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
2022-05 Index: 17
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 2022-05 Index: 17 E349855...

  • Page 2: Table Of Contents

    Table of contents Introduction...................... 4 Notes on operating instructions ................4 Explanation of pictures and symbols ..............5 Intended purpose .....................8 1.3.1 Intended purpose ATMOS C 051 Thorax ..............8 1.3.2 Intended purpose secretion canister 800 ml ............9 1.3.3 Intended purpose hose system................10 Function ........................12 Transport and storage ....................13 For your safety ....................
  • Page 3 Repairs ........................56 Sending in the device ....................56 Handling of batteries ....................57 10.0 Troubleshooting ..................... 58 11.0 Technical data ....................60 11.1 ATMOS C 051 Thorax ....................60 11.2 Secretion canister 800 ml ..................61 11.3 Hose system ......................62 12.0 Disposal/recycling ..................64 12.1 Expected service life ....................64 13.0...

  • Page 4: Introduction

    ATMOS C 051 Thorax will be preserved. § • The product ATMOS C 051 Thorax bears the CE marking CE 0124 according to the EC Directive of the council for medi- cal products 93/42/EEC and meets the basic requirements of Annex I of the Directive.

  • Page 5: 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 death 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 E349855...
  • Page 7 Do not reuse Sterilized using ethylene oxide STERILE EO Single sterile barrier system with protective packaging inside Single sterile barrier system with protective packaging outside Protection class II device Do not use if the packaging is damaged and follow the operating instruc- tions.

  • Page 8: Intended Purpose

    Product name: ATMOS C 051 Thorax Main functions: The ATMOS C 051 Thorax is a device for mobile, digital car- diothoracic drainage. The system generates a controlled vacuum close to the patient and has an electronic moni- toring system which shows the actual vacuum measured at the patient's side and the air leak.

  • Page 9: Intended Purpose Secretion Canister 800 Ml

    Secretion canister 800 ml Main functions: The secretion canister passes on 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. Via balancing scales, the amount of flu- id in the secretion canister is readable and documentable.

  • Page 10: Intended Purpose Hose System

    Other contra-indications: • No application with cardiothoracic drainage systems other than the ATMOS C 051Thorax • No separate use of the secretion canister and the hose system (i.e. without device) as gravity drainage •...
  • Page 11 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 meas- uring and rinsing hose measures and regulates the vacu- um applied on the patient's side. A bacterial and viral filter on the measuring and rinsing hose protects against con- tamination with bacteria and viruses. At defined intervals, a valve opens to conduct air through the measuring and rinsing hose into the secretion hose and to flush fluids, coagula and other blockages into the secretion canister.

  • Page 12: Function

    Other contra-indications: • No application with cardiothoracic drainage systems other than the ATMOS C 051 Thorax, ATMOS S 201 Tho- rax 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 13: Transport And Storage

    If damage occurs during transport: 1. Document and report damages in transit. 2. Fill in form QD 434 “Customer complaint/return shipment”. 3. Send the device to ATMOS (chapter „9.3 Sending in the device“ on page 56). Ambient conditions for transport and storage • Temperature: −10...+50 °C...

  • Page 14: For Your Safety

    • Prior to each use, check for damage to the device and the power cable. Do not operate the de- vice if you notice any damage. In this case, clean and disinfect the device and send it to ATMOS for repair.
  • Page 15 • Use only original accessories and original spare parts from ATMOS. This applies to the power cable in particular. • Follow the instructions regarding periodic tests in chapter „9.0 Maintenance and Service“ on page 56. • Assembly, new settings, alterations, extensions, and repairs may only be carried out by author- ized persons.
  • Page 16 • 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.

  • Page 17: 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 for repair or an authorised service partner.
  • Page 18 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.

  • 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 package for any possible damage and compare the contents for completeness.

  • Page 20: Start Up

    Attention! Prior to first start up of the ATMOS C 051 Thorax, the battery must be fully charged. Only the battery power supply unit supplied by ATMOS should be used. Please note the infor- mation on how to handle rechargeable batteries in chapter „9.4 Handling of batteries“ on page 57. Correct handling of the rechargeable batteries prolongs their maximum service life. Bat- teries are wearing parts and therefore excluded from the general warranty.

  • Page 21: Secretion Canister

    If the battery is too low for further operation, the ATMOS C 051 Thorax switches off automatically. The battery of the ATMOS C 051 Thorax can also be charged when the device is switched off. The state of charge can be seen on the display.
  • Page 22 3.3.2.1 Secretion canister 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...
  • Page 23 3.3.2.3 Insert 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.

  • Page 24: Connecting 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. 9. Remove the blue protection cap and use it to close the ...
  • 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 packaging. 2.

  • Page 26: Operation

    4.0 Operation Ambient conditions during operation • Temperature: +5...+35 °C • Relative humidity: 20...80 % • Air pressure: 700...1060 hPa Explanation of the display Display of the actual fistula Actual vacu- System information Attention: This is the current value. In the case Display of of a discontinuous fistula, the actual...

  • 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 therapy...

  • Page 28: Display Symbols

    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.

  • Page 29: Switching On

    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.
  • Page 30 Alternatively the tho- rax catheter 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.

  • 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 confirma- tion necessary.
  • Page 32 • The ATMOS C 051 Thorax has a vacuum regulator. This means, that the integrated pump only starts, if the actual vacuum doesn't correspond to the target vacuum. On the other hand the pumps 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 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...

  • Page 34: Therapy Progress

    Therapy progress 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 your choice e.g. long time display / short time. 4.8.1 Short time display The graphical diagram starts by selecting the menu.

  • Page 35: Long Time Display

    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 the buttons. • The scale can be increased or decreased by press- ing the buttons. • Time scaling: - The endpoint on the right side of the graphic is always the actual point of time.

  • Page 36: 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 37: Reading Out The Therapy 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 and device ID Graphic diagram of the therapy data Therapy Report ATMOS C 051 Thorax File name:  ATMOS_C_051_THORAX_ID0EC3_20200515_152026.pdf Device ID: 0EC3  Patient: ...

  • 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. For entering a selection menu press on the text box. These buttons can be found in every settings menu: •...
  • Page 39 Leakage Test The leakage test can be activat- Leakage test ed 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...

  • Page 40: Switch Off The Device

    4.10 Switch 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

    Possible reasons for this error to the secretion canister message are: - Secretion canister con- Leakages nection • Contact the ATMOS service If the target vacuum is not • Check for blockages: achieved, the warning mes- - Secretion canister sage "Vacuum too low" and - Hose "Secretion canister full or hose...
  • Page 42 "Inactive therapy" If the warning message is appears with tone. suppressed, it appears again 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 Perform an inspection accord- Contact the ATMOS service. ing to the manufacturer's spec- ifications every 12 months. This will be displayed on the device. Low battery capacity appears in Battery must be replaced by the display. the service. If the set target vacuum is over -50 mbar the notice "High tar-...

  • 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 canis- ter. • The rinsing process is initiated by opening a valve located in the measuring and rinsing hose.

  • 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 The Universal Bracket (Accessories)

    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.

  • Page 47: Attaching The Support To A Standard Rail

    To remove the ATMOS C 051 Thorax release the fixing screw by turning anticlockwise. The cardiothoracic drainage system must always be at- tached horizontally. 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...

  • Page 48: Attaching/Removing The Support To/From The Universal Bracket

    7.3.2 Attaching/removing the support to/from the universal bracket & Firmly hold the support during the entire process. 1. Attach the universal bracket( chapter „7.1 Attaching the universal bracket (Accessories)“ on page 46). 2. Place the support on the universal bracket by position- ing the thread on the bottom of the support over the fixing screw of the universal bracket 3.

  • Page 49: Attaching And Removing The Power Supply Unit (Accessory)

    Attaching and removing the power supply unit (accessory) Assembly recesses Recess for storage of the power supply unit and power cable 7.5.1 Attaching and removing the power supply unit to the support 1. Place the support onto the power supply unit by placing the thread at the bottom of the support over the fixing screw of the power supply unit.

  • Page 50: Inserting And Removing The Power Supply Unit And Power Cable

    Inserting and removing the power supply unit and power cable 1. Insert the power supply unit and power cable in the power supply unit. 2. Remove the power supply unit and the power cable from the power supply unit. 3. The device can be placed or removed from the support (see chapter „7.4 Placing / removing the device on/ from support (accessory)“...

  • Page 51: Removing The Carrying Handle

    1. Loosen the screws on the back of the device by 3 turns with the recommended screwdriver (TORX - screwdriv- er - T10). 2. If necessary remove the strap holders. The curve of the carrying handle must point towards the front of the device.

  • Page 52: Attaching The Carrying Strap

    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 pa- tient bed 1.

  • 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 required Handling of the cardiothoracic drainage system determines to a large extent its reliability and safety.

  • Page 54: Cleaning The Device Surface

    The device must never be autoclaved, rinsed under running water or immersed into any liq- uids! Recommended disinfectants Disinfectant Ingredients (in 100 g) Manufacturer ATMOS Green & Alkyl dimethyl benzyl ammonium < 1 g Metasys, Rum Clean SK chloride (Austria) <...

  • Page 55: Hygiene Plan

    Hygiene plan WHAT WHEN Details Manual wipe cleaning Device Manual wipe disinfection Secretion canister Single use product -> not for reprocessing, change after use Single use product -> not for Hose system reprocessing, change after use Single use product -> not for Disposable strap reprocessing, change after use Single use product -> not for Connectors reprocessing, change after use Manual wipe cleaning Carrying handle Manual wipe disinfection At 40 °C hand wash...

  • Page 56: Maintenance And Service

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

  • Page 57: Handling Of Batteries

    ) The lifetime of lithium-ionic batteries mainly depends on the ambient temperature. On princi- ple 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 guar- antee. There is a function guarantee of 6 months. Using other charging accessories may result in risk of explosions!

  • Page 58: Troubleshooting

    Mains cable defective or charge; charging symbol Check the mains cable. not connected properly. does not light up despite proper connection to the Contact the ATMOS service or a certi- Power supply unit or bat- power cable. fied service partner. The device must tery defective. be checked.
  • Page 59 Changing the secretion canister“ on Secretion canister is leak- page 23. ing. Internal error. Contact the ATMOS service or a certi- fied 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.

  • Page 60: Technical Data

    11.0 Technical data 11.1 ATMOS C 051 Thorax Voltage 100-240 V; 50/60 Hz Connection socket IEC320 type C7, cable length 4 m Power consumption max. 60 W Direct current voltage 12 V DC ± 2 %, max. 5 A via cable, 1.8 m length with plug 5.5 x 2.5 Rechargeable battery, built-in Lithium-ionic, 14.4 V nominal, 2900 mAh nominal Charger GTM 91099-6015-3.0-T2A Other safety lugs Pressure control valve „Pop-off valve“ in the canister...

  • Page 61: Secretion Canister 800 Ml

    (according to EN 60601-1) Classification of applied parts Type BF applied parts Type of protection IP33 CE mark Reference number (REF) 317.0000.0 ATMOS C 051 Thorax 317.0100.0 ATMOS C 051 Thorax 11.2 Secretion canister 800 ml Capacity max. 800 ml Properties • ATMOS disposable canister •...

  • Page 62: Hose System

    Filter class H13 (High-Efficiency Particulate Air/Arrestance)* *External test report (test laboratory) 11.3 Hose system Length 1.80 m Properties • ATMOS disposable hose • Transparent • Connection to the rinsing canister/device with Luer-Lock Material PVC (hose and connections) PP (adapter) ABS (plugs) Components • Double lumen hose system:...
  • Page 63 Dimensions D (mm) 5.15 x 8.15 mm/ 3.65 x 5.15 mm Weight 119 g Packaging Sterile wrapping: Foil 100 µm (Tyvek) Packaging unit 10 individually packed hose systems in a brown cardboard Sterilization EO (ethylene oxide) CE mark Reference number (REF) 312.1170.0 Hose system 312.1201. 0 Hose system with connector small 312.1202.

  • Page 64: Disposal/Recycling

    ATMOS C 051 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 dispose of the device professionally. 3. In other countries: dispose of the device properly and in accordance with country-specific laws and regulations.

  • Page 65: Notes On Emc (Electromagnetic Compatibility)

    HF-shielded room of a magnetic resonance imaging sys- ) 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:...
  • Page 66 For your notes...
  • 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...

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