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Operating Instructions
ATMOS S 61 Servant
ENT Workstation
English
GA1GB.110101.0
2023-10 Index 30

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  • Page 1 Operating Instructions ATMOS S 61 Servant ENT Workstation English GA1GB.110101.0 2023-10 Index 30...
  • Page 2: Table Of Contents

    1.2.2 Variotherm plus front-foil module ..............9 1.2.3 Hygrotherm front-foil module ..............9 Intended use ......................10 1.3.1 ATMOS S 61 Servant ENT workstation ............. 10 1.3.2 Hygrotherm ......................11 1.3.3 Variotherm plus ....................12 Function ........................12 Scope of delivery ..................... 13 Delivery ........................
  • Page 3 4.4.5 Time setting (1 – 99 s) ..................34 4.4.6 Temperature setting ..................35 4.4.7 Setting the flow rate ..................35 4.4.8 Information on the maintenance indicator of the ATMOS S 61 Servant ENT workstation with software version V 1.2 ..........36 4.5 Ear irrigation bulb incl. own separate suction channel (REF 530.2070.0) ..37 Compressed-air module ..................37 4.6.1 Activation ......................38 4.6.2...
  • Page 4 Accessories and consumables ...............57 Consumables ......................57 Accessories ......................57 Spare parts ....................... 58 Disposal ......................59 Technical data ....................60 Notes on EMC ....................62...
  • Page 5: Introduction

    The product ATMOS S 61 Servant ENT workstation bears the CE marking CE 0124 in accordance with the EC directive of the Council concerning medical devices 93/42/EEC and meets the basic requirements of Appendix I to this directive. The ATMOS S 61 Servant ENT workstation complies with all applicable require- ments of the directive 2011/65/EU restricting the use of certain hazardous substances in electrical and electronic equipment (“RoHS”). The declarations of conformity and our general terms and conditions can be obtained on our website at www.atmosmed.
  • Page 6: Explanation Of Pictograms And Symbols

    1.2 Explanation of pictograms and symbols In the operating instructions DANGER Warning of a danger resulting directly in fatal or serious injury. O bserve 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. Observe the necessary measures. ATTENTION Notice of a danger of damage to the product or other objects.
  • Page 7 Specifi cation of the degree of protection against the ingress of solids and IP X0 moisture Type B applied part Type BF applied part No domestic waste Do not reuse On (supply, mains connection) Off (supply, mains disconnection) ATMOS LED Light Cube on/off Compressed-air system Suction system Quick mirror heater Timer (Variotherm plus) Foot switch Vacuum regulator adjustment knob Introduction...
  • Page 8 Device of protection class I Protective earth connection Fuse Alternating current This side up Fragile! Handle with care Store in a dry place Keep away from sunlight Temperature limit Humidity limitation 1060 Atmospheric pressure limitation Warning of hot surface ATMOS LED technology Introduction...
  • Page 9: System Frame Label

    1.2.1 System frame label Do not lean against it! Please observe the operating instructions! WARNING: Do not remove the ATMOS S 61 Servant workstation from the system frame until the microscope is in park position. 1.2.2 Variotherm plus front-foil module        ...
  • Page 10: Intended Use

    (1) 042503651164084 (11) 200630 (21) 1234567 1.3 Intended use 1.3.1 ATMOS S 61 Servant ENT workstation Product name: ATMOS S 61 Servant ENT workstation Main function: • Medical suction • Ear irrigation (by means of compressed air or V ariotherm plus) •...
  • Page 11: Hygrotherm

    Warnings: Refer to chapter 2.0 “Notes for your safety” in the applicable operating instructions for the product. The product is: Active Sterility / specific Not sterile microbial condition: Single-use product / Not a disposable product. It can be used several times re-sterilization: on several patients.
  • Page 12: Variotherm Plus

    The product is a diagnostic and therapeutic device for ear, nose and throat physicians. The workspace including options and accessories can be individually configured by the user according to their personal needs. The product is used in clinics or in ENT practices. The ATMOS S 61 Servant ENT workstation treatment unit enables the modular installa- tion of the following functional modules: • Suction module •...
  • Page 13: Scope Of Delivery

    1.5 Scope of delivery The ATMOS S 61 Servant ENT workstation was subjected to an extensive functional test and was carefully packed prior to dispatch. Nevertheless, please check the contents of the shipment immediately upon receipt to ensure it is complete (see delivery note). 1.6 Delivery Please pay attention to any damage to the packaging when accepting the delivery of the goods. Report any damage directly to ATMOS or your partner.
  • Page 14: Notes For Your Safety

    - Black or brown: phase (L) • Caution! Temperatures above 40 °C may prevail at quick mirror heaters! • The ATMOS S 61 Servant ENT workstation may be used only by specialists authorized by ATMOS and trained in its operation under supervision (IEC 601-1 / EN 60601-1). • The mains voltage indicated on the type plate must correspond to the values of the mains supply.
  • Page 15 In the event of a light failure, remove the endoscope from the working area! • The ATMOS S 61 Servant ENT workstation may be operated only in rooms used for medical purposes, but not in areas subject to explosion hazards and in oxygen-rich environments.
  • Page 16: Specific Safety Instructions For Hygrotherm And Variotherm Plus

    • Prior to use, the user must check the outlet pressure. It must not exceed 2.2 bar. 2.4 Hygrotherm / Variotherm plus Important instructions for maintaining the hygienic status To loosen cerumen in the ear canal and stimulate the labyrinthine system, ATMOS pro- vides the warm water units Hygrotherm plus (37 °C) and Variotherm plus (20 – 47 °C). These units heat the drinking water that comes from the household connection to the respective pre-selected temperature.
  • Page 17: Avoiding Damage To The Device

    Service ˆ Ensure that the suspended particle filter is exchanged hygienically (see start-up) (dispose of the filter and carefully clean the filter glass). Avoid contact with contami- nated parts in the process. ˆ Biofilm growth cannot be excluded, depending on the quality of the available drink- ing water. We therefore recommend examining the drinking water quality at regular intervals at the drinking water connection of the devices and at the applied part in accordance with ISO 6222. If there is a significant rise of germs between the drinking water connection and the applied part, a biofilm-removing process with subsequent disinfection can be carried out.
  • Page 18: Set-Up And Start-Up

    3.1 Connections required for all units of the ATMOS S 61 Servant Flexible multi-port distributors must not be used as mains supply for the ATMOS S 61 Servant ENT workstation, ATMOS S 61 Servant ENT vision or an optional HF or radio frequency surgical device. Unit / device...
  • Page 19: Electrical Connection

    • Flexible multi-port distributors may not be used as mains supply. • The ATMOS S 61 Servant ENT workstation ENT treatment unit has a potential equal- ization port on the rear, which can be connected to the potential equalization rail of the room if necessary.
  • Page 20: Water Connection

    Requirements for water supply: • Easy-to-access water tap or ball valve with G 3 3/4" external thread. • The port must be able to be closed without any additional effort. • A connection with pipe ventilation is recommended. • Minimum height of the water tap from the floor: 35 cm. • Distance of the water tap to the ATMOS® S 61 Servant ENT workstation: < 3 m. • Water pressure required by the domestic system: > 2 bar, but < 5 bar. • The water which is provided by the household connection must meet at least the international WHO directives and the country-specific directives for drinking water. • The country-specific connection conditions must be observed for the connection to the public water supply.
  • Page 21: Water Drainage

    Water connection with water Water connection with ball valve and tap, 3/4" external thread and particle filter particle filter 3.4 Water drainage Prerequisites: • Permanently installed connection fitting with G3/4" external thread or • Drain outlet, standard HT 40 or HT 50 (connection adapters can be ordered for the adaptation of the waste water hose: REF 510.2130.0 for HT 40; REF 510.2129.0 for HT 50) or •...
  • Page 22: Set-Up Proposal

    3.5 Set-up proposal 1730 1961 979,5 2940 22 Set-up and start-up...
  • Page 23: Controls And Options With Complete Equipment

    3.6 Controls and options with complete equipment      Max. 2 kg!      Clipboard  Medication spraying (compressed air)  Heatable instrument tray  Quick mirror heater  LED light source  LED headlamp  Automatic suction unit ...
  • Page 24: Rear View

          On/off switch  Hose rinsing fl ushing valve  Pressure adjuster  Compressed air gauge  Vacuum regulator  Vacuum gauge   The plastic adapter of the hose rinsing system ( ) is a consumable (REF 506.2228.1). Exchange it weekly. Pull it out while twisting it slightly and replace it. 3.7 Rear view Connect the mains cable to the IEC plug ...
  • Page 25: Design Of The Secretion Canister

    3.8.1 Design of the secretion canister         Hose connection (grommet) REF 340.0057.0  Suction lid REF 530.1108.0  Sealing REF 320.0013.0  Bacterial fi lter REF 340.0054.0  Splash protection REF 312.0827.0  Secretion canister ...
  • Page 26: Connections In The Service Compartment

    3.10 Connections in the service compartment 3.10.1 Hoses Connect the compressed-air handle to the  p ressure  s ystem. Insert applied parts into the hanging strip Insert the three-hole gasket at the inlet hose of the water connection for ear irrigation. & Use only “three-hole gaskets”, because otherwise a malfunction of the device could be caused! Connect the water hose in the service compartment &...
  • Page 27 Initial start-up Each ATMOS S 61 Servant ENT workstation is checked by the manufacturer for function and safety prior to shipment. To ensure the safe functioning of the device after trans- port and installation at the operating company, the following points should be observed: The operating company should only operate the device once: 1. The device has been subjected to a functional test at the place of operation.
  • Page 28: Operation

    4 Operation 4.1 On/off switch After switching on the main switch, all integrated and connected devices are ready for operation. 4.2 Suction unit • Do not operate the suction system without a bacterial fi lter! It is integrated in the lid of the secretion canister. Always use the splash protection to extend the service life of the bacterial fi lter. The guarantee will expire in the case of improper use! •...
  • Page 29 Refilling the rinsing canister for hose rinsing A) Fully automatic refilling (REF 530.1060.0) The water storage canister is automatically refilled if necessary. & Attention: Make sure the water supply system is switched on and the water supply is ensured! Do not use any foaming cleaning agents or disinfectants. B) Manual refilling (REF 530.1050.0) Fill the canister with water and/or a non-foaming instrument disinfectant. Draining the reusable canister system &...
  • Page 30: Disposable Canister System

    Design of the secretion canister Hose connection (grommet) REF 340.0057.0 Suction lid Intake for foam REF 530.1108.0 prevention Sealing REF 320.0013.0 Bacterial fi lter REF 340.0054.0 Splash protection Suction hose REF 312.0827.0 (only for automatic) REF 006.0008.0, 220 mm Secretion canister &...
  • Page 31: Hygrotherm Ear Irrigation Module

    4.3 Hygrotherm ear irrigation module 4.3.1 Overview Front view  Temperature display (double-digit, resolu- tion of 1 °C), actual value display   Adjustment mode for the temperature    Up and down adjustment buttons  Irrigation handle Handle   Connection for double-lumen hose  Three-hole gasket  Knurled screw ...
  • Page 32: Activating The Hygrotherm

    4.3.3 Activating the Hygrotherm Ear irrigation bulb • Remove the handle from the support. & The Hygrotherm is automatically activated by the installed light barrier. The adjust- ment control of the Hygrotherm takes approx. 20 s until the desired tempera- ture is reached. & Check the temperature display! • The LED of the “set” button flashes as long as the actual temperature value deviates from the target value.
  • Page 33: Thermal Nystagmus Stimulation, Variotherm Plus

    4.4 Thermal nystagmus stimulation, Variotherm plus 4.4.1 Overview Front view            Stimulation time display (double-digit, Button used to select the warm stimula- tion level (e.g. 44 °C) resolution of 1 s)   Up and down adjustment buttons Button used to select the cold stimulation level (example 30 °C) (for temperature or second settings) ...
  • Page 34: Switching On

    4.4.2 Switching on Attention: Make sure the water supply is ensured! • A segment test is performed when the device is switched on. All LEDs are activated briefl y. Visually check the function of the LEDs during this time. • Prior to the caloric measurements, check the water pressure on the vacuum gauge in the service compartment! A target pressure of 2 bar to max. 2.2 bar must be present. Danger in the event of overpressure! 4.4.3 Activating the Variotherm plus •...
  • Page 35: Temperature Setting

    4.4.6 Temperature setting You can use the Variotherm plus at tempera- tures of 20 to 47 °C. The minimum tempera-  ture is defined by the temperature of the tap water.     Setting at 37 °C:  Press for the temperature. Warm stimulus (38 – 47 °C): Remove the handle.    Press and hold . Use to set the desired temperature.
  • Page 36: Information On The Maintenance Indicator Of The Atmos S 61 Servant Ent Workstation With Software Version V 1.2

    4.4.8 Information on the maintenance indicator of the ATMOS S 61 Servant ENT workstation with software version V 1.2 The ATMOS S 61 Servant ENT workstation has a maintenance indicator on the front panel. The indicator consists of a red and a yellow LED.
  • Page 37: Ear Irrigation Bulb Incl. Own Separate Suction Channel (Ref 530.2070.0)

    4.5 Ear irrigation bulb incl. own separate suction channel (REF 530.2070.0) The ear irrigation bulb with optional, separate suction channel may be used only for suction during ear irrigation or stimulation. Only the ear irrigation bulb with integrated sieve (hole diameter ≤ 1 mm) may be used. The suction channel is not suitable for any other suction procedure in the medical fi eld! The liquid pump is not suitable for pump- ing coarse particles, such as cerumen etc, which is why suction may be performed only with the bulb and sieve.
  • Page 38: Activation

    4.6.1 Activation Remove the handle from the support to activate the compressed-air module. The com- pressed-air module is automatically activated by the installed light barrier. 4.6.2 Adapting/depositing the sprayer Adapting: 1. Put the handle onto the medication bottle (  2.
  • Page 39: Compressed-Air Ear Irrigation Module (Ref 530.2080.0)

    ATMOS LS 21 LED or ATMOS HL 21 LED. & The on/off LED switch has three settings. This switch supplies two connections below it with power. Right position - right connection, left position - left connec- tion. The ATMOS LS 21 LED or ATMOS HL 21 LED can be connected there. For ATMOS LS 21 LED or ATMOS HL 21 LED: insert the plug fi rmly. 4.9 Instrument heating 4.9.1 Quick mirror heater...
  • Page 40: Heating Module For Instrument Tray

    Integration of three-channel endoscope management for rigid and fl exible endoscopes. & There are three endoscope quivers and two light channels for endoscopes. 4.10.1 ATMOS LED Light Cube two-channel option The ATMOS LED Light Cube is also activated when the unit is switched on. The adapters are screwed in as far as they will go and fi xed in the clipboard with a simple turning movement. The fi bre optic light cables can be plugged into the connection.
  • Page 41: Atmos Led Light Cube Three-Channel Option

    4.10.2 ATMOS LED Light Cube three-channel option The ATMOS Light Cube combines three high-performance cold light sources for medical application. In combination with a fi bre optic light cable and instruments connected to it, the light source enables the illumination of the viewing area for diagnostic purposes.
  • Page 42: Sterilization

    5.1.1 Cleaning the device surface • The surfaces of the ATMOS S 61 Servant ENT workstation are resistant against all surface disinfectants listed in the chapter “Recommended disinfectants”. • Wipe the unit surface with a cloth moistened with a cleaning or disinfecting solution.
  • Page 43: Secretion Canister, Bacterial Filter And Suction Hose

    - Thoroughly rinse the sprayer to eliminate any residues of these substances. & The air opening must be unobstructed! & Disinfect all components with the disinfectants specifi ed in 5.2. & When placing the twin tube nozzle again, make sure the mark (0, X or milling area) on the nozzle shows upwards! & Sprayer nozzles are available as spare parts at ATMOS. Sterilization...
  • Page 44: Instrument Trays

    5.1.5 Instrument trays Before disinfection, thoroughly rinse the trays under running water. A detergent or cleaning agent (surface disinfectant) may also be used. - Thoroughly rinse the sprayer to eliminate any residues of these substances. - Then use one of the disinfectants specified in chapter “5.3 Recommended surface disinfectants” on page 46. Melamine and anodized aluminium trays cannot be sterilized. 5.1.6 Endoscope quiver The endoscope quivers for the endoscope holder are used only to store endoscopes previously cleaned and disinfected.
  • Page 45 neodisher® Septo 3000 Glutaral 15.2 g Dr. Weigert, Hamburg (application concentrate) (Ethylenedioxy) dimethanol 19.7 g Sekusept® PLUS Glucoprotamin 25 g Ecolab, Düsseldorf (application concentrate) Sekusept® aktiv Sodium percarbonate, non-ionic surfactants, Ecolab, phosphonate Düsseldorf (application concentrate) Gigasept® Instru AF Cocospropylendiaminguanidindiacetate 14 g Schülke &...
  • Page 46: Recommended Surface Disinfectants

    5.3 Recommended surface disinfectants CORIAN® Disinfectant Ingredients in 100 g Manu- facturer Terralin Protect Benzyl-C12-16 alkyldimethyl-chloride 22 g Schülke & Mayr, ® Norderstedt (application concentrate) 2-phenoxyethanol 17 g Aminoalkylglycine 0.9 g Non-ionic surfactants, perfumes Other suitable active ingredients: • Ortho-phthalaldehyde • Glutaraldehyde • Glutaraldehyde and phenol •...
  • Page 47: Recommended Disinfectants For Endoscopes

    Other surfaces Disinfectant Ingredients in 100 g Manu- facturer Dismozon Magnesium monoperoxyphthalate hexahydrate 80.0 g Bode Chemie, ® Hamburg (granulate) End­of­product­12/2014 Dismozon plus Magnesium monoperoxyphthalate hexahydrate 95.8 g Bode Chemie, ® Hamburg (granulate) Kohrsolin Glutaral Bode Chemie, ® Hamburg (application concentrate) Benzyl-C12-18-alkyldimethyl-ammonium chlorides Didecyldimethylammonium chloride Perform...
  • Page 48 Automatic disinfection of endoscopes Disinfectant Ingredients in 100 g Manu- facturer Korsolex basic Glutaral 15.2 g Bode Chemie, ® Hamburg (Ethylenedioxy) dimethanol 19.7 g Surfactants, corrosion inhibitors, salts, perfumes neodisher® MediClean forte Non-ionic and anionic surfactants < 5 g Dr. Weigert, Hamburg (application concentrate) Enzymes Gigasept...
  • Page 49: Hygiene Plan

    6 Hygiene plan Cleaning and Disinfection Plan ATMOS S 61 Servant What When Qualifi ed and trained staff who are famil- Notes iar with sterilization procedures (please fi ll in the responsible Parts to be sterilized Cleaning Disinfection Sterilization person with a wa-...
  • Page 50 The steps specifi ed in this hy- • neodisher Septo MED (Dr. Weigert)  Sekusept aktiv (Ecolab) ® ® giene plan are a recommendation of ATMOS MedizinTechnik. Any additional • Perform (Schülke & Mayr) ® • neodisher Septo 3000 (Dr. Weigert) ®...
  • Page 51: Maintenance And Service

    7 Maintenance and service The ATMOS S 61 Servant ENT workstation is equipped with maintenance-free units for suction and compressed air. Nevertheless, simple maintenance work, which can either be done by the user themself or, if desired, by service technicians, is necessary from time to time to ensure trouble-free functioning of the device over a long period of time: •...
  • Page 52: Exchanging The Hose Box Of The Hose Pump

    7.3 Exchanging the hose box of the hose pump The hose box can be found in the unit’s pump compartment. It may be replaced only by authorized personnel during maintenance! 7.4 Hygrotherm / Variotherm plus: Decalcifi cation Preventive decalcifi cation should be carried out if the tap water is known for mineral precipitation, depending on where the device is used: 1. Close the water tap. 2.
  • Page 53 & This form is enclosed with the product and can be found at www.atmosmed.com. • The device must be well padded and packed in suitable packaging. • Place the QD 434 form “Delivery Complaint / Return Shipment” and the correspond- ing decontamination certificate in an envelope. • Affix the envelope to the outside of the package. • Send the product to ATMOS or your dealer. Maintenance and service...
  • Page 54: Troubleshooting

    8 Troubleshooting Description Cause Measure Electrical power supply No function, main switch No voltage at power plug Check the house fuses. actuated, control light not They may have blown lit up Cable/plug defective Replace the cable/plug Suction Low or no suction capacity, Suction hose is clogged Clean the suction hose but vacuum gauge indi- Oversuction protection...
  • Page 55 Automatic secretion canister evacuation The canister is not drained Sensor does not detect Clean the canister when filled above the filling level thoroughly sensor point The pump does not start Pump defective Inform the service up when the suction hose department is re-attached Waste water pump does Pump defective Inform the service not start up after switching...
  • Page 56 Hygrotherm / Variotherm plus Error on temperature display “E1” No water (water pressure • Check, whether the < 0.5 bar) water supply delivers a pressure of at least 2 bar (water tap open?). • Filter clogged? “E2” -5 V missing (supply voltage Inform the service on the controller board) technician. “E3” Safety NTC breakage Inform the service technician.
  • Page 57: Accessories And Consumables

    508.0429.0 Nozzle for irrigation handle, 110 mm Hose tips 502.0844.0 Splash protection to be slipped on nozzle 501.0331.0 506.5228.0 Spare hose for sprayer bottle (1 x) Diagnostic Cube support arm (ATMOS S 61 Servant) 512.1300.0 534.3020.0 ATMOS S 61 ENT professional monitor arm Deposit board (glass) 534.3050.0 534.3060.0 Deposit board (metal) Deposit board (glass), high 534.3055.0 534.3065.0 Deposit board (metal), high Diagnostic Cube deposit board 534.3035.0 Board adapter 534.3090.0...
  • Page 58: Spare Parts

    9.3 Spare parts Spare parts for ear irrigation / thermal nystagmus stimulation REF 530.1190.0 Irrigation handle Rubber bush for splash protection 501.0331.1 Three-hole sealing on device side 501.0320.0 530.1186.0 Three-hole-sealing on handle side Double-lumen hose for irrigation handle 530.1181.0 502.0984.0 Nozzle for irrigation handle, 40 mm Hygiene filter for water rinsing 000.0918.0...
  • Page 59: Disposal

    • The housing materials can be recycled completely. • The ATMOS S 61 Servant ENT workstation does not contain any hazardous goods. • The component parts of the ATMOS S 61 Servant ENT workstation must be disposed of properly and the materials separated carefully.
  • Page 60: Technical Data

    11 Technical data When fully equipped Voltage 230 V~ ± 10 %; 50/60 Hz Special voltages: 100 V~ ± 10 %; 50/60 Hz 115 V~ ± 10 %; 50/60 Hz 127 V~ ± 10 %; 50/60 Hz Current consumption Max. 8.5 A (230 V~) Max. 19.0 A (100 V~) Max. 16.5 A (115 V~) Max. 15.0 A (127 V~) Power consumption Max. 2300 VA Fuses 2 x T10 A / 250 V (f. 230 V~) 1 x M 15 A / 250 V (f. 100 V~, 115 V~, 127 V~) Standard suction unit High vacuum / high flow rate Suction capacity (free flow) 40 l/min Vacuum -91 kPa (-910 mbar or 682.5 mmHg) @NN, infinitely variable Suction hose 8.0 mm • Inner diameter 1.6 m •...
  • Page 61 Instrument heating Temperature Approx. 37 °C Economy light module 700 mA (regulated) LED power supply LED cold light module Number of channels Light intensity Min. 200 klx Colour temperature 5500 K ± 10% Operating mode Continuous operation Protective earth conductor resistance Max. 0.1 Ω Earth leakage current Max. 5 mA Housing leakage current Max. 0.1 mA Patient leakage current Max. 0.1 mA...
  • Page 62: Notes On Emc

    Within the vicinity of HF surgical devices and in settings outside of an HF-shielded room of a magnetic resonance imaging system. The customer or user of the ATMOS S 61 Servant ENT workstation must ensure that the device is used in a prescribed environment.
  • Page 63 13 Notes Notes...
  • Page 64 ATMOS MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Str. 16 79853 Lenzkirch / Germany Phone: +49 7653 689-0 info@atmosmed.com www.atmosmed.com...

This manual is also suitable for:

530.0000.0530.0001.0530.0002.0530.0003.0

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