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Atmos Scope, Руководство по эксплуатации

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Introduction

Date of manufacture

DE

Country of manufacture: Germany

Serial number

Reference number

IP68

Degree of protection

Protection class II device

Professional disposal

Type BF applied part

Medical device

This device complies with the relevant requirements
of the Eurasian Economic Union.

Содержание Scope

Страница 1: ...1 Operating Instructions ATMOS Scope English GA1GB 150259 0 2022 03 Index 03 ...

Страница 2: ...d third parties 15 2 3 Avoiding damage to the device 17 3 Setting up and starting up 18 3 1 Device overview 18 3 2 Leakage tester and tube 19 3 3 Combination with other devices 19 3 4 Preparing the device 20 3 5 Assembly and initial installation 20 3 5 1 Required additional devices 20 3 5 2 Installation of ATMOS Capture Suite Basic 20 3 5 3 Installation of the ATMOS Scope using ATMOS Capture Suite...

Страница 3: ...5 1 3 Avoiding damage to the device 28 5 1 4 Further cleaning instructions 30 5 2 Preparing and completing reprocessing 30 5 3 Preparing surfaces 31 5 3 1 Overview 31 5 3 2 Selecting process chemicals 32 5 3 3 Manual cleaning and disinfection 35 5 3 4 Mechanical cleaning and disinfection 37 5 3 5 Sterilization 39 6 Maintenance and service 40 6 1 Periodic tests 40 6 2 Sending in the device 40 6 3 W...

Страница 4: ...his document may only be re printed either in part or in whole with written permission from ATMOS These operating instructions must always be kept available near the product Care periodic tests regular cleaning and proper application are essen tial They ensure the operational safety and usability of the product Maintenance repairs and periodic tests may only be carried out by persons who have the ...

Страница 5: ...ble requirements of Directive 2011 65 EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment RoHS 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 ...

Страница 6: ...rve the necessary measures WARNING Warning of a danger that can cause fatal or serious injury Observe the necessary measures CAUTION Warning of a danger that can cause minor injury Observe the necessary measures NOTICE Notice of a danger that can damage the product or other objects Observe the necessary measures Warning of a danger that can cause fatal or serious injury ...

Страница 7: ...f the device 1 Action Proceed step by step Result of an action Move plug in this direction click Engage check correct fit On device and type plate Follow operating instructions blue This device complies with the relevant requirements of EU regulations UL Recognized Component Manufacturer ...

Страница 8: ...of manufacture Germany Serial number Reference number IP68 Degree of protection Protection class II device Professional disposal Type BF applied part Medical device This device complies with the relevant requirements of the Eurasian Economic Union ...

Страница 9: ...andling of endoscopes Intended patient target group Patients of all age groups without restrictions in whom an endoscopic examination is generally indicated The use of the device also depends on the patient s general condition and must therefore be critically evaluated by the responsible physician before each use Medical conditions to be diagnosed treated or monitored Endoscopy can be performed wh...

Страница 10: ...ction criteria None Indications Need for visual inspection of anatomy in defined organs Medical contra indica tions Non intact mucosa in the area of the application organs Other contra indica tions None Warnings None The product is active Sterility specific micro bial status Non sterile Single use product reprocessing Not a single use product Reprocessing according to instructions for use ...

Страница 11: ...nd white balance are no longer required 1 5 Scope of delivery Prior to dispatch the ATMOS Scope was subjected to an extensive functional test and was carefully packed Nevertheless please compare the contents of the shipment on completeness immediately upon receipt see delivery note Description REF ATMOS Scope Set includes Endoscope Adapter for leakage test Attachment for pressure compensation incl...

Страница 12: ...g information tag on pressure compensation Infection control return bag ATMOS Capture Suite Basic 507 7050 0 ATMOS Scope iPrime Set includes Endoscope Leakage tester Adapter for leakage test Attachment for pressure compensation including information tag on pressure compensation Infection control return bag ATMOS Capture Suite HD 507 7060 0 ...

Страница 13: ... Operating Instructions 1 6 Transport and storage Only transport the device in a shipping carton that is padded and offers sufficient protection If damage occurs during transport 1 Document and report damages in transit 2 Send the device to ATMOS see chapter 6 2 Sending in the device on page 40 ...

Страница 14: ...on Environmental conditions for transport and storage Temperature range 30 50 C Air humidity without condensation 5 90 Air pressure 700 1060 hPa Please observe the notes on pressure compensation screw on the adapter ...

Страница 15: ...eir safety instructions Report all serious incidents that have occurred in connection with this product to the manufacturer and your national competent authority 2 2 Danger for users patients and third parties Electric shock due to unsuitable power connection incorrect handling of the product or damage to product components Minor injuries are possible Prior to each use check the device and cable f...

Страница 16: ...ts see chapter 6 1 Periodic tests on page 40 Assembly new settings modifications extensions and repairs may only be carried out by authorized persons Do not modify the device without the manufacturer s permission During prolonged use of the ATMOS Scope the distal endoscope tip can heat up to 53 5 C Never leave the patient unattended near the device Keep the device fully functional at all times Mal...

Страница 17: ...chanical stress Damage to the USB cable and the distal tube of the ATMOS Scope is possible Make sure that both the USB cable and the distal tube are not pinched squeezed knotted or clamped off Do not pull on the USB cable or distal tube of the ATMOS Scope The pressure compensation valve may only be used with ATMOS accessories and can be fixed without tools Storage and operation in an unsuitable en...

Страница 18: ...18 Setting up and starting up 3 Setting up and starting up 3 1 Device overview ...

Страница 19: ...ge test to tube REF 507 7024 0 3 3 Combination with other devices Only qualified personnel are authorized to install electrical systems The manufactur er of an electrical medical system is responsible for ensuring that the performance safety technical data and intended use of the ATMOS Scope are not impaired Observe the following information when connecting the device in the required combination ...

Страница 20: ...ct according to the operating instructions 2 Check the leak tightness of the ATMOS Scope according to the operating instruc tions see 3 6 2 Performing a leakage test on page 22 3 Prior to use the live image should be checked 3 5 Assembly and initial installation 3 5 1 Required additional devices Please use a PC or an equivalent system in accordance with IEC 60950 1 or IEC 62368 1 respectively 3 5 ...

Страница 21: ...uite Basic 1 Launch the software 2 Open the settings 3 Select the ATMOS Scope as source 4 Close the software 5 Restart your computer 6 Installation is complete 3 6 Checks and tests Depending on the working distance the endoscopic image must be crisp clear and bright The following test sequence must be conducted on the device before reprocessing and immediately before use ...

Страница 22: ... turn it by 90 in a clockwise direction The tester is then firmly attached to the endoscope and cannot be removed Generate a test pressure of maximum 160 mmHg by pumping on the leakage tester Wait 30 s and observe the pressure If the value on the manometer display drops continuously do not place the endoscope in liquid as the device has a leak In this case please send in the device for repair Vent...

Страница 23: ... the endoscope under water Never immerse the endoscope in liquid if there is a pressure drop Testing the deflection mechanism Slowly operate the deflection lever to check the function CAUTION Limitations in deflection can indicate an endoscope defect In order to avoid major damage to the endoscope only use the endoscope if the deflection works smoothly and without limitation ...

Страница 24: ...ducts any longer CAUTION Damaged products Do not use products with a damaged camera chip e g recognizable by image inter ferences damaged glass surfaces or stubborn deposits that cannot be removed by cleaning Send damaged products to the manufacturer or a repair center authorized by them for inspection Names of authorized repair centers can be requested from the manufacturer ...

Страница 25: ...nd distal tube The outer sheath and inner components could become damaged Never move the tip of the distal tube or tip cover glass against resistance The tip contains components that may scratch or break when used incorrectly 4 1 1 Switching on and adjusting the system 1 Take the flexible ATMOS Scope in your hand The system turns on 4 1 2 Functions of the buttons with the ATMOS Capture Suite When ...

Страница 26: ... Capture Suite HD In the photo mode of the programs Trigger snapshot is stored by default on the upper button and Switch to video function on the lower button In the video mode of the programs the upper button is Video start stop and the lower button is Switch to snapshot function ...

Страница 27: ...change of parts It is the responsibility of the user to ensure that the required results of cleaning and disinfection are achieved Validation and routine monitoring of the procedure will usually be necessary Reprocessing may only be carried out by persons who have the necessary expertise The person in question must have the necessary equipment required to carry out these measures ...

Страница 28: ...s and tools that can be easily reprocessed or ones that are dispos able products Risk of infection due to unsuitable reprocessing Deadly diseases can be transmitted Make sure that all areas of the device can be reached easily Use only suitable load carriers with silicone pads for mechanical reprocessing 5 1 3 Avoiding damage to the device Damage to the device due to cleaning with fixatives Stains ...

Страница 29: ...cope as well as for all accessories Chloramines Phenol derivatives Incorrect cleaning and disinfection Corrosion due to moisture Remove the products immediately after the program is finished Never clean and or disinfect the product in an ultrasonic bath Avoid excessive pressure and tension on the flexible endoscope components Only place the device in suitable load carriers with silicone pads in or...

Страница 30: ...paring and completing reprocessing Prior to reprocessing 1 Prior to cleaning put the protection cap onto the USB connector 2 Make sure that the protection cap is fitted securely on the USB connector 3 Carry out the leakage test before immersing the device in liquids see chapter 3 6 2 Performing a leakage test on page 22 A leaky device will become damaged by penetrating liquids and can no longer be...

Страница 31: ...and that the distal end moves properly 7 Check the ATMOS Scope for leak tightness using the manual leakage tester see chapter 3 6 2 Performing a leakage test on page 22 8 Check whether an image is displayed and the LED lamp is turned on 5 3 Preparing surfaces 5 3 1 Overview Surface After each patient Pre treatment Pre cleaning Manual cleaning and immersion disinfection Mechanical cleaning and disi...

Страница 32: ...e cleaning agents and disinfectants particularly with regard to concentrations temperature duration of use and contact times as well as protective measures Cleaning agent manufacturer Active ingredients in 100 g if published or released by the manufacturer Type Cleaning agents manual reprocessing MetriSponge Metrex Water and nonhazardous ingredients 30 60 Propylene glycol 10 30 Nonionic surfactant...

Страница 33: ...concentrate mikrozid sensitive wipes Schülke Mayr 0 25 g Alkyl C12 16 dimethylbenzylammonium chloride 0 25 g Didecyldimethylammonium chloride 0 25 g Alkyl C12 14 ethylbenzylammonium chloride Wipes Ready to use Disinfectants manual reprocessing Metricide 28 Metrix Water and nonhazardous ingredients Glutaraldehyde Liquid concentrate Revital OX Resert Steris 2 Furancarboxylic acid 2 3 Hydrogen peroxi...

Страница 34: ...echanical reprocessing neodisher MediClean forte Dr Weigert 5 nonionic and anionic surfactants enzymes Liquid concentrate Intercept Cantel Quaternary ammonium compounds benzyl C12 18 alkyldimethyl chlorides 1 5 D Glucopyranose oligomeric decyl octyl glycosides 0 72 1 44 Liquid concentrate Intercept plus Cantel Trisodium phosphate 5 10 Phosphoric acid tripotassium salt 5 10 Propylene glycol 10 Liqu...

Страница 35: ...merse in cleaning solution Ensure that all accessible surfaces are moistened With the insertion tube lying in the solution clean it with a soft cloth and clean the ATMOS Scope handle with a soft cleaning brush until no residue is visible on the surface Move the movable component deflection lever 5 times in each direction as far as it goes during cleaning Using a disposable syringe thoroughly rinse...

Страница 36: ... splashing contaminated liquid Final rinse 1 min Cold drinking water Move 5 times Rinse the probes for 1 minute under cold running drinking water to remove any cleaning agent residues Move the deflection lever at least 5 times in each direction as far as possible Disinfection Disinfection Temp at least 20 25 C Cidex OPA drinking water 12 min Completely immerse the ATMOS Scope in the disinfection s...

Страница 37: ...he wash er disinfector for endoscopes and if necessary check with the manufacturer which cleaning and disinfection program is suitable for the product Product damage due to excessive temperatures During mechanical cleaning and disinfection the temperature should not exceed 65 C 149 F Position and gently fix the endoscope in a cleaning basket lined with silicone mats in the washer disinfector in ac...

Страница 38: ...den areas Mechanical cleaning and disinfection Pre rinse 3 min Drain Cleaning 7 min 55 C 131 F with 5 ml neodisher Mediclean forte Drain Rinse 2 min 55 C with drinking water Drain Accessories for storage screen basket silicone mat Lay the ATMOS Scope on the silicone bubble mat and fix the insertion tube at a minimum of 2 places Select a suitable program for cleaning and disinfection with the adjac...

Страница 39: ...Ensure that the sterilizing agent reaches all surfaces The implementation of the sterilization procedures mentioned with respect to achieving the desired or required sterilization effect lies within the user s responsibility Observe the operating instructions for your sterilizer Important Prior to sterilization put the attachment for pressure compensation on the pressure compensation valve of the ...

Страница 40: ... are carried out professionally original spare parts are used and warranty claims remain unaffected 6 1 Periodic tests At least every 24 months a repeat test of the electrical safety should be performed according to IEC 62353 6 2 Sending in the device 1 Clean and disinfect the product and accessories according to the operating instructions 2 Enclose any used accessories with the product 3 Use a ti...

Страница 41: ... immediately in written form within the specified warranty period after the invoice date where appropriate with reference to repairs and stating the invoice number Statutory warranty claims are not limited by this warranty This warranty only applies to defects that cannot be attributed to normal wear and tear misuse improper handling extraneous cause lack of or incorrect reprocessing or force maje...

Страница 42: ...lens system Send in the ATMOS Scope for repair Image is too dark insufficient illumina tion Glass surfaces are dirty Remove residues according to chapter 5 3 Preparing surfaces on page 31 check water quality Stubborn residue on the glass surfaces Clean again rub thoroughly if necessary LED is defective Send in the ATMOS Scope for repair Brightness is set incorrectly Adjust brightness in the softwa...

Страница 43: ...rilization Ensure adequate rinsing between the reprocessing phases Contaminated disin fectant and cleaning solutions that are used too frequently Replace the disinfecting and cleaning solutions at regular intervals Extraneous rust e g from rusty steam or reprocessing together with damaged or non stainless instru ments Check supply systems ensure material compatibility during common reprocessing pa...

Страница 44: ...e ATMOS Scope for repair Protection cap is not on connector Push protection cap firmly onto connector Deflection lever is stiff not working Defective tip mecha nism Send in the ATMOS Scope for repair No image on the PC Camera USB driver is not installed on the PC Install camera USB driver ATMOS Scope is not recognized by USB interface the USB interface may be turned off USB port via Windows contro...

Страница 45: ...eck the monitor settings Colored stripes on the monitor ATMOS Scope is defective Send in the ATMOS Scope for repair ATMOS Scope is not recognized by the PC USB port has switched off USB port must be permanently activated via the power settings in Windows ATMOS Scope is defective Send in the ATMOS Scope for repair ...

Страница 46: ...46 Accessories 8 Accessories Accessories REF ATMOS Capture Suite HD License Dongle 700 0047 0 ATMOS Controller for visualization 507 6200 0 ATMOS Medical Monitor 21 5 Touch 507 3128 0 ...

Страница 47: ...s materials 1 Clean and disinfect the product 2 In Germany Send the product back to ATMOS or your special ist dealer They will dispose of the product professionally 3 For other countries Dispose of the product properly and in accordance with country specific laws and regulations In principle the case is fully recyclable However please observe country specific laws and regulations ...

Страница 48: ...None Mode of operation Continuous operation Protective earth conductor resistance Earth leakage current Touch current Patient leakage current n a n a n a n a Environmental conditions Transport storage Temperature range 30 50 C Air humidity without condensation 5 90 Air pressure 700 1060 hPa Environmental conditions Operation Temperature range 10 32 C ...

Страница 49: ...s of the insertion tube Length 300 mm Ø 3 9 mm Weight 0 4 kg Periodical tests Follow the instructions for the individ ual components Protection class against electric shock acc to EN 60601 1 II Classification of applied parts Type BF applied parts Degree of protection IP68 Risk classification acc to MDR 2017 745 Class I CE marking Risk classification MDR Class I according to Rule 5 Reference numbe...

Страница 50: ...lities as well as operating rooms and outside of the HF 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 Guidance and manufacturer s declaration key features Please note the Technical Data in these instructions The essential features are fully usable even in the presence of electromagnetic d...

Страница 51: ...ause increased electromagnetic emissions or reduced immunity to electromagnetic interference and result in faulty operation WARNING 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 degradation of the performance of this equipment could result The distance may be...

Страница 52: ...ATMOS MedizinTechnik GmbH Co KG Ludwig Kegel Str 16 79853 Lenzkirch Germany Phone 49 7653 689 0 info atmosmed com www atmosmed com ...

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