Atmos C 051 Thorax Operating Instructions Manual
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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 1.3.21. GA1GB.710101.0 0124 2019-03 Index: 11...
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Page 2: Table Of Contents
Explanation of the display ...... 20 Intended use ..........5 Buttons and display symbols ....21 1.2.1 Intended use ATMOS® C 051 Thorax ..5 4.2.1 Buttons ............. 21 1.2.2 Intended use ATMOS® C 051 Thorax 4.2.2 Display symbols ........22 secretion canister ........ - Page 3 RF strap ............40 Communications equipment and the 7.8.1 Strap holder ..........40 ATMOS® C 051 Thorax ......55 7.8.2 Attaching the carrying handle....41 7.8.3 Removing the carrying handle ....41 7.8.4 Attaching the disposable strap ....41...
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Page 4: Introduction
Care and period tests in conjunction with professional execution provide for operational safety and readiness for use of your ATMOS® C 051 Thorax and are therefore a must besides regular cleaning. Repair work and period tests may be carried out only by expert personnel authorised by ATMOS. -
Page 5: Intended Use
Specification of the main function: The ATMOS® C 051 Thorax drainage system is a device for mobile, digital thoracic drainage. The device is meant for the short-term (< 30 days) application on humans. -
Page 6: Intended Use Atmos® C 051 Thorax Hose System
1.2.3 Intended use ATMOS® C 051 Thorax hose system Name: Hose system for the ATMOS® S / E 201 Thorax and ATMOS® C 051 Thorax Main function: Transport of generated vacuum from basic device to patient-sided tube end. Suction of secretion and air through the secretion hose into the secretion canister. Transport of the patient-sided vacuum to the vacuum sensor for detecting the current vacuum, which is at the patient side. -
Page 7: Function
Function The ATMOS® C 051 Thorax is an exceptionally handy, mobile, 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... - Page 8 Graphic symbols contained in these operating instructions Warning, special Important information diligent notice Symbols of ATMOS® C 051 Thorax and accessories The CE sign shows that this product Repeated reuse of Application parts meets the appropriate components which are...
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Page 9: For Your Safety
Note Damage to the device due to improperly installed protective contact socket! • The ATMOS® C 051 Thorax was produced in accordance with IEC 60601-1/EN 60601-1 and with VDE safety class ll. • The device may only be connected to a properly installed protective contact socket. -
Page 10: Caution
• 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. • A second functioning device (consumables included) must be available for every patient whose condition could become critical if the device in use should get damaged. -
Page 11: Warning
• Don´t take a shower / bath with the device. Danger of explosion due to unobserved ambient conditions! • The ATMOS® C 051 Thorax is not designed for the use in medical areas with an explosion hazard or which are oxygenated. Explosion-hazardous areas may be caused by the use of flammable anaesthetics, skin cleansing products and skin disinfectants. The ambient... - Page 12 • Canister and hose system should only be used once on every patient. • For hygienic reasons we recommend an exchange of both canister and hose system at the same time. Risk of injury by damaged device • If the device was dropped: Check the device for visible damage. A leakage test is recommended.
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Page 13: Setting Up And Starting Up
3.0 Setting up and starting up Scope of delivery Prior to dispatch, the ATMOS® C 051 Thorax was subjected to an extensive functional test and was carefully packed. On receipt of the goods please check the package for any possible damage and compare the contents for completeness. -
Page 14: Start Up
20% battery charge. Attention! Prior to first start up of the ATMOS® C 051 Thorax the battery must be fully charged. Only the battery recharging unit supplied by ATMOS should be used. Please note the information on how to handle rechargeable batteries in chapter „9.4 Handling of batteries“ on page 47. Correct handling of the rechargeable batteries prolongs their maximum service life. Batteries are wearing parts and therefore excluded from the general warranty. -
Page 15: Secretion Canister
32) Charge the battery in order to continue the therapy without interruption. 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. 3.3.2 Secretion canister •... - Page 16 3.3.2.1 Secretion canister overview Cover lid of the secretion channel Pop-off valve (10 mbar high pressure) Connection to the drainage unit (protected Cover lid for the connection to the by a hydrophobic bacterial filter) suction unit Scales (in ml) Cover lid for the pop-off valve Connection towards patient (secretion Secretion canister guide ...
- Page 17 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.
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Page 18: 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. Flow 9. Remove the blue cover cap and cover the upper Luer-Lock ... - Page 19 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.
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Page 20: Operation
Display of the preadjusted target vacuum to which the Day/Night Mode pump adjusts. Key lock activated The ATMOS® C 051 Thorax has a day/night mode, the device adjusts automatically to the environmental Flow displayed as bubbles lighting. Each additional coloured bubble represents an additional flow. -
Page 21: Buttons And Display Symbols
Buttons and display symbols 4.2.1 Buttons Figure Function Decrease target vacuum / in the menu: decrease selected value Increase target vacuum / in the menu: increase selected value Graphic diagram of the therapy Open the user settings Save entry Confirm information Back / Exit menu Warning / suppress the warning Changeover to vacuum scaling... -
Page 22: Display Symbols
Therapy in progress Upcoming warning suppressed Annual inspection is required Switching on 1. To switch on the ATMOS® C 051 Thorax please touch the sensor above of the symbol for 2 seconds. 2. The ATMOS logo appears with the software version number in the bottom right corner. - Page 23 Alternatively the thorax 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.
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Page 24: Function
• By pressing the button the pump will be stopped. • 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. -
Page 25: Key Lock
Key lock The ATMOS® C 051 Thorax is equipped with 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 26: Therapy Progress
Therapy progress The ATMOS® C 051 Thorax has 2 graphical diagrams to simplify the analysis of the air-flow and actual vacuum progress. Selection menu By selecting the button you reach the graphical diagram modus. By pressing the buttons you can select the modus of you choice e.g. long / short time. -
Page 27: 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 a patients therapy. Suitable USB flash drives for therapy data read-out •... -
Page 28: 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 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:... -
Page 29: Switch Off The Device
Switch off the device • To switch off the ATMOS® C 051 Thorax stop the therapy and touch the sensor for 2 seconds. • The ATMOS logo appears on the screen and the device shuts down. V1.3.21 User settings For accessing the user menu please press the button Please press the buttons for moving up and down in the menu selection. - Page 30 You can change the period Period time of hose rinsing time of hose rinsing with The vacuum unit can be Vacuum unit adjusted with The leakage test can be Leakage test activated or deactivated with WARNUNG Kritische Schräglage The warning message device WARNING in critical tilt can be activated or deactivated with...
- Page 31 The key tone can be activated Key tone or deactivated by pressing By pressing one of the two control panels (hour or minute) you may enter the individual settings. Time Now the time can be adjusted with By pressing one of the three control panels (Day, Month, Year) you may enter the individual settings.
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Page 32: Warning Messages
„vacuum - Secretion canister too low“ is displayed. Possible - Drainage hose reasons for this error indication • Contact the ATMOS service are: Leakage, blockage of the bacterial filter in the measuring and rinsing channel, clogging, a bend in the drainage hose, liquids were sucked into the pump. - Page 33 Start therapy by pressing the started after initial operation button. the warning "Inactive therapy" appears. Defective battery. The device Contact the ATMOS service! can no longer be used. WARNUNG Batterie defekt Das Gerät kann nicht betrieben werden! Batterie durch Service tauschen lassen! Perform an inspection according to the manufacturer's specifications every 12 months.
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Page 34: 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 channel into the secretion canister. • The rinsing is performed by opening a valve located in the measuring and rinsing channel. -
Page 35: Accessories, Consumables And Spare Parts
316.1100.0 Hose clamp 061.0079.0 Carrying handle 317.0090.0 Support for the ATMOS® C 051 Thorax and ATMOS® S 042 NPWT - 317.1160.0 standard rail Power supply unit storage box for support ATMOS® C 051 Thorax 317.1170.0 and ATMOS® S 042 NPWT... -
Page 36: Attaching/Removing The Device To/From 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 thoracic drainage unit is directly above the fixing screw of the universal bracket. -
Page 37: 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 supply cable to the device Mounting to a standard rail Adaptation for a rail clamp to a standard rail 7.3.1 Attaching the support directly to a standard rail 1. -
Page 38: Attaching / Removing The Support To / From The Universal Bracket
7.3.3 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 35). 2. Place the support on the universal bracket by positioning the thread on the bottom of the support over the fixing screw of the universal bracket 3. -
Page 39: Attaching And Removing The Power Supply Unit (Accessory)
Attaching and removing the power supply unit (accessory) Assembly recesses Recess for storage of power supply unit and power supply cable 7.5.1 Attaching and removing the power supply unit to the support 1. Place the support on the power supply unit by placing the mounting recesses of the support over the power supply unit mounting recesses. -
Page 40: Inserting And Removing The Power Supply Unit And Cable
Inserting and removing the power supply unit and cable 1. Insert the power supply unit and charging cable in the power supply unit support. 2. Remove the power supply unit and the charging cable from the power supply unit support. 3. -
Page 41: Attaching The Carrying Handle
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). -
Page 42: Attaching The Carrying Strap
attachment clip on your drainage unit. Now the ATMOS® C 051 Thorax can be worn over your shoulder. Attaching the drainage unit to a patient bed 1. To prepare attachment to a patient’s bed hook the... -
Page 43: Cleaning And Care
8.0 Cleaning and care General information on cleaning and disinfection Prior to cleaning Medical devices like the ATMOS® C 051 Thorax must be fail safe at all times. Therefore we recommend prior to every use: if required Handling of the drainage unit 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 drainage unit. -
Page 44: Cleaning The Device Surface
The device should never be autoclaved, rinsed under running water or immersed into any liquids! Recommended disinfectants Disinfectant Ingredients (in 100 g) Manufacturer ATMOS Green & Alkyl dimethyl benzyl ammonium < 1 g Metasys, Rum Clean SK chloride (Austria) < 1 g Dialkyl dimehtyl ammonium chloride <... -
Page 45: Hygiene Plan
Hygiene plan WHAT WHEN Details Manual wipe cleaning Drainage unit Manual wipe disinfection Single use product -> not for Canister 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 Ports reprocessing, change after use Manual wipe cleaning Carrying handle Manual wipe disinfection At 40 °C hand wash... -
Page 46: 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 47: Handling Of Batteries
) The lifetime of lithium-ionic 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 48: Troubleshooting
Hose system is not completely closed. Flow readout is always in Component error 1) Check whether the flow is also 0 l/min. 0 l/min when the system is open. Secretion has entered the 2) Contact the ATMOS service or a device. certified service partner. The device must be checked. -
Page 49: Technical Data
Data memory Internal memory for therapy data: 2.5 MB up to 12 days recording possible Canister ATMOS® disposable canister, transparent, pressure relief valve, graduation Max. volume of 800 ml, connection to the device with „Direct-Docking-System“. Material: SAN (Styrene Acrylonitrile) Suction hose... - Page 50 IP 33 Applied standards EN 60601-1: EN 60601-1/-2: EN ISO 10079-1 Classification according to Appendix IX EC Directive 93/42/EEC CE marking CE 0124 GMDN code 36787 UMDNS code 10-218 Suction device, thoracic 317.0000.0 ATMOS® C 051 Thorax Issue of technical data: 16.12.2016...
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Page 51: Disposal
ATMOS MedizinTechnik GmbH & Co. KG for a professional disposal. Prior to disposal respectively before transport all secretion canisters and tubes must be... -
Page 52: Notes On Emc (Electromagnetic Compatibility)
13.1 Guidelines and Manufacturer's Declaration - Emissions The ATMOS® C 051 Thorax is intended for use in the electromagnetic environment specified below. The customer or user of the ATMOS® C 051 Thorax should ensure that it is used in such an environment. Electromagnetic Environment - Emissions Test... -
Page 53: Guidance And Manufacturer's Declaration - Electromagnetic Immunity
13.2 Guidance and manufacturer's declaration - electromagnetic immunity The ATMOS® C 051 Thorax is intended for use in the electromagnetic environment specified below. The customer or user of the ATMOS® C 051 Thorax should ensure that it is used in such an environment. IEC 60601- Test Electromagnetic Immunity Test Compliance Level Level Environment - Guidance Electrostatic ±... -
Page 54: Guidelines And Manufacturer´s Declaration - Immunity
13.3 Guidelines and Manufacturer´s Declaration - Immunity The ATMOS® C 051 Thorax is intended for use in the electromagnetic environment specified below. The customer or user of the ATMOS® C 051 Thorax should ensure that it is used in such an environment. IEC 60601- Compliance Electromagnetic Environment - Immunity Test Test level Level... -
Page 55: Recommended Safety Distance Between Portable And Mobile Rf Communications Equipment And The Atmos® C 051 Thorax
ATMOS® C 051 Thorax is used exceeds the above compliance level, the ATMOS® C 051 Thorax is to be observed to verify the intended use. If abnormal performance characteristics are noted, additional measures might be necessary, e. g. a changed arrangement or another location for the device. - Page 56 ATMOS MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Str. 16 79853 Lenzkirch / Germany Phone: +49 7653 689-0 atmos@atmosmed.de www.atmosmed.com...
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