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Atmos S 201 Thorax Operating Instructions Manual

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

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  • Page 1 Operating Instructions ATMOS S 201 Thorax English These operating instructions are valid from software version 3.0.54 GA1GB.710201.0 2023-09 Index: 45 E349855...

  • Page 2: Table Of Contents

    1.3.1 Intended purpose ATMOS S 201 Thorax ....... 8 1.3.2 Intended purpose secretion canister 2 l (REF 312.1150.5)
  • Page 3 ATMOS S 201 Thorax ........

  • Page 4: Introduction

    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.

  • Page 5: Explanation Of Pictures And Symbols

    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.
  • Page 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, fire, and mechanical hazards only in accordance with UL60601-1/ ANSI/AAMI ES60601-1 (2005)/...
  • Page 7 Do not reuse Sterilised using ethylene oxide STERILE EO 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...

  • Page 8: Intended Purpose

    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.

  • Page 9: Intended Purpose Secretion Canister 2 L (Ref 312.1150.5) And Secretion Canister 2 L Without Water Lock (Ref 312.1140.0)

    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 fluid in the secretion canister is readable and documentable.
  • Page 10 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 •...

  • Page 11: Intended Purpose Secretion Canister 2 L Standard (Ref 312.1120.0)

    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 fluid in the secretion canister is readable and documentable.

  • Page 12: Intended Purpose Hose System

    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 •...
  • Page 13 Main functions: The double lumen hose system passes on the controlled vacuum generated by the device. The secretion hose drains fluids 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 filter on the measuring and rinsing hose protects the device against contamination with bacteria and viruses. At defined time intervals, a valve opens in order to direct air through the measuring and rinsing hose into the secretion hose and to flush fluids, coagula, and other blockages into...
  • Page 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 •...

  • Page 15: Function

    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...

  • Page 16: For Your Safety

    • 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.
  • Page 17 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.
  • Page 18 • 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 affect the performance of the device.
  • Page 19 Explosion and fire 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.

  • Page 20: Avoiding Damage To The Device

    • 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.
  • Page 21 • Do not close the ventilation slots on the bottom of the device. Otherwise the device could overheat. Exclusion of liability and warranty • no original ATMOS parts are being used, • the advice for use in these operating instructions is not being observed, • improper use, •...

  • Page 22: Setting Up And Starting Up

    3.0 Setting up and starting up 3.1 Scope of delivery The ATMOS S 201 Thorax was subjected to an extensive functional test and was carefully packed prior to dispatch. On receipt of the goods, please check the packaging for any possible damage and compare the contents for completeness (see bill of delivery).
  • Page 23 Rear side Type plate Charging socket Fixture for device attachment...

  • Page 24: Start-Up

    Attention: If the battery temperature is higher than 50 °C, it can no longer be charged. 1. Plug the recharger of the power cable into the charging socket of the ATMOS S 201 Thorax. 2. Plug the power plug into the socket.

  • Page 25: Secretion Canister

    3.3.2 Secretion canister • Always use the original ATMOS disposable secretion canister. • Vacuum connection system: The vacuum connection between device and secretion canister is established immediately when the secretion canister is engaged! Important safety • Due to hygienic reasons, it is recommended to always information on the change the hose system together with the canister.
  • Page 26 3.3.2.3 Filling the water lock Only applicable for REF 312.1150.5 and 312.1120.0, not for 312.1140.0 (see chapter ‘7.0 Accessories, consumables and spare parts’ on page 52). The water lock is on the right side of the secretion canister. A bacterial and viral filter and a riser are included. The water lock is filled with water through the riser. For filling the water lock, a sterile cannula 20 G, a sterile syringe, and 50 ml sterile water are required. With the cannula you may puncture the silicone seal above the riser and then fill the water lock. Prior to use, the water lock must be filled to the prescribed filling level (not above the 2 cm mark) and should be checked regularly to ensure proper operation. Obligatory: Temporary gravity drainage Optional: Normal operation, gravity drainage mode Prior to inserting the secretion canister into the device, make sure that the filler for the water lock is sealed with the plug.
  • Page 27 3.3.2.6 Changing the secretion canister Prior to exchanging the secretion canister, the chest tube must be clamped so that a continuous vacuum is always available to the patient. Removing the secretion canister 1. Always wear disposable gloves and observe the regulations when handling sterile products.

  • Page 28: Connecting The Hose System

    Device switched on = active drainage Device switched off = gravity drainage (The water lock must be filled!) WARNING Avoid improper use! The ATMOS S 201 Thorax without hybrid option is not suitable for passive gravity drainage. When the device is switched off, there is a risk of a renewed pneumothorax.

  • Page 29: Prerequisites For Operating The Secretion Canister For Temporary Gravity Drainage With The Device Switched Off

    The leakage test checks the tightness of the entire system. In order to use the ATMOS S 201 Thorax with hybrid option for gravity drainage, a leakage test must be passed before use! The leakage test must not be deactivated.

  • Page 30: Switching From Active Drainage To Passive Gravity Drainage

    Leakage test starts automatically! Only proceed shortly before connecting the patient! 6. Only proceed if the leakage test has been passed! 3.4.4 Switching from active drainage to passive gravity drainage Stop therapy by touching the button. Switch off the device. The measuring and rinsing hose can remain on the device. From a technical point of view, it is not necessary to clamp the measuring and rinsing hose.

  • Page 31: Operation

    4.0 Operation Ambient conditions for operation • Temperature range: +10...+35 °C • Relative air humidity: 30...95 % • Air pressure: 700...1060 hPa 4.1 Explanation of the display System information 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.

  • Page 32: Buttons And Display Symbols

    4.2 Buttons and display symbols 4.2.1 Buttons Figure Function Decrease target vacuum Increase target vacuum Gravity drainage mode Graphic diagram of the 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...

  • Page 33: Display Symbols

    Yellow: 100 to < 630 ml/min Orange: 630 ml to 5.51 l/min Red: >5.51 l/min to maximum. Up to 1.00 l/min, the flow is displayed in ml/min. 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.

  • Page 34: Switching On

    If the vacuum exceeds −30 mbar, the vacuum lines are no longer displayed. 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.
  • Page 35 Alternatively, the chest tube can be clamped near to the patient. Do not clamp the ATMOS hose system. If the leakage test is error-free, the message ‘Leakage test OK!’...

  • Page 36: Function

    4.6 Function 4.6.1 Target vacuum • Please note that an adjusted target vacuum over −50 mbar may cause pain and injuries to the patient. • On the main screen, the target vacuum can be set directly by touching the , or button. • ATTENTION: The change in the target vacuum takes effect immediately. There is no confirmation necessary.

  • Page 37: Suction

    • By touching the button, the pump is 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.

  • Page 38: Key Lock

    4.7 Key lock The ATMOS S 201 Thorax has an automatic key lock. 1. Automatic activation of the key lock If the settings on the display are not changed for a defined time, the key lock will be activated automatically (default factory setting 1 minute, individually adjustable in the user settings). This will prevent unintentional operation. 2. Manually activating the key lock The key lock can be manually activated after all the therapy values are set and the therapy is started.

  • Page 39: Therapy Process

    4.8 Therapy process The ATMOS S 201 Thorax offers 2 graphs that make it easier to analyse the course of the flow and actual vacuum. Selection menu By touching the button, you enter the menu for graphical diagram modus. By touching the respective buttons, you can select the modus of your choice, e.g. long time display / short time display.
  • Page 40 When changing the flow scaling in the long time display to the smallest scaling, the message appears that the scaling unit has changed from l/min to ml/min. If you have initially set the zoom values 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, the data is not displayed in the usual lines.

  • Page 41: Transfer Of Therapy Data

    If you are starting a new therapy, the previous data will be overwritten. ATMOS recommends: Perform the therapy data transfer at the end of the patient’s therapy. Suitable USB flash drives for therapy data transfer •...

  • Page 42: Reading Out The Therapy Data

    Complete data transfer • As soon as the therapy data is transferred, then the USB flashdrive may be removed. Now you return to the main screen. If the therapy data should be transferred during a patient’s therapy, follow the steps below: • Clamp the chest tube • Stop the current therapy •...

  • Page 43: User Settings

    4.9 User settings Touch the button to access user settings. Touch the buttons to move up and down in the menu selection. To select a settings menu, touch the text box. These buttons can be found in every settings menu: •...
  • Page 44 In the user settings, the following positions can be selected: The system language can be System language adjusted with When the device is started the standard vacuum is automatically pre-adjusted. Standard vacuum You can adjust the standard vacuum with You can change the cycle Cycle duration for hose duration for hose rinsing with rinsing...
  • Page 45 WARNING The warning message ‘Device Critical tilt Warning in critical tilt’ can be activated or deactivated with Critical tilt The key lock activation time Key lock activation time can be adjusted with The key tone can be activated Key tone or deactivated by using By touching one of the two buttons (hour or minute),...

  • Page 46: Switching Off The Device

    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 47: Warning Messages

    Leakages - Secretion canister connection • Contact ATMOS Service If the target vacuum is not • Check for blockages: reached, the alternating - Secretion canister warning message ‘Vacuum too - Hose low’...
  • Page 48 • Place the device in a cooler location. • Device is in the sun or near a WARNING heater. • Please ensure sufficient air Device temperature too high ventilation. • Ventilation slots are covered. Provide sufficient ventilation! Check fan! • Please contact ATMOS • Fan is defective. Service.
  • Page 49 Display Cause Recommended actions Carry out an inspection Contact ATMOS Service. according to the manufacturer’s specifications every 12 months. This will be displayed on the device. A dwindling battery capacity is Battery must be replaced by indicated to you on the device. ATMOS Service.

  • Page 50: Function

    6.0 Function 6.1 Hose rinsing • The ATMOS S 201 Thorax has an automatic hose rinsing function that works periodically. • The rinsing process transports secretion located in the secretion hose into the secretion canister. • The rinsing process is initiated by opening a valve located in the measuring and rinsing hose.
  • Page 51 6. Place the secretion canister below the thorax in an upright position for temporary gravity drainage. Make sure that the patient hose has no loops and/or kinks, as this could hinder the drainage of fluids and air. 7. The vacuum applied at the patient’s end corresponds to the water level in the riser of the water lock.

  • Page 52: Accessories, Consumables, And Spare Parts

    7.0 Accessories, consumables, and spare parts Accessories Universal bracket for ATMOS S 201 Thorax 312.1160.0 Carrying strap for ATMOS S 201 Thorax 312.0850.0 Hose clamp 061.0079.0 Consumables OT set for ATMOS E/S 201 Thorax 312.1031.0 Included in the OT set: Secretion canister 2 l, 10 pcs. (sterile)

  • Page 53: Attachment Of The Universal Bracket (Accessories)

    7.1 Attachment of the universal bracket (accessories) The universal bracket can be mounted to infusion tripods, wheelchairs, to crossrods and longitudinal bars of the bed, or to a standard rail. Align the fastening clamp 1. Pull the stop bolt 2. Rotate the fastening clamp 90°. 3.

  • Page 54: Cleaning And Care

    8.0 Cleaning and care 8.1 General information on cleaning and disinfection Prior to cleaning: Medical devices such as the ATMOS S 201 Thorax must operate safely and reliably at all times. Therefore, we recommend prior to every use: if required Handling of the cardiothoracic drainage system determines to a large extent its reliability and safety.

  • Page 55: Cleaning The Device Surface

    • Attention! The device should never be autoclaved, rinsed under running water, or immersed into any liquids! 8.4 Recommended disinfectants Disinfectant Contents in 100 g Manufacturer ATMOS Green & Clean SK Di alkyl dimethyl ammonium chloride < 1 g Metasys, Rum Alkyldimethylethylbenzylammoniumchloride < 1 g...

  • Page 56: Hygiene Plan

    8.5 Hygiene plan WHAT WHEN NOTES Manual wipe cleaning Device Manual wipe disinfection Disposable product – not Canister 2 suitable for reprocessing, change after use Disposable product – not Hose system 2 suitable for reprocessing, change after use A new carrying strap should be Carrying strap used for each patient.

  • Page 57: Maintenance And Service

    ATMOS recommends: Work should be carried out by an authorised ATMOS service partner. This ensures that repairs and testing are carried out professionally, original spare parts are used, and warranty claims remain unaffected.

  • Page 58: Changing The Fuse

    ) 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 excluded from the guarantee. There is a function guarantee of 6 months. Using other charging accessories may result in risk of explosions! 9.5 Changing the fuse...

  • Page 59: Troubleshooting

    The device must be checked. Excessively high vacuum Check for correct hose connections. applied from the outside. ‘Vacuum too high’ Ventilation valve is defective. Contact ATMOS Service or a certified service partner. The device must be checked. Battery almost empty. Connect device to the supply network.
  • Page 60 Leakage test failed. Contact ATMOS Service or a certified Internal error. service partner. The device must be checked. Component error. 1) Check whether the flow is also 0 l/min when the system is open. 2) Contact ATMOS Service or a Flow readout is always Secretion has entered the certified service partner. The device 0 l/min. device. must be checked. Internal error. Contact ATMOS Service or a certified ‘Device cannot be...

  • Page 61: Technical Data

    11.0 Technical data 11.1 ATMOS S 201 Thorax Input voltage 100 – 240 V~; 50/60 Hz Power consumption max. 70 VA Rechargeable battery, built-in Li-Ion, 14.4 V nominal, 3350 mAh nominal Fuses 1 x T 1.25 A/H, 250 V Other safety lugs Pressure control valve „pop-off“ in the canister. Vacuum limitation in the device to approx. 150 mbar.

  • Page 62: Secretion Canister 2 L

    Classification of applied parts Type CF applied parts Recovery time: 10 sec. Degree of protection IPX0 CE marking Reference number (REF) 312.1000.0 ATMOS S 201 Thorax 312.1080.0 ATMOS S 201 Thorax 11.2 Secretion canister 2 l Capacity Max. 2000 ml Characteristics • ATMOS disposable canister • Transparent •...

  • Page 63: Hose System

    >99.95%* Filter class H13 (High-Efficiency Particulate Air/Arrestance)* *External test report (test laboratory) 11.3 Hose system Length 1.80 m Characteristics • ATMOS disposable hose • Transparent • Adaption to canister/device by Luer lock PVC (tube and connectors) Material PP (adapter) ABS (plug) Components • Double lumen hose system:...
  • Page 64 Sterilisation EO (ethylene oxide) CE marking Reference number (REF) 312.1170.0 Hose system 312.1201.0 Hose system with connector small 312.1202.0 Hose system with connector medium 312.1203.0 Hose system with connector large 312.1204.0 Hose system with Y-connector medium 312.1205.0 Hose system with Y-connector large Bacterial and viral filter Bacterial filtration efficiency (BFE) 99.999778%*...

  • Page 65: Disposal/Recycling

    ATMOS S 201 Thorax Do not dispose of the device with household waste. 1. Clean and disinfect the device. 2. In Germany: Send in the device to ATMOS or your specialised dealer. They will recycle the device professionally. 3. In other countries: Recycle the device professionally and in accordance with country-specific laws and regulations.

  • Page 66: Notes On Emc (Electromagnetic Compatibility)

    It is not suitable for use in the vicinity of HF surgical devices and in settings outside of an HF- shielded room of a magnetic resonance imaging system. ) The customer or user of the ATMOS S 201 Thorax must ensure that it is used in such an environment.
  • Page 68 ATMOS MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Str. 16 79853 Lenzkirch / Germany Phone: +49 7653 689-0 info@atmosmed.com www.atmosmed.com...

This manual is also suitable for:

312.1000.0312.1080.0

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