ATMOS S 61 Servant ENT. workstation

Transcription

1 English ATMOS S 61 Servant ENT Operating Instructions workstation ENT treatment unit 0124 GA1GB Index: 28

2 Table of contents 1.0 Introduction Notes on operating instructions Intended use ATMOS S 61 Servant ENT workstation Hygrotherm Variotherm Function Explanation of pictures and symbols For your safety For your safety Hygrotherm / Variotherm: Important advice for maintaining the hygienic status Setting up and starting up Required connections for all units of ATMOS S 61 Servant Electrical connection Water connection Waste water drain Setting up proposal Controls and options when fully equipped Rear view Assembly of secretion canister Mount secretion canister Adjustment of front feet Connections in the service compartment Hoses Operation On / off switch Suction system Control and display of the suction performance Hose rinsing system Evacuation of the reusable canister system Disposable canister system Ear irrigation module Hygrotherm Overview Switching on Activation of the Hygrotherm Perform the ear irrigation Temperature setting...18 Further information, accessories, consumables and spare parts are available from: ATMOS MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Straße Lenzkirch Germany Phone +49 (0) / Fax: / / (Service Center) atmos@atmosmed.de Thermal nystagmus stimulation, Variotherm Overview Switching on Activation of the Variotherm Perform the thermal nystagmus stimulation Time setting (1-99 sec.) Temperature setting Adjusting flow quantity Information about the service display of the ATMOS S 61 Servant up from software version V Ear irrigation bowl with separate suction channel ( ) Compressed-air system Activation Adapt / deposit sprayer Ear irrigation module compressed air (REF ) LED-Light system Instrument heating Mirror quick-heater Heating module for instrument tray Clipboard endoscopy Option LED Light Cube Option endoscope management (heated) Hook for the headlight with automatic switching Cleaning and care General information on cleaning and disinfection Cleaning the unit surface Secretion canister (without autom. secretion canister evacuation), bacterial filter and suction hose Medicament sprayers Instrument trays Endoscope quivers Ear irrigation bowl Hose tip and jet connection Recommended instrument disinfectants Recommended surface disinfectants Recommended endoscope disinfectants Hygiene plan Maintenance and Service Replacing the fuse Changing the bacterial filter Changing the hose box of the hose pump Hygrotherm / Variotherm: Decalcification Hygrotherm / Variotherm: Filter replacement Sending in the device Troubleshooting Consumables, Accessories, Spare Parts Consumables Accessories Spare parts Technical data at complete equipment Disposal Notes on EMC

3 1.0 Introduction 1.1 Notes on Operating Instructions These operating instructions contain important notes on how to operate the ATMOS S 61 Servant ENT workstation safely, correctly and effectively. Their reading helps to avoid risks, and also to reduce repair costs and down-times. This increases, amongst other things, the reliability and service-life of the 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. Reprints (also in extracts) only with permission in written form by 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 S 61 Servant ENT workstation and are therefore a must besides regular cleaning. Repair work and period tests may only be carried out 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 S 61 Servant ENT workstation will be preserved. The product ATMOS S 61 Servant ENT workstation 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 product ATMOS S 61 Servant ENT workstation 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 The quality management system applied at ATMOS has been certified according to international standards EN ISO Prior to start-up please peruse chapter 2.0 For your safety, in order to be prepared for any possible dangerous situations. 1.2 Intended use ATMOS S 61 Servant ENT workstation Name: ATMOS S 61 Servant ENT workstation Main function: ATMOS S 61 Servant ENT workstation Suction Compressed air system for medication spraying and the Politzer manoeuvre Ear irrigation Thermal nystagmus stimulation Electric power supply for LED light handles and LED headlight Power supply for optional LED cold light source Mirror quick heater Medical indications / application: Standard ENT examination and/or therapy Specification of the main function: ATMOS S 61 Servant ENT workstation Suction at 40 l/min / 760 hpa Alternatively suction at 55 l/min / 920 hpa Ear irrigation with 37 C ± 1 C, max. 500 ml/min Alternatively ear irrigation with 37 C ± 2 C with compressed air system Compressed air for medication spraying, max. 2 bar Compressed air for the Politzer manoeuvre, regulated Electric power supply for LED, 700 ma LED cold light source 210 klux ± 10 %, colour temperature K User profile: Doctors and medical assistants Patient groups: Patients of all ages with and without restrictions Application organ: Mouth to pharynx, auditory canal to the ear drum and the nasal cavities Application time: ENT unit: Short term use (up to 30 days) Suction / compressed air / ear rinsing / light source: Temporary application on the patient (less than 60 minutes) Application site: 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. Contraindications: May not be used for irrigation of the paranasal sinuses. The ear irrigation should not be applied to an infected auditory canal or a perforated eardrum. The product is: active Sterility: The ENT unit is no sterile product. Single-use product / reprocessing: 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. 3

4 1.0 Introduction Hygrotherm Variotherm Name: ATMOS Hygrotherm Name: ATMOS Variotherm Main function: Medical indications / application: Specification of the main functions: Application organ: Application time: Application site: Device for the irrigation of the auditory canal Ear irrigation, cleaning of the ear Produces a jet of water for the ear irrigation at body temperature (37 C) with a flow rate of 400 ml/ min for the removal of cerumen. Auditory canal to the drumhead For the short-term application on patients (max. 60 minutes). In clinics and practices for ENT doctors and phoniatricians. The therapy with the ATMOS stimulation and irrigation device may only be performed by medical trained staff. Main function: Medical indications / application: Specification of the main functions: Application organ: Application time: Device for rinsing the auditory canal and stimulation of the vestibular organ Stimulation of the vestibular organ Produces a jet of water for the ear irrigation at body temperature (37 C) with a flow rate of 400 ml/ min for the removal of cerumen. Stimulation of the vestibular organ with a defined flow and a fixed temperature for the functional testing. Auditory canal to the drumhead For the short-term application (max. 60 minutes) on patients. Contraindications: The product is: Do not apply to an infected resp. contaminated auditory canal or to a perforated eardrum. active Application site: In clinics and practices for ENT doctors and phoniatricians. The therapy with the ATMOS stimulation and irrigation device may only be performed by medical trained staff. Sterility: Single-use product / reprocessing: Not necessary No single use product Contraindications: The product is: Do not apply to an infected resp. contaminated auditory canal or to a perforated eardrum. active Sterility: Not necessary Single-use product / reprocessing: No single use product 1.3 Function The treatment unit ATMOS S 61 Servant ENT workstation makes modular assembly possible for the following functional modules: Suction system Compressed-air system Ear irrigation module (Hygrotherm) System for thermal nystagmus stimulation LED light source LS 21 LED LED head light HL 21 LED 4

5 1.0 Introduction 1.4 Explanation of pictures and symbols Short cuts / symbols contained in these operating instructions Follow the arrows Please press where dot indicates General information Numeration Move, plug... in this direction Turn, shift... in this direction Activate the optional foot switch Subnumeration Replace Please read, important information Check click Engage, check correct fit Icons for the ATMOS S 61 Servant ENT workstation! Warning, special diligent notice Mirror quick heater Ground wire connection Fuse according to IEC 417/5016, DIN 30600/0186 Application part type B Adjustment Compressed air Suction ~ Alternating current On (feed-in, power connection) Potential equalisation Timer (ATMOS Variotherm) Off (feed-in, power connection) Foot switch Do not lean against it! Please observe operating instructions! WARNING: The ATMOS S 61 Servant workstation may only be removed from the system frame when the microscope is in the park position. 5

6 2.0 For your safety! 2.1 For your safety The ATMOS S 61 Servant ENT workstation is produced according to IEC 601 / EN and listed in the following classes: VDE Class of protection 1 Class IIa (EEC 93/42). The device may only be connected to a properly installed grounded electrical outlet. Correct configuration in assembly of country-specific connections: green / yellow: protective conductor (PE) blue: neutral conductor (N) black or brown: phase (L) Caution! Mirror and endoscope heaters may generate temperatures above 40 C! The ATMOS S 61 Servant ENT workstation may only be used under the supervision of skilled staff who have been authorised by ATMOS and trained in its operation (IEC / EN ). The mains voltage indicated on the type plate must correspond to the values of the supply network. Make sure prior to every application of the equipment that it is technically safe and in proper condition. Damaged leads and hoses must be replaced immediately! Display instruments and valves must be checked for correct function at regular intervals! Every morning a visual inspection of the hoses, secretion canister and cables must be performed. Exchange damaged parts! 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. Maximum load for clipboard: 2 kg! Never leave the patient unattended at the treatment unit. The control panel must be clearly visible and accessible for the user. 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 the fingers or any tools should be avoided. On the one hand this may damage the lenses and on the other hand there is a risk of injury. Existing water consuming devices may only be switched on when the water supply is guaranteed! The ENT unit requires clean water (drinking-water quality) for the operation. In case the clean water cannot be provided by the water supply, a pre-filter must be installed. The relevant country specific regulations for the installation must be considered! Please note: A medical insulating transformer with earth leakage monitor or any similar safety system acc. to EN is required, if several devices are connected over one common power supply. The transformer must correspond to the power consumption of all the devices to be connected. 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! Switch off main switch after finishing work in practice and close water supply, if present. 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 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. The ATMOS S 61 Servant ENT workstation meets the immunity to interference requirements of IEC / EN Electromagnetic Compatibility Medical Electrical Devices. The ATMOS S 61 Servant ENT workstation may not be operated with devices not complying with the requirements of standard EN Medical Electrical Equipment and EN 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! Prior to starting the treatment application parts have to be checked regarding their temperature. It is not allowed to use flammable substances with the device. The system frame for 2 modules incl. microscope must be screwed into the floor. 6

7 2.0 For your safety Specific safety information ATMOS Hygrotherm and ATMOS Variotherm Metal parts could be hot! Prior to spraying, the water temperature must be checked by the user (display)! The jet connection must not get into contact with contaminated material. The jet connection may only be used when a hose tip is installed! Be careful when inserting the hose tip as it could cause damage to the eardrum. For hygienic reasons jet connections must be changed after each patient. This also prevents retrograde contamination of the warm water system. Variotherm: May only be used for ear irrigation or vestibular stimulation! After the unit is switched on the flow rate must be checked at least once a day using a volume measuring funnel. The water jet must not exceed 500 ml/min. The jet stream must be straight. Prior to use the user must check the outlet pressure it must not exceed 2.2 bar. 2.2 Hygrotherm / Variotherm: Important advice for maintaining the hygienic status For loosening cerumen in the auditory meatus and for the stimulation of the labyrinthine system, ATMOS offers the warm water units Hygrotherm plus (37 C) and Variotherm plus (20-47 C). These units heat the drinking water which comes from the household connection to the preselected temperature. The operating instructions must be followed, or the increased number of pathogens in the rinse water can affect the health of sensitive patients. Requirements for starting up The water which is provided by the household connection must at least meet the WHO guidelines or the country-specific guidelines for drinking water. Connection Prior to connecting the ATMOS unit fresh water must flow through the wall connection for a period of approx. 1 minute.* Ensure that the installation is hygienically carried out! Disinfect the threaded connections with 70 % alcohol before screwing them into place.* Wear disposable gloves when carrying out maintenance work on parts which come into contact with the water.* * This work is carried out by the ATMOS service technician. Running operation Prior to operation switch on the device, remove the irrigation handle from the support for 10 min, so that fresh water is pumped into the pipes (after long standing periods, e.g. weekend, holidays: 30 min). During this period the heating can be switched off. Contact parts e.g. hose tips, must be exchanged after each patient (prevention of retrograde contamination). Prior to each use, spray water and check the temperature. Service Ensure that the suspended particle filter is hygienically changed (see starting up) (dispose of filter and carefully clean the filter glass). Ensure there is no contact with the contaminated parts. Depending on the quality of the available drinking water, a biofilm growth cannot be excluded. We, therefore, recommend to test the drinking water quality at regular intervals (acc. to ISO 6222) at the drinking water connection on the unit and on the application part. If there is a significant rise in germs between the drinking water connection and the application part then a biofilm removing process with subsequent disinfection by the ATMOS service must be performed. 7

8 3.0 Setting up and starting up ca. 250 <150 > Connection to central gas supply up to max. 8 bar. The standard NIST connection for central vacuum and central compressed air on the rear side of the device is optional. Connecting hoses are not included in delivery. 3.1 Required connections for all units of ATMOS S 61 Servant Flexible multi-port distributors may not be used as a power supply for the ATMOS S 61 Servant workstation, ATMOS S 61 Servant vision or for an optional HF or radiofrequency surgical device. Unit / Device ATMOS S 61 Servant ENT workstation ATMOS S 61 Servant vision ATMOS S 61 Servant instruments Water separating system (WTA) Monitor Patient chair Maximum required connections 1 x earthing contact socket outlet 1 x earthing contact socket outlet (basic version) or 1 x fixed connection for the integrated camera or stroboscope LED 3 x earthing contact socket outlet 1 x earthing contact socket outlet 1 x earthing contact socket outlet 1 x earthing contact socket outlet An adequate number of socket outlets with earthing contact should be mounted for possible connection of further electrically operated units which may be installed (e.g. installation of an electrically operated ATMOS patient chair, water separating system, camera, monitor, etc.) 3.2 Connection to electrical power line Prerequisites Installation acc. to IEC : earth leakage circuit breaker (FI-circuit breaker) with rated leakage current <0.03 A Connection of the power supply cable of the ATMOS S 61 Servant Workstation to a safety socket outlet near the device, max. 3 meters, preferably left (fig.). This may only be carried out by authorized qualified personnel. The supply circuit must be separated from other devices e.g. PCs etc. If isolating transformers are used then isolation monitoring must be integrated in the isolating transformer. Maximum power consumption: ATMOS S 61 Servant Workstation: 2,300 VA ATMOS S 61 Servant Vision: 300 VA ATMOS S 61 Servant Instruments: 250 VA Flexible multi-port distributors may not be used as a power supply. 8

9 3.0 Setting up and starting up 3.3 Water connection! Requirements for water supply: Easily accessible water tap or ball valve with external thread G 3/4. The connection may be closed without any additional effort. Connection including pipe aeration is recommended. Minimum height of the water tap: 35 cm. Distance of the water tap to the ATMOS S 61 Servant Workstation: < 3 m. Required pressure in domestic water system: >2 bar, but <5 bar. The water which is provided by the household connection must at least meet the WHO guidelines and the country-specific guidelines for drinking water. Country-specific regulations for the installation must be considered when the unit is connected to the public water supply. Before connecting: Rinse water supply line in order to remove any contamination from the system. When clean water is available, connect supply hose to the water tap mentioned above. For observance of the regulations of DIN EN 1717 we recommend adding a water isolating system. There is no special calcification safety device integrated in the water system. A calcification safety device must be connected when the respective drinking water is of hardness grade 3 (14-21 dh resp mmol/l = hard water) and with hardness grade 4 (from 21 dh resp. from 3.8 mmol/l = very hard water). Please contact your local water supplier and / or plumber. The water tap must be closed at the end of operation! Water hardness Millimol per litre dh 1 (soft) Calcification protection 2 (medium) 1.3 to to 14 system is not required 3 (hard) 2.5 to to 21.3 Calcification protection 4 (very hard) > 3.8 > 21.3 system is required The use of demineralised water may affect the function of the waste water disposal! Water connection with ball valve Water connection with water tap 3/4 external thread Water connection with ball valve and particle filter Water connection with water tap 3/4 external thread and particle filter 9

10 3.0 Setting up and starting up 3.4 Waste water drain 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 adoption of the discharge hose: for HT 40; for HT 50) or Conical connection for 1/2 hose inner diameter Connection height; approx.15 cm Distance from the wall connection to the installation site: < 3 m An anti-syphon trap is integrated in the unit! Connect waste water hose with unit and the G3/4 connection fitting. Thereby fit enclosed gaskets into the screwing. 3/4 wall connection Standard HT Conical hose connection 3.5 Setting up proposal ,

11 3.0 Setting up and starting up 3.6 Controls and options when fully equipped Heating module for instrument tray Nebulization of medications (compressed air) Clipboard max. 2 kg! Mirror quick heater LED light source LED headlight Automatic suction equipment Compressed air Ear irrigation / thermal nystagmus stimulation On / Off switch 1 Hose rinsing Adjustment vacuum Display vacuum Adjustment compressed air Display compressed air The plastic adapter of the hose rinsing system ( 1 ) is a consumable (REF ), exchange weekly. It is removed by twisting it out with a slight rotation. 11

12 3.0 Setting up and starting up 3.7 Rear view Plug the power cable into the IEC power socket. Please observe the safety instructions on page 7! 3.8 Assembly of secretion canister Prior to use, check the system for leak tightness, otherwise it is possible that the vacuum cannot built up! Insert bacterial filter ( 4 ) into splash guard ( 5 ) Insert splash guard into lid Insert suction hose ( 7 ) Insert the seal ( 3 ), attach lid to canister ( 6 ) Connect hose to grommet ( 1 ) Insert grommet into lid Insert the canister horizontally into both connections Fix hose to retainer clip Mount secretion canister Hose connection (grommet) Secretion canister lid Seal Bacterial filter Suction hose (only for automatic) , 220 mm Splash guard Intake for foam prevention: The hose connection with intake ensures a smoother liquid surface. Thereby a lower foam formation and prolonged filter durability are the result. Secretion canister 6 12

13 3.0 Setting up and starting up 3.9 Adjustment of front feet Adjust the screws of the feet through the boreholes with a flat-bladed screwdriver scaled Connections in the service compartment Hoses Insert phone jack into marked jack Insert application parts into the hanging strip Insert the three-hole gasket at the inlet hose of the water connection for ear irrigation. )) A three-hole gasket must be used otherwise a malfunction of the device could be the result! Connect water hose in the service compartment Open the tap on the treatment unit. Check whether all connections are leakproof. Connect compressed-air hose in the service compartment First start-up Prior to shipment each ATMOS S 61 Servant was checked by the manufacturer for function and safety. In order to ensure the safe functioning of the device after transport and installation, the following points should be observed: The user should only operate the device when 1. a functional test was carried out on the device at the place of operation. 2. the operating instructions were read and acknowledged. After transportation/storage of the device at low temperatures and prior to first start-up it should be kept at room temperature for at least four hours. If the device is not acclimatised the formation of condensation water is possible and a malfunction might be the result. 13

14 4.0 Operation 4.1 On / off switch After switching on the mains switch, all integrated and connected devices are ready for operation. 4.2 Suction system! Do not operate the suction system without a bacterial filter. Always use the splash guard, this will prolong the service life of the bacterial filter. The guarantee will expire in the case of improper use! Change the bacterial filter regularly. See details in chapter 5.0. The hose attachment must be exchanged after each patient Control and display of the suction performance Display vacuum Adjustment vacuum Remove the handle from the support to activate the suction system. The suction system is automatically activated via the installed light barrier. Set the desired vacuum via the controller. The end of the suction hose must be closed. Only in this case can vacuum be built up Hose rinsing system at least 30 sec. After each application rinse the suction hose thoroughly. Add the suction hose (without canula) with the suction nipple to the suction attachment for the hose rinsing and soak up the rinsing fluid at least 30 sec. 14

15 4.0 Operation Refilling storage canister for hose rinsing A) Fully automatic refilling ( ) If required, the water storage canister will be automatically refilled. Attention: Make sure that the water supply system is on and the water supply secured! Do not use any foaming cleaning agents or disinfectants. B) Manual refilling ( ) Fill the canister with water and/or a non-foaming instrument disinfectant Evacuation of the reusable canister system The canister system must be cleaned and disinfected at regular intervals. See details in chapter 6.0 Hygiene plan. A) Manually Empty the secretion canister when it is approximately half-full. Remove the secretion canister horizontally from the bracket in the service compartment and remove the suction hose. B) Automatically ( ) The secretion canister is emptied automatically when the filling level is reached. Mount secretion canister Hose connection (grommet) Intake for foam prevention Secretion canister lid Seal Bacterial filter Suction hose (only for automatic) , 220mm Splash guard The hose connection with intake ensures a smoother liquid surface. Thereby a lower foam formation and prolonged filter durability are the result. Secretion canister 15

16 4.0 Operation Disposable canister system A) Receptal B) Medi-Vac 16

17 4.0 Operation 4.3 Ear irrigation module Hygrotherm Overview Front view Temperature display (double-digit, resolution 1 C), actual value indication 2 Setting mode for the temperature 3 Adjustment button up or down 2 Irrigation handle 3 1 Handle 2 Connection for double-barrelled hose 3 Three-hole gasket 8 4 Knurled screw 6 5 Release lever Valve plunger 7 Jet connection 8 Splash guard 9 Sealing cap 2 10 Double-barrelled hose Switching on Attention: Make sure the water supply is guaranteed! When the device is switched on, a segment-test is performed. For a short period of time all LEDs will be activated. Visually check the function of the LEDs during this time. Prior to the caloric measurements check the water pressure at the manometer in the service compartment! A target pressure of 2 bar - max. 2.2 bar must be available. Danger by overpressure! 17

18 4.0 Operation Activation of the Hygrotherm Remove the handle from the support. The Hygrotherm is automatically activated via the installed light barrier. The adjustment control of the Hygrotherm requires ca. 20 s, until the desired temperature is reached. Check the temperature indication! As long as the temperature of the actual value deviates from the target value, the LED button set flashes. When the target and actual value correspond, the LED lights up permanently. Now you may begin with the irrigation of the auditory canal. The last active temperature level is selected. Ear irrigation bowl Handle ear irrigation module Performing the ear irrigation! Warning: May only be used with the ear irrigation bowl. The hose attachment must be exchanged after each patient. Remove the handle hold nozzle in working position and activate trigger perform ear irrigation Temperature setting You can apply the Variotherm at temperatures from 36 C to 38 C. In order to change the set temperature the button set must remain pressed. Now the set temperature is displayed on the temperature indicator. Press the adjustment button to change 3 the set temperature from C. By releasing the button set the new set temperature is adopted and the target temperature is displayed again on the temperature indicator. 3 Heating off: Press the set button to turn the heating on and off. 18

19 4.0 Operation 4.4 Thermal nystagmus stimulation, Variotherm Overview Front view Display of stimulation time (double-digit, resolution 1s) 2 Adjustment button up or down (for temperature or seconds setting) 3 Temperature indicator (double-digit resolution 1 C), actual value indication 4 Maintenance indicator 5 Button for selecting the irrigation level (37 C) 6 Button for selecting the warm stimulation level (e.g. 44 C) 7 Button for selecting the cold stimulation level (e.g. 30 C) 8 Button for adjusting the stimulation period 9 Button to Start/Stop the stimulation (150 ml/min) Irrigation handle 3 1 Handle Connection for double-barrelled hose 3 Three-hole gasket 4 Adjusting screw 5 Release lever Valve plunger 7 Jet connection Splash guard 9 Sealing cap 2 10 Double-barrelled hose 11 Set screw Switching on Attention: Make sure the water supply is guaranteed! When the device is switched on, a segment-test is performed. For a short period of time all LEDs will be activated. Visually check the function of the LEDs during this time. Prior to the caloric measurements check the water pressure at the manometer in the service compartment! A target pressure of 2 bar - max. 2.2 bar must be available. Danger by overpressure! 19

20 4.0 Operation Activation of the Variotherm Remove the handle from the support. The Variotherm is automatically activated via the installed light barrier. The adjustment control of the Variotherm requires ca. 20 s, until the desired temperature is reached. Check the temperature indication! As long as the temperature of the actual value deviates from the target value, the LED button set flashes. When the target and actual value correspond, the LED lights up permanently. Now you may begin with the irrigation of the auditory canal. The last active temperature level is selected. Ear irrigation bowl Handle thermal nystagmus stimulation On / off switch nystagmus binoculars Connection nystagmus binoculars Performing the thermal nystagmus stimulation! Warning: May only be used with the ear irrigation bowl. The hose attachment must be exchanged after each patient. Remove the handle select temperature and adjust if necessary if required set time press (flashing approx. 10 sec.) when the Variotherm is ready for use a beep can be heard hold nozzle in working position and activate trigger perform nystagmus stimulation after the time expires a beep sounds again Time setting (1-99 sec.) Remove the handle. 8 Press and hold 2 set the desired stimulation time. When selecting the respective temperature, the setting from the previous time will be adopted automatically. Now and again check the time setting of the timer Temperature setting You can apply the Variotherm at temperatures from 20 C to 47 C. The minimum temperature is defined by the temperature of the tap water. 2 Setting at 37 C: Press 5 for the temperature. Warm stimulus (38-47 C): Remove the handle. Keep 6 pressed. Set the desired temperature with 2. 6 Release. When selecting the button 6 the previous temperature setting will be adopted automatically Cold stimulus (20-36 C): Remove the handle Keep 7 pressed. Set the desired temperature with 2. 7 Release. When selecting the button 7 the previous temperature setting will be adopted automatically. Heating off: Press the active temperature level on the button Temperature to switch the heating on and off. 20

21 4.0 Operation Adjusting the flow quantity Prior to stimulation the set screw 11 must be locked in the upwards position. 2 Adjustment possibilities: High: Flow quantity for ear irrigation Low: Flow quantity for stimulation of the vestibule Prior to the ear irrigation the set screw is screwed downwards, inserted into the handle and then locked into position by continuing to screw it downwards. For fine adjustment of the flow the set screw 4 must be screwed in or out. )) Periodically check the water flow for the stimulation of the vestibular organ and readjust, if necessary Information about the service display of the ATMOS S 61 Servant up from software version V 1.2 The ATMOS S 61 Servant workstation has a service display on the front panel. The display consists of a red and a yellow LED. red LED yellow LED After switching on the module the electronics goes through a test cycle. The following indications are possible: red LED yellow LED Beep Remarks Immediately after start-up the LED test starts. Both LEDs light up simultaneously Start-up Lights up Lights up Yes during switch on (duration: 500 ms). Subsequently a functional and aggregate test follows. For this purpose six flashing signals light up (time-ratio light up/pause, 500 ms/500 ms). Operating time pressure pump First light up No o.k. Operating time suction pump Second light up No o.k. Operating time suction pump 2 Third light up No o.k. Operating time hose pump Fourth light up No o.k. Operating time drainage pump Fifth light up No o.k. Annual maintenance Sixth light up No o.k. Battery voltage Seventh light up No o.k. Possible maintenance cases: Operating time pressure pump First light up Yes Critical operating time Operating time suction pump Second light up Yes Critical operating time Operating time suction pump 2 Third light up Yes Critical operating time Operating time hose pump Fourth light up Yes Critical operating time Operating time drainage pump Fifth light up Yes Critical operating time Annual maintenance Sixth light up Yes Annual maintenance is due Battery voltage Seventh light up Yes Low battery voltage If one of the above maintenance cases occurs, please contact your local ATMOS Service partner. 21

22 4.0 Operation 4.5 Ear irrigation bowl with separate suction channel ( )! The ear irrigation bowl with optional, separate suction channel may only be used for suction during ear irrigation or stimulation. Only the ear irrigation bowl with integrated sieve (hole diameter 1 mm at a maximum) may be used. The suction channel is not suitable for any other suction procedure in the medical field! The liquid pump is not suitable for sucking off bigger particles, for example, cerumen, etc. Therefore, suction may only be performed with a bowl and sieve. Greasy and pasty substances can be sucked off but only limited. It is recommended to clean the bowl after each suction procedure and to rinse it with water (disinfectant) in order to prevent the pump valves from jamming. When you remove the suction nozzle with the ear irrigation bowl from the suspension, the suction system starts automatically. Apply the bowl with the lateral cut-out below the ear which needs to be irrigated and start irrigation. When the suction nozzle is put back to the suspension, the suction system stops automatically. 4.6 Compressed-air system Ear irrigation module (compressed air) Nebulization of medications (compressed air) Handle conpressed air Make sure equipment and hoses are firmly connected in order to build up a sufficient pressure. If you use politzer olives, control pressure in acc. with the appliance Activation Remove the handle from the support to activate the compressed-air system. The compressed-air system is automatically activated via the installed light barrier. 22

23 4.0 Operation Adapt / deposit sprayer Adapt: Deposit: 1 Insert ( ) the handle onto the medication bottle. Engage, then lift medication bottle with the handle from the support ( ). 1 2 Insert the medication bottle top down in the support. Press activator ( ) and pull handle ( ) backwards. 2 3 By pulling the trigger, compressed-air will be applied into the sprayer ( ). Handle the sprayer carefully to avoid injuries. Before using the sprayer bottle, check the durability of the included medications. Clean all parts of the sprayer regularly! Information can be found in chapter 5.0 Cleaning and chapter 6.0 Hygiene plan! Ear irrigation module compressed air (REF ) 2 To start the ear irrigation, close the vent valve ( ) and press the adjusting lever ( ). To terminate ear irrigation, release the adjusting lever ( ) and the vent valve ( ). Ear irrigation stops immediately! 1! Prior to every use the glass bottles must be checked for intactness (cracks, chippings on the winding, etc.). Broken glass vials may not be used for ear irrigation. Adjusting lever Vent valve 4.7 LED-Light system On / off LED LED port (for light source or headlight) LED port (for light source or headlight), optional connection for nystagmus binoculars 23

24 4.0 Operation 4.8 Instrument heating Mirror quick-heater A! Press A. The mirror quick-heater heats up for 10 seconds and then switches off automatically. Risk of burns! Prior to each use on your patient check the mirror temperature (e.g. on the back of your hand). Only heat up disinfected instruments! Heating module for instrument tray When the unit is switched on, the heating system for the instrument tray will also be activated and heated to 37 C. Place the instruments to be heated on the metal tray. Trays are designed for non-sterile instruments. Clean and disinfect the storage quivers regularly! For details please observe the instructions in chapter 5.0 Cleaning and care. 24

25 4.0 Operation 4.9 Clipboard endoscopy Integration of 3-channel endoscope management for rigid and flexible endoscopes Option LED Light Cube Screwing in the adapter The LED Light Cube is automatically activated when the unit is switched on. With a simple rotary motion the adapters are screwed in up to the stop position and fixed in the Clipboard. The light conductors can be plugged into the connection. The light channel is automatically activated when the light conductor is removed from the support. Manual on and off switching of the light channels by means of the control panel is also possible Option endoscope management (heated) Endoscope heating is activated automatically when the unit is switched on. The quivers are heated to 41 C. Clipboard with connected light conductors Operating the control panel Hook for the headlight with automatic switching The headlight can be easily removed and put back during the examination. Connect the headlight to the clipboard as described in chapter Always use the right light channel. This light channel is then automatically activated when the headlight is removed from the hook. In order to guarantee error-free operation, seal the light barrier of the right light channel with the provided blind plug. Clipboard with connected headlight 25

26 5.0 Cleaning and care 5.1 General information on cleaning and disinfection Prior to cleaning Set main switch of the ATMOS S 61 Servant ENT workstation to OFF prior to cleaning and disinfection! Prior to each use: if required )) The described measures relating to cleaning and disinfection resp. sterilisation do not replace the relevant instructions which must be adhered to prior to operation! For disinfection, you may use all surface and instrument disinfectants listed in the following sub-chapter Recommended disinfectants. Please ensure that all surfaces are dry wiped. Use a disposable cloth to absorb any liquid. If any disinfectant is spilled, make sure to dry wipe the surface immediately in order to prevent the liquid from penetrating gaps and edges. )) 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 plastic material used Cleaning the unit surface The surfaces of the ATMOS S 61 Servant ENT workstation are resistant against all surface disinfectants listed in chapter Recommended disinfectants. Wipe the unit surface with a cloth moistened with a cleaning or disinfecting solution. Disinfectant sprays or disinfectant tissues may also be used for cleaning and disinfection. ª ª Please observe 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! 26

27 5.0 Cleaning and care Secretion canister (without autom. secretion canister evacuation), 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: Carefully detach all hose connections on the lid system and remove the secretion canister carefully to prevent spills and contamination of the area. Dispose of secretion properly. Grip lid system firmly, open lid of the filter housing by turning anti-clockwise and remove filter. Thoroughly rinse all parts under running water. A detergent or cleaning agent may also be used if required. Check the DDS bacterial filter / oversuction stop: The DDS bacterial filter / oversuction stop are disposable products. 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. Only use original ATMOS bacterial filters. The device may never be operated without DDS bacterial filter / oversuction stop. Suction system and hose attachment: After every use, rinse out the suction system by drawing in a small amount of rinsing fluid (e.g. special cleanser for suction systems , dosage: 10 ml to 1 l water). ª ª Keeps the suction hoses from becoming sticky or clogged. The hose attachment is only connected and it can be removed for cleaning and disinfection. )) The suction capacity is limited due to the 1.25 l secretion canister. Therefore, do not use more than 1 l rinsing liquid and subsequently empty the canister.! 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. Thoroughly rinse to eliminate all residues from these substances. )) Make sure that the air opening is not closed! Disinfect all components with the disinfectants mentioned 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 tubes are available as spare parts at ATMOS Instrument trays Before disinfection, thoroughly rinse the trays under running water. A detergent or cleaning agent (surface disinfectant) may also be used if required. Thoroughly rinse to eliminate all residues from these substances. Subsequently disinfect with one of the disinfectants mentioned in 5.3. Melamine and anodized aluminium trays cannot be sterilised Endoscope quivers The metal quivers for the endoscope holder must only be used to hold endoscopes, which in advance must be cleaned and disinfected. The quivers must be cleaned daily and subsequently disinfected. To do this, the stopper at the lower end must be removed Ear irrigation bowl The ear irrigation bowl is not autoclavable! Cleaning and disinfection (also machine cleaning) up to 93 C Hose tip and jet connection The ATMOS Hygrotherm and the ATMOS Variotherm are properly operated with hose tips (disposable). These hose tips must be disposed off after each application to the patient. When using the hose tips the jet connection must be cleaned and disinfected daily. 27

28 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 glucoprotamin Sodiumpercarbonate, non-ionic surfactants, phosphonates 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 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 25 g Ecolab, Düsseldorf 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 alkali dispenser, complexing agents, corrosion inhibitors surface active materials, enzymes, stabilisers, corrosion inhibitors Bode Chemie, Hamburg Bode Chemie, Hamburg Bode Chemie, Hamburg neodisher FA Phosphates g Dr. Weigert, Hamburg neodisher MediClean forte Thermosept alka clean forte Thermosept RKN-zym non-ionic and anionic surfactants enzymes 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 Dr. Weigert, Hamburg < 5 g < 5 g < 5 g < 5 g Schülke & Mayr, Norderstedt 5-15 g Schülke & Mayr, Norderstedt 28

29 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 magnesium monoperoxyphthalate hexahydrate glutaral benzyl-c12-c18-alkyldimethyl-ammonium chlorides didecyldimethylammonium chloride 80 g Bode Chemie, Hamburg 95.8 g Bode Chemie, Hamburg 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 magnesium monoperoxyphthalate hexahydrate 80 g Bode Chemie, Hamburg Dismozon plus (Granulate) Kohrsolin FF magnesium monoperoxyphthalate hexahydrate glutaral benzyl-c12-18-alkyldimethyl-ammonium chlorides didecyldimethylammonium chloride 95.8 g Bode Chemie, Hamburg 5 g 3 g 3 g 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 methyl proionale, linalool 22 g 17 g 0.9 g Schülke & Mayr, Norderstedt 13 g Dürr Dental, Bietigheim-Bissingen When disinfectants containing aldehyde and amine are used on the same object colour changes may occur. 29

30 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, salts, corrosion inhibitors non-ionic and anionic surfactants enzymes Sodiumpercarbonate, non-ionic surfactants, phosphonates 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 neodisher MediClean forte Gigasept FF (neu) Endozime AW Plus Adaptaclean glutaral (ethylenedioxy)dimethanol surfactants, salts, corrosion inhibitors non-ionic and anionic surfactants enzymes succindialdehyde dimethoxytetrahydrofurane anionic and non-ionic surfactants, perfumes, methylisothiazolinone 2-propanol 15.2 g 19.7 g Bode Chemie, Hamburg < 5 g Dr. Weigert, Hamburg 11.9 g 3.2 g Schülke & Mayr, Norderstedt Ruhof, Mineola (USA) TM Potassium hydroxide, surfactants ASP, Norderstedt 30

31 6.0 Hygiene Plan Cleaning and disinfection plan ATMOS S 61 Servant What How When Who Parts to be reprocessed C Cleaning D S Disinfection Sterilization Notices After each application 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 (grommet) X X 2,4,5 Cleaning and disinfection (manual or automatic) X Secretion canister lid X X 2,4,5 Cleaning and disinfection (manual or automatic) X Seal X X 2,4,5 Cleaning and disinfection (manual or automatic) X Bacterial fi lter Exchange daily or when blocked X Splash guard X X 2,4,5 Cleaning and disinfection (manual or automatic) X Float ball X X Cleaning and disinfection (manual or automatic) X Suction hose in the canister X X 2,4,5 Cleaning and disinfection (manual or automatic) X Secretion canister X X Empty when the canister is full; at least daily; Cleaning and disinfection (manual or automatic) X Disposable canister system Exchange and disposal of full canister X Hose rinsing system Suction nozzle for hose rinsing Silicone attachment piece X X 3 Wipe cleaning and disinfection X X X 2,4,5.6 Cleaning and disinfection (manual or automatic) X Exchange of the silicone attachment X X Manual cleaning after each application X Suction nipple X 2,4,5.6 Cleaning and disinfection (manual or automatic) X Rinse the secretion hose with the hose rinsing system X X Secretion suction hose after each application; X 2,4,5.6 Exchange or disinfection of the hose X Cleaning with a brush; cleaning and disinfection Storage canister hose rinsing X X 2,4,5.6 X (automatic or manual) Ear irrigation / Thermal nystagmus stimulation Ear irrigation bowl X X 2,4,5 Cleaning and disinfection (manual or automatic) X Handle X X 3 Wipe cleaning and disinfection X Jet connection X X 2,4,5.6 Cleaning and disinfection (manual or automatic) X Splash guard X X 2,4,5 Cleaning and disinfection (manual or automatic) X Hose tip (disposable) Exchange after each application X Rinsing attachment X X 2,4,5 Cleaning and disinfection (manual or automatic) X Hygiene fi lter See operating instructions for hygiene fi lter X Rinsing lid with rinsing hose X X 2,4,5 Cleaning and disinfection (manual or automatic) X Cleaning and disinfection (manual or automatic); cleaning Rinsing bottle X X 2,4,5.6 X in the dishwasher with the glass care programme Medication nebulisation / Politzer Handle compressed air X X 3 Manual cleaning and disinfection X Sprayer jet X Cleaning after each application X X 2,4,5.6 Cleaning and disinfection (manual or automatic) X Sprayer head 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 X Cleaning in a cleaning and disinfection device; weekly or Sprayer bottle X X 2,4,5.6 when changing the medication X Exchange after each application, cleaning and Politzer olive X X 2,4,5.6 disinfection X Exchange after each application, cleaning and Politzer connection X X 2,4,5.6 disinfection X Endoscope management Plastic quiver X X 2,4,5 Cleaning with a brush; disinfection X Metal quiver X X 2,4,5.6 Cleaning with a brush; disinfection (automatic or manual) X Fixation adapter for plastic quiver X X 2,4,5 Cleaning and disinfection (manual or automatic) X Protective sleeve (tefl on element for metal quiver) X X 2,4,5 Cleaning and disinfection (manual or automatic) X 31

32 6.0 Hygiene Plan What How When Who Parts to be reprocessed C Cleaning D S Disinfection Sterilization Notices After each application 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 X X 4 Cleaning and disinfection (manual) X Instrument bowl with cover X X 4 Cleaning with a brush; disinfection (manual) X Visualization ATMOS Cam 21 / 31 X X 3 Wipe cleaning and disinfection X ATMOS Strobo 21 LED X X 3 Wipe cleaning and disinfection X ATMOS LS 31 LED X X 3 Wipe cleaning and disinfection X Flexible Endoscope X X 1,7,8 X 1 Immediate pre-cleaning after application X Rigid endoscope X X 1,7,8 X 1 Immediate pre-cleaning after application X Laryngoscope X X 1,7,8 X 1 Immediate pre-cleaning after application X Light cable X X 3 Wipe cleaning and disinfection X Light grip X X 3 Wipe cleaning and disinfection X Microscope X X 3 Wipe cleaning and disinfection X Headlight X X 3 Wipe cleaning and disinfection X Radiofrequency surgery ATMOS RS 221 (surface) X X 3 Wipe cleaning and disinfection X Ergonomic handles X X 1,2,4.5 X 1 Wipe cleaning and disinfection X Bipolar tweezers X X 1,2,4.5 1 X Immediate pre-cleaning after application; X Bipolar electrode X X 1,2,4.5 X 1 Cleaning and disinfection (manual or automatic); Use of enzymatic detergents X Bipolar electrode cable X X 1,2,4.5 1 X Immediate pre-cleaning after application; X Neutral electrode X X 1,2,4.5 X 1 Cleaning and disinfection (manual or automatic); Use of enzymatic detergents X Neutral electrode cable X X 1,2,4.5 1 X Immediate pre-cleaning after application; X ENT electrodes X X 1,2,4.5 X 1 Cleaning and disinfection (manual or automatic); Use of enzymatic detergents X Surfaces Housing X X 3 Wipe cleaning and disinfection X Roller shutter X X 3 Wipe cleaning and disinfection X System frame X X 3 Wipe cleaning and disinfection X Drawers X X 3 Wipe cleaning and disinfection X Writing surface X X 3 Wipe cleaning and disinfection X Instrument deposit X X 3 Wipe cleaning and disinfection X Mirror preheater X X 3 Wipe cleaning and disinfection X Tongue patches and swab Wipe cleaning and disinfection; X X dispenser Daily or when refi lling X Wipe cleaning and disinfection; Waste disposal X X 3 Daily or when refi lling X Wipe cleaning and disinfection; Instrument tray X X 3 Daily or when refi lling X 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 disinfectant FD 312 (Dürr Dental) Important information Wipe cleaning and 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. 4) Manual disinfection of instruments: 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) Automatic disinfection of instruments: 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) 1) Please observe the manufacturer s operating instructions. 2) Preferred: machine cleaning and disinfection in the washer disinfector 6) Material dimensionally stable at 134 C 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) For concentrations, contact time, temperature, material compatibility, please see the relevant information from the manufacturer. Wrong concentration of disinfectants may lead to material 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, from Robert Koch Institute. The medical products were categorised in the risk groups uncritical, semi-critical 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 S 61 Servant. 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 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 Lenzkirch/Germany Phone Fax info@atmosmed.de GA3GB Index: 14 32

33 7.0 Maintenance and Service The ATMOS S 61 Servant ENT workstation is equipped with maintenance-free pumps for suction and compressed air. Nevertheless, to ensure correct functioning of the unit over a long period of time simple maintenance work which can either be done by the user himself, or, if desired, by service technicians, is necessary from time to time: To ensure correct functioning of the automatic irrigation and suction mechanism, switch off the ENT unit prior to changing the secretion canister! There is a service compartment (lower part of the function column) which contains the parts needed for the maintenance procedures. The possible maintenance procedures are described in the following chapters. 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 ATMOS recommends an inspection according to the manufacturer s specifications. With integrated Variotherm: Carry out an inspection according to the manufacturer s specifications every 12 months. 7.1 Replacing the fuse The fuses are located on the back of the unit. 7.2 Changing the bacterial filter To this please attend the articles 4.7 and in this operating instructions! Set the vacuum controller to "maximum" (right stop). As soon as the vacuum gauge shows a vacuum value > -0.3 bar, while the suction hose is open, the filter has to be replaced. Use only original ATMOS bacterial filters. The device may never be operated without DDS bacterial filter / oversuction stop. To ensure proper function of the automatic secretion canister evacuation system, the filling level electrodes must always be clean and free from sediments! If there is no drastic vacuum at the handle after assembly of the secretion canister, check whether the bacterial filter is in the right position. 7.3 Changing the tube box of the tube pump The tube cassette is located in the unit's pump compartment. It may only be replaced by authorized personnel! 33

34 7.0 Maintenance and Service 7.4 Hygrotherm / Variotherm: Decalcification Depending on where the unit is used if the tap water is known for mineral precipitation, preventive decalcification should be carried out: Close tap. Unscrew the filter glass. Fill glass with approx. 100 ml of decalcifier on acetic / citric, or lactic acid base (for inst. Citrosteril, by Fresenius). Screw screw-top jar again. Reopen the tap. Switch on the device. Remove the irrigation handle from the support for s and then replace it. Allow to take effect. Remove the irrigation handle from the support and rinse 2-3 times. 7.5 Hygrotherm / Variotherm: Filter replacement If the filter cartridge is contaminated or discoloured then the filter element must be replaced as follows: Close water supply tap. Briefly switch on the unit to reduce pressure in the filter housing. Switch off the unit when "F 1" appears on the display. Unscrew plexiglass canister (, fig. 7) from filter housing (, fig. 7) by turning anti-clockwise. Remove filter cartridge (, fig. 7) and replace it with a new one (Art.No ). The filter element must not come into contact with contaminated objects in order to prevent the ingress of germs into the water system Filter housing Filter cartridge Sealing Plexiglass canister 7.6 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 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. 34

35 8.0 Troubleshooting Description Cause Measure Electric power supply No function, main switch is active, control light does not light up Suction Low or no suction rate, but vacuum gauge indicates vacuum Low or no suction rate, but vacuum gauge indicates few or no vacuum Suction pump does not switch on or off No suction, but force pump is operating No voltage to power plug Cable/plug defect Suction hose is clogged Active oversuction protection Filter moistened/blocked System leaky Suction hose snapped off Vacuum controller is open Secretion penetrated the suction pump Draggled/defect light barrier in suction hose holder Positions of handles have been mixed up Check house fuse, possibly it burnt through Exchange cable/plug Clean suction hose Check oversuction protection Replace filter Check all joints, new assembly of the system Remove breaks, pass hose a different way Set regulator to higher/maximum vacuum 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 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 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 Single or all three heater coils defect, no glow Change heater coil Automatic secretion canister evacuation Canister will not be drained when Sensor does not detect filling level Clean canister thoroughly filled above the sensor limit Pump does not activate when Pump defect Inform the service department suction hose is returned Effluent pump does not activate after Pump defect Inform the service department switching off the draining pump Effluent pump does not switch off Effluent pipe blocked Remove blockage Effluent pump does not start Electrodes in the effluent canister are dragged and thereby hot-wired Device is fed with demineralised water via water connection Clean effluent canister or let electrodes be cleaned Please use drinking water 35

36 8.0 Troubleshooting Description Cause Measure Automatic filling of the hose rinsing container Container overflows Charging valve does not close Inform the service department Sensor does not detect filling level Sensor defect - inform the service department Container does not get filled Water supply is interrupted Assure water supply Safety switch in the container is not activated Place hose rinsing container correctly in the holder Clean canister thoroughly LED power supply LED light source does not light Switch to position 0 Depending on used jack, set switch in position I or II Plug/cable/LED light source defect Inform service department to exchange the defective part Nystagmus binoculars connection Nystagmus binoculars do not light Switch to position 0 Set switch to position I Plug/cable/bulb defect Inform service department to exchange the defective part Heating system No heating Temperature sensor, control or heating element defective Inform the service department Hygrotherm / Variotherm Error in temperature display E1 No water (water pressure <0.5 bar) Check, whether the water supply delivers a pressure of at least 2 bar (is the water-tap open?). Filter clogged? E2-5 V is missing (supply voltage on Inform the service staff. the control board) E3 Break of the safety NTC Inform the service staff. E4 Short-circuit of the safety NTC Inform the service staff. E5 Break of the regulating NTC Inform the service staff. E7 Temperature too high, display only in the stimulation or irrigation mode. Check, whether temperature setting is too high. If necessary adjust the set temperature to a lower value. Inform the service staff. E8 Short-circuit of the regulating NTC The temperature probe from the regulating NTC must be checked by a service technician. 36

37 9.0 Consumables, Accessories, Spare Parts 9.1 Consumables Consumables for disposable secretion management REF Receptal 1.0 l bag, not autoclavable Receptal 1.0 l external container Disposable suction hose, not autoclavable (10 pcs.) Consumables for suction equipment REF DDS bacterial filter for secretion canister (10 pcs) Special cleaner for suction systems bottles, each 500 ml 9.2 Accessories Accessories for ear irrigation / thermal nystagmus stimulation REF Ear irrigation bowl Ear irrigation bowl with separate suction channel for the independent use of the ear irrigation bowl. Clipboard (REF ) is required Jet connection for water irrigation handle 80 mm Jet connection for water irrigation handle 110 mm Hose tips, 30 pcs flexible hose tips, to be slipped on jet connection for exact guiding of the water jet Splash protection to be slipped on jet connection Accessories for nystagmus stimulation REF Connection for nystagmus binoculars Nystagmus binoculars (connection for nystagmus binoculars is required) Accessories for compressed air system REF Sprayer bottle Sprayer, straight Sprayer with rotatable nozzle (360 rotation) Sprayer for powdery medications Spare nozzle for straight sprayer Spare nozzle for sprayer with rotatable nozzle (360 rotation) Spare hose for sprayer bottle, after change of medication (pack of 10) Accessories for light module economy REF Lithium-ionic rechargeable battery for the mobile use For ATMOS LED light source respectively LED headlight with power and eco mode, charging indication and holding clip. Universal battery quick charging power pack ( V) Accessories for instrument management REF Instrument tray, melamine, 190 x 150 mm Instrument tray, aluminium-anodized, 184 x 142 mm Instrument tray, stainless steel, 180 x 140 mm

38 9.0 Consumables, Accessories, Spare Parts 9.3 Spare parts Spare parts for ear irrigation / thermal nystagmus stimulation REF Irrigation handle Rubber bush for splash guard hole-sealing device side hole-sealing handle side Double lumen hose for irrigation handle Jet connection for water irrigation handle 40 mm Hygiene filter for water rinsing

39 10.0 Technical data at complete equipment Please note the technical specifications of the single devices in the separate operating instructions! Voltage 230 V~ ± 10 %; 50/60 Hz Special voltage: 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 A (100 V~) Max A (115 V~) Max A (127 V~) Power consumption Max. 2,300 VA Fuses 2 x T 10 A / 250 V (f. 230 V~) 1 x M 15 A / 250 V (f. 100 V~, 115 V~, -127 V~) Suction system standard Power density (free flow) 40 l/min Vacuum -91 kpa (-910 mbar or 682,5 optionally infinitely variable Secretion canister DDS 1,0 l Suction system professional Power density (free flow) 55 l/min Vacuum -95 kpa (-950 mbar or 712,0 optionally infinitely variable Secretion canister DDS 1,0 l Compressed-air system Power density (free flow) 20 l/min Pressure Min. 220 kpa, infinitely variable Sprayer For liquid, oily and powdery materials Ear irrigation basic Water temperature 37.5 C +/- 2 C Ear irrigation professional (Hygrotherm) Water temperature Adjustable C +/-0.5 C Flow Max. 450 l/min (adjustable on the handle) Thermal nystagmus stimulation (Variotherm) Water temperature 3 adjustable levels from C +/-0.5 C Flow Max. 450 l/min (adjustable on the handle) Timer setting 1 99 s Interface Nystagmograph triggering Instrument heating Temperature Approx. 37 C Light module economy LED power supply 700 ma regulated LED cold light module Number of channels 2 Light intensity Min. 200 klx Colour temperature 5500 K +/- 10 % Operating time Continuous operation 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 C Humidity without condensation % Pressure hpa 39

40 10.0 Technical data at complete equipment Ambient conditions operation Temperature C Humidity without condensation % Pressure hpa Maximum operational altitude 3000 m Contamination level Class 2 Overvoltage category II Dimensions HxWxD 88.5 x 41.2 x 54.0 cm Weight kg Period tests Repeat test of the electrical safety every 12 months. Recommended: inspection according to the manufacturer s specifications. With integrated Variotherm: Inspection according to the manufacturers specifications every 12 months. Safety class (EN ) I Degree of protection Application parts type BF Type of protection IP X0 Classification according to Appendix IX EC Class II a Directive 93/42/EEC CE marking CE 0124 GMDN code UMDNS code Ident No (230 V~) (100 V~) (115 V~) (127 V~) Technical data unchanged since: Disposal The materials of the housing 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 correctly and the materials are to be separated carefully. 40