Atmos S 201 Thorax Operating Instructions Manual Download Page 10

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1.4 Transport and storage

•

The device may only be transported in a upholstered and protective shipping box.

•

Please note down and immediately report any damages which occurred during shipping.

Please make use of the attached QD 434 Delivery complaint / Return shipment form if you

have a complaint or send back the device.

The form QD 434 can also be downloaded from our website www.atmosmed.com.

•

After transport of the device in temperatures below 0 °C or prior to first start up it should be

kept at room temperature for at least six hours. If the device is not acclimatized it may not be

used as damage to the diaphragms of the pump could occur.

•

Ambient conditions:

Transport / storage:

−10...+50 °C;

30...95 % air humidity without condensation at air pressure 700...1060 hPa

Operation and battery charging:

+10...+35 °C;

30...95 % air humidity without condensation at air pressure 700...1060 hPa

Operation altitude: max. 3000 m

1.5 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.

Notice of potential material damage.



Useful information on the handling of the device.

Action. Proceed step by step.

Result of an action.

Summary of Contents for S 201 Thorax

Page 1: ...E349855 0124 GA1GB 710201 0 2021 10 Index 42 Operating Instructions ATMOS S 201 Thorax English These operating instructions are valid from software version 3 0 53 ...

Page 2: ...f the display 27 4 2 Buttons and display symbols 28 4 2 1 Buttons 28 4 2 2 Display symbols 29 4 3 Explanation of the display in key lock modes 29 4 3 1 Key lock mode with bubbles 29 4 3 2 Key lock mode with bar chart 29 4 4 Switching on 30 4 5 Leakage test 30 4 6 Function 32 4 6 1 Target vacuum 32 4 6 2 Gravity drainage mode 32 4 6 3 Suction 33 4 7 Key lock 34 4 8 Therapy process 35 4 8 1 Short ti...

Page 3: ...2 Repairs 53 9 3 Sending in the device 53 9 4 Handling of batteries 53 9 5 Changing the fuse 54 10 0 Troubleshooting 55 11 0 Technical data 57 11 1 Bacterial and viral filter 58 12 0 Disposal 59 13 0 Notes on EMC Electromagnetic compatibility 60 13 1 Guidance and manufacturer s declaration ambient conditions 60 13 2 Guidance and manufacturer s declaration key features 60 13 3 Guidance and manufact...

Page 4: ... 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 The person in question must possess the necessary test devices and original spare parts required to carry out these measures This device bears the CE marking CE ...

Page 5: ... monitoring and balancing Application organ Thorax pleural cavity mediastinum pericardium Application time Short term use on the patient 30 days Application site The application site is the clinical environment The cardiothoracic drainage system may only be applied by healthcare professionals The device is applied unsterile The secretion canister and the hose system are sterile and disposable they...

Page 6: ...d and documented on the balancing scales An integrated bacterial and viral filter protects the device from possible contamination and from oversuction In the event of excess pressure the pop off valve opens immediately An optional water lock is used to visualize the air leak on the patient s side by the appearance of air bubbles Cover caps are used for proper sealing and disposal Intended use inte...

Page 7: ... therapy in which no vacuum should be applied to the patient Other contraindications Do not use with cardiothoracic drainage systems other than the ATMOS S 201 Thorax 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 under emergency conditions Should not be used in the homecare sector whi...

Page 8: ...g or deaf and must have adequate vision Intended patient population Patients of all ages with and without restrictions Medical condition to be diagnosed treated or monitored Accumulated air and fluids in the thorax pleural cavity mediastinum pericardium that require controlled drainage monitoring and balancing Application organ Thorax pleural cavity mediastinum pericardium Application time Short t...

Page 9: ... can be sucked off by the hose system The pump is controlled digitally and therefore ensures that the chosen required vacuum value is stable The air flow which is measured in real time is displayed in numbers At one key press flow data from up to 12 days is shown in graphic The secretion is collected in the secretion canister Its capacity is 2 l With the aid of the measuring and rinsing hose the v...

Page 10: ...10 50 C 30 95 air humidity without condensation at air pressure 700 1060 hPa Operation and battery charging 10 35 C 30 95 air humidity without condensation at air pressure 700 1060 hPa Operation altitude max 3000 m 1 5 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 WAR...

Page 11: ... complies with the relevant requirements of EU regulations 0124 This device complies with the relevant requirements of EU regulations E349855 UL Mark MEDICAL EQUIPMENT with respect to electrical shock fire 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...

Page 12: ...ng instructions Follow operating instructions blue Do not reuse STERILE Sterile device STERILE EO Sterilized using ethylene oxide NON STERILE Non sterile Double sterile barrier system Single sterile barrier system Protection class II device Applied part type CF IP XO Specification of the degree of protection against the ingress of solids and moisture Fuse ...

Page 13: ...ragile handle with care Keep dry Keep away from sunlight Temperature limit Atmospheric pressure limitation Humidity limitation UDI application identifier 01 UDI DI Identification of the manufacturer and the device 10 Batch code 11 Date of manufacture 17 Expiry date 21 Serial number ...

Page 14: ... 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 first 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 de...

Page 15: ...sily 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 le...

Page 16: ...ation in accordance with the EMC regulations Portable and mobile RF communication devices mobile phones may affect 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...

Page 17: ...t can be injured Operation of the secretion canister for temporary gravity drainage is only permitted with 312 1150 5 and 312 1120 0 For 312 1140 0 the use for temporary gravity drainage is prohibited see chapter 7 0 Accessories consumables and spare parts on page 48 Metal parts e g clamps must be removed before use in MRI Only remove the secretion canister when therapy is stopped It is mandatory ...

Page 18: ... with guidelines A ready to use spare device incl consumables must always be available The device supports the therapy of the patient it is not a substitute for the doctors 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 w...

Page 19: ...nly be operated at room temperature and should not be subjected to direct solar irradiation as this could lead to errors Do not close the ventilation slots on the bottom of the device Otherwise the device could overheat i Exclusion of liability and warranty If no original ATMOS parts are being used the advice for use in these operating instructions is not being observed improper use assembly new s...

Page 20: ... Basic device 1x Power cable L 3 m 507 0859 1 1x Operating instructions 1x Quick reference guide 3 2 Device overview Front side 1 2 3 4 5 1 On Off sensor 2 Touchscreen touch sensitive display 3 Handle 4 Light sensor 5 Release button of secretion canister 6 Connection for secretion canister 7 Connection for USB flashdrive Only use the USB connection for the transfer of therapy data A software updat...

Page 21: ...21 Rear side 10 9 11 9 Type plate 10 Charging socket 11 Fixture for device attachment ...

Page 22: ...s prolongs the maximum service life Batteries are wearing parts and therefore excluded from the general warranty The device should be recharged in a cool place without direct solar irradiation At ambient temperatures above 25 C the charging time could be prolonged drastically Defects which occur due to improper handling of the device are not covered by the guarantee Attention If the battery temper...

Page 23: ... spare parts on page 48 3 4 6 7 8 1 2 5 1 Pop off valve 10 mbar overpressure 2 Filler for water lock 3 Hydrophobic bacterial and viral filter 4 Filling level for water lock function 5 Scaling in ml 6 Protection cap for the pop off valve 7 Protection cap for the secretion hose 8 Patient connection secretion hose 9 Secretion canister guide 3 3 2 2 Secretion canister system overview Versions without ...

Page 24: ...e canister may only be removed when the pump is switched off 3 3 2 4 Pop off valve The pop off valve 1 is a protective device against the occurrence of overpressure which could lead to a tension pneumothorax The valve opens at an overpressure of 10 mbar within the rinsing canister 3 3 2 5 Inserting the secretion canister 1 1 2 click Attention Prior to use check the packaging of the sterile product...

Page 25: ...attention as secretion could be found in the connection space 9 Remove the cover cap 2 from the luer lock connection of the secretion hose 10 Separate the cover cap by rotating and pulling it simultaneously 11 Close the pop off valve 3 with the bigger cover cap 12 Close the luer lock connection 4 of the secretion hose with the smaller cover cap The connection on the rear of the secretion canister ...

Page 26: ...ral filter 1 to the upper canister connection on the secretion canister by rotating it clockwise 3 Connect the luer lock connection with the larger diameter to the lower connection of the canister 3 by rotating it clockwise 4 A leakage test is recommended chapter A change of the bar chart with flow scaling from 450 ml min to 150 ml min takes place automatically as soon as the hourly average value ...

Page 27: ...Actual vacuum Display of the current fistula Attention This is the current value In the case of a discontinuous fistula the value can decline temporarily to zero although the fistula still exists Display of the preadjusted target vacuum to which the pump adjusts Changeover to the graphic diagram Increase of the target vacuum Quick setting of the target vacuum to 5mbar User settings Display of the ...

Page 28: ...he therapy Open the user settings Save entry Confirm information Back Exit menu Warning suppress the warning Changeover to vacuum scaling Changeover to time scaling Changeover to flow scaling Start the therapy Stop the therapy Hold restart graphic Increase maximum of axis Decrease maximum of axis Scroll up the list Scroll down the list Activate key lock ...

Page 29: ... Yellow 100 630 ml min Orange 630 ml 5 51 l min Red 5 51 l min to maximum Up to 1 00 l min the flow is displayed in ml min Key lock activated Flow displayed as bubbles Day Night Mode The ATMOS S 201 Thorax has a day night mode i e the device adjusts automatically to the light conditions in a room Under low ambient light conditions the display has dark background illumination 4 3 2 Key lock mode wi...

Page 30: ... 4 4 Switching on 1 To switch on the ATMOS S 201 Thorax touch the sensor above the symbol for 2 seconds 2 The ATMOS logo appears with the software version number in the bottom right corner 3 Depending on the user settings the leakage test starts automatically after a short time see next chapter 4 Subsequently Therapy progress will appear in the display By pressing the buttons you can start a new t...

Page 31: ...akage test is faulty the message Leakage test failed appears Check the hose connections and whether the secretion canister is correctly clicked into place By touching the corresponding buttons you now have the option to a repeat the test b abort the test and continue by pressing the respective buttons on the screen ATTENTION If the leakage test is operated accordingly the leakage must not be ignor...

Page 32: ... starting the device The 5 5 Vac button can be used to set the target vacuum directly to 5 mbar For more information see 4 6 2 Schwerkraftdrainagemodus on page 32 34 If target vacuum is adjusted over 50 mbar the notice appears High target vacuum is set 4 6 2 Gravity drainage mode On the main screen the target vacuum can be set directly to 5 mbar by pressing the 5 5 Vac button If the 5 5 Vac symbol...

Page 33: ...rated by a symbol change from to in the lower left of the display By pressing the button the pump will be stopped The ATMOS S 201 Thorax has a vacuum regulator On the one hand this means that the integrated pump only starts if the actual vacuum does not correspond to the target vacuum On the other hand the pump performance depends on the difference between the actual vacuum and the target vacuum T...

Page 34: ...ues are set and the therapy is started Press the symbol to activate the key lock The display symbol appears above the Flow readout and shows an activated key lock 3 Deactivate the key lock A quick touch to the display and then the first contact point appears By touching the contact point the second contact point appears By a repeated touching of this contact point the key lock symbol above is deac...

Page 35: ...in menu Set the period duration of the hose rinsing to 5 minutes if you want to use the short time display for real time display of the flow such as for cough tests to detect blocked catheters etc 4 8 2 Long time display In the long time display the complete therapy process can be visualised The scaling can be switched between time flow and vacuum You can reach the different scalings by pressing t...

Page 36: ...alues and go back to the long time display the previously set zoom values are saved even if the device has been switched off in the meantime If the recorded therapy data is greater than the set scaling for the long time display then this is not displayed in the usual lines The target vacuum is recorded in light blue The actual vacuum is recorded in dark blue The flow value is recorded in green ...

Page 37: ...commends Use a USB flashdrive without content Other USB flash drives may not be recognized thus the therapy data read out does not start Start the therapy data transfer Press the release button The secretion canister swivels forward to the right Connect the USB flashdrive see Page 20 The device prepares for the therapy data transfer In order to start the transfer confirm the query on the device wi...

Page 38: ...ribed Connect the secretion canister Continue the therapy Open the clamp at the chest tube 4 8 4 Reading out the therapy data Connect the USB flashdrive to the PC Open the folder on the USB flashdrive This folder contains a PDF file and an excel file Open the PDF file Enter the desired Information 1 Patient data 2 Diagnosis 3 Description of the secretion Following information can be seen in the re...

Page 39: ...he buttons and for moving up and down in the menu selection To select a settings menu press the text box These buttons can be found in every settings menu By pressing the button you will return to the user menu The selected data are only saved if you press the memory key ...

Page 40: ...the device is started the standard vacuum is automatically pre adjusted You can adjust the standard vacuum with and Cycle duration for hose rinsing You can change the cycle duration for hose rinsing with and Vacuum unit The vacuum unit can be adjusted with and ON Leakage Test Leakage test The leakage test can be activated or deactivated with and ...

Page 41: ...k activation time can be adjusted with and Key tone The key tone can be activated or deactivated by pressing and Time By pressing one of the two buttons hour or minute you can access the individual settings Now you can change the time with and Date By pressing one of the three buttons Day Month Year you can access the individual settings Now you can change the date with and ...

Page 42: ...required If the setting is activated the user settings can only be unlocked and operated using a corresponding key code 4 10 Switching off the device To switch off the ATMOS S 201 Thorax stop the therapy and touch the sensor for 2 seconds The ATMOS logo appears on the screen and the device shuts down ...

Page 43: ...etion canister Hose Filter in the secretion canister Filter in the measuring hose Contact the ATMOS service The measurement of an excessively high vacuum results in the display of the warning message vacuum too high Possible reasons for this error message are Ventilation valve is defective There are further vacuum sources in the drainage area Remove vacuum sources Contact the ATMOS service If the ...

Page 44: ...he therapy has already started and has been interrupted by the pause symbol the warning message Inactive therapy appears with tone Press the Play symbol to start the therapy If the warning message is suppressed it appears again with tone after one minute The device must no longer be operated Possible causes Battery or pump defective Contact the ATMOS service Provide sufficient ventilation Check fa...

Page 45: ...the ATMOS service A dwindling battery capacity is indicated to you on the device Battery must be replaced by the service If the set target vacuum is over 50 mbar the notice High target vacuum is set appears When changing the flow scaling in the long time display to the smallest scaling the notice indicating that the scaling unit has changed from l min to ml min appears ...

Page 46: ...itioned at the same height as the patient catheter 6 3 Operation of the secretion canister for temporary gravity drainage Operation of the secretion canister for temporary gravity drainage is only permitted with 312 1150 5 and 312 1120 0 For 312 1140 0 the use for temporary gravity drainage is prohibited see chapter 7 0 Accessories consumables and spare parts on page 48 It is mandatory to fill the...

Page 47: ...uum applied at the patient s end corresponds to the water level in the riser of the water lock 8 The secretion hose and water lock must be inspected regularly by qualified medical staff to ensure correct operation ...

Page 48: ...ster 2 l 10 pcs sterile Hose system 10 St sterile 312 1031 0 Hose system 10 pcs 312 1170 0 Secretion canister 2 l 5 pcs 312 1150 5 Secretion canister 2 l without water lock 5 pcs 312 1140 0 Secretion canister 2 l standard 10 pcs 312 1120 0 Y port 50 pcs 312 1101 0 Paediatrics port different sides 1 pcs 312 1102 0 Fir tree port without luer lock 1 pcs 312 1103 0 Connection set for thorax chest tube...

Page 49: ...acket 4 Position the universal bracket to the required position 5 Turn the knob 2 until the universal bracket is fixated Attach the device to the universal bracket 6 Pull the locking system 4 and rotate it by 90 so that the stop bolt is drawn in 5 7 Place the device on the universal bracket 8 Pull the locking system and rotate it by 90 so that the bolt fixates the device 6 3 4 1 2 6 5 7 2 Attachin...

Page 50: ...e of the device Please observe the operating instructions for use prescribed by the manufacturers of disinfectants Pay attention regarding their concentration suitability for use and the contact time Do not use Disinfectants which contain organic or inorganic acids or bases as they could cause corrosion damage Disinfectants containing chloramides or phenol derivatives since these may cause stress ...

Page 51: ...hylbenzylammoniumchloride 1 g 1 g 1 g Metasys Rum Austria Dismozon pur granule End of product 12 2014 Magnesium peroxyphthalate Hexahydrate 80 g Bode Chemie Hamburg Dismozon plus granule Magnesium peroxyphthalate Hexahydrate 95 8 g Bode Chemie Hamburg Kohrsolin FF Application concentrate Glutaral Benzyl C12 18 alkyldimethyl ammonium chlorides Didecyldimethylammoniumchloride 5 g 3 g 3 g Bode Chemie...

Page 52: ...ct not suitable for reprocessing change after use Hose system 2 X X Disposable product not suitable for reprocessing change after use Carrying strap X X A new carrying strap should be used for each patient Ports 2 X X Disposable product not suitable for reprocessing change after use Universal bracket X X X Manual wipe cleaning X X X Manual wipe disinfection R Removal C Cleaning D Disinfection S St...

Page 53: ... abnormal displays on the screen Sudden occurrence of unusual noises Operational and functional errors that cannot be resolved by means of the measures described in the chapter 10 0 Troubleshooting on page 55 9 3 Sending in the device If the cardiothoracic drainage system has to be sent in for repair after consultation with the manufacturer or an authorised service partner we ask you to observe th...

Page 54: ...e vicinity of heaters Always charge the batteries using the respective charging accessories Overcharging will destroy the batteries The lifetime of lithium ion batteries mainly depends on the ambient temperature On principle batteries are depleted after 2 5 years New batteries should be fully charged prior to first use ATMOS has no influence on the use of the device therefore batteries are exclude...

Page 55: ...ster on page 25 Hose blocked or kinked Remove any blockages if necessary remove the measuring and rinsing hose from the connection to the secretion canister If the bacterial filter in the measuring and rinsing hose is blocked replace the hose system Check the hose system for kinks and remove kinks if necessary Bacterial and viral filter blocked on the measuring hose or secretion canister Check the...

Page 56: ...heck the hose system and rinsing canister for correct fit See 3 3 2 6 Changing the secretion canister on page 25 Secretion canister is leaking Internal error Contact ATMOS Service or a certified service partner The device must be checked Flow readout is always in 0 l min Component error 1 Check whether the flow is also 0 l min when the system is open 2 Contact ATMOS Service or a certified service ...

Page 57: ...ion hose ATMOS disposable suction hose for thorax double lumen with integrated bacterial and viral filter in the measuring channel 180 cm length Operating time Continuous operation in the specified temperature range Simultaneous battery recharging and operation possible Battery operation time at maximum continuous suction 1 h Battery operation time in normal operation without fistula 12 h Battery ...

Page 58: ...ification in accordance with Annex IX of EC Directive 93 42 EEC Class IIa CE marking CE 0124 GMDN code 36787 UMDNS code 10 218 Suction device thoracic ID no REF 312 1000 0 ATMOS S 201 Thorax 11 1 Bacterial and viral filter Bacterial filtration efficiency BFE 99 999778 Viral filtration efficiency VFE 99 73 Overall filtration efficiency 99 95 Filter class H13 High Efficiency Particulate Air Arrestan...

Page 59: ...ce may not be disposed of with domestic waste Please observe existing national laws and rules for disposal of old devices in the respective country Disposal within the Federal Republic of Germany In the Federal Republic of Germany the law for electrical devices ElektroG regulates the disposal of electrical devices It must be assumed that such suction devices can be contaminated Therefore according...

Page 60: ... S 201 Thorax has the following electrical components Type REF Max cable length Power cable L 3 m 507 0859 1 3 m Power cable L 5 m 008 0629 0 5 m 13 3 Guidance and manufacturer s declaration warnings WARNING The use of accessories transducers and cables other than those specified or provided by the manufacturer may cause increased electromagnetic emissions or reduced immunity to electromagnetic in...

Page 61: ...61 For your notes ...

Page 62: ...62 ...

Page 63: ...63 ...

Page 64: ...www atmosmed com ATMOS MedizinTechnik GmbH Co KG Ludwig Kegel Str 16 79853 Lenzkirch Germany Phone 49 7653 689 0 info atmosmed de ...

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