201 Thorax without hybrid option is not suitable for passive gravity drainage.
Whenthedeviceisswitchedo,thereisariskofarenewedpneumothorax.
• Inthecaseoflargerairleaksandinpatientswithstulas,thevacuumandthusthewater
column in the riser quickly drop to zero. This means that there is no vacuum at the patient’s
end, thus posing a risk of a renewed pneumothorax.
• If a high (negative) vacuum occurs (e.g. due to deep inhalation), the water in the water lock can
rise through the riser. The vacuum at the patient’s end ceases, thus posing a risk of a renewed
pneumothorax.
• The device may not be operated in MRI scanners (magnetic resonance imaging).
• The ATMOS S 201 Thorax is a medical device which is subject to special safety regulations. It
must be set up and put into operation in accordance with the EMC regulations. Portable and
mobileRFcommunicationdevices(mobilephones)mayaecttheperformanceofthedevice.
WARNING
Avoid improper use.
Your patient can be severely injured.
• A misplaced drainage system and a misplaced chest tube could hinder the drainage of air and
liquids. A complete blocking of the system during the drainage of liquids and air could cause a
rise in pressure and thus lead to a tension pneumothorax.
• Employ the device only according to its intended use.
• The product may only be used by medically trained persons who have been instructed in the
handling of the medical suction system.
• Please select the vacuum according to the patient and the application.
• Observe the valid guidelines.
• Observe the notes on hygiene and cleaning.
• Always place the drainage system at the same height as the patient’s catheter and check the
patient hose for any bends or clogging which could hinder the drainage of liquid and air. Never
placethedrainagesystemontheoor.
• Respond immediately to the warning message ‘Secretion canister full or hose blocked’ /
‘Vacuum too low’. Prior to exchanging the secretion canister, the chest tube must be clamped
so that a continuous vacuum is always available to the patient.
• Iftheuidlevelinthesecretioncanisteristoohigh,itcouldcauseablockageandthusa
tension pneumothorax.
• Check the secretion canister at regular intervals and always replace it when the maximum
llinglevelisreachedtoensurethepatient’ssafety.
• Check the hose system at regular intervals. Observe the instructions issued by the attending
physician.
• Bending of the patient hose leads to an interruption of the therapy and incorrect
measurements.

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• The hose system may not be clamped. Ideally, clamp the chest tube when changing the
secretion canister.
• Prior to the removal of the hose connector, the chest tube must be clamped.
• Faulty or damaged components must be replaced immediately.
• Avacuumover−50mbarcouldcausepainandinjurytothepatient.Avacuumover−50mbar
may only be adjusted under medical indication.
WARNING
Explosion and re hazard.
Burns and injuries are possible.
• Only use original accessories and original spare parts from ATMOS. This applies to the power
cable in particular.
• Never operate the product in potentially explosive areas or in areas that are oxygenated.
• Explosion-hazardousareasmaybecausedbytheuseofammableanaesthetics,skin
cleansingproducts,andskindisinfectants.Theambientconditionsspeciedinthetechnical
data (see chapter ‘11.0 Technical data’ on page 61) must be strictly observed.
CAUTION
Contact may cause allergic reactions!
Your patient can be injured.
• The materials used have been tested for their tolerability. In very rare cases, contact with
accessible materials on the device and its accessories may cause allergic reactions. This applies
in particular to contact injuries in conjunction with prolonged contact. If this occurs, seek
medical attention immediately.
CAUTION
Tripping hazard due to cables.
Injuries and fractures are possible.
• Lay the power cable properly.
CAUTION
Avoid improper use.
Your patient can be injured.
• Operation of the secretion canister for temporary gravity drainage is only permitted with
REF 312.1150.5 and 312.1120.0. For REF 312.1140.0, the use for temporary gravity drainage is
prohibited (see chapter ‘7.0 Accessories, consumables and spare parts’ on page 52).
• Metal parts (e.g., clamps) must be removed before use in MRI.
• Only remove the secretion canister when therapy is stopped.
• Itismandatorytollthewaterlockinthesecretioncanisterfortemporarygravitydrainage.
• Priortouse,thewaterlockmustbelledtotheprescribedllinglevel(2cm).
• Donotllthewaterlockabovealevelof2cm.
• Onlyusesterileliquidforllingthewaterlock.
• Everytimebeforeusingthesecretioncanister,makesurethatthellerofthewaterlockis
sealed with the plug.
• For temporary gravity drainage, place the secretion canister below the patient’s chest in an
upright position. Make sure that the patient hose has no loops and/or kinks, as this could
hinderthedrainageofuidsandair.
• The secretion canister must be prevented from tipping or falling over.
• Thepatienthoseandwaterlockmustbecheckedregularlybytrainedmedicalsta.

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2.3 Avoiding damage to the device
NOTICE
Damage to the device due to improper use!
The device may become damaged.
• Ensure that no liquid enters the device. If liquid gets into the device, operation of the device
must cease immediately. In this case, clean and disinfect the device and send it to ATMOS or an
authorised service partner for repair.
• Alwaysplacethedeviceonarm,levelsurface.Thedevicemustalwaysbeinaverticalposition
when you use it.
• Use only power cables that function properly.
2.3.1 General information
• Compliance with proper surgical procedures and techniques is the responsibility of the
attending physician. Observe the instructions issued by the attending physician.
• The user is obliged to regularly check the functionality of the drainage system during
operation.
• The control panel must be clearly visible and accessible for the operator.
• The secretion canister may only be used for temporary gravity drainage when the water lock is
lled(llingheight2cm,H2O sterile).
• The level in the riser of the water lock corresponds to the vacuum applied to the patient during
thetemporarygravitydrainage.Theuctuationsinthepatientvacuum,whicharesynchronous
with the patient’s breathing, can be observed in the riser.
• The appearance of air bubbles in the water lock indicates the escape of air from the thorax.
• While using the secretion canister for temporary gravity drainage, the warning messages as
well as all measuring functions and the hose rinsing function are not active.
• Thedevicemayonlybeoperatedbyqualiedpersonnel.
• The removal of the secretion canister from the device during the therapy may only be
performed by trained professionals who act in conformity with guidelines.
• A ready-to-use spare device incl. consumables must always be available.
• The device supports the therapy of the patient, but it is not a substitute for the doctor’s
diagnosis.
• The patient should be supervised constantly in accordance with the internal rules of the
hospital.
i
Electromagnetic compliance – damage to the device!
The device may become damaged.
• The ATMOS S 201 Thorax fully complies with the electromagnetic immunity requirements of
standard IEC 60601-1-2 / EN 60601-1-2 ‘Electromagnetic compatibility – Medical Electrical
Devices’.
i
Damage to the device due to improperly installed protective contact socket!
The device may become damaged.
• The ATMOS S 201 Thorax is designed in accordance with IEC 60601-1/EN 60601-1 and with
protection class ll.
• The device may only be connected to a properly installed protective contact socket.
• Priortorststart-up,checkwhetherthemainsvoltagespeciedonthetypeplatematchesthe
local mains voltage.