Atmos S 201 Thorax Operating Instructions Manual
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Summary of Contents for Atmos S 201 Thorax
- Page 1 Operating Instructions ATMOS S 201 Thorax English These operating instructions are valid from software version 3.0.52 GA1FR.710201.0 0124 2019-12 Index: 41...
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Page 2: Table Of Contents
Intended use ATMOS S 201 Thorax ....... . . 5... - Page 3 13.3 Recommended separation distances between portable and mobile RF communications equipment and the ATMOS S 201 Thorax ....50 14.0 Notes ............51...
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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 are familiar with the product. -
Page 5: Intended Use
Separate use of the secretion canister and hose system ( this means without the basic device) for temporary gravity drainage (less than 60 minutes). Specification of the main function: The ATMOS S 201 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 S 201 Thorax Hose System
Single-use product / reprocessing: Secretion canister is disposable. 1.2.3 Intended use ATMOS S 201 Thorax hose system Name: Hose system for the ATMOS S / E 201 Thorax and ATMOS C 051 Thorax Main functions: Transport of generated vacuum from the basic device to patient-sided hose end. -
Page 7: Function
Single-use product / reprocessing: Hose system is disposable. 1.3 Function The ATMOS S 201 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... -
Page 8: Explanation Of Pictures And Symbols
Graphic symbols contained in these operating instructions Warning, special Important diligent notice information Symbols used for the ATMOS S 201 Thorax and its accessories Repeated reuse of Application parts The CE marking shows components which are type CF that this product marked with a defibrillator proof;... -
Page 9: For Your Safety
• Prior to first starting up, check whether the mains voltage specified on the type plate matches the local mains voltage. 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, • assembly, new settings, alterations, extensions and repairs have been carried out by personnel not authorised by ATMOS. - Page 10 • The ATMOS S 201 Thorax is a medical device that 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.
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Page 11: Caution
2.2 Caution CAUTION Risk of injury! • A misplaced drainage system and a misplaced thoracic catheter 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 12: Warning
Danger of explosion due to unobserved ambient conditions! • The ATMOS S 201 Thorax is not designed for the use in medical areas with an explosion hazard or in ones that are oxygenated. Explosion-hazardous areas may be caused by the use of flammable anaesthetics, skin cleansing products and skin disinfectants. - Page 13 column in the riser quickly drop to zero. This means that there is no vacuum at the patient’s end, thus posing a risk of a renewed pneumothorax. • If a high (negative) vacuum occurs (e.g. due to deep inhalation), the water in the water lock can rise through the riser.
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Page 14: Setting Up And Starting Up
3.0 Setting up and starting up 3.1 Scope of delivery Prior to dispatch, the ATMOS S 201 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 15: Device Overview
On / Off sensor Touchscreen (touch-sensitive display) Handle Light sensor Release button Connection for USB flash drive 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. Measuring and rinsing hose Secretion hose... -
Page 16: Rear Side
3.2.2 Rear side Type plate Nut for mains supply Fixture for device attachment... -
Page 17: Start Up
• After that remove the power plug from the charging socket of the ATMOS S 201 Thorax As soon as the battery charge level is less than 20%, the drainage unit displays a warning window and triggers an audible warning message (peruse chapter ‘5.0 Warning messages’... -
Page 18: 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 set up immediately after connection! Important safety • For hygienic reasons we recommend an exchange of both information on the canister and hose system at the same time. - Page 19 3.3.2.4 Inserting the secretion canister 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. Wear disposable gloves and observe the regulations when handling sterile products.
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Page 20: Connecting The Hose System
8. Release the 2 Luer lock connections by a counter-clockwise rotation to separate the secretion canister and the device from the hose system. Pay attention as secretion could be found in the connection space. 9. Remove the cover cap from the Luer lock connection of the secretion hose. -
Page 21: Operation
630 ml – 5.51 l/min Red: > 5.51 l/min to maximum. Up to 1.00 l/min, the flow is displayed in ml/min. Day/Night Mode The ATMOS S 201 Thorax has a day/night mode, which means the device adjusts automatically to the light conditions in a room. Under low ambient light conditions, the display has dark background illumi- nation. -
Page 22: Buttons And Display Symbols
4.2 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 Changeover to time scaling... -
Page 23: Display Symbols
Upcoming warning suppressed Annual inspection is required 4.3 Switching on • To switch on the ATMOS S 201 Thorax, touch the sensor for 2 seconds. • The ATMOS logo appears with the software version number in the bottom right corner. - Page 24 Alter- natively 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...
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Page 25: Function
• By pressing the button the pump will be stopped. • The ATMOS S 201 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 26: Keylock
4.6 Keylock The ATMOS S 201 Thorax is equipped with an automatic key lock. 4.6.1 Automatic activation of the keylock If the settings are not changed for a defined time, the keylock will be activated automatically (default factory setting 1 minute, individually adjustable in the user settings). This will prevent unintentional operation. 4.6.2 Manually activate the keylock The keylock can be manually activated after all the therapy values are set and the therapy is started. -
Page 27: Therapy Progress
4.7 Therapy progress The ATMOS S 201 Thorax offers 2 graphs to simplify the analysis of the airflow 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. 4.7.1 Short time The graphical diagram starts by selecting the menu. In this modus the real measurements (flow, vacuum) from the last 30 seconds can be shown. -
Page 28: 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 29: Reading Out The Therapy Data
Complete data transfer • As soon as the therapy data is transferred then the USB flash drive may be removed. Now you return to the main screen. If the therapy data should be transferred during a patients therapy, follow the steps below: • Clamp the thoracic catheter • Stop the current therapy • Remove the secretion canister. Perform the therapy data transfer as described. •... -
Page 30: Switch Off The Device
Flow @ End 0.28 l/min 4.8 Switch 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. V3.0.52 4.9 User settings For accessing the user menu please press the button... - Page 31 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 automati- cally pre-adjusted. Standard-vacuum You can adjust the standard vacuum with Period time of hose rinsing You can change the cycle Cycle duration for hose duration for hose rinsing with...
- Page 32 WARNING The warning message ‘Device Critical tilt WARNING in critical tilt’ can be activated or deactivated with Critical tilt The key lock activation time Keylock activation time can be adjusted with The key tone can be activated Keytone or deactivated by pressing By pressing one of the two control panels (hour or minute) you may enter the...
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Page 33: 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 hose, clogging, a bend in the drainage hose, liquids were sucked into the pump. - Page 34 Start therapy by pressing the starting up the device, the start button. warning ‘Inactive therapy’ appears. • Battery is defective. The • Please contact the ATMOS device can no longer be used. service. WARNING Faulty battery The device can not be operated! Battery must be replaced by the service! Device temperature too high.
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Page 35: Function
6.0 Function 6.1 Hose rinsing • The ATMOS S 201 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. -
Page 36: Accessories, Consumables And Spare Parts
7.0 Accessories, consumables and spare parts 7.1 Accessories Universal bracket 312.1160.0 Bracket for fastening the ATMOS S 201 Thorax on the patient bed, standard rail, wheelchair, tripod, etc. Carrying strap for ATMOS S 201 Thorax 312.0850.0 Hose clamp 061.0079.0 Hose holder 312.1029.0... -
Page 37: Attachment Of The Universal Bracket (Accessories)
7.4 Attachment of the universal bracket (Accessories) The universal bracket can be mounted to infusion tripods, wheel- chairs, to the bed or to the standard rail. Align the fastening bracket 1. Pull the stop bolt 2. Rotate the fastening bracket 90°. -
Page 38: 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 drainage unit determines to a large extent its reliability and safety. -
Page 39: Cleaning Of The Device Surface
• Attention! The device should never be autoclaved, rinsed under running water or immersed into any liquids! 8.3 Recommended disinfectants Disinfectant Ingredients in 100 g Manufacturer ATMOS Green & Clean SK Di alkyl dimethyl ammonium chloride < 1 g Metasys, Rum Alkyl dimethyl ethyl benzyl ammonium chloride < 1 g... -
Page 40: Hygiene Plan
8.4 Hygiene plan WHAT WHEN Details Manual wipe cleaning Drainage unit Manual wipe disinfection Single-use product; not for Canister 2 reprocessing, change after use Single-use product; not for Hose system 2 reprocessing, change after use A new carrying strap should be Carrying strap used for each patient. -
Page 41: Maintenance And Service
• Prior to every use, perform a visual inspection of the device, hoses, secretion canisters, and connection cables. Damaged cables must be replaced immediately! • For repair works, the device can be sent either directly to ATMOS, or via the retailer you purchased it from. -
Page 42: Sending In The Device
6. Place the QD 434 ‘Delivery complaint / return shipment’ form and the respective decontami- nation certificate in an envelope. 7. Affix the envelope to the outside of the package. 8. Send the product to ATMOS or to your dealer. 9.4 Handling of batteries Rechargeable batteries are wear parts with a limited lifetime. Under optimal conditions of use, lithium-ion batteries are usually worn after approx. -
Page 43: Troubleshooting
Power cable defective or not Check the power cable. light up despite proper con- connected properly. nection to the power cable. Recharging unit, charging elec- Contact the ATMOS service or a certified tronics, or battery are internally service partner. The device must be defective. checked. ‘Vacuum too low’... - Page 44 Flow readout is always 0 l/ Component error 1) Check whether the flow is also 0 l/min min. when the system is open. 2) Contact ATMOS Service or a certified Secretion has entered the service partner. The device must be device. checked.
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Page 45: Technical Data
Max. volume of 2 l, connection to the device by means of ‘Direct Docking System’ Material: PC Suction hose ATMOS disposable suction hose for thorax, double lumen, with integrated bacterial filter in the measuring hose, 180 cm long Operating time Continuous operation in the specified temperature range. Simultaneous battery recharging and operation possible. Battery operation time at maximum continuous suction. - Page 46 EN 60601-1: Applied standards EN 60601-1/-2: EN ISO 10079-1 Classification in accordance with Annex II a IX of EC Directive 93/42/EEC CE marking CE 0124 GMDN code 36787, suction unit thoracic UMDNS code 10-218 Suction device, thoracic 312.1000.0 ATMOS S 201 Thorax Technical data unchanged since: 10.12.2015...
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Page 47: Disposal
• Pay attention to a careful separation of the different materials. • The housing material is fully recyclable. • The ATMOS S 201 Thorax has a lithium-ion battery which must be disposed of in accordance with existing directives. 12.1 Disposal within the EU The device described above is a high-quality medical product with a long service life. -
Page 48: Notes On Emc (Electromagnetic Compatibility)
13.1 Guidance and manufacturer’s declaration – electromag- netic emissions The ATMOS S 201 Thorax is intended for use in the electromagnetic environment specified below. The customer or user of the ATMOS S 201 Thorax should ensure that it is used in such an environment. Electromagnetic Environment - Emissions Test... -
Page 49: Guidance And Manufacturer's Declaration - Electromagnetic Immunity
13.2 Guidance and manufacturer’s declaration – electromag- netic immunity The ATMOS S 201 Thorax is intended for use in the electromagnetic environment specified below. The customer or user of the ATMOS S 201 Thorax should ensure that it is used in such an environment. Electromagnetic Immunity Test IEC 60601 Test Level Compliance Level... -
Page 50: Recommended Separation Distances Between Portable And Mobile Rf
The ATMOS S 201 Thorax is intended for use in electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the ATMOS S 201 Thorax can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment and the ATMOS S 201 Thorax as recommended below, according to the maximum output power of the communications equipment. -
Page 51: Notes
14.0 Notes... - Page 52 ATMOS MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Str. 16 79853 Lenzkirch / Germany Phone: +49 7653 689-0 atmos@atmosmed.de www.atmosmed.com...