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Table of Contents
Related Manuals for Atmos C 11
Summary of Contents for Atmos C 11
- Page 1 Operating Instructions ATMOS C 11 Systema English GA1GB.110300.0 2023-07 Index 23...
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Page 2: Table Of Contents
Canister systems ..................... 16 Disposable canister system ................... 19 Compressed-air module ..................21 ATMOS LS 21 LED – quick start ................23 ATMOS HL 21 LED – quick start ................25 LED cold light module ..................... 26 Endoscope management ..................27 Emptying the instrument disposal ................ -
Page 3: Introduction
To carry out these measures, the person must have the necessary test devices and original spare parts. The unit ATMOS C 11 Systema bears CE marking CE 0124 according to the EU Council Directive 93/42/EEC concerning medical devices and meets the basic requirements of Annex I to this directive. -
Page 4: Explanation Of Pictures And Symbols
1.2 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 fatal or serious injury. Observe the necessary measures. - Page 5 Manufacturer Date of manufacture Date of manufacture Country of manufacture: Germany Reference number Unique Device Identifier of a medical device Medical device Serial number European Article Number Batch code Specification of the degree of protection against the ingress of solids and IPX0 moisture Type BF applied part...
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Page 6: Intended Purpose
04250365193442 (11) 220411 (21) 12345678 1.3 Intended purpose Product name: ATMOS C 11 Systema Main functions: • Medical suction • Ear irrigation • Medication spraying or spraying • Electric power supply for visualization, illumination and illumination accessories • Instrument storage and deposit •... -
Page 7: Function
1.4 Function • Suction system module • Compressed-air module • Ear irrigation by means of compressed air • LED light handle ATMOS LS 21 LED • LED headlight ATMOS HL 21 LED • LED cold light source • Instrument deposit •... -
Page 8: Scope Of Delivery
1.5 Scope of delivery The ATMOS C 11 Systema was subjected to an extensive functional test and was careful- ly packed prior to dispatch. Nevertheless, please compare the contents of the shipment on completeness immedi- ately upon receipt (see delivery note). -
Page 9: Notes For Your Safety
• Never operate the product in potentially explosive areas or in areas that are oxygen- ated. • Use only original accessories and original spare parts from ATMOS. Avoid improper use or incorrect diagnosis. Your patient can be severely injured. •... - Page 10 • Never touch the device’s interfaces and the patient at the same time! • Use only original accessories and original spare parts from ATMOS. • Observe the specifications regarding periodic tests in chapter “6 Maintenance and service” on page 37.
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Page 11: Avoiding Damage To The Device
• Never use components marked with more than once. These components are intended for single use only. • Only use sterile packaged parts if the packaging is undamaged. • Never operate the device without a bacterial filter. • A suction catheter, suction attachment, or medical suction instrument must always be connected to the suction hose. -
Page 12: Setting Up And Starting Up
< 0.03 A. The installation must correspond with VDE 0107. • The power cable of the ATMOS C 11 Systema is connected to an earthing contact socket near the device (max. 5 m; see figure). This may only be carried out by author- ized qualified personnel. -
Page 13: Overview Of Complete Equipment
3.3 Overview of complete equipment Headlight holder with automatic switching (optional) Endoscope management for rigid or flexible, clean endoscopes (optional) Mirror quick heater (optional) Endoscope quiver for used endoscopes (optional) LED light handle (optional) Brightness controller Light guide cable 1-channel cold light source (optional) Instrument disposal for used instruments (optional) On/off switch Service compartment... -
Page 14: Rear View
3.4 Rear view Power connection 14 Setting up and starting up... -
Page 15: Operation
Never operate the suction system without a bacterial filter. Always use the splash pro- tection; this will prolong the service life of the bacterial filter. ATMOS does not assume any liability for malfunctions caused by operating the device without a bacterial filter. -
Page 16: Canister Systems
4.2 Canister systems 4.2.1 Reusable canister system Assembly of secretion canister DDS canister handle 340.0055.0 DDS bacterial filter DDS hose adapter set 340.0054.0 340.0057.0 DDS canister lid with gaskets 340.0053.0 DDS splash protection 340.0056.0 DDS secretion canister 1.5 l 340.0050.0 or 3.0 l 340.0051.0 4.2.2 Inserting/removing the DDS bacterial filter / oversuction stop ... - Page 17 4.2.3 Using the DDS splash protection Please wear gloves when inserting or removing the DDS splash protection! 4.2.4 Attaching/removing the DDS canister lid 1. Place the DDS secretion canister on a firm surface and set the DDS canister lid horizontally on top (the lid cannot not be turned!).
- Page 18 4.2.6 Closing/opening the DDS canister handle 1. To close, secure the snap-in hooks under the canister rim, and then press the clips towards the middle of the canister until they lock into place. 2. To open, pull the clips outwards and unhinge the snap-in hooks under the canister rim.
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Page 19: Disposable Canister System
Maximum load of the station: 15 kg! • The DDS changeover docking station for 2 canisters with changeover switch and Direct Docking System may be used with the ATMOS C 11 Systema. • The changeover lever is used to ... - Page 20 4.3.2 Assembling the Medi-Vac® canister system Medi-Vac® bag 1. Insert the Medi-Vac® suction bag into the Medi-Vac® external canister. 2. Close the canister tightly on all sides. 3. Check again for leaks; otherwise, no Patient vacuum can be built up. 4.
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Page 21: Compressed-Air Module
4.4 Compressed-air module NOTICE Prior to use, check the leak tightness of the compressed-air system. To do this, remove the handle and check for any escaping air. In case of leakage, contact the service technician (see chapter “6 Maintenance and service” on page 37). - Page 22 4.4.2 Adapting/depositing medication sprayers Attaching 1. Attach the handle to the medication bottle (). 2. Engage and then lift the medication bottle with the handle out of the holder (). By pulling the trigger, compressed-air will be applied into the sprayer (). Depositing 1.
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Page 23: Atmos Ls 21 Led - Quick Start
4.5 ATMOS LS 21 LED – quick start The ATMOS LS 21 LED has separate operating instructions. Please note: Read these separate operating instructions attentively and follow the safety notes listed... - Page 24 Storz* connection REF 507.4611.0 with detent REF 507.4657.0 REF 507.4612.0 for screwing Connection ATMOS LS 21 LED for ATMOS LS 21 LED ATMOS C 11 Systema Light guide adapter Olympus* REF 541.4300.0 white light REF 507.0949.0 REF 541.4400.0 warm white *Not included in scope of delivery.
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Page 25: Atmos Hl 21 Led - Quick Start
4.6 ATMOS HL 21 LED – quick start Headlight frame Focusing ring The ATMOS HL 21 LED has separate operating instructions. NOTICE Read these separate operating instructions attentively and follow the safety notes listed there to guarantee ideal and safe use of all functions! Please be sure to use the right-hand power connection, marked with 700 mA, for the headlight ATMOS HL 21 LED. -
Page 26: Led Cold Light Module
4.7 LED cold light module The 1-channel LED cold light module is delivered with an ATMOS/Storz adapter. Here you can connect the light guide cable to the ATMOS/Storz adapter. When the light guide cable is removed from its holder, the light source switches on automatically due to the built-in light barrier. -
Page 27: Endoscope Management
4.8 Endoscope management 4.8.1 Overview Plastic quiver for storage of clean endoscopes (removable) Plastic quiver for storage of used endoscopes and filling with disinfectant solution (removable) NOTICE • Please handle the instruments carefully when inserting or removing them. • Please note that only cleaned/disinfected endoscopes may be put into the storage quivers. -
Page 28: Emptying The Instrument Disposal
NOTICE As soon as the mirror quick heater is activated, all other electrical devices switch off au- tomatically until mirror heating is completed. In case that the suction system is required simultaneously, it is activated when the suction hose is removed from the holder and the mirror quick heater is switched off. -
Page 29: Reprocessing
5.1.1 Cleaning the treatment unit surface • The surfaces of the ATMOS C 11 Systema are resistant to all surface disinfectants listed in chapter “5 Reprocessing” on page 29. • Wipe the treatment unit surface with a cloth moistened with a cleaning or disinfect- ing solution. - Page 30 Prior to each use, please check whether the DDS bacterial filter is dry and clean. Wet or dirty DDS bacterial filters must be replaced with new ones. Replace the DDS bacterial filter at least once a day. Use only original ATMOS bacterial filters.
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Page 31: Recommended Instrument Disinfectants
Afterwards disinfection is required. • The ear irrigation bowl is not autoclavable! Cleaning and disinfection (also mechani- cal cleaning) up to 93 °C. Sprayer nozzles are available as spare parts from ATMOS. 5.2 Recommended instrument disinfectants Manual disinfection of instruments Disinfectant... - Page 32 Sekusept® aktiv sodium percarbonate, non-ionic surfactants, Ecolab, phosphonates Düsseldorf (Application concentrate) gigasept® instru AF cocospropylendiaminguanidindiacetate 14 g Schülke & Mayr, Norderstedt (Application concentrate) phenoxypropanols 35 g benzalkonium chloride 2.5 g non-ionic surfactants, pH-value regulators, corrosion inhibitors gigasept® FF (new) succindialdehyde 11.9 g Schülke &...
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Page 33: Recommended Surface Disinfectants
5.3 Recommended surface disinfectants Coated surfaces Disinfectant Ingredients in 100 g Manufac- turer Green & Clean SK di alkyl dimethyl ammonium chloride < 1 g Metasys, Rum (Austria) alkyl dimethyl ethyl benzyl ammonium chloride < 1 g alkyl dimethyl benzyl ammonium chloride <... -
Page 34: Recommended Endoscope Disinfectants
terralin protect benzyl-C12-16-alkyldimethyl, chlorides 22 g Schülke & Mayr, ® Norderstedt (Application concentrate) 2-phenoxyethanol 17 g aminoalkylglycines 0.9 g non-ionic surfactants, perfumes Surface disinfection FD 312 alkyl-benzyl-dimethyl ammonium chloride 13 g Dürr Dental, Bietigheim- non-ionic surfactants, complexing agents, hexyl Bissingen cinnamal, butylphenyl methylpropional, linalool 5.4 Recommended endoscope disinfectants Manual disinfection of endoscopes... - Page 35 Hygiene plan Cleaning and disinfection plan ATMOS C 11 Systema What When Qualifi ed and trained Recommendations staff who are familiar with reprocessing. (Please fi ll in the re- Parts to be reprocessed Cleaning Disinfection Sterilisation sponsible person -> use a water-based...
- Page 36 ENT instruments 2,4,5 ments must be rinsed with water, have to be dried and sterilised afterwards. Please consult the additional op- erating instructions for the ATMOS ENT instruments. Cleaning with a brush; subsequent disinfection (mech- Instrument disposal tray with cover 2,4,5...
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Page 37: Maintenance And Service
(see chapter 23 “Test instructions” in the service instructions ATMOS C 11 Systema). Circuit and wiring diagrams, etc. can be requested from and provided by ATMOS. In case of any malfunction, please contact your ATMOS partner or our service hotline +49 7653 689 222. -
Page 38: Troubleshooting
7 Troubleshooting Description Cause Measure Electric power supply No function, main switch No voltage on Check house fuses; they is active, control light does power plug possibly burnt through not light up Cable/plug defective Exchange cable/plug Suction Weak or no suction capac- Suction hose is clogged Clean suction hose ity at all, but vacuum is... - Page 39 Description Cause Measure Compressed air Compressed-air pump does Soiled/defective light barrier Clean both light barrier not switch on or off in compressed-air holder openings in the com- pressed-air holder; if necessary, inform the service department No compressed air, but Positions of handles have Insert handles in the suction pump is operating been mixed up...
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Page 40: Accessories And Consumables
8.1.1 Compressed-air handle The compressed-air handle is used to adapt applied parts for the compressed-air system. These are connected to the compressed-air system of the ATMOS C 11 Systema via a self-locking quick connector (10). For safety reasons, the hose and the... - Page 41 Two compressed-air handles are available that match the selected configuration of the ATMOS C 11 Systema. • REF 541.1010.0 Compressed air handle, standard, for use with medication sprayers, • REF 541.1110.0 Compressed air handle incl. additional air valve for use with medica- tion sprayers and ear irrigation.
- Page 42 Sprayer, double-barreled for oily medicines, REF 506.5120.0 Pressed Air Pressed Air Ventilation Sprayer, double-barreled for oily medicines The straight sprayer would not be able to transport oily medication very well or atomize it that finely, but the double-barreled sprayer can. The principle of operation is the same as that for the straight sprayer.
- Page 43 Ensure all parts are clean and dry before filling the bottle. 8.1.3 Monitor holder C11, REF 541.2200.0 To assemble the monitor support, please observe the notes in the service instruc- tions. Cover cap (000.0925.0) Screw M8x4 (051.0384.0) Base C 11 (541.1605.0) Accessories and consumables...
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Page 44: Disposal
9 Disposal • Die ATMOS C 11 Systema does not contain any hazardous materials. • The housing is recyclable. • Device and accessories must be decontaminated prior to disposal. • Pay attention to a careful separation of the different materials. -
Page 45: Technical Data
1 x 1000 mA (adjustable from 10 %–100 %) 1 x 700 mA (adjustable from 10 %–100 %) • LED cold light module min. 80 kLux (@1000 mA ) • ATMOS LS 21 LED 200 kLux (@700 mA) • ATMOS HL 21 LED 100 kLux (@700 mA) - Page 46 Periodical tests Repeat test of the electrical safety every 12 months. Recommended: inspection according to the manufacturer’s specifications. Protection class against electric shock (acc. to EN 60601-1) Classification of applied parts Type BF applied parts Degree of protection IPX0 CE marking Reference number (REF) 541.0000.0 542.0000.0...
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Page 47: Notes On Emc
Vicinity of HF surgical devices and in settings outside of an HF-shielded room of a mag- netic resonance imaging system. The customer or user of the ATMOS C 11 Systema must ensure that the device is used in a prescribed environment. - Page 48 WARNING Avoid placing the device on top of or next to another device. This could otherwise result in faulty operation. If such placement cannot be avoided, the proper functioning of the device must be monitored regularly. If possible, please switch off any nearby devices that are not in use.
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Page 49: Notes
12 Notes Notes... - Page 50 50 Notes...
- Page 51 Notes...
- Page 52 ATMOS MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Str. 16 79853 Lenzkirch / Germany Phone: +49 7653 689-0 info@atmosmed.com www.atmosmed.com...