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 3.0.48 GA1GB.710201.0 0124 2018-02 Index: 40...
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Page 2: Table Of Contents
1.2.1 Intended use ATMOS S 201 Thorax ....... 5 ®... - Page 3 Operation ............19 Explanation of the display .
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Page 4: Introduction
• The declaration of conformity and our general standard terms and conditions can be obtained on our website at www.atmosmed.com. • The quality management system applied at ATMOS has been certified according to international standards EN ISO 13485. • Prior to start-up please peruse chapter „2.0 For your safety“... -
Page 5: Intended Use
Drainage of secretion and air after a surgical opening of the thorax. Specification of the main function: The ATMOS S 201 Thorax drainage suction unit is a ® digital device for mobile 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 basic device to patient-sided tube end. -
Page 7: Function
Single-use product / reprocessing: Hose system is disposable. 1.3 Function The ATMOS S 201 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... -
Page 8: Explanation Of Pictures And Symbols
Graphic symbols contained in these operating instructions Warning, special Important diligent notice information Symbols of ATMOS S 201 Thorax & Accessories ® Repeated reuse of Application parts The CE sign shows components which are type CF that this product marked with a defibrillator proof;... -
Page 9: For Your Safety
• assembly, new settings, alterations, extensions and repairs have been carried out by personnel not authorised by ATMOS. Electromagnetic compliance, damage to the device! • The ATMOS S 201 Thorax fully complies with the electromagnetic immunity requirements of ® standard IEC 60601-1-2 / EN 60601-1-2 „Electromagnetic compatibility- Medical Electrical Equipment“. - Page 10 • The ATMOS S 201 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.
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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 which are oxygenated. Explosion-hazardous areas may be caused by the use of flammable anaesthetics, skin cleansing products and skin disinfectants. -
Page 13: Setting Up And Starting Up
3.0 Setting up and starting up 3.1 Scope of delivery The ATMOS S 201 Thorax was subjected to an extensive functional test and was carefully ® packed prior to dispatch. On receipt of the goods please check the package for any possible damage and compare the contents for completeness. -
Page 14: Device Overview
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 channel Secretion channel Rear side Type plate Nut for mains supply... -
Page 15: Start Up
(peruse chapter „5.0 Warning messages“ on page 30 30 for further information). Charge the battery in order to continue the therapy without interruption. If the battery is too low for further operation of the device the ATMOS ®... -
Page 16: 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 17 Exchanging the secretion canister Prior to exchanging the secretion canister the thoracic catheter must be clamped so that a continuous vacuum is always available at the patient. Removing the secretion canister 1. Always wear disposable gloves, pay attention to the regula- tions for the handling of sterile products.
- Page 18 Connecting the hose system Luer-Lock with integrated hydro- phobic bacterial filter Measuring and rinsing channel Luer-Lock Secretion channel Protective cap for sealing the secretion channel • Remove the sterile hose system from the sterile wrapping. • Connect the Luer-Lock with the bacterial filter to the upper canister connection on the secretion canister by a clockwise rotation.
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Page 19: 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, the device adjusts automati- cally to the environmental lighting. Under low ambient light conditions display has dark background illumi-... -
Page 20: 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 21: Display Symbols
® sensor above of the symbol for 2 seconds. • The ATMOS logo appears with the software version number in the bottom right corner. • After a short while the leakage test (chapter „4.4 Leakage test“ on page 22) starts automatically. -
Page 22: Leakage Test
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... -
Page 23: Function
• The ATMOS S 201 Thorax has a vacuum controller. 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 24: Keylock
4.6 Keylock The ATMOS S 201 Thorax has an automatic keylock. ® 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. Manually activate the keylock The keylock can be manually activated after all the therapy values are set and the therapy is started. -
Page 25: Therapy Progress
4.7 Therapy progress The ATMOS S 201 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 26: 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 27: 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® S 201 Thorax V2.0 File name: ATMOS_S_201_THORAX_ID0000_20150421_101400.pdf Device ID: 0000 Patient: Diagnosis:... -
Page 28: Switch Off The Device
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. V3.0.48 4.9 User settings For accessing the user menu please press the button... - Page 29 When the device is started the standard-vacuum is automatically pre-adjusted. Standard-vacuum The standard-vacuum can be adjusted with Period time of hose rinsing The period time of hose Period time of hose rinsing rinsing can be adjusted with Minute: The keylock activation time Keylock activation time can be adjusted with The keytone can be activated...
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Page 30: 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 31 Start therapy by pressing the started after initial operation button. the 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 32: 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 channel into the secretion canister. • The rinsing is performed by opening a valve located in the measuring and rinsing channel. -
Page 33: Accessories And Consumables
7.0 Accessories and consumables 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 ATMOS S 201 Thorax 312.0850.0 ® Hose clamp 061.0079.0 Hose holder 312.1029.0... -
Page 34: Attaching The Carrying Strap
7.2 Attaching the carrying strap Fix the carrying strap with the Velcro fastening to the handle, adjust the requested length and put the device over your shoulder. 7.3 Hose holder at the canister Pull off the adhesive strip and fix the holder as shown. -
Page 35: Cleaning And Care
8.0 Cleaning and care 8.1 General information on cleaning and disinfection Prior to cleaning: Medical devices like the ATMOS S 201 Thorax vision need to be fail safe at any time. ® Therefore we recommend prior to every use: if required Handling of the drainage unit determines to a large extent its reliability and safety. -
Page 36: 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 & Di alkyl dimethyl ammonium chloride < 1 g Metasys, Rum ®... -
Page 37: Hygienic Plan
8.4 Hygienic plan WHAT WHEN Details Manual wipe cleaning Drainage unit Manual wipe disinfection Single use product -> not for Canister 2 reconditioning, change after use Single use product -> not for Hose system 2 reconditioning, change after use A new shoulder belt should be Carrying strap used for each patient. -
Page 38: Maintenance And Service
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. • There are no warranty claims whatsoever on defects or malfunctions which arise from the use of third party accessories or consumables. -
Page 39: Sending In The Device
6. Place the form QD 434 „Delivery complaint / return shipment“ 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 condition of use, lithium-ionic batteries are usually worn after approx. -
Page 40: Troubleshooting
Secretion canister is leaking. checked. Hose system is not completely closed. Flow readout is always in 0 Component error 1) Check whether the flow is also 0 l/min l/min. when the system is open. 2) Contact the ATMOS service or a certi- Secretion has entered the fied service partner. The device must be device. checked. -
Page 41: Technical Data
Data memory Internal memory for therapy data: 2,5 MB. Up to 12 days recording possible. Canister ATMOS secretion canister, transparent, with integrated water lock, ® pressure control valve, graduation. Max. volume of 2 l, connection to the device with „Direct-Docking-System“... - Page 42 EN 60601-1: Applied standards EN 60601-1/-2: EN ISO 10079-1 Classification in accordance with II a Appendix IX 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 43: Disposal
ATMOS MedizinTechnik GmbH & Co. KG for a professional disposal. Prior to disposal respectively before transport all secretion canisters and tubes must be... -
Page 44: Notes On Emc (Electromagnetic Compatibility)
Guidance and manufacturer's declaration - electromagnetic 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 Compliance... - Page 45 Guidance and manufacturer's declaration - electromagnetic 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. IEC 60601- Test Electromagnetic Environment - Immunity Test...
- Page 46 S 201 Thorax is used exceeds ® the above compliance level, the ATMOS S 201 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 ®...
- Page 48 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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