Atmos Thorax S 201 Operating Instructions Manual
Hide thumbs
Also See for Thorax S 201:
- Operating instructions manual (68 pages) ,
- Quick start manual (4 pages) ,
- Quick manual (2 pages)
Related Manuals for Atmos Thorax S 201
Summary of Contents for Atmos Thorax S 201
- Page 1 Operating instructions ATMOS S 201 Thorax ® English These operating instructions are valid from software-version 3.0.40. 312.1000.B 2016-04 Index: 37...
-
Page 2: Table Of Contents
Intended use ............5 1.2.1 Intended use ATMOS S 201 Thorax ....... 5 ®... - Page 3 Operation ............19 Explanation of the display .
-
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 9001 and EN ISO 13485. • Prior to start-up please peruse chapter „2.0 Safety advice“ on page 9 in order to be prepared for any possible dangerous situations. -
Page 5: Intended Use
Recovery of the (natural) vacuum in the pleural cavity e.g. after the occurrence of a pneumothorax or a pleural effusion by drainage of air and secretion. Drainage of secretion and air after a surgical opening of the thorax. Specification of the main function: The ATMOS S 201 Thorax drainage system is a device for ®... -
Page 6: Intended Use Atmos ® S 201 Thorax Hose System
The secretion canister and hose system are sterile single use products, which can be applied in the sterile OT area. Contraindications: No application with other thoracic drainage systems as the ATMOS E / S ®... -
Page 7: Function
Sterility: Hose system is sterile. Single use product / reprocessing: Hose system is a single use product. 1.3 Function The ATMOS S 201 Thorax is an exceptionally handy, mobile, digital thoracic drainage suction ® device. The device is operated via an electrical, maintenance-free membrane 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 Symbols
t information Pictures contained in this manual Warning, special Important diligent notice! information Symbols of ATMOS S 201 Thorax & Accessories ® Multiple use of The CE sign Application part components marked shows that this type CF, 2 is not allowed. -
Page 9: Safety Advice
• The device should only be connected to a properly installed protective contact socket. • Prior to first use compare the normal voltage of the device (see label plate on the back side of the device) with the local mains voltage. ATMOS cannot guarantee perfect functioning neither will it be liable for damage to people or property • any non-original ATMOS parts are used, •... - Page 10 • The removal of the canister from the device during the therapy may only be performed by trained professionals who act in conformity with guidelines. • The ATMOS S 201 Thorax is a medical device which is subject to special safety regulations. It ®...
-
Page 11: Caution
2.2 Caution CAUTION Danger of injury • A misplaced drainage system and a misplaced patient hose 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
• Don´t take a shower / bath with the device. Danger of explosion due to unobserved ambient conditions! • The ATMOS S 201 Thorax may only be operated in rooms used for medical purposes, but not ®... -
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 thorough testing prior to packaging and shipment. ® On receipt of the goods please check the package for any possible damage and compare the contents for completeness. -
Page 14: Device Overview
Secretion canister release Connection for USB fl ash drives 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 Back side Label plate... -
Page 15: Starting Up
• When the battery is fully charged (the symbol does not blink anymore) remove the plug from the socket. • After that remove the recharger 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 16: Secretion Canister
3.3.2 Secretion canister • Always use the original ATMOS single use secretion canister. • Vacuum connection system: The vacuum connection between device and canister is set up immediately after connection! • For hygienic reasons we advise you to exchange hoses and Important safety canister together.. - Page 17 Exchanging the secretion canister Prior to exchanging the secretion canister the drain at the patients side must be clamped so that a continuous vacuum is always available at the patient. Exchange the canister at the latest when a fi lling level of 1900 ml is reached. Removing the secretion canister • Always wear disposable gloves, pay attention to the regulations for the handling of sterile products.
- Page 18 Connecting the hose system Luer-Lock with integrated hydrophobic bacterial fi lter Measuring and rinsing hose Luer-Lock Secretion channel Sealing cap for closing 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.
-
Page 19: Operation
630 ml - 1,00 l/min Red: > 1.00 l/min to maximum. Up to 1,00 l/min the fl ow is displayed in ml/min. Day/Night Mode The ATMOS S 201 Thorax has a day/night ® mode, the device adjusts automatically to the environmental lighting. Under low ambient light conditions display has... -
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
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. -
Page 23: Function
• By pressing the button the pump will be stopped. • The ATMOS S 201 Thorax has a vacuum adjustment. This means, that the integrated pump ®... -
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 / shorttime. -
Page 26: Transfer Of Therapy Data
4.7.3 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. Start transfer •... -
Page 27: Reading Out The Therapy Data
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 graphical representation 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: Secretion: Start date:... -
Page 28: Switch Off
• 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. V3.0.40 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 preadjusted. Standard-vacuum The standard-vacuum can be adjusted with Period time of hose rinsing Period time of hose rinsing Period time of hose rinsing can be adjusted with Minute: Key lock activation time can Keylock activation time be adjusted with The keytone can be activated...
-
Page 30: Warning Messages
Secretion canister Possible reasons for this error indication Drainage hose are: leakage, blockage of the bacterial Contact the ATMOS fi lter in the measuring and rinsing service channel, clogging, a bend in the drainage hose, liquids were sucked into the pump. The measurement of an excessively... - Page 31 Display Cause of error Troubleshooting • Battery defective. The device can • Contact ATMOS Service. no longer be used. WARNING Faulty battery The device can not be operated! Battery must be replaced by the service! Device temperature too high. • Device is in the sun / at the •...
-
Page 32: Functions
6.0 Functions 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, Consumables And Spare Parts
Surgical kit for ATMOS E / S 201 Thorax 312.1031.0 ® Included in the surgical kit: 10 x secretion canister, 2 l (sterile) 10 x hose system for ATMOS Thorax drainage systems (sterile) ® Exchange: once per patient Hose system, 10 pcs. 312.1170.0 Secretion canister, 5 pcs. -
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. Hose holder at the canister Pull off the adhesive strip and fi x 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 such as the ATMOS S 201 Thorax must always be ready for use and must ® function reliability. Therefore prior to every application: necessary The way the device is used determines 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 & Clean Di alkyl dimethyl ammonium chloride < 1 g Metasys, Rum ®... -
Page 37: Hygiene Plan
8.4 Hygiene plan WHAT WHEN Notes Manual wipe cleaning Drainage unit Manual wipe disinfection Single use product - not Canister 2 suitable for reprocessing, exchange after use Single use product - not Hose system 2 suitable for reprocessing, exchange after use A new shoulder belt Carrying strap should be used for each... -
Page 38: 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 39: Handling Of Rechargeable 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. Attention! Using other charging equipment may result in risk of explosions. ATMOS has no infl uence on the use of the device therefore batteries are excluded from the guarantee. There is a function guarantee of 6 months. 9.4 Exchange of fuses click... -
Page 40: Troubleshooting
Check the mains cable. up despite proper connection in properly to the mains cable. Mains cable or battery are internally Contact the ATMOS service or a certified defect service partner. The device must be checked. „Vacuum too low“ Leakage Check all the hoses and the canister for leakages. -
Page 41: Technical Data
Data memory Internal memory for therapy data: 2.5 MB Up to 12 days recording possible Canister ATMOS disposable canister, transparent, with integrated water ® lock, pressure control valve, graduation Max. volume of 2 l, connection to the device with direct docking... - Page 42 Applied standards EN 60601-1-2 EN ISO 10079-1 Classification acc. to 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 Ident No. 312.1000.0, ATMOS S 201 Thorax ® Technical Specifications unaffected since: 10.12.2015...
-
Page 43: Disposal
Therefore, this type of device is excluded from the law for electrical devices. In order to guarantee a proper disposal of your old device, please either pass on your old device to your specialised dealer or send it directly to ATMOS MedizinTechnik GmbH & Co. KG for a professional disposal. -
Page 44: Notes On Emc (Electromagnetic Compatibility)
If adjacent or stacked use is necessary, the device must be observed to verify normal operation in the configuration in which it will be used. Guidelines and Manufacturer‘s Declaration - 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 45 Guidelines and Manufacturer´s Declaration - 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 Environment –...
- Page 46 Guidelines and Manufacturer´s Declaration - 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 Environment - Immunity Test IEC 60601-Test Level...
- Page 47 The ATMOS S 201 Thorax is intended for use in electromagnetic environment in which radiated ® 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...
- 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...