Atmos Scope Operating Instructions Manual

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Operating Instructions

ATMOS Scope

English

GA1GB.150259.0

2024-12 Index 06

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Summary of Contents for Atmos Scope

Page 1 Operating Instructions ATMOS Scope English GA1GB.150259.0 2024-12 Index 06...
Page 2 Notes on the operating instructions ...............5 Explanation of pictograms and symbols ..............7 Intended use ......................11 Function ........................12 Scope of delivery .....................13 Transport and storage ....................15 Attaching the pressure compensation attachment ..........16 Removing the pressure compensation attachment ...........17 Notes on your safety ..................18 General safety instructions ..................18...
Page 3 Checking the deflection mechanism ..............30 Operation ......................31 Use/operation ......................31 4.1.1 Switching on and setting the system ..............31 4.1.2 Functions of the control buttons with the ATMOS Capture Suite ....31 4.1.3 Standby mode......................32 Sterilization ....................33 Safety instructions for sterilization ...............33 5.1.1 General safety instructions ................33...
Page 4 5.3.4 Manual cleaning with MetriSponge ..............42 5.3.5 Manual cleaning with Cidezyme ................43 5.3.6 Manual disinfection with Cidex OPA ..............45 5.3.7 Mechanical cleaning and disinfection ...............46 5.3.8 Sterilization with STERIS SYSTEM 1E ..............48 ® 5.3.9 Low-temperature plasma sterilization STERIS V_PRO .......49 ®...
Page 5 This manual is used to train and instruct operating personnel and is also intended as a reference manual. It may be reprinted, either in part or in whole, only with the written permission of ATMOS. These operating instructions must always be kept available near the product.
Page 6 The declarations of conformity and our general terms and conditions can be viewed on our website at www.atmosmed.com The quality management system at ATMOS has been certified according to international standard EN ISO 13485. These operating instructions apply to the following products: •...
Page 7 Explanation of pictograms and symbols In the operating instructions DANGER Warning of a danger resulting directly in fatal or serious injury. Observe the necessary measures. WARNING Warning of a danger of fatal or serious injuries. Observe the necessary measures. CAUTION Warning of a danger of minor injuries.
Page 8 Notice of potential material damage that can be caused. Useful information on handling the device.  Call for action. Proceed step by step. » Result of an action. Move/plug in this direction. Engage and check for tight fitting. click On device and type plate Follow the operating instructions (blue) This device complies with the relevant requirements of EU regulations.
Page 9 Date of manufacture Country of manufacture: Germany Serial number Item number IP68 Degree of protection Device of protection class II No domestic waste Applied part of type BF Medical product Introduction...
Page 10 This product meets the relevant requirements of the Eurasian Economic Union. Only available by prescription Caution! Fragile! Error message Warning message Standby mode Introduction...
Page 11 Intended use Name: ATMOS Scope Main function: For short-term endoscopic application in natural orifices for the visualization of existing structures Intended purpose: For endoscopic examinations on humans. Intended users / Physicians and medical specialists trained in handling user profile: endoscopes.
Page 12 Not a disposable product. Options for re-sterilization re-sterilization: according to the operating instructions. Function The flexible ATMOS Scope with integrated camera and LED light source combines all components required already in the handle: • LED light source • Camera electronics •...
Page 13 Scope of delivery Prior to dispatch, the ATMOS Scope was subjected to an extensive functional test and packed carefully. Nevertheless, please immediately compare the contents of the shipment for completeness upon receipt (see delivery note). Description ATMOS Scope 507.7000.0 The set includes: •...
Page 14 • Leakage tester • Adapter for leakage test • Pressure compensation attachment including information tag for pressure compensation • Infection control return bag • ATMOS Capture Suite Basic 507.7060.0 ATMOS Scope iPrime The set includes: • Endoscope • Leakage tester •...
Page 15 Transport the device only in a padded shipping box that provides sufficient protec- tion. The wooden packaging of the ATMOS Scope is not suitable for shipment in a service case and must be disposed of by ATMOS to meet the hygiene requirements.
Page 16  The attachment for pressure compensation should always be attached when  storing and transporting the ATMOS Scope. Attaching the pressure compensation attachment Attach the pressure compensation attachment to the valve and turn it clockwise 90°. The attachment is then firmly connected to the endoscope and cannot be removed.
Page 17 Removing the pressure compensation attachment Turn the pressure compensation attachment anti-clockwise 90°. The pressure compensation attachment can then be removed from the valve of the endoscope. Remove it before: • Immersion in liquids • Using on patients Introduction...
Page 18 Check the device for leak tightness (see chapter “3.6.3 Performing a leakage test” on page 29). Do not operate the device if the leakage test is failed. In this case, clean and disinfect the device and send it to ATMOS for repairs. Notes on your safety...
Page 19 • Position the device to allow you to easily disconnect it from the PC/laptop at any time. • Never touch plugs or power cables with wet hands. • Use only original accessories and original spare parts from ATMOS. • Follow the instructions regarding period tests (see chapter “6.1 Period tests” on page 52).
Page 20 Diseases can be transmitted. • Always wear disposable gloves when using the product. • Prepare the ATMOS Scope before using it on a patient, while observing chapter “5 Sterilization” on page 33. • Clean and disinfect the device according to the operating instructions;...
Page 21 2.3.1 Unsuitable mechanical stress Do not knock or drop the ATMOS Scope, and protect it from blows and impact. Damage to the USB cable and the distal tube of the ATMOS Scope is possible. • Do not bend, kink, pull or squeeze the insertion tube or distal tube. The outer sheath and inner components could become damaged.
Page 22 2.3.2 Storage and operation in an unsuitable environment The product may become damaged. • Observe the ambient conditions regarding transport, storage and operation. Please observe chapter “10 Technical data” on page 64. Please observe chapter “5.1.3 Avoiding damage to the device” on page 34. ...
Page 23 Setting up the device and putting it into service Device overview Setting up the device and putting it into service...
Page 24 Only qualified personnel are allowed to set up electrical systems. The manufacturer of a medical electrical system is responsible for ensuring that the performance, safety, technical data and intended use of the ATMOS Scope are not impaired. Setting up the device and putting it into service...
Page 25 3.5.1 Hardware system requirements The system requirements for the ATMOS Scope are the standard USB 3.0 and the system requirements of the ATMOS Capture Suite HD software. The new ATMOS Scope can always be used on PCs that meet these system requirements. Please use a PC or an equivalent system (in accordance with IEC 60950-1 or IEC 62368-1).
Page 26 Stable functioning of the ATMOS Scope will not be ensured if the mains supply is insufficient. The simultaneous operation of several USB devices, in particular, may be problematic. No USB hub may be used between the PC system and ATMOS Scope.
Page 27 Checks and tests 3.6.1 Carrying out the function check Carry out a visual inspection of the entire ATMOS Scope for visible damage and inspect the glass surfaces (see chapter “3.6.2 Checking the glass surfaces” on page 29). Remove the pressure compensation attachment and the protection cap of the USB connector.
Page 28 Check the ATMOS Scope for leak tightness using the manual leakage tester (see chapter “3.6.3 Performing a leakage test” on page 29). Check whether a picture is displayed and the LED light is switched on. The endo- scopic image must be crisp, clear and bright at the appropriate working distance.
Page 29 3.6.2 Checking the glass surfaces Visual inspection of the glass surfaces: The surfaces must be clean and smooth. If impairments are found during inspection, observe the notes on the cause and  how to remedy it in chapter “7 Troubleshooting” on page 55. 3.6.3 Performing a leakage test •...
Page 30 Never connect the leakage tester to or disconnect it from the endoscope under  water. Never immerse the endoscope in liquid if there is a pressure drop.  The leakage tester must not be immersed in water and may be cleaned only by ...
Page 31 Operation Use/operation Please observe also chapter “2 Notes on your safety” on page 18. Please disconnect the ATMOS Scope at least once a day from the PC (by pulling the USB connector). 4.1.1 Switching on and setting the system Take the flexible ATMOS Scope in your hand.
Page 32 4.1.3 Standby mode The ATMOS Scope has an automatic standby mode, which can be deactivated or activated by means of ATMOS Capture Suite HD or ATMOS Capture Suite Basic. Furthermore, it is possible to set the time until standby. If standby mode is active, the following symbol is displayed: Standby mode is left by pressing one of the two buttons on the device.
Page 33 5.1.1 General safety instructions Sterilize the ATMOS Scope before using it on patients. It is the responsibility of the user to ensure that the required cleaning and disinfec- tion results are achieved. Validation and routine monitoring of the procedure are usually necessary.
Page 34 5.1.2 Danger to users, patients and third parties Risk of infection due to unsuitable aids Deadly diseases can be transmitted. • Always wear your own personal protective equipment. The protective equip- ment consists of protective gloves, protective clothing, safety goggles and mouth and nose protection for all steps in which the product components are still contaminated.
Page 35 Follow the corresponding operating instructions for all aids, tools and devices used. Unsuitable cleaning agents and disinfectants The product may become damaged. Do not use any process chemicals containing the following ingredients on the ATMOS Scope as well as for all accessories: • Chloramines •...
Page 36 The image quality can be impaired by the slightest dirt such as fingerprints on the cover glass. You can protect the ATMOS Scope from dust by storing it on a soft cloth and covering it after using it. Preparing and completing the sterilization process Prior to sterilization Prior to cleaning, put the protection cap onto the USB connector.
Page 37 Sterilizing surfaces 5.3.1 Overview Surface Remarks ATMOS Scope with USB cable and USB protection cap Sterilization...
Page 38 Selecting process chemicals Material compatibility tests have been carried out for the following cleaning agents and disinfectants for the ATMOS Scope. Please follow the instructions of the manufacturer of the cleaning agents and disinfectants, in particular with regard to concentrations, temperature, duration of use, and exposure time as well as protec- tive measures.
Page 39 Helizyme, BBraun Surfactants, enzymes, complexing agents, corrosion inhibitors, Liquid concentrate additives mikrozid sensitive 0.25 g alkyl (C12–16) dimethyl benzyl ammonium chloride Ready-to-use wipes ® wipes, Schülke & Mayr 0.25 g didecyl dimethyl ammonium chloride 0.25 g alkyl (C12–14) ethyl benzyl ammonium chloride Cidezyme, ASP Subtilisin (proteolytic enzymes) Liquid concentrate...
Page 40 mikrozid sensitive 0.25 g alkyl (C12–16) dimethyl benzyl ammonium chloride Ready-to-use wipes ® wipes, Schülke & Mayr 0.25 g didecyl dimethyl ammonium chloride 0.25 g alkyl (C12–14) ethyl benzyl ammonium chloride Helipur H plus N, Aldehydes Liquid concentrate ® BBraun Glutaraldehyde 12.0 g, propan-2-ol, 7.5 g, ethyl hexanol 0.5 g, anionic surfactants Cidezyme, ASP...
Page 41 Disinfectants – Mechanical sterilization neodisher endo SEPT Glutaral, 10.5 g Liquid concentrate ® GA, Dr. Weigert neodisher SEPT PA, Peracetic acid, 15.0 g Liquid concentrate ® Dr. Weigert Rapicide PA, Cantel Hydrogen peroxide, 22% Liquid concentrate Acetic acid, 9% Peroxyacetic acid 5% 5.3.3 Manual cleaning and disinfection Please observe chapter “1.7 Attaching the pressure compensation attachment”...
Page 42 Repeat the manual cleaning if there is any visible dirt on the device. Drying Place the ATMOS Scope on a clean surface covered with a lint-free cloth and cover it with another lint-free cloth to dry it. The ATMOS Scope must be completely re-sterilised. Continue with the disinfection and/or sterilization.
Page 43 • With the insertion tube lying in the solution, clean it with a soft water, soft cloth cloth and clean the ATMOS Scope handle with a soft cleaning • Soft nylon brush, 1 min. brush until no residue is visible on the surface.
Page 44 Repeat the manual cleaning if there is any visible dirt on the device. Drying Place the ATMOS Scope on a clean surface covered with a lint-free cloth and cover it with another lint-free cloth to dry it. The ATMOS Scope must be completely re-sterilized. Continue with the disinfection and/or sterilization.
Page 45 Repeat the manual cleaning if there is any visible dirt on the device. Drying: Place the ATMOS Scope on a clean surface covered with a lint-free • Temp.: 30-45 °C cloth and cover it with another lint-free cloth to dry it. The ATMOS •...
Page 46 5.3.7 Mechanical cleaning and disinfection Check the device for leak tightness (see chapter “3.6.3 Performing a leakage test” on page 29). General notes on mechanical cleaning Inspect visible surfaces for residual contamination after mechanical cleaning/disin- fection. Repeat the cleaning process if necessary. The product is compatible with several washer-disinfectors for flexible endoscopes.
Page 47 Bristles: nylon Hardness: soft) Mechanical cleaning and disinfection: • Lay the ATMOS Scope on the silicone bubble mat and secure • 3 min. pre-cleaning with cold tap water the hose in place at a minimum of two points. • Drain •...
Page 48 Do not by any means use the pressure compensation attachment for the STERIS ® SYSTEM 1E process! With the pressure compensation attachment screwed on, liquid would enter the ATMOS Scope and destroy the inner components during the process with the STERIS SYSTEM 1E.
Page 49 Repeat the manual sterilization if there is any visible dirt on the device. Drying To dry the ATMOS Scope, lay it on a lint-free cloth in a clean environment and cover it with a soft cloth. The ATMOS Scope must be dried completely before using, storing or re-sterilizing it.
Page 50 16) and document the sterilization cycle by means of the serial number on the deflection lever. ATMOS recommend mainte- nance of the ATMOS Scope after 99 sterilisation cycles (see chapter “6 Maintenance and service” on page 52). The ATMOS Scope with the pressure compensation attachment should be placed...
Page 51 Contamination of the re-sterilized endoscope or accessories could pose a risk of infection to the patient and/or user. Do not bend the insertion tube of the ATMOS Scope with a diameter of less than 20 cm. The endoscope can become damaged by inappropriate storage.
Page 52 Procedure for repairs and service cases Contact your authorized ATMOS dealer to clarify the further procedure. Please observe the following procedure when sending in your ATMOS Scope: Clean and disinfect the product and accessories in accordance with the operat- ing instructions.
Page 53 Use service shipping packaging recommended by ATMOS to ship your ATMOS Scope The wooden packaging of the ATMOS Scope is not suitable for shipment in a service case. In a service case, ATMOS would have to dispose it to meet the hygiene requirements.
Page 54 Warranty The manufacturer grants a 24-month warranty on the working order of the product. This warranty is restricted to claims submitted in written form within the warranty period starting from the date of the invoice, if necessary with reference to repairs and specification of the invoice number.
Page 55 Troubleshooting Error symptom Possible cause Remedy ATMOS Scope is not Insufficient Make sure the system re- recognized by the PC power supply via quirements are met (USB 3.0), USB interface while removing any connected USB devices USB port has switched The USB port must be perma-...
Page 56 ATMOS Capture Suite software the PC (installs all software components required for operation) Image “freezes” “Buffer overflow” Disconnect the ATMOS Scope (no live video) from the PC (pull the USB plug) and re-connect it Poor colour repro- Screen not set Check the screen settings...
Page 57 Cloudy image Glass surfaces dirty Clean the glass surfaces in accordance with chapter “5.3 Sterilizing surfaces” on page 37 Leaky, defective lens See chapter “6.2 Procedure system for repairs and service cases” on page 52. Image too dark; insuf- Glass surfaces dirty Remove any residue in accord- ficient illumination ance with chapter “5.3 Sterilizing surfaces”...
Page 58 Leakiness Leakage tester is Check the connections between connected incorrectly the pressure compensation attachment, leakage tester hose and leakage tester Insertion tube See chapter “6.2 Procedure defective for repairs and service cases” on page 52. Moisture on USB Protection cap not on Slip the protection cap firmly connector USB connector...
Page 59 Corrosion, staining, Inadequate cleaning Clean again and rub thoroughly if discolouring (e.g. protein residue) necessary Insufficient rinsing Ensure sufficient rinsing between of the endoscope the sterilization phases between the steriliza- tion steps (especially before the steriliza- tion process) Disinfectant and Replace the disinfectant and cleaning solutions cleaning solutions at regular...
Page 60 Error message from the firmware Error code Description 0xF0000000 Unspecified error during processing 0xF0000001 Error on the status display 0xF0000002 Error in the USB module 0xF0000003 General error in the camera module 0xF0000004 Error in the camera interface 0xF0000005 Faulty sensor connection Troubleshooting...
Page 61 Warning messages from the firmware The following modules may generate warning messages: Module Restrictions Status indicator Unspecified error during processing Integrated LED lighting The integrated LED lighting is not working or is working only to a limited extent. USB transmission Reliable USB transfer is not possible, or enumer- ation could not be performed.
Page 62 Accessories Accessories ATMOS Capture Suite HD licence dongle 700.0047.0 ATMOS Controller for visualization 507.6200.0 ATMOS Medical Monitor 21.5" Touch 507.3128.0 Accessories...
Page 63 Clean and disinfect the product. In Germany: Send the product in the original packaging back to ATMOS or your specialist dealer. They will dispose of the product professionally. In other countries: Dispose of the product properly and in accordance with country-specific laws and regulations.
Page 64 10 Technical data Voltage 5 V⎓ (USB 2.0) Current consumption Max. 0.73 A (USB 2.0; 5 V≈) Power consumption Max. 3.65 W Other power sources None Operating mode Continuous operation Protective earth conductor resistance Earth leakage current Housing leakage current Patient leakage current Ambient conditions for transport/storage •...
Page 65 • Air pressure 700...1060 hPa Maximum operating altitude 3000 m (NN) Contamination level Overvoltage category Dimensions (H x W x D) 189 x 445 x 40 mm Dimensions of the distal tube Length: 300 mm; Ø: 3.9 mm Weight 0.4 kg Period tests Follow the instructions for the individual components Protection class (EN 60601-1)
Page 66 RF-shielded room of a magnetic resonance imaging system. The customer or user of the ATMOS Scope must ensure that the device is used in a prescribed environment. Guidelines and manufacturer’s declaration – Key features Observe the respective technical data in this manual.
Page 67 Portable RF communications equipment (e.g. radios, antenna cables) should be used no closer than 30 cm* to any part of the ATMOS Scope, including cables, specified by the manufacturer. Otherwise, this could result in degradation of the key features of the device.
Page 68 ATMOS MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Str. 16 79853 Lenzkirch / Germany Phone: +49 7653 689-0 info@atmosmed.de www.atmosmed.com...

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