Atmos C 051 Thorax Operating Instructions Manual
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Atmos C 051 Thorax Operating Instructions Manual

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Operating instructions
ATMOS C 051 Thorax
English
These operating instructions are valid from software version 1.3.22.
GA1GB.710101.0
0124
2021-04 Index: 16
E349855

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Summary of Contents for Atmos C 051 Thorax

  • Page 1 Operating instructions ATMOS C 051 Thorax English These operating instructions are valid from software version 1.3.22. GA1GB.710101.0 0124 2021-04 Index: 16 E349855...

  • Page 2: Table Of Contents

    Table of contents Introduction...................... 4 Notes on operating instructions ................4 Intended use ......................5 1.2.1 Intended use ATMOS C 051 Thorax ................5 1.2.2 Intended use secretion canister 800 ml ..............6 1.2.3 Intended use hose system ..................7 Function ........................9 Transport and storage ....................9 1.5 Explanation of pictures and symbols ..............10 For your safety ....................14 General safety instructions ..................14...
  • Page 3 7.3.1 Attach the support directly to a standard rail ............47 7.3.2 Attaching/removing the support to/from the universal bracket .......47 7.4 Placing / removing the device on/from support (accessory) ......48 7.5 Attaching and removing the power supply unit (accessory) ......48 7.5.1 Attaching and removing the power supply unit to the support ......48 7.5.2 Attaching and removing the power supply unit with support to the universal bracket ........................49 7.6 Inserting and removing the power supply unit and power cable .....49 7.7 Charging the device with power supply unit support (accessory) ....49 7.8 Attaching and removing the carrying handle, disposable strap and carrying strap ..........................50 7.8.1 Strap holders ......................50 7.8.2 Attaching the carrying handle ................50 7.8.3 Removing the carrying handle ................51...

  • Page 4: Introduction

    1.0 Introduction Notes on operating instructions These operating instructions are valid from software version 1.3.22. These operating instructions contain important notes on how to operate the ATMOS C 051 Thorax safely, correctly and effectively. Their reading helps to avoid risks, and also to reduce repair costs and down-times. This increases, among other things, the reliability and service life of the device. These operating instructions serve not only for new operating personnel to be instructed in its use, but also for use as a reference manual. This document may only be reprinted,...

  • Page 5: Intended Use

    Intended use 1.2.1 Intended use ATMOS C 051 Thorax Name: ATMOS C 051 Thorax Main function: The ATMOS C 051 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 current vacuum measured at the patient's side and the air leak. The objective therapy data are displayed in real time and illustrated in colour in a graph. Errors are automatically indicated by visual and acoustic warning messages. Intended use / intended Restoring the (natural) vacuum in the pleural cavity by purpose: draining off air and secretion. Intended users / user profile: • Trained doctors • Trained healthcare professionals Users must not be hard of hearing or deaf and must have adequate vision.

  • Page 6: Intended Use Secretion Canister 800 Ml

    For detailed information on the secretion canister and hose system, please refer to the separate intended uses. 1.2.2 Intended use secretion canister 800 ml Name: Secretion canister 800 ml Main function: The secretion canister transfers the controlled vacuum generated by the ATMOS C 051 Thorax. Fluids and air are drained through the secretion hose and collected in the secretion canister. The amount of fluid in the secretion canister can be read and documented on the balancing scales. An integrated bacterial and viral filter protects the device from possible contamination and from oversuction. As a protection, the pop-off valve opens when there is excess pressure in the secretion canister. Cover caps are used for proper sealing and disposal.

  • Page 7: Intended Use Hose System

    Medical contraindications: • Not suitable for use on patients with large air leaks (≥4,5 l/min) and coagulum. • Not suitable for cardiothoracic drainage therapy in which no vacuum should be applied to the patient. Other contraindications: • Do not use with cardiothoracic drainage devices other than the ATMOS C 051Thorax • No separate application of the secretion canister and the hose system (i.e. without basic device) as gravity drainage. • No application under emergency conditions. • Should not be used in the homecare sector which is not supervised by healthcare professionals.
  • Page 8 • Not suitable for use on patients with large air leaks (≥4.5 l/min) and coagulum. • Not suitable for cardiothoracic drainage therapy in which no vacuum should be applied to the patient. Other contraindications: • No application with other cardiothoracic drainage systems other than the ATMOS C 051 Thorax, ATMOS S 201 Thorax and ATMOS E 201 Thorax • No separate application of the secretion canister and the hose system (i.e. without device) as gravity drainage. • No application under emergency conditions. • Should not be used in the homecare sector which is not supervised by healthcare professionals. • No suction of flammable, corrosive or explosive fluids/...

  • Page 9: Function

    The product is: active not active Sterility / specific microbial Hose system is sterile. condition: Single-use product / Hose system is a disposable product. reprocessing: Function The ATMOS C 051 Thorax is an exceptionally handy, portable, digital thoracic drainage suction device. The device is operated with an electrical, maintenance-free diaphragm pump. During operation the pump creates a vacuum within the suction hose and the secretion canister by means of which secretion and air 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. The secretion is collected in the secretion canister. Its capacity is 800 ml. With the aid of the measuring and rinsing hose the vacuum at the end of the hose system is measured. Via the touch screen display the target vacuum can be set manually. The suction capacity is regulated automatically. 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 intruding into the measuring and rinsing hose or that a syphon effect 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 filters in the secretion canister and measuring hose prevent contaminated secretions from entering the device. The device is equipped with a disposable strap and a carrying handle. These enable mobility and mounting of the device e.g. to the patient bed. A universal bracket or the standard rail bracket can be ordered separately as accessories. Transport and storage •...

  • Page 10: Explanation Of Pictures And Symbols

    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. » · General information, numeration Sub-numeration Engage, check correct fit. click Follow the arrows Move in this direction, plug in. Please press where dot indicates Activate the optional foot switch Replace...
  • Page 11 Symbols used for the ATMOS C 051 Thorax and its accessories Medical device This device complies with the relevant requirements of EU regulations. This device complies with the relevant requirements of EU regulations. 0124 UL Mark MEDICAL EQUIPMENT with respect to electrical shock, fire, and mechanical hazards only in accordance with E349855 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. GOST Certificate (Russia) Unique Device Identifier of a medical device Article number Serial number Batch code Use-by date Manufacturer Date of manufacture Country of manufacture: Germany Warning, pay special attention Observe the operating instructions! Follow operating instructions (blue)
  • Page 12 Do not reuse Sterile device STERILE Sterilized using ethylene oxide STERILE EO Non-sterile STERILE Double sterile barrier system Single sterile barrier system Protection class II device Applied part type BF Specification of the degree of protection against the ingress of solids and IP 33 moisture Fuse Do not use if the packaging is damaged and follow the operating instructions. Fragile, handle with care Keep dry Keep away from sunlight Temperature limit Atmospheric pressure limitation Humidity limitation...
  • Page 13 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: For Your Safety

    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.
  • Page 15 • 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 vertically. 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 patients’ safety.
  • Page 16 (chapter “4.9 User settings” on page 38). • Minimal leakages can indicate small leaks in the system or to irregularities in the course of therapy. This can be excluded by clamping the patient catheter and as a result the flow 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 flow value illustrated then there is an internal leakage in the system which cannot be rectified by the user. This will be compensated by the system but illustrated as a minimal flow value. • The device may not be operated in MRI scanners (magnetic resonance imaging). • The ATMOS C 051 Thorax is a medical device which is subject to special safety regulations. It must to 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. 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.

  • Page 17: Avoiding Damage To The Device

    WARNING Explosion and fire hazard. Burns and injuries are possible. • Use only 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 flammable anaesthetics, skin cleansing products and skin disinfectants. The ambient conditions specified in the technical data (chapter “11.0 Technical data” on page 60) 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.
  • Page 18 • The ATMOS C 051 Thorax fully complies with the electromagnetic immunity requirements of standard IEC 60601-1-2 / EN 60601-1-2 „Electromagnetic compatibility - Medical Electrical Devices“. Damage to the device due to improperly installed protective contact socket! The device may become damaged. • The ATMOS C 051 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 first starting up, compare the mains voltage of the device (see rear of the power supply unit) with the local mains voltage.

  • Page 19: Setting Up And Starting Up

    3.0 Setting up and starting up Scope of delivery The ATMOS C 051 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) 317.0000.0 ATMOS C 051 Thorax 1x Basic device 1x Carrying handle 317.0090.0 5x Disposable strap 316.1200.0 1x Recharging unit 313.0089.0 1x Power cable, L = 4m 008.0941.0 1x Operating instructions 1x Quick reference guide Device overview...

  • Page 20: Start Up

    Cover sticker (no function  for user) Connection for USB flashdrive (therapy data transfer)  Only use the USB connection for the transfer of therapy data. A software update may only be performed by ATMOS or an authorized service person. Start up • Remove the device from the packaging. Check whether the mains current on the type plate of the power supply unit corresponds to the mains power supply. • Peruse safety information in chapter “2.0 For your safety” on page 14 prior to starting up the device for the first time. • The battery must be fully charged prior to the first use. Charging time approx. 2.5 hours. • Place the device on a safe and even surface. • Plug in the power cable to recharge the battery. • After transporting the device at low temperatures, keep the device at room temperature for at least six hours before initial start-up. If the device is not acclimatized it may not be used as...

  • Page 21: Secretion Canister

    1. Insert the plug of the battery power supply unit to the charging connector of the device. 2. Connect the power supply unit with the supplied country-specific power cable. 3. Plug the power plug into the socket. ª The ATMOS C 051 Thorax displays the symbol on the display. The bar on the far right flashes. As long as the power plug is inserted, the symbol is green As soon as the battery is fully charged the last bar of the symbol stops blinking 4. Unplug the power plug from the wall socket.
  • Page 22 3.3.2.1 Secretion canister system overview Pop-off valve (10 mbar overpressure) Protection cap of the secretion hose Connection to the cardiothoracic drainage Protection cap for the connection to the system ( protected by hydrophobic bacterial suction device and viral filter) Protection cap for the pop-off valve Scaling (in ml) Secretion canister guide Patient connection (secretion hose) Patient connection (measuring and rinsing hose) 3.3.2.2 Pop-off valve The pop-off valve 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.
  • Page 23 3.3.2.3 Inserting the secretion canister Attention! Prior to use, check the packaging of the sterile click products, the secretion canister system, and the hose system for intactness. Do not use defective secretion canisters or hose systems. 1. Wear disposable gloves and observe the regulations when handling sterile products. 2. Carefully remove the secretion canister from the packaging. 3. Insert the canister guides of the secretion canister into the canister guides on the rear side of the device ( see device overview). Hold the secretion canister slightly angled to the device.

  • Page 24: Connect The Hose System

    8. Release the 2 Luer-Lock - connections by a counter-clockwise rotation to separate the secretion canister from the hose system. Pay attention as secretion could be found in the connection space. Remove the blue protection cap  and use it to close the upper Luer lock connection of the secretion hose . Remove the black protection cap  and use it to seal the pop-off valve . 11. Remove the yellow protection cap and use it to close the connection to the device (Bacterial and viral) . 12. Dispose of the secretion canister properly. Reinsert the secretion canister 1.
  • Page 25 Attention! 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. 1. Carefully remove the sterile hose system from the sterile wrapping. 2. Connect the Luer lock with the bacterial and viral filter  to the lower canister connection ( on the secretion canister) by rotating it clockwise. 3. Connect the luer lock with the larger diameter to the upper connection of the canister ( on the secretion canister) by rotating it clockwise.

  • Page 26: Operation

    4.0 Operation Explanation of the display Display of the current fistula Actual System information Attention: This is the vacuum current value. In the case of Display of a discontinuous fistula, the the actual value may temporarily drop vacuum to zero although the fistula value. still exists. Therapy process Changeover to the graphic diagram User settings Adjusting button...

  • Page 27: Buttons And Display Symbols

    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 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 28: Display Symbols

    Annual inspection is required Explanation of the display in key lock modes 4.3.1 Key lock mode with bubbles In the key lock mode the flow is additionally displayed in traffic light coloured bubbles for at least one hour. Day/Night Mode Key lock acti- The ATMOS C 051 Thorax has a day/ vated night mode, i.e. the device adjusts automatically to the light conditions Flow displayed as bubbles in a room. Each additional coloured bubble represents an additional flow.

  • Page 29: Switching On

    150 ml/min if the average flow value is less than 150 ml/min for at least one hour. 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 is less than 150 ml/min. The recording is restarted in the process. If the hourly flow value exceeds the maximum of the flow scale, when the bar chart display is already active, then this bar is displayed in red. If the vacuum exceeds -30 mbar the vacuum lines are no longer displayed. Switching on 1. To switch on the ATMOS C 051 Thorax, touch the sensor above the symbol for two seconds. 2. The ATMOS logo appears with the software version number in the bottom right corner. 3. After a short time, depending on the user settings the leakage test starts automatically (see next chapter ). 4. Subsequently, ‘Therapy progress’ will appear in the display. By pressing the buttons you can start a new therapy recording or continue recording.
  • Page 30 If the leakage test is activated, it will start automatically once the device is switched on. The hose attachment towards the drainage catheter should already be sealed with a sterile plug when starting up the device. 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“ appears. Now you can remove the plug from the hose. By pressing the button you will reach the main menu. If the leakage test is faulty, the message „Leakage test failed“ appears. Check the hose connections and whether the secretion canister is correctly clicked into place. You now have the possibility to a) repeat the test...

  • Page 31: Function

    Function 4.6.1 Target vacuum • Please note, 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 pressing the buttons. • ATTENTION: The change in the target vacuum takes effect immediately. There is no confirmation necessary. • The target vacuum can be freely selected between -5 and -100 mbar in steps of 1 mbar. • If the buttons are pressed permanently, the increase / decrease will be accelerated. • The target vacuum of -20 mbar is preset when starting the device. • The button can be used to set the target vacuum directly to -5 mbar. For more information see “4.6.2 Gravity drainage mode” on page 31. If target vacuum is adjusted over -50 mbar the notice appears ,,High target vacuum is set“.
  • Page 32 • The ATMOS C 051 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. • The vacuum is measured at the patient-side of the hose system.

  • Page 33: Key Lock

    Key lock The ATMOS C 051 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 activate the key lock The key lock can be manually activated after all the therapy values 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.

  • Page 34: Therapy Process

    Therapy process The ATMOS C 051 Thorax offers 2 graphs to simplify the analysis of the flow and actual vacuum process. Selection menu By selecting the buttons you enter the menu for graphical diagram modus. By pressing the buttons you can select the modus of you choice e.g. long time display / short time. 4.8.1 Short time display: The graphical diagram starts by selecting the menu. In this modus the real measurements (flow, vacuum) from the last 30 seconds can be shown. Therefore you can visualize cough tests and other proceedings. By pressing the button the diagram can be frozen to enable a graphical interpretation. When you press the symbols again the short time display time diagram is restarted. By pressing the button you will return to the main 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...

  • Page 35: Long Time Display

    4.8.2 Long time display: In the long time modus 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 the buttons. • The scale can be increased or decreased by pressing the buttons. • Time scaling: - The endpoint on the right side of the graphic is always the actual point of time. - The scaling can be selected in 7 steps, between the display of the past 60 minutes and the last 12 days. - A vertical line shows when the therapy was interrupted.

  • Page 36: Transfer Of Therapy Data

    Transfer of therapy data You may transfer the therapy data to a USB flashdrive. The therapy data is saved as a PDF- and Excel-file. If you continue the therapy after the data transfer, the data will still be recorded. The transmitted data will not be deleted. 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 • Manufacturer: SanDisk, Kingston, ATMOS flash drive • System: USB 2.0, 3.0, 3.1 • Capacity: ≤ 32 GB • Formatting: FAT 32 • No stored encryption ATMOS recommends: Use a USB flashdrive without content. Other USB flashdrives may not be recognized, thus the therapy data transfer does not start. Start transfer •...

  • Page 37: Reading Out The Therapy Data

    • 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: Patient data Diagnosis Description of the secretion Following information can be seen in the report: Beginning and end of recording, flow at beginning and end of recording File name und device ID Graphic diagram of the therapy data Therapy Report ATMOS C 051 Thorax File name: ATMOS_C_051_THORAX_ID0C1C_20110212_063107.pdf Device ID: 0C1C Patient: Diagnosis: Secretion: Start date: End date: Recording time: 12.02.2011 / 04:28 12.02.2011 / 06:31...

  • Page 38: User Settings

    User settings Press the button to access user settings. Press the buttons 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: • Press the button to access the user menu. • The selected data are only saved if you press the memory 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...
  • Page 39 Leakage Test The leakage test can be Leakage test activated or deactivated with WARNING Critical tilt The warning message ‘Device Warning in critical tilt’ can be activated Critical tilt or deactivated with The key lock activation time Key lock activation time can be adjusted with The key tone can be activated Key tone or deactivated by pressing By pressing one of the two buttons (hour or minute) you can access the individual settings. Time Now you can change the time with...

  • Page 40: Switching Off The Device

    If the setting is activated, via key code 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 C 051 Thorax stop the therapy and touch the sensor for two seconds. • The ATMOS logo appears on the screen and the device shuts down.

  • Page 41: Warning Messages

    "Secretion canister full or hose patient catheter blocked" is activated. - Secretion hose system Possible reasons for this error to the secretion canister message are: - Secretion canister Leakages: connection • Contact the ATMOS service If the target vacuum is not • Check for blockages: achieved, the warning message - Secretion canister "Vacuum too low" and - Hose "Secretion canister full or hose - Bacterial and viral filter blocked" is activated. in the rinsing canister...
  • Page 42 If the warning message is tone. suppressed, it reappears after one minute, but without tone. If the therapy has already Press the Play symbol to start started and has been the therapy. interrupted by the pause symbol, the warning message If the warning message is "Inactive therapy" appears with suppressed, it appears again tone. with tone after one minute. The device must no longer be Contact the ATMOS service. operated. Possible causes • Battery or • pump defective.
  • Page 43 Display Cause Recommended actions Carry out an inspection Contact the 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. 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 44: Function

    6.0 Function Hose rinsing • The ATMOS C 051 Thorax has an automatic hose rinsing function which 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. • The manufacturer's default setting for the period between 2 rinsing cycles is 3 minutes. Gravity drainage mode while using the drainage system A physiological vacuum can be generated by setting the target vacuum to -5 mbar (press the button The automatic warning messages as well as all measuring functions and hose rinsing are retained. Thus, the physiological vacuum in the thorax is maintained while preserving the digital safety features.

  • Page 45: Accessories, Consumables And Spare Parts

    316.1100.0 Hose clamp 061.0079.0 Carrying handle for the ATMOS C 051 Thorax 317.0090.0 Support for the ATMOS C 051 Thorax standard rail 317.1160.0 Power supply unit for the ATMOS C 051 Thorax 317.1170.0 Consumables OT set for ATMOS C 051 Thorax 317.1100.0...

  • Page 46: Attaching/Removing The Device To/From The Universal Bracket

    2. Turn the holder clamp until the fixing pin clicks into place at the next fixing. Ensure that the fixing pin has engaged correctly before attaching the cardiothoracic drainage system to the universal bracket. Attaching the universal bracket: 1. Turn the turning knob of the universal bracket counter-clockwise until the clamp can be attached to the desired fixture. 2. Now turn the locking screw clockwise to fix the universal bracket. Ensure that the universal bracket is firmly attached to the desired fixture. Attaching/removing the device to/from the universal bracket Firmly hold the ATMOS C 051 Thorax during the whole process. 1. Place the device on the universal bracket. Ensure that the thread at the bottom of the cardiothoracic drainage system is directly above the fixing screw of the universal bracket. 2. Turn the fixing screw clockwise to mount the device. To remove the ATMOS C 051 Thorax release the fixing screw by turning anticlockwise. The cardiothoracic drainage system must always be attached horizontally.

  • Page 47: Attaching The Support To A Standard Rail

    Attaching the support to a standard rail Lateral guides for placement / removal of the device A recess for connecting the power cable to the device Mounting to a standard rail 7.3.1 Attach the support directly to a standard rail 1. Attach the support to the standard rail.  Check that the support is properly engaged before placing the device onto the support. 7.3.2 Attaching/removing the support to/from the universal bracket ...

  • Page 48: Placing / Removing The Device On/From Support (Accessory)

    Placing / removing the device on/from support (accessory) 1. Place the device on the support.  Make sure that the guides of the carrying handles or the lateral strap holders are inserted into the guides on the support. 2. Remove the device from the support by the carrying handle or on the canister recess.

  • Page 49: Attaching And Removing The Power Supply Unit With Support To The Universal Bracket

    7.5.2 Attaching and removing the power supply unit with support to the universal bracket  Firmly hold the power supply unit which is attached to the support during the entire process. 1. Attach the universal bracket( chapter “7.1 Attaching the universal bracket (Accessories)” on page 45). 2. Place the support with power supply unit to the universal bracket by positioning the thread on the bottom of the support with power supply unit over the fixing screw of the universal bracket. 3. Turn the fixing screw on the universal bracket in a clockwise direction in order to mount the power supply unit to it.

  • Page 50: Attaching And Removing The Carrying Handle, Disposable Strap And Carrying Strap

    Attaching and removing the carrying handle, disposable strap and carrying strap 7.8.1 Strap holders • The strap holders on the back of the device are already mounted on delivery. • If you do not require the strap holders they can be easily removed with a standard screwdriver (TORX - screwdriver T10). Strap holders Strap holder clips 7.8.2 Attaching the carrying handle To attach the carrying handle the strap holder clips and screws are required. These are provided on the device. 1. Loosen the screws on the back of the device by 3 turns with the recommended screwdriver (TORX - screwdriver- T10). 2. If necessary remove the strap holders. The curve of the carrying handle must point towards the front of the device.

  • Page 51: Removing The Carrying Handle

    7.8.3 Removing the carrying handle To remove the carrying handle from the device, loosen the screws by 3 turns with the recommended screwdriver (TORX - screwdriver - T10) out of the strap clips on the back of the device. 7.8.4 Attaching the disposable strap Strap carabiner + for attaching to carrying handle or strap holders 7.8.4.1 Attaching the disposable strap to the carrying handle To attach the disposable strap to the carrying handle the device with the mounted carrying handle is required (Chapter “7.8.2 Attaching the carrying handle” on page 50). 1. Click one of the strap carabiner in one of the recesses provided at the carrying handle. 2.
  • Page 52 Attaching the carrying strap Take the strap carabiner  and hook it to one of the strap holder clip at your cardiothoracic drainage system. 2. Now hook the other strap carabiner into the second strap holder clip at your cardiothoracic drainage system unit. Now the ATMOS C 051 Thorax can be worn over your shoulder. Attaching the cardiothoracic drainage system to a patient bed 1. For attachment to a patient’s bed exchange strap carabiner to a strap carabiner .

  • Page 53: Cleaning And Care

    8.0 Cleaning and care General information on cleaning and disinfection Prior to cleaning Medical devices such as the ATMOS C 051 Thorax must be operationally and functionally reliable. Therefore we recommend prior to every use: If applicable Handling of the cardiothoracic drainage system determines to a large extent its reliability and safety. The hygiene measures are necessary measures for the protection of patients and users, and to maintain functional reliability of the cardiothoracic drainage system. Prior to cleaning the device please remove all disposable parts such as secretion canister and hoses. Please remove the power cable, power supply unit, charging plug and if present, the carrying strap. The described actions relating to cleaning and disinfection or sterilization do not substitute the relevant instructions which must be adhered to prior to operation! Some disinfectants could cause discolouring to some of the plastic parts. Avoid the penetration or liquid entering the cardiothoracic drainage system, especially in the connections on the rear side 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 •...

  • Page 54: Cleaning The Device Surface

    Cleaning the device surface Prior to using the device on a new patient the complete device surface must always be cleaned with a damp (not wet) cloth and disinfected with a surface disinfection solution. In case the device is being used by the same patient the surface should still be cleaned at least once every week with a damp (not wet) cloth and afterwards be disinfected with a surface disinfectant. The device must never be autoclaved, rinsed under running water or immersed into any liquids! Recommended disinfectants Contents (in 100 g) Manufacturer ATMOS Green & < 1 g Metasys, Rum Clean SK (Austria) < 1 g Alkyldimethylethylbenzylammoniumchloride < 1 g Dismozon pur Magnesium peroxyphthalate 80 g Bode Chemie, Hamburg End of product Hexahydrate 12/2014 Dismozon plus Magnesium peroxyphthalate 95.8 g...

  • Page 55: Hygiene Plan

    Hygiene plan WHAT WHEN Notices Manual wipe cleaning Device Manual wipe disinfection Disposable product — not suitable Canister for reprocessing, change after use Disposable product — not suitable Hose system for reprocessing, change after use Disposable strap Disposable product — not suitable for reprocessing, change after use Disposable product — not suitable Ports for reprocessing, change after use Manual wipe cleaning Carry handle Manual wipe disinfection...

  • Page 56: Maintenance And Service

    2. Clean and disinfect the product and accessories according to the operating instructions. 3. Enclose any used accessories with the product. 4. Fill in form QD 434 “Delivery complaint / return shipment” and the corresponding Decontamination certificate.  This form is enclosed with each delivery and can be found at www.atmosmed.de. 5. The product must be well padded and packed in suitable packaging. 6. Place the form QD 434 “Delivery complaint / return shipment” and the respective decontamination certificate in an envelope. 7. Affix the envelope to the outside of the package. 8. Send the product to ATMOS or your dealer.

  • Page 57: Handling Of Batteries

    ) Always store device with batteries at a charge status of 20 - 40 %. ) Avoid deep discharge: Devices with permanently installed batteries should be recharged every 4-5 months. ) Never cover the device, never expose the device to direct sunlight and never charge, operate or store the device in close 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 excluded from the guarantee. There is a function guarantee of 6 months. Using other charging accessories may result in risk of explosions!

  • Page 58: Troubleshooting

    Fuses are defective. Check main fuse. Battery does not recharge; charging Power cable defective or Check the power cable. symbol does not light not connected properly. up despite proper Contact ATMOS Service or a certified connection to the power Power supply unit or service partner. The device must be cable. battery defective. checked. Check all connections for leaks. Connection of the hose system to the patient catheter, connection of the ‘Vacuum too low’...
  • Page 59 Leakage test failed. Hose system is not Check the hose system and rinsing completely closed. canister for correct fit. See “3.3.2.4 Changing the secretion canister” on Secretion canister is page 23 leaking. Internal error. Contact ATMOS Service or a certified service partner. The device must be checked. Flow readout is always in Component error 1) Check whether the flow is also 0 l/ 0 l/min. min when the system is open. 2) Contact ATMOS Service or a certified service partner. The device Secretion has entered the device.

  • Page 60: Technical Data

    Other safety equipment „Pop-off valve“ in the rinsing canister Vacuum in the device limited to approx. -150 mbar Acoustic and optical error warnings Pump performance Free flow 5 ± 0.5 l/min Vacuum adjustable from -5 mbar to -100 mbar, step size -1 mbar Display Graphic display, colour, with background lighting, display of target vacuum and actual vacuum in mbar, O, kPa and flow in l/min Data memory Internal memory for therapy data: 2.5 MB storage of up to 12 days possible Rinsing canister ATMOS disposable canister, transparent, pop-off valve, graduation. Max. volume of 800 ml, connection to the device with “Direct-Docking-System“. Material: SAN (Styrene Acrylonitrile). Suction 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 Battery operation time in normal 16 h operation (without fistula) Battery charging time Fully recharged (at least 95 %) in approx. 2 h...

  • Page 61: Bacterial And Viral Filter

    Periodic tests Inspection according to the manufacturers specifications every 12 months. Protection class (EN 60601-1) Degree of protection Type BF applied parts Type of protection IP33 CE marking ID no. (REF) 317.0000.0 ATMOS C 051 Thorax 317.0100.0 ATMOS C 051 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...

  • Page 62: Disposal

    12.0 Disposal • Please observe national disposal regulations (e.g. waste incineration). • Device and accessories must be decontaminated prior to disposal, as secretion residuals could pose a danger to a third party. • Pay attention to a careful separation of the different materials. • The housing material is fully recyclable. • The ATMOS C 051 Thorax has a lithium-ion battery which must be disposed of in accordance with existing directives. Disposal within the EU The device described above is a high-quality medical product with a long service life. After its life cycle, it must be disposed of professionally. According to the EC directives (WEEE and RoHS) the device may not be disposed of with domestic waste. Please observe existing national laws and rules for disposal of old devices in the respective country.

  • Page 63: Notes On Emc (Electromagnetic Compatibility)

    Medical electrical equipment is subject to special precautions with regard to EMC and must be installed according to the following EMC notes, which correspond to the requirements from DIN EN 60601-1-2:2016-05. 13.1 Guidance and manufacturer’s declaration – ambient conditions The ATMOS C 051 Thorax is suitable for use in the following environments: In fields of home health care in any buildings, outdoor areas and means of transport. and/or in professional healthcare facilities such as doctor’s practices, clinics, or first-aid facilities as well as operating rooms and outside of the HF-shielded room of a magnetic resonance imaging system ) The customer or user of the ATMOS C 051 Thorax should ensure that it is used in such an environment. 13.2 Guidance and manufacturer’s declaration – key features The ATMOS C 051 Thorax has the following electrical components: Type Max. cable length Battery recharging unit 313.0089.0 Power cable 008.0941.0 4 m Power cable 008.0920.0...
  • Page 64 ATMOS MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Str. 16 79853 Lenzkirch / Germany Phone: +49 7653 689-0 info@atmosmed.de www.atmosmed.com...

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