English ATMOS C 11 Systema Operating Instructions 0124 GA1GB.110300.0 2018-03 Index: 20
Content 1.0 Introduction...3 1.1 Notes on operating instructions...3 1.2 Intended use...4 1.3 Function...4 1.4 Explanation of symbols...5 1.5 Scope of delivery... 5 2.0 For your safety...6 3.0 Setting up and starting up...7 3.1 Required connections...7 3.2 Connection to electrical power line...7 3.3 Overview of complete equipment... 8 3.4 Back view...8 4.0 Operation...9 4.1 Suction system...9 4.1.1 Activation...9 4.2 Canister systems...10 4.2.1 Reusable canister systems...10 4.2.1.1 Bodywork secretion canister...10 4.2.2 Insert / Remove DDS bacterial filter / oversuction stop...10 4.2.3 Using the DDS splash protector...10 4.2.4 Attach / remove DDS secretion canister lid... 11 4.2.5 Attach / remove DDS secretion canister handle.. 11 4.2.6 Close / open DDS secretion canister handle... 11 4.2.7 Removing / securing DDS secretion canister...12 4.2.8 Insert DDS hose adapter...12 4.2.9 Connecting the hose...12 4.2.10 DDS changeover docking station...12 4.2.11 Draining of reusable canister system...12 4.3 Disposable canister system...13 4.3.1 Assembling the Receptal secretioncanister system...13 4.3.2 Assembling the Medi-Vac secretioncanister system...13 4.3.3 Assembling the Serres secretioncanister system...13 4.3.4 Bemis secretion canister system...14 4.4 Compressed-air system...15 4.4.1 Activation...15 4.4.2 Adapt / deposit sprayer...16 4.4.3 Ear irrigation module compressed air (REF 541.1100.0)...16 4.4.4 Ear irrigation bowl...16 4.5 ATMOS LS 21 LED - quickstart...17 4.5.1 Connection...17 4.5.2 Attaching the application part...17 4.5.3 Autostart function...17 4.5.4 Intensity control...17 4.6 ATMOS HL 21 LED - quickstart...18 4.6.1 Switching on...18 4.6.2 Focusing the headlight...18 4.6.3 Intensity control...18 4.7 LED cold light module...18 4.8 Endoscope management...19 4.8.1 Overview...19 4.8.2 Mirror quick-heater...19 4.9 Emptying the deposit for used instruments...20 5.0 Cleaning and care...21 5.1 General information on cleaning and disinfection...21 5.1.1 Cleaning the unit surface...21 5.1.2 Secretion canister, bacterial filter and suction hose...21 5.1.3 Test DDS bacterial filter / oversuction stop...21 5.1.4 Medicament sprayers...22 5.1.5 Instrument trays...22 5.1.6 Endoscope quivers...22 5.1.7 Ear irrigation bottle and ear rinsing bowl...22 5.2 Recommended instrument disinfectants...23 5.3 Recommended surface disinfectants...24 5.4 Recommended endoscope disinfectants...25 5.5 Cleaning and disinfection plan...26 6.0 Maintenance and Service...28 6.1 Sending in the device...28 7.0 Troubleshooting...29 8.0 Options, accessories, and consumables...31 9.0 Technical data...33 ATMOS MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Straße 16 79853 Lenzkirch Germany Phone: + 49 7653 689-0 Fax: + 49 7653 689-190 + 49 7653 689-292 (Service Centre) E-mail: atmos@atmosmed.de Internet: www.atmosmed.de 10.0 Disposal...35 11.0 Notes on EMC...36 2
1.0 Introduction 1.1 Notes on Operating Instructions These operating instructions contain important notes on how to operate the ATMOS C 11 Systema safely, correctly and effectively. Their reading helps to avoid risks, and also to reduce repair costs and down-times. This increases also the reliability and service-life of your device. These operating instructions serve not only for new operating personnel to be instructed in its use, but also for use as a reference manual. Reproduction, even partial, is only permitted with written permission from ATMOS. These operating instructions must always be kept available near the device. Care and period tests in conjunction with professional execution provide for operational safety and readiness for use of your ATMOS C 11 Systema and are therefore a must besides regular cleaning. Repair work and period tests may be carried out only by expert personnel authorised by ATMOS. By applying only original spare parts you will have the guarantee that operational safety, readiness for work and the value of your ATMOS C 11 Systema will be preserved. The unit ATMOS C 11 Systema bears CE marking CE 0124 according to the EC Directive of the council for medical products 93/42/EEC and meets the basic requirements of Appendix I of the directive. The unit ATMOS C 11 Systema complies with all applicable requirements of the Directive 2011/65/EC restricting the use of certain hazardous substances in electrical and electronic equipment ( RoHS ). 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, in order to be prepared for any possible dangerous situations. These operating instructions are valid for the following devices: ATMOS C 11 Systema (sitting) REF 541.0000.0 ATMOS C 11 Systema (standing) REF 542.0000.0 3
1.0 Introduction 1.2 Intended use Name: Main function: Medical indications / application: Specification of the main function: Application organ: Application time: Application site: Contraindications: The product is: Sterility: Single-use product / reprocessing: ATMOS C 11 Systema Suction Ear irrigation Compressed air for medication spraying Electric power supply for LED light handles and LED headlight Power supply for optional LED cold light source Instrument deposit Mirror quick heater Standard ENT examination and/or therapy Suction at 90 % vacuum / 100 mbar end pressure Ear irrigation with 37 C ± 2 C, max. 500 ml/min Compressed air for medication spraying, max. 2 bar Power supply for LED, 700 ma or 1.000 ma LED cold light source min. 80 klux ± 10 %, colour temperature 5.600 K Mouth to pharynx, auditory canal to the ear drum and the nasal cavities ENT unit: Short term use (up to 30 days) Suction / Compressed air / ear irrigation: Temporary application on the patient (less than 60 minutes) Application sites are clinics and practices for ENT doctors and phoniatrists. The examination and/or therapy with the ENT unit may only be executed by medically trained persons. May not be used for irrigation of the paranasal sinuses. May not be used for the Politzer manoeuvre. The ear irrigation should not be applied to an infected auditory canal or a perforated eardrum. active The ENT unit is no sterile product. The ENT unit is intended for multiple use. The device and parts of the accessories are reusable. For information on reprocessing, cleaning and disinfection please see the operating instructions. 1.3 Function Suction system Compressed-air system 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 Endoscope management Mirror quick heater 4
1.0 Introduction 1.4 Explanation of symbols Short cuts / symbols contained in these operating instructions Follow the arrows General information Move, plug... in this direction Please press where dot indicates Numeration Turn, shift... in this direction Please read, important information Subnumeration Replace Check click Engage, check correct fit Graphic symbols contained in these operating instructions! Warning, special diligent notice )) Important information Professional disposal Symbols of ATMOS C 11 Systema 0124 This product complies with the relevant requirements of EU Directive SN REF Serial number Order number Observe operating instructions! Manufacturing date Suction system Compressed-air system 2 This product is not re-sterilizable. Repeated reuse of components which are marked with a 2 is forbidden. In case of repeated reuse these components lose their function and there is a high infection risk. Potential equalisation 1.5 Scope of delivery The ATMOS C 11 Systema was subjected to an extensive functional test and was carefully packed prior to dispatch. Nevertheless, please compare the contents of the shipment on completeness immediately upon receipt (see delivery note). Scope of delivery ATMOS C 11 Systema (sitting): Basic module with two large drawers, one small drawer, service compartment for secretion canister, safe storage of three clean and three used endoscopes at a time, two connections for LED light handle ATMOS LS 21 LED and headlight ATMOS HL 21 LED, support for LED light handle with automatic start-up function by means of light barriers, three supports for medicament sprayers, two supports for rinsing bottles, suction module, suction hose, power cable, operating instructions Scope of delivery ATMOS C 11 Systema (standing): Basic module with three large drawers, one small drawer, service compartment for secretion canister, safe storage of three clean and three used endoscopes at a time, two connections for LED light handle ATMOS LS 21 LED and headlight ATMOS HL 21 LED, support for LED light handle with automatic start-up function by means of light barriers, three supports for medicament sprayers, two supports for rinsing bottles, suction module, suction hose, power cable, operating instructions 5
2.0 For your safety! For your safety The ATMOS C 11 Systema is produced according to IEC 601 / EN 60601 and listed in the following classes: -- VDE Class of protection 1 -- Class IIa (93/42/EEC). The device may only be connected to a properly installed safety socket. Correct configuration in assembly of country-specific connections: -- green/yellow: protective conductor (PE) -- blue: neutral conductor (N) -- black or brown: phase (L) The ATMOS C 11 Systema may be used in supervised operation by qualified personnel only which has been authorised by ATMOS and which has been trained for operating the appliance (IEC 60601-1/EN 60601-1). The mains voltage indicated on the type plate must correspond to the values of the supply network. Valves must be checked for correct function in regular intervals! Arrange a sight check every morning for the hoses, secretion canister and cables. Exchange damaged parts immediately! Only proper and undamaged plugs and extension cables may be used. Switch off the unit before you open it and separate it from the line voltage. Never leave the patient unattended at the treatment unit. This product is not re-sterilizable. Repeated reuse of components which are marked with a 2 is forbidden. In case of repeated reuse these components lose their function and there is a high infection risk. In case that there is no adapter attached to the light conductor, touching the light source with either a finger or any tool should be avoided. On the one hand this may damage the lens and on the other hand there is a risk of injury. It is not allowed to use flammable substances with the device. Switch off the main switch after finishing work in practice. If the device is connected to the mains by means of a mains distributor together with other electrical devices the total leakage current of all connected devices must not exceed 0.5 ma. In case of leakage currents exceeding this value, the devices have to be connected to the mains by means of wall mounted connectors. Alternatively the devices can be operated by using an isolating transformer according to IEC 60601-1 with insulation monitoring or any similar safety device. Do not place used contaminated instruments on the ENT unit except on destined places! The ambient conditions specified in the "Technical data" must be strictly observed! Care is to be paid in respect to light sources when working with endoscopes. Do not look directly into the light outlets! In case of possible light failure remove the endoscope from the working area. The ATMOS C 11 Systema may be operated only in rooms used for medical purposes, but not in areas subject to explosion hazards and in oxygen rich environments. The ATMOS C 11 Systema meets the immunity to interference requirements of IEC 60601-1-2 / EN 60601-1-2 Electromagnetic Compatibility Medical Electrical Devices. The ATMOS C 11 Systema may not be operated with devices not complying with the requirements of standard EN 60601-1 Medical Electrical Equipment and EN 60601-1-2 Electromagnetic Compatibility (Medical Electrical Equipment). ATMOS is not liable for personal injury and damage to property if -- no original ATMOS parts are being used. -- the advice for use in these operating instructions is not being observed. -- assembly, new settings, alterations, extensions and repairs have been carried out by personnel not authorised by ATMOS. Do not restrict the air supply at the rear of the unit! Pay attention to the correct fit of the light source ATMOS LS 21 LED in the holder. With every light source a warming of tissue due to radiation and absorption could occur. This could result in damage to the biological tissue. Please make sure to reduce duration of use to a minimum, to switch off the light source when not in use and to check heat development if necessary. Avoid looking directly into the light source. Never touch the connection of the LED light source or the metal parts of the bottle warmer and the patient simultaneously (700 ma & 1000 ma). In order to avoid the danger of an electric shock this device should only be connected to an earthed power connection. Warning: Do not modify the device without permission of the manufacturer. Caution: The light handles become warm during use. The potential equalization module must be connected according to EN 60601-1 3. edition chapter 8.6.7. This is required in order to equalize all the wiring from the various medical devices which are used together. 6
3.0 Setting up and starting up 1519 800 552 532 1600 640 1100 960 1160 2260 1500 3.1 Required connections (power supply) Unit / Device ATMOS C 11 Systema Optional: Monitor Microscope ATMOS i View Patient chair Maximum required connections 1x earthing contact socket outlet 1x earthing contact socket outlet 1x earthing contact socket outlet 1x earthing contact socket outlet 3.2 Connection to electrical power line According to the directions of VDE 0107 and VDE 0100, medically used rooms have to be equipped with a leakage current protective circuit (FI protective circuit) with a nominal leakage current of < 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 which is to be mounted near the unit (max. 5 m, see fig.). This may only be carried out by authorized qualified personnel. The power consumption comes to 270 W max. For the connection of further electrical devices, please allow for extra plugs (installation of an electrically operated patient chair, etc.). In order to switch on the unit bring the on/off switch into "on" position. In order to switch off the unit bring the on/off switch into "off" position. In this position the unit is disconnected from the power supply. 7
3.0 Setting up and starting up 3.3 Overview of complete equipment 19 18 17 16 15 14 13 12 Microscope, monitor and table are not shown. 1 2 3 4 5 6 7 8 9 10 11 1 Hook for headlight with automatic switching (optional) 2 Endoscope management for rigid or flexible, clean optics (optional) 3 Mirror quick heater (optional) 4 Disinfectant quiver for used endoscopes (optional) 5 LED light handle (optional) 6 Brightness controller 7 Connection for LED light source and LED headlight (optional) 8 1-channel cold light source (optional) 9 Deposit for used instruments (optional) 10 On / Off switch 11 Service compartment 12 Compartment for secretion canister 13 Drawers 14 Automatic suction equipment 15 Compressed air (optional) 16 Nebulization of medications (optional) 17 Ear irrigation module compressed air (optional) 18 Instrument deposit (optional) 19 Storage shelf (optional) 3.4 Rear view 1 Mains supply 1 8
4.0 Operation 4.1 Suction system Prior to application please check suction performance and leak tightness of the suction system. Please remove the hose from the support, seal the hose end with your finger. Check whether vacuum is built up. In case of any leakage (no vacuum build up, hissing sound) please contact the service engineer (see chapter 4.2.10 DDS changeover docking station and chapter 6.0 Maintenance and Service). Please take care to insert the suction hose into the left support, mark with this symbol, only (see figure below).!! Do not operate the suction system without a bacterial filter. Always use the splash guard for extension of the utilization of the bacterial filter. ATMOS does not assume any liability for malfunctions caused by operating the device without bacterial filter. Exchange the bacterial filter regularly. Advices in chapter 4.2.2. The hose attachment must be exchanged after each patient. Please note that the tube set can be cleaned and disinfected mechanically by 70 C. 4.1.1 Activation Take handle from holder. By the installed light barrier the suction system activates automatically. The bacterial filter/oversuction stop of the DDS reusable system and the overflow protections in the single-use secretion canisters safely prevent from oversuction. If the canisters are filled, the overflow protections separate the canister from the vacuum. This is recognizable due to the decreasing suction capacity at the handle. In this case please exchange the disposable bag in the single-use system respectively remove, empty, clean and disinfect the reusable canister system as described in chapter 5 and insert a new bacterial filter. 9
4.0 Operation 4.2 Canister systems 4.2.1 Reusable canister system 4.2.1.1 Bodywork secretion canister DDS canister handle 340.0055.0 DDS hose adaptor set 340.0057.0 DDS bacterial filter 340.0054.0 DDS canister lid with gaskets 340.0053.0 DDS splash protection 340.0056.0 DDS secretion collection canister 1,5 l 340.0050.0 resp. 3,0 l 340.0051.0 4.2.2 Insert / Remove DDS bacterial filter / oversuction stop )) Please wear gloves for inserting resp. removing the DDS bacterial filter! 4.2.3 Using the DDS splash protector 10
4.0 Operation 4.2.4 Attach / remove DDS secretion canister lid Place the DDS secretion canister on a firm surface, position the lid horizontally on top (the lid may not be twisted!). Press it tightly with both hands as far as it will go onto the canister. With one hand on the canister handle lift the complete canister upwards. With the other hand on the canister base guide the canister in order to prevent it from tilting when lifting it out. Unhinge the snap-in hook of the canister handle at the canister. Pull out the snap-in hook with both hands and remove the canister handle upwards. Remove bacterial filter/ oversuction stop from the canister handle. Remove the canister lid from the canister with both hands. Remove the splash protection. 4.2.5 Attach / remove DDS secretion canister handle Fix the secretion canister handle into the guiding of the lid with opened snap-in hook. Fix the snap-in hook below the canister edge and press at the upper part towards the centre of the canister until the handle snaps in. 4.2.6 Close / open DDS secretion canister handle To close, secure the snap-in hooks under the edge of the secretion canister, and then press the clips downwards until they lock into place. To open, pull the clips upwards to release the snap-in hooks and remove from under the edge of the secretion canister. 11
4.0 Operation 4.2.7 Removing / securing DDS secretion canister Open the storage compartment for the secretion canister (see page 8), remove the canister in lifting it vertically upwards; for reinserting it, allow it to slide vertically downwards into the securing device. 4.2.8 Insert DDS hose adapter Press the required DDS hose adapter with 6 mm or 10 mm diameter into the opening patient on the DDS secretion canister lid twisting slightly to ensure a tight fit. Twist slightly in the same manner when removing. 4.2.9 Connecting the hose Please put the hose on the hose adapter. 4.2.10 DDS changeover docking station 1 Maximum load of the station: 15 kg! The DDS changeover docking station for 2 canisters with changeover switch and direct docking may be used on the ATMOS C 11 Systema. The changeover lever serves to switch the vacuum to the canister towards which the lever points. To remove or insert a canister, switch the changeover lever towards the canister that is not being replaced. 4.2.11 Draining of reusable canister system The canister system has to be cleansed and disinfected regularly. Read more in chapter 5.0 Cleaning. Open the side drawer regularly to check the filling level. Drain the secretion canister manually at approx. half level. Pull the secretion canister horizontal out of the holder in the service compartment and remove the suction hose. 12
4.0 Operation 4.3 Disposable canister system Receptal bag Pump Patient 4.3.1 Assembling the Receptal secretion canister system Insert the Receptal bag into the Receptal canister. Close the canister tightly at all sides. Check again for density, otherwise no vacuum can be built up. Plug in the vacuum hose of the pump and connect the suction hose to the patient connection.! Only bags with integrated bacterial filter may be used! MediVac bag Patient 4.3.2 Assembling the Medi-Vac secretion canister system Insert the Medi-Vac bag into the Medi-Vac canister. Close the canister tightly at all sides. Check again for density, otherwise no vacuum can be built up. Pump Plug in the vacuum hose of the pump and connect the suction hose to the patient connection.! Only bags with integrated bacterial filter may be used! Serres bag Pump Patient 4.3.3 Assembling the Serres secretion canister system Insert the Serres bag into the Serres canister. Close the canister tightly at all sides. Check again for density, otherwise no vacuum can be built up. Plug in the vacuum hose of the pump and connect the suction hose to the patient connection.! Only bags with integrated bacterial filter may be used! 13
4.0 Operation 4.3.4 Bemis secretion canister system Insert the Bemis bag into the Bemis canister. Close the canister tightly at all sides. Check again for density, otherwise no vacuum can be built up. Plug in the vacuum hose of the pump and connect the suction hose to the patient connection.! Only bags with integrated bacterial filter may be used! 14
4.0 Operation 4.4 Compressed-air system Prior to application check the leak tightness of the compressed air system. Remove the handle and see if any air is escaping. If there is any leakage contact the service technician (see chapter 6.0 Maintenance and Service). Ear irrigation module compressed air (optional) Bent sheet of metal with integrated support for correct sprayer-alignment Nebulization of medications (compressed air) Handle for compressed air (optional) For security reasons you should avoid repeated activation of the handle of compressed air in a rapid sequence. Make sure equipment and hoses are firmly connected in order to build up a sufficient pressure. Pay note, insert the compressed air handle into the right support, marked with this symbol.! There should be no Politzer manoeuvre performed with the compressed-air system! 4.4.1 Activation Take handle from holder. By the installed light barrier the compressed-air system activates automatically. 15
4.0 Operation 4.4.2 Adapt / deposit sprayer Adapt: Deposit: Stick ( ) handle onto the medication bottle. Adapt medication bottle top down into in the attachment. 3 1 Let snap, then lift medication bottle with handle out of the attachment ( ). Press activator ( ) and pull handle ( ) backwards. 2 By pulling the trigger, compressed-air will be applied into the sprayer ( ). 1 2 Handle carefully when using a sprayer to avoid injuries. Before using the sprayer bottle, check the defensibility of the included medications. Clean all parts of the sprayer regularly! Read more in chapter 5.0 Cleaning. 4.4.3 Ear irrigation module compressed air (REF 541.1100.0) 1 2 Prior to application, please check water pressure and water temperature on the back of the hand. In order to start the ear irrigation, please close the vent valve ( ) and press the adjusting lever ( ). You stop ear irrigation in releasing the adjusting lever ( ) and the vent valve ( ). Ear irrigation stops. Change the jet connection after each patient. Only use reprocessed jet connections, in order to prevent spreading germs. The glass vials have to be checked for intactness prior to! every use (cracks, chippings on the winding, etc.). Broken glass vials may not be used for ear irrigation. Adjusting lever Vent valve 4.4.4 Ear irrigation bowl Purpose: To collect the water during ear irrigation. The ear irrigation bowl is connected to the adapter of the suction system and is then held under the patient`s ear. 16
4.0 Operation 4.5 ATMOS LS 21 LED - quickstart! The integrated ATMOS LS 21 LED features separate operating instructions. Please note: Read these separate operating instructions attentively and follow the stated notes for your safety to guarantee ideal and safe use of all functions! Never look directly into the light source! 4.5.1 Connection Endoscope* Endoscope with integrated light conducting cable* Light conducting adaptor Storz* Endoscope adaptor Wolf REF 507.4657.0 REF 507.4611.0 with detent REF 507.4612.0 for screwing Connection ATMOS LS 21 LED ATMOS LS 21 LED for ATMOS C 11 Systema REF 541.4300.0 white light REF 541.4400.0 warm white or Light conducting adaptor Olympus* REF 507.0949.0 *Not contained in scope of delivery. Optionally available.! Danger to the device! CAUTION! If the light source is used with unsuitable adaptors, the lens could be badly damaged! Use optics only with the supplied and/or optional adaptors! Make sure, the endoscopes with adaptor engage in the light source! 4.5.2 Attaching the application part click 4.5.3 Autostart function The light source is automatically activated when removing the light handle. 4.5.4 Intensity control Switch on the light source. Turn the brightness controller anti-clockwise to reduce the brightness or clockwise to increase it. )) When the device is switched off the last adjustment will be kept. 17
4.0 Operation 4.6 ATMOS HL 21 LED - quickstart 4.7 LED cold light module Headlight rack!! The ATMOS HL 21 LED features separate operating instructions. Please note: Read these separate operating instructions attentively and follow the stated notes for your safety to guarantee ideal and safe use of all functions! Please note to use the right power connection, marked with 700 ma, for the headlight ATMOS HL 21 LED. 4.6.1 Switching on Focusing ring a) When the headlight is connected to the power supply of the ENT workstation, the headlight is automatically activated when removed from the headlight hook. b) For the connection of the headlight to the battery Adjust the lateral switch on the LED battery to the desired position: -- ECO mode: Operation for approx. 4 hours. -- POWER mode: Operation for approx. 2 hours. 4.6.2 Focusing the headlight! The one-channel LED cold light module is delivered with an ATMOS/Storz adapter. The light conducting cable can be connected to the ATMOS/ Storz adapter. When removing the light conductor the light source switches on automatically due to the built in light barrier. In case you use a light conducting cable from another manufacturer you will then require a suitable adapter. Adapter exchange In order to release the adapter turn it to the left and then pull it out. Insert the new adapter and turn it to the right until it is firmly in place. Care is to be paid in respect to light sources when working with endoscopes. Do not look directly into the light outlets! In case of possible light failure remove the endoscope from the working area. Intensity control Switch on the light source. Turn the brightness controller anticlockwise to reduce the brightness or clockwise to increase it. )) When the device is switched off the last adjustment will be kept. The size of the light spot can be adjusted by turning the focusing ring. 4.6.3 Intensity control Switch on the light source. Turn the brightness controller anticlockwise to reduce the brightness or clockwise to increase it. )) When the device is switched off the last adjustment will be kept. 18
4.0 Operation 4.8 Endoscope management 4.8.1 Overview Plastic quivers for storage of clean optics (removable) Plastics quiver for storage of used optics and filling with disinfectant dilution (removable) Please treat the instruments carefully, when inserting resp. removing. Please put used contaminated endoscopes only into the appropriate quivers. Please take care to strictly separate clean from contaminated instruments. Please observe the manufacturer's instructions when reprocessing endoscopes and in addition general rules and instructions valid for reprocessing. Reprocessing of endoscopes for reuse may not be performed at the workstation! Furthermore please observe existing directives and rules. Clean and disinfect the storage quivers regularly! Therefore please note the instructions in chapter 5.0 Cleaning. 4.8.2 Mirror quick-heater! Danger of burning - Do never touch the cover of the mirror quick heater. The cover is hot! Power-on button Press the power-on button in order to activate the mirror quick heater. After 10 seconds it switches off automatically.! Fire hazard! Prior to each use on your patient check your instruments temperature (on the back of your hand or similar). Only store and heat clean instruments! As soon as the mirror heater is activated all other electrical devices are switched off automatically until mirror heating is finished. In case that the suction system is required simultaneously, it is activated when the suction hose is removed from the support and the mirror quick heater is switched off. 19
4.0 Operation 4.9 Emptying the deposit for used instruments Deposit for used instruments To be filled / emptied Please put the used instruments into the deposit for used instruments. To empty the deposit for used instruments open the drawer and remove the closed plastic container. The lid can be removed and emptied. Put a new or the reprocessed plastic container back into the drawer and close it. 20
5.0 Cleaning and care 5.1 General information on cleaning and disinfection Switch all devices off prior to cleaning and disinfection! The described action relating to cleaning and disinfection resp. sterilisation do not substitute the relevant instructions which must be adhered to prior to operation! For disinfection, you may use all listed surface and instrument disinfectants. Always observe the concentration specifications and instructions by the respective manufacturer! Do not use Disinfectants which contain organic or inorganic acids or bases as they could cause corrosion damage. Disinfectants containing chloramides or phenol derivatives, since these may cause stress cracks in the material used for the housing of the unit. 5.1.1 Cleaning the unit surface The surfaces of the ATMOS C 11 Systema are resistant against all surface disinfectants listed on page 24. Wipe the unit surface with a cloth moistened with a cleaning or disinfecting solution. You may also use disinfectant sprays or disinfectant tissues for cleaning and disinfection. ª ª Please note that the alcohol contained in these agents could corrode or cloud the protective covers if employed on a long term basis. All application parts which are exposed to direct contact with the patient during treatment must be exchanged or cleaned and disinfected immediately for hygienic reasons. Only deposit clean instruments on the board! Clean and disinfect the instruments regularly! Do not use any organic solvents (benzine, etc.) and no abrasive cleaning agents. 5.1.2 Secretion canister, bacterial filter and suction hose At the end of every working-day, following parts must be cleaned and disinfected: Reusable secretion canister with lid system and bacterial filter: -- Detach all hose connections carefully on the lid system and take secretion canister out carefully to prevent spills and contamination of the area. Dispose of the suction material correctly (also see chapter 4.2.7). -- Grip lid system firmly, open lid of filter housing by turning in anti-clockwise direction and remove filter. Rinse all parts thoroughly under running water. A detergent or cleaning agent may also be used if required. For disinfection, immerse the parts into disinfectants, observing the manufacturer's instructions regarding the residence time. -- The bacterial filters are disposables and must be disposed of. -- It can also be cleaned in a washer-disinfector (with neodisher MediClean forte) and thermally disinfected at 93 C. -- Max. cycles of reprocessing: DDS secretion canister system, silicone hose: 60 cycles )) Suction capacity is limited by the 1.5 l secretion canister. Therefore, do not use more than 1 l rinsing liquid and subsequently evacuate the canister. )) Insert a new filter! 5.1.3 Test DDS bacterial filter / oversuction stop The DDS bacterial filter / oversuction stop is disposable. 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. When the vacuum is adjusted to max and the suction hose shows more than -0,3 bar then the DDS bacterial filter must be replaced. Replace the DDS bacterial filter at least once a day. Use only original ATMOS bacterial filters. The device may never be operated without DDS bacterial filter / oversuction stop. 21
5.0 Cleaning and care! 5.1.4 Medicament sprayers The sprayer tube must be exchanged after each patient. Dismount the medication sprayer and thoroughly rinse all parts under running water. A detergent or cleaning agent may also be used if required. -- Use water to thoroughly rinse all residues of these substances. )) Make sure that the air opening is not closed! It can also be cleaned automatically and thermally disinfected (preferred). The sprayer nozzles can be cleaned by rinsing them with a neutral detergent. It is advantageous to have a sprayer bottle (REF 000.0577.0) which is exclusively used for cleaning and disinfection. )) When fixing the twin tube nozzle again, make sure that the mark (0,X or milling area) on the nozzle shows upwards! )) Sprayer tubes are available as spare parts at ATMOS. 5.1.7 Ear irrigation bottle and ear rinsing bowl The sprayer tube must be exchanged after each patient. Dismount the ear irrigation bottle and thoroughly clean all parts under running water. A detergent or cleaning agent may also be used if required. Residues of any cleaning agents must be removed completely. Afterwards disinfection is required. The ear irrigation bowl is not autoclavable! Cleaning and disinfection (also machine cleaning) up to 93 C. )) Sprayer tubes are available as spare parts at ATMOS. 5.1.5 Instrument trays Before disinfection, thoroughly rinse the trays under running water. A detergent may also be used if required. -- Use water to thoroughly rinse all residues of these substances. It can also be cleaned in a washer-disinfector (with neodisher MediClean forte) and thermally disinfected at 93 C. 5.1.6 Endoscope quivers The narrow plastic quivers of the endoscope holder are to be used solely for holding the endoscopes, these first having been cleaned and disinfected. The quivers are to be cleaned daily and subsequently disinfected. Plastic quivers are not autoclavable. Clean and disinfect manually. Machine cleaning up to max. 78 C. 22
5.0 Cleaning and care 5.2 Recommended instrument disinfectants Manual disinfection of instruments Disinfectant Ingredients in 100 g Manufacturer Korsolex med AF Korsolex basic Korsolex plus Korsolex extra neodisher Septo MED neodisher Septo 3000 Sekusept PLUS Sekusept aktiv Gigasept Instru AF Gigasept FF (neu) Gigazyme N-dodecylpropane-1,3-diamine N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine surfactants, corrosion inhibitors ph-value regulators, foam inhibitors glutaral (ethylenedioxy)dimethanol surfactants, salts, corrosion inhibitors N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine didecyldimethylammonium chloride surfactants, corrosion inhibitors complexing agents, ph-inhibitors (ethylenedioxy)dimethanol glutaral benzyl-c12-18-alkyldimethyl-ammonium chlorides didecyldimethylammonium chloride surfactants, foam inhibitors, corrosion inhibitors N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine didecyldimethylammonium chloride non-ionic surfactants, perfumes glutaral (ethylenedioxy)dimethanol 15.6 g 5.1 g 15.2 g 19.7 g 9.2 g 13.0 g 15.3 g 7.5 g 1.0 g 1.0 g 9.2 g 13.0 g 15.2 g 19.7 g Bode Chemie, Hamburg Bode Chemie, Hamburg Bode Chemie, Hamburg Bode Chemie, Hamburg Dr. Weigert, Hamburg Dr. Weigert, Hamburg glucoprotamin 25 g Ecolab, Düsseldorf Soduim percarbonate, non-ionic surfactants, phosphonate Cocospropylendiaminguanidindiacetate Phenoxypropanols Benzalkonium chloride non-ionic surfactants, ph-value regulators, corrosion inhibitors succindialdehyde dimethoxytetrahydrofurane anionic and non-ionic surfactants, perfumes, methylisothiazolinone non-ionic surfactants enzymes, corrosion inhibitors 14 g 35 g 2.5 g 11.9 g 3.2 g Ecolab, Düsseldorf Schülke & Mayr, Norderstedt Schülke & Mayr, Norderstedt 5-15 g Schülke & Mayr, Norderstedt Automatic disinfection of instruments Disinfectant Ingredients in 100 g Manufacturer Dismoclean 24 Vario Dismoclean 28 alka med Dismoclean twin basic / twin zyme Dismoclean twin basic Dismoclean twin zyme surfactants, micro-encapsulated enzymes, corrosion inhibitors, complexing agents alkali dispenser, complexing agents, corrosion inhibitors, surface active materials Bode Chemie, Hamburg Bode Chemie, Hamburg Bode Chemie, Hamburg alkali dispenser, complexing agents, corrosion inhibitors surface active materials, enzymes, stabilisers, corrosion inhibitors neodisher FA Phosphates 15-30 g Dr. Weigert, Hamburg neodisher MediClean forte non-ionic and anionic surfactants < 5 g Dr. Weigert, Hamburg enzymes Thermosept alka clean forte Thermosept RKN-zym non-ionic surfactants anionic surfactants NTA (nitrilotriacetic acid) and its salts enzymes, poly carboxylates corrosion inhibitors non-ionic surfactants, enzymes, corrosion inhibitors, glycols < 5 g < 5 g < 5 g < 5 g Schülke & Mayr, Norderstedt 5-15 g Schülke & Mayr, Norderstedt When using disinfectants containing aldehyde and amine at the same object colour changes may occur. 23
5.0 Cleaning and care 5.3 Recommended surface disinfectants Coated surfaces Disinfectant Ingredients in 100 g Manufacturer Green & Clean SK Di alkyl dimethyl ammonium chloride Alkyl dimethyl ethyl benzyl ammonium chloride Alkyl dimethyl benzyl ammonium chloride < 1 g < 1 g < 1 g Metasys, Rum (Austria) Dismozon pur (Granulate) End of product 12/2014 Dismozon plus (Granulate) Kohrsolin FF magnesium monoperoxyphthalate hexahydrate 80.0 g Bode Chemie, Hamburg magnesium monoperoxyphthalate hexahydrate 95.8 g Bode Chemie, Hamburg glutaral benzyl-c12-c18-alkyldimethyl-ammonium chlorides didecyldimethylammonium chloride 5 g 3 g 3 g Bode Chemie, Hamburg Perform Pentapotassium-bis(peroxymonosulphate)-bis(sulphate) 45 g Schülke & Mayr, Norderstedt Terralin Protect benzyl-c12-16 alkyldimethyl-, chloride 2-phenoxyethanol aminoalkylglycine non-ionic surfactants, perfumes 22 g 17 g 0.9 g Schülke & Mayr, Norderstedt Other surfaces Disinfectant Ingredients in 100 g Manufacturer Dismozon pur (Granulate) End of product 12/2014 Dismozon plus (Granulate) Kohrsolin FF Bacillocid rasant End of product Mikrobac forte magnesium monoperoxyphthalate hexahydrate 80.0 g Bode Chemie, Hamburg magnesium monoperoxyphthalate hexahydrate 95.8 g Bode Chemie, Hamburg glutaral benzyl-c12-18-alkyldimethyl-ammonium chlorides didecyldimethylammonium chloride glutaral benzyl-c12-18-alkyldimethyl-ammonium chlorides didecyldimethylammonium chloride benzyl-c12-18-alkyldimethyl-ammonium chlorides N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine 5 g 3 g 3 g 10 g 6 g 6 g 19.9 g 5 g Bode Chemie, Hamburg Bode Chemie, Hamburg Bode Chemie, Hamburg Perform Pentapotassium-bis(peroxymonosulphate)-bis(sulphate) 45 g Schülke & Mayr, Norderstedt Terralin Protect Surface disinfection F 312 benzyl-c12-16 alkyldimethyl-, chloride 2-phenoxyethanol aminoalkylglycine non-ionic surfactants, perfumes alkyl-benzyl-dimethyl-ammonium chloride non-ionic surfactants, complexing agents, hexyl cinnamal, butyl phenyl proionale, linalool 22 g 17 g 0.9 g Schülke & Mayr, Norderstedt 13 g Dürr Dental, Bietigheim-Bissingen 24
5.0 Cleaning and care 5.4 Recommended endoscope disinfectants Manual disinfection of endoscopes Disinfectant Ingredients in 100 g Manufacturer Helipur H plus N glutaral 12 g, BBraun, Melsungen 2-propanol ethyl hexanol surfactants, complexing agents, corrosion inhibitors, colorants, perfumes 7.5 g 0.5 g Helix Ultra peracetic acid BBraun, Melsungen Korsolex basic neodisher MediClean forte Sekusept aktiv glutaral (ethylenedioxy)dimethanol Surfactants, corrosion inhibitors, salts, perfumes non-ionic and anionic surfactants enzymes Soduim percarbonate, non-ionic surfactants, phosphonate 15.2 g 19.7 g Bode Chemie, Hamburg < 5 g Dr. Weigert, Hamburg Ecolab, Düsseldorf Automatic disinfection of endoscopes Disinfectant Ingredients in 100 g Manufacturer Korsolex basic glutaral (ethylenedioxy)dimethanol Surfactants, corrosion inhibitors, salts, perfumes 15.2 g 19.7 g Bode Chemie, Hamburg neodisher MediClean forte Gigasept FF (neu) (Granulate) non-ionic and anionic surfactants enzymes succindialdehyde dimethoxytetrahydrofurane anionic and non-ionic surfactants, perfumes methylisothiazolinone < 5 g Dr. Weigert, Hamburg 11.9 g 3.2 g Schülke & Mayr, Norderstedt Endozime AW Plus 2-propanol Ruhof, Mineola (USA) Adaptaclean TM Potassium hydroxide, surfactants ASP, Norderstedt 25
5.0 Cleaning and care Cleaning and disinfection plan ATMOS C 11 Systema What How When Who Reusable parts C Cleaning D S Disinfection Sterilisation Recommendations After each procedure Daily Weekly Monthly Qualified and trained staff who are familiar with reprocessing. (Please fill in the responsible person -> use a water-based overhead marker) Secretion canister Hose connection (nozzle) X X 2,4,5 Manual or automatic cleaning and disinfection X Canister lid X X 2,4,5 Manual or automatic cleaning and disinfection X Canister holder X X 2,4,5 Manual or automatic cleaning and disinfection X Bacterial fi lter Daily exchange or when fi lter is blocked X Splash protection X X 2,4,5 Manual or automatic cleaning and disinfection X Secretion collection canister Disposable canister system X X 2,4,5 Empty when the canister is full X Exchange and disposal of full canister Ear irrigation / Medication nebulisation Ear irrigation bowl X X 2,4,5 Manual or automatic cleaning and disinfection X Jet connection X X 2,4,5,6 Manual or automatic cleaning and disinfection X Splash protection X X 2,4,5 Wipe cleaning and wipe disinfection X Hose tip (disposable) Exchange after each procedure X Rinsing lid with rinsing hose X X 2,4,5 Manual or automatic cleaning and disinfection X Rinsing bottle X X 2,4,5,6 cleaning in the dishwasher with the glass care Manual or automatic cleaning and disinfection; programme X Handle for compressed air X X Manual Wipe cleaning and wipe disinfection X X Cleaning after each application X Sprayer jet X 2,4,5,6 Manual or automatic cleaning and disinfection X Sprayer head X X 2,4,5 Multiple rinsing of the sprayer head with water X Hose at sprayer head X X Weekly exchange of the hose or when changing the medication Sprayer bottle X X 2,4,5,6 ly or Cleaning in a cleaning and disinfection device; week- when changing the medication X X Endoscope management Plastic quiver X X 2,4,5 Cleaning with a brush; afterwards disinfection X Metal quiver X X 2,4,5,6 Cleaning with a brush; afterwards disinfection X Protective sleeve (teflon element for metal quiver) X X 2,4,5 Manual or automatic cleaning and disinfection X 26
5.0 Cleaning and care What How When Who Reusable parts C Cleaning D S Disinfection Sterilisation Recommendations After each procedure Daily Weekly Monthly Qualified and trained staff who are familiar with reprocessing. (Please fill in the responsible person -> use a water-based overhead marker) Instrument management ENT instruments X X 2,4,5 X Immerse instruments into solution immediately after use, complete wetting is required, air must be removed from any cavities, after the contact time instruments must be rinsed with water, have to be dried and sterilised afterwards. Please also observe the ATMOS operating instructions for ENT instruments. X Instrument bowl with cover X X 4 Cleaning with a brush; afterwards disinfection (manual) X Visualisation Immediate pre-cleaning after the procedure Flexible scope X X 1,7,8 x 1 (wipe disinfection) X Immediate pre-cleaning after the procedure Rigid scope X X 1,7,8 x 1 (wipe disinfection) X Immediate pre-cleaning after the procedure Laryngoscope X X 1,7,8 x 1 (wipe disinfection) X Light conductor X X 3 Wipe cleaning and wipe disinfection X Light source X X 3 Wipe cleaning and wipe disinfection X Microscope X X 3 Wipe cleaning and wipe disinfection X Headlight X X 3 Wipe cleaning and wipe disinfection X Surfaces Housing X X 3 Wipe cleaning and wipe disinfection X Cover lid X X 3 Wipe cleaning and wipe disinfection X Drawer X X 3 Wipe cleaning and wipe disinfection X Instrument deposit X X 3 Wipe cleaning and wipe disinfection X Mirror quick heater X X 3 Wipe cleaning and wipe disinfection X Wipe cleaning and wipe disinfection, daily when replacing with new Instrument tray X X 3 X instruments Recommended disinfectants 3) Surface disinfection for coated surfaces: Green & Clean SK (ATMOS) Dismozon plus (Bode Chemie) Kohrsolin FF (Bode Chemie) Perform (Schülke & Mayr) Terralin Protect (Schülke & Mayr) Other surfaces: Dismozon plus (Bode Chemie) Kohrsolin FF (Bode Chemie) Mikrobac forte (Bode Chemie) Perform (Schülke & Mayr) Terralin Protect (Schülke & Mayr) Surface disinfection FD 312 (Dürr Dental) Important information Wipe cleaning and wipe disinfection: All surfaces have to be wiped with a clean (disposable) wipe which is damped with disinfectant solution; the entire surface has to be wiped thoroughly and may not be dried afterwards. 1) Please observe the manufacturer s operating instructions. 2) Alternative to manual cleaning und disinfection: Wash-Disinfector 78 C / 172 F 6) Material dimensionally stable at 134 C 4) Instruments - manual disinfection: Korsolex med AF (Bode Chemie) Korsolex basic (Bode Chemie) Korsolex plus (Bode Chemie) Korsolex extra (Bode Chemie) neodisher Septo MED (Dr. Weigert) neodisher Septo 3000 (Dr. Weigert) Sekusept PLUS (Ecolab) Sekusept aktiv (Ecolab) Gigasept Instru AF (Schülke & Mayr) Gigazyme (Schülke & Mayr) Gigasept FF neu (Schülke & Mayr) 5) Instruments - automatic disinfection: Dismoclean 24 Vario (Bode Chemie) Dismoclean 28 alka med (Bode Chemie) Dismoclean twin basic/twin zyme (Bode Chemie) neodisher FA (Dr. Weigert) neodisher MediClean forte (Dr. Weigert) Thermosept alka clean forte (Schülke & Mayr) Thermosept RKN-zym (Schülke & Mayr) 7) Endoscopes - manual disinfection: Helipur H plus N (BBraun) Helix Ultra (BBraun) Korsolex Basic (Bode Chemie) neodisher MediClean forte (Dr. Weigert) Sekusept aktiv (Ecolab) 8) Endoscopes - automatic disinfection: Korsolex Basic (Bode Chemie) neodisher MediClean forte (Dr. Weigert) Gigasept FF neu (Schülke & Mayr) Endozime AW Plus (Ruhof) ADAPTACLEAN (ASP) Please see the manufacturer s instructions for concentration, contact time, temperature and the compatibility of materials. Wrong concentration of disinfectants may lead to damage! The above stated hygiene requirements are based on the regulations according to the Medical Devices Act, the Medical Devices Operator Ordinance, 18 IfSG and the recommendations of the Robert Koch Institute. Defi nition of the required reprocessing steps result from the recommendations of the Robert Koch Institute: Requirements for the reprocessing of medical products. The medical products were categorised in the risk groups uncritical, semicritical and critical. The reprocessing measures mentioned in this cleaning and disinfection plan are a recommendation of ATMOS MedizinTechnik. Any additional reprocessing measures are at the operator s discretion. All the recommended disinfectants which are stated herein are listed disinfectants (VAH/RKI) and have been tested on their suitability of use on the ATMOS C 11. ATMOS MedizinTechnik cannot be hold liable for any damage caused by wrong concentration of the disinfectants or by the application of any other disinfectants. Patients with suspicion of a clinical disease or who developed a transmissible spongiform encephalopathy (CJK, vcjk, etc.) have to be treated at facilities which are able to provide for the necessary preventive measures against infection. The reprocessing of the reusable instruments and material may only be performed at facilities which have an externally certifi ed QM Management acc. to DIN EN ISO 13485. The Medical Devices Act, IfSG, the RKI directives, BGR 250 and TRBA 250 always have to be considered. ATMOS MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Str. 16 79853 Lenzkirch/Germany Phone +49 7653 689-0 Fax +49 7653 689-190 info@atmosmed.de www.atmosmed.de GA3GB.110300.0 2017-05 Index: 05 27
6.0 Maintenance and Service Maintenance, repairs and period tests may only be carried out by persons who have the appropriate technical knowledge and are familiar with the product. To carry out these measures the person must have the necessary test devices and original spare parts. 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. At least every 12 months a repeat test of the electrical safety should be performed according to IEC 62353. ATMOS recommends an inspection according to the manufacturer s specifications. In case of any malfunction please contact your ATMOS partner or our service hotline +49 7653 689 222. 6.1 Sending in the device Remove and properly dispose of consumables. Clean and disinfect the product and accessories according to the operating instructions. Place used accessories with the product. Fill in the form QD 434 Delivery complaint / return shipment and the respective decontamination certificate. )) This form is enclosed to each delivery and can be found at www.atmosmed.com. The device must be well padded and packed in suitable packaging. Place the form QD 434 Delivery complaint / return shipment and the respective decontamination certificate in an envelope. Affix the envelope to the outside of the package. Send the product to ATMOS or to your dealer. 28
7.0 Troubleshooting Description Cause Measure Electric power supply No function, main switch is active, control light does not light up Suction Weak suction rate or no suction rate at all Vacuum is available at the canister support Weak or no suction rate at all No vacuum at canister support Suction pump does not switch on or off No suction, but force pump is operating Vacuum pump does not start No voltage to power plug Cable/plug defect Suction hose is clogged Active oversuction protection Filter moistened/blocked Suction hose snapped off System leaky Hose adapter is not securely connected to the canister lid Seal of the canister lid is defective Missing lid clip Secretion penetrated the suction pump Draggled/defect light barrier in suction hose holder Positions of handles have been mixed up Handle for compressed air system and the suction hose were simultaneously removed from the support Check house fuses, possibly they burnt through Exchange cable/plug Clean suction hose Check oversuction protection, replace, if necessary Replace filter Remove breaks, pass hose a different way Check all joints, new assembly of the system Insert the hose adapter correctly Replace the seal Filter, close upper edge of the secretion canister Inform the service department Clean both light barriers openings in the suction hose holder, if necessary inform service department Insert handles in the right holder Put the compressed air handle back into the support 29
7.0 Troubleshooting Description Cause Measure Compressed air Compressed air pump does not switch on or off No compressed air, but suction pump is operating Draggled/defect light barrier in compressed air holder Positions of handles have been mixed up Clean both light barriers openings in the compressed air holder, if necessary inform service department Insert handles in the right holder No adequate pressure build-up Leaky connections Check joints, if necessary inform service department Sprayer does not work Sprayer is clogged Clean sprayer, clean ventilation borehole in sprayer head Double sprayer nozzle is falsely clipped on (see fig. in chapter 5.1.3 medication sprayer). Mirror quick heater Heater does not switch on Switch or control unit defect Inform service department to exchange the switch or control unit Insufficient or no heater power Heater coil defect, no glow Exchange heater coil Heater does not switch on Vacuum pump active Put the vacuum handle back into the support Insufficient heating performance Interruption of heating due to required vacuum If the vacuum is no longer needed, please put the handle back into the support Light sources Light does not switch on Light does not switch off Headlight Headlight does not switch on Plug is loose (see error compressed air pump does not start) Light source does not sit properly in the support Other light source disturbs the sensor on the support The headlight hook is impaired by another weight Automatic headlight hook is not free moving Insert the plug Adjust the position of the light handle Reposition secondary light source Remove the weight Restore free mobility 30
8.0 Options, accessories, and consumables Suction REF ATMOS DDS secretion canister 1.5 l 340.0050.0 ATMOS DDS secretion canister 3 l 340.0051.0 DDS bacterial filter for secretion canister, 10 pcs. 340.0054.0 Disposable suction hose, not autoclavable, 10 pcs. 006.0058.0 Receptal external canister 1 l 312.0464.0 Receptal suction bag 1 l, not autoclavable, 50 pcs. 312.0463.0 Serres external canister 1 l 312.0465.0 Serres suction bag 1 l, not autoclavable, 36 pcs. 312.0466.0 Medi-Vac external canister 1 l 312.0473.0 Medi-Vac suction bag 1 l, not autoclavable, 50 pcs. 312.0474.0 Compressed-air system REF Sprayer bottle 000.0577.0 Sprayer, straight 506.5225.0 Sprayer with rotatable nozzle (360 rotation) 506.5120.0 Sprayer for powdery medications 505.0253.0 Spare nozzle for straight sprayer 505.0280.0 Spare nozzle for sprayer with rotatable nozzle (360 rotation) 000.0219.0 Spare hose for sprayer bottle, after change of medication (pack of 10) 506.5229.0 Ear irrigation / Thermal nystagmus stimulation REF Water storage canister 250 ml 508.0451.0 Ear irrigation bowl 505.0353.0 Jet connection for water irrigation handle 80 mm 508.0427.0 Jet connection for water irrigation handle 110 mm 508.0429.0 Hose tips, 30 pcs. 502.0844.0 Splash protection to be slipped on jet connection 501.0331.0 Seal 501.0311.1 31
8.0 Options, accessories, and consumables Instrument management REF Deposit for used instruments 541.1200.0 Instrument tray, melamine, 190 x 150 mm 000.0746.0 Instrument tray, melamine, 190 x 300 mm 000.0747.0 Instrument tray, aluminium-anodized, 184 x 142 mm 508.0058.0 Instrument tray, aluminium-anodized, 284 x 184 mm 505.0516.0 Instrument tray, stainless steel, 180 x 140 mm 508.0058.2 Instrument tray, stainless steel, 280 x 180 mm 508.0058.2 Serrated instrument holder, small 508.0567.0 Serrated instrument holder, big 508.0566.0 Holder for ear speculum / Politzer olives (in small tray) 508.0545.0 Light module economy Lithium-ionic rechargeable battery for the mobile use 507.4510.0 REF 32
9.0 Technical data Voltage 100-240 V~ ± 10 %; 50/60 Hz Current consumption Max. 1.5 A (230 V~) Max. 2 A (127 V~) Power consumption Max. 270 W Fuses 2 x T 2,0 A (high cut-off current 1.500 A), 250 V Suction system Power density (free flow) Max. 34 l/min Vacuum (absolute) 100 mbar Vacuum (relative) 90 % Compressed-air system Freeflow 18 l/min Pressure Min. 220 kpa Ear irrigation Water temperature 37 C +/- 2 C LED power connections 1x 1000 ma (adjustable from 10 % - 100 %) 1x 700 ma (adjustable from 10 % - 100 %) LED cold light module Min. 80 klux (1.000 ma) ATMOS LS 21 LED 200 klux (700 ma) ATMOS HL 21 LED 100 klux (700 ma) Operating time Continuous operation Pump: max. 15 min Mirror heater: ca.15 sec. Protective earth conductor resistance Max. 0,1 Ω Earth leakage current Max. 0.5 ma Enclosure leakage current Max. 0.1 ma Patient leakage current Max. 0.1 ma Ambient conditions for transport/storage Temperature -20...+50 C Humidity without condensation 30...95 % Pressure 500...1060 hpa Ambient conditions operation Temperature +10...+35 C Humidity without condensation 30...95 % Pressure 700...1060 hpa Maximum operational altitude to 3000 m (NN) Contamination level 2 Overvoltage category II Dimensions HxWxD Sitting 840 x 960 x 535 Standing 960 x 960 x 535 Weight (complete equipment, without microscope, without accessories and 105 kg mounting parts) Period tests Repeat test of the electrical safety every 12 months. Recommended: inspection according to the manufacturer s specifications. Safety class (EN 60601-1) I 33
9.0 Technical data Degree of protection Protection category Classification according to Appendix IX EC Directive 93/42/EEC Application parts type BF IP X0 CE marking CE 0124 GMDN code UMDNS code ID No. (REF) Class lia according to regulation no. 11 37004 ENT - treatment unit 11-585 ENT treatment unit 541.0000.0 (sitting) 542.0000.0 (standing) Issue of technical data: 12.01.2018 34
10.0 Disposal The 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. Please observe national disposal regulations (e.g. waste incineration). Before disposal respectively before transport all parts, which came into contact with the patient must be thoroughly cleaned, disinfected. The device surface must be disinfected. Disposal within the EC The device described above is a high-quality medical product with a long service life. After its life cycle it must be disposed of professionally. According to the EC directives (WEEE and RoHS) the device may not be disposed of in domestic waste. Please observe existing national laws and rules for disposal of old devices in the respective country. Disposal within the Federal Republic of Germany 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 to ATMOS MedizinTechnik for disposal. 35